GIMAPLAY 1 User Manual
Contents
1. 9 LCD Display 128x64 dot HIGH RESOLUTION THERMAL PRINTER 8 dots mm 1 channel hardcopy in real time with possibility to print the millimetric grid EASY PAPER LOADING Manual or Automatic RECORDING 5 seconds MEMORY for all 12 derivations DIGITAL FILTERS for elimination of muscles tremors power line and base line disturbs Internal Ni Cd Batteries with high capacity and fast charge time EASY OPERATION with one touch keys and menus Based on a RISC PROCESSOR for full digital signal processing 10 REALLY PORTABLE Small dimensions and light weight GIMAPLAY 1 USER MANUAL V 04 02 Pag 4 TECHNICAL CHARACTERISTICS POWER SUPPLY Internal rechargeable Ni Cd batteries INE POWER SUPPLY 220V 10 50 60Hz 150 mA max Isolation CL2 B BATTERY AUTONOMY 3 hours APPLIED PART CF type INPUT IMPEDANCE gt 100 Mohm FREQUENCY RESPONSE 0 05 145Hz CMRR gt 100 dB TIME CONSTANT gt 3 2 s ACQUISITION 12 bit 800 samples sec channel LEADS 12 Standard SENSITIVITY 5mm mV 10mm mV 20mm mV 5 SCROLLING SPEED 5mm s 10 mm s 25 mm s 50 mm s SIGNAL MEMORY 5s for each lead PRINTER thermal printer 8dots mm paper 58 mm 60 mm DISPLAY LCD 128 x 64 dots FILTERS muscles tremors 35Hz digital power line interferences 50Hz 60Hz digital high pass 0 5Hz digital DEFIBRILLATION PROTECTION internal HARDCOPY 1 channel DIMENSIONS 190 x 120 x 60 mm WEIGHT 900 g2. CES 1 Manual mode in real time at any time pressing the 3 Manual key To stop the print push again the same key 2 Isochronous mode suggested pushing the key 4 the first leads group will be printed and in the same time the other leads are acquired and printed in sequence for 5 or 10 seconds according to the frame length set up After traces print the message MEMORY DATA will be displayed Itis also possible to modify the parameters paper speed sensitivity of recording and to reprint the traces in memory pushing the key Copy 2 To exit this mode press again the key 4 3 Sequential Mode pushing the key 2 all the electrocardiograph leads are acquired and printed in real time The print can be stopped by pressing the key 2 at any time GIMAPLAY USER MANUAL V 04 02 Pag 11 3 11 LOADING THE THERMAL PAPER When the thermal paper is finished the PAPER ERROR message appears on the display Open the printer cover insert the paper roll into the printer slot with the thermo sensible side down and finally close the printer cover Keep pushing the feed key 1 until the paper comes out of the printer straight The paper used of high quality can be diagrammed or white in this case it is necessary to program the electrocardiograph for the Grid Print 3 12 BATTERIES CHARGE At the first utilization the batteries must be charged During the first charge it is suggested to turn off
3. GIMAPLAY USER MANUAL V 04 02 Pag 1 ELI Code 33331 GIMAPLA Y 1 1 CHANNEL ELECTROCARDIOGRAPH WITH GRAPHICAL DISPLAY AND PRINTER GIMA S p A Via Monza 102 20060 Gessate MI Italia ITALIA Tel 02 953854 1 Fax 02 95381167 e mail gima gimaitaly com www gimaitaly com EXPORT Tel 39 02 953854209 221 225 Fax 39 02 95380056 e mail export gimaitaly com www gimaitaly com GIMAPLAY USER MANUAL V 04 02 Pag 2 1 INTRODUCTION 2 CHARACTERISTICS AND SAFETY REFERENCES 3 USE INSTRUCTIONS 3 1 INITIAL SET UP AND AMBIENT CONDITIONS 3 2 RECOMMENDATIONS FOR SAFE USE 3 3 POWER ON OFF 34 KEY BOARD DESCRIPTION 3 5 DEFAULT OPERATIONAL SET UP 3 6 THE MAIN OPERATIONAL MODES 3 7 THE MODES MENU 3 8 PREPARATION OF THE PATIENT 3 9 ELECTRODES APPLICATION 3 10 PRINTING TRACES 3 11 LOADING THE THERMAL PAPER 3 12 BATTERIES CHARGE 4 MAINTENANCE 4 1 GENERAL RACCOMENDATIONS 4 2 PERIODIC CONTROLS S STANDARD ACCESSORIES 6 TROUBLE SHOOTING GIMAPLAY USER MANUAL V 04 02 Pag 3 1 INTRODUCTION Congratulations on your purchase of the new GIMAPLAY 1 electrocardiograph The GIMAPLAY 1 complies with the Medical Devices Directive 93 42 EEC and therefore is labeled with the corresponding mark CE 0068 2 CHARACTERISTICS AND SAFETY REFERENCES GIMAPLAY 1 is a 1 channel electrocardiograph and is in class Il CF according to the EN60601 1 and EN60601 2 25 norms FUNCTIONAL CHARACTERISTICS l 2 8
