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Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the council directive 93/ 42/ EEC for
medical devices and harmonized standards. The Manual is written for the current
Electrocardiograph. In case of modifications and software upgrades, the information contained in
this document is subject to change without notice.
The Manual describes, in accordance with Electrocardiograph's features and requirements, main
structure, functions, specifications, correct methods for transportation, installation, usage,
operation, repair, maintenance and storage, etc. as well as the safety procedures to protect both
the user and equipment. Refer to the respective chapters for details.
Please read the Manual very carefully before using this equipment. These instructions describe
the operating procedures to be followed strictly, Failure to follow these instructions can cause
measuring abnormality, equipment damage and personal injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring abnormality,
personal injury and equipment damage due to user's negligence of the operation instructions.
The manufacturer's warranty service does not cover such faults.
WARNING:
All the electrodes connected to the patients directly must be correct and tried.
Make sure the battery voltage is normal when choosing the UPS.
The AC power cable and the patient cable could not be enlaced.
(fl-�
Please peruse the relative content about the clinical restrictions and caution.
This device is not intended for treatment.
Instructions to User

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Summary of Contents for Contec CMS80A

  • Page 1 Instructions to User Dear Users, thank you very much for purchasing our product. This Manual is written and compiled in accordance with the council directive 93/ 42/ EEC for medical devices and harmonized standards. The Manual is written for the current Electrocardiograph.
  • Page 2: Table Of Contents

    Contents 1 Safety ............................1 1.1 Instructions for safe operations ............1 1.2 Warnings ..................... 1 1.3 Attentions .................... 1 2 Overview ............................3 2.1 Features ....................3 2.2 Major applications and scope of application ........3 2.3 Environment requirements ..............4 3 Principle and Caution .........................
  • Page 3 10.1 Automatic switch off ............... 21 10.2 AC interference ................21 10.3 EMG interference ................21 10.4 Baseline drift ................... 22 10.5 Others ....................22 11 KeyofSymbols ........................24 12 Function Specification ......................25 Appendix l ............................ 26 Appendix 2 ............................ 27...
  • Page 4: Safety

    1 Safety Instructions for safe operations > Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient's safety and monitoring performance about cables and transducers. It is recommended that the device should be inspected once a week at least. When there is obvious damage, stop using the monitor.
  • Page 5 When it is carried from cold environment to warm and humid environment, please do not use it immediately. Do not operate keys on front panel with sharp materials. Do not have the product immerged in liquid. ° When cleaning the device with water, the temperature should be lower than 60 The design of the instrument is considered sufficiently with the safety requirement, but the observation of the patient and the instrument can not be ignored.
  • Page 6: Overview

    2 Overview Through the broading market investigation, ous company assembles a lot of talents in the following majors: the appearance design of the product, structure design, transmission structure design, and circuit design, they produced the equipment successfully after their deep research and reduplicate tests.
  • Page 7: Environment Requirements

    The Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms.
  • Page 8: Principle And Caution

    3 Principle and Caution 3.1 Principle of measurement The equipment is constituted by power source system, signal gathering and processing, and controlling system etc. The power source system converts the Alternating Current or battery volt to the Direct Current which the equipment needs, meantime, it completes the charge of battery and the conversion of alternating current and direct current.
  • Page 9: Technical Specifications

    4 Technical Specifications Display Format: LCD Display; Battery Voltage Indication: three segments display. Power Requirements: Power adapter: AC: 100-240V, 50/60Hz; Output DC: 9V Lithium rechargeable battery: DC 7.4V Input Power: :::;55VA Sensitivity Setting: 5, 10, 20 (mrn/mV), conversion deviation: :::;5% Fuse Standard: AC 250V/2A Paper Speed: 25mrn/s, 50mrn/s ±5%...
  • Page 10: Accessories

    5 Accessories Attention: Followed is the models of accessories provided by the factory. It may damage this equipment if using the accessories with different models. };>- Power adapter (Input AC: 100-240V, 50/60Hz Output DC: 9V) Attention: User can choose the power cord according the request of local power net and also the safe standard.
  • Page 12 AC Power Computer Connector (OPTION) Patient Cable Connector Bottom View Back View...
  • Page 13: Electrode Placement

    6.2 Electrode placement Advice: Set the chest electrode first, then the limb electrode. 6.2.1 Chest electrode V l: Fourth inter-costal space at right border of sternum. V2: Fourth inter-costal space at left border of sternum. V3: Midway between V2 and V4. V4: Fifth inter-costal space at left mid-clavicular line.
  • Page 14 Attention: Tighten the knob after inserting the mainframe patient cable pin in the patient cable socket. 6.2.3 Electrode connection definitions and color code Electrode Electrode Line Electrode Socket Location Code Color Color Number Right arm Black Black Yellow Left arm Green Left leg Black...
  • Page 15: Paper Loading

    6.3 Paper loading Paper Cabinet Cover--�----�-----. Recording Paper� Paper Axis Rubber Stick ( l) The instrument uses 50mm single track wrap-round recording paper. (2) Open the paper cabinet cover, take out the paper axis, and put it into the recording paper according to the illustration, and place the side with grid adown, then clip them in the relevant position in paper fixer.
  • Page 16: Operating Guide

