Users Manual

13. Maintenance and Inspection
68
* As these functions are dependent on the design or software, these items
are not mandatory for periodic checks. Perform the test as necessary.
No Check Item Check Procedure Criteria
6. Arterial Oxygen Saturation (SpO
2
)
01 SpO
2
Accuracy Measure the error at 75%,
90% using a SpO
2
simulator.
Error should be within
±2% for SpO
2
of 70–
100%.
Prepare other reference
device, perform measurement
on healthy subject, and
compare the value.
Error between the 2
devices should be
within ±4%.
02 Pulse Rate
Accuracy
Input 60, 200bpm using the
SpO
2
simulator, and measure
the error.
Error should be within
±3bpm (20-250bpm)
Prepare other reference
device, perform measurement
on healthy subject, and
compare the value.
Error between the 2
devices should be
within ±6%.
03 SpO
2
Probe-Off
Detection
Check the display by
disconnecting the probe.
Waveform and numeric
data should disappear
from the display.
No Check Item Check Procedure Criteria
7. Speaker
01 Generation Generate synchronized tone
and check the sound.
Generating
synchronized tone.
No Check Item Check Procedure Criteria
8. Electrical Safety
01 Contact current Measure the leakage current
that runs through the ground
from the enclosure of the
device under normal condition
using a leak measurement
safety tester.
According to test procedure of
IEC 60601-1 8.7.4
From the enclosure to
the ground (NC)
≤0.1mA.
02 Patient leakage
current that runs
through the
ground from the
patient
connecting part
(NC)
Measure the patient leakage
current that runs through the
ground from the patient
connecting part using a leak
measurement safety tester.
According to test procedure of
IEC 60601-1 8.7.4
[AC/DC]
From the patient
connecting part to the
ground (NC)
≤0.01mA.