SublimeLine®

Transcription

SublimeLine®

SublimeLine
®
POLYtxt® (textured) silicone-gel-filled
mammary implants
Opticon®
Optimam®
Replicon®
Même®
Copyright © 2009 POLYTECH Health & Aesthetics GmbH, Dieburg, Germany
SublimeLine
®
The POLYTECH
Surface Type
POLYtxt
Base
Style
®
Projection
low L
moderate M
high H
extra high X
20724
20725
20726
20727
20734
20735
20736
20737
20744
20745
20746
20747
20774
20775
20776
20777
Même®
round base,
regular profile
Replicon®
round base,
anatomical profile
Opticon®
short base,
anatomical profile
Optimam®
oblong base,
anatomical profile
Fast and simple –
®
the POLYTECH
series:
a complete modular matrix of breast implants
that is logical, easy to understand and simple
to handle
SublimeLine Product description
®
The
from POLYTECH is a product
line designed for a strategic approach to choose
the right implant shape and size. Implant selection
is based on four different styles, which have been
named:
• Même® – round base, regular profile
• Replicon® – round base, anatomical profile
• Opticon® – short base, anatomical profile
• Optimam® – oblong base, anatomical profile
SublimeLine
SublimeLine®
Applying the modular
matrix will
ensure the desired results are achieved:
1. Measuring the breast base,
2. Assessing the breast shape, and
3. Selecting of the desired projection
will lead to the optimum implant.
As all implant styles are available with identical
base diameters, the choice of any of the four
different breast implant shapes can be matched
with any four given projections.
4 styles x 4 projections x 18 sizes =
288 different breast implant shapes
SublimeLine®
The use of the POLYTECH
matrix –
whether for breast augmentation or reconstruction
– ensures that the optimal implant is available for
every patient. With the systematic approach of the
modular matrix, implant selection for surgical
procedures is simplified, e.g. for the correction of
asymmetries or the reconstruction without surgical
adjustment of the contralateral breast.
3
Quality means safety
Information on materials
®
All breast implants of the
carry the
-mark for medical devices class III and fulfill the
highest quality standards that are required for
medical products.
SublimeLine
Highest material standards
The shell consists of a soft silicone elastomer with
an incorporated diffusion-barrier layer.
The POLYTECH
SublimeLine® implants are filled
with Formory® II, a highly cross-linked and formstable silicone gel. The cohesive nature of the silicone gel allows the manufacturing of implants
with different shapes and projections. The
approach necessary for the implantation has to
correspond to the implant size. After soft compression the implant returns automatically to its
original shape, due to the “memory effect” of the
gel.
Sizers are available in all styles marked with an
asterisk (*). These smooth-surfaced, silicone gelfilled sizers are delivered non-sterile and are
certified for resterilisation and reuse of the device.
The sizers match the respective implant style.
Silicone shell elongation tests demonstrate a
mean elongation of 950 % to rupture. This twice
exceeds the standard for breast implants that
requires only 450 % elongation.
The POLYtxt® textured surface is of a rough open
cell structure of an average 200–300 µm in height
and 100–400 µm in diameter to allow tissue
adherence.
Production of the implants is based on a
quality management according to ISO 9001 and
ISO 13485. All materials used are of implantable
medical quality.
4
Indications for use
• Augmentation of the breast
• Reconstruction of the breast
• Correction of asymmetry
• Aplasia or hypoplasia
• Combined breast and thoracic deformities
• Ptosis or atrophy
• Implant replacement
Important information
Please note the detailed instructions for use
included with each product.
Three simple steps to determine implant selection:
1
Measuring the breast base
to determine the base width:
All implant styles are available with base width
between 70 and 155 mm, in 5 mm incremental steps
2
Deciding for one of four different implant styles:
Même®: round base, regular profile
Replicon®: round base, anatomical profile
Opticon®: short base, anatomical profile
Optimam®: oblong base, anatomical profile
3
Determining the projection:
Each implant type is available in four different projections.
®
LS: Low SublimeLine
®
MS: Moderate SublimeLine
®
HS: High SublimeLine
®
XS: Extra-High SublimeLine
SublimeLine®
The POLYTECH
implants
feature the additional measurement D. This
describes the distance between the highest
point of projection of the implant and the
lower implant edge. It creates a correlation
between the correct positioning of the areola
and the inframammary fold. Using this
measurement with anatomical implants can
optimize the results.
base height
Measurement D
C
D
A
B
base width
projection
curve from lower
implant edge to
highest point of
projection
5
Même® SublimeLine ®
 0483
SublimeLine®
The silicone-gel-filled Même®
implants with textured POLYtxt® surface have a
round base and a regular profile.
