ottobock 17KF10 Free Motion Knee Joint Instruction Manual

ottobock 17KF10 Free Motion Knee Joint

Foreword

INFORMATION
Date of last update: 2021-05-28

• 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 following orthotic knee joints:

• 17KF10* Free motion orthotic knee joint, posterior placement

• 17KL40* Orthotic knee joint with 4-in-1 option ring lock

• 17KL20* Orthotic knee joint with covered Swiss lock

Product Description

Available sizes

mm

| 16

mm

| 5

mm

| Straight| Pair
17KF10=16-A| Alumini­ um
Article number| Material| Bars|
---|---|---|---
Length top/bot­ tom| Width| Thick­ ness| Quantity
17KL40=13| Stain­ less steel| 310/480

mm

| 13

mm

| 5

mm

| Pair
17KL40=13-A| Alumini­ um
17KL40=16| Stain­ less steel| 400/560

mm

| 16

mm

| 5

mm

| Pair
17KL40=16-A| Alumini­ um
17KL40=20| Stain­ less steel| 400/560

mm

| 20

mm

| 5

mm

| Pair
17KL40=20-A| Alumini­ um
Article number| Material| Bars| Ver­ sion| Quant­ ity
---|---|---|---|---
Length top/bot­ tom| Width| Thick­ ness
17KL20=13| Stain­ less steel| 300/490

mm

| 13

mm

| 5

mm

| Straight| Pair
Article number| Material| Bars| Ver­ sion| Quant­ ity
---|---|---|---|---
Length top/bot­ tom| Width| Thick­ ness
17KL20=13-A| Alumini­ um| 300/490

mm

| 13

mm

| 5

mm

| Straight| Pair
17KL20=20| Stain­ less steel| 400/560

mm

| 20

mm

| 5

mm

| Straight| Pair
17KL20=20-A| Alumini­ um

Components/design

*17KF10 (see fig. 1 )**

Item| Quantity [Piece (s)]| Designation| Article number
1| 1| Bearing nut| 17Y93=M5X7X6.4
2| 1| Upper joint section| –
3| 1| Lower joint section| –
4| 1| Joint screw| 501S32=M5X9X10
5| 1| Red washer| 507U5=10.6X7.4X1.5
6| 1| Bushing| 17Y17=10X4.5X7
*17KL40 (see fig. 2 )**

Item| Quantity [pcs.]| Designation| Article number
1| 1| Compression spring (lock)| 513D83=0.5X3.7X22
2| 1| Upper joint section| –
3| 1| Ring lock| 17Y13=9
4| 1| Red washer| 507U5=11.4X7.4X1.5
5| 1| Joint screw| 501S32=M5X9X10
6| 1| Lower joint section| –
7| 1| Bushing| 17Y17=10X4.5X7
8| 1| Compensating plate| –
9| 1| Bearing nut| 17Y93=M5X7X6.4
*17KL40 (see fig. 2 )**

Item| Quantity [pcs.]| Designation| Article number
10| 1| Spring-loaded thrust piece (ring lock)| 501D1
11| 1| Screw (lock)| 501S32=M3X12
17KL20=13 (see fig. 3 )

Item| Quantity [pcs.]| Designation| Article number
1| 1| Lock lever| 17Y20=1
2| 1| Spring| 513D83=1X4.1X22.8
3| 1| Connecting pin| 4A101=5X12.8
4| 1| Red washer| 507U5=19X14
5| 1| Countersunk washer| 507U57=16X5.4
6| 1| Joint screw| 501S32=M5X9X16
7| 1| Lower joint section| –
8| 1| Bearing nut| 17Y93=M5X9X8
9| 1| Lock ring| 507S96=4
10| 1| Upper joint section| –
17KL20=20 (see fig. 3 )

Item| Quantity| Designation| Article number
1| 1| Lock lever| 17Y20=2
2| 1| Spring| 513D83=1X4.1X26.2
3| 1| Connecting pin| 170D5=120
4| 1| Red washer| 507U5=25X20
5| 1| Countersunk washer| 507U57=22X7.6
6| 1| Joint screw| 501S32=M6X11X16
7| 1| Lower joint section| –
8| 1| Bearing nut| 17Y93=M6X9X10
9| 1| Lock ring| 507S96=4
10| 1| Upper joint section| –

Accessories

*17KF10 accessories**

• 743Y57 Alignment insert set, size 6

• *17KL40 accessories**

  • 743Y57 Alignment insert set, size 6
  • 17KL19=2 Duchenne bow kit (see fig. 4)

• *17KL20 accessories**

  •  743Y57 Alignment insert set, size 8
    or

  • 743Y57 Alignment insert set, size 9

  • 17MS30=A Pull-release cable (see fig. 5)

Intended use

Indications for use
The orthosis joint is intended exclusively for orthotic fittings of the lower limbs on one patient.
Use the orthotic joint in pairs only.

Indications
Partial or total paralysis of the leg muscles.
Orthopedic diseases of the lower limbs Indications must be determined by the physician.