4. axed and the room temperature must be above 20 deg centigrade to avoid the ecg signal to be disturbed by muscle tremors e Clean the skin where the electrodes will be placed with alcohol e Make sure that during recording the patient does not touch another person or conductive objects 3 9 ELECTRODES APPLICATION Apply a small quantity of conductive gel on the part of the skin where the electrodes will be placed not necessary if disposable electrodes with pre applied gel are used Position the electrodes according to the following scheme C1 on the 4 intercostal space on the right parasternal part C2 on the 4 intercostal space on the left parasternal part C3 on the 5 rib between C2 and C4 C4 on the 5 intercostal space on the left hemiclavicular region C5 on the left anterior axillary at the same level as C4 C6 on the left mid axillary at the level of C4 GIMAPLAY USER MANUAL V 04 02 Pag 10 Peripheral electrodes N Right leg R Right hand F Left leg L Left hand ECG DERIVATIONES ACCORDING TO IEC and AHA C1 White Red C2 White Yellow C3 White Green C4 White Brown C5 White Black C6 White Violet L Yellow F Green V Brown Red V2 Brown Yellow V3 Brown Green V4 Brown Blue V5 Brown Orange V6 Brown Violet LA Black LL Red It is important not to use electrodes of different material as this can create polarization currents and disturb the base line of the ECG signals 3 10 PRINTING TRA
5. ordance with the instructions in this manual e The unit is delivered with a set of standard accessories For reasons of safety reliability and compatibility with the CE standards use only the original accessories or others approved by the producer e GIMAPLAY 1 is equipped with thermal head printing mechanism which allows high quality hardcopy To ensure the quality and reliability of the printer use only the original paper or one approved by the producer e Make sure that the line voltage corresponds to the voltage indicated on the batteries charger supplied with the unit e GIMAPLAY 1 has the isolation class II CF which means no ground connection is needed Also the patient is fully isolated and defibrillation protected The defibrillation protection is guaranteed only if the original patient cable is used e Check periodically the integrity of all accessories and the unit itself e Do not use the unit in presence of anesthetics or flammable gases e The producer is responsible for the unit in terms of safety reliability and functionality only if The unit is used in accordance with the user instructions The electrical service at the location of use is according to the binding standards The repairs are performed by the producer or by an authorized service center GIMAPLAY USER MANUAL V 04 02 Pag 6 e The unit is equipped with long life rechargeable batteries However it is recommended to use only the original charger and
6. pears on the display Sensitivity of recording 10mm mV by default Pushing the key 6 it is possible to select the sensitivity of the trace 20mm mV 5mm mV 10mm mV The mode appears on the display Filters disabled by default Pushing the key 7 8 9 it is possible to enable the desired filter LP anti muscle tremors filter HP anti base line disturbs filter N5 N6 anti power line disturbs filter N5 for 50 Hz and N6 for 60 Hz Traces Group the Standard modality is predefined at power on and the display shows the I trace It is possible to select the desired trace by pushing the keys 10 and 11 With the Standard Modality the display will show I 11 HI aVr aVL aVF Vi Vx V3 V Vs Vo Changing to Cabrera modality the display will show aVL I aVR II aVF III Vi Vo Vs Va Vs Vg GIMAPLAY USER MANUAL V 04 02 Pag 9 3 7 THE MODES MENU It is possible to select the Modes Menu pushing the key 12 and on the display will be shown Mode Standard Grid off Table on Frame 5 sec Ezit It is possible to change the mode by pushing the keys 10 11 and the key 12 to confirm it In order to continue the work with the new settings select Exit and press the Menu key 12 3 8 PREPARATION OF THE PATIENT For a high quality ECG recording good preparation of the patient and correct positioning of the electrodes is necessary e The patient should be rel
7. se optional Consolle GIMAPLAY 1 Patient Cable Electrodes Set Power Cable Paper roll Gel Flacon User Manual 6 TROUBLE SHOOTING TROUBLES CAUSES AND REMEDIES Graphic not displayed Batteries discharged Faded hardcopy Non original paper or batteries discharged No hardcopy Wrongly positioned paper roll thermosensible side up Batteries not recharging Verify power cable connection Device does not turn on Recharge the batteries Faulty paper flow End of paper roll non original paper or wrongly positioned paper roll Baseline drift contact or patient movement Muscle tremors Patient not relaxed filter non active Interferences on trace Faulty patient cable dirty electrodes surface or insufficent skin contact Display turns off Excessive electrical discharge Switch off unit Dirty electrodes surface insufficent skin And wait 10 15 seconds then switch on
