H3+DIGITAL HOLTER RECORDER
REF 9515-165-50-ENG Rev A1
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.
USER MANUAL
Copyright 2005by Mortara Instrument, Inc.
7865 N. 86th StreetMilwaukee, 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 thereceiving organization without the express written consent of Mortara Instrument, Inc.Mortara is a registered trademark of Mortara Instrument, Inc. H3+ and H-Scribe aretrademarks of Mortara Instrument, Inc.
TECHNICAL SUPPORT AND SERVICE
Headquarters
Mortara Instrument, Inc.7865 North 86th StreetMilwaukee, WI 53224Tel: 414.354.1600Tel: 800.231.7437Fax: 414.354.4760Internet: http://www.mortara.com
Europe Economic Community Representative
Mortara Rangoni Europe, Srl(European Headquarters, Italy)Via Oradour 740016 S. Giorgio di Piano, BOTel: +39.051.6654311Fax: +39.051.6651012
Service/Technical Support Group
Mortara Instrument, Inc.7865 North 86th StreetMilwaukee, WI 53224Tel: 414.354.1600Service: 888.MORTARA
(888.667.8272)Fax: 414.354.4760E-mail: [email protected]
24 Hour Technical SupportSame Day Shipment ofReplacement PartsBiomedical Training ClassesExtended Warranties/Service Contracts
Sales Support/Supplies & Accessories
Mortara Instrument, Inc.7865 North 86th StreetMilwaukee, WI 53224Tel: 414.354.1600Fax: 414.354.4760E-mail: [email protected]
Mortara Instrument GmbH(Germany)Kaninenberghhe 5045136 EssenTel: +49.201.268311Fax: +49.201.268313
Mortara Instrument B.V.(The Netherlands)H. Dunantplein 63731 CL De Bilt Postbus 1313720 AC BilthovenTel: +31.30.2205050Fax: +31.30.2201531
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NOTICES
Manufacturers Responsibility
Mortara Instrument, Inc., is responsible for the effects on safety and performance only if:
Assembly operations, extensions, readjustments, modifications or repairs arecarried 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 asatisfactory maintenance schedule. Failure to do so may cause undue failure andpossible health hazards.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by a serial and reference number onthe 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 arereserved. No part of this document may be photocopied, reproduced or translatedto 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 materialincluding, but not limited to, implied warranties of merchantability and fitness for aparticular purpose. Mortara Instrument, Inc. assumes no responsibility for any errorsor omissions that may appear in this document. Mortara Instrument Inc. makes nocommitment to update or to keep current the information contained in this document.
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WARRANTY INFORMATION
Your Mortara WarrantyMORTARA INSTRUMENT, INC. (hereinafter referred to as Mortara) herebywarrants that Mortara products (hereinafter referred to as Products) shall be freefrom defects in material and workmanship under normal use, service and maintenancefor the warranty period of such Product from Mortara or an authorized distributor orrepresentative of Mortara. The warranty period is defined as twelve (12) monthsfollowing the date of shipment from Mortara. Normal use, service and maintenancemeans operation and maintenance in accordance with appropriate instructions and/orinformation guides. This Warranty does not apply to damage to the Products causedby 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 sheetsand/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 normaloperating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR ORREPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANYPRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEENDEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara ofany alleged defects promptly after discovery thereof within the warranty period.Mortaras obligations under the foregoing warranty will further be conditioned upon theassumption by the purchaser of the Products (i) of all carrier charges with respect to anyProducts returned to Mortaras principal place or any other place as specificallydesignated 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 andthat Mortara does not function as an insurer. A purchaser of a Product, by its acceptanceand purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harmor damage due directly or indirectly to an occurrence or consequence therefrom relatingto the Products. If Mortara should be found liable to anyone under any theory (exceptthe expressed warranty set forth herein) for loss, harm or damage, the liability of Mortarashall be limited to the lesser of the actual loss, harm or damage, or the original purchaseprice of the Product when sold.
EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARECONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES,PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS.
