ottobock 17B82 Free Moving Joints Instructions

17B82 Free Moving Joints
Instructions

17B82 Free Moving Joints

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 on 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 17B82* orthotic hip joint.

Product Description

2.1 Available sizes

2.2 Components/design

Scope of delivery (see fig. 1 )

Item

| Quantity [pcs.]| Designation|

Reference number

1| 1| Upper joint section|
2| 1| Screws| 501T7=7.5x9xM5
3| 1| Joint screw| 501A6=5x5xM5
4| 1| Ball bearing| 509K1=5x16x5
5| 1| Lower joint section|
Not included in the scope of delivery

Item

| Quantity [Piece (s)]| Designation|

Article number

(see fig. 1),item 6| 1| Sidebar| 17B38, 17B39, 17B40, 17B41,

17B84*

not illus­trated| 1| Lamination bar| 17Y128, 17Y129

Intended use

3.1 Indications for use
The orthotic hip joint is intended exclusively for orthotic fittings of the lower limbs of one patient.
3.2 Indications

• Partial or total paralysis of the leg muscles
• Orthopedic 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
Clothing getting caught in the orthotic joint
Risk of injury due to loss of orthotic joint functionality
► Make sure your clothing does not get caught in the orthotic joint.
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.
Shaping the bars

Required tools: 711S5 bending irons, 711S3 horizontal bending irons, 711S2 bending pusher set.

1. Use the 711S5 bending irons for bending.
2. Use the 711S3 horizontal bending irons or the 711S2 bending pusher set for horizontal bending.
3. Use a bending radius over 10 mm (see fig. 2).
4. Remove grooves and burrs by grinding.
5. For final assembly, secure the joint screw with Loctite 241.

Gluing in bars
Required materials: 636W28* special adhesive, degreasing cleaner
The bars must be glued in the insertion zones to ensure stability.

1. Clean the connecting surfaces with a degreasing cleaner.
2. Apply the special adhesive to the connecting surfaces.
3. Insert the bars.
4. Secure with the enclosed screws.
5. 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 sur­ face 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.

1. Rinse the product with clear fresh water.
2. 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 orthot­ ic joint.

1. Loosen the screws and disassemble the orthotic joint.
2. Remove the ball bearing from the orthotic joint and replace it with a new one.
3. Assemble the orthotic joint and tighten the screws.
4. 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.
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

References

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