16
Chapter 1
P/N 130859-US, Manual Revision: AA
Haemonetics
®
Cell Saver
®
Elite
®
+ User Manual
Blood
Product
Quality
Attention:
Actual performance results may vary depending on many in-use
variables.
Haemonetics recommends using the following RBC product criteria for quality
control procedures. Criteria are based on Haemonetics Default and standard
fat reduction protocol settings in laboratory performance with 10% hematocrit
blood pools.
Laboratory testing of the 225 mL bowl using Haemonetics Default settings
yielded the blood product quality results listed in the table below. Test results
are based on two-cycle procedures processing 10% hematocrit test pools.
Lysate and heparin were added to measure constituent washout. Results are
listed below for test pools prepared both with and without lysate. Mean values
are reported alongside standard error of the mean. Results may vary
depending on in-use variables.
Appendix B, “System Performance”
for complete blood quality
performance results for all bowl sizes and other settings, including Fat
Reduction, Emergency Mode, and partial bowl and low wash.
Table 6, RBC Product Criteria
Criteria
Product Performance
HCT
> 40%
RBC Recovery
> 80%
Free Hemoglobin Washout
> 95%
Heparin and Albumin Washout
> 95%
Table 7, 225 mL Bowl Test Results
Parameter
Without Lysate
With Lysate
HCT %
52 + 0.8
58 + 4.2
RBC Recovery %
95 + 1.3
94 + 1.8
WBC Removal %
40.7 + 4.3
36.9 + 11.3
Free Hemoglobin Washout %
-
99.0 + 0.2
Total Protein Washout %
a
a. Total protein measurement has been used as a surrogate instead of albumin only assay
(albumin being a sub-category of protein).
98.5 + 0.1
99.0 + 0.2
Potassium Washout %
-
98.7 + 0.2
Heparin Washout %
99.6 + 0.1
99.7 + 0.1
Fat Washout %
b
b. Fat reduction performance is applicable for the Fat Reduction setting.
99.6 + 0.13
