Covidien Nellcor OxiMax N-600x, Operator'S Manual

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Product Specifications
126
Operator’s Manual
Table 22. Electromagnetic Immunity Testing
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2:
2001
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floor should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electric fast
transient/burst
IEC 61000-4-4:
1995 + A1: 2000 +
A2: 2001
± 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 and/or hospital
environment.
Surge
IEC 61000-4-5:
2005
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality should
be that of a typical
commercial and/or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
IEC 61000-4-11:
2004
<5% UT
(>95% dip in UT)
for 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
Mains power quality should
be that of a typical
commercial and/or hospital
environment..
If the user of the oximeter
requires continued
operation during power
mains interruption, it is
recommended that the
oximeter be powered from
an uninterruptible power
supply or battery.
Note: UT is the AC main’s
voltage prior to application
of the test level.
40% UT
(60% dip in UT)
for five cycles
40% UT
(60% dip in UT)
for five cycles
70% UT
(30% dip in UT)
for 25 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(95% dip in UT)
for five seconds
<5% UT
(95% dip in UT)
for five seconds
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8:
2001
3 A/m 3 A/m If image distortion occurs, it
may be necessary to position
the oximeter further from
the sources of power
frequency magnetic fields or
to install magnetic shielding.
The power frequency
magnetic field should be
measured in the intended
installation location to
assure that it is sufficiently
low.