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The SpinalStim
Device Instruction Manual
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 and Operating Environments ...........................................................................
• 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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Inhaltsverzeichnis