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PROFESSIONAL MEDICAL PRODUCTS
ECG CARDIOPOCKET
CARDIOPOCKET ECG
ECG CARDIOPOCKET
ECG CARDIOPOCKET
Manuale d'uso - User manual
Manuel de l'utilisateur - Guía de Uso
ATTENZIONE: Gli operatori devono leggere
e capire completamente questo manuale
prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d'utiliser le produit.
ATENCIÓN: Los operadores tienen que leer
y entender completamente este manual antes
de utilizar el producto.
33257 / ECG80A
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province,
PEOPLE'S REPUBLIC OF CHINA
Made in P.R.C.
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. 199 400 401 - fax 199 400 403
Export: tel. +39 02 953854209/221/225 - fax +39 02 95380056
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
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IVD
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Summary of Contents for Gima ecg80a

  • Page 1 Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy Italia: tel. 199 400 401 - fax 199 400 403 Export: tel. +39 02 953854209/221/225 - fax +39 02 95380056 gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com PROFESSIONAL MEDICAL PRODUCTS ECG CARDIOPOCKET...
  • Page 2 ENGLISH 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. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
  • Page 3: Table Of Contents

    ENGLISH Contents SAFETY ..................24 Instructions for safe operations ............24 1.2 Warnings ..................24 Attentions ..................24 OVERVIEW ..................5 Features .................... 6 Major applications and scope of application ........6 Environment requirements ..............6 PRINCIPLE AND CAUTION ............6 Principle of measurement ..............
  • Page 4: Safety

    ENGLISH 1 SAFETY 1.1 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. • Necessary maintenance must be performed by qualified service engineers ONLY.
  • Page 5: Attentions

    ENGLISH 1.3 Attentions • Keep the Electrocardiograph away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture. • If the Electrocardiograph gets wet, please stop operating it. • 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: Features

    ENGLISH 2.1 Features • Operation of the product is simple and convenient. • The product is small in volume, light in weight (total weight is about 800g including batteries) and convenient in carrying. • The instrument can be used under AC&DC, with the lithium rechargeable battery inside, and it will record eighty ECG waveform persistently under the best DC conditions. • Voltage indication will be displayed when power on. • Classification: internal electrical power source, CF applied part. • EMC complies with the requirements of IEC60601-1-2:2001 (refer to the appendix 2). 2.2 Major applications and scope of application This product is single channel,12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in hospital...
  • Page 7: Caution

    ENGLISH and gaining controlling, etc. The controlling system coordinates the operation of print controlling equipment, liquid crystal screen and keyboard driver, it is responsible for the profile print driver, controlling information demonstration, keyboard management and some other control. 3.2 Caution 3.2.1 Observe the status of the patients and the instrument momentarily.
  • Page 8: Accessories

    ENGLISH 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: 12V ) Attention: User can choose the power cord according the request of local power net and also the safe standard. Power supply adapter should be accorded with relevant regulation according to IEC60601-1.
  • Page 9: Electrode Placement

    ENGLISH Bottom View AC Power Patient Cable Connector Back View Battery button Battery 6.2 Electrode placement Advice: Set the chest electrode first, then the limb electrode. 6.2.1 Elettrodo del petto:...
  • Page 10 ENGLISH V1: 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. V5: Left anterior axillary line at the horizontal lever of V4. V6: Left mid-axillary line at the horizontal lever of V4. Clean the positions around to which chest electrodes are to be attached with alcohol, lay the ECG medical gel on dia.25cm area around the position and the edge of chest electrode cap, press the suction bulb, firmly attach the electrodes to the positions between V1 and V6.
  • Page 11: Paper Loading

    ENGLISH 6.3 Paper loading: Paper cabinet cover Recording paper Paper axis   Bloccaggi Rubber stick o   b atteria   Paper fixer Battery lock 1. 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 gridding adown, then clip them in the relevant position in paper fixer.
  • Page 12 ENGLISH 1. Patient cabling indicator column: Press the button to choose the patient cabling indictor column, the guide arrow in the column just turning (for example: ), then press the button to choose the corresponding patient cable, the instrument switches to the corresponding patient cable inspection. The relevant patient cable No.
  • Page 13 ENGLISH In calibrating process Ending the Calibrating Please wait... OVER English Interface English Interface Attention: The calibrating process is operated automatically without pressing any button, and it will return after ending the calibrating. 6. Waveform-freezing: Press to freeze the current ECG waveform displayed on the LCD in order to preview.
  • Page 14: The Notice Of The Battery Operating

    ENGLISH Filter: OFF, 50Hz, 60Hz, 50Hz+, 60Hz+, totally five types of filter, among them, 50Hz+ and 60Hz+ denote the opening of 35Hz EMG filter. Attention: Switching on the EMG interference filter will fall the range of the recorded R-wave. Speed: 25mm/s, 50mm/s, totally two types of paper skipping speed mode. System Manual: Menu Backlight Contrast Language English Demo About Ver. English Interface 3.
  • Page 15 ENGLISH setting is for avoiding permanent damage on battery caused by excessive discharge. 3. Please charge the battery after power off. When this device be deposit for long time, the battery should be charge once every six months, this operation will prolong the use –pan of battery. 4. The icon of seven different state of power supply as following: AC power is on (no battery) The battery is only power supply and its power is full.
  • Page 16: Repairing And Maintenance

    ENGLISH 9 REPAIRING AND MAINTENANCE Attention: Before cleaning the device, make sure that the equipment is switched Σ 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 PHTHALATES patient.
  • Page 17: Sterilization

    ENGLISH 9.3 Sterilization To avoid extended damage to the equipment, sterilization is only recommended when stipulated 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.
  • Page 18: Emg Interference

    ENGLISH 10.3 EMG interference 1. A comfortable patient room. 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 patients.
  • Page 19: Troubleshooting

    ENGLISH 10.5 Troubleshooting Trouble Possible Reason Solution Big interference; 1. V1. It is firm whether 1. Checking ECG leaders, Random waveform. the grounding connections. grounding, and Power 2. The joint of two sides of source. conductance line is not stable. 2. Please make sure the 3.
  • Page 20: Key Of Symbols

    ENGLISH 11 KEY OF SYMBOLS Symbol Description Defibrillation-proof type CF applied part Warning – See User Manual Direction Key: Up Σ Direction Key: Down PHTHALATES Direction Key: Left Σ Direction Key: Right Keep away from sunlight Keep in a cool, dry place PHTHALATES Please read instructions carefully Σ Σ Function key:power supply/acknowledgment/shortcut menu PHTHALATES Σ Function Key: Pause/On THALATES Function Key: System Menu PHTHALATES Function Key: Print Function Key: Calibrate AC power is on (no battery or full of battery) The battery solely powered and the battery is full of electricity The battery solely powered and the battery is not full of electricity The battery solely powered and the electric power is going to be used up...
  • Page 21: Function Specification

    The warranty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons.

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