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Table of Contents
SYSTEM CONTENTS .....................................................................................................................1
IMPORTANT SAFEGUARDS .........................................................................................................2
BIOMET
®
SPINALPAK
®
NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM .........................3
• Description ............................................................................................................................3
• ElectricalRequirementsforBatteryPackandCharger .........................................................3
SYSTEM COMPONENTS ............................................................................................................3,4
FULL PRESCRIBING INFORMATION .............................................................................................5
• IndicationsforUse ................................................................................................................5
• Warnings,Precautions,AdverseEffects ...............................................................................5
DIRECTIONS FOR USE ..................................................................................................................6
• RecommendedUsage ...........................................................................................................6
OPERATING INSTRUCTIONS .....................................................................................................6,7
CHARGING THE BATTERY PACK ...............................................................................................7,8
BUTTON FUNCTIONS ....................................................................................................................9
LCD SYMBOL DESCRIPTION AND INSTRUCTIONS .....................................................................9
TREATMENT COMPLETION ........................................................................................................10
PATIENT COMPLIANCE MONITORING ......................................................................................10
ORDERING INFORMATION .........................................................................................................10
ELECTRODE INSTRUCTIONS FOR USE ......................................................................................10
SYMBOL DESCRIPTION ..............................................................................................................11
EQUIPMENT CLASSIFICATION ...................................................................................................11
CLEANING INSTRUCTIONS ........................................................................................................11
ELECTROMAGNETIC COMPATIBILITY .........................................................................12,13,14,15
PATIENT COUNSELING INFORMATION ......................................................................................16
STORAGE AND HANDLING ........................................................................................................16
DISPOSAL INSTRUCTIONS .......................................................................................................16