ottobock 3R series Single Axis Knee Joint, Brake Instruction Manual
- June 4, 2024
- ottobock
Table of Contents
ottobock 3R series Single Axis Knee Joint, Brake Instruction Manual
Illustrations
Notes regarding the document
INFORMATION
Date of last update: 2021-08-04
- 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.
This document and the product are intended exclusively for the fabrication of a prosthesis by orthopaedic technicians with technical knowledge of lower limb prosthetic fittings.
Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
Meanings of pictograms in the illustration
| Numbering for the illustrations| | Reference to the number of the
corresponding section
---|---|---|---
| Numbering for the illustrations| | Numbering for the parts of an
illustration
| Numbering for the illustrations| | Wrong
Product description
The product (3R15, 3R49) has the following key features:
- Monocentric prosthetic knee joint
- Product components for stance phase stability:
- Adjustable, load-dependent braking mechanism to secure the extension position
- Product components for swing phase control:
- Extensor (spring force adjustable)
- Material: Stainless steel (3R15), Titanium (3R49)
Intended use
Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.
Area of application
CAUTION
Excessive strain on the product
Fall due to breakage of load-bearing components
- Only use the product according to its allowable field of application.
Allowable field of application (3R15)
Recommended mobility grade: 1 + 2| Everyday prosthesis
Allowable body weight: ≤ 100 kg
MG 2: Restricted outdoor walker
The patient has the ability or the potential to walk slowly with the prosthesis and to negotiate low environmental obstacles like curbs, single steps or uneven surfaces. The amount of time and the distance he/she can walk are seriously limited due to his/her condition.
Unallowable amputation types
Hip disarticulation, Hemipelvectomy
Combination possibilities
CAUTION
Improper combination of prosthetic components
Injuries, malfunctions or product damage due to unallowable combination of prosthesis components
- Based on the instructions for use of all prosthetic components used, verify that they may be combined with each other and are approved for the patient’s area of application.
INFORMATION
In a prosthesis, all prosthetic components have to meet the patient’s
requirements regarding the amputation level, body weight, activity level,
environmental conditions and field of application.
Unallowable combinations
Prosthetic hip joints| All reference numbers
Environmental conditions
CAUTION
Use under unallowable environmental conditions
Fall due to damaged product
- Do not expose the product to unallowable environmental conditions (see the table “Unallowable environmental conditions” in this section).
- If the product was exposed to unallowable environmental conditions, take suitable steps (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop etc.).
Allowable environmental conditions
Temperature range: -10 °C – +60 °C
Use – Relative humidity: 0 % – 90 % (Non-condensing)
Storage/Transportation – Relative humidity: 100 %
Tyre pressure: 250 – 1100 mbar
Commercially available, solvent-free cleaning agents
Unallowable environmental conditions
Storage/Transportation: Mechanical vibrations, Impacts
Hygroscopic particles (e.g.Talcum powder), Dust, Sand, Fresh
water, Salt water, Acids, Sweat, Urine
Cleaning agents containing solvents
Reuse and lifetime
CAUTION
Reuse on another patient
Fall due to loss of functionality as well as damage to the product
- Only use the product for a single patient.
CAUTION
Exceeding the lifetime
Fall due to change in or loss of functionality and damage to the product
- Ensure that the maximum lifetime defined in this section is not exceeded.
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.
General safety instructions
CAUTION
Reaching into the area of the joint mechanism
Pinching of limbs (e.g. fingers) and the skin due to uncontrolled joint
movement
- Do not reach into the joint mechanism during daily use.
- Close attention is required during assembly and adjustment tasks.
CAUTION
Mechanical damage to the product
Risk of injury due to change in or loss of functionality
- Use caution when working with the product.
- If the product is damaged, check it for proper function and readiness for use.
- In case of changes in or loss of functionality, do not continue using the product (see “Signs of changes in or loss of functionality during use” in this section).
- Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).
Signs of changes in or loss of functionality during use
Changes in functionality can manifest themselves, for example, through a changed gait (swing phase, stance phase), incomplete extension, stiffness and the development of noise.
Scope of delivery
The scope of delivery is shown in Figure on page 2.
Only product components with reference numbers in the illustration can be
reordered separately.
Technical data
The technical data are shown in Figure on page 2.
: Proximal system height (PSH); : distal system height (DSH)
Preparing the product for use
Information on fabrication of a prosthesis
CAUTION
Incorrect alignment, assembly or adjustment
Injury due to incorrectly installed or adjusted as well as damaged prosthetic
components
- Observe the alignment, assembly and adjustment instructions.
CAUTION
Initial use of the prosthesis by the patient
Fall due to lack of patient experience, incorrect alignment or incorrect
adjustment of the prosthesis
- For the safety of the patient, use a suitable device (e.g. parallel bars, handrail, wheeled walker) during initial standing and walking.
Bench alignment of the prosthesis
INFORMATION
The prosthetic components and prosthesis shown in the illustrations are used
as examples to illustrate the general process. The instructions for use of the
prosthetic components selected for the patient contain detailed information
and have to be used for fabrication of the prosthesis.
- CAUTION! To enable the patient to stand safely, align the prosthesis using the alignment images for the sagittal plane (Figure on page 3) and for the frontal plane (Figure on page 3) as well as the instructions for use of all prosthetic components that were used.
