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Physicians Manual VNS Therapy Programming System For Healthcare Professionals May 2017 1 of 58 26-0009-7500/0 (OUS) Note: This manual contains information on the use of the VNS Therapy programming software programming system. Physicians should refer to the VNS Therapy Pulse Generator physicians manuals for additional important prescribing and safety information. Physicians Manual VNS Therapy Programming System Copyright 2017 LivaNova, Inc., Houston, Texas All rights reserved. 2 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 1. DESCRIPTION AND USE 8 1.1. General Description 8 Intended Use 8 1.1.1. 1.2. System Communication 8 1.2.1. Programmer Communications 8 1.2.2. Wand Communications 8 1.2.3. Communication Distance 9 1.2.3.1. Wand and Programmer 9 1.2.3.2. Wand and Generator 9 2. PRECAUTIONS 10 3. GET STARTED 11 3.1. Parts Included 11 3.2. Prepare System for Use 11 3.3. Basic Operation 11 3.3.1. Charge the Programmer 11 3.3.2. Turn Programmer ON/OFF 12 3.3.3. Turn the Programmer Screen ON/OFF 12 3.3.4. Check Programmer Battery 13 3.3.5. Set the Programmer Date and Time 13 3.3.6. Turn on Wand/Check Wand Battery 13 3.4. Connect Wand/Programmer 15 3.4.1. Preferred Wireless Wand Setup 15 3.4.2. Wired Wand Setup 15 4. INTERROGATING THE GENERATOR 16 4.1. 4.2. 4.3. Interrogate (No Preferred Wand) 16 Interrogate (With Preferred Wand) 18 Interrogate (Change Preferred Wand) 19 5. HOW TO USE THE SOFTWARE 20 5.1. Summary Screen 20 5.2. Quick Access Bar 21 6. PROGRAM THE DEVICE 23 6.1. Edit Patient Data 23 6.2. How to Adjust Parameter Settings 23 6.3. How to Configure Seizure Detection Settings 25 6.3.1. Turning the Detection Feature ON/OFF 25 6.3.2. 6.3.3. Use Verify Heartbeat Detection 26 Set Heartbeat Detection 26 6.3.3.1. Visual Indicators During Verify Heartbeat Detection 27 6.3.4. Set the AutoStim Threshold 27 6.3.5. Stimulation Settings on the AutoStim Tab 28 6.3.5.1. Detection and Time Restraints 28 6.4. Potential Error Conditions Related to Programming 28 6.4.1. Partial Programming (Model 102R) 28 6.4.2. Partial Programming Interruption (Models 103-106 and 1000) 28 6.4.3. Cross-programming (Model 102 Generators ONLY) 29 3 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 7. GUIDED PROGRAMMING 30 8. SCHEDULED PROGRAMMING 31 9. DAY/NIGHT PROGRAMMING 32 10.DEVICE DIAGNOSTICS 33 10.1. Reading Test Results 33 10.2. System Diagnostics 36 10.3. Normal Mode Diagnostics (Model 102) 36 10.4. Magnet Mode Diagnostics 36 10.5. AutoStim Diagnostics (Model 106 and 1000) 37 10.6. Generator Diagnostics 37 10.7. Diagnostic Test Differences Between Models of Generators 37 10.8. Potential Error Conditions Observed in Diagnostics 38 11.HISTORY 39 12.EVENTS AND TRENDS 40 13.MANAGING PROGRAMMER INFORMATION 41 14.PROGRAMMER SETTINGS 42 15.TROUBLESHOOTING 43 15.1. Non-responsive Programmer or Wand 43 15.2. Communication Issues 43 15.2.1. Wand Not Connecting to Programmer (Wireless) 43 15.2.2. Wand Not Connecting to Programmer (Backup Cable) 44 15.2.3. Wand Not Communicating with Generator 45 15.3. High/Low Lead Impedance and Low Output Current Issues 46 15.3.1. High Lead Impedance in the OR 46 15.3.2. Low Lead Impedance in OR 47 15.3.3. High Lead Impedance at Follow-up Visits (Model 102) 48 15.3.4. High/Low Lead Impedance or Low Output Current at Follow-up Visit (Models 103-106 and 1000) 49 15.4. Generator Battery Issues 50 15.4.1. Low Battery/End of Service Indications in OR 50 15.4.2. New Generator Disabled Due to EOS at First Interrogation 51 15.4.3. Sudden Decrease In Remaining Battery Power 52 15.5. Heartbeat Detection Issues 52 15.5.1. Heartbeat Detection Inaccurate (Over/Under) in OR or at Follow-up Visit 52 15.6. Seizure Detection Issues 53 15.6.1. Inaccurate AutoStims at Follow-up Visit for Generator Model 106 and 1000 53 16.GENERATOR RESET 55 17.MAINTENANCE, HANDLING, AND DISPOSAL 56 17.1. The Programmer 56 17.2. The Wand 56 17.3. Disposal 56 4 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 18.PROGRAMMING SYSTEM SPECIFICATIONS AND GUIDANCE 57 18.1. Wand and Programmer Specification 57 18.2. Electromagnetic Emissions Guidance for Wand 57 Diagnostic/Parameter Result Summary 34 DC DC Code Conversion and Estimated Impedance Range 36 Diagnostic Test Differences Between Models of Generators 37 Programming System Specification 57 Electromagnetic Emissions 57 Electromagnetic Immunity 58 Electromagnetic Immunity to Proximity Fields from RF Wireless Communications Equipment 58 19.CONTACT INFORMATION AND SUPPORT 59 List of Tables Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 List of Figures System Parts 11 Figure 1 Connect the Charger 12 Figure 2 Power On Programmer 12 Figure 3 Figure 4 Adjust Programmer Time and Date 13 Power On Wand 14 Figure 5 Power Indicator (Battery OK) 14 Figure 6 Figure 7 Low Battery Indicator 14 Wand Battery Replacement 15 Figure 8 Figure 9 Main Screen 16 Figure 10 Wand Search Screen 17 Figure 11 Wand (SN) Selection Screen 17 Successful Wand Connection 18 Figure 12 Figure 13 Interrogate Generator Screen 18 Figure 14 Main Screen - Preferred Wand 19 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Summary Screen 21 Quick Access Bar 22 Edit Patient ID Screen 23 Output Warning Screen 24 Confirmation Screen 25 Verify Heartbeat Detection Screen 26 Verify Heartbeat Detection - Test in Progress 27 Programming Failed Warning Screen 29 Accessing Diagnostics 33 Diagnostics Results Example 34 5 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Solution Steps for a Non-responsive Programmer or Wand 43 Solution Steps For Wand Not Connecting to Programmer (Wireless) 44 Solution Steps for Wand Not Connecting to Programmer (Backup Cable) 45 Solution Steps for Wand Not Communicating with Generator 46 Solution Steps for High Lead Impedance in OR 47 Solution Steps for Low Lead Impedance in OR 48 Solution Steps for High Lead Impedance at Follow-up Visits (Model 102) 49 Solution Steps for High/Low Lead Impedance or Low Output Current at Follow-up Visit (Models 103-
106 and 1000) 50 Solution Steps for Low Battery/End of Service Indications in OR 51 New Generator Disabled Due to EOS at First Interrogation 52 Solution Steps for Heartbeat Detection Inaccurate in OR or at Follow-up Visit 53 Solution Steps for Inaccurate Detection at Follow-up Visit (Model 106) 54 6 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 1. DESCRIPTION AND USE 1.1. General Description The LivaNova VNS Therapy Programmer, Model 3000 version 1.0, and Programming Wand (Wand), Model 2000, allows you to interrogate and program the following VNS Therapy generators:
Model 102 Pulse Model 102R Pulse Duo Model 103 Demipulse Model 104 Demipulse Duo Model 105 ApsireHC Model 106 AspireSR Model 1000 SenTiva Note: For a list of symbols and terms used with the LivaNova VNS Therapy Programming System, go to www.VNSTherapy.com/???. 1.1.1. Intended Use The VNS Therapy Programming System is intended for use only with VNS Therapy generators in a professional healthcare facility environment, and is subject to the same indications for use. 1.2. System Communication The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The wand and the programmer connect wirelessly. The system allows you to:
interrogate and adjust therapy parameters for the generator assess generator and lead function view device histories export session reports 1.2.1. Programmer Communications The programmer will indicate communication in the following ways:
Musical notes a successful interrogation, diagnostics, or applied changes Screen messages for successful, failed, or suggested operation 1.2.2. Wand Communications The wand indicator lights will illuminate when the:
wand is powered on (two green lights below power button) wand is connected to the programmer (four green lights around the power button) wand is communicating with the generator (white flashing generator icon) wand battery is low (orange battery indicator) 7 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 1.2.3. Communication Distance 1.2.3.1. Wand and Programmer The wireless connection between the programmer and wand will operate up to 3 meters
(approximately 10 feet) under most conditions. If communication is unstable, use the supplied USB cable to connect the wand and the programmer instead. 1.2.3.2. Wand and Generator The communication distance between the wand and the generator should not be more than 1 inch. 8 of 58 26-0009-7500/0 (OUS) 2. PRECAUTIONS Physicians Manual VNS Therapy Programming System For optimal performance and safety, review the following:
