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)

EN
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

EN
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

EN
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

EN
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