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MicroTransponder Vivistim Paired VNS System Manual

Non-implantable device
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Vivistim
Non-implantable Device Manual for
Healthcare Professionals
Wireless Transmitter: Model 2100
Stroke Application and Programming
Software (SAPS): Model 4001
NOTE: This page identifies the parts included in this Healthcare Professional's Manual. The information
contained herein is not intended to serve as a substitute for a complete and thorough understanding of
the material presented in all of the manuals for the Vivistim
parts, nor does this represent full disclosure of all pertinent information concerning use of this product,
potential safety complications, or efficacy outcomes. Copies of all Vivistim
are included with the system for full disclosure; copies are also available from MicroTransponder, Inc.
This manual contains information that shall not be made available to patients.
Released Version 0
26-0002-0005 © 2022 MicroTransponder, Inc., Austin, TX. All rights reserved.
MicroTransponder, Paired VNS, Vivistim are trademarks of MicroTransponder, Inc.
PAT.
www.microtransponder.com/patents
Rx Only
26-0002-0005/0 (en) (2022)
®
Paired VNS
™
System
®
™
Paired VNS
System and its component
®
Paired VNS
™
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Summary of Contents for MicroTransponder Vivistim Paired VNS System

  • Page 1 Copies of all Vivistim Paired VNS System manuals are included with the system for full disclosure; copies are also available from MicroTransponder, Inc. This manual contains information that shall not be made available to patients. Released Version 0 26-0002-0005 ©...
  • Page 2 ® ™ Vivistim Paired VNS System Quick Start Guide for Therapists NOTE: Read this manual in its entirety before seeing your first patient. WARNING: The IPG serial number is the only permanent unique patient identifier detected by the software. Always check the IPG serial number and the patient’s physical ID card before saving or over-writing a “Patient ID”...

  • Page 3: Table Of Contents

    ABLE OF ONTENTS ....................7 EVICE ESCRIPTION Intended Use / Indication ..................8 SAPS Warnings ....................... 9 SAPS Package Contents ..................9 WT Package Contents ..................... 9 ....................10 ETTING TARTED Stroke Application & Programming Software (SAPS) Hardware Setup ....10 How to Use the Stroke Application &...
  • Page 4 16.3 Wireless Transmitter ....................53 16.4 Stroke Application & Programming Software (SAPS) ..........54 ® 16.5 Other Applicable MicroTransponder Products ............54 16.6 Applicable Commercial Devices for Use with MicroTransponder IPG ..... 54 17 G ’ —E ..55 UIDANCE AND...
  • Page 5 IST OF IGURES Figure 1.1: (A) Device Placement, (B) In-office Set-up ............... 7 Figure 2.1: SAPS Hardware Set-up Overview .................. 10 Figure 2.22: Startup Menu Screen—Welcome Menu ............... 11 Figure 3.1: Log In ..........................13 Figure 3.2: Startup Menu Screen—Physician Mode ................. 14 Figure 3.3: Buttons Versus Tabs ......................
  • Page 6 IST OF ABLES Table 16.1: Characteristics of the Wireless Transmitter ..............54 Table 17.1: Guidance and Manufacturer’s Declaration—Electromagnetic Emissions ....... 55 Table 17.2: Guidance and Manufacturer’s Declaration—ESD and Power Fluctuations ....56 Table 17.3: Guidance and Manufacturer’s Declaration—Radiated Electromagnetic Fields ....57 Table 17.4: Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Wireless Transmitter ...............

  • Page 7: Device Description

    EVICE ESCRIPTION ® ® ™ The non-implantable components of the MicroTransponder Vivistim Paired VNS System ® (Vivistim System) include the Stroke Application & Programming Software (SAPS) and ™ Wireless Transmitter (WT). The SAPS and the WT enable the clinician to set Paired VNS parameters, initiate a therapy session, and test and modify the implanted device and its ®...

  • Page 8: Intended Use / Indication

    SAPS is intended for use only with the MicroTransponder Implantable Pulse Generator (IPG) and MicroTransponder Wireless Transmitter.

  • Page 9: Saps Warnings

    ® Vivistim System. WARNING: Do not modify this equipment without authorization of MicroTransponder. WARNING: The use of any software other than that specified herein will violate safety, effectiveness, and design controls of the programmable devices, and such use may result in an increased risk to users and patients.

  • Page 10: Getting Started

    ETTING TARTED 2.1 Stroke Application & Programming Software (SAPS) Hardware Setup Figure 2.1: indicates the proper setup: 1. Connect the power cord to the power port on the laptop and connect the other end to the wall outlet. 2. Connect the WT to a USB port on the laptop. 3.

  • Page 11: How To Use The Stroke Application & Programming Software (Saps)

    Figure 2.1:, although it may also be on the front right or side of the computer; press down). 3. The laptop will power up in the “microtransponder” login state. Log into the computer using the password provided.
  • Page 12 when the WT is connected properly, red when the WT is disconnected, and alternating white/green when SAPS is communicating (see Figure 2.). Figure 2.3: WT Interface “Connected” Indicator 26-0002-0005/0 (en) (2022)

  • Page 13: Using The Software (Saps)

    (SAPS) SING THE OFTWARE Unless a Log In has been performed by entering the appropriate password, the only buttons enabled in the Welcome menu are the Patient Log File and VNS Pairing Therapy buttons (see Figure 2.22). These buttons allow the physician or therapist to assign a task and perform a therapy session.

  • Page 14: Buttons Versus Tabs

    Figure 3.2: Startup Menu Screen—Physician Mode Notice that the orange Log In button has toggled to Log Out (circled in Figure 3.2) so that, if desired, the user may select the Log Out button and once again remove access to the additional SAPS screens.

  • Page 15: Parameter Text Color

    The buttons on the Welcome screen initiate functions such as programming the implant, accessing VNS Pairing Therapy, or accessing the Patient Log File. For example, the Program Implant button sends a signal from the WT to the IPG to update the IPG settings with those currently saved in the SAPS.

  • Page 16: Patient Log File Overview

    • trigger the delivery of stimulation so that stimulation can be synchronized with a specific rehabilitation movement using the On-Demand Mode (see Section 5.1: Therapist triggered therapy for more detail), or 3.3.3 Patient Log File Overview The third tab, Patient Log File, allows the physician or therapist to review on the computer screen or print out specific saved settings that were utilized during the rehabilitation session.

  • Page 17: Programming The Implant

    ROGRAMMING THE MPLANT The Program Implant menu (see Figure 4.1) allows the user to set the patient information, test and set stimulation parameters, set therapy mode(s), and check impedance during implant and follow-up visits. Figure 4.1: Program Implant Connecting to a Specific IPG Perform these six steps before therapy for each patient to connect to their specific IPG.

  • Page 18: Figure 4.4: Interrogate Button On Screen

    3. Select Contact Implant to allow the SAPS to find the patient’s IPG (see Figure 4.4 and Figure 4.5). Figure 4.4: Interrogate Button on Screen Figure 4.5: Contact Implant 4. A pop-up menu will appear. Select the IPG whose Serial # matches the one on the patient’s Patient Identification Card by clicking on their specific IPG and then pressing the Select button (circled in Figure 4.6).

  • Page 19: Figure 4.7: Serial # And Battery Status

    5. Verify that the selected IPG’s Serial # is displayed to the right of “Serial”, and check the IPG battery’s status, as indicated by the symbol to the right of “Implant Battery” (see Figure 4.7). A green circle indicates an adequately full battery. “ERI” or “EOL” displayed in place of the green circle indicates that the IPG’s battery is close to its end of life.

  • Page 20: Patient Information (Optional)

    Patient Information (Optional) The user may enter a patient identification, such as the patient’s initials or medical record number, into the SAPS if the user chooses. If the user does not provide a patient identification, the IPG’s unique serial number can be used. 1.

  • Page 21: Figure 4.11: Implant Setting Parameters

    Figure 4.11: Implant Setting Parameters CAUTION: Programming the output current to very low levels may result in ineffective therapy. CAUTION: Programming the output current to excessively high levels may result in patient discomfort. Always verify that settings are tolerable. Figure 4.12: Amplitude 26-0002-0005/0 (en) (2022)

  • Page 22: Figure 4.13: Frequency

    Figure 4.13: Frequency Figure 4.14: Train Duration 26-0002-0005/0 (en) (2022)

  • Page 23: Therapy Modes

    Figure 4.15: Pulse Width Therapy Modes The Program Implant menu includes 3 therapy modes: Stim Test Mode (see Section 4.4.1: Stim Test Mode), Therapist Trigger Mode (see Section 4.4.2: Therapist Trigger Mode), and Magnet Mode (see Section 7.2: Magnet Mode). 4.4.1 Stim Test Mode The Stim Test Mode (see Figure 4.16) is used to test the parameters displayed in the Implant Settings menu.

  • Page 24: Figure 4.16: Stim Test Mode

    Figure 4.16: Stim Test Mode Figure 4.17: Implant Settings 1. Select the button next to Stim Test Mode. The button will now toggle to On (see Figure 4.16). 2. Optionally, you may change the stimulation parameters displayed in the Implant Settings menu (see Figure 4.17).

  • Page 25: Therapist Trigger Mode

    each parameter. Example drop-down menus for each parameter are shown above in Figure 4.12 through Figure 4.15. 3. It is recommended to verify that the VNS settings chosen are tolerable for the patient. To verify these settings, select the Test button to deliver a single train of stimulation per the parameters displayed in the Implant Settings menu.

  • Page 26: Impedance

    Figure 4.19: Implant Settings 1. Select the button adjacent to Therapist Trigger Mode. This button will now toggle to On (see Figure 4.18). Therapist Trigger Mode must remain On to initiate a therapy session and trigger stimulation per the VNS Pairing Therapy menu (see Section 1.1.1: ). 2.

  • Page 27: Figure 4.20: Lead Impedance Check

    Ω (see Figure 4.22), the “Warning!” screen informs the patient to contact their physician or therapist to see if any further action needs to be taken. CAUTION: Changes in Lead impedance are common; therefore, changes of even ® several thousand ohms occur normally over time. Refer to the Microtransponder ® ™ Vivistim...

  • Page 28: Figure 4.22: Low Lead Impedance Notification

    Figure 4.22: Low Lead Impedance Notification Figure 4.23: Lead Impedance Displayed 26-0002-0005/0 (en) (2022)

  • Page 29: Delivering Paired Vns

    ™ ELIVERING AIRED After choosing and saving device settings, you can start a stimulation session. Therapist triggered therapy To begin on-demand stimulation therapy without a magnet: CAUTION: Prior to all patient MRI procedures, program the Therapist Trigger Mode to Off. 5.1.1 Select VNS Pairing Therapy Menu Select the VNS Pairing Therapy menu (see Figure 5.) to initiate a therapy session and trigger stimulation.

  • Page 30: Start Task

    Figure 5.2: Select Task 5.1.3 Start Task CAUTION: Before selecting the Start Task button when applying the Therapist Trigger Mode for on-demand therapy, verify all laptop connections (see Figure 2.1:), and verify that the WT is an appropriate distance from the patient (see Section 16.2: Communication Signals).

  • Page 31: Deliver Stimulation

    Figure 5.3: Start Task 5.1.4 Deliver Stimulation Once the Start Task button is selected, the program establishes a communication session with the device. Notice that both the Stimulate and the End Task buttons are now available and that the Status window is updated to “Ready to Stimulate” (see Figure 5.). At any time, you may select the End Task button to end the rehabilitation task.
  • Page 32 Once a session is initiated, you may trigger stimulation, implementing the programmed IPG therapy parameters. To stimulate, use the mouse and cursor to select the Stimulate button or press the push button. When the stimulation has been triggered, the Status window displays “Stimulating” for the length of the stimulation period (see Figure 5.).

  • Page 33: End Task

    5.1.5 End Task Upon completing a task, select the End Task button (see Figure 5.) to end the rehabilitation task. Once the End Task button has been selected, the Status returns to the “Stand by” mode and the system is ready to select a new task and/or begin a new session (see Figure 5.). NOTE: The SAPS automatically ends the task if the session is inactive for more than 10 minutes.