Do not load other software onto the programmer. Doing so may interfere with the efficiency and function of the pre-installed VNS Therapy Software. The programmer is tested to the same level as typical consumer electronic devices. However, the equipment is not rated for use in the patient environment (as defined by IEC 60601-1). Do not simultaneously touch the patient and programmer while programming. Additionally, do not plug the programmer into AC power while it is being used in a patient environment. Warning: Do not connect unapproved equipment. Doing so can damage the system and/or cause injury. Warning: Do not modify the system unless directed to by LivaNova. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Wand, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Warning: MR Unsafe devices include the programming wand, computer, and patient magnet. Theses devices must not be brought into the MR scanner room. Warning: Safeguard the VNS Therapy Programming System against theft. Theft could lead to malicious activities against the System. 9 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 3. GET STARTED 3.1. Parts Included The system includes the following items (Figure 1):
Touch-screen Programmer preloaded with the VNS Therapy Software A/C power adapter Wand model 2000 with two AA batteries Backup wand USB cable Figure 1. System Parts a. Programmer b. AC Power Adapter c. Wand d. Wand USB Cable If preparing for use in a sterile field, follow aseptic practices. Each part of the Programming System is designed to fit inside commonly available sterile covers (e.g. laser/camera arm drapes). LivaNova recommends using one sterile cover for each Programming System part. If any parts of the system are missing, contact LivaNova. 3.2. Prepare System for Use Before using the programming system in a patient session, make sure the programmer and wand are fully charged and ready to use. Verify the date and time on the programmer are correct. 3.3. Basic Operation 3.3.1. Charge the Programmer To charge the programmer, connect the AC adapter and plug into an outlet (see figure below). Charge the programmer when not in use so that there is enough battery power when using during a patient session. 10 of 58 26-0009-7500/0 (OUS) Figure 2. Connect the Charger Physicians Manual VNS Therapy Programming System 3.3.2. Turn Programmer ON/OFF To turn on the programmer, press and hold the power button for 3 seconds and then release (Figure 3). A few seconds after releasing the power button, you will see an on-screen logo, followed by automatic startup of the VNS software. Figure 3. Power On Programmer To turn off the programmer, press and hold the power button for 3 seconds and then release. Follow on-screen instructions to shut down the programmer. Note: The power button may not respond if the programmer is still shutting down.Wait for 30 seconds after a shut down to restart the programmer. 3.3.3. Turn the Programmer Screen ON/OFF Once the programmer is turned on, the screen will automatically turn off after 5 minutes of inactivity. You can also turn the screen on or off by quickly pressing and releasing the power button. Use this method when you want to preserve battery, but not shut down the programmer. 11 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 3.3.4. Check Programmer Battery After VNS software startup is complete, the programmer battery status can be checked at any time by viewing the indicator at the top right corner of any software screen. For more information, refer to How to Use the Software on page 19. 3.3.5. Set the Programmer Date and Time Accurate patient and device history stored in the programmer depends on correct time and date settings. To adjust the date and time, select Settings from the bottom navigation bar, then Programmer settings, and Date & Time. You can adjust the time by tapping the current display and scrolling up or down. To change the date, use the left or right arrow to adjust the calendar, and then tap the desired date. When finished, choose Save Changes. See Figure 4. Figure 4. Adjust Programmer Time and Date Select time to adjust time Select day on calendar to adjust date Note: The programmer does not automatically adjust for Daylight Saving Time or changes in time zone. Adjust the time and date manually as needed. 3.3.6. Turn on Wand/Check Wand Battery Turn the wand on by pressing and releasing the power button (Figure 5). If the battery is OK, green lights will illuminate (Figure 6). If the battery is low, the low battery indicator will illuminate (Figure 7). If the battery is low, replace the batteries by removing the cover located on the back of the wand
(Figure 8). 12 of 58 26-0009-7500/0 (OUS) Figure 5. Power On Wand Physicians Manual VNS Therapy Programming System Figure 6. Power Indicator (Battery OK) Figure 7. Low Battery Indicator 13 of 58 26-0009-7500/0 (OUS) Figure 8. Wand Battery Replacement Physicians Manual VNS Therapy Programming System Push and slide to open battery compartment Bottom of Wand Note: Once powered on, the wand will automatically power down (standby) after 60 seconds of inactivity to conserve battery. 3.4. Connect Wand/Programmer The system allows you to connect the wand to the programmer wirelessly or with backup USB cable. To connect wirelessly, you have two options:
Set up a preferred wand connection that is always used with that programmer. This setup is recommended for wands and programmers that are always used together. It provides a quicker connection when interrogating the patient's generator, since the programmer will automatically look for the preferred wand. Choose a wand as part of interrogating the patient's generator. This method is recommended if you have several interchangeable programming systems in your area. When interrogating a patient's generator, the programmer will search for all available wands in range. 3.4.1. Preferred Wireless Wand Setup To set up a preferred wireless connection between the wand and the programmer, do the following:
1. 2. 3. 4. Power on the programmer Select Settings from the bottom navigation bar Power on the wand Select the Wand Settings menu option, and enable the Preferred wand selection (while the wand is powered on) Select the desired wand serial number. Once connected, the software will show this serial number as your preferred wand. 5. 6. Use the back button (upper left) to return to the Main screen 3.4.2. Wired Wand Setup Included with the system is a USB cable that connects the wand to the programmer. Use this as a back up method when a wireless connection is not available. Once connected, the software will identify the specific wand connected via the cable. After interrogate is selected, the four green indicators will light up once the wand begins communicating with the generator. The green indicator lights will turn off after 60 seconds of inactivity. 14 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 4. INTERROGATING THE GENERATOR 4.1. Interrogate (No Preferred Wand) You must interrogate the generator before performing other functions, such as applying new parameters or performing diagnostics tests. To begin, power on the programmer. Upon startup, the Main screen will display (Figure 9). Figure 9. Main Screen Next, turn on the wand by pressing and releasing the power button. Two green lights will illuminate indicating the wand is ready to connect. While the green wand lights are illuminated (Figure 6), select Interrogate on the programmer screen. The programmer will search for available wands. See Figure 10. 15 of 58 26-0009-7500/0 (OUS) Figure 10. Wand Search Screen Physicians Manual VNS Therapy Programming System The programmer will show all powered-on wands in range. Select the wand you intend to use
