Medtronic MSW002 Instructions for Use

Reveal LINQ™ Mobile Manager Online Help

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.

Cardiac Compass™, CareLink™, CARELINK™, LINQ II™, Marker Channel™, Medtronic CareLink™, MyCareLink Heart™, MyCareLink Relay™, MyCareLink™, Quick Look™, Reveal LINQ™, Reveal™

1 Configuration

1.1 About Reveal LINQ Mobile Manager

Device description

The Reveal LINQ Mobile Manager application (called the “app” from now on) is installed on a tablet with Internet access and is the software of the Reveal LINQ Mobile Manager system. The app communicates with the Medtronic 24967 Patient Connector (called the “patient connector” from now on) to enable, connect, and send stored Reveal LINQ and LINQ II Insertable Cardiac Monitors (called the “device” from now on) data to the Medtronic CareLink Network. The Reveal LINQ Mobile Manager system also facilitates patient enrollment and device registration in the Medtronic CareLink Network. The app should be used by healthcare professionals only in a clinical or hospital environment.

Intended use

The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ and LINQ II Insertable Cardiac Monitors.

Contraindications

There are no known contraindications.

Electronic instructions for use/manuals

To view, download, print, or order manuals for this product, go to www.medtronic.com/manuals, or contact a Medtronic representative.

Software requirements

Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.

Paper manuals

Paper manuals are available to customers free of charge. They should arrive in 3 - 7 days. To order, go to www.medtronic.com/manuals, or contact a Medtronic representative.

Model number

MSW002

> About > About Reveal LINQ™ Mobile Manager to determine the model number for your app. All model numbers may not

Tap be available in your geography.

Symbols

For US audiences only

Patient Information icon

Contextual Help icon

Add/Edit Alias icon

Add icon

CareLink connectivity - disconnected icon

CareLink connectivity - connected icon

CareLink Sync off icon

Patient connector not connected icon

Patient connector connected icon

Patient connector low battery icon

Patient connector charging icon

Information icon

Non-programmable interlock icon

Lock icon

Warning icon

1.2 IT network, tablet, and data information

Required IT network characteristics and configuration

The use of this system requires your network to have internet access for the following purposes:

• To install and update the app from the app store.

• To log in to the app.

• To have the app in a connected status in order to have all app features and parameters available.

• To complete patient enrollment and device registration.

• To set up the home monitor.

• To communicate with the CareLink Network.

• To add physicians to the Physician List.

• To add follow-up clinics to the Follow-Up Clinic List.

• To conduct episode assessments.

• To read symptom journal entries from the MyCareLink Heart™ mobile app.

The use of this system also requires that Bluetooth® wireless technology is enabled on your tablet. The system cannot communicate with the device if the tablet is unable to establish a Bluetooth connection with the patient connector.

Failure to provide IT network access will lead to limited app functionality, including the following results:

• Installation of and updates to the app cannot be completed if the tablet is unable to access the app store.

• Comprehensive review of the device data and facilitation of patient enrollment and device registration activities in the CareLink Network cannot be completed if the app is unable to access the internet from the clinic’s IT network.

• You cannot log in and will be unable to use the app.

Follow your organization’s processes and policies to configure your network.

Supported tablets and technical specifications

For the list of supported tablets, and their specifications including network connectivity specifications, go to the following website:

www.medtronic.com/24967

Precautions when connecting to your IT network

Connecting the app to a secure IT network that includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your IT network could also introduce additional risks. Analyze, evaluate and control any risks identified.

Intended information flows

The device data and system logs are sent for processing through the system components in the following sequential order:

1. Device

2. Patient connector

The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by Medtronic is under license.

3. App installed on the tablet

4. Internet

5. CareLink Network

In response, a confirmation receipt is sent from the CareLink Network via the Internet to the app.

All information in transit is protected for security.

1.3 Security

Data in the app is protected by application level encryption. The app does not provide data protection for data exported from it to another destination. Data exported from the app should be handled in accordance with your clinic’s security policy for data handling and storage.

To help protect patient health information and to prevent unauthorized programming of the device, security measures for your tablet must include the following items:

• Implement a passcode or PIN to use the app.

• Only use the app and the patient connector on a managed, trusted, and secured network.

• The app must be used by healthcare professionals only in a hospital or clinical environment. Monitor all patient interactions with the tablet.

To protect the clinician app, Medtronic recommends that you implement the following security measures:

• Use the clinician app only on a managed, trusted network. Verify that your Wi-Fi networks comply, at minimum, with wireless standard 802.11b, 802.11g, or 802.11n, and use WPA2 or stronger encryption.

• Secure your network with industry best practices, which can include antivirus software, firewalls, and wireless security policies, according to the policies of your IT department.

• When installing or updating the clinician app, if your tablet displays a message indicating that a security certificate is invalid, the installation or update process is unable to continue. For assistance, contact your local Medtronic representative.

The app closes automatically when the app detects a failure to maintain security.

If you suspect that a cybersecurity event has occurred, contact your IT security or biomedical department for information on how to confirm and respond to the suspected incident.

2 Setting up the app

2.1 Pairing the patient connector

During the procedure, you may be asked to enter the security code and verify the serial number of the patient connector. This information is found on the back of the patient connector. You can also refer to the instructions for use provided with the patient connector for help in locating this information.

1. Ensure that Bluetooth wireless technology is enabled on your tablet. For most tablets, tap Settings > Bluetooth to enable it.

2. Open the app.

3. On the Reveal LINQ MOBILE MANAGER screen, tap CONTINUE.

4. Press the button on the patient connector you are using to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth connection is discoverable, and then turns solid

when the Bluetooth connection is established.

5. You may be prompted by the tablet to grant permission for the app to turn on Bluetooth wireless technology. Follow the tablet’s prompts to allow the app to turn on the tablet’s Bluetooth.

6. When prompted, select the patient connector you are using from the list.

7. When prompted, enter the security key code and tap CONTINUE.

8. If you are prompted by the tablet to accept a Bluetooth pairing request, confirm that the serial number in the request matches the serial number on the back of the patient connector.

• Decline the request if the serial number does not match the serial number on the back of the patient connector.

• Accept the request to pair the patient connector with the app.

2.2 Setting up the app

2.2.1 Overview

During the setup of the app on the tablet, you must log in to the app by entering a Username and Password and creating a unique Tablet Name. Logging in to the app is used to authorize the use of the app on the tablet and to manage access of the app on the tablet.

Logging into the app must be completed during the initial setup of the app. If you do not enter a Username, Password during setup of the app, you will not be able to continue beyond the ENTER USERNAME AND PASSWORD screen.

There are two steps to complete to log in to the app:

1. Enter a unique Username and Password on the ENTER USERNAME AND PASSWORD screen.

2. Create a unique Tablet Name and select your Hospital or Clinic on the CREATE TABLET NAME screen.

Enter your clinic’s Reveal LINQ Mobile Manager or CareLink Network credentials for the Username and Password to log into the app. Contact your Medtronic representative if you have questions about or have forgotten your clinic’s CareLink Network credentials.

The Tablet Name is unique to the tablet where the app is installed. If your clinic has the app installed on more than one tablet, you will need to create a unique Tablet Name for each tablet. The Tablet Name and Hospital or Clinic selections are entered once for each tablet where the app is installed. The selections can only be changed by deleting and reinstalling the app.

You may also be asked to enter your Username and Password into the app in the following scenarios:

• Occasionally when the app is launched

• After 30 days of disconnected use

• After 6 months of connected use

2.2.2 Entering a username and password

From the ENTER USERNAME AND PASSWORD screen, enter your Reveal LINQ™ Mobile Manager or CareLink Network Username and Password.

1. Enter your clinic’s Username.

2. Enter your clinic’s Password.

• Tap SHOW PASSWORD to display your clinic’s password.

• Tap HIDE PASSWORD to obscure your clinic’s password.

3. Tap CONTINUE.

2.2.3 Tablet identifying information

During setup of the app, you must log in to the tablet on the CREATE TABLET NAME screen by entering a unique Tablet Name and by selecting your Hospital or Clinic. Tablet identifying information is used to manage access to the app on the tablet.

• You must enter a primary tablet name and primary location to continue to log into the app.

• The tablet identifying information is set up once. After the Tablet Name and Hospital or Clinic settings are set on a tablet, they can only be changed by uninstalling and reinstalling the app on that tablet.

• The clinics listed in the Hospital or Clinic drop menu are associated with your Account Number.

• The Tablet Name must be unique. You cannot use the same tablet name for multiple tablets in your clinic.

2.2.4 Entering the tablet name and location information

1. Enter a unique tablet name in the Tablet Name field.

2. Select a hospital or clinic name from the Hospital or Clinic drop menu.

3. Tap SAVE to save your login information.

2.3 Password issues

2.3.1 Forgot password

If you have forgotten your password, you can reset it at the CareLink Network website.

The app locks after three failed password attempts. If the app locks, you must wait 10 min for the app to unlock before entering your password again.

Contact your Medtronic representative if you have questions about or have forgotten your clinic’s CareLink Network credentials.

2.3.2 Resetting a forgotten password

1. Tap Forgot Password?

2. Follow the instructions at the CareLink Network website to reset your password.

2.3.3 Password expired

You can reset an expired password at the CareLink Network website.

If your password has expired, a notification message and link to reset your password displays on the ENTER USERNAME AND PASSWORD screen.

2.3.4 Resetting an expired password

1. Tap Reset Password.

2. Follow the instructions at the CareLink Network website to reset your password.

2.4 Physician List

2.4.1 Physician List overview

On the SET UP PHYSICIAN LIST screen, you can add a physicians to the Physician List, or you can skip this step. Adding physicians to the Physician List allows you to more easily assign physicians to patients on the INSERT DEVICE > MONITORING INFORMATION screen during an INSERT DEVICE or CHECK PATIENT session.

Any physicians added to the Physician List are available locally on the tablet running the app. If you have installed the app on more than one tablet, you will need to add physicians to the Physician List for each additional tablet.

2.4.2 Adding physicians to the Physician List

1. Enter a physician’s first name in the First Name field.

2. Enter a physician’s last name in the Last Name field.

3. Enter one or more options for the physician’s location information:

• Enter a city name in the City field.

• Select a state from the State drop menu.

• Enter a zip code in the Postal Code field.

4. Select one of the following options:

• Tap SEARCH to search for the physician.

• Tap CLEAR FIELDS to clear all of the search fields.

Tapping SEARCH displays the physician information in the Search Results field.

5. Select a physician or physicians from the Search Results field and tap ADD TO LIST. A message appears when a physician or physicians have been successfully added to the Physician List.

2.4.3 Manually adding a physician to the Physician List

If the search for the physician did not return a result, you can manually add a physician to the Physician List.

When a search for a physician did not return a result, the Search Results screen displays a message that no results were found for the physician.

Physicians that are manually added are only available in the Physician List for 30 calendar days.

1. In the Search Results field, select I want to manually add this physician to the list.

2. Tap ADD TO LIST. The MANUALLY ADD TO LIST screen displays.

3. Enter the required information for the physician in the required fields:

• First Name

• Last Name

• City

• State

4. Enter additional optional physician information, if desired.

5. Select one of the following options:

• Tap ADD MANUALLY to manually add the physician to the Physician List.

• Tap CANCEL to exit the MANUALLY ADD TO LIST screen.

2.4.4 Removing a physician from the Physician List

You can remove a physician from the Physician List.

1. Tap PHYSICIAN LIST to view all physicians in your Physician List.

2. Tap next to the physician’s name you want to remove from the Physician List.

• Tap REMOVE to remove the physician from the Physician List.

• Tap CANCEL to exit the REMOVE PHYSICIAN screen.

2.4.5 Completing the Physician List set up

Tap one of the following buttons to save or skip adding physicians to your Physician List:

Button Result SAVE AND

CONTINUE

The physicians are saved to your Physician List. The physicians you added to your Physician List are now available as options on the INSERT DEVICE > MONI- TORING INFORMATION screen The Physician List can also be accessed from the following locations during a CHECK PATIENT session:

• On the Device & Patient Settings > Monitoring screen from the Implanting Physician drop menu.

• From the > Settings > Physician List, when CareLink™ Sync is turned ON.

SKIP THIS

No physicians are added or saved to your Physician List.

STEP

For Reveal LINQ devices only.

2.5 Follow-up clinics

2.5.1 Follow-Up Clinic List

On the SET UP FOLLOW-UP CLINIC LIST screen, you can add a follow-up clinic, or you can skip this step. Adding follow-up clinics allows you to more easily enroll patients in the CareLink Network during a device insertion.

Adding follow-up clinics to your Follow-Up Clinic List allows you to assign a patient to a follow-up clinic on the INSERT DEVICE > MONITORING INFORMATION screen.

Any follow-up clinics added to the Follow-Up Clinic List are available locally on the tablet running the app. If you have installed the app on more than one tablet, you will need to add follow-up clinics to the Follow-Up Clinic List for each additional tablet.

Contact your CareLink Network administrator or your Medtronic representative for questions about the CareLink™ Network User ID or Clinic Account Number.

2.5.2 Adding follow-up clinics to the Follow-Up Clinic List

1. Select CareLink™ Network User ID or Clinic Account Number from the Search By drop-down list.

2. Enter a CareLink Network User ID or Clinic Account Number in the Search Entry field for the clinic where the patient will be enrolled.

