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cobas e 411 analyzer

Operators Manual
Software Version 01-01
cobas e 411 analyzer

Revision history

Manual Version Template Version Revision date Changes


1.0 3.0

Order numbers Language Order number


English 0490 5148 018
French 0490 5148 080
German 0490 5148 001
Italian 0490 5148 050
Portuguese 0490 5148 046
Spanish 0490 5148 036

Edition notice cobas e 411 analyzer Operators Manual


This manual is for users of the cobas e 411 analyzer.
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves
the right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void. For warranty conditions, refer to the analyzer purchase
agreement. Contact your local Roche Diagnostics representative for further
information.
Software updates are done by Roche Diagnostics representatives.

Intended use This operators manual is intended to be used as an instructional aid in the
performance of tasks related to the operation and general maintenance of the
instrument. The manual contains detailed descriptions of instrument features and
general operational concepts, specifications, theory of operation, function and use of
controls, operating techniques, emergency procedures, product labeling and
maintenance procedures.

Copyrights 2001-2006, Roche Diagnostics GmbH. All rights reserved.

Trademarks COBAS, COBAS C, COBAS E, ELECSYS, and LIFE NEEDS ANSWERS are
trademarks of Roche.
All other trademarks are the property of their respective owners.

Instrument Approvals The cobas e 411 analyzer meets the requirements of Directive 98/79/EC of the
European Parliament and the Council of the European Union (EU) on in vitro
diagnostic medical devices. Furthermore, the cobas e 411 analyzer is manufactured
and tested according to International Standard IEC 61010-1, 2nd edition, Safety
requirements for electrical equipment for measurement, control and laboratory use,
Part 1: General requirements. This International Standard is equivalent to the
national standards Underwriters Laboratories (UL) 61010-1 2nd edition for the USA,
and CAN/CSA C22.2 No. 61010-1:2004 for Canada. Compliance is demonstrated by
the following marks:

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Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the USA.
C US

Notice to the purchaser The purchase of this product allows the purchaser to use it solely for detection by ECL
Technology for human in vitro diagnostic uses. No general patent or other license of
any kind other than this specific right of use from purchase is granted hereby. This
product may not be used by purchaser to conduct life science research or
development, patient self-testing, drug discovery or development or in any veterinary,
food, water or environmental testing or use.
US Pat. 5,147,806; US Pat. 5,779,976; US Pat. 6,325,973; US Pat. 5,466,416; US Pat.
5,624,637; US Pat. 5,720,922; US Pat. 5,061,445; US Pat. 5,068,088; US Pat. 5,247,243;
US Pat. 5,296,191, and corresponding patents in other countries.

Contact addresses

Manufacturer Hitachi High-Technologies Corporation


24-14. Nishi-shimbashi. 1-chome. Minato-ku
Tokyo. 105-8717 JAPAN

Authorized Representative Roche Diagnostics GmbH


EC REP Sandhofer Strasse 116
D-68305 Mannheim
Germany

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Table of contents

Revision history 2 7 Special operation: How to


Contact addresses 3 Overview B-93
Table of contents 5 How to apply barcode labels to tubes and vials B-94
Preface 7 How to upload results manually B-96
Where to find information 7 How to select two or more samples in Data Review
Online Help system 8 B-98
Customer information 9 How to archive sample data B-99
Conventions used in this manual 9 How to rerun a sample B-100
How to reset the system B-101
How to delete a single open request B-103
System description Part A How to assign calibrator and control positions B-104
How to install and define Roche controls B-106
1 Safety information How to install and define non-Roche controls B-107
Safety classifications A-5 How to edit control values B-109
Safety precautions A-5 How to request standby bottle QC B-110
System safety labels A-18 How to cancel a print job B-111
How to print a daily Alarm Trace report B-112
2 System overview How to print a System Communication Trace report
Overview of the cobas e 411 analyzer A-27 B-113
System components A-30 How to change documentation settings B-114
Analyzer unit A-30 How to program calculated tests B-115
Control unit A-34 How to change test settings B-116
Power components A-34 How to change calibration settings B-118
System specifications A-37 How to change the sample disk mode B-119

3 Control unit
Components A-55
Maintenance Part C
Software basics A-60
8 Maintenance
4 Analyzer components Overview C-5
Overview of the analyzer components A-71 Maintenance schedule C-8
Sample/reagent area components A-72 Maintenance log C-9
Consumables area components A-89 Daily maintenance C-12
Measuring area components A-97 Weekly maintenance C-15
Every two weeks maintenance C-19
Every two months maintenance C-24
Operation Part B As needed maintenance C-30

5 Overview
Operation Guide B-5
Troubleshooting Part D
Disk and rack systems B-5
Software keyboard B-5 9 Troubleshooting
Introduction D-5
6 Daily operation Alarms D-5
Overview B-11 Problem categories D-5
Pre-start inspection B-12 Contacting Technical Support D-8
Pre-routine operation B-18 Basic troubleshooting flow chart D-10
Routine operation B-31 Immunoassay troubleshooting D-11
Results B-81 Instrument troubleshooting D-14
Post-operation data management B-87 Chemistry troubleshooting D-24
Daily maintenance B-87
Switch off the analyzer B-88

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10 Data alarms
Introduction D-33
List of data alarms D-34
Data alarms D-36
Data problems without an alarm D-48
Instrument problems without an alarm D-49

Appendix Part E

11 Appendix

Glossary Part F

Glossary F-3

Index Part G

Index G-3

Notes Part H

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Preface

The Roche Diagnostics cobas e 411 analyzer is a fully automated, random-access,


software controlled system for immunoassay analysis. It is available as both a disk
system and a rack system. The differences between the two configurations are detailed
throughout this operator's manual.
The cobas e 411 analyzer was designed for both quantitative and qualitative in vitro
determinations using a wide variety of tests. Both disk and rack systems have a
throughput of approximately 85 tests per hour.
The cobas e 411 analyzer can be placed on a bench top, so saving space in the
laboratory environment. Handling of the system is easy; potential for manual errors is
reduced to a minimum. All assay reagent, calibrator, and control information is
automatically entered into the software through the use of barcodes.
The system consists of the analyzer, which performs all functions required for fully
automated sample and assay processing, and a control unit, which controls the
analyzer through the user software. This entirely automated process begins with the
recording of patient samplesprovided that they are in barcode labeled tubesup to
the electrochemiluminescence detection and results transmission.
Data transmission to and from the analyzer, results evaluation, documentation, and
quality control are performed automatically by the software. Also, the software is
responsible for the management of data between a connected Pre-Analytic Systems
Manager (PSM)(1) and the cobas e 411 analyzer. Several cobas analyzers can be
centrally controlled when integrated with the PSM.
This manual has detailed descriptions of cobas e 411 analyzer features and general
operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling, and maintenance procedures.

Keep this manual in a safe place to ensure that it is not damaged and remains available for use.

Where to find information

The information you need to operate the cobas e 411 analyzer is supplied in several
printed or online publications.

Operators Manual The Operators Manual contains information about safety, hardware, and operating
the system, as well as maintenance and troubleshooting. A table of contents at the
beginning of the book and each chapter, and an index at the end of this book help you
to find information quickly.

Online Help The online Help contains a detailed description of the software of the cobas e 411
analyzer. In addition to the software description, the whole Operators Manual is
included in the online Help. This makes it possible to retrieve information from both
online Help and Operators Manual using the search functions available for
electronically stored documents.

(1) Not available in the United States of America.

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Short Guide Also available with this manual is the Short Guide. This small document is designed
to complement your Operators Manual. The Short Guide tells you exactly what is
necessary to operate the analyzer, without the level of detail found in the Operators
Manual.

COBI-CD The COBI-CD (Compendium of Background Information) provides you with


background information about the technologies, test principles, their theory, and the
calibration methods used by the cobas e 411 analyzer. The information can be read
and printed using Adobe Acrobat Reader.
You cannot use the COBI-CD on the cobas e 411 system because the COBI-CD
requires Adobe Acrobat Reader to be viewed correctly. Adobe Acrobat Reader is not
installed on the control unit and such third-party software must not be installed.

For essential safety information, see Third-party software on page A-17.

Online Help system

The cobas e 411 analyzer provides online documentation in the form of context-
sensitive Help. Context-sensitive means that wherever you are located in the
software, choosing the Help feature displays Help text or a screen picture relating to
that area of the software. The online Help offers a quick and convenient way to find
information, such as explanations of screens and windows and how to perform
particular processes.

a To display the online Help


1 You can display Help from any screen. However, if you wish to see Help
information about a particular screen, display that screen on the monitor first.
2 Choose the ? button at the bottom left of the screen.
The Help window opens, usually displaying information concerning the current
software screen or window.
3 If the Help information displayed initially does not answer your questions, use the
contents, index, or search tab to locate more appropriate information.

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Customer information

Customer training Contact your local Roche service representative for any questions or information
regarding cobas e 411 analyzer system training and training material.

Contact customer service Contact your local Roche service representative for further information regarding the
cobas e 411 analyzer system service agreement.

Ordering information Replacement parts, consumable materials, reagents, calibrators, and controls should
be ordered from Roche Diagnostics. When ordering, please use the Roche Diagnostics
catalog number and reference name for each item. Contact your local Roche service
representative for the detailed ordering list.

Conventions used in this manual

Visual cues help you to locate and interpret information in this manual. This section
explains formatting conventions used in this manual.

Symbols The following symbols are used:

Symbol Used for


a Procedural step
o List item
e Cross-reference
h Call up of screen
Note

Caution

Warning

Laser radiation / optical safety

Biohazard

Disk system-specific

Rack system-specific

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Abbreviations The following abbreviations are used:

Abbreviation Definition
A
ANSI American National Standards Institute
C
CBT Computer Based Training
CCITT Comit consultatif international tlphonique et tlgraphique
(Consultative Committee on International Telegraph and Telephone)
CE Conformit Europenne
CLAS 2 Clinical Laboratory Automation System 2
CLIA Clinical Laboratory Improvement Amendments
COBI-CD Compendium of Background Information
CSA Canadian Standards Association
D
dBA decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
DIL diluent
E
EC European Community
ECL electrochemiluminescence
EMC electromagnetic compatibility
EN european standard
F
FIFO first in first out
H
HCFA Health Care Financing Administration
I
IEC International Electrical Commission
IVD in vitro diagnostic directive
K
KVA kilovolt-Ampere. Unit for expressing the power rating of AC
electrical machinery.
L
LDL lower detection limit see analytical sensitivity
LIS laboratory information system
LLD liquid level detection
M
MSDS material safety data sheet
N
NCCLS National Committee for Clinical Laboratory Standards
P
PC/CC ProCell/CleanCell
Q
QC quality control

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Abbreviation Definition
S
SD standard deviation
S/R sample/reagent
SVGA Super Video Graphics Adapter
T
TPA tripropylamine
U
UL Underwriters Laboratories Inc.
V
VDE Verband Deutscher Elektrotechniker (association of German
electrical engineers)

Use of example screens This manual includes examples of screens from the cobas e 411 analyzer software.
The equivalent screens might be different on your analyzer because the appearance of
a screen depends on the specific configuration of an instrument and on the access
level of the person operating it.

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System description A

1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3


2 System overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25
3 Control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-53
4 Analyzer components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-69
cobas e 411 analyzer 1 Safety information
Table of contents

Safety information

Before operating the cobas e 411 analyzer, it is essential that you read and understand
the warnings, cautions, and safety requirements contained in this manual.
The following safety precautions and instructions are intended for operators and also
for anyone responsible for the management of the analyzer.

In this chapter Chapter 1


Safety classifications ........................................................................................................ 5
Safety precautions ........................................................................................................... 5
Warnings .................................................................................................................... 5
Biohazards ................................................................................................................ 11
Cautions ................................................................................................................... 12
System safety labels ....................................................................................................... 18
Analyzer unit ........................................................................................................... 18
Positions of safety labels on the analyzer unit (disk system) ........................... 19
Positions of safety labels on the analyzer unit (rack system) .......................... 20
Positions of safety labels on the solid waste tray and Clean-Liner ................. 21
Power supply ............................................................................................................ 22
Circuit breaker ................................................................................................... 22
Rack sampler circuit breaker ............................................................................. 23
Electromagnetic compatibility (EMC) .................................................................. 23
Peripheral device connections ................................................................................ 23

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Safety classifications

Safety classifications

This section explains how precautionary information is formatted in the manual.


e Throughout this manual, safety icons are used to draw your attention to certain
information. You should familiarize yourself with the following symbols, stickers,
and icons: See System safety labels on page A-18.

Warning
Indicates a possibly hazardous situation which, if not avoided, may result in death or serious injury.

Caution
Indicates a possibly hazardous situation which, if not avoided, may result in slight or minor
injuries, or damage to equipment.

Biohazard
Indicates a possibly hazardous situation which, if not avoided, may result in infection.

Laser radiation/optical safety


Indicates a possibly hazardous situation which, if not avoided, may result in harm to your eyesight.

Safety precautions

Pay particular attention to each of the following safety precautions. If these safety
precautions are ignored, you may suffer serious or fatal injury.

Warnings

Air bubbles or films in system reagents


Perform a reagent prime after replacing the ProCell and CleanCell bottles back on the analyzer to
ensure that there are no air bubbles or films in the fluid system.

Application
This instrument is designed for clinical immunological test analysis using water-soluble samples
and reagents. Other analyses may not be applicable to this instrument. For clinical tests, the
instrument should be used under the management of a doctor or clinical inspector.

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Safety precautions

Avoid use of bleach


Do not use bleach, SysClean, or alkaline disinfectant (pH > 9.5) to clean the liquid waste container.
If such solutions are mixed with the contents of the liquid waste container, this could cause
potentially harmful fumes.

Bent or damaged microbead mixer paddle


Do not bend the microbead mixer during cleaning. If the microbead mixer is damaged it will have
to be replaced, as incorrect mixing may cause incorrect results.

Changing the Clean-Liner


o The system must be in Standby or switched off before continuing with this operation.
o Do not touch the System Reset or Reagent Scan buttons, or switch on the analyzer, while
changing the Clean-Liner.

Circuit breakers and fuses


If any of the instrument circuit breakers trip or fuses blow, contact your Roche service representative
before you try to operate the system again.

Contact with sample/reagent probe


Do not touch the sample/reagent probe until the analyzer enters S.Stop status as damage to the
probe may result.
Take care not to damage the lower end of the sample/reagent probe during cleaning.

Contact with solutions


Avoid direct contact with reagents and cleaning solutions. Follow the package insert information for
Roche Diagnostics reagents and cleaning solutions. Direct contact with these solutions may result in
irritation or injury to the skin.

Correct use
Always follow the instructions in the Operators Manual, as failure to do so may result in a risk to
your safety. Ensure that the Operators Manual is easily accessible at all times.

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Safety precautions

Damage to the measuring cell unit


Do not open the detection unit cover or service cover while the main circuit breaker is On.
Otherwise, damage to the photomultiplier may result.

Disconnecting the power supply


To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off)
position and the power cord must be removed. Rack systems are provided with more than one
power supply cord. All power supply cords must be removed to disconnect the equipment from the
mains power supply.

Disposal of ProCell
Do not dispose of undiluted ProCell together with any strong alkaline solution, for example
CleanCell.

Electrical safety precautions


Do not attempt to gain access to parts of the instrument marked with this label. Do not open the
back cover or attempt to work in any electronic compartment. As with any electronic equipment,
electric shock can occur. Installation, service, and repair must only be performed by authorized and
qualified personnel.
Do not open the cover of the photomultiplier tubes high voltage supply circuit board with the power
switch or circuit breaker turned On. Touching the board may cause death or severe injury.

Environmental conditions
This analyzer is approved for indoor use only. Refer to the system specifications in the System
overview chapter for details of the safe environmental operating conditions.

Flammables
Keep flammables away from the instrument when conducting maintenance or checks using alcohol.
When using isopropyl alcohol or ethanol on or around the instrument, use no more than 20 mL at a
time. Isopropyl alcohol and ethanol (70%) are flammable substances, and there is a danger of fire,
explosion, or burns.

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Safety precautions

Handling of cleaning solutions (detergents)


Always wear protective (chemical-resistant) gloves and safety glasses when handling cleaning
solutions. Roche Diagnostics cleaning solutions have corrosive properties. The handling of cleaning
solutions with bare hands may result in injury to your skin, and failure to wear suitable eye
protection may result in injury to your eyes.

Handling of reagents
o Avoid direct contact with reagents. Direct contact may result in irritation or injury to the skin.
o Refer to the labels on the reagent boxes for specific handling instructions.
o Avoid direct contact with CleanCell. Direct contact may result in irritation or injury to the
skin. Refer to the Clean Cell box label for specific handling instructions.
o Do not use reagents that are expired. Otherwise, inaccurate data may be obtained.
o Do not store reagents at a temperature of less than 2C as the microbeads should not be frozen.
o Before loading reagents on the analyzer, ensure that they contain no bubbles, foam, or films as
these may cause pipetting volume shortage and deterioration in measurement accuracy.

Importance of maintenance
Provide the system with proper maintenance and care to ensure consistent and accurate
functioning. Modifying or omitting the maintenance procedures may result in the loss of
performance or reliability of the system, which are the responsibility of the operator.

Impurities in samples
Ensure that samples contain no insoluble impurities when loading on the instrument. Insoluble
impurities such as fibrin, dust, or air bubbles in samples may cause pipetting volume shortage and
deterioration in measurement accuracy.

Installation, removal from use, transportation, and disposal of the analyzer


Only trained Roche Support personnel, or similarly qualified personnel supervised by authorized
service agents of Roche Diagnostics, are qualified to install, transport, and dispose of a cobas e 411
analyzer.
The customer is responsible for providing the necessary facilities. See the system specifications for
details of the necessary facilities with suitable environmental conditions.

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Safety precautions

Instrument covers
o Close the top cover before starting operation. Take care not to pinch your fingers or hand.
o Keep all covers closed and in place while the instrument is operating.
o When you close the rack sample cover, take care not to pinch your fingers or hand.
o Follow the procedures in the Operators Manual when opening the top cover for maintenance
and checks.

Instrument problems without alarms


Certain instrument problems may arise that the system does not monitor. If this is the case, no
alarm is issued to alert the operator. Erroneous control measurements provide an important
indicator of analyzer problems even when no alarms are issued. Such problems may include worn
parts, air leaks in the syringe system, or reagent contamination. When you encounter these types of
problems, you must decide whether to continue to process samples or to terminate the operation,
depending on the possibility of causing damage to the system or reporting erroneous test results.

Manual assignment of sample containers


It is sometimes necessary to manually assign a vial or other sample or calibrator container to a rack
or a specific sample disk position, for example, due to an unreadable barcode.
o Ensure that the position is not already assigned before manually assigning a position.
o Do not manually assign calibrator vials with barcodes to racks or sample disks.
Refer to the Operators Manual or online Help for more details on making manual assignments.

Moving parts
Do not touch moving parts when the instrument is operating, and do not wear loose garments or
jewelry that could catch in moving mechanisms. Otherwise, you may be injured or infected, or the
instrument may be damaged.

Operation and maintenance


During operation and maintenance of the instrument:
o Follow the instructions.
o Do not touch any parts of the instrument other than those specified.
Otherwise, you may be injured or infected, the instrument may be damaged, or may stop running.

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Operator qualification
Do not perform operation and maintenance unless you have been trained by authorized Roche
Diagnostics personnel or processes. Carefully follow the procedures specified in the Operators
Manual for the operation and maintenance of the system. Leave maintenance that is not described
in the Operators Manual to trained Roche Technical Support personnel. Follow standard
laboratory practices, especially when working with biohazardous material.
The operator is responsible for taking all necessary precautions against hazards associated with the
use of clinical laboratory chemicals. Specific recommendations for each reagent used on the analyzer
are found on the box label, package insert, or product information sheet for each chemistry.
Material Safety Data Sheets (MSDS) are available for Roche Diagnostics reagents.

Quality control measurement


An incorrectly measured result may lead to an error in diagnosis, therefore posing danger to the
patient.
o Check that quality control measurements are within the specified range before accepting the
sample results. The frequency of quality control depends upon the system settings and your local
legal requirements.
o Do not use reagents, calibrators, or controls that are expired. Otherwise, inaccurate data may
be obtained.
o Refer to package inserts for example assigned values and sample/control stability.

Rack line cover


Do not detach the cover. Because racks are moving at a high speed beneath the cover, you may be
injured if you touch racks in the A-line and C-line during operation.

Replacing reagent packs


o The instrument must be in Standby before performing this operation.
o If you open the reagent rotor cover during operation, your fingers may be entangled in it and
cause you injury.

Replacing system reagents


The instrument must be in Standby before performing this operation.

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Safety precautions

Residual liquid in pinch valve tubing


When replacing the pinch valve tubing, take care to avoid contact with any residual liquid
remaining in the old tubing. The liquid that flows through this tubing comes from the measuring
cell and so is potentially biohazardous. Wear approved disposable gloves. If you get any of the liquid
on your skin, wash it off immediately, apply disinfectant according to your own laboratory
practices, and consult a physician.

Sample evaporation
If the sample has been on board for more than two hours, repeat the analysis with a fresh sample.
Evaporation of samples that have been on board for more than two hours may lead to false results.

Biohazards

Biohazardous materials
Material of human or animal origin, and material from tissue cultures or in vitro cultures, must be
treated as potentially biohazardous. Always wear suitable protective equipment such as approved
disposable gloves, a fluid-resistant laboratory coat, and safety goggles, when handling biohazardous
materials. Handle all biohazardous materials according to your facility's biohazard procedure.
The following materials must be treated as potentially biohazardous materials and handled
accordingly:
o All in vitro diagnostic equipment, pretreatment systems, patient samples, serum-based
calibrators, quality control (QC) products, and waste materials.
o Everything that comes into contact with these potentially biohazardous materials, such as
syringes, tubes, waste containers, reservoirs, S/R probe, sipper probe, rinse stations, and sample
disk protective cover.

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Safety precautions

Handling of waste
Contents of the waste solution reservoirs, and subsequently the water used to rinse the containers,
are all potentially biohazardous. Contact with waste solution may result in infection.
o Handle all waste materials and mechanical components associated with the waste systems
according to your facility's biohazard procedures, and always wear adequate protective
equipment.
o Immediately wash off with water any waste solution that comes into contact with your skin,
apply disinfectant according to your own laboratory practices, and consult a physician.
o Dispose of waste according to the appropriate local regulations for handling biohazardous
waste.
o If your system is installed with a direct drain option, follow all local, state, and federal
regulations for waste disposal.
o Take special care when disposing ProCell and CleanCell, as these may produce toxic gases.
When pouring waste down the drain, run the faucet (tap) continuously to ensure the waste is
diluted with plenty of water.
o Always refer to the package inserts for details on particular warnings.
o Consult the reagent manufacturer for information on the concentrations of heavy metals and
other toxic constituents in each reagent.

Preventing infection
o Always wear approved protective equipment when operating or maintaining this system.
o Protective equipment should include (but not be limited to) approved protective gloves, a fluid-
resistant laboratory coat, and safety goggles.
o Wear a face shield if there is a chance of splash or splatter.
o Take extra care when working with protective gloves because these can be pierced or cut by
sharp edges, which can lead to infection.
o When wiping probes, use several layers of gauze and wipe from the top down to reduce the risk
of puncturing your protective gloves or skin.
o If any biohazardous material is spilled on the instrument, wipe it up immediately, wash off any
residual material, and apply disinfectant.
o If you get any biohazardous material on your skin, wash it off immediately, apply disinfectant
according to your own laboratory practices, and consult a physician.

Cautions

Aluminum parts
Do not use an acidic or an alkaline solution to clean the system reagent compartment or incubator.
The compartment is made of aluminum and these solutions degrade the metal.

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Safety precautions

Approved parts
Use only parts and devices approved by the manufacturer. Use of non-approved parts or devices
may result in instrument malfunction and incorrect results and may render the warranty null and
void.

Avoid damage to motorized components


Switch off the analyzer power before manually moving any motorized components. If power is on,
the motors are engaged and attempted movement may damage them.

Avoid damage to the probe


Do not bend the probe during cleaning, as this can crimp it. Be careful not to damage the tip of the
probe. If the probe is damaged, it will have to be replaced.

Barcode reader window


Take care not to scratch or smear the barcode reader window.

Check digits in barcodes


Use only barcodes with check digits. Barcode scanning errors could potentially go undetected when
a check digit is not used.

Continuous sample loading on sample disks


When loading additional samples on the sample disk after testing has begun, do not place a new
sample in a position where measurement has not been completed for the sample previously assigned
there. Otherwise, the new sample will be measured rather than the registered sample.

Cooling fan
Avoid touching the cooling fan of the detection unit while the analyzer is operating. Otherwise,
personal injury may result. Do not touch the fan unless the circuit break of the analyzer is turned
Off.

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Safety precautions

Data backup
If a momentary drop in power voltage occurs due to a power interruption or lightning, the control
unit of the instrument may become faulty or the system software, application software, or data may
be damaged. In addition, instrument malfunctions or operating errors may cause damage to result
data or assay parameters. To prevent such losses, be sure to back up result data and assay
parameters periodically.

Dry the incubator surface


Make sure that the incubator surface and its positions are dry or you may experience gripper
problems when you resume operation.

Electromagnetic devices
Do not operate the following devices in the same room where the system is installed:
o Mobile/cellular telephones
o Transceivers
o Cordless telephones
o Other electrical devices that may generate electromagnetic interference
Devices that emit electromagnetic radiation may cause the instrument to malfunction.

Loading and unloading racks and trays


Verify that the light on the rack sampler is green before you add a new rack or tray to the A-Line or
remove a tray of processed samples from the C-Line while the analyzer is in operation. Otherwise,
the instrument may be damaged or operation may stop. Do not add or remove single AssayCups
and AssayTips to a tray when it is on the analyzer.

Loading and unloading the sample disk


Verify that sampling has stopped before you load additional samples on the sample disk, remove
processed samples from the sample disk, or replace the sample disk while the analyzer is in
operation. When sampling has stopped, raise the sample disk cover before changing samples.
Otherwise, personal injury may result or the instrument may be damaged or operation may stop.

Loading samples and reagents


Be sure to load samples and reagents only into the specified positions on the instrument.

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Safety precautions

Loading STAT racks


When loading racks on the system from the STAT rack position, ensure the rack is inserted the right
way around.

Memory problems
If any message from the operating system indicates a problem with the Flash memory, contact your
Roche service representative.

Non-Roche controls
When measuring a non-Roche control, use only recommended sample tubes, cup-on-tube, or cup-
on-rack. Do not use the Roche control vials, as the system would register this as cup-on-tube and
would not be able to pipette the control material.

Organic solvents
o Do not use organic solvents on the AssayCups, AssayTips, and waste solution flow path, as these
parts are not guaranteed to be chemically resistant against organic solvents.
o Do not use organic solvents, other than isopropyl alcohol or ethanol, for maintenance and
checkup.

Photosensors
o Take care not to scratch or smear the photosensors in compartment positions 2 and 3.
o If the sensors become wet, use a cotton swab to dry them.
The sensors are rectangular windows located at the back of the compartment, just below the top
edge. These sensors check for the presence of a ProCell/CleanCell bottle set.

Power interruption
Roche recommends that an uninterruptible power supply be used with this equipment. A
momentary voltage drop or surge caused by power interruption or lightning may damage the
control section of this instrument or corrupt the system software, application software, or data.

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Safety precautions

Reagent rotor
o Do not touch the reagent rotor or the reagent cover during operation. Otherwise, the
instrument may be damaged, or may stop running.
o Do not insert your fingers into the openings in the reagent rotor cover or into the opening of the
reagent cap open/close mechanism. Otherwise, personal injury may result.
o Check that the reagent rotor cover is locked on the reagent disk during operation unless you are
exchanging reagents. If the cover is kept open, the cooling efficiency and temperature control
may be compromised and the reagents may deteriorate. Opening the cover during analysis also
causes an instrument alarm and stops the instrument operation.

Reduced sample volume


A reduced residual volume may only be used with Hitachi standard cups (not with primary or
secondary tubes).

Restrictions on samples
Do not use sample and cleaning or disinfectant solutions that are likely to adhere to the sample
probe, reagent probes, or measuring channel.

Sample disk protective cover


Make sure that you lay down the sample disk protective cover before you start operation.

Sipper shield
o To open the sipper shield, push the white metal area at the top to release the latch. Do not pull
the sipper shield without releasing the latch in this way, otherwise the latch may be damaged.
o Do not open the sipper shield while the analyzer is in operation, otherwise the analyzer will
immediately stop processing and an alarm will be issued.
o Close the sipper shield after replacing a system reagent or performing maintenance, otherwise
the instrument will not operate.

Spillage
Wipe up any liquid spilled on the instrument immediately. Liquid spilled on the instrument may
cause it to malfunction. Do not place any liquid on the analyzer except where recommended or
requested in the Operators Manual or online Help.

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Safety precautions

Stop processing
Choosing the Stop button causes all sampling and sample processing to be stopped. Results from
samples currently being processed are lost.

Switching on the instrument


After switching off the analyzer, wait for at least ten seconds before switching on again.

Third-party software
Do not install any third-party software products on the instruments control unit. Installing third-
party software may result in incorrect behavior of the system. The installation and use on the
instruments control unit of any third-party software is not approved or permitted by the
manufacturer. Installing third-party software may invalidate your warranty.

Tubing and fittings


Do not crimp the replacement pinch tubing or damage the fittings during this operation.

Use of microcups
Microcups must not be used on the cobas e 411 analyzer.

Viewing the screen for long periods


Take a rest for 10 to 15 minutes every hour to relax your eyes and body. Avoid spending more than
six hours per day looking at the monitor screen. Looking at the screen over long periods may tire
your eyes or body.

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System safety labels

System safety labels

Warning labels have been placed on the system to draw your attention to areas of
potential hazards. The labels and their definitions are listed below, according to the
area of the system where they are located.

If the labels are damaged, they must be replaced by Roche service personnel. Contact your local
Roche representative for replacement labels. Some of the photos of the label may differ from those on
your system, if they have changed since the photographs were taken for this manual.

Analyzer unit

Warning
The presence of this label on part of the analyzer indicates
that there is a danger of hazardous situations nearby
which may result in death or serious injury.

Biohazard warning
The presence of this label on part of the analyzer indicates
that there are potential biohazards nearby. The relevant
laboratory procedures on safe use must be observed.

Moving parts
This label identifies moving parts of the analyzer that you
must not touch if you are to avoid injuring yourself or
damaging the equipment.

Corrosive materials
This label indicates protective goggles and gloves should
be worn when working within the vicinity of this label as
there is a danger of coming into contact with corrosive or
caustic material.

STAT rack orientation


CAUTION: When setting the STAT rack, confirm the
direction of rack.
This label provides a caution that racks must be must be
places in the STAT (Short Turn Around Time) position
with the correct orientation. Placing the rack the wrong
way round may cause damage to the instrument.
Use SysWash
This label indicates that SysWash must be added to the
distilled water with a SysWash to water dilution ratio of
100+1 when refilling the system water container.

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System safety labels

Positions of safety labels on the analyzer unit (disk system)

Warning labels are attached to the instrument at the following positions:

Figure A-1 Safety label location: analyzer unit (disk system)

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System safety labels

Positions of safety labels on the analyzer unit (rack system)

Warning labels are attached to the instrument at the following positions:

Figure A-2 Safety label location: analyzer unit (rack system)

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System safety labels

Positions of safety labels on the solid waste tray and Clean-Liner


Warning labels are attached to the solid waste tray and Clean-Liner at the following
positions.

Figure A-3 Safety label location: solid waste tray and Clean-Liner

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System safety labels

Power supply

Electrical safety precautions


Do not attempt to gain access to parts of the instrument marked with this label. Do not open the
back cover or attempt to work in any electronic compartment. As with any electronic equipment,
electric shock can occur. Installation, service, and repair must only be performed by authorized and
qualified personnel.

Disconnecting the power supply


To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off)
position and the power cord must be removed. Rack systems are provided with more than one
power supply cord. All power supply cords must be removed to disconnect the equipment from the
mains power supply.

Circuit breaker
The following figure shows the circuit breaker and power cord.

Figure A-4 Safety label location: circuit breaker

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System safety labels

Rack sampler circuit breaker

The following figure shows the rack sampler circuit breaker and power cord. A label
warns that rack systems are provided with more than one power supply cord, because
the rack sampler has a separate power supply. All power supply cords must be
removed to disconnect the equipment from the mains power supply.

Figure A-5 Safety label location: rack sampler circuit breaker

Electromagnetic compatibility (EMC)

The cobas e 411 analyzer fulfils the electromagnetic compatibility (EMC)


requirements of EN 61326: 1997, +A1:1998, +A2:2001.

Peripheral device connections

All peripheral devices that are connected to the cobas e 411 analyzer must comply
with safety standard IEC 60950 (UL 1950) for information technology equipment or
with IEC 61010 (UL 3101) for laboratory instruments.

Approved parts
Use only parts and devices approved by the manufacturer. Use of non-approved parts or devices
may result in instrument malfunction and incorrect results and may render the warranty null and
void.

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System safety labels

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Table of contents

System overview

This chapter provides an overview of the cobas e 411 analyzer system, system
specifications, and product labeling.

In this chapter Chapter 2


Overview of the cobas e 411 analyzer ........................................................................... 27
Disk and rack systems ............................................................................................. 28
Disk system .............................................................................................................. 29
Rack system .............................................................................................................. 29
System components ....................................................................................................... 30
Analyzer unit ................................................................................................................. 30
Analyzer unit: disk system ................................................................................. 31
Analyzer unit: rack system ................................................................................ 32
Control unit ................................................................................................................... 34
Power components ........................................................................................................ 34
Operation switch ..................................................................................................... 35
Circuit breaker ......................................................................................................... 35
Rack sampler circuit breaker .................................................................................. 36
System specifications ..................................................................................................... 37
Technical data .......................................................................................................... 37
Instrument dimensions ........................................................................................... 37
Electrical .................................................................................................................. 38
Environmental conditions ...................................................................................... 39
Noise level ................................................................................................................ 39
Water supply ............................................................................................................ 40
Liquid waste ............................................................................................................. 40
Solid waste ............................................................................................................... 40
Throughput rate ...................................................................................................... 40
Sampling system ...................................................................................................... 40
Residual volume (disk system) ............................................................................... 42
Residual volume (rack system) ............................................................................... 42
Reagent system ........................................................................................................ 43
Incubation system ................................................................................................... 43
Measuring system .................................................................................................... 44

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Table of contents

Control unit ............................................................................................................. 44


Reagent kit box labels .............................................................................................. 45
Reagent packs .......................................................................................................... 46
Reagent barcode label .............................................................................................. 46
Package inserts ......................................................................................................... 47
Calibrator kits .......................................................................................................... 48
Calibrator barcode cards ......................................................................................... 49
Control kits .............................................................................................................. 50
Control barcode cards ............................................................................................. 51

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Overview of the cobas e 411 analyzer

Overview of the cobas e 411 analyzer

The Roche Diagnostics cobas e 411 Immunoassay System is an automated, random-


access, multichannel analyzer for immunological analysis. It is designed for both
quantitative and qualitative in vitro determination of a wide range of analytes by use
of electrochemiluminescence (ECL) technology.
The cobas e 411 analyzer can be placed on a bench top, thereby saving space in the
laboratory environment. All assay reagent, calibrator, and control information is
automatically entered into the software by using barcodes, or downloaded over the
cobas Link connection (if installed).
The system consists of the analyzer, which performs all functions required for fully
automated sample and assay processing, and a control unit, which controls the
analyzer through the user software. The process includes the recording of patient
samples, the ECL detection, and the transmission of results.
The software controls data transmission to and from the analyzer, evaluates results,
produces documentation, and implements quality control. Also, the software
manages data between a connected Pre-Analytic Systems Manager (PSM)(1) and the
cobas e 411 analyzer. Several cobas e 411 analyzers can be centrally controlled when
integrated with the PSM.
The advantages of the system include the following:
o Easy operation by means of a color touchscreen. Very few manual entries are
required.
o An integrated-barcode concept improves convenience and work flow. You do not
have to identify individual samples manually if you use barcode-labeled tubes.
Racks (on rack systems), reagent packs, and calibrator and control vials are
barcode-labeled and are also read automatically.
o Automatic entry of test applications. Transfer of test parameters to the system
using the reagent barcode label speeds the installation of new assays.
o Real-time monitoring of the analyzer allows the system to run unattended. Alarm
messages notify the operator of any problems.
o Continuous access to samples avoids interruption of routine testing while
ensuring that results will be available as quickly as possible.
o STAT (Short Turn Around Time) samples are prioritized and processed as soon as
possible as the first priority, once the current operation has been completed.
o Reagents are kept at a constant temperature (20 3C) on the analyzer, allowing
on-analyzer storage.

(1) Not available in the United States of America

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Overview of the cobas e 411 analyzer

Disk and rack systems

The cobas e 411 analyzer is available as a disk system and as a rack system. The
differences between the two configurations are detailed throughout this Operators
Manual. Both systems have a throughput of approximately 85 tests per hour.
To assist you in quickly identifying information that is specific to either the disk or
rack system, one of the following symbols is present to the left of the text.

Applies to disk system only

Applies to rack system only

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Overview of the cobas e 411 analyzer

Disk system

The following figure shows a cobas e 411 analyzer disk system:

Figure A-6 cobas e 411 analyzer (disk system)

Rack system

The following figure shows a cobas e 411 analyzer rack system:

Figure A-7 cobas e 411 analyzer (rack system)

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System components

System components

This chapter provides an overview of the following main components and functional
areas:
o Analyzer unit
o Control unit
o Power components

Analyzer unit

The analyzer unit on the disk system consists of the:


o Sample/reagent area
o Consumables area
o Measuring area
o Operation switch
e For further information, see Chapter 4 Analyzer components.

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Analyzer unit

Analyzer unit: disk system

A B C D
A Operation switch B Sample/reagent area C Measuring area
D Consumables and liquid waste area

Figure A-8 Analyzer unit (disk system)

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Analyzer unit

Analyzer unit: rack system


The only difference on the rack system is in the sample area. The sample disk is
replaced by a rack sampler, as shown in the following figure:

A B C D E
A Rack sampler B Operation switch C Reagent area
D Measuring area E Consumables and liquid waste area F Main circuit breaker (hidden)

Figure A-9 Analyzer unit (rack system)

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Analyzer unit

A
B

A Rack sampler circuit breaker B C-Line


C B-Line (hidden) D A-Line
E STAT (Short Turn Around Time) position

Figure A-10 Rack sampler

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Control unit

Control unit

The control unit is located at the top left of the analyzer and consists of the following
components:
o Touchscreen monitor
o Connections located on the left side for data storage, an external printer, and a
host interface.
e For further information, see Chapter 3 Control unit.

Figure A-11 Control unit

Power components

The power components include the following:


o Operation switch
o Circuit breaker
o Rack circuit breaker

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Power components

Operation switch

The operation switch is located on the lower left front side of the analyzer. Use the
operation switch to switch off the analyzer in order to perform certain maintenance
procedures or when the system is not in use for extended periods of time (for
example, overnight). The operation switch also switches off the power to the
touchscreen.
Provided that the circuit breaker is on, the reagent rotor and system reagent
compartment temperatures are maintained while the operation switch is off.

A Operation switch

Figure A-12 Operation switch

Circuit breaker

The circuit breaker is located on the right side panel of the analyzer, above the power
supply cord. The circuit breaker controls the power supplied to the temperature-
controlled reagent compartments when the operation switch is off. The circuit
breaker must be in the I (on) position whenever reagents are stored on the analyzer to
maintain liquid in the measuring cell.
When connecting or disconnecting the host cable, power the analyzer off at the circuit
breaker only.

For essential safety information, see Disconnecting the power supply on page A-7.

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Power components

A Circuit breaker B Power cord

Figure A-13 Circuit breaker

Rack sampler circuit breaker

There is a circuit breaker located on the left side of the rack sampler, above the rack
sampler power cord. This controls power to the sampler unit. The circuit breaker
should be kept in the I (on) position at all times. Use the operation switch to switch
the rack system on and off.

For essential safety information, see Disconnecting the power supply on page A-7.

A Rack sampler circuit breaker B Rack sampler power cord

Figure A-14 Rack sampler circuit breaker

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System specifications

System specifications

Technical data

A plate located on the right side of the analyzer displays the part number, serial
number, and power requirements.
The following figure shows an example of the analyzer plate.

Figure A-15 Analyzer plate example

Instrument dimensions

The following table lists the dimensions of the cobas e 411 analyzer, for both the disk
and rack systems:

Analyzer Height Depth Width Weight


31.4 in(a) 28.7 in 47.2 in 397 lbs
80 cm(a) 73 cm 120 cm 180 kg
(43 in, 109 cm with
top cover opened)

31.4 in(a) 37.4 in(b) 67 in 551 lbs


80 cm(a) 95 cm(b) 170 cm 250 kg
(43 in or109 cm
with top cover
opened)

(a) The height includes the touchscreen


(b) The depth includes the STAT position
Table A-1 Instrument dimensions

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System specifications

Electrical

The following table lists the power requirements and heat output of the cobas e 411
analyzer:

Installation requirements: The instrument complies with the safety requirements


of IEC 61010-1, 2nd edition; IEC 61010-2-081, 1st
edition; IEC 61010-2-101, 1st edition; UL 61010-1, 2nd
edition; CAN/CSA C22.2 No. 61010-1:2004.
Pollution degree: 2 (IEC 61010-1)
Overvoltage category: II (IEC 664)
The instrument complies with the electromagnetic
compatibility (EMC) requirements of EN 61326: 1997,
+A1:1998, +A2:2001.
The cobas e 411 analyzer must be connected to a three-
wire power supply cord with a safety ground.

AC Cord Set ratings:


Countries requiring UL and CSA:
115 V AC125V-15A /SJT type 314AWG
208 or 240 V AC250V-10A /SJT type 316AWG
Temperature rate Minimum 60C
Whole length 250050 mm
Safety Standard UL817 / CSA C22.2 No.21

Europe The AC Cord must be marked "HAR".


220 to 240 V AC250V-10A /31.16AWG
Temperature rate Minimum 60C
Whole length 250050 mm
Safety Standard CENELEC HD21

Connector type to e411 inlet IEC320 / EN60320 type


Supply voltage/frequency: 100 - 240 V AC, 50/60 Hz single phase
The power supply voltage is automatically detected by
the system.

Main supply voltage fluctuation: 10% of nominal voltage (90 VAC to 264VAC)

Power consumption:
1000 VA

1250 VA (Analyzer unit: 1000 VA; rack sampler unit:


250 VA)

Table A-2 Electrical specifications

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System specifications

Heat generation (approximate):


2879 kJ/hresp.
688 kcal/hresp.
2730 Btu/h

3778 kJ/hresp. (Rack sampler unit: 899 kJ/hr resp)


903 kcal/hresp. (Rack sampler unit: 215 kcal/hr resp.)
3583 Btu/h (Rack sampler unit: 853 Btu/hr)

Table A-2 Electrical specifications

Environmental conditions

The cobas e 411 analyzer is designed for indoor use only. The following table lists the
range of acceptable environmental conditions under which cobas e 411 analyzers will
reliably and accurately operate:

Temperature: Operation: 18 to 32C


Storage and transport: -20 to 75C

Temperature variation: Maximum 2C/h

Humidity (indoor use only): Operation: 20 to 80% (non-condensing)


Storage and transport: 5 to 95% (non-condensing,
<80% average per year)

Altitude: Operation up to 2000 m

Table A-3 Environmental conditions

Noise level

The following table lists the acoustic noise levels generated by the cobas e 411
analyzer in various operating modes:

Noise level requirement: IEC 61010-1: 2001


DIN 43635

Standby level: 60 dBA

Operation level (average): 63 dBA

Operation level (maximum): 70 dBA

Table A-4 Noise levels

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System specifications

Water supply

The following table lists the requirements for the water supply:

Water container: 3L

Water requirements: < 10 S/cm or > 0.1 megohm, bacteria-free


(SysWash is added, with a dilution 100+1)

Water consumption 3 L for 250 tests


(approximate): 12 mL/cycle

Table A-5 Water supply

Liquid waste

Liquid waste container: Capacity: 4 L, with overflow detection.

