LivaNova VNS Therapy 250 Physician'S Manual Download

Page: 1 / 92

26-0008-1100/5 (

Worldwide

) — 1 of 92

Note:

This manual contains information on the use of the LivaNova



VNS Therapy Programming

Software, Model 250 Version 8.1. Physicians should refer to the

VNS Therapy Pulse Generator

physician’s manuals for additional important prescribing and safety information. A copy of this VNS
Therapy manual is posted at www.livanova.com.

Physician’s Manual

VNS Therapy

Programming Software

Model 250 Version 8.1
Handheld Computer

June 2017

Worldwide Version

Caution:

U.S. federal law restricts this device to

sale by or on the order of a physician.

For Healthcare Professionals

0344

2011

Summary of Contents for VNS Therapy 250

Page 1: ...e Generator physician s manuals for additional important prescribing and safety information A copy of this VNS Therapy manual is posted at www livanova com Physician s Manual VNS Therapy Programming Software Model 250 Version 8 1 Handheld Computer June 2017 Worldwide Version Caution U S federal law restricts this device to sale by or on the order of a physician For Healthcare Professionals 0344 20...

Page 2: ...ts reserved LivaNova is a registered United States trademark of LivaNova PLC NCP Demipulse Demipulse Duo Perennia VNS Therapy AspireHC PerenniaFLEX PerenniaDURA and AspireSR are registered trademarks of LivaNova USA Inc Pulse and Pulse Duo are trademarks of LivaNova USA Inc Corresponding foreign trademarks may also be registered or pending ...

Page 3: ...cable to Model 100 101 and 102 Pulse Generators ONLY 26 4 2 PARAMETER Screen Menu 27 4 2 1 Interrogate Device 28 4 2 2 Device Diagnostics 28 4 2 2 1 Interrupted System and Generator Diagnostics 31 4 2 2 2 Diagnostic test parameters 34 4 2 2 3 System Diagnostics 39 4 2 2 4 Normal Mode Diagnostics 40 4 2 2 5 Magnet Mode Diagnostics 41 4 2 2 6 Generator Diagnostics 42 4 2 3 Program Patient Data scree...

Page 4: ...ation problems in OR 64 10 3 2 High Lead impedance on System Diagnostics in OR initial implant 68 10 3 3 High Lead impedance on System Diagnostics in OR Pulse Generator replacement 69 10 3 4 Low Lead impedance on System Diagnostics in OR initial implant 72 10 3 5 Low Lead impedance on System Diagnostics in OR Pulse Generator replacement 74 10 3 6 Low Battery End of Service indications prior to sur...

Page 5: ...ROGRAMMING EXAMPLE 27 TABLE 4 DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR COMMUNICATION 34 TABLE 5 DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR OUTPUT STATUS 35 TABLE 6 DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR OUTPUT CURRENT FOR MODELS 100 101 AND 102 36 TABLE 7 DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR LEAD IMPEDANCE 36 TABLE 8 DC DC CONVERTER CODES AND LEAD IMPEDANCE MODEL 100 SN 10 000 ...

Page 6: ...IGURE 13 PROGRAMMING FAILED WARNING SCREEN 24 FIGURE 14 CHANGED SETTINGS PROGRAMMING WARNING SCREEN 25 FIGURE 15 PROGRAMMING FAILED WARNING SCREEN 26 FIGURE 16 PARAMETER SCREEN MENU 28 FIGURE 17 DEVICE DIAGNOSTICS MENU 29 FIGURE 18 DEVICE DIAGNOSTICS SUB MENU 30 FIGURE 19 DIAGNOSTIC SINGLE FAILURE WARNING SCREEN 32 FIGURE 20 DIAGNOSTIC MULTIPLE FAILURE WARNING SCREEN 32 FIGURE 21 CHANGED SETTINGS ...

Page 7: ... ON SYSTEM DIAGNOSTIC TEST IN OR INITIAL IMPLANT OR GENERATOR REPLACEMENT 71 FIGURE 41 LOW LEAD IMPEDANCE ON SYSTEM DIAGNOSTICS IN OR INITIAL IMPLANT 73 FIGURE 42 LOW LEAD IMPEDANCE ON SYSTEM DIAGNOSTICS IN OR PULSE GENERATOR REPLACEMENT 74 FIGURE 43 LOW BATTERY END OF SERVICE INDICATIONS PRIOR TO SURGERY OUTSIDE OF THE STERILE FIELD INITIAL IMPLANT OR PULSE GENERATOR REPLACEMENT 76 FIGURE 44 HIGH...

Page 8: ...8 of 92 26 0008 1100 5 Worldwide Physician s Manual VNS Therapy Programming Software 8 1 ...

Page 9: ...ram a Pulse Generator s parameters and assess Pulse Generator function Use of the software without the Programming Wand to display the operating histories of all the Pulse Generators interrogated with your handheld computer Use of screen displays that provide prompts and messages to aid in interrogating and programming 1 2 Symbols Symbols and definitions used for the VNS Therapy System include the...

Page 10: ...mental sources of electromagnetic interference Note See the physician s manual for the VNS Therapy Pulse Generators for a complete description of the Pulse Generator its indications for use and its operation Note See the physician s manual for the Programming Wand for a description of the Programming Wand For Models 100 101 and 102 Pulse Generators each parameter is programmed and verified individ...

Page 11: ...ion see Troubleshooting on page 61 1 6 Communication Signals Four rapid ascending musical tones and a screen message signal the successful completion of an interrogation or programming operation Four rapid descending musical tones and a screen message signal a warning or a failed operation The DATA RCVD indicator on the Programming Wand lights up during a successful programming operation or interr...

Page 12: ...e handheld computer Before proceeding to the next section be sure you have arrived at the MAIN Menu as shown in Figure 1 If for any reason the software must be reinstalled directions for doing so are provided in the Troubleshooting section of this manual 1 Turn on the handheld computer by pressing the on off button The handheld computer will display the same screen it was displaying when it was la...

Page 13: ...k to the device via the Programming Wand 3 1 2 View Database overview Note See View Database on page 47 for more information View Database is used to view information from all Pulse Generator interrogations and programming events performed by your handheld computer and the Programming Software 3 1 3 View Last Parameters overview Note See View Last Parameters on page 53 for more information View La...

Page 14: ...gation the Programming Software automatically displays the PARAMETER screen see Figure 3 on page 15 unless an error condition i e Generator End of Service or High Lead Impedance is detected with the Pulse Generator If an error condition is detected with the Pulse Generator the associated warning message is displayed and must be acknowledged by the user before proceeding to the PARAMETER screen The...

Page 15: ...05 For the Models 100 101 102 Pulse Generators the progress bar across the bottom of the screen is an inactivity timeout indicator When the bar reaches the right margin the most recent interrogation will have expired and the warning shown in Figure 4 on page 16 will be displayed Also it will be necessary to reinterrogate the Pulse Generator before programming The inactivity timeout period can be a...

Page 16: ... and 102 Pulse Generators The Programming Software has three indicators Intensified Follow up Indicator IFI Near End of Service N EOS and End of Service EOS for Models 103 104 and 105 Pulse Generators On the PARAMETER screen the Near EOS status for Models 100 101 and 102 Pulse Generators is displayed on the lower portion of the screen see Figure 3 on page 15 For Model 103 104 and 105 Pulse Generat...

Page 17: ...f an interrogation or Diagnostics testing the Programming Software will display the associated warning message should the Pulse Generator battery reach Near EOS for Models 100 101 and 102 see Figure 6 on page 17 and IFI N EOS or EOS for Models 103 104 and 105 see Figure 7 Figure 8 and Figure 9 on pages 18 and 19 Figure 6 BATTERY STATUS INDICATOR NEAR EOS WARNING Screen Models 100 101 102 ...

Page 18: ...1100 5 Worldwide Physician s Manual VNS Therapy Programming Software 8 1 Figure 7 BATTERY STATUS INDICATOR IFI WARNING Screen Models 103 104 105 Figure 8 BATTERY STATUS INDICATOR N EOS WARNING Screen Models 103 104 105 ...

Page 19: ...isplayed Pulse Generator Battery Status Recommendations 100 101 102 Battery measurement not supported by Generator None displayed Near EOS No The Pulse Generator battery level is good No warning message is displayed from the Programming Software and no special attention is required 100 101 102 Battery measurement not supported by Generator None displayed Near EOS Yes The Pulse Generator is nearing...

