Service Manual
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Welch Allyn® H3+™ DIGITAL HOLTER RECORDER
SERVICE MANUAL
Manufactured by Welch Allyn, Inc., Skaneateles Falls, NY U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
© 2019 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn, Inc. Welch Allyn is a registered trademark of Welch Allyn, Inc. H3+ is a trademark of Welch Allyn, Inc. For patent information, please visit www.welchallyn.com/patents For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html 1.888.667.8272, [email protected]
9516-165-50-ENG Rev K
(also refer to TDR pages when making revision changes)
Revision Date: 2023-01
901142 HOLTER RECORDER
EU IMPORTER Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallyn.com
Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland
TABLE OF CONTENTS NOTICES ... 3 MANUFACTURER’S RESPONSIBILITY... 3 RESPONSIBILITY OF THE CUSTOMER... 3 EQUIPMENT IDENTIFICATION ... 3 COPYRIGHT AND TRADEMARK NOTICES ... 3 OTHER IMPORTANT INFORMATION ... 3 NOTICE TO EU USERS AND/OR PATIENTS ... 3 WARRANTY INFORMATION ... 4 YOUR WELCH ALLYN WARRANTY ... 4 USER SAFETY INFORMATION... 5 WARNING(S) ... 5 CAUTION(S) ... 6 NOTE(S) ... 6 EQUIPMENT SYMBOLS AND MARKINGS ... 8 SYMBOL DELINEATION ... 8 ELECTROMAGNETIC COMPATIBILITY(EMC) ... 9 GENERAL ... 13 SERVICE MANUAL PURPOSE ... 13 PERIODIC SAFETY INSPECTIONS ... 13 PROPER PATIENT CABLE ... 13 RECOMMENDED ACCESSORIES ... 13 STERILIZING THIS PRODUCT ... 13 LIQUID SPILLS ... 13 PRODUCT INFORMATION ... 13 DISPOSAL ... 13 MAINTENANCE AND CLEANING... 14 INTRODUCTION ... 14 RECOMMENDED CLEANING SUPPLIES ... 14 CLEANING AND INSPECTING TECHNIQUES ... 14 METALLIC AND PLASTIC PARTS CLEANING ... 14 EXTERIOR CLEANING ... 14 INTERIOR VISUAL INSPECTION ... 15 PREVENTATIVE MAINTENANCE SCHEDULE ... 15 BATTERY REMOVAL/INSTALLATION ... 15 TECHNICAL DESCRIPTION ... 17 H3+ OVERVIEW ... 17 H3+ SPECIFICATIONS ... 19 DISASSEMBLY ... 20 PARTS LIST ... 20 OPENING THE UNIT ... 21
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INSERTING THE BATTERY ... 22 ATTACHING THE PATIENT CABLE... 23 ATTACHING THE USB DOWNLOAD CABLE ... 24 COVER REMOVAL ... 25 KEYPAD REMOVAL ... 26 BOARD REMOVAL... 27 LCD REMOVAL ... 28 BOARD SEPARATION ... 29 PRINTED CIRCUIT BOARDS ... 30 INTRODUCTION ... 30 BLOCK DIAGRAM... 30 H3+ FRONT END PC BOARD ... 31 H3+ DIGITAL PC BOARD ... 32 TROUBLESHOOTING ... 33 INTRODUCTION ... 33 DEVICE LOG FILES... 34 CONFORMANCE TESTING ... 37 INTRODUCTION ... 37
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NOTICES Manufacturer’s Responsibility Welch Allyn, 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 Welch Allyn, Inc.
•
The device (H3+) 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 Welch Allyn, 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 Welch Allyn, Inc.
Other Important Information The information in this document is subject to change without notice. Welch Allyn, 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. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Welch Allyn, Inc. makes no commitment to update or to keep current the information contained in this document.
