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
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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.
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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
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The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by Medtronic is under license.
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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.
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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.
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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.
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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.
a
• From the > Settings > Physician List, when CareLink™ Sync is turned ON.
SKIP THIS
No physicians are added or saved to your Physician List.
STEP
a
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.
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• 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:
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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:
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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
a
a
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:
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Monitoring option:
Enter the serial number of the monitor in the Enter Serial Number field.
MyCareLink™ Monitor
b
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.
a
This option is available for the LINQ II ICM only.
b
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
a
This option is unavailable for LINQ II devices when CareLink Sync is turned OFF.
a
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
a
Confirm the patient’s address if it was previously entered. You can
also enter the patient’s address if it was not previously entered.
a
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
a
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
a
Confirm the patient’s postal code. You can also enter the patient’s
postal code if it was not previously entered.
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Table 4. Optional Patient Demographics information (continued)
Parameter Editable values
Country
a
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
a
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.
a
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
e
Available options set on the APP
- -
SETUP > SET UP FOLLOW-UP
CLINIC LIST screen.
Implanting Physician
de
Available options set on the APP
- -
SETUP > SET UP PHYSICIAN LIST
screen.
Follow-Up Physician
a
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
ac
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
b
No selectable values. Enter any
- desired patient history information in
the field.
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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
a
This option is available only when CareLink™ Sync is ON.
b
This option is available for the Reveal LINQ ICM only.
c
This option is available for the LINQ II ICM only.
d
For Reveal LINQ, when CareLink™ Sync is OFF, you can manually enter this information.
e
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.
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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.
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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)
a
Displayed for LINQ II ICMs only.
a
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
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