SublimeLine®
The textured
implants are available
in four projections: Low (TLS), Moderate (TMS),
High (THS) and Extra High Profile (TXS).
SublimeLine®
The Formory® II silicone-gel in the
implants provides maximum shape control. It is a
highly cross-linked, cohesive silicone gel. Because
of the "memory effect" of the gel, the implant is formstable and always returns to its original shape after
soft compression.
Même® SL TLS – Low Projection, POLYtxt®
Même® SL TMS – Moderate Projection, POLYtxt®
Order n°
Order n°
20724-0551*
20724-0651
20724-0851*
20724-0951
20724-110*
20724-125
20724-150*
20724-165
20724-185*
20724-215
20724-235*
20724-270
20724-295*
20724-330
20724-365*
20724-4001
20724-4401*
20724-4851
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
23
24
24
25
26
27
28
29
29
30
31
32
33
34
35
35
36
37
Volume (ml)
43
46
49
51
54
57
60
62
65
68
71
73
76
79
82
85
87
90
55
65
85
95
110
125
150
165
185
215
235
270
295
330
365
400
440
485
20725-0701*
20725-0901
20725-1051*
20725-120
20725-145*
20725-165
20725-195*
20725-220
20725-255*
20725-285
20725-320*
20725-360
20725-400*
20725-445
20725-4951*
20725-5451
20725-6001*
20725-6601
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
28
30
31
32
33
35
36
37
38
40
41
43
44
45
47
48
49
51
Volume (ml)
47
50
53
56
59
62
65
68
71
74
77
80
83
86
89
92
95
98
70
90
105
120
145
165
195
220
255
285
320
360
400
445
495
545
600
660
approximate measurements
Sizers – available in all sizes marked with asterisk
* silicone gel-filled, smooth sizers, non-sterile, can be resterilised, 
order n° e.g. 20724-150M, 20725-195M
1
6
Marked products will be manufactured on request; volumes above 750ml will be custom-made on demand.
Même® SublimeLine ®
 0483
The chemically and mechanically resistant, elastic
shell of the implants consists of several layers of a
silicone elastomer. In order to maintain a high level
of safety, the shell of the silicone-gel-filled
implants is equipped with an additional diffusion
barrier layer.
The implants are delivered individually packed and
sterile.
Même® SL THS – High Projection, POLYtxt®
Même® SL TXS – Extra-High Projection, POLYtxt®
Order n°
Order n°
20726-0901*
20726-1101
20726-1251*
20726-155
20726-180*
20726-210
20726-235*
20726-275
20726-315*
20726-360
20726-400*
20726-450
20726-505*
20726-560
20726-620*
20726-6901
20726-7601*
20726-8351
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
34
36
37
39
40
42
44
45
47
49
51
53
55
57
59
61
62
64
Volume (ml)
51
54
58
61
64
67
71
74
77
80
83
87
90
93
96
100
103
106
90
110
125
155
180
210
235
275
315
360
400
450
505
560
620
690
760
835
20727-105*
20727-125
20727-155*
20727-180
20727-215*
20727-250
20727-285*
20727-330
20727-380*
20727-430
20727-485*
20727-545
20727-610*
20727-675
20727-7551*
20727-8301
20727-9201*
20727-10101
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
40
43
45
47
49
51
53
55
57
59
61
63
65
67
69
71
73
75
Volume (ml)
55
59
62
66
69
73
77
80
84
87
91
94
98
101
105
108
112
115
105
125
155
180
215
250
285
330
380
430
485
545
610
675
755
830
920
1010
order n° e.g. 20726-235M, 20727-285M
1
7
Replicon® SublimeLine ®
 0483
SublimeLine
The silicone-gel-filled Replicon®
round base and an anatomical projection with the
highest point in the lower half.
SublimeLine®
The textured
SublimeLine®
soft compression.
Replicon® SL TLS – Low Projection, POLYtxt®
Replicon® SL TMS – Moderate Projection, POLYtxt®
Order n°
Order n°
20734-0501*
20734-0601
20734-0701*
20734-0851
20734-100*
20734-110
20734-125*
20734-150
20734-165*
20734-185
20734-210*
20734-235
20734-265*
20734-290
20734-320*
20734-350
20734-390*
20734-425
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
23
24
24
25
26
27
28
29
29
30
31
32
33
34
35
35
36
37
Volume (ml)
33
34
36
38
40
42
44
46
48
50
52
54
56
58
59
61
63
65
50
60
70
85
100
110
125
150
165
185
210
235
265
290
320
350
390
425
20735-0651*
20735-0751
20735-0951*
20735-110
20735-125*
20735-150
20735-170*
20735-195
20735-220*
20735-255
20735-280*
20735-320
20735-350*
20735-390
20735-435*
20735-480
20735-530*
20735-580
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
28
30
31
32
33
35
36
37
38
40
41
43
44
45
47
48
49
51
Volume (ml)
37
39
41
44
46
48
50
52
55
57
59
61
63
66
68
70
72
74
65
75
95
110
125
150
170
195
220
255
280
320
350
390
435
480
530
580
order n° e.g. 20734-125M, 20735-170M
1
8
Replicon® SublimeLine ®
 0483
barrier layer.