Notice to EU Users and/or Patients Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
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WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Welch Allyn, or if not otherwise noted, for a period of twenty-four (24) months from the date of shipment. Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. 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 Welch Allyn; 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 Welch Allyn; f) Other events outside of Welch Allyn’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 WELCH ALLYN TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Welch Allyn of any alleged defects promptly after discovery thereof within the warranty period. Welch Allyn’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 Welch Allyn’s principal place or any other place as specifically designated by Welch Allyn or an authorized distributor or representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Welch Allyn is limited and that Welch Allyn does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Welch Allyn is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN 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 PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL WELCH ALLYN 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 device.
Note:
Provides information to further assist in the use of the device.
NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording.
WARNING(S) •
Device (H3+) stores data reflecting a patient’s 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 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 Welch Allyn, 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 Welch Allyn, 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
Caution(s) •
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 with a 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 Welch Allyn, 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:
0 to +45 C -20 to +65 C 5 to 95%, non-condensing 700 to 1060 millibars
Note(s) •
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.
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USER SAFETY INFORMATION
•
The device conforms to the following standards: IEC 601-1 IEC 601-2-47 IEC 601-1-2 ANSI/AAMI EC38 93/42/EEC
•
General Requirements for Safety Particular Requirements for Safety, including Essential Performance Electromagnetic Compatibility Ambulatory Electrocardiographs Medical Device Directive
The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC 60601-1, CAN/CSA C22.2 No. 60601-1, AND IEC 60601-2-47
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EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document. Defibrillator-proof type CF applied part
Battery
Indicates compliance to applicable European Union directives
Do not dispose as unsorted municipal waste. Requires separate handling for waste disposal according to local requirements Follow instructions/directions for use (DFU) – mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days. Medical Device
Model Identifier
Reorder Number
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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 the appropriate EMC table for recommended separation distances between the radio equipment and the device. The use of accessories, transducers, and cables other than those specified by Welch Allyn may result in increased emissions or decreased immunity of the equipment.
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ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions CISPR 11
Group 1
The equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and 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 equipment 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
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment 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
+/- 2 kV for power supply lines +/- 1 kV for input/output lines
Not Applicable
Surge IEC 61000-4-5
+/- 1 kV differential mode +/- 2 kV common mode
Not Applicable
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles
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)
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment 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 equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 Vrms 80 MHz to 2.5 GHz
3 Vrms 150 kHz to 80 MHz
3 Vrms 80 MHz to 2.5 GHz
3.5 d = P 3Vrms
3.5 d = P 3V / m
80 MHz to 800 MHz
7 d = P 3V / m
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 equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. 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)
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment 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
d = 1.2 P
d = 2.3 P
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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GENERAL CARE Service Manual Purpose The purpose of this manual is to provide information to authorized service personnel to maintain and repair the H3+ Holter Recorder.
WARNING: No user serviceable parts are inside. Any modification of this device will void Manufacturer's Warranties and/or responsibilities. If you are not able to correct the H3+ Holter Recorder’s operation using the Troubleshooting guide in the Operator's Manual, contact an authorized Welch Allyn service representative for repair assistance.
Periodic Safety Inspections Follow the recommended maintenance schedule. Inspect the patient cable(s) periodically for fraying or other damage and replace as needed. Broken or frayed wires may cause interference or loss of signal. Pay particular attention to points where wires enter connectors.
Proper Patient Cable Use only the patient cable specified for this unit.
Recommended Accessories For the patient's safety and optimum equipment performance, use only the accessories specified by/or that meet Welch Allyn, Inc. specifications.
Sterilizing this Product Do not sterilize this product or any accessories unless specifically directed by the manufacturer. Sterilization and sterilization environments can seriously damage many components and accessories.
Liquid Spills Do not set beverages or other liquids on or near the H3+, and/or optional equipment.
Product Information See the Technical Description section of this manual.
Disposal This product and its accessories must be disposed of according to local laws and regulations. Do not dispose of this product as unsorted municipal waste. For more specific disposal information see www.welchallyn.com/weee.
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MAINTENANCE AND CLEANING Introduction This section provides maintenance and cleaning instructions for the H3+ Holter Recorder.
