Haemonetics Cell Saver Elite - Appendix B: System Performance; Cell Salvage

Chapter 12, Reference Information 217
Haemonetics
®
Cell Saver
®
Elite
®
User Manual P/N 120745-IE, Manual revision: AA
Appendix B: System Performance
Cell Salvage In accordance with ANSI/AAMI AT6:2005, laboratory studies were conducted
to confirm the performance of the Cell Saver Elite device. The following test
results are based on two-cycle procedures processing 10% hematocrit test
pools. Lysate and heparin were added to measure constituent washout. Mean
values are reported alongside standard error of the mean. System
performance is summarized below based on bowl type and operating mode.
Results may vary depending on in-use variables.
Table 21, Haemonetics Default
Parameter 225 mL Bowl 125 mL Bowl 70 mL Bowl
HCT % 56 +
0.3 50 + 0.4 51 + 0.2
RBC Recovery % 95 +
0.1 91 + 0.8 90 + 0.9
WBC Removal % 39.6 +
9.92 35.6 + 5.94 22.3 + 2.52
Free Hemoglobin
Washout %
98.8 +
0.06 99.6 + 0.01 99.3 + 0.01
Albumin Washout % 97.8 +
0.06 99.8 + 0.01 99.1 + 0.02
Potassium Washout % 96.4 +
0.16 97.2 + 0.04 96.5 + 0.48
Heparin Washout % 99.8 +
0.003 99.8 + 0.00 99.6 + 0.08
Table 22, Fat Reduction
Parameter 225 mL Bowl 125 mL Bowl 70 mL Bowl
HCT % 57 +
1.2 51 + 1.0 50 + 0.2
RBC Recovery % 94 +
0.5 92 + 0.7 91 + 0.5
WBC Removal % 51.4 +
8.74 39.8 + 3.29 40.7 + 4.07
Free Hemoglobin
Washout %
99.0 +
0.28 99.5 + 0.02 99.5 + 0.01
Albumin Washout % 99.4 +
0.01 99.9 + 0.07 99.5 + 0.10
Potassium Washout % 87.4 +
4.56 90.4 + 3.20 96.1 + 0.53
Heparin Washout % 99.5 +
0.01 99.6 + 0.04 99.2 + 0.45
Fat Washout % 99.6 +
0.13 97.2 + 0.93 93.3 + 1.03