Scanadu Scout User manual

Type
User manual
Scanadu Scout
User Guide
2
WELCOME TO
SCANADU SCOUT™
The Scanadu Scout™ is a non-invasive
system measuring the following physiological
parameters: temperature, heart rate, pulse
oximetry and blood pressure. The Scanadu
Scout™ obtains these vital signs from a gentle
touch on the forehead and sends them via
Bluetooth to the user’s smartphone.
Scanadu believes there is an unmet need in
healthcare to develop products and services
for consumers to better engage in their own
health. The Scanadu Scout™ is designed to
meet that need, aiming to be the change agent
of healthcare.
We Are The Last Generation to
Know So Little About Our Health
3
TABLE OF CONTENTS
1. At a Glance
2. Meet Your Scanadu Scout™
3. Setup and Your First Scan
4. App Navigation
5. Troubleshooting
6. Safety, Warnings and Maintenance
This User Guide includes information and instructions about the
Scanadu Scout™ investigational device. Please take a moment to
read it carefully before you begin using the device.
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE
The Scanadu Scout™ is intended for use by adults to track and trend
a variety of physiological measurements such as temperature, SpO2,
heart rate and non-invasive blood pressure on a holistic basis, for the
purpose of enabling adults to manage their health. It is not intended for
diagnostic purposes.
CAUTION – The Scanadu Scout™ is currently an investigational device,
limited by Federal (United States) law to investigational use only.
The Scanadu Scout™ has not yet been clinically tested for accuracy
compared to devices taking one or more similar measurements. Its
performance characteristics have not yet been established.
You should always consult your healthcare provider with any questions
you may have regarding a medical condition or symptom.
INTENDED USER
The device is intended to be used by adults age 18 and over.
4
The Scanadu Scout™ system consists of
three components:
1. The Scanadu Scout™ Device
Contains sensors and electronics used to
collect all measurements.
2. The Scanadu Scout™ Application
A mobile app used to condentially collect,
view, save and wirelessly transmit data to
the Scanadu server.
3. Your Smartphone
The system currently supports the
following devices:
Apple iPhone 4s, 5, 5s*
Samsung Galaxy S4, S5
Nexus 4, 5
*iPhone 6 and 6 Plus testing in progress
AT A GLANCE
Scanadu Scout™ App
Smartphone
SCANADU
SCOUT
SYSTEM
5
FRONT BACK
Touch
Sensor
Charging
Port
Infrared
Thermometer
SP02
Sensor
Power
Button
Power
Indicator
MEET YOUR
SCANADU SCOUT
6
Let’s get you all set up for your rst scan!
There are 2 easy steps to complete:
1. Open your Scanadu Scout™ Box.
2. Download the app.
1. Open your
Scanadu Scout™ Box
In the box you’ll nd:
Basic Quick Start Instructions (on box)
Scanadu Scout™ Investigational Device
USB Charging Cable
Pamphlet
GETTING PREPARED
7
1. Turn on Bluetooth™.
Make sure your phone can discover
Bluetooth™ devices.
2. Launch the Scanadu Scout™ app.
The app will walk you through connecting
the Scanadu Scout™ investigational device
to your phone and setting up a prole.
The device will turn off automatically after
you connect - this is normal.
2. Download the
Scanadu Scout™ Application
1. Using your smartphone, access the
appropriate mobile application store:
For iPhones, go to the App Store.
For Android devices (Samsung, Nexus),
go to Google Play.
2. Search for “Scanadu Scout.”
3. Install the Scanadu Scout™ app.
Now you are ready to
launch the app.
Let’s go!
CONNECT YOUR
SCANADU SCOUT
8
Before taking your rst scan, read these
instructions carefully.
For best results:
Make sure the two sensors are clean.
Have a seat and keep both feet at on the
ground.
Brace your left elbow on a table or armrest.
Press the power button. A white light will
indicate it is on.
Power
Button
Power
Indicator
YOUR FIRST SCAN
Hold device with the oval sensor area facing
you.
To get the best scan, hold the device in your
left hand and place your index nger on the
round touch sensor on the top of the device.
Push hair aside, hold the oval sensor area at
against the left side of your forehead until the
scan is complete.
Hold the device with gentle and steady
pressure to the forehead.
Keep your head, body and hand steady to
obtain the clearest scan.
Remain quiet during the scan.
