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Appendix B
P/N 130859-US, Manual Revision: AA
Haemonetics
®
Cell Saver
®
Elite
®
+ User Manual
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 28, Haemonetics Default
Parameter
225 mL Bowl
125 mL Bowl
70 mL Bowl
HCT %
58 ± 4.2
52 ± 2.4
52 ± 1.2
RBC Recovery %
94 ± 1.8
91 ± 2.9
90 ± 2.9
WBC Removal %
36.9 ± 11.3
29.4 ± 10.9
34.7 ± 10.9
Free Hemoglobin
Washout %
99.0 ± 0.2
99.6 ± 0.1
99.3 ± 0.1
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).
99.0 ± 0.2
99.6 ± 0.1
99.4 ± 0.1
Potassium Washout %
98.7 ± 0.2
98.6 ± 0.3
98.4 ± 0.2
Heparin Washout %
99.7 ± 0.1
99.7 ± 0.0
99.7 ± 0.1
Table 29, 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
