ottobock 17B95, 17B96 Knee Joint Modular Instruction Manual

17B95, 17B96
Instructions for use 

17B95, 17B96 Knee Joint Modular

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 import­ ant 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 17B95 and 17B96 orthotic knee joints.

Product description

2.1 Components/design

Scope of delivery (see fig. 1)

Item| Quantity [Piece
(s)]| Designation| Reference number
1| 1| Upper joint section|
2| 4| Screws| 50117
3| 1| Joint screw| 501S32
4| 1| Lower joint section|
6| 1| Bearing nut| 17Y93*
Scope of delivery (see fig. 2)

Item| Quantity [Piece
(s)]| Designation| Reference number
1| 1| Perlon cable| 21A18=2
2| 1| Locking rocker| 30Z22
3| 1| Notch pin| 506K2
4| 1| Countersunk screw| 501S41
5| 1| Threaded sleeve| 21Al2
6| 1| Bushing| 17Y89
7| 1| Lock wedge| 17Y88
8| 1| Compression spring| 513019*
Not included in the scope of delivery

Item| Quantity [Piece| Designation| Reference number
| (s)]|
(see
fig. 1),
item 5| 1| Sidebar| 17B38, 17B39, 17B40, 17B41, 17B84
Not illus- trated| 1| Lamination bar| 17Y128, 17Y129*

Intended use

3.1 Indications for use
The orthotic knee joints are to be used exclusively in pairs to provide orthot­ ic treatment for a patient’s lower limbs.
Only use the lamination bars for the lamination and prepreg technique.
Only use the sidebars for the thermoplastic and bar/clamp technique.
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.
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 Restrictions for use
Only use the 17B95=L/R16 and 17B96=16 orthotic knee joints up to a body weight of max. 50 kg.
3.4 Lifetime
The product is designed for a lifetime of 3 years when used as intended and assembled professionally.

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
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
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
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 use of the product and have it checked by authorized, qualified personnel.

CAUTION
Improper use of the lock
Risk of injury due to unexpected deactivation of the orthotic joint lock

• Fully extend the orthotic joint to activate the lock. Check whether the lock is engaged.
• Only deactivate the lock when you are able to control the flexion of 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
Use under unallowable environmental conditions
Damage to the product due to unallowable environmental conditions

• Do not expose the product to unallowable environmental conditions.
• If the product has been exposed to unallowable environmental condi­ tions, 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.).

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.
INFORMATION
Corrosion protection
The sidebars and orthotic joints are resistant to corrosion. Fine grinding and polishing increase corrosion protection. Use sintering powder (e. g. 618T40) for coating.
Gluing in bars
Required materials: 636W18 special glue and 636W19 hardener or
636W28 special glue, degreasing cleaner
The bars must be glued in the insertion zones to ensure stability.

1. Clean the connecting surfaces with a degreasing cleaner.
2. Mix the special glue and the hardener.
3. Apply the mixture to the insertion zones.
4. Insert the bars.
5. Secure with the enclosed screws.
6. Allow curing for at least 4 hours.
   INFORMATION: Final bonding strength will be reached after 16 hours.

Connecting the person’s cable

1. Cut the person’s cable to length according to the patient.
2. Screw the threaded sleeve onto the first-person cable (see fig. 3, item 4).
3. Thread the second perlon cable through the coupling piece.
4. Then slide the spring over the perlon cable and screw on the threaded sleeve.
5. Unscrew the preassembled threaded sleeve from the perlon cable.
6. Pass the perlon cable through the bore hole in the locking rocker and screw on the threaded sleeve (see fig. 2, item 1).

Using protective devices

• Protect the product against dirt: Use suitable protective devices (e.g. joint protectors).

Cleaning

Promptly clean the product after contact with water containing salt, chlorine or soap, or if it gets dirty.

1. Rinse system joints with clean fresh water.
2. Dry system joints with a cloth or allows to air dry. Avoid exposure to direct heat (e.g. from an oven or radiator).

 Maintenance

CAUTION
Wear and tear of the locking mechanism
Injuries due to changes in or loss of functionality

• In case of wear and tear of the locking mechanism, replace the lock wedge or the lock lever and/or the lower joint section.

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

• Shorten the maintenance intervals according to the expected loads.
• Compression spring: Replace the compression spring at least once a year or if there are signs of wear and tear.

Replacing the compression spring
Disassemble the locking rocker to replace the compression spring (see fig. 2).

1. Remove the notch pin and unscrew the countersunk screw.
2. Remove the bushing and the locking rocker from the upper joint section.
3. Replace the compression spring.
4. Position the bushing and the locking rocker on the upper joint section.
5. Press in the notch pin.
6. Install the countersunk screw and secure it with Loctite 241.
   The manufacturer requires at least a semi-annual inspection of the product to verify functionality and check for wear.
   Only use 633F7 special lubricant.
   Spare parts are listed in the section “Components/design”.

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 modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic­ al devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

© Ottobock · 647G1536=all_INT-15-2106
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

Documents / Resources

| ottobock 17B95, 17B96 Knee Joint Modular [pdf] Instruction Manual
17B95 17B96 Knee Joint Modular, 17B95, 17B96, Knee Joint Modular, Knee Modular, Joint Modular, Modular, Locked Knee Joints
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