ITC Avoximeter 1000E Whole Blood Oximeter User Manual
Page 78

ITC AVOXimeter 1000E Operator’s Manual
72
Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity
The ITC AVOXimeter 1000E is intended for use in the electromagnetic environment specified
below. The customer or the user of the ITC AVOXimeter System should assure that it is used in
such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
+ 6 kV contact
+ 8 kV air
+ 6 kV contact
+ 8 kV 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 domestic, commercial or
hospital environment.
Surge
IEC 61000-4-5
+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 domestic, commercial or
hospital environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in
U
T
for 0.5
cycle)
40 % U
T
(60 % dip in
U
T
) for 5
cycles
70 % U
T
(30 % dip in
U
T
) for 25
cycles
<5 % U
T
(>95 % dip in
U
T
) for 5 sec
<5 % U
T
(>95 % dip in
U
T
for 0.5
cycle)
40 % U
T
(60 % dip in
U
T
) for 5 cycles
70 % U
T
(30 % dip in
U
T
) for 25
cycles
<5 % U
T
(>95 % dip in
U
T
) for 5 sec
Mains power quality should be that of a
typical domestic, commercial or
hospital environment.
If the user of the ITC AVOXimeter
1000E requires continued operations
during power mains interruptions, it is
recommended that the ITC
AVOXimeter 1000E be powered from
an uninterruptible power supply or
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical domestic,
commercial or hospital environment.