Orthofix Inc OFIX-5000-001 Manual De Usuario
Spinal-Stim
®
Instruction Manual
Table of Contents
Prescription Information .............................................................................
• Indications ............................................................................................
• Contraindication ...................................................................................
• Warnings ..............................................................................................
• Precautions ...........................................................................................
• Adverse Events .....................................................................................
Device Information ......................................................................................
• Indications ............................................................................................
• Contraindication ...................................................................................
• Warnings ..............................................................................................
• Precautions ...........................................................................................
• Adverse Events .....................................................................................
Device Information ......................................................................................
• Device Description ................................................................................
• Device Life ............................................................................................
• 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 ..................................................................................
• 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 .................................................................................
Device Use and Care .................................................................................
• Care and Cleaning ..............................................................................
• Storage ...............................................................................................
• Travel ..................................................................................................
• Disposal ..............................................................................................
• Service ................................................................................................
• Storage ...............................................................................................
• Travel ..................................................................................................
• Disposal ..............................................................................................
• Service ................................................................................................
Clinical Information ...................................................................................
• Clinical Data Summary .......................................................................
• Adjunct Clinical Trial ...........................................................................
• Failed Fusion Clinical Trial ...................................................................
• Adjunct Clinical Trial ...........................................................................
• Failed Fusion Clinical Trial ...................................................................
Equipment Classification ...........................................................................
Compliance Statements ............................................................................
Warranty ...................................................................................................
Compliance Statements ............................................................................
Warranty ...................................................................................................
Device Box Components
1 – Spinal-Stim
1 – Power Supply
1 – Literature Pack
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.
To learn more about Orthofix, please visit our website at www.orthofix.com.
1
1
1
1
1
1
2
2
2
3
3
4
4
4
6
7
9
1
1
1
1
1
2
2
2
3
3
4
4
4
6
7
9
11
11
11
11
12
12
12
13
13
13
14
16
17
19
11
11
11
12
12
12
13
13
13
14
16
17
19