User Manual
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Welch Allyn® H3+™ DIGITAL HOLTER RECORDER USER 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. Software V3.0.0
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]
9515-165-60-ENG Rev C Revision Date 2019-08
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 ... 6 WARNING(S) ...6 CAUTION(S)...8 NOTE(S) ...9 EQUIPMENT SYMBOLS AND MARKINGS ... 10 SYMBOL DELINEATION ...10 GENERAL CARE ... 11 PRECAUTIONS ...11 INSPECTION ...11 CLEANING AND DISINFECTION ...11 CAUTIONS ...11 DISPOSAL ...11 ELECTROMAGNETIC COMPATIBILITY (EMC) ... 12 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGENTIC EMISSIONS ...13 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY...13 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY...14 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT ...15 INTRODUCTION ... 17 MANUAL PURPOSE ...17 AUDIENCE AND INDICATIONS FOR USE ...17 SYSTEM DESCRIPTION ...17 H3+ WITH PATIENT CABLE AND ACCESSORIES ...18 H3+ IN CARRYING CASE ...18 H3+ IN SINGLE-USE POUCH ...19 ADHESIVE STRIPS SECURE THE POUCH TO SKIN OR CLOTHING; SEALED EDGES PROTECT H3+ FROM MOISTURE ...19 PART NUMBERS ...20 SPECIFICATIONS ...20 OPERATION ... 21 ENTERING PATIENT ID AND SETTING THE DATE/TIME ...21
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TABLE OF CONTENTS
OPENING AND CLOSING THE BATTERY DOOR ...21 ATTACHING THE PATIENT CABLE ...21 PATIENT HOOKUP ...22 SKIN PREPARATION, ELECTRODE APPLICATION, AND SECURING THE H3+...22 POSITIONING THE ELECTRODES ...23 INSERTING THE BATTERY ...25 USING THE EVENT BUTTON FOR MENU NAVIGATION ...26 DISPLAYING ECG CHANNELS ...27 STARTING A RECORDING SESSION ...27 DURING THE RECORDING SESSION ...27 ENTERING (OPTIONAL) DIARY EVENTS ...28 ENDING A RECORDING SESSION ...28 PATIENT INSTRUCTIONS ...29 ELECTRODE PLACEMENT (AHA COLORS) ...30 MAINTENANCE ... 31 CLEANING THE H3+ AND ACCESSORIES ...31 PERIODIC MAINTENANCE ...32 DISPOSAL OF WASTE MATERIALS ...32 MESSAGES AND INFORMATION ... 33 TABLE OF MESSAGES ...33 DEVICE LOG FILES ...33 SYSTEM INFORMATION LOG ...34 SERIAL NUMBER AND PART NUMBER LOCATION ...34
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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 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 twelve (12) 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.
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WARRANTY INFORMATION
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.
WARNING(S)
This manual gives important information about the use and safety of this device. Deviating from operating procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the device.
Caretakers must closely supervise an infant or child who is wearing a Holter recorder to ensure the recorder is intact and the patient cable is properly secured. A patient cable with short lead wires is recommended for pediatric patients.
Device stores data reflecting a patient’s physiological condition to a properly equipped analysis system that 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.
Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this device. Before attempting to use this device for clinical applications, the operator must read and understand the contents of the user manual and other accompanying documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and bystanders, or damage to the device. Contact Welch Allyn service for additional training options.
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 60601-1, and IEC 60601-2-47. Only use parts and accessories supplied with the device and available through Welch Allyn, Inc.
Patient cables intended for use with the device include series resistance (7 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.
Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrodes, should not come into contact with other conductive parts including earth ground.
To avoid the possibility of serious injury or death during patient defibrillation, do not come in contact with device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.
A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
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USER SAFETY INFORMATION
Defibrillation protection is guaranteed only if the original patient cable is used. Any modifications of this device may alter defibrillator protection.
Simultaneous connection to other equipment may increase leakage current.
This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions.
ECG electrodes should be changed routinely for recordings extending beyond 24-hour duration, depending on quality and type of electrodes used.
To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device.
The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient.
The quality of the signal produced by the device may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines.
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the device; however, disturbance to the signal may occur.
Operations may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment.
The device is restricted to use on one patient at a time.
The performance of the device may be compromised by excessive motion.
Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.
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USER SAFETY INFORMATION
Caution(s)
To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, only use fingertips.
Do not attempt to clean the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. Use of unspecified cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the device. Do not sterilize the device or patient cables with Ethylene Oxide (EtO) gas.
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. Inspect cable and connection for damage or excessive wear prior to each use. Replace cable if damage or excessive wear is noted.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables should be stored after forming them into a loose loop.
The device will only work with devices that are equipped with the appropriate option.