Contact your CareLink Network administrator or your Medtronic representative for questions about the CareLink Network User ID or Clinic Account Number.

3. Tap SEARCH. The follow-up clinics are displayed in the Search Results field.

4. Select a clinic or clinics you want to add to your Follow-Up Clinic List.

5. Tap the Add icon. Your selected follow-up clinics are displayed in the Follow-Up Clinic List field.

6. To add additional follow-up clinics, enter a CareLink Network User ID or Clinic Account Number and repeat the search.

2.5.3 Renaming a follow-up clinic

You can rename a follow-up clinic with an alias.

1. Tap the Add/Edit Alias icon.

2. Enter a unique alias for the follow-up clinic you want to rename in the ALIAS field next to the follow-up clinic name. A follow-up clinic alias must be a unique name.

• If you have entered the same alias for two or more follow-up clinics on the ADD/EDIT ALIAS screen, the ALIAS field is highlighted in red.

• The EXISTING CLINIC screen displays if a duplicate alias is entered for an existing follow-up clinic in your Follow-Up Clinic List.

3. Tap one of the following options:

• Tap OK to rename the follow-up clinic.

• Tap CANCEL to exit the ADD/EDIT ALIAS screen.

2.5.4 Removing a follow-up clinic from the Follow-Up Clinic List

Tap next to the follow-up clinic you want to remove from the Follow-Up Clinic List.

• Tap REMOVE to remove the follow-up clinic from the Follow-Up Clinic List.

• Tap CANCEL to exit the REMOVE FOLLOW-UP CLINIC FROM LIST screen.

2.5.5 Completing the Follow-Up Clinic List setup

Tap one of the following buttons to add a follow-up clinic to the Follow-Up Clinic List, or to skip this step:

Button Result SAVE AND CON-

TINUE

SKIP THIS STEP No clinics are added or saved to your Follow-Up Clinic List.

The follow-up clinics are saved to your Follow-Up Clinic List. The clinics you added to your Follow-Up Clinic List are now available as options on the INSERT DEVICE >

MONITORING INFORMATION screen and during a CHECK DEVICE session on the > Settings > Follow-Up Clinic List.

2.6 Initial setup results

The Reveal LINQ MOBILE MANAGER screen is displayed. The app and patient connector are ready to use.

3 Patient connector

3.1 Adding a patient connector

The app will guide you through the following steps when you tap INSERT DEVICE or CHECK PATIENT from the Reveal LINQ MOBILE MANAGER screen.

During the procedure, you may be asked to enter the security code or serial number of the patient connector. This information is found on the back of the patient connector. You can also refer to the instructions for use provided with the patient connector for help in locating this information.

1. Ensure that Bluetooth wireless technology is enabled on your tablet. For most tablets, tap Settings > Bluetooth to enable it.

2. Press the button on the patient connector to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth connection is discoverable, and then turns solid

when the Bluetooth connection is established.

3. When prompted, select the patient connector you are using from the list or tap CANCEL. If you tap CANCEL, select one of the following options:

• Tap SEARCH to search for a different patient connector, and return to Step 2.

• Tap CANCEL to return to the home page.

4. If prompted, enter the security key code and tap CONTINUE.

5. If you are prompted by the tablet to accept a Bluetooth pairing request, confirm that the serial number in the request matches the serial number on the back of the patient connector.

• Decline the request if the serial number does not match the serial number on the back of the patient connector.

• Accept the request to pair the patient connector with the app.

The patient connector is paired and ready to use.

3.2 Charging

Medtronic recommends that you charge the patient connector and your tablet fully before conducting device’s INSERT DEVICE or CHECK PATIENT session.

For information on charging the patient connector, refer to the instructions for use provided with the patient connector.

4 Set up patient

4.1 Setting up patients

You can set up patients in the app up to 7 days before the patient’s device insertion. The information can be used to set up the device during the insertion procedure. CareLink™ Sync must be turned ON to set up patient in the app.

Patients set up in the app are available for association with a device for 7 days.

1. From the Reveal LINQ Mobile Manager screen, tap SET UP PATIENT. The SET UP PATIENT > PATIENT DEMOGRAPHICS screen displays.

2. Enter the required patient demographics:

Table 1. Required patient demographics parameters

Parameter Editable values

First Name Enter the patient’s first name as you would like it to appear in the

patient’s record.

Last Name Enter the patient’s last name as you would like it to appear in the

patient’s record.

Date of Birth Select the patient’s date of birth from the picker. This setting is

used to calculate the nominal Tachy Detection Interval setting. Gender Select the patient’s gender from the drop menu. Phone Number Enter the patient’s phone number.

3. Enter any optional patient demographics:

Table 2. Optional patient demographics information

Parameter Editable values

Address Enter the patient’s address. City Enter the city where the patient lives. State/Region Enter the state or region where the patient lives. Postal Code Enter the patient’s postal code. Country Enter the patient’s country of residence. Patient ID Enter the patient’s ID number from the patient ID card.

4. Tap one of the following options:

• Tap CANCEL to return to the Reveal LINQ Mobile Manager screen. No patient information is saved if you tap CANCEL.

• Tap INSERT NOW to save the patient data and continue with the device insertion. Use this option to continue inserting the device after entering the patient demographics for the patient.

• Tap SAVE FOR LATER to save the patient data and allow you to enter another patient’s information.

5 Insert device

5.1 Preinsertion

5.1.1 Overview

Before you begin, see the device’s instructions for use for the insertion procedure instructions.

Caution: Before inserting the device, verify that the patient connector and tablet are fully charged. The patient connector and tablet may run out of power during the insertion procedure if they are not fully charged. You will not be able to program or interrogate the patient’s device until the patient connector and the tablet have power.

• Do not open the device’s sterile package until the preinsertion steps are completed.

• Do not turn on data collection in the Reveal LINQ device before the insertion procedure is completed, or the device may detect the absence of cardiac signal ECG as episodes. Episodes cannot be cleared from the device using the app once they are detected.

• Complete the insertion procedure within 15 min of the INSERT DEVICE programming steps. If the device insertion procedure is not completed within 15 min of the INSERT DEVICE programming steps, you will need to reinterrogate the device. There can be a few minutes delay in re-discovering the device when re-interrogating the device if the device is not inserted within 15 minutes of the INSERT DEVICE programming steps.

5.1.2 Select a patient

1. Set aside device’s sterile packaging, which contains a scannable code for pairing the app with the device.

2. From the Reveal LINQ™ MOBILE MANAGER screen, tap INSERT DEVICE.

3. Select a patient from the SELECT A PATIENT list, then tap CONTINUE. To enter a new patient that is not on the SELECT A PATIENT list, tap NEW PATIENT.

5.1.3 Associating a device to a patient

You can associate the device to a patient on the INSERT DEVICE > ASSOCIATE INSERTABLE DEVICES screen by entering the device serial number. Associating a device to a patient allows the app to link the specific device with the patient and then to assign equipment to the patient.

Enter the device serial number using one of the following options:

Option: Steps:

Scanning the device code. 1. Tap SCAN CODE.

Enable the use of the camera on the tablet if it is not enabled. For most tablets, select Settings > Reveal LINQ Mobile Manager, and enable the camera setting.

2. Scan the code on the sterile device label with the camera on the tablet.

The INSERT DEVICE > ASSOCIATE EQUIPMENT screen displays.

Manually entering the device serial number 1. Tap ENTER MANUALLY.

The INSERT DEVICE > ASSOCIATE EQUIPMENT screen displays.

2. Enter the serial number of the device from the sterile device label in the Enter Serial Number field.

3. If you’re inserting a LINQ II ICM, select one of the following options. If you’re inserting a Reveal LINQ ICM, skip this step.

• Enter the device’s 16-digit code in the 16-digit Code field, then close the keyboard.

• Tap LOST PACKAGING. Note: There can be a small waiting period to auto-

identify the device when the LOST PACKAGING option is selected.

The INSERT DEVICE > ASSOCIATE EQUIPMENT screen dis- plays.

Sterile tray label unavailable If the device’s sterile tray label is not available, complete the fol-

lowing steps.

1. Tap LOST PACKAGING. The INSERT DEVICE > ASSOCIATE EQUIPMENT

screen displays.

2. Enter the device’s serial number in the Enter Serial Num- ber field, then close the keyboard.

The INSERT DEVICE > ASSOCIATE EQUIPMENT screen displays.

Note: There can be a small waiting period to auto-identify the device when the LOST PACKAGING option is selected.

5.1.4 Associating equipment to a patient

Users may only associate a monitor with a patient when CareLink™ Sync is ON.

On the INSERT DEVICE > ASSOCIATE EQUIPMENT screen, select one of the following monitoring options:

Monitoring option: MyCareLink Heart™ Mobile App (Download and set up the

app after insertion) MyCareLink Relay™ 24960

Select this option if the patient will be assigned the MyCareLink Heart™ mobile app for remote monitoring.

Select this option if the patient will be assigned a physical home communicator for remote monitoring. If the patient will be assigned a physical home communicator, enter the serial number using one of the following options: Scanning the barcode:

1. Tap SCAN BARCODE. Enable the use of the camera on the tablet with the app if it

is not enabled. For most tablets, select Settings > Reveal LINQ Mobile Manager, and enable the camera setting.

2. Scan the monitor’s barcode, found on the outer package, with the camera on the tablet.

Manually entering the serial number:

Monitoring option:

Enter the serial number of the monitor in the Enter Serial Number field.

MyCareLink™ Monitor

Select this option if the patient will be assigned a physical home communicator. If the patient will be assigned a physical home communicator, enter the serial number using one of the following options: Scanning the barcode:

1. Tap SCAN BARCODE. Enable the use of the camera on the tablet with the app if it

is not enabled. For most tablets, select Settings > Reveal LINQ Mobile Manager, and enable the camera setting.

2. Scan the monitor’s barcode, found on the outer package, with the camera on the tablet.

Manually entering the serial number: Enter the serial number of the monitor in the Enter Serial Num-

ber field.

No equipment selection at this time Select this option if the patient will not be remotely monitored at

this time.

This option is available for the LINQ II ICM only.

This option is available for the Reveal LINQ ICM only.

Tap CONTINUE after selecting a monitoring option for the patient.

5.1.5 Patient demographics

On the INSERT DEVICE > PATIENT DEMOGRAPHICS screen, confirm or update, if necessary, the patient demographics information.

1. Confirm the required patient demographics information for selected patient.

Table 3. Required Patient Demographics parameters

Parameter Editable values

First Name Confirm or update the patient’s first name

as you would like it to appear in the patient’s record.

Last Name Confirm or update the patient’s last name

as you would like it to appear in the patient’s record.

Date of Birth Confirm or update the patient’s date of

birth. This setting is used to calculate the

nominal Tachy Detection Interval setting. Gender Confirm or update the patient’s gender. Phone Number

This option is unavailable for LINQ II devices when CareLink Sync is turned OFF.

Confirm the patient’s phone number.

2. Confirm any optional patient demographics information for the selected patient.

Table 4. Optional Patient Demographics information

Parameter Editable values

Address

Confirm the patient’s address if it was previously entered. You can also enter the patient’s address if it was not previously entered.

City

Confirm the city where the patient lives. You can also enter the city where the patient lives if it was not previously entered.

State/Region

Confirm the state or region where the patient lives. You can also enter the state or region where the patient lives if it was not previously entered.

Postal Code

Confirm the patient’s postal code. You can also enter the patient’s postal code if it was not previously entered.

Table 4. Optional Patient Demographics information (continued)

Parameter Editable values

Country

Confirm the patient’s country of residence. You can also enter the patient’s country of residence if it was not previously entered.

Patient ID

Confirm the patient’s ID number from the patient ID card. You can also enter the patient’s ID number if it was not previously entered.

This option is unavailable for LINQ II devices when CareLink Sync is turned OFF.

3. Tap CONTINUE.

5.1.6 Monitoring information

On the INSERT DEVICE > MONITORING INFORMATION screen, select a Reason for Monitoring for the patient and any additional follow-up clinic, physician, or patient selections.

Table 5. Monitoring Information parameters

Parameter Programmable values Shipped value Reset value

Reason for Monitoring Syncope - -

Cryptogenic Stroke Suspected AF AF Ablation AF Management Palpitations Ventricular Tachycardia Seizures Other

Follow-Up Clinic

Available options set on the APP

- -

SETUP > SET UP FOLLOW-UP CLINIC LIST screen.

Implanting Physician

Available options set on the APP

- -

SETUP > SET UP PHYSICIAN LIST

screen.

Follow-Up Physician

Available options set on the APP

- -

SETUP > SET UP PHYSICIAN LIST

screen.

Patient Local Date and Time Month, Date, Year

Hour, Minute, AM, PM

Patient Comments

No selectable values. Enter any

This field defaults to the tablet’s date and time.

- -

Jan 01, 1994

desired patient comments information in the field.

Patient History

No selectable values. Enter any

- desired patient history information in the field.

