Boston Scientific LUX-Dx User manual

The LUX-Dx™
ICM System

If you’ve been experiencing
symptoms like fainting, a racing
heart, or shortness of breath,
your healthcare team may
recommend the LUX-Dx™ ICM. Also
called an insertable cardiac monitor,
it’s a small device that monitors and
records your heart rhythms.
The LUX-Dx™ ICM System
Has Three Parts:
The LUX-Dx™ ICM System is used to check for arrhythmias.
That’s when the heart is beating too fast, too slow, or in an
irregular pattern. It’s a diagnostic tool, which means it’s used
to identify a potential issue, not treat it.
The insertable cardiac
monitor (ICM)
1
The myLUX™ Patient App
2
A magnet
3

Heart Monitoring
Several types of devices can be used to monitor a person’s
health data, including wearables (typically worn on the wrist),
Holter monitors, and ICMs. Unlike wearables and Holter
monitors, ICMs do not require you to wear anything on your
wrist or chest, and they can provide data to your healthcare
team for longer periods of time.
How It Works
Your ICM device automatically records and stores irregular
heart rhythms, or arrhythmias. The app will then send the
data to your clinic. This generally happens overnight and
is silent. The clinic will look at the data and contact you if
there’s a need for further review.
Reasons Your Healthcare Provider May
Have Recommended an ICM
The following are some common reasons healthcare providers
might want to monitor your heart rhythm with an ICM. Talk to your
healthcare team about your specic condition.
Atrial Fibrillation: An abnormal heart rhythm that occurs
when the atria (upper chambers of the heart) brillate, which
means they move quickly and in an irregular pattern. Your
healthcare team may refer to this as AF, AFib, suspected AF,
post-ablation AF monitoring, or AF management.
Cryptogenic Stroke: A stroke with an unknown cause.
Monitoring the heart may help your healthcare team nd the
cause.
Syncope: Also called fainting or passing out; usually
happens when blood pressure is too low and the heart
doesn’t pump enough oxygen to the brain.
Palpitations: Feeling like your heart is beating very quickly,
uttering, or beating irregularly.
Ventricular Tachycardia: When the ventricles (lower
chambers of the heart) beat faster than normal and/or in an
irregular pattern.
Other: _____________________

Setting Up Your myLUX™
Patient App
After your procedure, you will receive a mobile device and
some accessories to take home. The mobile device contains
the myLUX™ Patient App, which will collect information
about irregular heart rhythms stored on your ICM device and
automatically send that information to your healthcare team.
Your healthcare team may help set up the app, or you may
be asked to do it at home. The printed Quick Start Guide you
receive will explain how to do it.
Remember that this mobile device is intended just for using
the app and transmitting your data to your healthcare
team. It’s not a phone that you can use to make calls, text,
or browse the internet, even in an emergency. In case of
emergency, be sure to call emergency medical services on
your regular phone.
The ICM device is small: about
the length of a paper clip. It
runs on a battery that’s safely
sealed within the device.
After making the incision, the provider will insert the ICM device
under your skin. Then the incision will be closed. Your healthcare
team will let you know how to care for your incision.
Recovery from your insertion procedure should not prevent
you from returning to an active lifestyle. But be sure to ask your
healthcare team what’s recommended for you.
The Insertion Procedure
At the beginning of your procedure, your healthcare team will
usually numb the area where the device will be inserted. The
provider will make a small incision. Typically the incision is on the
left side of the chest. But the provider will determine the best
place to insert it.
*POSSIBLE INSERTION LOCATIONS

Tap the myLUX™ Patient App icon.
If you see a screen that says
“Your monitoring is up to date,”
you’re all set.
If you see a screen identifying your
preferred language, tap “Next” and
follow the instructions until you see
the screen at left.*
*If you need to change the language of
your app, please refer to your Quick Start
Guide or Patient Handbook.
4
4A
4B
OR
Use the tab to peel o the adhesive
backing from the back of the
mobile device case.
Place the logo side of the blue
magnet on the adhesive and
press rmly.
Power on your mobile device.
1
2
3
4 Steps for Setting Up
Your myLUX™ Patient App:

