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17
Table 4 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity -
for equipment and systems that are not life-supporting
The
SLENDERTONE COREFIT is intended for use in the electromagnetic environment specified below. The customer or the user
of the
SLENDERTONE COREFIT should ensure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz 3 V/m
Portable and mobile RF communications equipment should be used
no closer to any part of the
SLENDERTONE COREFIT, 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…80MHz to 800 MHz
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
SLENDERTONE COREFIT is used exceeds
the applicable RF compliance level above, the
SLENDERTONE COREFIT should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the
SLENDERTONE COREFIT
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 2 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for all equipment and systems
The
SLENDERTONE COREFIT is intended for use in the electromagnetic environment specified below. The customer or the user
of the
SLENDERTONE COREFIT should ensure that it is used in such an environment.
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
± 6kV contact
± 8kV air
3 A/m
± 6kV contact
± 8kV air
3 A/m
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be at
least 30%.
Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
SLENDERTONE COREFIT is designed to support anticipated disturbance originating from electrostatic discharge, magnetic fields or
radio frequency transmitters. However, the performance of the
SLENDERTONE COREFIT device can still be affected by radio
frequency fields originating from other sources some of which may not be visible, and the device could potentially be exposed
to fields from these emitters without the user’s awareness.
Whenever the user realizes an unexpected change in any of the stimulation parameters, it is advised to terminate the
stimulation session immediately.
Equipment such as electrocautery or diathermy equipment, RFID readers, electronic article surveillance (EAS) systems or metal
detectors that emit strong radio frequency signals can cause electrical interference which may affect device stimulation
parameters. Ensure adequate separation between such emitters and the device during use.
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