Vi-CELL BLU -Application Notes

Instrument performance

Expected Value

Pre–Test Run

5 th Run

10 th Run

20 th Run

Test

Size Control Beads (10 µm Diameter)

10.08 µm ± 10%

10.23 µm

10.13 µm

10.34 µm

10.28 µm

Concentration Control Beads (4x10 6 /mL)

4.09x10 6 /mL ± 10% 3.64x10 6 /mL

3.72x10 6 /mL

3.76x10 6 /mL

3.72x10 6 /mL

Viability Control Beads (50% Viable)

51.71% ± 10%

54.94%

53.54%

54.04%

53.36%

Data charts showing results of evaluation runs. Solid line indicates expected values and dashed lines indicate +/– 10% acceptable boundary range.

Bead Diameter Determinations.

Cell Viability Determinations.

12

40 42 44 46 48 50 52 54 56 58 60

11.5

54.94

54.04

11

53.54

53.36

52.00

10.34

10.28 10.27

10.23

10.5

10.21

53.56

10.13

10.33

10

49.35

9.5

9

Bead Diameter [µm]

Viable Population [%]

8.5

8

1

2

3

4

5

6

7

1

2

3

4

5

6

7

Evaluation Number

Evaluation Number

Cell Concentration Determinations.

3.20 3.40 3.60 3.80 4.00 4.20 4.40 4.60 4.80 5.00

)Lm/snoillim( nitartnecnoC lleC

3.95

3.89

3.76

3.72

3.72

3.72

3.69

1

2

3

4

5

6

7

Evaluation Number

Conclusions Testing using standard control beads showed virtually no change of instrument performance over 20 cycles of VHP testing with all results falling within 10% of the expected values. While there was some minor cosmetic damage to the instrument, the system retained full sample analysis functionality through an estimated five years of VHP exposures. The combination of the sealed optics module, and VHP resistant coatings of the optical components inside, prevented any degradation of the optical system. The results show that the Vi–CELL BLU tolerates repeated VHP testing with no appreciable effect on system performance and is therefore ideally suited for use in environments where VHP sterilization is routinely used.

Product is not verified or validated for use in diagnostic procedures. © 2019 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

For Beckman Coulter’s worldwide office locations and phone numbers, please visit Contact Us at beckman.com PART-5077APP03.19