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1. Intro.
Instructions for Use Manual 1 Introduction
1 Introduction
CLIA Complexity: This StatStrip Glucose Hospital Meter Sys-
tem is WAIVED under the Clinical Laboratory Improvements
Amendmentsof1988(CLIA).LaboratorieswithaCerticate
of CLIA waiver can perform this test in a waived setting and
must follow the manufacturer’s instructions for performing the
test.Ifalaboratorymodiesthetestinstructions,thetestwill
no longer be considered waived.
Capillary Precautions
• Caution should be exercised when testing capillary
whole blood due to potential pre-analytical variability
in capillary specimen collection.
• A capillary whole blood specimen relies upon an
adequate,non-compromisedcapillarybloodow.
The healthcare provider must be aware that a
capillary whole blood specimen glucose result may
not always be the same as an arterial or a venous
whole blood glucose result, especially when the
patient's condition is rapidly changing.
• If a capillary whole blood glucose result is not con-
sistent with a patient’s clinical signs and symptoms,
glucose testing should be repeated with either an
arterial or venous specimen on the StatStrip Glucose
Hospital Meter System.
This manual provides all necessary instructions for the routine
operation and maintenance of the StatStrip Glucose Hospital
Meter System. Please read this manual carefully. It has
been prepared to help you attain optimum performance
from your Meter.
This section introduces the meter and covers requirements,
tests performed, procedural limitations, clinical utility, and
sample handling.
The StatStrip Glucose Hospital Meter is a hand-held, battery-
powered, in vitro diagnostic laboratory instrument that works in
conjunction with Nova Biomedical glucose electrochemical test
strips to measure glucose in a whole blood sample, a Quality
Control(QC)solution,linearity,orprociencysolutions.Inad-
dition to measuring glucose, the meter stores patient test data,
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1 9/13/18 8:29 AM
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