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.
Eluents A,B and C, and hemolytic agent.
Matched Chromatography Columns and Filters
Chromatography columns and filters specified by Lifotronic.
Calibrators specified by Lifotronic
Qc materials specified by Lifotronic
Voltage: Ac 100V`240V
Input power: 120VA
Ambient temperature: 10C~30C
Relative humidity: ≤80% (no condensation)
Atmospheric pressure: 75kgpa~106kPa
No frost, condensation, water seepage, moisture or direct sunlight.
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.
Net Weight: 36.8kg , Gross Weight : 51.5kg
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.
Perform a test using a standard sample ; the relative deviation of test result obtained should be within +/- 8%
Linear correlation coefficient r ≥0.9900.
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 ≤3%
Within 8h after stabilization upon startup, the relative deviation of test result of the same normal sample should not exceed+/-3%
The system pressure of the device can reach up to 12MP a.
The highest test speed of the analyzer is 1.5min/test.