VNS Therapy SENTIVA M2000 Wand Technical Manual Download Page 9

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GETTING STARTED

To get started, collect all the components of the VNS Therapy® System:
a)

Touch-screen programmer preloaded with VNS Therapy®

programmer software

Wireless wand (Model 2000) with two AA lithium or alkaline batteries

Programmer charger

Type A-C USB cable (used to connect to charger to charge the programmer)

Type C USB cable (option to connect programmer to wand)

Type A-C USB drive (used to import/export protocols and export

session reports)

Before Using the Programming System

in a Patient Session

Charge the Programmer

Charge the programmer

Turn the programmer ON

Check the programmer battery: Check the battery status on the

BATTERY INDICATOR at the top right corner of the programmer screen

Check the wand batteries: Confirm that the wand batteries are not low

Change the date and time if necessary. Accurate patient and device history

stored in the programmer depend on correct date and time settings

Connect the wand to the programmer

Interrogate the generator (check communication between the programmer

and the generator)

Charge the programmer before use so that there is adequate battery power
during a patient session.

To charge the programmer:
1.

Connect the adapter cord to the programmer and to the AC adapter

Plug the AC adapter into an outlet

A fully discharged battery may take four to five hours to charge.

Programmer

Adapter Cord

AC Adapter

Outlet

SenTiva System Management

Summary of Contents for SENTIVA M2000 Wand

Page 1: ...1 Technical Guide ...

Page 2: ...s of the Magnet End of Service Device Diagnostics In the Operating Room Preoperative System Checks Programming Diagnostics GENERAL DOSING GUIDELINES SenTiva Dosing Guidelines MRI SenTiva MRI Guidelines TROUBLESHOOTING Screen Freeze Wand Connection or Communication Issues Patient Cannot Feel Stimulation Patient Cannot Feel Magnet Stimulation Patient Does Not Perceive AutoStim Activation High Low Le...

Page 3: ...Therapy Physician s Manual Please note that not all products shown in this Technical Guide are cleared for sale in all markets Please check with your local representative to see what is available in your area INDICATIONS FOR USE CONTACT INFORMATION Contact Us General inqiuries for questions about LivaNova LivaNova products warranties etc or to request a call from company representative http www li...

Page 4: ...sonalized Vagus Nerve Stimulation VNS Therapy for drug resistant epilepsy DRE The VNS Therapy System includes four parts Generator and lead Programmer tablet and software Wand Magnet Vagus Nerve VNS Therapy Generator VNS Therapy Lead Programmer Programming Wand Watch Style Magnet Pager Style Magnet ...

Page 5: ...ware pre installed and a wand M2000 The programmer and the wand connect wirelessly This training module is developed for the M3000 programmer and M2000 wand The programmer and wand are required for use The programmer and wand work together to Interrogate communicate with the generator in order to adjust therapy parameters for the generator Assess whether the generator and lead are functioning as e...

Page 6: ...wand operates on two AA lithium or alkaline batteries The VNS Therapy System has a patient controlled feature that can be activated with a specially designed magnet The magnet can be used to Attempt to reduce the intensity of or abort an oncoming seizure or seizure in progress Temporarily inhibit stimulation Verify the generator is providing stimulation Reset the generator in combination with the ...

Page 7: ...el 105 ApsireHC Model 106 AspireSR Model 1000 SenTiva Please see the following chart to determine the generator s compatibility with other VNS Therapy components The table below details the compatibility for all components of the VNS Therapy system No longer distributed Not for sale in all markets Lead 300 302 303 304 402 502 220 201 M250 2000 M3000 Tunneler Programming Wand Programmer Accessory P...

Page 8: ...on demand stimulation that attempts to abort or de intensify an oncoming seizure or a seizure in progress The patient or caregiver initiates Magnet Mode by passing a VNS magnet over the implanted generator Automatic stimulation or AutoStim is an optional feature in some generator models AutoStim delivers stimulation when the generator detects a rapid relative heart rate increase 20 that may be ass...

Page 9: ...er battery Check the battery status on the BATTERY INDICATOR at the top right corner of the programmer screen 4 Check the wand batteries Confirm that the wand batteries are not low 5 Change the date and time if necessary Accurate patient and device history stored in the programmer depend on correct date and time settings 6 Connect the wand to the programmer 7 Interrogate the generator check commun...

