Specifications

Appendix B - Maximum Orbit/Resulting Lumen Diameter

Table 3 shows the maximum orbit/resulting lumen diameter for each DB 360 Crown at incremental rotational speeds

for 50 passes (about 5 minutes of treatment time.) To demonstrate that the orbit of the DB 360 has a maximum limit,

Table 4 summarizes the results at the maximum sanding time for each DB 360 Crown diameter (maximum rotational

speed for 90 passes, about 8 minutes of treatment time). Quantitative angiography is recommended to determine the

minimum vessel diameter.

Table 3. 0.014” DB 360 Crown Size and Rotational Speed: 50 Pass Maximum Diameters

Crown Size Rotational Speed Maximum Lumen Diameter *

Average +2 Standard Deviations

1.50 mm

80,000 rpms 2.62

140,000 rpms 3.63

200,000 rpms 3.69

1.75 mm

80,000 rpms 4.79

140,000 rpms 4.20

200,000 rpms 4.80

2.00 mm

80,000 rpms 5.16

120,000 rpms 5.38

160,000 rpms 5.43

2.25 mm

60,000 rpms 4.91

90,000 rpms 5.48

120,000 rpms 5.57

Table 4. 0.014” DB 360 Crown Size and Rotational Speed: 90 Pass Maximum Diameters

Crown Size Rotational Speed Maximum Lumen Diameter**

1.50 mm

200,000 rpms 3.38

1.75 mm 200,000 rpms 3.96

2.00 mm

160,000 rpms 5.00

2.25 mm

120,000 rpms 5.08

*These lumens are based on in vitro test results at approximately 5 minutes of treatment time (50 passes) at a rate of

approximately 1cm per second of travel speed, actual clinical results may vary.

**These lumens are based on in vitro test results at approximately 8 minutes of treatment time (90 passes) at a rate

of 1cm per second, actual clinical results may vary.

Note: A pass is defined as once down and back across the lesion. Orbit data presented is based on a 3 cm pass

distance at a travel rate of 1cm per second.