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The SpinalStim
Table of Contents
Prescription Information .............................................................................
• Indications ............................................................................................
• Contraindication ...................................................................................
• Warnings ..............................................................................................
• Precautions ...........................................................................................
• Adverse Effects .....................................................................................
Device Information ......................................................................................
• Device Description ................................................................................
• How the SpinalStim device Works ........................................................
• Device Life ............................................................................................
Device Operation .........................................................................................
• Turning the Device On and Off.............................................................
• Treatment Instructions .........................................................................
• Timing of Treatment Sessions ...............................................................
• Charging the Battery ............................................................................
• Visual and Audio Indicators ..................................................................
• Wearing the Device ..............................................................................
• Sizing the Device ..................................................................................
Device Accessories .....................................................................................
Device Use and Care .................................................................................
• Care and Cleaning ..............................................................................
• Storage ...............................................................................................
• Travel ..................................................................................................
• Disposal ..............................................................................................
• Service ................................................................................................
Clinical Information ...................................................................................
• Clinical Data Summary .......................................................................
• Adjunct Clinical Trial ...........................................................................
• Failed Fusion Clinical Trial ...................................................................
Equipment Classification ...........................................................................
SpinalStim Device Classifications ...............................................................
Compliance Statements ............................................................................
Warranty ...................................................................................................
Device Box Components
1 - SpinalStim Device
1 - Power Supply
1 - Literature Pack
Orthofix Patient Services: 800-535-4492 or 214-937-2718
To learn more about Orthofix, please visit our website at www.orthofix.com.
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Spinalstim5212cm

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