Zimmer Soleo SonoStim, Инструкция по эксплуатации

Страница: 94 / 96

Manufacturer's EMC Declaration
23
Page 81
Main features of the Soleo SonoStim / Soleo Galva (only electrical stimulation) are: trouble-free delivery of electrical
stimulation and ultrasound, in conjunction with the vacuum unit and vacuum with the set parameters and trouble-free
operation of all functions.
Guidelines and manufacturer's declaration - electromagnetic immunity
The Soleo SonoStim/Soleo Galva device is designed for operation in the electromagnetic environment specified below. The
customer or the user of the Soleo SonoStim/Soneo Galva device should ensure that it is used in such an environment.
Immunity
tests
IEC 60601 – Test
Level
Compliance level Electromagnetic environment - Guidelines
Conducted
RF
disturbance
variables in
accordance
with IEC
61000-4-6
Radiated
RF
disturbance
variables in
accordance
with IEC
61000-4-3
3 V
RMS
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
RMS
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment
should not be used any closer to the Soleo
SonoStim/Soneo Galva, including cables, than the
recommended separation distance calculated using
the equation relevant for the transmission
frequency.
Recommended separation distance:
d = 1.17 √P
d = 0.35 √P for 80MHz to 800 MHz
d = 0.7 √P for 800 MHz to 2.5 GHz
where P is the power rating of the transmitter in
watts (W) according to the transmitter manufacturer
and d is the recommended separation distance in
metres (m).
In accordance with an on-site investigation
a
, for all
frequencies, the field strength of a stationary radio
transmitter should be less than the coincidence
level
b
.
Errors may occur in the vicinity of devices 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 cases. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.