EMC Information
This medical device complies to the IEC 60601-1-2:2007 standard for Electromagnetic Compatibility.
See tables 1, 2, 4 and 6 for compliance details.
Table 1 - Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The
SLENDERTONE CONNECT ABS
containing a Bluetooth
®
Radio Module is intended for use in the electromagnetic environment
specified below. The customer or the user of the
SLENDERTONE CONNECT ABS
containing a Bluetooth
®
Radio Module should ensure
that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 2
The
SLENDERTONE CONNECT ABS
containing Bluetooth
®
Radio Module must emit
electromagnetic energy in order to perform its intended function.
RF emissions
CISPR 11
Class B
The
SLENDERTONE CONNECT ABS
containing Bluetooth
®
Radio Module is suitable for use
in all establishments, including domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Table 2 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - for all equipment and systems
The
SLENDERTONE CONNECT ABS
containing a Bluetooth
®
Radio Module is intended for use in the electromagnetic environment
specified below. The customer or the user of the
SLENDERTONE CONNECT ABS
containing a Bluetooth
®
Radio Module should ensure
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
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
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
(50/60Hz) magnetic
field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
E
ng
lish
Table 4 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity -
for equipment and systems that are not life-supporting
The
SLENDERTONE CONNECT ABS
containing a Bluetooth
®
Radio Module is intended for use in the electromagnetic environment
specified below. The customer or the user of the
SLENDERTONE CONNECT ABS
containing a Bluetooth
®
Radio Module 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 CONNECT ABS
containing
Bluetooth
®
Radio Module, 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 CONNECT ABS
containing Bluetooth
®
Radio Module is used
exceeds the applicable RF compliance level above, the
SLENDERTONE CONNECT ABS
containing Bluetooth
®
Radio Module 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 CONNECT ABS
containing Bluetooth
®
Radio Module.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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