Scanadu Scout User Manual

Scanadu Scout™

User Guide

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

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.

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

™

FRONT BACK

Touch

Sensor

Charging

Port

Infrared

Thermometer

SP02 Sensor

Power Button

Power

Indicator

MEET YOUR

SCANADU SCOUT™

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

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™

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.

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

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.

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

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 postscan 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.

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.

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

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

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 support@scanadu.com.

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.

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, highpower 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

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.

Scanadu Scout User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual