ottobock 4R118 Adapter Plate Instruction Manual

: June 3, 2024
: ottobock

ottobock 4R118 Adapter Plate

Product description

INFORMATION

Please read this document carefully before using the product and observe the safety notices.
Instruct the user in the safe use of the product.
Please contact the manufacturer if you have questions about the product or in case of problems.
Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
Please keep this document for your records.

Construction and Function

The 4R118 adapter plate is installed between the socket attachment block and the socket adapter of a TF prosthesis. It shifts the prosthetic knee joint in the posterior direction. The adapter plate can be used for repositioning between 10 mm and 25 mm.

Combination possibilities

This prosthetic component is compatible with Ottobock’s system of modular connectors. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.
Limited combination options for Ottobock components
This product can be combined with the following Ottobock components:

Socket attach ment block| 5R1=1, 5R1=2, 5R1=6, 5R2, 5R6=1, 5R6=2, 5R6=3
---|---
Socket adapter| 4R22, 4R37, 4R51, 4R55, 4R95

Intended use

Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

Area of application

The product must be used in TF prostheses only.
Approved for a body weight of up to 125 kg.

Environmental conditions

Storage and transport

Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative
humidity 20 % to 90 %, no mechanical vibrations or impacts
Allowable environmental conditions

Temperature range: –10 °C to +45 °C (14 °F to 113 °F)
Moisture: relative humidity: 20% to 90%, non-condensing
Unacceptable environmental conditions

Chemicals/liquids: fresh water, salt water, perspiration, urine,
acids, soapsuds, chlorine water
Unacceptable environmental conditions

Solids: dust, sand, highly hygroscopic particles (e. g. talcum)

Lifetime

This product was tested by the manufacturer with 3 million load cycles. Depending on the user’s activity level, this corresponds to a maximum lifetime of 5 years.

Safety

Explanation of warning symbols

Warning regarding possible risks of accident or injury.

Warning regarding possible technical damage.

General safety instructions

Risk of injury and risk of product damage

Comply with the product’s field of application and do not expose it to excessive strain.
Note the combination possibilities/combination exclusions in the instructions for use of the products.
Do not expose the product to prohibited environmental conditions.
Check the product for damage if it has been exposed to prohibited environmental conditions.
Do not use the product if it is damaged or in a questionable condition. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
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 function and readiness for use.
Do not use the product if its functionality is restricted. Take suitable 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 components relative to each other and by the development of noises.

Scope of delivery

4R118

Quantity| Designation| Reference num ber
1| Instructions for use| –
1| Adapter plate| –
4| Cap screw| 501T61=M6x12
4| Cap screw| 501T61=M6x25
4| Cap screw| 501T61=M6x30
4| Countersunk head screw| 501S41=M6x12
4| Countersunk head screw| 501S41=M6x16

Preparing the product for use

Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components

Observe the alignment and assembly instructions.

Preparing the prosthetic socket

The distal end of the prosthetic socket is ground to ensure full-surface contact of the adapter plate.

NOTICE! Grind parallel to the distal surface of the socket attachment block to avoid damage to the load-bearing structures.
Sand down the excess laminate on the distal end of the prosthetic socket.

Installation in the modular prosthesis

Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connections

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.

Mounting on socket attachment block

Recommended tools:
710D20 torque wrench, 636K13 Loctite®

Select the correct cap screws for the socket attachment block or the lamination disc (see selection table).
Position the adapter plate with the slotted holes on the socket attachment block or the lamination disc.
Adjust the desired posterior displacement.
Apply Loctite® to the cap screws, slide them through the slotted holes and tighten them crosswise (torque value 10 Nm).

Socket attachment block,
lamination disk| Cap screw
---|---
5R2| 501T61=M6x12
5R1=1, 5R1=2, 5R1=6| 501T61=M6x25
5R6=1, 5R6=2, 5R6=3| 501T61=M6x30

Fastening the socket adapter

To connect the adapter plate to a socket adapter, use 501S41=M6x16 countersunk screws.
> Required materials: 710D20 torque wrench, 636K13 Loctite 241

If the pyramid receiver or the pyramid adapter is rotatable: Place the pressure plate on the adapter.
Place the adapter on the connecting component.
Optional: Align the pyramid receiver or the pyramid adapter.
Secure the screws with Loctite.
Screw in the 2 posterior countersunk head screws and tighten them (tightening torque: 12 Nm).
Screw in the 2 anterior countersunk head screws and tighten them (tightening torque: 12 Nm).

Cleaning

Clean the product with a damp, soft cloth.
Dry the product with a soft cloth.
Allow to air dry in order to remove residual moisture.

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.

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.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

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.

CE conformity

The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

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.