Operating precautions and warnings, Limitations – ITC Avoximeter 1000E Whole Blood Oximeter User Manual

Page 11

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ITC AVOXimeter 1000E Operator’s Manual

5

Operating Precautions and Warnings

For in vitro Diagnostic use.

Do not allow blood, water, or other liquids to enter the instrument.

The ITC AVOXimeter 1000E instrument is designed for use only with ITC
AVOXimeter

1000E cuvettes.

Do not re-use test cuvettes.

Always keep cuvettes in sealed bag with desiccant.

When filling cuvette, do not use excessive pressure on the syringe or cause the
vent patch to bulge outward by overfilling the cuvette.

For proper calibration and calibration verification, use only the controls recommended
in this manual. Controls from other sources may yield erroneous results.

The ITC AVOXimeter 1000E instrument is designed to be used for testing in a
stationary position. DO NOT perform testing while carrying or holding the
instrument.

In order to charge the ITC AVOXimeter 1000E instrument, the AC power cord
should be plugged into an electrical service outlet and the AC/DC power module
while the DC power cord from the AC/DC power module is plugged into the DC
port in the back of the instrument.

DO NOT expose the ITC AVOXimeter 1000E instrument to extreme temperature
(above 35°C, 95°F). Such exposure could affect the performance of any type of
electronic instrumentation.

DO NOT drop the ITC AVOXimeter 1000E instrument, and do not use the results if
the instrument is dropped during a test.

Only properly qualified personnel should attempt to open and perform work on the
ITC AVOXimeter 1000E instrument as identified in this manual.

DO NOT remove the AC/DC power module from the ITC AVOXimeter 1000E
instrument by pulling on the cord.

The use of accessory equipment (e.g., printers, etc.) not identified in this manual
either in the patient vicinity, or that does not comply with either the equivalent
safety requirements of this equipment or UL/IEC 60601-1 or IEC 60601-1-2, may
lead to a reduced level of safety with the resulting system.

Any items exposed to human blood, plasma or serum must be handled cautiously as a
biohazardous material in accordance with laboratory safety practices and federal and
local regulations. Federal, state and local laws and regulations require that hazardous
waste be disposed of in a specific manner. Waste material from the ITC AVOXimeter
1000E

which may be classified as biohazardous include used cuvettes. It is important

that steps be taken to dispose of these materials in accordance with the prevailing
regulations in your location.

Limitations

Do not disturb the instrument while a test is in progress. As with all diagnostic tests, ITC
AVOXimeter 1000E

test results should be scrutinized in light of a specific patient’s condition and

therapy. Any results exhibiting inconsistency with the patient’s clinical status should be repeated
or supplemented with additional test data.

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