Bioness StimRouter Neuromodulation System Manuals

Manuals and User Guides for Bioness StimRouter Neuromodulation System. We have 6 Bioness StimRouter Neuromodulation System manuals available for free PDF download: Clinicians Manual, Clinician Manual, User Manual, User's Reference Card, Clinician's Reference Card

Bioness StimRouter Clinicians Manual (108 pages)

Neuromodulation System

Brand: Bioness | Category: Medical Equipment | Size: 4 MB

Table of Contents
6
Chapter 1: Introduction

12
Chapter 2: Warnings and Precautions

14
- Indications
  14
- Contraindications
  14
- Implantation Setting
  15
- Patient Screening
  15
- Warnings
  16
  - Magnetic Resonance Imaging (MRI) Warnings and Precautions
    16
  - Stimrouter External Component Restrictions
    17
- MRI Safety Information
  17
- MRI Conditional
  17
- Potential Adverse Events
  25
- Pregnancy
  25
- Long-Term Effectiveness of Neurostimulation
  26
- Programming
  26
- Device Components
  26
- Flammable Fuel, Chemicals or Environment
  26
- Driving and Operating Machinery
  26
- Electromagnetic Compatibility Warnings
  27
  - Medical Devices/Therapies
    27
  - Electrosurgery Devices
    27
  - High-Frequency Surgical Equipment
    27
  - Body-Worn Devices
    28
  - Security Screening Devices
    28
  - Cell Phones
    28
- Precautions
  28
  - Physician Training
    28
  - Post-Operative Care
    29
  - Implant Location
    29
  - For Single Patient Use Only
    29
  - Postural Changes
    29
  - Keep out of Reach of Children
    29
  - Skin Abnormalities
    29
  - Skin Irritation
    29
  - Known or Suspected Heart Problems
    30
  - Stimrouter Electrode Placement and Stimulation
    30
  - Expiration Date
    30
  - Implant Failure
    30
  - Storage and Handling
    31
- Adverse Effects
  31
Chapter 3: Clinical Experience

34
- Safety
  34
- Effectiveness
  34
Chapter 4: Environmental Conditions that Affect Use

36
- Storage and Handling
  36
- Radio Communication Information
  36
  - Conformity Certification
    37
Chapter 5: Patient Components

38
- Stimrouter Lead
  38
- Stimrouter External Plus Transmitter (EPT)
  38
  - Charging Socket and Charging Light
    39
- Stimrouter Electrode
  39
- Patient Programmer
  40
  - Operating Modes
    41
    
    Standby Mode
    41
    
    Program Mode
    42
    
    Stimulation Mode
    42
  - Charging Socket and Connection Port
    42
Chapter 6: Stimrouter Clinician Kit

44
Chapter 7: Device Description

46
- Programmer Connector Cable
  46
- Clinician's Programmer
  46
  - Operating Buttons
    47
  - Micro SD Slot
    47
  - Touchscreen Display
    47
  - Connector Port
    47
  - Clinician's Programmer Micro SD Card
    47
  - Clinician's Programmer Charger
    47
- Tester
  48
- Stimrouter Software
  48
  - Operating Modes
    48
    
    Online
    48
    
    Offline
    48
  - Information Icon
    49
  - Print Icon
    50
  - Save Icon
    50
  - Drop-Down Lists
    50
  - Menu Bars and Menus
    51
    
    Exit
    51
    
    Patients
    51
    
    Programs
    51
    
    History
    51
    
    Tools
    51
  - Tabs
    51
  - Navigation Buttons
    53
  - Intensity Level Bar
    54
  - Program Bar
    54
    
    Add Program Icon
    54
    
    Delete Program Icon
    54
    
    Program Bar Arrows
    54
  - Search Bars
    54
  - Stimulation Parameters
    55
Chapter 8: Clinician's Programmer Set-Up

58
Chapter 9: Software Records and History

62
Chapter 10: Patient Set-Up and Programming Instructions

70
- Preparing the Patient's Skin
  70
- Connecting the Stimrouter Electrode and EPT
  70
- Adhering the Stimrouter Electrode to the Skin
  71
- Confirming Set-Up
  73
- Removing the Stimrouter Electrode
  73
- Programming Instructions
  74
  - Programming Stimulation Settings
    74
  - Programming Time Settings
    76
- Programs
  77
  - Adding a Program
    77
  - Saving a Program
    77
  - Deleting a Program
    78
  - Printing a Program
    78
Chapter 11: Software Tools

