NanoVibronix PAINSHIELD MD, User Manual

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PAINSHIELD
®
ELECTROMAGNETIC
IMMUNITY
Table 2
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
PainShield
®
is intended for use in the electromagnetic environment
specified below. The customer or user of the PainShield
®
should
assure that it is used in such an environment.
Immunity
test IEC 60601
level Compliance
level Electromagnetic environment
- guidance
Electrostatic
discharge
(ESD), IEC
61000-4-2 8 kV contact
15 kV air 8 kV contact
15 kV air Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at
least 30 %.
Electrical fast
transient/
burst, IEC
61000-4-4 2 kV for
power
supply lines
1 kV for SIP/
SOP lines
2 kV for
power
supply lines Mains power quality should be
that of a typical commercial or
hospital environment.
Surge, IEC
61000-4-5 1 kV line to
line 2 kV line
to earth 1 kV line
to line
(Class II ME
equipment) Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage
dips and
interruptions
on power
supply input
lines
IEC 61000-4-11
0 % UT for
0.5 cycle
0 % UT for
1 cycle 70 %
UT for 25/30
cycles
0 % UT for
250/300
cycles
0 % UT for
0.5 cycle
0 % UT for 1
cycle
70 % UT for
25/30 cycles
0 % UT for
250/300
cycles
Mains power quality should be
that of a typical commercial
or hospital environment.
The user of the PainShield
®
during continued operation
not depend from power
mains interruptions, because
PainShield
®
powered from
a batteries. During system
charging is recommended that
the PainShield
®
be powered
from an uninterruptible power
supply.
Power
frequency
magnetic
field, IEC
61000-4-8 30 A/m 30 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
9.2