sterile.
Replicon® SL THS – High Projection, POLYtxt®
Replicon® SL TXS – Extra-High Projection, POLYtxt®
Order n°
Order n°
20736-0751*
20736-0951
20736-1151*
20736-130
20736-160*
20736-180
20736-210*
20736-240
20736-275*
20736-315
20736-350*
20736-395
20736-445*
20736-495
20736-550*
20736-6051
20736-6701*
20736-7351
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
34
36
37
39
40
42
44
45
47
49
51
53
55
57
59
61
62
64
Volume (ml)
42
44
47
49
52
54
57
59
62
64
67
69
72
74
77
79
82
84
75
95
115
130
160
180
210
240
275
315
350
395
445
495
550
605
670
735
20737-095*
20737-110
20737-130*
20737-160
20737-185*
20737-220
20737-255*
20737-290
20737-330*
20737-380
20737-425*
20737-480
20737-535*
20737-600
20737-6651*
20737-7301
20737-8101*
20737-8901
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
40
43
45
47
49
51
53
55
57
59
61
63
65
67
69
71
73
75
Volume (ml)
46
49
52
55
58
61
63
66
69
72
75
78
80
83
86
89
92
95
95
110
130
160
185
220
255
290
330
380
425
480
535
600
665
730
810
890
order n° e.g. 20736-210M, 20737-255M
1
9
Opticon® SublimeLine ®
 0483
SublimeLine
The silicone-gel-filled Opticon®
short base and an anatomical projection with the
SublimeLine®
The textured
SublimeLine®
soft compression.
Opticon® SL TLS – Low Projection, POLYtxt®
Opticon® SL TMS – Moderate Projection, POLYtxt®
Order n°
Order n°
20744-0451*
20744-0501
20744-0601*
20744-0701
20744-0851*
20744-0951
20744-110*
20744-120
20744-140*
20744-160
20744-175*
20744-200
20744-220*
20744-240
20744-270*
20744-295
20744-325*
20744-360
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
59
63
67
71
76
80
84
88
92
97
101
105
109
113
118
122
126
130
23
24
24
25
26
27
28
29
29
30
31
32
33
34
35
35
36
37
Volume (ml)
30
32
34
35
37
39
41
42
44
46
48
49
51
53
55
56
58
60
45
50
60
70
85
95
110
120
140
160
175
200
220
240
270
295
325
360
20745-0551*
20745-0651
20745-0751*
20745-0951
20745-1051*
20745-125
20745-145*
20745-165
20745-185*
20745-210
20745-235*
20745-265
20745-295*
20745-330
20745-365*
20745-400
20745-445*
20745-490
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
59
63
67
71
76
80
84
88
92
97
101
105
109
113
118
122
126
130
28
30
31
32
33
35
36
37
38
40
41
43
44
45
47
48
49
51
Volume (ml)
35
37
39
41
43
45
47
49
51
53
55
57
59
61
63
65
67
69
55
65
75
95
105
125
145
165
185
210
235
265
295
330
365
400
445
490
order n° e.g. 20744-110M, 20745-145M
1
10
Opticon® SublimeLine ®
 0483
barrier layer.
sterile.
