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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-specific 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.

Содержание Cue

Страница 1: ...1 User Manual For Use Under an Emergency Use Authorization EUA Only For in vitro diagnostic use...

Страница 2: ...ser 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...

Страница 3: ...s 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...

Страница 4: ...e Health App Dashboard 27 Cue Cartridge Reader Indicator Lights 28 Downloading and Installing the Cue Health App 30 Creating Your Cue Account and User Profile 32 Setting Up the Cue Cartridge Reader 35...

Страница 5: ...e 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...

Страница 6: ...set 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 Yo...

Страница 7: ...ill 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 Monit...

Страница 8: ...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 incorre...

Страница 9: ...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...

Страница 10: ...u 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 mor...

Страница 11: ...e 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 Name...

Страница 12: ...he 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...

Страница 13: ...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 an...

Страница 14: ...dge 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 fe...

Страница 15: ...y tests and at the Point of Care POC i e in patient care settings operating under a CLIA Certificate of Waiver Certificate of Compliance or Certificate of Accreditation This product has been authorize...

Страница 16: ...Cue Charging Cable The Cue Wireless Charging Base is available as an optional part accessory The Cue Health Monitoring System is used with test specific Cue Cartridges and sample collection devices Cu...

Страница 17: ...17 Cue Health Monitoring System Components Each Cue Health Monitoring System part component is described in the table on the next page...

Страница 18: ...Cue Health App and the test specific 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 Ad...

Страница 19: ...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 support cuehealth com or call toll free at 833 CUE TES...

Страница 20: ...ribes 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 b...

Страница 21: ...comes with a Cue test cartridge a Cue Sample Wand for collecting a sample and Instructions for Use The Instructions for Use tell you how to use the Cue Cartridge Reader the Cue Health App and the Cue...

Страница 22: ...ue Health App from the Apple App Store The Cue Health App displays test results from the Cue Health Monitoring System The Cue Health App must be open to see test results If the mobile smart device los...

Страница 23: ...ed cloud storage Accessories Available Separately Component Description Image Cue Wireless Charging Base The Cue Cartridge Reader may be charged wirelessly using the Cue Wireless Charging Base The Cue...

Страница 24: ...System Identifying Parts of Your Cue Cartridge Reader The Top and Front of Your Cue Cartridge Reader See Cue Cartridge Reader Indicator Lights in Chapter 3 for information on the meaning of the indica...

Страница 25: ...25 The Back of Your Cue Cartridge Reader USB Port Manual Reset Button...

Страница 26: ...26 The Bottom of Your Cue Cartridge Reader QR Code MAC Address Pin Number...

Страница 27: ...Cue Health App Dashboard Press the Home Button on the Cue Health App screen to see the Cue Dashboard Help Center Manage Profiles Manage Readers My Account Home Button Latest Activity Run Test Last Tes...

Страница 28: ...r 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 Lights Flash when co...

Страница 29: ...hese 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 Wan...

Страница 30: ...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 Cue Health Downloading the Cue Health App from the App Store...

Страница 31: ...nter 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 The Cue Health App needs to be ins...

Страница 32: ...e Account and User Profile 1 Launch the Cue Health App on your mobile smart device The Login screen will be displayed by the Cue Health App 2 Tap on Create Account 3 Input your email and create a pass...

Страница 33: ...eld 5 Tap on SUBMIT and follow the on screen instructions At the completion of profile creation the Permissions screen will be displayed by the Cue Health App 6 Follow the Cue Health App on screen ins...

Страница 34: ...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...

Страница 35: ...he 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 3 Foll...

Страница 36: ...ing and reconnecting the Cue Charging Cable You can also wake the Reader by placing it on top of the Cue Wireless Charging Base Make sure the Cue Wireless Charging Base is connected to wall power 5 In...

Страница 37: ...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...

Страница 38: ...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 Read...

Страница 39: ...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 Multiple Cue Cartridge Readers can be connected...

Страница 40: ...nt and User Profile in Chapter 3 for instructions on how to set up a Cue Account To Log In 1 Launch the Cue Health App on your mobile smart device The Login screen will be displayed by the Cue Health...

Страница 41: ...m If you do not follow all of the instructions you may get an incorrect or invalid result The Cartridge Reader should be placed on a stable flat and level surface while running a test Do not move or t...

Страница 42: ...der will still run to completion 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...

Страница 43: ...nvalid results are Storing or operating the Cue Cartridge Reader in temperatures that are too low or too high See Technical Specifications in Chapter 8 for more details Storing or operating the Cue Ca...

Страница 44: ...n 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 success...

Страница 45: ...plete the Cartridge Reader will automatically go into standby mode 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 Addr...

Страница 46: ...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 4 You m...

Страница 47: ...he 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 char...

Страница 48: ...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 Allow Notifications Allow Locati...

Страница 49: ...en 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 3 Confirm your mobile smart device Bluetooth is enabled 4...

Страница 50: ...Cartridge Reader is out of Bluetooth range of the 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 2 Tap o...

Страница 51: ...screen by tapping on the home button at the bottom of the screen 2 Tap on Manage Readers 3 From the list of CONNECTED Cue Cartridge Readers tap on the next to the one you would like to check The MAC a...

Страница 52: ...screen by tapping on the home button at the bottom of the screen 2 Tap on Manage Readers 3 From the list of CONNECTED Cue Cartridge Readers tap on the next to the one you would like to disconnect 4 Lo...

Страница 53: ...53 Cue Cartridge Reader is now disconnected from the Cue Health App...

Страница 54: ...nto your Cue Account access the Dashboard screen by tapping on the home button at the bottom of the screen 2 Tap on Manage Readers 3 From the list of CONNECTED and DISCONNECTED Cue Cartridge Readers t...

Страница 55: ...g 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 mor...

Страница 56: ...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 The TEST HISTORY and MEDI...

Страница 57: ...57 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...

Страница 58: ...iles 3 Tap on the profile of interest and tap on VIEW The TEST HISTORY and MEDICATION HISTORY of the profile can be accessed on the screen 4 From the TEST HISTORY list tap on the test result of intere...

Страница 59: ...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...

Страница 60: ...g 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 f...

Страница 61: ...ected after each use Wipe down with Clorox Germicidal Wipes containing 0 55 sodium hypochlorite as the active ingredient Do not spray any cleaning solution directly onto the Cue Cartridge Reader or in...

Страница 62: ...ipe 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 instru...

Страница 63: ...n to all symbols messages and indicator lights when you use the system They give you important information to help you use the system correctly and safely If you have questions contact Cue Health Cust...

Страница 64: ...ng table lists the Error Message and the Recommended Action Error Message Recommended Action App displays Tilt Warning Position the Cue Cartridge Reader on top of a stable flat and level surface App d...

Страница 65: ...w on screen instructions App displays Test Has Been Canceled Remove and dispose of the Cartridge Take a new sample using a new test specific Cue Sample Wand and use a new test specific Cue Cartridge t...

Страница 66: ...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...

Страница 67: ...tion 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 Chapter 8...

Страница 68: ...5W Dimensions 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 Display Cue Health App on an iPhone 8 or later mobile smart device screen Operational Temperature 59 F 15 C to 95 F 35...

Страница 69: ...ecifications 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 U...

Страница 70: ...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...

Страница 71: ...oring System does not work properly because of a defect in materials or workmanship Cue Health Inc agrees to replace free of charge any and all parts proven to be defective and subject to warranty Thi...

Страница 72: ...72 Notes...

Страница 73: ...73 Notes...

Страница 74: ...IN9000207 1_4 0...

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