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PhysioStim™ Device Instruction Manual
Table of Contents
Prescription Information ................................................................................................................... 1
• Indication ........................................................................................................................................ 1
• Contraindication........................................................................................................................... 1
• Warnings ......................................................................................................................................... 1
• Precautions ..................................................................................................................................... 1
• Adverse Effects .............................................................................................................................. 1
Device Description .............................................................................................................................. 2
• How the PhysioStim Device Works ........................................................................................ 2
• Device Life ...................................................................................................................................... 2
Device Operation ................................................................................................................................. 3
• Turning the Device On and Off ............................................................................................... 3
• Treatment Instructions ............................................................................................................... 4
• Timing of Treatment Sessions ................................................................................................. 4
• Charging the Battery .............................................................................................................. 4-5
• Visual and Audio Indicators...................................................................................................... 6
Device Application.........................................................................................................................7-11
Device Accessories .............................................................................................................................12
Device Use and Care .........................................................................................................................12
• Care and Cleaning .....................................................................................................................12
• Storage and Operating Environments ...............................................................................13
• Travel ...............................................................................................................................................13
• Disposal .........................................................................................................................................13
• Service ............................................................................................................................................14
Clinical Information ...........................................................................................................................14
Clinical Success of the PhysioStim Device ................................................................................14
Equipment Classification and Device Symbol Descriptions...............................................15
PhysioStim Device Classifications ................................................................................................16
Compliance Statements...................................................................................................................16
Information Regarding Electromagnetic Compatibility and Immunity.........................17
Warranty ................................................................................................................................................18
Device Box Components
1 - PhysioStim Device
1 - Device Strap
1 - Power Supply
1 - Literature Pack
1 - Sure Fit Cushion (Models 5302CE and 5303CE)
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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