15
2.11.1 Reagents
Diluent
Diluent is formulated to dilute the blood samples. It is used to determine the count and size
distribution of blood cells.
Lyse
Lyse breaks down the red cells and achieve WBC 3-part differential and the measurement of
HGB.
Probe Cleanser
Probe Cleanser is used for the regular cleaning of the analyzer.
2.11.2 Controls and Calibrators
The controls and calibrators are used for the analysis quality control and calibration of the
analyzer.
The controls are suspension of stimulated human blood, specifically manufactured to monitor
and evaluate the analysis precision of the analyzer. The controls are prepared with three
levels, namely low, normal and high. The calibrators are also suspension of stimulated human
blood, specifically manufactured for the calibration of the analyzer, so as to build the
metrological traceability of analysis results. For the use and storage of controls and calibrators,
please refer to the Instruction for Use of each product.
All references related to the controls and calibrators in this manual refer to the "controls" and
"calibrators" ZYBIO specifically formulated for Z3 by ZYBIO.
2.12 Information Storage Capacity
Table 2-12 Data storage requirements
The information stored should at least include the following:
result information, histograms, patient information, flags as
well as any special information of the analyzer.