Table 5. Monitoring Information parameters (continued)

Parameter Programmable values Shipped value Reset value

Sleeping Hours Near Home Monitorb (Daily Wireless Transmission Time)

12:00 AM - 5:00 AM 12:00 AM - 5:00 AM 12:00 AM - 5:00 AM 1:00 AM - 6:00 AM 2:00 AM - 7:00 AM 3:00 AM - 8:00 AM 4:00 AM - 9:00 AM 5:00 AM - 10:00 AM 6:00 AM - 11:00 AM 7:00 AM - 12:00 PM 8:00 AM - 1:00 PM 9:00 AM - 2:00 PM 10:00 AM - 3:00 PM 11:00 AM - 4:00 PM 12:00 PM - 5:00 PM 1:00 PM - 6:00 PM 2:00 PM - 7:00 PM 3:00 PM - 8:00 PM 4:00 PM - 9:00 PM 5:00 PM - 10:00 PM 6:00 PM - 11:00 PM 7:00 PM - 12:00 AM 8:00 PM - 1:00 AM 9:00 PM - 2:00 AM 10:00 PM - 3:00 AM 11:00 PM - 4:00 AM

This option is available only when CareLink™ Sync is ON.

This option is available for the Reveal LINQ ICM only.

This option is available for the LINQ II ICM only.

For Reveal LINQ, when CareLink™ Sync is OFF, you can manually enter this information.

For LINQ II, when CareLink™ Sync is OFF, this option is not available.

5.2 Insertion

Insert the device.

Refer to the device’s instructions for use for insertion procedure instructions.

5.3 Interrogating the device

1. Ensure that Bluetooth wireless technology is enabled on your tablet. For most tablets, tap Settings > Bluetooth to enable it.

2. From the INSERT DEVICE screen, tap the box next to The device has been inserted.

3. Tap ACTIVATE DEVICE.

4. Place a sterile sleeve over the patient connector if the patient connector is being used in the sterile field.

5. Press the button on the patient connector you are using to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth connection is discoverable, and then turns solid

when the Bluetooth connection is established.

6. If prompted, select the patient connector you are using from the list. If you are using a new patient connector, you will have to pair the app and the patient connector. See Section 3.1.

7. The patient connector pairs with the app.

8. Position the patient connector over the patient’s device.

The telemetry indicator light on the patient connector turns on when you have established telemetry with the device.

The patient connector interrogates the device. Device programming and activation occur at the end of this interrogation process. When interrogation is complete, the app displays a DEVICE ACTIVATED message.

5.4 Post-insertion data, settings, and reports

After the Insert Device steps are completed and the device is inserted in the patient, you can review the pre-insertion parameters, set additional device parameters, select Episodes and Trends, and generate Session Reports.

After reviewing the device information, tap END SESSION to end your current INSERT DEVICE session. The Session Summary screen displays. For information about the Session Summary screen, see Section 7.6.

5.5 Check the patient-enrollment and device-registration status

If CareLink™ Sync is turned ON when you start an INSERT DEVICE session, patient enrollment and device registration are sent to Medtronic servers when you end the session. If a patient’s device registration or patient enrollment is unsuccessful after you end the session, the app displays the Patient implant data was not sent message. When the app is open or running in the background, the app continuously tries to resend the patient enrollment and device registration for up to 7 days.

To check the patient-enrollment and device-registration statuses, from the Reveal LINQ MOBILE MANAGER screen, tap View next to the Patient implant data was not sent message.

The IMPLANT SESSION SUMMARY screen shows the following statuses for patient enrollment:

•

Patient enrollment successful

• Patient enrollment unsuccessful

Note: For troubleshooting information, see Section 10.4.

• Patient enrollment declined

The IMPLANT SESSION SUMMARY screen shows the following statuses for device registration:

• Device registration successful

• Device registration unsuccessful

Note: For troubleshooting information, see Section 10.4.

The app automatically removes the patient’s implant session summary from the IMPLANT SESSION SUMMARY screen when the following conditions occur:

• When all statuses for a patient change from unsuccessful to successful

• When patient enrollment or device registration is unsuccessful after 7 days

6 Check patient

6.1 Check Patient session

After device insertion, it is important to schedule regular patient sessions to read collected data and, if necessary, to adjust sensing and episode detection parameters. Medtronic recommends that you schedule the first patient session 3 months after device insertion. The frequency of subsequent sessions depends on the patient’s condition and the number of arrhythmia episodes that occur.

If the patient is not being remotely monitored, it is important that subsequent appointments occur before the device memory is full. Ensuring that appointments occur before the device’s memory is full will prevent older episode information from being overwritten by newer episode information.

If the patient is being remotely monitored, data transmissions are made regularly to CareLink through the MyCareLink Heart™ mobile app or the MyCareLink Relay™ 24960 Home Communicator.

6.2 Conducting a Check Patient session

1. Ensure that Bluetooth wireless technology is enabled on your tablet. For most tablets, tap Settings > Bluetooth to enable it.

2. From the Reveal LINQ™ MOBILE MANAGER screen, tap CHECK PATIENT.

3. Press the button on the patient connector you are using to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth connection is discoverable, and then turns solid

when the Bluetooth connection is established.

4. The patient connector pairs with the app. When prompted, select the patient connector you are using from the list. If you are using a new patient connector, you will have to pair the app and the patient connector. See Section 3.1.

5. Select a patient from the SELECT A PATIENT list. If communication with the patient’s LINQ II device is unavailable, a lock icon is shown next to the patient and you cannot select

the patient from the list. A device can place a lock on itself for up to 24 hours if it detects excessive Bluetooth connections. By temporarily locking itself, the device can prevent the battery from being depleted from excessive connections. Try to reconnect the patient’s LINQ II device later.

6. Tap CHECK DEVICE.

7. Place a sterile sleeve over the patient connector, if necessary.

8. Position the patient connector over the patient’s device. The telemetry indicator light on the patient connector turns on when you have established telemetry with the device.

9. Review the data displayed in the Quick Look tab. The Quick Look tab provides a summary of the data from the current collection period. This is the data collected since the last

in-clinic session.

6.3 Check patient data, settings, and reports

During a Check Patient session, you can review the device’s data, with episodes and trends, change device and patient settings, and view and save device reports.

After reviewing the device information, tap END SESSION to end your current CHECK PATIENT session.

7 Parameter field descriptions

7.1 Quick Look screen

The Quick Look screen displays after the device has been interrogated. You can view the AMPLITUDE indicator for R-Wave amplitude of the device, battery status, key parameter settings, dynamic ECG data from the device, episode counters, and information for Key Observations and counter parameters.

The Quick Look screen displays summary information about the device and patient.

Table 6. Summary information fields

Field Description

Reason for Monitoring

Implant Date This date is automatically filled in based on the date the insertion procedure occurred. LINQ Battery The battery status for the device is displayed in one of the following values.

Key Observations

This field describes the clinical reason the patient is being monitored. This information determines the current settings of the device based on the programmed value. This information is populated from the information that was entered in the MONITORING INFORMATION screen during an INSERT DEVICE session or during a CHECK PATIENT session on the Device & Patient Settings > Monitoring tab.

• Good: The battery has not yet reached Recommended Replacement Time or End of Service.

• RRT: The battery has reached the Recommended Replacement Time (RRT). The date displayed indicates when the battery reached RRT.

• EOS: The battery has reached End of Service (EOS). The date displayed indicates when the battery reached EOS.

The Key Observations section displays relevant information for device observations.

The counters section displays information in episodes and events and the totals recorded since the patient’s last in-clinic session.

Table 7. Counters Listings

Field CURRENT LIFETIME PARAMETERS

Symptom Lists the total number of epiTachy Pause

sodes or events since the patient’s last in-clinic session.

Brady

Lists the total number of episodes or events recorded for the device.

Lists the range of duration, frequency, or threshold that is used to determine if an event or episode is counted.

AT AF Time in AT/AF PVCs (% beats)

Displayed for LINQ II ICMs only.

7.2 Episodes

Tap the Episodes tab to view and assess the patient’s episodes. The Episodes tab displays a list of patient episodes. You can also view the detailed ECG for each available episode.

The AVAILABLE EPISODES list each available episode and information about that episode. Tap on an episode to see additional information for that episode. You can use the Assess Episode drop menu to mark the appropriateness of each episode as

Appropriate, Inappropriate, or Indeterminate. Assess Episode is disabled if the patient is not enrolled in your CareLink clinic or if there is no connection to the CareLink Network.

The information from an episode or episodes selected is displayed on the Reports tab and is included in the session report.

Episodes tab features

Use the selections on the Episodes tab to select, organize, and assess the episodes available in the AVAILABLE EPISODES list.

Table 8. AVAILABLE EPISODES list column titles

Column Information displayed

Report Used to select an episode or episodes for inclusion in the Session

Report.

ID Displays the episode ID number.

Next to the ID number, there may be an assessment icon indicating the episode has been marked Appropriate, Inappropriate,

or Indeterminate. Type Displays the type of episode. Date Displays the date the episode was detected. Time HH:MM Displays the time the episode was detected. Duration HH:MM:SS Displays the duration of the episode. Max Rate Displays the maximum rate in bpm for all episode types except

Brady episodes. Brady episodes display the minimum rate

in bpm. Med Rate Displays the median rate in bpm.

Table 9. AVAILABLE EPISODES list options

Feature Options Result

Report Tap the check box next to an episode or

episodes. Tap the check box next to ALL.

Type Use the radio button to select the episode

Type from the drop menu:

Selected episodes from the AVAILABLE EPISODES list are included in the Session Report.

Only the selected episode type is displayed in the AVAILABLE EPISODES list.

• All Types

• AF

• AT

• Brady

• Pause

• Symptom

• Tachy

Assess Episode

Select a category from the Assess Epi- sode drop menu:

• Appropriate

• Inappropriate

• Indeterminate

Use the categories in the Assess Episode drop menu to apply an adjudication status to an episode. If an episode has an adjudication status assigned in the CareLink Network, the status is displayed with the episode.

• Unassessed

INTERROGATE Tap INTERROGATE to view episodes that

were recorded during the patient’s previ-

New episodes, if available, are displayed in

the AVAILABLE EPISODES list. ous in-clinic INSERT DEVICE or CHECK PATIENT session, and any new episodes recorded since last session.

This option is available only when CareLink™ Sync is ON.

Tap on the episode row to view more details of the episodes ECG.

Table 10. Selected episode ECGs

Feature Option

Symptom Details

Lists any symptoms and symptom details that a patient has

marked using the MyCareLink Heart™ mobile app. Zoom Amplitude Use the - or + icons to adjust the episode’s ECG y-axis scale. Interval plot Select the view of the rate in ms or bpm. The selected rate pref-

erence is saved and used throughout the app and in the Session

Report. Episode plot The episode plot displays the full span of time when the ECG was

recorded, including time before and after the event.

Tap and hold the box, and then slide it to a specific time period of

the episode. You can also tap on a specific span of time to move

the box. The ECG displayed will correspond to the time selected. Plot line The plot line, displayed horizontally on the episode plot, shows

the detection rate for the episode. Episode ECG The episode ECG displays the full episode ECG strip.

Swipe left or swipe right on the ECG strip to view different seg-

ments of the ECG strip.

For LINQ II devices only.

Table 11. Marker Channel annotations

Marker Explanation

Ventricular sense

Pause detection (marks the first event in a detected pause episode)

Brady sense

Brady detection (marks the first event in a detected brady episode)

VT (Tachy) sense

VT (Tachy) detection (marks the first event in a detected VT episode)

(below the baseline)

FVT (Tachy) sense

FVT (Tachy) detection (marks the first event in a detected FVT episode)

(below the baseline)

AT detection (marks the end of at least 2 min of atrial arrhythmia)

(above the baseline)

AF detection (marks the end of at least 2 min of atrial arrhythmia)

(above the baseline) Δ Patient-activated symptom (only marked in a stored ECG recording)

Ignored event

An event that ends a noise interval.

Pause rejection (marks a pause that is determined to not be a pause episode)

FVT (Tachy) rejection (marks an event that would have been detected as FVT but was rejected due to noise)

7.3 Trends

>12

7.3.1 Overview

Tap the Trends tab to view Cardiac Compass trends or Rate Histograms recorded by the patient’s device.

7.3.2 Cardiac Compass

The Cardiac Compass tab displays clinical trends during a CHECK PATIENT session. Reveal LINQ device clinical trends are displayed for a 14 month (425 days) duration, and LINQ II device clinical trends are displayed for a 9 month (270 days) duration. The PVC trend is available for LINQ II devices only.

AT/AF total time per day – This trend may help you to assess the need to initiate or adjust the patient’s rate or rhythm control therapies. It may also reveal the presence of asymptomatic episodes of AT/AF.

The device records a daily total for the time (burden) the patient spent in atrial arrhythmia. This trend may be reported in hours or minutes per day depending on the maximum (total) atrial arrhythmia duration per day.

Figure 1. AT/AF total time per day

1 Total time per day

Ventricular rate during AT/AF – You may use this trend to perform the following assessments:

• Correlate patient symptoms to rapid ventricular responses to AT/AF.

• Prescribe or titrate antiarrhythmic and rate control drugs.

• Assess the efficacy of an AV node ablation or modification procedure.

The graph plots daily median ventricular rates during episodes of atrial arrhythmia. The vertical lines show the daily difference between the median rate and the maximum sensed ventricular rate. Multiple points on one day represent multiple episodes with different median rates.

Figure 2. Ventricular rate during AT/AF

1 Beats per minute 2 Max 3 Average

Average ventricular rate – The day and night heart rates provide information that may have the following clinical uses:

• Objective data to correlate with patient symptoms

• Indications of autonomic dysfunction or symptoms of heart failure

• Information regarding diurnal variations

For this trend, “day” is defined as the 12-hour period between 8:00 AM and 8:00 PM and “night” as the 4-hour period between midnight and 4:00 AM (as indicated by the Reveal LINQ clock).

