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Snoozeal User Guide

IMPORTANT SAFEGUARDS:

READ ALL INSTRUCTIONS BEFORE USE

Summary of Contents for Snoozeal

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

Page 2: ......

Page 3: ...eal 21 Washing 22 Software updates 22 Sleep tracking 23 Settings 25 Frequently asked questions 27 Trouble shooting 30 Specifications 34 Appendix A Remote Control instructions 37 Intended use 38 Before...

Page 4: ...This device should only be charged using the USB Cable provided Do not operate in close proximity e g 3 4 feet to a shortwave or microwave unit as other Electromagnetic equipment may produce instabili...

Page 5: ...n 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 When charging the device keep away from all liquids...

Page 6: ...have not been established PRECAUTIONS Consult your Doctor Dentist if you have gum disease or have bleeding from your gums you experience pain numbness or bleeding after using this product you have any...

Page 7: ...7 SNOOZEAL PACKAGE INCLUDES WHAT S IN THE BOX 1 MOUTHPIECE TOP VIEW FLEXIBLE SILICONE Electrodes USB C type connector Fig 1...

Page 8: ...8 2 CONTROL UNIT WITH BLUETOOTH Fig 2 USB C type connector 3 USB CABLE 15 CM CABLE CONNECT TO APPROPRIATELY APPROVED ADAPTER WITH 5 VDC MIN 0 5AMP OUTPUT Fig 3 LED light under the Logo...

Page 9: ...to Appendix A page 37 for additional instructions Fig 4 Power On Off Therapy Start Abort Therapy intensity level Bluetooth Pair Pause Restart therapy Intensity up Therapy time Intensity down Screen lo...

Page 10: ...sleep apnoea by strengthening tongue muscles via electrical muscle stimulation INDICATIONS FOR USE Snoozeal is indicated for use to reduce snoring and mild sleep apnoea AHI 15 for patients that are 18...

Page 11: ...whether you already have a Snoozeal device or not 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...

Page 12: ...use a pacemaker and that you are not pregnant It is very important that none of these apply to you as the Snoozeal device can interfere with your pacemaker or with your baby s development Also you hav...

Page 13: ...13 DASHBOARD Settings The dashboard is the main screen of the app where all the features are available from Sleep statistics Sleep tracking Snoozeal treatment Educational content Articles...

Page 14: ...acked 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 wa...

Page 15: ...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: ...13 or above you need to manually allow Bluetooth permission MY SNOOZEAL PHONE APPLICATION Before starting your treatment be sure to check your device for cracks or broken parts connect the controller...

Page 17: ...NNECT REMOTE CONTROL Indicates the device battery status Indicates if the device is connected to the phone Indicates the remaning time of the treatment Pauses the treatment Stops the treatment Treatme...

Page 18: ...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 reasons it can only be restarted after 30 minutes after the d...

Page 19: ...ed and can only be restarted after 30 minutes END OF THERAPY SESSION 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...

Page 20: ...ded to replace the Mouthpiece after three months of first use Before using the device for the first time you must charge the battery for at least 2 hours The Control Unit LED will flash blue and amber...

Page 21: ...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...

Page 22: ...cohol 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 t...

Page 23: ...Swipe to stop the recording FACTORS SLEEP TRACKING 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...

Page 24: ...levels and perceived sleep quality SET UP REMINDER In order to see a better overview of your sleep patterns over time it is important to track your sleep in a regularly Therefore you can set up a dai...

Page 25: ...dit 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...

Page 26: ...ing 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 NOTIFICATIONS Change the time of your notifications Enable or disab...

Page 27: ...hich makes the snoring sound You re more likely to snore if you are overweight smoke drink too much alcohol sleep on your back Is snoring dangerous It has been shown that Snoring a ects sleep quality...

Page 28: ...e 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...

Page 29: ...l increase and you can go up in intensity comfortably It is important to avoid increasing the intensity to beyond comfortable level as higher intensity will not lead to additional improvement What sho...

Page 30: ...emote Control If the above steps have been implemented then contact the Snoozeal s Help Support team Check the Control Unit has adequate power to run a 20 minutes therapy session Ensure the Remote Con...

Page 31: ...5 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...

Page 32: ...ship for a period of 3 months for the Mouthpiece and 1 year Control Unit and Remote Control only from the date of purchase For valid warranty claims the user may return after authorization the Signifi...

Page 33: ...r to instructions manual Catalogue number Serial number Manufacturer Date of manufacture Storage Temperature Limits Keep dry Non Sterile Type BF applied part WEEE directive SYMBOLS USED 13 F 25 C 158...

Page 34: ...y and Black Snoozeal is packed in a protective box package White and Grey Remote Control if your box included a Remote Control Mouthpiece Control Unit Color Packaging Power source Max output voltage M...

Page 35: ...lds from RF wireless communications equipment 385 MHz 27 V m 450 MHz 28 V m 710 745 780 MHz 9 V m 810 870 930 MHz 28 V m 1720 1845 1970 2450 MHz 28 V m 5240 5500 5785 MHz 9 V m IEC EN 61000 4 4 Immuni...

Page 36: ...ased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including peripherals such as antenna cable...

Page 37: ...37 REMOTE CONTROL INSTRUCTIONS if your box included a Remote Control APPENDIX A...

Page 38: ...charged Control Unit Press the Power on off button on Remote Control Press the and arrow on the Remote Control simultaneously for three seconds The blue LED on the Remote Control and the Snoozeal logo...

Page 39: ...otable tap water as shown in Fig 12 Avoid water reaching the USB port Dry with clean towel Follow instruction on washing 3 Connect the Control Unit and Mouthpiece as shown in Fig 13 4 Ensure your Cont...

Page 40: ...40 Fig 14 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...

Page 41: ...therapy session 9 To adjust the intensity of the therapy on the remote press the to increase intensity press to decrease intensity Keep increasing the intensity until you feel the contraction of the...

Page 42: ...e You are recommended to replace the Mouthpiece three months after first use 11 Pause therapy Press P button to pause Restart therapy Press P button again to restart If the therapy is paused for more...

Page 43: ...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 b...

Page 44: ...its original packaging to protect during transportation Install each battery with the positive and negative terminals properly aligned with the corresponding symbols in the battery compartment Imprope...

Page 45: ...things that can be done that will help to fix the issues 1 Ensure there are no battery low warnings and replace batteries if required 2 Ensure the controller in within 1 metre of the remote power off...

Page 46: ...ror then please contact Signifier Medical Technologies Do not use the product and contact Signifier Medical Technologies Any code not mentioned above and with a General Error Icon contact Signifier Me...

Page 47: ...g instructions for satisfying RF exposure compliance This transmitter must not be co located or operating in conjunction with any other antenna or transmitter Changes or modi cations not expressly app...

Page 48: ...anufactured by Signifier Medical Technologies in compliance with Medical Device Standards and Quality Standards ISO 13485 2016 Signifier Medical Technologies Limited 150 Aldersgate Street London EC1A...

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Page 52: ...045300001 dated 18 December 2019 1282...

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