FCC ID: QHJ-2100A Model 2100

Vivistim Paired VNS System Non-implantable Device Manual for Healthcare Professionals Wireless Transmitter: Model 2000 Stroke Application and Programming Software (SAPS): Model 4001 NOTE: This page identifies the parts included in this Healthcare Professionals 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 5 26-0002-0003 2021 MicroTransponder, Inc., Austin, TX. All rights reserved. MicroTransponder, Paired VNS, Vivistim are trademarks of MicroTransponder, Inc. PAT. www.microtransponder.com/patents Rx Only 26-0002-0003/5 (en) (2021) 1 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 patients 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. 3. Implement Magnet Mode Before Sending Patient for At-home Therapy. (p. 39) 4. If the patient needs an MRI, read and follow IPG Settings for MRI Procedures. (p. 51) To treat a patient:

1. Connect and Program the IPG. (p. 17) 2. Start and Deliver Treatment. (p. 20) Passwords:

Laptop: mti123 SAPS: mti Reset: reset1 26-0002-0003/5 (en) (2021) This is the END of the Quick Start Guide. 2 TABLE OF CONTENTS 1 DEVICE 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 2 GETTING STARTED ................................................................................................... 10 2.1 Stroke Application & Programming Software (SAPS) Hardware Setup ................... 10 2.2 How to Use the Stroke Application & Programming Software (SAPS) .................... 11 3 USING 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 ................................................................. 16 3.3.3 Patient Log File Overview ......................................................................... 16 3.3.4 On-Demand Mode Overview ..................................................................... 16 3.3.5 Entire Session VNS Scheduler Overview .................................................. 16 3.3.6 Independent Mode .................................................................................... 16 3.3.7 Study ......................................................................................................... 16 4 PROGRAMMING THE IMPLANT .................................................................................... 17 4.1 Connecting to a Specific IPG ................................................................................. 17 4.2 Patient Information (Optional) ................................................................................ 20 Implant Settings ..................................................................................................... 20 4.3 Therapy Modes ...................................................................................................... 23 4.4 4.4.1 Stim Test Mode ......................................................................................... 23 4.4.2 Therapist Trigger Mode ............................................................................. 25 Impedance ............................................................................................................. 26 5 DELIVERING PAIRED VNS ...................................................................................... 29 5.1 On-Demand Mode Menu ........................................................................................ 29 5.1.1 On-Demand Mode Therapy via the VNS Pairing Therapy Menu ............... 31 5.2 Entire Session VNS Scheduler ............................................................................... 36 5.2.1 Therapy Trigger Mode ............................................................................... 37 5.2.2 Magnet Mode ............................................................................................ 39 5.2.3 Setting Parameters ................................................................................... 41 4.5 6 STOPPING STIMULATION ........................................................................................... 42 6.1 Magnet Mode ......................................................................................................... 42 Therapist Trigger Mode .......................................................................................... 42 6.2 26-0002-0003/5 (en) (2021) 3 6.3 Resetting the IPG / Safe Mode ............................................................................... 42 7 SENDING THE PATIENT HOME .................................................................................... 45 7.1 Things to Review with the Patient .......................................................................... 45 7.2 Magnet Mode ......................................................................................................... 46 8 PATIENT LOG FILE ................................................................................................... 48 9 INTENTIONALLY BLANK ............................................................................................. 50 10 IPG SETTINGS FOR MRI PROCEDURES ...................................................................... 51 11 MAINTENANCE, HANDLING, AND STORAGE ................................................................. 52 12 PRECAUTIONS, WARNINGS, CONTRAINDICATIONS, AND HAZARDS ................................ 53 13 TROUBLESHOOTING.................................................................................................. 55 13.1 General Recommendations .................................................................................... 55 13.1.1 Non-responsive Laptop ............................................................................. 55 13.1.2 Other Hardware Issues ............................................................................. 55 13.2 Troubleshooting at Patient Follow-up Visits ............................................................ 55 13.2.1 Telemetry Lost in Therapy Visits ............................................................... 55 13.2.2 Unable to Initiate Communication .............................................................. 56 14.1 14 DEVICE LIFETIME ...................................................................................................... 57 IPG Lifetime, Removal, and Replacement .............................................................. 57 14.1.1 Signs of End of Life for the Vivistim System ............................................. 57 14.1.2 Replacement Based on Battery Status Indicators ...................................... 57 15 DEVICE DISPOSAL .................................................................................................... 58 16 VIVISTIM SYSTEM DEVICES ...................................................................................... 59 16.1 Conventions ........................................................................................................... 59 16.2 Communication Signals.......................................................................................... 59 16.3 Wireless Transmitter .............................................................................................. 59 16.4 Stroke Application & Programming Software (SAPS) ............................................. 60 16.5 Other Applicable MicroTransponder Products ...................................................... 60 16.6 Applicable Commercial Devices for Use with MicroTransponder IPG ..................... 60 17 GUIDANCE AND MANUFACTURERS DECLARATIONELECTROMAGNETIC IMMUNITY ...... 61 18 INFORMATION AND SUPPORT ..................................................................................... 65 19 GLOSSARY .............................................................................................................. 66 19.1 Definitions .............................................................................................................. 66 19.2 Symbols ................................................................................................................. 67 26-0002-0003/5 (en) (2021) 4 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 2.2: Application Warning Screen ........................................................................................... 11 Figure 2.3: Startup Menu ScreenWelcome Menu ......................................................................... 12 Figure 2.4: WT Interface Connected Indicator ................................................................................ 12 Figure 3.1: Log In ............................................................................................................................. 13 Figure 3.2: Startup Menu ScreenPhysician 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: Interrogate ...................................................................................................................... 18 Figure 4.6: Select Button .................................................................................................................. 18 Figure 4.7: Serial # and Battery Status ............................................................................................. 19 Figure 4.8: Time Button .................................................................................................................... 19 Figure 4.9: Time 19 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 5.1: On-Demand Mode .......................................................................................................... 29 Figure 5.2: Start / Stop On-Demand Magnet Trigger ........................................................................ 30 Figure 5.3: On-Demand Mode Therapy via the VNS Pairing Therapy Menu ..................................... 31 Figure 5.4: Select Task .................................................................................................................... 32 Figure 5.5: Start Task ....................................................................................................................... 33 Figure 5.6: Communication Established and Ready to Stimulate ..................................................... 33 Figure 5.7: Stimulate SelectedStatus Stimulating ....................................................................... 34 Figure 5.8: Status RefractoryNo Stimulation Allowed ................................................................. 34 Figure 5.9: Stimulation Counter ........................................................................................................ 34 26-0002-0003/5 (en) (2021) 5 Figure 5.10: Ten Minute Time Out of Task ....................................................................................... 35 Figure 5.11: Entire Session VNS Scheduler Mode ........................................................................... 36 Figure 5.12: Therapy Trigger Mode and Magnet Mode ..................................................................... 36 Figure 5.13: Select Therapy Trigger Mode ....................................................................................... 37 Figure 5.14: Start Therapy Trigger Mode.......................................................................................... 38 Figure 5.15: Stop Therapy Trigger Mode .......................................................................................... 39 Figure 5.16: Magnet with Cover Attached (A) and Detached (B) ...................................................... 40 Figure 5.17: Magnet Swipe .............................................................................................................. 40 Figure 6.1: Reset Button .................................................................................................................. 43 Figure 6.2: Password Prompt ........................................................................................................... 43 Figure 6.3: Accept Reset .................................................................................................................. 44 Figure 7.1: Magnet Mode ................................................................................................................. 46 Figure 7.2: Magnet Mode Session History ........................................................................................ 46 Figure 7.3: Magnet Mode Prompt ..................................................................................................... 47 Figure 8.1: Patient Log FileRead Statistics ................................................................................... 48 Figure 8.2: Patient Log FileExport Log .......................................................................................... 49 Figure 10.1: IPG Settings for MRI Procedures ................................................................................. 51 Figure 13.1: Telemetry Lost ............................................................................................................. 55 Figure 16.1: Wireless Transmitter .................................................................................................... 59 LIST OF TABLES Table 16.1: Characteristics of the Wireless Transmitter .................................................................... 60 Table 17.1: Guidance and Manufacturers DeclarationElectromagnetic Emissions ....................... 61 Table 17.2: Guidance and Manufacturers DeclarationESD and Power Fluctuations .................... 62 Table 17.3: Guidance and Manufacturers DeclarationRadiated Electromagnetic Fields ............... 63 Table 17.4: Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Wireless Transmitter ............................................. 64 26-0002-0003/5 (en) (2021) 6 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. 26-0002-0003/5 (en) (2021) 7 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 minutes1 while 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 IPGs 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 Use of screen displays that provide prompts and messages to aid in interrogating and with the laptop 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. 1 The clinician is responsible for establishing the duration of stimulation according to clinical best practices. 26-0002-0003/5 (en) (2021) 8 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 26-0002-0003/5 (en) (2021) 9 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 B C D Power Button Power Cord Push Button Wireless Transmitter Figure 2.1: SAPS Hardware Set-up Overview 26-0002-0003/5 (en) (2021) 10 2.2 How to Use the Stroke Application & Programming Software (SAPS) The SAPS has been pre-installed on the commercially available laptop provided. 1. Position the laptop within 1 m of the IPG implanted in the patients left chest. 2. Turn the laptop on (Typically the ON button is directly below the laptop screen on the front left, as shown above in 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 mti123. This password is case-sensitive. 4. The SAPS loaded onto the laptop will then start. A warning will appear that reminds you to ensure all other applications are closed (see Figure 2.2). CAUTION: If the laptop does not automatically launch the SAPS and display the Application Warning Screen (see Figure 2.2), then please reboot your computer and re-

