Cue Health Cue User manual

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User Manual
For Use Under an Emergency Use Authorization (EUA) Only
For in vitro diagnostic use

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Cue™ Health Monitoring System
User Manual
Basic Information
Please read this User Manual carefully. Contact Cue Health
Customer Support at [email protected] or call toll-
free at (833) CUE-TEST · [phone] if you have any
questions or comments.
Cue Health Inc.
San Diego, CA 92121
www.cuehealth.com
Cue™ is a trademark of Cue Health Inc.
IN9000207-1_4.0 2020-06

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Table of Contents
Chapter 1 - Introduction and User Safety ..................... 7
Welcome to Cue ........................................................... 7
Intended Use ................................................................ 7
Before Testing with the Cue Health Monitoring
System...................................................................... 8
Safety Denitions .......................................................... 9
Practices Used in This User Manual ............................ 11
Symbols and Descriptions........................................... 12
General Precautions.................................................... 14
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
Accessories Available Separately ................................ 23

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Table of Contents
Chapter 3 - Setting Up Your Cue Health
Monitoring System.................................................... 24
Identifying Parts of Your Cue Cartridge Reader............ 24
Your Cue Health App Dashboard ................................ 27
Cue Cartridge Reader Indicator Lights ........................ 28
Downloading and Installing the Cue Health App .......... 30
Creating Your Cue Account and User Prole ............... 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
Initiate Test.................................................................. 44

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Table of Contents
Chapter 5 - Cue Health Monitoring System
Management ............................................................. 46
Charging the Cue Cartridge Reader ............................ 46
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....................................................... 52
Unpairing the Cue Cartridge Reader from Your
Mobile Smart Device ............................................... 54
Managing User Account and Proles........................... 55
Forgot Your Password?............................................... 57
Printing Your Test Results............................................ 58
Accessing Product Documentation ............................. 60

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Chapter 6 - Cleaning and Disinfecting ........................ 61
Cleaning and Disinfecting............................................ 61
Chapter 7 - Troubleshooting ........................................ 63
Error Messages and Recommended Actions .............. 64
When to Use the Manual Reset Button ....................... 66
Chapter 8 - Technical Information and
Specications ........................................................... 67
How the Cue Health Monitoring System Works........... 67
Technical Specications .............................................. 68
Compliance with International Standards .................... 69
Disposing of Your Cue Health Monitoring System
and Components .................................................... 70
Chapter 9 - Warranty and Supplies ............................. 71
Manufacturer’s One Year Warranty .............................. 71
Supplies and Accessories ........................................... 71
Table of Contents

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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. Read this
manual thoroughly to help you understand the system and
its many features.
Intended Use
The Cue Health Monitoring System is an in vitro diagnostic
medical device for use with test-specic Cue Cartridge(s)
and the Cue Health Mobile Application (Cue Health App)
installed on a mobile smart device such as the Apple®
iPhone®8+ or later with iOS 13 or later.

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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.
It is important that you follow the instructions
in this User Manual. If you do not use the system
correctly, you may get an incorrect or invalid result, the
system may cancel your test, or you may damage the
system. Do not use the system if you cannot follow the
instructions.
If you have any questions, please contact Cue Health
Customer Support at [email protected] or call toll-
free at (833) CUE-TEST · [phone].

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Safety Denitions
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.
Follow the instructions given when you see a Warning
message. Do not proceed if you do not fully understand the
actions to take after seeing a Warning message.

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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
instructions clearer.