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EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OFLABOR CHARGES,A PURCHASERS SOLE EXCLUSIVE REMEDY AGAINSTMORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY ANDALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BETHE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THEEXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIEDWITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIMFOR 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 THEORIESOF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OFANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOTLIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THEWARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
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Warranty Information (Continued)
USER SAFETY INFORMATION
Means there is the possibility of personal injury to you or others.
Means there is the possibility of damage to the equipment.
Provides information to further assist in the use of the device.
Federal law restricts this device for sale to or on the orderof a physician.
Device (H3+) stores data reflecting a patients physiological condition and can bedownloaded to a properly equipped analysis system. The data, when reviewed by atrained 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 andaccessories that can come in direct patient contact must be in compliance with UL2601-1, IEC 601-1 and IEC 601-2-47.
To maintain designed operator and patient safety, only use parts and accessoriessupplied with the device and available thorough Mortara Instrument, Inc.
To avoid the possibility of serious injury or death, do not come in contact with thedevice or patient cable during patient defibrillation. Additionally, proper placementof defibrillator paddles in relation to the electrodes is required to minimize harm tothe patient.
A possible explosion hazard does exist; therefore do not use the device in thepresence of flammable anesthetics.
Defibrillation protection is guaranteed only if a Mortara Instrument, Inc. PatientCable is used.
Simultaneous connection to other equipment may increase leakage current.
ECG electrodes could cause skin irritation and should be examined daily. It maybe necessary to replace electrodes if signs of irritation or inflammation occur.
Before attempting to use the device for clinical applications, the operator must readand understand the contents of the User Manual and any documents accompanyingthe device.
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Warning
Warning
Caution
Note
To prevent possible damage to the Enter button, do not use sharp or hard objectsto 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-alcoholsterilizing 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 comeinto 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/orelectrical failures. Patient cables should be stored after forming them into aloose loop.
No user serviceable parts are inside. Any modification to any part of this device is tobe performed by Mortara Instrument, Inc. service personnel only. Any unauthorizedmodification of this device may alter defibrillation protection.
Environmental Conditions:Operating Temperature: -0 to +45 CStorage Temperature: -20 to +65 CRelative Humidity: 5 to 95%, non-condensingAmbient Air Pressure: 700 to 1060 millibars
User Safety Information (Continued)
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Caution
User Safety Information (Continued)
Proper patient preparation is important prior to proper application of ECG electrodesand 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 therecording 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 SafetyIEC 601-2-47 Particular Requirements for Safety,
including Essential PerformanceIEC 601-1-2 Electromagnetic CompatibilityANSI/AAMI EC38 Ambulatory Electrocardiographs93/42/EEC Medical Device Directive
The H3+ is a UL classified device:
Medical EquipmentWITH 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
vii
Note
5P35
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 whenusing 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. Ifthe 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 configurationin which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affectthe performance of medical equipment. See Table X-4 for recommended separationdistances between the radio equipment and the H3+ Recorder.
Accessories and Cables WarningThe use of accessories and cables other than those specified below, may result inincreased emissions or decreased immunity of the H3+.
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Description Reference Number3-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
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 thetable below. The customer or the user of the H3+ should assure that it is used insuch an environment.
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Emissions Test Compliance Electromagnetic Environment: Guidance
RF Emissions Group 1 The H3+ uses RF energy only for its internalCISPR 11 function. Therefore, its RF emissions are very low
and are not likely to cause any interference innearby electronic equipment.
RF Emissions Class B The H3+ is suitable for use in all establishments, CISPR 11 including domestic establishments and those
directly connected to the public low-voltage Harmonic Not Applicable power supply network that supplies buildings Emissions used for domestic purposes.IEC 61000-3-2
Voltage fluctuations/ Not Applicableflicker emissionsIEC 61000-3-3
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 thetable below. The customer or the user of the H3+ should assure that it is used insuch an environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Emissions Test Compliance Compliance Electromagnetic Environment: Level Guidance
Electrostatic +/- 6 kV contact +/- 6 kV contact Floors should be wood, Discharge (ESD) +/- 8 kV air +/- 8 kV air concrete, or ceramic tile. If floors IEC 61000-4-2 are covered with synthetic
material, the relative humidityshould be at least 30%.
