Appendix
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7.1.3
Table 204: Guidelines and manufacturer's
declaration – Electromagnetic interference
The MEDICAL_PLUS massage device has been designed for use in the elec-
tromagnetic environment specified below. The device operator must ensure
that it is used such an environment.
Interference
immunity tests
IEC 60601 - Test
level
Defined level Electromagnetic environment – Guidelines
Conducted
HF noise
IEC 61000-4-6
Radiated
HF noise
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile radios are not to be used at shorter distanc-
es to the MEDICAL_PLUS and its cables other than the recom-
mended safe distance, which has been calculated according to
the transmitting frequency are made.
Recommended safe distance:
80 MHz to 800 MHz
800 MHz to 2.5 GHz
P is the transmitter's maximum output power (nominal rating) in
Watts (W) according to the details provided by the manufacturer
of the transmitter and the recommend safe distance is given in
metres (m).
The field strength of the stationary radio transmitter is for all fre-
quencies
b
in accordance with tests that were carried out onsite
a
less than the determined level.
Interference is possible in the immediate surrounding of equip-
ment that carry the following symbols.
Comment 1: The higher value applies to 80 MHz und 800 MHz.
Comment 2: These guidelines might not apply to all situations. The propaga-
tion of electromagnetic waves is affected by absorption and reflexes caused
by buildings, objects and people.
a The field strength of a stationary transmitter e.g. standard cell phone
stations (mobile / cordless phones) and public mobile radio services, am-
ateur stations, MW and UHF radio and TV transmitters) cannot be pre-
cisely determined for theoretical reasons. It is recommended that an on-
site test should be carried out in order to determine the electromagnetic
environment caused by stationary HF transmitters. If the field strength of
the massage device determined at the installation site exceeds the de-
fined HF level listed above then the device must be monitored with regard
to its normal operation. If any abnormal characteristics are recorded then
it will be necessary to introduce additional measures, such as reorienta-
tion or converting the device.
b The field strength must be less than 3 V/m over the frequency ranges
from 150 kHz to 80 MHz.
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