ottobock 2R40 Pediatric Foot Adapter Instruction Manual

2R40 Pediatric Foot Adapter
Instruction Manual

2R40 Pediatric Foot Adapter

2R40=, 2R41=, 2R48, 4R66

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Product description

INFORMATION
Date of last update: 2021-06-07

• 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 manu­ facturer and to the relevant authority in your country. This is par­ ticularly important when there is a decline in the health state.
• Please keep this document for your records.

1.1 Construction and Function
The 2R40=1 and 2R40=2 foot adapters for children are used to con­ nect a SACH foot for children or a dynamic foot for children to the distal connector of the modular prosthesis. The 2R41=1 and 2R41=2 tube adapters and the 4R66 tube clamp adapter are used as compon­ ents for modular lower limb prostheses. They connect the  prosthetic foot to the proximal components. The 2R48 tube adapter has an angled connector and is used to join a prosthetic knee joint to a pros­ thetic hip joint.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock’s system of modular connectors for children. Functionality with components of other manufacturers that have  compatible modular connectors has not been tested.

• 2R41=1: Only combine the product with foot adapter 2R40=1.
• 2R41=2: Only combine the product with foot adapter 2R40=2.

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fit­ tings.
2.2 Area of application
The product was developed for use in a children’s prosthesis.
• The maximum approved body weight is specified in the technical data (see page 13).
2.3 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)
2.4 Lifetime
This product was tested by the manufacturer with 3 million load cycles. This would correspond to a lifetime of 5 years for a prosthesis for adults. The lifetime of the product cannot be generally determined because loads vary widely in the course of use by children.

Safety

3.1 Explanation of warning symbols
CAUTION
Warning regarding possible risks of accident or injury.
3.2 General safety instructions
CAUTION!

• 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 9).
• Note the combination possibilities/combination exclusions in the instructions for use of the products.
• Do not expose the product to prohibited environmental condi­ tions.
• 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 dition. Take suitable measures (e.g. cleaning, repair, replace­ ment, inspection by the manufacturer or a specialist workshop).
• 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).

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

*2R41=, 2R48 tube adapter only
4| Set screw| 506G3=M6x10
4 R66 tube clamp adapter only
1| Flat head screw| 501S42=M6x18
Spare parts/accessories (not included in the scope of delivery)**

Quantity| Designation| Reference number
Special adhesive with hardener| 636W28
636W18 and 636W19
Single-component pack for 2R40=1 consisting of: one cap screw, one washer| 2D6=M8
Single-component pack for 2R40=2 consisting of: one cap screw, one washer| 2D6=M6

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 Installing the foot adapter

Required tools and materials: Grinding tool, 710D20 torque wrench, degreasing cleaning agent (e.g. 634A3 acetone), special adhesive and hardener (see page 10, table of  spare parts/accessories)

1. For prosthetic feet with wooden components, roughen the con­ nection surface and remove the grinding dust.

2. 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.

3. Clean any soiling (e.g. caused by grease) on the metal surface of the foot adapter to be glued with a degreasing cleaning agent.

4. Position the foot adapter on the prosthetic foot, insert the screw and washer from below and tighten it (installation torque: 2 to 4 Nm).

5. After 3 to 4 hours, tighten the screw connection with the required installation torque (see table).

6. Leave the glued surface to harden (16 hours at 20 °C – the time increases for lower temperatures).

com- ponents**
2R40=2| 12-17| 10| –
2R40=1| 18-21| 20| –

5.2 Adjusting the tube 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.

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: 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.

5.3 Installing the tube clamp adapter
> Required materials: torque wrench (e.g. 710D20)

1. Loosen the tube clamp cap screw by two turns.
2. Insert the tube adapter fully into the tube clamp adapter up to the stop. Align the clamping slot anteriorly.
3. Tighten the cap screw (tightening torque: 10 Nm).

5.4 Installation in the modular prosthesis
> 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 anteriorly.
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 receiv­er.
> Required materials: 710D20 torque wrench, 636K13 Loctite

1. Connect the pyramid to the pyramid receiver.
2. For final assembly: Coat the set screws with Loctite.
3. Screw the set screws in and tighten (2R41=1: 9 Nm, 2R41=2, 2R48: 7 Nm).

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.

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.

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.

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.
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.

Technical data

Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
healthcare@ottobock.de · www.ottobock.com
© Ottobock · 647G97=all_INT-27-2107

References

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