Guidance and Manufacturer’s declaration-electromagnetic immunity
The Pain Relief Patch BlueTouch is intended for use in the electromagnetic environment specied
below. The customer or the user of the Pain Relief Patch BlueTouch should assure that it is used in the
following environment:
Immunity Test IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment - guidance
RF Common
mode/
Conducted
Susceptibility
IEC 61000-4-6
Radiated RF
Electromagnetic
Field
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 Pain Relief Patch BlueTouch, 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
d
=1,2 √P 80 MHz to 800 MHz
d =2,4 √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 xed 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 reection from structures, objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld strength in the location in which the Pain Relief Patch
BlueTouch is used exceeds the applicable RF compliance level above, the Pain Relief Patch BlueTouch
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Pain Relief Patch BlueTouch
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