80
Chapter 12: Maintenance and Cleaning

86
- Replacing Stimrouter Electrode
  86
  - Replacing the Patient Programmer Battery
    86
- Cleaning
  87
- Disinfecting
  88
  - Electronic Components
    88
Chapter 13: Troubleshooting

90
Chapter 14: Technical Specifications

100
Chapter 15: Appendix - EMI Tables

102
- Electromagnetic Emissions
  102

Bioness StimRouter Clinician Manual (107 pages)

Neuromodulation System

Brand: Bioness | Category: Medical Equipment | Size: 4 MB

Table of Contents
4
Chapter 1: Introduction

10
Chapter 2: Warnings and Cautions

12
- Indications for Use
  12
- Contraindications
  12
- Implantation Setting
  13
- Patient Screening
  13
- Warnings
  14
  - Magnetic Resonance Imaging (MRI) Warnings and Precautions
    14
    
    Stimrouter External Component Restrictions
    14
    
    MRI Information
    14
    
    MRI-Related Heating: Supplemental Information
    17
    
    Image Artifacts
    18
    
    Induced Currents
    19
    
    Potential Adverse Events
    19
    
    Pregnancy
    19
    
    Long-Term Effectiveness of Neurostimulation
    19
    
    Programming
    19
    
    Device Components
    19
    
    Flammable Fuel, Chemicals or Environment
    20
    
    Driving and Operating Machinery
    20
  - Electromagnetic Compatibility Warnings
    20
    
    Medical Devices/Therapies
    20
    
    Electrosurgery Devices
    21
    
    High-Frequency Surgical Equipment
    21
    
    Body-Worn Device
    21
    
    Security Screening Devices
    21
    
    Cell Phones
    22
  - Precautions
    22
    
    Physician Training
    22
    
    Post-Operative Care
    22
    
    Implant Location
    22
    
    For Single Patient Use Only
    22
    
    Postural Changes
    22
    
    Keep out of Reach of Children
    23
    
    Skin Abnormalities
    23
    
    Skin Irritation
    23
    
    Known or Suspected Heart Problems
    23
    
    Stimrouter Electrode Placement and Stimulation
    23
    
    Expiration Date
    24
    
    Implant Failure
    24
    
    Storage and Handling
    24
  - Adverse Effects
    24
    
    Risks Related to the Implant Procedure
    25
    
    Risks Related to Stimulation
    25
    
    Additional Risks Related to the Stimrouter System
    25
Chapter 3: Clinical Experience

26
Chapter 4: Environmental Conditions that Affect Use

28
- Storage and Handling
  28
- Radio Communication Information
  28
  - Conformity Certification
    29
Chapter 5: Patient Components

30
- Stimrouter Lead
  30
- Stimrouter External Plus Transmitter (EPT)
  30
- Stimrouter Electrode
  31
- Patient Programmer
  32
Chapter 6: Stimrouter Clinician Kit

36
Chapter 7: Device Description

38
- Configuration Cradle
  38
- Clinician's Programmer
  38
  - Tester
    40
- Stimrouter Software
  41
  - Operating Modes
    41
  - Information Icon
    42
  - Print Icon
    42
  - Data Entry
    42
  - Menu Bar and Menus
    43
  - Tabs
    43
  - Navigation Buttons
    45
  - Intensity Level Bar
    46
  - Program Bar
    46
  - Search Bars
    47
  - Stimulation Parameters
    47
Chapter 8: Clinician's Programmer Set-Up

50
Chapter 9: Software Records and History

54
- Patient Records
  54
- Usage History
  59
  - Viewing a Usage History
    59
  - Printing a Usage History
    60
- Session History
  61
Chapter 10: Patient Set-Up and Programming Instructions

64
- Preparing the Patient's Skin
  64
- Connecting the Stimrouter Electrode and EPT
  64
- Adhering the Stimrouter Electrode to the Skin
  65
- Confirming Set-Up
  67
- Removing the Stimrouter Electrode
  67
- Programming Instructions
  68
  - Programming Stimulation Settings
    68
  - Programming Time Settings
    70
- Programs
  71
  - Adding a Program
    71
  - Viewing a Program
    71
  - Deleting a Program
    72
  - Printing a Program
    72
Chapter 11: Software Tools

