User's Manual

PillCam Capsule Endoscopy
232 Guidance and Manufacturer's Declarations
PillCam Recorder DR3
Guidance and manufacturer’s declaration - electromagnetic emissions
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.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The PillCam recorder DR3 uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The PillCam recorder DR3 is suitable for use in
all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
N/A
Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment
and systems
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
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
N/A
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV line to line
2 kV line to earth
N/A
Mains power quality should
be that of a typical
commercial or hospital
environment.