Figure 3. Average ventricular rate

100

120

200

160

120

1 Beats per minute 2 Day 3 Night

PVC – This trend displays the percent of beats that are detected as PVCs per day.

Figure 4. PVC

1 Percentage of beats

Patient activity – The patient activity trend may help you to obtain the following types of information:

• A way to monitor a patient’s exercise regimen

• An early indicator of progressive diseases like heart failure, which cause fatigue and a consequent reduction in patient activity

The device uses data derived from the built-in accelerometer to determine weekly patient activity.

Figure 5. Patient activity

1 Hours per day

Heart rate variability – Reduced variability in the patient’s heart rate may help you to identify heart failure decompensation. The device measures each ventricular interval and calculates the median ventricular interval every 5 min. It then calculates and plots a variability value (in ms) for each day.

Note: The heart rate variability calculation does not include events that occur during automatically detected arrhythmia episodes (AT/AF or Tachy).

Figure 6. Heart rate variability

1 Milliseconds 2 Date

7.3.3 Rate Histograms

Ventricular rate during AT/AF histogram (time in or out of AT/AF) – The Time out of AT/AF and Time in AT/AF histograms show

ventricular events that occurred during automatically detected AT/AF episodes. The histograms show 20 rate ranges that are each 10 bpm wide. Rates slower than 40 bpm are included in the <40 bpm range; rates faster than 220 bpm are included in the >220 bpm

range. The information includes the AT/AF burden expressed in both the percentage of time and the total time that the patient spent in or out of AT/AF.

Figure 7. Time out of AT/AF

1 Percentage of time out of AT/AF 2 Total time 3 Rate (bpm)

Figure 8. Time in AT/AF

1 Percentage of time in AT/AF 2 Total time 3 Rate (bpm)

7.4 Device and Patient Settings

7.4.1 Overview

You can edit the parameters for the device during an INSERT DEVICE or CHECK PATIENT session. When you change a parameter value, the new value is shown as pending. You can change several parameter values together. To undo your pending changes and revert to the last programmed values, tap UNDO. The values remain pending until you tap SAVE.

From the Quick Look screen, tap Device & Patient Settings, and then select one of the following tabs:

• Monitoring

• Detection

• Sensitivity

• Equipment

• Demographics

7.4.2 Monitoring - Reveal LINQ ICM

Tap the Monitoring tab to confirm or update the Monitoring parameters for the Reveal LINQ ICM.

Table 12. Monitoring parameters

Parameter Programmable values Shipped value Reset value

Reason for Monitoring Syncope - -

Cryptogenic Stroke Suspected AF AF Ablation AF Management Palpitations Ventricular Tachycardia Seizures Other

Patient Local Date and Time Month, Day, Year

Hour, Minute, AM, PM

This field defaults to the tablet’s date and time.

Jan 01, 1994

Wireless Data Priority Tachy, Brady, Pause; Pause, Tachy, Brady Pause, Tachy, Brady

Tachy, Pause, Brady; Brady, Tachy, Pause; Brady, Pause, Tachy; Pause, Tachy, Brady; Pause, Brady, Tachy

Implanting Physician Available options set on the APP

- -

SET UP > SET UP PHYSICIAN LIST

screen. You can add a physician to the PHYSICIAN LIST in a session by tapping > Settings > Physician List.

Table 12. Monitoring parameters (continued)

Parameter Programmable values Shipped value Reset value

Sleeping Hours Near Home Monitor (Daily Wireless Transmission Time)

Patient History No selectable values. Confirm or

- enter any desired patient history information in the field.

7.4.3 Monitoring - LINQ II ICM

Tap the Monitoring tab to confirm or update the Monitoring parameters for the LINQ II ICM.

Table 13. Monitoring parameters

Parameter Programmable values Shipped value Reset value

Reason for Monitoring Syncope - -

Cryptogenic Stroke Suspected AF AF Ablation AF Management Palpitations Ventricular Tachycardia Seizures Other

Patient Local Date and Time Month, Day, Year

Hour, Minute, AM, PM

MyCareLink Heart™ Mobile App Optimization

ON OFF

This field defaults to the

Jan 01, 1994

tablet’s date and time. OFF OFF

Note: Tap ADVANCED SETTINGS to access this parameter setting.

When the MyCareLink Heart™ Mobile App Optimization is turned ON, the LINQ II ICM battery longevity is reduced.

7.4.4 Detection - Reveal LINQ ICM

Tap the Detection tab to edit the Detection parameters.

Table 14. Detection parameters

Parameter Programmable values Shipped value Reset value Tachy

Detection ON; OFF OFF ON Interval (Rate) 270 ms (222 bpm) 340 ms (176 bpm) 340 ms (176 bpm)

280 ms (214 bpm) 290 ms (207 bpm) 300 ms (200 bpm) 310 ms (194 bpm) 320 ms (188 bpm) 330 ms (182 bpm) 340 ms (176 bpm) 350 ms (171 bpm) 360 ms (167 bpm) 370 ms (162 bpm) 380 ms (158 bpm) 390 ms (154 bpm) 400 ms (150 bpm) 410 ms (146 bpm) 420 ms (143 bpm) 430 ms (140 bpm) 440 ms (136 bpm) 450 ms (133 bpm) 460 ms (130 bpm) 470 ms (128 bpm) 480 ms (125 bpm) 490 ms (122 bpm) 500 ms (120 bpm) 510 ms (118 bpm) 520 ms (115 bpm)

Duration 5; 12; 16; 24; 32; 48 beats 16 beats 16 beats

Brady

Detection ON; OFF OFF ON Interval (Rate) 2000 ms (30 bpm) 2000 ms (30 bpm) 2000 ms (30 bpm)

1500 ms (40 bpm) 1200 ms (50 bpm) 1000 ms (60 bpm)

Duration 4; 8; 12 beats 4 beats 4 beats

Pause

Detection On; Off Off On Duration 1.5; 3; 4.5 s 3 s 3 s

AT/AF…

AT/AF Detection Off; AT and AF; AF Only Off AF Only

Symptom

Detection Four 7.5 min Episodes;

Three 10 min Episodes; Two 15 min Episodes

Four 7.5 min Episodes Four 7.5 min Episodes

Tap ADVANCED SETTINGS to edit the parameters on the ADVANCED DETECTION SETTINGS screen.

Table 15. ADVANCED SETTINGS parameters

Parameter Programmable values Shipped value Reset value

AF: Detection Sensitivity Least Sensitive; Less Sensi-

tive; Balanced Sensitivity; More

Sensitive AT/AF: Ectopy Rejection Off; Nominal; Aggressive Off Off AT/AF: Recording Threshold All Episodes;

Episodes ≥6 min;

Episodes ≥10 min;

Episodes ≥20 min;

Episodes ≥30 min;

Episodes ≥60 min;

Only Longest Episode Detect Very Regular AT

Rhythms

7.4.5 Detection - LINQ II ICM

Tap the Detection tab to edit the Detection parameters.

Table 16. Detection parameters

Parameter Programmable values Shipped value Reset value Tachy

Detection ON; OFF OFF ON Interval (Rate) 270 ms (222 bpm) 340 ms (176 bpm) 340 ms (176 bpm)

Duration 5; 12; 16; 24; 32; 48 beats 16 beats 16 beats

Brady

Detection ON; OFF OFF ON

Off; On - All Rates; On - Rates ≥

67 bpm; On - Rates ≥ 100 bpm

Less Sensitive Less Sensitive

Episodes ≥10 min Episodes ≥10 min

Off ---

Table 16. Detection parameters (continued)

Parameter Programmable values Shipped value Reset value

Interval (Rate) 2000 ms (30 bpm) 2000 ms (30 bpm) 2000 ms (30 bpm)

1500 ms (40 bpm) 1200 ms (50 bpm) 1000 ms (60 bpm) 860 ms (70 bpm) 750 ms (80 bpm)

Duration 4; 5; 6; 7; 8; 9; 10; 11; 12

beats

Pause

Detection On; Off Off On Duration 1.5; 2; 3; 4; 5 s 3 s 3 s

PVCs

Detection Off; On Off Off

AT/AF…

AT/AF Detection Off; AT and AF; AF Only Off AF Only

Symptom

Duration Off; Two 15 min Epi-

sodes; Three 10 min Episodes

Tap ADVANCED SETTINGS to edit the parameters on the ADVANCED DETECTION SETTINGS screen.

4 beats 4 beats

Two 15 min Episodes Two 15 min Episodes

Table 17. ADVANCED SETTINGS parameters

Parameter Programmable values Shipped value Reset value

AF: Detection Sensitivity Least Sensitive; Less Sensi-

tive; Balanced Sensitivity; More

Sensitive AT/AF: Ectopy Rejection Off; Nominal; Aggressive Aggressive Aggressive AT/AF: Recording Threshold All Episodes;

Episodes ≥6 min;

Episodes ≥10 min;

Episodes ≥20 min;

Episodes ≥30 min;

Episodes ≥60 min; Brady: Nighttime ECGs Stored None; 1 ECG; Up to 3 ECGs 1 ECG 1 ECG Tachy: Require Rapid Onset On; Off On On

7.4.6 Sensitivity

Tap the Sensitivity tab to edit the sensing parameters.

Table 18. Sensitivity Parameters

Parameter Programmable Values Shipped Value Reset Value

Sensitivity 0.025 mV (25 µV) 0.035 mV (35 µV) 0.035 mV (35 µV)

0.035 mV (35 µV)

0.05 mV (50 µV)

0.075 mV (75 µV)

0.1 mV (100 µV)

0.125 mV (125 µV)

0.15 mV (150 µV)

0.175 mV (175 µV)

0.2 mV (200 µV)

Less Sensitive Less Sensitive

Episodes ≥10 min Episodes ≥10 min

Table 18. Sensitivity Parameters (continued)

Parameter Programmable Values Shipped Value Reset Value

Blank after Sense 130; 150; 170; 200; 250; 300;

400 ms

T-Wave Blanking Interval (LINQ II ICM) Sensing Threshold Decay Delay (Reveal LINQ ICM)

7.4.7 Equipment

Tap the Equipment tab to edit the Equipment options for the patient.

The Equipment tab is only available when the tablet is connected to the internet and CareLink™ Sync is turned ON.

You can change the patient’s Equipment settings if the patient has not been fully enrolled in the CareLink Network. If the patient has been fully enrolled in the CareLink Network, changes to the patient’s Equipment settings need to be completed through the CareLink Network.

Table 19. Equipment options per device

Device Equipment options

Reveal LINQ MyCareLink™ Monitor

LINQ II MyCareLink Heart™ Mobile App

130; 150; 200; 300; 400; 500 ms 150 ms 150 ms

150 ms 150 ms

No equipment selection at this time

Note: This option is not available if the patient is pre-enrolled in

the CareLink Network and an Equipment option was previously selected for the patient.

Note: The app must be downloaded and set up on the patient’s smart phone or tablet after device insertion.

MyCareLink Relay™ 24960 No equipment selection at this time

Note: This option is not available if the patient is pre-enrolled in

the CareLink Network and an Equipment option was previously selected for the patient.

7.4.8 Demographics - Reveal LINQ ICM

Tap the Demographics tab to view the patient’s personal information.

Confirm or edit the required patient Demographics parameters.

Table 20. Required Demographics Parameters

Parameter Editable Values

First Name Confirm or edit the patient’s first name as you would like it to

appear in the patient’s record.

Last Name Confirm or edit the patient’s last name as you would like it to

appear in the patient’s record.

Date of Birth Confirm or edit the patient’s date of birth from the picker. This

setting is used to calculate the nominal Tachy Detection Interval

setting. Gender Confirm or edit the patient’s gender from the drop menu. Phone Number Confirm or edit the patient’s phone number.

Confirm or edit the optional patient Demographics parameters.

Table 21. Optional Patient Demographics Information

Parameter Editable Values

Address Confirm or edit the patient’s address. City Confirm or edit the city where the patient lives. State/Region Confirm or edit the state or region where the patient lives.

Table 21. Optional Patient Demographics Information (continued)

Parameter Editable Values

Postal Code Confirm or edit the patient’s postal code. Country Confirm or edit the patient’s country of residence. Patient ID Confirm or edit the patient’s ID number from the patient ID card

7.4.9 Demographics - LINQ II ICM

Tap the Demographics tab to view the patient’s personal information.

Confirm or edit the required patient Demographics parameters.

Table 22. Required Demographics Parameters

Parameter Editable Values

First Name Confirm or edit the patient’s first name as you would like it to

appear in the patient’s record. Last Name Confirm or edit the patient’s last name as you would like it to

appear in the patient’s record. Date of Birth Confirm or edit the patient’s date of birth from the picker. This

setting is used to calculate the nominal Tachy Detection Interval

setting. Gender Confirm or edit the patient’s gender from the drop menu.

7.5 Reports

You can generate a Session Report on the Reports tab.

After an INSERT DEVICE or CHECK PATIENT session, the app saves the session data to the tablet. The session data can be generated into a Session Report.

After it has been generated, the Session Report is available in the app for 7 days. After 7 days, the Session Report is deleted from the app.