launch SAPS (see Section 13 Troubleshooting ). If this does not correct the issue or you have additional problems, please contact MicroTransponder per Section 18:

Information and Support. Figure 2.2: Application Warning Screen 5. Select Close to dismiss the Application Warning Screen and view the Startup Menu Screen (Welcome menu) (see Figure 2.3). Before proceeding to the next section, ensure that you have arrived at this Startup Menu Screen. 26-0002-0003/5 (en) (2021) 11 Figure 2.3: Startup Menu ScreenWelcome Menu CAUTION: If the computer does not display the Startup Menu Screen, see Section 12:

Precautions, Warnings, Contraindications, and Hazards and Section 13:

Troubleshooting before proceeding. For proper operation and communication, the USB plug of the WT must be plugged into a USB port of the laptop. The WT should be positioned within 1 m of the implanted IPG for proper communication. The Interface indicator on the SAPS user interface screen will be green in color when the WT is connected properly, red when the WT is disconnected, and alternating white/green when SAPS is communicating (see Figure 2.4). Figure 2.4: WT Interface Connected Indicator 26-0002-0003/5 (en) (2021) 12 3 USING THE SOFTWARE (SAPS) 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 2.3). These buttons allow the physician or therapist to assign a task and perform a therapy session. To access the rest of the program features, the Log In button must be selected

(see Figure 3.1). Figure 3.1: Log In To log in and access all other SAPS screens, select the Log In button (upper right menu bar, 4th button from the right) and type the password mti into the pop-up shown in Figure 3.1. At this point the program is unlocked, and all menus in the program are available (see Figure 3.2). 26-0002-0003/5 (en) (2021) 13 Figure 3.2: Startup Menu ScreenPhysician 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. After a period of 15 minutes, the Log In will time out, and you will need to log back in to continue the session. 3.1 Buttons Versus Tabs Within the SAPS, there are two types of clickable elements: buttons and tabs (see Figure 3.3). Figure 3.3: Buttons Versus Tabs 26-0002-0003/5 (en) (2021) 14 The buttons on the Welcome screen initiate functions such as programming the implant, initiating On-Demand Mode, 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. The tabs at the top of any screen allow the physician to manage the settings of each function. For example, the Program Implant tab allows the physician to review and edit the IPG settings. 3.2 Parameter Text Color When changing parameters for therapy, blue text indicates settings that have not been saved to the IPG (i.e., the Download to IPG button has not been pressed), and black text indicates settings that have been saved to the IPG. In Figure 3.4 below, Frequency, Train Duration, Pulse Width, Train Period, and Magnet Mode have been saved to the IPG, while Amplitude has not. Figure 3.4: Blue Text Indicates Settings Have Not Been Saved 3.3 Overview of SAPS Menus (Tabs) Used for Therapy Each tab at the top of the SAPS screen corresponds to a particular capability of the system, denoted by the tabs name. NOTE: See Figure 3.3 for the location of the menus and the corresponding buttons used to access the menus described in this section. CAUTION: New parameters and therapy modes are not input into the IPG and remain blue in color until the Test function or the Download Settings to IPG function is used. Always verify that the intended parameters and therapy modes are programmed into the IPG. The suggested method of doing so is by interrogating the IPG and comparing the displayed values to those intended to be programmed. Properly programmed parameters and therapy modes display black in color. 3.3.1 Program Implant Overview The first tab, Program Implant, is used by the physician or therapist to set the patient information, stimulation settings, and therapy mode(s) and allows for impedance checks during implant and follow-up visits. See Section 4: Programming the Implant for more detail. 26-0002-0003/5 (en) (2021) 15 3.3.2 VNS Pairing Therapy Overview The second tab, VNS Pairing Therapy, is used to actually deliver therapy and assign the correlating rehabilitation task. It allows the therapist to either:

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: On-Demand Mode Menu for more detail), or deliver automatic stimulation for a set period of time (stimulate throughout a therapy session using the Entire Session VNS Scheduler mode see Section 5.2: Entire Session VNS Scheduler for more detail). 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. For example, the therapist can review each stimulation usage for a given task. See Section 8 Patient Log File for more detail. 3.3.4 On-Demand Mode Overview The fourth tab, On-Demand Mode, allows the physician or therapist to set the type of triggering mechanism for on-demand therapy and its settings. See Section 5.1: On-Demand Mode Menu for more detail. 3.3.5 Entire Session VNS Scheduler Overview The Entire Session VNS Scheduler menu allows the physician or therapist to program the therapy setting for an entire session without the need for individual triggering. See Section 5.2:

Entire Session VNS Scheduler for more detail. 3.3.6 Independent Mode The Independent Mode menu allows the physician or therapist to program the stimulation to be delivered independent of user (physician, therapist, or patient) activation. It works similarly to the Entire Session VNS Scheduler menu otherwise. Generally, it is not recommended to use this mode. Contact MicroTransponder if you would like to use this mode (Section 18:

Information and Support). 3.3.7 Study The Study menu is useful if a clinical study is being conducted at the clinic. It allows the physician or therapist to administer therapy based on a subjects treatment group. This menu is password protected. Contact MicroTransponder if you would like to use this mode (Section 18:

Information and Support). 26-0002-0003/5 (en) (2021) 16 4 PROGRAMMING THE IMPLANT 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 4.1 Connecting to a Specific IPG Perform these six steps before therapy for each patient to connect to their specific IPG. 1. Select the Disconnect button to disconnect any IPG that is connected to SAPS that is different from your patients IPG Serial # (see Figure 4.2). Select Continue when prompted to confirm. Figure 4.2: Disconnect 2. Verify there is no Serial # displayed in SAPS; you will see 3 dashes next to Serial if this is the case (see Figure 4.3). Figure 4.3: Blank Serial #

