LivaNova VNS Therapy 250 User manual

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Note: This manual contains information on the use of the LivaNovaVNS 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:
MicrosoftPocket-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

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To select a button or field, tap it with the stylus.
Some information can be entered with a “soft” or “on-screen”
keyboard (an example of the soft keyboard is shown at the bottom of
Figure 27 on page 44). To maximize (enable) or minimize (disable) the
soft keyboard, tap the keyboard icon at the lower right-hand corner of
the screen. You can type letters or numbers by tapping them with the
stylus.
When a selection requires communication with the Pulse Generator, a
message will appear prompting you to hold the Programming Wand
over the Pulse Generator.
When a button is selected, a border will appear around the button (as
on the Interrogate Device button in Figure 1 on page 12).
To return to a previous screen, tap Menu or Exit.
A list of symbols is found in the front of this manual.
A glossary is found in the back of this manual.
The words ON and OFF appear in all capital letters only when they
refer to VNS stimulation.
References to Model 102 include both Models 102 and 102R.
For more information, 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 interrogation.
Caution: If the Procedure Failed message appears on the screen,
check both the connection between the handheld computer and the
Programming Wand and the positioning of the Programming Wand in
relation to the Pulse Generator (see the physician’s manual for the
Programming Wand). If you continue to have communication
problems, change the battery in the Programming Wand.
Caution: The DATA/RCVD indicator on the Programming Wand may
also light up or flicker in the presence of electromagnetic interference
(EMI) or noise. Information on how to detect EMI is provided in the
physician’s manual for the Programming Wand, sections entitled
Understanding the Indicator Lights and Troubleshooting. If the
presence of EMI or noise is suspected, you must verify that the
programming or interrogation occurred successfully by reviewing the
PARAMETER Screen shown in Figure 3 on page 15.

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2. HOW TO GET STARTED _______________
Caution: When in use,
LivaNova recommends
the handheld computer
to 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.
The VNS Therapy Programming Software Model 250 Version 8.1 has
been pre-installed on the 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 last turned off (unless it was reset since the last use).
2. If the computer doesn’t display the MAIN Menu, select Exit or Menu
until the MAIN Menu is displayed.
3. If you haven’t been able to access the MAIN Menu after following
Steps 1 and 2 above, see “Precautions ” on page 59 and
“Troubleshooting ” on page 61 before proceeding.
Figure 1. MAIN Menu

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3. HOW TO USE THE SOFTWARE __________
It is LivaNova’s intent to make the software as intuitive and “user friendly”
as possible. Messages and prompts will guide you through this software.
There are four menus in this software. The first is the MAIN Menu.
3.1. MAIN Menu
The following sections provide an overview of each of the MAIN Menu’s
four primary functions, as shown in Figure 1.
3.1.1. Interrogate Device overview
Note: See “Interrogate
Device” on page 14 for
more information.
The first option, Interrogate Device, is used to establish communication
with the implantable device (Pulse Generator). The other three options
work with data stored on the handheld computer itself and require no link
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 Last Parameters is used to view the most recent parameters selected
for a specific patient or Pulse Generator.
3.1.4. User Preferences overview
Note: See “User
Preferences Screen ” on
page 54 for more
information.
User Preferences allows you to select values for five user settings:
The number of minutes that the computer may be idle before a new
interrogation becomes necessary (applicable for Models 100C, 101,
and 102 only).
The maximum number of records viewable at a time
The size of type font for the diagnostics screens
The current time and date
Language selection, when available

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4. INTERROGATE DEVICE ________________
To retrieve information from the Pulse Generator or to program the Pulse
Generator, you must first select the Interrogate Device button from the
MAIN Menu. The START INTERROGATION Screen will be displayed
(see Figure 2).
Figure 2. START INTERROGATION Screen
To interrogate the Pulse Generator, place the Programming Wand over the
Pulse Generator and tap Start Interrogation. Tap Cancel to return to the
previous screen.
Upon completion of a successful interrogation, 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 PARAMETER screen displays the operating
parameters of the Pulse Generator with their current settings.
There is one line for each of the eight parameters. Each line contains three
types of information:
1. The name of the parameter and the units used to express its values
2. The present setting for that particular parameter (***** is shown for
any unknown or out of range parameter values)

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3. The New button, when tapped, displays the range of possible settings
for that parameter
Figure 3. PARAMETER Screen
↑Inactivity Timeout Indicator (Progress Bar)
Note: The inactivity
timeout function is not
used in Models 103,
104, and 105.
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 adjusted on the USER
PREFERENCES Screen. See See “User Preferences Screen ” on page 54.
Models 100, 101, 102 Models 103, 104, 105

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Note: For more
information on the
timeout function, see
“User Preferences
Screen ” on page 54.
Figure 4. TIMEOUT WARNING Screen
Caution: LivaNova
recommends that you
reinterrogate the Pulse
Generator after each
programming event to
verify that the
programming occurred
as planned.
Note that the timeout bar has advanced to the right margin.
In addition to the eight programmable parameters, the PARAMETER
screen will also indicate battery status for the Pulse Generator. The
Programming Software has one battery status indicator, Near End of
Service (Near EOS), for Models 100, 101, 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 Generators, the remaining
generator battery power is indicated by the battery icon located in the top
left portion of the PARAMETER screen (see Figure 3 on page 15). The
battery icon is shaded and colored to indicate various levels of remaining
generator battery power. As the battery level decreases and the Pulse
Generator enter states of IFI = Yes, N EOS = Yes or EOS = Yes, an
additional indicator is displayed at the bottom of the PARAMETER screen
(see Figure 5 on page 17).

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

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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

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Figure 9. PULSE DISABLED and BATTERY STATUS
INDICATOR - EOS WARNING Screen
Models 103, 104, 105
Table 1 shows the various indications of Pulse Generator battery level and
the associated recommendations.
Table 1. Pulse Generator Battery Level Indications and
Recommendations
Pulse
Generator
Model #
Estimated %
Battery Power
Remaining
Battery
Icon
Displayed
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 End of
Service (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.

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103/104/105 >75% to 100% IFI = No
The Intensified Follow-up Indicator (IFI) has
not been set. The Pulse Generator battery
level is good. No warning message is
displayed from the Programming Software
and no special attention is required.
103/104/105 >50% to 75%
103/104/105 >25% to 50%
103/104 >18% to 25%
105 >11% to 25%
103/104 >8% to 18% IFI = Yes
The Intensified Follow-up Indicator (IFI) has
been set for the Pulse Generator and a
warning message will be displayed by the
Programming Software to indicate this
status upon completion of interrogation or
Diagnostics testing. The Pulse Generator
battery has depleted to a level where more
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 reached End of
Service (EOS) and is NOT supplying
stimulation. The Programming Software will
display a warning message indicating this
status upon completion of interrogation or
Diagnostics testing. Immediate replacement
of the Pulse Generator is recommended. If
the Pulse Generator is not replaced, it will
eventually lose the ability to communicate
with the Programming Software.
Pulse
Generator
Model #
Estimated %
Battery Power
Remaining
Battery
Icon
Displayed
Pulse Generator Battery Status /
Recommendations
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