HemoCue HbA1c 501 Analyzer Starter SET

General Description:
HemoCue HbA1c 501 Analyzer Starter Set.

Intended use:
The HemoCue® HbA1c 501 Analyzer Set is intended for the quantitative determination of glycated haemoglobin (HbA1c) in capillary, and anticoagulated venous whole blood. The test is for point of care use to monitor glycaemic control in patients with diabetes mellitus. The HemoCue HbA1c 501 analyser is intended for use by health professionals in laboratories, clinics, and hospital settings.

Technical Specifications
·Automated, compact, portable, hand-held point-of-care device
·Assay principle: The HemoCue Hb 801 Analyzer measures haemoglobin concentration by assessing the absorbance of whole blood at two specific wavelengths: 506 nm and 880 nm. This method utilizes the isosbestic point of haemoglobin and oxyhaemoglobin.
·Specimen volume/Type: 10µL of blood (Venous, capillary)
·Time to result within one second.
·Result format/Units: Quantitative in g/dL
·Measuring range: 1.0 to 25.6 g/dL
·Factory calibrated/Built-in self-test.
·Compatibility: Only for use with the HemoCue Hb 801 Microcuvettes.
·Power Supply: USB adapter or 3 AA batteries (1.5V Alkaline or 1.2 V NiMH). 3AA batteries will last for 100-150 h of testing.

Manufacturer product reference code:
12190-1

QMS/Regulatory information:
· CE-IVD.
· ISO 13485: 2016.

Item supplied with:
1 x HemoCue HbA1C 501 Analyzer with accessories and power adapter
200 x HemoCue HbA1C Cartridges
200 x Safety Lancets - CE Marked, Asahi Polyslider Ltd. Japan.
1 x Carrying Case
1 x Set of Monthly Checks
1 x extra Daily Checks
1 x IFU

Shelf life:
18 months from date of manufacture (Test Cartridges).
12months for the Monthly check
24months for the daily check

Storage & transportation conditions:
Analyzer: 10 to 35 °C
Test Cartridges: 2 to 32 °C.

Weight - Volume
Estimated weight: 3.09 kg.
Estimated volume: 0,07m³.

Packaging and Labelling:
Unit presentation: 1(one) HemoCue HbA1c 501 Analyzer Starter Set01 Starter Set.