Product Manual

1
Section 1 Introduction
The Pro Advantage
®
Urine Analyzer reads urine test strips. It stores results and
prints reports without the need for special training.
The Pro Advantage
®
Urine Analyzer runs a self-test each time the power switch is
turned on. An optional barcode reader records patient ID. The barcode reader
verifies strip canister barcodes. Use only Pro Advantage
®
Urine Reagent Strips
with the canister barcode for correct results.
The Pro Advantage
®
Urine Analyzer is CLIA waived when used with strips of the
same brand as the analyzer. Only laboratories with a Certificate of CLIA Waiver
may use this analyzer in a waived setting. Users should read this complete test
procedure before performing a test using this analyzer. Failure to adhere to these
instructions for use and for performing QC testing is considered off-label use.
Off-label use is categorized as high complexity and subject to all CLIA regulations.
Intended Use
The Pro Advantage
®
Urine Analyzer is intended for use in conjunction with the Pro
Advantage
®
Urine Reagent Strips for the semi-quantitative detection of the
following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific
Gravity, Blood, pH, Protein, Urobilinogen and Leukocytes as well as the qualitative
detection of Nitrite. The instrument is intended for professional, in vitro diagnostic
use only.
Note: Keys on the Keypad are listed in bold. Display items on the
screen are listed in bold italics in the manual.