To view a report, complete the following steps:

1. Select the episodes you want to include in the report from the Episodes > AVAILABLE EPISODES list.

2. Determine if you want to include the following options in the report:

Option Outcome Include trends (Cardiac Compass and Histograms) This option is automatically selected for inclusion in the Ses-

sion Report. Tap the check box to deselect this option and remove it from the Session Report.

Include full episode list This option is automatically selected for inclusion in the Ses-

sion Report. When this option is selected, all available Epi-

sodes from the Episodes are included in the Session Report. The Session Report includes ECGs for each episode selected on the Episodes tab. Tap the check box to deselect this option. When Include full

episode list is deselected, only selected Episodes from the Episodes tab are included in the Session Report.

3. Tap VIEW AND SAVE REPORT.

Session report - Reveal LINQ device

The Session Report provides you a comprehensive view of the device data.

ECGs for each episode are available in the Session Report.

Table 23. Session Report - Reveal LINQ device

Session Report information Parameters

Patient Information Name

Patient ID

Device type and device serial number

Date of Birth

Implanted Date

Table 23. Session Report - Reveal LINQ device (continued)

Session Report information Parameters

Reason for Monitoring Quick Look Symptom

Tachy

Pause

Brady

Time in AT/AF

Battery Status

Key Observations Additional Parameter Settings Sensitivity

Blank After Sense

Sensing Threshold Decay Delay

AF: Detection Sensitivity

AT/AF: Ectopy Rejection Current ECG Amplitude

Heart Rate Episode List

ID#

Type

Date

Time HH:MM

Duration HH:MM:SS

Max Rate

Med Rate Trends - Cardiac Compass AT/AF

V. (ventricular) rate during AT/AF

Average V. (ventricular) rate

Patient Activity

Heart Rate Variability Trends - Histograms Total Time AT/AF

Time in AT/AF Episode ECG The episodes selected on the Episodes tab, including the ECG

and the Rate Plot for the selected episodes.

All episodes are listed in the Session Report when Include full episode list is selected.

Session Report - LINQ II device

The session report provides you a comprehensive view of the device data.

ECGs for each episode are available in the Session Report.

Table 24. Session report - LINQ II device

Session report information Parameters

Patient Information Name

Device type and device serial number

Date of Birth

Implanted Date

Reason for Monitoring Quick Look Symptom

Tachy

Pause

Brady

Time in AT/AF

PVCs (% beats)

Battery Status

Key Observations Additional Parameter Settings Sensitivity

Table 24. Session report - LINQ II device (continued)

Session report information Parameters

Blank After Sense

T-Wave Blanking Interval

AF: Detection Sensitivity

AT/AF: Ectopy Rejection

Brady: Nighttime ECGs Stored Current ECG Amplitude

Heart Rate Episode List

ID#

Type

Date

Time HH:MM

Duration HH:MM:SS

Max Rate

Med Rate

Symptom Details (logged by the patient in the

MyCareLink Heart™ Mobile App) Trends - Cardiac Compass AT/AF

V. (ventricular) rate during AT/AF

Average V. (ventricular) rate

PVC

Patient Activity

Heart Rate Variability Trends - Histograms Total Time AT/AF

Time in AT/AF Episodes The episodes selected on the Episodes tab, including the ECG

and the Rate Plot for the selected episodes.

All episodes are listed in the Session Report when Include full episode list is selected.

7.6 End Session

The END SESSION > SESSION SUMMARY screen displays a summary of patient information when you end your current INSERT DEVICE session.

If the SESSION SUMMARY screen displays

, indicating that the patient enrollment or device registration was unsuccessful, see

Section 10.4 for troubleshooting information.

8 Menu options

8.1 Pending Uploads

Data transmissions from an INSERT DEVICE or CHECK PATIENT session remain pending for 7 days or until they are sent successfully to the Medtronic CareLink Network. Data transmissions remain pending when CareLink™ Sync is turned OFF. The app will attempt to send any pending data transmissions when CareLink™ Sync is turned ON. Unsent data transmissions will be deleted after 7 days.

Tap > Pending Uploads to view any pending data transmissions to the Medtronic CareLink Network.

If there are pending data transmissions, the number of pending data transmissions are displayed next to the Pending Uploads option.

The PENDING UPLOADS screen displays the following information for a pending data transmission:

• Date: The date the data from the INSERT DEVICE or CHECK PATIENT session was collected.

• Patient Name: The patient’s name associated with the data.

• Days Left to Retry: The number of days remaining for the data to be transmitted to the CareLink Network.

The app will automatically transmit the data to the Medtronic CareLink Network when a Wi-Fi or cellular network connection is established. After 7 days of no connectivity to a Wi-Fi or cellular network, the data will be deleted.

8.2 Unenrolled Patients

The Unenrolled Patients screen displays a list of patients that have not been accepted by his or her assigned clinic from the Follow-Up Clinic List 7 days after the insertion occurred. The Unenrolled Patients screen will not display patients whose data has

not been sent to the CareLink Network because the app is not connected to the Internet.

To view the list of unenrolled patients, tap > Unenrolled Patients. Contact the patient’s follow-up clinic and request that the clinic accept the patient from their New Patients list in the CareLink Network.

• If there are new unenrolled patients, an exclamation point and the number of unenrolled patients is displayed next to the > Unenrolled Patients setting.

• If the app is not connected to the Medtronic CareLink Network, no unenrolled patients will be displayed on the Unenrolled Patients screen.

• The Unenrolled Patients menu option will not be visible when the CareLink™ Sync option is turned OFF.

8.3 Settings

8.3.1 Overview

Use the Settings option to turn ON or turn OFF the CareLink™ Sync setting. When CareLink™ Sync is turned ON, you can add physicians to the Physician List, or add clinics to the Follow-Up Clinic List, and access other features of the app.

8.3.2 CareLink™ Sync

CareLink™ Sync connects the app to the Medtronic CareLink Network. Connection to the network is enabled when the tablet is connected to the Internet and CareLink™ Sync is turned ON.

CareLink™ Sync is set to ON when the app is downloaded and set up. It remains ON unless you toggle the CareLink™ Sync switch

to OFF.

When the tablet is connected to the Internet and CareLink™ Sync is turned ON, the following features are available in the app:

• PHYSICIAN LIST setup

• Creation of your Follow-Up Clinic List

• Setting up and adding patients to the SELECT A PATIENT list

• Patient pre-enrollment in the Medtronic CareLink Network

• Device registration

• Access to the Unenrolled Patients list

• Access to the Pending Uploads list

• Associate equipment to patients during pre-enrollment in the Medtronic CareLink Network

• Episode assessment

• Viewing Symptom records

When CareLink™ Sync is turned OFF, the app is not connected to the Medtronic CareLink Network. Device registration and patient pre-enrollment must be completed manually.

When CareLink™ Sync is turned OFF, you will be unable to access the following app features:

• PHYSICIAN LIST setup

• Creation of your Follow-Up Clinic List

• Setting up and adding patients to the SELECT A PATIENT list

• Patient pre-enrollment in the Medtronic CareLink Network

• Device registration

• Access to the Unenrolled Patients list

• Access to the Pending Uploads list

• Associate equipment to patients during pre-enrollment in the Medtronic CareLink Network

• Episode assessment

• Viewing Symptom records

Turning on or turning off CareLink™ Sync

1. Tap > Settings > CareLink™ Sync.

2. Select one of the following options:

• Toggle the CareLink™ Sync switch ON to turn on CareLink™ Sync.

• Toggle the CareLink™ Sync switch OFF to turn off CareLink™ Sync.

8.3.3 Physician List

8.3.3.1 Adding physicians to the Physician List

You can add physicians to the Physician List when you are on the home screen or during an INSERT DEVICE or CHECK PATIENT session.

Tap > Settings > Physician List

The SET UP PHYSICIAN LIST screen is displayed.

8.3.3.2 Edit physician list

1. Enter a physician’s first name in the First Name field.

2. Enter a physician’s last name in the Last Name field.

3. Enter one or more options for the physician’s location information:

• Enter a city name in the City field.

• Select a state from the State drop menu.

• Enter a zip code in the Postal Code field.

4. Select one of the following options:

• Tap SEARCH to search for the physician.

• Tap CLEAR FIELDS to clear all of the search fields.

Tapping SEARCH displays the physician information in the Search Results field.

5. Select a physician or physicians from the Search Results field and tap ADD TO LIST. A message appears when a physician or physicians have been successfully added to the Physician List.

8.3.3.3 Manually adding a physician to the Physician List

If the search for the physician did not return a result, you can manually add a physician to the Physician List.

When a search for a physician did not return a result, the Search Results screen displays a message that no results were found for the physician.

Physicians that are manually added are only available in the Physician List for 30 calendar days.

1. In the Search Results field, select I want to manually add this physician to the list.

2. Tap ADD TO LIST. The MANUALLY ADD TO LIST screen displays.

3. Enter the required information for the physician in the required fields:

• First Name

• Last Name

• City

• State

4. Enter additional optional physician information, if desired.

5. Select one of the following options:

• Tap ADD MANUALLY to manually add the physician to the Physician List.

• Tap CANCEL to exit the MANUALLY ADD TO LIST screen.

8.3.3.4 Removing a physician from the Physician List

You can remove a physician from the Physician List.

1. Tap PHYSICIAN LIST to view all physicians in your Physician List.

2. Tap next to the physician’s name you want to remove from the Physician List.

• Tap REMOVE to remove the physician from the Physician List.

• Tap CANCEL to exit the REMOVE PHYSICIAN screen.

8.3.3.5 Completing the Physician List set up

Tap one of the following buttons to save physicians to your Physician List, or to cancel this step:

• Tap SAVE to save the physicians to your Physician List. The physicians you added to your Physician List are now available as options on the INSERT DEVICE > MONITORING

INFORMATION screen

The Physician List can also be accessed from the following locations during a CHECK PATIENT session: – On the Device & Patient Settings > Monitoring screen from the Implanting Physician drop menu. (For Reveal LINQ

devices only.)

– From the > Settings > Physician List, when CareLink™ Sync is turned ON.

• Tap CANCEL. No physicians are added or saved to your Physician List.

8.3.4 Follow-Up Clinic List

8.3.4.1 Adding follow-up clinics

You can add follow-up clinics to the Follow-Up Clinic List when you are on the home screen or during an INSERT DEVICE or CHECK PATIENT session.

Tap > Settings > Follow-Up Clinic List

The SET UP FOLLOW-UP CLINIC LIST screen is displayed.

1. Select CareLink™ Network User ID or Clinic Account Number from the Search By drop-down list.

2. Enter a CareLink Network User ID or Clinic Account Number in the Search Entry field for the clinic where the patient will be enrolled.

Contact your CareLink Network administrator or your Medtronic representative for questions about the CareLink Network User ID or Clinic Account Number.

3. Tap SEARCH. The follow-up clinics are displayed in the Search Results field.

4. Select a clinic or clinics you want to add to your Follow-Up Clinic List.

5. Tap the Add icon. Your selected follow-up clinics are displayed in the Follow-Up Clinic List field.

6. To add additional follow-up clinics, enter a CareLink Network User ID or Clinic Account Number and repeat the search.

8.3.4.2 Renaming a follow-up clinic

You can rename a follow-up clinic with an alias.

1. Tap the Add/Edit Alias icon.

2. Enter a unique alias for the follow-up clinic you want to rename in the ALIAS field next to the follow-up clinic name. A follow-up clinic alias must be a unique name.

• If you have entered the same alias for two or more follow-up clinics on the ADD/EDIT ALIAS screen, the ALIAS field is highlighted in red.

• The EXISTING CLINIC screen displays if a duplicate alias is entered for an existing follow-up clinic in your Follow-Up Clinic List.

3. Tap one of the following options:

• Tap OK to rename the follow-up clinic.

• Tap CANCEL to exit the ADD/EDIT ALIAS screen.

8.3.4.3 Removing a follow-up clinic from the Follow-Up Clinic List

Tap next to the follow-up clinic you want to remove from the Follow-Up Clinic List.

• Tap REMOVE to remove the follow-up clinic from the Follow-Up Clinic List.

• Tap CANCEL to exit the REMOVE FOLLOW-UP CLINIC FROM LIST screen.

8.3.4.4 Completing Follow-Up Clinic List setup

Tap one of the following buttons to add a follow-up clinic to the Follow-Up Clinic List, or to cancel this step:

• Tap SAVE to save the follow-up clinics to your Follow-Up Clinic List. The clinics you added to your Follow-Up Clinic List are now available as options on the INSERT DEVICE > MONITORING

INFORMATION screen and during a CHECK DEVICE session on the > Settings > Follow-Up Clinic List screen.

• Tap CANCEL. No clinics are added or saved to your Follow-Up Clinic List.

8.4 Patient Education

Patient Education is used to access a Medtronic webpage that has patient-focused information about the cardiac monitor system.

> Patient Education. The PATIENT EDUCATION window displays with a notice that tapping CONTINUE will open a website

Tap with patient-focused learning activities. The patient can watch an instructional video, view a setup exercise, and read answers to

frequently asked questions. To prevent the patient from accessing information in other areas of the app, it is important that you click

CONTINUE and that the webpage has opened before the tablet is handed to the patient.

Caution: If you hand the tablet to the patient before tapping CONTINUE, then another patient’s information in the app could be exposed. For example, > Load Saved Session could be used to access information about a patient’s saved session.

Patient Education is not available from the app menu when a CHECK PATIENT session is active.

