CARDIOGIMA 6M User Manual
Contents
1. Standard F1 for turning on the Standard or Cabrera modality Grid Off F2 for turning on off the hardcopy grid 6 Leeds F3 for three or six traces display and 3 6 12 traces print In 12 traces mode the sensitivity is fixed 2 5 mm mV Second Menu Base 1 F1 enables the first trace base line shift using the ft and M keys Base 2 F2 enables the second trace base line shift using the and W keys Base 3 F3 enables the third trace base line shift using the and MK keys Third Menu Base 4 Fi enables the fourth trace base line shift using the ft and V keys Base 5 F2 enables the fifth trace base line shift using the and M keys Base 6 F3 enables the sixth trace base line shift using the ft and W keys Fourth Menu Table Fi for turning on off the Patient Data Table Frame F3 to set the hardcopy frame length to 5 10 sec Clamp F3 to reset the base lines when the electrodes are disconnected or in case of excessive shift of the traces Fifth Menu for turning on the Filters as the key alternative v Main operational modes 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 relaxed 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 alco2. or vapour clean the unit with dry cotton the device cannot be sterilized The electrodes can be sterilized with oxide of ethylene do not scratch the screen do not spill liquid on the unit do not pull the patient cables 4 2 PERIODIC CONTROLS Periodically control the battery status bar When the charge value is lower than 75 please plug in the charger CARDIOGIMA 6M USER MANUAL V 04 05 Pag 12 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 case optional Consolle CARDIOGIMA 6M Patient Cable Electrodes Set Power Cable Paper roll Gel Flacon User Manual 6 TROUBLE SHOOTING TROUBLES CAUSES AND REMEDIES Pressing the Freeze key the graphic does not stop After pressing the Freeze key wait the cursor to reach the end of display then press the other keys Graphic not displayed Batteries discharged Faded hardcopy Non original paper or batteries discharged No hardcopy Wrongly positioned paper roll thermosensitive 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 Dirty electrodes surfac
3. 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 CARDIOGIMA 6M USER MANUAL V 04 05 Pag 6 e The unit is equipped with long life rechargeable batteries However it is recommended to use only the original charger and 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 left side The initials screen will display the battery status bar If the charge value is lower than 80 please plug in the charger To start the work connect the patient cable apply the electrodes on the patient and than push the key start F 3 4 KEY BOARD DESCRIPTION Batteries Charger Indicator Paper Feed Sequential Mode or Printing form Freeze Manual Mode Automatic Mode Freeze Paper Speed Sensitivity of Recording Filters Menu Vertical Arrows Traces Group Selection Horizontal Arrows Memory Scroll Tl A gt 1 1 CARDIOGIMA 6M USER MANUAL V 04 05 Pag 7 F1 F4 Menu Selections 3 5 DEFAULT OPERATIONAL SET UP At power on the default set up is Traces display print number 6 Traces
4. CARDIOGIMA 6M USER MANUAL V 04 05 Pag 1 ELI Code 33350 CARDIOGIMA 6M 3 6 12 CHANNELS ELECTROCARDIOGRAPH WITH GRAPHICAL DISPLAY AND PRINTER ror M TN te UM 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 CARDIOGIMA 6M USER MANUAL V 04 05 Pag 2 USER MANUAL 1 INTRODUCTION 2 CHARACTERISTICS AND SAFETY RIFERIMENTS 3 USE INSTRUCTIONS 3 1 INITIAL SET UP AND AMBIENTAL CONDITIONS 3 2 RECOMMENDATIONS FOR SAFE USE 3 3 POWER ON OFF 3 4 KEY BOARD DESCRIPTION 3 5 DEFAULT OPERATIONAL SET UP 3 6 THE MAIN OPERATIONAL MODES 3 7 SECONDARY OPERATIONAL MODES CHANGE 3 8 PREPARATION OF THE PATIENT 3 9 ELECTRODES APPLICATION 3 10 IMAGE FREEZING 3 11 PRINTING TRACES 3 12 LOADING THE THERMAL PAPER 3 13 BATTERIES CHARGE 4 MAINTENANCE 4 1 GENERAL RACCOMENDATIONS 4 2 PERIODIC CONTROLS S STANDARD ACCESSORIES 6 TROUBLE SHOOTING CARDIOGIMA 6M USER MANUAL V 04 05 Pag 3 1 INTRODUCTION Congratulations on your purchase of the new CARDIOGIMA 6M electrocardiograph The CARDIOGIMA 6M is build in compliance with the Medical Devices Directive 93 42 EEC and therefore is labeled with the corresponding mark CE 0068 2 CHARACTERISTICS AND SAFETY REFERENCES CARDIOGIMA 6M is a 3 6 channels electrocardiogra
