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Physician Guide

IMPORTANT SAFEGUARDS:

READ ALL INSTRUCTIONS BEFORE USE

Содержание eXciteOSA

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

Страница 2: ...n 15 Frequency of usage 20 Charging the Control Unit 20 Storing traveling with your eXciteOSA 21 Washing 21 Software updates 21 Settings 22 Frequently asked questions 24 Troubleshooting 26 Cybersecurity 27 eXciteOSA system operational requirements 29 eXciteOSA system transport and storage requirements 29 Symbols used 31 Specifications 32 Declarations 35 Table A Representative output with varying l...

Страница 3: ...e g 3 4 feet to a shortwave or microwave unit as other Electromagnetic equipment may produce instability in the simulator output Always keep the Control Unit away from water Unplug the Control Unit immediately if it falls into water Never use a damaged USB Cable to charge the Control Unit Recharge the battery using only the USB power cord with a UL certified USB wall charger not provided This prod...

Страница 4: ...erson 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 When charging the device keep away from all liquids No modification of this device is allowed Do not try to alter trim or change any components of the device The silicone on the Mouthpiece must be intact before use If there is any breach of the s...

Страница 5: ...al examination prior to using this device to rule out cavities dental implants metal prosthesis metal braces dental appliances and intraoral metallic jewelry piercings Patients should maintain regular follow up visits with a Dentist and Sleep Health Professional Patients should follow up with their sleep health clinician for a repeat Home Sleep Apnea Test after three months of therapy CLINICAL SUM...

Страница 6: ...disease or have bleeding from your gums or other oral conditions experience pain numbness or bleeding after using this product have any medical concerns This device should not be used while asleep the device should only be used when awake in contact with your head neck spine chest eyes ears or any other parts of the body other than inside the mouth as instructed the device has not been tested for ...

Страница 7: ...7 Mouthpiece Top view Electrodes Flexible silicone USB C type connector Fig 1 What s in the box eXciteOSA package includes 1 ...

Страница 8: ...8 2 3 Control Unit With Bluetooth USB Cable 15 cm cable connect to UL Certified USB wall charger not provided with 5 VDC Min 0 5 AMP output USB C type connector LED light under the logo Fig 2 Fig 3 ...

Страница 9: ...oth Smart mobile devices used must be compatible with Bluetooth Smart eXciteOSA device can be controlled by eXciteOSA Smartphone application Smartphone application can be downloaded from App Store Apple iOS or Play Store Google Android The log in sign up section allows you to authenticate or create an account Enter the e mail you want to register with Enter a secure password minimum 6 characters I...

Страница 10: ... 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 Select whether you already have a eXciteOSA device or not If you choose yes additional setup is required PROFILE SET UP ...

Страница 11: ...not pregnant It is very important that none of these apply to you as the eXciteOSA device can interfere with your pacemaker or with your baby s development Also you must be 18 years of age or older POLICY Enter your registered e mail and password If you forgot your password tap here You will receive an e mail with further instructions You can log in with one of these services this will require aut...

Страница 12: ...12 The dashboard is the main screen of the app where all the features are available from THE DASHBOARD Settings eXciteOSA therapy Educational content ...

Страница 13: ...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 Before use wash the Mouthpiece with cold and running tap water as shown in Fig 4 Avoid water reaching the USB port Dry with clean towel Fig 4 ...

Страница 14: ...t the Mouthpiece with the Control Unit as shown on Fig 5 Insert the Mouthpiece into the mouth and allow it to sit around the tongue as shown in Fig 6 and gently close your mouth Avoid grinding or clenching the Mouthpiece Fig 5 Figure 6 ...

Страница 15: ... device Before starting your therapy be sure to check your device for cracks or broken parts connect the controller to the mouthpiece insert the mouthpiece into the mouth Add a eXciteOSA device make sure that the device is nearby In order for the eXciteOSA device to work you need to allow Bluetooth connection For iOS 13 or above you need to manually allow Bluetooth permission ...

Страница 16: ...device to give off a different frequency The frequencies will not exceed 20 Hz Therapy Level Guide Therapy levels can be changed using the arrow buttons on the app THERAPY LEVEL RANGES POTENTIAL THERAPY LEVEL PATHS WEEK 1 WEEK 2 WEEK 3 WEEK 4 WEEK 5 WEEK 6 FOR A LOWER TOLERANCE PATIENT 1 TO 3 3 TO 4 4 TO 5 4 TO 5 5 TO 6 6 TO 7 FOR A MEDIUM TOLERANCE PATIENT 3 TO 5 6 TO 8 9 TO 10 11 TO 12 11 TO 12 ...

Страница 17: ...ime of the therapy Pauses the therapy Stops the therapy To change your therapy level simply slide the level setting at the bottom of your screen during your session It is important to set the device to the highest possible therapy level that still feels comfortable for you This will ensure the best possible outcome If therapy becomes painful or uncomfortable simply remove the mouthpiece or lower t...

Страница 18: ...h a countdown from 3 to 1 before initiating the actual 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 Keep this in mind when stopping the therapy COUNTDOWN STOP THERAPY ...

Страница 19: ...ly be restarted after 30 minutes 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 You can set a reminder at a specific time each day so that you don t miss your therapy PAUSE THERAPY END OF THERAPY SESSION SET A REMINDER ...

