cefar Easy - Page 21

19
GB
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CEFAR EASY Electrotherapy System is intended for use in the electromagnetic environment specified below. The
customer or the user of the CEFAR EASY Electrotherapy System should assure that it is used in such an environment
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Risk assessment on the CEFAR EASY
Electrotherapy System indicates
the compliance levels claimed are
acceptable when ESD-precautionary
measures are taken.
Electrical fast
transient/burst IEC
61000-4-4
±2kV for power supply lines
±1kV for input/output lines
Not Applicable -
Battery powered
Not Applicable
- signal lines less
then 3 meters
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+ 1kV dierential mode (line to line)
+ 2kV common mode (line to ground)
Not Applicable -
Battery powered
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% U
T
(>95% dip in U
T
) for 0,5 cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
Not Applicable -
Battery powered
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
CEFAR EASY Electrotherapy System
requires continued operation during
power mains interruptions, it is
recommended that the CEFAR EASY
Electrotherapy System be powered
from an uninterrupted power supply.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CEFAR EASY Electrotherapy System is intended for use in the electromagnetic environment deified below. The customer
or the user of the CEFAR EASY Electrotherapy System should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the CEFAR
EASY Electrotherapy System, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
[V
1
] V, where V
1
= 3V
d =
[
3,5
]
√P
V
1
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2,5 GHz
[E
1
] V/m, where E
1
= 3V/m
d =
[
3,5
]
√P 80 MHz to 800 MHz
E
1
d =
[
7
]
√P 800 MHz to 2,5 GHz
E
1
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 metres (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:
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 aected 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 due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the CEFAR EASY Electrotherapy System is used exceeds
the applicable RF compliance level above, the CEFAR EASY Electrotherapy System should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the CEFAR EASY Electrotherapy System .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V
1
] V/m.