FCC ID: 2A3QA-001 CUE Cartridge Reader

1 2 3 4 5 6 7 8 9 10 Practices Used in This User Manual Procedure steps in this User Manual are easy to find. They symbol, followed by a short description of begin with a 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 Italics Bold Italics Names of menus and buttons System response that occurs as a result of pressing an icon or an action command in the Cue Health App Used to emphasize important information 11 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 12 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. 13 14 15 16 17 18 19 20 Component Description Image Cue Cartridge Reader Cue Power Adapter Cue Charging Cable The Cue Cartridge Reader communicates with the Cue Health App and the test-specific Cue Cartridges to run a test on a sample. The Cue Power Adapter plugs into standard wall power. The Cue Charging Cable plugs into the Cue Power Adapter. The Cue Charging Cable connects the Power Adapter to the Cartridge Reader. 21 22 23 Component Description Image Cue Test Cartridge Pack A Cue Test Cartridge Pack 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 cartridge to run a test on the sample. Cue COVID-19 Test Cartridge Cue Sample Wand 24 25 The Cue Health App also stores test results and communicates with the internet and the secured 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 Cartridge Reader is secured by magnets when charging on top of the Cue Wireless Charging Base. 26 27 USB Port Manual Reset Button 28 29 Last Test Result 30 Cue Cartridge Reader Indicator Lights Status Indicators 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. Lights Flash when connected Lights Flash when the Cue Cartridge or the Cue Sample Wand is inserted Error, see Cue Health App for details 31 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 inside) from the Cue Cartridge Reader 32 33 34 35

36 37 38 39 40 41 42 43 44 45 46 47 48 Chapter 5 Cue Health Monitoring System Management 49 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

*Green indicates flashing light 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 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 Warning App displays The battery on your cartridge reader is too low to run a test Position the Cue Cartridge Reader on top of a stable, flat, and level surface. Connect the Cue Cartridge Reader to power. Use the Cue Health Monitoring System components/

accessories. 67 Error Message Recommended Action App displays Testing Error or Cartridge Error App displays Test Has Been Canceled Follow on-screen instructions. 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 to repeat the test. See the Cue Health App on-screen instructions for additional details. 68 69 70 Technical Specifications Cue Cartridge Reader Specifications Power Supply Input: 100-240V~, 50/60Hz, 0.2A Output: 5VDC, 1.5A, 7.5W Dimensions

(2.9 in x 2.9 in x 1.5 in)

(74 mm x 74 mm x 37 mm) Weight Display Operational Temperature Operational Humidity Operational Altitude Storage Temperature 5.29 oz (150 g) Cue Health App on a mobile smart device screen 59F (15C) to 95F (35C) 10% to 100%

0 ft (0 m) to 8530 ft (2600 m) 39F (4C) to 100F (38C) 71 Storage Humidity Storage Altitude 10% to 100%

< 8530 ft (2600 m) 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. FCC Part 15B ICES-003 IEC/EN 61326 Class B FCC Part 15.247 UL 60950-1 UL 62368-1 72 73 74 ___________________________________________________ ___________________________________________________ ___________________________________________________ ___________________________________________________ ___________________________________________________ ____________________________________________________ ____________________________________________________ ____________________________________________________ 75 76

Cue Health TUV SUD America inc. 10 Centennial Drive Peabody, MA 01960, USA 07 January 2022 Dear Sir or Madam, We, Cue Health Inc authorize Marlene Sealey of TUV SUD America, to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. Yours sincerely, Kind regards, stillo, Mr. (ex N Cue Health Inc erento anensastse TESTO aaa een mea eee Roderick Castillo Director, Regulatory and Clinical Affairs 4980 Carroll Canyon Road, Suite 100 san Diego, CA 9212}

Son EE rpneeames Roderick.castillo@cuehealth.com

Cue Health Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21048 07 January 2022 Confidentiality Request FCC ID: 2A3QA Pursuant to Sections 0.457(d) (1) (ii) and 0.459 of the Commission's Rules, Cue Health Inc. hereby requests permanent confidential treatment of information accompanying this application as outlined below:

- Block Diagrams

- Operational Description

~ Parts Lists and Tune-up Information

- Schematic Diagrams Cue Health Inc hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of 180 days:

Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d) (1) (ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Kind regards, Castillo, Mr. Roderick N Cue Health Inc Roderick Castillo Director, Regulatory and Clinical Affairs 4980 Carroll Canyon Road, Suite 100 San Diego, CA 92121 tantra ho TSP reiterate Roderick.castillo@cuehealth.com