ottobock 6A53 Sliding Adapter PPR Instructions

ottobock 6A53 Sliding Adapter PPR Instructions

Product description

INFORMATION

Date of last update: 2021-06-08

• 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.

Design and Function

The 6A53 and 6A54 Sliding Adapters permit the distal components of the modular prosthesis to be shifted in parallel, regardless of the angle adjustment by the pyramid adapters. The adjustments can be made either in the frontal plane (medial or lateral) or in the sagittal plane (anterior or posterior).
The sliding adapters are equipped with different connections:

Combination possibilities

This prosthetic component is compatible with Otto bock’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

• The maximum approved body weight is specified in the technical data (see page 9)

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.

Safety

Explanation of warning symbols

CAUTION

Warning regarding possible risks of accident or injury.
NOTICE: Warning regarding possible technical damage.

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 6).
• Note the combination possibilities/combination exclusions in the instructions for use of the products.
• Observe the maximum lifetime of the product.

NOTICE:

Risk of product damage and limited functionality

• 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).

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

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 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.

Adjusting adapter

The adapter includes a pyramid adapter adjustable in 2 mm increments. The pyramid adapter can be aligned proximally or distally. >
Required materials: 710D20 torque wrench, 636K13 Loctite 241

1. Align the sliding adapter in the desired displacement direction (a – p or m – l).

2. Lift the ring on the adjustable pyramid adapter slightly in order to displace the pyramid adapter (see fig. 3).

3. Set the desired displacement and press the ring back down until it engages.
   TIP: Mark the final position with a pen.

4. Connect the pyramid adapter with the applicable connecting component (see fig. 4).

This fastens the pyramid adapter in its position

Connecting the pyramid adapter and pyramid receiver

The pyramid adapter is fixed with the set screws of the pyramid receiver.

> Required materials: torque wrench (e.g. 710D20), 636K13 Loctite 241

1. Fitting:
   Screw in the set screws.
   Use the torque wrench to tighten the set screws (10 Nm).

2. Definitive assembly:
   Secure the set screws with Loctite.
   Screw in the set screws.
   Pre-tighten the set screws with the torque wrench (10 Nm) and then tighten them (15 Nm).

3. Replace any set screws that are protruding or are recessed too much with appropriate set screws (see selection chart).

Selection table for set screws

Reference number| Length (mm)
506G3=M8X12-V| 12
506G3=M8X14| 14
506G3=M8X16| 16

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 during 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.

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.

Technical data

Alumin

| 33

ium

Material|
Max. displacement [mm]| 20
Max. body weight [kg]| 125

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.

Customer Support

The 6A53 or 6A54 is covered by one or more of the following registered designs and design patent:

European Design: No 002040691-0001; No 002040691-0002

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

References

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