WORKSITE FLASH-M TESTING AGREEMENT
A. SUMMARY OF FLASH-M
FLASH-M is a non-contact, rapid screening device designed to detect the presence of the SARS-CoV-2 virus (COVID-19) via optical measurements. FLASH-M does not require any swabs, reagents, or samples to capture the optical data for COVID-19 detection.
The FLASH-M scan is safe, non-contact and takes 30 seconds of your time. The imaging data from FLASH-M will not store your personal information but will be used to identify specific markers common to all COVID-19 positive individuals.
COVID-19 rapid screening results will be returned within 30 seconds of a FLASH-M scan.
FLASH-M is the proprietary technology of HNu Photonics LLC.
Your employer is charged for the cost of your test.
If you agree to FLASH-M testing, the following will happen:
1. A FLASH-M image of your face will be taken at ~2 feet. This image will:
a. Center the camera on your face,
b. Use a gentle light to illuminate your face,
c. Capture your temperature profile,
d. Capture visual data from your eyes, mouth, and forehead,
e. Take less than 10 seconds.
2. Your COVID-19 data will be coded with a CHQR label and stored in your CHQR-ID account.
3. Results will be returned with 30 seconds of the FLASH-M scan.
D. RISKS AND DISCOMFORTS
FLASH-M is a non-invasive technique to test for the presence of COVID-19 within a subject. This testing method represents a minimal risk to the subject. The subject may experience minor discomfort from face illumination during the FLASH-M scan (similar to a camera flash). Any discomfort from the FLASH-M scan will last less than 30 seconds.
Individuals with a history of seizures or epilepsy should take caution that the “flash” may increase the risk of seizure.
· FLASH-M is a non-contact, non-invasive COVID-19 screening device that requires no sample, no reagents, and no consumables of any kind. Although FLASH-M has been submitted to the FDA for Emergency Use Authorization, it is not an FDA-approved diagnostic device. During the pendency of the FDA application, FLASH-M is being used for COVID-19 triage screening studies, meaning that if a FLASH-M screen suggests the possible presence of the SARS CoV-2 virus (i.e., a COVID-19 infection), the person screened will be recommended for PCR-based testing. FLASH-M should not be relied on for COVID-19 diagnosis. Further screening by PCR testing is required for a definitive diagnosis of COVID-19 infection.
· FLASH-M is currently under FDA EUA review for approval for COVID-19 detection.
· Individuals with a history of seizures or epilepsy should be aware that they may have an increased risk of seizure during FLASH-M image capture due to face illumination during acquisition.
The term of this agreement shall commence on the Effective Date and continue until terminated. This agreement may be terminated at any time and for any reason by either party by contacting a representative from HNu Photonics.
G. CONSENT TO BE TESTED
I _____________________________(PRINT NAME) consent to be tested with FLASH-M for the presence of the SARS-CoV-2 virus (COVID-19) and understand that FLASH-M has not received FDA EUA approval yet. Furthermore, I understand if I test “UNCLEAR” with FLASH-M, I shall seek the advice of a medical professional to confirm the presence of the SARS-CoV-2 virus with a CDC approved test.
Signature of Participant or Guardian (if participant is a minor) Effective Date