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bioMetric SpinalPak - Symbol Description; Equipment Classification; Cleaning Instructions

bioMetric SpinalPak
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10 11
Attentionseeinstructions
AlternatingCurrent
DirectCurrent
TypeB
Storage/Transport
temperaturelimits
Class II
NonSterile
Manufacturer
WEEE
SinglePatientUse
PrescriptionOnly
Warning:Theconcomitant
useofthestimulatoranda
pacemakerorcardioverter
mustbeassessedbya
cardiologistonan
individualbasiswithan
Electrocardiogram(EKG).
Caution:Thesafetyof
thisdeviceusedduring
pregnancyandnursing
inhumanshasnot
beenestablished.
Symbol Description
Equipment Classification
• Stimulator-Internallypoweredbyrechargeablebatteries
• Charger-ClassII,TypeB
• OrdinaryEquipmentwithoutprotectionagainstingressofwater
• Equipmentnotsuitableforuseinpresenceofflammableanestheticmixturewithairoroxygen
ornitrousoxide.
• Modeofoperation-continuous
Cleaning Instructions
UseadampclothforcleaninganypartoftheBiomet
®
SpinalPak
®
Non-invasiveSpineFusion
StimulatorSystem.Donotusecleaningproductsordetergents.
2
Rx only