Sana Beta User manual

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130 Miners Drive, Suite 101
Lafayette, CO 80026
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Sana Health Inc.
eIFU Document # PRT-0081
Released: May 13, 2020
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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
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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

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eIFU Document # PRT-0081
Released: May 13, 2020
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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

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eIFU Document # PRT-0081
Released: May 13, 2020
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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.

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eIFU Document # PRT-0081
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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

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eIFU Document # PRT-0081
Released: May 13, 2020
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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.

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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

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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.

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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.

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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.

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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.

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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. It is recommended
to save the session to see your progress over time.

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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. The device does not need to be so tight to cause discomfort but should feel snug and
secure. You should remove eye-glasses and other bulky headwear prior to using the device. We recommend
you connect the headphones to the device before you turn it on. Please also take the time to fit the headphones
for your comfort. You can use the ones supplied or your own. Most headphones, including the ones supplied,
come with a range of earbud sizes and means of 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 visible through closed
eyes, some people like it super bright
(especially when in pain) so test at
different levels and see what feels best
to you.
To adjust the light level, use the buttons on the top of the device. You will find them with your right hand when
you are wearing the device. The button nearest your ear turns the brightness down, the one nearest the center
of your forehead turns the brightness up. Press and hold to adjust light level quickly. Press and release for fine
adjustment.
Feel free to adjust the light levels between sessions, and within sessions to be comfortable. For example, you
will likely need a lower light level setting at night than in the middle of the day.

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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.
To adjust the sound level, use the buttons 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 for Left (L) and Right (R) ears; be sure to place
correct earbuds in correct ears for best results
CAUTION: To prevent possible hearing damage, do not listen at high volume levels for long
periods.
We recommend using noise cancelling headphones, but they are not essential. Most noise cancelling
headphones will need to be re-charged when not in use.

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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.

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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.
CLEANING
As needed, the hard plastic parts of the Sana device may be cleaned with a soft cloth dampened
with water. Do not use cleaning 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
removed, the foam may be gently hand washed with water. Hand-wash detergent may be used if needed but
should be fully and thoroughly rinsed from the foam. Do not use excess water; avoid fully soaking the foam
part. Press the foam part between absorbent surfaces (such as a towel) to remove excess water after cleaning
and lie flat to air dry fully before being re-fitted to the device.

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•Only use the foam provided with the device
•Do not use the device without the foam fitted
•Do not use harsh cleaning chemicals to wash the foam, use only a very small amount of hand-wash
laundry detergent and rinse the foam thoroughly. Do not use detergents known to irritate your skin. Do
not use dish soap
•Do not machine wash or tumble dry
•Do not fully saturate during washing of foam; use water sparingly and press excess water from foam
into absorbent material. Do not wring or mis-shape during washing or drying.
•Do not re-fit the foam to the device or use the foam until fully dry. Damp foam can damage the
device and cause irritation.
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. 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 does not change when used outside the home or clinic environment; use of the device during extended
travel, such as on a plane flight, is appropriate. Do not use the device while driving.
Storage and Transport Conditions:
Temperature -25°C to +70°C
Relative Humidity Up to 90%, non-condensing
Atmospheric pressure 700 hPa to 1060 hPa
FAULT CONDITIONS
If a fault is detected when the device is switched on, the device lenses will flash blue continuously. If this
happens, turn the device off, wait a few seconds and turn the device back on. If the fault continues, recharge the
device (see “charging” on p8) and turn the device on. If the fault continues, contact your physician for a
replacement immediately. The device will be returned to Sana for investigation and repair. There are no known
faults that can cause you harm.
CAUTION: Do not disassemble the device

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DEVICE RETURN & DISPOSAL
The device is expected to operate reliably for a minimum of 18 months. Should you experience device failure
prior to this, please contact Sana Customer Success at 720-310-3370 to arrange for device return and
replacement. The device may continue to function longer than this and can continue to be safely used.
Should you need to dispose of the device locally; please note that this product contains a rechargeable lithium
ion battery. At the end of device life, dispose of device in regular waste or according to local regulation for the
disposal of lithium ion batteries. Discharge battery prior to disposal. Do not dispose of device in fire or heat.
ADDITIONAL INFORMATION
In 1992, Richard Hanbury, the now-CEO of Sana Health, suffered a near-fatal car crash in Yemen, which left
him paralyzed. 14-months later he was given less than 5 years to live due to severe chronic nerve pain that was
debilitating both recovery and sleep quality.
Richard experienced by chance the “flow state” effect whilst in hospital and has since devoted some 24-years to
researching, developing and optimizing the algorithms that reliably recreate this “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 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. Please refer to
the website for up to date information on recent clinical studies (www.sana.io).
HOW IT WORKS
The Sana device is a non-addictive 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.
In the early 1930s, light and sound stimulation were reported to change the rhythm of brain activity, termed
“entrainment”. Brain activity can be tracked through brainwaves, which represent the electrical firing of the
neurons of the central nervous system and can be measured by electroencephalogram (EEG). It is through
these electrical signals that the brain communicates within itself and with other organ systems.
•Delta activity (0.5–3Hz) is dominant primarily during deep sleep
•Theta activity (4–7Hz) is typically seen in drowsy and relaxed states

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•Low alpha (8–10Hz) is the dominant brainwave bandwidth observed during meditation and the state of
turning inward (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 under the “More” Tab of the app or by visiting the Sana website at: https://www.sana.io/faqs

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MANUFACTURING INFORMATION
Manufactured for:
Sana Health Inc.
130 Miners Drive Suite 101
Lafayette CO 80026
Date of manufacture per product label and pack insert
Device serial number can be found on the package label, the pack insert
and on the device under the foam part. For instructions on removal of the
foam part, see “cleaning” on p14.
For more information, contact Sana Health:
[email protected]
eIFU 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 conforms to IEC 60601-1-2:2014 for immunity and emissions, however special precautions
regarding EMC (Electro Magnetic Compatibility) should be taken according to the information provided below.
•The use of accessories and cables other than those provided with the devices may result in increased
emission or decreased immunity of the device and result in improper operation.