- Additionally, observe the following points for the bench alignment of the prosthesis:
- on page 4: Mount the prosthetic joint with its extension assist cable as shown in the illustration.
Optimising the static alignment
- To optimise the static alignment, position the patient on the measuring device.
- In the sagittal plane, check the course of the load line relative to the marked alignment reference point and correct this if needed (see Figure on page 4).
- In the frontal plane, check the course of the load line relative to the marked points (prosthetic foot, prosthetic knee joint, spina iliaca anterior superior) and correct if needed (see Figure on page 4).
Optimising during dynamic trial fitting
CAUTION
Adjusting the Settings
Fall due to incorrect or unfamiliar settings
- Only adapt the settings to the patient gradually.
- Explain the effects of the adjustments on the use of the prosthesis to the patient.
Restore default settings
- Prior to the dynamic trial fitting, restore the factory settings as shown in the illustrations if the factory settings have been changed ( , and on pages 5 and 6).
- on page 6: Adjust gradually, Minimal braking action When resetting, set the axis friction gradually (45°) to minimal resistance to motion and then turn back slightly without creating play .
Setting the load-related braking action ( on page 6)
- Set the load-related braking action as shown in the illustration.
- Increase threshold – Joint brakes at a higher load
- Reduce threshold – Joint brakes at a lower load
- Increase gradually (rotation: approx. 45° – 90°).
- When the desired effect is reached, continue with “Setting axis friction”.
Setting axis friction ( on page 7)
- Set the axis friction as shown in the illustration.
- Decrease play – Increase resistance to motion
- Increase play – Decrease resistance to motion
- Reduce play and increase resistance to motion gradually (rotation: approx. 20°).
- Set the load-related braking action and axis friction so that the prosthetic knee joint switches from the stance phase to the swing phase and no longer jams.
- NOTICE! To prevent increased wear and tear, do not use axis friction to control the swing phase.
Setting the extension assist ( on page 7)
- Set the extension assist as shown in the illustration if necessary.
- Increase spring tension
- Reduce spring tension
- CAUTION! Set the extension assist so that the lower leg of the prosthesis swings through in the dorsal direction according to the patient’s requirements, but reaches full extension in time before the next heel strike.
Fine-tuning the settings
- CAUTION! The various settings of the prosthetic knee joint cannot be adjusted entirely independently of each other. When the settings cannot be fully adjusted to the comfort needs of the patient, the settings should be established primarily based on safety aspects.
- Adapt the settings of the prosthetic knee joint to the patient by means of fine-tuning and exercises.
- If the extension position is not reached with every step and at any walking speed, reduce the braking effect and/or increase the initial tension of the extension assist.
- Check the adjustment of the prosthesis settings during normal consultations and the annual safety inspection.
Advise the patient to check the prosthesis if changes in function occur.
Finishing the prosthesis
Put on protective cover
-
When the prosthesis is finished, put on the protective cover as shown in the illustration on page 8.
: Alternative positioning
: Recommended positioning -
CAUTION! To avoid product damage and the risk of falling, finish the prosthesis by replacing set screws that are too short or too long, and by tightening all screw connections. In doing so, note the instructions for use for all prosthesis components regarding torque values and thread lock.
Attaching the cosmetic cover
CAUTION
Use of talcum
Risk of injury, damage to the product due to lack of lubrication
- Do not use talcum on the product or other prosthesis components.
Recommended combinations
Foam cover| 3R6, 3S106
- After affixing the cosmetic elements, verify proper functioning of the prosthesis.
- To reduce friction and to eliminate noise, apply silicone spray directly onto the contact surfaces of the cosmetic foam cover.
Use
Information for use
NOTICE
Mechanical overload
Impaired functionality due to mechanical damage
- Check the product for damage prior to each use.
- Do not use the product if its functionality has been impaired.
- Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).
Cleaning
CAUTION
Use of unsuitable cleaning agents or disinfectants
Impairment of functionality and damage due to incorrect cleaning agents or
disinfectants
- Clean the product only according to the instructions given in this section.
- For the prosthesis, observe the cleaning instructions for all prosthetic components.
INFORMATION
- Clean the product if it gets dirty.
- For disinfection, only use disinfectants that do not affect the materials of the product. For further information, please consult the manufacturer.
- Observe the cleaning instructions for all prosthetic components.
- 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.
-
Arrange regular maintenance intervals with the patient depending on the level of use.
-
Following an individual period for the patient to get accustomed to the prosthesis, check the settings of the prosthetic joint and adapt them to the patient’s requirements again as needed.
-
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.
-
As part of the safety inspections, inspect the prosthetic joint for wear and proper functionality. Special attention should be paid to movement resistance, bearings and abnormal noises. Full flexion and extension must be ensured at all times. Readjust as required.
Lubrication
- on page 8: Do not lubricate or grease the prosthetic joint.
Replacing components
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.
-
When necessary, remove a worn brake bushing
(4B74=20.4X24.5-K) as shown in the illustration on page 9. -
To reassemble, perform these steps in reverse order.
-
In doing so, note the following points:
- Ensure the correct assembly of the bushing safety device.
- Clean the knee axis with isopropyl alcohol ( 634A58) before assembly.
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
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.
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
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>