ottobock 4R72 Titanium Double Adapters Instruction Manual
- June 3, 2024
- ottobock
Table of Contents
ottobock 4R72 Titanium Double Adapters
Product description
Date of last update: 2022-03-10
-
Please read this document carefully before using the product and observe the safety notices.
-
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=32, 4R72=45, 4R72=60, 4R72=75 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
Approved for a body weight of up to 150 kg.
Environmental conditions
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 ( see page 8 ).
Unallowable environmental conditions
Solids: Highly hygroscopic particles (e.g. talcum), continuous con
tact with sand
Chemicals/liquids: Acids, continuous use in liquid media
Safety
Explanation of warning symbols
Warning regarding possible risks of accident or injury.
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 6).
Observe the maximum lifetime of the product.
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).
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
**4R72=***
Quantity| Designation| Reference number
1| Instructions for use| 647H34
1| Double adapter| –
8| Set screw| 506G3=M8x12-V
Preparing the product for use
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
- Observe the alignment and assembly instructions.
Installation in the modular prosthesis
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
- The prosthetic components should be inspected 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
=32
| 4R72
=45
| 4R72
=60
| 4R72
=75
---|---|---|---|---
Weight [g]| 85| 95| 110| 125
System height [mm]| 69| 82| 97| 112
Build height [mm]| 32| 45| 60| 75
Material| Titanium
Max. body weight [kg]| 150