Scope Of Delivery; Instructions For Use; Preparation For Use - Ottobock 2R49-AL Instrucciones De Uso

Adapter combinations allow for controlled angle and length adaptation
in the sagittal and frontal plane as well as adjustment of inward and
outward rotation. These instructions for use apply to the following
tube adapters:
• 2R49=AL, 2R50=AL
1.2 Combination Possibilities
This prosthetic component is part of the Ottobock modular system. As
a result of its design, it may be combined with other prosthetic com­
ponents of the modular system. You can find possible restrictions in
this section. Contact the manufacturer with questions.
2 Application
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
2.2 Area of Application
Approved for a body weight of up to 136 kg (300 lbs).
2.3 Environmental Conditions
Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
2.4 Service Life
This prosthetic component has been tested by the manufacturer for 3
million load cycles according to ISO 10328. Depending on the
patient's activity level, this corresponds to a service life of 3 to 5
years.
3 Safety
3.1 Explanation of Warning Symbols
Warning regarding possible risks of accident or
CAUTION
injury.
Warning regarding possible technical damage.
NOTICE
3.2 General Safety Instructions
CAUTION
Unallowable combination of prosthesis components
Fall due to breakage or deformation of the product
► Only combine the product with prosthesis components that are
approved according to the section "Combination Possibilities".
► Based on the instructions for use of the prosthesis components,
verify that they may be combined with each other.
CAUTION
Excessive strain on the product
Fall due to breakage of load-bearing components
► Use the prosthetic components according to the classification
(see section "Area of Application").
CAUTION
Exceeding the service life
Fall due to change in or loss of functionality and damage to the
product
► Ensure that the approved service life is not exceeded (see sec­
tion "Service life").
CAUTION
Use under unallowable environmental conditions
Fall due to damaged product
► Do not expose the product to unallowable environmental condi­
tions (see the section "Environmental conditions").
► If the product has been exposed to unallowable environmental
conditions, check it for damage.
► If damage is apparent or in case of doubt, do not continue using
the product.
► Take suitable measures if required (e. g. cleaning, repair,
replacement, inspection by the manufacturer or a specialist
workshop etc.).
CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality
► Use caution when working with the product.
► If the product is damaged, check it for proper function and readi­
ness for use.
► In case of changes in or loss of functionality, do not continue
using the product (see "Signs of changes in or loss of functional­
ity during use" in this section).
► Take any necessary measures (e.g. repair, replacement, inspec­
tion by the manufacturer's customer service, etc.).
NOTICE
Mechanical overload
Impaired functionality due to mechanical damage
► Check the product for damage prior to each use.
► Do not use the product if its functionality has been impaired.
► Take any necessary measures (e.g. repair, replacement, inspec­
tion by the manufacturer's customer service, etc.).
Signs of changes in or loss of functionality during use
Among other factors, changes in functionality can be indicated by an
altered gait pattern, a change in the positioning of the prosthetic com­
ponents relative to each other and by the development of noises.

4 Scope of Delivery

The following single components and accessories are included in the
scope of delivery in the specified quantities and are available for
reordering as single components ( ), single components with minim­
um order quantities ( ) or single-component packs ( ):
Fig. Item Quant­ Designation
ity
– – 1 ( )

Instructions for use

– – 1 Tube adapter
For tube adapters with 30 mm diameter
– – 4 ( ) Set screw

5 Preparation for Use

CAUTION
Incorrect alignment or assembly
Injuries due to fall resulting from damaged prosthesis components
► Observe the alignment and assembly instructions.
CAUTION
Improper assembly of the screw connections
Fall due to breakage or loosening of the screw connections
► Clean the threads before every installation.
► Apply the specified installation torque values.
► Observe the instructions for securing the screw connections and
the use of the correct length.
5.1 Adjusting the adapter
CAUTION
Incorrect processing of tube
Fall due to damage to the tube
► Do not clamp the tube into a vice.
► For shortening the tube, use only a tube cutter.
CAUTION
Incorrect mounting of the tube
Fall due to breakage of load-bearing components
► Slide the tube all the way to the stop in the intended prosthetic
component when mounting.
Reference num­
ber
–
–
506G3=M8x14
Ottobock | 5