Page 20: ...re frequent clinical monitoring is recommended 105 5 to 11 103 104 0 to 8 N EOS Yes The Pulse Generator is near End of Service N EOS The Programming Software will display a warning message indicating this status upon completion of interrogation or Diagnostics testing It is recommended that the Pulse Generator be replaced as soon as possible 105 0 to 5 103 104 105 0 EOS Yes The Pulse Generator has ...

Page 21: ...g in boldface type see Figure 10 If there are values greater than or less than those shown on the screen you can view them by tapping the appropriate set of the double arrows Look at the left half of the screen and note that the parameter for which the value is being changed is enabled clearly visible and the other parameters are disabled grayed out In the example in Figure 10 Output Current is en...

Page 22: ...ents who are receiving replacement generators should be started at 0 mA Output Current followed by incremental increases of 0 25 mA to allow for reaccommodation to the therapy Figure 10 PARAMETER SETTINGS POP UP Menu 2 Select the new target value for the Output Current by tapping the desired value on the screen If the target value selected is greater than 0 25 mA above the currently programmed val...

Page 23: ...r signal which results in excessive battery depletion of the implanted Pulse Generator therefore use these low frequencies for short periods of time only Caution Stimulation at a combination of high frequency 50 Hz and ON time OFF time has resulted in degenerative nerve damage in laboratory animals ON time OFF time can be simulated by very frequent magnet activation LivaNova recommends that stimul...

Page 24: ...Software will re program the Pulse Generator If the user selects Cancel the Programming Software will default back to the START INTERROGATION screen see Figure 2 It is recommended that the Pulse Generator be interrogated immediately as this will verify the currently programmed settings After completion of the interrogation the Programming Software displays a warning message stating that device set...

Page 25: ...partial programming If an interruption occurs during a programming step for these Pulse Generators the Programming Software displays a warning message indicating that the procedure failed and allows the user to retry or cancel the programming operation see Figure 15 on page 26 If the user selects Retry the Programming Software will re program the Pulse Generator If the user selects Cancel the Prog...

Page 26: ...lse Generator as Patient B 2 Patient A s Pulse Generator was interrogated programmed with the Programming Software and the Programming Software is left on the PARAMETER screen 3 Inactivity timeout has not expired or is disabled 4 Patient B s Pulse Generator is programmed at the PARAMETER screen in step 2 without first performing an interrogation The result of the above scenario is that Patient B s...

Page 27: ...VNS patients in order to verify parameter settings 4 2 PARAMETER Screen Menu Tapping the Menu button at the right top of the PARAMETER Screen causes the PARAMETER Screen Menu to be displayed as shown in Figure 16 on page 28 Parameter After Step 2 At Step 4 After Step 4 Patient A Final Settings Patient B Initial Settings Patient B Intended Final Settings Patient B Actual Final Settings Patient A Fi...

Page 28: ... the Pulse Generator is required to reach the menu shown in Figure 16 An Interrogate Device button is available here so you can interrogate the device after each programming event A post programming interrogation should be performed to ensure that the Pulse Generator was programmed as desired 4 2 2 Device Diagnostics Tap the Device Diagnostics button on the PARAMETER Screen Menu to display the DEV...

Page 29: ... DC DC Converter Code can be used at patient follow up visits to assess lead impedance status for Models 100 101 and 102 An actual impedance measurement is reported for Models 103 104 and 105 The System Diagnostics is also used during implantation and routine follow up visits to assess nerve electrode impedance The Normal Mode Diagnostics Magnet Mode and Generator Diagnostics can be accessed by ta...

Page 30: ...y of an output stimulation is required for diagnostic data collection the Programming Software will automatically program the output current at the initiation of a Generator or System diagnostic tests The automatic programming is not performed for the Magnet or Normal Mode diagnostics Caution For the System Diagnostics on Models 100 101 and 102 Pulse Generators the Programming Software automatical...

Page 31: ...s not stimulating and that the diagnostic test must be repeated 4 2 2 1 Interrupted System and Generator Diagnostics For Models 100 101 and 102 Generators device parameters may be programmed to unintended settings if the communication between the Programming Wand and the Pulse Generator is interrupted during System or Generator Diagnostics When the Diagnostics test is first interrupted the Program...

Page 32: ...8 1100 5 Worldwide Physician s Manual VNS Therapy Programming Software 8 1 Figure 19 DIAGNOSTIC SINGLE FAILURE WARNING Screen Models 100 101 102 Figure 20 DIAGNOSTIC MULTIPLE FAILURE WARNING Screen Models 100 101 102 ...

