MicroTransponder Vivistim Paired VNS System User manual

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Vivistim® Paired VNS™System
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® Paired VNS™System and its component
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® 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 © 2022 MicroTransponder, Inc., Austin, TX. All rights reserved.
MicroTransponder, Paired VNS, Vivistim are trademarks of MicroTransponder, Inc.
PAT. www.microtransponder.com/patents
Rx Only

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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” in the software to avoid inadvertently
misidentifying a patient.
Therapist Trigger Mode
enables the therapist to
trigger stimulation
using the push button trigger.
Magnet Mode
enables the patient to
trigger stimulation
using a magnet
swipe.
To treat a patient:
1. Connect and Program the IPG. (p. 17)
2. Start and Deliver Treatment. (p. 20)
3. Implement Magnet Mode Before Sending Patient for At-home Therapy. (p. 34)
4. If the patient needs an MRI, read and follow “IPG Settings for MRI Procedures”. (p. 46)
This is the END of the Quick Start Guide.
Passwords: Contact your sales representative.

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TABLE OF CONTENTS
1DEVICE DESCRIPTION.................................................................................................7
1.1 Intended Use / Indication..........................................................................................8
1.2 SAPS Warnings.......................................................................................................9
1.3 SAPS Package Contents .........................................................................................9
1.4 WT Package Contents.............................................................................................9
2GETTING STARTED...................................................................................................10
2.1 Stroke Application & Programming Software (SAPS) Hardware Setup...................10
2.2 How to Use the Stroke Application & Programming Software (SAPS)....................11
3USING THE SOFTWARE (SAPS) ................................................................................13
3.1 Buttons Versus Tabs..............................................................................................14
3.2 Parameter Text Color.............................................................................................15
3.3 Overview of SAPS Menus (Tabs) Used for Therapy...............................................15
3.3.1 Program Implant Overview........................................................................15
3.3.2 VNS Pairing Therapy Overview.................................................................15
3.3.3 Patient Log File Overview .........................................................................16
4PROGRAMMING THE IMPLANT ....................................................................................17
4.1 Connecting to a Specific IPG .................................................................................17
4.2 Patient Information (Optional) ................................................................................20
4.3 Implant Settings .....................................................................................................20
4.4 Therapy Modes......................................................................................................23
4.4.1 Stim Test Mode.........................................................................................23
4.4.2 Therapist Trigger Mode.............................................................................25
4.5 Impedance.............................................................................................................26
5DELIVERING PAIRED VNS™......................................................................................29
5.1 Therapist triggered therapy....................................................................................29
5.1.1 Select VNS Pairing Therapy Menu............................................................29
5.1.2 Select Task...............................................................................................29
5.1.3 Start Task..................................................................................................30
5.1.4 Deliver Stimulation....................................................................................31
5.1.5 End Task...................................................................................................33
5.2 Magnet Mode.........................................................................................................34
6STOPPING STIMULATION...........................................................................................36
6.1 Magnet Mode.........................................................................................................36
6.2 Therapist Trigger Mode..........................................................................................36
6.3 Resetting the IPG / Safe Mode...............................................................................36
7SENDING THE PATIENT HOME....................................................................................39
7.1 Things to Review with the Patient ..........................................................................39
7.2 Magnet Mode.........................................................................................................40
8PATIENT LOG FILE ...................................................................................................43

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9INTENTIONALLY BLANK.............................................................................................45
10 IPG SETTINGS FOR MRI PROCEDURES......................................................................46
11 MAINTENANCE,HANDLING,AND STORAGE.................................................................47
12 PRECAUTIONS,WARNINGS,CONTRAINDICATIONS,AND HAZARDS................................48
13 TROUBLESHOOTING..................................................................................................50
13.1 General Recommendations....................................................................................50
13.1.1 Non-responsive Laptop.............................................................................50
13.1.2 Other Hardware Issues .............................................................................50
13.2 Troubleshooting at Patient Follow-up Visits ............................................................50
13.2.1 Telemetry Lost in Therapy Visits...............................................................50
13.2.2 Unable to Initiate Communication..............................................................51
14 DEVICE LIFETIME......................................................................................................51
14.1 IPG Lifetime, Removal, and Replacement..............................................................51
14.1.1 Signs of End of Life for the Vivistim®System.............................................51
14.1.2 Replacement Based on Battery Status Indicators......................................51
15 DEVICE DISPOSAL....................................................................................................52
16 VIVISTIM®SYSTEM DEVICES......................................................................................53
16.1 Conventions...........................................................................................................53
16.2 Communication Signals..........................................................................................53
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 GUIDANCE AND MANUFACTURER’S DECLARATION—ELECTROMAGNETIC IMMUNITY ......55
18 INFORMATION AND SUPPORT.....................................................................................59
19 GLOSSARY ..............................................................................................................60
19.1 Definitions..............................................................................................................60
19.2 Symbols.................................................................................................................61

