1. Manuals
  2. Brands
  3. LivaNova Manuals
  4. Handhelds
  5. VNS Therapy 250
  6. Physician's manual

LivaNova VNS Therapy 250 Physician's Manual

Programming software, for healthcare professionals
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Physician's Manual
VNS Therapy
Programming Software
Model 250 Version 8.1
Handheld Computer
For Healthcare Professionals
June 2017
Worldwide Version
Caution: U.S. federal law restricts this device to
sale by or on the order of a physician.
Note: This manual contains information on the use of the LivaNova
Software, Model 250 Version 8.1. Physicians should refer to the VNS Therapy Pulse Generator
physician's manuals for additional important prescribing and safety information. A copy of this VNS
Therapy manual is posted at www.livanova.com.
®
2011
VNS Therapy Programming
26-0008-1100/5 (Worldwide) — 1 of 92
0344

Advertisement

Table of Contents
loading

Summary of Contents for LivaNova VNS Therapy 250

  • Page 1 0344 2011  Note: This manual contains information on the use of the LivaNova VNS Therapy Programming Software, Model 250 Version 8.1. Physicians should refer to the VNS Therapy Pulse Generator physician’s manuals for additional important prescribing and safety information. A copy of this VNS Therapy manual is posted at www.livanova.com.
  • Page 2 LivaNova is a registered United States trademark of LivaNova, PLC. NCP, Demipulse, Demipulse Duo, Perennia, VNS Therapy, AspireHC, PerenniaFLEX, PerenniaDURA and AspireSR are registered trademarks of LivaNova USA, Inc. Pulse and Pulse Duo are trademarks of LivaNova USA, Inc. Corresponding foreign trademarks may also be registered or pending.

  • Page 3: Table Of Contents

    Physician’s Manual — VNS Therapy Programming Software (8.1) Table of Contents ........9 RIEF EVICE ESCRIPTION...
  • Page 4 Physician’s Manual — VNS Therapy Programming Software (8.1) ........53 ARAMETERS .
  • Page 5 Physician’s Manual — VNS Therapy Programming Software (8.1) 10.4.5. Sudden decrease in estimated device longevity (% battery power remaining) ....... . . 86 11.
  • Page 6 Physician’s Manual — VNS Therapy Programming Software (8.1) List of Figures MAIN M ........12 IGURE START INTERROGATION S .
  • Page 7 Physician’s Manual — VNS Therapy Programming Software (8.1) VIEW MAGNET HISTORY S ....52 IGURE CREEN VIEW LAST PARAMETERS S ....53 IGURE CREEN USER PREFERENCES S...
  • Page 8 Physician’s Manual — VNS Therapy Programming Software (8.1) 8 of 92 — 26-0008-1100/5 (Worldwide)

  • Page 9: Brief Device Description

    ® ® The LivaNova VNS Therapy Programming Software, Model 250 Version 8.1, enables you to interrogate and program LivaNova’ Pulse Generator using the Programming Wand. Software capabilities include: Use of the software with the Programming Wand to interrogate and ...

  • Page 10: Intended Use

    The Model 250 VNS Therapy Programming Software is intended for use Caution: LivaNova recommends that the only with the LivaNova Pulse Generators and Programming Wand and is software be loaded on a subject to the same indications for use. dedicated computer used only to program 1.4.

  • Page 11: Communication Signals

    Physician’s Manual — VNS Therapy Programming Software (8.1) To select a button or field, tap it with the stylus.  Some information can be entered with a “soft” or “on-screen”  keyboard (an example of the soft keyboard is shown at the bottom of Figure 27 on page 44).

  • Page 12: How To Get Started

    TARTED The VNS Therapy Programming Software Model 250 Version 8.1 has Caution: When in use, LivaNova recommends been pre-installed on the handheld computer. Before proceeding to the the handheld computer next section, be sure you have arrived at the MAIN Menu as shown in to be operated on Figure 1.

  • Page 13: How To Use The Software

    SE THE OFTWARE It is LivaNova’s intent to make the software as intuitive and “user friendly” as possible. Messages and prompts will guide you through this software. There are four menus in this software. The first is the MAIN Menu.

  • Page 14: Interrogate

    Physician’s Manual — VNS Therapy Programming Software (8.1) 4. I ________________ NTERROGATE EVICE To retrieve information from the Pulse Generator or to program the Pulse Generator, you must first select the Interrogate Device button from the MAIN Menu. The START INTERROGATION Screen will be displayed (see Figure 2).

