LegWorks ALL-TERRAIN KNEE User manual

All-Terrain Knee
Instructions for Use -
for Prosthetist
Distributeur

EN
All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 3
Contents
1. Product Diagrams .................................................................................................................... 4
2. Discription and Purpose ........................................................................................................ 5
3. Product Specications ............................................................................................................ 7
4. Our Technology ...................................................................................................................... 11
5. Safety ......................................................................................................................................... 13
5.1 User Instructions ................................................................................................................ 13
6. Setup and Operation ............................................................................................................ 14
6.1 Connections ....................................................................................................................... 14
6.2 Flexion Stop ........................................................................................................................ 17
6.3 Sagittal Plane Alignment ................................................................................................... 18
6.4 AutoLock Mechanism ........................................................................................................ 19
6.5 Friction Mechanism ........................................................................................................... 20
6.6 Adjustable Extension Assist .............................................................................................. 22
6.7 Cover ................................................................................................................................... 23
6.8 Manual Lock ....................................................................................................................... 25
7. Maintenance ............................................................................................................................ 26
7.1 User ..................................................................................................................................... 26
7.2 Prosthetist .......................................................................................................................... 27
8. Warranty ................................................................................................................................... 28
8.1 Exclusions ........................................................................................................................... 29
8.2 Liability ................................................................................................................................ 30
8.3 Disposal .............................................................................................................................. 30
9. CE Conformity ......................................................................................................................... 31

EN
All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists4
Product Diagrams
1
Friction
Mechanism
Screw
Cover
Manual
Lock
Pylon Clamp Screw
(12Nm/9ft lb)
Fig. 1 All-Terrain Knee Anterior Overview
Fig. 2 All-Terrain Knee Posterior Overview
Male Pyramid
(ATK-PA-01 and
ATK-PA-02)
Extension Assist
Spring
Extension
Assist Base
Lock Spring
Set Screw
Note: Stance Flexion
Male Pyramid Adapter not
pictured (ATK-SF-01 and
ATK-SF-02)

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 5
Discription and Purpose
2
Date of last update: 2018-05-17
Please read this document carefully.
The safety instructions are to be followed by both the prosthetist and the user.
Product Codes:
This instructional manual covers all current versions of the All-Terrain Knee:
Product Name Product Code
All-Terrain Knee ATK-PA-01
All-Terrain Knee with Stance Flexion ATK-SF-01
All-Terrain Knee Premium ATK-PA-02
All-Terrain Knee Premium with Stance Flexion ATK-SF-02
The Primary components and adjustments are identical across all knee versions.
Specific differences in components, features and adjustments are indicated within
the document by notation of the relevant Product Code.
Intended Use:
These instructions are for use by the prosthetist fitting and/or maintaining the
device.
All device models are intended for single person use.
All device models are to be used exclusively as part of an external lowerlimb
prosthesis.
All device models are developed for everyday use and must not be used for
unusual activities, such as extreme sports.
ATK-PA-01 and ATK-PA-02 are designed exclusively for Knee Disarticulation or
Transfemoral amputees.
ATK-SF-01 and ATK-SF-02 are designed exclusively for Transfemoral amputees.
Ensure that both the prosthetist and the user have read and understood the
Instructions for Use, especially safety information. If the user experiences
any problems with her device, she should immediately contact her
prosthetist. If the prosthetist experiences any problems, immediately
contact Loth Fabenim.

EN
All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists6
Discription and Purpose
2
Scope of Delivery:
All-Terrain Knee Device
All-Terrain Knee Device Cover
Instructions for Use (IFU)
Quick Reference Card (QRC)
Short User Guide
Extension Assist Springs: Medium stiffness (preinstalled), Strong stiffness
ATK-SF-01 and ATK-SF-02 only: Posterior Stance Flexion Bumpers: Firm,
Medium (preinstalled), and Soft stiffness
Function:
Stance-Phase Control: AutoLock Technology
Swing-Phase Control: Adjustable variable friction resistance (Variable
Cadence Controller) and spring extension assist
Design:
o ATK-PA-01 and ATK-SF-01: Waterproof in freshwater (e.g. shower, lake)
o ATK-PA-02 and ATK-SF-02: Waterproof and corrosion resistant in both
freshwater and saltwater (e.g. shower, pool, ocean)
Activity Level: Suitable for all activity levels
Indications:
Transfemoral (all device models), Knee Disarticulation (ATK-PA-01 and
ATK-PA-02 only)
K1-K4 mobility level (primary prosthesis)
Secondary prosthesis (bath or water leg)
Weight Limit:
ATK-PA-01 and ATK-SF-01 have been tested and passed to the 125kg (275 lb)
P6 ISO 10328:2006 standard
ATK-PA-02 and ATK-SF-02 have been tested and passed to the 150kg (330 lb)
P8 ISO 10328:2006 standard