26-0002-0003/5 (en) (2021) 17 4.5). 3. Select Interrogate to allow the SAPS to find the patients IPG (see Figure 4.4 and Figure Figure 4.4: Interrogate Button on Screen Figure 4.5: Interrogate 4. A pop-up menu will appear. Select the IPG whose Serial # matches the one on the patients Patient Identification Card by clicking on their specific IPG and then pressing the Select button (circled in Figure 4.6). Figure 4.6: Select Button 26-0002-0003/5 (en) (2021) 18 5. Verify that the selected IPGs Serial # is displayed to the right of Serial, and check the IPG batterys 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 IPGs battery is close to its end of life. You may want to verify the Lead impedance. See Section 4.5: Impedance. Figure 4.7: Serial # and Battery Status 6. You may also want to verify that the IPG date and time are synched with the computer. See the steps below. a. Press the Time button (circled in Figure 4.8:). Figure 4.8: Time Button b. A window appears showing the Current Device Time and Current PC Time (see Figure 4.9). Generally, the Set with PC Time button on the right-hand side is used to synchronize time. Each button can be used as described here:

o The Get Time button to view the current IPG time o The Set Time button to manually set the IPG time o The Set with PC Time button to set the IPG time to the current PC time Figure 4.9: Time 26-0002-0003/5 (en) (2021) 19 4.2 Patient Information (Optional) The user may enter a patient identification, such as the patients initials or medical record number, into the SAPS if the user chooses. If the user does not provide a patient identification, the IPGs unique serial number can be used. 1. Enter the patient identification into the Patient ID field, as shown in Figure 4.10. 2. Program this Patient ID to the IPG by selecting the Download Settings to IPG button, located in the center of the screen (see Figure 4.1). This is only required to be performed once. SAPS will recognize the programmed Patient ID each time the IPG is interrogated. The IPG retains this information indefinitely. Figure 4.10: Patient ID 4.3 Implant Settings To enable each of the therapy modes, the button next to the desired Therapy Mode is selected and turned on. 1. Turn on your desired Therapy Mode to adjust the Implant Settings. 2. Each of the implant setting parameters available in the Implant Settings menu has a box next to the setting (see Figure 4.11). Select the box to display all available parameters in a drop-down box. 3. Select the appropriate value for each parameter, and program the parameters into the IPG using the Download Settings to IPG function. Examples of parameters are shown in Figure 4.12 through Figure 4.15. 4. Once you choose new implant settings, always verify that the implant setting parameters chosen are tolerable for the patient using the Stim Test Mode function. See Section 4.4.1: Stim Test Mode. Once the values programmed via the Test function or the Download Settings to IPG function are input into the IPG, all subsequent therapy sessions will be performed at these parameters. The user can modify the parameters at any time by selecting new parameters and programming them into the IPG. 26-0002-0003/5 (en) (2021) 20 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 26-0002-0003/5 (en) (2021) 21 Figure 4.13: Frequency Figure 4.14: Train Duration 26-0002-0003/5 (en) (2021) 22 Figure 4.15: Pulse Width 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 Therapy Modes 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. 26-0002-0003/5 (en) (2021) 23 Figure 4.16: Stim Test Mode 24 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). For each of the settings (Amplitude, Frequency, Train Duration, Pulse Width), click the button next to the setting, and a menu will drop down containing all available parameters for that setting. Then select the appropriate value for each parameter. Example drop-down menus for each parameter are shown above in Figure 4.12 through Figure 4.15. 26-0002-0003/5 (en) (2021) 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. Selecting the Test button programs those displayed parameters into the IPG. The Download Settings to IPG function does not need to be performed. The user can modify the parameters at any time by selecting new parameters and programming them into the IPG using the Test function. This sequence can be repeated until the patients IPG is programmed to appropriate parameters. In the scenario where a Test is not performed, the Download Settings to IPG button must be selected to program the IPG with the therapy parameters displayed in the Implant Settings menu. CAUTION: If the Test function is not performed, new parameters are not input into the IPG until the Download Settings to IPG function is used. Verify that the intended parameters are programmed into the IPG. The suggested method of doing so is by interrogating the IPG and comparing the displayed parameters to those intended to be programmed. 4.4.2 Therapist Trigger Mode The Therapist Trigger Mode (see Figure 4.18) is used to enable the physician or therapist to initiate stimulation manually. Figure 4.18: Therapist Trigger Mode 26-0002-0003/5 (en) (2021) 25 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 use On-Demand Mode for therapy (see Section 5.1: On-Demand Mode Menu) and to initiate a therapy session and trigger stimulation per the VNS Pairing Therapy menu (see Section 5.1.1: On-Demand Mode Therapy via the VNS Pairing Therapy Menu). The status of the Therapist Trigger Mode is reflected in the On-Demand Mode menu (see Section 5.1: On-Demand Mode Menu) and vice versa. 2. Optionally, you may change the stimulation parameters displayed in the Implant Settings menu (see Figure 4.19). See Section 4.3: Implant Settings. 3. After all desired parameters have been set, press the Download Settings to IPG button to download the chosen parameters to the implant. Initiation of Paired VNS using Therapist Trigger Mode is detailed in Section 5:

Delivering Paired VNS. 4. It is recommended to verify that the VNS settings chosen are tolerable for the patient. See Section 4.4.1: Stim Test Mode for details. 4.5 Impedance In the Impedance portion of the Patient Information area of the Program Implant menu, the Lead impedance can be checked by selecting the Check or Lead Impedance buttons (circled in Figure 4.20). Doing so delivers a small current through the Lead to calculate the Lead impedance. This measurement pulse contains minimal charge and is not expected to cause any discomfort, even in the most sensitive patient. The Lead Impedance button is available at all times once the user is logged in. See Section 3: Using the Software (SAPS). 26-0002-0003/5 (en) (2021) 26 Figure 4.20: Lead Impedance Check 1. Select the Check or Lead Impedance button (circled in Figure 4.20). After the Check or Lead Impedance button is selected, the Lead impedance value is shown (see Figure 4.23). For any value above 10,000 (see Figure 4.21) or less than 250

(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 Paired VNS System Implantable Device Manual for Healthcare Professionals for more information. Figure 4.21: High Lead Impedance Notification 26-0002-0003/5 (en) (2021) 27 Figure 4.22: Low Lead Impedance Notification Figure 4.23: Lead Impedance Displayed 26-0002-0003/5 (en) (2021) 28 5 DELIVERING PAIRED VNS After choosing and saving device settings, you can start a stimulation session. The On-Demand Mode and Entire Session VNS Scheduler menus allow the user to configure the method by which the Vivistim System delivers stimulation. The On-Demand Mode menu allows stimulation trains to be individually triggered during a session by the therapist (found in Section 5.1: On-Demand Mode Menu). The Entire Session VNS Scheduler menu allows the stimulation trains for an entire therapy session to be programmed in advance (found in Section 5.2: Entire Session VNS Scheduler). 5.1 On-Demand Mode Menu To begin on-demand stimulation therapy without a magnet:

