Ottobock 4r72=32 Al Aluminum Double Adapter Instructions (+ PDF)

ottobock 4R72=32 AL Aluminum Double Adapter 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.

Construction and Function

The 4R72=32AL, 4R72=45AL, 4R72=60AL, 4R72=75AL, 4R72=90AL double adapters are used to connect two pyramid adapters. The pyramid receivers make it possible to make distal and proximal angle adjustments in the frontal and sagittal planes.

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

The maximum approved body weight is specified in the technical data.

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

Allowable environmental conditions

Chemicals/liquids: fresh water as dripping water, occasional contact with salty air (e.g. near the ocean)
Solids: dust

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)

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

Note the combination possibilities/combination exclusions in the instructions for use of the products.
Comply with the product’s field of application and do not expose it to excessive strain.
Observe the maximum lifetime of the product.
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).
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).

NOTICE

Risk of product damage and limited functionality

Check the product for damage and readiness for use prior to each 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	Double adapter	–
8	Set screw	506G3=M8x14

Preparing the product for use

CAUTION

Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components

Observe the alignment and assembly instructions.

Installation in the modular prosthesis

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.

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

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

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

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

CAUTION
Failure to follow the maintenance instructions
Risk of injuries due to changes in or loss of functionality and damage to the product

Observe the following maintenance instructions.
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 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 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 number	4R72= 32AL	4R72= 45AL	4R72= 60AL	4R72= 75AL	4R72= 90AL
Weight [g]	80	95	105	110	120
System height [mm]	69	82	97	112	127
Build height [mm]	32	45	60	75	90
Material	Aluminium
Max. body weight [kg]	136