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 7
Product Specications
3
Fig. 3 All-Terrain Knee ATK-PA-01 Build
Height Diagram
Product All-Terrain Knee
Part # ATK-PA-01
Amputation Level Transfemoral, Knee Disarticulation
Activity Level K1 - K4
Material Advanced Fiber-Reinforced Composites, Stainless
Steel
Maximum Body Weight 125 kg / 275 lb
Total Fitted Height (1) 186 mm
Eective tted height (2) 125 mm
Fitted height (3) 24 mm
Attachment Point to First Axis Oset 9 mm posterior oset
Product Weight 1,040 g. / 2.29 lb
Ground Clearance 11 mm
Proximal Connection Pyramid Adaptor
Swing Phase Control Variable Cadence Controller (Patent Pending)
Stance Phase Control AutoLock Technology (Patented)
Axes Four Axes
Flexion Angle (minus socket) 150 degrees
Distal Connection 30 mm tube clamp
Fig. 4 ATK-PA-01 Technical Specications

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists8
Product Specications
3
Fig. 5 All-Terrain Knee with Stance Flexion
ATK-SF-01 Build Height Diagram
Product All-Terrain Knee with Stance Flexion
Part # ATK-SF-01
Amputation Level Transfemoral
Activity Level K1 - K4
Material Advanced Fiber-Reinforced Composites, Stainless
Steel
Maximum Body Weight 125 kg / 275 lb
Total Fitted Height (1) 201 mm
Eective tted height (2) 141 mm
Fitted height (3) 40 mm
Attachment Point to First Axis Oset 19 mm posterior oset
Product Weight 1,230 g. / 2.71 lb
Ground Clearance 11 mm
Proximal Connection Pyramid Adaptor
Swing Phase Control Variable Cadence Controller (Patent Pending)
Stance Phase Control AutoLock Technology (Patented)
Axes Four Axes with Adjustable Stance Flexion
Flexion Angle (minus socket) 150 degrees
Distal Connection 30 mm tube clamp
Fig. 6 ATK-SF-01 Technical Specications

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 9
Product Specications
3
Fig. 7 All-Terrain Knee Premium ATK-PA-02
Build Height Diagram
Product All-Terrain Knee
Part # ATK-PA-02
Amputation Level Transfemoral, Knee Disarticulation
Activity Level K1 - K4
Material Advanced Fiber-Reinforced Composites, Stainless
Steel
Maximum Body Weight 150 kg / 330 lb
Total Fitted Height (1) 186 mm
Eective tted height (2) 125 mm
Fitted height (3) 24 mm
Attachment Point to First Axis Oset 9 mm posterior oset
Product Weight 1,044 g. / 2.30 lb
Ground Clearance 11 mm
Proximal Connection Pyramid Adaptor
Swing Phase Control Variable Cadence Controller (Patent Pending)
Stance Phase Control AutoLock Technology (Patented)
Axes Four Axes
Flexion Angle (minus socket) 150 degrees
Distal Connection 30 mm tube clamp
Fig. 8 ATK-PA-02 Technical Specications

EN
All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists10
Product Specications
3
Fig. 9 All-Terrain Knee Premium with Stance
Flexion ATK-SF-02 Build Height Diagram
Product All-Terrain Knee with Stance Flexion
Part # ATK-SF-02
Amputation Level Transfemoral
Activity Level K1 - K4
Material Advanced Fiber-Reinforced Composites, Stainless
Steel
Maximum Body Weight 150 kg / 330 lb
Total Fitted Height (1) 201 mm
Eective tted height (2) 141 mm
Fitted height (3) 40 mm
Attachment Point to First Axis Oset 19 mm posterior oset
Product Weight 1,234 g. / 2.72 lb
Ground Clearance 11 mm
Proximal Connection Pyramid Adaptor
Swing Phase Control Variable Cadence Controller (Patent Pending)
Stance Phase Control AutoLock Technology (Patented)
Axes Four Axes with Adjustable Stance Flexion
Flexion Angle (minus socket) 150 degrees
Distal Connection 30 mm tube clamp
Fig. 10 ATK-SF-02 Technical Specications

