Sana Beta User manual

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

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
2 of 24
INSTRUCTIONS FOR USE ....................................................................................................................................1
PURPOSE OF THIS DOCUMENT..........................................................................................................................2
INTENDED USE...................................................................................................................................................... 3
DEVICE DESCRIPTION ......................................................................................................................................... 3
PACK CONTENTS ...................................................................................................................................................4
CONTRAINDICATIONS..............................................................................................................................................4
GENERAL WARNINGS AND PRECAUTIONS .................................................................................................................5
INTENDED USERS...................................................................................................................................................5
RISKS AND BENEFITS..............................................................................................................................................5
PROPER USE AND USE SITUATIONS 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 WORKS ....................................................................................................................................................18
FREQUENTLY ASKED QUESTIONS..........................................................................................................................19
MANUFACTURING INFORMATION....................................................................................................................20
TECHNICAL INFORMATION.....................................................................................................................................20
ELECTROMAGNETIC COMPATIBILITY.......................................................................................................................20
DEFINITION OF SYMBOLS......................................................................................................................................23
REFERENCES.......................................................................................................................................................24
PURPOSE OF THIS DOCUMENT

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
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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. Please read this document carefully before using the Sana device and refer back to it as
needed.
INTENDED USE
The Sana device is intended for use to enhance rest and relaxation in healthy adults.
This may include such uses as:
To clear a busy mind
To support enhanced rest and relaxation
To improve sleep management
To reduce feelings of stress
To enhance recovery from fatigue
Note: The Sana Device is not approved by the FDA for the treatment of any specific medical condition.
DEVICE DESCRIPTION
The Sana Device is a simple mask and headphones you wear on your head. The device 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 Visual Stimulation (AVS), a form of
neurofeedback. This is a form of drug-free intervention that has been used for both performance enhancement
and fatigue management for decades and has been shown to be safe and effective.
The Sana device contains a sensor that contacts gently to your forehead to measure your heart rate variability
(HRV). This is used by The Sana device algorithm. Heart rate variability measures your state of relaxation.
The Sana device is physically comprised of a rigid outer layer that sits furthest from your head, which provides
the structure for the device and shuts out most of the ambient light. On the inside of the device, sitting against
your skin, is a soft, non-allergenic formed foam that provides comfort and excludes external stimuli during
treatment. The HRV sensor is also mounted on this inner surface. Between the structural outer part and the soft

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
4 of 24
inner layer is mounted circuitry and components to store and run the program, and the necessary lights and
sound required to deliver it. 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. The Sana device is supplied with a standard micro-USB cable, which can be
plugged into a normal 110V outlet connection to enable re-charging.
PACK CONTENTS
Your Sana device will be supplied pre-packaged in a re-usable carrying case. The case will contain:
•One Sana with head-strap pre-fitted
•One charger (Micro USB, max 5V; 1.2A output). Only use supplied charger to charge device.
•One information card –please 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
•Pregnant women
•Persons with a history or presence of photo-sensitive epilepsy or other light-sensitive
conditions
•Persons with a history or presence of condition(s) that may affect balance, such as seizure disorders,
tinnitus or vertigo
•Persons who are visually or hearing impaired (deaf), including those with a significant difference in
hearing between ears or sight between eyes
oUse of the device by persons with colorblindness is permitted provided the perception of color is
reasonably even in both eyes
•Not to be used if the skin around the eyes in the area of the device is broken or inflamed. Should
irritation occur based on contact of skin to the Sana device, discontinue use and seek advice from a
healthcare professional.

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
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GENERAL WARNINGS AND PRECAUTIONS
•WARNING: Do not use device when in a situation where lack of normal
vision and hearing may be unsafe, such as driving or walking
•WARNING: Do not wrap headphones around neck –choking hazard
•WARNING: Do not use device when charging. Always disconnect the
device from the charger before use
•WARNING: No modification of this equipment is allowed
•CAUTION: Keep Dry
•CAUTION: Use both headphone earbuds for maximum therapeutic effect
•CAUTION: Do not disassemble the device
•CAUTION: To prevent possible hearing damage, do not listen at high volume levels
for long periods.
•CAUTION: Use of the device may make you drowsy. Avoid driving or operating machinery immediately
after use until you understand how the device affects you. Use of alcohol or other substances that may
affect concentration may increase drowsiness. Avoid or limit alcohol or use of substances known to
impede function when using the device. Consult your physician before using this device with
prescription drugs that may impact 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 been
identified. If you have concerns about the safety of the device, or you feel unwell during or after use, you should
discontinue use immediately and contact Sana Customer Success at 720-310-3370 or s[email protected].
Stopping use of the Sana device mid-way through a therapy session has no known risks. You should stop using
the device immediately if you are concerned or feel unwell; you do not need to wait for the session to end.
During a session, you should expect to see pulses of amber light through your closed eyelids and hear pulses of
sound through the headphones. The speed, patterns and sequence of these pulses of light and sound will vary
through the 16-min program. The program starts relatively fast and then progressively slows through the 16
minutes.
Some people feel relief on first use, while others require up to 5 session until your brain patterns get used to the
device audio-visual inputs. This is quite normal, and each individual varies. During this training process, the

