ottobock 17F31 Side Bar And Joint Head Instructions
- June 4, 2024
- ottobock
Table of Contents
Instructions 17F31, 17F32
17F31 Side Bar And Joint Head
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 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 use of the 17F31 and 17F32 orthotic ankle joints.
Product Description
2.1 Available sizes
Article number| Side| Bar width| Joint head
Diameter| Slot width| Material
---|---|---|---|---|---
17F31=L26X2.5| Left| 15 mm| 26 mm| 2.5 mm| Stainless steel
17F31=R26X2.5| Right
17F31=L28X3| Left| 16 mm| 28 mm| 3 mm| Stainless steel
17F31=R28X3| Right
17F31=L30X3| Left| 17 mm| 30 mm| 3 mm| Stainless steel
17F31=R30X3| Right
17F32=L26X2.5| Left| 15 mm| 26 mm| 2.5 mm| Aluminum
17F32=R26X2.5| Right
Article number| Side| Bar width| Joint head
Diameter| Slot width| Material
---|---|---|---|---|---
17F32=L28X3| Left| 16 mm| 28 mm| 3 mm| Aluminum
17F32=R28X3| Right
17F32=L30X3| Left| 17 mm| 30 mm| 3 mm| Aluminum
17F32=R30X3| Right
2.2 Components/design
Scope of delivery (see fig. 1 ) 17F31=L/R26X2.5, 17F32=L/R26X2.5
Item| Quantity [pcs.]| Component| Reference number
1| 1| Joint bar|
2| 1| Bearing nut| 17Y93
3| 1| Joint screw| 501S32
4| 1| Ball| 509Y2=3/16″
6| 1| Spring| 513D18
7| 1| Set screw| 17Y18
Scope of delivery (see fig. 1 ) 17F31=L/R28X3, 17F31=L/R30X3,
17F32=L/R28X3, 17F32=L/R30X3
Item| Quantity [pcs.]| Component| Reference number
1| 1| Joint bar|
2| 1| Bearing nut| 17Y93
3| 1| Joint screw| 501S32
5| 1| Thrust piece with a ball| 17Y80
6| 1| Spring| 513D18
7| 1| Set screw| 17Y18
Accessories
Not included in the scope of delivery
Item| Quant city [pcs.]| Component| Reference number
| 1| Foot stirrup| 17B58*
Not included in the scope of delivery
Item| Quant city [pcs.]| Component| Reference number
not illus treated| 1| Shoe stirrup, double-sided| 17F33
1| System shoe stirrup| 17B65
1| System shoe plate| 17F35*
Intended use
3.1 Indications for use
The orthosis 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 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 the use of the
product and have it checked by authorized, qualified personnel.
CAUTION
Use under restricted environmental conditions
Risk of injury due to damage to the product
► Do not expose the product to restricted environmental conditions.
► If the product has been exposed to restricted environmental conditions,
check it for damage.
► If damage is apparent or in case of doubt, do not continue the product.
► Take suitable measures if required (e.g. cleaning, repair, replacement,
inspection by the manufacturer or a specialist workshop, etc.).
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).
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).
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.
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
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
- Use the 711S* bending irons for contouring the joint bar.
- INFORMATION: Do not use bending irons with sharp edges for the 17F32 aluminum joint bar; use only the 711S4 bending irons or bending irons with rounded edges.
- Contour the bar until the desired result is obtained.
- Observe the minimum bending radius of 10 mm (see fig. 2).
- Remove grooves and burrs by grinding.
- For final assembly, secure the joint screw with Loctite 241.
Bending the foot stirrups
> Required tools: Vice, 711S* bending iron, grinding machine
- Use the 711S* bending irons for contouring the foot stirrup.
- Clamp a bending iron in a vice and position the foot stirrup.
- INFORMATION: To prevent the risk of breakage, do not bend or otherwise modify the insertion zone. Adapt the foot stirrup with the bending iron.
- Remove grooves and burrs by grinding.
Mounting the foot stirrup
> Prerequisite: The orthotic ankle joints are disassembled. To do so,
remove the joint screw and the bearing nut from the joint.
- 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
Stainless steel
The 17F31 orthotic joint made of stainless steel has a shiny surface that is
protected against corrosion. Sanding, polishing, and sintering improve the
protection against corrosion.
► NOTICE! Do not use polishing pastes containing iron to polish stainless
steel. The micro-fine iron particles are sufficient to initiate cor
erosion.
Aluminum
The 17F32 orthotic joint is made of aluminum.
► NOTICE! Do not carry out any heat treatment at temperatures above 200
°C.
► Do not weld! Use a screw or rivet connection.
Ottobock recommends
| For sanding: | 649G9 belts, free of iron oxide, 280 – 320 grit |
|---|---|
| For polishing: | Polishing mop coated with Vienna chalk 649Z4 polishing paste, |
non-ferrous
For surface coating:| 618T40 Sintering powder
► After sanding, polish the surfaces, paying special attention to the edges.
► Do not heat the material longer than 5 minutes at max. 150 °C for
sur face coating.
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”.
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 · 647G3=all_INT-26-2106
References
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