User's Manual

PillCam Capsule Endoscopy
234 Guidance and Manufacturer's Declarations
Guidance and manufacturer’s declaration - electromagnetic immunity
The PillCam recorder DR3 is intended for use in the electromagnetic environment specified
below. The customer or the user of the PillCam recorder DR3 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 PillCam
recorder DR3, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
3V
rms
150 kHz to
80 MHz
3V
rms
150 kHz to
80 MHz
Recommended separation distance:
d = 1.2 P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
Recommended separation distance:
d = 1.2 P 80 MHz to 800 MHz range
d = 2.3 P 800 MHz to 2500 MHz
range
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Note 3: 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).
Note 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey
a
, should be less than the compliance level in each frequency range
b
.
Note 5: Interference may occur in the vicinity of equipment marked with the following symbol:
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
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 considered. If the measured field strength in
the location in which the PillCam recorder DR3 is used exceeds the applicable RF compliance level
above, the PillCam recorder DR3 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the PillCam recorder DR3.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.