Orthosoft Inc. R20S21A Manual Do Utilizador
SmartKnee Surgical Technique
51 of 58
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
—Consult the dealer or an experienced radio/TV technician for help.
5.6.2 System Controller
Table 1
– Guidance and
MANUFACTURER
’
S
declaration
–
ELECTROMAGNETIC EMISSIONS
–
Guidance and manufacturer’s declaration – electromagnetic emissions
The System Controller is intended for use in the electromagnetic environment specified below. The customer or the user
of the System Controller should assure that it is used in such an environment.
The System Controller is intended for use in the electromagnetic environment specified below. The customer or the user
of the System Controller should assure that it is used in such an environment.
RF emissions
CISPR 11
CISPR 11
Group 1
The System Controller uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
CISPR 11
Group 2
The System Controller must emit electromagnetic energy in
order to perform its intended function. Nearby electronic
equipment may be affected.
order to perform its intended function. Nearby electronic
equipment may be affected.
RF emissions
CISPR 11
CISPR 11
Class [A or B]
Harmonic emissions
IEC 61000-3-2
IEC 61000-3-2
[Class A, B, C, D,
or Not applicable]
or Not applicable]
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
flicker emissions
IEC 61000-3-3
[Complies or Not
applicable]
applicable]
TBD
The System Controller is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low voltage power
supply network that supplies buildings used for domestic
purposes.
establishments, including domestic establishments and
those directly connected to the public low voltage power
supply network that supplies buildings used for domestic
purposes.
TBD
The System Controller is suitable for use in all
establishments other than domestic, and may be used in
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the
following warning is heeded:
Warning: This equipment/system is intended for
use by healthcare professionals only. This
equipment/ system may cause radio interference or may
disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting
or relocating the System Controller or shielding the location.
establishments other than domestic, and may be used in
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the
following warning is heeded:
Warning: This equipment/system is intended for
use by healthcare professionals only. This
equipment/ system may cause radio interference or may
disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting
or relocating the System Controller or shielding the location.
TBD
The System Controller is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
RF emissions
CISPR 14-1
CISPR 14-1
Complies
The System Controller is not suitable for interconnection
with other equipment.
with other equipment.
RF emissions
CISPR 15
CISPR 15
Complies
The System Controller is not suitable for interconnection
with other equipment.
with other equipment.
Table 2
– Guidance and
MANUFACTURER
’
S
declaration
– electromagnetic
IMMUNITY
– for all
ME EQUIPMENT
and
ME
SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity