Guidance and Manufacturer’s declaration-electromagnetic immunity
The Pain Relief Patch BlueTouch is intended for use in the electromagnetic environment specied
below. The customer or the user of the Pain Relief Patch BlueTouch should assure that it is used in
the following environment:
Immunity Test IEC 60601-1-2
Test Level
Compliance Level Electromagnetic Environment
- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be made of
wood, concrete, or ceramic
tile. If oors 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 input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% Un
(>95% drop in Un)
for 0,5 cycle
40% Un
(60% drop in Un)
for 5 cycles
70% Un
(30% drop in Un)
for 25 cycles
<5% Un
(>95% drop in Un)
for 5 seconds
<5% Un
(>95% drop in Un)
for 0.5 cycle
40% Un
(60% drop in Un)
for 5 cycles
70% Un
(30% drop in Un)
for 25 cycles
<5% Un
(>95% drop in Un)
for 5 seconds
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the Pain Relief Patch
BlueTouch requires continued
operation during power mains
interruptions, it is recommended
that the Pain Relief Patch
BlueTouch be powered from
an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds
should be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.
NOTE Un is the a.c. mains voltage prior to application of the test level
