BreatheSuite BreatheSuiteMDIV1 User manual

BreatheSuiteMDIV1 (v1.1)
User Manual
BreatheSuite Metered Dose
Inhaler (MDI) Device

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 2
Table of Contents
Indications for Use 4
How it Works 7
Getting Started 10
Sign Up 10
Assigning a device to a prescription 13
Taking a puff and syncing a dose 15
Bluetooth Pairing & Syncing 19

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 3
Product Description 22
Frequently Asked Questions 24
Precautions 33
Warnings 38
Contraindications 40
Troubleshooting 41
Appendix 43

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 4
Indications for Use
The BreatheSuite MDI Device is an electronic device
intended for single-patient use of patients 5 years of
age and older. It assists asthma and COPD patients in
recording and monitoring the actuations and
technique of prescribed metered dose inhaler (MDI)
usage. The BreatheSuite System is composed of the
disposable, battery powered, portable BreatheSuite
MDI Device and a mobile application.
The BreatheSuite MDI Device is an accessory
designed to work with an MDI by attaching to the top
of the canister of the inhaler. The BreatheSuite MDI
Device does not interfere with regular MDI usage and
can be removed and reattached with ease. The

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 5
BreatheSuite MDI Device does not actuate the inhaler
but rather gathers information based on manual MDI
usage.
The BreatheSuite MDI Device measures the
parameters of MDI use and records them for review
by the patient. The BreatheSuite application records,
stores, and transmits usage events from the
BreatheSuite MDI Device to a remote storage system.
Furthermore, BreatheSuite MDI reminds the patient
of important steps of MDI use through visual
feedback in the BreatheSuite application.
The output of the BreatheSuite System is not
intended to diagnose or replace a diagnosis provided

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 6
by a licensed physician. The BreatheSuite system is
not intended for use as a MDI medication dose
counter, nor is it intended to indicate the quantity of
medication remaining in an MDI. The BreatheSuite
MDI Device is not intended to replace a physician’s
advice or inhaler labels; patients are expected to
always follow their doctor’s advice and inhaler labels.
The BreatheSuite System can be used both indoors
and outdoors as well as in home and work settings.
The BreatheSuite System may also be used in clinical
trials where researchers need to know information
about use of a MDI Medication(s) by a participant.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 7
How it Works
The BreatheSuite MDI Device collects information on
how you use your inhaler:
It measures how long you shake your
inhaler.
It senses if the inhaler mouthpiece is
horizontal.
It measures how long you inhale.
It senses if you push down on your
inhaler as you start to breathe in.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 8
It records the date and time of each
inhaler use.
This information is sent to the BreatheSuite app on
your smartphone using a Bluetooth connection.
The BreatheSuite app assists the user in recording
and monitoring inhaler usage and technique.
Not feeling well?
Don’t wait. Call your doctor right away.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 9
The BreatheSuite MDI Device and app provide
feedback on inhaler usage, but the communication of
data can be delayed. You know your health best,
never wait to call a doctor if you are not feeling well.
If you have any questions, please contact us!
1-855-667-8931; [email protected]om

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 10
Getting Started
For detailed instruction on how to use the
BreatheSuite MDI Device and app, including how-to
videos and in-app screenshots, visit
www.breathesuite.com/help/gettingstarted.
Sign Up
1. Download the
BreatheSuite app
from the Google Play
Store or the Apple
App Store.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 11
2. Create an account in
the BreatheSuite app
by pressing the “Sign
Up” button and then
entering your email
and creating a
password.
3. Verify your account
using the verification
code sent to your

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 12
email.
4. You’re done! You’re now ready to assign your
device to a prescription.
If you need any help setting up your BreatheSuite MDI Device, send
an email to [email protected]m or call toll-free 1-855-667-8931.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 13
Assigning a device to a prescription
1. Take the BreatheSuite MDI
Device out of the
packaging.
2. Hold down on the
BreatheSuite MDI Device to
begin setup, a flashing blue
light will appear on the
Device.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 14
3. A “Prescription Setup” page will appear in the
app. Select your:
a. Medication Type (Controller or Rescue)
b. Medication Name
c. Medication Dosage
d. Number of AM puffs (Controller Only)
e. Number of PM puffs (Controller Only)
and press “Save”. This will bring you to the
homepage of the BreatheSuite app.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 15
4. Attach the BreatheSuite
MDI Device to the top of
the canister of your inhaler
by gently pressing it down
until it stops. You’re now
ready to use BreatheSuite!
Taking a puff and syncing a dose
When it’s time to take a dose from your inhaler,
follow the instructions below.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 16
1. Make sure your
BreatheSuite MDI device
is attached to the top of
the canister of your
inhaler.
2. Shake your inhaler and
the BreatheSuite MDI
Device to mix your
medication and to wake
up your device.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 17
3. Take a puff from your
inhaler as prescribed,
pressing down on the top
of the BreatheSuite MDI
Device similar to how
you’d press on the top of
the inhaler canister.
4. Open the BreatheSuite
app on your smartphone
and ensure you are
connected to the

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 18
internet and that
Bluetooth is enabled.
5. The dose will be
automatically synced in
the app. If the dose does
not appear, shake the
device and press the
button in the app to sync
the device manually.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 19
Note: Never delay using your inhaler in order to attach your
BreatheSuite MDI Device.
Rescue inhalers are meant to be used for shortness of breath. Do not
delay using your inhaler to ensure your BreatheSuite MDI Device is
attached.
Bluetooth Pairing & Syncing
After the initial pairing, the BreatheSuite MDI Device
will automatically connect to the BreatheSuite app
when the app is open and the device is awake.
To view your inhaler usage, you must sync your
BreatheSuite MDI Device to the BreatheSuite app.
To keep your data up-to-date, sync your Device to the
BreatheSuite app at least once a day.

BreatheSuite MDI Device User Manual
Copyright 2021 - BreatheSuite Inc (v1.1) 20
To sync your BreatheSuite MDI Device:
1. Shake the BreatheSuite
MDI Device and wait for
the blinking blue light to
appear.
2. Ensure that Bluetooth is
enabled on your
smartphone and open
the BreatheSuite app.