H3+ User Manual Rev B1

Copyright © 2008 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. 2.09.

TECHNICAL SUPPORT AND SERVICE

Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. 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) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582 Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument Germany Kaninenberghöhe 50 45136 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Randweg 4 5683 CL Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Unit 11, 7 Inglewood Place Baulkham Hills NSW 2153 Australia Tel: +61 2 8824 5499 Fax: +61 2 8814 5399

24-Hour Technical Support Same-Day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

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NOTICES

Manufacturer’s 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 is used in accordance with the instructions for use. Responsibility of the Customer The user of this device 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.

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WARRANTY INFORMATION

Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s 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 Product/s caused by any or all of the following circumstances or conditions: a) Freight damage; b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara; c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides; d) Accident; a disaster affecting the Product/s; e) Alterations and/or modifications to the Product/s not authorized by Mortara; f) Other events outside of Mortara’s 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 PRODUCT/S 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. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s 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/s, 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 Product/s. 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/s 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.

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Warranty Information (Continued)

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S 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.

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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.

Warning(s) • Device stores data reflecting a patient’s physiological condition that 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 patient’s 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 through 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.

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User Safety Information (Continued)

Caution(s) • To prevent possible damage, do not use sharp or hard objects to depress the Enter 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; 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 electrodes, 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 modifications to any part of this device are to be performed by Mortara Instrument, Inc. service personnel only. Any unauthorized modifications of this device may alter defibrillation protection. • Environmental Conditions: Operating Temperature: Storage Temperature: Relative Humidity: Ambient Air Pressure:

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

User Safety Information (Continued)

Note(s) • Proper patient preparation prior to proper application of ECG electrodes and operation of the device is important. • 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 device is UL classified: Medical Equipment WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1, CAN/CSA C22.2 No. 601.1 AND IEC60601-2-47 5P35

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EQUIPMENT SYMBOLS Symbol Delineation

Attention, consult accompanying documents

Defibrillator-proof type CF input

Battery

Indicates compliance to applicable EEC directives

Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Electromagnetic compatibility with surrounding devices should be assessed when using the device. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device 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 device should not be used adjacent to or stacked on top of other equipment. If the device must be used adjacent to or stacked on top of other equipment, verify that the device 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 device.

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 device. 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

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Electromagnetic Compatibility (EMC) (Continued)

Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the device should ensure that it is used in such an environment.

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Emissions Test

Compliance

Electromagnetic Environment: Guidance

RF Emissions CISPR 11

Group 1

The device 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 device 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 Manufacturer’s Declaration: Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the device should ensure 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

Not Applicable

Not Applicable

Surge IEC 61000-4-5

Not Applicable

Not Applicable

Voltage dips, Not Applicable short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Not Applicable

Power frequency (50/60 Hz) magnetic field

3 A/m

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 AC Mains voltage prior to application of the test level.

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Electromagnetic Compatibility (EMC) (Continued)

Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the device should ensure that it is used in such an environment. Emissions Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

Recommended separation distance

80 MHz to 800 MHz 800 MHz to 2.5 GHz 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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

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Electromagnetic Compatibility (EMC) (Continued)

Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Device The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended in the table 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

1

1.2 m

2.3 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.

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Electromagnetic Compatibility (EMC) (Continued)

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TABLE OF CONTENTS

INTRODUCTION SECTION 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 labeling and Enter Button... 1-3 H3+ in Carrying Case with Neck Cord or Belt Clip... 1-3 Mortara Part Numbers... 1-4 Mortara Specifications... 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 Hookup... 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 Channels... 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 INFORMATION APPENDIX A Table of Messages... A-1 System Information Log... A-2 Serial Number and Part Number Location... A-2

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Table of Contents (Continued)

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INTRODUCTION SECTION 1

Manual Purpose The H3+™ digital Holter recorder user manual explains how to operate the H3+ digital 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 patient’s 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.

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SECTION 1

System Description The H3+ 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 hookup 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 hookup. The 2-channel, 5-wire patient cable records up to 48 hours of data and displays channel 1 and channel 2 during patient hookup. Either patient cable can be used with the H3+. 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+ 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.

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