Snoozeal User Guide IMPORTANT SAFEGUARDS: READ ALL INSTRUCTIONS BEFORE USE
CONTENTS Important safeguards 4 Appendix A What’s in the box 7 Remote Control instructions 35 Intended use 10 Using your Snoozeal with a Smartphone Application 14 Intended use 36 Before first use 36 Frequency of usage 20 Using your Snoozeal with a Remote Control 37 Charging the Control Unit 20 Frequency of usage 40 Storing & travelling with your Snoozeal 21 Replacing the batteries on the Remote Control 41 Washing 22 Software updates 22 Storing and travelling with your Snoozeal
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: • 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.
IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USE. WARNINGS To avoid the risk of physical injury: • This device should not be used by persons: - children (under 18 years of age) • Snoozeal should be kept away from children and pets (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.
IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USE. READ ALL INSTRUCTIONS BEFORE USE. CONTRAINDICATIONS Do not Use Snoozeal if: • you are pregnant or maybe pregnant • you have a pace maker or implanted electrodes • you have temporary or permanent implants, dental braces or jewellery in your mouth. • you are suffering from mouth ulceration • having or suspecting of having obstructive sleep apnoea with AHI greater than 15. Safety and effectiveness in the above conditions have not been established.
WHAT’S IN THE BOX SNOOZEAL PACKAGE INCLUDES: 1. MOUTHPIECE (TOP VIEW) Electrodes USB-C type connector FLEXIBLE SILICONE Fig 1.
2. CONTROL UNIT (WITH BLUETOOTH) USB-C type connector LED light under the Logo Fig 2. 3. USB CABLE (connect to appropriately approved adapter with 5 Vdc, min 0.5Amp output) 8 Fig 3.
4. REMOTE CONTROL (IF INCLUDED IN YOUR BOX) If Remote Control is included in your box, please refer to Appendix A (page 35) for additional instructions. Screen lock switch Therapy time Control Unit battery indicator Intensity down Bluetooth Pair Pause/Restart therapy Therapy intensity level Power On/Off Therapy Start/ Abort Remote locked Total therapy in minutes Bluetooth pair LED Intensity up Fig 4.
INTENDED USE Snoozeal is indicated for the reduction of snoring and mild sleep apnoea (AHI ≤15) in adults (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). Smartphone application can be downloaded from App Store (Apple iOS) or Play Store (Google Android). For using Snoozeal with the Remote Control, refer to Appendix A on page 35.
PROFILE SETUP Enter your full name Enter your country of residence Select your gender Select your date of birth Enter your ethnicity, height and weight* * This data helps us give you more accurate sleep tracking results and help improve our technology. * Your data is always safe with us. You can check our privacy policy for further details. Select whether you already have a Snoozeal device or not. If you choose yes, additional setup is required.
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. Next, please confirm 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 Snoozeal device may interfere with your pacemaker or with your baby’s development. Also, you have to be a legal adult.
DASHBOARD The dashboard is the main screen of the app where all the features are available from.
USING YOUR SNOOZEAL 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 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. Fig 5.
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.
MY SNOOZEAL PHONE APPLICATION My Snoozeal is the place where you can start your Snoozeal treatment or add your device. In order for the Snoozeal device to work, you need to allow Bluetooth connection. This screen will appear only if you haven’t already added a device.
THERAPY MODE Ensure your Control Unit is fully charged or holds enough charge for a complete 20 minute therapy. The Control Unit battery status can be checked on the therapy screen, top left of display. Indicates the device battery status Indicates if the device is connected to the phone.
COUNTDOWN After pairing your Snoozeal device with your mobile phone, you treatment will start with a countdown from 3 to 1 before initiating the actual treatment. THERAPY SESSION The therapy duration is 20 minutes, a timer will be displayed on therapy screen of the display to indicate the time remaining for completion of therapy session. To adjust the intensity of the therapy: • on the display press the to increase intensity, • press to decrease intensity.
PAUSE TREATMENT STOP TREATMENT Treatment can be paused at any time. It can be paused only for 3 minutes. After the 3 minutes have passed the treatment is considered stopped and can only be restarted after 3 hours. Treatment can be stopped at any time but due to safety reasons it can only be restarted after 3 hours after the device has been stopped or the treatment has ended. Keep this in mind when stopping the treatment.
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. Snoozeal can be used long term. This is comparable to maintaining your physical fitness by undertaking regular exercise. You are recommended to replace the Mouthpiece after three months of use.
STORING & TRAVELLING WITH YOUR SNOOZEAL MOUTHPIECE Once the Mouthpiece has been washed in clean 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. CONTROL UNIT The Control Unit and the Remote Control Unit must be kept dry throughout its use and storage. After use, store in a dry environment or the storage box.
WASHING MOUTHPIECE The Mouthpiece should be washed before and after 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. DO NOT immerse the Control Unit in water or cleaning solutions. Always store the Control Unit in a dry place.
SLEEP TRACKING The sleep tracking feature allows the user to record his sleep and get advanced details about his sleeping patterns and snoring habits. FACTORS Before you start recording, you can choose a few factors that apply to you as these may influence the quality of your sleep. SLEEP TRACKING STATISTICS After the sleep tracking stops, you will have the ability to see statistics regarding your snoring activity during your sleep.
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 24 Set up reminder Select time Tap ‘Done’ In order to see a better overview of your sleep patterns over time, it is important to track your sleep in a regularly.
