User`s Manual - St. Jude Medical Instructions for Use Website

User`s Manual - St. Jude Medical Instructions for Use Website
myMerlin™ Mobile Application
Confirm Rx™ Insertable Cardiac Monitor
Model APP1000
Software version 1.0
User's Manual
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Pat. http://patents.sjm.com
© 2016 St. Jude Medical, Inc. All Rights Reserved.
Important Telephone Numbers
Clinician's office
Special Instructions
1
Contents
Important Telephone Numbers .................................................................................. 1
Special Instructions ................................................................................................... 1
Introduction .............................................................................................................. 3
What is the myMerlin™ Mobile Application? ......................................................................... 3
How does my monitoring system work?................................................................................. 3
What is the insertion procedure like? .................................................................................... 3
What is recovery like? ........................................................................................................... 3
What is a follow-up visit like? ................................................................................................ 3
What special precautions do I need to follow? ....................................................................... 4
What items will I receive? ...................................................................................................... 4
When can I begin using the myMerlin™ Mobile Application? ................................................ 5
When do I record my heart's electrical activity with the myMerlin™ Mobile Application? ........ 5
Using the myMerlin™ Mobile Application .................................................................. 5
Precautions .......................................................................................................................... 5
Download the myMerlin™ Mobile Application ....................................................................... 5
Set up the myMerlin™ Mobile Application ............................................................................ 6
Keep your Smart Phone or Tablet at your Bedside ................................................................ 7
Record your Symptoms ........................................................................................................ 7
Additional Features .............................................................................................................. 7
Troubleshooting ................................................................................................................... 7
Glossary .................................................................................................................... 9
Technical Support ..................................................................................................... 9
i
Introduction
Your clinician has determined that it is beneficial for you to have a monitoring system to help
identify the cause of symptoms you experience. Your monitoring system consists of the
St. Jude Medical™ Confirm Rx™ insertable cardiac monitor (ICM) device and the myMerlin™
mobile application (app). This manual answers some common questions about your monitoring
system and explains how to use the app. Read all of the instructions in this manual before using
the app.
What is the myMerlin™ Mobile Application?
The myMerlin mobile application is a software application for your smart phone or tablet. The app
uses Bluetooth® 1 low energy (LE) technology to communicate with your device. The app can be
used to initiate recording of the heart's electrical activity by your device, read stored data from
your device, and send stored data to a clinician. Your clinician can also use the app to remotely
monitor your device.
How does my monitoring system work?
Your monitoring systems works in two ways:

Automatically. Your clinician will set your device to monitor and record your heart's electrical
activity.

On Command. When you experience symptoms, you can use the app to tell your device to
record your heart's electrical activity. Your clinician will identify the symptoms for which you
should record your heart's electrical activity. You can record this information at the
beginning of this book.
What is the insertion procedure like?
The insertion typically involves a simple surgical procedure. The doctor numbs the area with local
anaesthesia, makes a small incision, and places the device just under the skin in the chest
through the small incision.
What is recovery like?
Your clinician may ask you to limit some of your activities because of your symptoms. In general,
people who have a device can perform almost all their normal activities. Your clinician will also
give you information about caring for your incision and bathing.
What is a follow-up visit like?
You may go to your clinician's office or clinic for follow-up visits. During a follow-up visit, your
clinician uses a programmer, a specialized computer, to review information stored in your device.
Your clinician can also use the programmer, without surgery, to change how your device is set up.
Your clinician uses the information from your device to help identify the cause of your symptoms
or asymptomatic cardiac rhythms.
An office visit usually lasts about 30 minutes or less. Your clinician will determine your follow-up
visit schedule.
Your clinician may also remotely review the information stored in your device without you having
to visit the clinic.
1
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
3
What special precautions do I need to follow?
Your device is not magnetic and has no moving parts. However, you should avoid devices which
generate a strong electric or magnetic interference (EMI). EMI could cause inappropriate data
storage or prevent data storage. Moving away from the source of EMI or turning it off will usually
allow the device to return to its normal mode of operation.
You should always use caution with the following:

Medical procedures. Although your device should be unaffected by most medical
procedures, you should notify your doctor, dentist, physical therapist, chiropractor, or any
other health care provider that you have a device.

Communication equipment. Communication equipment such as microwave transmitters or
high-power amateur transmitters may generate enough EMI to interfere with the
performance of your device if you are too close to the source of EMI.

