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Related Manuals for Signifier eXciteOSA
Summary of Contents for Signifier eXciteOSA
- Page 1 User Guide IMPORTANT SAFEGUARDS: READ ALL INSTRUCTIONS BEFORE USE...
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Page 2: Table Of Contents
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 &... -
Page 3: Important Safeguards
Important safeguards READ ALL INSTRUCTIONS BEFORE USE. (for latest User Guide, please refer to https://exciteosa.com) WARNINGS To avoid the risk of electrocution, burns, fire or physical injury: • The device is only to be used while awake. It should not be used while sleeping. - Page 4 (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.
- Page 5 READ ALL INSTRUCTIONS BEFORE USE. CONTRAINDICATIONS PRECAUTIONS Do not Use eXciteOSA if: Consult your Doctor/Dentist if: • you are pregnant or maybe pregnant • you have gum disease or have bleeding from your gums or other oral conditions. • you have a pace maker or implanted electrodes •...
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Page 6: What's In The Box
What’s in the box? eXciteOSA package includes: Mouthpiece (Top view) Electrodes USB-C type connector Flexible silicone Fig.1... - Page 7 Control Unit (With Bluetooth) USB-C type connector USB-C type connector LED light under the logo Fig.2 USB Cable and adapter (15cm cable and included adapter) Fig.3...
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Page 8: Intended Use
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. - Page 9 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.
- Page 10 POLICY 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 confi rm that you do not use a pacemaker and that you are not pregnant.
- Page 11 THE DASHBOARD The dashboard is the main screen of the app where all the features are available from. Settings eXciteOSA therapy Educational content Articles...
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Page 12: Using Your Exciteosa With A Smartphone Application
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. - Page 13 To start using eXciteOSA, connect the Mouthpiece with the Control Unit as shown on Fig 5. Fig.5 Figure 6 Figure 6 Insert the Mouthpiece into the mouth and allow it to sit around the mouth and allow it to sit around the tongue as shown in Fig 6.
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Page 14: My Exciteosa Phone Application
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. In order for the eXciteOSA device to work, you need to allow Bluetooth connection. - Page 15 CONNECT 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. REMOTE CONTROL Indicates if the device is connected to the phone Indicates the device battery status Indicates the remaining time of the therapy...
- Page 16 COUNTDOWN Aft 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. STOP TREATMENT Treatment can be stopped at any time but due to safety...
- Page 17 PAUSE TREATMENT Treatment can be paused at any time. It can be paused only for 3 minutes. Aft er the 3 minutes have passed the treatment is considered stopped and can only be restarted aft er 30 minutes. SET A REMINDER You can set a reminder at a specifi c time each day, so that you don’t miss your treatment.
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Page 18: Frequency Of Usage
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. -
Page 19: Storing & Travelling With Your Exciteosa
The Control Unit must be kept dry throughout its use and storage. After 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. -
Page 20: Settings
Settings Manage all of your settings from a single place. See and edit you profi 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 notifi cations settings All legal matters can be found here... - Page 21 SEE/EDIT PROFILE Change any of Check the the data already Frequented Asked provided and then Questions to see tap ‘Save’, to save answers for your your changes. problems. REPORT A NOTIFICATIONS PROBLEM Change the time of Did anything go your notifi cations. wrong with the Enable or disable app or the device?
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Page 22: Frequently Asked Questions
Frequently asked questions Why do I snore? Snoring is caused by vibration of the structures of the throat during sleep. When you sleep, the muscles of the throat relax and partially collapse. The narrowest parts of the throat can then create turbulence of the air flowing through your throat which makes the snoring sound You’re more likely to snore if you: •... - Page 23 How does eXciteOSA device work? The eXciteOSA device will deliver small electric currents through the Mouthpiece to your tongue, this will stimulate the tongue muscle and improve its tone. The improved tone of the tongue muscle will help in keeping the breathing passage open during your sleep and reduce the vibration of the throat region.
- Page 24 It may become an uncomfortable sensation. What time of the day should I use the eXciteOSA device? The eXciteOSA can be used anytime during the day, but it is recommended to be used before you go to sleep at night.
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Page 25: Trouble Shooting
• Check there is no fluid ingress within the USB connector • Check there is no damage to the mini USB connector • Check there is no damage to the Mouthpiece • If the above steps have been implemented, then contact the eXciteOSA’s Help/Support team... -
Page 26: Exciteosa System, Operational Requirements
Temperature +41°F to +104°F (+5°C to +40°C) Humidity 15% to 90% Atmospheric Pressure 10.15 psi to 15.37 psi (70 kPa to 106 kPa) Operational life is 3 years. eXciteOSA system, transport and storage requirements Temperature -13°F to +158°F (-25°C to +70°C) Up to 90% Atmospheric Pressure 10.15 psi to 15.37 psi (70 kPa to 106 kPa) - Page 27 FAULTS & REPAIRS eXciteOSA should be used in accordance with this User Guide above and with the approved accessories and contains no user serviceable parts. Do not try to repair, alter or change the components of the three individual units of the eXciteOSA, as this will invalidate your warranty.
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Page 28: Symbols Used
Symbols used +158°F (+70°C) -13°F (-25°C) Storage Temperature Limits Refer to instructions manual Keep dry Catalogue number Non Sterile Serial number Type BF applied part Manufacturer WEE directive Date of manufacture... -
Page 29: Specifications
Control Unit Mouthpiece Colour White and Blue White and Grey Packaging eXciteOSA is packed in a protective box package Power source Rechargeable 100mAh LiPo cell 32.4 V Max output voltage Output varies with impedance (see Table A on page ??) - Page 30 Radio Frequency Information Control Unit Frequency Band Of Reception 2.4 GHz to 2.48 GHZ The Bandwidth of The Receiving Section in Those Bands 2 MHz Effective Radiated Power up to 3.5 dBm IEC 60601-1-2:2014 (EDITION 4) / EN 60601-1-2:2015 (Home healthcare environment) Standard Category CISPR 11 / EN 55011...
- Page 31 System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. If the eXciteOSA system is exposed to EM disturbance, there should not be any loss or degradation to performance. However the performance should be monitored for the...
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Page 32: Declarations
Declarations FOR USA FCC warning statement: This device complies with Part 15 of the FCC Rules. • Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. - Page 33 Distributed in the USA by Signifier Medical Technologies LLC 175 Highland Avenue Needham MA 02492 +1844 MILDOSA (+1844 645 3672) This product is Manufactured by Signifier Medical Technologies in compliance with Medical Device Standards and Quality Standards: ISO 13485:2016...
- Page 34 Table A: Representative output with varying loads Mouthpiece 900 Ohm 500 Ohm 338 Ohm load Measured Calculated Measured Calculated Measured Calculated Therapy level Voltage (V) current (mA) Voltage (V) current (mA) Voltage (V) current (mA) 2.21 2.46 1.67 3.34 1.34 3.96 5.11 3.46...
- Page 35 1282 User Guide English: 045300003 Dated January 2021...
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