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Vectra® Neo Clinical Therapy System
APPENDIX 2
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Vectra® Neo Clinical Therapy System is intended for use in the electromagnetic environment specifi ed below. The
customer or the user of the Vectra® Neo Clinical Therapy System should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any part of the
Vectra® Neo Clinical Therapy System, including cables, than
the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz
[ V
1
] V, where V
1
= 3V
d =
[
3,5
]]
√ P
V
1
Radiated RF
IEC 61000-4-3 3 V/m
80 MHz to 2,5 GHz
[ E
1
] V/m, where E
1
= 3V/m
d =
[
3,5
]]
√ P 80 MHz to 800 MHz
E
1
d =
[
7
]]
√ P 800 MHz to 2,5 GHz
E
1
where P is the maximum output power rating of the transmit-
ter in watts (W) according to the transmitter manufacturer
and
d is the recommended separation distance in metres (m).
Field strengths from fi xed RF transmitters, as determined
by an electromagnetic site survey,
a
should be less than the
compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aff ected by absorption and refl ection from structures,
objects and people.
a
Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the
Vectra® Neo Clinical Therapy System is used exceeds the applicable RF compliance level above, the Vectra® Neo Clinical Therapy System should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Vectra® Neo Clinical Therapy System .
b
Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than [ V
1
] V/m.
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)