User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
IV 1
General Precautions
and Safety Instructions
It is the sole responsibility of the user to ensure that they have read
and understood this user manual before using the Proof Diagnostics
Test System.
General Precautions
CAUTION:
• For FDA Emergency Use Authorization (EUA) only.
• For in vitro diagnostic use only.
• For prescription use only.
• The Proof Diagnostics Test System has not been FDA cleared
or approved; this test has been authorized by the FDA under an
EUA for use by laboratories certied under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that
meet the requirements to perform moderate, high or waived
complexity tests. This test is authorized for use 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 test has been authorized only for the detection of SARS-CoV-2
nucleic acid, not for any other viruses or pathogens.
• The use of the Proof Diagnostics Test System has been authorized
only for the duration of the declaration that circumstances
exist justifying the authorization of emergency use pursuant to
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.
• Single Use Only: Do not attempt to reuse any Test Kit consumables
(cartridges, swabs or sample vials).
• The Proof Diagnostics Test System is only for use by healthcare
professionals in a suitable laboratory, clinical environment or CLIA-
waived environment.
• Do not use specimens stored in viral transport media; only use
specimens stored in the Proof Diagnostics sample vial.
Reader Maintenance ����������������������������������������������������������� 25
Cleaning the Reader 25
Updating Reader Firmware 25
Error Alerts ����������������������������������������������������������������������������� 26
Technical Specications ����������������������������������������������������� 27
Table of Symbols ������������������������������������������������������������������ 28
Regulatory Notices ������������������������������������������������������������� 29
Support ����������������������������������������������������������������������������������� 30
Warranty ������������������������������������������������������������������������������� 30
Disposal ���������������������������������������������������������������������������������� 30