Apex Medical iCH Prime Instruction Manual page 23

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Guidance and Manufacturer's Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of this device should
make sure it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795
MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80
MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is
used in calculating the recommended separation distance for transmitters in these frequency ranges.
c) 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 device is used exceeds the
applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
IEC60601
Compliance
test level
3Vrms150 kHz to 3Vrms
80 MHz outside
a
ISM bands
3 V/m 80 MHz to 3V/m
2.5 GHz
Electromagnetic Environment-Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of this device,
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
=
150kHz to 80MHz
d 1 2 . P
= 150kHz to 80MHz
d 2 3 . P
=
80 MHz to 2.5G MHz
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 metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
d
frequency range .
Interference may occur in the vicinity of equipment
marked with the following symbol:
21
b
c
,