LegWorks ALL-TERRAIN KNEE Скачать руководство пользователя страница 28 | Manualshive

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All-Terrain Knee van LegWorks, distributeur Loth Fabenim B.V.

All-Terrain Knee Instructions for Use - For Prosthetists

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Warranty

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All device models of the All-Terrain Knee are covered by a 2-year warranty, no

changes or modifications are allowed.

General Conditions:

If it is being used by more than one user, product liability

pursuant to the Medical Devices Directive 93/42/EEC becomes null and void.

LegWorks warrants that all device models of the All-Terrain Knee and component
parts thereof will be free from defects in workmanship and materials for a period
of two years from the date of purchase by a prosthetist or distributor of prosthetic
products involved in the business of resale or distribution.

LegWorks does not warrant products to consumers directly, only through
prosthetists.

The All-Terrain Knee (ATK-PA-01) and the All-Terrain Knee with Stance

Flexion (ATK-SF-01) may be used in freshwater. The All-Terrain Knee

Premium (ATK-PA-02) and the All-Terrain Knee Premium with Stance Flexion

(ATK-SF-02) may be used in freshwater and saltwater. Regular care and

maintenance of all device models is needed to avoid corrosion (as described

above). Maintenance must be completed the same day as exposure and

is recommended as 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

[email protected] to obtain a return authorization number.

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 to LegWorks.
LegWorks will not accept units shipped directly from the end user. For any warranty-

related service LegWorks will provide a loaner unit for the length of time required to

repair the unit at no charge. Units that are not under warranty or are excluded from
the warranty will not receive a free loaner, however a loaner may be rented for a
nominal fee and deposit. Loaner units will be invoiced for their full value and a credit
issued upon their return. Any units returned under warranty for repair will carry a
six-month warranty on those repairs subject to exclusions. Loaner units must be
returned free from damage caused by abuse, neglect, or alteration, otherwise repair
charges will be billed to the purchaser. LegWorks reserves the right to determine
how units will be repaired including the option of reconditioned, or new parts.

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Содержание ALL-TERRAIN KNEE

Страница 1: ...All Terrain Knee Instructions for Use for Prosthetist Distributeur ...

Страница 2: ......

Страница 3: ...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 Conformi...

Страница 4: ... 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 ...

Страница 5: ...s 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 unusua...

Страница 6: ... 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 Disarticu...

Страница 7: ...rced Composites Stainless Steel Maximum Body Weight 125 kg 275 lb Total Fitted Height 1 186 mm Effective fitted height 2 125 mm Fitted height 3 24 mm Attachment Point to First Axis Offset 9 mm posterior offset 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 Technol...

Страница 8: ...omposites Stainless Steel Maximum Body Weight 125 kg 275 lb Total Fitted Height 1 201 mm Effective fitted height 2 141 mm Fitted height 3 40 mm Attachment Point to First Axis Offset 19 mm posterior offset 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 P...

Страница 9: ...inforced Composites Stainless Steel Maximum Body Weight 150 kg 330 lb Total Fitted Height 1 186 mm Effective fitted height 2 125 mm Fitted height 3 24 mm Attachment Point to First Axis Offset 9 mm posterior offset 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 Tec...

Страница 10: ...ed Composites Stainless Steel Maximum Body Weight 150 kg 330 lb Total Fitted Height 1 201 mm Effective fitted height 2 141 mm Fitted height 3 40 mm Attachment Point to First Axis Offset 19 mm posterior offset 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 Technolo...

Страница 11: ...atically engaged in late swing phase for extra safety The knee remains securely locked until midto late stance phase when it is disengaged for an effortless swing phase initiation The VCC utilizes a variable friction system with an optimized extension assist spring for efficient gait at multiple walking speeds The 4 bar kinematic arrangement of the All Terrain Knee mechanism results in swing phase...

Страница 12: ...and safety This allows new amputees to transition from early rehabilitation into more confident 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...

Страница 13: ...n downward slopes if available Any excessive changes in heel height may adversely affect the stability of the knee Care should be taken while carrying heavy loads All device models of the All Terrain Knee should only be fit by a qualified professional In the final stage of quality control all All Terrain Knee Collection units undergo functional testing to ensure optimal performance standards are m...

Страница 14: ...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 Col...

