Table 2. Unconstrained TransForm™ Occlusion Balloon Catheter Inflation Compliance Chart
(for 3 mm and 4 mm Compliant Sizes)
3 mm Diameter at Nominal
10 mm Balloon
15 mm Balloon
10 mm Balloon
Length
Length
Length
Infusion
Balloon
Infusion
Balloon
Infusion
Balloon
Volume
Size
Volume
Size
Volume
Size
(cc)
(mm)
(cc)
(mm)
(cc)
(mm)
0.02
1.6
0.02
1.5
0.02
2.0
0.04
2.7
0.04
2.4
0.04
2.8
0.06
3.0
0.06
2.7
0.06
3.1
0.08
3.2
0.08
3.0
0.08
3.4
0.10
3.1
0.10
3.6
0.12
3.2
0.12
3.8
0.14
4.0
0.16
4.2
Maximum
Maximum
Maximum
Allowed
Allowed
Allowed
Inflation Volume
Inflation Volume
Inflation Volume
0.08 cc
0.12 cc
0.16 cc
4 mm Diameter at Nominal
15 mm Balloon
20 mm Balloon
30 mm Balloon
Length
Length
Length
Infusion
Balloon
Infusion
Balloon
Infusion
Balloon
Volume
Size
Volume
Size
Volume
Size
(cc)
(mm)
(cc)
(mm)
(cc)
(mm)
0.02
1.6
0.02
1.7
0.02
1.8
0.04
2.7
0.04
2.7
0.04
2.7
0.06
3.2
0.06
3.1
0.06
3.1
0.08
3.4
0.08
3.3
0.08
3.3
0.10
3.5
0.10
3.4
0.10
3.5
0.12
3.7
0.12
3.5
0.12
3.6
0.14
3.8
0.14
3.6
0.14
3.7
0.16
3.9
0.16
3.7
0.16
3.8
0.18
3.9
0.18
3.7
0.18
3.8
0.20
4.0
0.20
3.8
0.20
3.9
0.22
4.1
0.22
3.9
0.22
3.9
0.24
3.9
0.24
3.9
0.26
4.0
0.26
4.0
0.28
4.1
0.28
4.0
0.30
4.0
0.32
4.1
0.34
4.1
0.36
4.1
Maximum
Maximum
Maximum
Allowed
Allowed
Allowed
Inflation Volume
Inflation Volume
Inflation Volume
0.22 cc
0.28 cc
0.36 cc
Table 3. Unconstrained TransForm Occlusion Balloon Catheter Inflation Compliance Chart
(for 5 mm Compliant Sizes)
5 mm Diameter at Nominal
10 mm Balloon Length
15 mm Balloon Length
Infusion
Infusion
Balloon
Balloon
Volume
Volume
Size (mm)
Size (mm)
(cc)
(cc)
0.02
1.7
0.02
0.04
2.7
0.04
0.06
3.3
0.06
0.08
3.6
0.08
0.10
3.9
0.10
0.12
4.1
0.12
0.14
4.2
0.14
0.16
4.4
0.16
0.18
4.6
0.18
0.20
4.7
0.20
0.22
4.9
0.22
0.24
5.0
0.24
0.26
5.2
0.26
0.28
0.30
0.32
0.34
0.36
Maximum Allowed
Maximum Allowed
Inflation Volume
Inflation Volume
0.26 cc
0.36 cc
5
20 mm Balloon Length
30 mm Balloon Length
Infusion
Infusion
Balloon
Volume
Volume
Size (mm)
(cc)
(cc)
1.0
0.02
1.4
0.02
2.3
0.04
2.5
0.04
2.9
0.06
3.0
0.06
3.2
0.08
3.3
0.08
3.4
0.10
3.5
0.10
3.6
0.12
3.7
0.12
3.8
0.14
3.8
0.14
3.9
0.16
3.9
0.16
4.0
0.18
4.0
0.18
4.2
0.20
4.1
0.20
4.3
0.22
4.2
0.22
4.4
0.24
4.3
0.24
4.5
0.26
4.4
0.26
4.7
0.28
4.5
0.28
4.8
0.30
4.5
0.30
4.9
0.32
4.6
0.32
5.0
0.34
4.7
0.34
5.1
0.36
4.8
0.36
0.38
4.9
0.38
0.40
5.0
0.40
0.42
5.0
0.42
0.44
5.1
0.44
0.46
0.48
0.50
0.52
0.54
0.56
0.58
0.60
0.62
Maximum Allowed
Maximum Allowed
Inflation Volume
Inflation Volume
0.44 cc
0.62 cc
Black (K) ∆E ≤5.0
Balloon
Size (mm)
1.0
2.3
2.9
3.2
3.4
3.6
3.7
3.8
3.9
3.9
4.0
4.0
4.1
4.1
4.2
4.2
4.3
4.3
4.3
4.4
4.4
4.5
4.5
4.6
4.7
4.7
4.8
4.8
4.9
4.9
5.0