Cue Health Monitoring System User Manual

: June 17, 2024
: Cue

Table of Contents

Cue Health Monitoring System
Product Information
Product Usage Instructions
About the Cue Health Monitoring System (Reader)
Indicator Lights
Document Detail
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Cue Health Monitoring System

Cue-Health-Monitoring-System-product-image

Product Information

Product Name: Cue Mpox (Monkeypox) Molecular Test
Document Number: AIIN9100158-4[1]
Title: Artwork, Quick Start Guide, Cue Mpox (Moneybox) Molecular Test
Document Owner: Maria Vestal
Status: CURRENT
Effective Date: 26-May-2023
Expiration Date: 26-May-2027

Specifications

Type : AIIN
Test Type : Molecular Test
Disease : Monkeypox

Product Usage Instructions

Step 1: Preparing the Sample
Collect a sample from the patient suspected of having Monkeypox using the provided collection kit. Follow the instructions in the collection kit to ensure proper sample collection.
Step 2: Sample Processing
Transfer the collected sample into the provided sample processing tube. Make sure to follow the instructions in the kit for proper sample processing.
Step 3: Test Cartridge Preparation
Open the test cartridge packaging and remove the cartridge. Insert the cartridge into the Cue device following the device’s instructions. Ensure that the cartridge is properly inserted and secured.
Step 4: Loading the Sample
Using the provided pipette, transfer a small amount of the processed sample into the designated well on the test cartridge. Be careful not to overfill or contaminate the well.
Step 5: Running the Test
Close the cartridge lid and start the test using the Cue device. Follow the device’s instructions to initiate the test run. The device will automatically analyze the sample and provide the test results.
Step 6: Reading the Results
Once the test is complete, the Cue device will display the test results. Interpret the results based on the device’s instructions and guidelines provided in the user manual.
Step 7: Disposing of the Cartridge
After reading the results, dispose of the used test cartridge following proper biohazard waste disposal guidelines. Do not reuse or recycle used cartridges.

Frequently Asked Questions (FAQ)

Q: How accurate is the Cue Mpox Molecular Test?
A: The Cue Mpox Molecular Test has been validated for accuracy and shows high sensitivity and specificity in detecting Monkeypox.
Q: Can the Cue device be used for other tests?
A: No, the Cue device is specifically designed for use with the Cue Mpox Molecular Test and cannot be used for other tests.
Q: How long does it take to get the test results?
A: The test results are typically available within [insert time frame] after starting the test on the Cue device.
Q: Is training required to use the Cue Mpox Molecular Test?
A: Yes, it is recommended to receive proper training on using the Cue device and performing the Cue Mpox Molecular Test before conducting tests independently.

For Use Under an Emergency Use Authorization (EUA) Only For in vitro diagnostic use
Cue Health Monitoring System (Reader) Get Started Here

Set Up Your Cue® Account
Download the Cue Health App from the Apple App® Store® or Google Play Store TM to your mobile smart device. Go to www.cuehealth.com for a list of= compatible devices. Follow the on-screen instructions to create your account and pair your Cue Health Monitoring System (Reader) to your mobile smart device.

Connect Reader to power
When prompted on the Cue Health App, connect your Reader directly to power using the supplied Cue Power Adapter and USB Charging Cable.

Find Reader QR code

Rotate your Reader upside-down so the bottom of the Reader is facing up and the QR code is visible to you.
The QR code is located on the bottom of the Reader

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Pair Reader to mobile device

When prompted on the Cue Health App, adjust the camera so the QR code is visible on-screen and inside of the capture outline.
When the QR code is recognized, the Reader is paired securely to the mobile smart device.

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Cue Reader is ready to use

To begin using the Reader to run tests, open the
Cue Health App and follow the on-screen instructions

Welcome to Cue®

Welcome
- This guide will help you get started using the Cue Health
- Monitoring System (Reader) and the Cue Health App.
Get Started
- See opposite page for instructions on downloading the Cue
- Health App, creating your Cue Account, and setting up your Cue Reader.
Questions
- Cue and the Cue logo are registered trademarks of Cue Health Inc. Apple and App Store are registered trademarks of Apple Inc. Google Play is a trademark of Google LLC. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cue is under license. Other trademarks and trade names are those of their respective owners.
- This product has not been FDA cleared or approved; but has been authorized for emergency use by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-COV-2 virus, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
- This product has not been FDA cleared or approved; but has been authorized for emergency use by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from monkeypox virus, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and diagnose infection with non-variola Orthopoxvirus under Section 564(0)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

About the Cue Health Monitoring System (Reader)

Cue Reader
Your Reader pairs with the mobile smart device, accepts Cue test-specific Cartridges, and runs tests

Your Cue Reader communicates with the Cue Health App using a secure wireless connection toy our mobile smart device with BLUETOOTH® wireless technology.
A Cue Reader can be used with multiple mobile smart devices, but only one smart device at a time can connect to a Reader to run a test and receive test results.

Charging with USB
Your Cue Reader can be quick-charged directly using a cable through the USB port located on the Reader.

Indicator Lights

Reader lights communicate status
The Cue Reader features 5
LED indicator lights located on the top of the

Cue Reader.

The lights provide quick feedback on the status of the Cue Reader together with the Cue Health App.
The lights display unique patterns to communicate charging status, battery level, prompts for testing actions, test status, and test errors.
Battery Level
When the Reader is connected to power, the lights will sequentially illuminate then flash to indicate the battery charge level
Prompts for an Action
While running a test or after a test has completed, the indicator lights will sweep from top to bottom or in reverse
Alerts
When connecting to the Cue Reader or at the start of a test, the indicator lights will flash in different patterns