ottobock 2R54-M10 Foot Adapter Instruction Manual

: June 4, 2024
: ottobock

Table of Contents

ottobock 2R54-M10 Foot Adapter
Product description
Intended use
- 2R8*
General safety instructions
Scope of delivery
Preparing the product for use
Maintenance
Warranty
Technical data
References
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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)

2R54=M8

| 2D7=M8
Single component pack for 2R31=M10,

2R54=M10

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.