ottobock 3R80 Modular Knee Joint Instruction Manual

ottobock 3R80 Modular Knee Joint Instruction Manual

1 Product description

INFORMATION
Date of last update: 2021-06-28
► 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.

1.1 Construction and Function

The 3R80* Prosthetic Knee Joint is a monocentric prosthetic knee joint with rotation hydraulics and a mechanically controlled stance phase stabilisation system. It is waterproof and equipped with a manually operated lock. The prosthetic knee joint has a pyramid adapter (3R80) or threaded connector (3R80=ST) as the proximal connection.

The integrated rotation hydraulics control the swing phase and secure the stance phase. Damping for flexion, extension and the stance phase are individually adjustable. This allows comfortable walking over a broad range of speeds.

Stance phase damping is activated when bearing weight on the prosthesis. The activation threshold is adjustable. It provides for stance phase flexion up to 4° while bouncing, and more
than 4° while yielding. Walking on slopes and down stairs step-over-step is therefore possible. An extension assist spring supports the swing phase by generating an extension moment. The additional spring included in the scope of delivery can be installed to increase the extension moment.

The lock keeps the prosthetic knee joint at full extension. This function is suitable for situations where flexion is to be prevented (e.g. when standing for extended periods of time or wading through water).

1.2 Combination possibilities

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.

Prosthetic components that are especially well suited for combination with the product are listed below.

2 Intended use

2.1 Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

2.2 Area of application 3R80*

Recommended for mobility grades 3 and 4 (unrestricted outdoor walker and unrestricted outdoor walker with particularly high demands). Approved for a body weight of up to 150 kg.

2R57=16-285-WF Approved for a body weight of up to 150 kg.

2.3 Environmental conditions

2.4 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.

3 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 Excessive strain on the product Risk of injury due to breakage of load-bearing components Use the prosthetic components according to the MOBIS classification.

⚠ CAUTION
Improper combination of prosthetic components Risk of injury due to breakage or deformation of the product

► Only combine the product with prosthetic components that are approved for that purpose.
► Based on the instructions for use of the prosthetic components, verify that they may be combined with each other.

⚠ CAUTION
Use under restricted environmental conditions
Risk of injury due to damage to the product
► Do not expose the product to restricted environmental conditions.
► If the product has been exposed to restricted environmental conditions, check it for damage.
► If damage is apparent or in case of doubt, do not continue using the product.
► Take suitable measures if required (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop etc.).

⚠ CAUTION
Exceeding the service life Risk of injury due to change in or loss of functionality and damage to the product
►Ensure that the approved service life is not exceeded.

⚠ CAUTION
Reuse on other patients and improper maintenance
Fall due to loss of functionality or damage to the product
► Only use the product for a single patient.
► Maintain the product regularly to extend the service life of the product (see the section “Maintenance”).

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

4 Scope of delivery

The scope of delivery for the product is shown on page 2 (see figure 1). The following single components and accessories are included in the scope of delivery in the spe cified quantities and are available for reordering as single components ( ), single components with minimum order quantities ( ) or single-component packs ( ):

5 Preparing the product for use

5.1 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 pros thesis
► For the safety of the patient, use a suitable device (e.g. parallel bars, handrail) during initial standing and walking.
► Do not use devices with insufficient stability (e.g. crutches or walking sticks)

Fabricating a prosthesis that is optimally tailored to the patient demands technical knowledge of orthopaedic technology. The alignment and adjustments may only be carried out by a prosthetist. The alignment and adjustments are mainly completed in the following steps:

1. Bench alignment
2. Static alignment
3. Dynamic trial fitting

These steps are first carried out with a test prosthesis in order to determine the best possible combination and positioning of the prosthetic components relative to each other. Once all set tings have been tailored to the patient, the definitive prosthesis is produced. The same steps are repeated for this purpose. In dynamic trial fitting, the patient must be given sufficient time to become familiar with the functions of the prosthesis, thereby learning safe use for everyday life.

5.2 Information on Using a 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.
► Only use the foam cover approved by the manufacturer (see section “Combination Possibilities” – see page 20).
► To reduce friction and to eliminate noise, apply 519L5 Silicone Spray directly onto the contact surfaces of the cosmetic foam cover.
► After fabricating the cosmetic cover, repeat the dynamic trial fitting since the cover affects the adjustments of the prosthesis (e.g. damping).

5.3 Bench Alignment

Use 2Z11=KIT INFORMATION: The connection area of the prosthetic knee joint can be protected against scratches with the protective film of the 2Z11=KIT during alignment in the workshop and testing in the trial fitting area. Use the protective film as illustrated in the accompanying document for the 2Z11=KIT. Remove the protective film before the patient leaves the fitting area.