8. the instrument Connect the line power supply to the charge connector placed on the back side near the main switch When the BATT LOW message appears on the display it is necessary to recharge the batteries During charging a dynamic charge bar appears on the display with the message Battery Charging At the charge end the charge bar will stop and the Charge Finished message will be shown so it is possible to disconnect the charger ATTENTION use only the original line power supply 4 MAINTENANCE 4 1 GENERAL RECCOMENDATIONS The equipment needs neither special servicing nor calibration For a correct maintenance is recommended a after use clean the patient cables and the electrodes removing the gel residue do not use aggressive chemical detergents or vapour clean the unit with dry cotton d the device cannot be sterilized The electrodes can be sterilized with oxide of ethylene e do not scratch the screen do not spill liquid on the unit g do not pull patient cables oc T 4 2 PERIODIC CONTROLS GIMAPLAY USER MANUAL V 04 02 Pag 12 Periodically control the battery status bar When the charge value is lower than 75 please plug in the charger IMPORTANT To insure a correct and long lasting operation of the batteries it is necessary to control the charge status If the device is not used it is suggested to recharge the batteries every 2 weeks 5 STANDARD ACCESSORIES Carrying ca
9. to follow the procedures described in this manual to ensure the long autonomy of the batteries The producer is not responsible for damage to persons or the unit following the usage of a non original charger 3 3 POWER ON OFF To turn on off the instrument press the main switch placed on its back side The initials screen will display the battery status bar If the charge value is lower than 75 please plug in the charger To start the work connect the patient cable apply the electrodes on the patient and press any key GIMAPLAY USER MANUAL V 04 02 Pag 7 3 4 KEY BOARD DESCRIPTION ejj ILS US LS la fre ira ee 1 Paper Feed 2 Sequential Mode or Printing Memory Data 3 Manual Mode 4 Isochronous Automatic Mode 5 Paper Speed 6 Sensitivity of Recording 7 Anti Muscle Tremors Filter 8 Anti Base Line Disturbs Filter 9 Anti Power Line Disturbs Filter 10 11 Vertical Arrows Traces Group Selection Modes Menu Selection 12 Modes Menu GIMAPLAY 1 USER MANUAL V 04 02 Pag 8 3 5 DEFAULT OPERATIONAL SET UP At power on the default set up is Traces Order Standard Paper Speed 25 mm s Sensitivity of recording 10 mm mV Filters Disabled Hardcopy frame length 5 seconds 3 6 THE MAIN OPERATIONAL MODES 1 3 Paper Speed 25mm s at power on Pushing the key 5 it is possible to select the paper speed 50mm s 5mm s 10mm s 25mm s 5mm s The mode ap
10. with paper roll CASE IP 20 OPERATION TEMPERATURE 10 C 40 C STORAGE TEMPERATURE 10 C 40 C RELATIVE OPERATIONAL UMIDITY 25 95 without condensation CONFORMITY STANDARDS 93 42 CEE EN60601 1 EN60601 1 2 IEC601 2 25 CLASSIFICATION II a class according to 93 42 CEE SERIAL NUMBER model symbol year month and progressive production GIMAPLAY 1 USER MANUAL V 04 02 Pag 5 3 USE INSTRUCTIONS 3 1 INITIAL SET UP AND AMBIENT CONDITIONS GIMAPLAY 1 is built according to the CE standards and therefore is protected against electromagnetic interference from other devices Nevertheless in order to protect your device from other equipment that does not conform to the standards it is recommended to e Avoid using cellular telephones in the vicinity especially during recording e Place the electrocardiograph as far as possible from electrical lines or static electricity sources to avoid the ECG signal disturbance e Avoid positioning of the electrocardiograph during recording close to other diagnostic or therapeutic equipment like X ray or ultrasound which can generate excessive electromagnetic interference e Perform the recording in a room with temperature between 20 and 25 degrees centigrade to avoid the patient feeling cold and induce the presence of muscle tremors e Do not expose the unit to excessive salty or humid environments 32 RECOMMENDATIONS FOR SAFE USE e Use the device in acc
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