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No Check Item
Check Procedure
Criteria
7. Non-invasive Blood Pressure
01
Automatic check
Connect 500ml air tank.
Conduct NIBP test in Test Menu.
Pass all items.
02 Static
Pressure
Accuracy
Connect a mercury manometer or
sphygmomanometer, increase pressure, and
measure the difference from the displayed
pressure.
Measure at 120mmHg and 180mmHg.
Error should be within
±4mmHg.
03 Measuring
operation
Perform NIBP simulator or BP measurement
on the subject.
BP can be measured.
No Check Item
Check Procedure
Criteria
8. Arterial Oxygen Saturation (SpO
2
)
01 Oxygen
Saturation
Display Accuracy
Measure error by 75% and 90% using
SpO
2
simulator.
SpO
2
error between 70%
to 100% should be within
±2%
Measure healthy people using other
reference equipment and compare the
numeric data.
Error between two devices
should be within ±4%
02 Pulse
detection
range
Input 60 and 200bpm using SpO
2
and
measure pulse rate error.
Error should be within the
below range.
Nellcor
(HS-8305N,HS-8312N):
±3bpm from 20 to 250bpm
Masimo
(HS-8305M,HS-8312M):
±3bpm from 26 to 239bpm
Measure healthy people using other
reference equipment and compare the
numeric data.
Error between two devices
should be within ±6%.
03 SpO
2
Probe off
detection
Check the display by connecting and
disconnecting the probe.
Waveform and numeric
data should disappear.
No. Check Item
Check Procedure
Criteria
9. Invasive Blood Pressure
01
BP value display
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.
Select ±2% of display full
scale (300mmHg) or
±1mmHg, whichever is
greater.
02 Pulse
detection
accuracy*1
Input 30, 120, and 160bpm using SpO
2
using the comprehensive tester and
measure pulse rate error.
Pulse rate error should be
within ±3%.
03
BP Probe off
detection
Check the display by connecting and
disconnecting the probe.
Waveform and numeric
data should disappear.
10
-
9
Summary of Contents for HS-8000 Series
Page 4: ...Blank Page ...
Page 20: ...xvi Blank Page ...
Page 21: ...General Description Chapter 1 General Description 1 2 Features 1 3 1 1 ...
Page 24: ...1 4 Blank Page ...
Page 25: ...Specification Chapter 2 Specification Performance 2 2 Specification 2 2 Performance 2 4 2 1 ...
Page 34: ...3 4 Blank Page ...
Page 62: ...4 28 Blank Page ...
Page 66: ...HS 8312M Accembly1 HS 8312M 01A 6 2 ...
Page 67: ...HS 8312M Assembly2 HS 8312M 02A 6 3 ...
Page 68: ...HS 8312M Assembly3 HS 8312M 03A 6 4 ...
Page 69: ...HS 8312M Assembly4 HS 8312M 04A 6 5 ...
Page 70: ...HS 8312N Assembly1 HS 8312N 01A 6 6 ...
Page 71: ...HS 8312N Assembly2 HS 8312N 02A 6 7 ...
Page 72: ...6 8 NIBPS 801 Assembly NIBP 801 01A ...
Page 96: ...8 18 Blank Page ...