Page 10: ...r OFF Press and hold the POWER button for 3 seconds and then release Follow the on screen instructions to shut down the programmer After 10 minutes of inactivity the screen will automatically turn off To manually turn the screen off Quickly press and release the POWER button Use this method when you want to preserve battery but not shut down the Programmer NOTE The POWER button may not respond if ...

Page 11: ...mer is IN SESSION To end the session tap on the END SESSION button at the left of the Patient ID Bar Quick Access Bar From any software screen tap the VNS Therapy logo on the title bar black bar at the top of the screen to access programmer settings and system information This drop down menu shows the following Programmer date and time OUT OF SESSION only Wand connection status Programmer battery ...

Page 12: ...12 Quick Access Bar Patient ID Bar Navigation Bar Main Screen Out of Session Summary Screen In Session ...

Page 13: ... Programmer Battery Before using the programmer with a patient confirm that the battery is fully charged To check the battery Look at the BATTERY INDICATOR in the top right corner of every screen Battery Indicator ...

Page 14: ...e batteries before using the device If only the Low Battery Indicator lights up no green arcs no communication will be possible until you replace the batteries 2 To replace batteries If batteries are low remove the battery compartment cover on the back of the wand and replace the batteries with two new AA lithium ion or alkaline batteries Turn Wand Power On Low Battery Indicator Wand Battery Repla...

Page 15: ...avigate to the Date Time screen OPTION 1 From the Main Screen tap the VNS Therapy logo on the title bar black bar at the top of the screen OPTION 2 From the Main Screen select SETTINGS from the bottom navigation bar On the Settings Screen tap the EDIT button at the top of the page near the time 2 To change time Tap the current display time and scroll up or down 3 To change date Use LEFT or RIGHT A...

Page 16: ...16 Tap and scroll to change time Use left and right arrows to change month Tap the desired date NOTE You must adjust the programmer manually for time zones or Daylight Savings Time ...

Page 17: ...ings Screen on the programmer tap on WAND SETTINGS PREFERRED WAND 5 Tap on the preferred wand serial number found on the back of the wand to enable the preferred wand or to change wands 6 Tap on BACK upper left to return to the Main Screen 7 Look for two green arcs on the wand to indicate the wand is available for connection with the programmer Once availablity is established four green arcs on th...

Page 18: ...ogrammer and wand are connected When they are not connected the green lights will go off after 2 minutes NOTE Wireless Preferred connection recommended for wands and programmers that are always used together Provides a quicker connection when interrogating a patient s generator because the programmer automatically looks for the preferred wand Choose a wand connection recommended if there are sever...

Page 19: ...cted 5 No preferred wand If you have not set up a preferred wand the programmer will show all powered on wands in range Select the serial number for the wand you intend to use The programmer will connect to that wand and display the wand s information on the screen indicating that the programmer and wand are connected 6 Place the wand over the generator 7 If the interrogation is working a generato...

Page 20: ...ator 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 Check box only app...

Page 21: ... status Ends current session Generator and patient information Interrogate generator Last known diagnostics measurements View stimulation events Current parameters Navigation bar to additional software features Shortcut buttons 1 2 3 7 5 9 4 8 6 10 1 3 2 5 4 6 7 10 10 10 9 8 ...

Page 22: ...osition after an AutoStim or magnet activation Guided Programming Simplifies programming with option of Standard or Custom Therapy Protocols Scheduled Programming Automatically change parameter steps according to a preset schedule Day Night Programming Delivers two independent sets of therapy parameter schedules at different times during a 24 hour period NOTE The programmer must be IN SESSION to a...

Page 23: ...e change to parameters 3 Tap APPLY CHANGES to program your changes NOTE After Implant Set output current to 0 mA slowly increase by 0 25 mA increments until patient feels stimulation at a comfortable level Replacement Generators Set output current at 0 mA slowly increase by 0 25 mA to previous therapy level to allow patient time to re adjust Edit Parameters Parameters NOTE At the end of each offic...

Page 24: ...ilable in addition to Normal and Magnet parameters 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 enabl...

Page 25: ...Detection is enabled the software will walk you through heartbeat detection setting verification and AutoStim Threshold selection To Verify Heartbeat Detection 1 Select VERIFY on the Detection Tab to confirm the accuracy of the heart rate detected by the generator or to change the Heartbeat Detection setting 2 Place the Wand over the generator and press START to begin the test Keep the Wand over t...