Table A-6 Liquid waste

The liquid waste container is not installed if the direct drain option is used.

Solid waste

Disposable solid waste container: Capacity: 420 AssayCups and 680 AssayTips, or just1100
items.

Table A-7 Solid waste

Throughput rate

Assay measurements: Up to 86 tests/hour

Table A-8 Throughput rate

Sampling system

The following table lists the specifications for the sampling system. Certain capacities
vary between the disk and rack systems.

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System specifications

Sample/Reagent pipetter principle: Conductive disposable AssayTip handling

Sample volume per test: 10 to 50 L

Sample/Reagent pipetter precision: For 10 L volumes, the coefficient of variance is < 1.2%
at an ambient temperature of 18 to 25C and < 2.4% at
an ambient temperature of 25 to 32C.
< 0.8% CV for 50 L volumes.
Sample detection: Liquid level detection and clot detection

Sample loading capacity:


30 positions for samples, controls, and calibrators

Rack tray: 15 racks with five positions each = 75


positions
Input buffer: 5 racks with five positions each = 25
positions
Total: 100 positions for samples, controls, and
calibrators

STAT (Short Turn Around Time)


capacity:
Any unoccupied position on the sample disk

STAT rack position at the front of the analyzer

Barcode symbologies: The barcode symbologies that can be read include the
following:
o PDF417
o NW7 (Codabar)
o Code 39
o Code 128
o Interleaved 2 of 5

Assay tips: 360 AssayTips (3 trays, with 120 AssayTips/tray)

Assay cups: 180 AssayCups (3 trays, with 60 AssayCups/tray)

Sample cups: 2 mL (Standard) Hitachi cup; NO micro cups

Primary sample tubes: 13 x 75 mm 16 x 75 mm


(external diameter x height) 13 x 100 mm 16 x 100 mm

Table A-9 Sampling system

For essential safety information, see Check digits in barcodes on page A-13

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System specifications

Residual volume (disk system)

The following table lists the residual volumes for the various sample container
options. These figures apply to the disk system only.

Sample Container Tube height Normal Reduced


residual volume residual volume
Standard Hitachi cup directly on the sample disk: 200 L 100 L
Standard Hitachi cup on top of a primary sample tube (16 mm diameter): 75 mm 200 L 150 L
Standard Hitachi cup on top of a primary sample tube (dia. = 16 mm): 100 mm 200 L 150 L
Primary sample tube (13 mm diameter): 75 mm 600 L
Primary sample tube (13 mm diameter): 100 mm 600 L
Primary sample tube (16 mm diameter): 75 mm 1000 L
Primary sample tube (16 mm diameter): 100 mm 1000 L
(a)
Calibrator/control vial: 150 L
Table A-10 Sample container residual volume (disk system)
(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.

For essential safety information, see Reduced sample volume on page A-16.

Depending on sample volumes and type of vial (for example, primary sample tube or sample cup),
the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air aspiration.

Residual volume (rack system)

The following table lists the residual volumes for the various sample container
options. These figures apply to the rack system only.

Sample Container Tube height Normal Reduced


residual volume residual volume
Standard Hitachi cup directly on the sample disk: 200 L 100 L
Standard Hitachi cup on top of a primary sample tube ( = 16 mm): 75 mm 200 L 100 L
Standard Hitachi cup on top of a primary sample tube ( = 16 mm): 100 mm 150 L 100 L
Primary sample tube ( = 13 mm): 75 mm 600 L
Primary sample tube ( = 13 mm): 100 mm 600 L
Primary sample tube ( = 16 mm): 75 mm 1000 L
Primary sample tube ( = 16 mm): 100 mm 1000 L
(a)
Calibrator/control vial: 150 L
Table A-11 Sample container residual volume (rack system)
(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.

For essential safety information, see Reduced sample volume on page A-16.

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System specifications

Depending on sample volumes and type of vial (for example, primary sample tube or sample cup),
the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air aspiration.

Reagent system

Assay reagents The following table lists the specifications for the assay reagents:

Reagent rotor temperature: 20C 3C


Reagent capacity: Up to 18 assays, 9 pretreatments, or 8 diluents in 18 reagent
positions
R1/R2 consumption: 50 to 80 L per reagent, dependent upon the assay
Microbead consumption: 30 to 50 L dependent upon the assay
Reagent detection: Liquid level detection
Positive reagent identification: Two-dimensional barcode (PDF417)
Automatic dilution: Available up to 1:400 (for applicable assays)
Evaporation protection: Reagent lids are automatically opened and closed
Table A-12 Assay reagent system

System reagents The following table lists the specifications for the system reagents:

Temperature: 28C 2C
Inventory control: Automatic based on counting (reagent rotor) or liquid level
detection (ProCell/CleanCell)
ProCell consumption: Approximately 2 mL per cycle
CleanCell consumption: Approximately 2 mL per cycle
Table A-13 System reagent system

Incubation system

The following table lists the specifications for the incubation system:

Incubator capacity: 32 AssayCups


Volume of AssayCups: 200 L
Incubation temperature: 37.0C 0.3C
Table A-14 Incubation system

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System specifications

Measuring system

The following table lists the specifications for the measuring system:

Measuring method: Integral measuring of an electrochemiluminescence signal


Calibration mode: 2-point calibration
ProCell consumption Approximately 2 mL per cycle
CleanCell consumption Approximately 2 mL per cycle
Cycle time: 42 s
Temperature: 28C 2C
Table A-15 Measuring system

Control unit

The following table lists the specifications for the control unit:

Type: Integral PC unit with touchscreen monitor


Data storage: Compact flash card
System interfaces: Standard PC ports (USB, ethernet, and serial) for other
communication devices (remote access, cobas Link)
Host interface: CCITT V. 24/RS-232-C (bidirectional)
The host should comply with the requirements of IEC (60950)
External printer: Connection through a USB port
e For further information and a list of recommended printer
models, see External printer on page A-58.
Touchscreen monitor: 39 cm (15 in) color TFT-LCD, XGA
Operating system Microsoft Windows XP (embedded version)
Table A-16 Control system

e For further information, see Chapter 3 Control unit.

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System specifications

Reagent kit box labels

The reagent pack comes as part of a reagent kit. On each reagent kit box, a large label
shows the intended use, storage temperature, contents, and catalog number of the kit.
A smaller side box label shows the lot and expiration date of the reagent pack, as well
as a barcode number. Both of these labels are shown in Figure A-16:

A Kit catalog number B Reagent Pack lot number

Figure A-16 Reagent box labels

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Reagent packs

The following figure shows an example of a reagent pack (e-pack) used on the
cobas e 411 analyzer.

Figure A-17 Reagent pack

Each reagent pack is a single ready-to use unit that consists of three bottles:
o A transparent bottle (with a transparent lid) containing suspended paramagnetic
microbeads (M).
o A black bottle (with a gray lid) containing reagent 1 (R1)
o A black bottle (with a black lid) containing reagent 2 (R2)
The reagent pack and reagent rotor are keyed to prevent you from placing reagents on
the analyzer incorrectly.

Reagent barcode label

Reagent packs have a barcode label that contains information required to run the
assay on the analyzer. This information includes, but is not limited to:
o Test number
o Lot number
o Master calibration curve parameters (for example, Rodbard parameters)
o Instrument settings
o Calibrator lot numbers and assigned values
o Expiration date
o Calibration frequency

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The following information can be identified on each reagent barcode label:

A
B

D
E
F
G
H
I

A Test code B Kit catalog number


C Reagent volume within the package D Reagent pack number
E Storage temperature F Abbreviation for in vitro diagnostics
G Reagent pack lot number H Expiration date
I Reagent barcode number

Figure A-18 T4 reagent barcode label

Package inserts

Each reagent kit comes with a package insert, which provides detailed information
required to perform the assay. This information includes, but is not limited to:
o Intended use
o Test principle
o Reagent handling and stability
o Calibration and QC information
o Measuring range
o Dilution
o Expected values.

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Calibrator kits

For most tests, calibrators for the Elecsys reagents can be ordered separately (for
example, Elecsys FT3 or Troponin-T CalSet). Each kit contains barcoded calibrator
vials. Some calibrators are in a ready to use liquid form and require no further action
other than to place them on the sample disk or rack when a calibration is necessary.
A few of the calibrators are lyophilized in glass bottles and must be reconstituted
before being transferred into plastic barcode-labeled vials. (Empty barcode-labeled
vials are packaged in these kits with lyophilized calibrators.) You can store
reconstituted calibrators in the plastic vials after transfer.
Calibrators also have color-coded caps to assist you in identification. A level 1
calibrator has a white cap, and a level 2 calibrator has a black cap.

D
B

A Empty calibrator vials to be filled B Bottles containing calibrators to


be reconstituted according to
the package inserts
C Calibrator barcode card D Package inserts
E Extra labels for calibrator aliquots that
should be kept separately

Figure A-19 Calibrator kit

Each calibrator bottle has a traditional linear barcode label that contains an identifier
to link it to information encoded in the reagent barcode label and the calibrator
barcode card.
Each calibrator kit contains calibrator barcode cards.
e For further information, see Calibrator barcode cards on page A-49.

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Calibrator barcode cards

Each calibrator kit comes with a barcode card. This cards is in the PDF417 format and
must be used with the corresponding calibrators. Information encoded in the
calibrator barcode cards includes, but is not limited to:
o Test number
o Calibrator lot number
o Lot identifier to calibrator barcode labels
o What calibrators are to be used and their number of determinations
o Target or assigned values
o Expiration date
Roche Diagnostics produces a factory master calibration for each calibration lot. The
results are encoded into the corresponding reagent barcode. Scan the new barcode
card when you use a new lot.
e For additional information, refer to Reagent concept on the COBI-CD.

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Control kits

For most tests, controls for the Elecsys reagents come packaged separately (for
example, Elecsys PreciControl Universal). Each kit contains barcoded control vials for
use on the analyzer.
Most of the controls are lyophilized in glass bottles and must be reconstituted before
being transferred into plastic barcode-labeled vials. (Empty barcode-labeled vials are
packaged in these kits with lyophilized controls.) You can store reconstituted controls
in the plastic vials after transfer.
Controls also have color-coded caps to assist you in identification. A level 1 control
has a light brown cap and a level 2 control normally has a dark brown cap. Read the
package insert to check the color of the caps on the level 1 and level 2 controls.
Each control bottle has a traditional linear barcode label that contains an identifier to
link it to information encoded in the reagent barcode label and the control barcode
card.
Control barcode cards come packed in each control kit. These cards are described in
more detail in the next section.

A
B E

C
D F
G

A Empty control vials to be filled with level 2 B Empty control vials to be filled with level 1
controls controls
C Bottles containing level 2 controls to be D Bottles containing level 1 controls to be
reconstituted according to the package reconstituted according to the package
inserts inserts
E Control barcode cards F Package inserts
G Extra labels for control aliquots that should
be kept separately

Figure A-20 PreciControl Universal kit

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Control barcode cards

Each control kit comes with barcode cards. These cards are also in the PDF417 format
and must be used with the corresponding controls. Information encoded in the
control barcode cards includes, but is not limited to:
o Test number
o Control lot number
o Control code (for example, PC U1)
o Lot identifier to control barcode labels
o Target or assigned values
o Control ranges
o Expiration date
Scan the new barcode cards when you use a a new control lot.

Figure A-21 PC Universal barcode cards

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Table of contents

Control unit

This chapter provides a detailed description of the control unit and its components
and an overview of the system software.

In this chapter Chapter 3


Components .................................................................................................................. 55
Touchscreen monitor .............................................................................................. 55
Software keyboard ................................................................................................... 56
Numeric keyboard ............................................................................................. 56
Full keyboard ..................................................................................................... 57
Keyboard transparency ..................................................................................... 57
Data storage ............................................................................................................ 58
External printer ....................................................................................................... 58
Service interface ....................................................................................................... 59
Host interface ........................................................................................................... 59
Software basics ............................................................................................................... 60
Status line ................................................................................................................. 61
Guidance prompt .................................................................................................... 61
Main menu screens .................................................................................................. 62
System Overview ............................................................................................... 62
Workplace .......................................................................................................... 62
Reagent ............................................................................................................... 62
Calibration ......................................................................................................... 63
QC ...................................................................................................................... 63
Utility ................................................................................................................. 63
Menu tabs ................................................................................................................ 63
List boxes .................................................................................................................. 63
Text boxes ................................................................................................................. 64
Options buttons ....................................................................................................... 64
Buttons ..................................................................................................................... 64
Standard buttons ............................................................................................... 64
Global buttons ................................................................................................... 65
Windows .................................................................................................................. 66
Selection menu for multiple items ......................................................................... 66

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Screen access levels .................................................................................................. 66


Online Help system ................................................................................................. 67

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Components

Components

The control unit consists of the following components:


o Color touchscreen monitor
o Software keyboard
o Data storage
o External printer
o Service interface
o Host interface

Touchscreen monitor

The 39 cm (15 in) color touchscreen monitor is located on the top left of the analyzer
and is used to:
o Display information
o Navigate through the software
o Initiate instrument functions
You can use a stylus to operate the touchscreen.
You can tilt the touchscreen to provide the best viewing angle. To use the touchscreen,
choose the item you want to request or change on the screen by lightly touching it
with a finger or stylus. When touching the touchscreen, do not press hard as this
could cause damage. Instead, tap the screen lightly and then remove your finger or
stylus.
You can access all items within the software using the touchscreen. Choose the
required item (such as a menu bar, list box, text box, or button) to complete your task.
For example, to display the Data Review screen in the Workplace menu, choose
Workplace and then choose the Data Review tab.

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Figure A-22 Touchscreen monitor

Software keyboard

The cobas e 411 analyzer software has an on-screen keyboard function. When you
touch a text box, a software keyboard pops up around the text box. The required
input determines whether the display is a full keyboard or numeric only.

Numeric keyboard

A B

A Full keyboard B Transparency


mode button button

Figure A-23 Numeric software keyboard

Use the numeric keyboard to type numeric values, touching each field in turn to enter
the required values. When all the numeric entries are complete, choose Close to
return to the previous screen.
Choose the Full keyboard mode button (A) to switch from the numeric keyboard to
the full keyboard mode.

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Full keyboard

A B

A Transparency button B Numeric keyboard mode button

Figure A-24 Full (alphanumeric) software keyboard

Use the full keyboard to type alphabetical or numeric values, either touching the Tab
key or touching each field in turn to move between fields. You can either:
o Choose Close to return to the previous screen
o Move to the next text box either by choosing Tab or by touching the required box.
The software keyboard moves aside automatically from the selected text box.
Choose the Numeric keyboard mode button to switch from the full keyboard to the
numeric keyboard mode.

Keyboard transparency
You can control the transparency of the software keyboards by choosing the
Transparency button (B). This enables you to see what is behind the keyboard
without having to move or close it.
There are three transparency states:
o No transparency (default)
o Normal transparency
o Increased transparency
Each time you choose the Transparency button, the transparency button will move to
the next transparency state.

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Data storage

The system uses flash memory, memory cards, and CD-ROMs for data storage. There
is no mechanical hard drive; the Windows XP operating system is embedded.
The memory contains a number of data files necessary for the analyzer and the
software to work together. These files include the following:
o Reagent data
O Up to 300 reagent packs
o Sample data
O Up to 2000 test records (for routine samples, STAT samples, and controls)
o Calibration data
O Up to 160 calibrators
o QC data
O Up to 100 controls
o Parameter data
O Up to 305 application parameters
O Up to 20 operator IDs
O Analyzer serial number (entered by Roche Diagnostics service personnel
during software installation)
o Log data
O Up to 20000 daily alarm blocks
O Up to 1000 operator ID logs
O Up to 180 logs for each maintenance item
O Up to 10 MB host communication log
The data CD-ROM contains read-only data, including assay reference tables
containing information that is linked to data encoded in the reagent barcode (for
example, test number, test code, available units, and unit conversion factors)

External printer

The instrument is designed to be used with one of the following printers:


o Brother HL-2040
o Canon LBP3000
o Hewlett Packard LaserJet 1320

The printers in the list above have been tested for use with the cobas e 411 analyzer and are
supported by Roche Diagnostics. You may be able to use an alternative USB printer that is not on
this list. However, Roche Diagnostics would be unable to provide support for use of any printer that
is not recommended for use with the cobas e 411 analyzer.

Connect the printer to the USB port marked PRINTER on the left side of the analyzer.
See the following figure for the location of this port.

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Figure A-25 Location of the USB ports and host interface

e For more information, see Reports in the Software description section of the online Help.

Service interface

The service port is used to connect an external storage device. This can be DVD-
RAM, or a removable USB service device if the data is to be backed up onto a PC.
Contact Roche Technical Support for information or assistance concerning the use of
this port.

Host interface

The instrument can be bidirectionally interfaced with a host.


Contact Roche Technical Support for information or assistance concerning the
interfacing of the cobas e 411 analyzer to the host.

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Software basics

This section provides an overview of the system software, with a brief description of
the following screen elements:
o Status line
o Guidance prompt
o Main menu screens
o Menu tabs
o List boxes
o Text boxes
o Option buttons
o Buttons
o Windows
The main menus and online Help system are also described.
e For more information, see the Software description section of the online Help.

The screen representations shown in this chapter and throughout this manual are for illustrative
purposes only. The screens do not necessarily show valid results. Also, the availability and
appearance of any specific screen depends on the access level assigned to the operator.

The screen is divided into various areas. Some of these areas do not change, and some
differ according to the currently active function. Following is an example of a screen
showing the various areas.

B
C
A Status line B Online Help
C Guidance prompt (no message displayed) D Global buttons

Figure A-26 Screen configuration

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Status line

The status line is displayed across the top of each screen.

Figure A-27 Status line

The status line displays the current operational mode, operator ID, date, and time.
The double status icon on the left changes colors to reflect the current operational
status of the system. The color codes, listed from lowest to highest priority, are:

Icon Color Meaning.


Host Blue Host communication is Off.
Green Host communication is On.
E Blue The analyzer is in Initialization, Operation, or Maintenance
mode.
Green The analyzer is in Standby mode.
Yellow An instrument alarm has been raised with a caution level. This
could mean the number of tests remaining for a reagent is less
than the caution level specified on the Reagent Level Check
window.
Red An instrument alarm of Stop, S.Stop, or E.Stop has been raised.
Table A-17 Status icon color codes

Choose the status icon at any time to display the System Overview screen.

Guidance prompt

The guidance prompt is shown in the lower left of each screen.

A Guidance prompt

Figure A-28 Guidance prompt screen area

In this area, the software explains how you can use a specific text box. When you select
a text box, the guidance prompt defines the information that you can enter. It may
also give an action to take, such as choosing a button or pressing a key.

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Main menu screens

The graphical user interface used by the control unit consists of six main menu
screens:
o System Overview
o Workplace
o Reagent
o Calibration
o QC
o Utility
Through these screens all instrument functions are controlled. Access to some
screens, especially those of the Utility menu, is confined to the access level of the user.
e For more information, see User access levels in the Software description section of the
online Help.

System Overview
The System Overview screen is the central screen used for performing daily operation.
From here you can view the status of reagents, calibrations, and quality control. You
can also check the quantities of consumables available on the analyzer.
The System Overview screen consists of the following areas:
o Work Flow Guide
o Inventory area
o Main screen buttons
e For more information, see System Overview screen in the Software description section of
the online Help.

Workplace
The Workplace menu screen consists of two main tabs: Test Selection and Data
Review.
o Test Selection is used to enter and review test selections for a sample.
o Data Review is used to search, review, backup, delete, and send data to the host.
e For more information, see Workplace menu in the Software description section of the
online Help.

Reagent
The Reagent menu screen is used to view detailed reagent and consumables
information.
e For more information, see Reagent menu in the Software description section of the online
Help.

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Calibration
The Calibration menu screen consists of three tabs: Status, Calibrator, and Install.
They are used to request calibrations, define calibrators, and view calibration results.
e For more information, see Calibration menu in the Software description section of the
online Help.

QC
The QC menu screen consists of six tabs: Status, Run Status, Individual, Cumulative,
Control, and Install. Use these screens to install, view and edit controls, and to
evaluate and accumulate quality control results.
e For more information, see QC menu in the Software description section of the online
Help.

Utility
The Utility menu screen consists of four tabs: System, Maintenance, Application, and
Calculated Test. These screens are used to enter system settings, application
parameters, and access maintenance and service functions.
e For more information, see Utility menu in the Software description section of the online
Help.

Menu tabs

You can use the menu tabs to select screens and windows that are grouped together
and used to perform related tasks. The menu tabs are accessible from every screen
(but not from popup windows). This makes the software navigation within the
menus, and between menus, very easy.
The menu tabs are for the five menus: Workplace, Reagent, Calibration, QC, and
Utility.

List boxes

List boxes display a list of choices. If there are more choices than can fit in the box, a
scroll bar is displayed.
Touchscreen: Choose the item within the list box on the screen by touching it. If a
scroll bar is displayed next to the list box, you can touch the scroll bar above or below
the current display position, or touch the arrows on the scroll bar, to move up or
down the list to view the available item choices.
Software Keyboard: You can use the Arrow keys to move quickly through the list by
pressing the Arrow key that points in the required direction. The currently selected
choice is indicated by the selection cursor, which appears as a highlight. You can also
use the Home, End, Page Up, and Page Down keys of the full software keyboard to
move through the list. When the required item is highlighted, press Enter.

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Text boxes

A text box provides a place for you to type information on a screen. Some text boxes
are read-only and used to display information. Other text boxes may be unavailable
for you to enter information if the content of the text box is appropriate for the
current mode or configuration.
Move to a text box by touching it on the screen to choose it. The full or numerical
software keyboard will be displayed, depending on the entry field.
After you have typed in a text box, press Enter or Tab, or just touch the next field, for
your information to be accepted. Press Tab (full keyboard only) or touch the required
field to move the cursor to the next text box or option button.

Options buttons

Option buttons are used to select a particular function. Sometimes when an option is
selected, other option buttons or text boxes become available.
Choose an option by touching it on the screen. An option is selected when the
corresponding option button is colored light blue. If it is dark blue, the option is not
selected.

Buttons

Buttons are used for execution of functions, confirmation of entries and selections,
and displaying pop-up windows. The available buttons depend on the menu or tab
that is active.
The black triangle in the upper right-hand corner of a button indicates that choosing
this button displays another window. The black triangle in the lower left corner of a
button indicates that choosing this button performs the specified function and closes
the window.
Choose a button by touching it on the touchscreen.

Standard buttons
The following buttons are used throughout the software. These buttons are explained
below, and will not be explained again with each individual screen.

OK Choose this button to accept the changes and entries made in a window and to close
the window.

Cancel Choose this button to close the window without saving the changes and entries made
in a window

Yes Choose this button to accept the changes made in a window, perform the action of
the window (for example, Delete), and close the window.

No Choose this button to close the window without saving the changes made in a
window or without executing the function of the window (for example, Delete).

Close Choose this button to close the window.

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Save Choose this button to save any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.

Update Choose this button to update any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.

Page Buttons Some screens have page buttons that can be used to display additional buttons to
display new screens. These page buttons are numbered (for example, x/3), to indicate
the page that you are on.

The page buttons only change the displayed buttons and not the entire appearance of the screen.

Global buttons
Use the global buttons to display screens that are used for specific functions. The
global buttons are accessible from every screen and are located on the right side of the
screen (except for the Help button which is located in the lower left corner of the
screen). The global buttons include: Stop, Logoff, S. Stop, Alarm, Print, Start, and
Help. The Stop, S. Stop, STAT Rack (rack systems only), and Start buttons are also the
system control buttons. You can select the global buttons using the touchscreen.

A Global buttons

Figure A-29 Global buttons

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Windows

Windows containing additional information are displayed, overlaying part of


currently displayed screens or windows.
Windows function in a similar way to screens. Information in a window can be
entered or edited through list boxes, text boxes, and option buttons. Action buttons
are also available.

Confirmation Window Many functions require confirmation before they are performed (for example,
Delete).
Confirmation windows are used to confirm these functions. Choose Yes to confirm
the function and to close the confirmation window, or choose No to close the
confirmation window without carrying out the function.

Selection menu for multiple items

Sample Range Start and Select Samples buttons on the Workplace > Data Review
screen are used to select consecutive or non-consecutive samples in the sample list.

a To select multiple non-consecutive samples


1 Select the first sample from the list. The selected sample is highlighted with a blue
background, and the results of the tests performed on this sample are displayed in
the test results list.
2 Choose Select Sample. The Select Sample button changes to white
3 Select the next sample. Use the scroll bar to display samples that are further down
on the list.
4 Repeat steps 3 and 4 until you have selected all the required samples. The selected
samples are all highlighted with a blue background.

a To select a range of consecutive samples


1 Select the first sample in the required range from the sample list on the left of the
screen.
2 Touch Sample Range Start. The button title changes to Sample Range End and the
color turns white.
3 Select the last sample in the range from the list on the left of the screen. Use the
scroll bar to display samples that are further down on the list.
4 Touch Sample Range End. The selected samples are highlighted with a blue
background.

Screen access levels

Access to some screens, especially those of the Utility menu, is confined to the access
level of the user. Some screens are not accessible with the operator level logon, or can
not be edited. Some boxes can only be viewed at the administrator level logon.
e For more information, see User access levels in the Software description section of the
online Help.

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Online Help system

The cobas e 411 analyzer provides online documentation in the form of context-
sensitive Help. Context-sensitive means that wherever you are located within the
software, choosing the Help feature displays information relating to the current
screen or window. The online Help offers a quick and convenient way to find
information, such as explanations of screens and windows and how to perform
particular processes.

A ? Help button

Figure A-30 Online Help button

To view online Help, choose the ?Help button at the bottom left of the screen.

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Table of contents

Analyzer components

This chapter provides a detailed description of the components to be found in each of


the areas of the analyzer.

In this chapter Chapter 4


Overview of the analyzer components ......................................................................... 71
Sample/reagent area components ................................................................................. 72
Sample disk .............................................................................................................. 73
Rack sampler ............................................................................................................ 74
A-Line ................................................................................................................. 74
Input buffer ........................................................................................................ 74
B-Line ................................................................................................................. 75
Output buffer ..................................................................................................... 76
C-Line ................................................................................................................ 77
STAT rack position ............................................................................................ 78
Racks .................................................................................................................. 79
Sample/Reagent (S/R) probe .................................................................................. 80
Barcode readers ....................................................................................................... 80
Sample barcode reader ...................................................................................... 80
Rack barcode reader and sample sensor ........................................................... 83
Barcode card reading station ............................................................................ 84
Reagent rotor ........................................................................................................... 85
Reagent cap open/close mechanism ....................................................................... 86
Microbead mixer ..................................................................................................... 86
Probe/mixer rinse station ........................................................................................ 87
Sample/Reagent (S/R) pipetter ............................................................................... 88
Consumables area components .................................................................................... 89
Gripper unit ............................................................................................................. 90
Pipetting station ...................................................................................................... 91
AssayCup disposal opening ..................................................................................... 91
System water container ........................................................................................... 92
Liquid waste container ............................................................................................ 92
Direct liquid drain (optional) ................................................................................. 93
Solid waste tray and Clean-Liner ............................................................................ 96

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Measuring area components ......................................................................................... 97


Incubator ................................................................................................................. 97
Sipper probe and rinse station ................................................................................ 98
Sipper pipetter ......................................................................................................... 99
System reagents (ProCell and CleanCell) ............................................................. 100
Detector unit .......................................................................................................... 101

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Overview of the analyzer components

Overview of the analyzer components

The cobas e 411 analyzer components are located in the following areas:
o Sample/reagent area components, comprising:
o Sample disk
o Rack sampler
o Sample/Reagent (S/R) probe
o Barcode reader
o Barcode card reading station
o Reagent rotor
o Reagent cap open/close mechanism
o Microbead mixer
o Probe/mixer rinse station
o Sample/Reagent (S/R) pipetter
o Consumables area components, comprising:
o Gripper unit
o AssayCup disposal opening
o Pipetting station
o System water container
o Liquid waste container
o Solid waste tray and Clean-Liner
o Measuring area components, comprising:
o Incubator
o Sipper probe
o Sipper pipetter
o System reagents (ProCell and CleanCell)
o Detection unit

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Sample/reagent area components

The sample/reagent area, occupying the left half of the analyzer, consists of the
following components:
o Sample disk or rack sampler (rack system)
o Rack barcode reader (rack system)
o Sample/reagent (S/R) probe
o Barcode reader
o Barcode card reading station
o Reagent rotor
o Reagent cap open/close mechanism
o Microbead mixer
o Probe/mixer rinse station
o Sample/reagent (S/R) pipetter

Applies to disk system only

Applies to rack system only

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Sample disk

The sample disk has 30 positions for samples, calibrators, and controls. You may place
patient samples in either primary sample tubes or sample cups. Built-in adapters
allow intermixing of different-sized primary sample tubes.

e For details of sample tubes that may be used, see Sampling system on page A-40.

You may place sample cups [2 mL (Standard) Hitachi cups only] directly on the
sample disk or on top of 16 mm primary sample tubes.

For essential safety information, see Use of microcups on page A-17.

Figure A-31 Sample disk

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Rack sampler

The rack sampler consists of an A-Line, B-Line, C-Line, and STAT (Short Turn
Around Time) rack position.

A-Line
Specimens are placed in five-position racks and are loaded onto a tray. Once a tray has
been loaded, you can add additional racks to the tray one at a time during operation,
provided the tray indication light is green (on). If the light is out (off), the pusher arm
is preparing to move. The pusher arm, which is located at the far left of the A-Line,
pushes the racks forward and onto the B-Line.
The A-Line shown in the following figure, holds a tray that accommodates 15 racks at
one time.

Tray Tray Tray


Part 3 Part 2 Part 1

Ouput
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

A A-Line
Input
buffer
tray
indication
light

STAT
B C
A Tray indication light B Rack pusher arm C Input buffer (hidden)

Figure A-32 A-Line of the rack sampler

Input buffer
The input buffer, shown in the following figure, has space for an additional five racks.
Therefore, added to the 15 racks on the A-Line, you can have a total of 20 racks
holding 100 specimens on board at any one time.

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Tray Tray Tray


Part 3 Part 2 Part 1

Ouput
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light

STAT
Figure A-33 Input buffer of the rack sampler

B-Line
The B-Line transports the racks to the rack barcode reader. Here each position in the
rack is scanned for a sample barcode. After the last position is scanned, the barcode
reader scans the rack ID. After the last specimen is sampled, the rack is transferred
through the output buffer onto the tray on the C-Line.

Tray Tray Tray


Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
A tray
indication
light
STAT

A Rack barcode reader B Rack in B-Line

Figure A-34 B-Line of the rack sample

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Output buffer
Racks are off-loaded from the B-Line into the output buffer, shown in the following
figure. If there is no tray, up to five racks can enter the output buffer. At this point the
sampling procedure stops.

Tray Tray Tray


Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light

STAT
Figure A-35 Output buffer with racks

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C-Line
When the sixth rack moves into the output buffer, a rack is pushed onto the tray on
the C-Line, shown in the following figure. You can remove the tray from the C-Line
any time the tray indication light is green (on). If the light is out (off), the system is
preparing to push a rack onto the C-Line tray.

Tray Tray Tray


Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light

STAT
A
A Output buffer

Figure A-36 C-Line of the rack sampler

You cannot remove single racks from the C-Line; you must remove an entire tray at
one time. If you remove the tray, the system continues to push racks into the output
buffer. If the buffer fills and there is no tray, the analyzer issues an alarm and stops
sampling racks.

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STAT rack position


The STAT (Short Turn Around Time) rack position is located at the front of the
analyzer and is in line to feed directly onto the B-Line. Place a rack in the position as
directed on the label and press the STAT key. When the rack currently being sampled
is completed, the STAT rack is pushed onto the B-Line and is sent on to the rack
barcode reader and sampling position.

Tray Tray Tray


Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light

STAT
A
A STAT position

Figure A-37 STAT rack position of the rack sampler

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Racks
Sample cups, primary sample tubes, calibrator vials, or control vials are placed in
racks shown below. Each rack holds a maximum of five samples. Each tube slot
contains adapters that allow the rack to hold different sizes of primary sample tubes.
Each rack has a unique ID found on the barcode label on the back end of the rack.
This rack ID is read by the barcode reader and transferred to the system. It appears
both on the screens and on the reports.

A B C
A Rack ID barcode B Tray guide
C Slot for tube

Figure A-38 Racks

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Sample/Reagent (S/R) probe

The sample/reagent probe is located on the back left wall of the analyzer and is
mounted on an arm (S/R arm) that moves horizontally between the sample disk or
rack and the pipetting station. The probe uses disposable AssayTips to avoid sample
carryover and has liquid level and clot detection for accurate pipetting. Liquid level
detection is accomplished by capacitance measurement. Clot detection is
accomplished by a pressure transducer.
Every new pipetting sequence uses a new AssayTip. For example, a TSH assay uses one
AssayTip for R1, R2, and the sample, and an additional new AssayTip for the
microbeads.
The AssayTip is washed externally at the rinse station between each aspiration step.
Additional AssayTips are used for sample dilutions or pretreatment.

A AssayTip

Figure A-39 S/R probe with AssayTip

Ensure that there is no foam on the surface of the sample.

Barcode readers

Sample barcode reader


The sample barcode reader is located toward the back wall of the analyzer.
During a sample scan, the barcode reader scans the information on the barcode-
labeled primary sample tubes, calibrators, or controls and transmits it to the software.
During a reagent scan, the barcode reader rotates to the reagent rotor side to read the
two-dimensional barcode labels on the reagent packs.
e For further information, see Reagent barcode label on page A-46.

The barcode reader is auto-discriminating, allowing the use of various types of


barcodes during operation. This barcode reader also reads PDF417 barcodes.

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e For additional information, refer to Reagent concept on the COBI-CD.

You can see the barcode reader on a rack system when the reagent rotor is removed.
To read barcode labels, the barcode reader rotates between the reagent rotor and the
barcode card reading station.

e For further information, see Barcode card reading station on page A-84.

A second barcode reader scans sample barcodes and rack ID barcodes.


e For information on this second barcode reader, see Rack barcode reader and sample sensor
on page A-83.

You can see the barcode reader on a disk system when either the sample disk or
reagent rotor is removed.

e For the location of the barcode reader on a disk system, see Figure A-40 (viewed from the
sample disk side) and Figure A-41 (viewed from the reagent rotor side).

To read barcode labels, the barcode reader rotates between the sample and reagent
rotors and the barcode card reading station.
e For further information, see Barcode card reading station on page A-84.

A Slot for calibrator or control barcode card B Barcode reader slot

Figure A-40 Barcode reader (sample disk side)

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A Barcode reader slot

Figure A-41 Barcode reader (reagent rotor side)

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Rack barcode reader and sample sensor


The rack barcode reader reads both sample barcode labels and the rack barcode label.
The barcode reader is auto-discriminating, allowing the use of various types of
barcodes during operation. The barcode symbologies that can be read include the
following:
o NW7 (Codabar)
o Code 39
o Code 128
o Interleaved 2 of 5
In addition to the barcode reader, there is also a sample sensor which detects whether
there is a tube available in the rack position.

A Barcode reader slot B Sample sensor window

Figure A-42 Rack sample barcode reader

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Barcode card reading station


At this station, the barcode reader scans calibrator and control information from the
calibrator or control barcode card. These cards are packed in calibrator or control
kits. When the barcode card is inserted, the barcode must face toward the back of the
analyzer.
e For further information, see:
Calibrator barcode cards on page A-49
Control barcode cards on page A-51

On a disk system, the barcode reading station is located between the sample disk and
reagent rotor.

Figure A-43 Barcode card reading station (disk system)

On a rack system, the barcode reading station is located to the back left of the reagent
rotor.

Figure A-44 Barcode card reading station (rack system)

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Reagent rotor

The reagent rotor contains 18 positions for assays, diluent, or pretreatment reagents.
These 18 positions can be used in any combination. There are restrictions on the
maximum number of each type of reagent that can be placed on the disk.

Figure A-45 Reagent rotor

The reagent rotor is temperature controlled at 20 3C.


You can place diluent or pretreatment reagent in any position on the reagent rotor. You can load
more than one reagent pack on the reagent rotor for each test.

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Reagent cap open/close mechanism

To prevent reagents from evaporating, and to promote ease of use, the reagent rotor
uses a reagent cap open/close mechanism during reagent pipetting. The mechanism is
located on the back wall of the reagent rotor compartment and emerges when
reagents need to be opened or closed. Caps are opened before pipetting or mixing the
specific reagent (for example, M, R1, or R2) and are closed when pipetting or mixing
for the specific reagent (for example, M, R1, or R2) is completed.

Figure A-46 Reagent cap open/close mechanism

The reagent cap open/close mechanism is normally hidden beneath the cover of the reagent disk
and cannot be seen in use.

Microbead mixer

The mixer is used to mix the microbeads to ensure a homogeneous suspension before
aspiration. The mixer is located to the right of the reagent rotor. In its home position,
it occupies the space directly to the left of the S/R probe.

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Figure A-47 Microbead mixer

Probe/mixer rinse station

The rinse station rinses the AssayTip or mixer externally with system water between
aspirations or before and after microbead mixing. The rinse station is located below
the S/R probe and mixer when the probe is in its Standby position and the mixer is in
its home position.

A
B

A S/R probe rinse station B Microbead mixer rinse station

Figure A-48 Rinse station

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Sample/Reagent (S/R) pipetter

The S/R pipetter is located on the back right of the analyzer. The pipetter is filled with
system water and uses positive displacement to aspirate and dispense from the S/R
probe.

A Sample/reagent pipetter

Figure A-49 Sample/reagent (S/R) pipetter

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Consumables area components

Consumables area components

The consumables area is on the right of the analyzer and consists of the following
components:
o Three AssayTip trays
o Three AssayCup trays
o Gripper unit
o AssayCup disposal opening
o Liquid waste container
o Solid waste tray and Clean-Liner
o System water container
One AssayTip tray holds up to 120 AssayTips, and one AssayCup tray holds up to 60
AssayCups. Therefore, a total of 360 AssayTips and 180 AssayCups can be placed on
the analyzer.

Figure A-50 AssayTip tray and AssayCup tray

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Gripper unit

The gripper can move in three directions:


o X (left and right)
o Y (forward and back)
o Z (up and down)
It is equipped with gripping fingers for gripping AssayTips or AssayCups. The gripper
takes an AssayTip from the AssayTip tray, or an AssayCup from the AssayCup tray,
and delivers it to the pipetting station. The gripper then moves the AssayCup to the
incubator, then to the aspiration station, and finally to the AssayCup disposal
opening.
During operation, the analyzer starts using AssayTips and AssayCups from tray 1,
position 1. As soon as tray 1 is empty, the analyzer starts using tray 2. As soon as tray
2 is empty, the analyzer continues with tray 3.
e For further information, see To replace AssayCup and AssayTip trays on page B-30.

z axis
B

A C

D
y axis

x axis

A Position 1 B Position 2
C Tray 3 D Tray 2
E Tray 1

Figure A-51 Gripper and trays

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Pipetting station

A five-position pipetting station is located to the upper left of the incubator.


AssayCups and AssayTips are moved by the gripper to this location for sample
pipetting, reagent pipetting, sample dilution, and sample pretreatment.
The AssayTips are discarded at the AssayTip eject station at the far right of the station.
Positions 1 and 2 are used for AssayTips, and positions 3 and 4 are used to hold
AssayCups for dilution or pretreatment. The S/R probe pipettes samples and reagents
at position 5.

A B C

D
A AssayTip positions 1-2 B AssayCup positions 3-5
C AssayTip eject station D AssayCup disposal opening

Figure A-52 Pipetting station

AssayCup disposal opening

AssayCups are discarded through a disposal opening located directly to the left of the
incubator.
e See Figure A-52 on page A-91 for the location of the AssayCup disposal opening.

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Consumables area components

System water container

The system water container is located in front of the pipetters. It holds three liters of
distilled water plus SysWash which should be added to prevent bacterial growth and
avoid reagent carryover.
An alarm is issued when the system water container is empty. A float mechanism
sensor, located beneath the aspiration inlet, triggers the alarm on the Inventory
screen.

Removing the system water container during operation causes the analyzer to enter P. Stop status.

Figure A-53 System water container

Liquid waste container

The liquid waste container is located in front of the ProCell and CleanCell reagents. It
holds four liters of waste and issues an alarm when it is approximately three-quarters
full. The alarm is triggered by a weight-sensitive mechanism that activates a
photosensor located in the compartment holding the container. An alarm is also
issued when the container is improperly positioned. This alarm is triggered by a plate
mechanism that activates a photosensor located at the front of the compartment.

Removing the liquid waste container during operation or an improperly positioned container
causes the analyzer to enter E. Stop status.

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Figure A-54 Liquid waste container

Direct liquid drain (optional)

The liquid waste container is not installed if the direct drain option is used.
Installation of the direct drain option or any container size change must be
undertaken by Roche service personnel, as there are software implications.
The direct drain is an optional system that routes the flow of the waste solution
directly into a prepared container, or the facility drainage. A reserve tank is provided
in front of the ProCell and CleanCell reagents to store the waste solution temporarily
if a problem arises with the flow.

A Tank inlet

Figure A-55 Direct drain reserve tank

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The tank can hold up to one Liter of waste solution, and the analyzer will enter S. Stop
mode when the liquid reaches a predetermined level. A tube extends from the right
side of the analyzer to the tank.

A
A Drain port

Figure A-56 Direct drain tube

Flow stagnation, or leaks may occur if the drain tube is bent or pinched. Check the condition of the
drain tube every day.

Do not connect any extension to the drain tube. It may cause flow stagnation.

If the reserve tank gets full, the analyzer will enter S. Stop mode. Check if the drain tube is bent or
pinched, and ensure that it is correctly placed. If you cannot find the cause, or if the tube is clogged,
contact a Roche service representative. Do not try to unclog the drain tube.

Figure A-57 Correct drain tube placement

Figure A-57 shows two examples of correctly installed drain tubes, running
horizontally or sloping downwards. The tube must not be bent, pinched, placed
above the level of the drain port, or form a U-bend along any part of its course.

Hands shown in photos and illustrations in the Operators Manual and online Help are to be
considered as hands covered with approved disposable gloves.

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Figure A-58 Incorrect drain tube placement

The drain tube must not be placed as shown in the examples in Figure A-58. The tube
on the left runs upward from the drain port. The tube on the right is forming a U-
bend. In both cases, flow stagnation will occur.

