►
Observe the maximum lifetime of the product.
►
To prevent mechanical damage, use caution when working with
the product.
►
If you suspect the product is damaged, check it for proper func
tion and readiness for use.
►
Do not use the product if its functionality is restricted. Take suit
able measures (e.g. cleaning, repair, replacement, inspection by
the manufacturer or a specialist workshop).
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
Quant
ity
Designation
Reference num
ber
1
Instructions for use
–
1
Tube adapter
–
For 2R2, 2R3, 2R37, 2R38, 2R38=10
4
Set screw
506G3=M8x12-V
For 2R49*, 2R50*, 2R57, 2R58, 2R76, 2R77, 2WR95*
4
Set screw
506G3=M8x14
5 Preparing the product for use
CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
►
Observe the alignment and assembly instructions.
CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connec
tions
►
Clean the threads before every installation.
►
Apply the specified torque values.
►
Follow the instructions regarding the length of the screws and
about how to secure the screws.
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.
►
To shorten the tube, use only a tube cutter or a cutting device.
>
Required materials:
719R3 tube cutter or 704Y14* cutting
device, 718R1 tube deburrer
1) Shorten the tube to the required length.
2) Deburr the inside and outside of the cut edge with the tube
deburrer.
5.2 Installation in the modular prosthesis
CAUTION
Incorrect mounting of the tube
Risk of injury due to breakage of load-bearing components
►
Slide the tube all the way to the stop in the intended prosthetic
component when mounting.
>
Required materials:
See instructions for use of the connection
components
1) Position the pyramid receiver of the tube adapter distally in the
prosthesis.
2) Align the clamping slot of one tube clamp adapter:
Tube clamp adapter:
anterior
Tube clamp adapter, sliding:
anterior
or
medial
3) Connect the connection components to the tube adapter as
described in the respective instructions for use.
Connecting the pyramid adapter and pyramid receiver
The pyramid adapter is fixed with the set screws of the pyramid receiv
er.
6
>
Required materials:
torque wrench (e.g. 710D20), 636K13 Loc
tite 241
1)
Fitting:
Screw in the set screws.
Use the torque wrench to tighten the set screws (
10 Nm
).
2)
Definitive assembly:
Secure the set screws with Loctite.
Screw in the set screws.
Pre-tighten the set screws with the torque wrench (
10 Nm
) and
then tighten them (
15 Nm
).
3) Replace any set screws that are protruding or are recessed too
much with appropriate set screws (see selection chart).
Selection table for set screws
Reference number
Length (mm)
506G3=M8X12-V
12
506G3=M8X14
14
506G3=M8X16
16
Alignment
The set screws in the pyramid receiver can be used to make static
adjustments during alignment, trial fittings and after the prosthesis is
finished.
Replacement and disassembly
The set position of the prosthetic component can be maintained dur
ing replacement or disassembly. In order to do this, unscrew the two
set screws that are screwed in the furthest and located next to each
other.
6 Cleaning
1) Clean the product with a damp, soft cloth.
2) Dry the product with a soft cloth.
3) Allow to air dry in order to remove residual moisture.
7 Maintenance
►
A visual inspection and functional test of the prosthetic compon
ents should be performed after the first 30 days of use.
►
Inspect the entire prosthesis for wear during normal consulta
tions.
►
Conduct annual safety inspections.
8 Disposal
In some jurisdictions it is not permissible to dispose of the product
with unsorted household waste. Improper disposal can be harmful to
health and the environment. Observe the information provided by the
responsible authorities in your country 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
accordance 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 unauthorised modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745
on
medical devices. The CE declaration of conformity can be down
loaded from the manufacturer's website.
9.3 Warranty
The manufacturer warrants this device from the date of purchase. The
warranty covers defects that can be proven to be a direct result of
flaws in the material, 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.
10 Technical data
Tube diameter: 30 mm
Stainless steel
Reference number
2R2
2R3
Weight [g]
195
315