Page 26: ...toward setting 1 If the heart rate reported by the Programmer is too low or displays BPM then the Heartbeat Detection setting should be adjusted upward toward setting 5 Refer to Troubleshooting in the Physician s Manual for more information 3 If the heartbeat detection is verified before the two minute test completes keep the Wand over the generator and select STOP on the screen Once you observe a...

Page 27: ...rs capable of heartbeat detection 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 BPM will display on the screen If BPM displays LivaNova recommends you temporarily disable all output currents for generators capable of heartbeat dete...

Page 28: ...e screen to go to the Parameters Screen 2 On the Parameters Screen tap on the DETECTION tab Tap the LOW HEARTRATE THRESHOLD field and select a threshold from the pop up menu range 30 60 BPM APPLY CHANGES Turn on Prone Position Detection The programmer will prompt you to calibrate the generator orientation within the body NOTE At the end of each office visit the generator must be interrogated by ta...

Page 29: ...creen 2 Instruct the patient to lie down flat on their back in the supine position Place the wand over the generator and press NEXT on the programmer screen 3 Look for the on screen confirmation that Prone Position Detection is now enabled CAUTION Low heart rate and prone position events are for informational purposes only Detected events are not to be used for alarms or medical diagnosis ...

Page 30: ...n prompts to make selections Tap APPLY CHANGES before leaving each screen In Guided Programming mode the SenTiva M1000 generator will Keep the current mode protocol and step in memory Increase or decrease parameters to the next protocol step in response to a single button NOTE Guided Programming mode is unavailable if Day Night programming is enabled Use the Guided Programming feature to adjust pa...

Page 31: ...LY CHANGES to save 2 Select DECREASE STEP to change the parameters to the previous protocol step Tap APPLY CHANGES to save 3 To exit Guided Programming press EXIT GUIDED To review current therapy protocol steps In Guided Mode view tap on the OVERVIEW button on the right side of the screen Overview Decrease Step Increase Step ...

Page 32: ...creases above that target must be done manually NOTE At the end of each office visit the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports Standard Protocol Steps Standard Protocol Persistent Parameter Settings For information on creating Custom Protocols see page 37 ...

Page 33: ...Mode Screen select either STANDARD or CUSTOM protocol and tap NEXT 4 Tap APPLY CHANGES to enable Guided Mode To turn on Scheduled Programming 1 In Guided Mode View tap the SCHEDULED APPLY button 2 On the Scheduled Apply Screen tap on ENABLE NOW at the center of the screen 3 On the next Scheduled Apply screen select the time interval between step increases then tap GENERATE SCHEDULE at the center o...

Page 34: ... patient s local time zone to ensure therapy changes occur at the intended times NOTE Protocols that utilize 0 25mA increases such as the Standard Protocol require a minimum of 14 days between scheduled automatic titration steps Custom protocols that utilize 0 125mA increases require a 7 day minimum interval between scheduled titration steps Scheduled Apply ...

Page 35: ...Night program tap YES 4 On the Nighttime Tab follow the on screen prompts to make selections for active start and end times 5 On the Daytime Tab the remaining hours from the 24 hour cycle are automatically shown as the daytime active period Customize stimulation parameters as desired 6 On the DETECTION TAB set AutoStim thresholds for both day and night Tap APPLY CHANGES 7 On the Apply Changes Scre...

Page 36: ...ERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports NOTE After programming the patient will experience 15 minutes of the alternate parameter set Assess for tolerability during this time Day AutoStim Threshold Night AutoStim Threshold ...

Page 37: ...p on THERAPY PROTOCOLS button To create a custom protocol 1 From the Therapy Protocols screen select CREATE PROTOCOL 2 From the Create Protocol Select a Starting Point screen select START FROM SCRATCH or choose an existing protocol as base 3 Add or delete steps maximum of 7 and set the output currents for each therapy mode When you are finished tap NEXT 4 Choose the custom persistent parameters th...

Page 38: ...38 Tap to delete steps ...

Page 39: ...followed by tapping the END SESSION button to ensure creation and accuracy of the session reports View History Data Summary data are stored in several diﬀerent locations 1 To view current parameter settings After interrogation parameter settings can be viewed on the Summary Screen 2 To view a history of parameters that have been used with this patient over time From the Summary Screen tap on the H...

Page 40: ...en instructions To transfer data between Programmers select IMPORT EXPORT on the Navigation Bar from the Main Screen This may be used to consolidate patient data between multiple computers or to copy a custom therapy protocol from one Programmer to another To export a full Programmer copy do the following 1 Insert external media into the Programmer USB drive type C 2 Select EXPORT DATA and follow ...

Page 41: ...en 2 Tap on the EVENTS tab 3 Tap on VIEW LAST TIMESTAMPS button The button reflects the total number of timestamps recorded The maximum number of timestamps shown are the most recent 50 for the M1000 generator To view a summary of the therapy that was delivered between office visits From the Summary Screen tap on the EVENTS button at the bottom of the screen to access these data View Last Timestam...

Page 42: ...istory of Magnet Inhibitions At the top are Magnet Stimulation timestamps and below are Magnet Inhibition timestamps In each case you can select the date header to select the time intervals to view Stimulations Inhibitions NOTE Ensure ADVANCED INTERROGATION is selected on the Main Screen in order to view Events and Trends after generator interrogation ...

Page 43: ... the TRENDS tab 2 To download timestamp information from the generator place the wand over the generator and tap the DOWNLOAD DATA button 3 Check the colored boxes to select the event types you want to include in your histogram 4 Tap on the button displaying the date to adjust the timeframes 5 Tap on EVENTS PER DAY to show one month of detection data in a day by day format 6 Tap on EVENTS PER HOUR...

Page 44: ...44 NOTE To view more details tap on the individual bars in the histogram ...

Page 45: ...ee the VNS Therapy Physician s Manual It is recommended except in cases of a medical emergency that the physician consult a LivaNova technical representative before a reset is performed Daily Assessment of Generator Function Patients are instructed to swipe the magnet over the generator daily to ensure that the device is working particularly if they do not feel it or have no voice change The highe...

Page 46: ...AutoStim Diagnostics Make sure to follow all the instructions on the Programmer screen as they vary for each selection It is 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 ...

Page 47: ...End of Service EOS Values Results OK IFI N EOS EOS What Does the Value or Result Mean OK Battery level is within normal operating range and no special attention is required IFI The battery has depleted to a level where more frequent clinical monitoring is recommended N EOS The Generator should be replaced as soon as possible EOS The generator is no longer supplying stimulation and immediate replac...

Page 48: ...or post implant shows that both the generator and lead are working properly LivaNova recommends you perform a System Diagnostics test before other diagnostic tests The Magnet Mode Diagnostics test will let you know if the generator is able to deliver the programmed magnet output current To perform this test do the following 1 Select TEST MAGNET 2 Quickly pass the magnet over the generator no more ...

Page 49: ... use with a test resistor and should only be accessed for troubleshooting scenarios during implantation surgery Go to Troubleshooting for more details on using Generator Diagnostics NOTE Once programmed ON lead impedance measurement readings are automatically performed once every 24 hours for Model 103 and higher generators Results from the 24 hour impedance check will be reported on the Summary S...

Page 50: ...nnected wirelessly or with a backup USB cable NOTE At the end of parameter adjustment in the Operating Room the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports 1 Conduct ECG to select implant location 2 Perform preoperative system checks 3 Program Patient ID and implant date 4 Access ...

Page 51: ...he generator To enter or edit patient data 1 Connect the wand to the programmer and interrogate the generator 2 On the Summary Screen review the patient and generator information that is displayed in the blue Patient ID bar at the top of the screen Tap the EDIT button below the patient information 3 On the Edit Patient ID screen enter or change information as needed 4 Tap APPLY CHANGES and CONFIRM...

Page 52: ...ab and then tap on ENABLE NOW to turn on Tachycardia Detection Perform System Diagnostic 1 System Diagnostic 1 tests the continuity of the lead and confirms delivery of the programmed output current to the vagus nerve To perform System Diagnostic 1 1 From the Summary Screen tap on the PERFORM DIAGNOSTICS button OR tap on the DIAGNOSTICS button in the Navigation Bar 2 On the Diagnostics screen tap ...

Page 53: ...Small ECG signals need high amplification e g setting 5 while large ECG signals do not e g setting 1 4 Keep the wand over the generator and press START on the programmer screen to begin the test Wait at least 10 seconds for the reading to stabilize 5 Compare the heart rate measured by the system in beats per minute BPM to the actual heart rate of the patient and adjust the Heartbeat Detection Sett...

Page 54: ...54 ...

