Itamar Medical Ltd.
Endo
PAT
TM
x Device
76
Operation Manual
Table 3 - from IEC 60601-1-2:2014
Guidance and manufacturer's declaration – electromagnetic immunity – EndoPAT
TM
x (EPX)
The
EPX
is intended for use in the electromagnetic environment specified below; The customer or the user of the
EPX
should assure that it is
used in such an environment.
Immunity test
IEC 60601-1-2Test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3V, 6V
10V/m
10V/m from 0.15 to
80MHz;
10V/m from 0.15 to
80MHz and 80% AM
at 1kHz
10V/m from 80MHz
to 2.7GHz
3V, 6V
10V/m
10V/m
from
0.15 to
80MHz;
10V/m
from
0.15 to
80MHz
and
80% AM
at 1kHz
10V/m
from
80MHz
to 2.7GHz
Portable and mobile RF communications equipment should be used
no closer to any part of the EndoPATx, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
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 frequency range.
D 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
EPX
is used
exceeds the applicable RF compliance level above, the
EPX
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
EPX
.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
