Photometer,HemoCue Glucose 201+/SET

General Description
Photometer, HemoCue glucose 201+/set

Intended Use
The HemoCue Glucose 201+ photometer is designed for the quantitative determination of glucose levels in whole blood. It is primarily used in the screening, diagnosing or monitoring of diabetes. This system is intended for professional use and provides lab-quality accuracy at the point of care. It can be used with capillary, venous, or arterial whole blood samples, including neonatal blood.

Technical specifications
· Assay Principle: Modified glucose dehydrogenase, measuring glucose photometrically.
· Sample volume/Type: Approximately 5 µL of Capillary, venous, or arterial whole blood, including neonatal blood.
· Measuring time: 40-240 seconds
· Results format: mg/dL or mmol/L.
· Measuring range: Whole blood values: 10-400 mg/dL (0.55-22.2 mmol/L).
· Factory calibrated and continuous built-in auto self-test (when switched on). Needs no further calibration.
· Sample collected directly from skin surface into single use microcuvette by capillary action.
· Compatibility: Uses HemoCue Glucose 201+ Microcuvettes (closed system).
· Power supply: AC Adapter or 4AA batteries (1.5 V Alkaline or 1.2 V NiMH rechargeable).

Supplier’s product reference:
HemoCue Glucose 201+ analyzer starter set

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

Items supplied with:
1 x HemoCue Glucose 201+ photometer with accessories, and power adapter
1 x 5 HemoCue Cleaner
1 x Carrying Case
200 x HemoCue Glucose 201+ Microcuvettes (separately shipped at 2 to 8°C)
200 x Safety Lancets - CE Marked, Asahi Polyslider Ltd. Japan.
4 x AA Batteries
1 x IFU

Shelf life:
9 months from date of manufacture (for Hemocue glucose 201+ microcuvettes), 24 months (for Hemocue cleaner).

Storage & transportation:
0 to 50C (for the photometer), 2 to 8C (for microcuvettes), 15 to 30 C (for cleaner).

Packaging and Labelling
Primary packaging
Unit presentation: 1(one) Photometer,HemoCue glucose 201+/set

Weight - Volume
Estimated weight: 3.2kg
Estimated volume: 0.03m3