HemoCue HbA1c 501 Bedienungsanleitung Seite 3

1. INTENDED USE
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The Hemocue HbA1c 501Test Cartridge, together with the Hemocue
501 Analyzer, which are parts of the Hemocue
convenient method for measuring hemoglobin A1c (HbA1c %) in both capillary
and anticoagulated venous whole blood samples. The test is used for monitoring
glycemic control in patients with diabetes mellitus and as a supplement of the
clinical evidence in the diagnosis of diabetes as well as in identifying patients at risk
for developing diabetes
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The Hemocue HbA1c 501 system uses a boronate affinity assay to separate the
glycated hemoglobin fraction from the nonglycated fraction. The Hemocue
501 system is intended to be used by professionals in laboratories, clinics and
hospitals.
IMPORTANT: Please read through and familiarize yourself with the contents of
this operating manual before using the system for the first time.
2. GENERAL INFORMATION
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The HemoCue HbA1c 501 system is a small, portable, and fully automated point-
of-care system for all healthcare environments. The system delivers rapid results
with laboratory equivalent accuracy and precision across all test parameters.
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The HemoCue HbA1c 501 system may be used as a basic test system where the
user manually records the results, or as an advanced system where accessories
enable automatic printing of results, input of patient and operator identification
numbers, and full connectivity to a PC. This makes the system highly versatile as it
can be tailored to specific user needs.
This manual contains all the information needed to operate and maintain the
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HemoCue HbA1c 501 system.
3. PRINCIPLES OF OPERATION
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The HemoCue HbA1c 501 system is a fully automated boronate affinity assay for
determination of the Hemoglobin A1c percentage (HbA1c %) in whole blood.
The Test Cartridge consists of a cartridge and a reagent pack containing the
reagents necessary for the determination of hemoglobin A1c, with a sampling area
for blood collection.
The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent
solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically
as well as a boronate resin that binds to the cis-diols of glycated hemoglobin.
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HbA1c
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HbA1c 501 system provides a
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HbA1c
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3. PRINCIPLES OF OPERATION
The blood sample (4μL) is collected at the sampling area of the reagent pack, which
is then inserted into the cartridge, where the blood is instantly lysed releasing the
hemoglobin and the boronate resin binding the glycated hemoglobin.
The reagent pack containing the blood sample is inserted in HemoCue
Analyzer (in which the cartridge has been placed). The cartridge is automatically
rotated, placing the blood sample in the measuring zone. The total hemoglobin is
photometrically measured by the diffused reflectance of the optical sensor
composed of both a LED (Light Emitting Diode) and a PD (Photo Diode).
The assembled cartridge is rotated and the rinsing solution washes out non-
glycated hemoglobin from the blood sample, enabling photomectical measurement
of glycated hemoglobin.
The ratio of glycated hemoglobin and total hemoglobin is calculated.
HbA1c % = A x [
Total Hemoglobin
Where 'HbA1c' and 'Total Hemoglobin' are the signals obtained from the HemoCue HbA1c 501
system, 'A' and 'B' are the slope and intercept factors to correct the value for the calibration
standard of NGSP.
* NGSP: National Glycohemogolbin Standardization Program
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4. HemoCue HbA1c 501 Analyzer CONTENTS
At delivery carefully inspect the product for any obvious physical damage.
If any damage is evident, please consult your local distributor.
Contents
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1. Hemocue HbA1c 501 Analyzer
2. Operating Manual
5. Daily Check Cartridge
4. Fan Filters
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HbA1c 501
HbA1c
x 100 ] + B
3. Exclusive Power Adapter
6. Monthly Check Cartridge
+
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