Steris HarmonyAIR G Series, Operator'S Manual

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9-3
Appendix - EMC Compliance Technical Data Operator Manual 10043124
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for ME Equipment and ME
Systems that are not Life-Supporting (per IEC 60601-1-2 clause 5.2.2.2 Table 4)
Table 9-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for ME
Equipment and ME Systems that are not Life-Supporting
The HarmonyAIR Surgical Lighting System G Series is intended for use in the electromagnetic
environment specified below. The Customer or the user of the HarmonyAIR Surgical Lighting System
G Series should assure that it is used in such an environment.
Immunity test IEC 60601 4th
Edition
Test Level
Compliance
Level
Electromagnetic Environment–
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms (Outside ISM)
6 Vrms (In ISM Bands)
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
(V1) = 3 Vrms
(V2) = 6 Vrms
(V3) = 10 Vrms
(E1) = 3 V/m
Portable and mobile communications
equipment should be separated from the
HarmonyAIR Mobile Stand by no less than the
distances calculated/listed below:
D= (3.5/V1)(Sqrt P)
D= (12/V2)(Sqrt P)
D= (12E1)(Sqrt P)
80 to 800 MHz
D= (23/E1)(Sqrt P)
800 MHz to 2.7 GHz
where P is the max. power in watts and D is the
recommended separation distance in meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance levels (V1
and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.