8.4 Classification
Protection against electrical shock:
● Class I ME equipment
Applied parts:
● B applied parts (Forehead pad, Chin rest)
IP Code:
● IP20 (Main unit)
● IP10 (Capturing window)
Mode of Operation:
● Continuous operation
8.5 Declaration of Conformity with EMC
Caution: Medical electrical equipment.
EMC (Electro Magnetic Compatibility) must be considered before any medical electrical
equipment is installed or put into service. Follow the information in the accompanying
documentation when installing and operating the REM 3000.
Caution: Portable or mobile RF communication equipment can effect Medical Electrical equipment.
Guidance and manufacturer's declaration -
electromagnetic emissions
Table 201
The REM 3000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the REM 3000 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The REM 3000 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 emission
CISPR 11
Class B
The REM 3000 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
Class A
Voltage fluctuation/
flicker emissions
IEC 61000-3-3
Complies
8-3
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