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Connectivity Manual
Version 1.1
Date of issue February 2003
We reserve the right to make changes in the course of technical development
without previous notice.
Edition
EVOLIS System
Softwarecopyrights
Manufacturer:
Distributor:
BIO-RAD
The software for the EVOLIS has been licensed to BIO-RAD for worldwide
distribution. The EVOLIS software is the intellectual property of STRATEC
Biomedical Systems AG. Intellectual property rights shall remain with
STRATEC Biomedical Systems AG
You are entitled to use the EVOLIS software and the printed accompanying
material at your place of work only.
Any violations of property rights or copyright or trademark may be subject to
legal action.
Trademarks
BIO-RAD
3, boulevard Raymond Poincar B.P. 3
92430 Marnes-la-Coquette, France
tel: +33 (0)1 47 95 60 00
fax: +33 (0)1 47 41 91 33
Contents
Contents
1
Introduction ........................................................... 5
1.1
Purpose .................................................................................5
1.2
Scope ....................................................................................5
1.3
Connectivity...........................................................................5
1.4
1.5
Procedure..............................................................................6
ASTM Interface...................................................... 7
2.1
Setup .....................................................................................7
2.2
Low-Level Protocol................................................................8
2.2.1
Physical Layer................................................................................ 8
2.2.2
2.3
2.4
2.4.1
Host to EVOLIS............................................................................ 10
2.4.2
2.4.3
EVOLIS to Host............................................................................ 11
2.5
2.5.1
2.5.2
2.5.3
2.5.4
2.5.5
Comment Record......................................................................... 18
2.5.6
2.5.7
2.5.8
2.5.9
3.1
Introduction..........................................................................20
3.2
Hardware Configurations.....................................................20
3.3
Page 3
Contents
Page 4
3.3.1
3.3.2
3.4
3.4.1
3.4.2
Setup Polling................................................................................ 25
4.1
4.2
4.2.1
4.3
1 Introduction
1.1 Purpose
Introduction
1.1
Purpose
1.2
Scope
Document includes description for the ASTM link, and ASCII file exchanges.
1.3
Connectivity
1.4
Page 5
1 Introduction
1.5 Procedure
1.5
Procedure
Page 6
2 ASTM Interface
2.1 Setup
ASTM Interface
2.1
Setup
2. BaudRate
3. DataBits
7 or 8, default is 7.
4. StopBits
1, 1.5 or 2, default is 1.
5. Parity
Page 7
2 ASTM Interface
2.2 Low-Level Protocol
2.2
Low-Level Protocol
2.2.1
Physical Layer
2.2.2
Establishment
Phase
Transfer Phase
Page 8
2 ASTM Interface
2.3 Logical Structure of the Message Level Protocol
During the transfer phase, if the LIS responds to a frame with an <EOT> the
EVOLIS does not stop transmitting and chooses to ignore the interrupt
request.
Termination
Phase
Error Recovery
Any character errors are detected (ie. parity error, framing error)
The frame checksum does not match the checksum computed on the
received frame.
The frame number is not the same as the last accepted frame or one
number higher.
2.3
The blocked stream of data sent between a host computer and the analyzer at
a given time is called a message.
Messages consist of a hierarchy of records of various types:
Level:
Segment Name:
Identifier (Record
TypeID):
Comments:
Page 9
2 ASTM Interface
2.4 Incoming and Outgoing Transmission Examples
Level:
Segment Name:
Identifier (Record
TypeID):
Comments:
Scientific Record
not allowed
for EVOLIS
Result Record
Manufacturer Information
Record
not allowed
for EVOLIS
2.4
2.4.1
Host to EVOLIS
Response from host includes patient demographics, patient ID, sample ID,
and test orders according to the following record hierarchy.
The response to requests for test orders is expected to be received within 10
seconds after the request has been sent.
Structure defined by ASTM 1394
Frame 1
:
Frame n
Page 10
2 ASTM Interface
2.4 Incoming and Outgoing Transmission Examples
In case there are no test orders available the LIS should respond with an
empty message containing header and terminator records only. The
terminator record should contain an I (no information available) flag in the
Termination Code Field.
