Signifier eXciteOSA Physician Manual
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Signifier eXciteOSA Physician Manual

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Physician Guide
IMPORTANT SAFEGUARDS:
READ ALL INSTRUCTIONS BEFORE USE

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Summary of Contents for Signifier eXciteOSA

  • Page 1 Physician Guide IMPORTANT SAFEGUARDS: READ ALL INSTRUCTIONS BEFORE USE...

  • Page 2: Table Of Contents

    Contraindications ........................6 What’s in the box? ........................7 eXciteOSA® smartphone application ..................9 Using your eXciteOSA® with a smartphone application ............13 My eXciteOSA® phone application ................... 15 Frequency of usage ........................20 Charging the Control Unit ......................20 Storing &...

  • Page 3: Important Safeguards

    Important safeguards READ ALL INSTRUCTIONS BEFORE USE. (for latest User Guide, please refer to https://exciteosa.com) CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN WARNINGS To avoid the risk of electrocution, burns, fire or physical injury: •...
  • 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: Intended Use

    Test after three months of therapy. CLINICAL SUMMARY • eXciteOSA® was used by 65 mild OSA patients, 20 minutes per day for 6 weeks, and 79% of group (51 patients) achieved an average reduction of 52% in AHI. • eXciteOSA® was used by 115 snoring patients, 20 minutes per day for 6 weeks, and 90% of...

  • Page 6: Contraindications

    READ ALL INSTRUCTIONS BEFORE USE. CONTRAINDICATIONS PRECAUTIONS Do not Use eXciteOSA® if you: Consult your Doctor/Dentist if you: • are pregnant or may be pregnant. • have gum disease or have bleeding from your gums or other oral conditions. • have a pacemaker or implanted electrodes.

  • Page 7: 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 8 Control Unit (With Bluetooth) USB-C type connector LED light under the logo Fig.2 USB Cable (15 cm cable connect to UL-Certified USB wall charger (not provided) with 5 VDC, Min 0.5 AMP output) Fig.3...

  • Page 9: Exciteosa® Smartphone Application

    Systems requirements The eXciteOSA® device can be controlled by the smartphone application. This app can be downloaded from the App store (Apple iOS) or Play Store (Google Android) The mobile app software can be used on iPhone 5S, iPhone 6/6 Plus, iPhone 6s/6s Plus, iPhone 7/ 7 Plus, iPhone 8/8 Plus, iPhone X, with iOS 11.0 and higher.
  • Page 10 Select your gender Select your date of birth Enter your ethnicity, height and weight* * This data allows for better eXciteOSA therapy options. Your data is secure with us. You can check our privacy policy, on our website https://exciteosa.com/privacy-policy, for further details.
  • Page 11 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 confirm that you do not use a pacemaker and that you are not pregnant.
  • Page 12 THE DASHBOARD The dashboard is the main screen of the app where all the features are available from. Settings eXciteOSA® therapy Educational content...

  • Page 13: Using Your Exciteosa® With A Smartphone Application

    Using your eXciteOSA® with a smartphone application Before starting your therapy be sure to: check the silicone 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 14 To start using eXciteOSA®, connect the Mouthpiece with the Control Unit as shown on Fig 5. Fig.5 Figure 6 Insert the Mouthpiece into the mouth and allow it to sit around the tongue as shown in Fig 6. and gently close your mouth.

  • Page 15: 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 16 Recommended Therapy Level The patient is recommended to set the device to the highest possible therapy level that is still comfortable to them. This will ensure the best possible outcome. Tolerance levels are likely to increase each week, and patients are encouraged to continue to raise levels accordingly.
  • Page 17 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. APPLICATION DURING A THERAPY SESSION Indicates if the device is connected to the phone Indicates the device battery status Indicates the remaining time of the therapy Pauses the therapy...
  • Page 18 COUNTDOWN After pairing your eXciteOSA® device with your mobile phone, your therapy will start with a countdown from 3 to 1 before initiating the actual therapy. STOP THERAPY Therapy can be stopped at any time but due to safety reasons it can only be restarted after 30 minutes after the device has been stopped or the therapy has ended.
  • Page 19 PAUSE THERAPY Therapy can be paused at any time. It can be paused only for 3 minutes. After the 3 minutes have passed the therapy is considered stopped and can only be restarted after 30 minutes. SET A REMINDER You can set a reminder at a specific time each day, so that you don’t miss your therapy.

  • Page 20: 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 mild OSA or snoring. After 6 weeks of therapy, only two, 20-minute sessions are required each week thereafter.

  • Page 21: Storing & Traveling 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 22: Settings

    Settings Manage all of your settings from a single place. See and edit your profile A list of your devices A list of frequently asked questions Had a problem with the app or device? You can report it here. Give us feedback here Manage your notifications settings Terms &...
  • Page 23 SEE/EDIT PROFILE Change any of Check the the data already Frequented provided and then Asked Questions tap ‘Save’, to save for further your changes. information. REPORT A NOTIFICATIONS PROBLEM Change the time of Did anything go your notifications. wrong with the Enable or disable app or the device? them, so that...

  • Page 24: Frequently Asked Questions

    Frequently asked questions How does the eXciteOSA® device work? The eXciteOSA device will deliver small electric currents through the Mouthpiece to your tongue, this will stimulate the tongue and improve its muscle function. The improved function of the tongue muscle will help in keeping the upper airway open during your sleep and reduce the vibration of the throat region.
  • Page 25 It is important to note that therapy levels outside of your comfort zone will not improve outcome or speed up results. How soon do I see the result with eXciteOSA®? You should notice an improvement in your snoring within 4 weeks. This is dependent upon adherence to the recommended therapy program of one 20-minute session daily.

  • Page 26: Troubleshooting

    • 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 by emailing support@signifiermedical.com or calling +1 844 MildOSA...

  • Page 27: Cybersecurity

    Just like Wi-Fi connections, Bluetooth can put your personal data at risk if you are not careful in public places. While it is better to use the eXciteOSA mobile app in a private environment, here are some steps you may wish to take when using Bluetooth within (10 m/30 ft) of strangers: •...
  • Page 28 Malware • Never jailbreak your iPhone or root an Android device, because you leave it open to the malware it was designed to be protected against. • Always install the latest OS updates for increased security. Android’s open-source system and delayed update roll out make it more susceptible to malware, which is why Android users should always use an anti-virus from the Google Play Store as an added layer of protection.

  • Page 29: 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 30 Do not try to repair, alter or change the components of the three individual units of the eXciteOSA®, as this will invalidate your warranty. If the Mouthpiece or Control Unit is not functional due to wear and tear, it will not be covered by the warranty. The mouthpiece must be replaced after 3 months of first use.

  • Page 31: 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 USB C...

  • Page 32: Specifications

    Control Unit Mouthpiece Color 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 37)
  • Page 33 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 34 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...

  • Page 35: Declarations

    Declarations FOR THE 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 36 Email: info@signifiermedical.com www.exciteosa.com Distributed in the USA by Signifier Medical Technologies LLC 175 Highland Avenue Needham MA 02492 +1 844 MildOSA This product is Manufactured by Signifier Medical Technologies in compliance with Medical Device Standards and Quality Standards: ISO 13485:2016...
  • Page 37 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 38 1282 Physician Guide North America eXciteOSA® is a registered trademark of Signifier Medical Technologies. All other trademarks are the property of their respective owners. ©2021 Signifier Medical Technologies. All rights reserved. EX0022 3/21...

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