(Figure 11), using the wand serial number (SN). The wand SN is located on the back of the wand. Figure 11. Wand (SN) Selection Screen ba022 SN location on back of Wand Note: To use a specific want in subsequent sessions, check the Automatically connect to the same wand every time box on the screen before choosing a wand. Once the wand has connected, the software will indicate a successful connection and four green lights will illuminate around the wand power button (Figure 12). 16 of 58 26-0009-7500/0 (OUS) Figure 12. Successful Wand Connection Physicians Manual VNS Therapy Programming System Successful wand connection lights illuminated Place the wand over the generator as shown on the software (Figure 13). Once the wand recognizes the generator, the interrogation will complete and the software will display the summary screen. For more details refer to How to Use the Software on page 19. Figure 13. Interrogate Generator Screen Generator icon will flash during interrogation 4.2. Interrogate (With Preferred Wand) If you have set up a preferred wand, the programmer will automatically connect to that wand when you press Interrogate. 17 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System The main screen will display to the preferred wand information. See Figure 14. Make sure wand is powered on before selection interrogate. After the programmer and wand are connected, place the wand over the generator to complete the interrogation. Figure 14. Main Screen - Preferred Wand 4.3. Interrogate (Change Preferred Wand) If you have set up a preferred wand, but want to connect to a different wand, perform the following steps:
1. 2. Power on the new wand Select the Change button on the Main Screen. The programmer will search for all wands that are powered on and in range. Select the intended wand serial number from the list. When you connect to the new wand, it will become the new preferred wand and the programmer will automatically connect to it in future sessions. Place the wand over the generator to complete the interrogation. Note: To clear the preferred wand and connect manually, select Settings from the Main screen. Within the Wand Settings, set the Preferred Wand status to Disabled. Select the back button on the upper left of the screen to return to the Main screen. Next time you interrogate, manually connect to a wand following the steps in Interrogate (No Preferred Wand) on page 15. 18 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 5. HOW TO USE THE SOFTWARE The VNS Therapy Software displays messages and prompts to guide you through the software. 5.1. Summary Screen After a successful interrogation, the Summary screen will display. From this screen, you can perform the following functions:
View generator ID information, including model number and serial number View and edit patient data, such as patient ID and implant date View last known diagnostics data, such as lead impedance and battery status Change settings to generator parameters, such as Normal, Magnet, AutoStim, or Detection settings Perform diagnostics View events and trends such as magnet activations and daily average AutoStims Access device history, including parameter settings associated with prior office visits Interrogate the generator again to verify parameters or refresh data End programming session Access other software options Note: The information displayed is specific to the generator model. Not all parameters will be applicable for all generator models. Note: An office visit is defined as any two interrogations separated by more than 12 hours. 19 of 58 26-0009-7500/0 (OUS) Figure 15. Summary Screen Physicians Manual VNS Therapy Programming System 1. Current programmer date and time 2. Wand connection and programmer battery status 3. Ends current session 4. Generator and patient information 5. 6. Interrogate generator again Last known diagnostics measurements 7. View stimulation events 8. Current parameters 9. Navigation bar to additional software features 5.2. Quick Access Bar From any software screen, tap the VNS Therapy logo on the title bar at the top of the screen to access programmer settings and system information (Figure 16). This drop-down bar shows the following:
Programmer date and time Wand connection status Programmer battery level Sliders to adjust system volume and display brightness Programming software version Wand software version and generator firmware, when in-session (i.e. connected) 20 of 58 26-0009-7500/0 (OUS) Figure 16. Quick Access Bar Physicians Manual VNS Therapy Programming System 21 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 6. PROGRAM THE DEVICE To program any information into the patient's generator, you must interrogate the generator. 6.1. Edit Patient Data For each patient's generator, enter the following information:
Patient ID: three alpha-numeric characters (maximum) Implant date: the date the generator was implanted After successful interrogation, the Patient ID, implant date, generator model, and serial number display at the top of the Summary screen. To enter or edit this information, do the following:
1. 2. 3. 4. Apply Changes and Confirm to program the information into the generator Interrogate the patient's generator Review the generator information displayed at the top of the screen Select Edit and enter the desired information (Figure 17) Figure 17. Edit Patient ID Screen 6.2. How to Adjust Parameter Settings After interrogation, the summary screen will display. To change generator settings from this screen, select Edit parameter or select Parameter on the navigation bar at the bottom. From the Parameters screen, you can change stimulation or detection parameters, depending on the model of generator. Refer to the Technical Manual for a full list of programmable parameters available for each generator. For models 102-105, only Normal Mode and Magnet stimulation parameters are available. For models 106 and 1000, AutoStim and Detection parameters are also available. Detection parameters will display on a separate tab. Review all tabs when adjusting parameters. 22 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System To change a parameter setting, first select the tab of interest on the Parameter screen, and then follow these steps:
1. Tap the Value for the parameter you want to change. A pop-up menu displays the range of possible values. If there are values greater than or less than those shown on the screen you can view them by scrolling up or down. Select the new target value for the parameter. For Output Current, if the target value selected is greater than 0.25 mA compared to the currently programmed value in the generator, an Output Warning will appear
(Figure 18). 2. Note: LivaNova recommends that during the initial parameter adjustments after implant, the output current be set to 0 mA and then slowly increased by 0.25 mA increments until the patient feels the stimulation at a comfortable level. Patients who are receiving replacement generators may also be started at 0 mA Output Current, followed by incremental increases of 0.25 mA to allow for re-accommodation to the therapy. Figure 18. Output Warning Screen 3. New parameter selections that have not been programmed to the generator are in green. Programmed, unchanged, settings are in black. Select Apply Changes at the bottom of the Parameter screen, to proceed to the Confirmation screen
(Figure 19). 4. 5. Confirm the updated parameter setting(s) are correct. If correct, place the wand over the generator and select Confirm to program the new settings to the generator. If incorrect, select Cancel to return to the Parameter screen to make further adjustments. 6. Upon successful update to parameters, you will be notified with an on-screen message showing the newly programmed parameter settings. 23 of 58 26-0009-7500/0 (OUS) Figure 19. Confirmation Screen Physicians Manual VNS Therapy Programming System If any parameter changes were made during a particular patient visit, it is recommended to perform a final interrogation prior to the end of the patient visit in order to confirm the generator is set to the desired values. To perform the final interrogation, navigate to the Parameter screen and then press the Interrogate button at the top right portion of the screen. Caution: For models 102(R) generators, do not use frequencies of 5 Hz or less for long-term stimulation. These frequencies always generate an electromagnetic trigger signal that results in excessive battery depletion of the implanted generator; therefore, use these low frequencies for short periods of time only. Caution: Excessive stimulation is the combination of an excess duty cycle (i.e. one that occurs when ON time is greater than OFF time) and high frequency stimulation (i.e. stimulation at ? 50 Hz). Excessive stimulation has resulted in degenerative nerve damage in laboratory animals. Furthermore, excess duty cycle can be produced by continuous or frequent magnet activation (>
8 hours). While LivaNova limits the maximum programmable frequency to 30 Hz, it is recommended that you do not stimulate with excess duty cycle. Physicians should also warn patients about continuous or frequent magnet use as this could lead to early battery depletion.
