Bioness bioventus StimRouter Neuromodulation System Manuals

Manuals and User Guides for Bioness bioventus StimRouter Neuromodulation System. We have 1 Bioness bioventus StimRouter Neuromodulation System manual available for free PDF download: Clinicians Manual

Bioness bioventus StimRouter Neuromodulation System Clinicians Manual (45 pages)

Brand: Bioness | Category: Personal Care Products | Size: 5 MB

Table of Contents
3
Chapter 1: Introduction

6
Chapter 2: Patient Components

7
Chapter 3: Stimrouter Clinician Kit

9
Chapter 4: Warnings and Cautions

10
- Indications for Use
  10
- Device Use and Stability
  10
- Device Materials
  10
- Essential Performance
  11
- Contraindications
  11
- Warnings
  11
- Magnetic Resonance Imaging (MRI) Safety Information
  11
- Pregnancy
  11
- Programming
  11
- Flammable Fuel, Chemicals or Environment
  11
- Driving and Operating Machinery
  11
- Electromagnetic Compatibility Warnings
  12
- Medical Devices/Therapies
  12
- Electrosurgery Devices
  12
- High-Frequency Surgical Equipment
  12
- Body-Worn Devices
  12
- Security Screening Devices
  12
- Cell Phones
  12
- Precautions
  12
- Post-Operative Care
  12
- Known or Suspected Heart Problems
  13
- Implant Failure
  13
- Postural Changes
  13
- For Single Use Only
  13
- Keep out of Reach of Children
  13
- Skin Abnormalities
  13
- Skin Irritation
  13
- Sensations Caused by Stimulation
  13
- Gel Electrode Expiration Date
  13
- Gel Electrode Placement and Stimulation
  13
- Adverse Effects
  14
- Risks Related to the Implant Procedure
  14
- Risks Related to Stimulation
  14
- Additional Risks Related to the Stimrouter System
  14
- Temperature
  14
- End-Of-Life Waste Management
  14
Chapter 5: Environmental Conditions that Affect Use

15
Chapter 6: Device Description

16
- Clinician's Programmer
  16
- Operating Buttons
  16
- Micro SD Slot
  16
- Touchscreen Display
  16
- Clinician's Programmer Micro SD Card
  16
- Clinician's Programmer Charger
  17
- Stimrouter Plus Software
  17
- Operating Modes
  17
- Online
  17
- Offline
  17
- Information Icon
  17
- Drop-Down Lists
  18
- Menu Bars and Menus
  18
- Exit
  18
- Patients
  18
- Programs
  18
- Tools
  18
- Tabs
  18
- Navigation Buttons
  19
- Intensity Level Bar
  19
- Add Program Icon
  19
- Delete Program Icon
  19
- Program Bar Arrows
  19
- Stimulation Parameters
  19
Chapter 7: Clinician's Programmer Set-Up

21
Chapter 8: Software Records and History

23
- Patient Records
  23
- Adding a New Patient
  23
- Copying a Record for an Existing Patient to an Unassigned System
  24
- Adding a Patient with an Assigned System
  24
- Opening a Patient Record
  24
- Modifying a Patient Record
  25
- Removing a Patient Record
  25
- Searching for a Patient Record
  25
- History
  26
- View Usage History
  26
- Select a Stimulation Program
  26
- Select a Time Period
  26
- Select Duration
  26
- Select Intensity
  26
- Change Date Ranges
  26
- View Sessions History
  27
- Save Usage Data
  27
Chapter 9: Patient Set-Up and Programming Instructions

27
- Preparing the Patient's Skin
  27
- Connecting the Gel Electrode and E-EFC
  27
- Adhering the Gel Electrode to the Skin
  28
- Confirming Set-Up
  29
- Removing the Gel Electrode
  29
- Programming Instructions
  29
- Programming Stimulation Settings
  29
- Programming Time Settings
  30
- Programs
  30
- Adding a Program
  30
- Deleting a Program
  30
Chapter 10: Software Tools

31
Chapter 11: Maintenance and Cleaning

34
- Replacing Gel Electrode
  34
- Cleaning
  34
- Disinfecting
  35
- Electronic Components
  35
Chapter 12: Troubleshooting

35
- Patient Forgets E-EFC
  35
- Patient Loses E-EFC
  35
- Patient Brings New E-EFC
  35
- Copying Patient Data to New Components
  35
- Troubleshooting Tables
  36
- Incident Reporting
  36
Chapter 13: Technical Specifications

37
Chapter 14: Network Safety, Security, and Privacy

39
Chapter 15: Appendix - EMI Tables

40
- Electromagnetic Emissions
  40
- Labeling LBL-000706 [A] RELEASED Clinician's Guide
  43

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Bioness bioventus StimRouter Neuromodulation System Manuals

Bioness bioventus StimRouter Neuromodulation System Clinicians Manual (45 pages)

Table of Contents

Chapter 1: Introduction

Chapter 2: Patient Components

Chapter 3: Stimrouter Clinician Kit

Chapter 4: Warnings and Cautions

Chapter 5: Environmental Conditions that Affect Use

Chapter 6: Device Description

Chapter 7: Clinician's Programmer Set-Up

Chapter 8: Software Records and History

Chapter 9: Patient Set-Up and Programming Instructions

Chapter 10: Software Tools

Chapter 11: Maintenance and Cleaning

Chapter 12: Troubleshooting

Chapter 13: Technical Specifications

Chapter 14: Network Safety, Security, and Privacy

Chapter 15: Appendix - EMI Tables

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