Guidance And Manufacturer's Declaration - Electromagnetic Immunity - smith&nephew SPIDER2 Limb Positioner Mode D'emploi

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Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The SPIDER2 is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIDER2 should ensure that it is used in such an
environment.
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.
T
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The SPIDER2 is intended for use in the electromagnetic environment specified below. The customer or user of the SPIDER2 should assure that it is used in such an
environment.
Immunity Test IEC 60601 Test Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 KHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
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, land mobile radios, amateur radios, AM and FM radio broadcasts, and TV
broadcasts 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 SPIDER2 is used exceeds the applicable RF compliance level above, the SPIDER2 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SPIDER2.
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
b
8
126-99-01 Rev. C
IEC 60601 Test Level
+/- 6 kV contact
+/- 8 kV air
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
+/- 1 kV line(s) to line(s)
+/- 2 kV line(s) to earth
<5% U (>95% dip in U )
T T
40% U (60% dip in U ) for 5 cycles
T T
70% U (30% dip in U ) for 25 cycles
T T
<5% U (>95% dip in U ) for 5 sec
T T
3 A/m
Compliance Level Electromagnetic Environment – Guidance
Not applicable Not applicable
3 V/m Recommended separation distance
d = 1.17 √ P
80 MHz to 2.5 GHz
d = 2.34 √ P
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 strength from fixed RF transmitters, as determined by an electromagnetic site survey,
than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
Compliance Level Electromagnetic Environment – Guidance
+/- 6 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%.
+/- 8 kV air
Not applicable Mains power quality should be that of a typical commercial or hospital
environment.
Not applicable Mains power quality should be that of a typical commercial or hospital
environment.
Not applicable Mains power quality should be that of a typical commercial or hospital
environment. If the user of the SPIDER2 requires continued operation
during power mains interruptions, it is recommended that the SPIDER2 be
powered from an uninterruptible power supply or a battery.
3 A/m Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Non-ionizing electromagnetic radiation
b
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SPIDER2 Limb Positioner Instructions for Use
should be less
a