No
Check Item
Check Procedure
Criteria
5. Respiration
01 Respiration
Waveform Accuracy
With comprehensive tester or reference
respiration signal generator, input
sinusoidal waveform of 0.5Hz with base
resistance of 1.5k
Ω
/1
Ω
change.
The displayed amplitude
should be within
10mm±2mm.
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
±5bpm.
03 Frequency
Characteristic*
With comprehensive tester or reference
respiration signal generator, input 0.5Hz
and 1.5Hz or 2.5Hz, and measure the
frequency characteristic.
The crest value for the
following frequency
should be more than
70% of the crest value at
0.5Hz input.
Adult Mode: 1.5Hz
Neonate Mode: 2.5Hz
*
As these functions are dependent on the design or software, these items are not mandatory for
periodic check. Perform the test as necessary.
No
Check Item
Check Procedure
Criteria
6. Temperature
Error should be within
±0.2
°
C for the range
within 25–45
°
C.
01 Temperature
Accuracy
Input 20, 30, and 40
°
C with a
comprehensive tester, and check the error
between the displayed values.
02 Temperature
Probe-Off Detection
Check the display by disconnecting the
probe.
The displayed value
should disappear from
the display.
No.
Check Item
Check Procedure
Criteria
7. Non-invasive Blood Pressure
01
Automatic Check
Connect the 500cc air tank.
Perform a NIBP test from the test menu.
Should pass all test items.
02
Pressure Accuracy
Connect a mercury manometer or
sphygmomanometer and pressurize.
Measure the error with the displayed NIBP
value. Measure at 120,180mmHg.
Error should be within
±3mmHg.
03 Measurement
Operation
Perform NIBP measurement on NIBP
simulator or on testee.
Proper NIBP
measurement should be
possible.
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 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
Detection
Range
Input 60, 200bpm using the SpO
2
simulator, and measure the error.
Error should be within
±3bpm for 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.
7
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39
Содержание DynaScope 7000 Series
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