1. Introduction
ABL800 FLEX Operator's Manual
Limitations of use and known interfering substances
Limitations of
use
The following limitations should be taken into consideration:
The ABL800 FLEX analyzers are designed for measurements of adult and fetal
hemoglobin with normal spectrum characteristics. Some spectra deviate from the
normal characteristics, e.g. for certain hemoglobinopathies and the ABL800 FLEX
analyzers do not compensate for this.
CAUTION - Fulfillment of user-specific analytical needs
The user should review the analyzer performance data to assure that the
performance fulfills the user-specific analytical needs.
WARNING – Clinical decisions
The validity of the test results from this instrument must be carefully
examined by a clinician and related to the patient’s clinical condition,
before any clinical decisions are taken on the basis of the test results.
CAUTION - Risk of erroneous results
Always meticulously follow the sampling procedures described in
chapter
12: Sampling
. Failure to follow these procedures may introduce clots or air
bubbles in the sample and yield erroneous results.
NOTICE:
Bilirubin measurements on plasma and creatinine measurements on
plasma and serum need to be measured in Other fluids mode, as the other modes
are intended for measurement on human whole blood only. Corrections for
Creatinine can be found in the Reference Manual.
F
HbF measurement:
The uncertainty in
F
HbF measurements exceeds the level required to measure
normal HbF levels in the adult range (
F
HbF reference range is 0-1 %).
The following substances are known to affect or interfere with measurements on
the ABL800 FLEX analyzers.
CAUTION -
Known
interfering
substances
Substance Interference
Halothane (anesthetic)
May give unreliable
p
O
2
results.
Lipid therapy (treatment)
In OXI measurements.
After measurement on blood from a patient who
has received lipid therapy it may be necessary
to clean the analyzer using the Cleaning
program.
Methylene Blue, HiCN
(medication)
In OXI measurements.
Anions:
Br
−
, I ,
and
Cl
(drugs)
−
S
2
−
O
4
−
Erroneously high
c
Cl
-
results.
Continued on next page
1-4
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