8.5 About

Use the About selection to view information about the app or the patient connector.

About Reveal LINQ™ Mobile Manager

Tap > About > About Reveal LINQ™ Mobile Manager to view the following information about the app:

• Reveal LINQ™ Mobile Manager app model number

• App version number

• UDI (Unique Device Identifier)

• App Install ID

• Copyright information

• Contact Medtronic support

• Legal information

• Account number

• Tablet name

About Patient Conntector

Tap > About > About Patient Conntector to view the following information about the patient connector:

• Model number

• Name

• Firmware version number

8.6 View Reports

View reports from INSERT DEVICE or CHECK PATIENT sessions that occurred within the last 7 days. The VIEW REPORTS option is only available when you are not in an INSERT DEVICE, CHECK PATIENT, or SET UP PATIENT session.

1. From the Reveal LINQ MOBILE MANAGER screen, tap > View Reports.

2. Tap the report you want to open, then tap OPEN.

8.7 Save Session

You can save the INSERT DEVICE or CHECK PATIENT session data to your tablet.

You can load a patient’s saved session to review the device data outside of an INSERT DEVICE or CHECK PATIENT session. Saved device data can also be retrieved after the 7-day period for storing the patient’s Session Report has expired and the Session Report has been deleted.

> Save Session to save interrogated device data to your tablet.

Tap

8.8 Load Saved Session

You can load session data from a previous INSERT DEVICE or CHECK PATIENT session. The Load Saved Session option is only available when you are not in an INSERT DEVICE, CHECK PATIENT, or SET UP PATIENT session.

To load session data from a previous session, complete the following steps:

1. Tap > Load Saved Session. The LOAD SAVED SESSION screen displays.

2. Select the desired session data from the list.

3. Select one of the following options:

• Tap LOAD SESSION to view the selected session data.

• Tap CANCEL to return to the Reveal LINQ™ MOBILE MANAGER screen.

4. To close the saved session, select one of the following options:

• Tap > End Session.

• Tap END SESSION in the bottom-right corner of the window.

8.9 Patient-data privacy

You can remove protected health information (PHI) from the app to manage the privacy of patient data.

The > Patient Data Privacy option is only available when you are outside of a SET UP PATIENT, INSERT DEVICE, or CHECK PATIENT session.

For more information about managing patient-data privacy and removing patient data from the app, see Section 9.1.

9 Manage patient-data privacy

9.1 About patient-data privacy management

Protected health information (PHI) is stored on the app in reports, saved sessions, pending uploads, and implant-session summaries. PHI that is accessible from the app, but that is not stored on the app, includes set-up patients and unenrolled patients. You can access these sources of PHI from the REPORT LIST, LOAD SAVED SESSION, IMPLANT SESSION SUMMARY, INSERT DEVICE, or UNENROLLED PATIENTS screens.

PHI is automatically removed from the app 7 days after it was added to the app. During the 7-day period, you can manually remove PHI from the app to manage patient-data privacy.

9.2 Remove protected health information from the app

Remove protected health information (PHI) from the app to manage patient-data privacy. Use the DELETE PROTECTED HEALTH INFORMATION button to remove reports, saved sessions, pending uploads, and implant-session summaries from the app.

Note: The DELETE PROTECTED HEALTH INFORMATION button does not remove set-up patients and unenrolled patients from the

app. Unenrolled patients and set-up patients are automatically removed from the app after 7 days. To manually remove set-up patients from the app, see Section 9.6.

1. From the Reveal LINQ MOBILE MANAGER screen, tap > Patient Data Privacy.

2. Tap DELETE PROTECTED HEALTH INFORMATION.

3. From the CONFIRM TO DELETE window, tap DELETE PROTECTED HEALTH INFORMATION.

9.3 Remove a report from the app

Remove a report from the app to manage patient-data privacy.

1. From the Reveal LINQ MOBILE MANAGER screen, tap > View Reports.

2. Tap next to the report that you want to remove.

3. Tap REMOVE.

9.4 Remove a saved session from the app

Remove a saved session from the app to manage patient-data privacy.

1. From the Reveal LINQ MOBILE MANAGER screen, tap

2. Tap next to the saved session that you want to remove.

3. Tap REMOVE.

> Load Saved Session.

9.5 Remove a pending upload from the app

Remove a pending upload from the app to manage patient-data privacy.

1. From the Reveal LINQ MOBILE MANAGER screen, tap > Pending Uploads.

2. Tap next to the pending upload that you want to remove.

3. Tap REMOVE.

9.6 Remove a set-up patient from the app

Remove a set-up patient from the app to manage patient-data privacy.

1. From the Reveal LINQ MOBILE MANAGER screen, tap INSERT DEVICE.

2. From the SELECT A PATIENT screen, tap

3. Tap REMOVE.

next to the patient that you want to remove.

9.7 Remove a patient’s implant-session summary from the app

Remove a patient’s implant-session summary from the app to manage patient-data privacy.

1. From the Reveal LINQ MOBILE MANAGER screen, tap VIEW next to the Patient implant data was not sent message.

2. Tap next to the implant-session summary that you want to remove.

3. Tap REMOVE.

10 Troubleshooting

10.1 Issue and system messages

Table 25. Issue messages

Issue code Message title Message description Action

0056 - - The app has failed an integrity check.

Contact your Medtronic representative and tap CLOSE.

0060 - - The app has failed a compatibility

check. Contact your Medtronic representative and tap CLOSE to close the app.

2108 LOGIN UNSUCCESS-

FUL

2108 The CareLink™ Net-

work is currently unavailable

2316 - - Tap CLOSE to close the app.

3230 - - The Bluetooth pairing failed. The app

3269 BLUETOOTH INTER-

RUPTED

This tablet requires login through the CareLink™ Network to continue. Please login again.

- The connection with the CareLink Net-

Check the following:

• Patient connector is on

• Tablet Bluetooth is on

• Patient connector is near the tablet

Tap CLOSE to close the message. Try one or more of the following items to try to resolve the issue:

• Check that the tablet’s Wi-Fi or cellular connection is enabled and that the tablet is connected to your network.

• Find an area with the stronger connection to the internet.

• Try to login the tablet in the CareLink Network at a later time.

work cannot be established. Try one or more of the following items to try to resolve the issue:

• Try to add the follow-up clinic or physician at a later time.

• Manually add the physician to the PHYSICIAN LIST, if applicable.

The app has a system error. Contact your Medtronic representative.

is unable to connect to the requested patient connector at the beginning of a session. Tap CLOSE to close the window. Try one or more of the following items to resolve the issue:

• Try to pair the app and the patient connector again.

• Try to pair the app with a different patient connector if you are unable to pair the app with the current patient connector.

Select one of the following options to close the window:

• Tap CLOSE to close the window. The app displays the screen you

Table 25. Issue messages (continued)

Issue code Message title Message description Action

Ending session will cause any pending parameter changes to be lost.

3269 CONNECTION LOST The Patient Connector connection cannot be

recovered. End Session and start a new session to reconnect. You may close this window and continue reviewing the current data. Ending session will cause any pending parameter changes to be lost.

3276 CONNECTION LOST The Patient Connector connection cannot be

recovered. End Session and start a new session to reconnect. You may close this window and continue reviewing the current data. Ending the session will cause any pending parameter changes to be lost.

3517 DEVICE NOT ACTIVA-

TED

The connection to the insertable device has been lost. The patient will not be monitored until device activation is complete. To complete activation:

were working on when the message was displayed.

• Tap END SESSION to close the window, end your current session and return to the Reveal LINQ MOBILE MANAGER screen. Any pending parameter changes will be lost if you tap END SESSION.

Try one or more of the following items to resolve the issue:

• Verify that the patient connector is turned on.

• Verify in the tablet’s Settings that Bluetooth wireless technology is enabled. For most tablets, tap Settings > Bluetooth.

• Move the patient connector closer to the tablet. The patient connector needs to be close to the tablet to establish a Bluetooth connection with the tablet.

Select one of the following options to close the window:

• Tap CLOSE to close the window and return to the previous window.

• Tap END SESSION to close the window and end your current session. Any pending parameter changes will be lost if you tap END SESSION.

To reconnect the patient connector to the device, perform one or more of the following steps:

• Verify that the patient connector is turned on.

• Reposition the patient connector to attempt to reestablish the connection with the device.

• Connect to the device with a different patient connector.

Select one of the following options to close the window:

• Tap CLOSE to return to your previous screen.

• Tap END SESSION to close the window and end your current session. Any pending parameter changes will be lost if you tap END SESSION.

• Pair the app with a different patient connector and restart your workflow.

To complete activation, complete the following steps:

Table 25. Issue messages (continued)

Issue code Message title Message description Action

• Press the button on the patient connector to turn it on

• Place the patient connector over the insertable device

• Select RESUME

• Press the button on the patient connector to turn it on

• Place the patient connector over the insertable device

• Select RESUME

To cancel activation, which will result in the patient not being monitored, tap

CANCEL ACTIVATION, then tap YES, CANCEL on the confirmation

screen.

3517 OPERATION UNSUC-

CESSFUL

The connection to the insertable device has been lost. Press the button on the patient connector to turn it on, place it over the inserted device, and then select RETRY.

Try one or more of the following options to try to resolve the issue:

• Tap CANCEL to close the message.

• Reposition the patient connector over the patient’s device and tap RETRY.

If the current patient connector is unable to establish a connection with the device, try to connect to the device with a different patient connector.

3517 OPERATION UNSUC-

CESSFUL

The connection to the insertable device has been lost. Press the button on the patient connector to turn it on, place it over the inserted device, and then select RETRY.

Try one or more of the following options to try to resolve the issue:

• Reposition the patient connector over the patient’s device and tap RETRY.

• Tap END SESSION to close the window and end your current session.

If the current patient connector is unable to establish a connection with the device, try to connect to the device with a different patient connector.

3517 SESSION EXPIRED The session with the insertable device has

expired. END SESSION and start a new session to reconnect. Pending parameter changes have been lost.

The current device session has expired. Tap END SESSION to close the window and end your current session. Any pending parameter changes have been lost and need to be re-programmed.

4514 INSERTABLE DEVICE

ERROR

Warning: Insertable Device Electrical Reset. Contact a Medtronic representative. Settings in the insertable device may have changed. Please review all programmed settings. To continue operation:

1. Select CLEAR to reset the indicator.

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app

• Tap END SESSION.

• Contact your Medtronic representative.

2. Save interrogated data.

4514 INSERTABLE DEVICE

ERROR

Warning: Insertable Device Electrical Reset. Contact a Medtronic representative. Settings in the insertable device may have changed. Please review all programmed settings. To continue operation:

1. Select CLEAR to reset the indicator.

2. Save interrogated data.

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app

• Tap CLOSE to close the message.

• Contact your Medtronic representative.

Table 25. Issue messages (continued)

Issue code Message title Message description Action

4514 INSERTABLE DEVICE

ERROR

Warning: Insertable Device Electrical Reset. Contact a Medtronic representative. To continue operation:

1. Select CLEAR to reset the indicator.

2. Save interrogated data.

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app

• Tap CLOSE to close the message.

• Contact your Medtronic representative.

4514 UNKNOWN INSERTA-

BLE DEVICE

4522 INSERTABLE DEVICE

ERROR

An insertable device with a different serial number, model number or software version has been detected under the patient connector.

Warning: Insertable Device Electrical Reset Contact a Medtronic representative. To continue operation:

1. Select CLEAR to reset the indicator.

2. Reprogram desired parameter values.

Note: All data in programmer will be cleared.

• Tap END SESSION.

• Repeat the interrogation.

• Contact your Medtronic representative.

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app.

• Tap END SESSION to close the session and return to the Reveal

LINQ MOBILE MANAGER

screen. Repeat your workflow.

• Contact your Medtronic representative.

4522 INSERTABLE DEVICE

ERROR

Warning: Insertable Device Electrical Reset Contact a Medtronic representative. To continue operation:

1. Select CLEAR to reset the indicator.

2. Reprogram desired parameter values.

Note: All data in programmer will be cleared.

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app.

• Tap CLOSE to close the session and return to the Reveal LINQ MOBILE MANAGER screen. Repeat your workflow.

• Contact your Medtronic representative.

4522 INSERTABLE DEVICE

ERROR

Warning: Insertable Device Electrical Reset Contact a Medtronic representative. To continue operation: Select CLEAR to reset the indicator. Note: All data has been cleared but key parameter values are unchanged.

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app.

• Tap END SESSION to close the session and return to the Reveal

LINQ MOBILE MANAGER

screen. Repeat your workflow.

• Contact your Medtronic representative.

4522 INSERTABLE DEVICE

ERROR

Try one or more of the following options to try to resolve the issue:

• Tap CLEAR to clear previously interrogated data in the app.

• Tap CLOSE to close the session and return to the Reveal LINQ MOBILE MANAGER screen. Repeat your workflow.

• Contact your Medtronic representative.

5506 CHECK INTERNET

CONNECTION

Internet connection is required to login. You must connect to the internet every 30 days to remain logged in.

Tap CLOSE to close the message. To enable all features of the app, ensure that Wi-Fi or cellular data serv-

Table 25. Issue messages (continued)

Issue code Message title Message description Action

Please check your internet settings and RETRY.

