Medtronic MSW002 Errata

Reveal LINQ Mobile Manager MSW002

Software Errata Sheet

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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CareLink™, LINQ II™, Marker Channel™, Medtronic CareLink™, MyCareLink Heart™, MyCareLink™, Reveal LINQ™

Software errata sheet

This document lists certain conditions that may occur during use of the Reveal LINQ Mobile Manager application (called the “app”
from now on) and suggests corrective actions for these conditions.

Condition Observed behavior and suggested corrective action

After upgrading the app from a 1.x version, data
does not carry over to the new version.

Some episode durations shown on the app are
different from the durations displayed on the
Medtronic CareLink Network.

The app uses inaccurate symbols to define bra­dycardia and tachycardia episode parameters.

When connecting to a patient connector while
Bluetooth is disabled in the Control Center in
iOS 11, the app does not notify you that
Bluetooth is disableda.

The app may terminate unexpectedly. Behavior

The app may hang when generating a report
PDF.

Behavior

The following types of information are no longer available after upgrading to the
new app version:

• App preferences and authentication information

• Clinic and physician lists

• Pending uploads, transmissions, device registrations, and reports

You are prompted to re-authenticate and re-register the tablet after upgrading.

Suggestion

Re-authenticate and re-register the tablet. Recreate clinic or physician lists. There
is no corrective action available to restore other missing data.

Behavior

A discrepancy of 1 s is observed between an episode duration on the app and the
same episode duration on the Medtronic CareLink Network.

Suggestion

There is no corrective action for you to perform. The app truncates episodes down
to the nearest second, while the Medtronic CareLink Network rounds intervals
greater than or equal to 0.5 s up to the next second. Refer to the applicable ECGs.

Behavior

The app uses the “≤” symbol to describe bradycardia episode parameters and the
“≥” symbol to describe tachycardia episode parameters. The Medtronic CareLink
Network uses “<” and “>” symbols to describe the same episode parameters.

Suggestion

There is no corrective action for you to perform. The Medtronic CareLink Network
correctly defines the episode parameters.

Behavior

The patient connector cannot be paired with the app.

Suggestion

Try one or more of the following options to resolve the condition and pair the
patient connector with the app.

• Re-enable Bluetooth in the Control Center.

• Turn off Bluetooth and then turn it on again in the Settings on the tablet.

• Restart the tablet.

The app terminates unexpectedly.

Suggestion

Restart the app and repeat the workflow.

• No data is lost.

• The data and reports are available for viewing when the app has been
restarted.

• All data and reports can also be retrieved from the CareLink Network.

• Reports are available for 7 days.

• Any data pending on the tablet remains pending on the tablet for 7 days.

• Re-enter patient data if necessary.

Behavior

The app hangs after tapping VIEW AND SAVE REPORT on the Reports tab.

Suggestion

Restart the application. Re-interrogate the device and save the session using
Save Session. Generate the PDF report. If the app hangs again, use the data
available within the app in the active patient session or the saved session.

3

Condition Observed behavior and suggested corrective action

Issue code 3230 may display when the app
times out and the clinician reconnects the
patient connector with the app.

The patient connector is not listed in the patient
connector selection pop-up window.

The app hangs on the SET UP FOLLOW-UP
CLINIC LIST screen.

Some channel marker symbols are displayed
incorrectly in the Episode ECG section in a
report or in the Episodes tab in the app.

The app hangs after the INSERT DEVICE
screen.

The Bluetooth connection between the app and
the patient connector is interrupted; the app
tries to reconnect but does not do so.

During the insertion workflow, while interrogat­ing the device, the user is unexpectedly redir­ected to the home screen.

Multiple episode-detection markers show up on
an ECG.

Behavior

Issue code 3230 is displayed when the app times out and the clinician attempts
to reconnect the patient connector with the app.

Suggestion

Tap CANCEL on the 3230 issue screen, and reconnect the patient connector
with the app.

Behavior

The patient connector cannot be paired with the app.

Suggestion

Retry the workflow for selecting or pairing the app with the patient connector.

Behavior

The app hangs unexpectedly.

Suggestion

Restart the app and repeat the workflow.

Behavior

The following channel markers are displayed inconsistently in the locations
indicated below.

• Report: the asystole rejected marker should be displayed as the letter “D”
with a strikethrough, instead it is displayed as “D” with an underscore.

• Report: the ignored VS marker should be displayed as the letter “V” with a
strikethrough, instead it is displayed as “V” with an underscore.

• Report and Episodes tab: all brady episodes should display the text “Ter­minated” along with a small black box at the end of the ECG. Instead these
indicators are not displayed.

