User Manual

1. Introduction 1
Your StimRouter User Kit . . . . . . . . . . . 1
Your Programming Session . . . . . . . . . . 1
User Registration Information . . . . . . . . . 2
Your Medical Device ID Card . . . . . . . . . 2
Bioness Customer Support . . . . . . . . . . 2
2. General Warnings and Cautions 3
Indications for Use . . . . . . . . . . . . . . . 3
Contraindications . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . 4
Diathermy. . . . . . . . . . . . . . . 4
Magnetic Resonance Imaging (MRI) . 4
Implanted Stimulation Devices . . . . 4
Flammable Fuel or Chemicals . . . . 5
Electrosurgery Devices . . . . . . . . 5
High-Frequency Surgical Equipment . 5
Driving and Operating Machinery. . . 5
Pregnancy . . . . . . . . . . . . . . 5
Long-Term Effectiveness of
Neurostimulation . . . . . . . . . . . 5
System Programming. . . . . . . . . 6
System Components . . . . . . . . . 6
Precautions. . . . . . . . . . . . . . . . . . . . 6
Medical Devices/Therapies . . . . . . 6
For Patient Use Only . . . . . . . . . 6
Postural Changes. . . . . . . . . . . 6
Keep out of Reach of Children . . . . 7
Skin Abnormalities . . . . . . . . . . 7
Skin Irritation . . . . . . . . . . . . . 7
User Patch Placement and Stimulation 7
X-Ray Examinations . . . . . . . . . 8
Known or Suspected Heart Problems 8
Device Failure . . . . . . . . . . . . 8
Care and Handling of Components. . 8
Storage and Operation Temperatures 8
Expiration Date. . . . . . . . . . . . . 8
Adverse Effects . . . . . . . . . . . . . . . . . 8
Risks Related to Stimulation . . . . . . 9
Risks Related to the Device . . . . . . 9
3. User Kit Contents 11
4. Device Description 13
Implantable Lead . . . . . . . . . . . . . . . 14
Stimulation End . . . . . . . . . . . 14
Pick-Up End . . . . . . . . . . . . . 14
User Patch . . . . . . . . . . . . . . . . . . . 14
Design Features . . . . . . . . . . . 14
Two Surface Gel Electrodes. . . . 14
Integrated Battery . . . . . . . . . 14
External Pulse Transmitter Cradle 14
EPT Latching Mechanism . . . . . 14
Accessories . . . . . . . . . . . . . 15
User Patch Carrying Case . . . . 15
Patch Sleeves . . . . . . . . . . . 15
External Pulse Transmitter. . . . . . . . . . 15
Remote Control . . . . . . . . . . . . . . . . 15
Operating Modes . . . . . . . . . . . 15
Standby . . . . . . . . . . . . . . 15
Program . . . . . . . . . . . . . . 16
Stimulation. . . . . . . . . . . . . 16
Operating Buttons . . . . . . . . . . 16
On/Off . . . . . . . . . . . . . . . 16
Mode . . . . . . . . . . . . . . . 16
Plus/Minus. . . . . . . . . . . . . 16
Volume . . . . . . . . . . . . . . 17
On/Off Indicator Lights . . . . . . . . 17
Remote Control . . . . . . . . . . 17
Stimulation. . . . . . . . . . . . . 17
Program . . . . . . . . . . . . . . 17
Table of Contents