Vapotherm Oxygen Assist Module, Инструкция по эксплуатации

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Page 28 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Appendix A
Guidance and manufacturer’s declaration – electromagnetic immunity
The Oxygen Assist Module is intended for use in the electromagnetic environment specified below. The customer or the user of
the Oxygen Assist Module should assure that it is used in such an environment.
IMMUNITY test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands
3 V/m
80 MHz to 2.7 GHz
3Vrms
6 Vrms in ISM
bands
3V/m
Portable and mobile RF communications equipment should
be used no closer to any part of the [
ME EQUIPMENt
or
ME SYStEM
], including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d
=1.2√P
d =1.2√P 80 MHz to 800 MHz
d =2.3√P 800 MHz to 2.3 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed 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 affected by absorption and reflection
from structures, objects, and people.
a
Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Oxygen Assist Module is used exceeds the applicable RF
compliance level above, the Oxygen Assist Module should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Oxygen Assist Module.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ V 1] V/m.