ottobock 17B26 Free Motion Knee Joints Instructions
- October 27, 2023
- ottobock
Table of Contents
ottobock 17B26 Free Motion Knee Joints
OVERVIEW
Foreword
INFORMATION
Date of last update: 2021-05-07
- 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.
These instructions for use provide you with important information on the processing of the 17B3, 17B26, 17B43, and 17B47 orthotic knee joints.
Product Description
Available sizes
Article number| Medial and lat eral joint| System
width| Posterior placement| Material
---|---|---|---|---
17B26= L/R16| Outside straight, inside bottom contoured| 16 mm| 16 mm|
Stainless steel
17B26= L/R20| 20 mm
17B47=
16
| Outside and inside straight| 16 mm
17B47=
20
| 20 mm
17B3=L/ R16| Outside straight, inside bottom contoured| 16 mm| 22 mm
17B3=L/ R20| 20 mm
17B43=
16
| Outside and inside straight| 16 mm
17B43=
20
| 20 mm
Components/design
Scope of delivery (see fig. 1 )
Item| Quantity [Piece
(s)]
| Designation| Article number
1| 1| Upper joint section|
2| 4| Screws| 501T7*
3| 1| Joint screw| 501A6=4x5xM5
4| 1| Ball bearing| 509K11=5x16x4
5| 1| Lower joint section|
Not included in scope of delivery
Item| Quantity [Piece
(s)]
| Designation| Article number
(see fig. 1),
item 6
| 1| Side bar| 17B38, 17B39,
17B40, 17B41,
17B84*
not illus trated| 1| Lamination bar| 17Y128, 17Y129
Intended use
Indications for use
The orthotic joint is intended exclusively for use as a pair for orthotic
fittings of the lower limbs on one patient.
Indications
- Partial or total paralysis of the leg muscles
- Orthopaedic diseases of the lower limbs Indications must be determined by the physician.
Lifetime
The product is designed for a lifetime of 3 years when used as intended and
assembled professionally.
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.
Combination possibilities
The 17B3, 17B26, 17B43, and 17B47 orthotic knee joints can be combined
with the 17Y32 or 17Y35 system extension assist.
Safety
Explanation of warning symbols
CAUTION
Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.
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 authorised, 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).
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.
Preparing the product for use
INFORMATION
Parallel alignment of the orthotic joints
Use the 743R6 alignment fixture to position the orthotic joints on the plaster
positive.
Gluing in bars
Required materials:
636W28* special adhesive, degreasing cleaner The bars must be glued in the
insertion zones to ensure stability.
- Clean the connecting surfaces with a degreasing cleaner.
- Apply the special adhesive to the connecting surfaces.
- Insert the bars.
- Secure with the enclosed screws.
- Allow curing for at least 4 hours.
INFORMATION: Final bonding strength will be reached after 16 hours
Improving corrosion protection
Polish or sinter the product for improved corrosion protection. Ottobock
recommends the 618T40* sintering powder for surface coating.
- Do not heat the material longer than 5 minutes at max. 150 °C for surface coating.
Using protective devices
- Use joint protectors to protect the product against soiling.
Cleaning
Promptly clean the product after contact with water containing salt, chlorine or soap, or if it gets dirty.
- Rinse the product with clear fresh water.
- Dry the product with a cloth or allow it to air dry. Avoid exposure 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 ball bearing
NOTICE
Canting the ball bearing
Mechanical damage
- Do not cant or damage the ball bearing while inserting it into the orthotic joint.
- Loosen the screws and disassemble the orthotic joint.
- Remove the ball bearing from the orthotic joint and replace it with a new one.
- Assemble the orthotic joint and tighten the screws.
- For the 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.
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.