Opticon® SL THS – High Projection, POLYtxt®
Opticon® SL TXS – Extra-High Projection, POLYtxt®
Order n°
Order n°
20746-0651*
20746-0751
20746-0951*
20746-115
20746-130*
20746-155
20746-175*
20746-205
20746-230*
20746-265
20746-295*
20746-335
20746-375*
20746-420
20746-460*
20746-510
20746-560*
20746-615
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
59
63
67
71
76
80
84
88
92
97
101
105
109
113
118
122
126
130
34
36
37
39
40
42
44
45
47
49
51
53
55
57
59
61
62
64
Volume (ml)
40
42
44
47
49
51
54
56
58
61
63
65
68
70
72
75
77
80
65
75
95
115
130
155
175
205
230
265
295
335
375
420
460
510
560
615
20747-0751*
20747-0951
20747-115*
20747-130
20747-160*
20747-185
20747-215*
20747-240
20747-280*
20747-320
20747-360*
20747-400
20747-450*
20747-500
20747-560*
20747-615
20747-6801*
20747-7501
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
59
63
67
71
76
80
84
88
92
97
101
105
109
113
118
122
126
130
40
43
45
47
49
51
53
55
57
59
61
63
65
67
69
71
73
75
Volume (ml)
44
47
50
52
55
58
61
63
66
69
71
74
77
79
82
85
87
90
75
95
115
130
160
185
215
240
280
320
360
400
450
500
560
615
680
750
order n° e.g. 20746-175M, 20747-215M
1
11
Optimam® SublimeLine ®
 0483
SublimeLine
The silicone-gel-filled Optimam®
implants with textured POLYtxt® surface have an
oblong base and an anatomical projection with the
SublimeLine®
The textured
SublimeLine®
soft compression.
Optimam® SL TLS – Low Projection, POLYtxt®
Optimam® TMS – Moderate Projection, POLYtxt®
Order n°
Order n°
20774-0601*
20774-0701
20774-0851*
20774-1001
20774-110*
20774-130
20774-150*
20774-170
20774-195*
20774-220
20774-240*
20774-275
20774-305*
20774-335
20774-375*
20774-415
20774-450*
20774-495
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
81
87
93
99
104
110
116
122
128
133
139
145
151
157
162
168
174
180
23
24
24
25
26
27
28
29
29
30
31
32
33
34
35
35
36
37
Volume (ml)
35
37
39
41
43
45
47
49
51
54
56
58
60
62
64
66
68
70
60
70
85
100
110
130
150
170
195
220
240
275
305
335
375
415
450
495
20775-0751*
20775-0901
20775-1051*
20775-125
20775-150*
20775-170
20775-200*
20775-225
20775-260*
20775-290
20775-330*
20775-370
20775-405*
20775-455
20775-505*
20775-555
20775-610*
20775-670
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
81
87
93
99
104
110
116
122
128
133
139
145
151
157
162
168
174
180
28
30
31
32
33
35
36
37
38
40
41
43
44
45
47
48
49
51
Volume (ml)
39
41
44
46
48
51
53
56
58
60
63
65
67
70
72
74
77
79
75
90
105
125
150
170
200
225
260
290
330
370
405
455
505
555
610
670
order n° e.g. 20774-150M, 20775-200M
1
12
Optimam® SublimeLine ®
 0483
barrier layer.
sterile.
Optimam® SL THS – High Projection, POLYtxt®
Optimam® SL TXS – Extra-High Projection, POLYtxt®
Order n°
Order n°
20776-0951*
20776-1101
20776-1301*
20776-155
20776-180*
20776-215
20776-250*
20776-280
20776-320*
20776-365
20776-415*
20776-460
20776-515*
20776-570
20776-640*
20776-7051
20776-7751*
20776-8551
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
81
87
93
99
104
110
116
122
128
133
139
145
151
157
162
168
174
180
34
36
37
39
40
42
44
45
47
49
51
53
55
57
59
61
62
64
Volume (ml)
44
46
49
52
54
57
60
62
65
68
70
73
76
78
81
84
86
89
95
110
130
155
180
215
250
280
320
365
415
460
515
570
640
705
775
855
20777-110*
20777-130
20777-160*
20777-185
20777-220*
20777-255
20777-290*
20777-335
20777-385*
20777-440
20777-495*
20777-555
20777-620*
20777-695
20777-7701*
20777-8551
20777-9401*
20777-10351
Dimensions (mm)
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
81
87
93
99
104
110
116
122
128
133
139
145
151
157
162
168
174
180
40
43
45
47
49
51
53
55
57
59
61
63
65
67
69
71
73
75
Volume (ml)
48
51
54
57
60
63
66
69
72
75
78
81
84
87
90
93
96
99
110
130
160
185
220
255
290
335
385
440
495
555
620
695
770
855
940
1035
order n° e.g. 20776-250M, 20777-290M
1
13
Notes
14
15
 +49 (0)6071 98 63 0 • +49 (0)6071 98 63 30
[email protected]
www.polytech-health-aesthetics.com
Quality made in Germany
Production exclusively in Dieburg, Germany
© 2009 POLYTECH Health & Aesthetics GmbH, Dieburg, Germany
Altheimer Str. 32 • 64807 Dieburg • Germany
2.2.83 2011-11
POLYTECH Health & Aesthetics GmbH

SublimeLine®

Transcription

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