[IS ALL THIS INFORMATION NECESSARY?]
6.3. How to Configure Seizure Detection Settings You can adjust seizure detection settings under the Detection tab on the Parameter screen for models 106 and 1000 generators. 6.3.1. Turning the Detection Feature ON/OFF You may enable or disable Detection. If Detection is Disabled, then the model 106 and 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. Note: If Detection is disabled, the parameters on the Detection tab are not visible and AutoStim is not activated. 24 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System When you enable Detection for the first time, the software will prompt you to set the Heartbeat Detection setting and AutoStim Threshold. These settings work together to ensure the generator is accurately detecting the patient's heartbeats, and set the criterion for AutoStim delivery based on changes in heart rate, respectively. Once Detection is enabled, you can adjust the settings from the Detection tab as needed. 6.3.2. Set Heartbeat Detection In order for the generator to accurately detect heartbeats, the heartbeat detection must be set for the individual patient. For model 106 and 1000 generators, you must 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). The setting will not change unless manually programmed to a different value. 6.3.3. Use Verify Heartbeat Detection When Detection is enabled, the software will walk you through heartbeat detection setting verification and AutoStim threshold selection. Afterwards, select the Verify button on the Detection tab to confirm the accuracy of the heart rate detected by the generator or to change the heartbeat detection setting. To do so, complete the following steps:
1. Press Verify to advance to the Verify Heartbeat Detection screen (Figure 20). If Detection has been Enabled, the Verify Heartbeat Detection screen will automatically display. Figure 20. Verify Heartbeat Detection Screen 2. On the Verify Heartbeat Detection screen, tap the Heartbeat Detection setting field to change the value (if desired). Place the wand over the generator and press Start to begin the test. Keep the wand over the generator during the entire Verify Heartbeat Detection process. The generator will transmit a signal and the programmer will display the detected heart rate in beats per minute (BPM) for up to two minutes (Figure 21). 3. 25 of 58 26-0009-7500/0 (OUS) Figure 21. Verify Heartbeat Detection - Test in Progress Physicians Manual VNS Therapy Programming System 4. 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 10% or 5 bpm, whichever is greater. If the heart rate reported by the programmer is too high, then the Heartbeat Detection setting should be adjusted downward (toward setting 1). If the heart rate reported by the programmer is too low, then the Heartbeat Detection setting should be adjusted upward (toward setting 5). Refer Troubleshooting on page 42 for more information. If the heartbeat detection is verified before the end of two minutes, place the wand over the generator and select Stop on the screen. 5. Once you observe accurate heartbeat detection, you have completed the verification process. If you are enabling Detection, select Next to set the AutoStim Threshold. Otherwise, select Done to return back to the Parameter screen. 6.3.3.1. Visual Indicators During Verify Heartbeat Detection During heartbeat verification, the following visual indicators will display in the BPM window:
?? indicates lost/no communication, or no heart beats detected by the generator
<40 BPM will display if the system detects a heart rate below 40 BPM
>230 BPM will display if the system detects a heart rate above 230 BPM Between 40-230, the system-calculated heart rate will display Caution: For Model 106, if AutoStim or Magnet stimulation is programmed on, the Verify Heartbeat Detection feature may be interrupted if AutoStim or Magnet stimulation is activated during the Verify Heartbeat Detection Process. In this case, ?? will display on the screen. If ?? displays, LivaNova recommends you temporarily disable all output currents for the model 106 (i.e. programmed to 0 mA) and retry the heartbeat verification. After the calibration process is completed, you may reprogram the output currents as appropriate. 6.3.4. Set the AutoStim Threshold The AutoStim Threshold is a setting on the Detection tab that can be set from 20% to 70% (in 10%
increments). This setting allows you to determine minimum heart rate change required for AutoStim, 26 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System and should be tailored to the individual patient. For the most sensitive detection and the smallest heart rate change for stimulation, choose 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. 6.3.5. Stimulation Settings on the AutoStim Tab The AutoStim parameter settings determine the stimulation output delivered when AutoStim Threshold is reached. Alter these settings from the stimulation tab on the Parameter screen. 6.3.5.1. Detection and Time Restraints In order to allow enough detection time between scheduled stimulation periods, the programming software will not allow you to program certain combinations of Normal Mode and AutoStim values. If you program a Normal Mode Off Time of 1.1 minutes or less while AutoStim/ Detection is enabled, you will be prompted to change the values. Otherwise, detection will be turned OFF at the next programming attempt. Caution: LivaNova recommends you monitor the patient briefly after parameter changes to ensure stimulation is tolerable. LivaNova also recommends the output current for the AutoStim Mode does not exceed the output current for the Normal Mode or the Magnet Mode, especially for patients who experience discomfort. 6.4. Potential Error Conditions Related to Programming 6.4.1. Partial Programming (Model 102R) Each parameter is programmed and verified individually during a programming event for model 102(R) generators. If the communication is interrupted during programming, generators can be set to unintended settings. The software will display a warning message indicating that the programming failed and device settings were altered or potentially altered due to the interrupted programming attempt. If this occurs, you should interrogate the generator immediately to verify current programmed settings. If necessary, reprogram to desired settings. 6.4.2. Partial Programming Interruption (Models 103-106 and 1000) For models 103-106 and 1000 generators, the device parameters are programmed and verified as a group during a programming event, which is not susceptible to partial programming. If an interruption occurs during programming, the software will display a warning message indicating that the procedure failed and allows the user to retry or cancel the programming operation (Figure 22). If you decide to cancel, interrogate the generator to verify settings before reattempting the programming operation. 27 of 58 26-0009-7500/0 (OUS) Figure 22. Programming Failed Warning Screen Physicians Manual VNS Therapy Programming System 6.4.3. Cross-programming (Model 102 Generators ONLY) Model 102(R) generators are susceptible to an event known as cross-programming. This occurs when parameter settings from a patient's generator are inadvertently programmed to another patient's generator. This can happen if you dont interrogate the generator between patients visits and both patients have the model 102 or 102R generator. Always perform an initial and final interrogation to verify parameter settings at each office visit for all patients. 28 of 58 26-0009-7500/0 (OUS) 7. GUIDED PROGRAMMING Physicians Manual VNS Therapy Programming System 29 of 58 26-0009-7500/0 (OUS) 8. SCHEDULED PROGRAMMING Physicians Manual VNS Therapy Programming System 30 of 58 26-0009-7500/0 (OUS) 9. DAY/NIGHT PROGRAMMING Physicians Manual VNS Therapy Programming System 31 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 10. 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 (see Figure 23). Figure 23. Accessing Diagnostics Depending on the model of generator interrogated, you may have access to different types of tests. Typical tests include System Diagnostics, Normal Mode Diagnostics, Magnet Diagnostics, and AutoStim Diagnostics. Make sure to follow all the instructions on the programmer screen, as they vary for each selection. It's important to note that the tests described in this section are designed for assessing system functionality using the implanted components. Another test, Generator Diagnostics, is designed specifically for use with a test resistor and should only be accessed for troubleshooting scenarios during implantation surgery. Please see Troubleshooting on page 42 for more details on accessing Generator Diagnostics. 10.1. Reading Test Results Figure 24 shows a typical results screen after completion of a diagnostics test. 32 of 58 26-0009-7500/0 (OUS) Figure 24. Diagnostics Results Example Physicians Manual VNS Therapy Programming System The various test parameters and their values/meanings across the different diagnostics tests are summarized in the Table 1. Additional details regarding specific diagnostics tests are further detailed in the remaining sections of this physician's manual. For model102 generators, the lead impedance values are estimated based on DC DC code (displayed in previous versions of VNS software) and the conversion between DC DC code and estimated impedance range are listed in Table 2. For abnormal result, refer to the Troubleshooting on page 42, for additional instructions. Table 1. Diagnostic/Parameter Result Summary Parameter Name(s) Parameter Description Lead Impedance Indicates measured or estimated impedance when delivering the output current during testing and whether it's within normal range. Parameter Values/
Results What Does the Value or Result Mean?
