VIMAP TECHNOLOGIES
VIMAP VMX-1010A Check List Rev R2 March 2012
Check List
4 Pages
Preview
Page 1
Número:
F-00047
Fecha Creación:
Check list
Título: Revisión:
12/03/2012
Página:
R2
Rev. Fecha:
Performance Check list :
1 de 4 16/03/2012
remark
Power switch
The front panel green led must be blinking in standby mode and lit continuously in working mode (when switch is on I position)
Standby switch
When the green led is on continuously, the display screen is displaying information. When the green led is blinking, the exhaust valve connector is open. (release gas output)
CO2 bottle connector
No leak with a bottle connected
Startup test
Without gas connected (or bottle closed) -
Screen will show the sequence 1 (see appendix1) A beep is audible (buzzer test) for a short time The warning led is lit for a short time (Led test)
Run /stop Button
Press the Run or stop button: nothing occurs until calibration is done (gas is present)
Gas input: provide gas to the device
Calibration message appears
Run button
Press the run button without tubing connected: warning message: pipe missing must appear (tubing detection test). Connect tubing (only gas patient output) and press run: same message Connect tubing (gas release output) and press run: insufflation must start. Note: with a pressure bottle below 10 bars, the run is disable.
Stop button
Press Stop : insufflation must stop, , the exhaust valve connector is open. (release gas output)
Número: Título:
F-00047
Fecha Creación:
Check list
Revisión:
Pressure control:
Página:
R2
Rev. Fecha:
12/03/2012 2 de 4 16/03/2012
In a closes cavity with different pressure set check pressure on display compared to manometer: Pressure measure is +/- 2 mmHg on the range 1 to 35 mmHg
Over pressure test
With an over pressure over 2 mmhg (pressure set +3 mmHg) for more than 1.5 seconds: -
Over pressure test
Overpressure message appears Desufflation is initiated Warning led is active
With an over pressure over 10 mmhg (pressure set +11 mmHg) immediately: -
Overpressure message appears Desufflation is initiated Warning led is active, buzzer is active
Gas input test
Reduce gas bottle pressure bellow 20 bars: Message must be display
Insufflation pause
After 5L the device must pause: -
No insufflation Release valve Close
Flow test:
At 3L/min +10% -30% see appendix 2 for protocol
Number of examination
If remaining exam is 0, then device must be return to factory for servicing.
Electrical safety test (IEC60601-1) Protective ground resistance with power <0.2 ohm cord Earth leakage current
N.C <0.5mA SFC <1.0mA
Número: Título: Revisión:
Enclosure leakage current
F-00047
Fecha Creación:
Check list
Página:
R2
Rev. Fecha:
N.C <0.1mA SFC <0.5 mA
patient leakage current (applied part is N.C <0.1mA considered at end of tubing) SFC <0.5 mA patient leakage current supply voltage on N.C <0.1mA applied part (applied part is considered at SFC <0.5 mA end of tubing)
Appendix 1 : Start Up sequence
12/03/2012 3 de 4 16/03/2012
Número:
F-00047 Check list
Título: Revisión:
R2
Fecha Creación: Página: Rev. Fecha:
12/03/2012 4 de 4 16/03/2012
Appendix 2 (flow protocol) Due to the ramp up of flow, the flow can’t be set to a fix value in normal operation. Please note also that flow is stopped on regularly base to allow pressure measurement without pressure drop (due to the flow). The display is only the peak value of the real flow. Measure without flowmeter: -
Material needed o A 2 litter balloon with adaptation to tubing (luer lock)
o
A tubing
o
A chronometer
Set up: -
Connect the tubing to the device (gas output and relief output) Connect the 2L balloon to the tubing (patient side) Set up pressure set at 15 mmHg and flow at 3L/min
Test protocol -
Gas ouput
Relief output
Press Run, the insufflation starts , Start the chronometer Wait until pressure displayed on the device reach 3 mmHg (take care that pressure will stay stable at 0 for a long time and will quickly increase after 2 mmHg) and stop chronometer.
This time is the time to insufflate a 2L balloon plus the tubing. Since the flow is not constant during this time, the flow integration gives a nominal value of 1 min and 20 s for such volume.Test result:If time is between 1’10’’ (+10% error) and 1’44’’ (-30 % error)