Restrictions for use
The product is not suited for use with heavy stress, such as sports, garden­ing or lifting/carrying heavy items, which result in greater physical exertion.

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
Exceeding the lifetime and reuse
Risk of injury due to loss of functionality as well as damage to the product

• Ensure that the maximum lifetime is not exceeded.

• Only use the product for one person.
  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, assembly or adjustment
  Risk of injury due to change in or loss of functionality

• Assembly, adjustment and maintenance operations may only be completed by qualified personnel.

• Observe the alignment, assembly and adjustment instructions.
  CAUTION
  Improper handling
  Risk of falling due to accidentally opening the lock

• Prior to handing over the orthosis, ensure that the locks are engaged securely and in parallel.

• Avoid accidentally opening the locks.

• Instruct the patient in the correct usage of the system joints.
  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
  NOTICE
  Thermal overloading of the product
  Damage due to improper thermal treatment

• Do not carry out any heat treatment on aluminum at temperatures above 150 °C.

• Do not carry out any heat treatment on steel or stainless steel at temperatures above 300 °C.

• Do not carry out any heat treatment on titanium.

• 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

Orthosis alignment

• Select suitable materials for the upper and lower leg areas to reduce the torsional stress on the orthosis.

• Record the parts and lot number in the patient file to enable tracing in accordance with product liability law.

• Use the 743Y57* alignment insert for the correct alignment of the orthot­ic joints.

• The orthotic joints are produced with a standard 7° knee flexion angle. When adjusting orthotic joints, do not exceed a knee flexion angle of 10 for aluminum and 15° for steel.

• When using the thermoplastic material, additional reinforcement is required in the area of the thigh and calf.
  Protecting the product against environmental influences

• Apply a protective coating to the aluminum bars or polish them slightly.

• The steel that is used can rust. Apply a cover or paint to the product for extra protection before handing it over to the patient.

• The joint mechanics must be protected against dirt by a suitable protec­tive device (e.g. joint protectors) to ensure proper functioning.
  Locking mechanism

• Orthotic joints with a ring lock or Swiss lock are ready to use on delivery. Do not adjust the locking mechanism or the orthotic joint.
  The 17KL20 and 17KL40 orthotic knee joints are ready to use on delivery.

• 17KL20*: Connect the lock bales to each other with a flexible material (such as a preformed hose). Do not connect the lock bales firmly to each other (for example by soldering).
  *Assembly is required for the 17KF10 orthotic knee joint.**

• Lubricate the bearing surfaces with 633F7 special lubricant.

• 17KF10*: Apply Loctite 241 to the screw connections and tighten the screws.
  Bending bars

• Align the bars with the bending irons without exposing the joint heads to any bending load.

• The bending radius must be at least 20 mm. The allowable bending range is marked with a dotted laser line on the bars – do not bend inside that range.

• INFORMATION: Limit the bending of bars to a minimum, as excessive bending of bars can result in loss of stability and prema­ture breakage of the bars.
  Heat treatment of bars
  All bars have been heat-treated.

• Heat the bars while observing the temperature limits for aluminum of 150 °C (302 °F) and for steel of 300 °C (572 °F).

• DANGER! Grinding and polishing the bars with much force can create temperatures of above 100 °C. Slowly air-cool the rails and do not immerse them in cold water for immediate cooling.
  Drilling bars
  Holes may be drilled in the bars.

• Drill the holes for the mounting material in the bars. The distance between the hole and the outer edge of the bar must be at least equal to the diameter of the hole.

• INFORMATION: The holes must not be repaired or filled under any circumstances.
  Installing mounting materials

• Install the mounting materials.
  INFORMATION: Make sure that the mounting materials do not obstruct the locking mechanism.
  Final assembly of orthosis joint

• Use the 633F7 special lubricant to grease the metal.

• Secure the screw connection with Loctite 241.

INFORMATION
Delivery of finished orthosis to the patient
Prior to delivery of the orthosis to the patient, the fit, support and all func­tions must be tested.
Pay attention to the parallel alignment of the orthosis joints. Check the locking mechanism and instruct the patient in handling the lock and the product.

INFORMATION
Instruct the patient not to unlock the orthotic knee joints under load.

Patient information

Inform the patient:
Verify lock functionality

• Before standing up, check that both locks are engaged. Carry out a function test.
  Inspect the orthosis for damage

• Inspect the orthosis for damage daily, paying special attention to the locks and bars. Contact the qualified personnel promptly if changes are noted.

Cleaning

Clean the orthotic joint promptly after contact with water containing salt, chlorine or soap, or if it gets dirty.

1. Rinse the orthotic joint with clean, fresh water and remove dirt.
2. Dry with a cloth or allow to air dry.

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 an inspection of the product every 6 months to verify functionality and check for wear at a minimum.
Only use 633F7 special lubricant.
Spare parts are listed in the section “Components/design”.
Before handing the orthosis over to the patient, secure all screw connec­tions with Loctite 241.
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 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.

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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