10 of 92 — 26-0008-1100/5
(Worldwide)
Physician’s Manual — VNS Therapy Programming Software (8.1)
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:
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