Appendix B
:
System Specifications
COOLTONE User Manual
44
-C
Table 9:
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions CISPR 11
Group 1
The device
CoolTone
must emit electromagnetic energy in
order to ensure its intended function.
Nearby electronic equipment may be affected.
RF Emissions CISPR 11
Class A
The device
CoolTone
is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public supply network that also
supplies buildings used for domestic purpose.
CAUTION:
The
CoolTone
is exclusively for
professional health care facilities such as hospitals
provided and tested.
The
CoolTone
has an essential performance of 1.35T +/-20%
which is not influenced by electromagnetic interference.
Harmonic emissions
IEC 61000-3-2
Not
performed
because the
device will
not be
connected to
public grid.
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Not
performed
because the
device will
not be
connected to
public grid.
Table 10:
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV Contact Discharge
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV Air Discharge
± 8 kV Contact
Discharge
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV Air Discharge
Floors should be made from
wood, concrete or ceramic tiles.
If floor is covered with synthetic
material, the relative humidity
must be at least 30 %
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV
100 kHz repetition
frequency
± 2 kV
100 kHz repetition
frequency
The supply voltage quality must
correspond to that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
Line-to-Line
± 0,5 kV, ± 1 kV
± 0,5 kV, ± 1 kV
Surge
IEC 61000-4-5
Line-to-Earth
± 0,5 kV, ± 1 kV, ± 2 kV
± 0,5 kV, ± 1 kV, ± 2 kV