Users Manual

13. Maintenance and Inspection
67
No Check Item Check Procedure Criteria
06 ECG Sensitivity With comprehensive tester,
apply 1mV voltage and
measure the displayed
amplitude.
According to test procedure of
IEC 60601-2-27: 2011
201.12.1.101.1
Wave form size on the
receiving monitor
should be within 0mm
±10% at sensitivity 1.
07 Heart Rate
Accuracy*
With ECG simulator, test
heartbeat 60, 180 beats/min.,
and check the displayed HR
value.
According to test procedure of
IEC 60601-2-27: 2011
201.12.101.15
For reference
heartbeat signal of 60,
180 beats/min., error
of the displayed HR
value should be within
±3 beats/min.
08 ECG Lead
Switch
With ECG simulator, check
that each lead is displayed
properly.
(Check for 3-electrode, and
4-electrode, 5-electrode.)
For each lead cable,
lead should be
correctly switched, and
waveform should be
correctly displayed.
09 Lead-Off
Indication
Remove each electrode, and
check that lead-off message is
displayed.
Lead-Off message for
the corresponded lead
should be displayed.
10 ECG Lead Cable
Recognition
Switch the ECG lead cable or
switch the setup of lead cable.
Should correctly
recognize the
connected lead cable.
* 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
5. Respiration
01 Respiration
Waveform
Sensitivity
With comprehensive tester or
reference respiration signal
generator, input sinusoidal
waveform of 0.5 Hz with base
resistance of 1.5 kΩ / 1 Ω
change.
The amplitude
displayed on the
receiving monitor
screen should be
within 10 mm ± 2 mm.
02 Respiration Rate
Accuracy*
Input reference respiration
signal to comprehensive tester
or respiration simulator, and
check the respiration rate
display. Test with the
respiration reference
load signal of 60, 120/min.
Error should be within
±5 Bpm.
03 Frequency
Characteristic*
With comprehensive tester or
reference respiration signal
generator, input 0.5 Hz and
1.5 Hz or 2.5 Hz, and measure
the frequency characteristic.
The crest value at
1.5 Hz should be more
than 70% of the crest
value at 0.5 Hz input.