ottobock 4R1 Adjustment Adapter Instruction Manual
- June 3, 2024
- ottobock
Table of Contents
4R1 Adjustment Adapter
Instruction Manual
4R1 Adjustment Adapter
Product description
INFORMATION
Date of last update: 2021-12-10
- 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 prob lems.
- 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.
1.1 Construction and Function
The 4R1 sliding adapter is used to optimise the alignment of leg prostheses.
The adapter can be repositioned in the frontal plane and the sagittal plane
via the dovetail guides while the patient’s weight is on the prosthesis.
Adjustments are reproducible using scales. The adapter is removed again before
finishing the prosthesis.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock’s system of modular
connectors. Func tionality with components of other manufacturers that have
compatible modular connectors has not been tested.
Intended use
2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.
2.2 Area of application
Approved for a body weight of up to 100 kg. The product may be used only for
fitting in a workshop.
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: 1 0 °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)
Safety
3.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
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 7).
- Note the combination possibilities/combination exclusions in the instructions for use of the products.
- 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 meas ures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist work shop).
- 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).
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 develop ment of noises.
Scope of delivery
| Quantity | Designation | Reference number |
|---|---|---|
| 1 | Instructions for use | – |
| 1 | Adapter | – |
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.
5.1 Mounting the adapter
Socket adapters are pre-assembled on the sliding adapter. It has a proximal
pyramid receiver and a distal pyramid. The socket adapters can be replaced.
The sliding adapter is installed in the prosthesis during the bench alignment
(e.g. between the prosthetic knee joint and prosthetic socket or between the
prosthetic foot and prosthetic socket).
Optional: Replacing socket adapters
- Remove the existing socket adapter.
- Install the socket adapter according to its instructions for use.
Connecting the pyramid adapter and pyramid receiver
Required materials: Torque wrench (e.g. 710D20)
- Install the set screws and tighten them with the torque wrench (10 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 disas sembly. In order to do this, unscrew the two set screws
that are screwed in the furthest and loc ated next to each other.
5.2 Adjusting adapter
The sliding adapter is used during the static and dynamic fitting. The
position is adjusted with the adjusting screws and secured with cap screws.
- Loosen the two cap screws (see fig. 1).
- NOTICE! To avoid increased wear and tear, loosen the cap screws before adjusting the adapter. Use the adjusting screws to adjust the position in the frontal plane and in the sagittal plane (see fig. 2).
- Tighten the cap screws slightly to secure the position of the adapter (see fig. 1).
5.3 Removing the adapter
After finishing the static alignment and the dynamic fitting, the adapter is
removed from the pros thesis and replaced with the definitive prosthetic
components. Ottobock recommends the 743A16 transfer device for transferring
the alignment parameters.
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
- 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.
9.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descrip tions 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.
Technical data
| Reference number | 4R1 |
|---|---|
| Weight (without socket adapter) [g] | 465 |
| Weight (with socket adapter) [g] | 610 |
| Height without adapter [mm] | 46 |
| Height with adapter [mm] | 82 |
| Build height [mm] | 68 |
| System height [mm] | 68 |
| Max. displacement medial/lateral [mm] | ±15 |
| Max. displacement anterior/posterior [mm] | ±25 |
| Max. body weight [kg] | 100 |
© Ottobock · 647G1529=all_INT-09-2201
Ottobock SE & Co. KGaA Max-Näder-Straße 15
37115 Duderstadt
Germany T +49 5527 848-0
F +49 5527 848-3360
[email protected]
www.ottobock.com