Страница 15: ...embly 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 firm posterior bumper gray If patient experiences heel strike as too rigid Select the soft posterior b...

Страница 16: ...umpers 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 A...

Страница 17: ...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 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 the b...

Страница 18: ...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 5 initial flexion 20mm Posterior Offset Line extends vertically through first axis Foot as per manufacturer s suggestion Shift knee anterior greater toe clearance Shi...

Страница 19: ... 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 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 ...

Страница 20: ... friction mechanism caps and disc springs are not loose i e able to rattle or make noise when tapped with a finger 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 affect 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 ...

Страница 21: ...on mechanism may keep the knee from reaching full extension preventing the AutoLock Technology from locking Setup and Operation 6 Ensure disc springs are aligned with the interior cylinder and in compression to prevent noise and loosening with use Fig 20 Friction Mechanism Cap and Disc Springs Friction Mechanism Cap Friction Mechanism Threaded Cap ...

Страница 22: ...t Bias Options Fig 21 Adjustable Extension Assist Posterior View 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 assembly Spring Assembly insert spring base into chosen spring Watch out for finger t...

Страница 23: ...rate sides of cover from knee before pulling away from the anterior location of the joint Fig 22 Cover should be removed when attaching the knee to a socket and or adjusting the set screws for alignment Fig 22 All Terrain Knee Cover Removal The cover has an o ring to minimize noise Ensure the o ring is present Bridge of Cover should be connected into the opening of the main body of the knee The co...

Страница 24: ...sis ensure the top of the cover does not come in contact with the socket and that a gap exists when the knee is fully extended In case a gap does not exist modify the socket or grind down the cover until a gap is evident Ensure that there is no possibility of cosmetic coverings or clothes getting caught between the cover and socket otherwise the knee will not properly lock This could lead to fall ...

Страница 25: ... Activating manual lock when knee in slightly flexed is difficult and should be avoided The manual lock screw is factory set DO NOT adjust unless MANUAL LOCK disengages when in use To adjust use a 4mm hex key at the front and 10mm socket wrench from the rear of the knee after removing the extension assist spring Fig 24 While the knee is fully extended and locked tighten using hex key in turn clock...

Страница 26: ...Stance Flexion ATKSF 01 should only be used in freshwater Exposure to non freshwater will result in corrosion and should be avoided If any incidental contact with nonfreshwater occurs the knee should be immediately rinsed with warm clean freshwater The All Terrain Knee Premium ATK PA 02 and the All Terrain Knee Premium with Stance Flexion ATK SF 02 can be used in freshwater and saltwater including...

Страница 27: ...tor other damage Maintenance must be carried out by prosthetist Visual inspection annually is recommended Check for visual defects that may affect proper function Maintenance instructions do not disassemble the knee joint If there is an issue with the product send the knee joint in for service LegWorks recommends readjusting the knee joint s settings once the user has gotten used to the prosthesis...

Страница 28: ...tenance must be completed the same day as exposure and is recommended as 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 to obtain a return authorization number All units in need of repair should be shi...

Страница 29: ...cost of shipping insurance ancillary damage to or loss of the use of the artificial leg in which the unit has been installed or any economic or physical loss to purchaser or end user LegWorks products are guaranteed to be compatible with modular components from other manufacturers if the following points are observed Use only with other components that are in compliance with their intended purpose...

Страница 30: ...nufacturer can only be held liable for the failure of its own components The manufacturer can only be held liable beyond this if it can be proved that its modular components were causally responsible for the damage to or loss of function of modular components from other manufacturers LegWorks recommends using the device only under the specified conditions for the intended purposes All device model...

Страница 31: ...um ATK PA 02 and the All Terrain Knee Premium with Stance Flexion ATK 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 All device models of the All Terrain Knee have been classified as a Class 1 Rule 1 medical device per the rules found in Annex IX L...

Страница 32: ...ANDS Tel 31 30 27 32 506 Fax 31 30 27 11 045 Email sales lothfabenim nl www lothfabenim nl Manufacture Authorized representative for EU countries QNET BV Kantstraat 19 5076 NP Haaren The Netherlands Tel 31 46 439 8479 LegWorks 77 Goodell Street Fourth Floor Buffalo NY 14203 United States of America Tel 1 408 692 5633 www legworks com ...

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