1. Ensure that the Therapist Trigger Mode is On, from either the Program Implant menu

(see Section 4.4.2: Therapist Trigger Mode) or from the On-Demand Mode menu as shown in Figure 5.1. This must be enabled to utilize the On-Demand Mode menu functions. If the button adjacent to Therapist Trigger Mode is Off, toggle it to On. Enabling Therapist Trigger Mode here automatically disables the Therapy Trigger Mode in the Entire Session VNS Scheduler menu, and vice versa. CAUTION: Prior to all patient MRI procedures, program the Therapist Trigger Mode to Off. This also disables On-Demand Magnet Trigger. Figure 5.1: On-Demand Mode 26-0002-0003/5 (en) (2021) 29 2. Program the settings into the IPG by selecting the Download Settings to IPG button. The values of the parameters programmed into the IPG, as displayed in the Implant Settings menu, will be delivered to the patient with every triggered therapy. 3. Select desired Therapy Mode (Figure 5.1). The Normal therapy mode is the default where a single stimulation is delivered when the button is pressed. You can choose to deliver a string of stimulations instead of a single stimulation by selecting the Continuous mode and then pressing and holding the push button to start the stimulation and releasing the push button to end the stimulation. 4. In the case where you may prefer to use a magnet to provide the trigger to initiate stimulation, select the Start button in the On-Demand Magnet Trigger section. This initiates on-demand VNS using a magnet swipe instead of VNS triggered through the VNS Pairing Therapy menu. You can choose to deliver a string of stimulations instead of a single stimulation by selecting the Continuous mode along with On-Demand Magnet Trigger and then using the magnet to start and stop the stimulation. Figure 5.2: Start / Stop On-Demand Magnet Trigger SAPS prevents the On-Demand Magnet Trigger function from operating simultaneously with the VNS Pairing Therapy function. Tasks performed during On-Demand Magnet Trigger therapy are not captured in the patient log file. The status of the Therapist Trigger Mode is reflected in the Program Implant menu (see Section 4.4.2: Therapist Trigger Mode) and vice versa. The on-demand stimulation therapy can now begin via the VNS Pairing Therapy menu. 26-0002-0003/5 (en) (2021) 30 5.1.1 On-Demand Mode Therapy via the VNS Pairing Therapy Menu The following five steps are an overview of the sequence of events required for delivering this therapy. 1. Select VNS Pairing Therapy menu 2. Select task 3. Start Task 4. Deliver Stimulation 5. End Task 5.1.1.1 Select VNS Pairing Therapy Menu Select the VNS Pairing Therapy menu (see Figure 5.3) to initiate a therapy session and trigger stimulation. Figure 5.3: On-Demand Mode Therapy via the VNS Pairing Therapy Menu 5.1.1.2 Select Task Select the specific task (see Figure 5.3) from the drop-down menu by selecting the task drop down menu button and selecting the appropriate task that the patient is going to perform for rehabilitation (see Figure 5.4). The patient log file associates this selected task with the triggered stimulations of the therapy until a different task is chosen. This allows for ease of comparison when the patient log file is reviewed. 26-0002-0003/5 (en) (2021) 31 Figure 5.4: Select Task 5.1.1.3 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). Select the Start Task button (see Figure 5.5). This enables the system to start a rehabilitation task and allows you to trigger the delivery of stimulation. 26-0002-0003/5 (en) (2021) 32 Figure 5.5: Start Task 5.1.1.4 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 5.6). At any time, you may select the End Task button to end the rehabilitation task. Figure 5.6: Communication Established and Ready to Stimulate 26-0002-0003/5 (en) (2021) 33 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 5.7). Meanwhile, the Stimulate button is disabled for double the time of the stimulation train duration (to allow for a 50% duty cycle). Stimulation can occur only as often as twice the stimulation train duration; no duty cycle over 50% is allowed by the software. For example, if a 0.5 second train duration is given, you cannot activate another stimulation for at least 0.5 seconds after the train duration ends. Figure 5.7: Stimulate SelectedStatus Stimulating The message Refractory appears in the Status window for a length of time equal to the programmed stimulation train duration immediately following the Stimulating message (see Figure 5.8). Figure 5.8: Status RefractoryNo Stimulation Allowed The value in the Stimulation Counter window increases by one for every stimulation delivered. This counter resets to 0 when the current task is ended and a new task started (see Figure 5.9). Figure 5.9: Stimulation Counter Once the stimulation ends and the refractory period has finished, the message in the Status window returns to Ready to Stimulate, the Stimulate button is once again selectable, and a new repetition of the task can be initiated and stimulated (see Figure 5.6). The user may then continue to deliver stimulation except during the stimulation refractory period. 26-0002-0003/5 (en) (2021) 34 5.1.1.5 End Task Upon completing a task, select the End Task button (see Figure 5.6) 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 5.5). NOTE: The SAPS automatically ends the task if the session is inactive for more than 10 minutes. When the SAPS automatically ends a task, it displays a message that The IPG is no longer in Therapy Session (see Figure 5.10). The task can be started where it ended by selecting the Start Task button again. Figure 5.10: Ten Minute Time Out of Task 26-0002-0003/5 (en) (2021) 35 5.2 Entire Session VNS Scheduler To begin Entire Session VNS Scheduler therapy:

1. Select the Entire Session VNS Scheduler tab. Figure 5.11: Entire Session VNS Scheduler Mode 2. Ensure that either Therapy Trigger Mode or Magnet Mode is On (see Figure 5.12) in the Entire Session VNS Scheduler menu or in the Implant Settings menu. One of these modes must be enabled to utilize the Entire Session VNS Scheduler functions. If the button next to the preferred mode is Off, toggle it to On. Figure 5.12: Therapy Trigger Mode and Magnet Mode Enabling Therapy Trigger Mode here automatically disables the Therapist Trigger Mode in the On-Demand Mode menu, and vice versa. 3. Program the settings into the IPG by selecting the Download Settings to IPG button. 4. Optionally, you may change the stimulation parameters displayed in the Implant Settings menu. See Section 4.3: Implant Settings. NOTE: The values of the parameters programmed into the IPG, as displayed in the Implant Settings portion of the Program Implant menu, will be delivered to the patient with each triggered therapy session for either the Therapy Trigger Mode or Magnet Mode. 26-0002-0003/5 (en) (2021) 36 CAUTION: Once therapy is started, the patient should perform rehabilitation tasks for the duration of the therapy session. If the patient needs to stop stimulation during a session or suspects an issue with the therapy during a session, the patient should contact you for guidance. Therapy Trigger Mode enables you to initiate a therapy session by triggering the therapy using the mouse and cursor to select the Start button on the VNS Pairing Therapy menu (see Section 5.2.1: Therapy Trigger Mode). Magnet Mode enables the user to trigger stimulation using a magnet swipe instead of through the button in the VNS Pairing Therapy menu. The status programmed for Magnet Mode here is reflected in the Magnet Mode setting on the Program Implant menu (see Section 5.2.2:

Magnet Mode) and vice versa. 5.2.1 Therapy Trigger Mode CAUTION: Before selecting the Start button when applying the Therapy Trigger Mode for entire session therapy, verify all laptop connections (see Figure 2.1: SAPS Hardware Set-up Overview), and verify that the WT is an appropriate distance from the patient (see Section 16.2: Communication Signals). To begin Therapy Trigger Mode therapy:

1. In the Entire Session VNS Scheduler menu, ensure that the button adjacent to Therapy Trigger Mode is toggled to On (see Figure 5.13) and that steps 1-4 in Section 5.2: Entire Session VNS Scheduler have been completed to enable the Therapy Trigger Mode therapy. Figure 5.13: Select Therapy Trigger Mode 26-0002-0003/5 (en) (2021) 37 2. Set the Therapy Trigger Mode parameters. Refer to Section 5.2.3: Setting Parameters for details on setting all Therapy Trigger Mode parameters. 3. Select the VNS Pairing Therapy tab. 4. To start stimulation, select the Start button (see Figure 5.14). NOTE: The task list drop-down menu is disabled and not required in this therapy mode. Figure 5.14: Start Therapy Trigger Mode 5. To stop the stimulation upon completion of the therapy session or at any time during the session, select the Stop button (see Figure 5.15). NOTE: The SAPS automatically terminates the session if this session is left inactive for more than 4 hours. 26-0002-0003/5 (en) (2021) 38 Figure 5.15: Stop Therapy Trigger Mode 5.2.2 Magnet Mode CAUTION: Prior to all patient MRI procedures, program the Magnet Mode to Off. Magnet Mode set to On enables you to initiate an Entire Session VNS Scheduler therapy session with the use of a magnet. To begin this therapy session:

1. In the Entire Session VNS Scheduler menu, ensure that the button adjacent to Magnet Mode is On. 2. Select the Magnet Mode Duration. Refer to Section 5.2.3: Setting Parameters for details on setting all Magnet Mode parameters. 3. Optionally, you may change the stimulation parameters displayed in the Implant Settings menu. See Section 4.3: Implant Settings. 4. Program the settings into the IPG by selecting the Download Settings to IPG button. The status of the Magnet Mode is reflected in the Program Implant menu (see Section 4: Programming the Implant) and vice versa. Once the appropriate device settings for Magnet Mode are downloaded to the IPG, stimulation may be triggered using a magnet swipe without further communication from the SAPS. NOTE: During a patients 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. 5. Remove the magnet cover, if applicable (see Figure 5.16 below). 26-0002-0003/5 (en) (2021) 39 B Magnet A Magnet Cover Figure 5.16: Magnet with Cover Attached (A) and Detached (B) 6. To begin stimulation, swipe the magnet across the patients chest where the IPG is located

