Comen H3 User Manual

Electrocardiograph
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Copyright
Date: 2021/03
Version: B00
Part No.: 046-001125-06
Product name: Electrocardiograph
Product model: H3
Statements
All rights reserved by Shenzhen Comen Medical Instruments Co., Ltd.
This instruction manual contains confidential information. It is only intended for
users as a reference for operation, maintenance and repair of Comen products. No
one shall disclose the contents hereof to any other person.
No part of this manual may be reproduced, transmitted, transcribed or stored in a
retrieval system in any form or by any means, electronic or mechanical, including
photocopying and recording, or translated into any other language, without written
permission of Comen.
The version number of this manual may be subject to upgrade without notice due
to changes of software, technical specifications or other reasons.
This manual is applicable to the H3 Electrocardiograph produced by our company.
Guarantee
When all of the following conditions are satisfied, Comen Company shall be
responsible for the safety, reliability and performance of the product:
The product is used according to the User Manual.
The product is installed, maintained or upgraded by persons accepted or
authorized by Comen.
The storage environment, working environment and electrical environment of
the product comply with the product specifications.
The serial number label or manufacturing mark of the product is clear and
identifiable. It is verified that this product is manufactured by Comen
User Manual of H3 Electrocardiograph
I

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Summary of Contents for Comen H3

  • Page 1 All rights reserved by Shenzhen Comen Medical Instruments Co., Ltd. This instruction manual contains confidential information. It is only intended for users as a reference for operation, maintenance and repair of Comen products. No one shall disclose the contents hereof to any other person.
  • Page 2 Acquisition of the right to return the goods: Contact the after-sales department of Comen Company, tell it the SN of the instrument made by Comen which is printed on the equipment nameplate; if this SN is not legible, the goods returned shall not be accepted.
  • Page 3 User Manual of H3 Electrocardiograph Preface This user manual provides the performance, operation instructions and safety information regarding the H3 Electrocardiograph and can serve as the start guide for new users. This user manual is applicable to the professional clinical medical staff or the persons who are experienced in using the medical equipment for reading.
  • Page 4 User Manual of H3 Electrocardiograph BLANK...
  • Page 5: Table Of Contents

    User Manual of H3 Electrocardiograph Contents Chapter 1 Safety Guidance ................1-1 1.1 Safety Information ..................1-1 1.2 Warnings and Cautions ................1-1 1.2.1 Precautions for Operating the Equipment ........... 1-2 1.2.2 Precautions for Using of the Rechargeable Lithium Battery ....1-4 1.2.3 Precautions for Cleaning, Disinfection and Maintenance ....
  • Page 6 User Manual of H3 Electrocardiograph Chapter 4 System Settings ................. 4-1 4.1 Switch on ....................4-1 4.2 Auto mode ....................4-1 4.3 Manual Mode ..................... 4-2 4.4 Rhythm Mode .................... 4-2 4.5 System Settings ..................4-3 4.5.1 Patient Information ................4-3 4.5.2 Common Settings ................
  • Page 7: Chapter 1 Safety Guidance

    Chapter 1 Safety Guidance 1.1 Safety Information Warning  To warn you of the conditions where serious consequence, disadvantageous matters or danger may occur. Failure to comply with the warning will result in severe personal injury or death of the user or the patient.
  • Page 8: Precautions For Operating The Equipment

    IEC 60601-1. Therefore, the personnel who connect the accessory equipments to signal input/output interfaces should confirm the whole system comply with the requirements in the valid version of IEC 60601-1. If there is any doubt, please contact Comen Company or local agents. ...
  • Page 9 ESU at the same time.  Only use the ECG cable or other accessories provided by Comen. The accessories of other types may damage the equipment or affect the performance and safety of the equipment.
  • Page 10: Precautions For Using Of The Rechargeable Lithium Battery

    Safety Guidance once a year. The test should be conducted by the trained and qualified personnel with safety test knowledge and experiences and the test results should be recorded. If there is any problem of the equipment in the above tests, it should be maintained. ...
  • Page 11: Precautions For Cleaning, Disinfection And Maintenance

    Only authorized installation or maintenance engineer can open the battery compartment and replace the battery. Only use the rechargeable lithium battery of the same mode provided by Comen.  When the service life of the battery is expired, or when there is peculiar smell, deformation, discoloration or distortion, stop using it immediately and dispose the battery according to the local regulations.
  • Page 12: Symbol Description

