ottobock 2R51 Single Axis Foot Adapter Instruction Manual
- June 5, 2024
- ottobock
Table of Contents
ottobock 2R51 Single Axis Foot Adapter
Product description
INFORMATION
Date of last update: 2022-03-21
- 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 2R10 (stainless steel), 2R33 (titanium) and 2R51 (aluminum) single axis foot adapters connect a single axis prosthetic foot to the distal connector of a modular prosthesis. The initial sluggishness of the single axis joint has no adverse effect on the function. With the 2R51 single-axis foot adapter, the 2S88 dorsal stop set has to be used with the 1H single-axis prosthetic foot.
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.
| Allowable single-axis feet
---|---
2R10**| 1H
2R33*
*2R51| 1H (requires 2S88 dorsal stop set), 1G9
Intended use
Indications for use
The product is intended exclusively for lower limb endoprosthetic fittings.
Area of application
The maximum approved body weight is specified in the technical data (see page 8).
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
- 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.
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 (see page 6).
- 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 questionable condition. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
- To avoid the risk of injury and product damage, do not use the product beyond the tested lifetime.
- To avoid the risk of injury and product damage, only use the product for a single patient.
- 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
Quantity| Designation| Reference
number
---|---|---
1| Instructions for use| –
1| Adapter| –
Spare parts/accessories (not included in the scope of deliv
ery)
Designation| Reference number
Dorsal stop set
Consisting of: 2 dorsal stops (hard, soft)
| 2S88*
Single component pack for single axis feet Consisting of: 1 lower joint
shell, 1 shell, 1 base plate, 3 rubber bumpers (soft, medium, hard), 2
hexagon nuts
| 2D5
Preparing the product for use
Incorrect alignment or assembly
- Risk of injury due to damaged prosthetic components
- Observe the alignment and assembly instructions.
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 how to secure the screws.
5.1 Mounting the adapter
Required materials: 710D4 torque wrench, for 2R51 with 1H*: 2S88 dorsal
stop set
- When using the 2R51 with the 1H*: Position the chosen dorsal stop in the prosthetic foot (see fig. 2).
- Set wide end of the chosen rubber bumper (see fig. 1, item 1) into the recess in the prosthetic foot.
- Slide the joint shell (see fig. 1, item 2) onto the foot adapter.
- Insert the foot adapter into the prosthetic foot. In doing so, make sure the rubber bumper meets the recess in the foot adapter.
- Push the foot adapter into the prosthetic foot until the joint shell and foot adapter sit fully in the recess in the prosthetic foot.
- Slide the base plate (see fig. 1, item 3) onto the foot adapter from below.
- Put the hexagon nuts (see fig. 1, item 5 ) onto the foot adapter from below and tighten then (torque value: 6 Nm).
- With the screw, attach the locking device for the hexagon nuts (see fig. 1, item 4) to the base plate.
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 unauthorized 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.
Technical data
Reference num
ber
| 2R10| 2R33| 2R51
---|---|---|---
Size range [cm]| 22 to
25
| 26 to
30
| 22 to
25
| 26 to
30
| 22 to
25
| 26 to
27
Reference num
ber
| 2R10| 2R33| 2R51
---|---|---|---
Weight [g]| 325| 340| 200| 210| 230| 235
Material| Stainless steel| Titanium| Aluminum
Max. body
weight [kg]
| 100
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>