A B
A Incorrect B Correct

Figure A-59 Correct and incorrect drain tube end placement

Make sure that the end of the tube does not touch the liquid surface, as this may stop
the flow (see Figure A-59).

To prevent clogging in the flowpath, pour approximately 100mL distilled or deionized water into
the tank inlet after each day's operation. See Clean the Direct Drain Flowpath in the Maintenance
chapter.

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Solid waste tray and Clean-Liner

The solid waste tray and Clean-Liner is located behind the front access door on the
analyzer. Used AssayCups and AssayTips are discarded into the waste tray during
operation.
A disposable Clean-Liner is placed inside the solid waste tray. The Clean-Liner has a
sliding cover to reduce potential splashing and to prevent AssayTips and AssayCups
from falling out of the tray upon removal from the analyzer. The sliding cover must be
open during operation. The tray shakes periodically during operation so that used
AssayTips and AssayCups do not accumulate at one end of the tray.
An alarm is issued if the solid waste tray is full (a maximum of 1100 AssayTips and
AssayCups) or if the solid waste tray and Clean-Liner are missing. A photosensor
monitors the presence of a tray. The amount of solid waste in the tray is displayed in
the Inventory area of the System Overview screen.
e For further information, see:
Empty the solid waste on page C-42

Removing the solid waste tray during operation causes the analyzer to enter E. Stop status.

Figure A-60 Solid waste tray and Clean-Liner

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Measuring area components

Measuring area components

The measuring area consisting of the following components:


o Incubator
o Sipper probe and rinse station
o Sipper pipetter
o System reagents (ProCell and CleanCell)
o Detector unit
The sipper probe aspirates the incubated reaction mixture into the detector unit for
determination of results.

Incubator

The incubator is maintained at a specific temperature (37.0C 0.3C) for the


reaction of the sample and the reagents that have been dispensed into an AssayCup.
The incubator has 32 positions.
When an assay is ready for measurement, the AssayCup is transferred by the gripper
to the aspiration station, and the sipper probe aspirates the reaction mixture for
measurement. The aspiration station, located in the lower right corner of the
incubator, is not temperature controlled.

A B
A Incubator positions B Aspiration station

Figure A-61 Incubator

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Sipper probe and rinse station

The sipper probe aspirates the reaction mixture into the measuring cell, and also
aspirates ProCell and CleanCell. It is located to the right of the incubator.
The sipper rinse station externally washes the sipper probe with system water between
measurements. When the sipper probe is in its Standby position, it is located directly
above the rinse station.

Figure A-62 Sipper probe and rinse station

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Sipper pipetter

The sipper pipetter is located directly to the right of the sample/reagent pipetter,
behind the liquid waste container. It uses positive displacement of system water to
aspirate and dispense from the sipper probe.

A Sipper pipetter location

Figure A-63 Sipper pipetter

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System reagents (ProCell and CleanCell)

ProCell and CleanCell are located in bottles in the pipetter area, behind the liquid
waste container.
o ProCell is the buffer solution containing tripropylamine (TPA). ProCell bottles
are identified by white caps.
o CleanCell is the cleaning solution used to clean the measuring cell after
measurement. CleanCell bottles are identified by black caps.
Two bottles of each reagent are stored on the analyzer, temperature controlled at
28.0C 2.0C. The keyed shape of the reagent compartment ensures that the reagent
can only be placed in the proper position.
A transparent sipper shield is fitted to the pipetter area. The sipper shield must be
opened to gain access to the system reagent bottles. It is opened and closed by
applying pressure to the white metal area at the top until the latch is released or
engaged. The sipper shield should not be opened during operation, otherwise the
analyzer will immediately stop processing and an alarm will be issued.

For essential safety information, see Sipper shield on page A-16.

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A B C

E FG H I

A Sipper shield latch B Bottle set 2


C Bottle set 1 D Sipper shield (in the open position)
E Position 1 (ProCell position) of bottle set 2 F Photosensor
shown with bottle removed
G Position 2 (CleanCell position) of bottle set 2 H Position 1 (ProCell position) of bottle set 1
shown with bottle removed
I Position 2 (CleanCell position) of bottle set 1

Figure A-64 ProCell (PC) and CleanCell (CC)

For essential safety information, see Photosensors on page A-15.

When starting from Standby, the sipper probe always attempts to first use ProCell and
CleanCell from bottle set 1. If the quantity is insufficient, bottle set 2 is used. When
starting from S. Stop or R. Stop, the bottle set in use when the analyzer was previously
in operation is pipetted.
The analyzer can operate with just one bottle of ProCell and one bottle of CleanCell
reagent, but they must be placed together either as bottle set 1 or as bottle set 2.

Detector unit

The detector unit receives the incubated reaction mixture aspirated from the sipper
probe.
e Information on the detector unit measuring cell is provided on the COBI-CD.

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Operation B

5 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
6 Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7
7 Special operation: How to . . . . . . . . . . . . . . . . . . . . . . . . . . . B-91
cobas e 411 analyzer 5 Overview
Table of contents

Overview
This chapter describes the Operation Guide, the disk and rack symbols, and the
software keyboard associated with the cobas e 411 analyzer.

In this chapter Chapter 5


Operation Guide ............................................................................................................. 5
Disk and rack systems ..................................................................................................... 5
Software keyboard ........................................................................................................... 5

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Table of contents

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Operators Manual Version 1.0 B-4
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Operation Guide

Operation Guide

This Operation Guide contains quick reference procedures for operating the Roche
Diagnostics cobas e 411 Immunoassay Analyzer. This Operation Guide can be used
for training purposes. More detailed information can be found in the Reference
Guide, Software Guide and Users Guide.
In the Operation Guide, you will find:
o Daily operating procedures
o Daily maintenance procedures
o Tips and quick references to further subjects (How To...)
o Procedures for special tasks that are not usually part of the daily work flow.

Disk and rack systems

The cobas e 411 analyzer is available as both a disk system and a rack system. The
differences between the two configurations are detailed throughout this operator's
manual.
To assist you in quickly identifying information that is specific to either the disk or
rack system, one of the following symbols is present to the left of the text.

Applies to disk system only

Applies to rack system only

Software keyboard

A software keyboard of the appropriate type is displayed on the touchscreen as


required. Depending on the type of input allowed, either numeric keys or a full
keyboard are displayed as required.
The figures below show both types of software keyboard.

Figure B-1 Numeric software keyboard

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Software keyboard

Figure B-2 Full (alphanumeric) software keyboard

e For a more detailed description, see Software keyboard on page A-56.

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Table of contents

Daily operation

This chapter describes the everyday tasks that are required for running the
cobas e 411 analyzer. Common procedures that are performed as part of the daily
work flow are also described here.

In this chapter Chapter 6


Overview ........................................................................................................................ 11
Pre-start inspection ....................................................................................................... 12
Check list for daily operation ................................................................................. 12
Switch the printer on .............................................................................................. 13
Switch the analyzer on ............................................................................................. 13
Check system alarms ............................................................................................... 17
Pre-routine operation ................................................................................................... 18
System Overview screen .......................................................................................... 18
Color scheme of the System Overview screen ........................................................ 19
Reagent overview ..................................................................................................... 19
Inventory area ................................................................................................... 20
Reagent Detail window .................................................................................... 21
Work Flow Guide .................................................................................................... 22
Maintenance ...................................................................................................... 22
Sample Data Clear ............................................................................................. 22
Reagent Load List .............................................................................................. 22
Calibration/QC Load List ................................................................................. 23
Replacing required reagents and consumables ...................................................... 23
Replacing reagent packs .................................................................................... 23
Replacing system reagents ................................................................................. 25
Checking the system water container ............................................................... 26
Checking the liquid waste container ................................................................ 27
Checking the external direct drain system (if fitted) ....................................... 29
Emptying the solid waste tray ........................................................................... 29
Replacing AssayCup and AssayTip trays .......................................................... 30
Routine operation ......................................................................................................... 31
Perform calibration and QC ................................................................................... 32
Prepare calibrators and controls ....................................................................... 32
Load calibrators and controls ........................................................................... 32

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Scan calibrator and control barcode cards ....................................................... 33


Load the sample disk and request calibration .................................................. 33
Load the racks and request calibration ............................................................ 34
Activate QC test ................................................................................................. 36
Measure calibrators and controls ...................................................................... 36
Validate calibration and control results .................................................................. 38
Accumulate QC results ...................................................................................... 41
Correct placement of 13 mm sample tubes on a sample disk ............................... 41
Correct placement of 13 mm sample tubes on a rack ........................................... 43
Routine sample measurements: disk system .......................................................... 45
Patient programming for interfaced, barcoded samples ................................. 45
Patient programming for interfaced, non-barcoded samples ......................... 47
Patient programming for non-interfaced, barcoded samples ......................... 48
Patient programming for non-interfaced, non-barcoded samples ................. 50
Routine sample measurements: rack system ......................................................... 53
Patient programming for interfaced, barcoded samples ................................. 53
Patient programming for interfaced, non-barcoded samples ......................... 54
Patient programming for non-interfaced, barcoded samples ......................... 56
Patient programming for non-interfaced, non-barcoded samples ................. 58
Measurement of additional routine samples ......................................................... 60
Continuous loading using the single disk mode .............................................. 60
Continuous loading using the multiple disk mode ......................................... 62
Continuous loading using the rack system ...................................................... 62
STAT test selections: disk system ............................................................................ 63
STAT patient programming for interfaced, barcoded or non-barcoded samples
63
STAT patient programming for non-interfaced, barcoded or non-barcoded
samples ............................................................................................................... 65
STAT test selections: rack system ............................................................................ 67
STAT patient programming for interfaced, barcoded samples ....................... 68
STAT patient programming for non-interfaced, barcoded or non-barcoded
samples ............................................................................................................... 69
STAT patient programming for interfaced, non-barcoded samples ............... 72
Dilution .................................................................................................................... 74
Manual predilution of samples ........................................................................ 75
Automatic dilution by the analyzer ................................................................. 75
Sample tracking: disk system .................................................................................. 76
Sample tracking: rack system .................................................................................. 77
Loading consumables during operation ................................................................ 79
Results ............................................................................................................................ 81
View patient results ................................................................................................. 82
Filter patient results ................................................................................................. 84
Print or upload patient results ................................................................................ 84
Completion Conditions area options ............................................................... 85
Printer Connection area options ...................................................................... 85
Automatic Printout area options ...................................................................... 85
Print a Result Report ............................................................................................... 85
Post-operation data management ................................................................................ 87
Review results .......................................................................................................... 87

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Table of contents

Delete documented samples ................................................................................... 87


Daily maintenance ......................................................................................................... 87
Switch off the analyzer ................................................................................................. 88
Prevent evaporation of the system reagents ........................................................... 88
Final power off checks ............................................................................................. 90

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Operators Manual Version 1.0 B-9
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Table of contents

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Operators Manual Version 1.0 B-10
cobas e 411 analyzer 6 Daily operation
Overview

Overview

Daily operation encompasses the routine tasks that are required to prepare the
system, analyze samples and maintain the system. The layout of the System Overview
screen gives the operator an intuitive guide for the tasks required for routine
operation.
The sections in this chapter contain detailed descriptions explaining how to
accomplish various daily operational tasks. The following diagram gives an overview
of the daily operation process.

Pre-start inspection

Switch on
(Initialization and Standby)
Check alarm button

Pre-routine operation

Routine operation
Rerun Calibration and control
Assigned Routine or STAT(a) sampling
------------------------------------------------------
Results

Sampling Stop
(Finalization, Stop, and Standby)

Maintenance

Switch off

Additional maintenance

(a)
Short Turn Around Time

Figure B-3 work flow diagram

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Pre-start inspection

Pre-start inspection

Before switching on, check the following aspects of the system:


o The system water container is full of distilled water with SysWash added to a
dilution ratio of 100+1.
o The waste solution container is empty.
o All surfaces are clean and clear of loose articles or debris.
o Probes and microbead mixer paddle are in good condition and not bent.
o No tubing is pinched or bent.
o Pipetter syringes and associated tubing are free of bubbles and are not leaking
system water.
o Required system reagents are on board.
If any problems arise, refer to the maintenance and troubleshooting chapters.

Check list for daily operation

Procedure Software tab or screen


Startup procedures
m Perform pre-start inspection (None)
m Switch on (None)
m Log on Logon screen
m Open the lids on the ProCell and CleanCell bottles (None)
m Check system alarms Alarm screen
m Perform troubleshooting on any alarms (if necessary) (None)
m Clear sample data Sample Data Clear window
m Print a reagent load list System Overview screen > Reagent Load List
m Replace required reagents (None)
m Replace AssayCup and AssayTip trays (if necessary) (None)
m Fill system water container with distilled water and SysWash (None)
m Empty solid waste (if necessary) (None)

Instrument Calibration/Quality Control


m Check if calibration or QC is requested by the system. Calibration/QC Load List
If not, select calibration or QC manually.
m Request controls Calibration/QC Load List
m Prepare calibrator and control material (if needed) (None)
m Load required calibrators and controls (None)
m Measure calibrators and controls Start Conditions screen
m Validate calibration and control results (None)

Table B-1 Daily operation check list

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Pre-start inspection

Procedure Software tab or screen


Sample Processing
m Program patient samples (if needed) (Performed at the host)
m Load patient samples (None)
m Start processing Start Conditions screen
m Track sample processing Sample Tracking window

Result evaluation
m Print reports Data Review screen
m Review results Data Review screen
m Delete documented samples Data Review screen

Daily maintenance
m Clean the S/R probe (None)
m Perform Finalization maintenance (if needed) Finalization window
m Switch off Shutdown window

Table B-1 Daily operation check list

Switch the printer on

If the printer is not already on, switch it on. Check that the printer paper supply is
adequate.
e Refer to the appropriate printer documentation for details, as the analyzer may be used
with several printer models. For further information, and a list of recommended printers,
see External printer on page A-58.

Switch the analyzer on

When the analyzer is in service, leave the circuit breakers set to On so that the analyzer
continues to regulate the temperature of reagent rotor. Use only the operation switch
to switch on or off the analyzer at the start and end of the day. However, if you have
had to shut down the analyzer completely, you need to switch the circuit breakers
back on before switching on the analyzer.

Use of the screen saver


In normal operation, the monitor will remain powered for prolonged periods. To preserve the image
quality of the monitor, Roche recommends that you enable the screen saver.
Use the Utility > System screen to activate the screen saver.

When the system is switched on, it performs initialization before entering Standby
mode.

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Pre-start inspection

a To switch on the circuit breakers


1 Switch on the circuit breaker, located on the right side of the analyzer, if it is not
already switched on.

2 Switch on the rack transport system circuit breaker located on the left side of the
analyzer (rack systems only).
If the rack transport system circuit breaker is not turned on then a yellow pop up
window appears on the screen with the message: Line main power off .

Always keep the analyzer switched on at the circuit breaker. Power from the circuit breaker keeps
the reagent rotor temperature-controlled.

a To switch the analyzer on


1 Switch the analyzer on at the operation switch, located on the front panel.

Figure B-4 Operation on/off switch location

A small green light on the switch lights when the system is on, and the Logon
screen is displayed while the system performs initialization. During initialization,
the mechanisms are reset to their home positions.
2 After initialization is complete, ensure that the screen displays a Standby status.

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Pre-start inspection

a To open the lids of the system reagents

For essential safety information, see Sipper shield on page A-16.

1 Open the sipper shield by pressing the white metal area at the top, as shown in the
following figure, until the latch is released.

A Press here to open or close the sipper shield

Figure B-5 Open the sipper shield

2 Open the lids on the ProCell and CleanCell bottles.

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Pre-start inspection

Figure B-6 Open lids of ProCell/CleanCell

3 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.

.
Do not open the sipper shield during a run, as the action will interrupt the run.

a To log on to the system


1 When the system has started and the Logon window appears, type your Operator
ID and password.

If the screen remains black when you switch on the analyzer, check the circuit breaker. If the circuit
breaker is off, switch it on. The analyzer should then power up.

Figure B-7 Logon window

2 Choose the Logon button on the window to log on and gain access to the software.
The Operator ID will be shown at the top of all screens, next to the date.

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Pre-start inspection

Check system alarms

If an alarm has been issued, there is a sound warning and the Alarm global button
shows red or yellow. The Alarm button can open the Alarm screen from the first
screen that appears, even if no log on has been performed. The Alarm screen
identifies any system alarm conditions.
You can sort the list of alarms according to the criteria shown in the headers that
appear above the list. For example, if you choose Level, the system sorts the list
according to the severity of the alarms.

Figure B-8 Alarm screen

a To review the Alarm screen


1 Choose the Alarm global button to display the Alarm screen.
2 Select each alarm to view the description and remedy (displayed in the lower half
of the screen).
3 Correct any alarm conditions by following the remedies outlined in the system
software.
If any problems arise, refer to the Troubleshooting chapter.
4 Choose Close to close the Alarm screen. When the Logon screen appears, continue
with the log-on procedure.
e See To switch on the circuit breakers on page B-14.

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Pre-routine operation

Pre-routine operation

Before you can start routine operation you must first prepare the system.

System Overview screen

Figure B-9 System Overview screen

The System Overview screen has a central role within the cobas e 411 analyzer
software. From here you have an overview of the whole system at any time. This
screen displays the status of each reagent, the details of the reagents loaded, and
details of the inventory. You can access other windows by choosing the corresponding
button or area of the screen. You can use the Work Flow Guide to prepare the system
for daily routine operation.
You can open the System Overview screen from any screen by choosing the double
status icon in the top left corner of the screen. The colors of the two halves of this icon
show you the status of the host communication and the analyzer.

Icon Color Meaning


Host Blue Host communication on the cobas e 411 analyzer side is set to Off
(independently of the availability of host communication).
Green Host communication on the cobas e 411analyzer side is set to On
(independently of the availability of host communication).

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Icon Color Meaning


E Blue The analyzer is in Initialization, Operation, or Maintenance mode.
Green The analyzer is in Standby mode.
Yellow An instrument alarm has been raised with a caution level. This could
mean the number of tests remaining for a reagent is less than the caution
level specified on the Reagent Level Check window.
Red An instrument alarm of Stop, S.Stop, or E.Stop has been raised.

Color scheme of the System Overview screen

The System Overview screen uses color to display the system status. The following
table gives the meaning of the color for each button in the Work Flow Guide area.

Button in Work Flow Guide area Color Meaning


Maintenance Blue System ready
Yellow Remaining time is below the yellow alarm caution level
Red Caution. Maintenance action is required. A mechanical
problem may have occurred that requires a manual reset.
Sample data clear Blue System ready
Yellow 80-90% of the database capacity is reached. It is
recommended that the operator delete the results.
Red The database is full. The operator should delete the results.
Reagent Load list Blue System ready
Yellow At least one parameter falls below the daily requirement limit
Red A reagent for at least one test is unavailable
Calibration/QC load list Blue System ready
Yellow One of the following conditions: applies:
o Calibrations change over
o Failed calibration
o Timeout
o QC violation

Reagent overview

Figure B-10 Reagent Overview area

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Pre-routine operation

Use the Reagent Overview area of the System Overview screen to view the status of the
consumables on board. Reagent Overview area consists of two sub-areas: the Reagent
area and the Inventory area.

Reagent Rotor Graphic Choosing a position segment of the reagent rotor section displays the Reagent Detail
window, with details of the reagent loaded in the chosen position. The color of the
segments of the Reagent Rotor graphic indicate the status of reagents, calibrators, and
controls.

Inner block: reagent pack Active Reagent pack currently in use for this test.

Warning Remaining tests in this reagent pack below yellow alarm level
(Utility > System (Page 2/3) > Reagent Level Check).
Caution No more reagent available for this assay on the analyzer, or no
diluent on the rotor, or no pretreatment.
Stand-by This is a standby reagent pack.

Zero tests, Used up The reagent pack has been used and is empty. There is still
reagent available in another reagent pack on the analyzer.
Free Pos. There is no reagent pack in this position.

Expired. The reagent pack has passed its use-by date.

Middle block: Calibrator Valid A calibration has been successfully generated.

Requested A calibration has been requested.

Failed Calibration of the reagent has failed.

Outer block: QC Valid QC result is within the confidence limits.

Requested Requested for QC measurement.

Violated QC result is not within the confidence limits.

Expired. The control has passed its use-by date.

Inventory area
This area displays the amount of system reagents, AssayCups, AssayTips, and solid
waste on the analyzer by means of seven bar-charts.

PC1/PC2 The blue bar indicates the amount of ProCell (PC) remaining, with a % figure below.
The PC1 column represents bottle 1 and PC2 bottle 2.

CC1/CC2 The blue bar indicates the amount of CleanCell (CC) remaining, with a % figure
below. The CC1 column represents bottle 1 and CC2 bottle 2.

Solid waste The gray bar indicates the amount of solid waste present in the solid waste container,
with the quantity displayed below (0=empty).

Vessel The blue bar indicates the amount of AssayCup trays remaining, with the quantity
displayed below.

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Tip The blue bar indicates the amount of AssayTip trays remaining, with the quantity
displayed below.

Reagent Detail window


h System Overview > and then select a position on the reagent rotor graphic

Figure B-11 Reagent Detail window

Use this window to view detailed information about the reagent loaded in the
position selected in the Reagent area of the System Overview screen.

Test The short name of the test for which the reagent pack is used.

Position The position the reagent pack occupies in the reagent rotor.

Reagent Type The type of reagent used (for example, ASSAY).

Reagent Lot No. The lot number of the current reagent pack.

Reagent Pack No. The sequence number of the current reagent pack.

Lot Expiration Date The expiration date of the current reagent pack lot.

First Registration Date and Time The date and time that the current reagent pack was first registered by the system.

No. of determinations This column displays the number of determinations remaining for the corresponding
reagent.

Last Calib Date (L-Calib) The date of the last lot calibration of the current reagent pack.

recommended at The recommended date for the next lot calibration

Last Calib Date (R-Calib) The date of the last reagent pack calibration of the current reagent pack

recommended at The recommended date for the next reagent pack calibration

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Pre-routine operation

Work Flow Guide

The Work Flow Guide area at the top of the System Overview screen is a step-by-step
guide through the preventive action.

Figure B-12 Work Flow Guide area

The Work Flow Guide area consists of six buttons: Maintenance, Sample Data Clear,
Reagent Load List, Calib/QC Load List, Parameter Download, and Sample Tracking.
The color of each button varies, depending on the status. Choosing these buttons,
displays screens and windows that enable users to take actions appropriate to the
situation.

Maintenance
Use Maintenance on the System Overview screen to perform maintenance actions.
Choosing Maintenance displays the Maintenance screen.

Sample Data Clear


Choose Sample Data Clear when the button is red or yellow to display the Sample
Data Clear window.

Figure B-13 Sample Data Clear window

Use the Sample Data Clear button to delete the sample results. Sample Data Clear
deletes all records of the samples and moves QC data to the QC view. Regular backing
up is recommended. If your system is connected to a host, make sure that all data has
been uploaded before performing Sample Data Clear.
e See How to archive sample data on page B-99.

Sample clear
It is strongly recommended that a sample clear is performed daily.

Reagent Load List


The Reagent Load List displays the reagents packs, reagent bottle sets, and other
consumables that need to be replenished on the system.

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a To print a Reagent Load List


1 Choose Reagent Load List on the System Overview screen.
A confirmation window is displayed.
2 Choose Yes to print the Reagent Load List.
3 Replace any required reagent, diluent or pretreatment reagent.
Ensure that reagent packs have not exceeded their expiration date.

You can also print a Reagent Load List from the Reagent tab of the Print global screen.

Calibration/QC Load List


The Calibration/QC Load List report describes in detail the calibrator that should be
loaded, and displays information about the requested measurement for each control.

a To print a Calibration/QC Load List


1 Choose Calib/QC Load List on the System Overview screen.
A confirmation window is displayed.
2 Choose Yes to print the Calibration/QC Load List.

You can also print a Calibration/QC Load List from the Reagent tab of the Print global screen.

Replacing required reagents and consumables

Replace all required reagent packs and system reagents as indicated by the Reagent
Load List. Ensure that reagent packs have not exceeded their expiration date.

For essential safety information, see Handling of reagents on page A-8.

Replacing reagent packs


Load reagents on the reagent rotor as directed by the Reagent Load List.

When you manually register a reagent pack, you must confirm that you have placed it in the correct
position.

For essential safety information, see Replacing reagent packs on page A-10.

e For further information, see:


Reagent Load List on page B-22
Reagent rotor on page A-85

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6 Daily operation cobas e 411 analyzer
Pre-routine operation

a To replace reagent packs


1 Open the reagent rotor cover by rotating it to the left until it reaches the stop, and
then lift it clear.

Figure B-14 Open/close the reagent rotor cover

2 Place the required reagents in the reagent rotor, ensuring that the reagent packs
are correctly oriented in the rotor.

Reagents on the reagent rotor are stored in temperature controlled conditions. If you plan to run
assays that currently are not stored on the analyzer, you must allow them to reach reagent rotor
temperature (20 3C) before starting analysis.

Figure B-15 Load new reagents, if necessary

3 Close the reagent rotor cover. The analyzer will not operate without the cover on
the disk.

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Pre-routine operation

The reagent rotor cover is keyed. It must be properly oriented, so that the cover fits into the key,
before it can be closed.

4 Choose Scan Reagent on the System Overview screen to activate a reagent scan.
When the reagent scan is complete, the reagent rotor indicator on the System
Overview screen is updated to displays the status of each reagent pack placed on
the reagent rotor.

Replacing system reagents


You must always replace ProCell and CleanCell bottles as sets. You must not exchange
them during a run.
e See System reagents (ProCell and CleanCell) on page A-100.

For essential safety information, see Replacing system reagents on page A-10.

a To replace system reagents


1 Lift the instrument cover.

For essential safety information, see Sipper shield on page A-16.

2 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
e For the location of the sipper shield, see Figure B-5 on page B-15.

Always replace ProCell and CleanCell bottles as sets. If you remove and replace a full (100%
volume) bottle from one of the system reagent compartment positions containing a photosensor, the
analyzer assumes that you have loaded a new bottle set, even if the bottle has been on the analyzer
for several hours or days. The analyzer consequently waits 15 minutes for temperature
equilibration, as is normal for a new bottle set.
If you need to load two new bottle sets of ProCell/CleanCell, load these new bottles as your first
inventory check. By the time you are ready to operate, the system reagents should be at the correct
temperature. If they are not, you will receive ProCell/CleanCell reagent temperature alarms.

e For further information on these alarms, refer to Data alarms on page D-31.

The bottles on the right (Set 1) are consumed first. If replacing the bottles on the right, move the
bottles from the left (Set 2) to the right. Then load the new bottles in the correct positions of Set 2.

For essential safety information, see Photosensors on page A-15.

3 Remove the empty ProCell and CleanCell bottles, indicated in the inventory area
on the System Overview screen, and replace them with a set of full bottles. Ensure
that each bottle is firmly in place in the correct position with the correct
orientation. Place ProCell only in the left hand position of each bottle set and

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Pre-routine operation

CleanCell in the right hand position. The keyed shapes of the reagent
compartment and reagent bottles ensure that the reagents are placed in the proper
position.

A B

C D E F
A Bottle set 2 B Bottle set 1
C ProCell position (bottle set 2) D CleanCell position (bottle set 2)
E ProCell position (bottle set 1) F CleanCell position (bottle set 1)

Figure B-16 System reagent positions

4 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
5 Close the instrument cover.
6 If a ProCell bottle with a new lot number was loaded, select Reagent and choose
the Inventory Set button. The Inventory Set pop-up window is displayed. Here
you can type in the lot number for each of the ProCell and CleanCell.

For essential safety information, see Air bubbles or films in system reagents on page A-5

Checking the system water container


If the system water container is empty, it needs to be refilled with a 100+1 solution of
SysWash in distilled water.

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Pre-routine operation

a To check the system water container


1 Check that the analyzer is in standby.
2 Raise and remove the system water container.

A Cap and valve (not visible) B System water container

Figure B-17 Remove the system water container

3 Remove the cap and discard any water remaining inside.


4 Clean the container if it appears to be dirty or contaminated.
e For detailed cleaning instructions, refer to Perform finalization maintenance on
page C-30.

5 Fill the container with distilled or deionized water.


6 SysWash has to be added, with a dilution 100+1. Add 35 mL of SysWash to the
distilled or deionized water, pouring carefully to avoid creating air bubbles.
7 Dry the outside of the container with paper towels, attach the cap to the container,
and return the container to the analyzer.

Checking the liquid waste container


Treat the waste from the waste container as potentially infectious. You may add an
appropriate volume of a germicidal agent (as directed in its product labeling) to
the empty liquid waste container before processing samples.

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Avoid use of bleach on page A-6.

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Pre-routine operation

a To check the liquid waste container


1 Put the analyzer into Standby mode.
2 Pull the liquid waste container toward you and cap it
3 Raise the container carefully while avoiding the liquid waste outlet. At the same
time, place a paper towel directly under the waste outlet to catch any drips.

Figure B-18 Remove the liquid waste container

4 Empty the container and rinse it thoroughly with water.


5 If the inside of the container appears to be dirty, use 70% isopropyl alcohol to
rinse the container. Follow with a thorough water rinse.
6 Wipe the outside of the container with a paper towel.
7 Use a paper towel to wipe the compartment where the container is to be placed.
8 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as
directed in its product labeling) to the liquid waste container.
9 Remove the paper towel under the waste outlet and replace the liquid waste
container.
10 Push the container forward so that the container opening is under the liquid waste
outlet.
11 Remove the cap from the container and store it nearby for the next container
removal.

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Checking the external direct drain system (if fitted)

a To check the external direct drain system


1 Inspect the level of the external direct drain waste tank.
2 Empty and rinse the external direct drain waste tank if there is a possibility of
insufficient capacity to hold the effluent from the next processing session.
3 Inspect the drain tubing to ensure that no part of it slopes upward or forms a U-
bend.

Emptying the solid waste tray


The solid waste tray is located behind the solid waste door, beneath the AssayTip and
AssayCup trays. If it is full you will need to remove the Clean-Liner and replace it with
a new one.
e See Solid waste tray and Clean-Liner on page A-96.

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Handling of waste on page A-12.

For essential safety information, see Changing the Clean-Liner on page A-6.

a To empty the solid waste tray


1 Put the analyzer into Standby mode.
2 Open the solid waste door and pull out the tray. The Clean-Liner has a clear
sliding lid.
3 Slide the lid forward to close the Clean-Liner.

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Pre-routine operation

A Sliding lid B Solid waste compartment door


C Waste tray

Figure B-19 Remove the Clean-Liner

4 Remove the Clean-Liner from the tray and dispose of it according to the waste
procedures that apply in your laboratory for potentially biohazardous material.
5 Place a fresh Clean-Liner in the tray.
6 Verify that the sliding door is open and that the opening is located at the back of
the tray.
7 Insert the tray into the analyzer and close the door.
The counter for the solid waste, which is located on the System Overview screen,
automatically resets to zero (0) when the tray is removed.

If you remove the solid waste tray for any reason you should discard the solid waste or replace the
Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during the
course of operation. When the analyzer senses that the solid waste tray is removed, the counter
resets to 0 (zero), and starts counting as if the tray is empty.

Replacing AssayCup and AssayTip trays

a To replace AssayCup and AssayTip trays


During operation, the analyzer starts using tips and cups from tray 1. When tray 1 is
empty the analyzer starts using tray 2, and then tray 3. When tray 3 is empty, the
analyzer returns to tray 1 if a new tray has been reloaded.
e For an explanation of the numbered tray references, see Figure A-51 on page A-90

1 Replace any empty AssayCup or AssayTip trays with full ones as required. Do not
add or remove single AssayTips or AssayCups.
2 Make sure that the trays are seated properly with the correct orientation. Trays are
keyed for proper placement.

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Figure B-20 Load new AssayCup or AssayTip trays

The level is checked and the inventory is automatically updated the next time the
system changes to another tray.
e For information on how you can also load AssayCups and AssayTips when the analyzer is
operating, see Loading consumables during operation on page B-79

Routine operation

After completing pre-routine operation, you are ready to start routine operation.
Routine operation involves procedures related to the following areas:
o Perform calibration and QC
o Validate calibration and control results
o Correct placement of 13 mm sample tubes on a sample disk
o Correct placement of 13 mm sample tubes on a rack
o Routine sample measurements: disk system
o Routine sample measurements: rack system
o Measurement of additional routine samples
o STAT test selections: disk system
o STAT test selections: rack system
o Dilution
o Sample tracking: disk system
o Sample tracking: rack system
o Loading consumables during operation

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Routine operation

Perform calibration and QC

Calibration and controls are normally processed at the beginning of routine


operation (before sample processing begins), but this can be done at any time during
routine operation.
Calibration and QC involves two steps:
o Measuring the calibrators and controls
o Validating the results.

Prepare calibrators and controls


Prepare calibrators as necessary, based on the Reagent Overview screen information,
updated at the last reagent scan. Not all calibrators require reconstitution; most are
ready to use. Refer to the specific calibrator package insert.
Prepare controls, if necessary, following the instructions on their package inserts.

Load calibrators and controls

a To load calibrators and controls onto the sample disk

1 Prepare all required calibrator and control materials according to the


manufacturer's instructions, using the Calibration/QC Load List as a guide.
e For more information see Calibration/QC Load List on page B-23.

2 Use QC materials to verify calibration as well as the precision and accuracy of the
instrument. Follow the regulatory requirements for your local area to establish
additional control runs for your laboratory.
3 Load calibrators and controls onto the sample disk.

For essential safety information, see Manual assignment of sample containers on page A-9.

e For more information, see:


How to assign calibrator and control positions on page B-104

For essential safety information, see Non-Roche controls on page A-15.

a To load calibrators and controls onto the rack

1 Prepare all required calibrator and control materials according to the


manufacturer's instructions, using the Calibration/QC Load List as a guide.
e For more information see Calibration/QC Load List on page B-23.

2 Use QC materials to verify calibration as well as the precision and accuracy of the
instrument. Follow the regulatory requirements for your local area to establish
additional control runs for your laboratory.
3 Load calibrators and controls onto the racks and place the racks on the loader.

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e For more information, see:


How to assign calibrator and control positions on page B-104

For essential safety information, see Non-Roche controls on page A-15.

For essential safety information, see Manual assignment of sample containers on page A-9.

Scan calibrator and control barcode cards


You should perform a barcode card scan if a new lot of calibrators or controls has
been loaded.

a To scan calibrator barcode cards


1 Choose Calibration > Install from the System Overview screen.
2 Insert the calibrator barcode card into the card reading station, with the barcode
facing the back of the analyzer. Push the card as far down as it will go into the
station.
3 Choose Scan BC Card to initiate a scan of the calibrator barcodes. When the
confirmation window is displayed, choose OK.
Once the barcode card has been successfully scanned, the barcode reader makes an
audible beep. Do not remove the card until the analyzer returns to Standby.
4 Repeat steps 2 to 3 for each card to be scanned.

a To scan control barcode cards


1 Choose QC > Install.
2 Insert the control barcode card into the card reading station, with the barcode
facing the back of the analyzer. Push the card as far down as it will go into the
station.
3 Choose Scan BC Card to initiate a scan of the control barcodes. When the
confirmation window is displayed, choose OK.
When the barcode card has been successfully scanned, the barcode reader makes
an audible beep. Do not remove the card until the analyzer returns to Standby.
4 Repeat steps 2 to 3 for each card to be scanned.

Load the sample disk and request calibration

a To load the sample disk

1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on
the sample disk. Ensure that both levels of calibrators are next to each other on the
sample disk.

When the calibrator barcode is scanned by the barcode reader, calibration is


automatically requested for the assay.

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2 Place the CalSet vials and control vials correctly in their keyed positions on the
sample disk, as shown in the following figure, with the barcode facing outward.

A Keyed vial B Keyed disk

Figure B-21 Keyed vial loaded on the sample disk

3 Open each CalSet vial lid to the vertical position (see Figure B-22).

Load the racks and request calibration

a To load the rack

1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on
the rack. Ensure that both levels of calibrators are next to each other on the rack.

When the calibrator barcode is scanned by the barcode reader, calibration is


automatically requested for the assay.
2 Place the CalSet vials and control vials correctly in their keyed positions on the
rack, with the barcode facing outward as shown in the following figure.

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A
B

A Keyed vial B Keyed rack

Figure B-22 Keyed vial loaded on the rack

3 Open each CalSet vial lid to the vertical position as shown above.

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Activate QC test
If a new control lot is loaded, you will need to activate the required tests.

a To activate or deactivate tests


1 Choose QC > Install.

Figure B-23 QC > Install screen

2 Select the required control from the control list.


3 Select the test that you wish to activate from the control list.
4 Choose Active Test to activate the selected test.
The Active Test button changes to Inactive Test if an active test is selected. To
deactivate an active test, select the test and choose Inactive Test.

Measure calibrators and controls


When the calibrators and controls have been placed on the sample disk or rack, the
calibrations and controls can be measured.
When validating control results, check for any anomalies. Unusally high or low
readings might indicate a problem that does not cause the analyzer to raise alarms.

For essential safety information, see Instrument problems without alarms on page A-9.

For essential safety information, see Air bubbles or films in system reagents on page A-5.

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For essential safety information, see Manual assignment of sample containers on page A-9.

a To measure calibrators and controls


1 Choose Start (global button). The Start Conditions screen is displayed.

Figure B-24 Start Conditions screen (rack system)

2 If the analyzer is running in the multiple sample disk mode, make sure that the
number in the Disk No. box reflects the sample disk currently loaded. Correct the
number if necessary.
When the calibrator barcode is scanned by the barcode reader, calibration is
automatically requested for the assay.

3 Choose Start. The monitor displays the previous screen and the calibration and
control run begins.

If automatic printout has been selected at Utility > System (Page 2/3) > Documentation Setup, the
Calibration Result report will be printed automatically when calibration is complete.

4 Remove calibrators and controls from the sample disk or rack when sampling is
complete. Close the lids of the calibrator and control vials and return them to the
refrigerator.

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Validate calibration and control results

If automatic printout has been selected for calibration and control samples on the
Documentation and Printer Setting window, the results will be printed automatically
when calibration is complete.

********************************************************************************************
Roche Diagnostics Immunoanalyzer cobas e 411 S/N 0703-37
********************************************************************************************
Calibration Result Operator-ID:Admin 2006-05-23, 12:35
------------------ -----------------
L Calibration was generated!

Test : TSH 0
Unit : ulU/ml
Reagent pack Lot no. : 139709
Reagent pack number : 32700
Reagent pack expiration date : 2006/07

L Calibration
L calibration date : 2005/12/14
Reagent pack no. for L Calib. : 32700
Calibrator Lot no. : 168530
Expiration date calibrator : 2006/04
Recalibration recommended at : 2006/01/11

RP Calibration
RP Calibration date : 2006/12/14
Reagent pack no. for RP Calib. : 32700
Calibrator Lot no. : 168530
Expiration date calibrator : 2006/04
Recalibration recommended at : 2005/12/21

Calibration Quality Criteria


Missing values : ----------
Monotony of curve : -----
Calibration factor : 1.00
Minimum signal : ----------
Min. acceptable difference : -----
Deviation of duplicates : -----
System errors : -----

Calibrators 1. signal 2. signal Target value


1 : 842.7 799.0 0.100 ulU/ml
2 : 26488 25430 1.61 ulU/ml

Figure B-25 Calibration Result report (quantitative assays)

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a Check the calibration status


1 Choose Calibration > Status. Use this screen to select tests for changeover, timeout
or QC violation.

Figure B-26 Calibration Status screen

The background display color on the Calibration/Status screen identifies the


calibration status of the test, as in the following table:

Color Calibration status.


None Calibration is available, or was successful.
Red No calibration available, or calibration failed. If no calibration is available then
it is not possible to calculate using a previous curve. If the calibration failed then
repeat the calibration for the test.
Green (in Calibration is selected. Calibration can be performed manually or by the system.
Select field)
Table B-2 Calibration status screen color codes

In the case of a rejected or failed calibration without a previous valid calibration, the instrument
stops test-specific sample pipetting (depending on the system settings), and it will be necessary to
perform a new calibration.

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2 Select the calibration to be checked in the Status list and choose the Calibration
Result button to display the Calibration Result window. This window is different
for quantitative and for qualitative assays.

Figure B-27 Calibration Result window (quantitative assays)

Figure B-28 Calibration Result window (qualitative assays)

3 Choose the Calibration Trace button to check the calibration trace. The
Calibration Trace window is displayed.

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Figure B-29 Calibration Trace window

Accumulate QC results
The results of controls measured are saved in the database and appear on the Data
Review screen as well as the QC > Individual screen. To ensure good quality statistical
data, it is important to accumulate these results regularly for the long-term quality
control data.

Correct placement of 13 mm sample tubes on a sample disk

Take special care to place sample tubes correctly on the sample disk. This is especially
important for 13 mm tubes, which are narrower and more likely to tilt if placed
incorrectly. If the tubes are not correctly seated in an upright position on the sample
disk, the sample/reagent probe may attempt to sample outside the tube, causing
errors and incorrect results.

The following figure illustrates correct and incorrect placement of a sample tube on
the sample disk. The tube should be seated correctly in the grommet at the base of the
sample disk so that the tube is vertical.

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A B

D
C

A Correctly placed tube (bottom of tube seated B Incorrectly placed tube (bottom of tube not
in the grommet) seated in the grommet)
C Correctly placed tube (overhead view) D Incorrectly placed tube (overhead view)

Figure B-30 Correct placement of a sample tube on the sample disk

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Correct placement of 13 mm sample tubes on a rack

Take special care to place sample tubes correctly on the rack. This is especially import
for 13 mm tubes, which are narrower and more likely to tilt if placed incorrectly. If
the tubes are not correctly seated in an upright position on the rack, the sample/
reagent probe may attempt to sample outside the tube, causing errors and incorrect
results.

The following figure illustrates correct and incorrect placement of a sample tube on
the rack. The tube should be seated correctly in the rack so that the tube is vertical.

A B

C D

A Correctly placed tube B Incorrectly placed tube


C Correctly placed tube (overhead view) D Incorrectly placed tube (overhead view)

Figure B-31 Correct placement of a sample tube on the rack

To improve the alignment of 13 mm tubes on the rack, Roche recommend that the
Roche Cup-Adapters (part name: CUP-ADAPTER FOR STANDARD RACK) is used.
Cup-Adapters are placed as an insert to the Standard Rack, as shown in the following
figure.

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A Cup-Adapters B Roche standard rack

Figure B-32 Fitting a Cup-Adapter to a 5-position standard rack

The Roche Cup-Adapters should be used only for the sample tubes specified for use
with the cobas e 411 analyzer. Tubes with an outer diameter greater than 13mm should
not be used in combination with Cup-Adapters, because the barcode label might be
damaged.
e For details of the various sample tubes specified for use with the cobas e 411 analyzer,
see System specifications on page A-37.

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Routine sample measurements: disk system

You can make a patient test selections at any time during operation.

Patient programming for interfaced, barcoded samples


In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to Yes.

a To perform sample programming


Perform sample programming from the host.

a To load patient samples


1 Place the barcoded samples on the sample disk. Make sure the barcodes are facing
out so the barcode reader scans them properly.

For essential safety information, see Loading and unloading the sample disk on page A-14.

Figure B-33 Load barcoded samples

2 Place a Stop barcode in the next open position on the disk.

If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

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a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).

Figure B-34 Start Conditions screen (disk system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
Check the following:
o The disk number displayed in the window is correct.
o The Host Communication setting is On (if a host connection is being used)
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.

If the host does not answer within 15 seconds, the position is skipped and the disk advances to the
next position.
If you are using the batch mode for the analyzer-host-communication, make sure that all requests
are loaded from the host to the analyzer.

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Patient programming for interfaced, non-barcoded samples


In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.

a To perform sample programming

1 Perform sample programming at the host.


2 Download sample IDs, test selections, disk number, and position to the analyzer
from your host. A sequence number is assigned to each sample ID during the
download.

3 Choose Workplace > Test Selection > Routine.


4 Print a Work List report.

a To load patient samples


1 Load samples on the sample disk according to the Work List report printed out at
the end of sample programming.

For essential safety information, see Loading and unloading the sample disk on page A-14.

Figure B-35 Load non-barcoded samples

2 Place a Stop barcode in the next open position on the disk.

If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).

Figure B-36 Start Conditions screen (disk system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.

Patient programming for non-interfaced, barcoded samples


In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to Yes.

a To load patient samples

1 Place the barcoded samples on the sample disk. Make sure the barcodes are facing
out so the barcode reader scans them properly.

For essential safety information, see Loading and unloading the sample disk on page A-14.

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Figure B-37 Load barcoded samples

2 Place a Stop barcode in the next open position on the disk.

If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

a To start processing
The first step is to do a sample scan.
1 Choose Sample Tracking.
2 Choose Sample Scan. Wait for the system to go to Standby.
3 Choose Workplace > Test Selection
4 Choose Start (global button).

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Figure B-38 Start Conditions screen (disk system)

5 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
Check the following:
Disk number displayed in the window is correct.
Host Communication setting is On (if a host connection is being used)
6 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.

Patient programming for non-interfaced, non-barcoded samples


In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.
Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.

When not using sample barcodes, you can either use a numeric sample ID or
alternatively type in characters using the software keyboard.

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a To perform sample programming


1 Choose Workplace > Test Selection.

Figure B-39 Test Selection screen (disk system)

2 Select the Routine option from the Sample area on the top left of the screen.
3 Type the disk number in the Disk No. text box.
4 Type the position number for the sample in the Pos. text box.
5 Type the sample number in the Sample ID text box if necessary.
6 Select the Pre-dilution button if the sample has already been diluted
7 Select the Normal or Reduced Sample Cup button.
8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
9 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
10 Choose Save to save the test selection.
11 Place a stop barcode in the next open position on the disk.

If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.

12 Print a Work List report (optional).

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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).

Figure B-40 Start Conditions screen (disk system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.

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Routine sample measurements: rack system

You can make patient test selections at any time during operation.

Patient programming for interfaced, barcoded samples


In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to Yes.

a To perform sample programming


1 Perform sample programming at the host.

a To load patient samples


1 Place the barcoded samples on the rack. Make sure the barcodes are visible
through the openings on the rack so the barcode reader scans them properly.
2 Load the racks on a tray and place the tray on the A-Line (supply). At the same
time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray
on the C-Line.

Figure B-41 Load barcoded samples on the A-Line

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a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).

Figure B-42 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each barcode is
scanned, the analyzer queries the host and receives test requests for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.

Patient programming for interfaced, non-barcoded samples

In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.

a To perform sample programming for real-time queries


1 Perform sample programming at the host. Make sure to program the rack ID and
position number at the host.
2 Print a work list at the host.

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a To load patient samples


1 Load non-barcoded samples on the racks according to the host work list.
2 Load the racks on a tray and place the tray on the A-Line (supply). At the same
time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray
on the C-Line.

Figure B-43 Load non-barcoded samples on the A-Line

a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).

Figure B-44 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.

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3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each rack position
is encountered, the host is queried to download the sample ID and test selections
to the analyzer.

Patient programming for non-interfaced, barcoded samples


In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to Yes.
Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.

You can only use a numeric sample ID when not using a host. This is because you
cannot perform a sample scan (as on the disk system); you must type all sample ID
numbers manually.

a To perform sample programming


1 Choose Workplace > Test Selection.

Figure B-45 Test Selection screen (rack system)

2 Select the Routine option from the Sample area on the top left of the screen.
3 Choose the Sample ID field to open the software keyboard. Type in the sample ID
of the sample in the Sample ID text box.
4 Select the Pre-dilution On button if the sample has already been diluted manually.
5 Select the Normal or Reduced button for Sample Cup.
6 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
7 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
8 Choose Save to save the test selection.

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It is not necessary to program a rack ID and position when the sample is barcoded.

a To load patient samples


1 Place the barcoded samples on the racks. Make sure the barcodes are visible
through the openings on the rack so the barcode reader scans them properly.
2 Load the racks on a tray and place the tray on the A-Line (supply). At the same
time, verify there is a tray on the C-Line (output buffer). If necessary, place a tray
on the C-Line.

a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).

Figure B-46 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each barcode is
scanned, the analyzer queries the host and receives test requests for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.

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Patient programming for non-interfaced, non-barcoded samples

You can only use a numeric sample ID when not using a host.
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.

a To perform sample programming


Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.
1 Choose Workplace > Test Selection.

Figure B-47 Test Selection screen (rack system)

2 Select the Routine option from the Sample area on the top left of the screen.
3 Type the rack number in the Rack No. text box.
4 Type the position number for the sample in the Pos. text box.
5 Type the sample number in the Sample ID text box, if necessary.
6 Select the Pre-dilution check box if the sample has already been diluted.
7 Select the Normal or Reduced button for Sample Cup.
8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
9 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
10 Choose Save to save the test selection.

a To load patient samples


1 Load the racks on a tray.
2 Place the tray on the A-Line (supply). At the same time, verify there is a tray on the
C-Line (output buffer). If necessary, place a tray on the C-Line.

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Figure B-48 Load barcoded samples on the A-Line

Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).

Figure B-49 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.

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e If you wish to track samples, add patients during routine operation, or process a STAT
(Short Turn Around Time) patient sample, proceed to one of the following sections:
Sample tracking: rack system on page B-77
Measurement of additional routine samples on page B-60
STAT test selections: rack system on page B-67.

Measurement of additional routine samples

The procedure for measuring additional routine samples varies, depending on


whether you are using a disk or rack system.

Continuous loading using the single disk mode

You can program additional routine samples at any time. When the analyzer starts
from Standby mode, the system always begins at position 1 on the disk and stops at
the position of the Stop barcode.

When the analyzer starts from Sampling Stop, the system remembers the last position
where the Stop barcode was and starts at that position.

For essential safety information, see Continuous sample loading on sample disks on page A-13.

For essential safety information, see Loading and unloading the sample disk on page A-14.

If you forget to place the Stop barcode on the disk, the disk turns continuously. If calibrators or
controls are present, they will be pipetted again.

The following example is a graphical representation of continuous loading.

a To program additional routine samples using the single disk mode


1 Load seven samples on the disk. Place the Stop barcode in position 8.

1 2
3
4
5
6
7

STOP 8

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2 When the sample in position 4 is complete, add seven more samples to the disk.
Move the Stop barcode to position 15.

1 2
3
X X 4
X 5
X
6
7
8
9
10
11
STOP 12
13
14
15

All 14 samples have been pipetted. The analyzer goes into Sampling Stop when it
reaches the Stop barcode in position 15.

1 2
3
X X 4
X 5
X
X 6
X
X 7
X 8
X 9
X
10
X
X 11
STOP X
X 12
13
14
15

3 Add samples starting at position 15 (the previous position of the Stop barcode).
After choosing Start the system continues sampling past position 30 until it sees
the Stop barcode again (here in position 6).

30 1 2 3
29
28 4
27 5
26 6
25 STOP
24
23
22
21
20
19
18 17
16 15

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Continuous loading using the multiple disk mode

When the analyzer starts from Standby mode, the system always begins at position 1
on the disk and stops at the position of the Stop barcode.
The analyzer enters the sampling stop mode when it recognizes the Stop barcode or
reaches position 30 on the sample disk.
When the analyzer starts from sampling stop and the system has reached position 30,
the analyzer will begin again at position 1. If using multiple disks, you should change
the disk and type the new disk number on the Workplace > Test selection screen
before choosing Start.

For essential safety information, see Continuous sample loading on sample disks on page A-13.

For essential safety information, see Loading and unloading the sample disk on page A-14.

If you forget to place the Stop barcode on the disk, the disk stops at position 30.

Continuous loading using the rack system

There are two ways to load continuously on the rack system:


o Add single racks to the A-Line. Refer to the photograph below.
o Add a loaded tray to the A-Line.

Figure B-50 Loading a rack on the A-Line during operation

Loading/unloading of racks
You can add single racks to the A-Line only when the tray indication light is green. When the light
is out, do not load racks onto the analyzer.

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Tray Tray Tray


Tray Part 3 Part 2 Part 1
indication
light Output
C-Line buffer

B-Line
A green light
indicates that you
can remove or 5 racks 5 racks 5 racks 5 racks
replace a tray

Input
A-Line buffer
Tray
indication
light

STAT
Figure B-51 Tray indication lights

You can add racks during operation. When the rack system is in sampling stop mode,
choose Start to continue sampling.

STAT test selections: disk system

You can make STAT (Short Turn Around Time) patient test selections when the
analyzer is in Operation, S. Stop, or Standby.

During STAT processing, the current sample finishes pipetting. The STAT samples are
pipetted next. When the STAT sampling is complete, the analyzer proceeds to the next
sample (the sample directly after where it had previously stopped) and resumes
pipetting routine samples.

STAT patient programming for interfaced, barcoded or non-barcoded samples


In the STAT mode, when the Test Selection screen is accessed, the software suggests an
available disk position. You can override the position suggested by the system.

Test selections must be made at the host system before a sample query from the analyzer.

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a To program STAT samples

Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.

1 Choose Workplace > Test Selection.

Figure B-52 Test Selection - STAT samples screen (disk system)

2 Select the Stat option from the Sample area on the top left of the screen.
o In non-barcode mode the cursor moves to the Pos. text box. Go to step 3.
o In barcode mode the cursor moves to the Sample ID text box. Go to step 4.
3 Type in the position number of the sample in the Pos. text box.

For essential safety information, see Loading samples and reagents on page A-14.

For essential safety information, see Manual assignment of sample containers on page A-9.

4 Type in the sample ID of the sample in the Sample ID text box.


5 Choose Pre-dilution On if the sample has already been diluted.
6 Select the Normal or Reduced Sample Cup button.

For essential safety information, see Use of microcups on page A-17.

7 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box and press Tab.

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8 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
9 Choose Save to save the test selection.

a To start processing STAT samples


1 Choose Stat Rack (global button).

Figure B-53 Start Conditions screen (disk system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.

STAT patient programming for non-interfaced, barcoded or non-barcoded samples

In the STAT mode, when the Test Selection screen is opened, an available disk
position is suggested by the software. You can override the position suggested by the
system.

a To program barcoded STAT samples


1 Load the sample at a vacant position behind the Stop barcode.
2 Choose S.Stop, and perform Sample Scan.

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a To program non barcoded STAT samples


Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.
1 Choose Workplace > Test Selection.

Figure B-54 Test Selection screen (disk system)

2 Select the Stat option from the Sample area on the top left of the screen.
3 Type in the position number of the sample in the Pos. text box.

For essential safety information, see Loading samples and reagents on page A-14.

For essential safety information, see Manual assignment of sample containers on page A-9.

4 Type in the sample ID of the sample in the Sample ID text box.


5 Select the Predilution On button if the sample has already been diluted
6 Select the Sample Cup Normal or Reduced button.

For essential safety information, see Use of microcups on page A-17.

7 Select the required dilution, if any, for the sample from the Sample Volume/
Dilution list box.
8 Select the test, combination of tests or test profiles for the sample from the test key
matrix. Selected tests and profile keys appear white.
9 Choose Save to save the test selection.

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a To load STAT samples


1 Load the STAT sample in the selected disk position on the sample disk.

a To start processing STAT samples


1 Choose Stat Rack (global button).

Figure B-55 Start Conditions screen (disk system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.

STAT test selections: rack system

You can make STAT (Short Turn Around Time) patient test selections when the
analyzer is in Operation, R. Stop, Standby, or Stop.

During STAT processing, the analyzer first finishes pipetting the current rack. The
samples in the STAT rack are pipetted next. When the STAT sampling is complete, the
analyzer proceeds to the next rack on the A-Line and resumes pipetting routine
samples.

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STAT patient programming for interfaced, barcoded samples

a To program STAT samples

1 Perform sample programming at the host.

Refer to the label on the STAT rack position to ensure correct orientation of the rack.

Figure B-56 Load barcoded samples at STAT rack position

a To start processing STAT samples


1 Place the barcoded STAT samples on a rack.
Make sure the barcodes are visible through the openings on the rack so the
barcode reader scans them properly.
2 Load the rack in the STAT rack position.

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a To start processing STAT samples


1 Choose Stat Rack (global button).

Figure B-57 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples. As each barcode is
scanned, the analyzer queries the host and receives test selections for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.

If multiple STAT racks are necessary, you must choose Stat each time a STAT rack is loaded in the
STAT rack position.

STAT patient programming for non-interfaced, barcoded or non-barcoded samples


You can only use a numeric sample ID when not using a host.

a To program STAT samples

Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.

1 Load the sample in the rack.


2 If using barcoded samples, make sure the barcodes are visible through the
openings on the rack so the barcode reader scans them properly. Choose
Workplace > Test Selection.

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Figure B-58 Test Selection screen - STAT samples (rack system)

3 Select the Stat option from the Sample area on the top left of the screen.
o In non-barcode mode the cursor moves to the Rack No. text box. Go to step 4.
o In barcode mode the cursor moves to the Sample ID text box. Go to step 6.
4 Type in the rack ID of the sample in the Rack No. text box.
5 Type in the position number of the sample in the Pos. text box.

For essential safety information, see Loading samples and reagents on page A-14.

For essential safety information, see Manual assignment of sample containers on page A-9.

6 Type in the sample ID of the sample in the Sample ID text box.


7 Choose Pre-dilution On if the sample has already been diluted.
8 Select Normal or Reduced Sample Cup.

For essential safety information, see Use of microcups on page A-17.

9 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
10 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
11 Choose Save to save the test selection.

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a To load STAT samples


1 Load the rack in the STAT rack position.

For essential safety information, see Loading STAT racks on page A-15.

Figure B-59 Load barcoded samples at STAT rack position

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a To start processing STAT samples


1 Choose Start (global button).

Figure B-60 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.

If multiple STAT racks are necessary, you must choose Stat each time a STAT rack is loaded in the
STAT rack position.

STAT patient programming for interfaced, non-barcoded samples

a To program STAT samples

1 Perform sample programming at the host.


2 Print a work list at the host. The list assigns sample positions.

a To load STAT samples


1 Load the STAT non-barcoded sample on the rack according to the host work list.
2 Load the rack in the STAT rack position.

Refer to the label on the STAT rack position to ensure correct orientation of the rack.

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Figure B-61 Load non-barcoded samples at STAT rack position

a To start processing STAT samples


1 Choose Start (global button).

Figure B-62 Start Conditions screen (rack system)

2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples. As each STAT rack

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position is encountered, the host is queried to download the sample ID and test
selections to the analyzer.

If multiple STAT racks are necessary, you must choose the Stat key each time a STAT rack is loaded
in the STAT rack position.

Dilution

Sample results that exceed the measuring range of the assay must be diluted and
measured again. Dilutions can be requested from the Workplace > Test Selection
screen and are performed automatically by the analyzer.

Figure B-63 Test Selection screen (disk system)

The Sample Volume/Dilution menu is activated only when both the following apply:
o The assays are encoded in the reagent barcode as being suitable for dilution.
o A bottle of suitable diluent is on the analyzer.

The diluent must be in the reagent rotor: this is an essential condition.


To select dilution: choose the sample volume dilution factor from the list box,
following the recommendations in the package insert, and choose the test for
dilution.
The sample result is recalculated based on the selected dilution factor, but the
measuring range is not. The resulting diluted sample result is therefore flagged as
being outside the measuring range.
e For additional information on dilutions, refer to Mechanical theory on the COBI-CD.

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Manual predilution of samples


If a sample is manually prediluted before analysis, you can set the instrument to flag
the corresponding sample ID on the reports and on the Workplace > Data Review
screen.

a To identify a sample as manually prediluted


1 Choose Workplace > Test Selection to display the Test Selection screen, used to
enter test selections and information for a sample.
2 Choose On (because the sample is already prediluted).
3 Program your sample as normal.
e For the sample programming procedure, refer to:
Routine sample measurements: disk system on page B-45
Routine sample measurements: rack system on page B-53

After changes have been made on the Test Selection screen, the Save button turns
yellow.
4 Choose Save to save the entries. A predilution flag is added to the sample ID.
After measurement, the target sample is flagged Prediluted on the Test Review
screen and on the result report.

The results for prediluted samples are not calculated using the dilution factor. The operator must
calculate the final results for manually prediluted samples.

Automatic dilution by the analyzer


Follow the instructions below to dilute a patient sample. The process is the same for
both the disk and rack systems.

a To set automatic dilution for a sample


1 Choose Workplace > Test Selection to display the Test Selection screen, used to
enter test selections and information for a sample.
2 Choose Previous or Next to select the sample.
3 Choose the key button for the test on which to set automatic dilution.
4 Select the required dilution factor from the Sample Volume/Dilution menu. After
changes have been made on the Test Selection screen, the Save button turns
yellow.
e Refer to the dilution section of the package insert for recommended dilutions.

5 Choose Save. The test key button appears with the dilution rate you have just
specified.
When measurement starts, the sample is automatically diluted by the analyzer. When
calculating the final sample concentration, the software calculates the result based on
the selected dilution factor.

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Sample tracking: disk system

Use the Sample Tracking window to monitor the progress of sample processing.

a To track a sample on the system


1 Choose the graphical icon representing the system in the status line (top left of the
screen) to display the System Overview screen.
2 Choose Sample Tracking to display the Sample Tracking window.

Figure B-64 Sample Tracking window (multiple disk)

The status conditions are as follows:

Routine A routine sample is loaded in this position.

Stat A STAT (Short Turn Around Time) sample is loaded in this


position.
Control A control is loaded in this position.

Calibrator A calibrator is loaded in this position.

Empty (E) This sample position is empty (the sample position is light
gray).
Processing (P) The sample, control or calibrator in this position is in process
(all assays have been pipetted), but results are not yet ready.
The sample position is green.
Incomplete (I) At least one ordered request for the sample has a missing
value. The sample position is red.

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Occupied (O) The sample in this position is still being processed. The
sample position is blue.
Completed (C) The processing of the sample in this position has been
completed satisfactorily. The sample position is white.
Stop BC (S) This sample position contains a stop barcode. The sample
position is yellow.

Sample positions that contain a STAT sample appear red throughout the operation, even though
their actual status changes.

3 To obtain more detailed information on the result of a specific sample, select the
sample from the Sample disk information area on the right side, and then choose
the Show Result button. The Test Review window is displayed.

Figure B-65 Test Review window (disk system)

Sample tracking: rack system

Use the Sample Tracking window to monitor the progress of sample processing.

e For further information see Sample Tracking window (rack system) on page E-18

a To track a sample on the system


1 Choose the graphical icon representing the system in the status line (top left of the
screen) to display the System Overview screen.
2 Choose Sample Tracking to display the Sample Tracking window.

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Figure B-66 Sample Tracking window (rack system)

Thirty positions (six rows) are listed on the screen, each row representing a rack. To
the right of each row is the rack ID number. The upper right corner of each button
corresponds to a position on the rack. Each position also lists a status.
The status conditions are as follows:

Routine A routine sample is loaded in this position.

Stat A STAT (Short Turn Around Time) sample is loaded in this


position.
Control A control is loaded in this position.

Calibrator A calibrator is loaded in this position.

Empty (E) This sample position is empty (the sample position is light
gray).
Processing (P) The sample, control or calibrator in this position is in process
(all assays have been pipetted), but results are not yet ready.
The sample position is green.
Incomplete (I) At least one ordered request for the sample has a missing
value. The sample position is red.
Occupied (O) The sample in this position is still being processed. The
sample position is blue.
Completed (C) The processing of the sample in this position has been
completed satisfactorily. The sample position is white.

Sample positions that contain a STAT sample appear red throughout operation, even though their
actual status changes.

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3 Obtain more detailed information on the result of a specific sample by selecting


the sample from the rack information area on the right side and choosing Show
Result. The Test Review window is displayed.

Figure B-67 Test Review window (rack system)

Loading consumables during operation

You can reload AssayCup and AssayTip trays during operation if you take suitable
precautions.

A
B

A Tray 3 B Tray 2
C Tray 1

Figure B-68 Tray areas in consumables compartment

When the AssayCup and AssayTip compartments are fully loaded, the analyzer begins
by using AssayCups and AssayTips from tray 1.

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When tray 1 is empty, the analyzer starts using tray 2, followed by tray 3.
When tray 3 is empty, the analyzer returns to tray position 1 to check if a new tray has
been loaded.
The analyzer indicates the current gripper position for AssayCups (Vessel) and
AssayTips (Tip) on the System Overview screen. In Figure B-69, the Inventory area
shows the gripper position markers at the tray 1 position for both AssayCups and
AssayTips. Trays 2 and 3 for both are full.

Figure B-69 System Overview screen showing the available consumables

When the AssayCup and AssayTip compartments are only partly loaded, the analyzer
starts using AssayCups and AssayTips from the positions last in use during the
previous run. The AssayCup position may be different from the AssayTip position in
this case.
Table B-3 shows how you can use to Vessel and Tip symbols in the System Overview
screen to determine when you can safely load additional consumables at the tray
positions.

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System Overview symbols Loading options


(Vessel/Tip)
Do not load consumables at any position.

You may load AssayCups and AssayTips at tray position 1.

You may load AssayCups and AssayTips at tray positions 1


and 2.

Do not load consumables at any position.

You may load AssayCups and AssayTips at position 1. Do not


load consumables at position 2.

You may load AssayCups and AssayTips at position 1. Do not


load consumables at position 2.

Table B-3 Examples of loading options at different gripper positions

Results

You can evaluate control and patient results on printed reports or on the Workplace >
Data Review screen. All samples can be viewed, deleted, printed, or uploaded from
this screen.
As results are generated on the instrument, they are saved in the database located on
the control unit. The database stores up to 2000 results, depending upon the number
of orders in the system. Once the figure of 2000 documents is reached, the system
automatically deletes the oldest documented result. You can manually delete any
results, documented or undocumented, from the database to free additional space.
As soon as results are printed, uploaded or printed/uploaded, they are considered to
be documented (the documentation mode is defined in the Utility > System >
Documentation Setup window).
After documentation, an H appears at the top of the row. Partial sample results can
be viewed from this screen as soon they are made available by the system.

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e For more information, see:


How to reset the system on page B-101
How to archive sample data on page B-99

View patient results

All samples can be viewed from the Data Review screen.

a To view patient results


1 Choose Workplace > Data Review to display the Data Review screen, used to
perform tasks related to reviewing routine and STAT results.

Figure B-70 Data Review screen (disk system)

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Figure B-71 Data Review screen (rack system)

2 Choose Search to display the Sample Search window, used to search for a sample
in the database.

Figure B-72 Search Sample window

3 Select either the Sequence Number option to search for a sample by sequence
number, or the Sample ID option to search by sample number.
4 Type the sequence or sample number, depending on the option selected in the
previous step.
5 Choose Down to search the sample list of the Data Review screen downward from
the currently selected sample, or Up to search upward from the currently selected
sample, until you find the required sample.

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6 Choose Cancel to close the Sample Search window and return to the Data Review
Screen. The chosen sample is highlighted.

Filter patient results

Use this function to filter the type of samples you want to view, document or print.
The default filter setting is Off.

a To filter patient results


1 Choose the Filter button to display the Filter window, used to define the criteria
for filtering the information displayed in the sample selection list of the Data
Review screen.

Figure B-73 Filter window

2 Enter filter criteria as required, and choose OK to save the selected filter criteria,
close the Filter window, and return to the Data Review Screen.
3 Select On in the Filter area of the Data Review screen to activate the filter. The
results are filtered according to the filter criteria you selected.

Print or upload patient results

The Documentation and Printer Setting window enables you to select the desired
documentation output option and the items to print out automatically.

If you choose Upload, or Print/Upload, when the host communication set to Off on the Start
Conditions screen, an alarm is issued.

a To print or upload patient results


1 Choose Utility > System.
2 Choose page 2/3
3 Choose Documentation Setup to display the Documentation and Printer Setting
window.

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4 Select an option in the Completion Conditions area.


5 Select an option in the Printer Connection area.
6 Select an option in the Automatic Printout area.
7 Choose OK to save the selected settings and close the Documentation and Setting
window.

Completion Conditions area options

Printout Send reports to the printer.

Upload Upload results to the host.

Print/Upload Send reports to the printer and also upload results to the host.

Printer Connection area options

Connected A printer is connected to the system.

Not connected A printer is not connected to the system; reports will not be sent to the printer.

Automatic Printout area options

Calibration Sample Select On to enable, or No to disable automatic printing of the results from
calibration samples.

Control Sample Select On to enable, or No to disable automatic printing of the results from quality
controls.

STAT Sample Select On to enable, or No to disable automatic printing of the results from STAT
samples.

Routine Sample Select On to enable, or No to disable automatic printing of the results from routine
samples.

Print a Result Report

Results can be printed out from the Workplace > Data Review screen.

a To print a Result Report


1 Select the required data on Workplace > Data Review before printing or viewing
this report.
2 Select a single sample, a range of samples, or non-consecutive samples to be
printed from the Sample selection list on the left side of the screen.
3 Choose Print (global button) > Workplace to display the Workplace Print screen.

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Figure B-74 Workplace print screen

4 Choose Result Report from the Workplace Items list.


5 Select the required print format, Normal or Condensed, from the Print Format
area.
6 Choose Print to print the report.
7 Choose Close to close the Print screen.
e For further information, see:
Results on page B-81

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Post-operation data management

Post-operation data management

Review results

You should review the results as they become available using the printout or on the
Workplace > Data Review screen. Use the Test Review window to check results in
more detail.
e For more information, see:
Results on page B-81

Repeat any questionable results, or those with an incomplete status, as necessary.


e For more information, see:
Dilution on page B-74

Delete documented samples

Samples are considered documented once they are printed out or uploaded to the
host.
Delete documented samples to free up additional space in the database. Filter settings
have no effect on this function.

a To delete all documented samples


1 Choose Workplace > Data Review
or System Overview (Workflow Guide) > Sample Data Clear.
2 Choose Delete All to delete all sample records.

Daily maintenance

Before the end of routine operation, it is important to ensure that all required
maintenance is performed. In addition to the routine daily maintenance, this could
also include other scheduled maintenance, for example, weekly and monthly
maintenance.
Perform the following tasks each day:
o Clean the sample/reagent probe
o Clean the sipper probe
o Finalization maintenance.
e For information about daily maintenance items to be performed, refer to your laboratory
maintenance schedule, Maintenance schedule on page C-8 and the Maintenance chapter.

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Switch off the analyzer

Switch off the analyzer

After routine operation is finished and you have perform all the required
maintenance, you can switch off the analyzer.
Under normal circumstances it is not necessary to shut down the analyzer by turning
off the main circuit breaker. Keep the circuit breaker on the right of the analyzer on at
all times to maintain the temperatures in the reagent rotor and system reagent
compartments.

Use of the screen saver


In normal operation, the monitor will remain powered for prolonged periods. To preserve the image
quality of the monitor, Roche recommends that you activate the screen saver.
Use the Utility > System screen to activate the screen saver.

a To switch off the analyzer


1 Set the operation switch to Off. The Sleep window is displayed.

Figure B-75 Sleep window

In the Sleep window, do not choose Shutdown unless you wish to shut down all of the analyzer
functions and components.
If choose Shutdown by mistake, turn off the main circuit breaker once, wait for at least ten seconds,
and then turn it on again to revive the analyzer.

Prevent evaporation of the system reagents

After switching off the analyzer, close the lids on the ProCell and CleanCell bottles to
prevent evaporation of their contents.

a To close the lids of the system reagent bottles

For essential safety information, see Sipper shield on page A-16.

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Switch off the analyzer

1 Open the sipper shield by applying pressure to the white metal area at the top, as
shown in the following figure, until the latch is released.

A Press here to open or close the sipper shield

Figure B-76 Open the sipper shield

2 Close the lids on the ProCell and CleanCell bottles.

Figure B-77 Close lids of ProCell/CleanCell

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Switch off the analyzer

3 Close the sipper shield by applying pressure to the white metal area at the top until
you hear the click of the latch engaging.

Final power off checks

If the analyzer will remain switched off for longer than seven days, it is important
to prepare the system properly and to perform the correct shutdown maintenance.
Failure to observe these recommendations may result in damage to the measuring
cell.

a To complete final power off checks


1 Check individual parts of the instrument.
2 If the analyzer is to be switched off at the circuit breaker, move any reagent packs
from the analyzer to the refrigerator as temperature control to the reagent rotor
will be off. Make sure that the reagent pack lids are tightly closed.
e For further information, refer to Protect the measuring cell during extended shutdown on
page C-44.

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Table of contents

Special operation: How to


This chapter describes special tasks that are not usually part of the daily work flow. It
complements the Daily Operation chapter, that describes everyday tasks and common
procedures for running the cobas e 411 analyzer.

In this chapter Chapter 7


Overview ........................................................................................................................ 93
How to apply barcode labels to tubes and vials ........................................................... 94
How to upload results manually ................................................................................... 96
How to select two or more samples in Data Review .................................................... 98
How to archive sample data .......................................................................................... 99
How to rerun a sample ................................................................................................ 100
How to reset the system .............................................................................................. 101
How to delete a single open request ........................................................................... 103
How to assign calibrator and control positions ......................................................... 104
How to install and define Roche controls .................................................................. 106
How to install and define non-Roche controls .......................................................... 107
How to edit control values .......................................................................................... 109
How to request standby bottle QC ............................................................................. 110
How to cancel a print job ............................................................................................ 111
How to print a daily Alarm Trace report ................................................................... 112
How to print a System Communication Trace report ............................................... 113
How to change documentation settings ..................................................................... 114
How to program calculated tests ................................................................................ 115
How to change test settings ......................................................................................... 116
How to change calibration settings ............................................................................ 118
How to change the sample disk mode ........................................................................ 119

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Overview

Overview

The sections in this chapter contain detailed descriptions explaining how to


accomplish specific non-routine tasks.
e For details of the differences for disk and rack systems, see Disk and rack systems on
page B-5.

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How to apply barcode labels to tubes and vials

How to apply barcode labels to tubes and vials

The size and placement of barcode labels on sample, calibrator, and control
containers must comply with certain specifications. The sample barcode reader may
fail to read any labels that do not conform to these restrictions.

a To apply barcode labels to sample tubes and calibrator and control vials
1 Ensure that the barcode label dimensions comply with Figure B-78.

A B
A Label width (16 mm minimum) B Barcode width (12 mm minimum)
C Quiet zone (5 mm minimum) D Barcode zone (50 mm maximum for
100 mm tubes; 38 mm maximum for
75 mm tubes)
E Quiet zone (5 mm minimum)

Figure B-78 Dimensions for barcode labels for tubes and vials

2 For sample tubes, position your barcode labels according to restriction shown in
Figure B-79. For calibrator and control vials, position your barcode labels
according to the restriction shown in Figure B-80.

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How to apply barcode labels to tubes and vials

A Upper margin: 12 mm minimum (for both 100 mm and 75mm sample tubes)

Figure B-79 Required position for barcode labels on sample tubes

A Minimum margin 2.5 1 mm

Figure B-80 Required position for barcode labels on vials

3 Press and smooth the labels to ensure that all the label edges adhere to the tubes or
vials.

Place all sample tubes upright and settled in their positions, with the barcode labels fully visible to
the barcode reader.

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Operators Manual Version 1.0 B-95
7 Special operation: How to cobas e 411 analyzer
How to upload results manually

How to upload results manually

If automatic uploading is switched off and the analyzer is connected to a host, you
must upload sample results manually. You can upload a single result or multiple
results at any time, and you can upload results more than once if necessary.
If automatic upload is activated, and the Utility > System > Review by Exception
window shows alarms listed as Exception Alarms on the right of the screen, you must
upload manually the results flagged with exception alarms.
The procedure is the same for both disk and rack systems.
e You can search for samples to upload manually using the Sample search facility.
For further information, see:
Sample tracking: disk system on page B-76
Sample tracking: rack system on page B-77

a To upload a single result or multiple results


1 Choose Workplace > Data Review.

Figure B-81 Data Review screen (rack system)

2 Select an individual sample to upload from the open requests (status O).
3 Select the result to upload from the Data Review list on the right of the screen.
e See How to select two or more samples in Data Review on page B-98

4 Choose Send to Host. The Send to Host window opens


5 Choose Send in the Send to Host window to confirm upload.

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How to upload results manually

The Send to Host window closes, and the system returns to the Workplace Data
Review window. The sample status changes to H (documented/sent to host) if all
results are sent to the host.

If you wish to validate the result before uploading, switch off Automatic Upload.

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7 Special operation: How to cobas e 411 analyzer
How to select two or more samples in Data Review

How to select two or more samples in Data Review

The sample data displayed on the Data Review screen can be selected, for example,
when a printout of all sample results is not required.
To apply an analyzer function to specific data items from the complete sample data
set, select the items in the Data Review screen. The following procedure describes the
selection of some sample results for printing. The procedure is the same for both disk
and rack systems.

a To display a list of samples


1 Choose Workplace > Data Review (see Figure B-81).
2 Choose Routine View to display all the sample results.

Choose QC View at Step 2 if you wish to display only the control results.

3 Select a sample from the list on the left of the screen. The selected sample is
highlighted in blue.
4 Choose Select. The Select button turns white, indicating that sample selection is
activated.
5 Select the next sample from the list. The selected sample is highlighted in blue (in
addition to the previous selection).
6 Choose Select.
7 Repeat steps 5 and 6 until all the samples required are selected.
8 Choose Print (global button). The Print window opens.
9 Choose Print in the Print window to confirm the print. The Print window closes.
To clear a complete selection, select any sample previously selected. The highlight will
disappear from all the samples.

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How to archive sample data

How to archive sample data

a To archive sample data


1 Choose Workplace > Data Review (see Figure B-81).
2 Choose Routine View.

QC View is an option, but this view displays only QC data.

3 Select samples for which data is to be backed up, from the list on the left of the
screen.
4 Choose Backup Data. The Backup Data window is displayed.

Figure B-82 Data Review - Backup Data window

5 Choose the target device for the backup.

If choosing External, ensure that the target device is connected and able to receive the data.

6 Type a folder name for the current backup in the Folder name box, and choose
OK.

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Operators Manual Version 1.0 B-99
7 Special operation: How to cobas e 411 analyzer
How to rerun a sample

How to rerun a sample

You must manually request the reruns of any samples.

a To rerun a sample
1 Choose Workplace > Data Review (see Figure B-81).
2 Select the sample required from the list on the left of the screen. The selected list is
highlighted in blue.
3 Choose Workplace > Test Selection. The selected sample ID and the tests
performed upon the sample will be displayed.
4 Choose Rerun from the Sample area of the screen.
5 Select the tests required for rerun. The selected test buttons will change to white
and the Save button changes to yellow when any test is selected.

Figure B-83 Test Selection screen - Rerun sample (disk system)

6 Select the sample dilution from the list box on the right of the screen.
7 Choose Save. The Save button changes from yellow to blue, and the test buttons
change back from white to blue.
8 Choose Data Review (see Figure B-81). Note that the sample is now listed twice on
the left of the screen - once for the original tests and once for the rerun selection.
9 Place the sample on the instrument and choose Start (global button).
10 Choose Start (large button) in the Start Conditions window.

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B-100 Operators Manual Version 1.0
cobas e 411 analyzer 7 Special operation: How to
How to reset the system

How to reset the system

System reset is necessary following system alarm events that put the analyzer into P.
Stop or Stop status. Examples are:
o Interference with the gripper action.
o Malfunction of the cap open/close mechanism.
o Any movement of the pipetter shield away from the fully closed position during
operation.
Resetting the system returns mechanical parts to their home or standby positions. It
does not reset any of the line mechanisms on a rack system.

a To reset the system


1 Choose Utility > Maintenance.

Figure B-84 Utility Maintenance screen (rack system)

2 Select System Reset from the Maintenance Items list.


3 Choose Select. The System Reset window opens.

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7 Special operation: How to cobas e 411 analyzer
How to reset the system

Figure B-85 System Reset window

4 Choose Start. The system reset begins and the System Reset window closes.

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B-102 Operators Manual Version 1.0
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How to delete a single open request

How to delete a single open request

You can delete single open requests from the Data Review screen. The procedure is the
same for disk and rack systems.

a To delete a single open request


1 Choose Workplace > Data Review (see Figure B-81).
2 Select the request to be deleted from the open requests (status O) on the left of
the screen.
3 Choose Delete Record.

Figure B-86 Delete Record window

4 Confirm the deletion in the Delete Record window. The window closes
automatically and the selected sample is no longer listed in the Data Review
window.

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Operators Manual Version 1.0 B-103
7 Special operation: How to cobas e 411 analyzer
How to assign calibrator and control positions

How to assign calibrator and control positions

Use the following procedure to assign a position to a calibrator or control if you are
using AssayCups without a barcode, or if the system cannot read the barcode.
The procedure is the same on both disk and rack systems.
The calibrator or control to be assigned must already be installed.

a To assign calibrators to positions


1 Choose Calibration > Calibrator.
2 Select from the list the calibrator to be assigned.
3 Choose Position Assignment. The Position Assignment window opens.

Figure B-87 Position Assignment window for calibrators (disk system)

4 Select a calibrator from the list on the left of the screen, and a position for the
calibrator from the list on the right.
5 Choose Assign to assign the selected calibrator to the position selected. The
calibrator and the corresponding lot number appear on the right of the screen,
and the Assign button becomes inactive. The OK button turns yellow and remains
yellow until you save the changes in step 7. You can assign a calibrator to one
position only.
6 Repeat steps 4 to 5 to assign further calibrators.
7 Choose OK to save the changes when each of the desired calibrators has an
assigned position. The Position Assignment window closes.

Calibrator vials must be assigned to consecutive positions on disks or racks.

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How to assign calibrator and control positions

a To assign controls to positions


1 Choose QC > Control.
2 Select from the list the control to be assigned.
3 Choose Position Assignment. The Position Assignment window opens (see
Figure B-88).
4 Select a control from the left hand list, and a position for the control from the
right-hand list.

Figure B-88 Position Assignment window for controls (rack system)

5 Choose Assign to assign the selected control to the position selected. The control
and the corresponding lot number appear on the right of the screen, and the
Assign button becomes inactive. The OK button turns yellow and remains yellow
until you save the changes in step 7. You can assign a control to one position only.
6 Repeat steps 4 to 5 to assign further controls.
7 Choose OK to save the changes when each of the desired controls has an assigned
position. The Position Assignment window closes.

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Operators Manual Version 1.0 B-105
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How to install and define Roche controls

How to install and define Roche controls

a To install and define Roche controls


1 Choose QC > Install > Individual.
2 Insert the control barcode card in the barcode card reader station, to the left of the
reagent rotor.
3 Choose Scan BC Card
4 Choose OK on the Scan BC Card window to confirm the scan.

Figure B-89 Scan Control BC Card window

During the reading process the system status changes from Standby to BC card
scan. When scanning is complete, the list on the left of the QC > Install >
Individual screen shows the control and its lot number, and the system status
returns to Standby. The right of the screen displays the tests that are on board and
encoded in the control barcode, together with the reagent lot number, T.Mean,
and T.SD. The Active Test button color is green.
5 Select a test you wish to activate, and choose Active Test. The selected test name
displays a green highlight, the caption of Active Test button changes to Inactive
Test, and the button color changes to blue.
6 Repeat step 5 for every test you wish to activate.

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How to install and define non-Roche controls

How to install and define non-Roche controls

a To install and define non-Roche controls


1 Choose QC > Install.
2 Select a vacant row on the left of the screen.
3 Choose Add to open the Add Control window.

Figure B-90 Add Control window

4 Enter the control information into the Add Control fields using the software
keyboard. The Material Code for non-Roche controls must be in the range 64-78.
5 Choose OK to confirm the entries. The Add Control window closes.
6 Select the non-Roche control on the left of the screen.
7 Choose Edit. The Edit Control window opens.
8 Choose Test Assign. The Test Assign window opens.

Figure B-91 Foreign (non-Roche) Control Test Assign window

9 Select a test on the left of the screen.


10 Choose Assign to copy the selected test to the list of assigned tests on the right of
the screen.

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How to install and define non-Roche controls

11 Repeat steps 9and 10 to assign other tests if required.


12 Choose OK to confirm the assignments. The Foreign Control Test Assign window
closes.
13 Select a test, and enter the T.Mean and T.SD values (Individual and Cumulative)
into the required fields using the software keyboard.
14 Choose Update to transfer the entries to the list. The Calculate button is only
active for tests that are set for QC violation.
15 Repeat steps 13 and 14 for every assigned test.
16 Choose OK to confirm the entries. The Edit Control window closes.
17 Select the defined non-Roche control in the QC > Install > Individual window.
18 Select a test to be activated for the defined non-Roche control, and choose Active
Test. The selected test name displays a green highlight, the Active Test button
caption changes to Inactive Test, and the button color changes to blue.
19 Repeat step 18 for any other test to be activated for the non-Roche control.

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How to edit control values

How to edit control values

a To edit control values


1 Choose QC > Install > Individual.

Figure B-92 QC Install Individual screen

2 Select the required control on the left of the screen.


3 Choose Edit. The Edit Control window opens.

Figure B-93 Edit Control window

4 Select the test to be edited, and enter the values given in the package into the
Individual T.Mean and T.SD fields.

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7 Special operation: How to cobas e 411 analyzer
How to request standby bottle QC

5 Choose Update to transfer the entries to the list of tests. The Calculate button is
only active for tests that are set for QC violation.
6 Choose OK to confirm the changes to the control values. The Edit Control
window closes.

How to request standby bottle QC

Stand by reagent packs currently on the analyzer require QC processing. All tests and
controls for standby reagent packs are displayed in the Stand By Bottle QC screen.

a To request standby bottle QC


1 Choose QC > Status.
2 Select the control to run on the standby reagent.
3 Choose Stand By Bottle QC. The Stand By Bottle QC screen opens.

Figure B-94 Stand By Bottle QC screen

4 Choose a required test from the list. The chosen line is highlighted.
5 Choose Select. A tick and a change of background in the Selection column identify
the selected test.
6 Repeat steps 4 and 5 for any other selections required.
7 Choose OK to confirm the selection. The Stand By Bottle QC screen closes. The
chosen tests are now identified in the Selection column on the QC > Status screen.
To deselect manually selected standby bottle QC controls, navigate to the Stand By
Bottle QC screen, highlight the reagents required, choose Deselect, followed by OK to
confirm the deselection.

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B-110 Operators Manual Version 1.0
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How to cancel a print job

How to cancel a print job

After you have requested the printout of a report from the analyzer, you might decide
that you wish to cancel your request. The cobas e 411 software does not provide an
option for canceling print jobs. Instead, you must cancel the print job by using the
options available on your printer. Consult your printers documentation to choose the
most appropriate procedure.

