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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 1
Code 33334 CARDIOGIMA 3M
1-3 CHANNELS ELECTROCARDIOGRAPH
WITH GRAPHICAL DISPLAY, PRINTER AND INTERPRETATION
GIMA S.p.A. – Via Marconi, 1 – 20060 Gessate (MI) – Italia
ITALIA: Tel. 02 953854.1 – Fax. 02 95381167
e-mail:
EXPORT: Tel. +39 02 953854209/221/225 – Fax. +39 02 95380056
e-mail:
gima@gimaitaly.com – www.gimaitaly.com
export@gimaitaly.com – www.gimaitaly.com
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CARDIOGIMA 3M USER MANUAL V. 04-05 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
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 RECCOMENDATIONS
4.2 PERIODIC CONTROLS
5. STANDARD ACCESSORIES
6. TROUBLE SHOOTING
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 3
1. INTRODUCTION
Congratulations on your purchase of the new CARDIOGIMA 3M electrocardiograph.
The CARDIOGIMA 3M complies with the Medical Devices Directive (93/42/EEC)
and therefore is labeled with the corresponding mark CE 0068.
2. CHARACTERISTICS AND SAFETY REFERENCES
CARDIOGIMA 3M is a 1-3 channels electrocardiograph and is in class II CF
according to the EN60601-1 and EN60601-2-25 norms.
FUNCTIONAL CHARACTERISTICS
1. LCD Graphical Display 320x240 dots, 1 or 3 channels in Standard or Cabrera
format with base line movement possibility.
2. High Resolution Thermal Printer (8 dots/mm). 1 or 3 channels hardcopy in
real time with possibility to print the millimetric grid.
3. Manual or Automatic recording.
4. 10 seconds memory for all 12 derivations.
5. Image Freeze with the possibility to scroll into the memory for
reviewing/hardcopy .
6. Integrated Digital Filters : Low pass, High pass and Notch 50/60 Hz .
7. Internal rechargeable Ni-Cd Batteries with high capacity and fast charge time.
8. Easy Operation with one touch keys and menus.
9. Based on a RISC processor for full digital signal processing.
10. Really portable. Small dimensions and light weight.
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CARDIOGIMA 3M 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: > 100 Mohm
FREQUENCY RESPONSE: 0.05 : 145Hz
CMRR: > 91 dB TIME CONSTANT: > 3,2 s
ACQUISITION: 12 bit 800 samples/sec/channel
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 MEMORY: 10s for each lead
PRINTER: thermal printer 8dots/mm, paper 58 mm
DISPLAY: LCD 320 x 240 dots, back light CFL
FILTERS: muscles tremors 35Hz digital; power line interferences
50Hz 60Hz digital; high pass 0.5Hz digital
DEFIBRILLATION PROTECTION: internal
DISPLAY/HARDCOPY: 1-3 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
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3. USE INSTRUCTIONS
3.1 INITIAL SET-UP AND AMBIENTAL CONDITIONS
CARDIOGIMA 3M 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:
• Avoid using cellular telephones in the vicinity especially during recording.
• Place the electrocardiograph as far as possible from electrical lines or
static electricity sources to avoid the ECG signal disturbance.
• 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.
• 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.
• Do not expose the unit to excessive salty or humid environments.
3.2 RECOMMENDATIONS FOR SAFE USE
• Use the device in accordance with the instructions in this manual.
• 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.
• CARDIOGIMA 3M is equipped with a 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.
• Make sure that the line voltage corresponds to the voltage indicated on the
batteries charger supplied with the unit.
• The CARDIOGIMA 3M has the isolation class II 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.
• Check periodically the integrity of all accessories and the unit itself.
• Do not use the unit in presence of anesthetics or flammable gases.
• 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 complies with the
binding standards.
CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 5
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 6
- The repairs are performed by the producer or by an authorized
service center.
• 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
.
1
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
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 7
Horizontal Arrows - Memory Scroll
F1-F4 Menu Selections
3.5 DEFAULT OPERATIONAL SET-UP
At power on the default set-up is:
• Traces display/print number: 3
• Traces Order: Standard
• Paper Speed: 25 mm/s
• Sensitivity of recording: 5 mm/mV
• Filters: Disabled
• Traces Group: I; II; III
• Hardcopy frame length: 5 seconds
3.6 THE MAIN OPERATIONAL MODES
1. Paper Speed: 25mm/s at power on. By pushing the key ???? it is possible to
select the paper speed: 50mm/s, 5mm/s, 10mm/s, 25mm/s…… 5mm/s ……..
2. 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……….