S:<ENQ>
R:<ACK>
S:<STX>1H|\^&|||LaborEDV||||||||1|19941115202738<CR><ETX><CR>
<LF>
R:<ACK>
S:<STX>2P|1|PatID01|42670070||Meier^Anna||19741001|F|||||
MARTINEZ<CR><ETX><CR><LF>
R:<ACK>
S:<STX>3O|1|||^^^HBsAg||20011115|||||||||S||||||||||X<CR><ETX>
<CR><LF>
R:<ACK>
S:<STX>4P|1|PatID02|43681136||Mueller^Fritz||19941001|M|||||
MARTINEZ<CR><ETX><CR><LF>
R:<ACK>
S:<STX>5O|1|||^^^HBsAg||20011115|||||||||S||||||||||X<CR><ETX>
<CR><LF>
R:<ACK>
S:<STX>6P|1|PatID03|43691135||Otto^Hans||19941001|M|||||
MARTINEZ<CR><ETX><CR><LF>
R:<ACK>
S:<STX>7O|1|||^^^HBsAg||20011115|||||||||S||||||||||X<CR><ETX>
<CR><LF>
R:<ACK>
S:<STX>0P|1|PatID04|00102105||Mayer^John||19941001|M|||||
MARTINEZ<CR><ETX><CR><LF>
R:<ACK>
S:<STX>1O|1|||^^^HBsAg||20011115|||||||||S||||||||||X<CR><ETX>
<CR><LF>
R:<ACK>
S:<STX>4L|1|N<CR><ETX><CR><LF>
R:<ACK>
S:<EOT>
2.4.2
Test Results
2.4.3
EVOLIS to Host
Page 11
2 ASTM Interface
2.4 Incoming and Outgoing Transmission Examples
Frame 1
:
Frame n
Page 12
2 ASTM Interface
2.5 Data Record Usage
2.5
2.5.1
Description
Valid
Max
Required
Contents Length
Record Type ID
Character
identifying the
record as a
message header
Delimiter Definition
Any received
delimiter set is
accepted.
The delimiters
defined in
ASTMSetupDialog
are sent.
Message Control
ID
Access Password
Sender Name / ID
Sender Street
Address
Reserved Field
Sender Telephone
No.
Characteristics of
Sender
10
Receiver ID
11
Comment
12
Processing ID
13
Version No.
14
20
1
Format is
YYYYMMDD
HHMMSS
14
Page 13
2 ASTM Interface
2.5 Data Record Usage
2.5.2
Page 14
Description
Valid
Max
Required
Contents Length
Record Type ID
Character
P
identifying the
record as a patient
information record
Sequence Number
Practice Assigned
Patient ID
Laboratory
Assigned Patient
ID
Patient ID No. 3
6^1
Patient Name
6^2
Mother's Maiden
Name
Birthdate
Patient Sex
10
11
Patient Address
12
Reserved Field
13
Patient Telephone
Number
14
Attending
Physician ID
15
Special Field 1
16
Special Field 2
17
Patient Height
18
Patient Weight
19
Diagnosis
20
Active Medications
21
Diet
22
23
Becomes our
PatientID
Becomes our
SenderID
2 ASTM Interface
2.5 Data Record Usage
Description
Valid
Max
Required
Contents Length
24
Admission and
Discharge Dates
25
Admission Status
26
Location
27
Nature of
Alternative
Diagnostic Code
and Classifiers
28
Alternative
Diagnostic Code
and Classification
29
Religion
30
Marital Status
31
Isolation Status
32
Language
33
Hospital Service
34
Hospital Institution
35
Dosage Category
2.5.3
Description
Valid
Max
Required
Contents Length
Record Type ID
Character
identifying the
record as a test
order record
Sequence Number
Specimen ID
Instrument
Specimen ID
5^4
Universal Test ID
5^5
Dilution
Priority
Requested /
Ordered Date and
Time
Test Abbreviation
Page 15
2 ASTM Interface
2.5 Data Record Usage
Page 16
Description
Valid
Max
Required
Contents Length
Specimen
Collection Date
and Time
YYYYMMDDHHM
MSS
Collection End
Time
10
Collection Volume
11
Collector ID
12
Action Code
13
Danger Code
14
Relevant Clinical
Information
15
Date/Time
Specimen
Received
16
Specimen
Descriptor (Type)
17
Ordering Physician
18
Physicians
Telephone
Number
19
20
21
Laboratory Field
No. 1
22
Laboratory Field
No. 2
23
Date/Time Results
Reported or Last
Modified
24
Instrument Charge
to Computer
System
25
Instrument Section
ID
26
Report Types
27
Reserved Field
28
Location of Ward
of Specimen
Collection
14
2 ASTM Interface
2.5 Data Record Usage
Description
Valid
Max
Required
Contents Length
29
Nosocomial
Infection Flag
30
Specimen Service
31
Specimen
Institution
2.5.4
Result Record
PLEASE NOTE, THAT THE RESULT RECORD CAN JUST BE SEND ONCE TO THE HOST
COMPUTER.
