pts Diagnostics CardioChek Plus, User Manual

Page: 4 / 51

I. INTRODUCTION
CardioChek ® Plus
Intended Use
The CardioChek Plus test system is a small, portable analyzer and test strip
system intended for multiple-patient use in professional healthcare settings.
This system should only be used with single-use, auto-disabling lancing
devices. This system is for
in vitro diagnostic use only. The test strips are
for the quantitative determination of glucose, total cholesterol, HDL (high
density lipoprotein) cholesterol, and triglycerides in venous whole blood and
capillary whole blood from the fingertip. A Chol/HDL ratio and estimated
values for LDL (low density lipoprotein) cholesterol and non-HDL
cholesterol are calculated by the CardioChek Plus analyzer.

Cholesterol measurements are used in the diagnosis and treatments
of disorders involving excess cholesterol in the blood and lipid and
lipoprotein metabolism disorders.

HDL (lipoprotein) measurements are used in the diagnosis and treatment
of lipid disorders (such as diabetes mellitus), atherosclerosis, and various
liver and renal diseases.

Triglycerides measurements are used in the diagnosis and treatment
of patients with diabetes mellitus, nephrosis, liver obstruction, other
diseases involving lipid metabolism or various endocrine disorders.

Glucose measurements are used in the diagnosis and treatment of
carbohydrate metabolism disorders including diabetes mellitus,
neonatal hypoglycemia, and idiopathic hypoglycemia, and of
pancreatic islet cell carcinoma.
This user guide is for professional users. The CardioChek Plus professional
test system may be used with an optional printer, optional software solutions (a
software accessory to provide personalized health related information using
cholesterol results), and has wireless communication capability to assist in data
reporting.
This analyzer is a component of a test system that includes PTS Panels ®
eGLU test strips, PTS Panels ® glucose test strips and PTS Panels ® lipid panel
test strips. The PTS Panels test strip box includes a lot-specific MEMo Chip
®
that contains the assay calibration curve and other important information
about the assay. PTS Panels test strips are sold separately, and are available
as single and multiple-analyte test strips.
The test system uses reflectance photometry and electrochemical biosensor
technology. Reflectance test strips utilize an enzymatic reaction to produce a
color change that is detected by the analyzer after whole blood is applied.
Electrochemical test strips measure an electrical current when whole blood is
applied.
4