Signifier Snoozeal User Manual
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Signifier Snoozeal User Manual

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Snoozeal User Guide
IMPORTANT SAFEGUARDS:
READ ALL INSTRUCTIONS BEFORE USE

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Summary of Contents for Signifier Snoozeal

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

  • Page 3: Table Of Contents

    Appendix A Important safeguards What’s in the box Remote Control instructions 37 Intended use Intended use Using your Snoozeal with a Before first use Smartphone Application Using your Snoozeal Frequency of usage with a Remote Control Charging the Control Unit Frequency of usage Storing &...

  • Page 4: Important Safeguards

    IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USE. (for latest User Guide, please refer to https://snoozeal.com/product/) 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 5 (choking hazard and electrical hazard). • Snoozeal to be used in home healthcare environment (or equivalent). • Snoozeal is a single person device and should not be shared or used by other individuals. • Do not use Snoozeal when driving a vehicle or operating machinery and other equipment.
  • Page 6 IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USE. READ ALL INSTRUCTIONS BEFORE USE. CONTRAINDICATIONS PRECAUTIONS Do not Use Snoozeal if: Consult your Doctor/Dentist if: • you are pregnant or maybe pregnant • you have gum disease or have bleeding from your gums.

  • Page 7: What's In The Box

    WHAT’S IN THE BOX SNOOZEAL PACKAGE INCLUDES: 1. MOUTHPIECE (TOP VIEW) Electrodes USB-C type connector FLEXIBLE SILICONE Fig 1.
  • Page 8 2. CONTROL UNIT (WITH BLUETOOTH) USB-C type connector LED light under the Logo Fig 2. 3. USB CABLE (15 CM CABLE, CONNECT TO APPROPRIATELY APPROVED ADAPTER WITH 5 VDC, MIN 0.5AMP OUTPUT) Fig 3.
  • Page 9 4. REMOTE CONTROL (IF INCLUDED IN YOUR BOX) If Remote Control is included in your box, please refer to Appendix A (page 37) for additional instructions. Therapy intensity level Power On/O Screen lock Therapy switch Start/ Abort Therapy time Remote locked Control Unit Total...

  • Page 10: Intended Use

    INDICATIONS FOR USE: Snoozeal is indicated for use to reduce snoring and mild sleep apnoea (AHI ≤15) for patients that are 18 years or older. Snoozeal device can be controlled by Snoozeal Smartphone application or by a Remote Control (if one is included in your box).
  • Page 11 Enter your ethnicity, height and weight* * This data helps us give you more accurate sleep tracking results and better Snoozeal treatment options. * Your data is always safe with us. You can check our privacy policy for further details.
  • Page 12 Policy (only for using the app with a Snoozeal device) There are a number of terms you have to agree to in order to use the Snoozeal device with the mobile app. First, make sure you read the Terms and Conditions page, and agree with them.
  • Page 13 DASHBOARD The dashboard is the main screen of the app where all the features are available from. Sleep statistics Settings Sleep tracking Snoozeal treatment Educational content Articles...

  • Page 14: Using Your Snoozeal With A Smartphone Application

    Before use, wash the Mouthpiece with cold and running potable tap water as shown in Fig 5. Avoid water reaching the USB port. Dry with clean towel. To start using Snoozeal, connect the Mouthpiece with the Control Unit as shown on Fig 6.
  • Page 15 Fig 6. Insert the Mouthpiece into the mouth and allow it to sit around the tongue as shown in Fig 7. and gently close your mouth. Avoid grinding or clenching the Mouthpiece. Fig 7.
  • Page 16 MY SNOOZEAL PHONE APPLICATION My Snoozeal is the place where you can In order for the Snoozeal start your Snoozeal treatment or add device to work, you need your device. to allow Bluetooth This screen will connection. appear only if For iOS 13 or above you you haven’t...
  • Page 17 CONNECT In order to start the treatment, 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 the device battery status Indicates if the device is connected to the phone.
  • Page 18 COUNTDOWN STOP TREATMENT A er pairing your Snoozeal device with Treatment can be stopped at any time your mobile phone, you treatment will but due to safety reasons it can only be start with a restarted a er countdown from...
  • Page 19 PAUSE TREATMENT SET A REMINDER Treatment can be paused at any time. It You can set a reminder at a specific can be paused only for 3 minutes. A er time each day, so that you don’t miss the 3 minutes your treatment.

  • Page 20: Frequency Of Usage

    FREQUENCY OF USAGE It is recommended you use Snoozeal 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 21: Storing & Travelling With Your Snoozeal

    The Control Unit and the Remote Control Unit must be kept dry throughout its use and storage. A er use, store in a dry environment or the storage box. If you plan to travel with your Snoozeal, place each unit in its original packaging to protect during transportation.

  • Page 22: Washing

    WASHING MOUTHPIECE The Mouthpiece should be washed before and a er each use. Use running tap water to wash the Mouthpiece (Fig 5). Dry with a clean towel and store in a dry place. DO NOT wash with alcohol based cleaning solutions. CONTROL UNIT Wipe the Control Unit surface with a damp cloth or antiseptic wipe once a week.

  • Page 23: Sleep Tracking

    SLEEP TRACKING In order for the sleep tracking to work, you The sleep tracking feature allows the user to need to allow access to record his sleep and get advanced details Microphone. about his sleeping patterns and snoring habits. FACTORS SLEEP TRACKING Before you start Once sleep tracking...
  • Page 24 RATE YOUR SLEEP Giving a subjective rating to your sleep helps you track your sleep quality in the long run. And, eventually, point out connections between factors, snoring levels and perceived sleep quality. Choose your mood Confirm your choice If you don’t want to track your mood, you can skip this step SET UP REMINDER In order to see a better overview...

