Address 130 Miners Drive, Suite 101
Lafayette, CO 80026 United States
Sana Health Inc.
eIFU Document # PRT-0081
Released: May 13, 2020
[email protected]
www.sana.io
Email Web
INSTRUCTIONS FOR USE
Страница 1: ...Address 130 Miners Drive Suite 101 Lafayette CO 80026 United States Sana Health Inc eIFU Document PRT 0081 Released May 13 2020 info sana io www sana io Email Web INSTRUCTIONS FOR USE ...
Страница 2: ...TUATIONS FOR THE DEVICE 6 EXPECTED OUTCOMES FROM USE OF THE DEVICE 7 OPERATING INSTRUCTIONS 7 FIRST USE 7 CHARGING 8 TURNING ON OFF 8 CONNECTING TO THE APP 9 STARTING THE DEVICE WITH THE APP 10 ADJUSTING FIT 13 ADJUSTING BRIGHTNESS 13 ADJUSTING VOLUME 14 OTHER FEATURES OF THE APP 14 CLEANING 16 STORAGE AND TRANSPORT 17 FAULT CONDITIONS 17 DEVICE RETURN DISPOSAL 18 ADDITIONAL INFORMATION 18 HOW IT ...
Страница 3: ...evice uses audio visual stimulation to increase balance between the left and right side of your brain leading to greater relaxation Ongoing use of your Sana mask resembles the effect of long term meditative practices which leads to a more restful state overall Sana can clear a busy mind and accelerate mental and physical recovery The underlying mechanism of action for the Sana device is Audio Visu...
Страница 4: ...ease keep this for refernece One Quick Start Guide One set of headphones with standard plug in jack You may use your own headphones or the ones supplied Cordless Bluetooth headphones cannot be used You will also need to download the Sana Relief app Google Play Android or iTunes App Store Apple and register your account CONTRAINDICATIONS This device is not for use by Persons under the age of 18 Pre...
Страница 5: ...concentration or balance INTENDED USERS The Sana device is intended for use by generally healthy adults who wish to improve their ability to rest relax or improve their sleep habits The Sana device is intended for use at home or when traveling such as on airplanes and hotel rooms RISKS AND BENEFITS The Sana device has been in development for over twenty 20 years and no known serious risks have bee...
Страница 6: ...to be comfortable to wear and should be used in a place where you feel relaxed and at ease Use the device in a comfortable location where you can safely have both hearing and sight interrupted such as a lounge chair or your bed You should remove eye glasses and other bulky headwear prior to using the device The device may make you sleepy so make sure the location is comfortable and safe for you to...
Страница 7: ...regular use of the device is important We recommend 1 2 uses per day as part of your normal routine more as needed including one use as you go to sleep at night OPERATING INSTRUCTIONS A video showing you how to use the device can be found here https www sana io instructions sana device Operating Conditions Temperature 5 C to 40 C Relative Humidity 15 to 90 non condensing Atmospheric Pressure 700 h...
Страница 8: ... charged the blue lights will turn off To stop charging simply pull the connector out of the device WARNING Do not use device when charging Always disconnect the device from the charger before use NOTE if the device needs to charge but you want to conduct a therapy session charging for approximately 15 minutes will provide enough battery life for a single session TURNING ON OFF When you want to us...
Страница 9: ...ore app and iOS devices from the Apple Store app Once downloaded access the app from you home screen In order to use the Sana Relief App for the first time you must create a Sana account Select the Sign Up option from the screen and complete with the required information After completing this step make sure to verify your account with the code sent to the email you provided After setting up your a...
Страница 10: ...20 info sana io www sana io Email Web 10 of 24 The first step to use your Sana Device is to connect it to the App On the Home screen select the Connect to your Sana Device Option Make sure that the Mask is charged see Charging section and that the Bluetooth is enabled on your phone Follow the direction from the app to connect ...
Страница 11: ...y 13 2020 info sana io www sana io Email Web 11 of 24 STARTING THE DEVICE WITH THE APP Once the Sana Device is connected to the My Relief App you are ready to start your relief Select the Start your Relief option on your My Relief tab Once prompted add your current Sleep Pain and Mood state optional and click continue ...
