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HemoSphere Advanced Monitor G Guidance and Manufacturer’s Declaration
Table G-5 Electromagnetic Immunity (RF Radiated and Conducted)
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified
below. The customer or user of the HemoSphere advanced monitor should assure that it is used in such
an environment.
Conducted RF
IEC 61000-4-6
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms 150 kHz to
80 MHz
6 Vrms (ISM band)
150 kHz to 80 MHz
3 V/m 80 to 2700
MHz
3 Vrms
6 Vrms
3 V/m
Portable and mobile RF communication equipment
should be used no closer to any part of the HemoSphere
advanced monitor, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended Separation Distance
d = [1.2] x ; 150 kHz to 80 MHz
d = [1.2] x ; 80 MHz to 800 MHz
d = [2.3] x ; 800 MHz to 2500 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 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 with
the following symbol:
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 HemoSphere advanced monitor is used exceeds the applicable RF
compliance level above, the HemoSphere advanced monitor should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the HemoSphere
advanced monitor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14
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