Страница 20: ...place the Mouthpiece after three months of first use which includes the maintenance period Charging the control unit 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 if there is inadequate charge to run a full 20 minute therapy session When Control Unit logo Fig 8 blinks blue and amber recharge the Control Un...

Страница 21: ...cohol based cleaning solutions The app will notify you of any necessary software updates Please follow the instruction on the app 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 Wipe the Control Unit surface wi...

Страница 22: ... 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 Conditions can be found here Delete your account here Log out of your account ...

Страница 23: ... the device Describe the problem and let us know We ll try to solve it and take the appropriate measures Check the Frequented Asked Questions for further information Change the time of your notifications Enable or disable them so that you can have a smoother experience SEE EDIT PROFILE REPORT A PROBLEM FAQ NOTIFICATIONS ...

Страница 24: ...ght accumulation of saliva during their first few uses How should the mouthpiece fit in my mouth Two tabs of the mouthpiece should sit comfortably above and below the tongue The mouthpiece is designed such that when you gently close your mouth it will naturally sit around your tongue and won t move during your therapy session Please do not bite down on the mouthpiece as this may cause damage to th...

Страница 25: ...ot 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 Although you may see improvement within 4 weeks we recommend you finish the 6 week therapy period to ensure you gain the optimal improvement possible How ...

Страница 26: ...20 minutes therapy session 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 eXciteOSA s Help Support team by emailing support signifiermedical com or calling 1 844 MildOSA ...

Страница 27: ...l data less secure The following best practices may help keep your personal information safer Don t use the same password for multiple accounts especially for the most sensitive ones such as bank accounts credit cards legal or tax records and files containing medical information Otherwise someone with access to one of your accounts may end up with access to many others Don t use passwords that can...

Страница 28: ...developers Android users should always use the Google Play Store rather than other third party app shops Avoid suspicious links phishing and robocalls Be suspicious of questionable downloads in an email from a friend robocalls urging prompt action on a past due account or any automated process asking you to update verify your account or other personal information Don t fall prey to tricky pop ups ...

Страница 29: ...Humidity 15 to 90 Atmospheric Pressure 10 15 psi to 15 37 psi 70 kPa to 106 kPa Operational life is 3 years 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 When the device is exposed to extreme temperatures please wait at least 60 minutes before attempting to use the device ...

Страница 30: ...erial components and workmanship for a period of 3 months for the Mouthpiece and 1 year Control Unit only from the date of purchase For valid warranty claims the user may return after authorization the eXciteOSA directly to the local eXciteOSA contact or Signifier Medical Technologies LLC eXciteOSA warranty does not include any misuse or abuse such as dropping or immersing the Control Unit in wate...

Страница 31: ...ls used Catalogue number Keep dry Manufacturer Type BF applied part USB C Serial number Non Sterile Refer to instructions manual Storage Temperature Limits 13 F 25 C 158 F 70 C Date of manufacture WEE directive ...

Страница 32: ...Operating temperature From 41 F to 104 F 5 C to 40 C Storage temperature 13 F to 158 F 25 C to 70 C Atmospheric Pressure Range 10 15 psi to 15 37 psi 70 kPa to 106 kPa Humidity Relative Humidity 20 to 85 Relative Humidity up to 100 Degree of Protection Control Unit IP44 IP 44 Protection protected against objects 1 ml and splashing water IP42 Protection protected against objects 1 ml and dripping w...

Страница 33: ... Air 2 4 8 15kV Contact 8kV IEC EN 61000 4 3 Immunity Radiated RF Immunity 10 V m 80 MHz to 2 7 GHz 3 V m 2 7 GHz to 6 GHz IEC EN 61000 4 3 IEC EN 61000 4 39 Immunity Immunity to Proximity fields from RF wireless communications equipment 385 MHz 450 MHz 710 745 780 MHz 810 870 930 MHz 1720 1845 1970 2450 MHz 5240 5500 5785 MHz 27 V m 28 V m 9 V m 28 V m 28 V m 9 V m IEC EN 61000 4 4 Immunity Elect...

Страница 34: ...ased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the eXciteOSA System including cables specified by the manufacturer Otherwise degradation of the performance of thi...

Страница 35: ...ting 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 modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment FOR CANADA This device complies with Industry Canada s licence exempt RSSs Operation is subje...

Страница 36: ...nifiermedical 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 ...

Страница 37: ...34 1 34 3 96 2 4 6 5 11 3 46 6 92 2 59 7 66 3 6 7 7 44 5 31 10 62 3 74 11 07 4 8 06 8 96 6 91 13 82 5 6 16 57 5 10 9 12 11 9 1 18 2 6 6 19 53 6 12 6 14 10 7 21 4 7 8 23 08 7 14 7 16 33 12 3 24 6 9 1 26 92 8 17 3 19 22 14 1 28 2 10 4 30 77 9 19 5 21 67 17 9 35 8 11 4 33 73 10 21 4 23 78 20 2 40 4 12 5 36 98 11 23 4 26 21 8 43 6 13 8 40 83 12 25 3 28 11 23 7 47 4 15 2 44 97 13 27 2 30 22 25 50 16 5 ...

Страница 38: ...rth 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 1282 ...

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