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Cue Health Cue User Manual

Health monitoring system
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For Use Under an Emergency Use Authorization (EUA) Only
For in vitro diagnostic use
User Manual
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Summary of Contents for Cue Health Cue

  • Page 1 For Use Under an Emergency Use Authorization (EUA) Only For in vitro diagnostic use User Manual...
  • Page 2 User Manual Basic Information Please read this User Manual carefully. Contact Cue Health Customer Support at support@cuehealth.com or call toll- free at (833) CUE-TEST · (833) 283-8378 if you have any questions or comments. Cue Health Inc. San Diego, CA 92121 www.cuehealth.com...

  • Page 3: Table Of Contents

    Chapter 2 - Cue Health Monitoring System Overview and Features ..........16 Cue Health Monitoring System Components ....17 Cue Health Monitoring System Package Contents ..19 Cue Test Cartridge Pack ..........20 Compatible Mobile Smart Devices ......22 Cue Health App ............22...
  • Page 4 Creating Your Cue Account and User Profile ....32 Setting Up the Cue Cartridge Reader ......35 Account Login ............40 Chapter 4 - Running a Test on the Cue Cartridge Reader ............... 41 Reasons for Incorrect or Invalid Results ....... 43...
  • Page 5 Account Settings ............48 Pairing Additional Cue Cartridge Readers to Your Mobile Smart Device ..........49 Connecting the Cue Cartridge Reader to the Cue Health Mobile App ........... 50 Checking the MAC Address of a Connected Cue Cartridge Reader ............. 51 Disconnecting the Cue Cartridge Reader from the Cue Health App ............
  • Page 6 When to Use the Manual Reset Button ....... 66 Chapter 8 - Technical Information and Specifications ............67 How the Cue Health Monitoring System Works ... 67 Technical Specifications ..........68 Compliance with International Standards ....69 Disposing of Your Cue Health Monitoring System and Components ............

  • Page 7: Chapter 1 - Introduction And User Safety

    Chapter 1 Introduction and User Safety Welcome to Cue The Cue Health Monitoring System is a fast and easy to use system for performing medical tests. Your results are delivered and saved to a mobile smart device in minutes. This User Manual will guide you through the proper setup and use of the Cue Health Monitoring System.

  • Page 8: Before Testing With The Cue Health Monitoring System

    Before Testing with the Cue Health Monitoring System Review the Quick Start Guide and this User Manual before you run a test using the Cue Health Monitoring System. The Quick Start Guide will help you quickly set up your system and get ready to run a test. This User Manual gives you all the information you need to use your system correctly and safely.

  • Page 9: Safety Definitions

    This User Manual includes three types of important messages. They are Warnings, Cautions, and Notes. It is important that you pay close attention to these messages to make sure you use the Cue Health Monitoring System correctly and safely. Warning A Warning message tells you what you need to do to prevent possible risk of injury or damage to your health.
  • Page 10 Caution A Caution message tells you what you need to do to prevent damage to your Cue Health Monitoring System. Do not proceed if you do not fully understand the actions to take after seeing a Caution message. Note A Note is used to give you more information to make the...

  • Page 11: Practices Used In This User Manual

    Words in: Description Names of menus and buttons Bold System response that occurs as a result of pressing an icon or an action command in Italics the Cue Health App Bold Used to emphasize important information Italics...

  • Page 12: Symbols And Descriptions

    Symbols and Descriptions The table below describes the symbols used on the Cue Health Monitoring System packaging and on the system parts. Symbol Description Consult User Manual Serial Number Do not use if seal or packaging is broken or damaged...
  • Page 13 Symbol Description Manufacturer Keep dry Electrical and Electronic Equipment Waste: Discard product at separate collection facility for recovery and recycling. Caution: Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

  • Page 14: General Precautions

    • Do not leave the Cue Health Monitoring System in temperatures below 39°F (4°C) or above 100°F (38°C). • If you make changes to any of the parts of your Cue Health Monitoring system or use any parts that did not come with the system, you may harm yourself and the system.
  • Page 15 • The Cartridge Reader should be placed on a stable, flat, and level surface while running a test. Do not move or tilt the Reader while a test is in progress. • This product has not been FDA cleared or approved. •...

  • Page 16: Chapter 2 - Cue Health Monitoring System Overview And Features

    Cue Cartridges and sample collection devices (Cue Sample Wand). The Cue Cartridge Reader connects to the Cue Health App installed on your Apple iPhone 8+ or later device. The iPhone mobile smart device is the primary display for the test system.