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Operators Manual Version 1.0 B-111
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How to print a daily Alarm Trace report

How to print a daily Alarm Trace report

a To print a daily Alarm Trace report


1 Choose Print (global button) to open the Print window.
2 Choose Utility.
3 Select Alarm Trace from the Utility Items list.

Figure B-95 Print Utility Alarm Trace window

4 Choose Daily for the Alarm Trace option.


5 Choose Print for the Alarm Information option.
6 Choose Data Range for the Data Selection option.
7 Enter the Start and End dates and times (mm/dd/yyyy/hh/mm) of the Alarms
required in Data Range.
8 Choose OK to confirm the dates and times selected.
9 Choose View to review the data selected.
10 Choose Print. The Print window opens.
11 Choose All or a page range for the results.
12 Choose OK to send the Alarm Trace report to the printer.

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How to print a System Communication Trace report

How to print a System Communication Trace report

a To print a System Communication Trace report


1 Choose Print (global button) to open the Print window.
2 Choose Utility.
3 Select Communication Trace from the Utility Items list.

Figure B-96 Print Utility Communication Trace window

4 Choose Print for the Communication Information option.


5 Choose OK to confirm.
6 Choose View to review the data selected.
7 Choose Print. The Print window opens.
8 Choose All or a page range for the results.
9 Choose OK to send the System Communications Report to the printer.

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Operators Manual Version 1.0 B-113
7 Special operation: How to cobas e 411 analyzer
How to change documentation settings

How to change documentation settings

If the communication link with the host breaks down, the system displays a Host
Communication error and the host cannot document the results. In this event the
operator can change the settings to print out the results without uploading.

a To change documentation settings


1 Choose Utility > System > Page 2/3.
2 Choose Documentation Setup. The Documentation and Printer Setting window
opens.

Figure B-97 Documentation and Printer Setting window

3 Set the Completion Conditions to Printout.


4 Choose OK to save the new settings to the system. The Documentation and
Printer Setting window closes.

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B-114 Operators Manual Version 1.0
cobas e 411 analyzer 7 Special operation: How to
How to program calculated tests

How to program calculated tests

You can configure the system to divide the result of one test by the result of another
test to derive a third parameter of diagnostic significance.
Before programming ensure that the tests required for the calculation are registered
on the system.

a To program calculated tests


1 Choose Utility > Calc. Test.

Figure B-98 Calc. Test (Calculated Test) Screen

2 Enter the User Test No.


3 Enter the Test Name (such as calc1).
4 Select test names from the Numerator and Denominator list boxes to provide the
primary results for the calculation of the derived result.
5 Enter a unit if one is appropriate. If the primary tests used in the calculation use
the same units, the derived result is a ratio and has no units.
6 Choose the material for the test (Serum/Plasma, Urine, or Other).
7 Enter the range of the derived result.
8 Choose Save and check that the entries move to the Calculated Test list.

This programming generates two test requests. If one test fails then the calculation will fail.

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Operators Manual Version 1.0 B-115
7 Special operation: How to cobas e 411 analyzer
How to change test settings

How to change test settings

The following procedure describes how you can change various parameters that the
system records for a test. You can use it to change test units, expected values, dilution
ratios, and the User Test No.

a To change test settings


1 Choose Utility > Application.
2 Select the test to be changed from the Test List on the left of the screen.
3 Choose Utility > Application > Analyze.

Figure B-99 Utility Application Analyze screen

4 Select a default dilution ratio from the list box. Refer to the reagent package insert
for the recommended dilution ratio.
5 Choose Save to confirm the dilution change.
6 Choose Utility > Application > Range.

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How to change test settings

Figure B-100 Utility Application Range screen

7 Change the User Test No., the Unit, and the Expected Values as required.

The User Test No. defines the order of the test keys in Workplace > Test Selection.

8 Choose Save to confirm the parameter changes at the previous step.

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7 Special operation: How to cobas e 411 analyzer
How to change calibration settings

How to change calibration settings

You can change QC settings and calibration parameters. Changes are necessary for
QC violations, when calibration must be repeated because the controls are out of
range. If timeout calibration is set, the system will not recommend a calibration when
control test results are out of range. The default setting is always Timeout.

a To change calibration settings


1 Choose Utility > Application > Calib.

Figure B-101 Utility Application Calib. screen

2 Select a test from the Test List.


3 Set QC Violation to On. The QC Violation Setting area becomes active.
4 Select the SD rule to apply (1S, 2S, or 3S).
5 Select the controls from those listed for Control1, Control2, and Control3. Only
controls activated for the chosen test are listed.
6 Choose Save to confirm the settings. The Save button will change color from
yellow to blue when the setting is successfully saved.

If the control is out of range, the system suggests QC Violation as a cause for calibration, showing
green in the Select column of the Status window (Calibration > Status).
If the control is repeated and the result is within range, the suggestion is removed.

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How to change the sample disk mode

How to change the sample disk mode

Change the sample disk mode only when the analyzer is in Standby.
Complete all open requests before making the change, as data related to uncompleted
requests will be deleted during the process.

a To change the sample disk mode


1 Choose Utility > System.

Figure B-102 Utility System screen (disk system)

2 Choose Change in the Sample Rotor Mode area. The Sample Rotor Mode window
opens.

Figure B-103 Sample Rotor Mode window (disk system)

3 Select Single or Multiple to change the mode, and choose OK. A yellow
Confirmation window appears.
4 Choose Yes to change the mode. The yellow Confirmation window will close. The
OK button in the Utility > System screen changes to yellow.

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How to change the sample disk mode

5 Choose OK to save the mode setting. The OK button changes to blue.

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8 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
cobas e 411 analyzer 8 Maintenance
Table of contents

Maintenance

This chapter provides step-by-step instructions for performing essential maintenance


procedures on the cobas e 411 analyzer, together with a maintenance schedule. As the
operator, you are responsible for providing the proper care and maintenance to
ensure consistent and accurate functioning.
The following procedures are written for trained operators with a working knowledge
of all mechanical functions and software functions of the cobas e 411 analyzer.

In this chapter Chapter 8


Overview .......................................................................................................................... 5
Maintenance procedures ........................................................................................... 5
Performing maintenance .......................................................................................... 6
Maintenance items .................................................................................................... 6
Maintenance schedule ..................................................................................................... 8
Daily ........................................................................................................................... 8
Weekly ........................................................................................................................ 8
Every two weeks ......................................................................................................... 8
Every two months ...................................................................................................... 9
As needed ................................................................................................................... 9
Maintenance log .............................................................................................................. 9
Daily maintenance ......................................................................................................... 12
Clean the sample/reagent probe ............................................................................. 12
Clean the direct drain flow path ............................................................................. 13
Check for condensation inside compartments ...................................................... 14
Weekly maintenance ..................................................................................................... 15
Clean the sipper probe ............................................................................................ 15
Clean the incubator and aspiration station ........................................................... 17
Every two weeks maintenance ...................................................................................... 19
Clean the rinse stations ........................................................................................... 19
Liquid flow cleaning ................................................................................................ 22
Every two months maintenance ................................................................................... 24
Replace the pinch valve tubing ............................................................................... 24
As needed maintenance ................................................................................................ 30
Perform finalization maintenance .......................................................................... 30

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Operators Manual Version 1.0 C-3
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Table of contents

Clean the system water container ........................................................................... 31


Clean the liquid waste container or direct drain (as appropriate) ........................ 33
Clean the microbead mixer ..................................................................................... 35
Clean the ProCell and CleanCell compartments ................................................... 36
Clean the reagent rotor and compartment ............................................................ 39
Empty the solid waste .............................................................................................. 42
Protect the measuring cell during extended shutdown ......................................... 44

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Operators Manual Version 1.0 C-4
cobas e 411 analyzer 8 Maintenance
Overview

Overview

This chapter contains an overview of maintenance on the system including the


following topics:
o Types of required cleaning solutions
o Types of maintenance
All of the software screens shown are examples only. Your screens may vary
depending on your system setup.
The maintenance procedures are listed in order of descending frequency. Each
procedure is presented in the same way, with planning information at the beginning,
followed by the procedure.

Maintenance procedures

Each maintenance task section is divided into two parts: Introduction and Procedure.
The introduction provides important information about the procedure including the
following matters:
o Materials required
o Time required
o Precautions
The procedures provide step-by-step directions for performing the required
maintenance. Some maintenance tasks are divided into several procedures. You must
perform each procedure in the order specified, as well as following each step in the
correct order. Specific notes, precautions, warnings, and cautions are included in the
procedures when appropriate.
These maintenance recommendations are based on using the system eight hours per
day, five days per week. You may adjust your maintenance frequency based on your
laboratory's actual use. Scheduled maintenance follows the Recommended Scheduled
Maintenance table.
e See Maintenance log on page C-9.

Replacement parts may be needed for a specific maintenance procedure. Materials


required are listed in the Introduction section of the procedure.

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Moving parts on page A-9.

For essential safety information, see Instrument covers on page A-9.

Roche Diagnostics
Operators Manual Version 1.0 C-5
8 Maintenance cobas e 411 analyzer
Overview

For essential safety information, see Operation and maintenance on page A-9.

Performing maintenance

There are two types of maintenance on the system:


o Operator-controlled maintenance, performed primarily by the operator, such as
cleaning (for example, Clean the sample/reagent probe) or replacement (for
example, Replace the pinch valve tubing). There may be limited interaction with
system-controlled actions when performing some operator-controlled
maintenance procedures (for example, Liquid flow path cleaning).
o System-controlled maintenance, performed by selecting a maintenance item (for
example, Perform finalization) from the Maintenance Items list on the
Maintenance screen and choosing the Select button. The system then
independently performs the function.
Each time a system-controlled maintenance item is performed, the item is updated
(date and time) in the Maintenance screen. After performing maintenance, measure
control samples to ensure that the instrument operates properly. Inaccurate results
may cause a wrong diagnosis.
Operator-controlled maintenance items can also be set up in the Maintenance screen.
If this option is selected, the user performs the item and chooses Select. The item is
updated by date and time.

Maintenance items

Figure C-1 Maintenance - maintenance items screen (disk systems)

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C-6 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Overview

Figure C-2 Maintenance - maintenance items screen (rack systems)

This section lists all system-controlled maintenance items and a brief description of
their function.

System Reset Resets mechanical parts to their home or standby positions. A system reset is often
necessary if the analyzer is in a P. Stop or Stop status due to an alarm condition. This
button does not reset any of the line mechanisms on a rack system.
The system will stop during reagent scan or after a start if the PC/CC bottles have not
been manually opened. A reset must then be done because the sipper needle path is
blocked over the bottles. Close the sipper shield, select System Reset and choose Start.

Liquid Flow Cleaning Washes the sipper flow paths and the measuring cell with SysClean.

L. and A. Reset All (rack systems Initiates a complete system and line reset for the rack analyzer A-, B-, and C-lines, and
only) returns all analyzer mechanisms to their home or standby positions. An L. and A.
Reset All is often necessary if the analyzer is in a Stop or P. Stop status due to an alarm
condition.

Rack Clear Clears the B-line of any racks and transfers them to the C-line.
(rack system only)

Sipper Pipetter Prime Primes sipper flow paths with system water to purge them of air, for the specified
number of cycles.

S/R Pipetter Prime Purges the sample/reagent pipetter flow path of air for the specified number of cycles.

Measuring Cell Preparation Conditions the measuring cell for the specified number of cycles.

Finalization Maintenance Primes the system with water, and fills the measuring cell with ProCell. This allows
the analyzer to stand unused for several hours, such as when left overnight.

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Operators Manual Version 1.0 C-7
8 Maintenance cobas e 411 analyzer
Maintenance schedule

Media Write Opens the Media Write window to select the internal or external target device for data
storage.

Measuring Cell Exchange Purges tubing. Also used by Roche service representatives.

Maintenance schedule

It is important that you keep to the recommended schedule for all maintenance
actions. You can find detailed descriptions of the maintenance tasks later in this
chapter.

For essential safety information, see Importance of maintenance on page A-8.

Daily

Maintenance task Operator System Page


time (min) time (min)
Clean the sample/reagent probe 1 0 C-12
Clean the direct drain flow path 5 0 C-13
Check for condensation inside compartments 5 0 C-14
Table C-1 Maintenance schedule: Daily

Weekly

Maintenance task Operator System Page


time (min) time (min)
Clean the sipper probe 1 0 C-15
Clean the incubator and aspiration station 5 0 C-17
Table C-2 Maintenance schedule: Weekly

Every two weeks

Maintenance task Operator System Page


time (min) time (min)
Clean the rinse stations 7 0 C-19
Liquid flow cleaning 4 17 C-22
Table C-3 Maintenance schedule: Every two weeks

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C-8 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Maintenance log

Every two months

Maintenance task Operator System Page


time (min) time (min)
Replace the pinch valve tubing 5 15 C-24
Table C-4 Maintenance schedule: Every two months

As needed

Maintenance task Operator System Page


time (min) time (min)
Perform finalization maintenance 0.5 4 C-30
Clean the system water container 10 0 C-31
Clean the liquid waste container or direct drain (as appropriate) 5 0 C-33
Clean the microbead mixer 2 0 C-35
Clean the ProCell and CleanCell compartments 5 0 C-36
Clean the reagent rotor and compartment 15 0 C-39
Empty the solid waste 2 0 C-42
Protect the measuring cell during extended shutdown 0-10 0 C-44
Table C-5 Maintenance schedule: As needed

Maintenance log

Use the Maintenance log to record the dates when the maintenance tasks were
performed and the initials of the person who performed them.
For convenience, the cobas e 411 analyzer maintenance log is printed on two sheets.
You can make photocopies of both parts of the maintenance schedule sheet provided
on the following pages for your own records.

Roche Diagnostics
Operators Manual Version 1.0 C-9
8 Maintenance cobas e 411 analyzer
Maintenance log

cobas e 411 analyzer monthly maintenance log (days 1 to 16)

Serial Number______________Month______________Year__________

Daily 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Clean: Sample/Reagent probe
Direct drain flow path (if fitted)
Check: Condensation inside compartments
Operator

Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Clean: Sipper probe
Incubator and aspiration stations
Operator

Every two weeks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16


Clean: Rinse stations
Perform: Liquid flow cleaning *
Operator

Every two months 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16


Replace: Pinch valve tubing
Operator

As needed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Perform: Finalization maintenance
Clean: System water container
Liquid waste container or direct drain
Microbead mixer
ProCell and CleanCell compartments
Reagent rotor and compartments
Reagent compartment
Perform: Empty solid waste tray
Protect the measuring cell (extended shutdown)

Operator

* Every two weeks or 2500-3000 cycles, whichever comes first

For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operators Manual
Version 1.0.

2006 Roche Diagnostics

Roche Diagnostics
C-10 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Maintenance log

cobas e 411 analyzer monthly maintenance log (days 17 to 31)

Serial Number______________Month______________Year__________

Daily 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean: Sample/Reagent probe
Direct drain flow path (if fitted)
Check: Condensation inside compartments
Operator

Weekly 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean: Sipper probe
Incubator and aspiration stations
Operator

Every two weeks 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31


Clean: Rinse stations
Perform: Liquid flow cleaning *
Operator

Every two months 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31


Replace: Pinch valve tubing
Operator

As needed 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Perform: Finalization maintenance
Clean: System water container
Liquid waste container or direct drain
Microbead mixer
ProCell and CleanCell compartments
Reagent rotor and compartments
Reagent compartment
Perform: Empty solid waste tray
Protect the measuring cell (extended shutdown)
Operator

* Every two weeks or 2500-3000 cycles, whichever comes first

For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operators Manual
Version 1.0.

2006 Roche Diagnostics

Roche Diagnostics
Operators Manual Version 1.0 C-11
8 Maintenance cobas e 411 analyzer
Daily maintenance

Daily maintenance

Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.

Clean the sample/reagent probe

Dirt on the sample/reagent (S/R) probe may cause contamination and carryover, and
affect results. Clean this part daily to prevent contamination.

Planning Recommended frequency: Daily


Operator time: Approximately one minute
System time: None
Precautions: The operation switch must be off.
Wear suitable protective gloves.
Take care not to bend the probe during cleaning.
Table C-6 Planning considerations

Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Table C-7 Required materials

For essential safety information, see Preventing infection on page A-12.

a To clean the sample/reagent probe


1 Switch off the power to the analyzer.

For essential safety information, see Avoid damage to motorized components on page A-13.

For essential safety information, see Avoid damage to the probe on page A-13.

2 Move the sample/reagent probe to an area where you can readily access it.
3 Wipe the outer surfaces of the sample/reagent probe and its tip with a gauze pad
soaked in distilled or deionized water.

Roche Diagnostics
C-12 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Daily maintenance

A Sample/reagent probe B Sample/reagent probe tip

Figure C-3 Clean the sample/reagent probe

4 Inspect the probe. If any dirt is visible, wipe the outer surfaces with a gauze pad
soaked in 70% isopropyl alcohol, and a second wipe with a gauze pad soaked in
distilled or deionized water.
5 Switch on the analyzer.
The analyzer performs a start-up reset operation, and each mechanism returns to
its home or standby position.

Clean the direct drain flow path

If your analyzer is equipped with the direct drain system, crystallization from waste
solution in the flowpath could cause clogging. To prevent crystallization, clean the
flowpath after each day's operation.

Recommended frequency: Daily, at the end of operations


Operator time: Approximately five minutes
System time: None
Precautions: The operation switch must be off.
Wear suitable protective gloves.
Table C-8 Planning considerations

Item
Syringe (minimum capacity 100 mL) with attached tubing
Distilled or deionized water (approximately 100 mL)
Table C-9 Required materials

For essential safety information, see Preventing infection on page A-12.

Roche Diagnostics
Operators Manual Version 1.0 C-13
8 Maintenance cobas e 411 analyzer
Daily maintenance

a To clean the direct drain flow path


1 Introduce approximately 100 mL of distilled or deionized water into the reserve
tank inlet by using a syringe with attached tubing.
2 Check that the water flows freely through the drain tube. If the flow stagnates,
check the condition of the drain tube.

A Tank inlet

Figure C-4 Checking the direct drain flow path

If the tube is clogged, contact your Roche service representative. Do not try to unclog the tube
yourself.

Check for condensation inside compartments

Condensation inside the reagent rotor compartment or system reagent compartments


may cause corrosion or malfunction. Inspect these compartments daily, and wipe off
any condensation with dry gauze pads.
e For safety information and instructions on how to access the compartments, see:
Clean the ProCell and CleanCell compartments on page C-36
Clean the reagent rotor and compartment on page C-39

Planning Recommended frequency: Daily


Operator time: Approximately five minutes
System time: None
Precautions: The analyzer must be switched off at the operation switch.
Wear protective gloves.
Table C-10 Planning considerations

Materials Item
Gauze pads
Table C-11 Required materials

Roche Diagnostics
C-14 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Weekly maintenance

Weekly maintenance

Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.

Clean the sipper probe

Dirt on the sipper probe may cause contamination and carryover, thereby affecting
results. Clean this part weekly to prevent contamination.

Planning Recommended frequency: Weekly


Operator time: Approximately one minute
System time: None
Precautions: The operation switch must be off.
Take care not to bend the probe during cleaning.
Table C-12 Planning considerations

For essential safety information, see Preventing infection on page A-12.

Materials Item
Gauze pads
Cotton swabs
70% isopropyl alcohol
Table C-13 Required materials

a To clean the sipper probe


1 Switch off the power to the analyzer.
2 Lift the instrument cover.

For essential safety information, see Sipper shield on page A-16.

3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.

Roche Diagnostics
Operators Manual Version 1.0 C-15
8 Maintenance cobas e 411 analyzer
Weekly maintenance

Figure C-5 Sipper shield

For essential safety information, see Avoid damage to motorized components on page A-13.

For essential safety information, see Avoid damage to the probe on page A-13.

4 Move the sipper probe to an area where you can readily access it.
5 Wipe the outer surfaces of the sipper probe with a gauze pad soaked in 70%
isopropyl alcohol, followed by a wipe with a gauze pad soaked in distilled or
deionized water.

A
B

A Sipper probe B Sipper probe rinse station

Figure C-6 Sipper probe and rinse station

6 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.

Roche Diagnostics
C-16 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Weekly maintenance

7 Switch on the analyzer at the operation switch.


The analyzer performs a start-up reset operation, and each mechanism
automatically returns to its home or standby position.

Clean the incubator and aspiration station

Spills on the incubator may cause gripper movement alarms. The incubator and
aspiration station should be cleaned regularly.

Planning Recommended frequency: Weekly


Operator time: Approximately five minutes
System time: None
Precautions: The operation switch must be off.
Wear suitable protective gloves.
Table C-14 Planning considerations

Materials Item
Gauze pads
Cotton swabs
Distilled or deionized water
Table C-15 Required materials

For essential safety information, see Aluminum parts on page A-12.

For essential safety information, see Preventing infection on page A-12.

a To clean the incubator and aspiration station


1 Switch off the power to the analyzer.

For essential safety information, see Avoid damage to motorized components on page A-13.

2 Move the sample/reagent probe arm to the far left.


3 Move the gripper towards the front of the analyzer.
4 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released, and then move the sipper arm to the far right.
5 Clean the top of the incubator and aspiration station with gauze pads dampened
with distilled or deionized water.
6 Inspect the incubator and the aspiration station. Remove any residual dirt using a
light scrubbing motion with the water-soaked gauze pads.

For essential safety information, see Aluminum parts on page A-12.

Roche Diagnostics
Operators Manual Version 1.0 C-17
8 Maintenance cobas e 411 analyzer
Weekly maintenance

7 Wet a cotton swab with distilled or deionized water and swab each of the 32
positions on the incubator, as well as the aspiration station.

A B C
A Wipe incubator surface B Swab incubator positions
C Aspiration station

Figure C-7 Clean the incubator surface and incubation positions

8 Use a dry gauze pad to dry the incubator when you have finished cleaning.

For essential safety information, see Dry the incubator surface.

9 Switch on the power to the analyzer.


The analyzer performs a start-up reset operation, and each mechanism
automatically returns to its home or standby position.

Roche Diagnostics
C-18 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two weeks maintenance

Every two weeks maintenance

Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.

Clean the rinse stations

The analyzer has one rinse station for the sample/reagent (S/R) probe and the
microbead mixer, and one for the sipper probe.
Contamination of the rinse stations can be responsible for carryover. To prevent
contamination, clean the rinse stations at least every two weeks.

Planning Recommended frequency: Every two weeks


Operator time: Approximately seven minutes
System time: None
Precautions: The operation switch must be off.
Wear suitable protective gloves.
Table C-16 Planning considerations

Materials Item
Cotton swabs
Distilled or deionized water (approx 300 mL)
Syringe with attached tubing
70% isopropyl alcohol
Table C-17 Required materials

You may find it easier to use two syringes for this procedureone for aspirating liquid and the
other for refilling the rinse stations.

a To clean the rinse stations


1 Switch off the power to the analyzer.

For essential safety information, see Avoid damage to motorized components on page A-13.

For essential safety information, see Avoid damage to the probe on page A-13.

2 Move the sample/reagent probe, the microbead mixer, and the sipper probe to an
area away from the rinse stations.

For essential safety information, see Preventing infection on page A-12.

Roche Diagnostics
Operators Manual Version 1.0 C-19
8 Maintenance cobas e 411 analyzer
Every two weeks maintenance

A Microbead mixer arm (being moved) B Rinse station


C Sipper probe (moved)

Figure C-8 Move components from the rinse stations

3 Aspirate the water out of the microbead mixer rinse station using a syringe with
tubing attached.

A B C D
A Microbead mixer B Microbead mixer rinse station
C Attached tube D Syringe

Figure C-9 Aspirating and refilling the rinse station

Roche Diagnostics
C-20 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two weeks maintenance

4 Use a cotton swab soaked in 70% isopropyl alcohol to clean thoroughly the
microbead mixer rinse station and the sipper rinse stations.

A Swab B Rinse station

Figure C-10 Swabbing the rinse station

5 Wipe the microbead mixer rinse station and the sipper rinse station again using a
fresh cotton swab soaked in distilled or deionized water.
6 Fill the syringe with distilled or deionized water, and refill the microbead mixer
rinse station. This should take approximately 50-100 mL of water.
7 Flush the sample/reagent probe and sipper rinse stations with water (50-100 mL).
8 Aspirate the water out of the microbead mixer rinse station again, by using the
syringe.
9 Refill the microbead mixer rinse station, and flush all the rinse stations with
distilled or deionized water again.
10 Switch on the analyzer at the operation switch.
The analyzer performs a start-up reset operation, and each mechanism
automatically returns to its home or standby position.

Roche Diagnostics
Operators Manual Version 1.0 C-21
8 Maintenance cobas e 411 analyzer
Every two weeks maintenance

Liquid flow cleaning

Contamination in the sipper system may degrade sample accuracy and precision, or
possibly block the measuring cell flow. To keep the sipper liquid flow clean and
maintain the integrity of the measuring cell, perform the following liquid flow
cleaning procedural steps in the correct order.

Planning Recommended frequency: Every two weeks or after 2500-3000 tests, whichever comes
first.
Operator time: Approximately 4 minutes.
System time: Approximately 17 minutes.
Precautions: Wear suitable protective gloves, plus eye and face protection.
Table C-18 Planning considerations

Materials Item
SysClean
SysClean adapter
Distilled or deionized water
Table C-19 Required materials

For essential safety information, see Handling of cleaning solutions (detergents) on page A-8.

For essential safety information, see Contact with solutions on page A-6.

a To perform liquid flow cleaning


1 Open the sipper shield.
2 Remove the ProCell bottle from bottle set 1 in the system reagent compartment.
3 Fill the 'USER' compartment (the smaller compartment) of the SysClean adapter
to the ledge of the compartment with SysClean reagent. The compartment holds
approximately 9 mL of fluid.
4 Carefully insert the filled SysClean adapter into the ProCell position of bottle set 1
in the system reagent compartment, with the edge marked 'USER' facing the back
of the analyzer.

For essential safety information, see Spillage on page A-16.

For essential safety information, see Avoid use of bleach on page A-6.

Roche Diagnostics
C-22 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two weeks maintenance

A B

A USER compartment of the SysClean adapter B Ledge of the USER compartment

Figure C-11 SysClean adapter in the ProCell position of bottle set 1 (system reagent
compartment)

5 Remove the liquid waste container and clean it thoroughly with distilled or
deionized water. Replace the empty liquid waste container.
e For additional information on cleaning the liquid waste container, see Clean the liquid
waste container or direct drain (as appropriate) on page C-33.

6 Verify that ProCell and CleanCell bottles are correctly located in the other three
positions, with the lids open and adequate ProCell and CleanCell in the bottles.
7 Close the sipper shield.
8 Choose Utility > Maintenance.
9 Choose Maintenance from the Maintenance Type list.
10 Select Liquid Flow Cleaning from the Maintenance Items list.
11 Choose Select to display the Liquid Flow Cleaning window.

Figure C-12 Liquid Flow Cleaning window

Roche Diagnostics
Operators Manual Version 1.0 C-23
8 Maintenance cobas e 411 analyzer
Every two months maintenance

12 Type 1 in the Cycles text box and choose Start. Wait for the analyzer to return to
Standby.
13 Remove the liquid waste container and rinse it thoroughly with distilled or
deionized water. Return the liquid waste container to the analyzer.
e For additional information on cleaning the liquid waste container, see Clean the liquid
waste container or direct drain (as appropriate) on page C-33.

14 Open the sipper shield, remove the SysClean adapter.


15 Dispose of any remaining SysClean in an appropriate manner, and rinse the
SysClean adapter thoroughly.

For essential safety information, see Spillage on page A-16.

16 Return the ProCell bottle to its correct position in bottle set 1 in the system
reagent compartment.
17 Close the sipper shield.

Every two months maintenance

Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.

Replace the pinch valve tubing

Worn pinch valve tubing can allow liquid to leak out. Leakage will affect both the
accuracy of the pipetting volumes and the ability of the analyzer to properly clean the
measuring cell.
This maintenance task is divided into the following procedures:
o Procedure 1: To purge the tubing of liquid
o Procedure 2: To remove the tubing from the fittings
o Procedure 3 (optional): To replace a broken fitting
o Procedure 4: To prime the sipper
o Procedure 5: To prepare the measuring cell
Perform these procedures in the correct order.

Planning Recommended frequency: Every two months


Operator time: Approximately five minutes
System time: Approximately 15 minutes
Precautions: The operation switch must be off while changing the tubing.
Wear suitable protective gloves.
Table C-20 Planning considerations

Roche Diagnostics
C-24 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two months maintenance

Materials Item
Pinch valve tubing
Tube joint B
Paper towels
Gauze pads
Table C-21 Required materials

It is highly recommended that you keep a spare Tube joint B on-site. There is a risk that this part
may be damaged during replacement of the Pinch valve tubing.

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Residual liquid in pinch valve tubing on page A-11

For essential safety information, see Spillage on page A-16.

For essential safety information, see Tubing and fittings on page A-17.

a Procedure 1: To purge the tubing of liquid


1 Choose Utility > Maintenance > Maintenance.
2 Choose Measuring Cell Exchange and choose Select to open the Measuring Cell
Exchange window.
3 Choose Start. The tubing is purged of liquid.
4 When the analyzer returns to Standby, switch the power off at the Operation
switch.

Roche Diagnostics
Operators Manual Version 1.0 C-25
8 Maintenance cobas e 411 analyzer
Every two months maintenance

a Procedure 2: To remove the tubing from the fittings


The pinch valve tubing and fittings are located above the sample/reagent and sipper
pipetters.

A E

B F

C G

D H

A Pinch valve (left side, sample/reagent probe) B Tubing (left side, sample/reagent probe)
C Fitting (sample/reagent probe) D Fitting (sample/reagent probe)
E Pinch valve (right side, sipper probe) F Tubing (right side, sipper probe)
G Fitting (sipper probe) H Fitting (sipper probe)

Figure C-13 Pinch value tubing and fittings

1 Ensure that the power to the analyzer is off.


2 Remove the system water container.
3 Cover the area beneath the pipetters with paper towels to prevent spillages and
potential contamination.

Roche Diagnostics
C-26 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two months maintenance

Figure C-14 Place paper towels under the pipetters

4 Carefully remove the tubing from the fittings on the metal plate and discard.
There may still be some liquid in the tubing. The liquid that flows through this
tubing comes from the measuring cell and is potentially biohazardous. Use gauze
pads and paper towels to prevent spillage.

Figure C-15 Absorb liquid as it drains from the tubing

5 Remove the tubing from the pinch valve and discard.


6 Take a new piece of tubing, and verify that the tubing length is 180 mm. If it is not,
discard and use the correct tubings as detailed in the list of materials.
7 Insert the tubing through the pinch valve.

Roche Diagnostics
Operators Manual Version 1.0 C-27
8 Maintenance cobas e 411 analyzer
Every two months maintenance

A B

A Pinch valve B Tubing

Figure C-16 Insert new tubing through the pinch valve

8 Carefully slide the ends of the tubing over each of the fittings in turn.

A B

A Fitting B Tubing

Figure C-17 Fit new tubing on to the fitting

Roche Diagnostics
C-28 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two months maintenance

9 Repeat the procedure for the other pinch valve tubing.


e See Figure C-13 on page C-26 for details of how the pinch valve tubing should be fitted.

a Procedure 3 (optional): To replace a broken fitting

It is only necessary to perform this procedure if any of the fittings are broken.

1 Screw out the fitting counterclockwise from the valve block.

A
B
C

A Fitting B O-ring
C Valve block

Figure C-18 Replacing a fitting

2 Screw the new fitting (Tube joint B) in clockwise.


3 Repeat steps 1 to 2 if any other fittings are broken.
4 Continue with the pinch valve tubing replacement procedure.

a Procedure 4: To prime the sipper


1 Switch on the power to the analyzer and wait for initialization to complete.
2 Choose Utility > Maintenance to display the Maintenance screen.
3 Choose Maintenance on the Maintenance Type list.
4 Choose Sipper Pipetter Prime and choose Select. The Sipper Pipetter Prime
window opens.
5 Type 10 in the Sipper Pipetter Prime Count text box in the Sipper Pipetter Prime
window.
6 Choose Start to purge air from the sipper system with ProCell.
7 Check for leaks at the fittings and on the tubing while the system is priming.
Priming is complete when the system returns to Standby.

Roche Diagnostics
Operators Manual Version 1.0 C-29
8 Maintenance cobas e 411 analyzer
As needed maintenance

a Procedure 5: To prepare the measuring cell


1 Choose Measuring Cell Preparation from the Maintenance Items list, and choose
Select to open the Measuring Cell Preparation window.
2 Type 10 in the Measuring Cell Preparation Count text box in the Measuring Cell
Preparation window.
3 Choose Start. The window closes and the system begins purging the measuring
cell with ProCell. Preparation is complete when the system returns to Standby.

As needed maintenance

Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.

Perform finalization maintenance

Finalization allows the module to stand unused for several hours (for example,
overnight). The system is primed with water, and the measuring cells are filled with
ProCell.
Before going into Standby mode, the system automatically performs finalization
maintenance. Finalization must be manually initiated if it was not performed
automatically (for example, due to an emergency stop), or did not complete (for
example, when an alarm is issued), or if the system stands unused for several hours.
If you choose S. Stop (Sample stop), finalization is bypassed and the analyzer goes
directly into Standby mode.

Planning Recommended frequency: Daily (if the analyzer does not automatically enter finalization
during the course of the day)
Operator time: Approximately 30 seconds
System time: Approximately four minutes
Precautions: None
Table C-22 Planning considerations

Materials None

a To perform finalization maintenance


1 Choose Utility > Maintenance, and select Finalization Maintenance in the
Maintenance Items list.
2 Choose Select to display the Finalization Maintenance window.
3 Choose Start to perform the Finalization Maintenance process.
Once the process has been completed, the system goes into Standby mode.

Roche Diagnostics
C-30 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
As needed maintenance

Clean the system water container

A contaminated system water container can adversely affect analyzer performance.


Clean the system water container as needed.

Planning Recommended frequency: As needed


Operator time: Approximately 10 minutes
System time: None
Precautions: The analyzer must be in Standby or switched off at the
operation switch.
Wear suitable protective gloves.
Table C-23 Planning considerations

Materials Item
Gauze pads
Cleaning brush
Distilled or deionized water
Paper towels
70% isopropyl alcohol
Table C-24 Required materials

a To clean the system water container


1 Put the analyzer into Standby.
2 Raise and remove the system water container.

A Cap and valve (not visible) B System water container

Figure C-19 Remove the system water container

3 Remove the cap and discard any water remaining inside.


4 Rinse the container with water, and then rinse with distilled or deionized water.

Roche Diagnostics
Operators Manual Version 1.0 C-31
8 Maintenance cobas e 411 analyzer
As needed maintenance

5 Inspect the inside of the container and scrub away any visible dirt or
contamination using a large cleaning brush immersed in 70% isopropyl alcohol.
Rinse thoroughly with distilled or deionized water.
6 Remove the valve on the bottom of the system water container.

Figure C-20 Remove the valve from the system water container valve

7 Clean the valve with a wet brush, then rinse with distilled or deionized water. If
the valve appears to be dirty, use a brush immersed in 70% isopropyl alcohol to
clean the valve. Then, rinse thoroughly with distilled or deionized water.
8 Use a gauze pad to wipe and clean the aspiration inlet for the distilled or deionized
water supply.
9 Connect the valve to the container bottom and fill the container with distilled or
deionized water.
10 Add 35 mL of SysWash to the distilled or deionized water, pouring carefully to
avoid creating air bubbles. This gives a SysWash dilution of 1+100.
11 Dry the outside of the container with paper towels, attach the cap to the container,
and return the container to the analyzer.

A Aspiration inlet

Figure C-21 Clean the aspiration inlet

Roche Diagnostics
C-32 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
As needed maintenance

Clean the liquid waste container or direct drain (as appropriate)

The liquid waste container must be checked and emptied as necessary. A full liquid
waste container causes an alarm and interrupts the operation of the analyzer. This
applies to the internal liquid waste container, and also to any external liquid waste
tank in cases where the optional direct drain arrangement is used.

Recommended frequency: As needed


Operator time: Approximately five minutes
System time: None
Precautions: The analyzer must be in Standby or switched off at the
operation switch.
Table C-25 Planning considerations

Materials Item
70% isopropyl alcohol
Paper towels
Germicidal agent, pH 9 (optional)
Table C-26 Required materials

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Avoid use of bleach on page A-6.

a To clean the liquid waste container


1 Switch off the power to the analyzer or put the analyzer into Standby.
2 Pull the liquid waste container toward you, cap it, and raise it carefully while
avoiding the liquid waste outlet.

Roche Diagnostics
Operators Manual Version 1.0 C-33
8 Maintenance cobas e 411 analyzer
As needed maintenance

Figure C-22 Remove the liquid waste container

3 Empty the container and rinse it thoroughly with water.


4 If the inside of the container appears to be dirty, use 70% isopropyl alcohol to
rinse the container. Follow with a thorough water rinse.
5 Wipe the outside of the container with a paper towel.
6 Use a paper towel to wipe the compartment where the container is to be placed.
7 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as
directed in its product labeling) to the liquid waste container.
8 Remove the paper towel under the waste outlet and replace the liquid waste
container.
9 Push the container forward so that the container opening is under the liquid waste
outlet. Be sure to remove the cap.

a To clean the liquid waste container for direct drain (if fitted)
1 Switch off the power to the analyzer or put the analyzer into Standby.
2 Remove the window plate (4 screws) to gain access to the container.
3 Empty the container and rinse it thoroughly with water. Keep paper towels at
hand to mop up any drips or spillages.
4 If the inside of the container appears to be dirty, rinse it with 70% isopropyl
alcohol. Follow with a thorough water rinse.
5 Wipe the outside of the container with a paper towel.
6 Use a paper towel to wipe the area around the container.
7 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as
directed in its product labeling) to the container.

Roche Diagnostics
C-34 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
As needed maintenance

8 Position the drain tubing with no upwards slope or U-bend. See Analyser
Components - Direct drain system (optional).
9 Replace the container window plate.

Clean the microbead mixer

Clean the microbead mixer when necessary. Check the microbead mixer periodically,
and remove visible dirt, for example red dots on the mixer arm or the paddle.
Impurities on the microbead mixer may cause problems and affect results.

Planning Recommended frequency: As needed


Operator time: Approximately two minutes
System time: None
Precautions: The analyzer must be in Standby or switched off at the
operation switch.
Wear protective gloves.
Do not bend the mixer.
Table C-27 Planning considerations

Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Table C-28 Required materials

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Avoid damage to motorized components on page A-13.

For essential safety information, see Bent or damaged microbead mixer paddle on page A-6.

a To clean the microbead mixer


1 Switch off the power to the analyzer or put the analyzer into Standby.
2 Move the microbead mixer arm to a readily accessible position.

Roche Diagnostics
Operators Manual Version 1.0 C-35
8 Maintenance cobas e 411 analyzer
As needed maintenance

A Mixer paddle

Figure C-23 Move the mixer paddle for cleaning

3 Wipe the outer surface of the microbead mixer paddle carefully, using a gauze pad
soaked in 70% isopropyl alcohol. Repeat with a new gauze pad soaked in distilled
water. Take care not to bend the mixer paddle during cleaning.
4 Switch on the power to the analyzer. The analyzer performs a start-up reset and
each mechanism returns to its home or standby position.

Clean the ProCell and CleanCell compartments

Clean the system reagent compartment whenever necessary to remove any liquid or
residue spilled from the ProCell and CleanCell reagents.

Planning Recommended frequency: As needed


Operator time: Approximately five minutes
System time: None
Precautions: The analyzer must be in Standby or switched off at the
operation switch.
Wear protective gloves.
Table C-29 Planning considerations

Materials Item
Gauze pads
Cotton swabs
Distilled or deionized water
70% isopropyl alcohol
Table C-30 Required materials

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As needed maintenance

For essential safety information, see Spillage on page A-16.

For essential safety information, see Aluminum parts on page A-12.

a To clean the ProCell and CleanCell compartments


1 Switch off the power to the analyzer or put the analyzer into Standby.
2 Lift the instrument cover.

For essential safety information, see Sipper shield on page A-16.

3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
e For the location of the sipper shield, see Figure C-5 on page C-16.

For essential safety information, see Avoid damage to motorized components on page A-13.

4 Move the sipper arm manually as far to the left as the arm will allow.
5 Remove all four ProCell and CleanCell reagent bottles from their compartments.
6 Wipe the sipper shield with a damp gauze pad and repeat with a dry gauze pad.

A Sipper shield latch B Sipper shield (in the open position)

Figure C-24 Clean the sipper shield

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8 Maintenance cobas e 411 analyzer
As needed maintenance

7 Wipe the inside of the compartments with damp (not wet) gauze pads. Do not
allow water to pool in the bottom of the compartments. Avoid the photosensors in
the two inside compartments, that check for the presence of ProCell/CleanCell
bottle sets. Each sensor is in a rectangular window at the back of its compartment,
just below the top edge. If you wet the sensors, dry them with a cotton swab.

For essential safety information, see Photosensors on page A-15.

B C
A Photosensor locations (visible when bottle B Bottle set 2, CleanCell position
removed)
C Bottle set 1, ProCell position

Figure C-25 Clean the ProCell and CleanCell compartments

8 Wipe the compartment with a dry gauze pad.


9 Return the ProCell and CleanCell reagents to their respective system reagent
compartments.
10 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
11 Close the instrument cover.
12 Switch on the analyzer again.
The analyzer performs a start-up reset operation, and each component returns to
its home or standby position.

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As needed maintenance

Clean the reagent rotor and compartment

To maintain the efficiency of the analyzer, the reagent rotor and compartment must
be cleaned as soon as any signs of dirt or contamination appear. Any reagent spills
must be cleaned up as they occur.
This maintenance task is divided into the following procedures:
o Procedure 1: To clean the reagent rotor
o Procedure 2: To clean the reagent rotor compartment
Perform these procedures in the correct order.

Planning Recommended frequency: As needed


Operator time: Approximately 15 minutes
System time: None
Precautions: The analyzer must be switched off at the operation switch.
Wear protective gloves.
Table C-31 Planning considerations

Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Cloth or lint-free towels
Table C-32 Required materials

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Spillage on page A-16.

For essential safety information, see Avoid damage to motorized components on page A-13.

a Procedure 1: To clean the reagent rotor


1 Switch off the power to the analyzer at the operation switch.
2 Remove the cover from the reagent rotor.
3 Close completely all the reagent pack caps, and remove all the reagent packs from
the reagent rotor.
4 Loosen and remove the black thumbscrews on the center of the reagent rotor.

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As needed maintenance

B
A Thumbscrews B Alignment pin

Figure C-26 Loosen and remove thumbscrews

5 Remove the reagent rotor from the compartment.


6 Wipe the inside and outside of the reagent rotor with gauze pads soaked with
distilled or deionized water.

A Compartment B Body of the disk

Figure C-27 Wipe the reagent rotor

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As needed maintenance

7 Inspect the reagent rotor, and use gauze pads soaked with 70% isopropyl alcohol
to clean any visible dirt from the rotor. Wipe the cleaned rotor with gauze pads
soaked with distilled or deionized water.
8 Dry the reagent rotor with a cloth or lint-free towels.
9 Set the reagent rotor to one side while cleaning the reagent rotor compartment.

a Procedure 2: To clean the reagent rotor compartment


1 Ensure that the analyzer is switched off at the Operation switch.
2 If you find any condensation inside the compartment, wipe it off with dry gauze
pads.
3 Wipe the reagent rotor compartment and the barcode reader window with gauze
pads soaked with distilled or deionized water.

