HemoCue Hb 801 Starter SET

General Description:
The HemoCue Hb 801 System is an automated point-of-care device for quantitative determination of haemoglobin in capillary or venous whole blood.

Intended Purpose of use:
The HemoCue Hb 801 System is intended for measuring haemoglobin concentration for adults, adolescents, children, and infants above 1 month old. It is for professional use by health workers, professionals, and laboratory personnel in near-patient (point of care) and blood donation settings, including primary care, low-resource hospital settings, and ambulances. Not for individual/self-testing.

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 either mg/dL or mmol/L.
·Measuring range: 1.0 to 25.6 g/dL (10-256 g/L, 0.62-15.9 mmol/L)
·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:
HemoCue 801 starter set.

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

Item supplied with:
1 x HemoCue Hb 801 with accessories and power adapter
1 x Carrying Case
200 x Safety Lancets - CE Marked, Asahi Polyslider Ltd. Japan.
200 x HemoCue Hb 801 Microcuvettes
3 x AA batteries

Item Required but not provided:
Protective gloves, lint-free wipe, disinfectant, pipette, or other transfer device (for venous samples). Spare parts: battery cover, microcuvette holder, power adapter, USB cable, plug. Optional items: HemoCue software applications.

Shelf life:
30 months (for HemoCue Hb 801 Microcuvettes).

Storage & transportation:
Analyzer: 0 to 50 °C.
Microcuvettes: 10 to 40 °C.

Weight - Volume
Estimated weight: 2,8 kg.
Estimated volume: 0,02691m3.

Packaging and Labelling:
Unit presentation: 1(one) HemoCue Hb 801 Starter Set.