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.

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Practices Used in This User Manual
Procedure steps in this User Manual are easy to nd. They
begin with a symbol, followed by a short description of
the action to be performed.
Procedure steps are numbered and should be performed in
that order.
When there is a system response to the procedure step
performed, it appears in italics below the procedure step.
Words in: Description
Bold Names of menus and buttons
Italics
System response that occurs as a result of
pressing an icon or an action command in
the Cue Health App
Bold
Italics Used to emphasize important information

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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
Storage temperature range
Humidity Storage range
Catalog number

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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.

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General Precautions
The Cue Health Monitoring System may not work correctly
if there is damage to the package or the system parts.
• Do not use the Cue Health Monitoring System if the
package seals are broken.
• Do not use Cue Health Monitoring System if any part is
damaged.
• Do not run a test if the room temperature is outside
of the testing conditions stated in the test-specic
Cue Cartridge Instructions for Use. Testing in room
temperatures that are too high or too low may cause an
incorrect or invalid result.
• Do not use the Cue Health Monitoring System in altitudes
higher than 8530 feet (2600 meters). Testing at altitudes
that are too high may cause an incorrect or invalid result.
• 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. You will also void your warranty.

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• The Cartridge Reader should be placed on a stable, at,
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.
• This product has been authorized by FDA under an
EUA for use by laboratories certied under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA),
42 U.S.C §263a, to perform moderate complexity/high
complexity tests and at the Point of Care (POC), i.e., in
patient care settings operating under a CLIA Certicate
of Waiver, Certicate of Compliance, or Certicate of
Accreditation.
• This product has been authorized only for the detection
of nucleic acid from SARS CoV-2, not for any other
viruses or pathogens.
• This product is only authorized for the duration of
the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostic
tests for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Act, 21 U.S.C §360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.

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Chapter 2
Cue Health Monitoring System Overview
and Features
The Cue Health Monitoring System include three parts.
These parts include the Cue Cartridge Reader, the Cue
Power Adapter, and the Cue Charging Cable. The Cue
Wireless Charging Base is available as an optional part
(accessory). The Cue Health Monitoring System is used
with test-specic 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.

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Cue Health Monitoring System Components
Each Cue Health Monitoring System part (component) is
described in the table on the next page.

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Component Description Image
Cue
Cartridge
Reader
The Cue Cartridge
Reader communicates
with the Cue Health App
and the test-specic Cue
Cartridges to run a test
on a sample.
Cue Power
Adapter
The Cue Power Adapter
plugs into standard
wall power. The Cue
Charging Cable plugs
into the Cue Power
Adapter.
Cue
Charging
Cable
The Cue Charging Cable
connects the Power
Adapter to the Cartridge
Reader.

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Cue Health Monitoring System Package Contents
Make sure that your system contains the following parts
(components):
• One (1) Cue Cartridge Reader
• One (1) Cue Power Adapter
• One (1) Cue Charging Cable
• User Manual
• Quick Start Guide
Contact Cue Health Customer Support at
[email protected] or call toll-free at
(833) CUE-TEST · [phone] if you do not have all of
these parts. Also contact Cue Health Customer Support if a
part is damaged.

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Cue Test Cartridge Pack
The table on the next page describes Cue Test Cartridge
Packs. Cue Test Cartridge Packs are available for dierent
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.