Страница 12: ...and headphones as explained on previous steps When ready Click the Play button you will have 5 seconds to place the Sana Device in position to start the session You can stop the session at any point by clicking the STOP symbol on the screen If you decide to Stop mid session or at the end of the session you will have the option to save or discard the session It is recommended to save the session to...
Страница 13: ... adjustment so you can adjust the fit to be most comfortable ADJUSTING BRIGHTNESS The device works best when your eyes are closed and you can see light through your closed eyes The minimum level should be such that you can see the light levels change when you have your eyes closed the maximum is whatever is still comfortable adjust to what feels comfortable and good to you some people like it just...
Страница 14: ...ons on the top of the device You will find them with your left hand when you are wearing the device The button nearest your ear turns the volume down the one nearest the center of your forehead turns the volume up Press and hold to adjust volume level quickly Press and release for fine adjustment CAUTION Use both headphone earbuds for maximum therapeutic effect NOTE Some headphones are labelled fo...
Страница 15: ... APP The My Relief App comes with various functionalities to help you track your progress and understand more about your Sana Device The first and main source of information about your progress can be found on your Me tab By clicking here you will see details of your daily usage your Sleep Mood and Pain average over time and a graphic representation of the changes of your sleep mood and pain ...
Страница 16: ...g wipes cleaning chemicals or excessive water Use only water Take care not to use any abrasive material especially on the lenses of the device to avoid scratching CAUTION Keep Dry As needed the foam part that sits against the face may be carefully removed from the device for cleaning It is held onto the device using Velcro fastening and may be simply peeled off the inside of the device Once remove...
Страница 17: ...ge to avoid damaging the device We recommend you keep the device charged so it has sufficient battery life for therapy when you need it please refer to section charging on p8 The case is appropriate both for storage and transport of the device including for air travel For international use a power adaptor may be required to allow re charging of the device headphones and tablet Use of the device do...
Страница 18: ...his flow state This is the technology built into the Sana device and has been developed in conjunction with multiple pain management facilities sleep management facilities military organizations and elite sports teams During development the Sana device has been used by over 1 300 users No device related adverse events have been reported Sana is engaged in clinical trials to investigate use of the ...
Страница 19: ...daydreams dissociation from external stimulation Ongoing use of your Sana device resembles the effect of long term meditative practices which leads to a more restful state overall Sana can clear a busy mind and accelerate mental and physical recovery FREQUENTLY ASKED QUESTIONS Frequently asked questions and a reminder of the operating instructions in this document can be found on the FAQs option u...
Страница 20: ...FU document number PRT 0081 Revision 01 dated May 13 2020 Date reflects authoring date controlled copy per Sana Health Quality Management System effective date per system release TECHNICAL INFORMATION Model Sana Beta Per IEC 60601 1 2005 Ed 3 A1 C1 2014 the Sana device in its entirety is considered a Type BF applied part Ingress protection IP21 ELECTROMAGNETIC COMPATIBILITY The Sana device conform...
Страница 21: ... Complies Guidance and Manufacturer s Declaration Immunity The Sana device is intended for use in the electromagnetic environment specified below The customer or user of the Sana device should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000 4 2 8kV Contact 15kV Air 8kV Contact 15kV Air Floors shoul...
Страница 22: ...21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz and 50 0 MHz to 54 0 MHz Guidance and Manufacturer s Declaration Immunity to RF wireless communication equipment The Sana device is intended for use in the electromagnetic environment specified below The customer or user of the Sana device should ensure that it is used in such an environment Test Frequency Band Service Modulation Maximum Power D...
Страница 23: ...used in such an environment For some services only the uplink frequencies are included The carrier shall be modulated using a 50 duty cycle square wave signal As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not represent actual modulation it would be worst case DEFINITION OF SYMBOLS Caution Per ISO15223 1 2016 E Keep Dry Per ISO15223 1 2016 E Possi...
Страница 24: ...n 2017 03 ISO 15223 2 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 2 Symbol development selection and validation FDA guidance on Medical Device Labeling Final guidance for Industry and FDA reviewers Document issued April 19 2001 Sana Health Quality Manual Document QM 001 available on request The Sana Device A Non Invasive Treatment for...
