REF 9515-165-50-ENG Rev A1

H3+
DIGITAL HOLTER RECORDER

USER MANUAL

Manufactured by Mortara Instrument, Inc. Milwaukee U.S.A.

CAUTION: Federal law restricts this device for sale to or on the order of a physician.

Copyright 2005
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc.
No part of this document may be transmitted, reproduced, used, or disclosed outside of the
receiving organization without the express written consent of Mortara Instrument, Inc.
Mortara is a registered trademark of Mortara Instrument, Inc. H3+ and H-Scribe are
trademarks of Mortara Instrument, Inc.

TECHNICAL SUPPORT AND SERVICE

Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel:
414.354.1600
Tel:
800.231.7437
Fax:
414.354.4760
Internet: http://www.mortara.com
Europe Economic
Community Representative
Mortara Rangoni Europe, Srl
(European Headquarters, Italy)
Via Oradour 7
40016 S. Giorgio di Piano, BO
Tel:
+39.051.6654311
Fax:
+39.051.6651012
Service/Technical
Support Group
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel:
414.354.1600
Service: 888.MORTARA
(888.667.8272)
Fax:
414.354.4760
E-mail: techsupport@mortara.com

Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel:
414.354.1600
Fax:
414.354.4760
E-mail: sales@mortara.com
Mortara Instrument GmbH
(Germany)
Kaninenberghhe 50
45136 Essen
Tel:
+49.201.268311
Fax:
+49.201.268313
Mortara Instrument B.V.
(The Netherlands)
H. Dunantplein 6
3731 CL De Bilt
Postbus 131
3720 AC Bilthoven
Tel:
+31.30.2205050
Fax:
+31.30.2201531

24 Hour Technical Support

Same Day Shipment of
Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts

NOTICES

Manufacturers Responsibility
Mortara Instrument, Inc., is responsible for the effects on safety and performance only if:
Assembly operations, extensions, readjustments, modifications or repairs are
carried out only by persons authorized by Mortara Instrument, Inc.
The device (H3+) is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this product is responsible for ensuring the implementation of a
satisfactory maintenance schedule. Failure to do so may cause undue failure and
possible health hazards.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by a serial and reference number on
the back of the device. Care should be taken so that these numbers are not defaced.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are
reserved. No part of this document may be photocopied, reproduced or translated
to another language without prior written consent of Mortara Instrument, Inc.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc. makes no warranty of any kind with regard to this material
including, but not limited to, implied warranties of merchantability and fitness for a
particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors
or omissions that may appear in this document. Mortara Instrument Inc. makes no
commitment to update or to keep current the information contained in this document.

ii

WARRANTY INFORMATION

Your Mortara Warranty

MORTARA INSTRUMENT, INC. (hereinafter referred to as Mortara) hereby
warrants that Mortara products (hereinafter referred to as Products) shall be free
from defects in material and workmanship under normal use, service and maintenance
for the warranty period of such Product from Mortara or an authorized distributor or
representative of Mortara. The warranty period is defined as twelve (12) months
following the date of shipment from Mortara. Normal use, service and maintenance
means operation and maintenance in accordance with appropriate instructions and/or
information guides. This Warranty does not apply to damage to the Products caused
by any or all of the following circumstances or conditions:
a) Freight damage;
b) Parts and/or accessories of the Products not obtained from or approved by Mortara;
c) Misapplication, misuse, abuse and failure to follow the Product instruction sheets
and/or information guides;
d) Accident, a disaster affecting the Products;
e) Alterations or modifications to the Products not authorized by Mortara;
f) Other events outside of Mortaras reasonable control or not arising under normal
operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR
REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY
PRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN
DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of
any alleged defects promptly after discovery thereof within the warranty period.
Mortaras obligations under the foregoing warranty will further be conditioned upon the
assumption by the purchaser of the Products (i) of all carrier charges with respect to any
Products returned to Mortaras principal place or any other place as specifically
designated by Mortara or an authorized distributor or representative of Mortara, and (ii)
all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and
that Mortara does not function as an insurer. A purchaser of a Product, by its acceptance
and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm
or damage due directly or indirectly to an occurrence or consequence therefrom relating
to the Products. If Mortara should be found liable to anyone under any theory (except
the expressed warranty set forth herein) for loss, harm or damage, the liability of Mortara
shall be limited to the lesser of the actual loss, harm or damage, or the original purchase
price of the Product when sold.
EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE
CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES,
PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS.