9
In this section, we will cover the following areas
of the Scanadu Scout™ app:
1. Menu Page
2. New Scan
3. Trends
4. History
5. Settings
APP NAVIGATION
1. Menu Page
Tap to start
new scan
Tap or slide screen to
the right to reveal menu
Menu Button
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2. Scanning
Cancel
Scan
Scan
Stage
Scan
Progress
Scan Progress Page
You’ll see this page during a scan. If the scan appears to
stall, cancel and start over. As you get more familiar, the scan
duration will decrease while the scan quality will increase.
Results that may
need attention can
easily be identied
by the colored
circles.
Tap on the circles
to learn more
about what the
results mean.
Scroll up to add
context to your
scans by tagging
prior activities.
Tap to activate
tags.
Add notes about
specic events or
thoughts.
Scanning: New Scan Results
This page appears after your scans are completed, revealing the
results of your most recent scan.
11
Most recent
scan
Start
New Scan
Tap to
Explore
Category
Past scans
graphed
3. Trends
Your Scans Visualized
This page shows a quick summary of past scans and reveals
trends over time in each category. Your most recent scan is
also displayed.
Trends: Diving into Specic Categories
These screens are accessed through tapping on a specic
category on the trends summary page.
Quick Access
to Help
Tap to See
Recommended
Ranges
Category
Average for
Selected Date
Number of Scans
Completed for
Selected Date
Tap to Change
Timeline Scale
Tap hold and drag
white line to scroll
to dierent dates.
The color of the
“Details” button
corresponds to
the ranges, as we
saw in the results
page.
12
4. History
Previous Scans
Snapshots of your past scans are located here, allowing you to
compare across categories. Scroll to explore all scans.
Tags
Tap to
Expand
Edit Tags,
Notes, or
Delete Scans
History: Access to your Complete Scans
You may recognize the results page as it is similar to the post-
scan page.
Tap on the scan
number to access
all snapshots from
that day.
Tap on a specic
date to expand
details.
Scroll down to see
more snapshots.
13
5. Settings
Settings: Edit Ranges
We are all unique. Vital signs that are completely normal to
you could be outside of the ranges we’ve determined based
on Medical Consensus. On the Ranges page, you’ll be able to
personalize your ranges.
Trends pages will
look like this
once ranges are
personalized.
In range is
signied by the
color white.
Out of range is
signied by grey.
Biometrics
(Please keep
up-to-date)
Add, Edit, or
Delete Devices
Prole Photo
(Tap to Edit)
Set Preferred
Units
Set Preferred
Vital Sign
Ranges
Personalize your Scans
You’ll nd your personal information with the most up-to-date
biometrics here, as well as all your connected devices.
14
6a. Hidden Features
PPG Wave while scanning.
Watch your PPG wave dance across the screen in real time as
you scan.
Double Tap
“SCANADU” to
Unlock Features
PPG: What is that?
The PPG or Photmoplethysmogram uses light waves to measure
changes in the blood vessels with each pulse beat. In our system,
we combine the PPG signals with those from other sensors in
calculating your vital signs.
After double
tapping
“SCANADU,” the
“Pulse Wave”
toggle will show
up in the Settings
page.
Be sure to tap
“OK” to complete
the activation
of this hidden
feature.
PPG Wave
ECG Wave
15
6b. Hidden Features
Share Button
Now you can share your Trends and Results with your family
and friends, as well as your doctor.
Trends and Results
The share button may be accessed from the Trends and Results
screens. We want to keep your information safe, so we’ll always
ask you if you want to share or not.
Pull down on the
date banner area
to reveal the share
button.
Tap the share
button to send
your screens
via SMS, email,
Twitter or
Facebook.
Double Tap
“SCANADU” to
Unlock Features
16
Problem
Device doesn’t
connect to the app
Device can’t
complete a scan
Device doesn’t
turn on
Temperature
reading is incorrect
Not getting a
temperature reading
Possible Cause(s)
Bluetooth™ is not
enabled on your mobile
phone
The sensors are not
making valid contact
with the forehead
Too much noise or
movement during the
scan
Bluetooth™
connection failed
The battery is very low
Placed the device on
your forehead too soon
Device is warm due
to previous scan or
ambient environment
Forehead is wet due to
perspiration or activity
Solution
Turn on Bluetooth™ on
your mobile phone
Make sure your index
nger is on the top
sensor and the oval
sensor area is at to
your forehead
Be still and refrain from
talking while scanning
Turn Bluetooth™ off,
then on again to
refresh the connection
Recharge battery
Put the device on
forehead only when
directed by the app
Wait 5 minutes
between scans
Cool down prior to
scanning, scan only
when your forehead
is dry
We care about what you think. If you have any questions or comments
about this User Guide, the device or the app, please send an e-mail to
TROUBLESHOOTING
Reminders, for best results:
Make sure the two sensors are clean.
