LegWorks ATK HydraPro Instructions For Use Manual Download Page 24 | Manualshive

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LegWorks ATK HydraPro Instructions For Use Manual Download Page 24

English

ATK HydraPro |

Instructions for Use

© Copyright LegWorks 2019

HYD-IFU-02

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The ATK HydraPro (HYD-PA-02) and the ATK HydraPro with Stance Flexion
(HYD-SF-02) have been tested and passed to the 150kg P8 ISO 10328:2006
standard.

All device models by LegWorks meet the conformity standards of the CE

Mark, as outlined in Medical Device Directive 93/42/EEC, and have been
classified as a Class 1, Rule 1 medical device per the rules found in Annex IX.
LegWorks has completed the essential requirements of Annex I, the clinical
evaluation of X, and self-declared using Annex VII.

CE CONFORMITY

For sales inquiries, or to request information regarding the ATK HydraPro,

please email [email protected]

, or call +1 (408) 692-5633.

For warranty requests, customer complaints, or service requests, please

email [email protected]

, or call +1 (408) 692-5633.

ORDERING AND CONTACT INFORMATION

77 Goodell Street

Fourth Floor

Buffalo, NY 14203

United States of America

+1 (408) 692-5633

legworks.com

Made in Germany

Manufactured for LegWorks

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Summary of Contents for ATK HydraPro

Page 1: ...ATK HydraPro INSTRUCTIONS FOR USE ...

Page 2: ...TECHNOLOGY 9 SAFETY 10 User Instructions SETUP and OPERATION 11 Connections Bumper Selection Guidelines Bumper Adjustment Instructions Sagittal Plane Alignment AutoLock Mechanism Flexion Stop Friction Mechanism Friction Mechanism Removal Friction Mechanism Installation Adjustable Extension Assist Cover Manual Lock MAINTENANCE 21 User Prosthetist WARRANTY 22 Exclusions Liability Disposal ORDERING A...

Page 3: ...tions 8 7 Stance Phase Function 9 8 Adjustable Stance Flexion Adaptor Assembly 11 9 Proximal Connection 12 10 Sagittal Plane Alignment 13 11 Lock Spring Set Screw 13 12 Absence of Flexion Stop 14 13 Malpositioned Flexion Stop 14 14 Appropriate Flexion Stop 14 15 Friction Mechanism 15 16 Friction Mechanism Cap and Disc Springs 15 17 Friction Mechanism Removal 16 18 Friction Mechanism Installation 1...

Page 4: ...English ATK HydraPro Instructions for Use Copyright LegWorks 2019 HYD IFU 02 4 PRODUCT DIAGRAMS Fig 1 ATK HydraPro Anterior Overview Fig 2 ATK HydraPro Posterior Overview ...

Page 5: ...t be used for unusual activities such as extreme sports HYD PA 02 is designed exclusively for Knee Disarticulation or Transfemoral amputees HYD SF 02 is designed exclusively for Transfemoral amputees Ensure that both the prosthetist and the user have read and understood the Instructions for Use especially the safety information If the user experiences any issues with the device they should immedia...

Page 6: ...hase Control AutoLock Technology Swing Phase Control Adjustable variable friction resistance Variable Cadence Controller and spring extension assist Design HYD PA 02 and HYD SF 02 Waterproof and corrosion resistant in both freshwater and saltwater e g shower pool ocean Activity Level Suitable for K3 and K4 activity levels INDICATIONS Transfemoral both device models Knee Disarticulation HYD PA 02 m...

Page 7: ...ight 2 125mm 4 15 16 in Fitted Height 3 24mm 15 16 in Tube Clamp Depth 4 45mm 1 3 4 in Attachment Point to First Axis Offset 9mm Posterior Offset Product Weight 1 052g 2 32 lb Ground Clearance 11mm 7 16 in Proximal Connection Pyramid Adaptor Swing Phase Control Hydraulic Variable Cadence Controller Stance Phase Control AutoLock Technology Patented Axes Four Axes Flexion Angle minus socket 150 degr...

Page 8: ... Height 2 141mm 5 9 16 in Fitted Height 3 40mm 1 9 16 in Tube Clamp Depth 4 45mm 1 3 4 in Attachment Point to First Axis Offset 19mm Posterior Offset Product Weight 1 242g 2 74 lb Ground Clearance 11mm 7 16 in Proximal Connection Pyramid Adaptor Swing Phase Control Hydraulic Variable Cadence Controller Stance Phase Control AutoLock Technology Patented Axes Four Axes Flexion Angle minus socket 150 ...

Page 9: ...ock Technology and swing phase control mechanism Hydraulic Variable Cadence Controller or Hydraulic 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 mid to late stance phase when it is disengaged for an effortless swing phase initiat...

Page 10: ...the premises Failure to observe this warning may cause the user to fall Please be aware of finger traps in the knee joint at all times 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...

