VNS Therapy SENTIVA M3000 Programmer Technical Manual
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VNS Therapy SENTIVA M3000 Programmer Technical Manual

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Summary of Contents for VNS Therapy SENTIVA M3000 Programmer

  • Page 1 Technical Guide...

  • Page 2: Table Of Contents

    Table of Contents PRODUCT OVERVIEW VNS Therapy System Components and Support Materials SENTIVA SYSTEM MANAGEMENT Getting Started In Office Programming Manual Programming Tachycardia Detection/ Prone Position/Low Heart Rate Detection Guided Programming Scheduled Programming Day/Night Programming Therapy Protocols Viewing Device Data...

  • Page 3: Indications For Use

    Manual for additional important prescribing and safety information. Indication for Use The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.
  • Page 4 Product Overview INTRODUCTION TO VNS THERAPY The VNS Therapy® System supports the delivery of personalized Vagus Nerve Stimulation (VNS) Therapy for drug-resistant epilepsy (DRE). The VNS Therapy® System includes four parts: • Generator and lead • Programmer (tablet and software) •...
  • Page 5 VNS Therapy Lead Programmer (M3000) The external portion of the VNS Therapy® System consists of a programmer (a computer tablet with VNS Therapy® programmer software pre-installed) and a wand (M2000). The programmer and the wand connect wirelessly. This training module is developed for the M3000 programmer and M2000 wand.
  • Page 6 Wand USB Cable Magnet The VNS Therapy® System has a patient controlled feature that can be activated with a specially designed magnet. The magnet can be used to: • Attempt to reduce the intensity of or abort an oncoming seizure or seizure in progress •...
  • Page 7 Product Compatibility There are diff erent VNS Therapy® generator models, including the new SenTiva® generator. The VNS Therapy® Programmer, Model 3000, and Wand, Model 2000, allow you to interrogate and program the following VNS Therapy® generators: • Model 102 Pulse™...
  • Page 8 VNS Therapy® Modes The VNS Therapy® System can function in three different modes: NORMAL MODE In Normal Mode, the generator initiates intervals of stimulation at preset ON and OFF times throughout the day. Specific stimulation parameters are set by the healthcare provider.

  • Page 9: Sentiva System Management

    SenTiva System Management GETTING STARTED To get started, collect all the components of the VNS Therapy® System: a) Touch-screen programmer preloaded with VNS Therapy® programmer software b) Wireless wand (Model 2000) with two AA lithium or alkaline batteries c) Programmer charger...
  • Page 10 Turn the Programmer ON/OFF Charge the programmer before use so that there is adequate battery power during a patient session. To turn programmer ON: POWER Press and hold the button for 3 seconds and then release. You will then see an on-screen logo, and the VNS software will start. To turn programmer OFF: POWER Press and hold the...
  • Page 11 • IN SESSION (programmer is communicating with a generator) Quick Access Bar – From any software screen, tap the VNS Therapy® logo on the title bar (black bar at the top of the screen) to access programmer settings and system information.
  • Page 12 Quick Access Bar Patient ID Bar Main Screen (Out of Session) Summary Screen (In Session) Navigation Bar...
  • Page 13 Check the Programmer Battery Before using the programmer with a patient, confi rm that the battery is fully charged. To check the battery: Look at the BATTERY INDICATOR in the top right corner of every screen Battery Indicator...
  • Page 14 Check the Wand Batteries 1. To turn wand ON: Press and release the POWER button • If the battery is OK, green arcs around the power button will light up to indicate that the wand has power - Two green arcs indicate that the wand is available for connection with the programmer - Four green arcs indicate that the wand is connected to the programmer...
  • Page 15 This will ensure that the session is properly time-stamped. 1. Navigate to the Date & Time screen: • OPTION 1: From the Main Screen, tap the VNS Therapy® logo on the title bar (black bar at the top of the screen) SETTINGS •...
  • Page 16 Tap and scroll to change time Use left and right arrows to change month Tap the desired date NOTE: You must adjust the programmer manually for time zones or Daylight Savings Time.
  • Page 17 Connect the Wand to the Programmer The programmer and the wand can be connected wirelessly or with a backup USB cable. WIRELESS CONNECTION To set up wireless connection: 1. Turn on the programmer 2. Turn on the wand. Look for two green lights on the wand, indicating that power is on and the wand is ready to connect SETTINGS 3.
  • Page 18 NOTE: Wireless “Preferred” connection - recommended for wands and programmers that are always used together. Provides a quicker connection when interrogating a patient’s generator because the programmer automatically looks for the preferred wand. “Choose a wand” connection recommended if there are several interchangeable programming systems in your area.
  • Page 19 Interrogate the Generator You must interrogate the generator before performing other functions, such as changing parameters or performing diagnostic tests. To interrogate the generator: 1. Turn on the programmer 2. Turn on the wand. Look for two green lights on the wand, indicating that power is on and the wand is ready to connect 3.
  • Page 20 NOTE: Check box only appears if the programmer does not have a preferred wand. If a preferred wand is selected, the programmer will search and automatically connect to the preferred wand. After a successful interrogation, the Summary Screen will display. From this screen, you can perform the following functions: •...
  • Page 21 Current Programmer date and time Wand connection and Programmer battery status Ends current session Generator and patient information Interrogate generator Last known diagnostics measurements View stimulation events Current parameters Navigation bar to additional software features Shortcut buttons...

