Mindray BC-30s - 2.7 Performance Requirements

Product Specifications
2-4
Mean Corpuscular Hemoglobin Concentration MCHC
Red Blood Cell Distribution Width Coefficient of Variation RDW-CV
Red Blood Cell Distribution Width Standard Deviation RDW-SD
Hematocrit HCT
Platelet count PLT
Mean Platelet Volume MPV
Platelet Distribution Width PDW
Plateletcrit PCT
Platelet Larger Cell Ratio* P-LCR*
Platelet Larger Cell Count* P-LCC*
*Note: for BC-30s only.
Table 2 Histograms
White Blood Cell Histogram WBC Histogram
Red Blood Cell Histogram RBC Histogram
Platelet Cell Histogram PLT Histogram
2.7 Performance Requirements
2.7.1 Background/Blank Count
Background refers to the background count performed automatically by the analyzer
during the startup process; its result shall meet the requirements in the following table.
The blank count requirements apply to both whole blood and predilute modes.
Blank count test method: run diluent on the analyzer consecutively for 3 times, the
highest value among the 3 results shall meet the requirements in the following table.
Table 2-4 Background/blank count requirements
Parameter Background/blank count requirements
WBC
≤ 0.20× 10
9
/ L
RBC
≤ 0.02× 10
12
/ L
HGB
≤1 g/L
HCT
≤ 0.5 %
PLT
≤ 5 × 10
9
/ L
2.7.2 Carryover
Carryover refers to the transfer of blood cells from high concentration sample to low
concentration sample.
Verification method:
Prepare a high concentration sample (centrifuged high value control or special high
value linearity control) which is within the range specified in Table 2-6, mix and then test it