SETTINGS Manage all of your settings from a single place. See and edit your profile A list of frequently asked questions Had a problem with the app or device? You can report it here.
SEE/EDIT PROFILE FAQ Change any of the data already provided and then tap ‘Save’, to save your changes. Check the Frequented Asked Questions to see answers for your problems. REPORT A PROBLEM NOTIFICATIONS Did anything go wrong with the app or the device? Describe the problem and let us know. We’ll try to solve it and take the appropriate measures. Change the time of your notifications. Enable or disable them, so that you can have a smoother experience.
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.
FREQUENTLY ASKED QUESTIONS Do I have sleep apnoea? Sleep apnoea is a serious health condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death. It is often associated with day time sleepiness and your partner may notice you breath hold or stop breathing in the night. If you have these symptoms or are concerned you may have the condition, please refer to your doctor.
FREQUENTLY ASKED QUESTIONS At what level should I start and what is the optimum level for my treatment? The intensity always starts at level 1; it is recommended that you increase the intensity to a level that is comfortable for you for each therapy session. The therapy changes frequencies at 5 minute intervals. At these intervals the stimulation will automatically drop in intensity for comfort.If you feel any discomfort or lack of stimulation, then the intensity can be reduced or increased accordingly.
TROUBLE SHOOTING 1. 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 Ensure the Remote Control is within 6.8 feet (2 meters) of the Control Unit 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 Snoozeal’s Help/Support team 2.
SNOOZEAL SYSTEM, OPERATIONAL REQUIREMENTS Temperature +50°F to +104°F (+10°C to +40°C) Relative Humidity for Control Unit and Remote Control 20% to 85% Relative Humidity for Mouthpiece 100% Atmospheric Pressure 10.15 psi to 15.37 psi (70 kPa to 106 kPa) SNOOZEAL SYSTEM, STORAGE REQUIREMENTS Temperature +23°F to +140°F (-5°C to +60°C) Relative Humidity less than 85% Atmospheric Pressure 10.15 psi to 15.
DISPOSAL Please return the products to your supplier for disposal. The Control Unit contains a rechargeable battery and should not be disposed in general waste. FAULTS & REPAIRS Snoozeal should be used in accordance with the 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 Snoozeal, as this will invalidate your warranty.
SYMBOLS USED Refer to instructions manual +60°C -5°C Storage Temperature Limits Catalogue number Keep dry Serial number Non Sterile Manufacturer Type BF applied part Date of manufacture WEEE directive 33
SPECIFICATIONS Color Packaging Power source Control Unit Mouthpiece White and Blue White and Grey (if your box included a Remote Control) White, Grey and Black Snoozeal is packed in a protective box package Rechargeable 100mAh LiPo cell Non-rechargeable AAA Alkaline batteries Max output voltage (500Ω) 32.
APPENDIX A REMOTE CONTROL INSTRUCTIONS (if your box included a Remote Control) 35
INTENDED USE Snoozeal is indicated for the reduction of snoring and mild sleep apnoea (AHI ≤15) in adults (18 years or older). BEFORE FIRST USE 4. The Remote Control display will show one or more Control Units (Fig 9). (Bluetooth identity can be 1. Charge the Control Unit fully for 2 hours located as the characters before first use. The flashing blue light following the "BT ID:" on will become continuous when the the packaging) Control Unit is fully charged. 5. Once the correct Control 2.
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. 2. Wash the Mouthpiece only with cold and running potable tap water as shown in Fig 12. Avoid water reaching the USB port. Dry with clean towel. (Follow instruction on washing) 3.
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.
USING YOUR SNOOZEAL 6. Power on the Remote Control through the Power on/off 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 36"). 7. To start therapy, press the Power on/off button, the therapy will start at the lowest intensity (intensity 1). 8. The therapy duration is 20 minutes, a timer will be displayed on Remote Control to indicate the time remaining for completion of therapy session. 9.
11. Pause therapy - Press P button to pause. Restart therapy - Press P button again to restart. If the therapy is paused for more than 3 minutes, it will terminate session. 12. The stimulation will stop automatically when the therapy session has finished. 13. At the end of the therapy session, remove the Mouthpiece from your mouth and disconnect the Control Unit. 14. To power down the Remote Control, press the Power on/off button for three seconds. 15.
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. 4. Close the battery compartment cover.
• Install each battery with the positive (+) and negative (-) terminals properly aligned with the corresponding symbols in the battery compartment. • Improper installation of the batteries may cause battery leakage. • Do not mix new and used batteries. It may cause damage to the remote or shorten the battery life. • Use alkaline batteries only. • Do not use rechargeable batteries with this remote. • Remove the batteries from the battery compartment, when the remote is not to be used.
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 Functionality No paired icon: Pairing: No device found to pair.
Icon 142 Functionality Battery 152 161 221 Firmware Upgrade Comment 1. Connect the controller to the charger 2. Ensure controller is within 3.4 feet (1 meter) of remote 3. Turn on remote and wait for 10 seconds 4. Repower and attempt to pair 1. Do not connect the controller to the charger 2. Have controller within 3.4 feet (1 meter) of mobile app device 3. Turn off remote and wait 10 sec 4. Repower and re-pair to the app and start the upgrade again 5.
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. • This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
Signifier Medical Technologies 150 Aldersgate Street, London, EC1A 4AB, UK Email: ukoffice@snoozeal.com www.snoozeal.
045300001 dated 18 December 2019