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
6 of 24
brain will often optimize balance, hearing and visual processes - this can feel a little unsettling, a bit like stepping
off a boat onto dry land. This is normal, and by the fifth use should have gone away. If at any point it feels too
much, or if these feelings don’t go away, please discontinue use and contact Sana Customer Success for
advice.
The soft cushion that sits against your face is made of fabric-covered polyurethane foam in regular use in
consumer electronics and wearable devices. It is very unlikely that you will have any reaction to this material,
but if you do; discontinue use and contact Sana Customer Success.
The sound is delivered through headphones. You may use the ones supplied or your own. You can adjust the
volume. The maximum sound level is limited to 60dB (maximum normally available through commercial
earphones), which is well within levels that are normally considered safe to your hearing.
The light is transmitted at low frequency (0.5Hz –10Hz). The maximum intensity of light is around 35LUX
(similar to the very edge of a candle flame). You can adjust how bright the light is. By contrast a bright summer
day can exceed 32,000LUX. Vision damage from bright lights is complex and cannot be easily assigned a value
of LUX, but generally intensities of less than 5,000 LUX are considered very low risk of causing damage to your
eye.
The device is manufactured in the USA.
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. 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 relax and
potentially fall asleep. Please do take the time to adjust the device and your position for comfort and relaxation.
We advise you to be in a quiet place of rest, such as a comfortable chair or your bed, ideally reclined to at least
30-degrees and with your head and neck supported…. Anywhere you might normally go to take a nap.
You may use the device as often as you like. We recommend that you use the device any time you feel overly
fatigued.
The device also helps relax you towards sleep. Sleep is very important to all of us. We recommend you use the
device in bed each night right before you want to go to sleep. If you wake in the night, you may use the device to
help you get back to sleep.
WARNING: Do not use device when in a situation where lack of normal vision and hearing may be
unsafe, such as driving or walking
WARNING: Do not wrap headphones around neck –choking hazard
CAUTION: To prevent possible hearing damage, do not listen at high volume levels for long periods.
CAUTION: Use of the device may make you drowsy. Avoid driving or operating machinery immediately after use
until you understand how the device affects you. Use of alcohol or other substances that may affect
concentration may increase drowsiness. Avoid or limit alcohol or use of substances known to impede function
when using the device. Consult your physician before using this device with prescription drugs that may impact
concentration or balance.

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
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EXPECTED OUTCOMES FROM USE OF THE DEVICE
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.
Expected benefits include improved sleep management, calmer thoughts, with a quieter mind, enhanced rest
and ability to relax, reduction in feeling of stress and enhanced ability to recover from fatigue.
You should see benefit within the first few uses of the device. The effects may last longer and be more effective
over time, so continued and 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 hPa to 1060 hPa
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. You may use the headphones supplied or your own, pick a set
that is most comfortable to you; in-ear or over-ear are both appropriate, but the headphones must be plug-in
(not cordless Bluetooth). Keep the chargers (and the headphones you want to use) in the case with the device
so they don’t get lost.
CAUTION: Keep Dry

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
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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.
To charge the device, plug the provided micro-
USB connector into the port on the bottom of the
device and plug into any normal electrical outlet.
Charging can take up to 4 hours. Only use
supplied charger to charge device, to avoid
possible harm to the device.
When the device is charging, the lenses will
illuminate blue. When fully 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 use the device, attach
your headphones and slide the power
switch on the bottom of the device to the
ON position. The lenses will briefly
illuminate amber to indicate that the
device is on. This is the time to put both
headphone earbuds in your ears, put the
device on and prepare for the 16-minute
therapy.
Refer to the instructions below to start the
session using the Sana Relief app.
At the end of therapy, the light and sound will turn off. You can turn the device off at any time by sliding the
power switch to the OFF position.

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
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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.
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 account, the app will guide you through 4 more set up steps, which will help you
understand further your Sana Device.

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
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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.