Electrical Fast +/- 2 kV for Not Applicabletransient/burst power supply lineIEC 61000-4-4 +/- 1 kV for
input/output lines
Surge +/- 1 kV Not ApplicableIEC 61000-4-5 differential mode
+/- 2 kV common mode
Voltage dips, 95% dip in UT)and voltage for 5 cyclesvariations on 40% UTpower supply (60% dip in UT)input lines for 0.5 cycleIEC 61000-4-11
Power frequency 3 A/m 3 A/m Power frequency magnetic (50./60 Hz) fields should be at levels magnetic field characteristic of a typical
location in a typical commercial or hospital environment.
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. Thecustomer or the user of the H3+ should assure that it is used in such an environment.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones andland mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predictedtheoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in whichthe H3+ is used exceeds the applicable RF compliance level above, the H3+ should be observed toverify 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.
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Emissions IEC 60601 Compliance Electromagnetic Environment: Test Text Level Level Guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000-4-6 150 kHz to 150 kHz to equipment should be used no closer to
80 MHz 80 MHz any part of the H3+, including cables, thanthe recommended separation distancecalculated from the equation applicable tothe frequency of the transmitter.
Recommended separation distance
Radiated RF 3 Vrms 3 VrmsIEC 61000-4-3 80 MHz to 80 MHz to 80 MHz to 800 MHz
2.5 GHz 2.5 GHz
80 MHz to 2.5 MHz
Where P is the maximum output powerrating of the transmitter in watts (W)according to the transmitter manufacturerand d is the recommended separationdistance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic sitesurveya, should be less than the compliancelevel in each frequency rangeb.
Interference may occur in the vicinity ofequipment marked with the following symbol:
Electromagnetic Compatibility (EMC) (Continued)
Table X-4 Recommended Separation Distances Between Portable and Mobile RFCommunications Equipment and the H3+.
The H3+ is intended for use in the electromagnetic environment in which radiated RFdisturbances are controlled. The customer or the user of the H3+ can help to preventelectromagnetic interference by maintaining a minimum distance between portable andmobile RF communications equipment (transmitters) and the H3+ as recommendedbelow, according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommendedseparation distance d in meters (m) can be estimated using the equation applicable tothe frequency of the transmitter, where P is the maximum output power rating of thetransmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 800 MHz, the separation distance for the higherfrequency range applies.
NOTE 2: These guidelines may not apply in all situations.Electromagnetic propagation is affected by the absorption andreflection from structures, objects, and people.
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Rated Maximum Output Separation Distance According to Power of Transmitter W 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
Electromagnetic Compatibility (EMC) (Continued)
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TABLE OF CONTENTS
INTRODUCTION SECTION 1H3+ Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Audience and Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
H3+ with Patient Cable and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Front View with LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Bottom View with Enter Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3H3+ in Carrying Case with Neck Cord or Belt Clip . . . . . . . . . . . . . . . . . . . . 1-3
Mortara Part Numbers/ H3+ Digital Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Mortara Specifications/ H3+ Digital Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
OPERATION SECTION 2Entering Patient ID and Setting the Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Opening and Closing the Battery Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Attaching the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Patient Hook-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Skin Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Positioning the Electrodes for a 3-Channel Patient Cable . . . . . . . . . . . . . . . . . . . . . 2-3Positioning the Electrodes for a 2-Channel Patient Cable . . . . . . . . . . . . . . . . . . . . . 2-4Inserting the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Using the Enter Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Displaying ECG Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7Starting a Recording Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7Entering (Optional) Diary Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8Ending a Recording Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
MAINTENANCE SECTION 3Cleaning the H3+ and Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Disposal of Waste Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
MESSAGES AND TROUBLESHOOTING APPENDIX ATable of Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1System Information Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Serial Number and Part Number Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
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Table of Contents (Continued)
INTRODUCTIONSECTION 1
H3+ OverviewManual 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 workingknowledge of medical procedures and terminology as required for monitoringcardiac patients.
