27 Appendices
Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 97 / 106
27.2 Guidance and manufacturer´s declaration Electromagnetic interference
emission and interference immunity of the Keratograph 5M
Guidance and manufacturer´s declaration: Electromagnetic emissions of the Keratograph 5M,
IEC 60601-1-2, based to table 1
The OCULUS Keratograph 5M is intended for operation in the electromagnetic environment specified below.
The user of the Keratograph 5M should ensure that it is being used in such an environment.
Emissions test Compliance Electromagnetic environment - Guidelines
HF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not like-
ly to cause any interference in nearby electronic equip-
ment.
HF-emissions CISPR 11 Class B
Harmonics emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker
emissions IEC 61000-3-3
complies
Electromagnetic immunity, IEC 60601-1-2, based on table 4
Immunity test test level Compliance lev-
el
Electromagnetic environment
- guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 8 kV contact
± 15 kV
air discharge
± 8 kV
± 15 kV
Floors should be made of wood
or concrete or covered with ce-
ramic tiles. If the floor is cov-
ered with synthetic material, the
relative humidity must be at
least 30%.
Power frequency (50/60Hz) mag-
netic field IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Power frequency magnetic
fields should be at levels char-
acteristic of a typical location in
a typical commercial or hospital
environment.
Electromagnetic immunity, IEC 60601-1-2, based on table 5, 8
Electrical Fast transient/bursts
IEC 61000-4-4
± 2 kV for power
supply lines
100 kHz repeti-
tion frequency
± 1 kV for input/
output lines
± 2 kV
-----------------
± 1 kV
The quality of the supply volt-
age should correspond to that
of a typical business- or hospi-
tal environment.
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