ottobock 2R54-M10 Foot Adapter
ottobock 2R54-M10 Foot Adapter
Product description
INFORMATION
- 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 foot adapters 2R8* (steel), 2R31* (titanium) and 2R54* (aluminium) are for connecting the prosthetic foot to the distal connection of the modular prosthesis.
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.
Intended use
Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.
Area of application
2R8=M8, 2R31=M8, 2R54=M8 and 2R54=M10
Approved for a body weight of up to 100 kg.
2R8=M10
Approved for a body weight of up to 125 kg.
2R31=M10
Approved for a body weight of up to 136 kg (300 lbs).
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 |
2R8*
| Allowable environmental conditions |
| Temperature range: –10 °C to +45 °C (14 °F to 113 °F) |
| Moisture: relative humidity: 20% to 90%, non-condensing |
| Chemicals/liquids: fresh water as dripping water, occasional con tact with salty air (e.g. near the ocean) |
| Solids: dust |
2R54*
| Prohibited environmental conditions |
| Chemicals/moisture: salt water, perspiration, urine, acids, soapsuds, chlorine water |
| Solids: dust in high concentrations (e.g. construction site), sand, highly hygroscopic particles (e.g. talcum) |
| Allowable environmental conditions |
| Temperature range: –10 °C to +45 °C (14 °F to 113 °F) |
| Chemicals/liquids: fresh water, soapsuds, chlorine water |
| Moisture: Submersion: max. 1 h in 2 m depth, relative humidity: no restrictions |
| Solids: Dust, occasional contact with sand |
| Clean the product after contact with humidity/chemic als/solids, in order to avoid increased wear and damage (Cleaning). |
| Prohibited environmental conditions |
| Solids: highly hygroscopic particles (e.g. talcum), dust in high con centrations (e.g. construction site), intensive contact with sand |
| Chemicals/liquids: salt water, perspiration, urine, acids, continu ous use in liquid media |
| Allowable environmental conditions |
| Temperature range: –10 °C to +45 °C (14 °F to 113 °F) |
| Chemicals/liquids: fresh water, salt water, perspiration, urine, soapsuds, chlorine water |
| Moisture: Submersion: max. 1 h in 3 m depth, relative humidity: no restrictions |
| Solids: Dust, occasional contact with sand |
| Clean the product after contact with humidity/chemic als/solids, in order to avoid increased wear and damage (Cleaning). |
| Unallowable environmental conditions |
| Solids: Highly hygroscopic particles (e.g. talcum), continuous con tact with sand |
| Chemicals/liquids: Acids, continuous use in liquid media |
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 7).
- Note the combination possibilities/combination exclusions in the instructions for use of the
- Do not expose the product to prohibited environmental condi
- Check the product for damage if it has been exposed to prohib ited environmental conditions.
- Do not use the product if it is damaged or in a questionable con Take suitable measures (e.g. cleaning, repair, replace ment, 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
- To avoid the risk of injury and product damage, only use the product for a single
- To prevent mechanical damage, use caution when working with the
- If you suspect the product is damaged, check it for proper func tion and readiness for
- 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
Scope of delivery
| 2R8*, 2R31*, 2R54* Foot adapters | ||
| Quantity | Designation | Reference num ber |
| 1 | Instructions for use | – |
| 1 | Foot adapter | – |
| Spare parts/accessories (not included in the scope of deliv ery) | ||
| Quantity | Designation | Reference number |
| Ottobock special adhesive with hardener | 636W28 | |
| 636W18 and 636W19 | ||
| Single component pack for 2R8=M8 | 2D6=M8 | |
| Single component pack for 2R8=M10 | 2D6=M10 | |
| Each consisting of | ||
| 1 | Washer | – |
| 1 | Cap screw (steel) | – |
| Single component pack for 2R31=M8, 2R54=M8 | 2D7=M8 | |
| Single component pack for 2R31=M10, 2R54=M10 | 2D7=M10 | |
| Each consisting of | ||
| 1 | Washer | – |
| 1 | Cap screw (titanium) | – |
Preparing the product for use
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
- Observe the alignment and assembly instructions.
Mounting the adapter
CAUTION
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.
Required tools and materials: Grinding tool, 710D20 torque wrench, degreasing cleaning agent (e.g. 634A3 acetone), special adhesive and hardener (see page 9, table of spare parts/accessories)
- For prosthetic feet with wooden components, roughen the connection surface and remove the grinding dust. INFORMATION: The foot adapter has to be glued to the prosthetic foot. Use the specified special adhesive for this purpose.
- Mix the special adhesive and hardener well together and apply to the connection surface.
- Clean any soiling (e.g. caused by grease) on the metal surface of the foot adapter to be glued with a degreasing cleaning agent. Position the foot adapter on the prosthetic foot, insert the screw and washer from below and tighten it (installation torque: 2 to 4 Nm).
- After 3 to 4 hours, tighten the screw connection with the required installation torque (see table).
- Leave the glued surface to harden (16 hours at 20 °C – the time increases for lower temperatures).
| Reference number | Prosthetic foot size [cm] | Torque [Nm] | |
| Prosthetic feet with wooden components | Prosthetic feet with plastic com ponents | ||
| 2R8=M8 | All | 40 | – |
| 2R31=M8 2R54=M8 | 20 | – | |
| 2R8=M10 2R31=M10 2R54=M10 | 21-25 | 20 | 50 |
| 26-30 | 30 | 50 | |
Maintenance
- A visual inspection and functional test of the prosthetic components should be performed after the first 30 days of
- Inspect the entire prosthesis for wear during normal consultant
- Conduct annual safety
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 down loaded 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 number | 2R8* | 2R31* | 2R54* |
| Weight [g] =M8 =M10 | 115 125 | 65 70 | 70 80 |
| Material | Steel | Titanium | Aluminium |
| Max. body weight [kg] =M8 =M10 | 100 125 | 100 136 | 100 100 |
Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany T +49 5527 848-0 · F +49 5527 848-3360
[email protected] · www.ottobock.com
Welcome to Ottobock. We help people regain their movement.