iii

Warranty Information (Continued)

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF

LABOR CHARGES, A PURCHASERS SOLE EXCLUSIVE REMEDY AGAINST
MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND
ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE
THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE
EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED
WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM
FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS,
DAMAGE OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS,
WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES
OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF
ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

iv

USER SAFETY INFORMATION

Warning

Means there is the possibility of personal injury to you or others.

Caution

Means there is the possibility of damage to the equipment.

Note

Provides information to further assist in the use of the device.

Federal law restricts this device for sale to or on the order

of a physician.

Warning
Device (H3+) stores data reflecting a patients physiological condition and can be
downloaded to a properly equipped analysis system. The data, when reviewed by a
trained physician or clinician, can be useful in determining a diagnosis. However,
the data should not be used as a sole means for determining a patients diagnosis.
To maintain designed operator and patient safety, peripheral equipment and
accessories that can come in direct patient contact must be in compliance with UL
2601-1, IEC 601-1 and IEC 601-2-47.
To maintain designed operator and patient safety, only use parts and accessories
supplied with the device and available thorough Mortara Instrument, Inc.
To avoid the possibility of serious injury or death, do not come in contact with the
device or patient cable during patient defibrillation. Additionally, proper placement
of defibrillator paddles in relation to the electrodes is required to minimize harm to
the patient.
A possible explosion hazard does exist; therefore do not use the device in the
presence of flammable anesthetics.
Defibrillation protection is guaranteed only if a Mortara Instrument, Inc. Patient
Cable is used.
Simultaneous connection to other equipment may increase leakage current.
ECG electrodes could cause skin irritation and should be examined daily. It may
be necessary to replace electrodes if signs of irritation or inflammation occur.
Before attempting to use the device for clinical applications, the operator must read
and understand the contents of the User Manual and any documents accompanying
the device.

User Safety Information (Continued)

Caution
To prevent possible damage to the Enter button, do not use sharp or hard objects
to depress the button; use fingertips only.
Do not attempt to clean the device or patient cable by submerging into a liquid,
autoclaving or steam cleaning.
Wipe the exterior surface of the device and patient cable with a non-alcohol
sterilizing disinfectant; then dry with a clean cloth.
Conductive parts of the patient cable, electrodes and associated Type CF connections,
including the neutral conductor of the patient cable and electrode, should not come
into contact with other conductive parts, including earth ground.
The device and patient cable should be cleaned after each use.
Do not pull or stretch patient cables since this could result in mechanical and/or
electrical failures. Patient cables should be stored after forming them into a
loose loop.
No user serviceable parts are inside. Any modification to any part of this device is to
be performed by Mortara Instrument, Inc. service personnel only. Any unauthorized
modification of this device may alter defibrillation protection.
Environmental Conditions:
Operating Temperature:
Storage Temperature:
Relative Humidity:
Ambient Air Pressure:

vi

-0 to +45 C
-20 to +65 C
5 to 95%, non-condensing
700 to 1060 millibars

User Safety Information (Continued)

Note
Proper patient preparation is important prior to proper application of ECG electrodes
and operation of the device.
Patient cables should be checked for cracks or breakage prior to use.
Complete lead fail will cause a greater draw on battery power which may cause the
recording period to end early due to low battery voltage.
As defined by IEC 60601-1 and IEC 60601-2-47, this device is classified as follows:
- Internally powered
- Type CF defibrillator proof applied parts
- Ordinary equipment
- Not suitable for use in the presence of flammable anesthetics
- Continuous operation
The device conforms to the following standards:
IEC 601-1
General Requirements for Safety
IEC 601-2-47
Particular Requirements for Safety,
including Essential Performance
IEC 601-1-2
Electromagnetic Compatibility
ANSI/AAMI EC38
Ambulatory Electrocardiographs
93/42/EEC
Medical Device Directive
The H3+ is a UL classified device:
Medical Equipment
WITH RESPECT TO ELECTRIC SHOCK,FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL2601-1, IEC60601-1, CAN/CSA C22.2 No. 601.1
AND IEC60601-2-47
5P35

vii

EQUIPMENT SYMBOLS
Symbol Delineation

Attention, consult accompanying documents

Defibrillator-proof type CF input

Battery

Indicates compliance to applicable EEC directives

viii

ELECTROMAGNETIC COMPATIBILITY (EMC)