Suggestion

A “D” with an underscore should be interpreted as Asystole Rejection. A “V” with
an underscore should be interpreted as Ignored VS. The missing brady termi­nated marker is not primary information used for diagnosis.

Behavior

The app hangs unexpectedly during the insertion workflow.

Suggestion

End the session and restart the insertion workflow. Re-perform any insertion
steps up to the point where you experienced the issue, and then resume the
insertion workflow as normal.

Behavior

The BLUETOOTH INTERRUPTED message blinks on and off.

Suggestion

End the session and restart your workflow.
If the 24967 patient connector has been left over the LINQ II device for 10
minutes or more, the LINQ II device will not communicate with the 24967 patient
connector or the MyCareLink Heart app for 24 hours. If this occurs, you will see
a lock icon next to the patient’s name in the SELECT A PATIENT list.

Behavior

The app unexpectedly returns to the home screen.

Suggestion

Restart the insertion workflow.

Behavior

An additional red triangle detection indicator shows up on an ECG.

Suggestion

There is no corrective action for you to perform. It is possible to have multiple
detection indicators: the detection event for the current episode is indicated, and
the additional detection indicator also corresponds to a real episode-detection
event. Consider correlating the episode you are viewing with the corresponding
detection marker.

4

Condition Observed behavior and suggested corrective action

ECG values are clipped when viewing reports. Behavior

When a report is viewed, some ECG values are partially clipped.

Suggestion

View the report on the Medtronic CareLink Network.

ECG data isn’t visible in the Available Epi-
sodes list.

Marker Channel annotations and other episode
ECG details overlap on a report.

The app crashes when attempting to connect to
a patient connector.

Text in the Episode List on the Reports tab is
clipped.

The app hangs if the tablet auto-locks while the
app is searching for the device.

The Postal Code field displays an error mes­sage if non-numeric characters are entered.

The app and the Medtronic CareLink Network
show different episode durations for the same
episode.

Report labels display incorrectly in certain lan­guages.

Behavior

When an available episode is expanded in the Episodes tab, ECG data doesn’t
appear where it is expected.

Suggestion

Tap the area where the missing data should be. The missing data will appear.

Behavior

Episode labels, including Marker Channel annotations, overlap each other on a
report, making them difficult to read.

Suggestion

If the information is unreadable, view the report on the Medtronic CareLink Net­work.

Behavior

During a CHECK PATIENT session, the app crashes when attempting to con-
nect to a patient connector.

Suggestion

Restart the app and the CHECK PATIENT session.

Behavior

Information from selected episodes is clipped when displayed on the Reports
tab.

Suggestion

Generate the Session Report. The information will not be clipped in the report.

Behavior

During the insertion workflow, the app hangs if the tablet auto-locks while the
patient connector is searching for the insertable device.

Suggestion

Force close the app and restart the app and the insertion workflow.

Behavior

If letters, hyphens, or other non-numeric characters are entered into any Postal
Code field in the app, an error message is displayed and the user is prompted to
correct the entered data.
Patient auto-enrollment and orders of patient monitors are not completed.

Suggestion

If possible, enter only numbers into the Postal Code field. Otherwise, log into the
appropriate clinic on the Medtronic CareLink Network to enroll the patient and
order the appropriate patient monitor.

Behavior

The app lists an episode duration that is up to one second longer or shorter than
the duration shown on the Medtronic CareLink Network.

Suggestion

View the Episode ECG in the app.

Behavior

When the tablet language is set to a language other than English, French, Italian,
German, or Spanish, report labels that should say In Clinic or Remote display a
software string instead.

Suggestion

Change the tablet language to English, French, Italian, German, or Spanish,
then generate the report again.

5

Condition Observed behavior and suggested corrective action

Reports are unavailable after app update. Behavior

When the app is updated, the report from the previous session is unavailable
from the Reports tab.

Suggestion

No action available. The report from the previous session is no longer accessi­ble. The information is available on the Medtronic CareLink Network.

Pending data transmissions disappear after
app update and don’t show up on the Medtronic
CareLink Network.

Behavior

When the app is updated, pending data transmissions disappear from the
Pending Uploads screen, but don’t become available on the Medtronic
CareLink Network.

Suggestion

No action available. The pending data transmissions are no longer available.

Re-authentication and tablet re-registration are
required after app update.

Behavior

When the app is relaunched after updating, it prompts you to log in and to
re-register the tablet.

Suggestion

To log in, enter your clinic’s Username and Password.
To re-register the tablet, enter a new Tablet Name and select your Hospital or
Clinic on the CREATE TABLET NAME screen.
Contact your Medtronic representative if you have questions about or have for­gotten your clinic’s Username or Password.

a

The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. Any use of the word mark by Medtronic is under license.

6

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*M016249C001*

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[phone]

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M016249C001 A
2021-05-17