For essential safety information, see Barcode reader window on page 13.

A Barcode Reader Window

Figure C-28 Cleaning the reagent rotor compartment

4 Inspect the reagent rotor compartment and the barcode reader window. Remove
any visible dirt or contamination using gauze pads soaked with 70% isopropyl
alcohol. Then wipe the cleaned reagent rotor compartment and barcode reader
window with gauze pads soaked with distilled or deionized water.
5 Dry the reagent rotor compartment and the barcode reader window with a cloth
or lint-free towels.
6 Return the reagent rotor to the compartment.
7 Note that the rotor is keyed; make sure that the alignment pin on the center plate
is aligned with the hole on the rotor.
8 Replace and secure the thumbscrews.

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8 Maintenance cobas e 411 analyzer
As needed maintenance

9 Place the reagent packs back into the reagent rotor.


10 Replace the reagent rotor cover.

Empty the solid waste

During operation, the solid waste tray is filled with disposed tips and cups. Check the
solid waste tray regularly, and empty as needed.

Planning Recommended frequency: As needed


Operator time: Approximately two minutes
System time: None
Precautions: The analyzer must be in Standby or switched off at the
operation switch.
Wear protective gloves.
Table C-33 Planning considerations

Materials Item
Clean-Liner
Table C-34 Required materials

For essential safety information, see Preventing infection on page A-12.

For essential safety information, see Handling of waste on page A-12.

For essential safety information, see Changing the Clean-Liner on page A-6.

a To empty the solid waste


1 Switch off the power to the analyzer or put the analyzer into Standby.
2 Open the solid waste door and pull out the tray.
3 Slide the clear lid forward to close the Clean-Liner.

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A Sliding lid B Solid waste compartment door


C Waste tray

Figure C-29 Remove the Clean-Liner

4 Remove the Clean-Liner from the tray and dispose of it according to the waste
handling and disposal procedures that apply in your laboratory.
5 Place a fresh Clean-Liner into the tray.
6 Verify that the sliding door is open and that the opening is located at the back of
the tray.
7 Insert the tray into the analyzer and close the door.
On the System Overview screen, the solid waste counter automatically resets to 0
(zero) when the solid waste tray is removed.
8 Dispose of the Clean-Liner appropriately, as it contains potentially biohazardous
material.

If you remove the solid waste tray for any reason you should also discard the solid waste or replace
the Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during
the course of operation. When the analyzer senses that the solid waste tray was removed, the
counter resets to 0 (zero).

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8 Maintenance cobas e 411 analyzer
As needed maintenance

Protect the measuring cell during extended shutdown

If the analyzer is not going to be used for more than seven days, it is important to
prepare the system properly and perform the correct shutdown maintenance. Failure
to observe these recommendations may result in damage to the measuring cell.
Different shutdown procedures are recommended, depending upon the duration of
inactivity. Certain procedures may require the assistance of a Roche Diagnostics
service representative.

Shutdown period Shutdown procedure Startup process


One week No special action necessary after operation No special action
One to four weeks After operation, perform a sipper prime (5 times) Perform measuring
to fill the measuring cell with system water. The cell preparation (30
measuring cell will remain in the instrument. times).
Four weeks and After operation, perform a sipper prime (5 times) Perform measuring
longer to fill the measuring cell with system water. Seal cell preparation (30
the sipper probe by using flexible tubing. The times).
measuring cell will still remain in the instrument.
Table C-35 Measuring cell protection measures for different shutdown periods

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Troubleshooting D

9 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
10 Data alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-31
cobas e 411 analyzer 9 Troubleshooting
Table of contents

Troubleshooting

This chapter provides general information about troubleshooting problems on the


cobas e 411 system.

In this chapter Chapter 9


Introduction .................................................................................................................... 5
Alarms .............................................................................................................................. 5
Problem categories .......................................................................................................... 5
Sample/reagent problems ......................................................................................... 6
Instrument/hardware problems ............................................................................... 6
Computer/software problems .................................................................................. 6
Facility problems ...................................................................................................... 7
Operator's primary responsibility ............................................................................ 7
Contacting Technical Support ....................................................................................... 8
General information ............................................................................................ 8
Immunoassay problems ...................................................................................... 8
Software problems ............................................................................................... 8
Instrument problems .......................................................................................... 9
Basic troubleshooting flow chart .................................................................................. 10
Immunoassay troubleshooting ..................................................................................... 11
Reagents, calibrators, and controls ......................................................................... 11
When handling reagents ................................................................................... 11
When reconstituting/handling calibrators ....................................................... 12
When reconstituting/handling controls ........................................................... 12
For problems with a single sample ................................................................... 13
For problems with a single assay ...................................................................... 13
When handling system water ............................................................................ 14
When using a diluent ........................................................................................ 14
Instrument troubleshooting ......................................................................................... 14
Troubleshooting at power up .................................................................................. 14
General mechanical problem isolation .................................................................. 14
The instrument does not power up ........................................................................ 15
Cannot access another software screen .................................................................. 15
The touchscreen does not switch on ...................................................................... 16

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Table of contents

The touchscreen is difficult to see .......................................................................... 16


The solid waste tray does not come out or produces unusual sounds ................. 16
The reagent rotor cover does not open or close ..................................................... 17
The sample disk does not move .............................................................................. 17
Trouble placing a reagent pack on the reagent rotor ............................................. 17
Trouble replacing an AssayTip or AssayCup tray .................................................. 18
Trouble replacing a system reagent (ProCell or CleanCell) .................................. 18
Trouble replacing the system water container ....................................................... 19
Trouble replacing the solid waste tray .................................................................... 20
Empty liquid waste container causes an alarm ...................................................... 20
The direct drain reserve tank is full ........................................................................ 20
Probes do not descend to the liquid surface .......................................................... 21
Results do not print automatically ......................................................................... 21
Data backup write error .......................................................................................... 22
Bubbles in syringes ................................................................................................. 23
Chemistry troubleshooting ........................................................................................... 24
False measurements ................................................................................................. 24
Values out of measuring range .......................................................................... 24
Drift .......................................................................................................................... 24
Erratic test results .................................................................................................... 25
Assay calibration ...................................................................................................... 25
Calibration cannot be performed ..................................................................... 25
Duplicates are out of limits ............................................................................... 25
Monotony or minimum acceptable difference are not fulfilled ...................... 26
Missing values .................................................................................................... 26
Values are out of limits ...................................................................................... 26
Calibration factor is out of limits ..................................................................... 27
Recovery of controls ................................................................................................ 28
Intra assay precision ................................................................................................ 28
Inter assay precision ................................................................................................ 29
System to system variance ....................................................................................... 29
Method comparison ................................................................................................ 29
Auto dilution not possible ...................................................................................... 30

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Introduction

Introduction

To identify and isolate problems effectively, you must understand the theory of
operation, operating procedures, emergency procedures and test reaction
descriptions covered in this manual.
The information in this chapter will help you to recognize the causes of various
operational problems, find information to resolve operational problems, and
minimize the potential for operator-induced problems.
e If you are unable to resolve the problem, and you need support, see Contacting Technical
Support on page D-8 for a list of information that Roche might request if you call for
assistance.

Alarms

If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm.
There are two types of alarm:
o Instrument alarms
These are displayed alarms that indicate abnormal instrument conditions, such as
reagent rotor temperature, and mechanical malfunctions.
o Data alarms
These are printed or displayed alarms or flags that indicate unusual reaction
conditions, such as insufficient sample or reagent, or measures values outside the
limits.
e For further information, see Data alarms on page D-31.

Problem categories

The problems that may be encountered can be separated into the following categories:
o Sample/reagent problems
o Instrument/hardware problems
o Computer/software problems
o Facility problems

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9 Troubleshooting cobas e 411 analyzer
Problem categories

Sample/reagent problems

o Insufficient sample volumes of:


O Sample cups
O Sample tubes
e See:
Residual volume (disk system) on page A-42
Residual volume (rack system) on page A-42
o Reagent packs not loaded correctly with the white bottle furthest from the center
of the reagent rotor
o Diluent bottles not loaded with the correct barcode label facing outwards
o Incorrect sample preparation
O Proper reconstitution
O Aliquoting/labeling
o Incorrect sample storage
O Refrigerating
O Freezing
O Thawing
O Labeling after use
o Manually program calibrators
o Operator error

Instrument/hardware problems

o Electrical/electronic
o Mechanical:
O Pinch valve tubing leaking
O AssayCup/AssayTip jammed
O Problem with solid waste tray removal
o Operator error:
O Incorrect size of sample tubes or cups used
O Incorrect replacement of AssayCup/AssayTip
O Incorrect or insufficient maintenance
O Caps not removed from liquid waste containers
O Caps not opened on ProCell/CleanCell bottles

Computer/software problems

o Incorrect system parameters


o Faulty barcode card or software settings
o Disk system:
O Single disk mode
O Multiple disk mode
O Starting from Standby compared with starting from S. Stop

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Problem categories

o Orders/result database capacity exceeded (up to 2000 results can be stored, for
routine samples, STAT (Short Turn Around Time) samples, and controls)
o Alarms
o Operator error

Facility problems

o Temperature
o Humidity
o Power supply
o Water supply
o Drain
e See System specifications on page A-37.

Operator's primary responsibility

Your primary responsibility lies in the following areas:


o Reagent, calibrator, and control preparation and storage
o Sample and sample container preparation
o Computer parameters and general computer input/output operations
o Basic operator technique, including instrument and computer operation
o Basic component replacement
o Maintenance

For essential safety information, see Electrical safety precautions on page A-7.

e See Safety information on page A-3 for further information.

When troubleshooting, review the alarms and isolate the problem to the area denoted
by the alarms. In many cases, you may be able to find the problem, correct it, and
resume test processing. The remainder of this section provides you with instructions
and guidelines to assist you in isolating problems.

If there is a problem with barcode reading, first check the position of the barcode label.

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9 Troubleshooting cobas e 411 analyzer
Contacting Technical Support

Contacting Technical Support

If it becomes necessary to consult Technical Support to troubleshoot a test or


instrument problem, you should be prepared with the following information. You can
make a copy of the Technical support information form on page E-5 and use this to
record the necessary information before calling Technical Support. The information
that is needed depends upon whether you have encountered a chemistry problem,
immunoassay problem, or instrument problem.

General information
The following general information is required for all problems:
o Account number or customer ID number
o Contact name and telephone number
o Instrument serial number
o Description of the problem, including relevant alarm(s) and alarm code numbers
o When the problem first occurred (for example, after reagent pack lot change)
o Whether the problem was observed with just one system or with all systems
o Copies of the original instrument printouts (send by fax or e-mail)

Immunoassay problems
The following general information is required for immunoassay problems:
o Whether the problem was observed with just one assay or with all assays
o Whether the problem was observed with just one sample type or with all sample
types
o Control results from the last few controls performed
o Sample type used (serum, plasma, urine, or saliva)
o Sample tube used (manufacturer, diameter, primary or secondary tube)
o Elapsed time between specimen collection and measurement
o Patient results (with correlation results, if relevant)
o Test(s) affected and other tests on board
o Whether SysWash was added to the system water container
o Catalog number, lot numbers, and expiration dates of reagents
o Catalog number, lot numbers, and expiration dates of calibrators and controls
o Calibration signals (HetIA) from the last few calibrations performed
o Control results from the last few controls performed
o Details of reagent/calibrator/control handling (such as calibration frequency,
stability, ambient temperature, foam, and evaporation)
o When the reagent was loaded onto the system

Software problems
The following general information is required for software problems:
o The version of software installed
o The sequence number of the reagent packs

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Contacting Technical Support

Instrument problems
The following general information is required for instrument problems:
o Rack or disk system
o Instrument maintenance and service history
o Whether a host or Pre-Analytic Systems Manager (PSM)(1) was connected
o Number of tests performed
o Other instrument or maintenance related information
o Error code and error description

(1) Not available in the United States of America

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Basic troubleshooting flow chart

Basic troubleshooting flow chart

The following flow chart details the basic decisions to be made when performing
troubleshooting on the cobas e 411.

Problem detected

Was an
instrument alarm Follow the remedy
Yes
generated? displayed on screen

No

Does
Was a No the alarm
Yes Follow appropriate remedy data alarm recur?
Yes
in Data alarms chapter generated?
Continue normal
operation
Does Yes
the alarm No
recur?
No
Continue normal
operation
Yes Check the Troubleshooting
chapter for a description of
this problem

Was a
description of this Yes Follow the remedy
problem
found?

Does the
Yes problem
No recur?

Print out relevant data, ready to send to


Technical Support No

Continue normal
Identify the type of problem: operation
Immunoassay problem?
Software problem?
Instrument problem?

Copy the Technical Support information


form in the Appendix and record the
information for the type of problem
encountered

Call
Technical Support

Figure D-1 Basic troubleshooting flow chart

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Immunoassay troubleshooting

Immunoassay troubleshooting

Mechanical problems are evident when the analyzer displays an alarm message. A
chemistry problem may display a data alarm, or may only become evident with an
unexpected result.
Deciding that a problem exists is the first step in the process. The following situations
may require troubleshooting:
o Error codes on calibration documentation.
o Data alarms on control or patient samples.
o Quality control sample results outside established range.
o Patient tests with unexpected results.
When troubleshooting a problem, open the Print screen (using the Print global
button), choose Utility tab, and print an alarm list. Use this list to assist you with
troubleshooting.
To troubleshoot effectively, eliminate extraneous information and pinpoint the
problem. Use the calibration documentation, quality control results, or patient results
to decide which of the following conditions apply, and perform the associated checks
outlined in the following sections:
e See also:
For problems with a single sample on page D-13
For problems with a single assay on page D-13

Reagents, calibrators, and controls

Sometimes conditions arise that cannot be detected by the analyzer. These conditions
do not generate alarms and therefore must be detected by the operator. When one or
more of these conditions are present, test results can be extremely high, low or erratic.
To identify the cause of high, low or erratic test results, first verify the handling of
reagents, calibrators and controls by considering the following lists of checks.

For essential safety information, see Handling of reagents on page A-8.

For essential safety information, see Contact with solutions on page A-6.

e See Safety information on page A-3 for further information.

When handling reagents


o Has the catalog number changed?
o Have the lot numbers changed? Do they match the lot numbers in the Reagent
Detail window?
o Was the reagent stored appropriately?
o Was the reagent kit stored in an upright position and at the correct temperature
(2-8C)?

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Immunoassay troubleshooting

o Was the reagent allowed to reach the correct temperature on board (15 minutes
from room temperature or one hour from 4C) before starting the instrument?
o Were the reagent packs within the allowed stability after opening and the
expiration dates not exceeded?
o Were the system reagent bottles closed overnight?
o Were the partly used ProCell/CleanCell bottles replaced from the left to right side?
o Was any foam observed on the surface of the reagents?
o Were any bubbles observed in the pipetters or syringes?

For essential safety information, see Handling of reagents on page A-8.

When reconstituting/handling calibrators


o Has the lot number changed?
o What is the correct reconstitution volume?
o Was the correct amount of time allowed for reconstitution?
o What is the recommended storage?
o What is the expiration date of the calibrator lot?
o What is the expiration date of the reconstituted material?
o Was fresh, bacteria-free, deionized water used in reconstitution?
o Were volumetric pipettes used (where appropriate)?
o Were the calibrators brought to room temperature before starting the instrument?
o Were the reconstituted calibrators brought to room temperature and allowed to
stand closed for 15 minutes after 1 mL of distilled water was added?
o Were the calibrators carefully mixed, avoiding the formation of foam?
o Were the lyophilized calibrators carefully dissolved?
o Were the calibrators transferred to the correct barcoded vials?
o Was the calibrator on board the analyzer for longer than the time recommended
in the package insert? (Due to possible evaporation effects, no more than five
calibration procedures should be carried out.)
o Were the calibrators checked and found to be within the allowed stability after
opening?
o Were drops observed hanging on the CalSet cap?
o Was crystallized material observed on the CalSet cap? (If so, discard the CalSet
vial.)

When reconstituting/handling controls


o Has the lot number changed?
o What is the correct reconstitution volume?
o Was the correct amount of time allowed for reconstitution?
o What is the recommended storage?
o What is the expiration date of the control lot?
o What is the expiration date of the reconstituted material?
o Was fresh, bacteria-free, deionized water used in reconstitution?
o Were volumetric pipettes used (where appropriate)?

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Immunoassay troubleshooting

o Were the lyophilized controls carefully reconstituted with, for example, 3 mL for
PreciControl Universal and PreciControl Tumor Marker (stand closed for 30
minutes), and 2 mL for PreciControl Cardiac (stand closed for 15 minutes)?
o Were the controls transferred to the correct barcoded vials?
o Were the controls checked and found to be within the allowed stability after
opening, and the expiration date not exceeded?
o Was any foam observed on the surface of the controls?
o Were drops observed hanging on the control vial cap? (You need to clean the
control caps carefully with a paper tissue.)
o Was crystallized material observed on the control vial cap? (If so, discard the
control vial.)
o Were the controls aliquoted and frozen? (This is recommended for controls such
as PreciControl Universal, Cardiac, and Tumor Marker.)

For problems with a single sample


Check for:
o Sufficient sample volume, including adequate sample container residual volume.
o Sample integrity (fibrin, hemolysis, icterus, and lipemia).
o Appropriate type of sample (serum, plasma, urine, and saliva).
o Bubbles in the sample cup or tube.
o Sample reproducibility.
o Recommended sample containers used.
o Air bubbles or foam on the surface of the samples.
o Sample stability within the specified range (refer to package inserts).
o Correct preparation of the sample material (allow 30 minutes waiting time for
clotting, and centrifuge the samples before putting them on the analyzer).
o Presence of precipitates in the sample. Samples containing precipitates must be
centrifuged before testing at a minimum of 2500 rpm for 10 minutes (primary
and normal cups).
o Correct placement of sample cups in sample disk or rack.
o Residual volume within the specified range.
e For further information, see:
Residual volume (disk system) on page A-42
Residual volume (rack system) on page A-42.

For problems with a single assay


Check for:
o Calibrators not at room temperature before operation.
o Incorrectly prepared calibrators.
o Expired reagent(s).
o Expired calibrators.
o Calibrators on-board stability exceeded.
o Correct lot number in the Reagent Detail window.

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9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting

When handling system water


o Was distilled water used according to the specification (conductivity <10 S/cm)?
o Was the system water container carefully refilled with distilled water in order to
avoid air bubbles?
o Was the correct amount (35 mL) of SysWash added to the system water?

When using a diluent


o Was the recommended dilution ratio used?
o Was the end concentration after dilution still within stated linearity?
o Was the diluent checked and found to be within the allowed stability after
opening, and the expiration date not exceeded?
o Was the diluent used recommended for this particular assay?

Instrument troubleshooting

When troubleshooting a problem, open the Print screen (using the Print global
button), choose Utility tab, and print an alarm list. Use this list to assist you with
troubleshooting.

Troubleshooting at power up

If the instrument does not power up, this could be caused by one of the conditions
listed in the following table.
To troubleshoot a problem, determine the category below that best describes the
problem, and follow the recommended remedy. If all remedies are unsuccessful, call
Technical Support.

Cause or description Remedy


The instrument is unplugged. Plug instrument power cord into socket.
The operation switch (located at the front of Switch the operation switch to the on
the instrument) is in the off position. position.
The analyzer circuit breaker (right side of Switch the analyzer circuit breaker to the on
instrument) in off position. position
The circuit breaker for the instrument power Have your facility electrician check the
line in your facility is in the off position. appropriate circuit breaker.
Rack unit power cable is unplugged at the Plug the power cable into the rack unit. If the
loader or unloader. instrument still does not power up, call
Technical Support.
Table D-1 Troubleshooting at power up

General mechanical problem isolation

The control unit controls and monitors all mechanical functions of the instrument.
When a mechanical problem arises within the instrument, it is immediately

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cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting

recognized by the system. An audible alarm sounds, if enabled on the Alarm Sound
Setting window (Alarm > Sound), and the alarm indicator on the global Alarm
button lights, alerting you to the problem. Choose Alarm (global button) to display
the Alarm screen with the specific alarm code, date and time the alarm occurred and a
description of the alarm. Choose a specific alarm to display the alarm details and
appropriate remedy.
For certain problems affecting the instrument's performance, the system terminates
the operation mode and enters the sampling stop or stop mode. In the sampling stop
mode, the system allows completion of the samples in process unaffected by the
failure. If the problem affects all samples in process, the computer immediately
terminates the operation mode with a stop or emergency stop.

For essential safety information, see Instrument problems without alarms on page A-9.

The instrument does not power up

If you are having problems switching the analyzer on, follow the steps below:
1 Are the operation on/off switch and analyzer circuit breaker turned off?
o If yes, go to step 2.
o If no, go to step 3.
2 Switch on both the analyzer circuit breaker and power switches.
3 Is the power cable plug disconnected at either the instrument or the outlet?
o If yes, go to step 4.
o If no, go to step 5.
4 Firmly connect the power cable.
5 Is the outlet working?
o If yes, go to step 7.
o If no, go to step 6.
6 Check the circuit breaker in the laboratory distribution box.
7 If the instrument still does not power up, call Technical Support.

Cannot access another software screen

If you are unable to access another software screen, follow the steps below:
1 Switch the analyzer off at the circuit breaker.
2 Switch the analyzer on at the circuit breaker. If you are still unable to access
another screen, then call Technical Support.

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9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting

The touchscreen does not switch on

If you are having problems with the touchscreen, follow the steps below:
1 Is the operation on/off switch on the right side of the analyzer switched off?
o If yes, go to step 2.
o If no, go to step 3.
2 Switch the operation switch on. Does the touchscreen switch on?
o If no, go to step 3.
3 Firmly connect the cable.
4 Call Technical Support.

The touchscreen is difficult to see

If the touchscreen is difficult to see, follow the steps below:


1 Is the touchscreen dirty?
o If yes, go to step 2.
o If no, go to step 3.
2 Gently wipe the surface with a dry cloth.
3 Is the ambient lighting too bright?
o If yes, go to step 4.
o If no, go to step 5.
4 Either reduce the brightness of the ambient lighting or change the direction of the
adjustable monitor face.
5 Call Technical Support.

The solid waste tray does not come out or produces unusual sounds

If you are having problems removing the solid waste tray or unusual sounds are
coming from the solid waste tray area, follow the steps below:
1 Are the tray and Clean-Liner seated correctly?
o If yes, go to step 3.
o If no, go to step 2.
2 Reseat the tray and Clean-Liner.
3 Are there stray cups or tips behind the tray?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the stray cups and tips and replace the tray and Clean-Liner.
5 Call Technical Support.

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D-16 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting

The reagent rotor cover does not open or close

If you are having problems opening or closing the reagent rotor cover, follow the steps
below:
1 The reagent rotor cover is keyed. Is the reagent rotor cover correctly oriented for
placement?
o If yes, go to step 3.
o If no, go to step 2.
2 Make sure that the reagent rotor cover fits into the key, which is there to prevent
the cover being placed in the wrong orientation.
3 Is there an obstacle around the cover?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Call Technical Support.

The sample disk does not move

If the sample disk does not move properly, follow the steps below:
1 Is the sample disk seated correctly?
o If yes, go to step 3.
o If no, go to step 2.
2 Remove and reseat the sample disk.
3 Is there an obstacle around the sample disk?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Call Technical Support.

Trouble placing a reagent pack on the reagent rotor

If you are having problems placing a reagent pack on the reagent rotor, follow the
steps below:
1 Reagent packs are keyed for correct placement. Is the reagent pack correctly
oriented?
o If yes, go to step 3.
o If no, go to step 2.
2 Reorient the reagent pack (the transparent cap and the barcode should face the
outside of the reagent rotor).

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Instrument troubleshooting

3 Is there an obstacle beneath the reagent rotor?


o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the reagent pack damaged?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the reagent pack.
7 Call Technical Support.

Trouble replacing an AssayTip or AssayCup tray

If you are having problems replacing an AssayTip or AssayCup tray, follow the steps
below:
1 AssayTip and AssayCup trays are keyed for correct placement. Is the AssayTip or
AssayCup tray correctly oriented?
o If yes, go to step 3.
o If no, go to step 2.
2 Remove and reseat the AssayTip or AssayCup tray.
3 Is there an obstacle around the tray?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the tray damaged or deformed?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the tray.
7 Call Technical Support.

Trouble replacing a system reagent (ProCell or CleanCell)

If you are having problems replacing a ProCell or CleanCell reagent bottle, follow the
steps below:
1 The system reagent bottles are keyed for correct placement. Is the bottle in its
correct position?
o If yes, go to step 3.
o If no, go to step 2.
2 Remove the bottle and check the position before placing the reagent into its
correct position. ProCell must only be placed in positions 1 and 3, and CleanCell
in positions 2 and 4.

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The analyzer can operate with just one bottle set of ProCell and CleanCell reagent, but they must be
placed either in positions 1 (ProCell) and 2 (CleanCell), or in positions 3 (ProCell) and 4
(CleanCell).

3 Is there an obstacle beneath the system reagent bottle?


o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the system reagent bottle damaged or deformed?

Sometimes the system reagent bottle appears to bulge until the cap is opened. You may be able to fit
the bottle in the compartment after opening the cap.

o If yes, go to step 6.
o If no, go to step 7.
6 Replace the system reagent bottle.
7 Call Technical Support.

Trouble replacing the system water container

If you are having problems replacing the system water container, follow the steps
below:
1 The system water container must be correctly oriented for placement. Verify that
the cap is closest to the rear of the analyzer. Is the container facing the right way?
o If yes, go to step 3.
o If no, go to step 2.
2 Reseat the container and gently push down until you feel a snap indicating that
the bottle is connected.
3 Is there an obstacle around the system water container?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the system water container damaged or deformed?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the system water container.
7 Call Technical Support.

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Trouble replacing the solid waste tray

If you are having problems replacing the solid waste tray, follow the steps below:
1 Does the Clean-Liner fit properly (the opening in the sliding door must point to
the rear of the analyzer) and is not damaged or bent?
o If yes, go to step 3.
o If no, go to step 2.
2 Try a different Clean-Liner.
3 Is there an obstacle around the solid waste tray?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the solid waste tray damaged or deformed?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the solid waste tray.
7 Call Technical Support.

Empty liquid waste container causes an alarm

If your empty liquid waste container gives an alarm stating that the container is full,
follow the steps below:
1 Is there an obstacle causing the tray on which the container rests, to remain in the
down position (that is, is it still activating the sensor)?
o If yes, go to step 2.
o If no, go to step 3.
2 Remove the obstacle.
3 Call Technical Support.

The direct drain reserve tank is full

If the direct drain reserve tank is full and operation has stopped, follow the steps
below:
1 Is the drain tube placement correct? For correct placement of the tube, see Direct
liquid drain (optional) on page A-93.
o If yes, go to step 3.
o If no, go to step 2.
2 Place the tube correctly.
3 Call Technical Support.

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D-20 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting

Probes do not descend to the liquid surface

If the S/R probe or sipper probe tip does not descend to the liquid surface, follow the
steps below:
1 Are there bubbles on the liquid surface?
o If yes, go to step 2.
o If no, go to step 3.
2 Eliminate the bubbles in the sample container with an applicator stick.
3 Did the probe tip touch something during descent?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 If the S/R probe or sipper probe tip still does not descend to the liquid surface, call
Technical Support.

Results do not print automatically

If results do not print automatically, follow the steps below:


1 Is the printer switched on and online?
o If yes, go to step 3.
o If no, go to step 2.
2 Switch the printer on.
3 Is automatic printing selected on the Automatic Printout Setting window?
(automatic printout can be set for Calibration Data, Control Results, STAT
Samples, and Routine Samples)
o If yes, go to step 5.
o If no, go to step 4.
4 Specify the correct automatic printing settings.
5 Call Technical Support.

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9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting

Data backup write error

Problem A read/write error occurs.

Possible causes There is a problem writing to or reading from the USB storage device (flash memory
card or DVD-RAM) used to store the data backup.

Actions/Prevention Use the following flow chart to troubleshoot data backup write errors.

USB storage device


read/write error

Is there a
removable storage device
Yes connected to the No
USB port?

Replace the current storage medium


with new medium that offers sufficient
Does
free space. Connect the current USB storage
Yes the alarm
recur? device to the USB port.
Then choose Backup Data from the
Workplace > Data Review screen.

No

Does No
the alarm Continue normal operation
recur?

Yes

Use the most recent backup on the Continue normal operation


USB storage device to restore data.
Connect the backup USB storage Information is read into the analyzer from
Does
device to the USB port. the alarm No the storage device backup. Therefore the
Switch off the analyzer at the circuit recur? data reflects the status of the analyzer at
breaker. Wait a minute and then the time that the backup was created on
switch the analyzer back on at the the removable storage device.
circuit breaker.
Yes

Call
Technical Support

Figure D-2 Data backup write error troubleshooting flowchart

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D-22 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting

Bubbles in syringes

If you see bubbles in either the S/R syringe or sipper syringe, follow the steps below:
1 Perform S/R pipetter prime (item 7 on the Maintenance Items list) or sipper
pipetter prime (item 6 on the Maintenance Items list), or both primes if bubbles
are seen in both syringes, from Utility > Maintenance. Choose Parameter and type
10 in the Prime Cycles text box.
2 If there are still bubbles in the syringe, repeat this process for the appropriate
syringe.
3 If bubbles remain in the syringe after the second pipetter prime, call Technical
Support.

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Chemistry troubleshooting

False measurements

Values out of measuring range

Problem Values out of measuring range (values below the lower detection limit or values above
the measuring range).

Possible causes o Foam on sample.


o Foam on assay or system reagents.
o Foam on controls.
o Reagent pack stressed (storage or transport conditions not as recommended, for
example, temperature and upright position).
o Air bubbles in the system water container.
o Dirty gripper (deposits contaminate the reaction mixture in the vessels).
o Unstable system table.
o Incorrect sample container used.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Drift

Problem The control or sample shows drift over a period of time.

Possible causes o Evaporation or incorrect storage conditions of reagent packs, ProCell, and
CleanCell.
o Reagent packs are not at the correct temperature.
o Recommended calibration frequency not followed.
o Recommended handling of controls or samples not followed (for example,
stability and evaporation).

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

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cobas e 411 analyzer 9 Troubleshooting
Chemistry troubleshooting

Erratic test results

Problem The test results obtained are erratic.

Possible causes o Foam on sample.


o Foam on assay or system reagents.
o Foam on controls.
o Reagent pack stressed (storage or transport conditions not as recommended, for
example, temperature and upright position).
o Incorrect sample container used.

Actions/Prevention o Have you handled the reagents, samples and controls according to package
inserts?
o Have you performed the recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Assay calibration

Calibration cannot be performed

Problem The calibration cannot be performed.

Possible causes o Calibration not activated in the software.


o Reagent pack or calibrator not on board.
o Calibrator expiration date exceeded.
o Calibrator vial barcode or calibrator lot-specific barcode card not read, or wrong
calibrator barcode card is used.
o The calibration data link is not available for the current reagent pack and CalSet
combination.
o Vials Cal1 and Cal2 not on same rack, or empty space between calibrator vials.

Actions/Prevention o Check the barcodes of calibrator vial, calibrator barcode card, and reagent pack. Is
the barcode damaged, or not in the correct position?
o Wipe off the dust on the surface of the barcode reader.
o Dry the calibrator vial if it is wet.
o Check calibrator position.
o If you are still experiencing problems, contact Technical Support.

Duplicates are out of limits

Problem The calibration is not released because duplicates are out of limits.

Possible causes o Possible causes in connection with calibrator or reagent handling:


O Foam on calibrator or assay reagents.
O Calibrator handling not as recommended.
o Air bubbles in the system water container.

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Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Perform a new assay calibration (new CalSet).
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Monotony or minimum acceptable difference are not fulfilled

Problem The calibration is not released because the monotony has not been fulfilled.

Possible causes o Calibrator not transferred to the correct barcoded calibrator vials (for example,
content of bottle Cal1 transferred to vials Cal1 and Cal2).

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new CalSet).

Missing values

Problem The calibration is not released because of missing values.

Possible causes o Possible causes in connection with calibrator handling:


O Foam on calibrator.
O Empty calibrator.
O Insufficient volume of calibrator or calibrators.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new CalSet).
o If you are still experiencing problems, contact Technical Support.

Values are out of limits

Problem The calibration is not released because of values below the minimum signal (valid for
quantitative and qualitative assays), or the signal difference between vials Cal1 and
Cal2 or the maximum signal is out of limits (valid for qualitative assays only).

Possible causes o Possible causes in connection with reagent handling:


O Reagent pack not within allowed stability after opening.
O Reagent pack expiration date exceeded.
O Reagent pack stressed (storage or transport conditions not as recommended,
for example, temperature and upright position).
O Reagent pack not at correct temperature.
O Foam on assay or system reagents.
o Possible causes in connection with calibrator handling:
O Calibrators not within allowed stability after opening or reconstitution.
O Calibrator expiration date exceeded.

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O Calibrator handling not as recommended.


O Calibrator not transferred to the correct barcoded calibrator vials (for
example, content of bottle Cal1 transferred to vials Cal1 and Cal2).
O Calibrator not at correct temperature.
O Foam on calibrator.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new reagent pack or new CalSet).
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Calibration factor is out of limits

Problem The calibration is not released because the calibration factor is out of limits.
This problem is only valid for quantitative assays, and applies to reagent pack
calibration only.

Possible causes o Possible causes in connection with reagent handling:


O Reagent pack not within allowed stability after opening.
O Reagent pack expiration date exceeded.
O Reagent pack stressed (storage or transport conditions not as recommended,
for example, temperature and upright position).
O Reagent pack not at correct temperature.
O Foam on assay or system reagents.
o Possible causes in connection with calibrator handling:
O Calibrators not within allowed stability after opening or reconstitution.
O Calibrator expiration date exceeded.
O Calibrator handling not as recommended (stability and evaporation).
O Calibrator not transferred to the correct barcoded calibrator vials (for
example, content of bottle Cal1 transferred to vials Cal1 and Cal2).
O Calibrator not at correct temperature.
O Foam on calibrator.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new reagent pack or new CalSet).
o Have you performed recommended maintenance?
If you are still experiencing problems, contact Technical Support.

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Chemistry troubleshooting

Recovery of controls

Problem The control values are out of range.

Possible causes o Possible causes in connection with control handling:


O Controls not at correct temperature.
O Control not within allowed stability after opening or reconstitution.
O Control expiration date exceeded.
O Foam on controls.
O Control handling not as recommended.
o Possible causes in connection with reagent handling:
O Reagent packs not at correct temperature.
O Reagent packs not within allowed stability after opening.
O Reagent pack expiration date exceeded.
O Reagent packs stressed (storage or transport conditions not as recommended,
for example, temperature and upright position).
O Foam on assay reagents or system reagents.
o Possible causes in connection with calibrator handling:
O Recommended calibration frequency not followed.
O Calibration not performed correctly.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Use another control vial.
o Perform a new reagent pack calibration (new reagent pack and CalSet).
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Intra assay precision

Problem The intra assay precision is outside the expected range.

Possible causes o Reagent packs or sample not at correct temperature.


o Foam on assay or system reagents.
o Air bubbles in the system water container.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

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cobas e 411 analyzer 9 Troubleshooting
Chemistry troubleshooting

Inter assay precision

Problem The inter assay precision is outside the expected range.

Possible causes o Reagent packs or sample not at correct temperature.


o Foam on assay reagents.
o Reagent pack stressed (storage or transport conditions not as recommended, for
example, temperature and upright position).
o Calibration not carefully performed.
o Recommended calibration frequency not followed.
o Air bubbles in the system water container.

Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

System to system variance

Problem There is a deviation of control and samples when measured with different systems.

Possible causes o Recommended handling of assay, system reagents, calibrators, or controls not
followed (for example, stability and evaporation).
o Calibration not carefully performed.

Actions/Prevention o Have you handled the reagents, system reagents, calibrators, and controls
according to the package inserts?
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Method comparison

Problem There is a deviation of method comparison when compared with competitors


(internal, external).

Possible causes o Different standardizations (reference material).


o Different antibodies (for example, HCG on Elecsys/ES).
o Different methods (such as RIA or ELISA).
o Different units (conversion factor between units sometimes different from
competitor to competitor).
o Different sample material anticoagulants.
o Recommended calibration frequency not followed.
o Calibration handling not as recommended.
o The number of samples is too small, or all results are within a very limited range
compared to the measuring range of the assay.

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Chemistry troubleshooting

o Reagent lot to reagent lot variance.


o System to system variance.

Actions/Prevention o Have you handled the reagents, calibrators, and samples according to the package
inserts?
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.

Auto dilution not possible

Problem An auto dilution is no longer possible, even though a bottle of Elecsys Universal
Diluent or Elecsys Diluent MultiAssay is on board.

Possible causes The Elecsys Universal Diluent bottle may have been incorrectly placed on the reagent
rotor. If this happens, the MODULAR ANALYTICS barcode is read instead of the
cobas e 411 (Elecsys) barcode. This is because the barcode reader is outside the
reagent rotor on the cobas e 411, whereas it is inside the reagent rotor on the
MODULAR ANALYTICS.
If the wrong barcode is read, it will not be possible to use this diluent for auto dilution
on the cobas e 411 analyzer. The reason for this is that if the same lot number is
scanned again by the barcode reader, it will not be accepted by the system because the
information will already be in the database.

Actions/Prevention Take care to position the Elecsys Universal Diluent or Elecsys Diluent MultiAssay
Reagent Pack carefully, so that the cobas e 411 (Elecsys) barcode is read, and not the
one for the MODULAR ANALYTICS.

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cobas e 411 analyzer 10 Data alarms
Table of contents

Data alarms

This chapter describes the data alarms generated by the cobas e 411 analyzer system,
together with the cause of each alarm and suggested remedies.

In this chapter Chapter 10


Introduction .................................................................................................................. 33
List of data alarms ......................................................................................................... 34
Data alarms .................................................................................................................... 36
>AB ......................................................................................................................... 36
>Curr ...................................................................................................................... 36
<SigL ....................................................................................................................... 37
>Test ........................................................................................................................ 37
<Test ........................................................................................................................ 37
AB.E ......................................................................................................................... 38
ADC.E ..................................................................................................................... 38
Cal.E ........................................................................................................................ 38
Calc.? ........................................................................................................................ 39
Cancel [Power Fail/Power Off Cancel] .................................................................. 39
Cancel [E.STOP Cancel] ......................................................................................... 39
Cancel [STOP Cancel] ............................................................................................ 39
Cancel [P.STOP/A.STOP Cancel] .......................................................................... 40
Cancel [S.STOP Cancel] ......................................................................................... 40
Cancel [Recovery Cancel] ....................................................................................... 40
Cancel [Sample ID Error Cancel] .......................................................................... 40
CarOvr .................................................................................................................... 41
ClcT.E ...................................................................................................................... 41
Cell.T ....................................................................................................................... 41
Curr.E ...................................................................................................................... 41
FacA ......................................................................................................................... 42
H ............................................................................................................................... 42
Inc.T ........................................................................................................................ 42
L ................................................................................................................................ 43
Over.E ...................................................................................................................... 43
ReagEx ..................................................................................................................... 43

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Table of contents

Reag.F ...................................................................................................................... 44
Reag.H ..................................................................................................................... 44
Reag.S ...................................................................................................................... 44
Reag.T ..................................................................................................................... 45
Samp.C .................................................................................................................... 45
Samp.S ..................................................................................................................... 45
SLLD.E .................................................................................................................... 46
SLLD.N .................................................................................................................... 46
SysR.S ...................................................................................................................... 46
SysR.T ...................................................................................................................... 47
SysR.U ..................................................................................................................... 47
Data problems without an alarm ................................................................................ 48
Drift of result data ................................................................................................... 48
Erroneous operation ............................................................................................... 48
Poor reproducibility ................................................................................................ 48
Result data at high level ........................................................................................... 48
Result data at low level ............................................................................................ 49
Trouble for each test ............................................................................................... 49
Trouble for all tests ................................................................................................. 49
Instrument problems without an alarm ...................................................................... 49

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cobas e 411 analyzer 10 Data alarms
Introduction

Introduction

If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm. These alarms comprise data
alarms (referring to irregular measuring results or conditions) and instrument alarms
(referring to irregular system conditions).

Alarm levels Alarms are classified into five levels:

Data alarm This alarm is attached to measurement results of patient or QC samples.


If a data alarm occurs that will affect subsequent measurements, an
instrument alarm of the warning level occurs at the same time. The
analyzer does not stop operation.
Warning This alarm is generated by data alarms or problems with the instrument.
If this alarm occurs during operation, the analyzer does not stop
operation. The operator must judge whether to continue or interrupt
measurement.
Sampling stop This alarm concerns troubles on the instrument. For the pipetted sample,
measurement is continued.
Stop This alarm concerns troubles on the instrument. The analyzer stops
operation within one cycle (6 seconds). For the sample under
measurement, no result data are obtained and the measurement must be
repeated.
Emergency stop This alarm concerns troubles on the instrument. The analyzer
immediately stops operation. For the sample under measurement, no
result data are obtained and the measurement must be repeated.

Alarm indication Data alarms are indicated on the Workplace > Data Review screen, on the Test Review
window (Workplace > Data Review > Test Review), and on printed reports. If a data
alarm occurs, a symbol (also referred to as flag) is attached to the measurement result.
These flags are strings of three to six characters, which are all explained in this
chapter.
Instrument alarms are indicated by the Alarm button (global button) on the System
Overview screen as well as by an audible alarm. If an alarm occurs, the Alarm button
lights up. Its color indicates the alarm level: yellow indicates warning level; red
indicates emergency stop.
In case of an alarm, choose the Alarm button to open the Alarm window. This
window provides an alarm list and descriptions and remedies for each listed alarm.

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10 Data alarms cobas e 411 analyzer
List of data alarms

List of data alarms

The following table displays the data alarms and their presentation (flag) on screens
and reports.

Flag Alarm
>AB AB level range over
>Curr Measuring cell current range over
<SigL Low level signal
>Test Measurement range (upper)
<Test Measurement range (lower)
AB.E AB level check error
ADC.E ADC abnormal
Cal.E Calibration result abnormal
Calc.? Calculation not possible
Cancel Power Fail/Power Off Cancel
Cancel E.STOP Cancel
Cancel STOP Cancel
Cancel P.STOP/A.STOP Cancel
Cancel S.STOP Cancel
Cancel Recovery Cancel
Cancel Sample ID Error Cancel
CarOvr Potential microparticle carry over
Cell.T Cell temperature
ClcT.E Calc Test Error
Curr.E Measuring cell current check
FacA Instrument factor A reset
H Outside of expected value (upper)
Inc.T Incubator temperature
L Outside of expected value (lower)
Over.E Overflow
Reag.F Assay reagent film detected; Diluent film detected; Pretreatment film
detected
Reag.H Assay reagent hovering; Diluent hovering; Pretreatment hovering
Reag.S Assay reagent short; Diluent short; Pretreatment reagent short
Reag.T Abnormal reagent disk temperature
ReagEx Reagent expired
Samp.C Sample clot
Samp.S Sample short
SLLD.E Sample LLD abnormal
SLLD.N Sample LLD noise
Table D-2 List of data alarms

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List of data alarms

Flag Alarm
SysR.S System reagent short
SysR.T System reagent temperature
SysR.U System reagent temperature unstable
Table D-2 List of data alarms

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10 Data alarms cobas e 411 analyzer
Data alarms

Data alarms

For each data alarm, this section gives the nature of the alarm, a fuller description of
the problem, the cause or causes, and appropriate remedies.