Electromagnetic compatibility with surrounding devices should be assessed when

using the H3+.
An electronic device can either generate or receive electromagnetic interference.
Testing for electromagnetic compatibility (EMC) has been performed on the H3+
according to the international standard for EMC for medical devices (IEC 60601-1-2).
This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The H3+ should not be used adjacent to, or stacked on top of other equipment. If
the H3+ Recorder must be used adjacent to or stacked on top of other equipment,
verify that the H3+ Recorder operates in an acceptable manner in the configuration
in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect
the performance of medical equipment. See Table X-4 for recommended separation
distances between the radio equipment and the H3+ Recorder.

Accessories and Cables Warning

The use of accessories and cables other than those specified below, may result in
increased emissions or decreased immunity of the H3+.
Description

Reference Number

3-Channel Patient Cable AHA

9293-036-50

3-Channel Patient Cable IEC

9293-036-51

2-Channel Patient Cable

9293-037-50

H3+ USB Cable

25019-006-50

ix

Electromagnetic Compatibility (EMC) (Continued)

Table X-1 Guidance and Manufacturers Declaration: Electromagnetic Emissions

The H3+ is intended for use in the electromagnetic environment specified in the
table below. The customer or the user of the H3+ should assure that it is used in
such an environment.

Emissions Test

Compliance

Electromagnetic Environment: Guidance

RF Emissions
CISPR 11

Group 1

The H3+ uses RF energy only for its internal

function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.

RF Emissions
CISPR 11

Class B

Harmonic
Emissions
IEC 61000-3-2

Not Applicable

The H3+ is suitable for use in all establishments,

including domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Not Applicable

Electromagnetic Compatibility (EMC) (Continued)

Table X-2 Guidance and Manufacturers Declaration: Electromagnetic Immunity

The H3+ is intended for use in the electromagnetic environment specified in the
table below. The customer or the user of the H3+ should assure that it is used in
such an environment.
Emissions Test

Compliance

Compliance
Level

Electromagnetic Environment:
Guidance

Electrostatic
Discharge (ESD)
IEC 61000-4-2

+/- 6 kV contact
+/- 8 kV air

+/- 6 kV contact
+/- 8 kV air

Floors should be wood,

concrete, or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.

Electrical Fast
transient/burst
IEC 61000-4-4

+/- 2 kV for
Not Applicable
power supply line
+/- 1 kV for
input/output lines

Surge
IEC 61000-4-5

+/- 1 kV
differential mode
+/- 2 kV
common mode

Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11

<5% UT
Not Applicable
(>95% dip in UT)
for 5 cycles
40% UT
(60% dip in UT)
for 0.5 cycle

Power frequency
(50./60 Hz)
magnetic field

3 A/m

Not Applicable

3 A/m

Power frequency magnetic

fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the

test level.

xi

Electromagnetic Compatibility (EMC) (Continued)

Table X-3
Guidance and Manufacturers Declaration: Electromagnetic Immunity
The H3+ is intended for use in the electromagnetic environment specified below. The
customer or the user of the H3+ should assure that it is used in such an environment.
Emissions
Test

IEC 60601
Text Level

Compliance
Level

Electromagnetic Environment:
Guidance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to
80 MHz

3 Vrms
150 kHz to
80 MHz

Portable and mobile RF communications

equipment should be used no closer to
any part of the H3+, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance

Radiated RF
IEC 61000-4-3

3 Vrms
80 MHz to
2.5 GHz

3 Vrms
80 MHz to
2.5 GHz

80 MHz to 800 MHz

80 MHz to 2.5 MHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following symbol:

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the H3+ is used exceeds the applicable RF compliance level above, the H3+ should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the H3+.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

xii

Electromagnetic Compatibility (EMC) (Continued)

