2 years

Visual Inspection – Check the integrity of mechanical parts, internally and externally.

Visual Inspection – Check any damage or contamination, internally and externally.

Visual Inspection – Check that no loose parts or foreign bodies remain in the device after servicing or
repair.

Visual Inspection – Check the integrity of all relevant accessories.

Power on test – Check that the monitor boots up and displays an ECG wave. The wave might be a flat
line if no simulator is attached.

NBP accuracy test and calibration – Check that the difference between the manometer and displayed
values is not greater than 3 mmHg or if the NBP pump assembly has not been exchanged.

NBP leakage test – Check that the leakage test value is less than 6 mmHg.

NBP linearity test – Check that the difference is not greater than 3 mmHg.

Valve test – Check that the value is less than 10 mmHg.

ECG performance test – Check the displayed ECG wave and HR value against the simulator configuration.
Check that the value is 100 bpm +/- 2 bpm or 120 bpm +/- 2 bpm.

Respiration performance test – Check that the value is 40 rpm +/- 2 rpm or 45 rpm +/- 2 rpm.

SpO2 performance test – (for Philips FAST SpO2 Technology) Check that the value is between 95% and
100%.

SpO2 performance test – (for Nellcor OxiMax SpO2 Technology) Check that the value is between 95%
and 100%.

SpO2 performance test – (for Masimo rainbow SET SpO2 Technology) Check that the value is between
95% and 100%.

SpO2 performance test – (SET Tester and RRa Simulator) Verify that all enabled parameters are within
specified range.

SpO2 performance test – (Sensor Port Test Tool) Confirm that each LED turns on one at a time and then
all LEDs turn on.

SpO2 performance test – (Shield Continuity) Verify that the resistance is less than 5Ω.

Invasive pressure performance test – Check that the value is 200 mmHg ± 5 mmHg.

Invasive pressure performance test – Check that the value is 200 mmHg ± 5 mmHg. (repeated for the
second pressure connector.)

Temperature performance test – Check that the value is 40°C ± 0.2°C or 100°F ± 0.4°F.
Microstream CO2 performance test – Leakage Check with M1026-60144 Flowmeter (only for M3015A
with HW Rev. A and B and Firmware Revision < P.01.32) – Part 1 – Check the ambient pressure and the
cell pressure shown in the monitor’s status line. The cell pressure should be approximately 20 mmHg
lower than ambient pressure.

Microstream CO2 performance test – Leakage Check with M1026-60144 Flowmeter (only for M3015A
with HW Rev. A and B and Firmware Revision < P.01.32) – Part 1 – Check that the value on the
flowmeter (x1) decreases to between 0 and 4 ml/min, accompanied by an audible increase in pump
noise.

Microstream CO2 performance test – Leakage Check with M1026-60144 Flowmeter (only for M3015A
with HW Rev. A and B and Firmware Revision < P.01.32) – Part 2 – Check that the value on the
flowmeter (x2) decreases to between 0 and 4 ml/min, accompanied by an audible increase in pump
noise.

Microstream CO2 performance test – Leakage Check with M1026-60144 Flowmeter (only for M3015A
with HW Rev. A and B and Firmware Revision < P.01.32) – Part 2 – Check that the cell pressure shown in
the status line on the display decreases to between 300 and 500 mmHg.

Microstream CO2 performance test – Leakage Check for 867041, M3015B and M3015A with HW Rev C
or M3015A with HW Rev. A/B without M1026-60144 Flowmeter – Check that for 30 seconds the change
of the pressure reading is less than 20 mbar.

Microstream CO2 performance test – Leakage Check for 867041, M3015B and M3015A with HW Rev C
or M3015A with HW Rev. A/B without M1026-60144 Flowmeter – Integrity of the Leakage Test Kit –
Check that the pressure does not increase more than 8 mbar in 1 minute.

Microstream CO2 performance test – Flow Rate Check and Calibration – Check on the flowmeter the
flow that the 867041 or M3015A/B Measurement Extension or MP5 mCO2 pump draws (x5). It should
be 50 +15/-7.5 ml/min.

Microstream CO2 performance test – Noise Check – Check the noise index (x6) displayed next to the
CO2 value on the display (this indicates the level of noise on the CO2 wave). Check that it is less than 3.0
mmHg.

Microstream CO2 performance test – CO2 Cal Check and Calibration – Check that the value on the
instrument (measurement value on the main screen, x7) matches the calculated mmHg value ± 2.6
mmHg.

Microstream CO2 performance test – CO2 Cal Check and Calibration – Check that the calculated mmHg
value is within calculated tolerance.

Microstream CO2 performance test – Calibration Verification – Check the difference between measured
CO2 value and calculated value, based on 10% CO2 cal. gas. (x6 < ± {0.07 x value calculated}).

Cardiac Output (C.O.) performance test – Check displayed value against the simulator configuration.
Expected test result: C.O. = 5 +/– 1 l/min.

Cardiac Output (C.O.) performance test – Service Tool Procedure, Version 1 – Check that the Tblood =
37.0°C +/- 0.1°C.
Cardiac Output (C.O.) performance test – Service Tool Procedure, Version 2 – Check that the Tinj = 0.0°C
+/- 0.1°C.

IntelliVue Dock flexible sync out performance test – Verify that the ECG signal is displayed.

MSL assurance test – Check that the pins of the connectors are not jolted.

MSL assurance test – Check that no pin is bent inwards or outwards.

Battery performance test – Check that the battery age is less than 3 years or 500 charge/discharge
cycles.

1 year

Perform the Microstream CO2 calibration. (or after 4000 hours of continuous use)

Mainstream CO2 accuracy check – Check that the expected value is 5% of the ambient pressure
±2mmHg.

Sidestream CO2 accuracy check – Check that the expected value is 5% of the ambient pressure ±2mmHg.

Sidestream CO2 flow check – Check on the flowmeter the flow that the Sidestream CO2 extension pump
draws. It should be 50 ml/ min ± 10 ml/min.

Perform battery conditioning.