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Bioness bioventus StimRouter Neuromodulation System Clinicians Manual

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Clinician's Guide
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355
USA
Telephone: (800) 211-9136 or (661) 362-4850
Website: StimRouter.com
Rx Only
©2022 Bioventus LLC
Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
StimRouter and Bioness are trademarks of Bioness Inc. | StimRouter.com
LBL-000706
602-00725-001 Rev. A
Labeling LBL-000706 [A] RELEASED
08/2022

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Summary of Contents for Bioness bioventus StimRouter Neuromodulation System

  • Page 1 Telephone: (800) 211-9136 or (661) 362-4850 Website: StimRouter.com Rx Only ©2022 Bioventus LLC Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. StimRouter and Bioness are trademarks of Bioness Inc. | StimRouter.com LBL-000706 602-00725-001 Rev. A Labeling LBL-000706 [A] RELEASED 08/2022...
  • Page 2 For more information regarding these recommended procedures, please contact Customer Service. Bioventus is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines. Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: (800) 211-9136 or (661) 362-4850 Website: StimRouter.com...

  • Page 3: Table Of Contents

    Table of Contents List of Symbols Caution Chapter 1: Introduction ................ 1 Warning Class II Equipment (Double Insulated) Chapter 2: Patient Components ............3 StimRouter Lead ....................3 Type BF Applied Part(s) StimRouter External Electric Field Conductor (E-EFC) ........3 Non-Ionizing Radiation Charging Socket and Charging Light ............
  • Page 4 Skin Abnormalities ..................14 Program Bar ....................27 Skin Irritation ....................14 Add Program Icon ................27 Sensations Caused by Stimulation ............15 Delete Program Icon ................27 Gel Electrode Expiration Date ..............15 Program Bar Arrows ................27 Gel Electrode Placement and Stimulation ..........15 Stimulation Parameters ................
  • Page 5 Programs ......................49 Guidance and Manufacturer’s Declaration Electromagnetic Emissions ..69 Adding a Program ..................49 Guidance and Manufacturer’s Declaration Electromagnetic Immunity ..71 Deleting a Program ..................49 Recommended Separate Distances for Device ......... 74 Chapter 10: Software Tools ............... 51 Resetting the E-EFC ..................

  • Page 6: Chapter 1: Introduction

    Introduction The StimRouter Neuromodulation System is intended to help relieve chronic pain of peripheral origin. The StimRouter Neuromodulation System is made up of implanted components from the StimRouter Implantable Lead and Lead Introducer Kit (ST2-1000) and external components from the StimRouter User Kit (ST2- 5050).

  • Page 7: Chapter 2: Patient Components

    Patient Components StimRouter Lead The StimRouter Lead is flexible and approximately 15 cm (6 in.) in length. The lead has a stimulation end and a receiver end. The lead implantation places the stimulation end near or at the targeted peripheral nerve. The receiver end of the StimRouter lead receives the signal from the E-EFC and conducts the stimulation pulse through the lead to the stimulation end.

  • Page 8: Gel Electrode

    The typical lifespan of the Gel Electrode is two to four days, depending on: E-EFC Charging Socket • The number of hours of use. • The number of times the Gel Electrode is adhered and removed from the skin. Location of Charging Light •...

  • Page 9: Chapter 3: Stimrouter Clinician Kit

    StimRouter Clinician Kit The StimRouter Clinician Kit includes the following: • Clinician’s Programmer, Tablet with Software and Stylus • Clinician’s Programmer Micro SD Card • Clinician’s Programmer Charger Clinician’s Programmer Labeling LBL-000706 [A] RELEASED Clinician’s Guide Chapter 3 - StimRouter Clinician Kit...

  • Page 10: Chapter 4: Warnings And Cautions

    Warnings and Cautions Use the StimRouter system only as instructed in the User’s Guide. Indications for Use The StimRouter Neuromodulation System is indicated for pain management in adults who have severe, intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

  • Page 11: Essential Performance

    Essential Performance occur during diathermy treatment whether neurostimulation is turned on or off. All patients are advised to inform their health-care professionals The StimRouter System does not have Essential Performance as there is no that they should not be exposed to diathermy. performance necessary (as defined by IEC 60601) to avoid unacceptable risks, •...