Table X-4
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the H3+.
The H3+ is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the H3+ can help to prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the H3+ as recommended
below, according to the maximum output power of the communications equipment.
Rated Maximum Output
Power of Transmitter W

Separation Distance According to

Frequency of Transmitter (m)
150 KHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.1 m

0.2 m

0.1

0.4 m

0.7 m
2.3 m

1.2 m

10

4.0 m

7.0 m

100

12.0 m

23.0 m

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by the absorption and
reflection from structures, objects, and people.

xiii

Electromagnetic Compatibility (EMC) (Continued)

ivx

TABLE OF CONTENTS

INTRODUCTION SECTION 1
H3+ Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Audience and Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
H3+ with Patient Cable and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Front View with LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Bottom View with Enter Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
H3+ in Carrying Case with Neck Cord or Belt Clip . . . . . . . . . . . . . . . . . . . . 1-3
Mortara Part Numbers/ H3+ Digital Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Mortara Specifications/ H3+ Digital Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

OPERATION SECTION 2
Entering Patient ID and Setting the Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Opening and Closing the Battery Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Attaching the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Patient Hook-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Skin Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Positioning the Electrodes for a 3-Channel Patient Cable . . . . . . . . . . . . . . . . . . . . . 2-3
Positioning the Electrodes for a 2-Channel Patient Cable . . . . . . . . . . . . . . . . . . . . . 2-4
Inserting the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Using the Enter Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Displaying ECG Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Starting a Recording Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Entering (Optional) Diary Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Ending a Recording Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

MAINTENANCE SECTION 3
Cleaning the H3+ and Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Disposal of Waste Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

MESSAGES AND TROUBLESHOOTING APPENDIX A

Table of Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
System Information Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Serial Number and Part Number Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

xv

Table of Contents (Continued)

xvi

INTRODUCTION
SECTION 1

H3+ Overview
Manual Purpose
The H3+ User Manual explains how to operate the H3+ Digital Holter Recorder.
It shows the user how to
Start and end a patient recording
Prepare device configurations
Audience and indications for use
This manual is written for clinical professionals who are expected to have a working
knowledge of medical procedures and terminology as required for monitoring
cardiac patients.
The H3+ is indicated for use in a clinical setting, by qualified medical professionals
only, for recording ECG data of patients requiring ambulatory (Holter) monitoring
of up to 48 hours. Such monitoring is most frequently used for the purpose of
prospective and retrospective cardiac data and arrhythmia analysis. Holter analysis
is appropriate for the indications below:
Evaluation of adult patients with symptoms suggesting arrhythmia.
Evaluation of adult patients with pacemakers
Reporting of time domain heart rate variability
Evaluation of a patients response after resuming occupational or
recreational activities (e.g., after M.I or cardiac surgery)
Evaluation of ECG documenting therapeutic interventions in individual
patients or groups of patients
Clinical and epidemiological research studies
Infant patient evaluation is limited to QRS detection only
Conventions
Keys, such as Enter, appear in bold Arial font.
Text on the LCD screen of the H3+ appears in regular Arial font.

1-1

SECTION 1

System Description
The H3+ Digital Recorder provides two or three channels of continuous ECG data
recorded over a 24-hour or 48-hour period. An LCD screen and Enter button allow
for checking the lead quality during patient hook-up and starting the recording.
The 3-Channel 5-wire patient cable records 24 hours of data and displays ECG leads
I, II and V during patient hook-up. The 2-Channel 5-wire patient cable records ECG
for up to 48 hours and displays Channel 1 and Channel 2 during patient hook-up.
Either patient cable can be used with the H3+ digital recorder.
During recording, the LCD will display R and the time of day as HH:MM:SS indicating
that the H3+ is in the recording mode. The Enter button can be used to enter event
markers in the patient record.
The H3+ Digital Recorder uses a single AAA alkaline battery and stores acquired
ECG data in internal memory. The recorded data will remain in memory until it has
been cleared by the clinician.
Stored ECG data will be downloaded for analysis to the H-Scribe Holter Analysis
System with a USB interface cable after the H3+ has been disconnected from the
patient cable. After the data is downloaded, the memory can then be cleared and
the H3+ is ready for use on the next patient.

