HemoCue Glucose 201 RT Starter SET

General Description:
HemoCue Glucose 201 RT is a point-of-care glucometer system used for quantitative determination of glucose level in capillary, venous, or arterial whole blood.

Intended Purpose:
The HemoCue Glucose 201 RT is intended for quantitative determination of glucose in whole blood (capillary, venous or arterial), supplementing the clinical evidence in the diagnosis of diabetes, the detection of idiopathic hypoglycaemia, monitoring patients with diabetes and monitoring neonatal blood glucose levels. The test should not be used on critically ill neonates in neonatal intensive care settings. The test is for professional use by healthcare professionals and laboratory personnel, intended for near-patient (point-of-care) and laboratory testing. The HemoCue Glucose 201 RT Microcuvettes are only to be used with HemoCue Glucose 201 RT Analyzer.

Technical Specifications
·Automated, compact, portable, battery operated, hand-held point-of-care device for measuring glucose in capillary, arterial, and venous whole blood.
·Assay Principle: Modified glucose oxidase/dehydrogenase in which the total amount of glucose is measured at the end point photometrically.
·Specimen volume/Type: <4µL of blood (venous, capillary, arterial blood).
·Time to result: ≤ 5 minutes.
·Result format/Units: Quantitative either mg/dL or mmol/L, Factory setting.
·Measuring range: plasma equivalent values: 0.61 to 30.8 mmol/L (11-555mg/dL) and whole blood 0.55-27.8 mmol/L (10-500 mg/dL). (Can measure hypoglycemia, Normal, and hyperglycemia levels)
·Calibration: Factory calibrated/Built-in self-test. (No need to recalibrate)
·Power Supply: 4 AA batteries or AC Adapter. The analyser is automatically turned off when left idle. Battery usage last for more than 100 tests.
·Operating Temp: 15 to 30 °C (59–86 °F).

Manufacturer product reference code:
124702-1

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

Item supplied with:
1 x HemoCue Glucose 201 RT Analyzer with accessories and power adapter.
200 x HemoCue Glucose RT Microcuvettes.
200 x Safety Lancets - CE Marked, Asahi Polyslider Ltd. Japan.
1 x Analyzer Carrying case.
1 x set of Hemocue cleaner (5).
1 x set of AA batteries (4).
1 x IFU.

Item Required but not provided:
HemoCue Glucose 21RT Control can be ordered separately. (if required)

Shelf life:
12 months from date of manufacturing /for microcuvette.

Storage & transportation conditions:
0 to 30 °C.
See Product Leaflet Shipping.

Weight - Volume
Estimated weight: 3,2kg
Estimated volume: 0,03m³.

Packaging and Labelling:
Unit presentation: 1(one) set containing HemoCue Glucose containing Analyser, box of 200 lancet, box of 200 HemoCue Glucose 201 RT microcuvettes, carry case, one set of AA battery (4) and set of cleaners.