  • Page 12: Electromagnetic Compatibility Warnings

    Electromagnetic Compatibility Warnings Body-Worn Devices Although unlikely, body-worn medical devices may interfere with the RF Medical Devices/Therapies communication used in the StimRouter system. Stimulation control may be delayed. Examples of a body- worn device are a pain pump or an insulin pump and a Operation of the StimRouter system in close proximity (e.g., 1 meter or 3 feet) to monitoring device.

  • Page 13: Known Or Suspected Heart Problems

    • Warmth and swelling of the incision site. irritation, remove the Gel Electrode every three to four hours for 15 minutes. • Fever Sensations Caused by Stimulation • Dizziness As with other nerve stimulation devices, the StimRouter Neuromodulation achieves • Bleeding pain relief by causing different sensations to be felt in the area of treatment.

  • Page 14: Adverse Effects

    Adverse Effects Temperature In the unlikely event that any of the following occurs, the StimRouter system should The StimRouter E-EFC can heat up to 43°C during operation in extremely hot be stopped and the Gel Electrode removed. areas/rooms. If this occurs turn off stimulation, remove E-EFC, and set aside until temperature is within operational conditions.

  • Page 15: Chapter 5: Environmental Conditions That Affect Use

    Environmental Conditions that Affect Use Storage and Handling All StimRouter components should be kept dry and protected from extreme changes in temperature and humidity. Components should not be used or stored where they could come in contact with water, such as by sinks, bathtubs and shower stalls, or expose them to weather conditions such as rain or snow.

  • Page 16: Conformity Certification

    Changes or modifications to components not expressly approved by Bioventus could void the user’s authority to operate the equipment. Conformity Certification The StimRouter complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: Device Description 1.

  • Page 17: Clinician's Programmer Charger

    WARNING: The Clinician’s Programmer should only contain the installed Operating Mode Function Descriptions Windows operating system and proprietary StimRouter Plus software. ® • Do not use the Clinician’s Programmer for any purpose other than that • Add a new patient. described in this manual.

  • Page 18: Drop-Down Lists

    GREEN when the StimRouter is online and connected to an E-EFC; Menu Function Descriptions GRAY when no E-EFC is detected. • Open a patient record in online mode. FLASHING RED when a E-EFC is connected and a correctable error • Open any patient record in offline has occurred (for example, RF communication failure).

  • Page 19: Navigation Buttons

    Intensity Level Bar Menu Function Descriptions Used to adjust stimulation intensity. Can be adjusted while stimulation is on or • Restore the Clinician’s Programmer Restore off. See Figure 6-3. database from backup. Decrease 1 mA Increase 1 mA Table 6-2: StimRouter Plus software navigation menus, navigation tabs and functions that can be performed from each menu/tab Decrease 5 mA Increase 5 mA...
  • Page 20 Timing Parameter Definition Specification Burst Parameter Specification 1-60 seconds, Time that stimulation is 0 to 30 mA max and limited by Pulse Time On 1 second Intensity* applied per cycle Duration and Pulse Rate., 1 mA resolution resolution 1-60 seconds, Maximum Voltage 130 V 1 second...

  • Page 21: Chapter 7: Clinician's Programmer Set-Up

    Clinician’s Programmer Set-Up Connecting the Clinician’s Programmer To connect the Clinician’s Programmer: 1. Insert the Clinician Programmer Charger into the Clinician Programmer charging port and plug the charger into a power socket. See Figure 7-1. Clinician’s Programmer Clinician’s Programmer Charger Clinician Programmer Charging Port Figure 7-1: The Clinician’s Programmer set-up...

  • Page 22: Logging Into The Stimrouter Plus Software

    Logging into the StimRouter Plus Software To log into the StimRouter Plus software: 1. Turn the Clinician’s Programmer on by pressing the on/off button on the upper left corner of the Clinician’s Programmer. 2. If the login screen does not open automatically, then, press “Start” and then “StimRouter”...