1-2

SECTION 1

H3+ with Patient Cable and Accessories

Front View with LCD Display

Patient Cable

Bottom View with Labeling and Enter Button

Milwaukee, WI

5P35

USA

Medical Equipment

UL60601-1,IEC60601-1,
CAN/CSA C22.2 No. 601.1,
IEC60601-2-47

Model:
H3+

H3+ in Carrying Case with Neck Cord or Belt Clip

With adjustable neck cord attachment and patient cable

Neck cord attaches to a

detachable retention clip

Carrying Case (back) with Belt Clip

1-3

SECTION 1

Mortara Part Numbers/ H3+ Digital Recorder

H3+ Digital Recorder
Description

Part Numbers

H3+ Holter Recorder

H3PLUS-XXX-XXXXX

H3+ USB Cable

25019-006-50

H3+ Battery Door

8348-003-50

H3+ Carrying Case

8485-022-50

3-Channel H3+ Patient Cable / AHA

9293-036-50

3-Channel H3+ Patient Cable / IEC

9293-036-51

2-Channel H3+ Patient Cable / Universal

9293-037-50

H3+ User Manual English

9515-165-50-ENG

H3+ 2-CH Short Form Instruction Card - English

9503-165-01-ENG

H3+ 3-CH Short Form Instruction Card - English

9503-165-02-ENG

Patient Diaries Box of 100

5004-008-51

H3+ Hook up Kits, Case of 24

9424-012-51

To order additional supplies, contact a Mortara Instrument customer service

representative at:
Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, WI 53224
Phone: 1-888-MORTARA (667-8272)
Fax: (414) 354-4760
Internet: http://www.mortara.com

1-4

SECTION 1

Mortara Specifications/ H3+ Digital Recorder

H3+ Digital Recorder
Feature

Specifications

Instrument Type

Digital Holter Recorder

Input Channels

Simultaneous acquisition of two or

three channels

Leads Acquired

Modified I, II and V or
Bipolar Channel 1 and Channel 2

Input Impedance
Input Dynamic
Electrode Offset Tolerance
Frequency Response

Meet or exceed the requirements of

ANSI/AAMI EC38

Digital Sampling Rate

180 s/sec/channel used for standard

recording and storage.

Special Functions

Pacemaker Detection, ECG Display

during hookup

A/D Conversion

12-bit

Storage

Internal, non-volatile memory

Device Classification

Type CF defibrillator proof applied

parts, internally powered

Weight

1 Ounce (28 g) without battery

Dimensions

2.5 x 1.0 x .75 inches

(64 x 25 x 19 mm)

Battery

1 AAA Alkaline Required for up

to 48 Hours

1-5

SECTION 1

1-6

OPERATION
SECTION 2

Entering Patient ID and Setting the Date/Time

The H-Scribe System is used to enter the patient ID. The H3+ USB cable is connected
to the H-Scribe Holter Analysis System and the H3+ for loading this information from
the H-Scribe System to the H3+ digital recorder. The Patient ID information is moved
to the H3+ by selections made at the H-Scribe System. Refer to the H-Scribe User
Manual for instruction.
The H-Scribe System is used to set the current date and time. The Date/Time settings
are typically set before initiation of the patient recording on the H3+ and do not need
to be set on a per patient basis. Refer to the H-Scribe User Manual for instruction.

Opening and Closing the Battery Door

The battery compartment is accessible via the battery door of the H3+ Recorder.
To open the battery door, depress and slide the battery door until it is free. Lift and
remove the battery door.

To close the battery door, place the battery door on the H3+ as shown below and slide the
door in the opposite direction until the door snaps into place.

2-1

SECTION 2

Attaching the Patient Cable

The H3+ Patient Cable consists of a connector block, main cable and five leadwires
connected to the main cable. Each leadwire terminates in a snap connector.
Insert the connector block into the input connector on the side of the H3+.

Input Connector

NOTE: Be careful to insert the connector block parallel to the

input connector of the H3+.

Patient Hook-Up
Skin Preparation
Skin preparation is important to perform before electrode attachment to help insure
good signal quality when recording patient data. Poor skin to electrode contact may
cause noise or artifact to be included in the recording which can affect the analysis
of the ECG data. Low amplitude signals may also be the result of poor skin to
electrode contact.
To prepare the skin
1. Identify the (5) electrode sites on the torso by referring to the next section on
Positioning the Electrodes.
2. Remove any hair from the electrode sites using a razor.
3. Wipe oils from the electrode sites with an alcohol prep pad and wipe the skin dry
with gauze.
4. Remove any dead skin from the electrode sites with an abrasive cleaner. Two to
three moderate rubs at each site is sufficient.
When the electrode sites have been identified and prepped, apply an electrode to
each of the (5) sites. Secure each electrode by exerting slight pressure around the
outer edge and inner ring of the electrode.
Attach lead wires to the electrodes. Excess lead wire length may be formed into
stress loops and secured with tape to prevent any pulling on the electrodes.

2-2

SECTION 2

Positioning the Electrodes for a 3-Channel Patient Cable

3-Channel Electrode Placement Bipolar Bipolar - Unipolar

AAMI

IEC

RA
LA
RL

R
L
N

LL
V

F
C

Right clavicle as shown

Left clavicle as shown
Reference or ground lead, should be placed to maximize
patient comfort
Lower left side of the rib cage or body as shown
Precordial exploring lead

IEC
R = Red
L = Yellow
N = Black
F = Green
C = White
R and L = Channel 1 is Bipolar lead I
R and F = Channel 2 is Bipolar lead II
C and R/L/F = Channel 3 is a
Unipolar Chest Lead

AAMI
RA = White
LA = Black
RL = Green
LL = Red
V = Brown
RA and LA = Channel 1 is Bipolar lead I
RA and LL = Channel 2 is Bipolar lead II
V and RA/LA/LL = Channel 3 is a
Unipolar Chest Lead

2-3

SECTION 2

Positioning the Electrodes for a 2-Channel Patient Cable

2-Channel Bipolar Bipolar Electrode Placement

1-

2-

Reference
2+
1+

Lead Colors
1 - = White
2 - = Black
Reference = Green
1+ = Red
2+ = Brown
1+ to 1 - = Channel 1
2+ to 2 - = Channel 2

11+
22+
Reference

Channel 1 negative lead

Channel 1 positive lead
Channel 2 negative lead
Channel 2 positive lead
Reference electrode

1+ is referenced to 1- resulting in Bipolar Channel 1.

2+ is referenced to 2- resulting in Bipolar Channel 2.
Electrodes can be positioned according to clinician preference.

2-4

SECTION 2

Inserting the Battery

The H3+ Recorder is powered with a single AAA alkaline battery.
To insert a new battery into the battery compartment, remove the battery door of the
H3+. If a battery has been left in the compartment, remove and discard the battery.
Insert a new battery with the + end aligned as indicated inside the battery compartment.

NOTE: The H3+ recorder requires a fully-charged battery to

record a 24-hour or 48-hour session. Always use a new battery
to insure operation
A new battery is required if the Low Battery indicator appears as shown below.

Close the battery door of the recorder.

Upon insertion of the battery, the LCD will display:

SOFTWARE VERSION (e.g. V 1.0)
Once the patient cable is connected the H3+ recorder channel mode will display:
2-CH (2-Channel patient cable) OR
3-CH (3-Channel patient cable)

2-5

SECTION 2

Using the Event Button

The Enter button is located on the bottom-side of the H3+ Recorder. One button is
available for navigating through the LCD screens, for starting the recording and for
selecting event markers during the recording.

Milwaukee, WI

5P35

USA

Medical Equipment

UL60601-1,IEC60601-1,
CAN/CSA C22.2 No. 601.1,
IEC60601-2-47

Model:
H3+

The Enter button is used to move to the next menu item.