No user-serviceable parts are inside. Damaged or suspected inoperative equipment must be immediately removed for use and must be checked/repaired by qualified service personnel prior to continued use.
This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) devices, etc.
When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations.
AAA batteries are known to leak their contents when stored in unused equipment. Remove battery from device when not used for an extended period of time.
To prevent possible damage to the device, the following environmental conditions must be adhered to: Operating Temperature: Storage Temperature: Relative Humidity: Ambient Air Pressure:
10 to +45 C -20 to +65 C 5 to 95%, non-condensing 700 to 1060 millibars
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USER SAFETY INFORMATION
Note(s)
Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
It is the responsibility of the medical facility to provide the patient with instructions during use. Refer to the “Patient Instructions” section within this user manual.
If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, display will indicate a lead fault condition.
The device is set to the U.S. Central Time Zone when shipped from the factory. If a change is required, set the correct date and time prior to using the recorder. Refer to the instructions within this user manual.
The patient cable life expectancy is six months continuous use with proper care.
The device will automatically turn off (blank screen) if the batteries have been severely discharged.
When the H3+ has not been used over a period of several months, the date and time may be lost. The following sequence of steps should be performed to recharge the recorder’s internal lithium battery.
Insert an AAA alkaline battery into the recorder battery compartment and let it power the recorder for a minimum period of 24 hours.
Connect the H3+ recorder to the H3+ interface cable and connect it to HScribe or a Welch Allyn Web Upload client computer to set the time and date.
No preliminary or ongoing scheduled periodic calibration by the user or Welch Allyn personnel is required. The design for the device is such that the system contains no elements requiring calibration.
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 60601-1 General Requirements for Safety IEC 60601-2-47 Particular Requirements for Safety, including Essential Performance IEC 60601-1-2 Electromagnetic Compatibility 93/42/EEC Medical Device Directive
The device is UL classified: Medical Equipment
5P35
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
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EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation 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..
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.
Defibrillator-proof type CF applied part
Battery Do not dispose as unsorted municipal waste. Requires separate handling for waste disposal according to local requirements
Indicates compliance to applicable European Union directives 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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GENERAL CARE Precautions
Turn off the device before inspecting or cleaning. Do not immerse the device in water. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces.
Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs. Verify that all cables and connectors are securely seated. Check the case for any visible damage. Inspect cables and connectors for any visible damage. Inspect buttons and controls for proper function and appearance.
Cleaning and Disinfection Refer to section 3 for proper cleaning and disinfection procedures.
Sterilization EtO sterilization is not recommended but may be required for cables and lead wires. Frequent sterilization will reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a maximum temperature of 50°C/122°F. After EtO sterilization, follow the recommendations from the sterilizer manufacturer for required aeration.
Cautions Improper cleaning products and processes can damage the device, produce brittle lead wires and cables, corrode the metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining the device.
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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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 applicable 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 device.
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ELECTROMAGNETIC COMPATABILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagentic 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 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 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
Not Applicable
Not Applicable
Surge IEC 61000-4-5
Not Applicable
Not Applicable
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11
Not Applicable
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 COMPATABILITY (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
Electromagentic 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 V/m 80 MHz to 2.5 GHz
3 Vrms 150 kHz to 80 MHz
3 V/m 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 equpment 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 COMPATABILITY (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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ELECTROMAGNETIC COMPATABILITY (EMC)
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INTRODUCTION Manual Purpose The H3+™ digital Holter recorder user manual explains how to operate the H3+ recorder. It shows the user how to:
Start and end a patient recording Prepare device configurations Instruct the patient on electrode replacement NOTE: This manual may contain screen shots. Any screen shots 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.
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
System Description The H3+ provides three channels of continuous ECG data typically recorded over a 24-hour or 48-hour period. An LCD screen and event button allow for checking the lead quality during patient hookup and starting the recording. The 5-wire patient cable allows display of ECG leads I, II, and V during patient hookup. Either a standard 27-inch (69 cm) or short 15-inch (38 cm) 3-channel patient cable can be connected depending on clinician preference. 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 event button can be used to mark time points within the recorded ECG data.
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INTRODUCTION
The H3+ uses a single AAA alkaline battery and stores acquired ECG data in internal memory. The recording will continue and automatically end when the H3+ factory-set duration is reached, the H3+ is connected to the Holter analysis system via USB interface cable, or the battery is removed. The recorded data will remain in memory when the battery is removed. Stored ECG data will be downloaded for analysis to the Holter system with a USB interface cable after the H3+ has been disconnected from the patient cable. After the data is downloaded, the memory is then erased and the H3+ is ready for use on the next patient.
H3+ with Patient Cable and Accessories Front view with LCD display
Bottom view with labeling and Event button
H3+ in Carrying Case With LCD window and patient cable; clip on back secures the carry case to clothing
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