Software release 1.1 for Medtronic and Vitatron devices
InSync® 8040
Legacy® II/Visa
Thera® (including i Series™)/Prodigy
Thera® DR 7968i
®
Programming guide supplement
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
The following are trademarks of Medtronic: InSync, Medtronic, Prodigy, Thera
The following are trademarks of Vitatron: Legacy II, Vitatron
Introduction
The information in this technical literature supplement covers only the
features updated by the Longevity Projection Update software release 1.1
and the operation of your updated Medtronic programmer. This
information is intended as a supplement to the technical literature
supplied with the programmer software for InSync 8040, Legacy II,
Thera/Thera-i/Prodigy, and Thera DR 7968i pacemakers.
Instructions for installing the Longevity Projection Update software
release 1.1 are covered separately in the software installation instructions
provided with the software.
Use the Longevity Projection Update software release 1.1 and this
supplement with the InSync 8040, Legacy II, Thera/Thera-i/Prodigy, and
Thera DR 7968i pacemaker models listed in the following section, “About
the Longevity Projection Update software.”
Refer to the section “About the programmer software” for more
information about the programmer software and the corresponding
technical literature that covers operation of your programmer.
Refer to the section “Software feature update” for a detailed description of
the changes to the longevity feature.
About the
Longevity
Projection Update
software
Installing the Longevity Projection Update software release 1.1 in your
programmer updates all previous versions of the software for the devices
listed below and the following software applications:
■
Software model 9980 for InSync 8040 pacemakers.
■
Software model 9849 for Vitatron Legacy II/Visa pacemakers.
■
Software model 9879 for Thera/Thera-i/Prodigy pacemakers.
■
Software model 9847 for Thera DR 7968i pacemakers.
The following pacemaker models will be updated:
InSync
This supplement contains information about the update to the longevity
estimator function in the software and is intended as an addendum to any
previous versions and the following technical literature that you received
with the software models 9980, 9849, 9879, and 9847 previously installed
in your programmer.
■
Software model 9980 Device Programming Guide and the Device
Reference Guide, used with InSync 8040 pacemakers.
■
Software model 9849 Pacemaker Information and Programming
Guide, used with Vitatron Legacy II/Visa pacemakers.
■
Software model 9879 Pacemaker Information and Programming
Guide, used with Thera/Thera-i/Prodigy pacemakers.
■
Software model 9847 Pacemaker Information and Programming
Guide Supplement, used only with Thera DR 7968i pacemakers.
Note: Although Vitatron Legacy II/Visa software supports all Legacy II
and Visa pacemakers, this Longevity Projection Update feature is
applicable to Legacy II pacemakers only. The Longevity Projection feature
is not supported on Visa pacemakers.
Software
feature update
The presentation of “Estimated Time to Replacement” of the device
families mentioned in the previous section has been changed to improve
the usability and clinical accuracy of the system.
Remaining longevity is a calculated estimate of the time remaining until
pacemaker replacement will be required. This calculated estimate is
based on the programmed parameter settings and event summary data
accumulated by the pacemaker since the previous patient session.
Important: Approximately 5% of patients will reach ERI sooner than the
minimum estimate due to battery variation. Elective pacemaker
replacement should NOT be based on this estimate. For replacement use
only the ERI condition or the battery status “Replace Pacer”.
The representative screen (Figure 1) shows the on-screen explanation of
the longevity estimate.
Figure 1. A representative screen showing the on-screen explanation of
the longevity estimates.
On the Battery Lead and Data Summary screens the presentation of the
“Estimated Time to Replacement” value has changed. It has been
updated to show a single average value and a minimum value.
On the Battery Lead Report, Data Summary Report, and the Trace Report
the “Estimated Time to Replacement” value has changed. It has been
updated to show the average value followed by the minimum value.
4Longevity Projection Update
The Strength Duration screen and report will only display the “Estimated
Time to Replacement” value.
The following representative programmer screens compare the new
presentation (Figure 2) and the previous presentation (Figure 3) of the
longevity values on the Battery Lead screen.
Figure 2. A representative Thera/Thera-i/Prodigy Battery Lead screen
showing the new presentation of the longevity values (circled in the
screen for reference).
Figure 3. A representative Thera/Thera-i/Prodigy Battery Lead screen
showing the previous presentation of the longevity values (circled in the
screen for reference).
Additionally, the More Info screen displays “Estimated Time to
Replacement” using three values: “Maximum”, “Average”, and “Minimum”
values in years or in months depending on the longevity of the device.
Longevity Projection Update5
The representative programmer screens compare the new presentation
(Figure 4) and the previous presentation (Figure 5) of the longevity values
on the More Info screen.
Figure 4. A representative programmer Thera/Thera-i/Prodigy More Info
screen showing the new presentation of the longevity values (circled in
the screen for reference).
Figure 5. A representative Thera/Thera-i/Prodigy More Info screen
showing the previous presentation of the longevity values (circled in the
screen for reference).
The changes to longevity projection feature are the only changes
documented in this supplement.
6Longevity Projection Update
Medtronic
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
www.medtronic.com
Tel. +1-763-514-4000
Fax +1-763-514-4879
Medtronic E.C. Authorized
Representative/Distributed by
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.co.uk
Tel. +41-21-802-7000
Fax +41-21-802-7900
Technical manuals:
www.medtronic.com/manuals
Vitatron
Vitatron B.V.
P.O. Box 5227
6802 EE Arnhem
The Netherlands
www.vitatron.com
Tel. +31-(0)-26-376-7777
Fax +31-(0)-26-376-7666