    Complies with medical European device directive 93/42/EEC Community symbol Warning: Only use the indicates ECG cable provided by separate collection Comen. Other types of electrical ECG cable may decrease electronic the defibrillation energy equipment. delivered to the patient.
  • Page 13 Safety Guidance (2) Symbols of Packing Symbol Description Symbol Description Stacking layers limit Fragile Keep dry...
  • Page 14: Chapter 2 General Introduction

    This instrument is applicable to clinic units to detect and record people’s routine ECG signals. 2.3 Contraindications None 2.4 Top Panel of the Main Unit H3 electrocardiograph applies 6.2 inch color LCD. The top panel of the main unit is shown as follows:...
  • Page 15: Functions Of Keys And Indicators

    General Introduction Figure 2-1 Top panel of main unit Display screen Recorder latch Recorder Print key Indicators(from top to bottom: working status indicator, AC indicator and battery charge and discharge indicator) On / Off key 2.5 Functions of Keys and Indicators On/Off key: press this key to turn on or turn off this equipment.
  • Page 16: External Connectors

    General Introduction Print key: press this key to record ECG waveform; press this key for 3s and release this key to enter touch screen calibration interface. Battery charge and discharge indicator: when AC power supply is connected, this indicator is light until the battery is fully charged.
  • Page 17: Back Panel

    USB connector connecto Figure 2-3 Right panel Note  Currently our ECG machine H3 supports such external printers as PANTUM P3255DN. Warning  The accessories connected to the analog and digital interfaces should be validated according to the respective IEC standards. Furthermore all configurations should comply with the valid version of the IEC 60601-1.
  • Page 18: Bottom Panel

    General Introduction Equipotential grounding AC power connector terminal Figure 2-4 Back panel 2.7 Bottom panel The bottom panel of this equipment is shown as the following figure: Battery compartment Nameplate Handwriting Figure 2-5 Bottom panel...
  • Page 19: Screen Display

    General Introduction 2.8 Screen Display The main screen is shown as follows: Figure 2-6 Main screen NO. Definition Name Description Display patient ID, sex, name and age, Patient click here to enter the [Register] information settings Measurement Auto/manual/ rhythm, click here to mode change measurement mode circularly.
  • Page 20 General Introduction 10mm/mV, 20mm/mV, 10/5mm/mV, 20/10 mm/mV and AGC are supported. Click here to enter [Lowpass Filter], Lowpass 75Hz, 100Hz, 150Hz and off are Filter supported. Real-time heart Display the real-time heart rate value rate value of current patient It can be used as the reference for the connection status of all leads.
  • Page 21 General Introduction leads manually. File Click here to enter [File List] screen. Click here to enter configuration Config. screen.
  • Page 22: Chapter 3 Operation Preparation

    Chapter 3 Operation Preparation Warning  Only use the ECG cable or other accessories provided by Comen. The accessories of other types may damage the equipment or affect the performance and safety of the equipment. 3.1 Connect the Power Cord and Ground Lead Warning ...
  • Page 23: Loading Record Paper

    Operation Preparation battery has been installed which can be used directly. Because of the power loss in the storage and transportation, for the initial use, the battery power may be inadequate and at this time the battery should be charged. When the service life of the battery is expired (cycle life ≥300 times) or the running duration of a fully charged battery shortens obviously, the battery should be replaced in time.
  • Page 24: Recorder Inner Structure

    Operation Preparation 3.2.1 Recorder Inner Structure Paper exit Paper platen Fixing device Thermosensitive rolled print head paper Figure 3-1 Inner structure of recorder 3.2.2 Loading Rolled Thermosensitive Record Paper Press the latch on the left panel of this equipment to open the recorder cover Take out the paper roller from the fixing device Unwrap the new record paper and load it into the fixing device.
  • Page 25: Connect Ecg Cable

    Operation Preparation Unwrap the new folded record paper and place it into the paper tray. Pay attention to that when the free end of the record paper is vertical, the grid surface of the record paper should face the thermosensitive print head; Pull about 2cm of paper out from the paper exit and close recorder cover.
  • Page 26: Electrodes Connection