The H3+ is indicated for use in a clinical setting, by qualified medical professionalsonly, for recording ECG data of patients requiring ambulatory (Holter) monitoringof up to 48 hours. Such monitoring is most frequently used for the purpose ofprospective and retrospective cardiac data and arrhythmia analysis. Holter analysisis 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 orrecreational activities (e.g., after M.I or cardiac surgery)
Evaluation of ECG documenting therapeutic interventions in individualpatients 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 datarecorded over a 24-hour or 48-hour period. An LCD screen and Enter button allowfor 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 leadsI, II and V during patient hook-up. The 2-Channel 5-wire patient cable records ECGfor 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 indicatingthat the H3+ is in the recording mode. The Enter button can be used to enter eventmarkers in the patient record.
The H3+ Digital Recorder uses a single AAA alkaline battery and stores acquiredECG data in internal memory. The recorded data will remain in memory until it hasbeen cleared by the clinician.
Stored ECG data will be downloaded for analysis to the H-Scribe Holter AnalysisSystem with a USB interface cable after the H3+ has been disconnected from thepatient cable. After the data is downloaded, the memory can then be cleared andthe H3+ is ready for use on the next patient.
1-2
SECTION 1
H3+ with Patient Cable and AccessoriesFront View with LCD Display
Bottom View with Labeling and Enter Button
H3+ in Carrying Case with Neck Cord or Belt Clip
With adjustable neck cord attachment and patient cable
Carrying Case (back) with Belt Clip
1-3
Patient Cable
Neck cord attaches to adetachable retention clip
M i l w a u k e e , W I U S AMedical Equipment
Model:H3+
UL60601-1,IEC60601-1,CAN/CSA C22.2 No. 601.1,IEC60601-2-475P35
SECTION 1
Mortara Part Numbers/ H3+ Digital RecorderH3+ Digital Recorder
To order additional supplies, contact a Mortara Instrument customer servicerepresentative at:
Mortara Instrument, Inc.7865 N. 86th StreetMilwaukee, WI 53224Phone: 1-888-MORTARA (667-8272)Fax: (414) 354-4760Internet: http://www.mortara.com
1-4
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
SECTION 1
Mortara Specifications/H3+ Digital RecorderH3+ Digital Recorder
1-5
Feature Specifications
Instrument Type Digital Holter Recorder
Input Channels Simultaneous acquisition of two orthree channels
Leads Acquired Modified I, II and V or Bipolar Channel 1 and Channel 2
Input Impedance Meet or exceed the requirements of Input Dynamic ANSI/AAMI EC38Electrode Offset ToleranceFrequency Response
Digital Sampling Rate 180 s/sec/channel used for standardrecording and storage.
Special Functions Pacemaker Detection, ECG Displayduring hookup
A/D Conversion 12-bit
Storage Internal, non-volatile memory
Device Classification Type CF defibrillator proof appliedparts, 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
SECTION 1
1-6
OPERATIONSECTION 2
Entering Patient ID and Setting the Date/TimeThe H-Scribe System is used to enter the patient ID. The H3+ USB cable is connectedto the H-Scribe Holter Analysis System and the H3+ for loading this information fromthe H-Scribe System to the H3+ digital recorder. The Patient ID information is movedto the H3+ by selections made at the H-Scribe System. Refer to the H-Scribe UserManual for instruction.
The H-Scribe System is used to set the current date and time. The Date/Time settingsare typically set before initiation of the patient recording on the H3+ and do not needto be set on a per patient basis. Refer to the H-Scribe User Manual for instruction.
Opening and Closing the Battery DoorThe 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 andremove the battery door.
To close the battery door, place the battery door on the H3+ as shown below and slide thedoor in the opposite direction until the door snaps into place.
2-1
SECTION 2
Attaching the Patient CableThe H3+ Patient Cable consists of a connector block, main cable and five leadwiresconnected 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+.
