Technical Data - Otto Bock 453D4 Derma Seal forte Instructions For Use Manual

7.1 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 disregard of this
document, particularly due to improper use or unauthorised modification of
the product.
7.2 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.
7.3 Warranty
The manufacturer warrants this device from the date of fitting. The warranty
covers defects that can be proven to be a direct result of flaws in the materi­
al, production or construction and that are reported to the manufacturer
within the warranty period.
Further information on the warranty terms and conditions can be obtained
from the competent manufacturer distribution company.

8 Technical Data

The selection of the sock size depends on the length and circumference of
the residual limb. The residual limb length is measured over the condyles.
The length of the gel of the residual limb sock should exceed that of the
prosthetic socket.
Reference
Number
453D4=1
453D4=2
453D4=3
453D4=10
453D4=20
Reference
Number
453D5=1
12 | Ottobock
Sock length
[cm]
30
30
40
70
75
Sock length
[cm]
30
453D4
Gel length Distal circum­
[cm] ference [cm]
25
25
30
25
30
453D5
Gel length Distal circum­
[cm] ference [cm]
25
Proximal cir­
cumference
15 to 22 20 to 32
20 to 26 28 to 42
20 to 26 28 to 45
15 to 22 20 to 32
20 to 26 28 to 42
Proximal cir­
cumference
15 to 20 20 to 28
[cm]
[cm]