    Operation Preparation 3.4 Electrodes Connection Warning  Please ensure that all the electrodes are attached to the correct positions on the patient body. Do not allow the electrodes (including neutral electrodes) and patients to contact any other conductive parts or the ground. The contact resistance between the patient and electrodes exerts great influence on the quality of ECG;...
  • Page 27: Positions Of Limb Electrodes

    Operation Preparation Chest 6 White/violet Brown/violet 3.4.1 Positions of Limb Electrodes Limb Electrode (Clamp type): Electrode Reed Clamp Figure 3-3Limb electrode Connect limb electrode: R electrode — Right limb connected as figure 3-4 L electrode — Left limb N electrode —Right leg F electrode —Left leg C1~C6 chest electrode connected as figure 3-6 Figure 3-4Positions of four limb electrodes...
  • Page 28: Positions Of Chest Electrodes

    Operation Preparation The limb electrodes are placed above the wrist joint of the forearm and above the inner side of the ankle joint of the lower leg, on those parts the electrodes and skin contact tightly. Connect the limb electrodes: Check that the electrodes are clean;...
  • Page 29: Inspection Before Power On

    Operation Preparation Figure 3-6Positions of chest electrodes Check that the electrodes are clean firstly; Align all lead wires and connect the electrode connectors to electrodes well; Clean electrode area on chest surface with alcohol; Daub the round area of 25mm diameter on each electrode site with conductive gel evenly;...
  • Page 30 Operation Preparation familiar with the performance of the equipment and the operation methods must be mastered and the cautions and warnings; following inspection procedures are recommended before power on. Environment Check whether there is other electric equipment in the surrounding environment, such as ESU, ultrasonic equipment, radioactive equipment etc, which may generate interference.
  • Page 31: Chapter 4 System Settings

    Chapter 4 System Settings 4.1 Switch on When AC power supply is used, first connect the power cord and the AC indicator ) turns light. Then press the ( ) key to switch on the equipment, then the equipment enters the working status. When AC power supply is used, if the battery power is insufficient, the battery will be charged at the same time and the AC power indicator ( ) and battery...
  • Page 32: Manual Mode

    System Settings Note  Recording mode can not be changed during the course of printing. Stop printing before changing the recording mode.  Only when [Save Option] is set as “On”, the ECG waveform and data printed under auto mode can be saved in [File List] screen, or it can not be saved.
  • Page 33: System Settings

    System Settings determined by the settings of [Rhythm Lead 1], [Rhythm Lead 2], [Rhythm Lead 3] and [Rhythm Lead Type]. Specific operation steps: Click Auto/ Manual/ Rhythm mode hotkey to switch to Rhythm mode; Press key to sample ECG waveform automatically and [Sampling] prompt message will appear in the prompt message area.
  • Page 34 System Settings Figure 4-1 Patient information screen Note  Patient information can’t be changed during the process of recording.  Under auto mode, a new patient case will be formed after every printing when [Save Option] is set as [On]. ...
  • Page 35: Common Settings

    System Settings  [Doctor]: entering doctor’s name within 20 characters  [Technician]: entering technician’s name within 20 characters  [Bed NO].: entering the bed number within 20 characters  [Hospital NO.]: entering hospital number within 10 characters  [Update patient information]: click to delete the patient information of last patient.
  • Page 36 System Settings Figure 4-2 Common Settings screen  [AC Filter]: [50Hz], [60Hz] and [OFF] AC filter is used to resist the interference of the AC power supply to avoid the reducing or distortion of the ECG signal.  [EMG Filter]:[ 25Hz], [35Hz], [45Hz] and [OFF] EMG filter is used to resist the interference on the ECG signal caused by strong muscle vibration.
  • Page 37 System Settings  [Display Format]: the display formats of ECG waveform on the main screen include [3× 4] and [6× 2]. This option is merely available under automatic mode and manual mode.  [Lead Sequence]: [Standard ]and [Cabrera]. Lead Lead Order Lead Group 1 Lead Group 2 Lead Group 4...
  • Page 38 System Settings Figure 4-4 Simultaneous Sampling of Each Group  [ECG Criteria]: select the naming criteria of lead wires (IEC and AHA) [IEC]: When this standard is set, then the lead on the lead map will be named as:C1, C2, C3, C4, C5, C6, R, L, N, F. [AHA]:When this standard is set, then the lead on the lead map will be named as:V1, V2, V3, V4, V5, V6, RA, LA, RL, LL.
  • Page 39: Print Settings