5.3.1 Determining the Effective Heel Height

Required measuring equipment:
743S12 Heel Height Measuring Device (see fig. 2)

1. Measure the posterior heel height (x1) of the shoe.
2. Measure the anterior heel height (x2) of the shoe.
3. Determine the effective heel height (x) using the formula (x = x1 – x2).

5.3.2 Shortening the Tube Adapter

CAUTION
Incorrect processing of tube Fall due to damage to the tube
►Do not clamp the tube into a vice.
►To shorten the tube, use only a tube cutter or a cutting device.

Recommended tools and materials: 719R5 Tube Cutter, 718R1 Tube Deburrer

1. CAUTION! The length of the tube must not be less than the required length for the patient, since length compensation in the insertion area of the prosthetic knee joint is prohibited. Use the tube cutter to shorten the tube to the required length (see fig. 7).
2. Carefully deburr the inside and outside of the tube with the tube deburrer (see fig. 8).
3. Dispose of the remainder.

5.3.3 Installing the Tube Adapter

⚠ CAUTION
Incorrect mounting of the tube Risk of injury due to breakage of load-bearing components Slide the tube all the way to the stop in the intended prosthetic component when mounting.

⚠ 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.

Recommended tools and materials: 710D4 Torque Wrench, degreasing cleaner (e.g. 634A3 Acetone)

1. Loosen the cap screw by approx. 2 turns (see fig. 10).
2. Clean the contact surfaces of the prosthetic knee joint and tube adapter using a degreasing cleaning agent.
3. Slightly rotate the tube as you insert it into the prosthetic knee joint to the stop (see fig. 9).
4. Using the torque wrench, tighten the cap screw (10 Nm) (see fig. 10).

Installing the Prosthetic Foot
> Recommended tools and materials:
710D4 Torque Wrench, 636K13 Loctite®

1. Position the pyramid receiver of the tube adapter on the pyramid adapter of the prosthetic foot.

2. For final assembly:
   Use Loctite® to secure the set screws of the pyramid receiver.

3. Screw in the set screws.

4. Use the torque wrench to tighten the set screws (10 Nm).

5. Replace any set screws that are protruding or recessed too much with suitable ones (see selection table).

6. For final assembly:

Use the torque wrench to retighten the set screws (15 Nm).

5.3.4 Determining Socket Flexion

Required measuring equipment and materials:
662M4 Goniometer, Pin

1. On the lateral side of the residual limb, mark the course of the thigh bone.
2. With the patient lying down, instruct the patient to fully bend the contralateral leg and hold it with the hands.
3. Slide the flat hand under the patient’s back (see fig. 3).
4. Bring the residual limb to full flexion.
5. Slowly move the residual limb in the extension direction until pressure on the hand is reduced.
6. Slowly move the residual limb back in the flexion direction until the pressure reduction stops.
7. In this residual limb position, measure the angle (hip flexion contracture) with the gonio meter.
8. INFORMATION: Correct socket flexion () during bench alignment is crucial for optimum walking. Take the individual situation of the patient into account for the tolerance. If the angle = 0°, the optimum value of the angle = 3 to 5° to the alignment reference line. If the angle > 0°, the optimum value of the angle = +5 to 10°.

5.3.5 Determining the Socket Reference Point

Required measuring equipment and materials:
743A80 50:50 Gauge, Pin

1. Position the 50:50 gauge on the lateral side of the prosthetic socket in the distal area and mark a centre point (see fig. 5).
2. Position the 50:50 gauge in the proximal area and mark a centre point .
3. Using these points, mark the centre line of the prosthetic socket.
4. Clearly mark the tuberosity height as the tuberosity reference point on the centre line.
5. Clearly mark the socket reference point 30 mm proximal to the tuberosity reference point.

5.4 Static Alignment

5.5 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.

During dynamic trial fitting, the alignment and settings of the prosthesis are checked and adapted for optimum walking according to the needs and abilities of the patient. The patient has to learn the safe use of the prosthesis through intensive training. The following subsections describe the adjustment possibilities for adapting the product to the patient. The list below provides an overview of the sequence for working through the subsections:

• Checking the Factory Settings
• Setting Flexion Damping
• Setting Extension Damping
• Setting Stance Phase Damping
• Setting the Stance Phase Damping Threshold The adjustment is illustrated graphically in the supplied Quick Start Guide.

5.5.1 Opening the Covers

Tools required:
Flat screwdriver

1. Open the extension damping and flexion damping covers (see fig. 11).
2. Open the stance phase damping cover (see fig. 12).

5.5.2 Checking the Factory Settings

Tools required: 710H10=2×3 Adjustment Wrench

1. Check whether the settings match the factory settings (see table).
2. In case of deviations, restore the factory settings using the adjustment wrench.

5.5.3 Setting Flexion Damping

Tools required: 710H10=2×3 Adjustment Wrench

CAUTION! Even at slow walking speeds, the prosthetic foot has to swing through adequately.