PLEASE NOTE, THAT THE DATA VALUE IN FIELD NO. 4 INCLUDES ONLY THE FINAL
CALCULATED RESULT, DEPENDING ON THE ASSAY PROGRAMMATION .
Field ASTM Field
No.
Description
Record Type ID
Character
R
identifying the
record as a
result record
Sequence Number
Test ID
Data or
Measurement
Value
Units
Reference Ranges
Result Abnormal
Flags
Nature of
Abnormality
Testing
Result Status
10
Date of Change in
Instrument
Normative Values
or Units
Valid
Contents
Max
Length
Required
Final
calculated
result,
depends
on value
Page 17
2 ASTM Interface
2.5 Data Record Usage
Description
Valid
Contents
Max
Length
Required
11
Operator
Identification
12
Date/Time Test
Started
13
Date/Time Test
Completed
14
Instrument ID
2.5.5
Comment Record
Comment Records are used either to describe reasons for rejected test orders
or to supply additional result information, e.g. result relevant flags.
2.5.6
Not applicable.
2.5.7
Description
Valid
Required Sent
Contents
Record Type ID
Character
identifying the
record as the last
record in the
message
2
3
Sequence Number
Termination Code
2.5.8
Scientific Record
2.5.9
Page 18
2 ASTM Interface
2.6 Referenced Documents
2.6
ASTM
Standards
Referenced Documents
Page 19
Introduction
The EVOLIS has the possibility to receive worklist files and transmit result
files from and to a network server. Both file formats (Import and Export) can be
defined within the EVOLIS software.
The import of worklist files can be performed manually by the user or
automatically with a polling sequence.
3.2
Hardware Configurations
The communication between the EVOLIS and the host system is established
using an Ethernet card.
In case that the EVOLIS computer should be connected to an other host
system, please install the necessary protocol or client and configure it
according to the specifications for this host.
FOR ALL TYPE OF SERVERS TAKE CARE OF FOLLOWING RESTRICTIONS:
THE FILE NAMES SHOULD NO BE LONGER THAN 20 CHARACTERS
DO NOT USE SPECIAL CHARACTERS IN THE FILE NAMES EXCEPT - AND _
CHARACTERS FOR FILE NAMES ALLOWED: NUMBERS FROM 0 TO 9 AND LETTERS
FROM A TO Z (SMALL AND BIG CAPITALS)
3.3
3.3.1
1. Choose File | Open at the main menu of the EVOLIS software and the
file open dialog will be shown.
Page 20
Page 21
PLEASE NOTE, THAT THE HEADER LABELS MUST CONSISTS OF THE SAME
RECORDS AS SHOWN IN THE 'AVAILABLE FIELDS' LIST!
7. Select the entry 'Use Header Row to determine Mappings' or create
the 'Select Fields' box, if the header from the file should not be used to
determine mappings. The 'Selected fields' must be created in the
order they appear in the file.
8. Select the separator character. As default comma is defined.
9. Click on the OK button.
ONCE A PATIENT IMPORT SETTING HAS BEEN CREATED, IT CAN BE SAVED (SAVE
SETTINGS) FOR RE-USE (OPEN SETTINGS) LATER.
Patient ID
Patient Name
Birthdate
YYYYMMDD
Sex
Test name
Collection
Date
YYYYMMDDHHMMSS
Page 22
3.3.2
Example 1
File:
Patient ID,Test name,Test name,Test name
AD001,CMV-IgG,HSV-IgG,RUB-IgG
AD002,CMV-IgG,HSV-IgG,RUB-IgG
BF056,CMV-IgG,HSV-IgG,RUB-IgG
RR008,CMV-IgG,HSV-IgG,RUB-IgG
RR015,CMV-IgG,HSV-IgG,RUB-IgG
Meaning:
First Line: Header Row (Separator ,)
Second Line: Data fields (Separator ,)
Table 3-2: File includes Patient ID and Test names
Page 23
Example 2
File:
Patient ID,Patient name,Test name,Test name,Test name,Test
name,Birthdate,Sex
AD001,Williams Mandy,CMV-IgG,HSV-IgG,RUB-IgG,,19710520,F
AD002,Graham Michael,CMV-IgG,HSV-IgG,RUB-IgG,TOX-IgG,19520815,M
BF056,Mulder Ken,CMV-IgG,HSV-IgG,RUB-IgG,TOX-IgG,19801208,M
RR008,Fox Judy,CMV-IgG,HSV-IgG,,,19750416,F
RR015,Black Bill,CMV-IgG,HSV-IgG,RUB-IgG,,19860904,M
Meaning:
First Line: Header Row (Separator ,)
Second Line: Data fields (Separator ,)
Table 3-3: File includes Patient ID, Test names and Details
IF A PATIENT DOES NOT HAVE ALL FIELDS WHICH ARE DEFINED IN THE HEADER
(E.G. PATIENT RR008 HAS JUST TWO TEST NAME), THE DATA FIELD MUST BE
EMPTY BUT SEPARATED VIA ,.
