10
Guidance and manufacturer's declaration – electromagnetic immunity
The Dena Electrocardiograph is intended for use in the electromagnetic environment specified
below. The customer or the user of the Dena 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
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Dena
Electrocardiograph
, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d
= 1.17
P
d
= 1.17
P
80 MHz to 800 MHz
d
= 2.33
P
800 MHz to 2.5 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 the oretically 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 Dena is used
exceeds the applicable RF compliance level above, the Dena should be observed to verify normal operation. If abnormal performance is observed,
additional measures may necessary, such as reorienting or relocating the Electrocardiograph.
b
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
