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Signifier eXciteOSA Manual

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Instructions for Use
IMPORTANT SAFEGUARDS:
READ ALL INSTRUCTIONS BEFORE USE

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Summary of Contents for Signifier eXciteOSA

  • Page 1 Instructions for Use IMPORTANT SAFEGUARDS: READ ALL INSTRUCTIONS BEFORE USE...

  • Page 2: Table Of Contents

    Contents Important safeguards ........................ 3 Intended use ..........................5 Contraindications ........................6 What’s in the box? ........................7 Systems requirement / eXcite smartphone application ............9 Using your eXcite with a smartphone application ............. 13 eXcite ............................ 15 Recommended therapy level ....................16 Frequency of usage ........................

  • 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 READ ALL INSTRUCTIONS BEFORE USE. WARNINGS To avoid the risk of physical injury: • Do not use this device if you are under the age of 18 • eXcite should be kept away from children and pets OSA® (choking hazard and electrical hazard). •...

  • Page 5: Intended Use

    Intended use eXcite is intended for the reduction of snoring and mild obstructive sleep apnea by strengthening tongue muscles via electrical muscle stimulation. INDICATIONS FOR USE eXcite is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI < 15) and snoring for patients that are 18 years or older.

  • Page 6: Contraindications

    READ ALL INSTRUCTIONS BEFORE USE. CONTRAINDICATIONS PRECAUTIONS Do not use eXcite 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

    Electrodes 1) damaged 2) unintentionally opened before use 3) packaging is exposed to environmental conditions outside of those specified please do not use the device and contact Signifier Medical Technologies. Cleaning cap (please retain) USB-C type connector Flexible silicone Fig.1...
  • Page 8 Control unit (with Bluetooth) Extender cable USB-C type connector LED lights below the logo Fig.2 Fig.3 eXcite USB charging cable (15 cm cable connect to UL-Certified USB wall charger (not provided) with 5 VDC, Min 0.5 AMP output) Fig.4 Note: Only use the eXcite USB charging cable provided.

  • Page 9: Osa Smartphone Application

    The mobile app software can be used on iPhone 11, iPhone 11 Pro & iPhone 11 Pro Max and above, with iOS 15.0 and higher. The mobile app software can also be used with Android devices with Bluetooth support and Android 10.0 and above. eXciteOSA uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.
  • Page 10 Enter your ethnicity, height and weight* * This data allows for better eXcite 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. Select whether you already have an eXcite device or not.
  • Page 11 POLICY There are a number of terms you have to agree to in order to use the eXcite 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 eXcite therapy Educational content...

  • Page 13: Using Your Excite Osa With A Smartphone Application

    Using your eXcite 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 silicone - DO NOT USE THE MOUTHPIECE.
  • Page 14 To start using eXcite , connect the mouthpiece to the control unit as shown on Fig 6. Fig.6 Figure 7 Insert the mouthpiece into the mouth and allow it to sit on and around the tongue (as shown in Fig 7). and gently close your mouth.

  • Page 15: Excite App

    eXcite The eXcite smartphone application is where you can start your eXcite therapy or add your device. In order for the eXcite device to work, you need to allow Bluetooth connection. For iOS 13 or above you need to manually allow Bluetooth permission.

  • Page 16: Recommended Therapy Level

    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. Follow the instructions on the eXcite screen to connect and make sure the control unit is close to your phone. You should see a blue flashing light to connect via Bluetooth to the phone.
  • Page 18 COUNTDOWN After pairing your eXcite 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 eXcite 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. Once the desired results are achieved, it is recommended to have a once a week regular maintenance regime.

  • Page 21: Storing & Traveling With Your Excite Osa

    Storing & traveling with your eXcite MOUTHPIECE Once the mouthpiece has been washed in tap water and dried, it can be stored in its storage stand. The mouthpiece is packaged in a removable stand which can be used for storage or act as a regular stand the mouthpiece.

  • Page 22: Settings

    Settings Manage all of your settings from a single place. See and edit your profile A list of your devices Purchase device and mouthpieces here A list of frequently asked questions Had a problem with the app or device? You can report it here. Give us feedback here Enable Virtual Assistant for assistance during sessions...
  • 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

    How does the eXcite device work? The eXciteOSA device will deliver small electric pulses 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 How soon do I see the result with eXcite You should notice an improvement in your snoring within 6 weeks. This is dependent upon adherence to the recommended therapy program of one 20-minute session daily. Although you may see improvement within 6 weeks, we recommend you finish the 6-week therapy period to ensure you gain the optimal improvement possible.

  • Page 26: Troubleshooting

    Troubleshooting The control unit powers up but the mouthpiece does not work: • Check the control unit has adequate power to run a 20 minutes therapy session • Check there is no fluid ingress within the USB connector • Check there is no damage to the mini USB connector •...

  • Page 27: Cybersecurity

    Cybersecurity Bluetooth Security 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 eXcite 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 iOS 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: Excite Osa System, Operational Requirements

    eXcite 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. eXcite system, transport and storage requirements Temperature -13°F to +158°F (-25°C to +70°C) Humidity up to 90% Atmospheric Pressure 10.15 psi to 15.37 psi (70 kPa to 106 kPa) When the device is exposed to extreme temperatures, please wait...
  • Page 30 The mouthpiece must be replaced after 90 days of first use. WARRANTY Signifier Medical Technologies LLC provides a warranty to the original purchaser confirming the product will be free from defects in the material, components and workmanship for a period of 90 days for the mouthpiece and 1 year (control unit only) from the date of purchase.
  • Page 31 Your invoice of purchase should state the name and the contact details of your local Signifier Medical Technologies contact. For assistance in setting up, using or maintaining the unit, or to report unexpected operation or events please contact Signifier Medical Technologies customer service.

  • Page 32: Symbols Used

    Symbols used +158°F (+70°C) -13°F (-25°C) Storage Temperature Limits Refer to instructions manual Humidity Limits Catalog number Serial number Keep dry Country & date Manufacturer Type BF applied part of manufacture WEE directive USB C Federal Communications Commission Medical Device...

  • Page 33: Specifications

    Specifications Control Unit Mouthpiece Color White and Blue White and Grey Packaging eXcite is packed in a protective box package Power source Rechargeable 100mAh LiPo cell 30.8 V Max output voltage Output varies with impedance 70mA Max output current Output varies with impedance 100 uS for each of the two biphasic output pulses of opposite polarity, resulting in a balance d.c.
  • Page 34 Specifications Control Unit Mouthpiece Atmospheric Pressure Range 10.15 psi to 15.37 psi (70 kPa to 106 kPa) Humidity Relative Humidity 15% to 90% Relative Humidity up to 100% Control Unit ( IP44) (IP 44 - Protection protected against objects > 1 ml and splashing water, IP42 - Protection protected against objects >...
  • Page 35 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) / BS EN 60601-1-2:2015+A1:2021 (Home healthcare environment) Standard Category CISPR 11 / EN 55011...
  • Page 36 WARNING: • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. •...

  • Page 37: 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 38 Distributed in the USA by Signifier Medical Technologies LLC 109 Highland Avenue, Suite 303 Needham, MA 02494 +1 844 MildOSA This product is Manufactured by Signifier Medical Technologies in compliance with Medical Device Standards and Quality Standards: ISO 13485:2016...
  • Page 39 Instructions for Use - North America eXcite is a registered trademark of Signifier Medical Technologies. OSA® All other trademarks are the property of their respective owners. ©2023 Signifier Medical Technologies. All rights reserved. EX0023 11/23...

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