1
Section 1 Introduction
The
AimStrip
®
Urine Analyzer and
CTMI
CT-120 Analyzer read urine test strips. It
stores results and prints reports without the need for special training.
The
AimStrip
®
Urine Analyzer and
CTMI
CT-120 Analyzer run 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
AimStrip
®
and
Fisherbrand
®
Urinalysis Reagent Strips with the canister barcode for correct
results.
The
AimStrip
®
Urine Analyzer and the
CTMI
CT-120 Analyzer are 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
AimStrip
®
Urine Analyzer and the
CTMI
CT-120 Analyzer are intended for use
in conjunction with the
AimStrip
®
and
Fisherbrand
®
Urinalysis 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.
