Ottobock 17b59*, 17b63* Ankle Joint Instruction Manual (+ PDF)

ottobock 17B59, 17B63 Ankle Joint

Instructions

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 use of the 17B59* and 17B63* orthotic ankle joints.

Product description

Available sizes

Article number	Medial and lateral joint	System width	Joint head diameter	Slot width	Length from joint centre	Material
17B59=16	Inside, outside straight	16 mm	26 mm	2.5 mm	57 mm	Stain less steel
17B59=20	Inside, outside straight	20 mm	28 mm	3 mm	66 mm
17B63=L /R16	Inside con toured, outside straight	16 mm	26 mm	2.5 mm	57 mm
17B63=L /R20	Inside con toured, outside straight	20 mm	28 mm	3 mm	66 mm

Components/design (see Fig. 1)

Scope of delivery (see fig. 5) 17B59=16, 17B63=L/R=16
Item	Quantity [Piece (s)]	Component	Article number
1	1	Joint body

Scope of delivery (see fig. 5) 17B59=16, 17B63=L/R=16
Item	Quantity [Piece (s)]	Component	Article number
2	2	Screws	501T7*
3	1	Joint screw	501S32*
4	1	Bearing nut	17Y93*
5	1	Ball	509Y2*
7	1	Compression spring	513D18*
8	1	Set screw	17Y18*

Scope of delivery (see fig. 5) 17B59=20, 17B63=L/R=20
Item	Quantity [Piece (s)]	Component	Article number
1	1	Joint body
2	2	Screws	501T7*
3	1	Joint screw	501S32*
4	1	Bearing nut	17Y93*
6	1	Thrust piece with ball	17Y80
7	1	Compression spring	513D18*
8	1	Set screw	17Y18*

Accessories

Not included in scope of delivery
Item	Quantity [Piece (s)]	Component	Article number
not illustrated	1	Lamination bar	17Y128, 17Y129
	1	Side bars	17B38, 17B39, 17B40, 17B41, 17B84, 17B85
	1	System lamination foot stirrup	17B99, 17B101
	1	Foot stirrup	17B107
	1	System foot stirrup	17B108

Not included in scope of delivery
Item	Quantity [Piece (s)]	Component	Article number
not illustrated	1	System shoe stirrup	17F70
not illustrated	1	System shoe plate	17F35

Intended use

Indications for use

The product is intended exclusively for use in pairs for orthotic treatment of the lower limbs.

Indications

Partial or total paralysis of the leg muscles
Orthopedic 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.

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 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.

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 authorised, qualified personnel.

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
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.

INFORMATION
Parallel alignment of the orthotic joints
Use the 743R6 alignment fixture to position the orthotic joints on the plaster positive.

Insert the contoured foot stirrup into the orthotic ankle joint.
Assemble the foot stirrup and the orthotic joint with the bearing nut and the joint screw.
For final assembly, secure the screw connection with Loctite 241.

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.

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 to cure for at least 4 hours.
INFORMATION: Final bonding strength will be reached after 16 hours.

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, perspiration, urine or splashed water (e.g. after rain) and soiling.

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.
Only use 633F7 special lubricant. Spare parts are listed in the section “Components/design”. If you have any doubts, please contact the manufacturer.

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 unauthorized 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.