We Are The Last Generation to Know So Little About Our Health

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.

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Table of Contents

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.

  • At a Glance
  • Meet Your Scanadu Scout™
  • Setup and Your First Scan
  • App Navigation
  • Troubleshooting
  • 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.

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At a Glance

The Scanadu Scout™ system consist of three components:

  • The Scanadu Scout™ Device
    Contains sensors and electronics used to collect all measurements
  • The Scanadu Scout™ Application
    A mobile app used to confidentially collect, view, save and wirelessly transmit data to the Scanadu server.
  • 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

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Meet your Scanadu Scout™

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Getting Prepared

Let’s get you all set up for your first scan!

There are 2 easy steps to complete:

  • Open your Scanadu Scout™ Box.
  • Download the app.

1.Open your Scanadu Scout™ Box

In the box you’ll find:

  • Basic Quick Start Instructions (on box)
  • Scanadu Scout™ Investigational Device
  • USB Charging Cable
  • Pamphlet

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Connect your Scanadu Scout™

2. Download the Scanadu Scout™ Application

  • 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
  • Search for “Scanadu Scout.”
  • Install the Scanadu Scout™ app.

Now you are ready to launch the app. Let’s go!

  • Turn on Bluetooth™
      1. Make sure your phone can discover Bluetooth™ devices.
  • Launch the Scanadu Scout™ app.
      The app will walk you through connecting the Scanadu Scout™ investigational device to your phone and setting up a profile.
      The device ill turn off automatically after you connect – this is normal.

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Your First Scan

Before taking your first scan, read these instructions carefully. For best results:

  • Make sure the two sensors are clean.
  • Have a seat and keep both feet flat on the ground
  • Brace your left elbow on a table or armrest.
  • Press the power button. A white light will indicate it is on.
  • 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 finger on the round touch sensor on the top of device.
  • Push hair aside, hold the oval sensor area flat 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.

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App Navigation

In this section, we will cover the following areas of the Scanadu Scout™ app:

  • Menu page
  • New Scan
  • Trends
  • History
  • Settings

1. Menu Page

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2. Scanning

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.

Scanning : New Scan Results

This page appears after your scans are completed, revealing the results of your most recent scan.

  • Results that may need attention can easily be identified by the colored circles.
  • Tap on the circles to learn more about what the results mean.
  • Scroll up to add context to your scan by tagging prior activities.
  • Tap to activate tags.
  • Add notes about specific events or throughts.

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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 Specific Categories

These screens are accessed through tapping on a specific category on the trends summary page.

  • Tap hold and drag white line to scroll to different dates
  • The color of the “Details” button corresponds to the ranges, as we saw in the results page.

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4. History

Previous Scans

Snapshots of your past scans are located here, allowing you to compare across categories. Scroll to explore all scans.

History: Access to your Complete Scans

You may recognize the results page as it is similar to the post-scan page.

  • Tap on a specific date to expand details.
  • Scroll down to see more snapshots.
Tap on the scan number to access all snapshots from that day.

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5. Settings

Personalize your Scans

You’ll find your personal information with the the most up-to- date biometrics here, as well as all your connected devices.

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 signified by the color white.
  • Out of range is signified by grey.

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Troubleshooting

Problem Possible Cause(s) Solution
Device can’t complete a scan
The sensors are not making valid contact with the forehead Make sure your index finger is on the top sensor and the oval sensor area is flat to your forehead
Too much noise or movement during the scan Be still and refrain from talking while scanning
Bluetooth™ connection failed Turn Bluetooth™ off, then on again to refresh the connection
Device doesn’t turn on The battery is very low Recharge battery
Device doesn’t connect to the app Bluetooth™ is not enabled on your mobile phone Turn on Bluetooth™ on your mobile phone
Temperature reading is incorrect
Not getting a temperature reading
Placed the device on your forehead too soon Put the device on forehead only when directed by the app
Device is warm due to previous scan or ambient environment Wait 5 minutes between scans
Forehead is wet due to perspiration or activity Cool down prior to scanning, scan only when your forehead is dry

Reminders, for best results:

  • Make sure the two sensors are clean.
  • Have a seat and keep both feet flat 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 finger on the round touch sensor on the top of the device.
  • Push hair aside, hold the oval sensor area flat 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.

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.

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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 modifications 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 specifications.

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 defibrillator.
  • Do not use this device during an MRI scan.
  • Do not use in the presence of flammable 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 Celsius 36 – 40 SD ≤ 0.5
Heart Rate bpm 40 – 150 SD ≤ 4
SpO2 % 90 – 100 SD ≤ 3%
70 – 90 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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