    7 Operating Guide l The instrument starts self checking after its turning on. In the self checking process: 2 The instrument will show the following state after self checking (under NORM mode): Patient cabling indicator column� ,-.��-. P atient cabling state indicator Column choosing...
  • Page 17 read-only. Mode Conversion: shows the mode conversion of the systemic lead, it divides into Auto lead conversion (AUTO) and Manual lead conversion (MANU). Leading condition indication: The device has the four states indicator for lead, such as "SAT.", "DROP", "NORM" and "OVER".
  • Page 18 English Interface Ending the Calibrating: English Interface Attention: The calibrating process is operated automatically without pressing any button, and it will return after ending the calibrating. (5) Waveform-freezing: Press to freeze the current ECG waveform displayed on the LCD in order to preview. Press again to renew the operation.
  • Page 19 English Interface (1) Short menu: Press to enter this interface. Press • to choose the relevant items and the item 1111 to return. just turning, then press button to set the information, and then press (2) Contents explanation: Sensitivity: Smm/m V, l Omm/m V, 20mm/m V, these three types of sensitivities. Switch Mode: MANU, AUTO, shows the two operation mode: Manual and Automatic.
  • Page 20 English Interface Short menu: 1111 to enter this interface. Press to choose the relevant items and the item Press 1111 just turning, then press button to set the information, and then press to return. (4) Contents explanation: Backlight: 0-99 seconds, the time of turning on the backlight, and the backlight normally off when it sets O second.
  • Page 21: The Notice Of The Battery Operating

    8 The Notice of The Battery Operating This device includes hermetical rechargeable lithium battery, which needn't maintenance. This battery is with perfect automatic charge and discharge circuit. When you connect power supply adapter with alternating current, the charge will be start automatically. When this device is on, an icon is displayed on top right comer of LCD screen.
  • Page 22: Repairing And Maintenance

    9 Repairing and Maintenance fil Attention: Before cleaning the device, make sure that the equipment is switched off and disconnected from the power line. If there is any sign that the ECG cable may be damaged or deteriorated, replace it with a new one instead of continuing its application on the patient.
  • Page 23: Disinfection

    as necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first. Recommended sterilization material: • Ethylate: 70% alcohol, 70% isopropanol • Acetaldehyde 9.4 Disinfection To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first.
  • Page 24: Troubleshooting

    10 Troubleshooting 10.1 Automatic switch off ( 1) Check battery capacity. The instrument has the function of protecting the circuit when the battery over discharged. (2) Check the AC power voltage. The instrument has the function of protecting the circuit when its overvoltage.
  • Page 25: Baseline Drift

    (2) Soothe the patient from irritation or excitement. 10.4 Baseline drift ( 1 )Make sure the steady installation of the electrodes. (2) Verify the electrode attachment and patient cable wire performance. (3) Check the cleaning of electrode and patient skin. Daub enough ECG medical gel on the electrodes and patient.
  • Page 26 1. Electrode electric conductivity is 1. The alcohol of use is asked for not good The waveform The batteries are drained well is not 3. The electrode is loose contact 2. Use ethyl alcohol to wash Regular against skin electrode wafer and the skin under Big undulation, 4.
  • Page 27: Keyofsymbols

    11 Key of Symbols Description Symbol Defi b rillation-proof type CF applied part Refer to instruction manual/booklet Direction Key: Up. Direction Key: Down. Direction Key: Left. Direction Key: Right. Function key: power supply/acknowledgment/shortcut menu. Function Key: Pause/On. Function Key: System Menu. Function Key: Print.
  • Page 28: Function Specification

    The battery solely powered and the electric power is going to be used up. Battery charging. 12 Function Specification Display Information Display Mode Cardiograph System information Battery Requirement POWER ADAPTOR: (Input AC: l 00-240V, 50/60Hz;Output DC 9V) DC 7.4V lithium rechargeable battery Battery Useful Life The battery can keep on working for more than one hour when it is fully charged.
  • Page 29: Appendix L

    Appendix 1 Signal input/output socket This socket is TTL electrical level serial interface, its available transmission distance is 5 meters. Baud rate: 115200,8,N, 1. When connected to PC, it need electrical level conversion module. � SIGNAL INPUT/OUTPUT INPUT OUTPUT...
  • Page 30 Appendix 2 Guidance and manufacture's declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS Guidance and manufacture's declaration -electromagnetic emission The ECG80A Electrocardiograph (ECG) is intended for use in the electromagnetic environment specified below. The customer of the user of the ECG80A Electrocardiograph (ECG) should assure that it is used in such an environment Emission test compliance...
  • Page 31 discharge ±8KVair ±8KVair concrete or ceramic tile. If (ESD) covered with IEC 61000-4-2 floor synthetic material, relative humidity should be at least 30%. Power frequency Mains power quality should (50Hz) magnetic that typical field commercial hospital IEC 61000-4-8 environment NOTE: UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacture's declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture's declaration-electromagnetic immunity...
  • Page 32 J.Jp = [ ;, 800MHz to 2.5GHz 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 survey, should be less than the compliance level in each frequency...
  • Page 33 Recommended separation distances between portable and mobile RF communications equipment and the ECG80A Electrocardiograph (ECG) The ECG80A Electrocardiograph (ECG) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ECG80A Electrocardiograph (ECG) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ECG80A Electrocardiograph (ECG) as recommended below, according to the maximum...

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