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 11
Our Technology
4
The All-Terrain Knee utilizes a proprietary stance-phase control mechanism (the
AutoLock) and swing-phase control mechanism (Variable Cadence Controller or
VCC). The mechanisms comprise a 4-linkage (4 bar) kinematic chain. The AutoLock
technology is based on a knee lock that is automatically engaged in late-swing-
phase for extra safety. The knee remains securely locked until midto-late stance-
phase when it is disengaged for an eortless swing-phase initiation. The VCC utilizes
a variable friction system with an optimized extension assist spring for ecient
gait at multiple walking speeds. The 4 bar kinematic arrangement of the All-Terrain
Knee mechanism results in swing-phase footclearance comparable to 4 and 6 bar
polycentric knee mechanisms.
1. Knee Flexion 2. Locked engaged
via spring
3. Lock securely
held in place
4. Toe load
unlocks knee
5. Knee exion
begins
Fig. 11 Stance Phase Function

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists12
Our Technology
4
The All-Terrain Knee is suitable for users in mobility classes 1-2, due to its 2-in-1
function. It can either be used as a manual locking knee joint, or as a mechanical
knee joint that allows for a natural gait as the user becomes more condent in their
stability and safety. This allows new amputees to transition from early rehabilitation
into more condent household and limited community ambulation.
As the user’s mobility continues to improve, the friction mechanism can be adjusted
to ensure that excessive heel-rise and terminal impact are prevented. The All-
Terrain Knee continues to be suitable for users in mobility classes 3 and 4, for both
everyday use and recreational use, due to the Variable Cadence Controller, which
allows amputees to walk at multiple speeds, while still beneting from the stability
and natural walking motion of the AutoLock Technology.

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 13
5.1 User Instructions
Safety
5
Do not adjust your knee or change your alignment. Alert your prosthetist immediately
to any suspicious sounds from the knee (clicking, crackling, etc.). Inspect your
prosthesis often, clean with a towel. Do not tamper with any screws on the knee.
Observe all the above points, otherwise the warranty becomes null and void.
The user should immediately report any changes, i.e. excessive movement in the
knee during stance-phase, inconsistent locking, etc. to their prosthetist.
Always use a handrail when descending stairs and on downward slopes if available.
Any excessive changes in heel height may adversely aect the stability of the knee.
Care should be taken while carrying heavy loads.
All device models of the All-Terrain Knee should only be t by a qualied
professional.
In the nal stage of quality control, all All-Terrain Knee Collection units undergo
functional testing to ensure optimal performance standards are met. As a result, the
product may ship with visible indentation marks on the pyramid.
If there are any visible changes, wear and tear, or functional limitations, replace
the part, or contact the manufacturer for a replacement part, or servicing request.
Please make sure the user is competent in handling of his prosthesis before leaving
the premises. Failure to observe this warning may cause the user to fall.
Please be aware of nger traps in the knee joint at all times.

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists14
6.1 Connections
Setup and Operation
6
The proximal connection consists of a M10 bolt that is attached directly to a male
pyramid adaptor (Fig. 13).
ATK-SF-01 and ATK-SF-02 Only - Adjustable Stance Flexion Adapter
The All-Terrain Knee versions with Stance Flexion feature a proximal articulating
pyramid adapter with anterior and posterior bumpers that compress upon loading,
providing up to 12 degrees of total movement throughout stance phase.
ATK-SF-01 and ATK-SF-02 are shipped with the adapter pre-installed with the medium
grade posterior bumper inserted.
Bumper Options:
Anterior or Posterior Bumper Color Hardness
Anterior Blue Medium (preinstalled)
Posterior Black Soft
Posterior Blue Medium (preinstalled)
Posterior Gray Firm

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 15
Setup and Operation
6
Fig. 12 Adjustable Stance Flexion Adaptor Assembly
1. Top Adaptor Assembly
2. Anterior Bumper
3. Posterior Bumper
4. Plate
5. M10 Washer
6. For ATK-SF-01: 6 mm
Hex Bit M10 Adaptor
Screw
7. For ATK-SF-02: 16 mm
Hex Head M10
Adaptor Screw
Bumper Selection Guidelines:
If patient experiences excessive motion or a sensation of instability with the
preinstalled bumper: Select the rm posterior bumper (gray).
If patient experiences heel strike as too rigid: Select the soft posterior bumper
(black).