5506 CHECK INTERNET

CONNECTION

5506 CHECK INTERNET

CONNECTION

5506 Internet not connected - The connection with the CareLink Net-

8218 - - A firmware update failed. Tap OK to

8423 INSUFFICIENT STOR-

AGE SPACE

8423 NOT ENOUGH FREE

SPACE

Internet connection is required to login. You must connect to the internet every 30 days to remain logged in. Please check your internet settings and RETRY.

Certain features of this software require a connection to the internet.

The insertable device data could not be saved to the tablet. Ensure that your tablet has sufficient storage space and try saving again.

There is insufficient data memory to run this app. To increase the available memory, delete any unnecessary files, videos, images or applications.

ice is enabled and that the tablet is connected to your network. Enable the Wi-Fi or cellular setting on your tablet, and connect to your network.

The app must be connected to the internet every 30 days to remain logged in to the CareLink Network. Try one or more of the following options to fix the issue:

• Tap RETRY to try to reconnect to your Wi-Fi or cellular network.

• Enable the Wi-Fi or cellular setting on your tablet, and connect to your network.

Tap CLOSE to close the message. Tap CLOSE to close the message.

To enable all features of the app, ensure that Wi-Fi or cellular data service is enabled and that the tablet is connected to your network.

• Tap RETRY to try to reconnect to your Wi-Fi or cellular network.

• Enable the Wi-Fi or cellular setting on your tablet, and connect to your network.

work cannot be established due to an internet connection issue. Try one or more of the following items to try to resolve the issue:

• Check that the tablet’s Wi-Fi or cellular connection is enabled and that the tablet is connected to your network.

• Try to add the follow-up clinic or physician at a later time.

• Manually add the follow-up clinic to the Follow-Up Clinic List, if applicable.

• Manually add the physician to the PHYSICIAN LIST, if applicable.

close the message. Tap OK to close the message.

Ensure that your tablet has sufficient storage space and try saving again. Retry your work flow again.

Tap OK to close the message. Verify that there is a minimum 30 MB of internal storage available to run the app.

Table 25. Issue messages (continued)

Issue code Message title Message description Action

The required minimum free space to run this app is: 30 MB on internal storage.

8434 INVALID PARAME-

TERS

The insertable device data could not be saved to the tablet. Some parameters have invalid values. Reprogram device settings and try saving again.

1. Tap OK to close the message.

2. Reprogram the device parameters.

3. Tap > Save Session to retry saving the device data to the tablet.

Table 26. System messages

Message title Message description Action

A newer version of the application is available.

Application update available An optional app update is available.

• Tap UPDATE to install the update now.

• Tap CANCEL to install the update later.

Application update available You must update the application to continue. A required app update is available. You must

install the app update to continue using the app.

• Tap UPDATE to install the update and continue.

• Tap CANCEL to close the app and install the update later. You will not be able to continue using the app until the app update is installed.

Are you sure you want to cancel device activation?

The patient will not be monitored until device activation is complete.

Tap RESUME to return to the ACTIVATE DEVICE screen. Tap YES, CANCEL to cancel device activation and return to the INSERT DEVICE screen.

Note: The device will not be activated and all detection parameters will remain disabled.

CANNOT CONNECT TO INSERTABLE DEVICE

The insertable device could be out of range of the Patient Connector. To continue, try re-positioning the Patient Connector closer to the insertable device.

Tap OK to close the message. Try one or more of the following options to try to resolve the issue:

• Position the patient connector closer to the device and try to re-pair the patient connector with the device.

• Use a different patient connector and pair it with the device.

CARELINK™ SYNC IS TURNED OFF

Data cannot be sent or received from the CareLink™ Network. Patient pre-enrollment and device registration MUST be completed manually through the Medtronic websites.

Tap OK to close the message. Turn ON CareLink Sync. To turn ON CareLink Sync, complete the fol- lowing steps:

• Tap > Settings > CareLink Sync.

• Slide to toggle switch to ON.

CHECK INTERNET CONNECTION

The CareLink™ Network connection failed. You can complete your workflow disconnected, but data will not be sent to or received from the CareLink™ Network.

To resolve the CareLink Network connection issue, try one or more of the following items:

• Check your tablet connectivity to verify that your tablet is connected to the internet through your Wi-Fi or cellular network.

• Find an area with the stronger connection to the internet.

• Tap RETRY.

• Tap CONTINUE DISCONNECTED to continue your workflow without a connection to the CareLink Network.

Table 26. System messages (continued)

Message title Message description Action

CHECK INTERNET CONNECTION

The CareLink™ Network connection failed. You can complete your workflow disconnected, but data will not be sent to or received from the CareLink™ Network.

To resolve the CareLink Network connection issue, try one or more of the following items:

• Check your tablet connectivity to verify that your tablet is connected to the internet through your Wi-Fi or cellular network.

• Find an area with the stronger connection to the internet.

• Tap RETRY.

Tap CONTINUE DISCONNECTED to continue your workflow without a connection to the CareLink Network.

CHECK INTERNET CONNECTION

You are not connected to the CareLink™ Network. Data cannot be sent or received. Check your internet connection and select RETRY. To continue without saving, select CANCEL.

To resolve the CareLink Network connection issue, try one or more of the following items:

• Check your tablet connectivity to verify that your tablet is connected to the internet through your Wi-Fi or cellular network.

• Find an area with the stronger connection to the internet.

• Tap RETRY.

Tap CANCEL to continue your workflow without saving the device data.

CLEAR ELECTRICAL RESET

Clearing this Electrical Reset indication will also clear any previously interrogated data in the programmer. Select CONTINUE to complete the clear.

Tap CONTINUE to clear the previously interrogated device data. Tap CANCEL to return to the previous screen.

CONFIRM END SESSION Are you sure you want to end this session? • Tap YES to end your current session.

• Tap CANCEL to close the message and remain in your current session.

CONNECTED TO THE CARELINK™ NETWORK

DATA WILL BE CLEARED Changing Symptom Episode Duration will clear all

You are connected to the CareLink™ Network, all features are available.

Symptom episodes from the insertable device. Select CONTINUE to proceed with the change.

Tap OK to close the message.

• Tap CONTINUE to clear the symptom episode data on the app and the device.

• Tap CANCEL to return to the previous screen.

DEVICE NOT SETUP The insertable device has not been setup. The inser-

tion workflow needs to be completed before the device can be used.

• Tap CONTINUE INSERTION to navigate to the INSERT DEVICE steps in order to complete the device setup.

• Tap CANCEL to end your current session and to return to the SELECT A PATIENT screen.

Note: If you tap CANCEL and want to continue the session with the current device, you will need to complete the INSERT DEVICE steps to complete the device setup before you can continue with additional work flow steps.

FILE CANNOT BE READ Verify that file is correct and try again. Tap OK to close the message.

Verify that the file you are reading is the correct file you wish to view.

INCOMPATIBLE DEVICE The device you are attempting to associate is not

compatible with the Reveal LINQ™ Mobile Manager application. This application is intended for use with a Reveal LINQ™ or LINQ™ II device. To continue, scan the bar code or manually enter the serial number of a compatible device.

INCOMPATIBLE EQUIPMENT

The equipment you are attempting to associate is not compatible with the insertable device.

Tap OK to close the message.

• Verify that you have a compatible implantable device.

• Scan the barcode or manually enter the serial number of the compatible implantable device.

Tap OK to close the message.

Table 26. System messages (continued)

Message title Message description Action

To continue, scan the barcode or manually enter the serial number of compatible equipment.

• Verify that you have compatible equipment.

• Scan the barcode or manually enter the serial number of the compatible implantable device.

INVALID CHARACTERS ENTERED

NO CAMERA ACCESS The app is not able to access the camera. The camera

Invalid characters have been entered. Please re-enter the text.

can be used to scan barcodes of the insertable device and associated equipment instead of manually entering the serial codes.

Tap OK to close the message. Correct the characters in the field.

Tap OK to close the message. Enable camera access with the app. For most tablets select the Settings, locate the app, and

enable Camera access. To continue, check the Settings of your tablet to enable camera access to the Reveal LINQ™ Mobile Manager app.

OPERATION UNSUCCESSFUL

The connection to the insertable device has been lost. Press the button on the patient connector to turn it on, place it over the inserted device, and then select RETRY.

• Place the patient connector close to the device and tap RETRY.

• Tap CLOSE to close the window, end the current session, and return to the Reveal LINQ MOBILE MANAGER screen.

PATIENT NOT ENROLLED IN THIS CLINIC

Some features are not available including:

• Episode Assessment

• Symptom Details

Tap OK to close the message. Check the patient’s clinic enrollment status on the CareLink Network.

• Equipment Information Please visit the CareLink™ Network and check the patient’s enrollment status.

PATIENT PRE-ENROLLED IN CARELINK™

The selected patient has been pre-enrolled in the CareLink™ Network but has not yet been accepted by this clinic or is pre-enrolled in a different clinic.

Tap OK to close the message. Check the patient’s clinic enrollment status on the CareLink Network.

Some features are not available including:

• Episode Assessment

• Symptom Details Please visit the CareLink™ Network and check the patient’s enrollment status.

TABLET PASSCODE REQUIRED

You must set a passcode on this tablet to continue. To set a passcode on this tablet:

1. Tap CLOSE to close the message.

2. Turn on and set a passcode or Touch ID.

1. Close this dialog.

2. Open the Settings on this tablet.

3. Turn on and set passcode or Touch ID.

4. Relaunch this app and allow permission

3. Restart the app.

4. Allow permission requests.

requests.

TEMPORARILY DISCONNECTED

You have chosen to work disconnected, certain features require internet connection. To access connected features:

1. End Session.

2. Check internet connection.

3. Begin another session.

Tap OK to close the message. Try one or more of the following options to try to resolve the issue:

• Tap END SESSION to end the current INSERT DEVICE or CHECK PATIENT session.

• Check your tablet connectivity to verify that your tablet is connected to the internet through your Wi-Fi or cellular network.

UNABLE TO CONTINUE An insertable device with a different serial number,

model number or software version has been detected under the patient connector.

A different device has been detected by the patient connector. Verify that you have a compatible implantable device. Tap END SESSION to close the current session.

Open the tablet’s Settings and tap Set- tings > Passcode or Touch ID.

Table 26. System messages (continued)

Message title Message description Action

VALUES NOT PROGRAMMED

WARNING: EXPIRED EQUIPMENT

This screen has values which have not been programmed.

The equipment you are attempting to associate is expired beyond its shelf life.

• Tap BACK to return to the previous screen and program the parameter values.

• Tap CONTINUE to continue with your current session. Your current session will continue, but the pending parameter changes will be lost.

Tap OK to close the message.

• Verify that you have a compatible implantable device within the expiration date.

• Scan the barcode or manually enter the serial number of the compatible implantable device.

10.2 Charging

Table 27. Patient Connector Messages

Issue code Message title Message description Action

3248 CONNECT CHARGER - Tap OK to close the message.

The patient connector battery charge is getting low. Charge the patient connector battery before it becomes too low to use or switch to a different patient connector and follow the prompts on the app.

3248 - - Tap END SESSION to close the window.

The patient connector battery charge is low and has less than 25 minutes of estimated service. Connect the patient connector to the Medtronic-supplied charger or switch to a different patient connector and follow the prompts on the app.

10.3 Updates

Medtronic will periodically push updates to the app on the tablet and software on the patient connector.

If an app update is available, you will be prompted to update the app when you launch the app unless you have enabled automatic updates on your tablet. Medtronic recommends accepting all app updates when they are available if automatic updates are not enabled on your tablet.

Standard app updates

If the app displays a message that a newer version of the app is available, select one of the following options:

• Accept the update to update the app to the latest version.

• Decline the update to keep the app at the same version.

If you decline the app update, you will not have the most current version of the app. You will continue to receive the notification to update the app until you accept the update.

Required app updates

If the app displays a message that the app must be updated, select one of the following options:

• Accept the update to update the app to the latest version.

• Decline the update to keep the app at the same version.

If you decline the update, the app will close. You cannot use the app until you accept the app update.

Patient connector software updates

When an update to the patient connector software is available, the update begins automatically after the patient connector pairs with the app.

The patient connector software update process occurs automatically. You do not need to take any action for the process to start or complete.

When the software update initiates, ensure that the patient connector has sufficient power. Plug in the patient connector if the software update initiates and the amber indicator light is lit.

When the patient connector software is updating, a software update screen displays and a progress bar shows the status of the software update. When the progress bar fills completely, the patient connector software is updated and the software update screen closes.

If you close the app or navigate away from the patient connector software update screen during the software update, the software update continues until the patient connector software update completes. You cannot cancel the patient connector software update.

10.4 Troubleshooting unsuccessful patient enrollment and device registration

Successful patient enrollment and device registration requires an Internet connection and communication with Medtronic servers. If patient enrollment or device registration is unsuccessful, take one of the following actions:

• Ensure that Wi-Fi or cellular data is enabled and that the tablet is connected to your network.

• Keep the app open. When the app is open or running in the background, the app continuously tries to resend the patient enrollment and device registration for up to 7 days. When the Medtronic server is not available, it typically becomes available within 24 hours.

• Manually complete patient enrollment or device registration. – If patient enrollment is unsuccessful, contact the patient’s follow-up clinic and request to have the patient manually enrolled in

the Medtronic CareLink network. – If device registration is unsuccessful, contact your Medtronic representative to manually register the patient’s device. Note: After you manually complete patient enrollment or device registration, the app does not update the patient-enrollment or

the device-registration status from to on the IMPLANT SESSION SUMMARY window. To remove the patient’s implant-session summary from the app, see Section 9.7.

