RevoFit2. Diagnostic Kit

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Emil Walker
5 years ago
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(MDD) - 93/42/EEC RevoFit2 Diagnostic Kit PK2150-320-05 Advisory: Do not use on patients with neuropathy, neuromas, or other nerve issues.

1 (MDD) - 93/42/EEC RevoFit2 Diagnostic Kit PK Advisory: Do not use on patients with neuropathy, neuromas, or other nerve issues. Fabrication only by a certified professional, trained in the RevoFit system. Filament will wear, inspect and replace regularly. Consultatif: Ne pas utiliser chez les patients atteints de neuropathie, de névrome ou d'autres problèmes nerveux. Fabrication uniquement par un professionnel certifié, formé au système RevoFit. Le filament sera porté, inspecté et remplacé régulièrement. Beratend: Nicht bei Patienten mit Neuropathie, Neuromen oder anderen Nervenproblemen anwenden. Fertigung nur durch einen zertifizierten Fachmann, der im RevoFit System geschult wurde. Filament wird regelmäßig getragen, kontrolliert und ersetzt. Consultivo: No lo use en pacientes con neuropatía, neuromas u otros problemas nerviosos. Fabricación solo por un profesional certificado, entrenado en el sistema RevoFit. El filamento se desgastará, inspeccionará y reemplazará regularmente. WE ARE HERE TO HELP! Tech Support: ClickMedical.co/RevoSupport Help@clickmedical.co US PATENT# REF PK001 harmonized & notified body Click Medical, LLC 1205 Hilltop Parkway Warehouse 101 Steamboat Springs, CO, USA (970)

RevoFit2 Diagnostic Kit Contents: 6ft RevoFit Tubing 7ft of Lace + Lace Feeder RevoFit2 Dial

For any warranty or product failure please do not return to distributor, simply contact CLICK

co Help Line: 970 670 7012 Recommended Designs: +Additional Kit Required Below Knee: 3 Panel

3 RevoFit2 Diagnostic Kit Contents: 6ft RevoFit Tubing 7ft of Lace + Lace Feeder RevoFit2 Dial Base High Power Boa Dial WARRANTY: Accedents happen, WE GET IT! For any warranty or product failure please do not return to distributor, simply contact CLICK MEDICAL DIRECTLY AT: Help@ClickMedical.co Help Line: Recommended Designs: +Additional Kit Required Below Knee: 3 Panel Design or Symes Door Above Knee: Adjustable Medial /Lateral Panels + Adjustable Strap in Definitive (addional kits required) Recommended Suspension System: RevoLock Lanyard Kit PN:

4 Design Overview: 1 Determine location of panels or areas of adjustment 2 Determine location of reel On panel On frame 3 Determine lace routing For Inline Routing - Use port II and III Inline - mounted on panel For Remote Routing - Use port I and II Remote - mounted on socket frame Inline - mounted on socket frame Fabrication Overview: Glue on RevoFit Components 1 Wrap Casting Tape 2 Cut Out Windows 3 Install + Shape Pads 4 Lace Socket 5 Install Reel + Tune Pads 6

5 Diagnostic Instructions: 1 a. Roughly sand socket. Pull Plastic. 2 b. Draw in trim lines. c. Determine reel, panel and lace path location. d. Roughly draw in lace path. 3 Draw tube guide lines: 4 Reel mounting: a. Ensure that lace path crosses all panels with the ¼ spacing rule. b. Ensure tubing crosses panels perpendicularly. c. Don t turn tubing until 1cm past any panel edge. Perpendicular crossings Frame mount option: Use port 1 and 2 Diameter: 1.25 or 3cm 1/2 Panel mount option: Use port 2 and 3 1/4 1/4 1/4 1/4 Do not kink tubing 1 or 2cm Note: Indicate position of lace path 5 Peel backing paper and stick to check socket. 6 Glue on tubing: a. Glue on tubing according to lace pattern. b. Cut second end of tubing to length, plug and insert second end into dial base. Super Glue NOTE: Take picture of socket for reference use in step 8. 7 Wrap all parts of system in casting tape. 8 Mark with a pen the location of the panels to cut out: Hint: Immediately follow with packaging wrap to ensure a tight bond and smooth finish. HINT: Use photo from step 6 above.

6 9 Diagnostic Instructions Continued: Cut out the panels: Use small end of blade for round corners Sand edges Clear tube holes Scalloped blade Finish sanding exit holes by hand until extra smooth 10 Prepare housing: 1. Trim tube ends to edge of housing 2. Clear all debris 11 Drill pilot hole to access tab for reel removal: Note of location of the inner for the future pilot hole Grind flush with top of reel housing. Take care to not damage reel housing. Locate inner pilot hole. for Drill through Test and clear hole lamination at an before installing angle creating a dial. tunnel to access the pilot hole & release tab (2mm drill bit). 12 Fabricate and install pads: Convex pad Skive edges Pad thickness, material and shape are used to refine pressure and fit. Pad Material: Pads should be dense enough to create pressure and not compress under tension. Pad Thickness: Average 3/16 (4.75mm) Push shore: 35 Slight convex shape allows for better application of pressure. Panel INCORRECT - Pad too thin when panel is flush with socket Weak Closure Force Panel Frame Pad CORRECT - Pad is the correct thickness when panel sits above socket when fit is snug to patient Good Closure Force Critical distance Panel Frame Pad 5-10mm

7 Diagnostic Instructions Continued: 13 Feed lace: 14 Attach lace to reel: 1 2 Leave 8cm of lace on both ends Feeder 8 cm Lace 1cm Insert laces into smallest end of pass through on spool. Tie double overhand knots on each end. 15 Insert reel into socket - turn counter-clockwise to lock: Pilot hole Finished! - Fit patient - Tune in fit, by refining pad shape... if necessary. - Provide IFU's and replacement lace pack to patient Wind up and test Pull panel out to keep lace from becoming pinched in the reel How to remove dial: a. Open dial b. Use tool to press inward on tab c. Simultaneously turn housing clockwise Push towards center of reel Tab location: If you inserted the reel PRIOR to drilling an access hole use vise grip instructions below. Once dial is removed, drill pilot hole. Inline Remote 1/4 turn - Turn the housing not the dial itself Pull dial to open Depending on the location, either at 4 o clock or 11o clock. Always at 8:30. Locate tab (see above): Lock on to housing of dial with needle nose vise grips at tab location. Rotate clockwise to remove.

SCULL HANDLES AND GRIPS INSTRUCTION BOOKLET

SCULL HANDLES AND GRIPS INSTRUCTION BOOKLET Contents Section I: Scull Grip Replacement: Fixed Handle or 10 cm Length Adjustment System Refer to this section if you need to replace the grips on your fixed