Wireless communication devices. Wireless communication devices such as computers that
operate on a wireless network, cellular phones, smart phones, tablets, and even cordless
telephones may generate enough EMI to interfere with the performance of your device if you
are too close to the source of EMI.

Household appliances. Household appliances such as microwave ovens, electric blankets,
and power tools should not damage your device. However, they may interfere with the
performance of your device.

Industrial equipment. A variety of industrial equipment may generate enough EMI to
interfere with the performance of your device. These include, but are not limited to: arc
welders; induction furnaces; very large or defective electric motors; and internal combustion
engines with poorly shielded ignition systems.

Metal detectors and security systems. Metal detectors found in airports and government
buildings, and electronic article surveillance/anti-theft (EAS) systems such as those at the
point of sale and entrances/exits of stores, libraries, banks, etc., emit signals that may
interfere with the performance of your device. To minimize the possibility of interference,
simply walk through these areas at a normal pace and avoid lingering near or leaning on
these systems. If your device triggers an alarm, show your identification card to security
personnel.

Mobile devices. The device has been tested for use with smart phones and tablets. Based
on the results of the tests, the device should not be affected by the normal operation of
smart phones and tablets when used more than 15 cm from the device.
To minimize the possibility of interference, do not carry a smart phone in a breast pocket or
on a belt within 15 cm of the device. Use your smart phone or tablet on the side of your
body opposite from the device.
Do not place your smart phone or tablet directly over your inserted device.
What items will I receive?
You will receive product documentation regarding your monitoring system. In addition, you will
need to download the myMerlin™ mobile application onto your smart phone or tablet. You can
use your own smart phone or tablet if it meets the system requirements of the app. Refer to the
Download the myMerlin™ Mobile Application section (page 5) for information.
St. Jude Medical will provide you with a mobile device if necessary. This mobile device allows you
to communicate with your device as well as transmit data. The app will be pre-downloaded onto
the mobile device for you.
4
Your Patient Identification Card
A patient identification card will be given to you. This card does the following things:

Identifies you as having an inserted medical device

Identifies the device and serial number and location of your device to help determine if you
can safely receive an MRI scan

Helps you pass through security systems like those in airports

Provides information that allows your physician to be contacted in an emergency
For additional information about your card, contact Technical Support.
When can I begin using the myMerlin™ Mobile Application?
In most cases, you can begin using the app immediately after your device is inserted. Your
clinician will give you instructions on when to use the app.
When do I record my heart's electrical activity with the myMerlin™
Mobile Application?
Your clinician will give you specific instructions on when to record your heart's electrical activity
with the app.
Using the myMerlin™ Mobile Application
The app has two main functions:

Record Symptoms. Begin data recording in your device when you experience symptoms.

Automatic Remote Monitoring. Your clinician can remotely review the data stored in your
device.
NOTE: You can record important telephone numbers and special instructions at the
beginning of this book.
To ensure that your app communicates and transmits data properly:

Enable Bluetooth® wireless technology on your smart phone or tablet.

Make sure that you are connected to a cellular or Wi-Fi network. The app transfers data
through the use of a cellular or Wi-Fi network. The time it takes for data to transmit depends
on the strength of the cellular or Wi-Fi signal.

Keep your smart phone or tablet at your bedside during your scheduled nightly checks.

Turn on notifications for the app.
Precautions



Do not use the app if your smart phone or tablet is damaged.
Keep your smart phone or tablet charged or have a power supply nearby. Familiarize yourself
with your smart phone or tablet's battery life so you can anticipate its recharging needs.
For regulatory statements regarding your smart phone or tablet, refer to the manufacturer's
website.
Download the myMerlin™ Mobile Application
Your clinician will let you know when you can start using the app. You can use the app with smart
phones or tablets that meet the following minimum system requirements:

Android™ 2 OS version 5.0 or greater

Bluetooth® LE wireless technology version 4.0 or greater
2
Android is a trademark of Google, Incorporated.
5
The app has been successfully tested with multiple smart phone and tablet configurations such as
the following:

Samsung™ Galaxy S™ 5 3 mobile digital device, Android 5.1.1 software

Samsung™ Galaxy J3™ 4 mobile digital device, Android 6.0.1 software
Other smart phones and tablets may be compatible with the app. If you are unsure whether your
smart phone or tablet is compatible, contact Technical Support.
To download the app:
1.
Make sure your smart phone or tablet is connected to a cellular or Wi-Fi network.
2.
Use the browser on your smart phone or tablet to navigate to www.sjm.com/heartmonitoring.
3.
Tap the myMerlin for Confirm Rx icon.
4.
Follow the onscreen prompts to install the app.
If you encounter problems downloading the app, contact Technical Support.
NOTE: To keep your personal information secure:
•
•
•
Only download and install the official SJM registered application.
Use your smart phone or tablet's locking capability so that a PIN is required
to unlock the mobile device.
Inform the clinic or SJM in the event that your smart phone or tablet is lost or
stolen.
Set up the myMerlin™ Mobile Application
After you download the app, set up the app on your smart phone or tablet. You will need the serial
number located on your patient identification card.
To set up the app:
1.
Tap the Set up now button on the myMerlin app Welcome screen.
2.
Scroll down the screen to review the Terms and Conditions and Privacy Policy. Select the
Agree button.
NOTE: Before you continue with the setup, make sure that Bluetooth® wireless
technology is on and that you are connected to a cellular or Wi-Fi network. Keep your
smart phone or tablet within 1.5 m of you during the setup process.
3.
Tap the Continue with Setup button on the Setup screen.
4.
Enter your date of birth and the serial number of your Confirm Rx™ ICM and then tap the
Next button.
5.
Tap the Pair Now button to pair your device with your smart phone or tablet.
NOTE: Pairing with Bluetooth® wireless technology may take several minutes.
6.
If prompted, enter the code that is shown on the screen.
7.
Tap the Done button to complete the setup.
There may be times when you need to set up the app after the initial setup. The setup steps are
the same as those in this section except that an additional activation code is required. Follow the
instructions on the screen of your smart phone or tablet to complete the activation code process.
3
4
Samsung, Galaxy S, and Galaxy J3 are trademarks of Samsung Electronics Co., Ltd.
Samsung, Galaxy S, and Galaxy J3 are trademarks of Samsung Electronics Co., Ltd.
6
Keep your Smart Phone or Tablet at your Bedside
The app automatically reads the data from your device and sends it to a database where your
clinician can review it. The data transfer occurs during the night while you sleep.
Make sure your smart phone or tablet is sufficiently charged and keep it at your bedside every
night.
Record your Symptoms
When you experience symptoms, you can use the app to wirelessly record data.
NOTE: Your clinician will tell you whether or not you need to record symptoms. Your
app will not have the Record Symptoms button if you do not need to record symptoms.
To record your symptoms:
1.
Tap the Record Symptoms button on the bottom of the Home screen.
2.
Select the symptoms you are experiencing and then tap the Done button.
The app starts connecting to your device. The estimated time to completion is displayed in
the progress bar.
NOTE: Connecting to your device may take several minutes. Make sure that you keep
your smart phone or tablet with you during this time.
Once the recording completes, a notification appears on the screen.
3.
Tap the Done button.
Additional Features
You can use the buttons at the bottom of the Home screen to access information about your
monitoring system. Refer to the table below for details.
Table 1. Additional features
Button name
Description
History
Tap this button to view a history of events.
Resources
Tap this button to access learning resources and frequently
asked questions (FAQs).
More
Tap this button to view information about your monitoring
system as well as contact information.
Troubleshooting
An error message appears on the screen of your smart phone or tablet when there is an issue with
your app. Follow the prompts on the screen to resolve the issue. If you are unable to resolve the
issue, contact Technical Support.
7
Glossary
Application (app)
A software application that you download onto your smart phone or tablet.
Clinician
The person that you see at your doctor's office. This may be your doctor, a nurse, a technician, or
someone else that works for your doctor.
Device
The inserted part of your monitoring system; records your heart's electrical activity.
Technical Support
If you have trouble using the app or have any questions regarding its use, contact your clinic.
9
Manufacturer:
St. Jude Medical
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
+1 818 362 6822
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Manufacturing Site:
St. Jude Medical Puerto Rico LLC
Lot A Interior - #2 Rd Km. 67.5
Santana Industrial Park
Arecibo, PR 00612
USA
Manufacturing Site:
St. Jude Medical Operations (M) Sdn. Bhd.
Plot 102, Lebuhraya Kampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia
sjm.com
November 2016
ARTEN100151677 B
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
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