  • Page 17: Cue Health Monitoring System Components

    Cue Health Monitoring System Components Each Cue Health Monitoring System part (component) is described in the table on the next page.
  • Page 18 Component Description Image The Cue Cartridge Cartridge Reader communicates Reader with the Cue Health App and the test-specific Cue Cartridges to run a test on a sample. Cue Power The Cue Power Adapter Adapter plugs into standard wall power. The Cue...

  • Page 19: Cue Health Monitoring System Package Contents

    • Quick Start Guide Contact Cue Health Customer Support at support@cuehealth.com or call toll-free at (833) CUE-TEST · (833) 283-8378 if you do not have all of these parts. Also contact Cue Health Customer Support if a part is damaged.

  • Page 20: Cue Test Cartridge Pack

    Cue Test Cartridge Pack The table on the next page describes Cue Test Cartridge Packs. Cue Test Cartridge Packs are available for different tests including a test for SARS-CoV-2 virus (COVID-19). Cue Test Cartridge Packs are sold separately and must be used before the Use By date printed on the cartridge pack label.
  • Page 21 Component Description Image A Cue Test Cartridge Test Pack comes with a Cartridge Cue test cartridge, a Pack Cue Sample Wand for collecting a sample, and Instructions for Use. The Instructions Cue COVID-19 for Use tell you how to Test Cartridge...

  • Page 22: Compatible Mobile Smart Devices

    Health Monitoring System. The Cue Health App must be open to see test results. If the mobile smart device loses power, the test on the Cue Health Monitoring System will still run to completion. The result will not be displayed until the mobile smart device is charged.

  • Page 23: Accessories Available Separately

    The Cue Health App also stores test results and communicates with the internet and the secured cloud storage. Accessories Available Separately Component Description Image The Cue Cartridge Wireless Reader may be Charging charged wirelessly Base using the Cue Wireless Charging Base. The...

  • Page 24: Chapter 3 - Setting Up Your Cue Health Monitoring System

    System Identifying Parts of Your Cue Cartridge Reader The Top and Front of Your Cue Cartridge Reader Indicator Lights* Cartridge Port *See “Cue Cartridge Reader Indicator Lights” in Chapter 3 for information on the meaning of the indicator light patterns.
  • Page 25 The Back of Your Cue Cartridge Reader USB Port Manual Reset Button...
  • Page 26 The Bottom of Your Cue Cartridge Reader Code Address Number...

  • Page 27: Your Cue Health App Dashboard

    Your Cue Health App Dashboard Manage Profiles Manage My Account Readers Help Center Run Test Latest Activity Last Test Result Home Button Press the Home Button on the Cue Health App screen to see the Cue Dashboard.

  • Page 28: Cue Cartridge Reader Indicator Lights

    You will see different light patterns on top of the Reader. The light patterns will tell you when the Reader is connected to the Cue Health App. The light patterns will also tell you when a cartridge is inserted, and when there is an error.
  • Page 29 Prompts for an Action You will see these light patterns on top of the Reader after you insert a Cue Cartridge into the Cartridge Port. Insert Sample Wand with collected specimen into the Cue Cartridge Remove Cue Cartridge (with Sample Wand...

  • Page 30: Downloading And Installing The Cue Health App

    Downloading and Installing the Cue Health App You can download and install the Cue Health App to your iPhone mobile smart device from the Apple App Store. The Cue Health App is downloaded and installed the same way as other apps on your mobile smart device. The Cue Health App is free of charge.
  • Page 31 3. Launch the Apple App Store app. 4. Search for the “Cue Health App” by Cue Health Inc. and tap on the Cue Health App icon. 5. Tap Install. 6. Enter your App Store password information as required. The application downloads. Once installed, the Cue Health App icon appears on your mobile smart device home screen.

  • Page 32: Creating Your Cue Account And User Profile

    Creating Your Cue Account and User Profile Your test results will be saved to your Cue Account and in a secured cloud storage. To Create your Cue Account and User Profile: 1. Launch the “Cue Health App” on your mobile smart device.
  • Page 33 “Permissions” screen will be displayed by the Cue Health App. 6. Follow the Cue Health App on-screen instructions to progress through the “Permissions” screens. After progressing through the “Permissions” screens, the “Set Up the Cue Cartridge Reader” screen will be displayed by the Cue Health App.
  • Page 34 Multiple User Profiles can be created under one Cue Account. The primary Cue Account holder will have access to all User Profiles and test results under the same Cue Account.