  • Page 23: Chapter 8: Software Records And History

    Software Records and History Patient Records This section reviews how to add, copy, open, modify, remove and search for a patient record. Adding a New Patient Follow these instructions when a patient does not have a record in the Clinician’s Programmer database and no data has been stored on the E-EFC.

  • Page 24: Copying A Record For An Existing Patient To An Unassigned System

    4. If this prompt does not appear and the patient’s components are new, then Adding a Patient with an Assigned System reset the patient’s E-EFC. See “Resetting the Patient’s E-EFC” section of Follow these instructions when a patient does not have a record in the Clinician’s this guide.

  • Page 25: Modifying A Patient Record

    Removing a Patient Record To remove a patient record: 1. Make certain that the Clinician’s Programmer is not connected to an operational E-EFC. 2. From the Patient List select the patient record to remove, and then press the “Remove” button. See Figure 8-6. 3.

  • Page 26: History

    History Select Duration This section reviews how to view and save patient usage history of the connected Select Duration to view the average number of hours the selected program was E-EFC. used during the designated time period. View Usage History Select Intensity Use the Usage button on the History tab to view detailed graphs of a patient’s Select Intensity to view the last intensity value in mA for the selected program...

  • Page 27: View Sessions History

    View Sessions History Use the Sessions button on the History tab to open a list of individual usage sessions for the connected E-EFC. Patient Set-Up and Programming Instructions Inspect the E-EFC for damage prior to use. Preparing the Patient’s Skin Figure 8-11: View Sessions History To prepare the skin: Open individual session details by clicking to to the left of the session’s date to...

  • Page 28: Adhering The Gel Electrode To The Skin

    E-EFC E-EFC Gel Electrode Figure 9-3: Grasp the edges of the E-EFC attached to the Gel electrode Figure 9-1: Gel Electrode and E-EFC connecting 4. Align the Gel Electrode directly over the end of the lead. The center of the gel pad should be above the StimRouter lead.

  • Page 29: Confirming Set-Up

    6. Firmly adhere the Gel Electrode to the skin, making sure that the 2. Attach the Gel Electrode liner to the gel pads. Without the liner attached, electrode is in full contact with the skin. If the Gel Electrode is not firmly the gel pads on the back of the Gel Electrode will lose their adhesiveness.

  • Page 30: Programming Time Settings

    5. Slowly increase the intensity to a level that is tolerable for the patient and 4. If needed adjust the intensity level. achieves paresthesia. 5. Press the “Stop & Save” button to stop stimulation and save the time settings to the Clinician’s Programmer, Patient Programmer and E-EFC. 6.

  • Page 31: Chapter 10: Software Tools

    Software Tools Resetting the E-EFC System information can be found on the Info Tab of the Tools Menu. From the Info Tab users can look up the installed software version on all components of the StimRouter system. For example, “E-EFC SW VER: 1.0.0.4” indicates to the user that the E-EFC software version is 1.0.0.4.

  • Page 32: Adding A User/Administrator

    Both users and administrators have access to the Info Tab of the Tools Menu. Removing a User/Administrator Administrators have extended authorizations and have access to the Users, Backup To remove a user/administrator: and Restore tabs of the Tools Menu. Administrators can define automatic backup options, manually back up the Clinician’s Programmer database, manually restore 1.

  • Page 33: Enabling Automatic Database Backup

    Enabling Automatic Database Backup To enable automatic database backup: 1. Press “Tools” on the Menu Bar, press the Backup Tab, and then check “Enable automatic database backup”. The Clinician’s Programmer database will back up once daily and each time the software is exited. See Figure10-5. Figure 10-6: Restoring the Clinician’s Programmer database 4.

  • Page 34: Chapter 11: Maintenance And Cleaning

    Maintenance and Cleaning Replacing the Gel Electrode The typical lifespan of the Gel Electrode is two to four days, depending • The number of hours of use. • The number of times the electrode is adhered to and removed from the skin.

  • Page 35: Disinfecting

    Disinfecting Electronic Components All StimRouter Clinician Kit electronic components may be cleaned and low- level disinfected using CaviWipes™ or equivalent (if available), or wipes or cloths saturated (but not dripping) with 70% isopropyl alcohol (IPA). Troubleshooting Note: Do not attempt to disinfect the Gel Electrode. If infection is a concern, discard the Gel Electrode and use a new electrode.