Page 33: ...wide 33 of 92 Physician s Manual VNS Therapy Programming Software 8 1 Figure 21 CHANGED SETTINGS INTERRUPTED DIAGNOSTIC WARNING Screen Models 100 101 102 Figure 22 PARAMETER Screen with UNKNOWN SETTINGS Models 100 101 102 ...

Page 34: ...an 5 Communication This parameter is an indicator of the communication status during diagnostics Table 4 shows the possible values and interpretation for the communication parameter If the communication indicator shows the FAULT message an error has occurred during a communication The error may be the result of improper positioning of the Programming Wand over the Pulse Generator of EMI or noise b...

Page 35: ... Models 103 104 and 105 this parameter indicates whether the programmed current is being delivered during the diagnostic tests 8 Current Delivered On the Models 103 104 and 105 Pulse Generators this parameter indicates the output current delivered during the execution of the diagnostic test This parameter is not displayed for Models 100 101 102 Pulse Generators Output Status Status Reading Signifi...

Page 36: ...urrent Status Reading Significance OUTPUT CURRENT Setting Shows the current at which the diagnostic test was run For System Diagnostics and Generator Diagnostics Pulse Generator Test the software automatically programs the Pulse Generator to 1 0 mA After the System diagnostics the Pulse Generator will be reprogrammed to the pretest output current setting After the Generator Diagnostics Pulse Gener...

Page 37: ... Converter Codes and Lead Impedance Model 100 SN 10 000 Table 9 DC DC Converter Codes and Lead Impedance Model 101 See the physician s manual for the Pulse Generator for details DC DC Converter Code Estimated Lead Impedance 1mA 500 μsec 0 0 8 kOhms 1 0 8 2 kOhms 2 2 4 kOhms 3 4 6 5 kOhms 4 6 5 10 kOhms 5 10 16 kOhms 6 16 20 kOhms 7 20 kOhms DC DC Converter Code Estimated Lead Impedance 1mA 500 μse...

Page 38: ...gure 7 on page 18 13 Near End of Service Near EOS N EOS This indicator applies to all models Pulse Generators The Programming Software displays a warning message if it detects a near End of Service indicator of Yes see Figure 6 on page 17 When this message is displayed LivaNova recommends performing a System Diagnostics Test to verify the Near EOS status for the Models 100 101 102 Pulse Generators...

Page 39: ...hown in Figure 23 on page 40 which LivaNova recommends you perform before other tests is performed with the Bipolar Lead and the Pulse Generator connected A successful System Diagnostics during surgery shows that both components are working properly Test failure may be due to defects of either of the components or a faulty electrical connection between the Pulse Generator and the Bipolar Lead conn...

Page 40: ...se Generator If the output current is set to 0 0 mA the diagnostic test is run with an output current of 1 0 mA a pulse width of 500 μsec and a frequency of 20 Hz If the output current is programmed greater than 0 0 mA the diagnostic test is run at the programmed settings 4 2 2 4 Normal Mode Diagnostics The Normal Mode Diagnostics test indicates whether or not the device Models 100 101 and 102 is ...

Page 41: ... test is similar to the Normal Mode test see Figure 25 on page 42 This test determines whether the device is delivering the programmed magnet output current While performing the Magnet Mode Diagnostics test hold the magnet over the Pulse Generator for at least one second immediately remove it from the area and quickly place the Programming Wand over the Pulse Generator This action described in gre...

Page 42: ...gram the Pulse Generator to values shown in Table 11 for both normal and magnet modes Table 11 Minimum Normal Mode and Magnet Mode Diagnostic Settings Models 100 101 and 102 4 2 2 6 Generator Diagnostics Note See System Diagnostics on page 39 The optional Generator Diagnostics Pulse Generator Test as shown in Figure 26 on page 43 is performed when the System Diagnostics fails during the surgical i...

Page 43: ...tion For the Models 100 101 and 102 Pulse Generators during both the System Diagnostics and the Generator Diagnostics Pulse Generator Test the Programming Software automatically programs the output current to 1 0 mA the pulse width to 500 μsec and the frequency to 20 Hz Caution During a System Diagnostic for Model 103 104 and 105 Pulse Generators a test pulse of 0 25 mA is first used to assess the...

Page 44: ... System and Generator Diagnostics on page 31 4 2 3 Program Patient Data screen A three character patient identification code to be selected by the physician and the implant date become a permanent part of the Device History when they are programmed into the Pulse Generator To enter the Patient ID and implant date first select the Program Patient Data button on the PARAMETER Screen Menu The PROGRAM...

Page 45: ...the PARAMETER Screen 4 2 4 Display Device History screen When you tap the Display Device History button the DEVICE HISTORY Screen will be displayed as shown in Figure 28 on page 45 Via this screen you can access Patient data Device data and the 15 most recent Magnet activations For Models 100 101 and 102 Pulse Generators the Manufactured Date parameter is shown as N A Figure 28 DEVICE HISTORY Scre...

Page 46: ...R Screen and returns you to the MAIN Menu Caution When in use LivaNova recommends the handheld computer be operated on battery power only unplugged from AC power Having the handheld computer plugged into AC power during use may contribute to communication difficulties When not in use the handheld computer should be plugged into AC power to maintain charge 4 2 8 Handheld computer battery status The...

Page 47: ...base of the handheld computer Historical programming events including the latest can be viewed using either of two methods 1 Tap the View Database button on the PARAMETER Screen Menu 2 Tap the View Database button on the MAIN Menu The VIEW DATABASE Screen will be displayed as shown in Figure 29 on page 48 5 1 Specify Search Limits Before you actually view patient information records in the databas...

Page 48: ...ogically the records you retrieve Tapping Patient ID arranges records by ascending Patient ID codes Tapping Serial Number arranges the records by ascending Pulse Generator serial numbers 5 1 2 View All Records Note See User Preferences Screen on page 54 Selecting View All Records allows you to view all the records in the database up to the limit set in the USER PREFERENCES Screen The highest limit...

Page 49: ...ping the new values on the soft keyboard at the bottom of the screen 5 1 4 Patient ID Note See Program Patient Data screen on page 44 Make sure the View All Records button is unchecked or you won t be able to use the Patient ID option To limit your search to a particular patient tap the Patient ID button and enter the three character patient ID code by typing it on the soft keyboard at the bottom ...

Page 50: ... allows you to view all the records you choose to access The Up and Dn buttons at the top of the screen allow you to page up or page down from record to record By indicating your preference from the drop down menu at the top of the screen you again have the choice to sort the records by Date Patient ID or Pulse Generator Serial Number 5 2 2 View Diagnostic History Tap the View Diagnostic History b...

Page 51: ...ecting the Device Diagnostics button from the PARAMETER Screen Menu The VIEW DIAGNOSTIC HISTORY Screen is a scrollable screen that shows the Device Diagnostics that have been performed By indicating your preference from the drop down menu at the top of the screen you can choose to sort the data according to Date Patient ID or Serial Number 5 2 3 View Magnet History Tap the View Magnet History butt...

Page 52: ...W MAGNET HISTORY Screen The VIEW MAGNET HISTORY Screen is a scrollable screen that shows a history of Magnet Activations of the Pulse Generator You can sort these events by Date Patient ID or the Pulse Generator Serial Number by indicating your preference from the drop down menu at the top of the screen ...

Page 53: ... side of the device can also access the data Caution Magnet activation time stamps and total activation counts may be duplicated for Model 105 Pulse Generator See Precautions on page 59 for more details For Model 105 Pulse Generator using the cross pattern swiping technique for magnet activations may cause duplication in the magnet activation time stamps and in the total magnet activation counts D...

Page 54: ...tervals from 1 minute to 90 minutes Turning the timer to OFF is also available If the handheld computer is idle for the amount of time indicated in the button the Pulse Generator must be reinterrogated before performing any programming Tap Save Settings after making changes to this button Note See Cross programming applicable to Model 100 101 and 102 Pulse Generators ONLY on page 26 This function ...

Page 55: ...et Time button to reset the date and time Tapping the drop down arrow to the right of the System Date displays a calendar of the current month To scroll to earlier or later months tap or touch and hold the small black arrows in the upper left or right hand corners Tapping the day of the month for the current date closes the calendar and puts the date you tapped into the System Date button Setting ...

Page 56: ...nsferring a database from another handheld computer to your handheld computer However if this is to be performed the handheld computer from which the database is being transferred from MUST have the same underlying Operating System and the same version and build Programming Software as your handheld computer Otherwise database corruptions SQL errors may occur 7 7 Export Database to Text File The u...

Page 57: ...nplugged from AC power Having the handheld computer plugged into AC power during use may contribute to communication difficulties When not in use the handheld computer should be plugged into AC power to maintain charge The bar at the bottom of the screen indicates the percentage of the battery charge still available on the handheld computer When the handheld computer is operating on battery power ...

Page 58: ...Caution The FlashCard should never be stored near a magnet and should always be left in the handheld computer The FlashCard should be handled and stored in the standard manner for computer disks Although no component of the VNS Therapy System will withstand rough handling or abuse no unusual handling precautions are necessary ...

Page 59: ...mming Wand is turned on indicated by the green POWER light If the green light stops shining before the EMI source has been located turn on the Programming Wand again If EMI or other electrical noise is detected the yellow DATA RCVD light will come on and remain on as long as the Programming Wand is in the presence of an EMI signal Programming in an area with EMI can be difficult or impossible but ...

Page 60: ...mputer is upgraded to Version 8 1 VNS Programming Software from a previous version of VNS Programming Software previous records of Model 100B will not be completely transferred The parameter setting information will be available but the model number will be blank the serial number will be shown as and the End of Service status will be shown as No instead of N A Only use a serial cable provided by ...

Page 61: ...ns simultaneously for at least 5 seconds 4 When prompted follow on screen instructions to clear all data in the memory Note This operation only clears the data in the temporary memory of the handheld device and does NOT affect the VNS patient programming data 5 If prompted follow the on screen messages to tap cross hair targets to realign the screen tap the box labeled Next and perform an exercise...

Page 62: ...e hard reset If this occurs simply reinsert the FlashCard to automatically re install the VNS Therapy Programming Software In order to keep the handheld from performing hard resets it is important to keep the handheld charged even when the handheld is not in use A database of VNS Therapy transactions performed on your handheld computer is stored both in the memory resident on the handheld computer...

Page 63: ...following steps to realign the screen See Figure 38 on page 64 1 Plug in the handheld computer to the A C outlet 2 Verify that the FlashCard is fully inserted in the handheld computer 3 Press the power button and the navigation button simultaneously both on the front of the handheld 4 When prompted follow the on screen instructions to tap cross hair targets to realign the screen 5 As soon as this ...

Page 64: ...ror messages There is an error establishing communication with the device Failed to retrieve diagnostic data Generator failed to respond to programming initialization Failure in programming data sequence Invalid data was received from generator Failure of the Pulse Generator and Programming Wand to clearly communicate with each other to interrogate program or run diagnostic tests can be attributed...

Page 65: ...ine battery which is located in the handle of the Wand 2 Verify that the Programming Wand is properly connected to the Programming Computer see Programming Wand physician s manual for details a Disconnect power cord from wall outlet b Verify connection of Programming Wand cable and Programming Computer cable 3 Verify the proper positioning of the Programming Wand over the Pulse Generator Repositio...

Page 66: ... the presence of EMI Programming interrogating or completing diagnostic tests in an area with EMI will be difficult or impossible The problem can usually be resolved by repositioning the patient the Programming Wand or source of EMI Note LivaNova recommends interrogating the Pulse Generator as the last step of any programming or diagnostic session to verify correct settings for each parameter 7 Re...

Page 67: ...onnect power cord from wall outlet Verify connection of Wand cable and Computer cable Proceed with session Verify that the Wand is placed directly over the Generator site Rotate Wand 45 degrees slight pressure may be applied If during surgery verify that pocket depth is not greater than 1 inch Verify that Wand is 3 4 feet away from all electronic equipment and computers including Programming Compu...

Page 68: ... pin s and tighten the setscrew s until the hex screwdriver clicks d Visually inspect the Lead receptacle s and verify that the Lead pin s is past the back end of the connector block s Note See the physician s manual for the Pulse Generator e For the single pin Model Pulse Generators verify that the end of the Lead connector ring is inside the Lead receptacle f Gently grasp and pull on the connect...

Page 69: ... of the Pulse Generator and Lead Defective Lead Defective Pulse Generator To alleviate the condition perform these steps see Figure 40 on page 71 1 Reinsert the connector pin s into the Lead receptacle s a Back out the setscrew s remove the Lead pin s and leave the hex screwdriver engaged in the setscrew s b Verify that the setscrew s is not visible in the Lead receptacle s c Insert the connector ...

Page 70: ...82 8804 U S and Canada or 1 281 228 7330 Worldwide If the Generator Diagnostics indicates OK Lead impedance perform these steps 1 Back out the setscrew s and remove the test resistor 2 Insert the Lead connector pin s into the Lead receptacle s in the Pulse Generator 3 Tighten the setscrew s until the hex screwdriver clicks 4 If the System Diagnostics continues to indicate HIGH Lead impedance conta...

Page 71: ...oled fluid Retry System Diagnostics System Diagnostics Results Back out setscrew s and remove Lead pin s Insert test resistor into Pulse Generator and tighten setscrew s with hex screwdriver until the screwdriver clicks resistor is packaged with generator On the Computer select Other Diagnostics Select Generator Diagnostics Proceed with implant Contact Cyberonics Clinical Technical Support at 1 86...

Page 72: ...teps a Remove the Lead connector pin s from the Lead receptacle s b Insert the connector pin s of the test resistor assembly into the Lead receptacle s in the Pulse Generator c Tighten the setscrew s until the hex screwdriver clicks d Perform the Generator Diagnostics If the Generator Diagnostics indicates LOW Lead impedance call LivaNova at 1 866 882 8804 U S and Canada or 1 281 228 7330 Worldwid...

Page 73: ...r is packaged with generator On the Computer select Other Diagnostics Select Generator Diagnostics Proceed with implant Contact Cyberonics Clinical Technical Support at 1 866 882 8804 U S and Canada or 1 281 228 7330 Worldwide OK Lead Impedance LOW Lead Impedance 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...

Page 74: ... 4 Perform the Generator Diagnostics If the Generator Diagnostics indicates LOW or OK Lead impedance contact LivaNova at 1 866 882 8804 U S and Canada or 1 281 228 7330 Worldwide Figure 42 Low Lead Impedance on System Diagnostics in OR Pulse Generator Replacement Error message encountered A LOW Lead impedance has been detected Lead Impedance LOW Back out setscrew s and remove Lead pin s Insert tes...

Page 75: ...r be replaced immediately If you have any questions please consult the Physician s Manual or contact Cyberonics Warning message The Pulse Generator is currently disabled due to a Vbat EOS threshold Note that the generator is NOT supplying stimulation It is recommended that you contact Cyberonics or refer to the Physician s Manual The potential causes for receiving any of these battery indications ...

Page 76: ...the Physician s Manual Perform System Diagnostics or Generator Diagnostics with device in sterile package Record results Evaluate Diagnostic Results Lead Impedance any Impedance Value any IFI No Proceed with implant Contact Cyberonics Clinical Technical Support at 1 866 882 8804 U S and Canada or 1 281 228 7330 Worldwide Wait approximately 30 minutes with Generator at room temperature First time S...

Page 77: ... Pulse Generator More frequent clinical monitoring is recommended If you have any questions please consult the Physician s Manual or contact Cyberonics Warning message The Pulse Generator is nearing End of Service N EOS It is recommended that the Pulse Generator be replaced as soon as possible If you have any questions please consult the Physician s Manual or contact Cyberonics Warning message The...

Page 78: ...between Programming Wand and Programming Computer Electromagnetic interference EMI i e electronic equipment Programming Computer Pulse Generator battery at EOS Defective Programming Wand Defective Programming Computer Defective Pulse Generator Communication problems are often intermittent and are rarely related to the Pulse Generator The surrounding environment typically causes these problems Perf...

Page 79: ...ed equipment Computer screen office equipment etc If EMI is detected the yellow DATA RCVD light will come on and remain on while in the presence of EMI Programming interrogating or completing diagnostic tests in an area with EMI will be difficult or impossible The problem can usually be resolved by repositioning the patient the Programming Wand or the source of EMI Note LivaNova recommends interro...

Page 80: ...IMIT DCDC Converter 7 and the Normal Mode Diagnostics reports Lead Impedance HIGH Output Status LIMIT DCDC Converter 7 while Near End of Service reads NO then there is possible Lead discontinuity Lead disconnection from the Pulse Generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective Pulse Generator Near End of Service reads YES then Lead discontinuity Lea...