M103-106 and 1000:
Measured lead impedance value (ohms) and overall status of OK, LOW, or HIGH OK: Impedance is within acceptable operating range. No special attention is required. M102: Estimated lead impedance range (ohms) and overall status of OK, LOW, or LIMIT LOW: Impedance is lower than expected and it may be indicative of a short circuit condition or a defective generator. See Section 14, Troubleshooting for additional instructions. HIGH or LIMIT: Impedance is higher than expected and the generator may not be able to deliver the programmed therapy. See Section 14, Troubleshooting for additional instructions. 33 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Parameter Name(s) Parameter Description Parameter Values/
Results What Does the Value or Result Mean?
Generator Battery Indicates battery status of the generator using one of the following:
OK Intensified Follow-up Indicator (IFI) Near End of Service (N EOS) End of Service (EOS) M103 and subsequent models:
OK IFI = Yes N EOS = Yes EOS = Yes M102:
OK N EOS = Yes Output Current / Current Delivered Parameter value Indicates the stimulation output current applied /
delivered during the diagnostics test, and overall status of whether the current was delivered OK: Battery level is within normal operating range and no special attention is required. IFI = Yes: The battery has depleted to a level where more frequent clinical monitoring is recommended. N EOS = Yes:
M103 and subsequent models: The Generator should be replaced as soon as possible. M102: A System Diagnostics Test is recommended to verify the Near EOS status. If confirmed, the pulse generator should be replaced as soon as possible. EOS = Yes: The generator is no longer supplying stimulation and immediate replacement is recommended. If the generator is not replaced, it will eventually lose the ability to communicate with the software. Indicates the stimulation output current applied /
delivered during the diagnostic test. OK: Current is being delivered at the programmed level. M103-106 and 1000:
LOW: Programmed current is possibly not being delivered at the specified level. M102:
Limit: Programmed current is possibly not being delivered at the specified level. 34 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Caution: Battery depletion can occur between visits and may not be detected by the various battery indicators. Therefore, for patients with magnet activation enabled, LivaNova recommends a daily magnet activation by the patient as a means to check stimulation and to consult with the physician to perform diagnostics testing if patient no longer feels stimulation. Table 2. DC DC Code Conversion and Estimated Impedance Range DC DC Code Estimated Impedance Range 0 1 2 3 4 5 6 7
<1.7 k*
1.8-2.8 k*
2.9-4.0 k*
4.1-5.2 k*
5.3-6.5 k*
6.6-7.7 k*
7.8-8.9 k*
>9.0 k*
*Correspondence to estimated lead impedance value at 1mA, 500s 10.2. System Diagnostics The System Diagnostics test assesses the electrical continuity between the generator and the bipolar lead when connected. The test measures the generator's ability to deliver programmed output current and the lead impedance status. A successful System Diagnostics during surgery or post-implant shows that both the generator and lead are working properly. You can perform this test on all generators supported by the VNS Programming Software during implantation and patient follow-up visits. LivaNova recommends you perform this test before other diagnostic tests. 10.3. Normal Mode Diagnostics (Model 102) The Normal Mode Diagnostics test will let you know if the generator is ready to deliver output current. Perform this test regularly at follow-up visits only if the patient can tolerate at least .75 mA. Any setting less than 0.75 mA with a frequency less than 15 Hz or ON time less than 30 sec will render an unreliable test result. Make sure the patients settings meets the minimum requirement. Note: For models 103-106 and 1000 generators, the System Diagnostics test serves the same function as Normal Mode Diagnostics since the test is run at the programmed device settings. 10.4. Magnet Mode Diagnostics The Magnet Mode Diagnostics test will let you know if the generator is delivering the programmed magnet output current. To do perform this rest, pass the magnet over the generator for at least one second and then place the wand over the generator. This action will enable stimulation at the programmed Magnet Mode output current. If you perform this incorrectly, the test will be invalid and a message will display on the screen indicating the magnet swipe was not detected. Pass the magnet over the generator again to restart the test. 35 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System For the model 106 generator, do not leave the magnet over the generator for longer than 3 seconds when performing the Magnet Mode Diagnostics. Otherwise, stimulation will stop and the Magnet Mode Diagnostics results will invalid. In addition, similar to Normal Diagnostics, any setting less than 0.75 mA with a frequency less than 15 Hz or ON time less than 30 sec will result in an unreliable test. Make sure the patient's settings meet the minimum requirement. 10.5. AutoStim Diagnostics (Model 106 and 1000) The AutoStim Diagnostics test determines whether the device is delivering the programmed AutoStim output current. The desired AutoStim current should be programmed before you perform the AutoStim diagnostic. The result will indicate whether the programmed AutoStim current is being delivered given the lead impedance that is present. 10.6. 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. Please see Troubleshooting on page 42 for more details on using Generator Diagnostics. 10.7. Diagnostic Test Differences Between Models of Generators Some Diagnostic tests operate differently depending on which model generator is used. These differences are outlined below in Table 3. Table 3. Diagnostic Test Differences Between Models of Generators Items of Interest Model 102(R) Models 103-106 and 1000 Parameter Settings During System Diagnostics Stimulates at 1.0mA, 500s, and 20 Hz Caution: Patients with lower parameter settings may feel discomfort during this test. Parameter Settings During Generator Diagnostics Stimulates at 1.0mA, 500s, and 20 Hz. Caution: The Generator Diagnostics test should only be run in the operating room setting with the test resistor. Caution: The model 102 generator will be set to 0mA after the test. Normal Mode Output Current is programmed to 0mA: Stimulates at 1.0mA, 500s, and 20Hz. Normal Mode Output Current is programmed to > 0mA: Stimulates at the programmed Normal Mode parameters Normal Mode Output Current is programmed to 0mA: Stimulates at 0.25mA Normal Mode Output Current if programmed to > 0mA: Stimulates at the programmed Normal Mode parameters. Lead Impedance Lead impedance is not directly measured. Instead, a DC-DC Converter Code is reported and is indicative of the estimated lead impedance at 1mA and 500s. The actual lead impedance measurement is reported. 36 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 10.8. Potential Error Conditions Observed in Diagnostics If diagnostics testing is interrupted, follow on-screen instructions to repeat the test and verify the patient's parameters. The model 102 parameters are especially susceptible to be changed to unintended settings during an interrupted diagnostic test due to the break in communication between the programmer and the wand; therefore, it's especially important to re-verify the patient's parameters after a diagnostic test interruption. Always re-interrogate to verify settings after an interrupted diagnostics test. 37 of 58 26-0009-7500/0 (OUS) 11. HISTORY Physicians Manual VNS Therapy Programming System 38 of 58 26-0009-7500/0 (OUS) 12. EVENTS AND TRENDS Physicians Manual VNS Therapy Programming System 39 of 58 26-0009-7500/0 (OUS) 13. MANAGING PROGRAMMER INFORMATION Physicians Manual VNS Therapy Programming System 40 of 58 26-0009-7500/0 (OUS) 14. PROGRAMMER SETTINGS Physicians Manual VNS Therapy Programming System 41 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 15. TROUBLESHOOTING This section provides solution steps to resolve error conditions with the programming system components or with the implanted generator and lead. For other programming system issues not included in this section, contact LivaNova. 15.1. Non-responsive Programmer or Wand If your programmer or wand becomes non-responsive, follow the solution steps in the figure below. Figure 25. Solution Steps for a Non-responsive Programmer or Wand Issue Non-responsive Programmer or Wand Solution Steps for Programmer:
Charge programmer Plug programmer into A/C outlet Shut down Press hold the power button for 3 seconds, and then release. Follow on-screen instructions to shut down. If programmer is still non-responsive, press and hold power button for 5 seconds and then release to force a shut down. Reboot Power on the programmer Solution Steps for Wand:
Verify wand battery power - If the red low battery light is on, replace the wand batteries Perform soft reset - Press and hold wand power button for 3 seconds and release Device Responsive?