  • Page 35: Setting Up The Cue Cartridge Reader

    After creating a Cue Account, the “Set Up the Cartridge Reader” screen will be displayed by the Cue Health App. 1. Place the Cue Cartridge Reader on top of a stable, flat, and level surface. 2. Connect the Cue Charging Cable to the Cue Power Adapter and plug the Power Adapter into wall power.
  • Page 36 The Reader is now ready for pairing with a mobile smart device. Another way to wake the Cue Cartridge Reader is by disconnecting and reconnecting the Cue Charging Cable. You can also wake the Reader by placing it on top of the Cue Wireless Charging Base.
  • Page 37 If the QR code does not scan quickly, make sure the Cartridge Reader is connected to power. When the QR code is recognized, the Cue Health App will display a message that says, “Reader Authorized Successfully”. This means that the Cue Cartridge Reader is paired securely to the mobile smart device.
  • Page 38 Health App on the smart mobile device. If the camera scan of the Reader QR code does not work, the Cue Health App will let you to manually enter the Cartridge Reader MAC address and Pin Number. The MAC address and Pin are on the bottom of the Reader. See “Identifying Parts of Your Cue Cartridge Reader”...
  • Page 39 When you choose a paired Cue Cartridge Reader to run a test, that Reader is connected to the Cue Health App. One Cue Cartridge Reader can only connect with the Cue Health App on one mobile smart device at one time.

  • Page 40: Account Login

    Account Login If you already have a Cue Account, you can log in directly. If you do not have a Cue Account, see “Creating Your Cue Account and User Profile” in Chapter 3 for instructions on how to set up a Cue Account.

  • Page 41: Chapter 4 - Running A Test On The Cue Cartridge Reader

    Do not move or tilt the Reader while a test is in progress. The Cue Health App will tell you if the Cartridge Reader battery is too low to complete a test. Connect the Reader...
  • Page 42 The test result will be saved. The mobile smart device must be charged to see the test result. Make sure your mobile smart device is close to the Cartridge Reader after a test completes so you can view your result on the screen in the Cue Health App.

  • Page 43: Reasons For Incorrect Or Invalid Results

    Reasons for Incorrect or Invalid Results Always follow the directions in this User Manual when you store, handle, and operate the Cue Health Monitoring System. Some reasons for incorrect or invalid results are: • Storing or operating the Cue Cartridge Reader in temperatures that are too low or too high.

  • Page 44: Initiate Test

    Initiate Test To Initiate a Test: 1. Launch the Cue Health App on your mobile smart device. Cue Health The “Login” screen is displayed by the Cue Health App after launch. 2. Log into your Cue Account. The “Dashboard” screen is displayed by the Cue Health App after successful account login.
  • Page 45 If two or more Cartridge Readers are paired, you must identify the Reader you want to use by its MAC address. See “Checking the MAC Address of a Connected Cue Cartridge Reader” in Chapter 5 for more details.

  • Page 46: Chapter 5 - Cue Health Monitoring System Management

    Charging the Cue Cartridge Reader To Charge your Cue Cartridge Reader: 1. Plug the Cue Power Adapter into wall power. 2. Connect Cue Charging Cable to the USB port of the Cue Power Adapter. 3. Connect the other end of the Cue Charging Cable to the USB port of the Cue Cartridge Reader to start charging.
  • Page 47 When you connect or disconnect the Cue Charging Cable, the lights on the Reader will light up one- by-one (sequentially) and then flash to tell you the charge level. Lights illuminate sequentially Battery is 80% charged Battery is 20% charged...

  • Page 48: Account Settings

    Account Settings To Access Your Account Settings: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen. 2. Tap on “My Account”. 3. Tap on “Settings”. 4. Within the “Settings” menu, you can: •...

  • Page 49: Pairing Additional Cue Cartridge Readers To Your

    Pairing Additional Cue Cartridge Readers to Your Mobile Smart Device To Pair Additional Cue Cartridge Readers to your mobile smart device: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen.

  • Page 50: Connecting The Cue Cartridge Reader To The Cue

    Connecting the Cue Cartridge Reader to the Cue Health App To Connect a Paired Cue Cartridge Reader to the Cue Health App: A Cue Cartridge Reader that is “Paired” to your mobile smart device can disconnect if the Cartridge Reader is out of Bluetooth range of the mobile smart device.

  • Page 51: Checking The Mac Address Of A Connected Cue Cartridge Reader

    Cartridge Reader To Check the MAC address of the Connected Reader on the Cue Health App: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen. 2. Tap on “Manage Readers”.

  • Page 52: Disconnecting The Cue Cartridge Reader From The Cue Health App

    Disconnecting the Cue Cartridge Reader from the Cue Health App To Disconnect the Cue Health App from connected Cue Cartridge Readers: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen.
  • Page 53 Cue Cartridge Reader is now disconnected from the Cue Health App.