CURRENT TIME (HH:MM:SS)

ID CONFIRMATION

NOTE: If an ID was not entered via H-Scribe, this display will be

shown as ID: only
With each single Enter button push, the H3+ set time and ECG waveform display
for each channel will cycle in the following order:
With a 3-Channel Cable:
I -> II -> V -> Time -> I -> II -> V -> Time -> I -> II -> V ->
With a 2-Channel Cable:
CH1 -> CH2 -> Time -> CH1 -> CH2 -> Time -> CH1 ->
NOTE: If the Time and/or the ID are not set properly, refer to the
H-Scribe User Manual for instructions on using the USB cable to
set Time/ Date and ID. After this is done, remove the battery and
begin again.

2-6

SECTION 2

Displaying ECG Channels

This function is used to visually inspect all
ECG channels before starting a recording to
ensure good signal quality. New electrode
sites may be prepped and leads repositioned
at this time if necessary.
After the first channel is displayed on the
LCD, use the Enter button to move to the
next Channel I, II, and V or CH1 and CH2.
If any lead is in fail, the LCD will show the lead label(s) in the lower right area of
the LCD as one or a combination of RALALLV or +1- +2-.
NOTE: The waveform is shown at 4 mm/mV gain to allow full
representation of the ECG in the LCD dsplay.

Starting a Recording Session

1. If necessary, clear the memory using the H3+ USB cable with H-Scribe software.
2. Perform patient skin preparation and hook up.
3. Attach the patient cable to the H3+.
4. Remove the battery door of the H3+.
5. Insert a new AAA battery in the battery compartment.
6. Verify that the correct Time and ID have been entered.
7. Verify the amplitude and signal quality by displaying each of the leads or channels
using the Enter button to cycle through the menu.
8. To begin recording, press and hold the Enter button for a period of 3 seconds. The
following information will be displayed in the LCD indicating that H3+ is in the
recording mode.
During H3+ normal operation, R and the current
time (HH:MM:SS) are displayed in the middle of the
LCD continuously for the entire recording session.
If during recording the battery is removed, the
H3+ will stop recording and the LCD will be
blank. The recorded data must be downloaded or
cleared at the H-Scribe to begin recording again.
In the event of a lead fail condition occurring
during recording, a lead fail indicator is displayed
to the right of the Time.

2-7

SECTION 2

Entering (Optional) Diary Events

During the recording session, the patient may be
instructed to mark a period in time on the H3+ for
analysis purposes. Once entered, the patient may
be instructed to document the Time and Symptom
in the Patient Diary.
To enter an event after the first minute of recording, press the Enter button on the
H3+. An indication message is displayed at the right of the current time until a
new one can be entered.
NOTE: In the event of a simultaneous lead fail, the indicator
replaces the lead fail indicator. If lead fail persists, the lead fail
indicator is displayed again after the Event period.

Ending a Recording Session

At the end of the recording session, the time is
cleared from the LCD screen and the ID is
displayed in reversed color to indicate the recording
period has ended and that the H3+ memory is full.
To proceed:
1. Remove the battery door of the H3+.
2. Remove the battery and dispose of the battery properly.
3. Replace the battery door.
4. Remove the patient cable from the recorder.
The H3+ data can then be acquired at the H-Scribe Holter Analysis System through
connection of the H3+ USB Cable. Once the data is acquired, the memory will be
cleared by the user and the H3+ is ready to connect to a patient for the next
recording session.

2-8

MAINTENANCE
SECTION 3

Cleaning the H3+ and Patient Cable

Clean the exterior surfaces of the H3+ and the patient cable with a damp cloth. Dry the
equipment completely before use.
WARNING: The H3+ is not water-proof. Prevent liquid
from penetrating, and avoid submerging the H3+ in any liquid.
Sterilization is not allowed.

Periodic Maintenance
Check the H3+ and patient cable everyday to be sure they are not damaged or broken.

Disposal of Waste Materials

The H3+ needs one alkaline battery and disposable monitoring electrodes.
Their disposal must be in accordance with the following procedures:
Battery: applicable disposal or recycling standards
Electrodes: normal waste

3-1

Maintenance (Continued)

3-2

APPENDIX A MESSAGES AND INFORMATION

APPENDIX A

The following table describes error and lead fail messages and symbols that are displayed
on the H3+ Digital Holter Recorder LCD during power up, patient hook-up, recording
and during connection to the H-Scribe.

