No.
Check Item
Check Procedure
Criteria
8. Arterial Oxygen Saturation (SpO
2
)
01 SpO
2
Accuracy
Measure the error at 75%, 90% using a
SpO
2
simulator.
Error of SpO
2
(70% to
100%) should be within
±2%.
Prepare other reference device, perform
measurement on healthy subject, and
compare the value.
Error between the 2
devices should be within
±4%.
02 Pulse
Detection
Range
Input 60, 200bpm using the SpO
2
simulator, and measure the error.
Error should be within
±3bpm for 20 to 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
9. Invasive Blood Pressure
01
BP Accuracy
Apply the voltage of 0, 100 and
200mmHg using a comprehensive
tester, and measure the difference
between the values displayed in the
display unit and input value as
displayed error of BP value.
Error should be within (full
scale, 300mmHg) ±2% or
±1mmHg, whichever is
larger.
02 Pulse
Detection
Accuracy*
Input 30, 120 and 160bpm to a
comprehensive tester, and measure
the pulse rate error.
Pulse rate error should be
within ±3%.
03 BP
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
10. Cardiac Output (CO)
01
CO Accuracy
Measure the error by inputting 5L/min.
using a waveform simulator or CO
simulator.
Should be within 0.1 to
10L/min ±10%.
Should be within 10 to
20L/min ±15%.
Measure the error by connecting the
waveform simulator or CO simulator,
and inputting the blood temperature of
36
°
C, 37
°
C and 38
°
C.
Should be within ±0.3
°
C for
the blood temperature of 17
to 45
°
C.
02 Temperature
Accuracy
Measure the error by connecting the
waveform simulator or CO simulator,
and inputting the injectate temperature
of -1
°
C and 35
°
C.
Should be within ±0.5
°
C for
the injectate temperature of
-1 to 35
°
C.
03 CO
Probe-Off
Detection
Check the display by disconnecting
the probe.
Numeric data should
disappear from the display.
11-10
Summary of Contents for DS-8200
Page 4: ...Blank Page ...
Page 44: ...1 4 Blank Page ...
Page 112: ...4 40 Blank Page ...
Page 116: ...5 4 Blank Page ...
Page 156: ...8 4 Blank Page ...
Page 166: ...9 10 Blank Page ...
Page 208: ...11 4 ...