NOTE: Be careful to insert the connector block parallel to theinput connector of the H3+.
Patient Hook-UpSkin Preparation
Skin preparation is important to perform before electrode attachment to help insuregood signal quality when recording patient data. Poor skin to electrode contact maycause noise or artifact to be included in the recording which can affect the analysisof the ECG data. Low amplitude signals may also be the result of poor skin toelectrode contact.
To prepare the skin
1. Identify the (5) electrode sites on the torso by referring to the next section onPositioning 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 drywith gauze.
4. Remove any dead skin from the electrode sites with an abrasive cleaner. Two tothree moderate rubs at each site is sufficient.
When the electrode sites have been identified and prepped, apply an electrode toeach of the (5) sites. Secure each electrode by exerting slight pressure around theouter edge and inner ring of the electrode.
Attach lead wires to the electrodes. Excess lead wire length may be formed intostress loops and secured with tape to prevent any pulling on the electrodes.
2-2
Input Connector
SECTION 2
Positioning the Electrodes for a 3-Channel Patient Cable3-Channel Electrode Placement Bipolar Bipolar - Unipolar
AAMI IEC
RA R Right clavicle as shownLA L Left clavicle as shownRL N Reference or ground lead, should be placed to maximize
patient comfortLL F Lower left side of the rib cage or body as shownV C Precordial exploring lead
2-3
IEC AAMIR = Red RA = WhiteL = Yellow LA = BlackN = Black RL = GreenF = Green LL = RedC = White V = Brown
R and L = Channel 1 is Bipolar lead I RA and LA = Channel 1 is Bipolar lead I R and F = Channel 2 is Bipolar lead II RA and LL = Channel 2 is Bipolar lead IIC and R/L/F = Channel 3 is a V and RA/LA/LL = Channel 3 is a
Unipolar Chest Lead Unipolar Chest Lead
SECTION 2
Positioning the Electrodes for a 2-Channel Patient Cable2-Channel Bipolar Bipolar Electrode Placement
1 - Channel 1 negative lead1+ Channel 1 positive lead2 - Channel 2 negative lead2+ Channel 2 positive leadReference 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
1-2-
1+
2+
Reference
Lead Colors1 - = White2 - = BlackReference = Green1+ = Red2+ = Brown
1+ to 1 - = Channel 1 2+ to 2 - = Channel 2
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 theH3+. 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 torecord 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 ButtonThe Enter button is located on the bottom-side of the H3+ Recorder. One button isavailable for navigating through the LCD screens, for starting the recording and forselecting event markers during the recording.
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 beshown as ID: only
With each single Enter button push, the H3+ set time and ECG waveform displayfor 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 theH-Scribe User Manual for instructions on using the USB cable toset Time/ Date and ID. After this is done, remove the battery andbegin again.
2-6
M i l w a u k e e , W I U S AMedical Equipment
Model:H3+
UL60601-1,IEC60601-1,CAN/CSA C22.2 No. 601.1,IEC60601-2-475P35
SECTION 2
Displaying ECG Channels
This function is used to visually inspect all ECG channels before starting a recording toensure 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 ofthe LCD as one or a combination of RALALLV or +1- +2-.
NOTE: The waveform is shown at 4 mm/mV gain to allow fullrepresentation of the ECG in the LCD dsplay.
Starting a Recording Session1. 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 channelsusing the Enter button to cycle through the menu.
8.To begin recording, press and hold the Enter button for a period of 3 seconds. Thefollowing information will be displayed in the LCD indicating that H3+ is in therecording mode.
During H3+ normal operation, R and the currenttime (HH:MM:SS) are displayed in the middle of theLCD continuously for the entire recording session.
If during recording the battery is removed, theH3+ will stop recording and the LCD will beblank. The recorded data must be downloaded orcleared at the H-Scribe to begin recording again.
In the event of a lead fail condition occurringduring recording, a lead fail indicator is displayedto the right of the Time.
2-7
SECTION 2
Entering (Optional) Diary EventsDuring the recording session, the patient may beinstructed to mark a period in time on the H3+ foranalysis purposes. Once entered, the patient maybe instructed to document the Time and Symptomin the Patient Diary.