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LIST OF FIGURES
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......................................................................................................14
Figure 3.4: Blue Text Indicates Settings Have Not Been Saved.......................................................15
Figure 4.1: Program Implant.............................................................................................................17
Figure 4.2: Disconnect .....................................................................................................................17
Figure 4.3: Blank Serial #.................................................................................................................17
Figure 4.4: Interrogate Button on Screen .........................................................................................18
Figure 4.5: Contact Implant..............................................................................................................18
Figure 4.6: Select Button..................................................................................................................18
Figure 4.7: Serial # and Battery Status.............................................................................................19
Figure 4.8: Time Button....................................................................................................................19
Figure 4.9: Time19
Figure 4.10: Patient ID .....................................................................................................................20
Figure 4.11: Implant Setting Parameters..........................................................................................21
Figure 4.12: Amplitude.....................................................................................................................21
Figure 4.13: Frequency....................................................................................................................22
Figure 4.14: Train Duration ..............................................................................................................22
Figure 4.15: Pulse Width..................................................................................................................23
Figure 4.16: Stim Test Mode............................................................................................................24
Figure 4.17: Implant Settings............................................................................................................24
Figure 4.18: Therapist Trigger Mode................................................................................................25
Figure 4.19: Implant Settings............................................................................................................26
Figure 4.20: Lead Impedance Check................................................................................................27
Figure 4.21: High Lead Impedance Notification................................................................................27
Figure 4.22: Low Lead Impedance Notification.................................................................................28
Figure 4.23: Lead Impedance Displayed..........................................................................................28
Figure 6.1: Reset Button ..................................................................................................................37
Figure 6.2: Password Prompt...........................................................................................................37
Figure 6.3: Accept Reset..................................................................................................................38
Figure 7.1: Magnet Mode.................................................................................................................40
Figure 7.2: Magnet Mode Session History........................................................................................41
Figure 7.3: Magnet Mode Prompt.....................................................................................................41
Figure 8.1: Patient Log File—Read Statistics...................................................................................43
Figure 8.2: Patient Log File—Export Log..........................................................................................44
Figure 10.1: IPG Settings for MRI Procedures .................................................................................46
Figure 13.1: Telemetry Lost .............................................................................................................50
Figure 16.1: Wireless Transmitter ....................................................................................................53

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LIST OF TABLES
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.......................................................................58

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1 DEVICE DESCRIPTION
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
settings. The complete device system (the Vivistim®System) is shown in Figure 1.1.
A
B
Figure 1.1: (A) Device Placement, (B) In-office Set-up
The Vivistim®System, when used as intended, provides a drug-free way to treat upper extremity
motor deficits associated with a stroke by pairing rehabilitation movements with Vagus Nerve
Stimulation. The Lead electrodes are attached to the left vagus nerve in the neck. The Lead is
tunneled from the neck to the chest, where it is connected to the Implantable Pulse Generator
(IPG), and the IPG is placed subcutaneously (or sub-muscularly) in the pectoral region. The
SAPS is delivered to the clinician preloaded onto a commercially available laptop. The SAPS,
via the WT, allows the clinician to program the output settings of the IPG (e.g., amplitude,
frequency, pulse width) and read the status and history of the IPG. The SAPS also stores the
number of stimulations, task performed, and IPG status that occur for each rehabilitation activity
for future review by the clinician.

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The SAPS and WT allow the implanted components (the IPG and Lead) to stimulate the vagus
nerve while a rehabilitation movement occurs. The therapist initiates the stimulation using a
USB push button or mouse click, so as to synchronize the stimulation with an appropriate
timepoint during rehabilitation movements. When directed by a physician and with appropriate
programming to the IPG, the patient can initiate at-home use by swiping a magnet over the IPG
implant site. Swiping activates the IPG to deliver stimulation for ~ 30 minutes1while
rehabilitation movements are performed at home. At-home use does not require the use of
SAPS or the WT. In addition, the magnet provided to the patient to initiate home therapy also
has a safety feature; if the patient desires to stop stimulation, holding the magnet over the
device stops stimulation for as long as it is held over the device.
The physician or therapist is responsible for training the patient on use of the magnet and
providing the Microtransponder®Vivistim®Paired VNS™System Manual for Patients. The
Microtransponder®Vivistim® Paired VNS™System Quick Start Guide for Patients is
located in the Microtransponder®Vivistim®Paired VNS™System Manual for Patients, and an
additional copy is on the last page of this manual.
Software capabilities include:
• Use of SAPS with the WT by a rehabilitation therapist or neurologist or other physician to
interrogate and program an IPG’s parameters and assess IPG function
• Use of SAPS with the WT by a rehabilitation therapist or neurologist or other physician to
initiate a therapy session during rehabilitation at the clinic
• Use of SAPS without the WT to display the operating histories of all the IPGs interrogated
with the laptop
• Use of screen displays that provide prompts and messages to aid in interrogating and
programming
Other User Manuals:
• Microtransponder®Vivistim®Paired VNS™System Manual for Patients
• Microtransponder®Vivistim®Paired VNS™System Implantable Device Manual for
Healthcare Professionals
1.1 Intended Use / Indication
The MicroTransponder®Vivistim®Paired VNS™System is intended to be used to stimulate the
vagus nerve during rehabilitation therapy to reduce upper extremity motor deficits and improve
motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
SAPS is intended for use only with the MicroTransponder Implantable Pulse Generator (IPG)
and MicroTransponder Wireless Transmitter.
1The clinician is responsible for establishing the duration of stimulation according to clinical best practices.

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1.2 SAPS Warnings
NOTE: The SAPS system, as described herein, should only be used with equipment described
in this manual. SAPS should not be used with medical device equipment other than the
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.
1.3 SAPS Package Contents
The SAPS package contains the following:
• Software (installed on commercially available laptop)
• Documentation
1.4 WT Package Contents
The WT package contains the following:
• 1 Wireless Transmitter
• Documentation

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2 GETTING STARTED
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. (Optional) Connect the push button to a USB port on the laptop.
A Power Button
B Power Cord
C Push Button
D Wireless Transmitter
Figure 2.1: SAPS Hardware Set-up Overview