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 Professional’s Manual.
Vivistim® Paired VNS™ System Quick Start Guide for Therapists NOTE: Read this manual in its entirety before seeing your first patient. WARNING: The IPG serial number is the only permanent unique patient identifier detected by the software. Always check the IPG serial number and the patient’s physical ID card before saving or over-writing a “Patient ID” in the software to avoid inadvertently misidentifying a patient.
TABLE OF CONTENTS 1 DEVICE DESCRIPTION .................................................................................................7 1.1 1.2 1.3 1.4 Intended Use / Indication.......................................................................................... 8 SAPS Warnings ....................................................................................................... 9 SAPS Package Contents .........................................................................................
6.3 Resetting the IPG / Safe Mode ............................................................................... 42 7 SENDING THE PATIENT HOME ....................................................................................45 7.1 7.2 Things to Review with the Patient .......................................................................... 45 Magnet Mode ......................................................................................................... 46 8 PATIENT LOG FILE .................
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 Screen—Welcome Menu ............................................................
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 .......................................................................................
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.
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.
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.
2 GETTING STARTED 2.1 Stroke Application & Programming Software (SAPS) Hardware Setup Figure 2.1: indicates the proper setup: 1. Connect the power cord to the power port on the laptop and connect the other end to the wall outlet. 2. Connect the WT to a USB port on the laptop. 3. (Optional) Connect the push button to a USB port on the laptop. A Power Button B Power Cord C Push Button D Wireless Transmitter Figure 2.
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 patient’s 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.
Figure 2.3: Startup Menu Screen—Welcome 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.
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.
Figure 3.2: Startup Menu Screen—Physician Mode Notice that the orange Log In button has toggled to Log Out (circled in Figure 3.2) so that, if desired, the user may select the Log Out button and once again remove access to the additional SAPS screens. 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.
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.
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.
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.
3. Select Interrogate to allow the SAPS to find the patient’s IPG (see Figure 4.4 and Figure 4.5). Figure 4.4: Interrogate Button on Screen Figure 4.5: Interrogate 4. A pop-up menu will appear. Select the IPG whose Serial # matches the one on the patient’s Patient Identification Card by clicking on their specific IPG and then pressing the Select button (circled in Figure 4.6). Figure 4.
5. Verify that the selected IPG’s Serial # is displayed to the right of “Serial”, and check the IPG battery’s status, as indicated by the symbol to the right of “Implant Battery” (see Figure 4.7). A green circle indicates an adequately full battery. “ERI” or “EOL” displayed in place of the green circle indicates that the IPG’s battery is close to its end of life. You may want to verify the Lead impedance. See Section 4.5: Impedance. Figure 4.7: Serial # and Battery Status 6.
4.2 Patient Information (Optional) The user may enter a patient identification, such as the patient’s initials or medical record number, into the SAPS if the user chooses. If the user does not provide a patient identification, the IPG’s unique serial number can be used. 1. 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).
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.
Figure 4.13: Frequency Figure 4.
Figure 4.15: Pulse Width 4.4 Therapy Modes The Program Implant menu includes 3 therapy modes: Stim Test Mode (see Section 4.4.1: Stim Test Mode), Therapist Trigger Mode (see Section 4.4.2: Therapist Trigger Mode), and Magnet Mode (see Section 7.2: Magnet Mode). 4.4.1 Stim Test Mode The Stim Test Mode (see Figure 4.16) is used to test the parameters displayed in the Implant Settings menu.
Figure 4.16: Stim Test Mode Figure 4.17: Implant Settings 1. Select the button next to Stim Test Mode. The button will now toggle to On (see Figure 4.16). 2. Optionally, you may change the stimulation parameters displayed in the Implant Settings menu (see Figure 4.17). 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.
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.
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).
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 Ω (see Figure 4.21) or less than 250 Ω (see Figure 4.22), the “Warning!” screen informs the patient to contact their physician or therapist to see if any further action needs to be taken.
Figure 4.22: Low Lead Impedance Notification Figure 4.
DELIVERING PAIRED VNS™ 5 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).
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.
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.
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.
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.
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).
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.
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.
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).
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.
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.
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 patient’s 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 patient’s 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.
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.
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.
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).
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.
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.
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.
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.
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 .
Figure 8.
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.
11 MAINTENANCE, HANDLING, AND STORAGE The WT is not permanently affected by exposure to or storage in temperatures in the range of -20°C to 70°C. 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.
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).
• Software restrictions—No 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 use—Using the commercial laptop containing SAPS for other purposes (such as internet access) may damage the system or interfere with proper functioning of the SAPS.
13 TROUBLESHOOTING This section provides troubleshooting instructions in 3 parts: Section 13.1: General Recommendations and Section 13.2: Troubleshooting at Patient Follow-up Visits. 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.
1. Verify that the WT is properly connected to the laptop. The USB plug from the WT should be inserted into one of the laptop’s 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.
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.
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).
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.
Outer Material PMMA plastic (plexiglas - black) Size ~10 cm × 7.5 cm × 2.5 cm; no sharp corners Cable Length ~2 m Weight ~131 g Connector Type USB Communication Distance ≤1 m Communication Band Medical Implantable Band (MICS, ~403 MHz) Table 16.1: Characteristics of the Wireless Transmitter 16.4 Stroke Application & Programming Software (SAPS) The SAPS software was developed by MicroTransponder to manage IPG therapy and therapy information.
17 GUIDANCE AND MANUFACTURER’S DECLARATION—ELECTROMAGNETIC 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 The Wireless Transmitter must emit electromagnetic energy to perform its intended function.
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.
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.
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.
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.
19 GLOSSARY 19.1 Definitions Duty Cycle—Percentage of time during which stimulation occurs; stimulation time divided by the sum of signal on and off times. Electrode—The mechanical and electrical interface of the Vivistim® System to the vagus nerve. The electrode is part of the Lead. EMI—Electromagnetic interference EOL (end of life)—The SAPS software displays an EOL indicator when there is less than 5% of the battery remaining.
Signal “off” time—Interval between stimulations when there is no stimulation; measured in minutes. Signal “on” time—Length 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. Train—Duration (in seconds) that the signal frequency is output from the IPG.
Consult Instructions for Use Reference Number Batch Code Manufacturer Magnetic Resonance Unsafe MR Conditional Serial Number Temperature Limitation (Storage and Transport) Number of Radio Frequency (RF) Communication Channels Keep Dry 26-0002-0003/5 (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 Magnet Cover 2.
