Cogentix Medical Urgent PC Instrucciones De Uso página 10

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Urgent PC Stimulator is intended for use in the electromagnetic environment
specified below. The customer or the user of the Urgent PC Stimulator should assure
that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Electrostatic ± 6kV contact
discharge (ESD)
± 8kV air
IEC 61000-4-2
Electrical fast ± 2kV for power
transient/burst supply lines
IEC 61000-4-4
± 1kV for input/
output lines
Surge ± 1kV differential
IEC 61000-4-5 mode
±2 kV common
mode
Voltage <5 % U T
dips, short (>95 % dip in U T )
interruptions for 0,5 cycle
and voltage
40 % U T
variations on
(>95 % dip in U T )
power supply
for 5 cycles
input lines
70 % U T
IEC 61000-4-11
(>95 % dip in U T )
for 25 cycles
<5 % U T
(>95 % dip in U T )
for 5 sec
Power 3 A/m
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
18
Compliance Electromagnetic
Level Environment –
Guidance
± 6 kV Floors should be wood,
contact concrete or ceramic tile.
If floors are covered with
± 8 kV air
synthetic material, the
relative humidity should
be at least 30%.
Not Not applicable
applicable
Not Not applicable
applicable
Not Not applicable
applicable
Not Not applicable
applicable
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Urgent PC Stimulator is intended for use in the electromagnetic environment
specified below. The customer or the user of the Urgent PC Stimulator should assure
that it is used in such an environment.
Immunity IEC 60601
Compliance
Test Test Level
Level
Conducted 3 Vrms 3 Vrms Portable and mobile RF communications
equipment should be used no closer to any part of
RFIEC 150 kHz to
the Urgent PC Stimulator, including cables, than
61000-4-6 80 MHz
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1,2√P
d = 1,2√P 80 MHz to 800 MHz
Radiated 3 V/m 3 V/m
d = 2,3√P 800 MHz to 2,5 GHz
RFIEC 80MHz to
61000-4-3 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 metres (m).
Field strength 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
affected 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 Urgent
PC Stimulator is used exceeds the applicable RF compliance level above, the Urgent PC
Stimulator should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
Urgent PC Stimulator
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Electromagnetic Environment – Guidance
19