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8 126-99-01 Rev. C SPIDER2 Limb Positioner Instructions for Use
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 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 floors 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
Not applicable 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
Not applicable 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
)
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 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.
Power frequency (50/60 Hz)
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 a.c. mains voltage prior to application of the test level.
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 Compliance Level Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 KHz to 80 MHz
Not applicable Not applicable
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 MHz to 2.5 GHz
Recommended separation distance
d = 1.17 √ P 80 MHz to 800 MHz
d = 2.34 √ P 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 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:
Non-ionizing electromagnetic radiation
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.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
©2014 Smith & Nephew, Inc.
All Rights Reserved
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