EZ EM PROTOCO2L 6400 - Page 38

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
37
Table 3
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 Insu
fflator should assure that it is used in such an environment.
Immunity Test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
–
guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
PROTOCO
2
L Colon Insufflator, including cables, than
the recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
IEC 61000
-
4
-
6
Conducted RF
3 Vrms
3 V
rms
d
= 1,2

P
150 kHz to 80 MHz
IEC 61000
-
4
-
3
Radiated RF
3 V/m
3 V/m
d
= 1,2

P
80 MHz to 800 MHz
80 MHz to 2.5 GHz
d
= 2,3

P
800 MHz to 2.5 GHz
where
P
is the maximum output power rating of the
transmitter in watts
(W) according to the transmitter
manufacturer and
d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
, should
be less than the compli
ance level in each frequency
range
b
.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 Thes
e guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) tele
phones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be cons
idered. If the measured field strength in the location in which the
PROTOCO
2
L Colon Insufflator is used exceeds the applicable RF compliance level above, the PROTOCO
2
L
Colon Insufflator should be observed to verify normal operation. If abnormal performanc
e is observed,
additional measures may be necessary, such as re
-
orienting or relocating the PROTOCO
2
L Colon Insufflator.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m