  • Page 36: Troubleshooting Tables

    2. Make sure the Clinician Programmer and the E-EFC are no more than a Incident Reporting few inches apart and not touching. Any serious incident that has occurred in relation to the device should be reported 3. The StimRouter Plus software will detect the unregistered E-EFC and ask if to the manufacturer.

  • Page 37: Chapter 13: Technical Specifications

    Technical Specifications E-EFC Charger Specifications Use medical Class II safety approved power supply provided/approved by Bioventus with the following ratings: Manufacturer’s Model No. FRIWO FW7555M/05 Input Voltage 100-240 V AC Current 400 mA Frequency 50-60 Hz Output Voltage 5 V ± 5% Current 2400 MA Charging Cable...

  • Page 38: Gel Electrode Specifications

    Gel Electrode Specifications FCC ID # RYYEYSHSN Pulse Parameters Electrode Size 7.5 cm each Pulse Balanced biphasic Dimensions Length 119 mm (4.68 in.) Width 33.5 mm Waveform Symmetric or Asymmetric (1.31 in.) Height 2.3 mm (0.09 in.) Weight 10 grams Intensity* 0-30 mA peak, 1 mA resolution (positive phase) Environmental Ranges...

  • Page 39: Privacy Of Stimrouter Wireless Communication

    • Wireless Interference: The StimRouter System was designed and tested to not have interference from other RF devices (including other StimRouter Systems, WiFi networks, Cellular Devices, Microwaves and other Bluetooth devices). ® StimRouter System is not susceptible to the wide range of expected EMI emitters, such as Electronic Article Surveillance Systems (EAS), Radio Frequency Identification Systems (RFID), Tag Deactivators, and Metal Detectors.

  • Page 40: Chapter 15: Appendix - Emi Tables

    Appendix - EMI Tables Electromagnetic Emissions The StimRouter system is medical electrical equipment and was tested for electromagnetic compatibility (EMC) in accordance with International Electrotechnical Committee (IEC) 60601-1-2. The following tables provide information regarding the EMC testing and guidance for safe use of the system. The StimRouter system should be configured and used in accordance with the instructions provided in this manual.
  • Page 41 Guidance and Manufacturer’s Declaration Electromagnetic Electromagnetic Environment - Emissions Test Compliance Immunity Guidance The StimRouter system is intended for home use in addition to use in the The StimRouter system uses RF electromagnetic environment specified below. The user of the StimRouter system energy for short-range communications.
  • Page 42 Electromagnetic Electromagnetic IEC 60601 Test Compliance IEC 60601 Compliance Immunity Test Environment - Immunity Test Environment - Level Level Test Level Level Guidance Guidance d = 0.4√P 80 MHz to Power frequency Radiated RF 3 V/m 10 V/m Power magnetic fields 800 MHz 80 MHz to 2.5 26 MHz to 1...

  • Page 43: Labeling Lbl-000706 [A] Released Clinician's Guide

    Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the StimRouter System The StimRouter system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the StimRouter system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the StimRouter system as recommended below, according to the maximum output power of the communications equipment.
  • Page 44 DEFAULT 10/3/2022 Document Detail Type: Labeling Document No.: LBL-000706[A] Title: 602-00725 StimRouter Clinicians Guide Owner: NEILL.POUNDER Neill Pounder Status: RELEASED Effective Date: 18-Aug-2022 Expiration Date: Reference Document No. Content Type Relation Fixed Rev Status WVR-000129 [A] DOCUMENT Related RELEASED Title:StimRouter Label Inspection Revision Notes Document Build Access Activity...
  • Page 45 10/3/2022 Document Detail Review Build No.: Closed Date: 8/18/2022 8:39:17PM Review: Standard Release Review Review Purpose: This Review verifies all basic documents and has the typical reviewers attached. Review Note: SYSTEM AUTO CLOSE REVIEW Level Owner Role Actor Sign-off By Sign-off Date BV Configuration Analyst BV AMBER.PLOTNER Amber...

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