3. Filters: disabled by default. By pushing the key
desired filter, according to the keys F
; F2; F3:
1
- LP: anti muscle tremors filter
- HP: anti base line disturbs filter
- NOTCH: anti power line disturbs filter
4. Traces Group: the Standard mode is predefined at power on. With this
modality, on the display will show:
- First Group: I; II; III
- Second Group: aVr; aVL; aVF
- Third Group: V
Fourth Group: V4; V5; V
-
; V2; V
1
3
6
It is possible to select the desired group by pushing the keys © and ª.
Changing to Cabrera modality, the display will show:
- First Group: aVL; I; -aVR
- Second Group: II; aVF; III
- Third Group: V
- Fourth Group: V
; V2; V3
1
; V5; V6
4
≈ it is possible to enable the
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CARDIOGIMA 3M 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:
push the key Menu (F
; F2; F
F
1
3.
), different menus will be displayed according to the keys
4
First Menu:
- Standard (F
- Grid Off (F
- 3 Leeds (F
): for turning on the Standard or Cabrera modality.
1
): for turning on/off the hardcopy grid.
2
): for one or three traces display/print.
3
Second Menu:
- Base 1 (F
- Base 2 (F
): enables the first trace base line shift using the © and ªkeys.
1
): enables the second trace base line shift using the © and
2
ªkeys.
- Base 3 (F
Third Menu:
- Table (F
- Frame (F
- Clamp (F
or in case of excessive shift of the traces.
- Fourth Menu: for turning on the Filters as the key
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.
• The patient should be relaxed and the room temperature must be above 20
deg. Centigrade in order to avoid the ecg signal to be disturbed by muscle
tremors.
• Clean the skin where the electrodes will be placed with alcohol.
• Make sure that during recording the patient does not touch another person or
conductive objects.
): enables the third trace base line shift using the © and ªkeys.
3
) : for turning on/off the Patient Data Table.
1
): to set the hardcopy frame length to 5/10 sec.
2
): to reset the base lines when the electrodes are disconnected
3
≈ alternative (v. Main
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CARDIOGIMA 3M 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
C2: on the 4
C3: on the 5
C4: on the 5
th
intercostal space on the right parasternal part.
th
intercostal space on the left parasternal part.
th
rib, between C2 and C4.
th
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: Left leg
L: Left hand
ECG DERIVATIONES ACCORDING TO IEC and AHA:
IEC AHA
---------------------------------------------------------------------------------------------------------N Black RL Green
R Red RA White
C1 White/Red V1 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
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.
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 10
3.10 IMAGE FREEZING
By pushing the key “Freeze”
acquisition will continue for 10 seconds (RECORD).
When the acquisition is finished (MEMORY), through the
possible to review the traces memorized and to print them by 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 0 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”
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
Η it is possible to stop the display. The data
← and → keys it is
¬. To exit this mode
¬ at any time.
3.13 LOADING THE THERMAL PAPER
When the thermal paper is finished, the “paper missing” message appears on the
display. Cut the paper straight and insert it into the printer inlet window with the
thermo sensible side down. The printer will feed it automatically.
Keep pushing the feed key until the paper comes out of the printer straight.
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 11
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 utilization 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
- do not use aggressive chemical detergents, or vapour.
- clean the unit with dry cotton.
- the device cannot be sterilized. The electrodes can be sterilized with oxide
- 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
80%, 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.
residue
of ethylene.
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 12
5. STANDARD ACCESSORIES
Carrying case (optional)
Consolle CARDIOGIMA 3 M
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
Graphic not displayed Batteries discharged
Faded hardcopy Non original paper or batteries discharged
No hardcopy Wrongly positioned paper roll, thermosensitive
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
Baseline drift Dirty electrodes surface, insufficent skin
Muscle tremors Patient not relaxed; filter non active
Interferences on trace Faulty patient cable; dirty electrodes surface
After pressing the “Freeze” key wait the
cursor to reach the end of display, then press
the other keys.
side up.
wrongly positioned paper roll
contact or patient movement
or insufficent skin contact
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CARDIOGIMA 3M USER MANUAL V. 04-05 Pag. 13
PARAMETERS CALCULATION
STANDARD INTERVALS
RR: The time between two consecutive QRS complexes, computed from the
heart rate median value.
PQ (PR):
QRS:
QT:
QTC:
rate). The formula used for computing QTC is:
P-R interval is the time between the P wave start and the QRS complex start.
The length of the QRS complex.
The interval between the QRS complex start and the end of the T wave.
The normalized QT interval (QT that the patient would have at a 60BPM heart
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 doctor should never confirm
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.
the measurement points.
the machine analysis results without controlling
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