Page 55: ...d with the patient s seizure To select the AutoStim Threshold 1 From the Summary Screen tap on the EDIT PARAMETERS button OR tap on the PARAMETERS button in the Navigation Bar at the bottom of the screen 2 On the Parameters Screen tap on the Detection Tab and confirm that Tachycardia Detection is enabled 3 Select an AutoStim Threshold The threshold is the amount of heart rate increase needed to tr...

Page 56: ...utton in the Navigation Bar at the bottom of the page 2 On the Diagnostics screen tap TEST SYSTEM to start the test 3 Review the results tap DONE 4 Tap INTERROGATE button on the top right corner of the screen and then tap the END SESSION button at the top left of the screen Diagnostics Button Perform Diagnostics Button Test System NOTE At the end of parameter adjustment in the operating room the g...

Page 57: ...Time Output Current Pulse Width ON Time Output Current Pulse Width ON Time mA Hz μsec seconds minutes mA μsec seconds mA μsec seconds 0 25 20 250 30 5 0 375 250 60 0 5 500 60 0 5 20 250 30 5 0 625 250 60 0 75 500 60 0 75 20 250 30 5 0 875 250 60 1 0 500 60 1 0 20 250 30 5 1 125 250 60 1 25 500 60 1 25 20 250 30 5 1 375 250 60 1 5 500 60 1 5 20 250 30 5 1 625 250 60 1 75 500 60 1 75 20 250 30 5 1 8...

Page 58: ...prone position when they occur within 7 5 minutes of an AutoStim or Magnet Mode activation Low Heart Rate Range 30 60 BPM Configure generator to log low heart rate episodes when they occur within 7 5 minutes of an AutoStim or Magnet Mode activation Tachycardia detection must be enabled LivaNova recommends that stimulation with Normal Mode ON time OFF time be avoided Duty Cycle ON Time 4 seconds ON...

Page 59: ...ased coughing pharyngitis paresthesia dyspnea dyspepsia and nausea This information is not intended to serve as a substitute for a complete and thorough understanding of the material presented in the Physician s Manuals for the VNS Therapy system and its component parts and does not represent full disclosure of all pertinent information concerning the use of this product potential safety complicat...

Page 60: ...so center must be outside the exclusion zone Imaging techniques such as computed tomography x ray and ultrasound are safe to perform in the MRI exclusion zone Review the most current labeling prior to performing an MRI scan For full MRI safety information refer to MRI Instructions for Use at www easy mri com Patients with implants in other locations must follow Group B scan conditions SenTiva MRI ...

Page 61: ...mity coil C7 T8 Max Spatial Gradient 3000 Gauss cm Max Slew Rate 200 T m s RF Coil Transmit Body coil or Transmit receive head or extremity coils Receive No Restrictions Max SAR Transmit head coil 3 2 W kg Transmit body coil 2 0 W kg System Programming Stimulation OFF Sensing OFF for select models with AutoStim mode Optional device features OFF Model 1000 only Exposure Time Transmit head or extrem...

Page 62: ...OUP B C7 T8 MRI Exclusion Zone Imaging techniques such as computed tomography x ray and ultrasound are safe to perform in the MRI exclusion zone Review the most current labeling prior to performing an MRI scan For full MRI safety information refer to MRI Instructions for Use at www easy mri com Permissable scans include head knee ankle and wrist ...

Page 63: ...cylindrical closed bore 1 5T or 3T scanner Operating Mode Normal Operating Mode Exclusion Zone C7 T8 Max Spatial Gradient 3000 Gauss cm Max Slew Rate 200 T m s RF Coil Transmit receive head or extremity coils Max SAR Transmit receive head coil 3 2 W kg System Programming Stimulation OFF Sensing OFF for select models with AutoStim mode Optional device features OFF Model 1000 only Exposure Time Tran...

Page 64: ...ody or transmit receive head or extremity coils Receive No Restrictions Transmit head coil 3 2 W kg Transmit body coil 2 0 W kg Equivalent to clipping the lead at the anchor tether Yes 1 5T or 3T Normal Operating Mode None 3000 Gauss cm 200 T m s Transmit Receive head or extremity coils only Transmit receive head coil 3 2 W kg Exclusion Zone C7 T8 None MR Conditional Yes Yes Static Magnet Strength...

Page 65: ...t heating or other unusual sensations so the operator can terminate the procedure if needed Post MRI Instructions After the MRI procedure an appropriate healthcare professional with access to a VNS Therapy programming system should assess the condition of the VNS Therapy system To assess the VNS Therapy system Interrogate the VNS Therapy generator If the generator was reset during the scan reprogr...

