ottobock Polycentric Knee Joint Instructions

Polycentric Knee Joint
**Instructions

17K43, 17K45, 17K46, 17K47**

Polycentric Knee Joint

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Foreword

INFORMATION
Date of last update: 2021-05-10

• 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 problems.
• Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly import­ and when there is a decline in the health state.
• Please keep this document for your records.

These instructions for use provide you with important information on the pro­ cessing of the 17K43, 17K45, 17K46, and 17K47 orthotic knee joints.

Product Description

2.1 Available sizes
The 17K43, 17K45, 17K46, and 17K47 orthotic joints are made of stainless steel and are available in one size.
2.2 Components/design

Scope of delivery for 17K43, 17K47 (see fig.1 , see fig. 4 )

Item| Quantity [pcs.]| Designation| Reference number
1| 1| Joint bar, the upper section|
Scope of delivery for 17K43, 17K47 (see fig. 1 ,see fig. 4 )

Item| Quantity [pcs.]| Designation| Reference number
2| 2| Bushing| 17Y17=6x8x2
3| 1| Joint center piece| 17Y127
4| 3| Oval head screw| 501S42=M3x6
5| 2| Joint screw| 501S32=M4x12x8
6| 1| Joint bar, the lower section|
7| 1| Extension stop, 6 °| 17Y90=6
8| 1| Spacer bushing| 17Y17=3.1x6x2.1
9| 2| Bearing nut| 17Y93=6x5xM4
Scope of delivery for 17K45, 17K46 (see fig. 2 , see fig. 3 )

Item| Quantity [pcs.]| Designation| Reference number
1| 1| Joint bar, the upper section|
2| 1| Flexion stop, 100 °| 17Y91=100
3| 2| Bushing| 17Y17=6x8x2
4| 1| Joint centerpiece| 17Y92
5| 4| Oval head screw| 501S42=M3x6
6| 2| Joint screw| 501S32=M4x12x8
7| 1| Joint bar, the lower section|
8| 1| Extension stop, 6 °| 17Y90=6
9| 2| Bearing nut| 17Y93=6x5xM4
Scope of delivery for 17K43, and 17K47 (see fig. 5 )

Item| Quantity [pcs.]| Designation| Reference number
1| 3| Extension stop| 17Y90=6 (pre-assembled) 17Y90=10
17Y90=20
17Y90=30
Scope of delivery for 17K45, and 17K46, (see fig. 5 )

Item| Quantity [pcs.]| Designation| Reference number
1| 3| Extension stop| 17Y90=6 (pre-assembled) 17Y90=10
Scope of delivery for 17K45, and 17K46, (see fig. 5 )

Item| Quantity [pcs.]| Designation| Reference number
| | | 17Y90=20
17Y90=30
2| 3| Flexion stop| 17Y91=0
17Y91=60
17Y91=80
17Y91=100 (pre-assembled)

Intended use

3.1 Indications for use
The orthotic knee joints are to be used exclusively in pairs for the orthotic treatment of the lower limbs in knee orthoses or KAFOs.
3.2 Indications
• Orthopaedic diseases of the lower limbs Indications must be determined by the physician.
3.3 Lifetime
The product is designed for a lifetime of 3 years when used as intended and assembled professionally.
3.4 Qualification
Patients may be fitted with the product only by trained qualified personnel. The qualified personnel must be familiar with the handling of the various techniques, materials, machines, and tools.

Safety

4.1 Explanation of warning symbols

CAUTION Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.
4.2 Safety instructions
CAUTION
Excessive strain on load-bearing components
Injuries due to changes in or loss of functionality

• Only use the product for the defined area of application.
• If the product has been exposed to extreme strain (e.g. due to falling), take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).

CAUTION
Incorrect alignment or assembly
Injuries due to changes in or loss of functionality

• The product may only be installed by trained, qualified personnel.
• Observe the alignment and assembly instructions.

CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality

• Use caution when working with the product.
• Check the product for proper function and readiness for use.
• In case of changes in or loss of functionality, discontinue the use of the product and have it checked by authorized, qualified personnel.

CAUTION
Excessive strain due to use on more than one patient
Risk of injury and loss of functionality as well as damage to the product

• Use the product on only one patient.
• Observe the maintenance recommendations.

NOTICE
Thermal overloading of the product
Damage due to improper thermal treatment

• Do not carry out any heat treatment at temperatures above 300 °C (570 °F).
• Prior to thermal treatment, remove all temperature-critical components (such as plastic parts).

NOTICE
Exposure of the product to unsuitable environmental conditions
Damage, brittleness, or destruction due to improper handling

• Avoid storage in condensing ambient humidity.
• Avoid contact with abrasive substances (e.g. sand, dust).
• Do not expose the product to temperatures below -10 °C (14 °F) or above +60 °C (140 °F) (e.g. sauna, excessive sunlight, drying on a radiator).

Preparing the product for use

CAUTION
Repeated bending at the same position
Risk of injury due to breakage of the bar, change in or loss of functionality
► Avoid repeated bending at the same position.
INFORMATION
Increased wear and tear
The orthotic knee joints are intended only for use in combination with free- motion or foot lifting orthotic ankle joints. Wear occurs more rapidly in combinations involving orthotic ankle joints with a dorsal stop.
INFORMATION
Parallel alignment of the orthotic joints
Use the 743R6 alignment fixture to position the orthotic joints on the plaster positive.

Shaping the bars
> Required tools: Vice, 2x 711S* bending irons, grinding machine, screwdriver, Loctite 241

1. Loosen the joint screw and disassemble the joint.
2. Use the 711S* bending irons for contouring the bar.
3. Clamp a bending iron in the vice and position the bar.
4. Adapt the bar with the second bending iron.
5. Contour the bar until the desired result is obtained.
6. Observe the minimum bending radius of 10 mm (see fig. 6).
7. Remove grooves and burrs by grinding.
8. For final assembly, secure the joint screw with Loctite 241.

Replacing the stop
The 6 ° extension stop and the 100 ° flexion stop are pre-installed on the product on delivery.

1. Loosen the screw and remove it from the joint centerpiece.
2. Disassemble the stop.
3. Insert the new stop into the joint centerpiece.
4. Install the screw in the joint centerpiece.

Improving corrosion protection
Polish or sinter the bars for improved corrosion protection. Ottobock recom­ mends the 618T40* sintering powder for surface coating.

• Do not heat the material for more than 5 minutes at max. 150 °C.
  Using protective devices

• Use joint protectors to protect the product against soiling.

Cleaning

After contact with water containing salt, chlorine, or soap, or if they get dirty, the orthotic joints must be promptly cleaned.

1. Rinse the orthotic joints with clean fresh water.
2. Dry the orthotic joints with a cloth or allow them to air dry. Avoid expos­ ure to direct heat (e.g. from an oven or radiator).

Maintenance

INFORMATION
The product may be exposed to increased loads by the patient.

•  Shorten the maintenance intervals according to the expected loads.
  The manufacturer requires at least a semi-annual inspection of the product to verify functionality and check for wear.
  Spare parts are listed in the section “Components/design”.
  Only use 633F7 special lubricant.

Replacing the bushing

1. Loosen the joint screws and remove the bearing nuts.
2. Loosen and remove the oval head screws.
3. Disassemble the joint centerpiece.
4. Remove the bushing from the bar and replace it with a new bushing.
5. For final assembly, secure the screw connection with Loctite 241.

Disposal

Dispose of the product in accordance with national regulations.

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 accord­ ance 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 unauthor­ used a modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic­ all 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
© Ottobock · 647G1702=all_INT-02-2106

Documents / Resources

| ottobock Polycentric Knee Joint [pdf] Instructions
17K43, 17K45, 17K46, 17K47, Polycentric Knee Joint, Polycentric, Knee Joint, Polycentric Joint, Joint
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