EZ EM PROTOCO2L 6400 - Page 37

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
36
Table 2
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The PROTOCO
2
L Colon Insufflator is intended for use in
the electromagnetic environment specified below.
The customer or the user of the PROTOCO
2
L Colon Insufflator should assure that it is used in such an
environment.
Immunity Test
IEC 60601
test level
Compliance level
Electromagnetic environment
–
guidance
IEC 61000
-
4
-
2
Electrostatic
+/
-
6 KV contact
+/
-
6 KV contact
discharge (ESD)
+/
-
8 KV air
+/
-
8 KV ai
r
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
IEC 61000
-
4
-
4
Electrical fast
+/
-
2 KV for power
+/
-
2 KV for power
transient burst
supply lines
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment.
+/
-
1 KV for
input/output
+/
-
1 KV for
input/out
put
lines
lines
IEC 61000
-
4
-
5
Surge
+/
-
1 KV differential
+/
-
1 KV differential
mode
mode
Mains power quality should be that of a
typical commercial or hospital
environment.
+/
-
2 KV common
mode
+/
-
2 KV common
mode
IEC 61000
-
4
-
11
<5 %
Ut
<5 %
Ut
(>95 % dip in
Ut
)
(>95 % dip in
Ut
)
for 0.5 cycle
for 0.5 cycle
Volt
age dips, short
interruptions and
voltage variations on
power supply input
lines
40 %
Ut
40 %
Ut
(60 % di
p in
Ut
)
(60 % dip in
Ut
)
for 5 cycles
for 5 cycles
70 %
Ut
70 %
Ut
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
PROTOCO
2
L Colon Insufflator requires
continued operati
on during power mains
interruptions, it is recommended that the
PROTOCO
2
L Colon Insufflator be
powered from an uninterruptible power
supply or battery.
(30% dip in
Ut
)
(30% dip in
Ut
)
for 25 cycles
for 25 cycles
<5 %
Ut
<5 %
Ut
(>95 % dip in
Ut
)
(>95 % dip in
Ut
)
for 5 sec
for 5 sec
IEC 61000
-
4
-
8
Power
frequency
3 A/m
3 A/m
(50/60 Hz)
magnetic field
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.