Yes No Contact LivaNova Technical Support Verify:
Programmer has adequate charge Programmer has correct date/time Yes Proceed with intended use 15.2. Communication Issues 15.2.1. 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 battery Electromagnetic interference (EMI), such as OR lights Defective wand or programmer 42 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System See Figure 26 for solution steps to resolve problems between the wand and programmer via wireless connection. Figure 26. Solution Steps For Wand Not Connecting to Programmer (Wireless) Error Messages No wands found Wand (serial number of connected wand) not found Check Wand Power Press and release power button. Does wand power indicator light appear?
Yes No Replace batteries Retry connecting to wand No Successful Connection?
Yes Verify Wand Selection Confirm wand ID matches wand selected on programmer Check for Interference Confirm wand is 3-4 feet away from all electronic equipment Reconnect to Wand Proceed with intended use No Successful Connection?
Yes Connect with backup cable No Successful Connection?
Yes Contact LivaNova Technical Support 15.2.2. Wand Not Connecting to Programmer (Backup Cable) Potential reasons for no connection between the wand and the programmer via backup cable include the following:
43 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Improper cable connection between wand and programmer Depleted wand battery Improper USB port recognition of the programmer cable Defective wand or programmer See Figure 27 for solution steps to resolve problems between the wand and programmer via backup cable connection. Figure 27. Solution Steps for Wand Not Connecting to Programmer (Backup Cable) Error Messages Wand not connected Check Wand Power Press and release power button Does wand power indicator light appear?
Yes No Replace batteries Retry connecting to wand No Successful Connection?
Verify Cable Connection Confirm cable is connected to wand and programmer. Reinsert if necessary. Yes Proceed with intended use No Successful Connection?
Yes Contact LivaNova Technical Support 15.2.3. 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) 44 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Defective wand, programmer, or generator See Figure 28 for solution steps to resolve communication problems between the wand and generator. Figure 28. Solution Steps for Wand Not Communicating with Generator Error Messages Generator not found... Error communicating with generator Check Wand Placement Confirm wand is placed over the generator Rotate wand 45 degrees Confirm generator pocket is not more than 1 inch below the skin, not muscle (during surgery) Retry Communication No Successful Communication?
Yes Contact LivaNova Technical Support Proceed with session 15.3. High/Low Lead Impedance and Low Output Current Issues 15.3.1. 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) Allowing nerve to become dry (initial implant only) Defective lead or generator See Figure 29 for solution steps. 45 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Figure 29. Solution Steps for High Lead Impedance in OR Error message Lead Impedance HIGH Verify Lead Insertion into Generator Back out setscrew(s), remove lead pin(s), and leave the hex screwdriver engaged in setscrew(s). Verify the setscrew(s) is not visible in the lead receptacle(s). Insert connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks. Confirm the lead pin(s) is past the back end of the connector block. For single-pin generators, verify the end of the connector ring is inside of the lead receptacle. For Initial Implant: Irrigate dry nerve site and remove pooled fluid if necessary. Verify proper lead electrode placement on the nerve. Retry System Diagnostics. Troubleshoot Generator Back out setscrew(s) and remove lead pin(s). Insert test resistor into generator and tighten setscrew(s) with hex screwdriver until the screwdriver clicks. Select More on the programmer. Select Generator Diagnostics Start on the programmer. Troubleshooting HIGH Lead Impedance Value?
OK Proceed with implant. Lead Impedance Value?
OK Reinsert Lead into Generator Back out setscrew(s) and remove test resistor. Verify the setscrew(s) is not visible in the lead receptacle(s). Engage the hex screwdriver in the setscrew(s). Insert connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks. Visually inspect the lead receptacle(s) and verify that the lead pin(s) is past the back end of the connector block(s). Retry System Diagnostics. HIGH Contact LivaNova Technical Support HIGH Lead Impedance Value?
OK Proceed with implant. 15.3.2. Low Lead Impedance in OR If a system diagnostics test results in low lead impedance, the following are possible causes:
During Initial Implant Incorrect placement of the lead on the nerve Excessive irrigation of the nerve Defective generator or lead During Generator Replacement Short-circuit condition within the lead Defective generator See Figure 30 for solution steps. 46 of 58 26-0009-7500/0 (OUS) Figure 30. Solution Steps for Low Lead Impedance in OR Physicians Manual VNS Therapy Programming System Error message Lead Impedance LOW Type of Implant?
Initial Implant Generator Replacement Check the Lead Verify lead electrodes have been correctly placed on the nerve. Remove pooled fluid if nerve site is saturated. Retry System Diagnostics Troubleshoot Generator Back out setscrew(s) and remove lead pin(s). Insert test resistor into generator and tighten setscrew(s) with hex screwdriver until the screwdriver clicks. Select More Troubleshooting on the programmer. Select Generator Diagnostics Start on the programmer. Lead Impedance Value?
OK Proceed with Implant LOW OK Type of Implant?
Lead Impedance Value?
LOW Contact LivaNova Technical Support Initial Implant Generator Replacement Reinsert Lead into Generator Back out setscrew(s) and remove test resistor. Verify the setscrew(s) is not visible in the lead receptacle(s). Engage the hex screwdriver in the setscrew(s). Insert connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks. Visually inspect the lead receptacle(s) and verify that the lead pin(s) is past the back end of the connector block(s). Retry System Diagnostics. Lead Impedance Value?
