7 Maintenance
► A visual inspection and functional test of the prosthetic components
should be performed after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consultations.
► Conduct annual safety inspections.
8 Disposal
This product may not be disposed of with regular domestic waste in all juris
dictions. Disposal that is not in accordance with the regulations of the coun
try where the product is used may have a detrimental impact on health and
the environment. Please observe the information provided by the responsible
authorities in the country of use regarding return, collection and disposal
procedures.
9 Legal information
All legal conditions are subject to the respective national laws of the country
of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in accord
ance with the descriptions and instructions provided in this document. The
manufacturer will not assume liability for damage caused by disregarding the
information in this document, particularly due to improper use or unauthor
ised modification of the product.
9.2 CE conformity
This product meets the requirements of the European Directive 93/42/EEC
for medical devices. This product has been classified as a class I device
according to the classification criteria outlined in Annex IX of the directive.
The declaration of conformity was therefore created by the manufacturer
with sole responsibility according to Annex VII of the directive.
10 Technical data
Sizes [cm]
Heel height [mm]
System height with
adapter [mm]
Product weight
without adapter [g]
1D10
22
23
24
55
58
61
290
320
350
25
26
27
10 ±5
64
67
70
390
470
505
28
29
30
72
74
76
565
605
685
19