    System Settings and output. Note  When [Printer Select] is set as [Internal], only [1 Channel] is available in [Rhythm Lead Type] option; when [Printer Select] is set as [External] and [Close], [1 Channel] and[3 Channel] are available in [Rhythm Lead Type] option 4.5.3 Print Settings Click [Config.] to enter setting screen, and select the [Printer], shown as following figure:...
  • Page 40 System Settings are available; under auto and rhythm mode, only two kinds of speed [25mm/s] and [50mm/s] are available.  [Wave Gain]: there are seven wave gains including [AGC], [2.5mm/mV], [5 mm/mV], [10mm/mV], [20mm/mV], [10/5 mm/mV] and [20/10 mm/mV]. In [20/10 mm/mV], 20 represents the sensitivity of limb leads, and 10 represents the sensitivity of chest leads, [AGC] means auto gain control.
  • Page 41 System Settings  [Report Text]: [Off], [Basic] and [Detailed]; [Off]: only ECG waveforms are output. [Basic]: what output includes ECG waveforms, patient information, intervals, axis, amplitude and so on, shown as the following figure: Figure 4-6 Basic information [Detailed]: what output includes ECG waveforms, patient information, intervals, axis, amplitude, Minnesota Code, diagnosis information and so on, shown as the following figure: Figure 4-7 Detailed information...
  • Page 42 System Settings Select] is set as [External] or [Close], available average template includes [3× 4+1R], [6× 2+1R] and [Off]. [3× 4+1R]: 12 leads of average template waveform are recorded in 3 channels and 4 sequences and add one average template waveform of the rhythm lead. [2×...
  • Page 43 System Settings Note  If incorrect paper type is selected, the equipment may not print normally.  [Pacing Logo]: [OFF],[I],[II],[V1],[V2],[V3],[V4],[V5],[V6]. If [Pacing Logo] is set to lead, there will be pacing marks displayed above ECG waveform when pacing pulse is detected. ...
  • Page 44 Warning  When the recorder is abnormal, it must be maintained or modified by the qualified engineer designated by Comen Company, otherwise Comen company shall not be responsible for the safety, reliability and performance of the instrument. 4-14...
  • Page 45: System Settings

    System Settings 4.5.4 System Settings Click the [Config.] to enter the setting screen and select [System], shown as the following figure: Figure 4-8 System Settings Screen  [Key Beep]: click it to activate or deactivate the touch sound.  [QRS Beep]: click it to activate or deactivate the heart beat sound. Heartbeat sound is the brief “beep…beep…beep”...
  • Page 46: Network Settings

    System Settings  [Time Format]: [12-Hour ]and [24-Hour]  [System Time]: set the system time of the electrocardiograph according to local time.  [Language]: you can select a language for ECG displaying and recording  [Demo Mode]: click it to activate or deactivate the Demo function. Warning ...
  • Page 47 System Settings Figure 4-9 Network Settings Screen  [IP address]: 255.255.255.217, the IP address of this electrocardiograph.  [Remote IPaddr]: 200.200.200.99, the IP address of the computer connected with this electrocardiograph.  [Remote Port]: 5065, the remote port number connected with PCECG workstation.
  • Page 48 System Settings computer and the patient cases saved in [File List] screen can be viewed on the computer connected. Please refer to Chapter 5.4 for detail. FTP (File Transfer Protocol) allows one computer to acquire files from or transfer files to another computer. You can connect the ECG machine to a computer and designate a user name and password to use the computer in a safe way.
  • Page 49  [FTP Password]: When selecting the [FTP transfer], it is necessary to set this option. The system sets this option as COMEN by default. User can also set as required. The set FTP Password needs to be consistent with the relevant setting of the FTP receiving software.
  • Page 50: Ecg Recording

    System Settings transfer file directory as required. 4.7 ECG Recording Take the ECG recording under auto mode with 3× 4 display format, 3× 4+1R average template and detailed report information as an example, and the output ECG report includes part (a) and part (b),shown as the follows: Figure 4-9 (a) Report format 3×...
  • Page 51 System Settings  Patient information: Second ID, name, age, height, sex and weight.  Measurement information  Heart Rate  P Time Limit (Average Value of the Average Cardiac Beat P Wave Time Limits of Many Leads)  PR Interval (Average Value of the Average Cardiac Beat PR Intervals of Many Leads);...
  • Page 52: Switch Off