  • Page 22: In Office Programming

    IN OFFICE PROGRAMMING The SenTiva® (M1000) VNS Therapy System offers a number of new features that help simplify and customize patient care. The generator’s output current for the programmed stimulation in all modes must be 0 mA for the first 14 days after implantation.

  • Page 23: Manual Programming

    Manual Programming Use Manual Programming to adjust stimulation and/or detection parameters individually. To manually program parameters: 1. From the Summary Screen, tap on the EDIT PARAMETERS button, or tap on PARAMETERS in the Navigation Bar at the bottom of the screen 2.

  • Page 24: Tachycardia Detection/ Prone Position/Low Heart Rate Detection

    Stimulation Tab Detection Tab Tachycardia Detection You may enable or disable Detection. If Detection is Disabled, then the model 1000 generators use only Normal and Magnet stimulation. If Detection is Enabled, then parameters for AutoStim will become available, in addition to Normal and Magnet parameters.
  • Page 25 In order for the generator to accurately detect heartbeats, the heartbeat detection must be set for the individual patient. Manually select from a range of heartbeat detection sensitivity values: 1 (least sensitive; for use with largest amplitude ECG signals) to 5 (most sensitive; for use with smallest amplitude ECG signals).
  • Page 26 Wait for the heart rate display to stabilize (at least 10 seconds) and compare the generator-detected heart rate displayed on the Programmer with an independent source (such as BPM from another ECG monitor or a manual pulse count). Accurate detection should be within ±5 BPM or 10%. If the heart rate reported by the Programmer is too high, then the Heartbeat Detection setting should be adjusted downward (toward setting 1).
  • Page 27 20%. For the least sensitive detection and thus the largest heart rate change for stimulation, choose 70%. NOTE: Additional guidance for how to program this patient-specific setting can be found in the VNS Therapy System Physician’s Manual.
  • Page 28 Prone Position/Low Heart Rate Detection To receive extra patient-specifi c information, you can confi gure the model 1000 generator to log low heart rate episodes and/or the occurrence of prone position when these events occur within 7.5 minutes of an AutoStim or Magnet Mode activation.
  • Page 29 To complete the Prone Position Detection setup: 1. Instruct the patient to sit or stand upright as straight as possible. Place the wand over the generator and press NEXT on the programmer screen 2. Instruct the patient to lie down fl at on their back in the supine position. NEXT Place the wand over the generator and press on the...