74
Chapter 12: Maintenance and Cleaning

84
- Replacing Stimrouter Electrode
  84
- Battery Replacement
  84
  - Replacing the Clinician's Programmer Battery
    84
  - Replacing the Patient Programmer Battery
    85
- Cleaning
  86
- Disinfecting
  86
  - Electronic Components
    86
  - Clinician Kit Carrying Case
    86
Chapter 13: Troubleshooting

88
Chapter 14: Technical Specifications

98
- Troubleshooting Wireless Technology
  100
Chapter 15: Appendix - EMI Tables

102
- Electromagnetic Emissions
  102

Bioness StimRouter User Manual (90 pages)

Neuromodulation System

Brand: Bioness | Category: Medical Equipment | Size: 4 MB

Table of Contents
6
Chapter 1: Introduction

12
Chapter 2: Warnings and Cautions

14
- Indications for Use
  14
- Contraindications
  14
- Warnings
  15
  - Magnetic Resonance Imaging (MRI) Warnings and Precautions
    15
  - Stimrouter External Component Restrictions
    16
- MRI Safety Information
  16
- MRI Conditional
  16
- Potential Adverse Events
  28
- Pregnancy
  28
- Long-Term Effectiveness of Neurostimulation
  28
- Programming
  28
- Device Components
  28
- Flammable Fuel, Chemicals or Environment
  29
- Driving and Operating Machinery
  29
- Electromagnetic Compatibility Warnings
  29
  - Medical Devices/Therapies
    29
  - Electrosurgery Devices
    30
  - High-Frequency Surgical Equipment
    30
  - Body-Worn Devices
    30
  - Security Screening Devices
    31
  - Cell Phones
    31
- Precautions
  31
  - Post-Operative Care
    31
  - Known or Suspected Heart Problems
    32
  - Implant Failure
    32
  - Postural Changes
    32
  - For Single Patient Use Only
    32
  - Keep out of Reach of Children
    32
  - Skin Abnormalities
    32
  - Skin Irritation
    32
  - Sensations Caused by Stimulation
    33
  - Stimrouter Electrode Expiration Date
    33
  - Stimrouter Electrode Placement and Stimulation
    33
  - Storage and Handling
    34
- Adverse Effects
  34
Chapter 3: Clinical Experience

36
- Safety
  36
- Effectiveness
  36
Chapter 4: Environmental Conditions that Affect Use

38
Chapter 5: Stimrouter User Kit

40
Chapter 6: Device Description

42
- Stimrouter Lead
  42
- Stimrouter External Pulse Transmitter (EPT)
  42
  - Charging Socket and Charging Light
    43
- Stimrouter Electrode
  43
  - Stimrouter Electrode Liner
    44
  - Stimrouter Electrode Carrying Case
    44
- Stimrouter Patient Programmer
  45
  - Operating Buttons
    45
    
    On/Off Button
    45
    
    Mode Button
    45
    
    Plus/Minus Buttons
    46
    
    Volume Buttons
    46
  - Operating Modes
    46
    
    Standby Mode
    46
    
    Program Mode
    46
    
    Stimulation Mode
    47
  - Indicator Lights
    47
    
    Patient Programmer Indicator Light
    47
    
    Stimulation Indicator Light
    47
    
    Program Mode Indicator Light
    47
  - Information Icons
    48
    
    Patient Programmer Icon
    48
    
    EPT Icon
    48
    
    Radio Frequency (RF) Icon
    48
  - Digital Display
    48
    
    Stimulation Intensity Level
    48
    
    Program Selection
    49
    
    System Errors
    49
    
    Charging Status
    49
  - Audio Alerts
    50
  - Charging Socket
    50
  - Connection Port
    51
  - Battery Compartment
    51
  - Patient Programmer Neck and Wrist Straps
    51
  - System Charger Set
    52
Chapter 7: Set-Up Instructions

54
Chapter 8: Operating Instructions

60
Chapter 9: Maintenance and Cleaning

68
- Recharging the Patient Programmer Battery
  68
- Replacing the Patient Programmer Battery
  68
- Recharging the EPT Battery
  70
- Replacing the Stimrouter Electrode
  70
- Registering a New Component
  71
- Cleaning
  72
- Disinfecting
  73
  - Electronic Components
    73
Chapter 10: Troubleshooting

74
Chapter 11: Technical Specifications

78
Chapter 12: Appendix - EMI Tables

84
- Electromagnetic Emissions
  84

Bioness StimRouter User Manual (59 pages)

Implantable Neurostimulator

Brand: Bioness | Category: Medical Equipment | Size: 3 MB

Table of Contents
5
1 Introduction

9
- Your Stimrouter User Kit
  
  9
- Your Programming Session
  
  9
- User Registration Information
  
  10
- Your Medical Device ID Card
  
  10
- Bioness Customer Support
  
  10
2 General Warnings and Cautions

11
- Indications for Use
  
  11
- Contraindications
  
  11
- Warnings
  
  12
  - Diathermy
    12
  - Magnetic Resonance Imaging (MRI)
    12
  - Implanted Stimulation Devices
    12
  - Flammable Fuel or Chemicals
    13
  - Electrosurgery Devices
    13
  - High-Frequency Surgical Equipment
    13
  - Driving and Operating Machinery
    13
  - Pregnancy
    13
  - Long-Term Effectiveness of Neurostimulation
    13
  - System Programming
    14
  - System Components
    14
- Precautions
  
  14
  - Medical Devices/Therapies
    14
  - For Patient Use Only
    14
  - Postural Changes
    14
  - Keep out of Reach of Children
    15
  - Skin Abnormalities
    15
  - Skin Irritation
    15
  - User Patch Placement and Stimulation
    15
  - X-Ray Examinations
    16
  - Known or Suspected Heart Problems
    16
  - Device Failure
    16
  - Care and Handling of Components
    16
  - Storage and Operation Temperatures
    16
  - Expiration Date
    16
- Adverse Effects
  
  16
  - Risks Related to Stimulation
    17
  - Risks Related to the Device
    17
3 User Kit Contents