Have a seat and keep both feet at on the
ground.
Brace your left elbow on a table or armrest.
To get the best scan, hold the device in your
left hand and place your index nger on the
round touch sensor on the top of the device.
Push hair aside, hold the oval sensor area at
against the left side of your forehead until the
scan is complete.
Hold the device with gentle and steady
pressure to the forehead.
Keep your head, body and hand steady to
obtain the clearest scan.
Remain quiet during the scan.
Recharge your device at least once a week,
assuming 3-5 scans per day.
17
SAFETY, WARNINGS
& MAINTENANCE
1. GENERAL SAFETY AND PRECAUTIONS
The device should not be used in conjunction with water or in a wet
environment.
Do not take scans while operating a moving vehicle.
Do not expose the unit to strong shocks or vibrations.
Do not disassemble, repair or modify the unit. Changes or
modications not expressly approved by Scanadu will void your
authority to operate the device.
Do not take a scan if the sensor surfaces are damaged.
Do not take scans in a location where the unit will be exposed to
strong electromagnetic forces, such as near an arc welder, high-
power radio transmitter, etc.
Audio and video products and similar equipment may cause
interference. Please stay away from such equipment when you are
scanning.
Disperse any static electricity from your body before using the unit.
Do not use this unit in locations subject to high or low temperatures
or humidity. It should be used within the temperature and humidity
range according to the product specications.
2. WARNINGS
The Scanadu Scout™ is an investigational device, limited by Federal
(United States) law to investigational use only. Its measurements
may not be accurate and are for reference only.
This device is not designed or intended for diagnostic purposes.
Do not attempt self-diagnosis or self-treatment based on the scan
results or analysis. Self-diagnosis or self-treatment may lead to
deterioration of your health. Patients should always consult their
physician if they notice changes in their health, regardless of scan
results.
Do not use this device with a debrillator.
Do not use this device during an MRI scan.
Do not use in the presence of ammable anesthetics, drugs or
pressurized oxygen (such as in a hyperbaric chamber, ultraviolet
sterilizer or oxygen tent).
Keep out of reach of infants, small children, or anyone incapable of
using the device properly.
The device has not been tested for use on children. Adult use only.
Do not use on patients with a cardiac pacemaker, ICDs or other
implanted electronic devices such as a deep brain stimulator.
3. MAINTENANCE
No regular maintenance of this system is required but for best signal
quality, the sensor contacts should be cleaned periodically with a dry
soft cloth. Keep up-to-date with the latest Scanadu Scout™ app.
4. SCANADU SCOUT™ SPECIFICATIONS
Scanadu Inc.
NASA Ames Research Building 20, Moffett Field, CA 94035
Product Name
Scanadu Scout™
Model
White Module: SSM-001-W
Black Module: SSM-001-B
Communication Protocol
Bluetooth LE
Battery Type
3.7V 140mAh Lithium Polymer
Battery Life
1-week use after full charge; 3-5 scans per day
Weight
36 grams
Size
ø63.3mm x 18.4 mm
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5. PERFORMANCE CHARACTERISTICS
Parameter Unit Range Accuracy
BP systolic mm Hg 80 - 150 SD ≤ 9.9, mean ≤ 0.4
BP diastolic mm Hg 60 - 120 SD ≤ 9.9, mean ≤ 0.4
Temperature Celcius 36 - 40 SD ≤ 0.5
Heart Rate bpm 40 - 150 SD ≤ 4
SpO2 % 90 - 100
70 - 90
SD ≤ 3%
SD ≤ 5%
6. FCC COMPLIANCE
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
NOTE: The information in this guide is subject to change without notice.
© 2015 Scanadu, Inc. All rights reserved.
601-00001 Revision 2 | February 2015
Scanadu, Inc. | NASA Ames Research Building 20 | Moffett Field, CA
94035 | United States | www.scanadu.com
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Scanadu Scout User manual

Type
User manual

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