11 Contextual Help Content

11.1 Amplitude gauge

The amplitude gauge displays the sensed signal of the device and indicates if the device has a strong or weak sensed signal.

The amplitude gauge displays a strong sensed signal with the following indicators:

• The sensed signal is >= 0.20 mV.

• The sensed signal value is displayed in green.

The amplitude gauge displays a weak sensed signal with the following indicators:

• The sensed signal is < 0.20 mV.

• The sensed signal value is displayed in red.

11.2 Reason for Monitoring - Reveal LINQ ICM

Reason for Monitoring is used to recommend certain nominal settings.

You can edit parameters from the Device & Patient Settings screen.

When you select a Reason for Monitoring, parameter values for AF Detection Sensitivity, Ectopy Rejection, AT/AF Recording Threshold, and Wireless Data Priority are automatically set to default settings. You can change these default settings after you select a Reason for Monitoring.

When you change a parameter value, the new value is shown as pending. You can change several parameter values together. The values remain pending until you tap SAVE. Pending changes will be lost if the session is ended or the app is closed before tapping SAVE.

To undo your pending changes and revert to the last programmed values, tap UNDO.

Ectopy Rejec-

tion

Reason for Monitoring

a,b

AF Detection Sensitivity

Syncope Least Sensitive Aggressive Only Longest Episode Pause, Tachy, Brady Cryptogenic Stroke Balanced Sensitivity Aggressive All Episodes Tachy, Pause, Brady Suspected AF Less Sensitive Nominal Episodes ≥6 min Tachy, Pause, Brady AF Ablation Balanced Sensitivity Nominal All Episodes Tachy, Pause, Brady AF Management Balanced Sensitivity Nominal All Episodes Tachy, Pause, Brady Palpitations Less Sensitive Nominal Episodes ≥6 min Tachy, Pause, Brady

AT/AF Recording Threshold

Wireless Data Priority

Reason for Monitoring

a,b

AF Detection Sensitivity

Ectopy Rejec-

tion

AT/AF Recording Threshold

Wireless Data Priority

Ventricular Tachycardia Least Sensitive Aggressive Episodes ≥10 min Tachy, Pause, Brady Seizures Least Sensitive Aggressive Episodes ≥10 min Pause, Tachy, Brady Other Less Sensitive Aggressive Episodes ≥10 min Pause, Tachy, Brady

For all Reasons for Monitoring, Tachy Detection Interval is programmed automatically to the closest value less than or equal to 230 bpm minus the patient’s age, as calculated from the information entered in the patient’s Date of Birth.

For all Reasons for Monitoring, AT/AF Detection is set to AF Only.

AF Detection Sensitivity, Ectopy Rejection, AT/AF Recording Threshold, and Wireless Data Priority parameters are set to pending automatically according to the selected Reason for Monitoring.

11.3 Reason for Monitoring - LINQ II ICM

Reason for Monitoring is used to recommend certain nominal settings.

You can edit Reason for Monitoring parameters from the Quick Look > Device & Patient Settings screen.

When you select a Reason for Monitoring, parameter values are automatically set to default settings. These default settings are described in the LINQ II LNQ22 Insertable Cardiac Monitor Clinician Manual. You can change these default settings after you select a Reason for Monitoring.

When you change a parameter value, the new value is shown as pending. You can change several parameter values together. The values remain pending until you tap SAVE.

To undo your pending changes and revert to the last programmed values, tap UNDO.

11.4 Date of Birth

Date of Birth is used to calculate the nominal Tachy Detection Interval setting.

11.5 Patient Local Date and Time

• Changes to the Patient Local Date and Time will be applied to new data only. Timestamps of previously stored data will not be modified.

• Changing the Patient Local Date and Time may cause temporary errors in CareLink Network reporting.

• Any episodes awaiting wireless transmission to the CareLink Network when the Patient Local Date and Time is changed will not be sent unless a manual transmission is requested.

11.6 Blank After Sense

Blank After Sense can minimize R-wave oversensing.

Blank After Sense temporarily suspends sensing after R-wave detection for the duration of the programmed value. (Nominal

setting=150 ms)

The following figure shows T-waves that are inappropriately sensed as R-waves by the device due to a low Blank after Sense setting.

Figure 9. T-Wave sensed as R-Wave

The following figure shows the elimination of T-wave sensing after programming Blank after Sense to a higher setting.

Figure 10. ECG sensed correctly

11.7 Sensing Threshold Decay Delay - Reveal LINQ ICM

Sensing Threshold Decay Delay can minimize R-wave oversensing.

Normally, after a sensed-R-wave, sensitivity is temporarily reduced. Sensing Threshold Decay Delay delays the return of sensitivity to the programmed value after a sensed R-wave. (Nominal setting = 150 ms)

The following figure shows T-waves that are inappropriately sensed as R-waves by the Reveal LINQ device due to a low Sensing Threshold Decay Delay setting.

Figure 11. T-Wave sensed as R-Wave

The following figure shows the elimination of T-wave sensing after programming Sensing Threshold Decay Delay to a higher setting.

Figure 12. ECG sensed correctly

11.8 T-Wave Blanking Interval - LINQ II ICM

T-Wave Blanking Interval can minimize R-wave oversensing.

Normally, after a sensed-R-wave, sensitivity is temporarily reduced. T-Wave Blanking Interval delays the return of sensitivity to the programmed value after a sensed R-wave. (Nominal setting = 150 ms)

The following figure shows T-waves that are inappropriately sensed as R-waves by the device due to a low T-Wave Blanking Interval setting.

Figure 13. T-Wave sensed as R-Wave

The following figure shows the elimination of T-wave sensing after programming T-Wave Blanking Interval to a higher setting.

Figure 14. ECG sensed correctly

11.9 Sensitivity

Set Sensitivity to determine the amplitude threshold for R-wave detection. The nominal Sensitivity setting is 0.035 mV (35 µV).

• Select a lower Sensitivity setting to make the device more sensitive. A lower Sensitivity setting makes the device more sensitive by detecting smaller amplitude signals.

• Select a higher Sensitivity setting to make the device less sensitive. A higher Sensitivity setting makes the device less sensitive by detecting larger amplitude signals.

The following figure shows R-waves that are not sensed by the device due to a high Sensitivity setting.

Figure 15. ECG undersensing example

The following figure shows optimal sensing of R-waves by the device after programming Sensitivity to a lower setting.

Figure 16. ECG sensed correctly

11.10 Sleeping Hours Near Home Monitor (Daily Wireless Transmission Time) - Reveal LINQ ICM

Sleeping Hours Near Home Monitor (Daily Wireless Transmission Time) determines the start time for daily wireless

transmissions. Select a time when the patient is expected to be near their home monitor for at least the next 5 hours (for example,

during sleep). Note that the patient must avoid interacting with their home monitor during this time interval in order to avoid disrupting their daily wireless transmissions. For example, the patient must refrain from pushing any buttons on the home monitor.

This option is available for Reveal LINQ ICM only.

11.11 Wireless Data Priority - Reveal LINQ ICM

Wireless Data Priority determines the selection of episodes for wireless transmission to the CareLink Network. The nominal setting

for Wireless Data Priority is determined by Reason for Monitoring. However, the nominal setting can be overridden by selecting a different value. This setting is unrelated to Episode Priority, which affects episode storage on the device.

11.12 Brady: Nighttime ECGs Stored - LINQ II ICM

Brady: Nighttime ECGs Stored is used to set user preferences for the number of Brady ECGs stored between midnight and 6:00

AM.

If you select None to be stored, Brady episodes will still be detected and the brady episode counter will be incremented on the Quick Look tab. But no corresponding episode logs or episode records will be stored during this time period.

If you select 1 ECG to be stored, the ECG of the first detected Brady episode during this time period will be stored.

If you select Up to 3 ECGs to be stored, the device will function normally: the ECGs for the first three episodes will be stored. If a longer episode is detected, then it will overwrite the last stored episode.

11.13 Trends: Cardiac Compass

The vertical dotted lines in the Cardiac Compass mark the current date and the date of the previous session.

The Cardiac Compass displays 425 days of data for the Reveal LINQ ICM and 270 days of data for the LINQ II ICM. Any data from before that time period will no longer be displayed.

A key to the left side of the timeline at the top of the screen explains that the P icon represents a Programming Change, the I icon represents an Interrogation, an underlined letter means that the action was taken remotely, and the S icon represents a Symptom.

11.14 Trends: Rate Histograms

These histograms show data from the last session to the current date. Each histogram shows the total number of days in AT/AF and out of AT/AF since the last session.

11.15 MyCareLink Heart™ Mobile App Optimization

When MyCareLink Heart™ Mobile App Optimization is enabled, patients will experience increased connectivity between the patient app and the device. However, this parameter will affect the device’s battery longevity. Refer to the LINQ II LNQ22 Insertable Cardiac Monitor Clinician Manual for LINQ II ICM battery-longevity projections.

11.16 Implanting Physician

Select the Implanting Physician from the drop menu.

The Implanting Physician information is entered on the SET UP PHYSICIAN LIST screen during the setup of the app. If this step was skipped during the setup of the app, then no Implanting Physician names are available in the Implanting Physician drop menu. The Implanting Physician drop menu is not displayed when CareLink™ Sync is turned OFF.

Manually added physicians are periodically removed from the Physician List. If the implanting physician is not available in the Implanting Physician drop menu and CareLink™ Sync is turned ON, tap information.

If the tablet is not connected to the internet, check the tablet’s Wi-Fi or internet connection.

> Settings > Physician List to add physician

11.17 Follow-Up Physician

Select the Follow-Up Physician from the drop menu.

The follow-up physician information is entered on the Set Up Physician List screen during the setup of the app. If this step was skipped during the setup of the app, then no follow-up physician names are available in the Follow-Up Physician drop menu. The Follow-Up Physician drop menu is not displayed when CareLink™ Sync is turned OFF.

Manually added physicians are periodically removed from the Physician List. If the follow-up physician is not available in the Follow-Up Physician drop menu and CareLink™ Sync is turned ON, tap > Settings > Physician List to add physician information.

If the tablet is not connected to the internet, check the tablet’s Wi-Fi or internet connection.

11.18 Follow-Up Clinic List

Select the Follow-Up Clinic from the drop menu.

The Follow-Up Clinic information is entered on the Follow-Up Clinic List during the set up of the app. If this step was skipped during set up of the app, no clinics are available in the Follow-Up Clinic drop menu.

Medtronic, Inc.

*M016238C001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636

Technical manuals

www.medtronic.com/manuals

Medtronic MSW002 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Configuration

1.1 About Reveal LINQ Mobile Manager

1.2 IT network, tablet, and data information

1.3 Security

2 Setting up the app

2.1 Pairing the patient connector

2.2 Setting up the app

2.2.1 Overview

2.2.2 Entering a username and password

2.2.3 Tablet identifying information

2.2.4 Entering the tablet name and location information

2.3 Password issues

2.3.1 Forgot password

2.3.2 Resetting a forgotten password

2.3.3 Password expired

2.3.4 Resetting an expired password

2.4 Physician List

2.4.1 Physician List overview

2.4.2 Adding physicians to the Physician List

2.4.3 Manually adding a physician to the Physician List

2.4.4 Removing a physician from the Physician List

2.4.5 Completing the Physician List set up

2.5 Follow-up clinics

2.5.1 Follow-Up Clinic List

2.5.2 Adding follow-up clinics to the Follow-Up Clinic List

2.5.3 Renaming a follow-up clinic

2.5.4 Removing a follow-up clinic from the Follow-Up Clinic List

2.5.5 Completing the Follow-Up Clinic List setup

2.6 Initial setup results

3 Patient connector

3.1 Adding a patient connector

3.2 Charging

4 Set up patient

4.1 Setting up patients

Table 1. Required patient demographics parameters

Table 2. Optional patient demographics information

5 Insert device

5.1 Preinsertion

5.1.1 Overview

5.1.2 Select a patient

5.1.3 Associating a device to a patient

5.1.4 Associating equipment to a patient

5.1.5 Patient demographics

Table 3. Required Patient Demographics parameters

Table 4. Optional Patient Demographics information

5.1.6 Monitoring information

Table 5. Monitoring Information parameters

5.2 Insertion

5.3 Interrogating the device

5.4 Post-insertion data, settings, and reports

5.5 Check the patient-enrollment and device-registration status

6 Check patient

6.1 Check Patient session

6.2 Conducting a Check Patient session

6.3 Check patient data, settings, and reports

7 Parameter field descriptions

7.1 Quick Look screen

Table 6. Summary information fields

Table 7. Counters Listings

7.2 Episodes

Table 8. AVAILABLE EPISODES list column titles

Table 9. AVAILABLE EPISODES list options

Table 10. Selected episode ECGs

Table 11. Marker Channel annotations

7.3 Trends

7.3.1 Overview

7.3.2 Cardiac Compass

Figure 1. AT/AF total time per day

Figure 2. Ventricular rate during AT/AF

Figure 3. Average ventricular rate

Figure 4. PVC

Figure 5. Patient activity

Figure 6. Heart rate variability

7.3.3 Rate Histograms

Figure 7. Time out of AT/AF

Figure 8. Time in AT/AF