(see Figure 5.17). This will cause the VNS session to begin for the programmed Magnet Mode Duration. NOTE: The magnet need only be swiped across the patients chest where the IPG is located to trigger stimulation. Holding the magnet over the IPG for greater than 30 seconds stops the stimulation until the magnet is removed. Figure 5.17: Magnet Swipe 26-0002-0003/5 (en) (2021) 40 5.2.3 Setting Parameters For each of the settings (Train Period, Magnet Mode Duration, Randomization, Probability, and Second Train Period), you must select the button next to the setting to enable all available parameters for that setting, shown in a drop-down box. Not all parameters are available at all the times based on the modes that are chosen. For example, Magnet Mode Duration is accessible only when Magnet Mode is enabled. The appropriate value is selected for each parameter. Parameter examples are shown in Figure 4.11 through Figure 4.15. The Train Period parameter is reflected in the Program Implant menu (see Section 7.2: Magnet Mode) and vice versa. 26-0002-0003/5 (en) (2021) 41 6 STOPPING STIMULATION 6.1 Magnet Mode NOTE: Review this section with all patients. NOTE: A commercial magnet with a pull force rated at 4.5 kg or greater is sufficient to stop stimulation. In the event that stimulation is too strong or becomes uncomfortable or there is some device malfunction while the patient is at home, you or the patient may stop stimulation. To stop stimulation, you or the patient must place the magnet over the patients chest where the IPG is located and hold the magnet in place for at least 30 seconds. Stimulation is stopped for as long as the magnet is placed over the IPG. If at home, the patient should contact their physician (neurologist or physical medicine & rehabilitation [PM&R] doctor) or therapist for an immediate appointment so that the device can be further tested. CAUTION: In the event that stimulation continues once the magnet has been removed from the patients chest, the magnet must be placed back over the patients chest where the IPG is located to stop stimulation. The magnet should be held in place and the patients physician contacted for further instruction. Stimulation will be stopped as long as the magnet is held in place. NOTE: During a patients first therapy session, verify that the patient can terminate stimulation. Also verify that the patient is given an appropriate magnet to take home with them for this use. 6.2 Therapist Trigger Mode If you are using the VNS Pairing Therapy menu of the SAPS, stimulation may also be terminated by selecting End Task (see Section 5.1.1: On-Demand Mode Therapy via the VNS Pairing Therapy Menu and Figure 5.6). Selecting End Task disables the Stimulate button. 6.3 Resetting the IPG / Safe Mode In the event that the IPG reports a Safe Mode condition, the IPG must be reset to resume programming or therapy. 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). 26-0002-0003/5 (en) (2021) 42 Figure 6.1: Reset Button 3. When prompted (as shown in Figure 6.2), enter the password reset1. Figure 6.2: Password Prompt 4. Select the Accept button to complete the reset (see Figure 6.3). 26-0002-0003/5 (en) (2021) 43 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. 5. The IPG must now be reprogrammed to the appropriate mA setting for the patient. 26-0002-0003/5 (en) (2021) 44 7 SENDING THE PATIENT HOME CAUTION: If the patient will be having an MRI, make sure that all therapy modes are turned to Off (see Section 10: IPG Settings for MRI Procedures). For normal at-home use, make sure that Magnet Mode is turned to On (see Section 7.2:

Magnet Mode). 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. If the patient experiences any pain or suspects an issue with the device, they should contact you. More stimulation is not necessarily better. The patient should avoid devices that generate a strong electric or magnetic field. The patient should always let you know when they are scheduled to have an MRI. The patient should always let you know if they have a lifestyle change. For example, the patient could start playing a sport or start smoking. In a patients first visit, make sure to discuss Section 12: Precautions, Warnings, Contraindications, and Hazards and Section 5.2.2: Magnet Mode in addition to the Microtransponder Vivistim Paired VNS System Quick Start Guide for Patients (see the last page of this manual). Additionally, make sure to address:

Verify that the patient can terminate stimulation with a magnet. Verify that the patient is given a magnet to take home with them for this use. Tell the patient how long you have programmed their therapy session to be. If the patient has any questions about their magnet, they should contact you. If the patient loses their magnet, they can contact you or go to the hardware store and buy a replacement. They must find a magnet of pull force 4.5 kg or greater a magnet with a pull force lower than 4.5 kg will not activate or deactivate the IPG. 26-0002-0003/5 (en) (2021) 45 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 per the parameters represented in the Entire Session VNS Scheduler menu. The button adjacent to Magnet Mode must be toggled to On and programmed to enable this function. Off must be selected and programmed to terminate this capability. The amount of Therapy performed and the Session History are displayed, as shown circled in Figure 7.2. Figure 7.1: Magnet Mode Figure 7.2: Magnet Mode Session History 26-0002-0003/5 (en) (2021) 46 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. Select OK. Figure 7.3: Magnet Mode Prompt 3. Optionally, you may change the stimulation parameters displayed in the Implant Settings menu. See Section 4.3: Implant Settings. 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. To trigger stimulation in Magnet Mode, the magnet must be swiped across the patients chest where the IPG is located. Parameters programmed for Magnet Mode are reflected in the Entire Session VNS Scheduler menu (see Section 5.2: Entire Session VNS Scheduler) and vice versa. 47 26-0002-0003/5 (en) (2021) 8 PATIENT LOG FILE 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. To export the IPG statistics, select the Read Statistics button (circled in Figure 8.1). These are saved in .csv format to the hard drive of the laptop. To export the SAPS log, select the Export Log button. These are saved in .txt format to the hard drive of the laptop. You may choose a particular date range for export or choose to Export All (circled in Figure 8.2). Figure 8.1: Patient Log FileRead Statistics 48 26-0002-0003/5 (en) (2021) Figure 8.2: Patient Log FileExport Log 26-0002-0003/5 (en) (2021) 49 9 INTENTIONALLY BLANK 26-0002-0003/5 (en) (2021) 50 10 IPG SETTINGS FOR MRI PROCEDURES 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. Select the Download Settings to IPG button to save these settings to the IPG. 4. Following the MRI procedure, program the IPG to the appropriate settings to resume stimulation. Figure 10.1: IPG Settings for MRI Procedures CAUTION: All non-implantable components of the Vivistim System, including the WT, SAPS software, and any off-the-shelf accessories such as the magnet, are considered MR Unsafe and are also to be left outside of the MRI scan room. These could become dangerous flying objects if attracted by the strong magnetic field of the MRI scanner. 51 26-0002-0003/5 (en) (2021) 11 MAINTENANCE, HANDLING, AND STORAGE The WT is not permanently affected by exposure to or storage in temperatures in the range of

-20C to 70C. Humidity up to and including 100% has no effect on the WT. Additionally:

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. 26-0002-0003/5 (en) (2021) 52 12 PRECAUTIONS, WARNINGS, CONTRAINDICATIONS, AND HAZARDS Refer to the Microtransponder Vivistim Paired VNS System Implantable Device Manual for Healthcare Professionals and the Microtransponder Vivistim Paired VNS System 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). UseThe Vivistim System should only be prescribed and monitored by physicians who have specific training and expertise in the management of stroke and the use of this device. The IPG, Lead, WT, and SAPS should only be used as part of the Vivistim System. WT is MR UnsafeThe WT must not be exposed to magnetic resonance imaging