5. MORY 10s for each lead PRINTER thermal printer 8dots mm paper 110 mm DISPLAY LCD 320 x 240 dots back light CFL FILTERS muscles tremors 35Hz digital power line interference 50Hz 60Hz digital high pass 0 5Hz digital DEFIBRILLATION PROTECTION internal DISPLAY 3 6 channels HARDCOPY 3 6 12 channels DIMENSIONS 240 x 160 x 65 mm WEIGHT 1 500 g 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 CARDIOGIMA 6M USER MANUAL V 04 05 Pag 5 3 USE INSTRUCTIONS 3 1 INITIAL SET UP AND AMBIENTAL CONDITIONS CARDIOGIMA 6M 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 specially 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
6. Order Standard Paper Speed 25 mm s Sensitivity of recording 5 mm mV Filters Disabled Traces Group I II III aVR aVL aVF Hardcopy frame length 5 seconds 3 6 THE MAIN OPERATIONAL MODES 1 3 Paper Speed 25mm s at the turning on Pushing the key it is possible to select the paper speed 50mm s 5mm s 10mm s 25mm s 5nim s Sensitivity of recording 5mm mV by default Pushing the key it is possible to select the sensitivity of the trace 10mm mV 20mm mV 5mm mv Filters disabled by default Pushing the key it is possible to enable the desired filter according to the keys Fy F2 F5 LP anti muscle tremors filter HP anti base line disturbs filter NOTCH anti power line disturbs filter Traces Group the Standard modality is predefined at power on With this modality on the display will show First Group E IL III aVr aVL aVF Second Group Vi V2 V3 Va Vs Vo It is possible to select the desired group pushing the keys ft and 9 Changing to Cabrera modality the display will show First Group aVL 1 aVR II aVF MI Second Group Vi Vo V3 Va Vs Vg CARDIOGIMA 6M USER MANUAL V 04 05 Pag 8 3 7 SECONDARY OPERATIONAL MODES CHANGE Using the menu options it is possible to access the secondary operational parameters as follows pushing the key Menu F4 different menus will be displayed according to the keys Fi Fz Fs First Menu
7. e insufficent skin 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 CARDIOGIMA 6M USER MANUAL V 04 05 Pag 13 PARAMETERS CALCULATION STANDARD INTERVALS PA PR Interval S ia RS i Complex ks er Interval et ee gt RR The time between two consecutive QRS complexes computed from the heart rate median value PQ PR P R interval is the time between the P wave start and the QRS complex start ORS The length of the QRS complex OT The interval between the QRS complex start and the end of the T wave QTC The normalized QT interval QT that the patient would have at a 60BPM heart rate The formula used for computing QTC is QTC QT sqr 1000 RR WARNING The electrocardiograms in general the biosignals do not correspond to precise mathematical functions The measurement points defined by the machine are extremely sensitive to noise disturbs For an accurate interpretation the doctor have to control and validate the measurement points The doctor should never confirm the machine analysis results without controlling first the morphology of the representative cycles and the correct position of the measuring points Each electrocardiogram and the relative analysis becomes a diagnostic document only after the doctor approval and his signature
8. hol e Make sure that during recording the patient does not touch another person or conductive objects CARDIOGIMA 6M USER MANUAL V 04 05 Pag 9 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 Peripheral electrodes N Right leg R Right hand F Leftleg L Left hand ECG DERIVATIONES ACCORDING TO IEC and AHA IEC AHA N Black RL Green R Red RA White C1 White Red V Brown Red C2 White Yellow V2 Brown Yellow C3 White Green V3 Brown Green C4 White Brown V4 Brown Blue C5 White Black V5 Brown Orange C6 White Violet V6 Brown Violet L Yellow LA Black F Green LL Red CARDIOGIMA 6M USER MANUAL V 04 05 Pag 10 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 IMAGE FREEZING By pushing the key Freeze H it is possible to stop the display The data acquisition will co
