Intended Use; Environmental Conditions - Ottobock Lamination Anchors Instrucciones De Uso

1.1 Construction and Function
Lamination anchors are laminated into a prosthetic socket. They serve
to connect the prosthetic socket to the distal prosthetic components.
This document applies to the following lamination anchors:
Lamination anchor, four-arm
Reference Distal connection
number
4R111 Pyramid receiver, rotating
4R111=N, Threaded connector
4R111=T
4R116, Pyramid adapter, rotating
4R116=T,
4WR95=2
4R117, Pyramid adapter, rotating
4R117=T
4R119=N, Threaded connector
4R119=NT
4R119, Pyramid receiver, rotating
4R119=T,
4WR95=1
Lamination anchor, three-arm
Reference Distal connection
number
4R41 Pyramid receiver, rotating
4R42 Pyramid adapter
4R42=1, Pyramid adapter with 9.5 mm
4R42=5 bore for shuttle lock
4R43 Threaded connector
4R89 Pyramid adapter, rotating
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of
modular connectors. Functionality with components of other manufac­
turers that have compatible modular connectors has not been tested.

2 Intended use

Figure
2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fit­
see fig. 2
tings.
see fig. 3
2.2 Area of application
Product approved for max. body weight
see fig. 4
• The maximum approved body weight is specified in the technical
data (see Page 19).
see fig. 5
Additional constraints
• 4R41, 4R42, 4R42=1, 4R42=5, 4R43, 4R89, 4R111, 4R111=N,
see fig. 6 4R116, 4R117, 4R117=T, 4R119=NT, 4R119=T, 4WR95=1: Use
of products permissible in TT prostheses and TF prostheses.
4R111=T, 4R116=T, 4R119, 4R119=N, 4WR95=2: Use of
see fig. 7 •
product only permitted in TF prostheses.

2.3 Environmental conditions

Storage and transport
Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative
Figure
humidity 20 % to 90 %, no mechanical vibrations or impacts
see fig. 8
4R41, 4R42=1, 4R42=5, 4R43, 4R89, 4R111, 4R111=N, 4R116,
see fig. 9
4R117
Allowable environmental conditions
Temperature range: –10 °C to +45 °C
see fig. 10
Moisture: relative humidity: 20% to 90%, non-condensing
see fig. 11
13