Signifier eXciteOSA User manual
User Guide
IMPORTANT SAFEGUARDS:
READ ALL INSTRUCTIONS BEFORE USE
Contents
Important safeguards ................................................................................................................ 3
What’s in the box? ...................................................................................................................... 6
Intended use............................................................................................................................... 8
eXciteOSA smartphone application.......................................................................................... 8
Using your eXciteOSA with a smartphone application .......................................................... 12
My eXciteOSA phone application ............................................................................................ 14
Frequency of usage .................................................................................................................. 18
Charging the control unit......................................................................................................... 18
Storing & travelling with your eXciteOSA................................................................................ 19
Washing .................................................................................................................................... 19
Settings..................................................................................................................................... 20
Frequently asked questions .................................................................................................... 22
Trouble shooting...................................................................................................................... 25
eXciteOSA system, operational requirements........................................................................ 26
eXciteOSA system, transport and storage requirements ....................................................... 26
Symbols used ........................................................................................................................... 28
Specications........................................................................................................................... 29
Declarations ............................................................................................................................. 32
Table A: Representative output with varying loads................................................................ 34
3
Important safeguards
WARNINGS
To avoid the risk of electrocution, burns, re or physical injury:
• The device is only to be used while awake. It should not be used while sleeping.
• Only the supplied products should be used together. Do not use attachments other than
those recommended by the manufacturer.
• Discontinue use if the product appears damaged in any way.
• Never attach the Mouthpiece directly to a charging source other than the control unit
provided.
• This device should only be charged using the USB Cable provided.
• Do not operate in close proximity (e,g. 3.4 feet) to a shortwave or microwave unit as
other Electromagnetic equipment may produce instability in the simulator output.
• Always keep the Control Unit away from water.
• Unplug the Control Unit immediately if it falls into water.
• Never use a damaged USB Cable to charge the Control Unit.
• This product contains no user serviceable parts. Refer to “Warranty” and “Trouble
Shooting” if appliance no longer works as expected.
• The device is only to be used as specied in this document.
READ ALL INSTRUCTIONS BEFORE USE.
(for latest User Guide, please refer to https://exciteosa.com)
4
WARNINGS
To avoid the risk of physical injury:
• This device should not be used by persons:
зchildren (under 18 years of age)
• eXciteOSA should be kept away from children and pets
(choking hazard and electrical hazard).
• eXciteOSA to be used in a home or healthcare environment (or equivalent).
• eXciteOSA is a single person device and should not be shared or used by other
individuals.
• Do not use eXciteOSA when driving a vehicle or operating machinery and other
equipment.
• When charging the device, keep away from all liquids.
• No modication of this device is allowed. Do not try to alter, trim or change any
components of the device.
• The silicon on the Mouthpiece must be intact before use. If there is any breach of the
silicon (including electrodes) - DO NOT USE THE MOUTHPIECE.
READ ALL INSTRUCTIONS BEFORE USE.
5
CONTRAINDICATIONS
Do not Use eXciteOSA if:
• you are pregnant or maybe pregnant
• you have a pace maker or implanted
electrodes
• you have dental braces or jewellery in
your mouth.
• you are suffering from mouth ulceration
or recent dental work.
• having or suspecting of having
obstructive sleep apnoea with AHI
greater than 15.
PRECAUTIONS
Consult your Doctor/Dentist if:
• you have gum disease or have bleeding
from your gums or other oral conditions.
• you experience pain, numbness or
bleeding aer using this product.
• you have any nose, throat conditions and
previous oral surgery
• you have any medical conditions
зFacial skeletal abnormalities
зObesity (BMI > 35)
This device should not be used:
• while asleep (device only to be used
when awake)
• in contact with your head, neck, spine,
chest, eyes, ears or any other parts of
the body other than inside the mouth as
instructed.
Adverse Reactions:
• accumulation of saliva
• tingling sensation on tongue
READ ALL INSTRUCTIONS BEFORE USE.
Safety and effectiveness in the
above conditions have not been
established.
6
Mouthpiece (Top view)
Electrodes
Flexible silicone
USB-C type connector
Fig.1
What’s in the box?
eXciteOSA package includes:
1
7
2
3
Control Unit (With Bluetooth)
USB Cable and adapter (15cm cable and included adapter)
USB-C type connector
LED light under the logo
USB-C type connector
Fig.2
Fig.3
8
Intended use
eXciteOSA smartphone application
eXciteOSA is intended for the reduction of snoring and obstructive sleep apnoea by
strengthening tongue muscles via electrical muscle stimulation.
INDICATIONS FOR USE: eXciteOSA is indicated for use to reduce snoring and mild sleep
apnoea (AHI<15) for patients that are 18 years or older.
eXciteOSA device can be controlled by eXciteOSA
Smartphone application. Smartphone application can
be downloaded from App Store (Apple iOS) or Play Store
(Google Android).
The log in & sign up section allows you to
authenticate or create an account.
Enter the e-mail you want to register with
Enter a secure password (minimum 6 characters)
If you are already registered you can login here
You can sign up with one of these services
(this will require authentication on the appropriate external service)
LOG IN & SIGN UP
SIGN UP
9
Enter your full name
Enter your country of residence
Select your gender
Select your date of birth
Enter your ethnicity, height and weight*
* Your data is always safe with us. You can check our Privacy
policy, on our website https://exciteosa.com/privacy-policy,
for further details.
Select whether you already have
a eXciteOSA device or not.
If you choose yes, additional setup is required.
PROFILE SET UP
10
There are a number of terms you have to agree
to in order to use the eXciteOSA device with the
mobile app.