  • Page 30: Guided Programming

    Guided Programming Use the Guided Programming feature to In Guided Programming mode, adjust parameters to the next step of a the SenTiva M1000 generator will: standard or custom protocol. This feature • Keep the current mode, simplifi es programming by allowing you protocol, and step in memory to increase or decrease parameters with •...
  • Page 31 To review current therapy protocol steps: OVERVIEW In Guided Mode view, tap on the button on the right side of the screen Overview To change parameters in Guided Programming: 1. Select INCREASE STEP to increase parameters to the next protocol step. APPLY CHANGES to save 2.
  • Page 32 Standard Protocol Steps Standard Protocol Persistent Parameter Settings For information on creating Custom Protocols, see page 37 NOTE: Guided Programming mode is unavailable if Day/Night programming is enabled. In the Standard Therapy Protocol, maximum target for output current for Normal Mode is 1.750mA. Increases above that target must be done manually.

  • Page 33: Scheduled Programming

    Scheduled Programming The generator must already be in Guided Mode before Scheduled Programming can be used. Use Scheduled Programming to automatically change parameter steps according to a preset schedule. Scheduled programming may be useful to patients who live far from their healthcare provider. To enable Guided Programming: 1.
  • Page 34 Scheduled Apply NOTE: If the patient resides in a diff erent time zone or plans to travel, program the schedule based on the patient’s local time zone to ensure therapy changes occur at the intended times. NOTE: Protocols that utilize 0.25mA increases such as the Standard Protocol require a minimum of 14 days between scheduled automatic titration steps.

  • Page 35: Day/Night Programming

    Day/Night Programming Use Day/Night Programming to deliver two independent therapy parameter schedules at diff erent times during a 24-hour period. In Day/Night Programming mode, the SenTiva M1000 will: • Deliver therapy according to two independent sets of parameters • Deliver each therapy protocol at a specifi ed time during a 24-hour period To enable Day/Night Programming: 1.
  • Page 36 Day AutoStim Threshold Night AutoStim Threshold NOTE: After programming, the patient will experience 15 minutes of the alternate parameter set. Assess for tolerability during this time. NOTE: At the end of each offi ce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the...

  • Page 37: Therapy Protocols

    Therapy Protocols You can access, create, and manage therapy protocols from the Main Screen prior to interrogation. This allows you to defi ne the mode, output current, and parameter settings before you begin working with a patient. To access therapy protocols: 1.
  • Page 38 Tap to delete steps...

  • Page 39: Viewing Device Data

    Viewing Device Data Use the History tab to review historical information about the patient’s experience with the device. You can: • View Summary Data • Review Magnet Activation Counts and Timestamps • Review Inhibited Stimulation Timestamps • Run Daily and Hourly Histograms NOTE: At the end of each offi ce visit, the generator must be interrogated by tapping the...

  • Page 40: Export Full Programmer Copy

    View and Export Session Reports REPORTS To view all session reports saved on the Programmer, select the navigation bar from the Main Screen. Use the search fi eld and drop down menus to fi lter the reports by Date and Time, generator model, or Patient ID. Tap any session report to view.
  • Page 41 View Events & Trends Data To view a summary of the therapy that was delivered between offi ce visits: From the Summary Screen, tap on the EVENTS button at the bottom of the screen to access these data. View Last Timestamps Review Magnet Stimulation Counts and Timestamps To view Magnet Stimulation counts and timestamps:...

  • Page 42: Timestamp Data

    Review Inhibited Stimulation Timestamps From the same screen where you can view the Magnet Stimulation timestamp information, you can also view the history of Magnet Inhibitions. At the top are Magnet Stimulation timestamps and below are Magnet Inhibition timestamps. In each case, you can select the “date” header to select the time intervals to view.

  • Page 43: Trend Data

    Review Daily or Hourly Histograms of Trend Data You can view histograms of trend data that may include: • Tachycardia detections (without stimulation) • AutoStim stimulations • Magnet mode stimulations • Prone position (model 1000 only) • Low heart rate (model 1000 only) NOTE: The data download is only required for M1000 if the user wants to view specifi c timestamps.
  • Page 44 NOTE: To view more details, tap on the individual bars in the histogram.