  • Page 15: Figure 3 Parameter Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) 3. The New button, when tapped, displays the range of possible settings for that parameter Figure 3. PARAMETER Screen Models 100, 101, 102 Models 103, 104, 105 ↑ Inactivity Timeout Indicator (Progress Bar) Note: The inactivity For the Models 100, 101, 102 Pulse Generators, the progress bar across the timeout function is not...

  • Page 16: Figure 4 Timeout Warning Screen

    “User Preferences Screen ” on page 54. Note that the timeout bar has advanced to the right margin. Caution: LivaNova recommends that you reinterrogate the Pulse In addition to the eight programmable parameters, the PARAMETER Generator after each screen will also indicate battery status for the Pulse Generator.

  • Page 17: Figure 5 Parameter Screen With Active Battery Status

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 5. PARAMETER Screen with ACTIVE BATTERY STATUS INDICATOR Models 103, 104, 105 Upon completion of an interrogation or Diagnostics testing, the Programming Software will display the associated warning message should the Pulse Generator battery reach Near EOS for Models 100, 101, and 102 (see Figure 6 on page 17) and IFI, N EOS, or EOS for Models 103, 104, and 105 (see Figure 7, Figure 8, and Figure 9 on pages 18 and 19).

  • Page 18: Figure 7 Battery Status Indicator - Ifi Warning Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 7. BATTERY STATUS INDICATOR - IFI WARNING Screen Models 103, 104, 105 Figure 8. BATTERY STATUS INDICATOR - N EOS WARNING Screen Models 103, 104, 105 18 of 92 — 26-0008-1100/5 (Worldwide)

  • Page 19: Figure 9 Pulse Disabled And Battery Status Indicator - Eos Warning Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 9. PULSE DISABLED and BATTERY STATUS INDICATOR - EOS WARNING Screen Models 103, 104, 105 Table 1 shows the various indications of Pulse Generator battery level and the associated recommendations. Table 1. Pulse Generator Battery Level Indications and Recommendations Pulse...
  • Page 20 Physician’s Manual — VNS Therapy Programming Software (8.1) Pulse Estimated % Battery Pulse Generator Battery Status / Generator Battery Power Icon Recommendations Model # Remaining Displayed 103/104/105 >75% to 100% IFI = No The Intensified Follow-up Indicator (IFI) has 103/104/105 >50% to 75% not been set.

  • Page 21: How To Program New Parameter Settings

    Physician’s Manual — VNS Therapy Programming Software (8.1) 4.1. How to Program New Parameter Settings The PARAMETER Screen shown in Figure 3 on page 15 is used to change the Pulse Generator’s parameter settings. Table 2 shows the range of possible settings for all parameters.

  • Page 22: Figure 10 Parameter Settings Pop-Up Menu

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 10. PARAMETER SETTINGS POP-UP Menu Note: LivaNova recommends that during the initial programming, the output current be programmed at 0 mA and then slowly increased by 0.25 mA increments until the...

  • Page 23: Partial Programming Due To Interrupted Programming

    ON time ≥ OFF time has resulted in degenerative nerve damage in laboratory animals. ON time ≥ OFF time can be simulated by very frequent magnet activation. LivaNova recommends that stimulation at these combinations of ranges be avoided. 4.1.1.

  • Page 24: Figure 13 Programming Failed Warning Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) warning message indicating that the procedure failed and device settings were altered due to the interrupted programming attempt (see Figure 13 on page 24). The warning message also indicates some troubleshooting options and allows the user to retry or cancel the programming operation. If the user selects Retry, the Programming Software will re-program the Pulse Generator.

  • Page 25: Figure 14 Changed Settings Programming Warning Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 14. CHANGED SETTINGS PROGRAMMING WARNING Screen Models 100, 101, 102 For Models 103, 104, and 105 Generators, the device parameters are programmed and verified as a group during a programming event; therefore, these Pulse Generators are not susceptible to partial programming.

  • Page 26: Cross-Programming (Applicable To Model 100, 101, And 102 Pulse Generators Only)

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 15. PROGRAMMING FAILED WARNING Screen Models 103, 104, 105 4.1.2. Cross-programming (applicable to Model 100, 101, and 102 Pulse Generators ONLY) Models 100, 101, and 102 Pulse Generators are susceptible to an event known as cross-programming, where parameter settings from one patient's Pulse Generator are inadvertently programmed to another patient's Pulse Generator.

  • Page 27: Parameter Screen Menu

    *Unintentionally altered or incorrectly displayed values. Due to the susceptibility of Model 100, 101, and 102 Pulse Generators to cross-programming, LivaNova recommends that an initial and a final interrogation be performed at each office visit for all VNS patients in order to verify parameter settings.

  • Page 28: Interrogate Device

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 16. PARAMETER Screen Menu The functions available via this menu are explained in the following paragraphs. 4.2.1. Interrogate Device Interrogation of the Pulse Generator is required to reach the menu shown in Figure 16.

  • Page 29: Figure 17 Device Diagnostics Menu

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 17. DEVICE DIAGNOSTICS Menu Use this screen to select function assessments to be performed on the Pulse Generator. The System Diagnostics, as well as the DC-DC Converter Code, can be used at patient follow-up visits to assess lead impedance status for Models 100, 101, and 102.

  • Page 30: Figure 18. Device Diagnostics Sub-Menu

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 18. DEVICE DIAGNOSTICS Sub-menu In the event that the System Diagnostics fails, the Generator Diagnostics (Pulse Generator Test), which uses the resistor assembly connected at implantation, verifies proper Pulse Generator operation. When you select any of the four diagnostics tests from the DEVICE DIAGNOSTICS Sub-menu, additional instructions will be provided on the handheld screen.

  • Page 31: Interrupted System And Generator Diagnostics

    500 μsec, and a frequency of 20 Hz. If the output current is programmed greater than 0.0 mA, the diagnostic test is run at the programmed settings. Caution: LivaNova recommends interrogating the Pulse Generator after any diagnostics in order to verify parameter settings. Caution: If an error message occurs and the Communication parameter reads “FAULT”, return to the MAIN Menu and select...

  • Page 32: Figure 19 Diagnostic - Single Failure Warning Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 19. DIAGNOSTIC - SINGLE FAILURE WARNING Screen Models 100, 101, 102 Figure 20. DIAGNOSTIC - MULTIPLE FAILURE WARNING Screen Models 100, 101, 102 32 of 92 — 26-0008-1100/5 (Worldwide)

  • Page 33: Figure 21 Changed Settings - Interrupted Diagnostic Warning Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 21. CHANGED SETTINGS - INTERRUPTED DIAGNOSTIC WARNING Screen Models 100, 101, 102 Figure 22. PARAMETER Screen with UNKNOWN SETTINGS Models 100, 101, 102 26-0008-1100/5 (Worldwide) — 33 of 92...

  • Page 34: Diagnostic Test Parameters

    3. Serial Number: This parameter is a numeric code assigned to the Pulse Generator and programmed into the Pulse Generator by LivaNova. 4. Implanted: This parameter represents the implant date as programmed by the physician. 5. Communication: This parameter is an indicator of the communication status during diagnostics.
  • Page 35 Physician’s Manual — VNS Therapy Programming Software (8.1) 6. Output Status: For the Models 100, 101, and 102 Pulse Generators, this parameter indicates whether the program current is being delivered at the specified value. Table 5 shows the possible values and interpretation for this parameter.
  • Page 36 Physician’s Manual — VNS Therapy Programming Software (8.1) Table 6. Device Diagnostic Screen Status Readings for Output Current for Models 100, 101, and 102 Output Current Significance Status Reading OUTPUT CURRENT Setting Shows the current at which the diagnostic test was run. For System Diagnostics and Generator Diagnostics (Pulse Generator Test), the software automatically programs the Pulse Generator to 1.0 mA.
  • Page 37 Physician’s Manual — VNS Therapy Programming Software (8.1) Impedance to assess how hard the device has to work to deliver a selected output current, or how much the flow of current is impeded (see Table 8, and Table 9). This parameter is not displayed for Models 103, 104, and 105.
  • Page 38 Pulse Generators. The Programming Software displays a warning message if it detects a near End of Service indicator of "Yes" (see Figure 6 on page 17). When this message is displayed, LivaNova recommends performing a System Diagnostics Test to verify the Near EOS status for the Models 100, 101, 102 Pulse Generators.

  • Page 39: System Diagnostics

    Lead. For a failed Generator Diagnostics, see “Troubleshooting ” on page 61. If either component is defective or damaged, contact LivaNova and return the item (following the disinfection procedure described in the physician’s manual for the VNS Therapy Pulse Generators) with a completed Returned Product Form.

  • Page 40: Normal Mode Diagnostics

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 23. SYSTEM DIAGNOSTICS Screen Models 100, 101, 102 Models 103, 104, 105 Caution: For Models 100, 101, and 102 Pulse Generators, avoid performing the System Diagnostics on Pulse Generators for which the output current is normally less than 1 mA because the patient may experience increased sensation, coughing, a flushed face, or other adverse effects.

  • Page 41: Magnet Mode Diagnostics

    Physician’s Manual — VNS Therapy Programming Software (8.1) output current is not being delivered. Possible reasons for failure to deliver the programmed output current include high lead impedance and low battery voltage. For Models 103, 104, and 105 Pulse Generators, performing a Normal Mode Diagnostics is the same as performing System Diagnostics.

  • Page 42: Generator Diagnostics

    Physician’s Manual — VNS Therapy Programming Software (8.1) Standby" will be displayed at the top of the screen for the Models 100, 101, and 102 Pulse Generators. Figure 25. MAGNET MODE DIAGNOSTICS Screen Models 100, 101, 102 Models 103, 104, 105 To obtain accurate information on Models 100, 101, and 102 Pulse Generators from the device diagnostics, program the Pulse Generator to values shown in Table 11 for both normal and magnet modes.

  • Page 43: Figure 26 Generator Diagnostics Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 26. GENERATOR DIAGNOSTICS Screen Models 100, 101, 102 Models 103, 104, 105 For the Models 100, 101, 102 Pulse Generators, if the Generator Diagnostics (Pulse Generator Test) is successfully completed, the output current will automatically be programmed to 0 mA.

  • Page 44: Program Patient Data Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) Caution: For Models 103, 104, and 105 Pulse Generators, during the Generator Diagnostics on a device with the output current set to 0.0 mA the Programming Software will deliver only a 0.25 mA pulse to assess the impedance value.

  • Page 45: Display Device History Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) day for that month and year, the calendar closes and the selected month/ day/year is entered into the field. You can also enter the date by tapping on the digits representing the month/day/year and entering the new values on the soft keyboard.

  • Page 46: View Database Screen

    MAIN Menu. 4.2.8. Handheld computer battery status Caution: When in use, LivaNova recommends the handheld computer The bars at the bottom of the PARAMETER Screen menu and the USER be operated on battery PREFERENCES screen indicate the battery status on the handheld power only (unplugged computer.

  • Page 47: View Database

    Physician’s Manual — VNS Therapy Programming Software (8.1) 5. V ____________________ ATABASE Each successful interrogation and programming event is recorded in the database of the handheld computer. Likewise, every time a magnet is successfully used to initiate activation of a Pulse Generator, the event is recorded in the database of the Pulse Generator.

  • Page 48: Sort By Date, Patient Id, Or Serial Number

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 29. VIEW DATABASE Screen The message at the top of the screen indicates that only 25 records can be retrieved at a time. (That value can be changed to 50, 75, or 100 by selecting the User Preferences button from the MAIN Menu.) 5.1.1.

  • Page 49: Earliest Date/Latest Date

    Physician’s Manual — VNS Therapy Programming Software (8.1) 5.1.3. Earliest Date/Latest Date Make sure the View All Records button is unchecked or you won’t be able to use the date option. When you use the date option, the default for both the Earliest Date and Latest Date buttons is the current date.

  • Page 50: View Diagnostic History

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 30. VIEW PARAMETER HISTORY Screen Models 100, 101, 102 Models 103, 104, 105 This screen is a scrollable screen that shows the parameter settings for each successful interrogation, programming event, and/or partial programming event.

  • Page 51: View Magnet History

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 31. VIEW DIAGNOSTIC HISTORY Screen Models 100, 101, 102 Models 103, 104, 105 Note: The four The VIEW DIAGNOSTIC HISTORY Screen is a scrollable screen that diagnostic tests are shows the Device Diagnostics that have been performed. By indicating Normal Mode, Magnet your preference from the drop-down menu at the top of the screen, you can Mode, Generator...

  • Page 52: Figure 32 View Magnet History S

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 32. VIEW MAGNET HISTORY Screen The VIEW MAGNET HISTORY Screen is a scrollable screen that shows a history of Magnet Activations of the Pulse Generator. You can sort these events by Date, Patient ID, or the Pulse Generator Serial Number by indicating your preference from the drop-down menu at the top of the screen.

  • Page 53: View Last Parameters

    Physician’s Manual — VNS Therapy Programming Software (8.1) 6. V _____________ ARAMETERS You can view the parameter settings from the most recent Pulse Generator interrogation via the VIEW LAST PARAMETERS Screen (see Figure 33 on page 53). This screen can be accessed from the MAIN MENU screen. Figure 33.

  • Page 54: User Preferences Screen

    Physician’s Manual — VNS Therapy Programming Software (8.1) 7. U __________ REFERENCES CREEN Eight functions can be accessed from the USER PREFERENCES Screen (see Figure 34). This screen can be accessed via the MAIN MENU screen. Figure 34. USER PREFERENCES Screen 7.1.

  • Page 55: Set Maximum Number Of Records To View

    Physician’s Manual — VNS Therapy Programming Software (8.1) 7.2. Set Maximum Number of Records to View By tapping the drop-down menu to the right of Set the maximum number of database records to retrieve, the number of records available to view can be limited to 25, 50, 75, or 100.

  • Page 56: Backup To Flashcard

    Restore from FlashCard Caution: The Restore from FlashCard function, also accessible This feature is not recommended by LivaNova in typical use conditions from Database utilities, because database restoration occurs automatically. You could use this overwrites the database on the handheld...

  • Page 57: Handheld Computer Battery Status

    Handheld Computer Battery Status Caution: When in use, The bar at the bottom of the screen indicates the percentage of the battery LivaNova recommends charge still available on the handheld computer. When the handheld the handheld computer computer is operating on battery power the bar should be checked be operated on battery regularly to prevent a loss of power.

  • Page 58: Maintenance , Handling , And Storage

    Physician’s Manual — VNS Therapy Programming Software (8.1) 8. M AINTENANCE ANDLING TORAGE The FlashCard should be handled and stored in the standard manner for Caution: The FlashCard should never computer disks. Although no component of the VNS Therapy System will be stored near a magnet withstand rough handling or abuse, no unusual handling precautions are and should always be...

  • Page 59: Precautions

    (unplugged from AC power). When not in use, the handheld computer should be plugged into AC power to maintain charge. LivaNova recommends that no other software be loaded onto the VNS  Therapy System computer because it may interfere with proper functioning of the software already installed on the handheld computer.

  • Page 60: Figure 36 Correct Flash Card

    FlashCards are generally not interchangeable! Do not insert the  FlashCard from one handheld computer into any other handheld computer, unless directed to do so by LivaNova Clinical Technical Support. FlashCards should only be inserted in the handheld computer with the ...

  • Page 61: Troubleshooting

    Physician’s Manual — VNS Therapy Programming Software (8.1) 10. T __________________ ROUBLESHOOTING This section provides troubleshooting instructions in four parts: (1) general recommendations, (2) hardware issues, (3) problems in the Operating Room (OR) and (4) problems at patient follow-up visits. 10.1.

  • Page 62: Hardware Issues

    A/C outlet prior to resuming use with the programming system. If you are still not able to restore the database or reinstall the application software, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide). 10.2.

  • Page 63: 10.2.2.2. Screen Alignment For The Dell Axim X50 Handheld

    Physician’s Manual — VNS Therapy Programming Software (8.1) 6. Verify that the handheld computer has adequate charge and unplug the handheld computer from the A/C outlet prior to resuming use with the programming system. Figure 37. Dell Axim X5 Handheld Computer 10.2.2.2.

  • Page 64: Other Hardware Issues

    Figure 38. Dell Axim X50 Handheld Computer 10.2.3. Other hardware issues For all other hardware issues for the handheld computer, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide). 10.3. Troubleshooting in the OR 10.3.1.
  • Page 65 Physician’s Manual — VNS Therapy Programming Software (8.1) Electromagnetic interference (EMI) i.e., OR lights, Programming  Computer Pulse Generator battery at end of service (EOS)  Defective Programming Wand  Defective Programming Computer  Defective Pulse Generator  Communication problems are often intermittent and are rarely related to the Pulse Generator.
  • Page 66 Programming Wand, or source of EMI. 7. Retry interrogation, diagnostic test, or programming. Note: LivaNova recommends 8. If problems persist, contact LivaNova at 1 (866) 882-8804 (U.S. and interrogating the Pulse Canada) or +1 (281) 228-7330 (Worldwide). Generator as the last...

  • Page 67: Figure 39 Communicationp

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 39. Communication Problems in the OR and at Follow-up Visits Error Message: “There is an error establishing communication with the device” or “Failed to retrieve diagnostic data.” Test Wand Battery — Press and release both RESET buttons. Note how long the green light stays on. <25 sec >25 sec How long does green light stay on?

  • Page 68: High Lead Impedance On System Diagnostics In Or - Initial Implant

    Tighten the setscrew(s) until the hex screwdriver clicks. d. Perform the Generator Diagnostics. 6. If the Generator Diagnostics indicates “HIGH” Lead impedance, call LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228- 7330 (Worldwide). 68 of 92 — 26-0008-1100/5 (Worldwide)

  • Page 69: High Lead Impedance On System Diagnostics In Or - Pulse Generator Replacement

    Tighten the setscrew(s) until the hex screwdriver clicks. d. Perform the System Diagnostics. 8. If the System Diagnostics continues to indicate “HIGH” Lead impedance, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide). 10.3.3.
  • Page 70 Tighten the setscrew(s) until the hex screwdriver clicks. d. Perform the Generator Diagnostics.  If the Generator Diagnostics indicates “HIGH” Lead impedance, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide).  If the Generator Diagnostics indicates “OK” Lead impedance, perform these steps: 1) Back out the setscrew(s) and remove the test resistor.

  • Page 71: Figure 40 High Lead Impedance On

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 40. High Lead Impedance on System Diagnostic Test in OR - Initial Implant or Generator Replacement Error message encountered: “A HIGH Lead impedance has been detected...” Lead Impedance “HIGH” Back out setscrew(s), remove Lead pin(s), and leave the hex screwdriver engaged in setscrew(s). Verify that the setscrew(s) is not visible in the Lead receptacle(s).

  • Page 72: Low Lead Impedance On System Diagnostics In Or - Initial Implant

    Tighten the setscrew(s) until the hex screwdriver clicks. d. Perform the Generator Diagnostics.  If the Generator Diagnostics indicates “LOW” Lead impedance, call LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide).  If the Generator Diagnostics indicates “OK” Lead impedance, perform these steps: 1) Back out the setscrew(s) and remove the test resistor.

  • Page 73: Figure 41 Low Lead Impedance On

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 41. Low Lead Impedance on System Diagnostics in OR - Initial Implant Error message encountered: “A LOW Lead impedance has been detected...” Lead Impedance “LOW” Verify that the Lead electrodes have been correctly placed on the nerve. If the nerve site is saturated, remove pooled fluid.

  • Page 74: Low Lead Impedance On System Diagnostics In Or - Pulse Generator Replacement

    3. Tighten the setscrew(s) until the hex screwdriver clicks. 4. Perform the Generator Diagnostics. If the Generator Diagnostics indicates “LOW” or “OK” Lead  impedance, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide). Figure 42. Low Lead Impedance on System Diagnostics in...

  • Page 75: Low Battery/End Of Service Indications Prior To Surgery, Outside Of The Sterile Field - Initial Implant Or Pulse Generator Replacement

    YES, or any other battery level warning message appears, wait 30 minutes and retry the diagnostic. 4. If the problem persists, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide). 26-0008-1100/5 (Worldwide) — 75 of 92...

  • Page 76: Figure 43 Low Battery /End Of

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 43. Low Battery/End of Service Indications Prior to Surgery, Outside of the Sterile Field - Initial Implant or Pulse Generator Replacement Battery Status Indicator or Message encountered: IFI, N EOS, or EOS = Yes. Warning message - "The Intensified Follow-up Indicator (IFI) has been set for the Pulse Generator.

  • Page 77: Low Battery/End Of Service Indications During Surgery, Inside The Sterile Field - Initial Implant Or Pulse Generator Replacement

    If the System Diagnostics test returns a battery level indicator other than IFI = No or any other battery level warning message appears when the device is programmed to “0 mA”, contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide).

  • Page 78: Troubleshooting At Follow-Up Visits

    Physician’s Manual — VNS Therapy Programming Software (8.1) 10.4. Troubleshooting at Follow-up Visits 10.4.1. Communication problems at follow-up visits A communication problem can cause the following error messages: “There is an error establishing communication with the device”  “Failed to retrieve diagnostic data” ...

  • Page 79: High Lead Impedance On A Diagnostic Test At Follow-Up Visit For Models 100, 101, And 102 Pulse Generators

    Programming Wand, or the source of EMI. Note: LivaNova c. Retry interrogation, diagnostic testing, or programming. recommends d. If problems persist, contact LivaNova at 1 (866) 882-8804 (U.S. interrogating the Pulse and Canada) or +1 (281) 228-7330 (Worldwide). Generator as the last step of any 10.4.2.
  • Page 80 Physician’s Manual — VNS Therapy Programming Software (8.1) To alleviate the condition, perform these steps (see Figure 44 on page 82): 1. Interrogate the device. 2. Perform a System Diagnostics and record the results. For the System Diagnostics, the Software automatically programs ...
  • Page 81 Near End of Service reads “YES”, then End of service is pending. Replace the Pulse Generator as soon as possible. 4. Contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide) to report any incidents of high Lead impedance.

  • Page 82: Figure 45 High Lead Impedance

    Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 44. High Lead Impedance on a Diagnostic Test at Follow-up Visit for Models 100, 101, and 102 Pulse Generators Error message encountered: Lead Impedance “HIGH” ”A HIGH Lead Impedance has been detected...” Perform a Systems Diagnostic* Possible Lead and Normal Mode Diagnostics*...

  • Page 83: High Lead Impedance, Low Lead Impedance, Or Low Output Current On A Diagnostic Test At Follow-Up Visit For Model 103, 104, And 105 Pulse Generators

    Consider lowering the output current while increasing pulse width. 3. Contact LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide) to report any incidents of high impedance, low impedance, or low output current.
  • Page 84 Physician’s Manual — VNS Therapy Programming Software (8.1) Figure 45. High Lead Impedance, Low Lead Impedance, or Low Output Current on an Interrogation or Diagnostic Test at Follow-up Visit for Models 103, 104, and 105 Pulse Generators Error message encountered: Error message encountered: Error message encountered: Lead Impedance “LOW”...

  • Page 85: Pulse Generator Disabled Due To Vbat < Eos Found At First Interrogation After Implantation Or Other Surgical Procedure

    “The Pulse Generator is currently disabled due to a Vbat < EOS  threshold. Note that the generator is NOT supplying stimulation. It is recommended that you contact LivaNova or refer to the Physician's Manual.” If the device was damaged during the implantation, the device will still function normally but may have a decreased battery life.
  • Page 86 Physician’s Manual — VNS Therapy Programming Software (8.1) LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228- 7330 (Worldwide). Patients should continue with regularly scheduled visits including System Diagnostic testing to ensure proper device functionality. Ensure that patients (epilepsy indication only) continue using their Magnets regularly to verify that stimulation is felt as described in the labeling.
  • Page 87 Physician’s Manual — VNS Therapy Programming Software (8.1) 11. G ________________________ LOSSARY Adverse Event (AE) Any symptom, sign, illness, or experience that develops or worsens in severity and/or frequency during the course of the study (i.e., any changes from baseline) Antiepileptic drug(s) duty cycle Percentage of time during which stimulation occurs;...
  • Page 88 Near End of Service Note: See “How to nominal parameters Program New Parameter Specific preset parameters available with the software; LivaNova Settings” on page 21 for suggests that the Pulse Generator be set to these parameters when specific nominal patients are first stimulated settings.
  • Page 89 Physician’s Manual — VNS Therapy Programming Software (8.1) ramp-up Gradual increase over approximately two seconds in output current at the beginning of stimulation greater than 10 Hz in signal frequency refractory Resistant to previous treatment alternatives defined by the treating physician;...
  • Page 90 Physician’s Manual — VNS Therapy Programming Software (8.1) Vagus Nerve Stimulation 90 of 92 — 26-0008-1100/5 (Worldwide)
  • Page 91 Physician’s Manual — VNS Therapy Programming Software (8.1) 12. L ________ IST OF PPROVED OMPUTERS Computers that have been qualified for use with the Model 250 Version 8.1 Programming Software are listed below: Dell Axim X5 Pocket PC 2002 Handheld Computer ...
  • Page 92 Physician’s Manual — VNS Therapy Programming Software (8.1) 13. P RODUCT NFORMATION AND UPPORT If there are questions regarding use of the VNS Therapy System or any of its accessories, contact LivaNova: LivaNova USA, Inc. 100 Cyberonics Boulevard Houston, Texas 77058 USA Telephone: +1 (281) 228-7200...

Table of Contents