  • Page 54: Unpairing The Cue Cartridge Reader From Your Mobile Smart Device

    Unpairing the Cue Cartridge Reader from Your Mobile Smart Device To Unpair the Cue Cartridge Reader from your mobile smart device: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen.

  • Page 55: Managing User Account And Profiles

    Managing User Account and Profiles To Manage User Account: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen. 2. Tap on “My Account” for more options.
  • Page 56 To Manage Profiles: 1. When logged into your Cue Account, access the Cue Dashboard by tapping on the home button at the bottom of the screen. 2. Tap on ”Manage Profiles”. 3. Tap on the profile of interest and tap on “VIEW” for more options.

  • Page 57: Forgot Your Password

    Forgot Your Password? To Retrieve your Password: 1. Launch the Cue Health App on your mobile smart device. 2. Tap on “Forgot Password?” 3. Follow the on-screen instructions.

  • Page 58: Printing Your Test Results

    Printing Your Test Results To Print your Test Results: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen. 2. Tap on “Manage Profiles”. 3. Tap on the profile of interest and tap on “VIEW”.
  • Page 59 Printing Test Results from the Cue Health App requires that a printer be connected to the mobile smart device. If you print results in public places, you could be sharing your personal information.

  • Page 60: Accessing Product Documentation

    Accessing Product Documentation To Access Product Documentation: 1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen. 2. Tap on “Help Center” for options.

  • Page 61: Chapter 6 - Cleaning And Disinfecting

    ® Germicidal Wipes containing 0.55% sodium hypochlorite as the active ingredient. Do not spray any cleaning solution directly onto the Cue Cartridge Reader or into the Cartridge Port. Do not put any part of the Cue Health Monitoring System under water or any other liquid.
  • Page 62 If part of your device becomes wet, wipe off all moisture and allow sufficient time for drying before use. Only Clorox Germicidal Wipes should be used. Other products have not been tested and should not be used. Follow manufacturer’s instruction for handling and storage of wipes.

  • Page 63: Chapter 7 Troubleshooting

    They give you important information to help you use the system correctly and safely. If you have questions, contact Cue Health Customer Support at support@cuehealth.com or call toll-free at (833) CUE-TEST · (833) 283-8378.

  • Page 64: Error Messages And Recommended Actions

    Error Messages and Recommended Actions Certain messages displayed by the Cue Health App indicate an error. An error message requires your attention and action. The following table lists the Error Message and the Recommended Action. Error Message Recommended Action App displays “Tilt Position the Cue Cartridge Reader Warning”...
  • Page 65 Remove and dispose of the “Test Has Been Cartridge. Take a new sample Canceled” using a new test-specific Cue Sample Wand and use a new test- specific Cue Cartridge to repeat the test. See the Cue Health App on-screen instructions for additional details.

  • Page 66: When To Use The Manual Reset Button

    When to Use the Manual Reset Button If the Cartridge Reader is not responding as described in this User Manual you must reset the Reader. Press and hold the Manual Reset Button for one second. Do not hold the Manual Reset Button for more than 3 seconds. Pressing the Manual Reset Button for 10 seconds will bring the Reader back to the out-of-the box settings.

  • Page 67: Chapter 8 - Technical Information And Specifications

    Chapter 8 Technical Information and Specifications This section provides technical information on your Cue Health Monitoring System. How the Cue Health Monitoring System Works The Cue Health Monitoring System detects test-specific targets using electrochemical biosensor technology.

  • Page 68: Technical Specifications

    (3.0 in x 3.0 in x 1.5 in) (74 mm x 74 mm x 37 mm) Weight 5.3 oz (150 g) Cue Health App on an iPhone 8+ (or later) Display mobile smart device screen Operational 59°F (15°C) to 95°F (35°C)

  • Page 69: Compliance With International Standards

    Altitude For test-specific Cue Cartridge technical specifications, refer to the test-specific Instructions for Use. Compliance with International Standards The Cue Health Monitoring System will be tested to the following standards: • UL 61010-1. 3rd Edition. • UL 61010-2-101. 2nd Edition.

  • Page 70: Disposing Of Your Cue Health Monitoring System And Components

    Disposing of Your Cue Health Monitoring System and Components Dispose of used products according to regulations applicable in your country. For information about the correct method of disposal, contact your local authorities.

  • Page 71: Chapter 9 Warranty And Supplies

    System will be free from defects in materials and workmanship for a period of one (1) year from the date of the original purchase. If during this time the Cue Health Monitoring System does not work properly because of a defect in materials or workmanship, Cue Health Inc.
  • Page 72 Notes...
  • Page 73 Notes...
  • Page 74 IN9000207-1_4.0...

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