  • Page 34: Magnet Mode

    SAPS. NOTE: During a patient’s first therapy session, give the patient the magnet and review this ® ® ™ section and the Microtransponder Vivistim Paired VNS System Quick Start Guide for Patients with them. 4. Remove the magnet cover, if applicable (see Figure 5.9 below).
  • Page 35 Figure 5.10: Magnet Swipe 26-0002-0005/0 (en) (2022)

  • Page 36: Stopping Stimulation

    If the IPG reports a Safe Mode condition or needs to be reset for any reason: 1. Contact MicroTransponder per Section 18: Information and Support. 2. After contacting MicroTransponder, select the Reset button to reset the IPG (see Figure 6.1). 26-0002-0005/0 (en) (2022)

  • Page 37: Figure 6.1: Reset Button

    Figure 6.1: Reset Button 3. When prompted (as shown in Figure 6.2), enter the password provided. Figure 6.2: Password Prompt 4. Select the Accept button to complete the reset (see Figure 6.3). 26-0002-0005/0 (en) (2022)

  • Page 38: Figure 6.3: Accept Reset

    Figure 6.3: Accept Reset NOTE: A reset of the device will program the device off (output current = 0.0 mA). NOTE: All settings and device history are preserved. After a successful reset, the IPG stimulation output may be reprogrammed from 0.0 mA as appropriate for the patient to resume operation at their previously programmed settings.

  • Page 39: Sending The Patient Home

    7.1 Things to Review with the Patient ® ® ™ In every patient visit, make sure to review the Microtransponder Vivistim Paired VNS System Quick Start Guide for Patients and discuss the following items with the patient: • The patient should not pick at their surgical scars, as they may cause infection.

  • Page 40: Magnet Mode

    7.2 Magnet Mode CAUTION: Prior to all patient MRI procedures, program the Magnet Mode to Off. The Magnet Mode (see Figure 7.1) implements the ability to initiate stimulation with a magnet. The button adjacent to Magnet Mode must be toggled to On and programmed to enable this function.

  • Page 41: Figure 7.2: Magnet Mode Session History

    Figure 7.2: Magnet Mode Session History 1. Select the button next to Magnet Mode. The button will now toggle to On (see Figure 7.1). 2. When this mode is turned on, you are prompted to set the Magnet Mode Duration and reminded to save changes, as shown in Figure 7.3.
  • Page 42 4. After all desired parameters have been set, press the Download Settings to IPG button to download the chosen parameters to the implant. Once the IPG is programmed to respond to the magnet, it is no longer necessary for the patient to be in close proximity to the WT as there is no longer communication required between SAPS and the IPG to trigger stimulation during a task.

  • Page 43: Patient Log File

    ATIENT Information on device use is stored in a log file within the device. The Patient Log File menu (see Figure 8.1) allows the user to view the information on the computer screen or export the information from the device to a file that can be used later. •...

  • Page 44: Figure 8.2: Patient Log File-Export Log

    Figure 8.2: Patient Log File—Export Log 26-0002-0005/0 (en) (2022)

  • Page 45: Intentionally Blank

    NTENTIONALLY LANK 26-0002-0005/0 (en) (2022)

  • Page 46: Ipg Settings For Mri Procedures

    10 IPG S MRI P ETTINGS FOR ROCEDURES Prior to any MRI procedure, all therapy modes must be disabled. These are accessed through the SAPS Program Implant menu (see Figure 10.1). 1. Set IPG to 0 mA. 2. Set both Therapist Trigger Mode and Magnet Mode to Off. 3.

  • Page 47: Maintenance , Handling , And Storage

    • To clean the WT, wipe it down with a mixture of water, soap, and alcohol. • The WT is standard lab-type equipment and is reusable. • Please return the WT to MicroTransponder in the case of malfunction for evaluation and disposal. 26-0002-0005/0 (en) (2022)

  • Page 48: Precautions , Warnings , Contraindications , And Hazards

    Manual for Patients for additional precautions, warnings, contraindications, and hazards to be ® avoided relating to the Vivistim System. Call the physician or contact MicroTransponder if you have any questions (see Section 18: Information and Support). ® • Use—The Vivistim...
  • Page 49 SAPS laptop. • Do not modify equipment—Do not modify this equipment without the authorization of MicroTransponder. Any modifications to the unit, unless expressly approved by MicroTransponder, could void your authority to operate this equipment. • Set laptop time—It is important that the laptop time be set to the correct local time and periodically verified.

  • Page 50: Troubleshooting

    If the problem persists, contact MicroTransponder per Section 18: Information and Support. 13.1.2 Other Hardware Issues For all other hardware issues for the laptop, contact MicroTransponder per Section 18: Information and Support. 13.2 Troubleshooting at Patient Follow-up Visits 13.2.1 Telemetry Lost in Therapy Visits...

  • Page 51: Unable To Initiate Communication

    In certain instances, the user may be unable to communicate with the IPG. After trying all other remedies (verifying all connections, restarting the computer, etc.), please contact MicroTransponder for assistance in resetting the IPG. Contact information is provided in Section 18: Information and Support.

  • Page 52: Device Disposal

    15 D EVICE ISPOSAL Return the SAPS and the WT to MicroTransponder for examination and safe disposal. Please contact MicroTransponder for additional instructions (see Section 18: Information and Support). 26-0002-0005/0 (en) (2022)

  • Page 53: Vivistim ® System Devices

    ® 16 V IVISTIM YSTEM EVICES 16.1 Conventions The SAPS operates in a Windows environment with drop-down menus. Standard mouse and keypad functions are used to navigate through a Windows environment on the laptop. • The names of selectable buttons (or fields) and drop-down menus appear within the button. Each of these buttons or fields represents an operation, parameter, or parameter value.

  • Page 54: Stroke Application & Programming Software (Saps)

    Table 16.1: Characteristics of the Wireless Transmitter 16.4 Stroke Application & Programming Software (SAPS) The SAPS software was developed by MicroTransponder to manage IPG therapy and therapy information. The SAPS has the following capabilities: • Allows the physician to set the IPG stimulation parameters •...

  • Page 55: Guidance And Manufacturer ' S Declaration -Electromagnetic Immunity

    17 G ’ —E UIDANCE AND ANUFACTURER ECLARATION LECTROMAGNETIC MMUNITY The Wireless Transmitter (Model 2100) is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Transmitter should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...

  • Page 56: Table 17.2: Guidance And Manufacturer's Declaration-Esd And Power Fluctuations

    The Wireless Transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Transmitter should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Level Electromagnetic environment - guidance Electrostatic discharge...

  • Page 57: Table 17.3: Guidance And Manufacturer's Declaration-Radiated Electromagnetic Fields

    The Wireless Transmitter is intended for use in the radiated electromagnetic fields specified below. The customer or the user of the Wireless Transmitter should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment - guidance test level Level Portable and mobile RF communications equipment...

  • Page 58: Table 17.4: Recommended Separation Distance Between Portable And Mobile Rf Communication Equipment And The Wireless Transmitter

    The Wireless Transmitter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Wireless Transmitter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Wireless Transmitter as recommended below, according to the maximum output power of the communications equipment.

  • Page 59: Information And Support

    18 I NFORMATION AND UPPORT Prior to contacting MicroTransponder for specific technical help relating to communication, it is recommended that the WT connection be verified and the laptop and SAPS be restarted. Other technical solutions are detailed in Section 13: Troubleshooting.

  • Page 60: Glossary

    19 G LOSSARY 19.1 Definitions Duty Cycle—Percentage of time during which stimulation occurs; stimulation time divided by the sum of signal on and off times. ® Electrode—The mechanical and electrical interface of the Vivistim System to the vagus nerve. The electrode is part of the Lead. EMI—Electromagnetic interference EOL (end of life)—The SAPS software displays an EOL indicator when there is less than 5% of the battery remaining.

  • Page 61: Symbols

    ® ™ Vivistim —Trade name of MicroTransponder’s Paired VNS System for motor deficits associated with stroke. VNS—Vagus Nerve Stimulation WT (Wireless Transmitter)—An RF device that connects via a USB plug to the laptop’s USB port and provides communication with the IPG;...
  • Page 62 Consult Instructions for Use Reference Number Batch Code Manufacturer Magnetic Resonance Unsafe MR Conditional Serial Number Temperature Limitation (Storage and Transport) Number of Radio Frequency (RF) Communication Channels Keep Dry 26-0002-0005/0 (en) (2022)
  • Page 63 Contact your clinician for medical care and medical advice or if you have any questions about your ® ® ™ MicroTransponder Vivistim Paired VNS System. Your health care provider may program the session to be shorter or longer than 30 minutes.

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