Page 11: ... that compress upon loading providing up to 12 degrees of total movement throughout stance phase The HYD SF 02 is shipped with the adapter pre installed with the medium grade posterior bumper inserted BUMPER OPTIONS SETUP AND OPERATION Anterior or Posterior Bumper Color Hardness Anterior Blue Medium pre installed Posterior Black Soft Posterior Blue Medium pre installed Posterior Gray Firm 1 Top Ad...

Page 12: ... 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 redo to 30Nm 22 ft lb 6 Check prosthetic alignment see section 3 For the distal connection ensure the 30mm pylon is fully inserted Tighten pylon clamp screw to 120Nm 9 ft...

Page 13: ...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 Fig 10 Sagittal Plane Alignment AUTOLOCK TECHNOLOGY MECHANISM Fig 11 Lock Spring Set Screw Turn undo by 1 4 turn increments Turn redo by 1 4 turn increments ...

Page 14: ...ioned Flexion Stop Fig 14 Appropriate Flexion Stop times circle times circle times circle times circle check circle check circle Incorrect No contact point exists between socket and lower body of knee in maximum flexion Damage to knee may occur Incorrect Socket is in direct contact with extension assist spring assembly in maximum flexion Damage to knee may occur Correct Socket naturally contacts t...

Page 15: ...requires a more free swinging knee the friction mechanism assembly can be removed Fig 21 and stored for later use this does not affect the integrity of the knee s assembly FRICTION MECHANISM Turn undo by 1 4 turn increments Turn redo by 1 4 turn increments Fig 15 Friction Mechanism Gap present with disc springs in slight compression Fig 16 Friction Mechanism Cap and Disc Springs Over tightening th...

Page 16: ...AL Fig 17 Friction Mechanism Removal 1 Turn the 4mm hex head bolt counter clockwise while maintaining a firm grip on the friction mechanism threaded cap on the opposite side Turn until the threading releases 2 Pull the friction mechanism cap the two disc springs and the threaded bolt out of the knee while maintaining pressure on the friction mechanism threaded cap on the opposite side 3 Carefully ...

Page 17: ...e interior cylinder of the knee 3 Insert friction screw with friction mechanism cap and washers and tighten until threading engages with the opposite side 4 Turn knee so friction mechanism threaded cap is facing up apply Loctite 242 or similar Allow to penetrate threading of screw 5 Tighten friction unit bolt head until there is no rattling or audible noise when tapping the opposite side friction ...

Page 18: ...ng base into chosen spring WEAK BLUE MED WHITE STRONG RED EXTENSION ASSIST BIAS OPTIONS Watch out for finger traps when compressing the spring POSTERIOR VIEW REMOVAL Insert flathead screw driver below the spring base and above horizontal shaft Compress spring up ward and pull outward INSTALLATION Align horizontal groove of extension assist base with horizontal shaft prior to closing spring assembl...

Page 19: ...g 20 Cover should be removed when attaching the knee to a socket and or adjusting the set screws for alignment Fig 20 ATK HydraPro Cover Removal COVER O RING The cover has an o ring to minimize noise Ensure the o ring is present The bridge of the cover should be connected into the opening of the main body of the knee AUTOLOCK RELEASE Activation of the AutoLock Release unlocks the knee which initia...

Page 20: ...ion securely en gages the knee lock when knee is fully extended Turning it to the horizontal position allows for AutoLock operation The manual lock can be engaged with knee flexed or fully extended Activating manual lock when knee in slightly flexed is difficult and should be avoided MANUAL LOCK Fig 22 Manual Lock The manual lock screw is factory set DO NOT adjust unless MANUAL LOCK disengages whe...

Page 21: ...ct your prosthetist as it could affect function or safety PROSTHETIST Maintenance The joint must be inspected and repaired if necessary at least every 6 months Inspect alignment screw connections suitability of user weight degree of mobility loss of lubricant for damage for soiling of the bush ings extension stop visual inspection of proximal adaptor other damage Maintenance must be carried out by...

Page 22: ... soon after exposure as possible Failure to comply with this required maintenance for water exposure will void any warranty coverage for corrosion Procedure for obtaining warranty service Contact LegWorks customer service at warranty legworks com All units in need of repair should be shipped by the purchaser to LegWorks It is the responsibility of the purchaser to prepay and insure units shipped t...

Page 23: ...urpose weight limit of weakest component applies the use of tested individual components with the CE mark does not release the prosthetist from their obligation to check to the best of their capabilities the prosthesis for its sustainability cor rect assembly and safety If the prosthesis has been exposed to an unusually high stress e g a fall it must be inspected immediately for possible damage Sa...

Page 24: ...al device per the rules found in Annex IX LegWorks has completed the essential requirements of Annex I the clinical evaluation of X and self declared using Annex VII CE CONFORMITY For sales inquiries or to request information regarding the ATK HydraPro please email sales legworks com or call 1 408 692 5633 For warranty requests customer complaints or service requests please email warranty legworks...

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