Immunity test
IEC 60601 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 wood, concrete or ceramic tile.
If floor 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
±2kV 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(s) to line(s)
±1 kV differential mode
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% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Pch Life TENS & PMS requires continued
operation during power mains interruptions, it is
recommended that the Pch Life TENS & PMS
be powered from an uninterruptible power
supply or a battery.
Power frequency
(50Hz/60Hz) magnetic
field IEC 61000-4-8
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
3A/m
The Pch Life TENS & PMS is intended for use in the electromagnetic environment specified below. The customer or the user of
Pch Life TENS & PMS should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 V
rms
150 kHz to 80 MHz
3 Vrms
Portable and mobile RF communications equipment should
be used no closer to any part of the Pch Life TENS & PMS,
including cables,than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
P
d
167
.
1
P
d
167
.
1
80 MHz to 800 MHz
P
d
333
.
2
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,
a
should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked
with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz-2.5 GHz
3 V/m
NOTE 1
At 80 MHz 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.
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 due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Pch Life TENS & PMS is used exceeds the applicable RF compliance level
above, the Pch Life TENS & PMS should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the Pch Life TENS & PMS. Over the frequency range
150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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29
2) Guidance and manufacture’s declaration – electromagnetic immunity
3) Guidance and manufacture’s declaration – electromagnetic immunity
The Pch Life TENS & PMS is intended for use in the electromagnetic environment specified
below. The customer or the user of Pch Life TENS &PMS should assure that it is used in such
an environment.