(MRI). Magnet is MR UnsafeThe patient must not carry metal (magnets, jewelry, etc.) into the MR scanner room. Metal objects can become dangerous flying objects if attracted by the strong magnetic field of the MRI scanner. Environmental and medical therapy hazardsPatients should exercise reasonable caution in avoiding devices that generate a strong electric or magnetic field. EMI effects on other devicesThe Vivistim System should be movedtypically at least 1.8 m (6 ft)away from equipment with which it may be interfering. Programming or interrogating the IPG may momentarily interfere with other sensitive electronic equipment nearby. CommunicationThe IPG listens for a communication signal from the WT. Communication usually takes less than 2 seconds but may be prolonged or interrupted in the presence of electromagnetic interference (EMI). CAUTION: Do not use the Vivistim System in an environment where explosive or flammable gases are present. CAUTION: Do not use the Vivistim System in an environment where the non-implantable components of the system may get wet. These components are not waterproof and should be kept dry, except for normal cleaning with a damp cloth. CAUTION: Electrostatic discharge (ESD) discharge precautions should be taken before handling the system. A grounded metal object should be touched before touching the laptop, Wireless Transmitter, and push button. CAUTION: Degradation of the Vivistim systems ability to communicate during exposure to frequency ranges associated with television broadcasts (~203 MHz) and frequency ranges associated with satellites (~400 MHz), including global positioning system (GPS) signals found in cellphones and other mobile electronic devices, can occur. Programming and pairing with the system should be performed either outside of these environments or with this equipment turned off. 26-0002-0003/5 (en) (2021) 53 Software restrictionsNo other software shall be loaded onto the SAPS laptop, because it may interfere with proper functioning of the SAPS already installed on the commercially available laptop. Laptop useUsing the commercial laptop containing SAPS for other purposes (such as internet access) may damage the system or interfere with proper functioning of the SAPS. Use only SAPS softwareThe 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. Interference informationThis equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate RF energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. EMI interferenceProgramming in the presence of an EMI signal can be difficult or impossible, but problems can usually be resolved by repositioning the patient, the WT, or the EMI source. Avoid large metal structures when programmingProgramming while the IPG and/or patient are on a metal table or near large metal structures can be difficult or impossible, but problems can usually be resolved by placing the WT closer to the IPG or moving to a different location. No internetInternet access has been purposely disabled on the laptop. Do not enable the internet on the SAPS laptop. Do not modify equipmentDo 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 timeIt is important that the laptop time be set to the correct local time and periodically verified. This time is used to set the device time and to timestamp the operations in the log file. The magnet effects on other devicesThe magnet provided to the patient to start and stop at-home therapy may damage televisions, computer disks, credit cards, and other items affected by strong magnetic fields. The patient should keep the magnet away from such items. 26-0002-0003/5 (en) (2021) 54 This section provides troubleshooting instructions in 3 parts: Section 13.1: General Recommendations and Section 13.2: Troubleshooting at Patient Follow-up Visits. 13 TROUBLESHOOTING 13.1 General Recommendations 13.1.1 Non-responsive Laptop The SAPS laptop will power up in the Welcome menu of the SAPS application. If for any reason this does not occur, power off the laptop and power it back on. 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 An example of an error message following a communication problem is shown in Figure 13.1. Figure 13.1: Telemetry Lost A communication problem can cause an error message (such as the Telemetry Lost message shown in Figure 13.1) during interrogation, checking impedance, programming stimulation parameters, or while performing any other therapy required communications. The most common causes of communication problems are connection issues. Performing these steps may restore communication:

26-0002-0003/5 (en) (2021) 55 1. Verify that the WT is properly connected to the laptop. The USB plug from the WT should be inserted into one of the laptops USB ports. Figure 2.4 shows the indicator for proper connection. 2. Verify that the patient and IPG are within 1 m of the WT. 3. Verify that the programming problem is not a result of EMI from nearby electrical or magnetic equipment. Examples of possible sources of EMI are laptop displays, portable telephones, fluorescent lighting, OR lights, and magnetic pads for surgical instruments. 4. Verify that the programming problem is not a result of the IPG or WT being placed on a metal table. Failure of the IPG and WT to clearly communicate with each other at any time can be attributed to several factors, such as:

WT not properly connected to laptop Programming in the presence of an EMI signal (e.g., OR lights, the programming laptop itself, other computers, or other medical devices). This can be difficult or impossible, but problems can usually be resolved by repositioning the patient, the WT, or the EMI source. Movement of the patient away from the WT during communication Proximity of the IPG or WT to a metal table or large metal object Presence of metal barriers between the IPG and WT IPG battery at end of life (EOL) Software (SAPS) needing to be restarted by restarting computer Defective WT Defective laptop Defective IPG Communication problems are often intermittent and are rarely related to the IPG. The surrounding environment typically causes these problems. Restarting the laptop solves most communication and other system issues that are not connection related. 13.2.2 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. 26-0002-0003/5 (en) (2021) 56 14 DEVICE LIFETIME 14.1 IPG Lifetime, Removal, and Replacement All MicroTransponder IPGs eventually require surgical replacement as a result of battery depletion. IPG replacement does not, of itself, require Lead replacement unless a Lead discontinuity (a break) is suspected. 14.1.1 Signs of End of Life for the Vivistim System The most common reason for the absence of stimulation is battery depletion, although there may be other reasons. When end of life (EOL) occurs, the IPG will be unable to provide stimulation. If the IPG is not explanted or replaced at EOL, the battery voltage will continue to gradually decrease, and communication with the IPG may not be possible. 14.1.2 Replacement Based on Battery Status Indicators During patient visits, you will use SAPS to check the status of the patients IPG (see Figure 4.8: ). The SAPS will display warning messages if the battery is nearing its depletion. 26-0002-0003/5 (en) (2021) 57 15 DEVICE DISPOSAL 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). 26-0002-0003/5 (en) (2021) 58 16 VIVISTIM SYSTEM DEVICES 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. To select a button or field, move the cursor over the button and select the button using the mouse or keypad selector. A glossary and list of symbols is found in the back of this manual (see Section 19: Glossary). 16.2 Communication Signals The WT communicates wirelessly bidirectionally through the air and tissue with the IPG at a distance up to 1 m from the WT by converting USB communications into radio frequency (RF) communications using a unique, proprietary, and secure protocol that implements the Medical Implantable Band (MICS, ~403 MHz). This ensures that the IPG is not programmable by other MICS programmers and that the WT cannot program other MICS based devices. The communication portion of the Vivistim System is designed to minimize the possibility of mis-

programming or phantom programming with the IPG. Phantom programming is the inadvertent programming via environmental sources of electromagnetic interference (EMI). All IPG parameters are programmed and verified during each programming event. 16.3 Wireless Transmitter The WT (see Figure 16.1) is the bi-directional RF communication link between SAPS and the implanted IPG. The WT uses the FCC-approved MICS band (~403 MHz) to communicate with the IPG at distances of up to 1 m. The WT has a 2 m cable with a USB connector that plugs into the commercially available laptop. The WT is powered via the USB connection on the laptop and does not require any additional power source, such as its own battery or additional power connection. Figure 16.1: Wireless Transmitter 26-0002-0003/5 (en) (2021) 59 Outer Material Size Cable Length Weight Connector Type Communication Distance Communication Band PMMA plastic (plexiglas - black)

~10 cm 7.5 cm 2.5 cm; no sharp corners

~2 m

~131 g USB 1 m Table 16.1: Characteristics of the Wireless Transmitter Medical Implantable Band (MICS, ~403 MHz) 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 Allows the physician to check the status of the IPG battery level Allows the physician to check the Lead impedance Allows the physician to record the rehabilitation task information Stores the therapy session history for review at a later time Requires the physician to use a SAPS password to access implant programming and therapy functions log and therapy information Allows users without the SAPS password (but with the laptop password) to access patient The software is delivered to the physician pre-installed on a commercially available laptop. See Section 3: Using the Software (SAPS) for more information on use of the SAPS. 16.5 Other Applicable MicroTransponder Products Model 1001 IPG Model 3000 Lead 16.6 Applicable Commercial Devices for Use with MicroTransponder IPG A commercial magnet with a pull force rated at 4.5 kg or greater is sufficient to close the reed switch within the IPG and stop stimulation. 26-0002-0003/5 (en) (2021) 60 17 GUIDANCE AND MANUFACTURERS DECLARATIONELECTROMAGNETIC IMMUNITY The Wireless Transmitter (Model 2000) 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 RF emissions CISPR 11 Group 1 RF emissions Class B Harmonics emissions IEC 61000-3-2 Voltage fluctuation/flicker emissions IEC 61000-3-3 Not Applicable1 Not Applicable1 The Wireless Transmitter must emit electromagnetic energy to perform its intended function. Nearby electronic equipment may be affected. The Wireless Transmitter is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 1 The Wireless Transmitter is rated less than 75 W, and the Harmonic current emissions basic standards has no limits for this type of product. The Wireless Transmitter does not have any component that may produce flicker. Table 17.1: Guidance and Manufacturers DeclarationElectromagnetic Emissions 26-0002-0003/5 (en) (2021) 61 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 Electrostatic discharge

(ESD) IEC 61000-4-2

+/-8kV contact

+/-2kV, +/-4kV, +/-8kV,

+/-15kV air

+/-8kV contact

+/-2kV, +/-4kV, +/-

8kV,

+/-15kV air

+/-2 kV for power supply lines Electromagnetic environment - guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

+/-2 kV for power supply lines

+/- 1 kV for input/output lines Not Applicable

+/-1 kV differential mode

+/-1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment.