Page 81: ...ile Near End of Service reads NO then Generator cannot deliver programmed output Consider lowering the output while increasing pulse width Near End of Service reads YES then End of service is pending Replace the Pulse Generator as soon as possible If the System Diagnostics report Lead Impedance OK Output Status OK DCDC Converter 0 3 and the Normal Mode Diagnostics reports Lead Impedance OK Output ...

Page 82: ...ctrode electrode detachment from the nerve or defective Pulse Generator End of service is pending Replace the Pulse Generator as soon as possible Contact Cyberonics Clinical Technical Support at 1 866 882 8804 U S and Canada or 1 281 228 7330 Worldwide YES NO Systems Diagnostics Results DC DC code 4 7 Output Status OK Lead Impedance HIGH Normal Mode Results DC DC code 7 Output Status LIMIT Lead Im...

Page 83: ...mpedance reports HIGH 5300 Ohms then there is possible Lead discontinuity Lead disconnection from the Pulse Generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective Pulse Generator If the output current reports OK and Lead impedance reports LOW 600 Ohms then there is a possibility of a short circuit condition within the Lead or defective Pulse Generator If t...

Page 84: ...e Pulse Generator Contact Cyberonics Clinical Technical Support at 1 866 882 8804 U S and Canada or 1 281 228 7330 Worldwide Lead Impedance HIGH Output Current LOW Possible Causes Lead discontinuity Lead disconnection from the Pulse Generator Fibrosis between the nerve and electrode Electrode detachment from the nerve Defective Pulse Generator Lead Impedance OK Output Current LOW Possible Causes I...

Page 85: ...first interrogation following implantation may be an indication that the device was damaged during the surgery The Pulse Generator is currently disabled due to a Vbat EOS threshold Note that the generator is NOT supplying stimulation It is recommended that you contact LivaNova or refer to the Physician s Manual If the device was damaged during the implantation the device will still function normal...

Page 86: ...ear the Pulse Generator Static electricity i e electrostatic discharge or ESD imparted to the device during a surgical procedure This occurrence is detectable during the implantation procedure by performing a System Diagnostics test after the device has been secured in the pocket as prescribed in the product labeling However if this condition occurred and was not detected it is possible that the l...

Page 87: ...uty cycle for which the ON time is greater than the OFF time generalized onset seizure epilepsy Type of seizure that involves all parts of the brain and usually an alteration in consciousness high Lead impedance Resistance to the flow of output current produced by the Pulse Generator caused by any of the following dry nerve during surgery Lead discontinuity Lead disconnection from the Pulse Genera...

Page 88: ...aNova suggests that the Pulse Generator be set to these parameters when patients are first stimulated output current Amount of electrical current delivered in a single pulse of a stimulation measured in mA patient code Any three character value assigned by the treating physician generally programmed at time of implantation often patient s initials first middle last partial onset seizure Type of se...

Page 89: ...tion rate of pulses in a stimulation measured in number of pulses per second Hz signal OFF time Interval between stimulations when there is no stimulation measured in minutes signal ON time Length of time the programmed output current is delivered not including ramp up and ramp down times measured in seconds stimulation parameters Programmed output current signal frequency pulse width signal ON ti...

Page 90: ...90 of 92 26 0008 1100 5 Worldwide Physician s Manual VNS Therapy Programming Software 8 1 VNS Vagus Nerve Stimulation ...

Page 91: ... OF APPROVED COMPUTERS ________ Computers that have been qualified for use with the Model 250 Version 8 1 Programming Software are listed below Dell Axim X5 Pocket PC 2002 Handheld Computer Dell Axim X5 Pocket PC 2003 Handheld Computer Dell Axim X50 Windows Mobile 2003 2nd Edition Handheld Computer ...

Page 92: ... accessories contact LivaNova LivaNova USA Inc 100 Cyberonics Boulevard Houston Texas 77058 USA Telephone 1 281 228 7200 1 800 332 1375 US and Canada Fax 1 281 218 9332 LivaNova Belgium NV Ikaroslaan 83 1930 Zaventem Belgium Telephone 32 2 720 95 93 Fax 32 2 720 60 53 For 24 hour Clinical and Technical support call Telephone 1 866 882 8804 US and Canada 1 281 228 7330 Worldwide Internet www livano...

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