Fukuda Denshi DS-8200, Руководство по обслуживанию

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No. Check Item Check Procedure Criteria
4. ECG
01 Input Impedance Measure input impedance with safety
tester.
Comply with the test method of IEC
60601-2-27:2005 50.102.3.
Should be 2.5M
Ω
or above.
02 Suppression
Characteristic of
Common-Mode
Signal
With the simulator, input 50Hz or 60Hz
20Vr.m.s. signal, and measure
fluctuation of each lead.
Comply with the test method of IEC
60601-2-27:2005 50.102.10.
Should be 90dB or above
for standard sensitivity
(sensitivity 1).
03 Transient
Characteristic
*1
Apply standard voltage of 1m V with
comprehensive tester, and check the
time when the waveform amplitude that
drops in the same manner as natural
logarithm becomes 37% of the
amplitude that can be obtained after
0.04 seconds by being applied
standard voltage.
Comply with the test method of IEC
60601-2-27:2005 50.102.8.
Diagnostic Mode: at least 3.2
sec
Monitor Mode: at least 0.3
sec
ESIS Mode: at least 0.1 sec
*Patient: Adult, ECG Drift Filter: OFF
04 Frequency
Characteristic
*1
With comprehensive tester, apply
sinusoidal voltage. Measure the
frequency characteristic at test voltage
of 100Hz, 40Hz, 15Hz.
Comply with the test method of IEC
60601-2-27:2005 50.102.8.
Diagnostic Mode
(3-electrode): at least 100Hz
(-3dB)
Diagnostic Mode (other than
3-electrode): at least 150Hz
(-3dB)
Monitor Mode: at least 40Hz
(-3dB)
ESIS Mode: at least 15Hz
(-3dB)
* ECG Drift Filter: OFF
05 Heart Rhythm
Detection
With comprehensive tester, input
bipolar signals of 0.3mV and 3mV with
sensitivity 1, and check if the heartbeat
rhythm is detected. The heartbeat rhythm should
be detected by bipolar
signals of 0.3mV and 3mV
with sensitivity 1.
06 ECG Accuracy
*1
With comprehensive tester, apply 1mV
voltage and measure the display width. Error should be within 10mm
±10% for sensitivity 1.
07 Record Sensitivity With comprehensive tester, apply 1mV
voltage and measure the recording
width. Error should be within ±10%
for sensitivity 1.
08 Heart Rate
Accuracy
With ECG simulator, test heartbeat 60,
180 beats/min., and check the
displayed HR value.
Comply with the test method of IEC
60601-2-27:2005 50.102.15.
For reference heartbeat
signal of 60, 180 beats/min.,
error of the displayed HR
value should be within ±3
beats/min.
09 ECG Lead Switch With ECG simulator, check that each
lead is displayed properly.
※
Check 3-electrode, 4-electrode,
5-electrode and 10-electrode.
For each lead cable, lead
should be correctly switched,
and waveform should be
correctly displayed.
10 Lead-Off Indication Remove each electrode, and check
that lead-off message is displayed.
Lead-Off message for the
corresponding lead should be
displayed.
11 ECG Lead Cable
Recognition Check by switching various ECG lead
cables or the setup of the tool to
recognize lead cables. Should correctly recognize
the connected lead cable.
12 Heartbeat Sound
*1
With ECG simulator, input ECG and
check the heartbeat sound. Correct heartbeat sound
should generate.
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