Page 66: ...and lead For other programming system issues not addressed in this section please contact LivaNova Contact Us General Inqiuries for questions about LivaNova LivaNova products warranties etc or to request a call from a company representative http www livanova com contact us 24 hour Technical Support for technical questions with programmer generator or wand 1 866 882 8804 US and Canada 1 281 228 733...

Page 67: ...wand not found Check Wand Power Press and release power button 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 Replace batteries Connect with backup cable Contact LivaNova Technical Support Retry connecting to wand Yes No No Yes Yes No Yes No Yes ...

Page 68: ...r is still non responsive press and hold power button to force a shut down approximately 10 seconds Reboot Power on the programmer Solution Steps for Wand Verify wand battery power If the orange low battery light is on replace the wand batteries Perform soft reset Press and hold wand power button for 5 seconds and release Verify Programmer has adequate charge Programmer has correct date time Proce...

Page 69: ...ort recognition of the Programmer cable Defective Wand or Programmer Wand not connected Check Wand Power Press and release power button Verify Cable Connection Confirm cable is connected to wand and programmer Reinsert if necessary Proceed with intended use Retry connecting to wand Replace batteries Contact LivaNova Technical Support Yes No No No Yes Yes Does wand power indicator light appear Succ...

Page 70: ...ice EOS Magnet placed over generator Defective Wand Programmer or generator 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 Remove Magnet Presence Confirm magnet is not placed over the generator Retry Communication Su...

Page 71: ... the CAUSE The generator is currently disabled due to CAUSE The generator is NOT supplying stimulation Note If the CAUSE is a wand reset and the reset was intended continue with the session Perform a System Diagnostics Record results Lead Impedance Result Output Current Result The generator is able to deliver programmed output current and the VNS system is working properly Probable Diagnosis The p...

Page 72: ...djusting magnet setting Lead Impedance High or Low See Troubleshooting in the programming system Physician s Manual Lead Impedance Ok Output Current Ok Magnet Mode stimulation is functioning properly and the patient may have become accustomed to the settings Consider raising the magnet current if perceived stimulation is desired Lead Impedance Ok Output Current Low Generator cannot deliver the pro...

Page 73: ...s and record results Examine office visit data in Device History or Events Investigate consecutive office visits to identify any changes in the average number of AutoStims per day delivered Yes Current Delivered If 0 If 0 Current Not Delivered No Disabled Message Patient Report The generator is delivering AutoStim If perceived stimulation is desired consider raising the AutoStim current Re evaluat...

Page 74: ...eceptacle 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 TROUBLESHOOTING on the programmer Select GENER...

Page 75: ...gage 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 Troubleshoot Generator Back out setscrew s and remove lead pin s Insert test resistor into generator and tighten setscrew s with hex scre...

Page 76: ...d results Possible Causes Lead discontinuity Lead disconnection from the generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective generator Possible Causes Increased impedance in the system Possible Causes Lead discontinuity Lead disconnection from the generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective generator ...

Page 77: ... to low storage temperatures Defective generator 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 Lead Impedance any Impedance Value any IFI No Proceed with implant Contact LivaNova Technical Support Wait app...

Page 78: ...rator battery power 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 ha...

Page 79: ...onfirm Detection is enabled Check Wand Placement Verify wand is over the generator Adjust Heartbeat Detection setting upward toward 5 Done Contact LivaNova Technical Support Contact LivaNova Technical Support Retry with different settings BPM Ok All settings attempted with out success Low Yes Yes No High No Adjust Heartbeat Detection setting downward toward 1 Confirm accuracy in different body pos...

Page 80: ...rapy Tachycardia Detection Issues INACCURATE AUTOSTIMS AT FOLLOW UP VISIT Sometimes generator detection settings may miss detecting heart rate changes that may be associated with a seizure The following conditions may be potential causes Heart rate changes Exercise physical activity and normal sleep can increase the heart rate and cause the generator to falsely declare an event Duty cycle Because ...

Page 81: ...332 www VNSTherapy com LivaNova Belgium NV Ikaroslaan 83 1930 Zaventem Belgium Tel 32 2 720 95 93 Fax 32 2 720 60 53 2019 LivaNova USA Inc a wholly owned subsidiary of LivaNova PLC All rights reserved LivaNova SenTiva AspireSR and VNS Therapy are registered trademarks of LivaNova USA Inc SenTecGd19U1 ...

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