LOW OK Proceed with Implant 15.3.3. High Lead Impedance at Follow-up Visits (Model 102) Possible causes for high lead impedance at follow-up visits for the model 102 generator include the following:
47 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Lead discontinuity Lead disconnected from generator Fibrosis between nerve and electrode Electrode detachment from nerve Defective generator High battery impedance, generator approaching EOS See Figure 31 for solution steps. Figure 31. Solution Steps for High Lead Impedance at Follow-up Visits (Model 102) Error message Lead Impedance HIGH Perform a Systems Diagnostic and Normal Mode Diagnostics and record all results. Near End of Service?
Yes Replace generator as soon as possible No Evaluate results Systems Diagnostics Results =
Output Status: LIMIT Lead Impedance: HIGH Systems Diagnostics Results =
Output Status: OK Lead Impedance: HIGH Systems Diagnostics Results =
Output Status: OK Lead Impedance: OK Systems Diagnostics Results =
Output Status: OK Lead Impedance: OK Normal Mode Results =
Output Status: LIMIT Normal Mode Results =
Output Status: LIMIT Normal Mode Results =
Output Status: LIMIT Normal Mode Results =
Output Status: OK Possible lead discontinuity, lead disconnection from the generator, fibrosis between the nerve and electrode, electrode detachment from the nerve, or a defective generator. Generator cannot deliver programmed output. Reduce output current or frequency and widen pulse width. Generator is performing as intended Contact LivaNova Technical Support 15.3.4. High/Low Lead Impedance or Low Output Current at Follow-up Visit (Models 103-106 and 1000) Possible causes for high or low lead impedance or low output current at follow-up visits for models 103-
106 and 1000 generators include the following:
Lead discontinuity 48 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Lead disconnected from generator Fibrosis between nerve and electrode Electrode detachment from nerve Defective generator Short-circuit condition within the lead See Figure 32 for solution steps. Figure 32. Solution Steps for High/Low Lead Impedance or Low Output Current at Follow-up Visit (Models 103-106 and 1000) Error message A LOW Lead Impedance has been detected... Lead Impedance LOW Error message been detected... Lead Impedance HIGH Error message being delivered... Output Current LOW A HIGH Lead Impedance has Programmed current is possibly not Perform a Systems Diagnostics. Record results. System Diagnostics Values Lead Impedance OK Output Current OK Generator is delivering stimulation as intended. Lead Impedance HIGH Output Current OK Lead Impedance HIGH Output Current LOW Lead Impedance OK Output Current LOW Lead Impedance LOW Output Current OK Possible Causes:
Lead discontinuity Lead disconnection from the generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective generator Possible Causes:
Lead discontinuity Lead disconnection from the generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective generator Possible Cause:
Increased impedance in the system Possible Causes:
Short-circuit condition within the lead Defective generator Contact LivaNova Technical Support 15.4. Generator Battery Issues 15.4.1. 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:
Generator has been recently exposed to low storage temperatures 49 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Defective generator During Surgery:
Electrosurgical equipment used near the generator Generator exposed to electrostatic discharge (ESD) See Figure 33 for solution steps. Figure 33. Solution Steps for Low Battery/End of Service Indications in OR Error Message Generator Battery N EOS Generator Battery EOS Frequent monitoring recommended. The Intensified Followup Indicator (IFI) is set Generator disabled Perform System Diagnostics or Generator Diagnostics with device in sterile package. Record results. Diagnostic Results Lead Impedance any Impedance Value any IFI = No Proceed with implant. Same battery status indicator or warning message as above 1 Number of attempts 2 Contact LivaNova Technical Support Wait approximately 30 minutes with generator at room temperature. 15.4.2. New Generator Disabled Due to EOS at First Interrogation Generator models 103-106 and 1000 batteries 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) See Figure 34 for solution steps. 50 of 58 26-0009-7500/0 (OUS) Figure 34. New Generator Disabled Due to EOS at First Interrogation Physicians Manual VNS Therapy Programming System Error message Generator is currently disabled... Enable Stimulation and Check System Select OK Enter desired parameters Select Apply Changes Perform System Diagnostics Test IFI=Yes or No Battery Status?
N EOS=Yes or EOS=Yes Proceed with intended use Monitor Patient for low battery indicators Note: Battery life will be shortened Replace Generator immediately All Other Errors Contact LivaNova Technical Support 15.4.3. Sudden Decrease In Remaining Battery Power If the generator battery suddenly decreases at an office visit, the following are possible causes:
First visit after VNS or other surgery: exposure to specific conditions in the OR (see Low Battery/End of Service Indications in OR) during surgery. If this condition occurred and was not detected in the OR, it is possible you may detect this at the follow up visit. Device will still function normally, but will have decreased battery life. Monitor the patient closely for any low battery indicators. Significant change in the lead impedance or increase in programmed stimulation parameters can also result in a change in the estimated battery power remaining. Evaluate battery power remaining between consecutive patient visits before adjusting stimulation parameters. Review lead impedance for any significant changes. If any device issue is suspected, contact LivaNova Technical Support. 15.5. Heartbeat Detection Issues 15.5.1. Heartbeat Detection Inaccurate (Over/Under) in OR or at Follow-up Visit The heartbeat detection setting may need to be adjusted to correctly detect heartbeats. See Figure 35 for solution steps to correct an over/under detection reading. Note: The wand must be held over the generator during the entire Verify Heartbeat Detection process. 51 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Figure 35. Solution Steps for Heartbeat Detection Inaccurate in OR or at Follow-up Visit Heartbeat Detection is inaccurate BPM is too high, low, ***** or ?????
Confirm the programmer is not plugged into a wall outlet. Check Hardware Check Software Confirm Detection is enabled. Check Wand Placement Verify wand is over the generator Check Verify Heartbeat Mode For Model 1000, switch to manual Verify Heartbeat Low
*****/?????
Adjust Heartbeat Detection setting upward
(toward 5). Contact LivaNova Technical Support BPM?
High Adjust Heartbeat Detection setting downward
(toward 1). Confirm accuracy in different body positions (e.g. off-the-shelf heart rate monitor or ECG). Yes Done. OK?
No Retry with different settings. No All settings attempted with out success?
Yes Contact LivaNova Technical Support 15.6. Seizure Detection Issues 15.6.1. Inaccurate AutoStims at Follow-up Visit for Generator Model 106 and 1000 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 - Because the generator can only detect events during OFF time, the OFF time affects accuracy. Shorter OFF time means less chance for the generator to detect events. Longer OFF time, on the other hand, means more chance for the generator to detect events. Heart rate changes - Exercise, physical activity, and normal sleep can increase the heart rate and cause the generator to falsely declare an event. See Figure 36 for solution steps. 52 of 58 26-0009-7500/0 (OUS) Figure 36. Solution Steps for Inaccurate Detection at Follow-up Visit (Model 106) Physicians Manual VNS Therapy Programming System Too many or too few AutoStims Confirm Heartbeat Detection settings (See Solution Steps for Heartbeat Detection Inaccurate in OR or at Follow-up Visit) Number of AutoStims Too many Adjust Threshold for AutoStim setting toward 70%. Too few Adjust Threshold for AutoStim setting toward 20%. Monitor accuracy over course of therapy. Still Inaccurate after several adjustments?
No Yes Contact LivaNova Technical Support Continue with programmed setting 53 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 16. GENERATOR RESET To reset the generator, you will need the programming system and a LivaNova Magnet. Contact LivaNova Technical Support for assistance. 54 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 17. MAINTENANCE, HANDLING, AND DISPOSAL Follow guidelines below for proper handling and storage for the programming system. To clean external surfaces of the Programming System components, wipe with pre-moistened or damp cloth using one of the following cleaners: isopropyl alcohol (70-90%), ethanol, or CaviCide. Do not sterilize any parts of the system. Regularly inspect the system parts for damage. Return any damaged parts to LivaNova. Do not operate the system near water or other fluids. Do not immerse any components in liquids. 17.1. Debris can damage the programmer touchscreen display. Frequently wipe with a soft cloth, using approved The Programmer cleaners. Be sure to power off computer and disconnect AC adapter from electrical outlet before cleaning. For information on operating and storage conditions, see the programming system specification table on section 17. 17.2. The Wand Check the wand battery periodically to verify battery status. Warning: Risk of Fire. Battery can explode or leak and cause injury if installed backwards, disassembled, charged, crushed, mixed with used or other battery types, or exposed to fire or high temperature. Disposed of used batteries promptly. Remove (and install) the battery only when the wand is not in contact with the patient and not connected to the programmer Never connect the Programming Wand to external equipment while the battery compartment is open. For information on operating and storage conditions, see the programming system specification table in section 17. 17.3. Disposal When replacing the wand AA batteries, dispose the used batteries in accordance with all applicable federal, state, and local regulations. Return the programming system hardware to LivaNova for examination and safe disposal. 55 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 18. PROGRAMMING SYSTEM SPECIFICATIONS AND GUIDANCE 18.1. Wand and Programmer Specification For a complete list of wand and programmer hardware specifications, see the table below. Table 4. Programming System Specification Wand Programmer Storage Conditions Temperature Relative Humidity Operation Conditions Temperature Relative Humidity
-20 C to +55 C
-20 C to +55 C Up to 95%, including condensation 10% to 93%, non-condensing
+15 C to +40 C
+15 C to +40 C 15% to 93%, non-condensing 10% to 93%, non-condensing Communication Distance between Wand and Programmer From 0 to 3 Meters Power Source Transmitter Power Transmitter Operating Frequency Receiver Bandwidth Cables Applied Part Operating: internally powered Recharge: Class II Internally powered: 2 Alkaline AA Batteries (IEC LR6) or 2 Lithium AA Batteries (IEC FR6) Inductive: 1.5 dBm and -0.5 dBm Bluetooth: 10.4 dBm Inductive: 82 kHz 89 kHz (102 only) Bluetooth:2402 - 2480 MHz Inductive: 12.5 to 135 kHz Bluetooth: 2402 - 2480 MHz USB Type C backup cable (2.87 m) Entire device is Type BF N/A 18.2. Electromagnetic Emissions Guidance for Wand The wand is intended to be used in the electromagnetic conditions specified in the tables below. Table 5. Electromagnetic Emissions Emissions Test Compliance Level RF Emissions CISPR 11 Group A Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. 56 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System Table 6. Electromagnetic Immunity Immunity Test Compliance Level Electrostatic discharge (ESD) IEC 61000-4-2 Power Frequency Magnetic Field IEC 61000-4-8 Radiated RF IEC 61000-4-3 Table 7.
+/- 8 kV contact discharge
+/-15 kV air discharge 30 A/m 50 & 60 Hz 3 V/m 80 MHz to 2.7 GHz Electromagnetic Immunity to Proximity Fields from RF Wireless Communications Equipment Test Frequency Service Compliance Level 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 TETRA 400 GMRS 460, FRS 460 LTE Band 13, 17 GSM 800/900 TETRA 800, IDEN 820, CDMA 850, LTE Band 5 GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1,3,4,25, UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 WLAN 802.11 a/n 27 V/m 28 V/m 9 V/m 28 V/m 28 V/m 28 V/m 9 V/m 57 of 58 26-0009-7500/0 (OUS) Physicians Manual VNS Therapy Programming System 19. CONTACT INFORMATION AND SUPPORT If there are questions regarding use of the VNS Therapy System or any of its accessories, contact LivaNova:
LIVANOVA USA 100 Cyberonics Boulevard Houston, Texas 77058 Telephone: +1 (281) 228-7200 1 (800) 332-1375 (US and Canada) LIVANOVA BELGUIM NV Ikaroslaan 83 1930 Zaventem, Belguim Telephone: +32.2.720.95.93 For 24-hour Clinical and Technical Support, call:
USA:
Telephone: 1 (866) 882-8804 (US and Canada)
+1 (281) 228-7330 (Worldwide) Europe/EMMEA:
Telephone: +32 2 790 27 73 Internet: www.VNSTherapy.com 58 of 58 26-0009-7500/0 (OUS)
1 2 | Radio Information | Users Manual | 34.36 KiB |
RADIO APPROVALS 1. WIRELESS TECHNOLOGY INFORMATION - PROGRAMMING WAND 1.1. FCC Information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. 1.2. Industry Canada Information CAN ICES 3 (A)/NMB 3 (A). This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. 2. WIRELESS TECHNOLOGY INFORMATION - PROGRAMMER Information for the Programmer is available at the manufacturers website, www.dell.com. LIVANOVA USA 100 Cyberonics Boulevard Houston, Texas 77058 Tel: +1.800.332.1375 Fax: +1.281.218.9332 Internet: www.VNSTherapy.com LIVANOVA BELGUIM NV Ikaroslaan 83 1930 Zaventem Belgium Tel: +32.2.720.95.93 Fax: +32.2.720.60.53 26-0000-0000 (WW) 2017 Cyberonics, Inc, a wholly-
owned subsidiary of LivaNova PLC. All rights reserved. Cyberonics AspireSR and VNS Therapy are registered trademarks of Cyberonics, Inc.
frequency | equipment class | purpose | ||
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1 | 2017-08-30 | 0.082 ~ 0.089 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | Original Equipment |
2 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter |
app s | Applicant Information | |||||
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1 2 | Effective |
2017-08-30
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1 2 | Applicant's complete, legal business name |
Cyberonics, Inc.
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1 2 | FCC Registration Number (FRN) |
0011023082
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1 2 | Physical Address |
100 Cyberonics Blvd.
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1 2 |
Houston, Texas 77058
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1 2 |
United States
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@metlabs.com
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1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
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1 2 |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 2 | Grantee Code |
RW6
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1 2 | Equipment Product Code |
2000TRX
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
S****** R******
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1 2 | Title |
Manager, Design Assurance Quality Engineering
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1 2 | Telephone Number |
281-2********
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1 2 | Fax Number |
281-8********
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1 2 |
s******@cyberonics.com
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app s | Technical Contact | |||||
1 2 | Firm Name |
Cyberonics, Inc.
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1 2 | Name |
S******** B****
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1 2 | Physical Address |
100, Cyberonics blvd
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1 2 |
Houston, Texas 77058
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1 2 |
United States
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1 2 | Telephone Number |
281-2********
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1 2 |
S******@livanova.com
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app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 10/14/2017 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DCD - Part 15 Low Power Transmitter Below 1705 kHz | ||||
1 2 | DSS - Part 15 Spread Spectrum Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Model 2000 Programming Wand | ||||
1 2 | The Model 2000 Programming | |||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output Power listed is conducted. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Eurofins MET Laboratories, Inc.
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1 2 | Name |
J******** F********
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1 2 | Telephone Number |
512-2********
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1 2 | Fax Number |
512 2********
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1 2 |
j******@metlabs.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 0.08200000 | 0.08900000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0100000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC