Introduction; Intended Use; Summary And Explanation - Siemens CLINITEK Status+ Operator's Manual

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Introduction

The introduction explains how to get started, unpack, and install your
®
CLINITEK Status + analyzer. The introduction also includes an overview
of the analyzer.

Intended Use

The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to
use analyzer. It is designed to read only
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and
®
Clinitest hCG tests.
This analyzer is intended for the measurement of the following in
urine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose,
Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio,
Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and
human Chorionic Gonadotropin (hCG).
These measurements are used to assist diagnosis in the following
areas:
• Kidney function
• Urinary tract infections
• Metabolic disorders (such as diabetes mellitus)
• Liver function
• Pregnancy
Tests perfomed using the CLINITEK Status+ analyzer are intended for in
vitro diagnostic use only.
The CLINITEK Status+ analyzer is intended for near patient (point-of-
care) facilities and centralized laboratory locations.

Summary and Explanation

The urinalysis strips also measure physical characteristics, including
acid-base balance and urine concentration. Test results can be used
along with other diagnostic information to rule out certain disease
states and to determine if microscopic analysis is needed.
CLINITEK Status+ Analyzer Operator's Guide 7