Recommended Cleaning Supplies Anti-static mat & wrist band, properly grounded Clean, lint-free cloth Hospital grade germicidal solution DRY, low pressure, compressed air (30 psi) NOTE: The equipment and solvent mentioned above are standard shop commodities that are available from commercial sources.
Cleaning and Inspecting Techniques This section contains instructions for periodic cleaning and inspection of the instrument as preventative maintenance measures. It also contains specific cleaning procedures to be conducted. Parts having identical cleaning procedures are grouped under common headings. No special tools are required.
WARNING Ventilate work area thoroughly when using solvents. Observe manufacturers warnings on solvent containers with regard to personnel safety and emergency first aid. Be sure that first aid equipment is available before using chemicals. Observe shop safety and fire precautions. Ventilate all work areas where solvents are used. Store solvents and solvent-soaked rags in approved containers. Refer to manufacturers’ instructions on containers for recommended fire-fighting procedures, and make sure that fire-fighting equipment is available.
Metallic and Plastic Parts Cleaning
CAUTION Do not wipe over surfaces of nameplates or labels with abrasive cleaners or materials, as this will eventually wear away the nameplate information. Do not use solvents to clean plastic parts.
Exterior Cleaning Use a cloth with a hospital grade germicidal or a 10% bleach solution (1 part bleach, 9 parts water) to clean the external housing and the patient cable.
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MAINTENANCE AND CLEANING
Interior Visual Inspection Check all connectors for loose, bent or corroded contact points Check wire, harnesses and cables for signs of wear or deterioration. Inspect leads for security of mounting, or deterioration. Check terminals and connections for proper installation, loss or wear. Inspect chassis and covers for warping, bending, surface damage or missing captive hardware. Check for any other form of mechanical damage, which may indicate a failure.
Preventative Maintenance Schedule Maintenance to be Performed
Period
Notes
Clean and inspect unit.
6 mo.
Perform every 3 mo. if unit is in heavy use.
Replace Battery Door
2 yrs
May become loose over time, dependent upon use
Battery Removal/Installation Remove the battery door.
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MAINTENANCE AND CLEANING
Remove the Battery.
Check battery connection terminals for debris and/or corrosion.
CAUTION Be sure that the polarity of the battery is correct. Use only Welch Allyn approved Alkaline replacement battery (Welch Allyn part #4800-009).
Install the battery.
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TECHNICAL DESCRIPTION H3+ Overview System Description The H3+ Digital Recorder, software version V3.0.0 or newer provides three channels of continuous ECG data recorded over an extended period of time. An LCD screen and Enter button allow for checking the lead quality during patient hook-up and starting the recording. The H3+ Digital Recorder prior to V3.0.0 has the option to use either a 2 or 3 channel patient cable. The 2 channel, 5 wire patient cable records ECGs for up to 48 hours and displays Channel 1 and Channel 2 during patient hook up. The 3-Channel 5-wire patient cable records 24 hours of data and displays ECG leads I, II and V during patient hookup. 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.
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TECHNICAL DESCRIPTION
H3+ Specifications FEATURE
Specifications
INSTRUMENT TYPE
Digital Holter Recorder
INPUT CHANNELS
•
V3.0.0- Simultaneous acquisition of three channels
•
Prior to V3.0.0- Simultaneous acquisition of two or three channels
LEADS ACQUIRED
•
V3.0.0- Modified I, II, III, aVR, aVL, aVF and V Prior to V3.0.0- Modified I, II and V or Bipolar Channel 1 and Channel 2
INPUT IMPEDANCE INPUT DYNAMIC ELECTRODE OFFSET TOLERANCE FREQUENCY RESPONSE
•
V3.0.0- Meet or exceed the requirements of IEC 60601-2-47
•
Prior to V3.0.0- 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
•
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) 1 AAA Alkaline Required
BATTERIES
V3.0.0- Internal, non-volatile memory.Prior to V3.0.0Internal, non-volatile memory up to 48 hr
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