BeneVision N1 - 5.4.4 Temp Test; 5.4.5 NIBP Tests; 5.4.6 IBP Test and Calibration; 5.4.6.1 Performance Test

5-8
1. Connect the SpO
2
sensor to the SpO
2
connector on the monitor. Set Patient Category to Adult and PR Source to
SpO
2
on the monitor.
2. Apply the SpO
2
sensor to your ring finger (it is assumed that you are healthy).
3. Check the Pleth wave and PR reading on the screen and make sure that the displayed SpO
2
is within 95% and100%.
4. Remove the SpO
2
sensor from your finger and check that the SpO
2
sensor off alarm is triggered.
The SpO
2
accuracy has been verified in human experiments by comparing with the arterial blood sample reference
measured by a CO-oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the
measurements are expected to fall within the specified accuracy range compared to CO-oximeter measurements.
NOTE
 A simulator can only verify whether the monitor is functional. The accuracy of a pulse oximeter monitor
or a SpO
2
sensor needs to be verified by clinical data.
5.4.4 Temp Test
Tools required:
 Resistance box (with accuracy greater than or equal to 0.1 Ω)
1. Connect the two pins of any Temp connector of a module to the two ends of the resistance box using two wires.
2. Set the resistance box to 1354.9 Ω (the corresponding temperature is 37°C).
3. Verify that the displayed value is within 37±0.1°C.
4. Repeat steps 1 to 3 to verify each Temp channel of the monitor.
5.4.5 NIBP Tests
Refer to section 5.2.2 NIBP Tests.
5.4.6 IBP Test and Calibration
5.4.6.1 Performance Test
Tools required:
 Patient simulator Medsim300B, MPS450, or equivalent equipment
 IBP adapter cable for test (use P/N 009-002199-00 for Medsim300B; use P/N 009-002198-00 for MPS450)
1. Connect the patient simulator to the IBP connector on the monitor.
2. Set the patient simulator to output 0 mmHg to an IBP channel.
3. Select Zero IBP in the IBP setup menu. Then select
Zero.
4. Set static pressure to 200 mmHg on the patient simulator.
5. Check that the value displayed on the monitor is within 200±4 mmHg.
6. If the error is beyond ±4 mmHg, calibrate the IBP module. If the IBP module was calibrated with a dedicated
reusable IBP sensor, check the calibration together with this IBP sensor.