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
·Fully automated, compact, point-of-care device.
·Assay principle: Boronate affinity assay to separate the glycated hemoglobin fraction from the non-glycated fraction.
·Specimen volume/Type: 4µL, Capillary blood or venous whole blood.
·Time to result: Within 5 minutes.
·Result format/Units: Quantitative in mmol/mol (IFCC), or in % (NGSP).
·Measuring range: 20 – 130 mmol/mol (IFCC), 4.0 – 14.0 % (NGSP)
·Power Supply: Mains adapter 9 V DC / 2 A.
·Compatibility: Compatible with the HemoCue HbA1c 501 Test Cartridges.

Manufacturer product reference code:
405210

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).

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

Weight - Volume
Estimated weight: 11 kg.
Estimated volume: 0,07m³.

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