Itamar Medical EndoPAT 2000, Руководство по эксплуатации

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Itamar Medical Ltd.
Endo PAT
TM
x Device 75 Operation Manual
Table 2 - from IEC 60601-1-2:2014
Guidance and manufacturer's declaration – electromagnetic immunity – EndoPAT TM x (EPX)
The EDx is intended for use in the electromagnetic environment specified below; The customer or the user of the EPX should assure that it is
used in such an environment.
Immunity test IEC 60601-1-2 Test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
8 kV contact
2, 4, 8, 15kV air
8 kV contact
2, 4, 8, 15kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power supply lines
1 kV for input/output lines
2 kV for power supply lines
1 kV for input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 1 kV line(s) to line(s)
2 kV line(s) to earth
2 kV Signal input/output) to
earth
1 kV line(s) to line(s)
N/A
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
0% UT; 0.5cycle at 0°, 45°, 90°,
135°,180°, 225°, 270° and 315°
0% UT; 1cycle and 70% UT;
25/30 cycles
Single phase at 0° 0% UT;
250/300 cycle
0% UT; 0.5cycle at 0°, 45°,
90°, 135°,180°, 225°, 270°
and 315°
0% UT; 1cycle and 70%
UT; 25/30 cycles
Single phase at 0° 0% UT;
250/300 cycle
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the EndoPATx requires continued operation
during power mains interruptions, it is
recommended that the EndoPATx
be powered from an uninterruptible power supply
or a battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
30 (A/m) 30 (A/m) Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.