    System Settings waveform. The doctor should be responsible for printed reports 4.8 Switch Off When using built-in battery, press key to shut down this instrument; When using AC supply power, press key to shut down this instrument and then pull out the plug. 4-22...
  • Page 53: Chapter 5 File Management

    Chapter 5 File Management 5.1 Review Review function means the ECG waveform of previous 10 minutes can be viewed in the review screen. The 12-lead ECG can be reviewed, analyzed and printed in the review screen. Click “Review” hotkey to enter the review screen, shown as the following figure.
  • Page 54: Copy

    File Management  [Gain]: 10mm/mV、20mm/mV. Set the waveform gain in the uncompressed waveform area and click the option of [Off ] to complete the setting.  [Analysis]: Select [Analysis] and prompt message [Analysis] will be displayed until analysis result. Click [Print] to print the selected 12-lead ECG waveform of 10 seconds and analysis report simultaneously.
  • Page 55  You are recommended to use the USB flash disk supplied or designated by Comen, like Kingston, PNY, ADATA or Apacer, or it may fail to be recognized by the electrocardiograph or reduce the performance and safety of the electrocardiograph.
  • Page 56: Transfer Files To Computer

    File Management USB flash disk in a capacity of 0~2G and 2G~8G. 5.4 Transfer Files to Computer Use the network cable to connect the electrocardiograph to your computer. Note  If the electrocardiograph is connected to your computer via a switch, please use the straight network cable;...
  • Page 57 Double click “My Computer”, input ftp://root:comen@200.200.200.217and press [Enter] to view the patient files displayed in file list screen. Note  The IP address in ftp://root:comen@200.200.200.217 is the same as the local IP address of the electrocardiograph. If the local IP address electrocardiograph 200.200.200.217,...
  • Page 58 File Management be ID confusion, resulting in failure to be recognized by the electrocardiograph.
  • Page 59: Chapter 6 Prompt Message

    Chapter 6 Prompt Message The prompt message during operation is shown in the following table Prompt message Causes Leads fall off form patient’s body [Lead off] [Low Battery] Low battery The data is being sampled or printed [Sampling printing] Remind the users of reviewing patient’s ECG data [Copy ] [Process] The ECG data is being processed...
  • Page 60: Chapter 7 Cleaning And Maintenance

    Chapter 7 Cleaning and Maintenance 7.1 Cleaning Caution  Turn off the equipment before cleaning. If the AC power supply is used, disconnect the AC power supply and remove the power cord and ECG cable before cleaning. 1) Cleaning of Main Unit and ECG Cable: Soak the soft and clean lint free cloth in mild soapsuds or in the non-corrosive washing solution after dilution, wipe the surface of the electrocardiograph and ECG cable and use the clean and dry soft cloth to clean.
  • Page 61: Disinfection

    Cleaning and Maintenance Caution  Do not allow the liquid to enter the inner of the equipment during cleaning. Do not immerse the equipment and ECG cable into liquid in any case.  Do not use abrasive material to clean electrodes. ...
  • Page 62 Cleaning and Maintenance before using the rechargeable lithium battery (hereinafter called “Battery”). 1) Battery Capacity identification: Current capacity of the rechargeable battery can be identified according to the battery symbol at the bottom right corner on the screen: : Full capacity. : Capacity is not full.
  • Page 63: Record Paper

     Do not reverse the anode and cathode when connecting the battery, otherwise explosion may be caused.  The waste battery should be sent back to Comen Company or disposed of according to the local regulations. Note  At present, Comen Company would conditionally provide curcuit...
  • Page 64: Maintenance Of Main Unit, Ecg Cable And Electrodes

    Cleaning and Maintenance 7.3.3 Maintenance of Main Unit, ECG Cable and Electrodes Caution  Safety tests should be conducted periodically for the equipment at least once every two years and the test mainly includes: Check whether there is mechanical and functional damage for the main unit and accessories.
  • Page 65 Cleaning and Maintenance  The cables and leads should be coiled into a disk with larger diameter in storage or be hung, wresting or sharp angle folding should be avoided;  If the cables and lead wires are found to be damaged or aging, new cable and lead wires should be replaced.
  • Page 66: Appendix I Accessories

