Zimmer OptonPro, Руководство по эксплуатации

Страница: 52 / 54

Manufacturer's EMC declaration
19
44
The main features of the Opton
Pro
are as follows: Delivery of shockwaves for therapeutic purposes and interference-free
control of all functions.
Guidelines and manufacturer's declaration – electromagnetic immunity
The Opton
Pro
is intended for operation in one of the electromagnetic environments specified below. The customer or user of the
Opton
Pro
should ensure that it is used in such an environment.
Interference
immunity tests
IEC 60601 test
level Compliance
level
Electromagnetic environment – Guidelines
Conducted RF
disturbances
IEC 61000-4-6
Radiated RF
disturbances
IEC 61000-4-3 3 V
effective value
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
effective value
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment should
be used no closer to any part of the Opton
Pro
, including
cables, than at the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d= 1.17 √P
d= 1.17 √P for 80MHz to 800 MHz
d= 2.33 √P for 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in Watt (W) according to the transmitter
manufacturer and d is the recommended separation distance
in metres (m).
The field strength of stationary radio transmitters should be
less than harmonization level at all frequencies according to
an on-site test
ab
.
Interference may occur in the vicinity of equipment which is
marked with the following symbol:
NOTE 1 At 80 Hz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment regarding fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location where the Opton
Pro
is used exceeds the applicable RF compliance level above, the Opton
Pro
should
monitored to verify normal operation. If unusual performance is noticed, additional measures may be necessary such as re-orienting
or relocating the Opton
Pro
.
b
In the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 204 as per EN 60601-1-2:2006-10