User Manual

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EnglishTrialStimulatorManual 5
Storage and Usage Environment
Componentpackaging–Donotusethecomponentifanyofthefollowinghave  occurred:
 Thestoragepackagehasbeendamaged,pierced,oraltered.Inthiscase,sterilitycannotbeguaranteedand
infectionmayoccur.
 Thecomponentitselfshowsanysignsofdamage.Thecomponentmaynotfunction
 properly.
 Theuse‐bydatehasexpired.Inthiscase,componentperformancecannotbeguaranteed.
Usageenvironment:
Thefollowingliststheappropriatetemperature,humidity,andpressureusageconditionsforuseoftheTS:
 Temperature:5°Cto40°C
 Humidity:15%to95%
 Pressure:106kPato
70kPa
ShippingandStorageenvironment:
Thefollowingliststheappropriatetemperature,humidity,andpressureconditionsforshippingandstoringtheTS:
 Temperature(shortterm:3days):‐25
o
Cto70
o
C
 Temperature(longterm):20
o
Cto30
o
C
 Humidity(shortterm:3days):15%to95%
 Humidity(longterm):30%to85%
 Pressure(shortterm:3days):57kPato106kPa
 Pressure(longterm):70kPato106kPa
Ifthe
 TSwasstoredattemperaturesoutsideofthisrange,donotuseituntilithasreturnedtotheoperating
temperaturerange.
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LABEL SYMBOLS
Thissectionexplainsthesymbolsfoundontheproductandpackaging.
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Symbol Description
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AxonicsTrialStimulator

TrialStimulatordefaultwaveformwith14Hz
frequency,0mAamplitudeand210µspulse
width
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ProductSerialNumber
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Manufacturer
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ProductModelNumber
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ManufacturingDate
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Nonionizingelectromagneticradiation
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ConformitéEuropéenne (European
Conformity).Thissymbolmeansthatthe
devicefullycomplieswithAIMDDirective