User's Manual

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24
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Guidanceandmanufacturer’sdeclaration
ElectromagneticImmunity
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment
specifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulatorSystemshouldassurethat
itisusedinsuchanenvironment.
Immunity IEC60601
TestLevel
Compliance
Level
Electromagneticenvironment
guidance
Electrostatic discharge
(ESD)
IEC61000‐4‐2 ±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
Pass Mainspowerqualityshouldbethat 
of a typical commercial or home
environment
Surge
IEC61000‐4‐5
±1kVline(s)toline(s)
±2kVline(s)toearth
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 Mainspowerqualityshouldbethat 
of a typical commercial or home
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s
NOTE UT is the a.c. mains voltage
prior to application of the test level.
 Mainspowerqualityshouldbethat 
of a typical commercial or home
environment
Powerfrequency
(50/60Hz)magnetic
field
IEC61000‐4‐8
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3A/mPower frequency magnetic fields
shouldbeatlevelscharacteristicof
a typical location in a typical
commercial, hospital,  or home
environment.
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