B. Braun Omnitest 5 Manual page 3

Overview
does Omnitest® 5 meet the requirements
of isO 15197:2013?
Which sort of blood has to be used?
What is the hematocrit range?
Why could the result be different from a
competitor device?
Which medications may affect the measurement?
What is the test principle of Omnitest® 5?
What is Omnitest® 5 calibrated against?
Which laboratory system was used for the
calibration of Omnitest® 5?
What are the components of the Omnitest® 5
set?
What are the components of Omnitest® 5
(solo version)?
yes
Omnitest® 5 measures the blood glucose level with fresh capillary or
venous whole blood.
20 – 60 % within 10 – 600 mg/dL or
20 – 60 % within 0.6 – 33.3 mmol/L.
General measurement deviation of ± 15 % according to
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isO standard possible
different blood sample (e.g. time, puncture site, venous or capillary)
n
no effect in case of normal therapeutic concentrations.
see also instructions for use (iFu) for test strips.
the FAd-glucose dehydrogenase enzyme on the test strips reacts
specifically with glucose in blood. the current generated is converted
and displayed as a blood glucose value.
the Omnitest® 5 system is plasma-calibrated to allow easy comparison
of results with laboratory methods. Blood glucose meters which are
calibrated against a whole blood method may have different results in
comparison to the Omnitest® 5 results.
the laboratory system used to calibrate the Omnitest® 5 system is
ysi 2300 stAt plus, which is equipped with a glucose oxidase system.
1 protective meter case
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1 Omnitest® 5 blood glucose meter
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incl. 2 batteries
10 Omnitest® 5 test strips
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1 Omnican® Lance lancing device with
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10 Omnican® Lance soft lancets
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1 check strip
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1 user manual
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1 quick reference guide
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1 proper test instructions
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1 protective meter case
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1 Omnitest® 5 blood glucose meter
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incl. 2 batteries
1 check strip
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1 user manual
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1 quick reference guide
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1 proper test instructions
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Omnitest® 5
3