+/-2 kV common mode

+/-2 kV common mode, 1.25/50 s Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT

(>95% dip in UT) For 0.5 cycle 40% UT

(60% dip in UT) For 5 cycles 70% UT

(30% dip in UT) For 25 cycles

< 5% UT

(>95% dip in UT) For 5 s

<5% UT

(>95% dip in UT) For 0.5 cycle 40% UT

(60% dip in UT) For 5 cycles 70% UT

(30% dip in UT) For 25 cycles

< 5% UT

(>95% dip in UT) For 250 cycles

(5 s @50 Hz) Mains power quality should be that of a typical commercial or hospital environment. If the user of the Wireless Transmitter requires continuous operation during power mains interruptions, it is recommended that the Wireless Transmitter be powered from an uninterruptible power supply or a battery. Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m NOTE: UT is the a.c. mains voltage prior to application of the test level. Power frequency magnet fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Table 17.2: Guidance and Manufacturers DeclarationESD and Power Fluctuations 26-0002-0003/5 (en) (2021) 62 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 test level Compliance Level Electromagnetic environment - guidance Conducted RF IEC 61000-4-6 Radiated RF IEC61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Wireless Transmitter is used exceeds the applicable RF compliance level above, the Wireless Transmitter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Wireless Transmitter. b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m. Portable and mobile RF communications equipment should be used no closer to any part of the Wireless Transmitter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

= 1.2

= 1.2 80 MHz to 800 MHz

= 2.3 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strength from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Table 17.3: Guidance and Manufacturers DeclarationRadiated Electromagnetic Fields 26-0002-0003/5 (en) (2021) 63 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. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter M 150 kHz to 80 MHz 80 MHz to 800 MHz

= 1.2

= 1.2 800 MHz to 2.5 GHz

= 2.3 0.01 0.1 1 10 100 0.12 0.37 1.2 3.7 12 0.23 0.74 2.3 7.4 23 Table 17.4: Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Wireless Transmitter Telemetry Description The Model 1001 IPG and Model 2000 Wireless Transmitter communicate with each other using ultra-low power Medical Implant Communications Service (MICS Band) telemetry in the frequency range 402 405 MHz. 0.12 0.37 1.2 3.7 12 26-0002-0003/5 (en) (2021) 64 18 INFORMATION AND SUPPORT 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. If issues continue, please contact MicroTransponder. MicroTransponder, Inc. 2802 Flintrock Trace, Suite 226 Austin, TX 78738 www.microtransponder.com info@microtransponder.com 26-0002-0003/5 (en) (2021) 65 19 GLOSSARY 19.1 Definitions Duty CyclePercentage of time during which stimulation occurs; stimulation time divided by the sum of signal on and off times. ElectrodeThe mechanical and electrical interface of the Vivistim System to the vagus nerve. The electrode is part of the Lead. EMIElectromagnetic interference EOL (end of life)The SAPS software displays an EOL indicator when there is less than 5% of the battery remaining. EOL indicates that the IPG will cease to function in the very near future and needs to be replaced for therapy to continue. ERI (Elective Replacement Indicator)The SAPS software displays an ERI indicator when there is less than 15% of the battery remaining. This is a warning to the user that the IPG is quickly approaching EOL and may stop functioning in the near future. High Lead ImpedanceFor the purposes of the Vivistim System IFUs, any impedance above 10,000 is considered high. Resistance to the flow of output current produced by the IPG, caused by any of the following: possible fibrosis between the nerve and electrode, dry nerve

(during surgery), Lead fracture, Lead disconnection from the IPG, or high battery impedance approaching end of life (EOL). IPG (Implantable Pulse Generator)The stimulator portion of the Vivistim System, typically implanted in the chest below the clavicle. The IPG provides stimulation to the vagus nerve through a connected Lead and Lead electrode. LeadAn implantable part of the Vivistim System; delivers electrical impulses from the IPG to the electrodes attached to the vagus nerve; contains flexible conductive wires within a bio-

compatible insulating sheath. Low Lead ImpedanceLower than expected resistance to the flow of output current produced by the IPG potentially caused by a short-circuit condition resulting from a break within the Lead body or connector boot. MRIMagnetic resonance imaging MR UnsafeAn item that poses hazards in all MRI environments. Output currentAmount of electrical current delivered in a single pulse of a stimulation, measured in mA. Paired VNSVNS delivered by the Vivistim System. Patient IDAn identifier assigned by the treating physician; generally programmed at time of implantation. Pulse widthDuration of a single pulse within a stimulation; measured in s. Signal frequencyRepetition rate of pulses in a stimulation; measured in pulses per second

(Hz). 26-0002-0003/5 (en) (2021) 66 Signal off timeInterval between stimulations when there is no stimulation; measured in minutes. Signal on timeLength of time the programmed output current is delivered; measured in seconds. SAPS (Stroke Application & Programming Software)Software that allows the physician or therapist to set the VNS parameters and initiate stimulation paired with rehabilitation tasks. TrainDuration (in seconds) that the signal frequency is output from the IPG. Vagus nerveEither of the pair of tenth cranial nerves arising from the medulla and supplying mainly the viscera, especially with autonomic sensory and motor fibers. VivistimTrade name of MicroTransponders Paired VNS System for motor deficits associated with stroke. VNSVagus Nerve Stimulation WT (Wireless Transmitter)An RF device that connects via a USB plug to the laptops USB port and provides communication with the IPG; used in conjunction with SAPS. 19.2 Symbols This manual and accompanying non-implantable device labeling use these symbols and definitions. Refer to the Microtransponder Vivistim Paired VNS System Implantable Device Manual for Healthcare Professionals for symbols relating to the implantable components of the Vivistim System. Caution, pay special attention to the information following the symbol For USA audiences only Rx Only For Prescription use only For Prescription use only Communication Distance Non-ionizing Radiation Date of Manufacture Do Not Use if Package is Damaged Authorized Representative in the European Union 26-0002-0003/5 (en) (2021) 67 Consult Instructions for Use Reference Number Batch Code Manufacturer MR Conditional Serial Number Magnetic Resonance Unsafe Temperature Limitation (Storage and Transport) Number of Radio Frequency (RF) Communication Channels Keep Dry 26-0002-0003/5 (en) (2021) 68 Vivistim Paired VNS System Quick Start Guide for Patients 1. To turn on your IPG, remove the magnet cover, if applicable, and swipe the magnet once across your chest, above where the IPG is implanted. The IPG will then stimulate your vagus nerve for a therapy session typically lasting 30 minutes.2 The device will automatically stop stimulation and shut off at the time programmed by your health care provider. NOTE: You may not feel stimulation. Magnet 2. To stop the stimulation during a session, hold the magnet over the IPG. Continue holding it will take approximately 30 seconds for the stimulation to stop. When you remove the magnet, stimulation will continue until your therapy session end time. 3. If you wish to stop the stimulation for the rest of your therapy session, you must hold the magnet over your chest until your therapy session end time.3 4. If you lose your magnet, you will need to contact your clinician for a new one or replace it with a magnet that is strong enough. A commercial magnet with a pull force rated at 4.5 kg or greater is sufficient. Magnet Cover Magnet Force: 4.5+ kg 5. The magnet provided to you may damage TVs, computer disks, credit cards, and other items affected by strong magnetic fields. Please keep the magnet away from such items. Contact your clinician for medical care and medical advice or if you have any questions about your MicroTransponder Vivistim Paired VNS System. 2 Your health care provider may program the session to be shorter or longer than 30 minutes. 3 For example, if your health care provider programmed the session to last 30 minutes and you started your session at 8:00 am, then your session would end at 8:30 am. If you want to completely stop stimulation starting at 8:20 am, then you would need to hold the magnet in place for 10 minutes, which is until the pre-programmed session time would end at 8:30 am. 26-0002-0003/5 (en) (2021) 69

SN Label Part Number:

29-MM11927 0 FCC ID: QHJ-2100A Rev. 2100 PAT. www.microtransponder.com/patents PAT. www.microtransponder.com/patents SN Label Part Number:

29-MM11927 0 FCC ID: QHJ-2100A Rev. 2100 54 5, Transparent windows PANTONE 765 C 2 General tolerances, U.O.S. / Tolerancias generales, excepto las especificadas: 0,2 mm CCC# 29-105023 - MC 0889

ANT-403-USP Data Sheet Product Description The Splatch uses a grounded-line technique to achieve outstanding performance from a tiny surface-mount element. This unique antenna is designed for hand or reflow-mounting directly to a products circuit board. Its low cost makes it ideal for volume applications. Unlike many compact antennas, the Splatch exhibits good proximity performance, making it an appropriate choice for handheld applications such as remote controls, pagers and alert devices. Features Very low cost Ultra-compact package Direct PCB attachment Perfect for compact portable devices Suitable for hand- or reflow-assembly Resistant to proximity effects Ideal for concealed / internal mounting Electrical Specifications Center Frequency:

Recom. Freq. Range:

Bandwidth:

Wavelength:

VSWR:

Peak Gain:

Impedance:

Connection:

Oper. Temp. Range:

403MHz 400 406MHz 6MHz

-wave 2.0 typical at center 8.7dBi 50-ohms Surface-mount 40C to +130C by 12.70 mm

(0.5") 9.14 mm

(0.36") 2.62 mm

(0.103") 5.1 mm

(0.20") 1.27 mm

(0.05") Recommended Footprint 5.1 mm

(0.20") 2.54 mm

(0.10") 2.03 mm

(0.08") Recommended Mounting 40.37 mm

(1.59) 7.11 mm

(0.28) 10.54 mm

(0.42) No ground plane or traces under the antenna PCB pads for the Splatch Vias to ground plane Ground plane on bottom layer for counterpoise 50-ohm microstrip line

(0.21 minimum) Electrical specifications and plots measured on 3.88 cm x 8.00 cm (1.53 x 3.15) reference ground plane. 91.82 mm

(3.62) 79.88 mm

(3.15) Ordering Information ANT-403-USP (supplied in tubes of 63 pieces) ANT-403-USP-T (Tape and reel of 1,000 pieces) 7.62 mm

(0.03) 38.86 mm

(1.53) 7.62 mm

(0.03) Please see AN-00502 for more details on PCB layout. 1 Revised 1/3/2017 Counterpoise Quarter-wave or monopole antennas require an associated ground plane counterpoise for proper operation. The size and location of the ground plane relative to the antenna will affect the overall performance of the antenna in the final design. When used in conjunction with a ground plane smaller than that used to tune the antenna, the center frequency typically will shift higher in frequency and the bandwidth will decrease. The proximity of other circuit elements and packaging near the antenna will also affect the final performance. For further discussion and guidance on the importance of the ground plane counterpoise, please refer to Linx Application Note AN-00501: Understanding Antenna Specifications and Operation. 1.38 Reflected Power 25%

VSWR Graph VSWR 3:1 2:1 1:1 353MHz 403MHz 0%

453MHz What is VSWR?

The Voltage Standing Wave Ratio (VSWR) is a measurement of how well an antenna is matched to a source impedance, typically 50-ohms. It is calculated by measuring the voltage wave that is headed toward the load versus the voltage wave that is reflected back from the load. A perfect match has a VSWR of 1:1. The higher the first number, the worse the match, and the more inefficient the system. Since a perfect match cannot ever be obtained, some benchmark for performance needs to be set. In the case of antenna VSWR, this is usually 2:1. At this point, 88.9% of the energy sent to the antenna by the transmitter is radiated into free space and 11.1% is either reflected back into the source or lost as heat on the structure of the antenna. In the other direction, 88.9% of the energy recovered by the antenna is transferred into the receiver. As a side note, since the :1 is always implied, many data sheets will remove it and just display the first number. How to Read a VSWR Graph VSWR is usually displayed graphically versus frequency. The lowest point on the graph is the antennas operational center frequency. In most cases, this is different than the designed center frequency due to fabrication tolerances. The VSWR at that point denotes how close to 50-ohms the antenna gets. Linx specifies the recommended bandwidth as the range where the typical antenna VSWR is less than 2:1. 2 ANT-403-USP Data Sheet by Gain Plots E / Vertical Gain H / Horizontal Gain Total Gain XZ-Plane Gain YZ-Plane Gain XY-Plane Gain About Gain Plots The true measure of the effectiveness of an antenna in any given application is determined by the gain and radiation pattern measurement. For antennas gain is typically measured relative to a perfect (isotropic) radiator having the same source power as the antenna under test, the units of gain in this case will be decibels isotropic (dBi). The radiation pattern is a graphical representation of signal strength measured at fixed distance from the antenna. Gain when applied to antennas is a measure of how the antenna radiates and focuses energy into free space. Much like a flashlight focuses light from a bulb in a specific direction, antennas focus RF energy into specific directions. Gain in this sense refers to an increase in energy in one direction over others. It should also be understood that gain is not free, gain above 0dBi in one direction means that there must be less gain in another direction. Pictorially this can be pictured as shown in the figures to the right. The orange pattern represents the radiation pattern for a perfect dipole antenna, which is shaped like a donut. The pattern for an omnidirectional antenna with gain is shown in blue. The gain antenna is able to work with a device located further from the center along the axis of the pattern, but not with devices closer to the center when they are off the axis the donut has been squished. Gain is also related to the overall physical size of the antenna, as well as surrounding materials. As the geometry of the antenna is reduced below the effective wavelength (considered an electrically small antenna) the gain decreases. Also, the relative distance between an electrically small antenna and its associated ground impacts antenna gain. Copyright 2017 Linx Technologies 159 Ort Lane, Merlin, OR 97532 Phone: +1 541 471 6256 Fax: +1 541 471 6251 www.linxtechnologies.com 3 ANT-403-USP Data Sheet by

Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 January 12, 2022 FCC IDs: QHJ-2100A Cover Letter Dear Examiner:

The QHJ-2100 is referred to within engineering testing units as the following and these are electronically and mechanically equivalent:

Wireless Transmitter, Wolfgang Programmer Interface, RF02, & Model 2100 Wireless Transmitter Wolfgang Programmer Interface radio description:

Uses transceiver: Microsemi ZL70103 Communication: MedRadio (402.45 to 404.55 MHz) Communicates with: Wolfgang Implantable Pulse Generator (Microsemi ZL70321) Type of equipment approval: Original certification Applicable rule parts:

CFR Title 47, Part 95, Subpart I Wolfgang Programmer Interface FCC ID: QHJ-2100A Seeking original certification Sincerely, Chester Burress MicroTransponder, Inc. Sr. Director of Technical Operations, GMQ

Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 February 9, 2022 FCC IDs: QHJ-2100A Dear Examiner:

I am writing to avoid the possibility of an inadvertent disclosure of proprietary information. The accompanying Form 731 is being filed with the commission. Included as exhibits with the enclosed application are block diagrams, schematics, and a detailed description of the theory of operation of the device. It is our intention to provide the commission with a full disclosure of our product so that its merits can be evaluated. Indeed, we are pleased to provide any further information that the commission might wish to see. It is not our intention, however, to make our proprietary process a matter of public record. In view of the fact that the bill of materials, block diagrams, schematics, and associated theory of operation disclose the mechanism of our process, we ask that these portions

(bill of materials, block diagrams, schematics, and theory of operation) of our application be withheld from public inspection as provided under FCC 47 CRF 0.457(d) and 0.459. These documents contain details of the proprietary operation of product. These details are not readily discernible - even to technically sophisticated individuals - from our hardware and constitute trade secrets. We request therefore that these documents be segregated from the body of our evaluation report and withheld from public inspection. Thank you for your attention. Please let me know if the Commission disagrees with our position or requires further justification. Sincerely, Chester Burress MicroTransponder, Inc. Sr. Director of Technical Operations, GMQ

Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 February 9, 2022 FCC IDs: QHJ-2100A Tune-up Procedure Exclusion Dear Examiner:

The QHJ-2100 Model 2100 employs a solid state design that does not require a tune-up procedure and therefore has no requirement to be held confidential. Sincerely, Chester Burress MicroTransponder, Inc. Sr. Director of Technical Operations, GMQ