1 introduction, Intended use of the itc avoximeter 1000e, Summary and explanation of the test – ITC Avoximeter 1000E Whole Blood Oximeter User Manual

Page 7: Introduction, Avoximeter 1000e, Intended use of the itc

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ITC AVOXimeter 1000E Operator’s Manual

1

1 Introduction

Intended Use of the ITC

AVOXimeter 1000E

The ITC AVOXimeter 1000E is a battery-operated bedside whole blood oximeter that performs
individual point-of-care measurements of oxyhemoglobin saturation (%Hb0

2

) and total

hemoglobin concentration [THb] on freshly-drawn or heparin or EDTA anticoagulated whole blood
samples. Oxygen content [0

2

] of the blood sample is automatically calculated from the %Hb0

2

and

THb measurements.

No sample preparation is required, and analysis is quickly accomplished by injecting the sample
into a disposable cuvette and inserting the cuvette into the instrument. The ITC AVOXimeter
1000E

then illuminates the sample with multiple wavelengths, records the optical density of the

sample at each of the wavelengths, and computes the results. In less than 10 seconds, the
oxyhemoglobin fraction, the total hemoglobin concentration, and the oxygen content of the
sample are shown in appropriate units on the liquid-crystal display on the front panel.

Data management capabilities are included with the instrument. These capabilities include
storage of up to 500 patient or QC results, designation of quality control levels and lot numbers,
tagging of test results with date, time, Patient ID and/or Operator ID, entry of oximetry site and
subsite, and printing of results.

The instrument also can calculate ten hemodynamic variables (such as body surface area,
estimated oxygen consumption rate, and cardiac output using the Fick principle) from data that
are entered by the operator. It can also calculate differences in oxygen saturation between
adjacent anatomical sites from which blood samples were taken (saturation step-ups), to aid in
diagnosing intracardiac and great vessel shunts.

Summary and Explanation of the Test

The ITC AVOXimeter 1000E measures whole blood %Hb02 and [THb] using disposable single-
use cuvettes. The operator inserts a whole blood sample into a cuvette, the cuvette is inserted
into the test chamber on the instrument, and the results are displayed. The results will remain on
the display while the cuvette remains in the instrument.

The result can be automatically printed along with the time and date the test was run, the Patient
ID, Operator ID, and other information entered. The result is also saved in an internal database,
which has the capability to store up to 500 results.

Individual ITC AVOXimeter 1000E instruments can be customized so that optical quality control
tests must be performed whenever a specified period of time has elapsed. In addition, up to three
liquid control lot numbers for each level of liquid QC can be stored in the ITC AVOXimeter 1000E
and can be tagged to the stored or printed liquid QC records. The instruments can also be
configured so that only authorized operators can operate the system and that patient IDs are
required for each test run.

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