Zimmer Cryo 7, Инструкция по эксплуатации, Страница: 41 / 45

Manufacturer’s EMC declaration
16
Page 31
Table 1
Guidelines and manufacturer’s declaration –
Electromagnetic emissions
The Cryo 7 device is intended to be used in the electromagnetic environment as indicated below. The customer or
user of the Cryo 7 device must ensure that it is used in such an environment.
Interference emission
measurements Compliance Electromagnetic environment
–
Guidelines
HF emitted interference
according to CISPR 11 Group 1 The Cryo 7 device must emit electromagnetic energy
to guarantee its intended function. Electronic devices
located in the vicinity may be impaired.
HF emitted interference
according to CISPR 11 Class A The Cryo 7 device is suitable for use in all
establishments, including domestic establishments,
and in those which are connected directly to the public
grid which also supplies buildings used for residential
purposes.
Harmonic emissions according
to IEC 61000-3-2 Not applicable
Voltage fluctuations/flickers
according to IEC 61000-3-3 Not applicable
Table 2
Guidelines and manufacturer’s declaration –
Electromagnetic immunity
The Cryo 7 device is intended to be used in the electromagnetic environment as indicated below. The customer or
user of the Cryo 7 device must ensure that it is used in such an environment.
Immunity tests IEC 60601
–
test level Compliance level Electromagnetic environment
–
Guidelines
Electrostatic discharge
(ESD) according to 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 of wood,
concrete or ceramic tiles. In the
case of plastic coverings, the
relative humidity must be at
least 30%.
Rapid electrical
transients/bursts according
to IEC 61000-4-4 ± 2 kV
100 kHz repetition
frequency ± 2 kV
100 kHz repetition frequency The quality of the supply voltage
must correspond to that of a
typical business or hospital
environment.
Surges according to IEC
61000-4-5
(external conductor
–
external conductor)
± 0.5 kV, ± 1 kV ± 0.5 kV, ± 1 kV
Surges according to IEC
61000-4-5
(external conductor
–
ground)
± 0.5 kV, ± 1 kV, ± 2 kV ± 0.5 kV, ± 1 kV, ± 2 kV
Voltage dips according to
IEC 61000-4-11 0% UT; 0.5 cycles
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0% UT; 0.5 cycles
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
The quality of the supply voltage
must correspond to that of a
typical business or hospital
environment.
0% UT; 1 cycle
and
70% UT; 25/30 cycles 0% UT; 1 cycle
and
70% UT; 25/30 cycles