THIS MEANS:
NUMBER SEPARATORS HEADER FIELD = NUMBER SEPARATORS DATA FIELD
The Patient Editor (see Figure 3-4: Patient editor with the imported worklist)
represents the example file 2.
1. To show patient details select a Patient ID.
2. Click on the Edit button.
3.4
3.4.1
File Polling
The EVOLIS software allows the User to configure specific locations that the
software will poll looking for ASCII patient information files. When a valid file is
found, it is imported into the software, interpreted and the patient database
updated with the new patient details. The User determines the frequency the
software polls the specified directory.
Page 24
3.4.2
Setup Polling
THE SYSTEM TIME OF THE SERVER AND THE SYSTEM TIME OF THE EVOLIS
COMPUTER MUST BE SYNCHRONIZED!
IF THE SYSTEM TIME OF THE SERVER IS BEHIND THE SYSTEM TIME OF THE
EVOLIS COMPUTER AND THEY DEVIATE MORE THAN THE DEFINED POLLING TIME
THE WORKLIST FILES WILL NEVER BE IMPORTED !
Page 25
4 Export of files
4.1 Directory for Export Files
Export of files
4.1
4 Export of files
4.2 Assay Definition for Export
If a file should be exported and the target file is not available, the following
message appears:
4.2
Within every assay definition you will find in the sub-category Read a report
section, which can be customized to the customer needs.
1. To set up or open the settings, click on the Read Step.
2. Double click on Report Settings.
Page 27
4 Export of files
4.2 Assay Definition for Export
PLEASE NOTE, THAT THE DEFAULT SETTING ONLY INCLUDES THE ASSAY HEADER
AND READER RESULTS. THE EXPORT FILE FORMAT CAN BE INDIVIDUALLY
CUSTOMIZED FOR EACH TEST ACCORDING TO THE CUSTOMER NEEDS.
3. Select the Export tab.
Page 28
4 Export of files
4.2 Assay Definition for Export
Define the settings according to the customer needs from the available header
and data fields windows.
4.2.1
Fields:
Meaning:
Assay Header
Kinetic readings
Validation criteria
QC evaluation
Qualitative
Quantitative
Quantitative notes
Patient ID
Patient ID
Assay
Assay name
Well Location
e.g. A1
Layout Label
e.g. T1
Flag
Reader value
Reader mean
Reader SD
Reader CV
Reader SE
Reader units
Reader units
Qual. Value
Qual. Mean
Quant. 1 value
Quant. 1 mean
Quant. 1 SD
Quant. 1 CV
Quant. 1 SE
Quant. 1 units
Spread. Value
Spread. Mean
Spread. SD
Spread. CV
Spread. SE
Spred. Units
Page 29
4 Export of files
4.3 Examples of Export Files
Fields:
Meaning:
Quant. 2 value
Quant. 2 mean
Quant. 2 SD
Quant. 2 CV
Quant. 2 SE
Quant. 2 units
4.3
Example 1
File:
Meaning:
[HSV-IgG]
No header information
[Results]
Patient ID,Assay,Reader value,Qual. value
"","HSV-IgG","0.009","NC1"
"","HSV-IgG","0.011","NC2"
"","HSV-IgG","0.093","NC3"
"","HSV-IgG","1.455","PC1"
"","HSV-IgG","1.465","PC2
"AD001","HSV-IgG","0.004","neg"
"AD002","HSV-IgG","0.075","equ"
"BF056","HSV-IgG","0.011","neg"
"RR008","HSV-IgG","0.002","neg"
"RR015","HSV-IgG","0.987","pos"
Page 30
4 Export of files
4.3 Examples of Export Files
Example 2
File:
Meaning:
[HSV-IgG]
Time:;11:15:00
Date:;27/09/00
OVER limit:;3.000
Operator:;User
Wavelengths:;450nm/620nm
-0.01<=NCi<=0.50;-0.01<=0.010<=0.50
;-0.01<=0.009<=0.50
;-0.01<=0.011<=0.50
;-0.01<=0.093<=0.50;Removed
Valid(NC)>=2;2>=2
PCi>=0.550;1.460>=0.55
;1.455>=0.55
;1.465>=0.55
valid(PC)=2;2=2
Validation Criteria
Header Field
Page 31