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists16
Setup and Operation
6
Bumper Adjustment Instructions:
1. Turn M10 bolt to remove proximal assembly
2. Select the desired posterior bumper and insert into channel as shown.
3. Ensure that the anterior bumper is properly seated into channel as shown.
4. Install combined assembly onto knee using M10 bolt with washer while
ensuring that bumpers remain properly aligned and housed within the
adapter while tightening the bolt.
5. Torque M10 bolt to 30Nm / 22 ft lb
6. Check prosthetic alignment (see section 3)
Using a torque
wrench, tighten
the M10 bolt to
30 Nm (22ft lb)
M10 Bolt
For the distal connection, ensure
the 30mm pylon is fully inserted.
Tighten pylon clamp screw to
12Nm (9 ft lb) by turning the bolt
with a 5mm hex bit (For ATK-PA-02
and ATK-SF-02: use 6mm hex bit)
using a torque wrench.
If a loud creaking sound occurs at
heel strike, apply a small amount
of multipurpose oil or silicone
spray to the surface area of the
pylon that rests within the knee’s
tube clamp.
Fig. 13 Proximal Connection

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 17
Setup and Operation
6
6.2 Flexion Stop
In maximum exion, it is vital that a exion stop is in eect and contacts the All-
Terrain Knee in the proper location. See examples below:
A exion stop must be provided between the socket and the distal posterior
portion of the knee to prevent hyper exing of the knee and damage to
internal mechanisms of knee.
Fig. 14 Absence of Flexion Stop
Fig. 15 Malpositioned Flexion
Stop
Fig. 16 Appropriate Flexion
Stop
Incorrect: No contact point exists between socket
and lower body of knee in maximum exion.
Damage to knee may occur.
Incorrect: Socket is in direct contact with extension
assist spring assembly in maximum exion.
Damage to knee may occur.
Correct: Socket naturally contacts the body of
knee below the spring assembly. A exion stop
(e.g. crepe) may need to be axed to socket to
achieve this.
Alternatively, a exion stop may need to be axed
to the knee’s pylon adaptor and the sidewalls
surrounding the extension assist spring.

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists18
6.3 Sagittal Plane Alignment
Position the knee’s rst axis 20mm posterior
to the plumb line bisecting proximal aspect of
socket (baseline recommendation)
To increase ease of unlocking, increase toe
load:
Shift knee posterior
Plantarflex foot
Increase socket flexion
Tighten pylon clamp of knee to 12Nm (9 ft lb)
Setup and Operation
6
Alignment
Reference Line
(descends from
proximal socket
bisection point)
Socket Flexion:
3-5⁰ initial exion
20mm Posterior
Oset Line
(extends vertically
through rst axis)
Foot (as per
manufacturer’s
suggestion)
Shift knee
anterior
- greater
toe
clearance
Shift knee
posterior
- greater geo-
metric stability
- increased ease
of unlocking
Fig. 17 Sagittal Plane Alignment

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists 19
Setup and Operation
6
6.4 AutoLock Mechanism
Lock Spring Set Screw (5mm hex)
The Lock Spring Set Screw applies force to the lock
spring to ensure proper performance locking upon
full extension) of the AutoLock Mechanism.
Factory Setting:
¼ turn protrusion from surface
With user in parallel bars adjust as follows:
Posterior View
If lock fails to engage
If there is a loud click at
full extension
Turn 1/4 Turn
Turn 1/8 Turn
Fig. 18 AutoLock Sensitivity Adjustment

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.
All-Terrain Knee Instructions for Use - For Prosthetists20
6.5 Friction Mechanism
Setup and Operation
6
Fig. 19 Friction Mechanism
Minimum Friction Setting (MFS): failure to achieve
MFS causes mechanism to loosen and fall o with use.
Ensure the friction mechanism caps and disc springs
are not loose i.e. able to rattle or make noise when
tapped with a nger.
If user requires a more free-swinging knee, the friction
mechanism assembly (Fig. 20) can be removed and
stored for later use; this does not aect the integrity
of the knee’s assembly.
Gap present with
disc springs in slight
compression
With user in parallel bars, adjust as follows:
If knee does not reach
full extension
If excessive terminal impact
by 1/4 turn
increments
by 1/4 turn
increments