User Manual

15. GUIDANCE AND MANUFACTURER’S DECLARATION
SORIN – ORCHESTRA PLUS LINK – U386A
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15. GUIDANCE AND MANUFACTURER’S DECLARATION
15.1 ELECTROMAGNETIC EMISSIONS
The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment
specified below. The user of the ORCHESTRA PLUS LINK should ensure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The ORCHESTRA PLUS LINK uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference to nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The ORCHESTRA PLUS LINK is suitable for use in all
clinical establishments, as an accessory of Orchestra Plus
programmer
Harmonic emissions
IEC 61000-3-2
Class A
15.2 ELECTROMAGNETIC IMMUNITY
The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment
specified below. The user of the ORCHESTRA PLUS LINK 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
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment
specified below. The user of the ORCHESTRA PLUS LINK should ensure that it is used in
such an environment.
Portable and mobile RF communications equipment should be used no closer to the
ORCHESTRA PLUS LINK, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.