  • Page 25: Settings

    SETTINGS Manage all of your settings from a single place. See and edit you 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. Feedback make us improove the product Manage your notifications settings All legal matters can be found here Log out of your account...
  • Page 26 SEE/EDIT PROFILE Change any of the Check the Frequented data already provided Asked Questions to and then tap ‘Save’, see answers for your to save your changes. problems. REPORT A PROBLEM NOTIFICATIONS Did anything go wrong Change the time of with the app or the your notifications.

  • Page 27: 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 28 How does Snoozeal device work? The Snoozeal 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 29 It may become an uncomfortable sensation. What time of the day should I use the Snoozeal device? The Snoozeal can be used anytime during the day, but it is recommended to be used before you go to sleep at night...

  • Page 30: Trouble Shooting

    • 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 Snoozeal’s Help/Support team 2. The Remote Control does not connect to the Control Unit: •...
  • Page 31 SNOOZEAL 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. SNOOZEAL 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 32 Do not try to repair, alter or change the components of the three individual units of the Snoozeal, as this will invalidate your warranty. If the Mouthpiece, Remote Control or Control Unit is not functional due to wear and tear, it will not be covered by the warranty.
  • Page 33 SYMBOLS USED +158°F (+70°C) Refer to instructions manual Storage Temperature Limits -13°F (-25°C) Keep dry Catalogue number Non Sterile Serial number Type BF applied part Manufacturer WEEE directive Date of manufacture...

  • Page 34: Specifications

    (if your box included a Remote Control) Color Color White and Blue White and Grey White, Grey and Black Packaging Snoozeal is packed in a protective box package Packaging Rechargeable Non-rechargeable AAA Power source Power source 100mAh LiPo cell Alkaline batteries 32.4 V...
  • Page 35 Radio Frequency Information Control Unit Remote Frequency Band Of Reception 2.4 GHz to 2.48 GHZ The Bandwidth of The Receiving Section in Those Bands 2 MHz E ective 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 36 Snoozeal System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. IF the Snoozeal system is exposed to EM disturbance, there should not be any loss or degradation to performance. However the performance should be monitored...

  • Page 37: Remote Control Instructions

    APPENDIX A REMOTE CONTROL INSTRUCTIONS (if your box included a Remote Control)

  • Page 38: Intended Use

    INTENDED USE INDICATIONS FOR USE: Snoozeal is indicated for use to reduce snoring and mild sleep apnoea (AHI ≤15) for patients that are 18 years or older. BEFORE FIRST USE 4. The Remote Control Check all the components are intact,...

  • Page 39: Using Your Snoozeal With A Remote Control

    USING YOUR SNOOZEAL WITH A REMOTE CONTROL Note: for directions on using the mobile application, iOS and Android, please refer to the App User Guide. 1. 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 40 Fig 13. 5. Insert the Mouthpiece into the mouth and allow it to sit around the tongue as shown in Fig 14. and gently close your mouth. Avoid grinding or clenching the Mouthpiece. Fig 14.
  • Page 41 USING YOUR SNOOZEAL 6. Power on the Remote Control through the Power on/o button, the remote will pair automatically with Control Unit as shown in Fig 15. (If Bluetooth paring has been completed - see "Before first use” page 38).

  • Page 42: Frequency Of Usage

    (Follow instruction on washing). FREQUENCY OF USAGE It is recommended you use Snoozeal 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.

  • Page 43: Replacing The Batteries

    REPLACING BATTERIES ON THE REMOTE REMOTE CONTROL 1. Replace both batteries with new ones when the symbol is displayed on the Remote Control. 2. Open the battery compartment cover on the underside of the remote. 3. Install two new AAA size alkaline batteries with the positive (+) and negative (-) terminals properly aligned with the corresponding symbols in the battery compartment (do not replace batteries during a therapy session).

  • Page 44: Storing And Travelling With Your Snoozeal

    The Control Unit and the Remote Control Unit must be kept dry throughout its use and storage. A er use, store in a dry environment or the storage box. If you plan to travel with your Snoozeal, place each unit in its original packaging to protect during transportation.

  • Page 45: Error Codes

    ERROR CODES The Snoozeal is designed to operate safely at all times, our product will operate in a safe mode if it encounters an error code. Contact Signifier Medical Technologies’s Help/Support team in the event of persistent error codes. Icon...
  • Page 46 Do not use the product and contact Signifier Medical Technologies 122 131 User presented with Any code not mentioned above and with a Other fail-safe General Error Icon and General Error Icon contact Signifier Medical three digit number not errors Technologies for advice stated above...

  • Page 47: 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 48 Signifier Medical Technologies Limited 150 Aldersgate Street, London, EC1A 4AB, UK Email: uko ice@snoozeal.com www.snoozeal.com This product is Manufactured by Signifier Medical Technologies in compliance with Medical Device Standards and Quality Standards: ISO 13485:2016...
  • Page 49 TABLE A: REPRESENTATIVE OUTPUT WITH VARYING LOADS Mouthpiece 900 Ohm 500 Ohm 338 Ohm load Therapy Measured Calculated Measured Calculated Measured Calculated level Voltage current Voltage current Voltage current (mA) (mA) (mA) 2.21 2.46 1.34 3.96 5.11 3.46 6.92 2.59 7.66 7.44 5.31...
  • Page 52 1282 045300001 dated 18 December 2019...

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