Limitations Of The Procedure - Bayer HealthCare Elite XL User Manual

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1. PRESERVATIVES:
2. ARTERIAL SPECIMEN: Arterial specimens with pO
3. NEONATAL USE: The Glucometer Elite
4. METABOLITES: Reducing substances such as ascorbic acid
5. HEMATOCRIT: At normal glucose levels, Glucometer Elite
6. LIPEMIC SPECIMEN: Cholesterol up to 500 mg/dL
CONTRAINDICATION (Bayer advises against): Capillary
blood glucose testing may not be clinically appropriate when
peripheral blood flow is decreased. Shock, severe hypotension,
hyperosmolar hyperglycemia and occurrence of severe dehydra-
tion are examples of clinical conditions which may adversely
affect the measurement of glucose in peripheral blood.
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Limitations of the Procedure

• Fluoride – Do not use fluoride as a preservative for blood
specimens.
• Iodoacetic acid – Do not use iodoacetic acid as a
preservative for blood specimens.
>200 mmHg had a small bias (average of –6%) on the
Glucometer Elite in comparison to the laboratory method
glucose results. The reference range for arterial pO
110 mmHg (11.04 to 14.36 kPa).
is the only Glucometer Elite System qualified for neonatal
use. It is intended for monitoring treatment of hypo-
glycemia in neonates. The Glucometer Elite XL System
is not intended for diagnosis of neonates for hypoglycemia.
Do not use any other Glucometer Elite
for neonatal testing.
and uric acid at normal blood concentrations do not signifi-
cantly affect Glucometer Elite XL blood glucose test results.
Test Strip results are not significantly affected by hematocrits
in the range of 20% to 60%. At glucose levels above
300 mg/dL (16.7 mmol/L), hematocrit levels above 55% will
cause lowered results. For Neonatal Use: At glucose levels
between 20 mg/dL (1.1 mmol/L) and 120 mg/dL (6.7 mmol/L),
Glucometer Elite XL results are not significantly affected by
hematocrit levels in the range of 20% to 70%.
(13.0 mmol/L) or triglycerides up to 3000 mg/dL
(33.9 mmol/L) do not significantly affect the results.
Glucose values, however, in specimens beyond these
levels should be interpreted with caution.
Atkin S, Jaker MA, Chorost MI, Reddy S, Fingerstick Glucose
Determination in Shock. Annals of Internal Medicine 1991,
114: 1020–24
of
2
is 80 to
2
® XL System
® Blood Glucose Meter
1
Glucometer Elite
®
XL