Adjust flexion damping using the adjustment wrench so that the prosthetic foot does not swing through too far, according to the patient’s walking speed.

5.5.4 Setting Extension Damping

Tools required: 710H10=2×3 Adjustment Wrench

CAUTION! The prosthetic knee joint has to reach full extension, even at slow walking speeds. The extension assist force can be increased if required (see section “Installing the Compression Spring” ­ see page 29).

Using the adjustment wrench, adjust extension damping so that the prosthetic knee joint does not swing too hard against the extension stop.

5.5.5 Setting Stance Phase Damping

Required training location:

Stairs and ramp with handrail (e.g. 758G8=1 Test Platform)

Tools required: 710H10=2×3 Adjustment Wrench

1. Place the prosthetic foot on the bottom step so that the middle of the foot goes slightly beyond the step’s edge.

2. Briefly lock the prosthetic knee joint by extending the residual limb.

3. Initiate flexion while bearing weight.

4. INFORMATION: In case of problems switching between the swing phase and stance phase, readjust the stance phase damping threshold (see section “Setting the Threshold” ­ see page 28).
   Adjust stance phase damping so that the prosthetic knee joint does not flex too quickly or slowly while walking down stairs.

5. Once stance phase damping and the threshold are correctly adjusted for walking down stairs, check the settings while walking down a ramp and adjust if necessary.

6. Harmonise the settings for walking down stairs and walking down a ramp according to the needs of the patient.

5.5.6 Optional: Setting the Threshold

Tools required: 710H10=2×3 Adjustment Wrench

Use the adjustment wrench to adapt the stance phase damping threshold to the needs of the patient.

5.5.7 Optional: Installing the Compression Spring

The additional compression spring is installed in the lower joint section if the patient needs more support in order to bring the prosthetic knee joint to full extension.

Required tools and materials:
Torque wrench (2 Nm), 513D59=1.3X8.8X86 Compression Spring

1. Unscrew the spring retainer from the lower joint section (see fig. 17).
2. Insert the compression spring into the larger compression spring in the lower joint section (see fig. 18).
3. Screw the spring retainer into the lower joint section (installation torque: 2 Nm).
4. Check the settings of the prosthetic knee joint and reaching extension with a walking test.

5.5.8 Closing the Covers

1. Close the extension damping and flexion damping covers (see fig. 19).
2. Close the stance phase damping cover (see fig. 20).

5.6 Finishing the Prosthesis

Required tools:
Torque wrench

1. Tighten all screws of the prosthetic components to the specified installation torque values.
2. Verify proper functioning of the prosthesis.

6 Use

6.1 Information for use

⚠ CAUTION
Overheating of the hydraulics due to excessive strain Burns, injuries caused by falling due to changes in functionality and damage to prosthetic com ponents

► Do not touch overheated prosthetic components.
► Reduce all activities if there are changes in functionality, in order to allow the overheated prosthetic components to cool down.
► If overheating or changes in functionality occur, have the prosthesis checked by authorised qualified personnel.

⚠ CAUTION
Use in wet areas Fall due to slipping or altered functioning of the prosthetic knee joint
► Before using the prosthesis in wet areas, lock the prosthetic knee joint (see section “Locking the Prosthetic Knee Joint” – see page 30).
► Adjust the walking speed to the local conditions.
► On wet surfaces, only use prosthetic feet with a non-slip sole.

Inform the patient.
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.).

INFORMATION
Leak in the product’s hydraulic system
Environmental damage or skin irritation due to leaking hydraulic oil

►Before each use, check the product for leaking hydraulic oil. ►In case of leaks, do not continue using the product and have it repaired promptly.

6.1.1 Locking the Prosthetic Knee Joint

Locking the Prosthetic Knee Joint

1. Bring the prosthetic knee joint to full extension under load.
2. Push down the lock lever (see fig. 21).
3. Check to verify that the prosthetic knee joint is locked.

Unlocking the Prosthetic Knee Joint

1. Bring the prosthetic knee joint to full extension under load.
2. Pull up the lock lever (see fig. 22).
3. Check to verify that the prosthetic knee joint is unlocked.

6.2 Cleaning

CAUTION Use of unsuitable cleaning agents or disinfectants Impairment of functionality and damage due to incorrect cleaning agents or disinfectants
► Only clean the product with the approved cleaning agents.
► Only disinfect the product with the approved disinfectants.
► Observe the instructions for cleaning and care.

INFORMATION
► Clean the product after contact with liquids or 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.

1. Clean the product with a damp cloth and soap.
2. Rinse the product with clean, fresh water.
3. Dry the product with a soft cloth.
4. NOTICE! Do not store the product while moist.
   Allow to air dry in order to remove residual moisture.

7 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 thesettings 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.

8 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.

9 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 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.

9.2 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.

10 Technical data

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

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