>AB

Alarm AB level range over

Description During run preparation, the ProCell count level was out of range (the ProCell signal
was <200 or >400 counts).

Cause The ProCell has evaporated or may be contaminated.

Remedy 1 Check for bubbles in the ProCell bottle.


2 Try a new bottle of ProCell.
3 Rerun all flagged samples.
4 If the error recurs, call Technical Support.

>Curr

Alarm Measuring cell current range over

Description The measuring cell current was out of range when checked during run preparation.

Cause Abnormal measuring cell condition.

Remedy 1 Choose Utility > Maintenance > Maintenance and perform the Liquid Flow
Cleaning maintenance item (10 cycles).
2 Rerun all flagged samples.
3 If the alarm recurs, call Technical Support.

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Data alarms

<SigL

Alarm Low level signal

Description The signal is lower than the specified lower limit value coded in the reagent pack
barcode. For qualitative and quantitative assays.

Cause o The ProCell has expired.


o The standard solution does not reach room temperature.
o The volume of the reaction mixture in the AssayCup is insufficient.
o Abnormal measuring cell condition.

Remedy 1 Replace ProCell.


2 Rerun the sample.
3 If the alarm persist, call Technical Support.

>Test

Alarm Measurement range (upper)

Description The measured value is above the upper limit of the measuring range encoded on the
reagent pack barcode.

Cause The sample concentration is above the upper limit of the measuring (reportable)
range.

Remedy Rerun using the recommended dilution and check the measured value.

<Test

Alarm Measurement range (lower)

Description The measured value is below the lower limit of the measuring range encoded on the
reagent rack barcode.

Cause The sample concentration is below the lower limit of the measuring (reportable)
range.

Remedy Report the result as less than the lower detection limit of the assay. Rerun is not
requested.

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Data alarms

AB.E

Alarm AB level check error

Description The ProCell level check failed.

Cause ProCell liquid level check failed. The ProCell Volume is inadequate for run
preparation.

Remedy 1 Replace the low volume ProCell bottle with a new bottle.
2 Rerun all flagged samples.
3 If the alarm recurs, call Technical Support.

ADC.E

Alarm ADC abnormal

Description The analog-digital converter data is abnormal.

Cause o Numerical conversion is abnormal.


o The cell count is abnormal.

Remedy 1 If other instrument alarms exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance > Maintenance and perform the System Reset
maintenance item.
3 If the alarm recurs call Technical Support.

Cal.E

Alarm Calibration result abnormal

Description There is no valid calibration data in the system for this reagent pack (that is, a new
assay on the analyzer).

Cal.E appears on each control and patient sample for the affected test until the problem is resolved.

Cause o There is no valid calibration stored in the system.


o The attempted calibration is questionable or failed.

Remedy 1 Check the calibrators and reagents and repeat the calibration.
2 Set new calibrators and a reagent pack if necessary, and repeat the calibration.
3 Rerun the samples after a successful calibration is obtained.

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Data alarms

Calc.?

Alarm Calculation not possible

Description The denominator becomes zero in calculation.

Cause Internal calculation error occurred.

Remedy Rerun the sample.

Cancel [Power Fail/Power Off Cancel]

Alarm Power failure - operation stopped.

Description The test concerned was cancelled by power fail or power off.

Cause Test cancelled due to power failure or power off. Sample(s) may be excluded; refer to
printout.

Remedy Correct condition and rerun any excluded samples.

Cancel [E.STOP Cancel]

Alarm E.STOP - operation stopped.

Description The test concerned was cancelled by E.Stop.

Cause Test cancelled due to E.Stop. Sample(s) may be excluded; refer to printout.

Remedy Correct alarm condition and rerun any excluded samples.

Cancel [STOP Cancel]

Alarm Stop - operation stopped by operator.

Description Operation stopped by operator or the test concerned was cancelled by Stop.

Cause Operation stopped by operator. Sample(s) may be excluded; refer to printout.

Remedy Correct alarm condition and rerun any excluded samples.

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Data alarms

Cancel [P.STOP/A.STOP Cancel]

Alarm P.STOP/A.STOP - operation stopped.

Description The test concerned was cancelled by P.Stop.

Cause Test cancelled due to P.Stop or A.Stop. Sample(s) may be excluded; refer to printout.

Remedy Correct alarm condition and rerun any excluded samples.

Cancel [S.STOP Cancel]

Alarm S.STOP - operation stopped.

Description Operation stopped by operator or the test concerned was cancelled by S.Stop.

Cause Sampling stopped due to S.Stop. Sample(s) in process will be completed.

Remedy Correct alarm condition and continue with samples to be processed.

Cancel [Recovery Cancel]

Alarm Instrument handling error - determination not performed.

Description Determination not performed.

Cause Test cancelled due to instrument handling error. Sample(s) may be excluded; refer to
printout.

Remedy Rerun any excluded samples.

Cancel [Sample ID Error Cancel]

Alarm Sample ID Error Cancel.

Description Sample ID scanning was not successful.

Cause The sample ID that was scanned just before pipetting is different from the ID scanned
during the sample scan. All tests for the sample were cancelled.

Remedy Verify that sample tubes are not removed until the Status screen reads Proc or
Complete.

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Data alarms

CarOvr

Alarm Potential microparticle carry over

Description The signal level of this sample is low.

Cause Carryover from the previous sample may have occurred.

Remedy Rerun the sample.

ClcT.E

Alarm Calc Test Error.

Description Data flag is attached. If one or both of two tests are flagged, no result.

Cause A data alarm has occurred for a test needed in the calculation. It is not valid for the
alarm Calculation not possible (Calc.?).

Remedy Repeat BlankCell calibration.

Cell.T

Alarm Abnormal measuring cell temperature

Description Measuring cell temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.


o The room temperature is out of range.

Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the alarm recurs, call Technical Support.

Curr.E

Alarm Measuring cell current check

Description The measuring cell current check failed.

Cause ProCell liquid level check failed. The ProCell volume is inadequate for run
preparation.

Remedy 1 Replace the low volume bottle with a new bottle.


2 Rerun all flagged samples.
3 If the error recurs, call Technical Support.

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Data alarms

FacA

Alarm Instrument factor A reset

Description The instrument factor A was set to 1.0 by the system.

Cause For information only.

Remedy Repeat BlankCell calibration.

Alarm Outside of expected value (upper)

Description For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
For control samples, a concentration exceeded the 3 SD values specified on QC >
Install.

Cause o The sample concentration is higher than the expected value.


o A proper expected value range is not specified.

Remedy 1 Follow laboratory protocol for high samples.


2 Specify a proper range under Expected Values in Utility > Application > Range.

This alarm DOES NOT cause an incomplete sample status alarm.

Inc.T

Alarm Incubator temperature

Description Incubator temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.


o The room temperature is out of range

Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the error recurs, call Technical Support.

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Data alarms

Alarm Outside of expected value (lower)

Description For patient samples, the calculated concentration is less than the lower limit of the
expected value range.
For control samples, a concentration was less than the 3 SD values entered on QC >
Install.

Cause o The sample concentration is lower than the expected value.


o A proper expected value range is not specified.

Remedy 1 Follow laboratory protocol for low samples.


2 Specify a proper range under Expected Values in Utility > Application > Range.

This alarm DOES NOT cause an incomplete sample status alarm.

Over.E

Alarm Overflow

Description The result is mathematically overflowed.

Cause Wrong calibrator. The data contains more than six digits (including a negative sign
and decimal point).

Remedy Minimize the difference in concentration between the sample and the calibrator.

ReagEx

Alarm Reagent expired

Description An expired reagent was used for the measurement.

Cause For information only.

Remedy Not applicable

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Data alarms

Reag.F

Alarm Assay reagent film detected; Diluent film detected; Pretreatment film detected

Description Foam or film was detected above reagent.

Cause o Foam or film was detected above reagent.


o Foam or film was detected above diluent.
o Foam or film was detected above pretreatment reagent.
o Foam or film was detected above ProCell or CleanCell.

Remedy Remove foam or air bubbles with an applicator stick and rerun the affected sample.

Reag.H

Alarm Assay reagent hovering; Diluent hovering; Pretreatment hovering

Description The reagent probe hovers over the reagent rotor.

Cause A premature LLD signal was detected during reagent pipetting, causing the S/R probe
to hover over the reagent pack.

Remedy 1 Dry the lids on the affected reagent pack.


2 Check for bubbles in the affected reagent pack. If bubbles are present, remove with
an applicator stick.
3 Choose Utility > Maintenance > Maintenance and perform the System Reset
maintenance item.
4 If the error recurs, call Technical Support.

Reag.S

Alarm Assay reagent short; Diluent short; Pretreatment reagent short.

Description The liquid level cannot be detected in the reagent pack.

Cause o There is no reagent in the reagent pack, the assay reagent volume is insufficient.
o The diluent volume is insufficient.
o The pretreatment volume is insufficient.

Remedy 1 Verify that reagent, diluent, and pretreatment volumes are adequate. Replace the
low reagent, if necessary, and perform a reagent scan after the replacement.
2 If adequate reagent volumes are present, verify volumes on the Reagent screen.
3 Resume operation and rerun the sample.
4 If the alarm recurs, call Technical Support.

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Data alarms

Reag.T

Alarm Abnormal reagent disk temperature

Description Reagent rotor temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.


o The room temperature is out of range.

Remedy 1 Verify that the reagent rotor cover is securely in place.


2 Check the fans at the rear are operating normally and are free of obstructions.
3 Check that room temperature is between 18C and 32C.
4 If the alarm recurs, call Technical Support.

Samp.C

Alarm Sample clot

Description A sample clot is detected during aspiration.

Cause o The sample volume is insufficient.


o There are clots in the sample.

Remedy 1 Check sample volume, and fill the required volume in the sample container as
necessary.
2 Check the sample for fibrin. Remove any clots.
3 Rerun the sample.

Samp.S

Alarm Sample short


e See also: Samp.C on page D-45.

Description The sample volume is insufficient or missing.

Cause o The sample is missing from the sample disk.


o The sample volume is insufficient.

Remedy 1 Load the sample if it is not already on board.


2 Check sample volume, and fill the required volume in the sample container as
necessary. If the sample appears to be sufficient, contact Technical Support.
3 Rerun the sample.

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10 Data alarms cobas e 411 analyzer
Data alarms

SLLD.E

Alarm Sample LLD abnormal

Description The S/R probe does not start liquid level detection (LLD) or LLD is not completed.

Cause o The S/R probe is dirty or wet.

Remedy 1 Clean and dry the S/R probe, and resume measurement.
2 If the alarm recurs, call Technical Support.

SLLD.N

Alarm Sample LLD noise

Description The S/R probe detects noise.

Cause There are bubbles in the sample container.

Remedy 1 Remove the bubbles with an applicator stick.


2 Rerun the sample.

SysR.S

Alarm System reagent short

Description Liquid short signal is detected, or the liquid level cannot be detected in the ProCell
reservoir.

Cause The volumes in the system reagent bottles (ProCell and CleanCell) are insufficient.

Remedy 1 Check levels in ProCell and CleanCell bottles, and replace as necessary.
2 Resume operation and rerun the sample.
3 If the alarm recurs, call Technical Support.

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Data alarms

SysR.T

Alarm System reagent temperature

Description ProCell/CleanCell temperature is out of range. The system performs an initial check
30 minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.


o The room temperature is out of range.

Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the alarm recurs, call Technical Support.

SysR.U

Alarm System reagent temperature unstable.

Description System reagent temperature is unstable.

Cause ProCell/CleanCell temperature was unstable.

Remedy ProCell and CleanCell must be at 28C before operation. Either bring the reagent to
temperature, or place it on the analyzer approximately 15 minutes before operation.

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10 Data alarms cobas e 411 analyzer
Data problems without an alarm

Data problems without an alarm

Drift of result data

Cause o Concentration or deterioration of sample


o The standard solution is concentrated or has deteriorated.

Remedy Avoid leaving the sample in the sample cup for a long time.

Erroneous operation

Cause o Neglect of preliminary or periodical check.


o Fibrin contained in sample or dust contained in reagent.
o The sample container that was used, was not recommended.

Remedy 1 Carry out preliminary or periodical check according to the specified procedure.
2 Eliminate fibrin or dust. Be sure to check the sample and reagent before setting
them.
3 Use the recommended sample container.

Poor reproducibility

Cause o A maintenance item is overdue.


o Deterioration of reagent or precipitation of insoluble matter.
o Deterioration of ProCell or CleanCell.
o Poor distilled water quality.
o Reagent handling was not done as recommended.

Remedy 1 Carry out daily checks and periodic maintenance according to the specified
maintenance procedure.
2 Set a new reagent pack.
3 Set new ProCell or CleanCell bottles.
4 The water quality must be 10 S/cm (microsiemens per cm) or less.
5 Use the recommended reagent handling.

Result data at high level

Cause o Concentration of control or sample.


o Deterioration of ProCell or CleanCell.
o The reagent, control, and standard handling was not done as recommended.

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Instrument problems without an alarm

Remedy 1 If the sample has been loaded for more than two hours, repeat the analysis with a
fresh sample.
2 Set a new ProCell/CleanCell bottle.
3 Use the recommended reagent, control and standard handling.

Result data at low level

Cause o Reagent handling was not done as recommended.


o Deterioration of ProCell or CleanCell.

Remedy 1 Use the recommended reagent handling.


2 Set a new ProCell or CleanCell bottle.

Trouble for each test

Cause Improper preparation or management of a control (high value, low value).

Remedy 1 Prepare a new control.


2 Set a new reagent pack.

Trouble for all tests

Cause o Intrusion of air bubbles into S/R or sipper syringe (poor reproducibility).
o Liquid leakage from the sample or reagent syringe coupling (poor
reproducibility).
o Deterioration of ProCell or CleanCell.
o The electrode of the measuring cell is contaminated or has deteriorated (high
value or low value).

Remedy 1 Carry out maintenance.


2 Set a new ProCell or CleanCell bottle.
3 Choose Utility > Maintenance > Maintenance and perform the Liquid Flow
Cleaning maintenance item.
4 Call Technical Support.

Instrument problems without an alarm

In the case of an instrument problem but no alarm, call Technical Support.

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Instrument problems without an alarm

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D-50 Operators Manual Version 1.0
Appendix E

11 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
cobas e 411 analyzer 11 Appendix
Table of contents

Appendix

This chapter contains additional information, including product information for


system reagents.

In this chapter Chapter 11


Technical support information form ......................................................................... E-5

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Table of contents

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cobas e 411 analyzer 11 Appendix
Table of contents

Technical support information form

Day______________Month______________Year__________

Customer information
Account number or customer ID number
Contact name and telephone number

General information
Instrument serial number
Description of the problem, including relevant
alarm(s) and alarm code numbers
When the problem first occurred (for example, after
reagent pack lot change)
Whether the problem was observed with just one
system or with all systems
Copies of the original instrument printouts (send by
fax or e-mail)

Problem category (tick box)


Immunoassay problems dm Complete the details below for Immunoassay problems
Software problems dm Complete the details below for Software problems
Instrument problems dm Complete the details below for Instrument problems

Immunoassay problems Details


Whether the problem was observed with just one
assay or with all assays
Whether the problem was observed with just one
sample type or with all sample types
Control results from the last few controls performed
Sample type used (serum, plasma, urine, or saliva)
Sample tube used (manufacturer, diameter, primary
or secondary tube)
Elapsed time between specimen collection and
measurement
Patient results (with correlation results, if relevant)

Test(s) affected and other tests on board

Whether SysWash was added to the system water


container
Catalog number, lot numbers, and expiration dates of
reagents
Table E-1 Technical support information form

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cobas e 411 analyzer 11 Appendix
Table of contents

Catalog number, lot numbers, and expiration dates of


calibrators and controls
Calibration signals (HetIA) from the last few
calibrations performed
Control results from the last few controls performed

Details of reagent/calibrator/control handling (such


as calibration frequency, stability, ambient
temperature, foam, and evaporation)
When the reagent was loaded onto the system

Software problems Details


The version of software installed
The sequence number of the reagent packs

Instrument problems Details


Instrument serial number
Rack or disk system
Instrument maintenance and service history

Whether a host or Pre-Analytic Systems Manager


(PSM) was connected
Number of tests performed
Other instrument or maintenance related
information

Error code and error description

Table E-1 Technical support information form

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Glossary F

12 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
cobas e 411 analyzer Glossary
2-dimensional barcode -AssayCup disposal opening

Glossary

This glossary is a compendium in which to look up the aliquot Portion of sample material pipetted into any
meaning of technical terms used in conjunction with the secondary cup.
cobas e 411 automatic analyzer.
alphanumeric sorting The listing of information, in a
printout or on a screen, in a pre-defined order by letters
Numbers
or numbers.

2-dimensional barcode A type of barcode on reagent analyte The constituent in the sample that is to be
packs, calibrators, and control barcode cards or sheets. determined.
These matrix barcodes, which use PDF417 symbology,
contain more information than traditional linear analytical instrument A device or a combination of
barcodes. devices used to carry out an analytical process.

A analytical sensitivity The lowest analyte


concentration that can be distinguished from zero. It is
calculated as the concentration of two or three standard
accuracy The absolute deviation of a result from a pre- deviations above the lowest standard used in the master
defined target value in percent or absolute units. calibration. Roche Diagnostics uses master calibrators to
determine the lower detection limit (LDL).
action key A key, on the keyboard, that has a pre-
defined function. For example, START, STAT, or analytical unit The hardware unit containing the
ALARM. sampling, reagent, incubator, gripper, and measuring cell
components.
adequate sample volume A starting sample volume
that exceeds the combination of the volume of sample application sheet A document that lists all the
that will be required for assays and the residual volume information necessary to perform a specific assay or test
specified for the container that holds the sample. on an instrument.

air purge The removal of air from the hydraulic tubing arbitrary units A result classification using 1+, 2+, and
between the probes (reagent or sample) and their 3+ classes instead of numerical concentration results.
respective pipetters.
ASCII Abbreviation for American Standard Code for
alarm A visual or audible operator notification of any Information Interchange. A character code used by most
system irregularity. computers.

alarm code The classification number for an alarm. aspiration station A position located next to the
Each alarm has a major classification code and a minor incubator where an AssayCup containing the reaction
classification code. mixture is placed for aspiration into the measuring cell
by the sipper probe.
ALARM global button A button used to display the
Alarms global menu. Detailed information is displayed in assay 1. A specific test.
the Detail window. 2. The process of measuring a substance.

alarm level A level that identifies the source and AssayCup A plastic vessel that is used to hold the assay
severity of a problem. There are five levels: data alarm, reaction mixture. An alternative term is reaction vessel.
warning, sampling stop, stop, and emergency stop. A
system uses the alarm levels to determine how to respond AssayCup disposal opening 1. One of two openings
to any problem that generates alarms. to the right of the incubator where used AssayCups are
disposed into the solid waste tray.
A-Line A section of the input buffer where samples or 2. The opening to the left of the incubator where used
racks are placed for processing. AssayCups are disposed into the solid waste tray.

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Operators Manual Version 1.0 F-3
Glossary cobas e 411 analyzer
AssayTip -BC

AssayTip A disposable pipette tip made of black, backup operation A function that performs
conductive plastic. AssayTips are used by the sample/ measurement by using only analysis unit when a trouble
reagent (S/R) probe. occurs in the rack sampler and a rack cannot be
conveyed.
assigned value (Roche-defined) Roche-defined
concentration for calibrator material that is encoded on bandwidth 1. A network's capacity to carry data.
the calibrator barcode card or transfer sheet. 2. Also used in optics to characterize a photometer.
See also target value.
barcode A numeric or alphanumeric code used on
ASTM Abbreviation for American Society for Testing sample tubes, racks, and reagent packs to identify the
and Materials, a US organization that develops and samples, racks, and reagents. Different barcode standards
proposes industry standards. are available. See also barcode type.

ASTM protocol A host interface protocol according to barcode card A card bearing a barcode that encodes
the American Society for Testing Materials standard. either assigned values (calibrator card) or target values
and ranges (control card) for assays.
automatic calibration 1. Automatic time-out
calibration. A calibration of a parameter performed if a barcode labeler A pre-analytical instrument or
specified time interval expires. The calibration can be module for the automatic labeling of sample tubes.
defined for each method separately.
2. Automatic calibration after bottle or lot exchange. A barcode mode The operational mode when a system is
calibration performed if a new bottle or lot is registered. configured to operate using barcoded samples.
The calibration can be defined for each method
separately. barcode reader The device that reads the code from
3. Automatic calibration on QC failure. A calibration sample or reagent barcode labels or reagent pack
request is generated by the system if a QC value is outside barcodes. This term also applies to handheld barcode
a pre-defined range. The calibration can be defined for readers.
each method separately.
barcode scan The process of reading barcode
Automated Download (ADL) A service that provides information into the memory of an instrument.
the information necessary for analysis, for example
analytical parameters or concentration information from barcode type Typical sample barcode types used in the
the data center. ADL is a cobas TeleService application. IVD industry are Code39, NW7 (Codabar), ITF, and
See also TeleService. Code 128.

automatic QC A quality-control function that takes batch mode/operation 1. A computing technique in


sample measurements by moving the dedicated QC rack which a number of data transactions are collected over a
to the sample line from the rack rotor. period of time and aggregated for sequential processing
at a given time.
automatic start-up The automatic start of instrument 2. The operation of an analytical instrument in such a
or system initialization and priming functions without way that one or more analytical processes must be
operator intervention. See also maintenance pipe. completed for a sequence of samples before the next
sequence can be started.
B
batch registration A function to register the test-
selection information of the same combination as the
backup 1. The saving of data onto supplementary sample number of the specified realm in registration of
storage media such as disks or tape. If such data is routine samples.
required again but is no longer available from the main
storage (instrument hard disk), it can be restored from a baud A unit of transmission speed equal to the number
backup copy. of discrete conditions or signal events per second.
2. An internal instrument-specific process to establish the
data for a backup; only used in a case of routine BC Abbreviation for barcode.
instrument break down. See also restore.

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F-4 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
BC card scan -calibration trace

BC card scan A scan to read the information from the button A button is found on a screen or pop-up
two-dimensional calibrator barcode card or control window. It can be touched either to initiate an action or
barcode card. to move to a different screen.

BCR Abbreviation for barcode reader.


C
biohazardous A classification used to identify material
that poses a health threat, for example something calculated result See calculated test.
contaminated with biological material.
calculated test A test result calculated from different
bit The smallest addressable unit of computer memory. individual analytical methods with a given formula such
as ratio A/B.
blank cell Calibration procedure for ECL instruments
performed by Roche Diagnostics service staff. calibration The set of operations that establish, under
specified conditions, the relationship between values
B-line The transport line that moves racks from the indicated by the analytical instrument and the
STAT port, or A-line to the sample barcode reader and corresponding known values of an analyte.
then to the sampling position.
calibration curve A plot of known concentrations of
blocked result A result can be blocked by the operator calibrators against their signals established during
(B) or the system (S). A blocked result is printed or calibration.
uploaded to the host with the respective flag (B or S).
calibration factor 1. In electrochemiluminescence:
boot Also booting-up. The process that causes one of the six calibration quality criteria used to verify
computer software to start performing programmed the validity of a calibration. This criterion is only used for
instructions, usually from ROM. reagent pack calibrations. It is derived by comparing two
different calibrations. A factor of 1.0 is achieved when
bottle A glass or plastic container with a lid used for two calibrations are equal. A successful calibration has a
liquids. Some bottles may be used directly on systems. factor of 0.8-1.2.
2. In clinical chemistry: the slope of a calibration curve
bottle set 1 The set of ProCell/CleanCell bottles that (only applicable to linear calibrations). One of the factors
occupies positions 1 and 2 (position on the right) in the used to create a calibration curve (S1Abs, K, A, B, C).
system reagent compartment.
calibration frequency A specified interval at which an
bottle set 2 The set of ProCell/CleanCell bottles that assay should be calibrated. Typically found on reagent
occupies positions 3 and 4 (position on the left) in the package inserts.
system reagent compartment.
calibration function Also known as calibration mode.
bound/free separation The physical separation of The type of calibration (for example, Rodbard function,
reagent or sample that is bound to a solid phase (the linear function, or cutoff function). A mathematical
microbeads) from free reagent or sample. model that describes the relationship between a signal
and a concentration in the calibration curve.
Bracketing A mode of operation in which patient See calibration curve.
results have to be surrounded by successful control
results before they are released. calibration monitor A function that prints the
measured absorbance of the standard solution and the
bridging principle One of three test principles that can calibration factors, at the time of calibration, for every
be applied to ECL immunoassays. It is used to detect measurement item.
antibodies (such as IgG, IgM, or IgA) in the sample.
See also competitive principle, sandwich principle. calibration quality criteria Criteria applied to the
auto-validation of every calibration on the analyzer.
buffer The temporary storage of data by any software in
a defined section of the computer memory. calibration trace A function for checking day-to-day
changes by saving calibration results for the same item.

Roche Diagnostics
Operators Manual Version 1.0 F-5
Glossary cobas e 411 analyzer
calibration type -cobas Link data station

calibration type 1. The kind of standard solution used check digit A verification number used in barcodes
in calibration including 1-point, 2-point, span, and full. and software.
The factors updated differ depending on which type of
calibration is performed. check sum The result of a mathematical procedure to
2. In electrochemiluminescence: lot calibration (L-Cal) validate the integrity of a set of data.
or reagent pack calibration (R-Cal).
3. In clinical chemistry: bottle or cassette calibration. circuit breaker 1. The main power switch on the
instrument. It controls the power to the Peltier elements
calibration validation Analysis, performed by and, consequently, controls the temperature in the
software, to check a calibration data set against specific reagent rotor, incubator, and measuring detection unit.
criteria encoded in a reagent barcode. Calibration 2. A switch that controls power to the Peltier elements,
validation results are: successful or failed. thereby controlling the temperature in the reagent rotor,
incubator, system reagent compartment, and measuring
calibration verification A procedure required by cell
HCFA and CLIA. Calibration verification is the assaying
of calibration materials in the same manner as patient CLAS 2 Clinical Laboratory Automation System,
samples to confirm that the calibration of the instrument second generation.
kit or test system has remained stable throughout the
laboratory's reportable range for patient test results (for CleanCell An auxiliary reagent used to rinse the tubing
example, Elecsys CalChecks). system and measuring cell after each measurement and
condition the electrodes in the measuring cell.
calibrator 1. A material of known composition or
properties that can be presented to the analytical cleaning solution See wash solution.
instrument for calibration purposes.
2. The test portion or test solution used for calibration of Clean-Liner A disposable liner used in the solid waste
an analytical procedure. tray of Elecsys 2010/cobas e411.

calibrator code The identification number of the client/server A network in which computer processing
standard solution in calibration measurement. is distributed among many individual PCs (clients) and a
more powerful, central computer (server).
capacitance The property of an electrical non-
conductor that provides the basis for liquid level C-line The transport line that receives racks from the B-
detection in the S/R (sample/reagent) probe and sipper Line via the output buffer.
probes. The probes carry a high-frequency, low-voltage
electrical charge. Frequency and electrical charge clot detection 1. A device built into the pipetting
characteristics are altered and sensed when the probe system to detect clots and to avoid false pipetting.
touches liquid. 2. The procedure of detecting a clot.

CapTwist An opener to aid the manual removal of cobas A modular range of in vitro diagnostics systems
ProCell and CleanCell bottle caps. from Roche Diagnostics/Hitachi High-Technologies.

carryover A process by which materials are carried into cobas e pack The name given to a reagent cassette
a reaction mixture where they do not belong. used on cobas e systems and Elecsys systems.

CC Abbreviation for clinical chemistry and for cobas Link The infrastructure of network connections
CleanCell that enables cobas TeleService to exchange information
between the Roche service network and a customer's
cell holder A container holding the electrode in the laboratory.
electrode measurement unit.
cobas Link data station A specific desktop computer,
channel 1. The number of reagent positions on an located in the laboratory, that has been configured to act
analytical instrument. as a gateway between Roche systems and the Internet. As
2. A specific reagent position. well as providing a communication link, the data station
also stores data and documentation for assay processing
and can provide a data archive.

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F-6 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
cobas TeleService -data disk

cobas TeleService The set of software applications control material A material used to assess the
that use cobas Link to exchange service information performance of an analytical procedure or part of an
between Roche service network and a customer's analytical procedure. Also called the control sample.
laboratory. cobas TeleService provides remote
monitoring and diagnosis, hotline support, and software control name The name of a control material, for
and documentation updates. example PreciControl Universal.

Code39 A barcode type for sample tubes that can be control SD value The acceptable variation SD value of
read by the barcode reader. a quality control sample.

coefficient of variation A statistical measure used to control unit An external PC or printer by which an
describe imprecision. Often abbreviated to CV. analytical system is controlled. The control unit also
serves as the user interface.
communication The exchange of data between
different computers. correction item A function that corrects the
measurement result of one item by using figures or the
compensated test A test that has the result modified measurement result of other tests.
by a formula that takes account of known or defined
interference factors. CPU The Central Processing Unit of the system or
computer.
competitive principle One of three test principles that
can be applied to ECL immunoassays. It is used to detect cross-reactivity The reaction of an antibody with an
analytes of low molecular weight (for example, FT3). antigen other than the one that elicited its formation as a
See also bridging principle, sandwich principle. result of shared, similar, or identical antigenic
determinants.
Complete A sample status found on several screens
indicating that all requested determinations have been CSF Abbreviation for cerebral spinal fluid. A sample
completed. type for clinical analysis.

conditioning The process of letting serum-type liquid cumulative QC The accumulated data and associated
flow through the flow path before electrolyte statistics of individual QC data.
measurement.
cup-on-tube The placement of a smaller secondary
consumables A generic term for items that are used sample container (for example a Hitachi Cup) on top of a
during test processing and must be replaced on a regular primary sample tube.
basis by the operator. Examples of consumables include
AssayCups, printer paper, and reaction cells. CV See coefficient of variance.

consumables area The area of an analyzer where the cycle The instrument time interval during which
consumables, such as AssayCups and AssayTips, are pipetting or measurement can be carried out.
stored.
cyclic QC Controls run at fixed intervals.
container See sample container.
D
continuous access The instrument function that
enables an operator to permanently access the sample
loading area of an analyzer. DAT Abbreviation for Drugs of Abuse Testing. The
abbreviation DAU is also used.
continuous loading/access The ability to load (or
unload) sample or reagents at any time. data alarm An alarm that occurs if a measurement
result or calibration result is abnormal.
control ID The abbreviated name for a control
material, for example PC U1 or PC TSH. Control IDs are data disk 1. The floppy disk or Zip Disk used to store
used on software screens and windows where limited patient data.
space prevents the use of longer names. 2. The floppy disk contains files that enable

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Operators Manual Version 1.0 F-7
Glossary cobas e 411 analyzer
data entry field -dual value method

communication between the analyzer and the user deviation of duplicate measurements See
software. The files might include analyzer-specific duplicate limit.
adjustment files, assay reference tables, or calibration
data. Diagnostics The status that is required to perform
system diagnostics and hardware error tracking actions.
data entry field A field on the software screen where a The field service engineer may request a system to go to
user can enter or edit data. Diagnostics mode to perform such procedures. The
system may require initialization afterwards to resume
data field A field on the software screen that contains normal operation.
information. There is no user access to this type of field.
diluent (DIL) A liquid agent used to reduce the
data flags Printed or displayed alarms or flags that concentration of a sample in electrolyte measurement.
indicate unusual reaction or instrument conditions, for
example insufficient sample or reagent or substrate dilute waste solution A waste solution resulting after
depletion rinsing with water.

database A defined section of the computer memory dilution factor A software preset or manually assigned
where all instrument, assay, and patient-relevant data are dilution ratio that is used by the analyzer to perform a
processed and stored. requested dilution.

database management system A software system disk position A dedicated position on the reagent or
that provides the necessary procedures and programs to sample disk.
collect, create, organize, store, retrieve, and maintain
databases or data files with security and integrity. dispense The process of adding sample material or
reagents by the pipetter probe into a reaction vessel or
DAU Drug of Abuse in Urine. The old term for DAT or cell
Drugs of Abuse Testing.
dispenser technology A technique in which a rinsed
DB Abbreviation for database. probe transfers reagents into a reaction vessel and the
reagent container is directly connected with the pipetter
DBMS Abbreviation for database management system. probe.

default profile A pre-defined set of tests that the disposable Typically a plastic tip, vessel, or cuvette that
analyzer automatically applies to a sample unless the is discarded after a single use.
operator specifies a different set of tests.
DMS Abbreviation for data management system.
default value A set value registered in advance (initial
setting). document (to ...) The process of printing or uploading
a result report to a LIS.
deionized water supply A device that produces
purified water. down time The period of non-operation between an
instrument failure and the resumption of operation.
demographics Patient-related data such as name, date
of birth, and gender. download The process of receiving data from Roche by
a network link.
detection unit A hardware unit comprising a
photomultiplier tube, Peltier elements, flow-through dual value method A mode of expression of the
measuring cell, magnet drive assembly, and an amplifier control chart in real-time quality control. For X-axis and
circuit board. Y-axis, measure simultaneously the average and the
standard deviation of control of a low value and a high
determination The process of quantifying analytes. value, and display them by X and Y coordinates,
respectively.
deviation A value minus its reference value.

Roche Diagnostics
F-8 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
duplicate limit -functional sensitivity

duplicate limit A calibration quality criterion. For a


F
successful calibration, duplicate measurements must be
within a specified limit.
FDA Abbreviation for Food and Drug Administration.
dynamic range The reportable range of an assay. This A US government-controlled agency responsible for
range extends from the lower detection limit to the limit regulating diagnostic and pharmaceutical products.
of linearity.
FIFO Abbreviation for first in, first out. A logistic
process for handling goods or data.
E
filter A process that sorts data for viewing,
ECL Abbreviation for electrochemiluminescence, the documenting, or printing according to pre-defined
detection technology used on immunoassay analyzers. criteria

emergency stop An instrument alarm level that first registration The date and time when a reagent
immediately stops all instrument functions. pack or sample was successfully recognized by the
barcode reader for the very first time
electromotive force (EMF) The physical principle
that provides the basis for electrolyte measurement. fixing knob A screw lid that fixes the reaction disk.

endpoint assay An analytical technique taking flag An identifier used to call an operator's attention to
measurements after a reaction is completed or has been a result.
halted.
float sensor A sensor that detects the surface of
error handling A process during which the analyzer solutions. The sensor position moves up and down
attempts to recover from an error condition (for depending on the surface level.
example, an AssayTip is not picked up from the
magazine). If the analyzer cannot successfully recover front access panel A door behind which the floppy
from error, an alarm is issued and the instrument is disk drive and solid waste tray are located.
halted.
function key 1. An analyzer button that an operator
ESC key The Escape key on a computer keyboard can use to control various analyzer actions (for example,
typically used to close a window in the software. moving specific items), depending on the current
operational mode.
E-stopped A status indicating that the system has 2. Any one of a set of keys (F1 to F12), located along the
performed an emergency stop (E. Stop). This could be top of the keyboard, used to enter a specific command.
due to hardware failure or because any of the safety
devices have requested an emergency stop. The system functional sensitivity The concentration of an analyte
requires either complete power off, or at least at which a pre-defined level of imprecision is obtained.
initialization, to resume normal operation.

expected range The pre-defined range of test result


values expected for a defined group of healthy patients or
materials. Also known as normal range or reference range.

expected value A value for a test result that can be


considered as a normal result.

expiration date Also called the expiry date. The end of


a period until which Roche Diagnostics guarantees
product claims for its reagents, calibrators, and controls.

extended dynamic range The measuring range for


an assay at its highest dilution.

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Operators Manual Version 1.0 F-9
Glossary cobas e 411 analyzer
global action key -Internet

host interface protocol A technical description that


G
defines data transfer between a host computer and an
analytical system. See also ASTM protocol.
global action key A keyboard key that remains active
on all screens
I
global button A button that allows access to the global
software screens and that can be used at any time. IA Abbreviation for immunoassay.

gripper A technical device that transports AssayCups IC Abbreviation for immunochemistry.


and AssayTips to their required destination on the
analyzer (for example, to the incubator). The gripper ID A unique alphanumerical set of data that clearly
moves in three directions (X, Y, and Z). identifies a patient sample or rack. Also known as an ID
no.
GUI Abbreviation for graphical user interface.
ID reader Typically an optical device that reads ID or
Id-no. data and transfers them to the instrument
H
database.

hardware (HW) The mechanical and electrical in vitro qualitative assay A determination outside
components of a computer and its peripheral devices. the living body of constituents of a substance without
regard to quantity.
Het IA Abbreviation for heterogeneous immunoassay.
in vitro quantitative assay A determination outside
HIA Abbreviation for homogeneous immunoassay. the living body of constituents of a substance with regard
to a specified number or amount.
HIS Abbreviation for Hospital Information System. A
computer system that manages the hospital's overall incubator A temperature-controlled aluminum block
information processing. Sometimes also (incorrectly) for AssayCups on cobas and Elecsys instruments.
referred to as LIS (Laboratory Information System).
initial BlankCell procedure The calibration
Hitergent 1. A detergent, with antibacterial properties, procedure for ECL instruments performed by Roche
that can be added to the reaction bath where it acts as a Diagnostics service staff when setting up an ECL-based
surfactant, reducing the formation of foam. analyzer for the first time.
2. A surfactant diluted for use in some cleaning
procedures. Initialization Also known as Initializing. The
operational mode of an analyzer that occurs immediately
home position The position to which a certain part of after switching on and during which the instrument
the instrument returns on reset. The start position of a prepares itself for operation.
mechanism.
input buffer A section of an analyzer where samples are
homogeneous immuno assay (HIA) An analytical loaded by using a rack or rack tray. See also rack loader.
technique employing antigens and antibodies. An HIA
uses assay protocols similar to clinical chemistry without instrument alarm A displayed alarm that indicates an
a bound-free separation (for example, latex assays). unusual instrument condition such as an abnormal
reaction bath temperature or a mechanical malfunction.
host computer 1. A computer used for overall
management and control of the computer network. Instrument Manager Typically, PC-based software
2. A clinical laboratory computer that stores and that controls or supervises one or more analytical
processes patient requests and results. A host is able to instruments.
communicate with analytical instruments.
interface See parallel interface, user interface.
host communication Data exchange with a clinical
laboratory information system (LIS). Internet A publicly available, internationally
interconnected system of computers.

Roche Diagnostics
F-10 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
intranet -master calibration

intranet An access-restricted network used internally in loading capacity The maximum number of samples
an organization. that can be loaded onto the input buffer.

inventory control The real-time monitoring of the local area network (LAN) A computer network
quantities of all consumable items (liquid and solid) on covering a limited area, such as an office or a home.
an analyzer.
log file A set of data, typically stored in the control unit,
IVD Abbreviation for in vitro diagnostics. A diagnostic that traces instrument-related or operator-related
procedure performed outside the living body with activities such as maintenance.
specimen body fluid.
log off The procedure of terminating access to a system.
IVDD Abbreviation for In Vitro Diagnostics Directive. A Also known as log out or logoff. The reverse procedure is
set of rules and regulations laid out by the EU known as log on or log in.
commission to ensure the safety of IVD products.
Log off button A button used to terminate access to a
system. See also log off.
L
log on The procedure of gaining access to a system by
lab automation The process of managing the entire entering a user name and, if required, a password. Also
analytical process with minimal operator intervention. known as log in or logon. The reverse procedure is
known as log out or log off.
LDL Abbreviation for lower detection limit.
See analytical sensitivity. Log on button A button used to gain access to a
system. See also log on.
level detection A check for the availability of sufficient
liquid in a container. lot calibration (L-cal) A mandatory calibration when
a new lot of reagents is introduced to an analytical
LIMS Abbreviation for Laboratory Information instrument.
Management System. See LIS.

linear barcode A conventional one-dimensional


M
barcode with limited data capacity.
maintenance item A maintenance procedure
liquid level detection (LLD) The ability of an performed by the system or the operator.
analytical instrument to sense liquid by using the sample
or reagent probes. maintenance key A button for position movement,
used for a probe position check.
liquid waste container A reservoir for liquid waste
generated by an analyzer; its size and location vary maintenance procedure A procedure that must be
between instruments. performed on a regular basis (for example daily, weekly,
monthly, or every three months) to secure reliable
LIS Abbreviation for Laboratory Information System. A operation of the analyzer.
clinical laboratory computer system for the management
and storage of patient data and results. An LIS manual dilution An off-system, pre-analytical step
communicates with analytical instruments. performed by laboratory staff to reduce the analyte
concentration in a sample.
list box On a screen, a type of box that lists available
choices: for example, a list of available tests from which master calibration A reference standardization that
the operator can choose. uses master test kit reagents and certified reference
standard material (for example, World Health
loader A section of an analyzer that hold trays and racks Organization reference material) measured at Roche
waiting to be processed. Also known as the input buffer Diagnostics. The resulting reference standard curve,
or the A-line. typically using 10 to 12 points, is the basis for the
production of in-house master calibrators.

Roche Diagnostics
Operators Manual Version 1.0 F-11
Glossary cobas e 411 analyzer
master curve -onboard

master curve A lot-specific master calibration curve missing value In ECL assays, a calibration quality
(n=5 or 6) measured at Roche Diagnostics using lot- criterion. All calibrator values must be available for a
specific test-kit reagents and master calibrators. The successful calibration.
shape of the lot-specific master curve is characterized by
a four-parameter Rodbard function. The data mode Defined states of operation of an analyzer.
characterizing this curve is stored in the lot-specific
reagent barcode. Lot-specific, calibrator-assigned values monochromatic Absorbance measurement at one
(CalSet-assigned values) are read from the lot-specific (primary) wavelength.
master calibration curve and encoded in the CalSet
calibrator barcode transfer sheet. monotony of curve A calibration quality criterion. All
measured calibrator values must fall in either ascending
Material Safety Data Sheets (MSDS) Documents (sandwich or bridging principle) or descending
that list components of chemical solutions and (competition principle) order for a successful calibration.
precautions for the handling and disposal of the
solutions. multi-wavelength spectrophotometer A
spectrophotometer in which detectors are placed at
mean The sum of values divided by the number of multi-wavelength positions to enable simultaneous light
values. reception.

measure point Time at which absorbance reading is


N
taken and used to calculate results.

measuring cell A flow-through device that is used to NaOH-D A detergent used in cell wash and probe wash.
generate light during the ECL detection process.
nipple A part for connecting a syringe and the flow
measuring range See reportable range. path.

message In computing, a defined set of alphanumeric non-barcode mode A mode of instrument operation
data that transfers information from computer to during which the instrument identifies samples by using
computer or from an analytical instrument to the the rack and position numbers.
operator.
normal range See expected values.
microbeads Paramagnetic streptavidin-coated
microparticles used as the solid phase for heterogeneous nozzle A pipe or tube of varying diameter that is used
immunoassays in the Elecsys format. to direct or modify the flow of a liquid or gas.

