1 year

Has electrical safety

Device appearance and installation checks – Inspect the Trio Monitor to ensure that the outer housing
of the device is clean and has no scratches or cracks.

Device appearance and installation checks – Inspect the Trio Monitor to ensure that when shaking the
device, there are no loose components.

Device appearance and installation checks – Inspect the Trio Monitor to ensure that all keys are smooth
and free for operation.

Device appearance and installation checks – Inspect the Trio Monitor to ensure that labels are complete,
sufficient, and accurate.

Device appearance and installation checks – Inspect the Trio Monitor to ensure that standard
configuration is complete and all connectors are installed securely.

Perform IBP pressure calibration.

NIBP calibration – (0 mmHg) Check that the difference between the indicated pressure of the digital
mercury manometer and the indicated pressure in the NIBP parameter tile of the Trio Monitor does not
exceed 3 mmHg. 0 – 3 mmHg

NIBP calibration – (50 mmHg) Check that the difference between the indicated pressure of the digital
mercury manometer and the indicated pressure in the NIBP parameter tile of the Trio Monitor does not
exceed 3 mmHg. 47 – 53 mmHg

NIBP calibration – (200 mmHg) Check that the difference between the indicated pressure of the digital
mercury manometer and the indicated pressure in the NIBP parameter tile of the Trio Monitor does not
exceed 3 mmHg. 197 – 203 mmHg

NIBP pneumatic – Check that the prompt ‘Pneum testing…’ appears at the bottom of the NIBP
parameter area, indicating that the system has started performing the pneumatic test.

NIBP pneumatic – Check that the system automatically inflates the pneumatic system to about 180
mmHg.

NIBP pneumatic – Check that after approx. 20 seconds, the system automatically deflates, marking the
completion of the test.

NIBP pneumatic – Check that no message appears at the bottom of the NIBP parameter area.

ECG calibration – Check that the message CALIBRATION MODE appears in red at the lower left of the
ECG waveform area.

ECG calibration – Check that the highlighted tile reads STOP CAL.
ECG calibration – Check that a 1mV peak to peak square wave appears in the ECG waveform area. This is
the Cal Pulse.

ECG calibration – (size x1) Check that the Cal Pulse measures 1 cm +/- 5%. 0.95 – 1.05 cm

ECG calibration – (size x2) Check that the Cal Pulse measures 2 cm +/- 5%. 1.9 – 2.1 cm

ECG calibration – (size x.25.) Check that the Cal Pulse measures 25 mm +/- 5%. 23.75 – 26.25 mm

ECG calibration – (size x.5.) Check that the Cal Pulse measures 50 mm +/- 5%. 47.5 – 52.5 mm

ECG and RESP testing – Check if ECG waveforms and RESP waveforms are displayed.

ECG and RESP testing – (HR=30 (gain × 4); RR=15) Check if the displayed ECG and RESP waveforms, HR
and RR values are correct.

ECG and RESP testing – (HR=240; RR=120) Check if the displayed ECG and RESP waveforms, HR and RR
values are consistent with the parameters set up on the simulator.

ECG and RESP testing – (Remove ECG lead) Check that the Trio immediately alarms and displays ECG
LEAD OFF at the top right side of the Message Area.

NIBP testing – (Systolic = 90 mmHg) Check readings for consistency. Reading should not deviate greater
than +/- 5 mmHg. 85 – 95 mmHg

NIBP testing – (Mean = 70 mmHg) Check readings for consistency. Reading should not deviate greater
than +/- 5 mmHg. 65 – 75 mmHg

NIBP testing – (Diastolic = 60 mmHg) Check readings for consistency. Reading should not deviate greater
than +/- 5 mmHg. 55 – 65 mmHg

SpO2 testing – (SpO2=98; PR=70) Check that the SpO2 and PR values displayed on the Trio Monitor are
equal to the SpO2 simulator values +/- 2%. SpO2 range is 96 – 100% and PR range is 68 – 72%.

SpO2 testing – (Change the SpO2 and PR values on the simulator) Check that the displayed values on
Trio are equal to the SpO2 simulator values +/- 2%. Free text

SpO2 testing – (Remove SpO2 sensor) Check that Trio immediately alarms and displays the message
SpO2 SENSOR OFF in the message area in the top right corner of the display.

TEMP testing – (34ºC) Check that the displayed TEMP value on the Trio Monitor is 34ºC +/- .1ºC. 33.9 –
34.1

TEMP testing – (40ºC) Check that the displayed TEMP value on the Trio Monitor is 40ºC +/- .1ºC. 39.9 –
40.1

IBP testing – Perform zero calibration for IBP.

IBP testing – (100 mmHg) Perform IBP calibration.

IBP testing – (40 mmHg) Check that the unit displays 40 ± 1 mmHg.

IBP testing – (100 mmHg) Check that the unit displays 100 ± 2 mmHg.
IBP testing – (200 mmHg) Check that the unit displays 200 ± 4 mmHg.

IBP testing – (Set the Patient Simulator to output an arterial wave with a value of 120/80) Check that the
unit displays the following values: Systolic 120 +/- 2%. 117.6 – 122.4 mmHg

IBP testing – Check that the unit displays the following values: Diastolic 80 +/- 2%. 78.4 – 81.6 mmHg

IBP testing – Confirm that the corresponding waveform is displayed correctly.

IBP testing – (Unplug the IBP sensor) Check that IBP SENSOR OFF is displayed in the Message Area in the
top right corner of the display.