Product Classification

H9 is classified according to the following standards:

In accordance with the Category of Medical Device classification and the Rules for the classification of Medical Devices:

The glycated hemoglobin analyzer(HPLC) is a blood analysis system in the category of clinical analytical instruments (6840), and its management level is level II.

Matched Reagent

Eluents A,B and C, and hemolytic agent.

Matched Chromatography Columns and Filters

Chromatography columns and filters specified by Lifotronic.

Calibrator

Calibrators specified by Lifotronic

Qc materials

Qc materials specified by Lifotronic

Power supply

Voltage: Ac 100V`240V

Frequency: 50Hz/60Hz

Input power: 120VA

Operating Environment

Ambient temperature: 10C~30C

Relative humidity: ≤80% (no condensation)

Atmospheric pressure: 75kgpa~106kPa

No frost, condensation, water seepage, moisture or direct sunlight.

Storage Conditions

Ambient temperature: 0C~55C

Relative humidity: ≤93%;

Atmospheric pressure: 75kPa~106kPa

Storage location: The device should be stored in a well-ventilated indoor ware house free from acid, alkali and other hazardous gases.

Storage period : Not longer than one year.

Package Dimensions 

Length: 850mm

Width: 480mm

Height: 730mm

Weight

Net Weight: 36.8kg , Gross Weight : 51.5kg

Valid Period 

The product has a service life of 5 years. A device beyond its service life shall be disposed of according to applicable laws and regulations.

For more information, please contact the manufacture or its agent.

Contraindications

None.

Performance Indexes

     Accuracy

     Perform a test using a standard sample ; the relative deviation of test result obtained should be within +/- 8%

      Linearity

      Linear correlation coefficient r ≥0.9900.

      Reproducibility

      When testing calibrators with a concentration of 4.0%~6.5% (20.2mmol/~47.5mmol/mol), the coefficient of variation (CV) from repeated measurements should be ≤1.5%.

      Carryover Rate

      Carryover rate ≤3%

      Stability

       Within 8h after stabilization upon startup, the relative deviation of test result of the same normal sample should not exceed+/-3%

        System Pressure

        The system pressure of the device can reach up to 12MP a.

        Test Speed

       The highest test speed of the analyzer is 1.5min/test.