First, make sure you read the Terms and Conditions
page, and agree with them.
Next, please con rm that you do not use a
pacemaker and that you are not pregnant. It is
very important that none of these apply to you
as the eXciteOSA device can interfere with your
pacemaker or with your baby’s development.
Also, you have to be a legal adult.
POLICY
Enter your registered e-mail and password
If you forgot your password, tap here. You will
receive an e-mail with further instructions.
You can log in with one of these services
(this will require authentication on the appropriate external service)
LOG IN
11
The dashboard is the main screen of the app where all the features are available from.
THE DASHBOARD
Settings
eXciteOSA therapy
Educational content
Articles
12
Using your eXciteOSA with a
smartphone application
Before starting your treatment be sure to: check the silicon on the Mouthpiece is not
cracked or broken before use. If there is any evidence of damage to the silicon - DO NOT
USE THE MOUTHPIECE.
Before use, wash the Mouthpiece with cold and running potable tap water as shown in Fig 4.
Avoid water reaching the USB port. Dry with clean towel.
Fig.4
13
To start using eXciteOSA, connect the
Mouthpiece with the Control Unit as
shown on Fig 5.
Insert the Mouthpiece into the
mouth and allow it to sit around the
tongue as shown in Fig 6. and gently
close your mouth. Avoid grinding or
clenching the Mouthpiece.
Fig.5
Figure 6
mouth and allow it to sit around the
tongue as shown in Fig 6. and gently
close your mouth. Avoid grinding or
Figure 6
14
My eXciteOSA phone application
My eXciteOSA is the place where you can start your eXciteOSA therapy or add your device.
This screen will appear if you haven’t already
added a device.
Before starting your therapy be sure to: check
your device for cracks or broken parts, connect
the controller to the mouthpiece, insert the
mouthpiece into the mouth.
Add a eXciteOSA device
(make sure that the device is nearby)
In order for the eXciteOSA device to work,
you need to allow Bluetooth connection.
For iOS 13 or above you need to manually
allow Bluetooth permission.
15
In order to start the therapy, you need to pair your phone with the
control unit. Please make sure that the control unit is close to your
phone.
CONNECT
REMOTE CONTROL
Indicates if the device is connected
to the phone
Indicates the device battery status
Indicates the remaining time
of the therapy
Pauses the therapy
Stops the therapy
Therapy intensity controller
(you can choose between 15 levels; please wait a couple of
seconds before the new setting takes eff ect)
Reading mode/Newsletter
16
A er pairing your eXciteOSA device with your mobile
phone, your therapy will start with a countdown from 3
to 1 before initiating the actual treatment.
Treatment can be stopped at any time but due to safety
reasons it can only be restarted a er 30 minutes a er
the device has been stopped or the treatment has
ended. Keep this in mind when stopping the treatment.
COUNTDOWN
STOP TREATMENT
17
Treatment can be paused at any time. It can be
paused only for 3 minutes. A er the 3 minutes have
passed the treatment is considered stopped and can
only be restarted a er 30 minutes.
Treatment can be paused at any time. It can be paused only for 3 minutes. A er the 3
minutes have passed the treatment is considered stopped and can only be restarted
a er 30 minutes.
You can set a reminder at a speci c time each
day, so that you don’t miss your treatment.
PAUSE TREATMENT
END OF THERAPY SESSION
SET A REMINDER
18
Frequency of usage
It is recommended you use eXciteOSA once daily for a continuous 20 minutes. It can take up
to 6 weeks of daily therapy before you will gain the desired improvement in your snoring.
Once the desired results are achieved, it is recommended to have a once a week regular
maintenance regime. eXciteOSA can be used long term. This is comparable to maintaining
your physical tness by undertaking regular exercise.
You are recommended to replace the Mouthpiece aer three months of rst use, which
includes the maintenance period.
Charging the control unit
Before using the device for the rst time, you must
charge the battery for at least 2 hours. The Control Unit
LED will ash blue and amber if there is inadequate
charge to run a full 20 minute therapy session. When
Control Unit logo (Fig 8) blinks blue and amber, recharge
the Control Unit. To charge the Control Unit, use
the USB Cable provided and connect the Control
Unit jack into a USB power adapter. During
charging, the eXciteOSA logo will blink.
When fully charged, the eXciteOSA logo
will become continuous blue.
Fig.8
19
Storing & travelling with your eXciteOSA
Once the Mouthpiece has been washed in potable tap water and dried, it can be stored in
its storage stand. The Mouthpiece is packaged in a removal stand which can be used for
storage or regular stand for the Mouthpiece.
The Mouthpiece should be washed before and aer each use. Use potable, running tap
water to wash the Mouthpiece. Dry with a clean towel and store in a dry place. DO NOT
wash with alcohol based cleaning solutions.
The Control Unit must be kept dry throughout its use and storage. Aer use, store in a dry
environment or the storage box. If you plan to travel with your eXciteOSA, place each unit in
its original packaging to protect during transportation.
Wipe the Control Unit surface with a damp cloth or antiseptic wipe once a week. DO NOT
immerse the Control Unit in water or cleaning solutions. Always store the Control Unit in a
dry place.
MOUTHPIECE
MOUTHPIECE
CONTROL UNIT
CONTROL UNIT
Washing
20
Settings
Manage all of your settings from a single place.
See and edit you pro le
A list of your devices
A list of frequently asked questions
Had a problem with the app or device?
You can report it here.
Feedback make us improve the product
Manage your noti cations settings
All legal matters can be found here
Log out of your account
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1
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