Medtronic D00U001 Errata

CareLink SmartSync™
Software Errata Sheet
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
CareLink SmartSync™, CareLink™, Paceart Optima™, Paceart™, Quick Look™, SessionSync™, SureScan™

Contents

2.5 Unexpected behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
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1 Introduction

This document lists certain conditions that may occur during use of CareLink SmartSync applications and suggests corrective actions for these conditions.

1.1 Software models

The software models within the CareLink SmartSync Device Manager Application include the following:
• CareLink SmartSync Platform (M01A01)
• CareLink SmartSync Common Application (M01A02)
• CareLink SmartSync Host Application1 (D00U001)
Each condition listed in this document applies to one or more apps that are available through the CareLink SmartSync Device Manager Application.

1.2 CE mark of conformity

CE mark of conformity Software model number
M01A01
2017

1.3 Download or order the instructions for use

To view, download, print, or order a PDF version of this app help, go to www.medtronic.com/manuals, or contact a Medtronic representative.
The PDF version of this app help can be viewed using a current version of any major internet browser. For best results, use Adobe™* Acrobat™* Reader software with the browser.
Paper copies of this app help are available to customers free of charge. They should arrive in 3 to 7 days. To order, go to www.medtronic.com/manuals or contact a Medtronic representative.
M01A02 D00U001

1.4 Reporting errors and serious incidents

If a serious incident related to the CareLink SmartSync app occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.
If you find information in this app help that is incorrect, contact a Medtronic representative.

2 Observed conditions and suggested corrective actions

2.1 App closes unexpectedly

Condition Observed behavior and suggested corrective action
The device manager app closes unexpectedly when you tap FLASH.
The implantable device app closes unexpect­edly when you view the ARRHYTHMIA EPI-
SODES window while an episode is in progress.
Behavior
When you tap FLASH on the device manager app immediately after the base or patient connector has been restarted, the app closes unexpectedly.
Suggestion
Restart the app.
Behavior
When you view the ARRHYTHMIA EPISODES window while an episode is in progress, the implantable device app closes unexpectedly.
Suggestion
Restart the app. When you view the ARRHYTHMIA EPISODES window, data from the episode that was in progress appears.
1
Referred to as the device manager app.
4
During initial interrogation, the app stops responding and then closes unexpectedly.
Behavior
During initial interrogation, the app stops responding for several seconds and then closes unexpectedly.
Suggestion
Restart the app.
The app closes unexpectedly or displays a sys­tem message while generating a report when there is insufficient tablet storage.
Behavior
When there is insufficient tablet storage to save a report, the app closes unex­pectedly or displays a system message after an attempt to generate a report.
Suggestion
Force close the app. Remove apps and files as needed to increase available tablet storage and restart the app.

2.2 App stops responding or displays a system error message

Condition Observed behavior and suggested corrective action
The implantable device app displays a system error message during interrogation.
The implantable device app stops responding after a failed attempt to program the Time Zone parameter.
The app stops responding or displays a system error message.
Behavior
During interrogation, you tap CONTINUE in the INTERROGATE - UNSUC­CESSFUL window and the app displays a system error message.
Suggestion
Force close the app through the operating system, then restart the app.
Behavior
If you attempt to program the Time Zone parameter and the programming fails, the implantable device app stops responding when you return to the DEVICE
DATE/TIME window.
Suggestion
Force close the app through the operating system, then restart the app.
Behavior
The app stops responding or displays a system error message in the following scenarios:
• When you repeatedly move the app from the background to the foreground
• When you lock the tablet immediately after you open the app
• When you force close the app and the tablet goes to sleep, then you wake up the tablet and immediately open the app
• When you adjust the sensitivity values while using the single complex view of the analyzer
Suggestion
Force close the app through the operating system, then restart the app.
The implantable device app displays a system error message when you program the parame­ters for data collection setup.
Behavior
If the Bluetooth® connection between the app and the patient connector is lost when you program the parameters for data collection setup, the implantable device app displays a system error messagea.
Suggestion
Force close the app through the operating system, ensure that Bluetooth wire­less technology is enabled on your tablet, and then restart the app.
a
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. Any use of the word mark by Medtronic is under license.
The app stops responding during interrogation. Behavior
If you have more than 2 Bluetooth accessories connected to the tablet, or if multiple applications are running in the background, the app stops responding during interrogation.
Suggestion
Force close the app through the operating system, then restart the app. To pre­vent the issue, minimize the number of connected Bluetooth accessories and the number of applications running in the background.
5
The implantable device app displays a system error message when you view cardiac events in
PLOT view.
Behavior
When you view cardiac events in PLOT view in the ARRHYTHMIA EPISODES window, the app displays a system error message.
Suggestion
Force close the app through the operating system, then restart the app.
The app stops responding when you program emergency VVI pacing and move the app to the background.
The app stops responding or closes unexpect­edly when you initiate a transmission using the SessionSync feature.
The device manager app displays a system error message during registration.
The implantable device app stops responding during interrogation when the last measured pulse width value is invalid.
Behavior
When you program emergency VVI pacing and move the app to the background, the app stops responding when you bring the app to the foreground.
Suggestion
Force close the app through the operating system, then restart the app.
Behavior
When you initiate a SessionSync transmission of a report or implantable device data (PDD file) and the Patient Name or report name includes the ampersand character (&), the device manager app or implantable device app stops responding or closes unexpectedly.
Suggestion
Force close the app through the operating system, then restart the app.
Behavior
When you try to register the device manager app with Wi-Fi™* disabled on the tablet, the app displays the No Internet Access message. When you enable Wi-Fi™* and tap Retry, the app displays a system error message.
Suggestion
Force close the app through the operating system, ensure that Wi-Fi™* is ena­bled on the tablet, and then restart the app.
Behavior
If the last measured pulse width value is invalid, the implantable device app stops responding when you attempt to reinterrogate the implantable device.
Suggestion
Force close the app through the operating system, then restart the app.
The app stops responding or displays a system error message when system memory is low.
The implantable device app does not display waveform strips in the FROZEN STRIP window after a failed attempt to program Medtronic nom­inal parameters and stops responding when there is an attempt to generate a report.
Behavior
The app stops responding or displays a system error message in the following scenarios when system memory is low:
• When you stay in a Read From File session for an extended period of time, choose to extend the session, exit the Read From File session, and then attempt to re-enter the same Read From File session
• When auto-identification is used to identify the implantable device, the device is interrogated, and then report generation is in progress after the Quick Look screen is loaded
• During the report generation step of reinterrogating an implantable device
Suggestion
Force close the app through the operating system, then restart the app or end the session and reinterrogate the implantable device.
Behavior
When programming Medtronic nominal parameters fails and the order of the waveforms in the Live Rhythm Monitor is changed, no waveform strips appear in the FROZEN STRIP window. In this scenario, the EMERGENCY button is not available. If you attempt to generate a report, the implantable device app stops responding.
Suggestion
Force close the app through the operating system, then restart the app.
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