User's Manual

14
Guidance and manufacturer’s declaration – electromagnetic immunity
The Wireless ECG Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Wireless ECG Monitor should assure that it is used in such an environment
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are
not life-supporting
Guidance and manufacturer’s declaration – electromagnetic immunity
The Wireless ECG Monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the Wireless ECG Monitor should assure that it is used in such an environment
Radiated RF 3 V/m
[E
1
]V/m
d = [1.17]√P…80MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz d = [2.33]
√
P…800 MHz to 2.5GHz
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,
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 Wireless ECG Monitor is
used exceeds the applicable RF compliance level above, the Vpatch System should be
observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orientating or relocating the Wireless ECG Monitor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
[V
1
]V/m
Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are
not life-supporting