9. ng the green button and place the paper roll with the thermal sensible side down leaving about 5 cm out Replace the printer cover by inserting it on the left side opening and then push it down until it locks CARDIOGIMA 6M USER MANUAL V 04 05 Pag 11 Keep pushing the feed key 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 v Secondary operational modes 3 14 BATTERIES CHARGE At the first use the batteries must be charged During the first charge it is suggested to turn off the instrument Connect the line power supply to the charge connector placed on the back side near the main switch When the Battery Low message appears on the display it is necessary to recharge the batteries During charging the front LED is on When the LED is flashing or at maximum 4 hours time disconnect the charger Batteries can also be charged connecting the optional cable to the car cigar lighter It is a good practice to disconnect the charger after charge finished 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 after use clean the patient cables and the electrodes removing the gel residue donotuse aggressive chemical detergents
10. ntinue for 10 seconds RECORD When the acquisition is finished MEMORY pushing the and keys it is possible to review the traces memorized and to print them pressing the key 3 11 PRINTING TRACES 1 Manual mode in real time at any time pressing the Manual key To stop the print push again the same key 2 Isochronous mode suggested pushing the key 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 Basic model After first group print the message DATA FROM MEMORY will be displayed It is also possible to modify the parameters paper speed sensitivity of recording and to reprint the traces in memory pushing the key Copy To exit this mode press again the same key Parameter calculation Interpretation model After traces hard copy the table with parameter calculation will be printed for Par C model and then the interpretation for Int model After machine automatically returns to normal operation 3 Sequential Mode push the key all the electrocardiograph leads are acquired and printed in automatic sequence The print can be stopped pressing the key at any time 3 13 LOADING THE THERMAL PAPER When the thermal paper is finished the paper missing message appears on the display Open the printer cover pressi
11. ph and is in class If CF according to the EN60601 1 and EN60601 2 25 norms FUNCTIONAL CHARACTERISTICS l 8 9 LCD Graphical Display 320x240 dots 3 or 6 channels in Standard or Cabrera format with base line movement possibility High Resolution Thermal Printer 8 dots mm 3 or 6 channels hardcopy in real time with possibility to print the millimetric grid Manual or Automatic recording 10 seconds memory for all 12 derivations Image Freeze with the possibility to scroll into the memory for reviewing hardcopy Integrated Digital Filters Low pass High pass and Notch 50 60 Hz Internal rechargeable 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 11 Easy drop in paper loading CARDIOGIMA 6M USER MANUAL V 04 05 Pag 4 TECHNICAL CHARACTERISTICS POWER SUPPLY Internal rechargeable Ni Cd batteries LINE POWER SUPPLY 220V 10 50 60Hz 150 mA max Isolation CL2 B BATTERY AUTONOMY 2 5 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 isochrone LEADS 12 Standard or Cabrera SENSITIVITY 5mm mV 10mm mV 20mm mV 5 SCROLLING SPEED 5mm s 10 mm s 25 mm s 50 mm s SIGNAL ME
12. 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 accordance 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 CARDIOGIMA 6M 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 9 Make sure that the line voltage corresponds to the voltage indicated on the batteries charger supplied with the unit e The CARDIOGIMA 6M has the isolation class If CF which means no ground connection is needed Moreover 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
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