  • Page 45: Functions Of The Magnet

    Device longevity is dependent on stimulation parameters, impedance, duration of implant, and battery voltage. Higher stimulation parameters as well as higher duty cycles affect the longevity of the device, making the projection shorter. Additional information can be found in the VNS Therapy Physician’s Manual.

  • Page 46: Device Diagnostics

    DEVICE DIAGNOSTICS Several Diagnostics tests are available in the programming software to assess functionality of the implanted system. You may access them after a completed interrogation by selecting DIAGNOSTICS, or PERFORM DIAGNOSTICS on the Summary Screen. Depending on the model of generator interrogated, you may have access to different types of tests.
  • Page 47 Diagnostic/Parameter Result Summary Lead Impedance Description: Indicates measured or estimated impedance when delivering the output current during testing and whether it’s within normal range. Values/Results: Measured lead impedance value (ohms) and overall status of OK, LOW, or HIGH What Does the Value or Result Mean?: Impedance is within acceptable operating range.
  • Page 48 CAUTION: Battery depletion can occur between office visits. Therefore, LivaNova recommends that epilepsy patients with magnet activation enabled should perform a daily magnet activation to check stimulation. If stimulation is not felt, instruct the patient to consult with the physician to perform diagnostics testing.
  • Page 49 AutoStim Diagnostics The AutoStim Diagnostics test determines if the generator is able to deliver the programmed AutoStim output current. The desired AutoStim output current should be programmed before you perform the diagnostic test. Generator Diagnostics The Generator Diagnostics test is designed specifically for use with a test resistor and should only be accessed for troubleshooting scenarios during implantation surgery.

  • Page 50: In The Operating Room

    10. Perform System Diagnostic #1 17. Close incisions Perform Preoperative System Checks BEFORE the surgery, prepare the VNS Therapy® System: 1. Charge the programmer 2. Turn the programmer ON 3. Check the programmer battery: Check the battery status on the battery indicator at the top right corner of the programmer screen 4.

  • Page 51: Programming & Diagnostics

    Program Patient ID and Implant Date Enter or edit the patient data in the programmer during the preoperative preparation, immediately before surgery. In the Operating Room you will be prompted to enter the ID upon initial interrogation with the generator. To enter or edit patient data: 1.
  • Page 52 Perform System Diagnostic #1 System Diagnostic #1 tests the continuity of the lead and confi rms delivery of the programmed output current to the vagus nerve. To perform System Diagnostic #1: 1. From the Summary Screen, tap on the PERFORM DIAGNOSTICS button, DIAGNOSTICS OR tap on the...
  • Page 53 Edit Parameters Enable Now Detection Tab Verify Tachycardia Detection Setting To verify the Tachycardia Detection setting: 1. From the Summary Screen, tap on the EDIT PARAMETERS button, OR tap on the PARAMETERS button in the Navigation Bar at the bottom of the screen 2.
  • Page 55 Select AutoStim Threshold The AutoStim Threshold is the percent heart rate increase over baseline that is required to trigger automatic stimulation (AutoStim). Values range from 20% (most sensitive) to 70% (least sensitive) and should refl ect the magnitude of heart rate increase associated with the patient’s seizure. To select the AutoStim Threshold: 1.
  • Page 56 Perform System Diagnostic #2 and Final Interrogation Before closing, perform Diagnostic Test #2 to confi rm that the system is working properly and delivering the programmed output current. To perform System Diagnostic #2 and Final Interrogation: 1. From the Summary Screen, tap on the PERFORM DIAGNOSTICS button, DIAGNOSTICS...

  • Page 57: General Dosing Guidelines

    General Dosing Guidelines SENTIVA DOSING GUIDELINES Phase 1: Output Current Increase Output Current to therapeutic effect as tolerated by the patient NORMAL MODE: 0.25 mA steps to therapeutic e ect AUTOSTIM MODE Normal Mode + 0.125 mA AutoStim should be comfortable for patients MAGNET MODE: Normal Mode + 0.25 mA Magnet Mode should be >...
  • Page 58 Phase 2: Duty Cycle Increase duty cycle over time and assess clinical outcome  Adjustments to duty cycle should be less frequent (3 - 6 months)  OFF TIME (minutes) 0.2 0.3 0.5 0.8 Recommended Not recommended Recommended progression for duty cycle Not available with AutoStim Enabled LivaNova recommends that stimulation with Normal Mode ON time >...

