Orthofix SpinalStim 5212CE Manuel D'instructions page 3

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.
Device Instruction Manual
™
1
1
1
1
1
1
2
2
2
2
3
3
4
4
4
6
7
9
11
11
11
12
12
13
13
14
14
14
15
16
17
17
19