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Performance, EMC and Electrical Safety
EN
Principle of the method and procedure
The microcuvette serves both as a pipette and as a measuring cuvette and is for single-use only. Blood is drawn into the microcuvette by capillary action and an azidemethemoglobin reaction occurs.
Analyzer measures transmittance at two wavelengths to compensate for turbidity. The hemoglobin level is automatically calculated and presented. The system is factory calibrated against hemiglobincyanide
(HiCN) method, the international reference method for hemoglobin determination recommended by International Council for Standardization in Haematology (ICSH). No further calibration is needed.
Measuring range
The system has a measuring range of 0.5 – 25.6 g/dL (5 – 256 g/L, 0.3 – 15.9 mmol/L) and a detection limit of 0.1 g/dL (1 g/L, 0.1 mmol/L).
The system is linear within displayed range 0 – 25.6 g/dL (0 – 256 g/L, 0 – 15.9 mmol/L).
For information regarding subjects below, refer to HemoCue Hb 201 Microcuvettes Package Insert
Limitations
Reference Values
Reporting of Serious Incidents
Storage and Handling (HemoCue Hb 201 Microcuvettes)
Composition
Specific Performance Characteristics
References
• HemoCue Hb 201 Microcuvettes Package Insert
• Makarem, A. In clinical Chemistry: Principles and Techniques, 2nd ed., Henry, R.J., Cannon, D.C., and Winkelman, J.W., Harper and Row, Hagerstown, M.D., 1974, pp. 1125–1147
• Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard; CLSI Document H15
EMC and Electrical Safety
The analyzer has been tested and complies with following standards:
• IEC 61010-1
• IEC/EN 61010-2-101
• IEC/EN 61326-2-6 (including applicable parts of IEC/EN 61326-1)
The analyzer has been tested for indoor use.
It is recommended to evaluate the electromagnetic environment prior to use of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these can interfere with the proper operation.
Note: It is the manufacturer's responsibility to provide equipment electromagnetic compatibility information to the customer or user.
Note: It is the user's responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended.
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