3 Key Things to Remember
The LUX-Dx™ ICM System generally works on its own. You’ll
just need to remember a few things:
Plug your mobile device in each night so it
stays charged.
Place the mobile device within six feet of where
you sleep at night.
If you see a screen with an exclamation point icon,
follow the instructions to get reconnected.
Additional Help/
Resources
To learn more about the LUX-Dx™ ICM
System, tap the “Learn” button on the
myLUX™ Patient App.
If you’d like to see videos about your
system and how to use your app, please
visit bostonscientic.com/LUXDx.
For additional questions, call your clinic
or Boston Scientic at 1.866.484.3268.
Monitoring Your Connection
Be sure to look at your mobile device occasionally
to check the connection.
If you see the check mark icon,
your monitoring is up to date and
no action is needed from you.
If you see the exclamation point
icon, you know that your app is
not able to connect to your ICM
device or the internet.
If your app cannot connect
to your ICM device or to a
cellular or Wi-Fi network, a
message will appear on the
screen instructing you to
check your connection. Tap on
this message and follow the
instructions on the screen. A
message will conrm when
your app is connected.

myLUX™ Patient App and Insertable Cardiac Monitor System
Important Information
The ICM system consists of the following: Insertable Cardiac Monitor (“ICM device”);
Magnet; and myLUX patient app (“app”). The myLUX™ Patient App is for use with
a BSC Insertable Cardiac Monitor (ICM) system which is a small device designed to
monitor and record your heart rhythm once it has been placed under your skin. This
information is shared via an automatic transmission to the clinic and your doctor
for medical evaluation. The ICM and app are not intended to assist with medical
emergencies; this means that it doesn’t provide any treatment to the potential
rhythms that could be recorded. Your myLUX™ Patient App is designed to work only
with the ICM that your doctor has prescribed and implanted in you.
The ICM system does not treat cardiac arrhythmias (abnormal heartbeats that are
too fast, too slow, or irregular), but rather it collects information for your health care
provider to use to support their medical evaluation of your symptoms or condition.
The ICM device’s monitoring of your heart will not cause any noticeable sensations.
Your ICM system is set up to automatically collect data stored on your ICM device and
send it to your clinic to review according to the schedule your healthcare provider has
set up.Your health care provider may also ask you to manually transmit data, however
additional instruction will be provided if you need to do this as it should only be done
on a limited basis.
Electromagnetic elds are created by devices which use electricity, including those
which are plugged into a wall outlet or battery operated. Devices which emit strong
electromagnetic elds may have the potential to temporarily interfere with your ICM
device’s ability to detect and monitor your heart rhythm. They could also delay or
prolong communication between your ICM device and your myLUX™ Patient app.
The magnet when provided with the ICM system may cause interference with devices
sensitive to magnetic elds such as hearing aids, pacemakers, and other implanted
devices. It can also permanently disable some magnetic strip cards.
Ask your health care provider if you have questions about any risks with using the
myLUX™ App, the magnet or your ICM device.
Please refer to the Patient Handbook for the full warnings, precautions and important
safety information.
Rx only
92505919 (Rev. A)
Rhythm Management
4100 Hamline Avenue North
St. Paul, MN 55112-5798
www.bostonscientific.com
Medical Professionals:
1.800.CARDIAC (227.3422)
Patients and Families:
1.866.484.3268
© 2020 Boston Scientic Corporation
or its aliates. All rights reserved
CRM-786502-AA
Discover more about the
LUX-Dx™ ICM System.
Tap the “Learn” button on the
myLUX™ Patient App anytime.
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THROUGH INNOVATIVE MEDICAL SOLUTIONS THAT IMPROVE THE HEALTH OF PATIENTS AROUND THE WORLD.