  • Page 59: Additional Information

    Additional Information Please see important safety information or visit www.VNSTherapy.com. The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.

  • Page 60: Sentiva Mri Guidelines

    SenTiva MRI Guidelines Scan Conditions - SenTiva® Model 1000 No special MRI equipment/coils required GROUP A Permissable Scan Area Generator in upper left chest, at or above MRI Exclusion Zone armpit (above rib 4)† Note: The scan iso-center must be outside the exclusion zone †...
  • Page 61 Additional Restrictions Transmit head or extremity coil: none Transmit body coil: Circularized Polarized mode only For full MRI safety information, the VNS Therapy System Physician’s Manual can be found at www.easy-mri.com For technical product questions, contact LivaNova Technical Services at 1-866-882-8804...
  • Page 62 Scan Conditions - SenTiva® Model 1000 implanted lower than rib 4 (below armpit level) Requires local transmit-receive coil Availability may vary GROUP B MRI Exclusion Zone Permissable scans include head, knee, ankle, and wrist Imaging techniques such as computed tomography, x-ray, and ultrasound are safe to perform in the MRI exclusion zone.
  • Page 63 Optional device features OFF (Model 1000 only) Exposure Time Transmit head or extremity coil: No restrictions Additional Restrictions None For full MRI safety information, the VNS Therapy System Physician’s Manual can be found at www.easy-mri.com For technical product questions, contact LivaNova Technical Services at 1-866-882-8804...
  • Page 64 Special Cases Suspected Lead Break Suspected Lead Break Lead only ≤ 2 cm remaining* ≤ 2 cm Lead only Lead only >2 cm remaining >2 cm remaining Exclusion Zone C7-T8 None C7-T8 None C7-T8 usion Zone MR Conditional Conditional Static Magnet 1.5T or 3T 1.5T or 3T 1.5T or 3T...
  • Page 65 4. Turn off any other optional device features (Model 1000 only) 5. Interrogate the generator* to verify that programming was successful 6. Verify that placement of the VNS Therapy system is located between the C7 and T8 vertebrae 7. Instruct the patient to notify the MR system operator of pain, discomfort,...

  • Page 66: Troubleshooting

    Troubleshooting This section provides steps to resolve error conditions with the programming system components or with the implanted generator and lead. For other programming system issues not addressed in this section, please contact LivaNova. Contact Us General Inqiuries (for questions about LivaNova, LivaNova products, warranties, etc.

  • Page 67: Wand Connection Or Communication Issues

    Wand Connection or Communication Issues WAND NOT CONNECTING TO PROGRAMMER (WIRELESS) Potential reasons for no wireless connection between the Wand and the Programmer include the following: • Wand not powered on • Depleted Wand batteries • Electromagnetic interference (EMI), such as OR lights •...
  • Page 68 ANOMALOUS BEHAVIOR OR NON-RESPONSIVE SYSTEM Issue: Non-responsive Programmer or Wand Solution Steps for Programmer: Charge programmer – Plug programmer into A/C outlet Shut down – Press and hold the power button for 5 seconds, and then release. Follow on-screen instructions to shut down If programmer is still non-responsive, press and hold power button to force a shut down (approximately 10 seconds) Reboot –...
  • Page 69 WAND NOT CONNECTING TO PROGRAMMER (BACKUP CABLE) Potential reasons for no connection between the Wand and the Programmer via backup cable include the following: • Improper cable connection between Wand and Programmer • Depleted Wand batteries • Improper USB port recognition of the Programmer cable •...
  • Page 70 WAND NOT COMMUNICATING WITH GENERATOR Potential causes for communication issues between the Wand and generator include the following: • Depleted Wand batteries • Moving Wand away from generator during communication • Electromagnetic interference (EMI), such as OR lights • Generator battery at End of Service (EOS) •...

