Gima ecg80a User manual

Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. [phone] - fax [phone]
Export: tel. [phone]/221/225 - fax [phone]
[e-mail] - [e-mail]
www.gimaitaly.com
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.
M-33257-M-Rev.0.12.15
ECG CARDIOPOCKET
CARDIOPOCKET ECG
ECG CARDIOPOCKET
ECG CARDIOPOCKET
Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de Uso
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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)
Eiestrasse 80, 20537 Hamburg Germany
33257 / ECG80A
PROFESSIONAL MEDICAL PRODUCTS
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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 modications and software upgrades, the information contained in this
document is subject to change without notice.
The Manual describes, in accordance with the Electrocardiograph’s features
and requirements, main structure, functions, specications, 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.
Please peruse the relative content about the clinical restrictions
and caution.
This device is not intended for treatment.
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Contents
1 SAFETY .......................................................................................... 24
1.1 Instructions for safe operations...................................................... 24
1.2 Warnings......................................................................................... 24
1.3 Attentions........................................................................................ 24
2 OVERVIEW....................................................................................... 5
2.1 Features............................................................................................ 6
2.2 Major applications and scope of application.................................... 6
2.3 Environment requirements................................................................ 6
3 PRINCIPLE AND CAUTION ............................................................ 6
3.1 Principle of measurement................................................................. 6
3.2 Caution ............................................................................................. 7
3.3 Clinical restrictions............................................................................ 7
4 TECHNICAL SPECIFICATIONS ...................................................... 7
5 ACCESSORIES................................................................................ 8
6 INSTALLATION ................................................................................ 8
6.1 Sketch on each side and accessory................................................. 8
6.2 Electrode placement......................................................................... 9
6.3 Paper loading:................................................................................. 11
7 OPERATING GUIDE ...................................................................... 11
8 THE NOTICE OF THE BATTERY OPERATING............................. 14
9 REPAIRING AND MAINTENANCE................................................ 16
9.1 Maintenance ................................................................................... 16
9.2 Cleaning.......................................................................................... 16
9.3 Sterilization ..................................................................................... 17
9.4 Disinfection ..................................................................................... 17
10 TROUBLESHOOTING ................................................................... 17
10.1 Automatic switch off....................................................................... 17
10.2 AC interference............................................................................... 17
10.3 EMG interference............................................................................ 18
10.4 Baselinedrift................................................................................... 18
10.5 Troubleshooting .............................................................................. 19
11 KEY OF SYMBOLS........................................................................ 20
12 FUNCTION SPECIFICATION ........................................................ 21

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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qualiedservice
engineers ONLY. Users are not permitted to maintain it by themselves.
• TheElectrocardiographcannotbeusedtogetherwithdevicesnot
specied in User’s Manual.
• Whenthecardiacdebrillatorbeusedwithotherelectricstimulate
devices, Please select the electrode provided by our company.
• TheelectrodeanditsconnectorofthisECGmustkeepfromother
conductor, for example, the earth.
• AccordingtheStandardIEC60601,thisdeviceisbelongedtointernal
electrical power source, CF applied part. it is applied for cardiac
examination. This device is safe and reliable.
• PleaseselecttheECGcablewhichisprovidedbyourcompany,ifthe
 debrillationtimeisover5s,youshoulduseone-offchestelectrode,
which can avoid the metal electrode burn patient’s skin. Please don’t use
it with electric stimulator at the same time, if it is compulsory,
a professional technician must guide on the scene.
1.2 Warnings
• Explosivehazard—DONOTusetheElectrocardiographinenvironment
with inammable gas such as some ignitable anesthetic agents.
• WhenotherdevicebejoinedwiththisECGdevice,itmustbeaccorded
with Standard IEC60601, internal electrical power source. because
creepage summation may injure the patient, the creepage current be
inspected by the other device.
• Thedisposalofscrapinstrumentanditsaccessories(includingbattery)
should follow the local laws and regulations.
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25
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sufcientlywiththesafety
requirement, but the observation of the patient and the instrument
can not be ignored.
• Theinstrumenthasnormalusefullifeforveyearssincetherst
electried use.
• Theinstrumentdosenothavelow-voltagealarmfunction,itonlyshows
the battery energy, please change the battery when the battery energy
is used out.
2 OVERVIEW
Through the broading market investigation, our 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 ECG successfully after their deep research and reduplicate tests.
This equipment adopts the thermal recording mode (the key point of thermal
recordingtechniqueisthecorecomponent---thermalrecordingprobe.
Thethermalrecordingprobeisthehigh-techcomponentwithadvanced
component integrated technology, integrating a large amount of heating
elements (8points/millimetre) and its controlled circuit based on the ceramic
basalbody.Itdoesn’thavethefalsedifferencewhichcausedbynon-
linearity, damping, and incongruence of pen warmth of the traditional hot
pen ECG. In the frequency response which is the important index of affecting
thedescriptiveauthenticity,theproductcanreach0.05-150Hzfrequency
response which is the world level, aslo the equipment has advanced digital
baselinedriftinglter,AlternatingCurrentlter,andMyo-electricity
disturbancelter.Thesamplingrateofleadsignalis800Hz,
the closure frequency of low pass lter machine with guards against mixes
foldsis(-3dB)220Hz.Thesamplingrateishigherthanthestandardofnot
lowerthan500HzwhichmadebyAmericanAHAAssociationandEuropean
CSE Association.
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