To enter an event after the first minute of recording, press the Enter button on theH3+. An indication message is displayed at the right of the current time until anew one can be entered.
NOTE: In the event of a simultaneous lead fail, the indicatorreplaces the lead fail indicator. If lead fail persists, the lead failindicator is displayed again after the Event period.
Ending a Recording SessionAt the end of the recording session, the time iscleared from the LCD screen and the ID isdisplayed in reversed color to indicate the recordingperiod 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 throughconnection of the H3+ USB Cable. Once the data is acquired, the memory will becleared by the user and the H3+ is ready to connect to a patient for the nextrecording session.
2-8
MAINTENANCESECTION 3
Cleaning the H3+ and Patient CableClean the exterior surfaces of the H3+ and the patient cable with a damp cloth. Dry theequipment 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 MaintenanceCheck the H3+ and patient cable everyday to be sure they are not damaged or broken.
Disposal of Waste MaterialsThe 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 INFORMATIONAPPENDIX A
The following table describes error and lead fail messages and symbols that are displayedon the H3+ Digital Holter Recorder LCD during power up, patient hook-up, recordingand during connection to the H-Scribe.
Table of Messages
A-1
Message Description/SolutionReplace existing battery with a fully charged battery.
ID:XXXXXXXXXXX Displayed prior to start of recording to confirm the ID XXXXXXXXXXXXXX has been entered. If the field after the ID: is blank, no
ID has been loaded from H-Scribe to the H3+.
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 iscleared at the H-Scribe system.Lead fail indication during recording. Check that allleadwires and electrodes are connected. Check that thepatient cable is connected to the recorder.
R Recording indicationEvent marker indication
USB Indicates that the H3+ USB download cable isconnected to the H3+
RA RA in fail during hook-up. Check if the lead wire is off or the electrode needs to be replaced.
LA LA in fail during hook-up. Check if the lead wire is off or the electrode needs to be replaced.
LL LL in fail during hook-up. Check if the lead wire is off or the electrode needs to be replaced.
V V in fail during hook-up. Check if the lead wire is off or the electrode needs to be replaced.
A combination of More than one lead in fail or all leads in fail during RA//V hook-up. Check the lead wires and electrodes.+1- Channel 1 in fail during hook-up. Check if the lead
wire is off or the electrode needs to be replaced.+2- Channel 2 in fail during hook-up. Check if the lead
wire is off or the electrode needs to be replaced.A combination of More than one lead in fail or all leads in fail during 1+/2- hook-up. Check the lead wires and electrodes.
APPENDIX A
The following system information log is provided for your convenience. You needthis information if the H3+ needs servicing. Be sure to update the information logwhen your device has been serviced.
Record the model and serial number of all components, dates of removal, and/orreplacement of components, and the name of the vendor from whom the componentwas purchased and/or installed.
In addition to having records of this information, the system information provides awarranty record of when your device was placed in service.
System Information LogManufacturer: Telephone Numbers:
Mortara Instrument, Inc. Domestic: 800-231-74377865 N. 86th St. European: +39-51-6650-701Milwaukee, WI 53224
Sales Department: 800-231-7437Service Department: 888-MORTARA
Product Information:
Name of Unit/Product: ___________________
Date of Purchase: ___/___/_____
Purchased Unit From: ___________________
Serial Number: __________________________
Software Version: ________________________
Serial Number and Part Number LocationFor questions and service information, when calling have the serial number and partnumber available.
The Serial Number and Part Number (REF) are found under the battery, in thebattery 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 systemconfiguration management codes important for post-distribution 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) todemonstrate the conformity of the product,including all applicable options, to the essentialrequirements (ANNEX I),
the EC Certificate ANNEX II N0178/B2P3/1 forapproval of the quality system,
the ISO 13485 Certificate N 0178/13485/3 forapproval 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 StreetMilwaukee, WI 53224USA
Date: 01-April-05
M0238.061 Rev. 1