  • Page 71: Patient Cannot Feel Stimulation

    - Generator battery at end of service (EOS) - “High” lead impedance, defective, or disabled generator - Short-circuit condition within the lead • For more detailed information, consult the Troubleshooting section of the VNS Therapy® System Physician’s Manual Patient Report “Cannot feel stimulation” Interrogate the generator “Disabled Message?”...

  • Page 72: Patient Cannot Feel Magnet Stimulation

    Patient Cannot Feel Magnet Stimulation • Possible causes: - Patient has become accustomed to the programmed setting - Incorrect technique for swiping magnet - Magnet output current is programmed to 0 mA - Generator battery at end of service (EOS) - Device implanted too deep in the chest - Defective generator or disabled generator - “High”...

  • Page 73: Patient Does Not Perceive Autostim Activation

    Patient Does Not Perceive AutoStim Activation • Possible causes: - AutoStim Threshold is too high (e.g., 70% threshold versus 50%) - Patient has become accustomed to the programmed setting - AutoStim output current is programmed to 0 mA - Generator battery at end of service (EOS) - Defective generator or lead - Disabled generator Patient Report...

  • Page 74: High/Low Lead Impedance And Low Output Current Issues

    High/Low Lead Impedance and Low Output Current Issues HIGH LEAD IMPEDANCE IN THE OR If a System Diagnostics test results in high lead impedance, the following are possible causes: • Improper connection between the lead and the generator • Incorrect placement of lead on the nerve (initial implant only) •...
  • Page 75 LOW LEAD IMPEDANCE IN THE OR If a System Diagnostics test results in low lead impedance, the following are possible causes: • Incorrect placement of the lead on the nerve • Excessive irrigation of the nerve • Defective generator or lead •...
  • Page 76 HIGH/LOW LEAD IMPEDANCE OR LOW OUTPUT CURRENT AT FOLLOW-UP VISIT Possible causes for high or low lead impedance or low output current at follow-up visits for the model 1000 generator include the following: • Lead discontinuity • Lead disconnected from generator •...

  • Page 77: Generator Battery Issues

    Generator Battery Issues LOW BATTERY/END OF SERVICE INDICATIONS IN OR If a generator displays a low battery or End of Service (EOS) indicator while implanting, the possible causes include the following: Prior to Surgery: During Surgery: • Generator has been recently •...
  • Page 78 NEW GENERATOR DISABLED DUE TO EOS AT FIRST OFFICE VISIT Generator model 1000 battery can temporarily drain and become disabled if exposed to certain conditions. These conditions include the following: • Electrosurgical equipment used near the generator • Generator exposed to electrostatic discharge (ESD) Enable Stimulation and Check System Error Message •...

  • Page 79: Heartbeat Detection Issues

    Heartbeat Detection Issues HEARTBEAT DETECTION INACCURATE (OVER/UNDER) IN OR OR AT FOLLOW-UP VISIT The heartbeat detection setting may need to be adjusted to accurately detect heartbeats. NOTE: The Wand must be held over the generator during the entire Verify Heartbeat Detection process. Heartbeat Detection is inaccurate BPM is too high, low, or reports “??”...

  • Page 80: Tachycardia Detection Issues

    Tachycardia Detection Issues INACCURATE AUTOSTIMS AT FOLLOW-UP VISIT Sometimes generator detection settings may miss detecting heart rate changes that may be associated with a seizure. The following conditions may be potential causes: Duty cycle Heart rate changes Because the generator can only Exercise, physical activity, and normal detect events during OFF time, the sleep can increase the heart rate and...
  • Page 81 100 Cyberonics Boulevard Ikaroslaan 83 wholly-owned subsidiary of Houston, Texas 77058 1930 Zaventem LivaNova PLC. All rights reserved. Tel: +1.800.332.1375 Belgium LivaNova®, SenTiva®, AspireSR® Fax: +1.281.218.9332 Tel: +32.2.720.95.93 and VNS Therapy® are registered www.VNSTherapy.com Fax: +32.2.720.60.53 trademarks of LivaNova USA, Inc. SenTecGd19U1...

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