    Appendix I Accessories Warning  Only use the ECG cable or other accessories provided by Comen. The accessories of other types may damage the equipment or affect the performance and safety of the equipment. Model Type Name 12-lead; IEC 040-000688-00...
  • Page 67: Appendix Ii Technical Specifications

    Appendix II Technical Specifications IEC60601-1 Medical Electrical Safety Equipment-Part 1: General Standards Requirements for Safety and essential performance IEC60601-2-25 Medical Electrical Equipment-Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic...
  • Page 68 Technical Specifications Working mode Continuous operation 235mm× 190mm× 52.6mm Dimension 1.18kg (including main unit, recorder and battery, not including Weight accessories) Display 6.2 inch LCD color touch screen with resolution of 800× 480 pixels Work Temperature 5℃~40℃ Work ≤93% Relative Humidity Environment Atmospheric Pressure 700hPa~1060hPa...
  • Page 69 Technical Specifications Specifications 11.1V 2600mAh Under ambient temperature 25℃± 5℃, charge to 90% for less than Charge time 3 hours and charge to 100% for less than 3.4 hours. For a fully charged battery under Battery ambient temperature of 25℃± 5℃, the electrocardiograph should print at least reports, conduct...
  • Page 70 Technical Specifications HR calculation Peak detection Input Method With defibrillator-proof protection Standard 12 leads and switching leads Leads automatically 30~300bpm; Heart rate measurement range and accuracy ± 1% or ± 1bpm ,whichever is greater Sampling Mode 12 channels simultaneously ≥5s Time Constant Frequency Characteristics 0.05Hz ~ 150Hz ( +0.4dB...
  • Page 71 Technical Specifications ≤0.5mm Multichannel crosstalk skew between <100μs channels AC Filter: 50Hz, 60Hz, OFF DFT Filter: OFF, 0.05Hz, 0.10Hz, 0.20Hz, 0.50Hz Filter EMG Filter: 25Hz, 35Hz, 45Hz, OFF LOWPASS Filter: OFF, 75Hz, 100Hz, 150Hz ≥110dB CMRR The response time of exiting standby Standby Function status is less than 10s.
  • Page 72: Appendix Iii Emc

    H3 meets the requirement of electromagnetic compatibility in IEC60601-1-2.  H3 meets the requirement of Group I Class A in CISPR 11/EN 55011.  The user needs to install and use according to electromagnetism compatibility information which is attached with it.
  • Page 73 Table 1 declaration - electromagnetic emission H3 is intended for use in the electromagnetic environment specified below. The customer or the user of H3 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 74 Table 2 declaration - electromagnetic immunity H3 is intended for use in the electromagnetic environment specified below. The customer or the user of H3 should assure that it is used in such an environment. Immunity IEC 60601 test Compliance Electromagnetic...
  • Page 75 (100 % dip in UT) 0 % UT and voltage environment. If the user of for 1 cycles (100 % dip in variations on the H3 requires continued 70 % UT power operation during power (30 % dip in UT)
  • Page 76 Table 3 declaration - electromagnetic immunity H3 is intended for use in the electromagnetic environment specified below. The customer or the user of H3 should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic test...
  • Page 77 Radiated 3V/m 3V/m  80 MHz to 800 80 MHz to 2.7 GHz  61000-4-3 800 MHz to 2.7 where P is the maximum output power rating of the transmitter in watts according transmitter manufacturer and d is recommended separation distance in meters (m).
  • Page 78 RF compliance level above, H3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating H3.
  • Page 79 Recommended separation distances between portable and mobile RF communications equipment and H3 H3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of H3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and H3, as recommended below, according to the maximum output power of the communications equipment.
  • Page 80 Table 5 declaration - IMMUNITY to proximity fields from RF wireless communications equipment H3 is intended for use in an electromagnetic environment in which RF wireless communications equipment are controlled. Immunit IEC60601 test level Complia Electromagne y test nce level...
  • Page 81 2450 MHz **Pulse 28 V/m 28 V/m Modulat ion: 217Hz 5240 MHz **Pulse 0.2 W 9 V/m 9 V/m 5500 MHz Modulat 5785 MHz ion: 217Hz Note * - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

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