Table of Messages
Message

Description/Solution
Replace existing battery with a fully charged battery.

ID:XXXXXXXXXXX
XXXXXXXXXXXXXX

Displayed prior to start of recording to confirm the ID

has been entered. If the field after the ID: is blank, no
ID has been loaded from H-Scribe to the H3+.

R
USB
RA
LA
LL
V
A combination of
RA//V
+1+2A combination of
1+/2-

When in reverse color (white on dark background)

indicates that the memory is full after a recording period.
A new recording cannot begin until the memory is
cleared at the H-Scribe system.
Lead fail indication during recording. Check that all
leadwires and electrodes are connected. Check that the
patient cable is connected to the recorder.
Recording indication
Event marker indication
Indicates that the H3+ USB download cable is
connected to the H3+
RA in fail during hook-up. Check if the lead wire is off
or the electrode needs to be replaced.
LA in fail during hook-up. Check if the lead wire is off
or the electrode needs to be replaced.
LL in fail during hook-up. Check if the lead wire is off
or the electrode needs to be replaced.
V in fail during hook-up. Check if the lead wire is off
or the electrode needs to be replaced.
More than one lead in fail or all leads in fail during
hook-up. Check the lead wires and electrodes.
Channel 1 in fail during hook-up. Check if the lead
wire is off or the electrode needs to be replaced.
Channel 2 in fail during hook-up. Check if the lead
wire is off or the electrode needs to be replaced.
More than one lead in fail or all leads in fail during
hook-up. Check the lead wires and electrodes.

A-1

APPENDIX A

The following system information log is provided for your convenience. You need
this information if the H3+ needs servicing. Be sure to update the information log
when your device has been serviced.
Record the model and serial number of all components, dates of removal, and/or
replacement of components, and the name of the vendor from whom the component
was purchased and/or installed.
In addition to having records of this information, the system information provides a
warranty record of when your device was placed in service.

System Information Log

Manufacturer:

Telephone Numbers:

Mortara Instrument, Inc.

7865 N. 86th St.
Milwaukee, WI 53224

Domestic: 800-231-7437
European: +39-51-6650-701
Sales Department: 800-231-7437
Service Department: 888-MORTARA

Product Information:
Name of Unit/Product: ___________________
Date of Purchase: ___/___/_____
Purchased Unit From: ___________________
Serial Number: __________________________
Software Version: ________________________

Serial Number and Part Number Location

For questions and service information, when calling have the serial number and part
number available.
The Serial Number and Part Number (REF) are found under the battery, in the
battery compartment of the unit similar to the one pictured below.

Serial Number (SN) and Part Number (REF) Location

A-2

EC Declaration of Conformity
(Directive 93/42/EEC)
We,
Manufacturers Name:

Mortara Instrument, Inc.

Manufacturers Address:

7865 North 86th Street

Milwaukee, WI 53224
USA

declare under our sole responsibility, that to the best

of our knowledge, the product(s):
Product Name:

H3+

Catalogue Number:

H3+AXX-XXXXX
(X designates alpha characters denoting system
configuration management codes important for postdistribution servicing)

Serial Number(s):

105100001165 and subsequent

Product Options (Configurations):

Domestic, International

Class:

Domestic, International

are in conformity with the dispositions of the directive

which are applicable to them.
This declaration is based on following elements:
Directive 93/42/EEC concerning medical devices:
Class:

IIa
technical file (ref.H3+, ANNEX VII) to
demonstrate the conformity of the product,
including all applicable options, to the essential
requirements (ANNEX I),
the EC Certificate ANNEX II N0178/B2P3/1 for
approval of the quality system,
the ISO 13485 Certificate N 0178/13485/3 for
approval of the quality system.

Notified Body:

LNE/G-MED (N 0459)
33 Avenue du Gnral Leclerc, BP8,
92260 Fontenay-aux-Roses - France

Identification of Individual Signing/Location:

Mortara Instrument, Inc.

Manager of Quality Assurance
and Regulatory Affairs

Harlan L. Van Matre

Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
USA
Date:

M0238.061 Rev. 1

01-April-05