19
4 Device Description

21
- Implantable Lead
  
  22
  - Stimulation End
    22
  - Pick-Up End
    22
- User Patch
  
  22
  - Design Features
    22
    
    Two Surface Gel Electrodes
    22
    
    Integrated Battery
    22
    
    External Pulse Transmitter Cradle
    22
    
    EPT Latching Mechanism
    22
  - Accessories
    23
    
    User Patch Carrying Case
    23
    
    Patch Sleeves
    23
- External Pulse Transmitter
  
  23
- Remote Control
  
  23
  - Operating Modes
    23
    
    Standby
    23
    
    Program
    24
    
    Stimulation
    24
  - Operating Buttons
    24
    
    On/Off
    24
    
    Mode
    24
    
    Plus/Minus
    24
    
    Volume
    25
  - On/Off Indicator Lights
    25
    
    Remote Control
    25
    
    Stimulation
    25
    
    Program
    25
  - Digital Display
    25
    
    Intensity
    25
    
    Battery Charging
    25
    
    Battery Fully Charged
    25
    
    Radio Frequency Registration Error
    26
    
    Radio Frequency Registration Complete
    26
    
    Radio Frequency Registration in Progress
    26
  - Leds
    26
    
    User Patch Icon
    26
    
    Radio Frequency (RF) Icon
    26
    
    Remote Control Icon
    27
  - Visual Alerts
    27
    
    Low Battery, Remote Control
    27
    
    Low Battery, User Patch
    27
    
    Faulty Electrode Contact
    27
    
    Radio Frequency Failure
    27
    
    Component Malfunction
    27
  - Audio Alerts
    27
    
    Beep
    27
  - Battery Compartment
    28
  - Accessories
    28
    
    Remote Control Charger
    28
    
    Remote Control Neck Strap
    28
    
    Remote Control Wrist Strap
    28
    
    Remote Control Pouch
    28
5 Technical Specifications

29
6 Environmental Conditions that Affect Use

33
- Storage and Handling
  
  33
- Radio Communication Information
  
  33
- Security Screening Devices
  
  34
- Cell Phones
  
  34
7 Set-Up Instructions

35
- Charging the Remote Control
  
  35
- Preparing the Skin
  
  36
8 Operating Instructions

37
- Overview
  
  37
- Attaching the EPT to a User Patch
  
  38
- Applying the User Patch to the Skin
  
  38
- Turning on the Remote Control
  
  39
- Adjusting the Volume of Audio Alerts
  
  40
- Selecting a Stimulation Program
  
  40
- Turning Stimulation on
  
  41
- Adjusting Stimulation Intensity
  
  41
- Saving a New Default Stimulation Intensity Level
  
  42
- Turning Stimulation off
  
  43
- Taking off the User Patch
  
  44
- Removing the External Pulse Transmitter
  
  44
9 Maintenance and Cleaning

47
- Recharging the Remote Control Battery
  
  47
- Replacing the Remote Control Battery
  
  47
- Registering a New Component
  
  48
- Replacing the User Patch
  
  50
- Cleaning the Components
  
  51
- Cleaning the Patch Sleeves
  
  51
10 Troubleshooting

53
- User Patch
  
  53
  - Faulty Electrode Contact
    53
  - Battery Low Charge
    54
  - Battery Failure
    54
- Remote Control
  
  55
  - Battery Low Charge
    55
  - Battery Failure
    55
  - Battery Discharges Rapidly
    55
  - Battery Charging Error
    56
- External Pulse Transmitter
  
  56

Bioness StimRouter Clinician's Reference Card (2 pages)

Neuromodulation System

Brand: Bioness | Category: Medical Equipment | Size: 0 MB

Bioness StimRouter User's Reference Card (2 pages)

Electrode/External Pulse Transmitter EPT Set-Up

Brand: Bioness | Category: Transmitter | Size: 1 MB

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More Bioness Manuals

Bioness StimRouter Neuromodulation System Manuals

Bioness StimRouter Clinicians Manual (108 pages)

Table of Contents

Chapter 1: Introduction

Chapter 2: Warnings and Precautions

Chapter 3: Clinical Experience

Chapter 4: Environmental Conditions that Affect Use

Chapter 5: Patient Components

Chapter 6: Stimrouter Clinician Kit

Chapter 7: Device Description

Chapter 8: Clinician's Programmer Set-Up

Chapter 9: Software Records and History

Chapter 10: Patient Set-Up and Programming Instructions

Chapter 11: Software Tools

Chapter 12: Maintenance and Cleaning

Chapter 13: Troubleshooting

Chapter 14: Technical Specifications

Chapter 15: Appendix - EMI Tables

Bioness StimRouter Clinician Manual (107 pages)

Table of Contents

Chapter 1: Introduction

Chapter 2: Warnings and Cautions

Chapter 3: Clinical Experience

Chapter 4: Environmental Conditions that Affect Use

Chapter 5: Patient Components

Chapter 6: Stimrouter Clinician Kit

Chapter 7: Device Description

Chapter 8: Clinician's Programmer Set-Up

Chapter 9: Software Records and History

Chapter 10: Patient Set-Up and Programming Instructions

Chapter 11: Software Tools

Chapter 12: Maintenance and Cleaning

Chapter 13: Troubleshooting

Chapter 14: Technical Specifications

Chapter 15: Appendix - EMI Tables

Bioness StimRouter User Manual (90 pages)

Table of Contents

Chapter 1: Introduction

Chapter 2: Warnings and Cautions

Chapter 3: Clinical Experience

Chapter 4: Environmental Conditions that Affect Use

Chapter 5: Stimrouter User Kit

Chapter 6: Device Description

Chapter 7: Set-Up Instructions

Chapter 8: Operating Instructions

Chapter 9: Maintenance and Cleaning

Chapter 10: Troubleshooting

Chapter 11: Technical Specifications

Chapter 12: Appendix - EMI Tables

Bioness StimRouter User Manual (59 pages)

Table of Contents

1 Introduction

Your Stimrouter User Kit

Your Programming Session

User Registration Information

Your Medical Device ID Card

Bioness Customer Support

2 General Warnings and Cautions

Indications for Use

Contraindications

Warnings

Precautions

Adverse Effects

3 User Kit Contents

4 Device Description

Implantable Lead

User Patch

External Pulse Transmitter

Remote Control

5 Technical Specifications

6 Environmental Conditions that Affect Use

Storage and Handling

Radio Communication Information

Security Screening Devices

Cell Phones

7 Set-Up Instructions

Charging the Remote Control

Preparing the Skin

8 Operating Instructions

Overview