ottobock 3R38 Single Axis Knee Joint Children Instructions

ottobock 3R38 Single Axis Knee Joint Children Instructions

3R38, 3R39

1. Notes regarding the document

INFORMATION
Date of last update: 2021-08-11

• 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.

1.1 Characteristics (product, document)
The following characteristics are important for identification: ( [1] – page: 2)

2. Product description

The product (3R38, 3R39) has the following key features:

• Monocentric prosthetic knee joint

3R38:

• Product components for swing phase control:
  – Extension assist (adjustable spring force)

3R39:

• Product components for stance phase stability:
  – Locking mechanism for the extension position

3. Intended use

3.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.

3.2 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
Children’s prosthesis (Everyday prosthesis)

Positioning in the prosthesis
Only according to the sections and illustrations in the instructions for use

3.3 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.

This prosthetic component is compatible with Ottobock’s system of modular connectors for children. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.

3.4 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:
Use: -10 °C – +45 °C
Storage, Transportation: -20 °C – +60 °C
Relative humidity: 20 % – 90 % (Non-condensing)
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

3.5 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 has been load-tested by the manufacturer. The maximum lifetime is 2 years.

4. 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, 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.
► 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
Noticeable changes in functionality may include poor response, incomplete extension, diminished swing phase control or stance phase stability, abnormal noises, etc.

5. Scope of delivery

6. Technical data

7. Preparing the product for use

7.1 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.

7.2 Bench alignment of the prosthesis

Assembling the tube

CAUTION
Incorrect mounting of the tube
Risk of injury due to breakage of load-bearing components
► Clean the contact surfaces of the tube and the tube adapter using a degreasing cleaning agent.
► Position the tube in the tube adapter so the minimum insertion depth is met.

7.3 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.

Fine-tuning the settings

• The extension position has to be reached with every step and at any walking speed.
• Adapt the settings of the prosthetic knee joint to the patient by means of fine-tuning and exercises.
• Check the adjustment of the prosthesis settings during normal consultations and every 3 months during the safety inspection. Advise the patient and guardian to have the prosthesis inspected if changes in function occur.

► CAUTION! Allow the patient to walk only with safeguards in place, as the prosthetic knee joint may switch to swing phase flexion damping too late with the factory settings.

If stance phase damping cannot be activated at the beginning of the stance phase, reduce the switching threshold in small increments until it can be activated even with different walking speeds and stride lengths.

► Adjust the swing phase flexion damping so the lower leg of the prosthesis does not swing through too far in the dorsal direction, but reaches full extension in time for the next heel strike.
► Adjust the swing phase extension damping so the prosthetic knee joint does not swing too hard against the extension stop, but reaches full extension in time for the next heel strike.

Using the lock ( 14 – page: 14)
► Practise using the lock.

7.4 Attaching the cosmetic cover
CAUTION
Use of highly hygroscopic particles (grease-absorbent substances such as talcum)
Risk of injury, damage to the product due to lack of lubrication
► Do not allow the product to come into contact with highly hygroscopic particles.
► Note the following points for attaching the cosmetic cover:
• Adapt the cosmetic cover to the patient and mount it on the prosthesis.
• Check the settings from the dynamic trial fitting.
► To reduce friction and to eliminate noise, apply 519L5 Silicone Spray directly onto the contact surfaces of the cosmetic foam cover.

7.5 Finishing the prosthesis
► CAUTION! To avoid a risk of falling, replace set screws that are too short with longer ones.
► Replace set screws that are too long and can cause product damage (for instance through collision or friction) with shorter ones.
► Before the patient leaves the fitting area, finish the prosthesis by tightening all screw connections. In doing so, note the instructions for use for all prosthetic components regarding installation torque values and thread lock.

8 Use

8.1 Information for use

CAUTION
Malfunctions and improper use of the lock
Falling due to unexpected deactivation of the prosthetic knee joint lock

► Fully extend the prosthetic knee joint to activate the lock. Then carefully check whether the lock has actually engaged.
► Only deactivate the lock when you are able to control flexion of the prosthetic knee joint.

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.).

8.2 Using the lock slide
CAUTION
Malfunctions and improper use of the lock
Falling due to unexpected deactivation of the prosthetic knee joint lock
► Fully extend the prosthetic knee joint to activate the lock. Then carefully check whether the lock has actually engaged.
► Only deactivate the lock when you are able to control flexion of the prosthetic knee joint.

8.3 Cleaning
INFORMATION

• Clean the product if it gets dirty.
• Observe the instructions for cleaning and drying in the section “Environmental conditions” (see page 30).
• Only use cleaning agents and disinfectants that do not affect the materials of the product. Test the chosen agent for material compatibility in an inconspicuous location.
• Do not spray the product directly with a pump spray or propellant spray cleaner and disinfectant.
• Only apply cleaners and disinfectants using a soft, lint-free cloth.
• Dry with a soft, lint-free cloth. Allow to air dry in order to remove residual moisture.
• Observe the cleaning instructions for all prosthetic components.

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.

Permissible cleaning agents and disinfectants
Requirements:
Free of solvents, chlorine and phosphates

Cleaning light soiling

1. Clean the product with a damp, soft cloth.
2. Dry the product with a soft cloth.
3. Allow to air dry in order to remove residual moisture.

Cleaning heavier soiling

Required materials: cleaning cloth, 634A58 isopropyl alcohol, soft cloth

• NOTICE! Verify material compatibility. Do not remove lubricant from bearing points.
• Clean the product with a cleaning cloth and isopropyl alcohol.
• Dry the product with a cloth.

Cleaning with Disinfectants

Required materials: colourless, alcohol-free disinfectant (verify material compatibility!), soft cloth
► Disinfect the product with the disinfectant.
► Dry the product with a cloth.
► Allow to air dry in order to remove residual moisture.

9 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.
• NOTICE! Do not lubricate and grease the prosthetic joint.
• NOTICE! Repair work must be performed exclusively by the manufacturer’s technical service.
• 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.
• Perform a safety inspection every 3 months.
• 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.
• In case of changes in prosthesis function or relevant patient changes (such as the activity level, body weight, body height), perform unscheduled inspections and implement measures according to the situation.
• Follow the maintenance instructions according to Figure 15 and 16 on page 15 and 16.

10 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.

11 Legal information

11.1 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.

1 1.2 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

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