Ottobock 1C63 Triton Gebrauchsanweisung Seite 18

8.2 CE Conformity
This device meets the requirements of the 93/42/EEC guidelines for medical devices. This device
has been classified as a Class I device according to the classification criteria outlined in appendix
IX of the guidelines. The declaration of conformity was therefore created by Otto Bock with sole
responsibility according to appendix VII of the guidelines.
INFORMATION
Explanation of the warning symbol :
ISO 22675 – "P" – "m" kg*
* Body mass limit not be exceeded!
)
F or specific conditions and limitations of use see
manufacturer's written instructions on intended use!
INFORMATION
This component has been tested according to ISO 22675 standard for two million load cycles.
Depending on the amputee's activity this corresponds to a duration of use of two to three years.
We recommend carrying out regular yearly safety checks.
9 Appendix
9.1 Technical Data
Sizes (cm)
Heel Height
(mm)
Foot module
System
with slim
Height (mm)
footshell
Weight (g)
Heel Height
(mm)
Foot module
System
with normal
Height (mm)
footshell
Weight (g)
max. Body Weight MG 3 (kg)
max. Body Weight MG 4 (kg)
Mobility Grade
18
In the standard mentioned on the left, test levels
)
(P) are assigned to certain maximal body masses
(m in kg). In some cases, which are marked with
, no test level is assigned to the product-related
maximal body mass.
In these cases, the test loads have been adapted
adequately on the basis of the specified test level.
21 22 23
15 15 15
36 35 35
435 450 520 550 600 615 665
– – –
– – –
– – – 560 610 635 675 245 270 300
100
24 25 26 27
15 15 15 15
36 40 40 45
10 10 10 10
42 43 45 49
3 – 4
28 29 30
– – –
– – –
– – –
10 10 10
49 52 55
150