HemoCue Glucose 201, Operating Manual

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Storage and handling of the HemoCue Glucose 201
Microcuvettes
Storage for microcuvettes kept in a vial
Store unopened HemoCue Glucose 201 Microcuvettes below
46 °F (8° C) (incl. storage in a freezer). Note, microcuvettes stored in
a freezer must be allowed to reach room temperature (approx.
30 minutes) before analysis. Microcuvettes kept in an opened vial are
stable for 30 days when stored in a refrigerator at 35–46 °F (2–8 °C).
After breaking the seal, the vial can be stored at room temperature at
59–86 °F (15–30 °C) for up to 3 days. Close the lid immediately after
microcuvettes are removed from the vial.
Storage for individually packaged microcuvettes
Store unopened HemoCue Glucose 201 Microcuvettes below
46 °F (8° C) (incl. storage in a freezer). Note, microcuvettes stored in a
freezer must be allowed to reach room temperature (approx. 30 minu-
tes) before analysis. The individually packaged microcuvettes can be
stored at room temperature at 59–86 °F (15–30 °C) for up to 3 days.
HemoCue Glucose 201 Analyzer
The analyzer can be stored at 32 – 122 °F (0 – 50 °C). The HemoCue
Glucose 201 system is designed for use at room temperature 64 –86 °F
(18– 30 °C). The analyzer should not be operated at high
(i.e. > 90 % non-condensing) humidity.
Quality Control
The HemoCue Glucose 201 Analyzer has an internal quality control,
the ”selftest”. Every time the analyzer is turned on, it will automatically
verify the performance of the optronic unit of the analyzer. This test
is performed every second hour if the analyzer is left turned on. The
HemoCue Glucose 201 system must be verified on the day of testing
using commercially available controls, recommended by HemoCue.
Contact HemoCue America, Technical Support, for advice.
Results
The measuring range is 0–444 mg/dL (24.6 mmol/L). Results above
444 mg/dL (24.6 mmol/L) will be displayed as HHH and should be
confirmed with another laboratory method. To establish HemoCue
glucose reference values and an intervention level, neonatal blood
samples should be evaluated against a suitable laboratory method
taking into consideration the difference between whole blood
and plasma reference values. Any results with HemoCue Glucose
Systems suggesting clinical intervention in the hyperglycemic range
on pre-term neonates (<37 weeks), should be verified against a
suitable laboratory reference method. For specific performance
characteristics, see the package insert for the HemoCue Glucose 201
Microcuvettes.
Limitations
HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use
only. The HemoCue Glucose 201 Analyzer is only to be used together
with HemoCue Glucose 201 Microcuvettes. For additional limitations
of the procedure, see the package insert for the HemoCue Glucose
201 Microcuvettes. The HemoCue Glucose 201 Analyzer with plasma
conversion multiplies the obtained whole blood glucose value by a
factor and displays a plasma equivalent glucose result. Since this fac-
tor is based on the relationship between plasma and whole blood at
normal hematocrit, care should be taken when evaluating results in
situations where the hematocrit may be extreme.
Expected values
Fasting plasma blood glucose, adults 74–106 mg/dL (4.5-5.9 mmol/L). 5
For diagnosis of diabetes mellitus, follow local recommendations or
use the following value according to WHO:
Fasting plasma glucose, capillary or venous
≥
126 mg/dL (
≥
7.0 mmol/L). 6