4
5
Testing Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
28
Helpful Hints on Getting a Good Drop of Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
28
How to Obtain a Blood Sample From a Fingerstick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
29
Quick Reference - How to Run a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30
7
Memory
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31
How to Review Results Stored in Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31
How to Clear Results Stored in Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32
8
Care and Cleaning
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33
Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33
Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35
Disinfection Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
36
9
Troubleshooting
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
38
10
Interpreting Results
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
40
11
CLIA Information
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
41
General CLIA Information (US Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
41
12
Specifications
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42
CardioChek PA Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42
PTS Panels Test Strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42
Optional CardioChek/PTS Connect Printer/Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . .
42
13
Contact Information
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
43
Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
43
14
Warranty
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
44
CardioChek PA Analyzer Limited One-Year Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
44
15
Explanation of Symbols
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
45
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
45
16
Index
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
46
CardioChek PA System Intended Use
The CardioChek PA test system (consisting of the CardioChek PA analyzer and PTS Panels
test strips) is 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 and is 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.
•
Cholesterol measurements are used in the diagnosis and treatment 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.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are
calculated by the CardioChek PA analyzer.
The CardioChek PA
analyzer from PTS Diagnostics is intended for
in vitro
diagnostic
use, using whole blood samples. This point-of-care (POC) test system is designed
for professional use. The CardioChek PA test system has an optional printer and the
CardioChek Link®
software solution to assist in data reporting.
Introduction
1
