LivaNova VNS Therapy 250 User manual

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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

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©Copyright 2012-2017 LivaNova, PLC, London, UK
All rights 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.

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Table of Contents
1. BRIEF DEVICE DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.1. General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4. System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.5. Conventions Used in this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.6. Communication Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2. HOW TO GET STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3. HOW TO USE THE SOFTWARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1. MAIN Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.1. Interrogate Device overview . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.2. View Database overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.3. View Last Parameters overview . . . . . . . . . . . . . . . . . . . . . . 13
3.1.4. User Preferences overview . . . . . . . . . . . . . . . . . . . . . . . . . 13
4. INTERROGATE DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.1. How to Program New Parameter Settings . . . . . . . . . . . . . . . . . . . . 21
4.1.1. Partial Programming Due to Interrupted Programming
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.1.2. Cross-programming (applicable 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 screen . . . . . . . . . . . . . . . . . . . . . . . 44
4.2.4. Display Device History screen . . . . . . . . . . . . . . . . . . . . . . . 45
4.2.5. View Database screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.2.6. Close Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.2.7. Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.2.8. Handheld computer battery status . . . . . . . . . . . . . . . . . . . . 46
5. VIEW DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.1. Specify Search Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.1.1. Sort by Date, Patient ID, or Serial Number . . . . . . . . . . . . . 48
5.1.2. View All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.1.3. Earliest Date/Latest Date . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.1.4. Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.1.5. Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.2. View the Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.2.1. View Parameter History . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.2.2. View Diagnostic History . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.2.3. View Magnet History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

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6. VIEW LAST PARAMETERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7. USER PREFERENCES SCREEN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.1. Set Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.2. Set Maximum Number of Records to View . . . . . . . . . . . . . . . . . . 55
7.3. Set the Font Size for Database Displays . . . . . . . . . . . . . . . . . . . . . 55
7.4. Set Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7.5. Backup to FlashCard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
7.6. Restore from FlashCard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
7.7. Export Database to Text File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
7.8. Language Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
7.9. Handheld Computer Battery Status . . . . . . . . . . . . . . . . . . . . . . . . . 57
8. MAINTENANCE, HANDLING, AND STORAGE . . . . . . . . . . . . . . . . . . . . . . . . 58
9. PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
10. TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
10.1. General Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
10.1.1. Non-responsive Handheld Computer . . . . . . . . . . . . . . . . . . 61
10.2. Hardware Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
10.2.1. Restore and reinstall software . . . . . . . . . . . . . . . . . . . . . . . 62
10.2.2. Handheld screen alignment . . . . . . . . . . . . . . . . . . . . . . . . . 62
10.2.2.1.Screen alignment for the Dell Axim X5 handheld
computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
10.2.2.2.Screen alignment for the Dell Axim X50 handheld
computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
10.2.3. Other hardware issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
10.3. Troubleshooting in the OR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
10.3.1. Communication 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 surgery,
outside of the sterile field – initial implant or Pulse Generator
replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
10.3.7. Low Battery/End of Service indications during surgery,
inside the sterile field – initial implant or Pulse Generator
replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
10.4. Troubleshooting at Follow-up Visits . . . . . . . . . . . . . . . . . . . . . . . . 78
10.4.1. Communication problems at follow-up visits . . . . . . . . . . . . 78
10.4.2. High Lead Impedance on a Diagnostic Test at follow-up
visit for Models 100, 101, and 102 Pulse Generators . . . . . 79
10.4.3. High Lead Impedance, Low Lead Impedance, or Low
Output Current on a Diagnostic Test at follow-up visit
for Model 103, 104, and 105 Pulse Generators . . . . . . . . . . 83
10.4.4. Pulse Generator disabled due to Vbat < EOS found
at first interrogation after implantation or other
surgical procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

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10.4.5. Sudden decrease in estimated device longevity (% battery
power remaining) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
11. GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
12. LIST OF APPROVED COMPUTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
13. PRODUCT INFORMATION AND SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
List of Tables
TABLE 1PULSE GENERATOR BATTERY LEVEL INDICATIONS AND
RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
TABLE 2PROGRAMMABLE PARAMETERS FOR THE PULSE GENERATOR . . 21
TABLE 3CROSS-PROGRAMMING EXAMPLE . . . . . . . . . . . . . . . . . . . . . . . . 27
TABLE 4DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR
COMMUNICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
TABLE 5DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR OUTPUT
STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
TABLE 6DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR OUTPUT
CURRENT FOR MODELS 100, 101, AND 102 . . . . . . . . . . . . . . . . 36
TABLE 7DEVICE DIAGNOSTIC SCREEN STATUS READINGS FOR LEAD
IMPEDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
TABLE 8DC-DCCONVERTER CODES AND LEAD IMPEDANCE (MODEL
100, SN ³10,000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
TABLE 9DC-DCCONVERTER CODES AND LEAD IMPEDANCE
(MODEL 101) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
TABLE 10 DC-DC CONVERTER CODES AND LEAD IMPEDANCE
(MODEL 102) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
TABLE 11 MINIMUM NORMAL MODE AND MAGNET MODE DIAGNOSTIC
SETTINGS (MODELS 100, 101, AND 102) . . . . . . . . . . . . . . . . . . . 42

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List of Figures
FIGURE 1 MAIN MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FIGURE 2 START INTERROGATION SCREEN . . . . . . . . . . . . . . . . . . . . . 14
FIGURE 3 PARAMETER SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
FIGURE 4 TIMEOUT WARNING SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . 16
FIGURE 5 PARAMETER SCREEN WITH ACTIVE BATTERY STATUS
INDICATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
FIGURE 6 BATTERY STATUS INDICATOR - NEAR EOS WARNING
SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
FIGURE 7 BATTERY STATUS INDICATOR - IFI WARNING
SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
FIGURE 8 BATTERY STATUS INDICATOR - N EOS WARNING
SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
FIGURE 9 PULSE DISABLED AND BATTERY STATUS INDICATOR
- EOS WARNING SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
FIGURE 10 PARAMETER SETTINGS POP-UP MENU . . . . . . . . . . . . . . . . 22
FIGURE 11 OUTPUT WARNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
FIGURE 12 START PROGRAMMING SCREEN . . . . . . . . . . . . . . . . . . . . . . 23
FIGURE 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 - INTERRUPTED DIAGNOSTIC
WARNING SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
FIGURE 22 PARAMETER SCREEN WITH UNKNOWN SETTINGS . . . . . . 33
FIGURE 23 SYSTEM DIAGNOSTICS SCREEN . . . . . . . . . . . . . . . . . . . . . . 40
FIGURE 24 NORMAL MODE DIAGNOSTICS SCREEN . . . . . . . . . . . . . . . 41
FIGURE 25 MAGNET MODE DIAGNOSTICS SCREEN . . . . . . . . . . . . . . . 42
FIGURE 26 GENERATOR DIAGNOSTICS SCREEN . . . . . . . . . . . . . . . . . . 43
FIGURE 27 PROGRAM PATIENT DATA SCREEN . . . . . . . . . . . . . . . . . . . 44
FIGURE 28 DEVICE HISTORY SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
FIGURE 29 VIEW DATABASE SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
FIGURE 30 VIEW PARAMETER HISTORY SCREEN . . . . . . . . . . . . . . . . . 50
FIGURE 31 VIEW DIAGNOSTIC HISTORY SCREEN . . . . . . . . . . . . . . . . . 51

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FIGURE 32 VIEW MAGNET HISTORY SCREEN . . . . . . . . . . . . . . . . . . . . 52
FIGURE 33 VIEW LAST PARAMETERS SCREEN . . . . . . . . . . . . . . . . . . . 53
FIGURE 34 USER PREFERENCES SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . 54
FIGURE 35 LANGUAGE SELECTION SCREEN . . . . . . . . . . . . . . . . . . . . . 57
FIGURE 36 CORRECT FLASHCARD ORIENTATION . . . . . . . . . . . . . . . . . . . . . 60
FIGURE 37 DELL AXIM X5 HANDHELD COMPUTER . . . . . . . . . . . . . . . . . . . 63
FIGURE 38 DELL AXIM X50 HANDHELD COMPUTER . . . . . . . . . . . . . . . . . . 64
FIGURE 39 COMMUNICATION PROBLEMS IN THE OR AND AT FOLLOW-UP
VISITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
FIGURE 40 HIGH LEAD IMPEDANCE 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 LEAD IMPEDANCE ON ADIAGNOSTIC TEST AT
FOLLOW-UP VISIT FOR MODELS 100, 101, AND 102 PULSE
GENERATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
FIGURE 45 HIGH LEAD IMPEDANCE, LOW LEAD IMPEDANCE, OR
LOW OUTPUT CURRENT ON AN INTERROGATION OR
DIAGNOSTIC TEST AT FOLLOW-UP VISIT FOR MODELS
103, 104, AND 105 PULSE GENERATORS . . . . . . . . . . . . . . . . . . . 84

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1. BRIEF DEVICE DESCRIPTION ___________
1.1. General Description
The LivaNova®VNS Therapy®Programming Software, Model 250
Version 8.1, enables you to interrogate and program LivaNova’ Pulse
Generator using the Programming Wand.
Software capabilities include:
Use of the software with the Programming Wand to interrogate and
program 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
following:
Notice for reader to pay special attention to details that
follow
Serial Number
Storage
Batch Code
Date of Manufacture
Information
Sidebar Note (cross-references and other useful
information)
MRI Unsafe

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1.3. Intended Use
Caution: LivaNova
recommends that the
software be loaded on a
dedicated computer
used only to program
the Pulse Generator.
The Model 250 VNS Therapy Programming Software is intended for use
only with the LivaNova Pulse Generators and Programming Wand and is
subject to the same indications for use.
1.4. System Requirements
Note: See “List of
Approved Computers”
on page 91 for a list of
computers that have
been qualified for use
with the VNS Therapy
Programming Software
Model 250 Version 8.1.
The computer must have the following minimum specifications:
MicrosoftPocket-PC (2002, 2003 Operating System) or Windows
Mobile (2003 2nd Edition)
At least 16 MB of memory
Compact FlashCard
Serial communication capability
The communication system of the VNS Therapy Programming Software
Model 250 Version 8.1 is designed to minimize the possibility of
misprogramming or “phantom” programming. Phantom programming is
the inadvertent programming via environmental 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 individually during a programming event. For
the Models 103, 104, and 105 Pulse Generators the parameters are
programmed and verified as a group during a programming event.
1.5. Conventions Used in this Manual
The following conventions are used throughout this manual:
The VNS Therapy Programming Software Model 250 Version 8.1
operates in a Windows environment with drop-down menus. You will
use a stylus to navigate through a Windows environment on the
handheld computer. The stylus resembles a small pen and is kept with
handheld computer.
Screen titles appear in all capital letters. The names of selectable
buttons (or fields) and drop-down menus appear in bold typeface. Each
of these buttons or fields represents an operation, parameter, or
parameter value.
Humidity limitations—Indicates the range of humidity to
which the medical device can be safely exposed