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
9 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
9 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
9 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
9 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
9 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
9 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.
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