Summary of Contents for Sana Beta
-
Page 1: Instructions For Use
INSTRUCTIONS FOR USE Address 130 Miners Drive, Suite 101 Sana Health Inc. info@sana.io Email Lafayette, CO 80026 eIFU Document # PRT-0081 www.sana.io United States Released: May 13, 2020... -
Page 2: Table Of Contents
LECTROMAGNETIC COMPATIBILITY ............................23 EFINITION OF YMBOLS ............................... 24 EFERENCES PURPOSE OF THIS DOCUMENT Address 130 Miners Drive, Suite 101 Sana Health Inc. info@sana.io Email Lafayette, CO 80026 eIFU Document # PRT-0081 www.sana.io United States Released: May 13, 2020 2 of 24... -
Page 3: Intended Use
This document is intended to help new users of the Sana device to understand the device, how to use it safely and to provide other information that may be helpful to gain the most benefit from the device. It contains important information on who should use the device, how and when it should be used and what to expect during use. -
Page 4: Pack Contents
The Sana device is controlled by an ‘app’, allowing you to log your progress. The app connects to the device via standard Bluetooth connection. Finally, the device contains a small rechargeable battery used to power the device. -
Page 5: General Warnings And Precautions
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. -
Page 6: Proper Use And Use Situations For The Device
PROPER USE AND USE SITUATIONS FOR THE DEVICE The Sana device is intended 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. -
Page 7: Expected Outcomes From Use Of The Device
FIRST USE The Sana device will come packaged in a re-usable soft case with an outer label. You can remove the label, but please keep the case to store the device. Please check the device is not damaged and the case contains one device, one set of headphones and one charger. -
Page 8: Charging
CHARGING The Sana device contains a rechargeable battery. You will need to re-charge the device when it is not in use. The battery will store enough charge for 2 to 3 days of normal use, but we recommend you keep it charged up. -
Page 9: Connecting To The App
CONNECTING TO THE APP The first step to set up your app is to download it; the Sana Relief App can be downloaded for Android from the Play Store app, and iOS devices from the Apple Store app. Once downloaded access the app from you home screen. - Page 10 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.
-
Page 11: Starting The Device With The App
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. - Page 12 You will see the Relief screen, place your Sana Device 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.
-
Page 13: Adjusting Fit
ADJUSTING FIT The Sana device should be comfortable to wear. Please get into your chosen location for therapy and put the device on. Adjust the strap and position so the device fits snugly but comfortably to your face and shuts out the majority of ambient light. -
Page 14: Adjusting Volume
ADJUSTING VOLUME When using the Sana device, you should connect your headphones to the audio-jack located on the bottom of the device near the charging port. You can use the headphones supplied or your own. The volume should be loud enough for you to clearly hear the supplied tones but should not be so loud to be uncomfortable. -
Page 15: Other Features Of The 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. -
Page 16: Cleaning
For more information you can always access your “More” tab. In here you can learn more about your Sana Device, contact our support team with any questions or problems, see the instructional video on how to use your device, and modify any account and password information. -
Page 17: Storage And Transport
STORAGE AND TRANSPORT When not in use or charging, the Sana device and its accessories should be stored in the reusable case provided. Keep device and accessories out of reach of children and pets. Disconnect headphones prior to storage to avoid damaging the device. -
Page 18: Device Return & Disposal
Sana is engaged in clinical trials to investigate use of the device for various conditions. This work is ongoing. The Sana Device is not FDA approved for use in the treatment of any clinical condition, and is intended only for use in the management of rest and recovery in healthy individuals at this time. -
Page 19: Frequently Asked Questions
(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. -
Page 20: Manufacturing Information
*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. IP21 Ingress protection... - Page 21 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 Sana device Beta Device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
- Page 22 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.
-
Page 23: Definition Of Symbols
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. -
Page 24: References
• Sana Health Quality Manual, Document QM-001 (available on request) • “The Sana Device: A Non-Invasive Treatment for Pain”, R. Hanbury, MBA, Sana Health Founder and Sana Device Inventor, 2019 • EN 50332-1:2013: Sound system equipment: Headphones and earphones associated with personal music players - Maximum sound pressure level measurement methodology - Part 1: General method for "one package equipment"...