Microcup A secondary sample cup made by Hitachi nozzle head The cover of the device holding multiple
with a small dead (residual) volume rinse nozzles.

microparticle See microbead. nozzle seal A seal placed between the tube and the
probe to connect them.
microbead mixer A paddle or propeller that
thoroughly mixes the microbead reagent to ensure nozzle tip A tip attached to the end of the nozzle that
resuspension before use. sucks up rinse water remaining after a reaction cuvette
has been washed.
minimum sample volume The smallest volume of
sample required to ensure faultless sample aspiration. In O
practice this is the sum of the residual volume plus the
volume required to assay all requested tests.
onboard 1. A technical device or function that is part of
minimum signal In ECL assays, a calibration quality the analytical instrument and can be used by the
criterion. A pre-defined, assay-specific signal level that instrument at any time.
must be achieved to establish a valid calibration. 2. The availability of reagents and consumables on an
analytical instrument for use at any time.

Roche Diagnostics
F-12 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
one-way serial processing -plunger

one-way serial processing The sample flow and paramagnetic A property of microbeads that do not
processing along a single, serial process lane that allows exhibit magnetic forces themselves but are capable of
no bypass function and no rerun. becoming magnetic in the presence of a magnet or
magnetic field used with ECL technology.
online help On-screen documentation that a user can
request in a context-sensitive manner and search for any parameters A set of criteria or definitions used to
given term. establish how an assay is performed. Examples of
parameters include sample and reagent volumes and
online support A service that supports the preparation incubation times and temperatures. Such information is
for analysis and maintenance management by typically encoded on reagent barcode labels and cannot
exchanging information over networks. be changed by the operator.
See also TeleService.
password A form of authentication that uses secret
open request See pending requests. data to control access to a resource.

Operate The operational mode during which the patient ID A set of alphanumeric data that
instrument processes samples. unmistakably identifies a particular patient. For example,
a social security number and a sample number.
operating system A software program that controls all
basic functions of a computer (for example, Windows, PC Abbreviation for personal computer.
Linux, and Palm OS).
pending requests Also known as open requests. The
operator The person who uses and controls the results for a sample are partially available; other tests have
analytical instrument or a computer system. not yet been performed or completed.
See also user.
photomultiplier A light-sensitive tube that collects and
operator ID An alphanumeric ID that a system uses to amplifies emitted photons from the ECL reaction and
identify a particular operator. Access levels differ for converts them into an electric signal.
operators, administrators, and service personnel.
photon A quantum of electromagnetic energy, having
order Also called a request. A test selected for a specific both particle and wave behavior, that carries the light
sample or control. emitted from the ECL reaction.

order date/time A field used to maintain the arrival pinch valve A valve that pinches the suction tube and
date and time of an order in the laboratory. The date/ switches the flow path.
time data may be entered manually or transmitted by LIS
protocols. pipette (to ) The process of aspirating and
dispensing sample and reagents performed by an
order ID The sample order identification refers to a appropriate probe.
number of sample tubes (one or more specimen types) of
a given patient collected for a panel of different tests. pipetting station The part of the analytical unit that
Typically, the sample order identification is printed on performs all pipetting-related functions. See also pipetter.
order sheets.
pipetter A device used for pipetting a fixed amount of
output buffer A section of an analyzer to which sample or reagent.
samples are moved on completion of the analytical
process and from which they can be unloaded. pipetter technology A technique used to transfer
See also rack unloader. reagents into a reaction vessel by using a rinsed probe or
a disposable tip. Reagents are aspirated from cassettes,
bottles, or reagent packs.
P
plunger A rod that connects with the drive arm and
parallel interface The interface (Centronics type) moves up or down, depending on the pipetting amount.
through which the analyzer can be connected to an
external printer.

Roche Diagnostics
Operators Manual Version 1.0 F-13
Glossary cobas e 411 analyzer
pop-up window -quantitative measurement

pop-up window A small screen window that contains prozone The lack of agglutination in an antibody-
additional information or additional options required for antigen mixture where the concentration of antibody is
making entries or decisions. high. The antibody excess leads to the formation of small
complexes that do not clump to form visible
positive displacement Water in the pipetter that is agglutination. Agglutination occurs if the sample is
displaced by the plunger during an aspirate/dispense subsequently diluted. The cobas product range can
cycle. The positive displacement is equal to the amount of identify the presence of prozone phenomena by
sample or reagent that is aspirated or dispensed by the determining the change in test sample absorbance when
probe. additional antigen is added in a separate pipetting step.

post-analytical The sample management process, PSD Abbreviation for Primary Sample Distribution.
typically storage and archiving, after results have been
reported. PSID Abbreviation for Positive Sample Identification.

potentiometric assay An assay in which analytes (for PSM Abbreviation for Pre-Analytic Systems Manager,
example Na, K, or Cl) are measured in millivolts by ion- which is PC-based software in a laboratory environment
selective electrodes. connected to one or more pre-analytic or analytical
devices. A PSM controls the sample flow and offers
Power Up The system status while it is loading extended data management. PSM is not available in the
programs, performing self-checks, and so on. United States of America.

PPID Abbreviation for Positive Patient Identification. pushing spring A part that presses down a seal piece.

pre-analytical The sample management process before


Q
the analytical phase. Pre-analytical processing typically
involves actions such as sorting and aliquoting.
QA Abbreviation for quality assurance. All the planned
precision The closeness of agreement between and systematic activities implemented within the quality
independent test results obtained under prescribed system and demonstrated as needed to provide adequate
conditions. confidence that an entity will fulfill requirements for
quality.
PreClean A phosphate buffer used to wash and
resuspend the microbeads during the pre-wash step. QC Abbreviation for quality control. The operational
techniques and activities that are used to fulfill
pre-dilution A dilution step performed before samples requirements for quality.
are analytically processed on the analyzer.
QC error An alarm generated in real-time when either a
PRID Abbreviation for Positive Reagent Identification. low value or a high value exceeds the limit of 3SD (QC
error 1) or 2.5 SD (QC error 2).
primary tube The original tube containing the sample
that has been drawn from the patient. qualitative assay An assay that does not allow the
determination of the concentration of an analyte, only a
ProCell An auxiliary reagent that transports the classification of the analyte (for example, positive or
reaction mixture from an AssayCup into the measuring negative).
cell and aids the ECL detection technology.
qualitative measurement The determination of a
profile A user-defined set of test requests. substance without calculating and reporting the
concentration with a qualitative assay.
protocol 1. A convention or standard that controls or
enables the connection, communication, and data quantitative assay An assay that allows the
transfer between two computing end points. Protocols determination of the concentration of an analyte.
can be implemented by hardware, software, or a
combination of the two. quantitative measurement The determination of a
2. A set of rules that guides how an activity should be substance by calculating and reporting the concentration
performed. with a quantitative assay.

Roche Diagnostics
F-14 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
query download -recalibration

query download A communication process between reagent A composition of chemicals used to determine
instrument PC and LIS by which a pre-defined data set is the concentration of substances in body fluid.
transmitted upon request of the analytical instrument.
reagent cap open/close mechanism A mechanism
that prevents evaporation by automatically opening and
R
closing the reagent pack caps before and after reagent
pipetting or operation.
RA Abbreviation for random access.
reagent compartment A temperature-controlled
rack A sample carrier device that holds sample cups or section on an analyzer that holds reagents and diluents.
primary sample tubes (including those for routine
samples, standard and washing solutions, quality control, reagent rotor The device in the reagent compartment
STAT, and rerun samples). The rack enables easy into which the reagent bottles are placed.
transportation on analytical systems and modules.
Different rack types can be distinguished by their reagent rotor cover The cover that closes the reagent
differing colors. compartment.

rack circuit breaker A technical device controlling the reagent rotor position One of the multiple positions
power to the rack sampler unit. on the reagent rotor.

rack ID A barcode (one-dimensional or binary) at the reagent interrupt A function that allows a user to
end of the rack that unmistakably identifies the rack. place reagents on the system while in the Operation
mode.
rack loader Area where the racks to be measured are
set. Fifteen racks can be placed on the rack tray and 15 reagent pack A complete set of physically combined
racks on the input buffer. and ready-to-use reagent bottles for Elecsys assays. The
components of a reagent pack cannot be interchanged
rack pusher arm An arm, located on the A-line, for with another reagent pack.
pushing racks. See also cobas e pack.

rack sampler A sample-handling device that presents reagent pack calibration (R-cal) The calibration
sample tubes in racks to the analytical unit. performed when a reagent has been onboard the analyzer
more than 24 hours or when generated by an operator-
rack tray A device for carrying many racks and setting released calibration. A reagent pack calibration is valid
them in a rack sampler. for one specific assay.

RAM Abbreviation for random access memory. reagent pack number A unique number on the
Semiconductor memory devices used in computers. reagent bottle label that identifies each reagent pack.
RAM content gets lost when a computer is switched off.
reagent probe The probe used to transfer or pipette
random access The ability of an analytical instrument reagents from the reagent bottles to the reaction cells.
to process requests from a patient sample in any order.
reagent probe rinse station The area located
rate assay A determination in which measurements between the reagent rotors and reaction disk where
are taken as the reaction proceeds. The rate of the reagent probes are rinsed both internally and externally
reaction is proportional to the sample component being with water.
analyzed. Also known as a kinetic assay.
reagent scan A scan of the reagent rotor to read
raw data The unprocessed values obtained during the information from the reagent barcode into the analyzer
analytical process on an instrument (for example mVolt and to update the inventory.
or absorbance).
real time The display of information on the monitor at
reaction mixture The mixture of reagents and sample the very moment a change to such information occurs.
material.
recalibration The repetition of a calibration.

Roche Diagnostics
Operators Manual Version 1.0 F-15
Glossary cobas e 411 analyzer
reflex testing -sample ID

reflex testing A request for additional testing based on RSP module The restopper module of MODULAR
customer-defined algorithms or rules and previous test PRE-ANALYTICS.
results.
ruthenium A rare metallic chemical element of the
repeat The performance of the same test on a sample platinum group that is employed in
again under unchanged conditions. electrochemiluminescent (ECL) reactions.

repeat limit A user-definable limit at which a test is run ruthenium complex [Ru(byp)32+] N-
again under unchanged conditions. hydroxysuccinimide (NHS) ester. This chemical complex
is employed in the ECL detection technology.
reportable range The range of results that can be
reported for the assay. It stretches from the lower
S
detection limit to the high end of the calibration curve.

request See order. S. Stop button Abbreviation for sampling stop. A


button used to stop the pipetting of samples but process
Reset The operational mode during which the analyzer already scheduled activities without interruption or loss.
sets and aligns all mechanical parts to their home
positions. S.Stop Abbreviation for sampling stop. A system
operating mode in which no new samples are pipetted,
residual volume The volume at the bottom of the but samples already pipetted will be completed without
sample tube that cannot be aspirated by the sample interruption or loss.
probe.
S/R arm See sample/reagent arm.
restore The command for reloading data from a storage
device onto the hard disk of the analyzer PC. S/R pipetter See sample/reagent pipetter.
See also backup.
S/R probe See sample/reagent probe.
result The value reported by an analytical device during
or after the assay of a sample or control. S1Abs The absorbance of standard solution 1. The
displayed value is 10 000 times greater than the actual
Result Date/Time The instrument fills the result date measured absorbance.
and time after the result calculation is finished. It may be
maintained by work area management systems for sample blank A control solution used to determine the
information purpose. background measurements (such as turbidity or color) of
test samples.
rinse bath See reagent probe rinse station.
sample container A device in which sample material
rinse nozzle A nozzle that supplies or drains the is transported or stored, typically made from glass or
detergent or water used for rinsing a reaction cell. plastic. Also referred to as sample tube.

rinse station A technical device that cleans disposable sample cup A small container that is used for samples
tips or probes with deionized water or cleaning solutions and also for calibrator and control material. A sample
to avoid contamination and carryover. cup can be placed either on specific racks, other inserts,
or on sample tubes. Compared to a sample tube, a sample
Rodbard function A mathematical algorithm used to cup allows the use of smaller liquid volumes and so
convert measured signals into concentrations. It uses reduces the residual volume.
four parameters to define the shape and the position of
the calibration curve. sample disk A rotor into which sample containers are
placed.
ROM Abbreviation for read-only memory.
Semiconductor memory devices used in computers. sample ID A set of alphanumeric data that
ROM content remains when a computer is switched off. unmistakably identifies a particular sample.
See also patient ID.

Roche Diagnostics
F-16 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
sample probe -solid waste tray

sample probe The rinsed probe used to transfer secondary tube A sample container of variable size
sample material from the sample disks to the reaction into which aliquots are transferred
cells.
sequence number A number automatically assigned
sample scan A scan of the sample disk to read the to each sample by the analyzer and used to track samples
information from the primary sample tubes into the and orders.
analyzer.
serum index A function by which the absorbance
sample splitting The act of making one or more characteristics of the samples are described to assess the
aliquots from a primary or secondary specimen. presence of lipemia, hemolysis, and icterus.

sample tray See sample disk. serum work area (SWA) The section of a clinical
laboratory where all CC, HIA, and HetIA tests (including
sample tube A glass or plastic container for liquid pre-analytical and post-analytical work) are processed.
samples to be used with the system. It may or may not
have a barcode label, which may be used for positive Service The status that is required to perform a
sample identification. A sample tube contains sample of maintenance action. See maintenance item, maintenance
one specific specimen (sample) type. procedure.

sample type One of four types of sample that can be shutdown The process of powering off an instrument.
analyzed: serum, plasma, cerebrospinal fluid, or urine.
The sample volume and normal value are settable for shutter A door, located on the lid of the reagent rotor,
each type. that is used to load and unload cobas c packs (reagent
cassettes).
sampling stop An instrument alarm level that
indicates a problem with the sampling system. signal The emission of light converted into an electrical
See also S.Stop. signal that is subsequently converted into an analyte
concentration.
sandwich principle One of three test principles that
can be applied to ECL immunoassays. It is used to detect sipper arm A horizontally moving arm that holds the
higher molecular weight analytes, such as TSH. sipper probe.
See also bridging principle, competitive principle.
sipper pipetter A device, filled with deionized water,
scan See barcode scan. that uses positive displacement to aspirate and dispense
from the sipper probe.
scroll The action of moving through text or graphics
(up, down, left, or right) to see parts of the file or list that sipper probe The probe that aspirates reaction mixture
cannot fit on the screen. out of the AssayCup into the measuring cell. This probe
also aspirates ProCell and CleanCell.
scroll arrow An arrow on either end of a scroll bar that
you use to scroll through the contents of the window or Sleep mode Also called sleeping. A mechanical and
list box. electrical status of an analytical instrument during which
no immediate processing can be initiated by the operator.
scroll bar A bar that appears at the bottom or right
edge of a window whose contents are not entirely visible. software A computer-operated program that processes
Each scroll bar contains a scroll box and two scroll data in a defined manner. Software is usually intellectual
arrows. property of the software supplier or its licensee.

scroll box In a scroll bar, the small box that shows the solid waste compartment A metal waste container
position of information currently in the window or list holding a liner that collects discarded solid waste.
box relative to the contents of the entire window.
solid waste tray A metal waste container holding a
SD Abbreviation for standard deviation. liner that collects discarded solid waste.

Roche Diagnostics
Operators Manual Version 1.0 F-17
Glossary cobas e 411 analyzer
standard -tip

standard Traceable reference material used to create the SysClean An auxiliary reagent used for the periodic
master calibration curve. cleaning of the measuring cell.

standard deviation A statistic used as a measure of the system cleaning solution See wash solution.
dispersion or variation in a distribution of data.
system error 1. A calibration quality criterion that
standard rack A standardized transportation device originates from a hardware failure while a calibration
for a maximum of five sample containers on Roche measurement is performed.
Diagnostics/Hitachi High-Technologies instruments. 2. The general term for a case of instrument-related
problems.
standard tray A metal device that holds and carries
multiple standard racks and that can be placed directly in system reagent A non-test specific reagent that is
the sample reception area of an analyzer. needed to perform testing on an analyzer.

Standby An operational mode of the analyzer during systematic error An error that is generated by a cause
which power is on but no sample analysis or maintenance giving deviation to measured values. An alarm generated
procedures are being performed. when control of a low value or a high value is changed in
the same direction in real-time quality control.
Start button A button used to start system operation
(Operating status) and begin the pipetting of samples, SysWash A system-specific agent used to avoid reagent
measurement, and the result calculation process. carryover. It also prevents bacterial growth.

Startup An operational mode of an analyzer, following


T
power-on, during which the instrument prepares itself
for operation.
target range The allowed range of recovery for an
STAT Abbreviation for Short Turn Around Time. analyte in a control material.
Terminology used by the medical clinical professionals to
prioritize the processing of a sample in a laboratory. target value The mean of all participant responses
after removal of outlying values.
STAT application A special test application (for
example, reduced incubation time) for STAT or TDM Abbreviation for Therapeutic Drug Monitoring.
emergency samples to achieve faster result reporting.
See also STAT. technical limit The dynamic range of an assay.

STAT port Special entry area for STAT samples, which test code The abbreviated name for a test. This code is
will be processed with priority. displayed on test buttons shown on software screens or
windows.
STAT sample Emergency sample. Results should be
available within shortest possible time. See also STAT. test principle A technique that serves as the basis for
designing an assay to detect or quantify analytes.
status A general term used to refer to the current status
of the system. Explicit terminology may be used to test protocol The sequence of test steps used to
address sub-parts of the system status (such as analyzer perform an assay (for example, volumes and timings).
status and printer status).
text box A box, on a screen, where a user can type
stop barcode A special barcode used on disk systems information or a command.
to halt sample scanning.
time-out calibration An instrument mode that
STOP button A button used to immediately stop all automatically generates a calibration request after a pre-
system operations, including test processing functions. defined interval.
The system may need special attention to resume its
normal operation state. tip See AssayTip.

SW Abbreviation for software.

Roche Diagnostics
F-18 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
tip eject station -web tunnel

tip eject station An opening in the instrument user The person who operates and controls the
housing through which AssayCups and AssayTips are analytical instrument or a computer system.
discarded. See also operator.

touch screen An input device that allows the user to user interface The part of a system exposed to a user.
interact with the computer by touching the display In a computer system, the user typically interacts with an
screen. operating system or with application software. With
these the user interacts by using menus, icons, keystrokes,
transaction The smallest unit of interaction between mouse clicks, and similar means.
the two computers. One computer (a host computer or
Instrument Manager) sends a message and a receiving
V
computer returns a reply.

tray A container used to collect a number of racks for validation The process of checking results or data
easier handling (such as Hitachi trays 75 or 150). against defined rules or ranges in clinical laboratories.
Validation can be against technical or clinical criteria.
tray indication light A light, at the left side of both the
A-Line and C-Lines, that indicates the mode of vessel See AssayCup.
operation.
vial A small sample container with flip-top lid, mainly
trend An upward or downward tendency in data values used for calibrator and control material.
after the exclusion of the random error and cyclic effects.
virtual private network (VPN) A way of using a
tripropylamine (TPA) One of two electrochemically public telecommunication infrastructure, such as the
active substances used in the ECL reaction. Internet, to provide remote offices or individual users
with secure access to their organization's network.
turn-around-time 1. The time between the decision to
perform a test and the time when the doctor receives the W
result and can act on it.
2. Inside the laboratory (Lab-TAT): Time between
receiving a sample and sending out the validated result. WAM Workarea management: PC-based software that
controls and monitors sample tracking and offers
two-way processing A type of sample flow allowing extended data management for a defined workarea in a
two directions, typically a main lane to feed analytical clinical laboratory environment.
modules with samples and a return line to handle rerun
and reflex testing. waste Anything discarded by the analyzer; waste can be
liquid or solid.
U waste solution reservoir Container that collects
reaction waste.
ultrasonic unit A mechanical unit, in a waterproof
pack, that generates ultrasound used to stir samples. water level sensor A sensor that monitors the water
level of temperature-controlled water.
unit A chosen reference quantity of an analyte used to
compare quantities of the same dimension (for example, water supply tank A tank used to store ion-exchanged
mol/L, g/L, or U/L). water.

unloader The output buffer. An unloader holds racks water supply tube A tube for connecting a water
after the completion of the analytical process. supply tank and an analyzer.

upload The process of sending data to Roche by a web tunnel A web service that transports encrypted
network link. data from a company network to a dedicated server
application outside of the network.

Roche Diagnostics
Operators Manual Version 1.0 F-19
Glossary cobas e 411 analyzer
window -workarea consolidation

window An object displayed on a monitor. By using


several windows, a user can handle multiple functions on
a PC in parallel. A user can overlap, resize, or reposition
windows.

work list A report generated by an analytical


instrument. A work list aids a user by listing calibrators,
controls, and samples currently loaded on the sample
disk.

workarea consolidation The combination of separate


workstations to produce one physical or logical workarea
in a laboratory. This combination can be achieved
through mechanics (a conveyor, for example), facilitated
sample transfer (racks or trays), and data management.

Roche Diagnostics
F-20 Operators Manual Version 1.0
Index G
cobas e 411 analyzer Index

Index

Symbols
<SigL (data alarm), D-37 replacing, B-30
<Test (data alarm), D-37 tray positions, A-90
>AB (data alarm), D-36 Assigning
>Curr (data alarm), D-36 calibrator positions, B-104
>Test (data alarm), D-37 control positions, B-104
Automatic Printout area options, B-85
A
B
AB level check error (data alarm), D-38
AB level range over (data alarm), D-36 Barcode card reading station, A-84
AB.E (data alarm), D-38 Barcode cards, calibrator, A-49
Abbreviations, 10 Barcode labels
Abnormal reagent disk temperature (data alarm), D-45 applying correctly, B-94
Access levels, software screens, A-66 calibrator, A-49
Accumulating QC results, B-41 control, A-50
ADC abnormal (data alarm), D-38 reagent, A-46
ADC.E (data alarm), D-38 Barcode readers
Administrator logon, A-66 rack, A-83
Alarm screen sample, A-80
reviewing, B-17 Barcodes
Alarm types, D-5 supported symbologies, A-41
Alarms, issued by the system, B-17 use of check digits, A-13
A-Line (of rack sampler), A-74 B-Line (of rack sampler), A-75
Analyzer Boxes
components, A-71 list, A-63
dimensions, A-37 text, A-64
safety labels, A-18 Bubbles, in syringes, D-23
troubleshooting, D-14 Buttons
unit, A-30 global, A-65
Analyzer compartments options, A-64
cleaning, C-36, C-39 standard, A-64
removing condensation, C-14 types, A-64
Approvals, instrument, 2
Approved parts, A-13, A-23 C
Archiving sample data, B-99
Assay calibration, troubleshooting, D-25 Cal.E (data alarm), D-38
Assay reagent film detected (data alarm), D-44 Calc.? (data alarm), D-39
Assay reagent hovering (data alarm), D-44 Calc.Test Error (data alarm), D-41
Assay reagent short (data alarm), D-44 Calculated tests, programming, B-115
AssayCup trays Calculation not possible (data alarm), D-39
replacing, B-30 Calibration
troubleshooting, D-18 assay troubleshooting, D-25
AssayCups measuring, B-36
disposal opening, A-91 performing, B-32
inventory, B-20, B-21 validating, B-38
tray positions, A-90 Calibration result abnormal (data alarm), D-38
AssayTip trays Calibration settings, changing, B-118
replacing, B-30 Calibration/QC Load List
troubleshooting, D-18 in daily operation, B-23
AssayTips loading calibrators, B-32
inventory, B-20, B-21 loading controls, B-32

Roche Diagnostics
Operators Manual Version 1.0 G-3
Index cobas e 411 analyzer

printing, B-23 Contact addresses, 3


Calibrators Containers
assigning positions, B-104 direct liquid drain, A-93
barcode cards, A-49 liquid waste, A-92
kits, A-48 solid waste, A-96
loading, B-32 system water, A-92
preparing, B-32 Continuous loading
troubleshooting, D-11 using multiple disk mode, B-62
Cancel [E.STOP Cancel] (data alarm), D-39 using rack systems, B-62
Cancel [P.STOP/A.STOP Cancel] (data alarm), D-40 using single disk mode, B-60
Cancel [Power Fail/Power Off Cancel] (data alarm), Control kits, A-50
D-39 Control unit, A-34, A-53
Cancel [Recovery Cancel] (data alarm), D-40 components, A-55
Cancel [S.STOP Cancel] (data alarm), D-40 specifications, A-44
Cancel [Sample ID Error Cancel] (data alarm), D-40 Control values, editing, B-109
Cancel [STOP Cancel] (data alarm), D-39 Controls
Canceling print jobs, B-111 assigning positions, B-104
Cap open/close mechanism, reagent, A-86 loading, B-32
CarOvr (data alarm), D-41 measuring, B-36
Cell temperature (data alarm), D-41 preparing, B-32
Cell.T (data alarm), D-41 troubleshooting, D-11
Checking Copyrights, 2
liquid waste container, B-27 Cups
system alarms, B-17 See, AssayCups
system water container, B-27 Curr.E (data alarm), D-41
Checks, final power off, B-90
Circuit breaker D
main, A-35
rack sampler, A-36 Daily Alarm Trace reports, printing, B-112
ClcT.E (data alarm), D-41 Daily maintenance, C-12
CleanCell Daily Maintenance button, operation, B-22
cleaning compartments, C-36 Daily operation
inventory, B-20 routine operation, B-31
preventing evaporation, B-88 work flow, B-11
use, A-100 Data
Cleaning post-operation management, B-87
CleanCell compartments, C-36 storage, A-58
liquid flow path, C-22 Data alarms
liquid waste container, C-33 <SigL, D-37
microbead mixer, C-35 <Test, D-37
ProCell compartments, C-36 >AB, D-36
reagent probe, C-12 >Curr, D-36
reagent rotor/compartment, C-39 >Test, D-37
rinse stations, C-19 AB level check error, D-38
sample probe, C-12 AB level range over, D-36
sample/reagent probe, C-12 AB.E, D-38
sipper probe, C-15 abnormal reagent disk temperature, D-45
Clean-Liner, solid waste, A-96 ADC abnormal, D-38
C-Line (of rack sampler), A-77 ADC.E, D-38
Compartments assay reagent film detected, D-44
See, Analyzer compartments assay reagent hovering, D-44
Consumables assay reagent short, D-44
loading during operation, B-79 Cal.E, D-38
replacing, B-23 Calc.?, D-39
Consumables area, A-89 Calc.Test Error, D-41

Roche Diagnostics
G-4 Operators Manual Version 1.0
cobas e 411 analyzer Index

calculation not possible, D-39 system reagent temperature, D-47


calibration result abnormal, D-38 system reagent temperature unstable, D-47
Cancel [E.STOP Cancel], D-39 Data drifting, D-48
Cancel [P.STOP/A.STOP Cancel], D-40 Data problems without alarms, D-48
Cancel [Power Fail/Power Off Cancel], D-39 Data Review screen, selecting samples, B-98
Cancel [Recovery Cancel], D-40 Dead volumes
Cancel [S.STOP Cancel], D-40 See, Residual volumes
Cancel [Sample ID Error Cancel], D-40 Defining
Cancel [STOP Cancel], D-39 non-Roche controls, B-107
CarOvr, D-41 Roche controls, B-106
Cell.T, D-41 Deleting single open requests, B-103
ClcT.E, D-41 Diluent film detected (data alarm), D-44
Curr.E, D-41 Diluent hovering (data alarm), D-44
diluent film detected, D-44 Diluent short (data alarm), D-44
diluent hovering, D-44 Dilutions
diluent short, D-44 automatic, B-75
FacA, D-42 automatic dilution, B-75
H, D-42 manual predilution, B-75
Inc.T, D-42 samples, B-74
incubator temperature, D-42 Dimensions, analyzer, A-37
instrument factor A reset, D-42 Direct drain
L, D-43 checking waste level, B-29
list of all alarms, D-34 liquid waste, A-93
low signal level, D-37 Disk systems, A-28, B-5
measurement range, lower, D-37 Disks, sample, A-73
measurement range, upper, D-37 Disposal opening, AssayCups, A-91
measuring cell current check, D-41 Distilled water container
measuring cell current range over, D-36 See, System water container
measuring cell temperature, D-41 Documentation settings, changing, B-114
outside expected higher value, D-42
outside expected lower value, D-43 E
Over.E, D-43
overflow, D-43 Editing control values, B-109
potential microparticle carry over, D-41 Electrical specifications, A-38
pretreatment film detected, D-44 Electromagnetic compatibility, A-23
pretreatment hovering, D-44 EMC
pretreatment reagent short, D-44 See, Electromagnetic compatibility.
Reag.F, D-44 Emptying
Reag.H, D-44 solid waste, B-29
Reag.S, D-44 solid waste tray, C-42
Reag.T, D-45 Environmental conditions, A-39
reagent expired, D-43 Erroneous operation, D-48
ReagEx, D-43 Evaporation of system reagents, preventing, B-88
Samp.C, D-45 Extended shutdown, C-44
Samp.S, D-45
sample clot, D-45 F
sample LLD abnormal, D-46
sample LLD noise, D-46 FacA (data alarm), D-42
sample short, D-45 False measurements, troubleshooting, D-24
SLLD.E, D-46 Final power off checks, B-90
SLLD.N, D-46 Finalization maintenance, C-30
SysR.S, D-46 Flash memory, A-58
SysR.T, D-47
SysR.U, D-47
system reagent short, D-46

Roche Diagnostics
Operators Manual Version 1.0 G-5
Index cobas e 411 analyzer

License, 3
G
Liner
Global buttons, A-65 See, Clean-Liner
Gripper unit, A-90 Liquid flow path cleaning, C-22
Guidance prompt, A-61 Liquid waste
container, A-92
H direct drain, A-93
specifications, A-40
H (data alarm), D-42 Liquid waste container
Help checking, B-27
See, Online Help cleaning, C-33
Host interface, A-59 List boxes, A-63
Load list, reagents, B-23
I Loading
calibrators, B-32
IEC 61010 (noise levels), A-39 consumables during operation, B-79
Inc.T (data alarm), D-42 continuous, using multiple disk mode, B-62
Incubation, specifications, A-43 continuous, using rack systems, B-62
Incubator temperature (data alarm), D-42 continuous, using single disk mode, B-60
Incubator, description, A-97 controls, B-32
Input buffer (of rack sampler), A-74 Logging on, B-16
Inserts, package, A-47 Low signal level (data alarm), D-37
Installation, safety precautions, A-8
Installing
non-Roche controls, B-107
M
Roche controls, B-106 Main circuit breaker, A-35
Instrument Maintenance, C-3
approvals, 2 as needed, C-30
dimensions, A-37 cleaning liquid waste container, C-33
troubleshooting, D-11, D-14 cleaning reagent rotor/compartment, C-39
Instrument factor A reset (data alarm), D-42 cleaning the CleanCell compartments, C-36
Intended use, 2 cleaning the microbead mixer, C-35
Interface cleaning the ProCell compartments, C-36
host, A-59 cleaning the rinse stations, C-19
USB, A-58 cleaning the sample/reagent probe, C-12
Inventory cleaning the sipper probe, C-15
AssayCups, B-20, B-21 daily, B-87, C-12
AssayTips, B-20, B-21 emptying the solid waste tray, C-42
CleanCell, B-20 every two months, C-24
ProCell, B-20 every two weeks, C-19
solid waste, B-20 finalization maintenance, C-30
Inventory area, B-20 items, C-6
liquid flow path cleaning, C-22
K performing, C-6
procedures, C-5
Keyboard protecting the measuring cell, C-44
See, Software keyboard replacing the pinch valve tubing, C-24
Kits weekly, C-15
calibrator, A-48 Maintenance log, C-9
controls, A-50 Maintenance schedule, C-8
reagent, A-46 Measurement range
lower (data alarm), D-37
L upper (data alarm), D-37
Measurements, troubleshooting false values, D-24
L (data alarm), D-43
Labels, reagent barcode, A-46

Roche Diagnostics
G-6 Operators Manual Version 1.0
cobas e 411 analyzer Index

Measuring interfaced, barcoded samples (rack systems), B-53


additional routine samples, B-60 interfaced, non-barcoded samples (disk systems), B-47
calibrators, B-36 interfaced, non-barcoded samples (rack systems), B-54
controls, B-36 non-interfaced, barcoded samples (disk systems), B-48
Measuring area, components, A-97 non-interfaced, barcoded samples (rack systems), B-56
Measuring cell current check (data alarm), D-41 non-interfaced, non-barcoded samples (disk systems),
Measuring cell current range over (data alarm), D-36 B-50
Measuring cell, protecting during extended shutdown, non-interfaced, non-barcoded samples (rack systems),
C-44 B-58
Measuring system, specifications, A-44 Patient results
Memory deleting, B-87
cards, A-58 filtering, B-84
saving space, B-22 printing, B-84
Menu tabs, A-63 reviewing, B-87
Microbead mixer uploading, B-84
cleaning, C-35 viewing, B-82
description, A-86 Peripheral devices, safety standards, A-23
rinse station, A-87 Pinch valve tubing, replacing, C-24
Mixer Pipetter
See, Microbead mixer sample/reagent, A-88
Monitor, touchscreen, A-55 sipper, A-99
Pipetting station, A-91
N Port
See, Interface
Noise levels (IEC 61010-1), A-39 Potential hazards, A-5
Non-Roche controls, installing and defining, B-107 Potential microparticle carry over (data alarm), D-41
Power off
O analyzer, B-88
checks, B-90
Online Help, A-67 Power on
Operation analyzer, B-13
overview, B-11 printer, B-13
System Overview screen, B-18 Power requirements, A-38
Operation switch, A-35 Power supply, safety labels, A-22
Operator, responsibility for troubleshooting, D-7 Pre-Analytic Systems Manager (PSM), 1-7, A-27
Operators Manual Predilution, manual, B-75
conventions used, 9 Pre-routine operation, B-18
finding information, 7 Pre-start inspection, B-12
version, 2 Pretreatment film detected (data alarm), D-44
Option buttons, A-64 Pretreatment hovering (data alarm), D-44
Organic solvents, safety precautions, A-15 Pretreatment reagent short (data alarm), D-44
Output buffer (of rack sampler), A-76 Preventive action, Work Flow Guide, B-22
Outside expected higher value (data alarm), D-42 Print jobs, canceling, B-111
Outside expected lower value (data alarm), D-43 Printers
Over.E (data alarm), D-43 approved models, A-58
Overflow (data alarm), D-43 connection port, A-58
switching on, B-13
P Printing
daily Alarm Trace reports, B-112
Package inserts, A-47 System Communication Trace reports, B-113
Parts, approved, A-13, A-23 Probe
Patents, 3 rinse station, A-87
Patient programming sample/reagent
calculated tests, B-115 sipper, A-98
interfaced, barcoded samples (disk systems), B-45

Roche Diagnostics
Operators Manual Version 1.0 G-7
Index cobas e 411 analyzer

ProCell Reagent system, specifications, A-43


cleaning compartments, C-36 Reagents
inventory, B-20 replacing, B-23
preventing evaporation, B-88 system, A-100
use, A-100 troubleshooting, D-11
Programming ReagEx (data alarm), D-43
See, Patient programming Replacing
Prompt, guidance, A-61 AssayCup trays, B-30
PSM (Pre-Analytic Systems Manager), 1-7, A-27 AssayTip trays, B-30
AssayTips, B-30
Q consumables, B-23
pinch valve tubing, C-24
QC reagent packs, B-24
accumulating results, B-41 reagents, B-23
activating a test, B-36 system reagents, B-25
measuring, B-36 Reproducibility, poor, D-48
performing, B-32 Requesting standby bottle QC, B-110
Rerunning samples, B-100
R Resetting system, B-101
Residual volumes, A-42
Rack barcode reader, A-83 Result data
Rack sampler at high level, D-48
A-Line, A-74 at low level, D-49
B-Line, A-75 Result data drifting, D-48
C-Line, A-77 Result Report
input buffer, A-74 printing, B-85
output buffer, A-76 Results, B-81
Rack sampler circuit breaker, A-36 deleting, B-87
Rack systems, A-28, B-5 reviewing, B-87
Reading station, barcode card, A-84 uploading manually, B-96
Reag.F (data alarm), D-44 Reviewing Alarm screen, B-17
Reag.H (data alarm), D-44 Rinse stations, A-87
Reag.S (data alarm), D-44 Rinse stations, cleaning, C-19
Reag.T (data alarm), D-45 Roche controls, installing and defining, B-106
Reagent Rotor, reagent, A-85
pipetter, A-88 Routine operation
Reagent area, A-72 procedures, B-31
Reagent barcode labels, A-46 work flow, B-11
Reagent cap open/close mechanism, A-86
Reagent Detail window (Reagent Overview), B-21
S
Reagent disk
See, Reagent rotor S/R probe
Reagent expired (data alarm), D-43 See, Sample/reagent probe
Reagent kits, A-46 Safety
Reagent Load list classifications, A-5
daily operation, B-22 information, A-3
Reagent load/unload list precautions, A-5
printing, B-23 Safety labels
Reagent overview area, B-19 analyzer unit, A-18
Reagent packs power supply, A-22
description, A-46 Safety standards, peripheral devices, A-23
replacing, B-24 Samp.C (data alarm), D-45
Reagent probe, cleaning, C-12 Samp.S (data alarm), D-45
Reagent rotor, A-85 Sample area, A-72
Reagent rotor/compartment, cleaning, C-39 Sample barcode reader, A-80

Roche Diagnostics
G-8 Operators Manual Version 1.0
cobas e 411 analyzer Index

Sample clot (data alarm), D-45 Sipper probe, A-98


Sample containers, A-42 Sipper probe, cleaning, C-15
Sample data Sipper shield, C-16
archiving, B-99 SLLD.E (data alarm), D-46
selecting two or more samples, B-98 SLLD.N (data alarm), D-46
Sample Data Clear Software
pre-routine operation, B-22 basics, A-60
Sample disk mode, changing, B-119 buttons, A-64
Sample disks, description, A-73 guidance prompt, A-61
Sample LLD abnormal (data alarms), D-46 list boxes, A-63
Sample LLD noise (data alarm), D-46 logging on, B-16
Sample measurements main menu screens, A-62
disk systems, B-45 menu tabs, A-63
rack systems, B-53 online Help, A-67
Sample pipetter, A-88 option buttons, A-64
Sample probe, cleaning, C-12 screen access levels, A-66
Sample programming selecting multiple items, A-66
interfaced, barcoded samples (disk systems), B-45 status line, A-61
interfaced, barcoded samples (rack systems), B-53 text boxes, A-64
interfaced, non-barcoded samples (disk systems), B-47 version, 2
interfaced, non-barcoded samples (rack systems), B-54 Software keyboard
non-interfaced, barcoded samples (disk systems), B-48 Solid waste
non-interfaced, barcoded samples (rack systems), B-56 emptying, B-29
non-interfaced, non-barcoded samples (disk systems), inventory, B-20
B-50 specifications, A-40
non-interfaced, non-barcoded samples (rack systems), Solid waste tray
B-58 Clean-Liner, A-96
Sample racks, description, A-79 emptying, C-42
Sample sensor, A-83 replacing, D-20
Sample short (data alarm), D-45 Solvents, safety precautions, A-15
Sample tracking Specifications
disk systems, B-76 control unit, A-44
rack systems, B-77 electrical, A-38
Sample tubes, applying barcode labels, B-94 environmental, A-39
Sample/reagent probe incubation system, A-43
description liquid waste, A-40
Sample/reagent probe, cleaning, C-12 measuring system, A-44
Samples noise levels, A-39
automatic dilution, B-75 reagent system, A-43
dilutions, B-74 sampling system, A-40
manual predilution, B-75 solid waste, A-40
measuring additional, B-60 throughput, A-40
rerunning, B-100 water supply, A-40
residual volumes, A-42 Specifications, system, A-37
results, B-81 Spillage, safety precautions, A-16
Sampling system, specifications, A-40 Standby bottle QC, requesting, B-110
Screen Status line, A-61
See, Touchscreen monitor Switch, operation, A-35
Screen access levels, A-66 Switching off analyzer, B-88
Short Turn Around Time (STAT) Switching on analyzer, B-13
test selections (disk systems), B-63 Symbols, 9
test selections (rack systems), B-67 Syringes, problems with bubbles, D-23
Shutdown, extended, C-44 SysR.S (data alarm), D-46
Single open requests, deleting, B-103 SysR.T (data alarm), D-47
Sipper pipetter, A-99 SysR.U (data alarm), D-47

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Operators Manual Version 1.0 G-9
Index cobas e 411 analyzer

System alarms, checking, B-17 emptying liquid waste container, D-20


System Communication Trace reports, printing, B-113 erratic test results, D-25
System Overview screen facility problems, D-7
inventory area, B-20 false measurements, D-24
operation, B-18 flowchart, D-10
reagent overview area, B-19 hardware problems, D-6
System reagent short (data alarm), D-46 instrument problems, D-6, D-11, D-14
System reagent temperature (data alarm), D-47 inter assay precision, D-29
System reagent temperature unstable (data alarm), D-47 intra assay precision, D-28
System reagents introduction, D-5
opening lids, B-15 method comparison, D-29
preventing evaporation, B-88 operators responsibility, D-7
replacing, B-25 precision, inter assay, D-28
See, Reagents precision, intra assay, D-28
System resetting, B-101 probes, D-21
System water container, A-92 problem categories, D-5
checking, B-27 reagent problems, D-6, D-11
replacing, D-19 recovery of controls, D-28
Systems replacing AssayCup trays, D-18
disk, B-5 replacing AssayTip trays, D-18
rack, B-5 replacing solid waste tray, D-20
replacing system water container, D-19
T result data, D-48, D-49
results do not print automatically, D-21
Tabs, menu, A-63 sample problems, D-6
Technical data, system, A-37 software problems, D-6
Technical Support trouble for all tests, D-49
contacting, D-8 trouble for each test, D-49
information required, D-8 types of alarm, D-5
Test settings, changing, B-116 variance between systems, D-29
Text boxes, A-64
Throughput rate, A-40 U
Tips
Inventory, B-21 Uploading results manually, B-96
See, AssayTips USB interface, A-58
Touchscreen monitor, A-55 User access levels
TPA (Tripropylamine), A-100 See, Access levels
Trademarks, 2 User interface
Tray, solid waste, A-96 See, Software basics
Trays
See, AssayCup trays V
See, AssayTip trays
Tripropylamine (TPA), A-100 Validating calibration, B-38
Troubleshooting Vessels inventory
assay calibrations, D-25 See AssayCups, inventory
auto dilution not possible, D-30
bubbles in syringes, D-23 W
calibrator problems, D-11
chemistry problems, D-24 Waste containers
computer problems, D-6 direct liquid drain, A-93
contacting Technical Support, D-8 liquid waste, A-92
control problems, D-11 Waste tray, solid
control unit problems, D-6 emptying, C-42
data backup, D-22 replacing, D-20
drift, D-24

Roche Diagnostics
G-10 Operators Manual Version 1.0
cobas e 411 analyzer Index

Waste, solid
emptying, B-29
inventory, B-20
Water container, system, A-92
Water supply, requirements, A-40
Weekly maintenance, C-15
Windows
confirmation type, A-66
description, A-66
Work Flow Guide, preventive action, B-22

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Operators Manual Version 1.0 G-11
Index cobas e 411 analyzer

Roche Diagnostics
G-12 Operators Manual Version 1.0
Notes H