Click RevoFit2 User manual

(MDD) - 93/42/EEC
harmonized & notified body
Click Medical, LLC
1205 Hilltop Parkway
Warehouse 101
Steamboat Springs, CO, USA
(970) 670-7012
RevoFit2™
Lamination Kit
PK2000-320-05
REF PK001
Advisory:
Do not use on patients with neuropathy, neuromas, or other nerve issues.
Fabrication only by a certied 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 certié, formé au système RevoFit. Le
lament sera porté, inspecté et remplacé régulièrement.
Beratend:
Nicht bei Patienten mit Neuropathie, Neuromen oder anderen Nervenproblemen anwenden.
Fertigung nur durch einen zertizierten 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 certicado, entrenado en el sistema RevoFit.
El lamento se desgastará, inspeccionará y reemplazará regularmente.
US PATENT# 8443501
WE ARE HERE TO HELP!
Tech Support: 970 670 7012
ClickMedical.co/RevoSupport
Help@clickmedical.co


RevoFit2™Lamination Kit Contents:
Recommended Designs:
T6
6ft RevoFit Tubing 7ft Lace
Lace Tool
RevoFit2
Lamination Dummy
High Power
Boa Dial
Below Knee:
3 Panel Design
or Symes Door
Above Knee:
2 System with
Medial/Lateral Panels +
Adjustable Strap
Recommended
Suspension System:
RevoLock™ Lanyard Kit
PN:3000-220-05
Patient Replacement
Lace Pack
+Additional Kit Required
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: 970 670 7012
WARRANTY:

Design Overview:
Fabrication Overview:
On frame
On panel
1
3
2
1
3
56
2
Determine location of panels or areas
of adjustment
Determine lace routing
For Inline Routing - Use port II and III For Remote Routing - Use port I and II
Inline - mounted on panel
Remote - mounted on socket frame
Inline - mounted on socket frame
Determine location of reel
Glue on RevoFit
Components Laminate
Cut Out
Windows
4
Install +
Shape Pads
Lace
Socket
Install
Reel +
Tune Pads

Lamination Instructions:
Prep the mold with a thin rst lamination layer:
Reinforce areas under the tubing and under
the panel cutout areas.
1a. Roughly sand socket.
b. Draw in trim lines.
c. Determine reel, panel and lace path location.
d. Roughly draw in lace path.
2
Draw tube guide lines:
3Reel mounting:
If mounting reel on frame, glue it into place now.
If mounting reel on panel refer to Step 3 before gluing.
4
Panel mount option:
Use port 2 and 3
Frame mount option:
Use port 1 and 2
Perpendicular crossings
1” or 2cm
Diameter:
1.25” or 3cm
Note: Indicate position of lace path
a. Ensure that lace path crosses all panels with the ¼spacing rule.
b. Ensure tubing crosses panels perpendicularly.
c. Don’t turn tubing until 1cm past any panel edge.
Do not kink tubing
1/2
1/4 1/41/41/4
Laminate again:
7
Glue on tubing:
5Trim one tube, pack with clay, insert into bayonet:
c. Insert Tube
Make sure tubing is
inserted
2cm into silicone.
6
b. Pack Clay
Cut otabs for lamination
a. Cut at an angle so tube
pierces into the silicone easily. Glue dots
NOTE: Take picture of socket for reference after second lamination.
HINT: Use photo from step 6 above.
a. Glue on tubing according to lace pattern.
b. Cut second end of tubing to length,
plug and insert second end into bayonet.
Do not displace tubing or
reel housing while laminating
Insert free end of tube.
Make sure tubing is
inserted 2cm into
silicone.
Mark with a pen the location of the panels to cut out:
8

Note of location of
the inner for the
future pilot hole
Lamination Instructions Continued:
Cut out the panels:
9
Sand edges
Clear tube holes
Prepare housing:
10
Finish sanding exit
holes by hand until extra smooth
1. Trim tube ends
to edge of housing
2. Clear all debris
Grind ush with top of reel housing.
Take care to not damage reel housing.
Use small end of blade for round corners
Scalloped blade
Drill pilot hole to access tab for reel removal:
11
Locate inner for
pilot hole.
Drill through
lamination at an
angle creating a
tunnel to access the
pilot hole & release
tab (2mm drill bit).
Test and clear hole
before installing
dial.
Fabricate and install pads:
12
Pad thickness, material and shape
are used to rene pressure and t.
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.
Convex pad Skive edges
Panel
INCORRECT - Pad too thin when panel is ush with socket
CORRECT - Pad is the correct thickness when panel sits above socket when t is snug to patient
Good Closure Force
Weak Closure Force
5-10mm
Frame
Critical distance
Pad
Panel
Frame Pad
Panel

1cm
13 Attach lace to reel:
12
14
Feeder
Lace
Insert reel into socket - turn counter-clockwise to lock:
15
Wind up and test
Pull panel out to keep lace
from becoming pinched in the reel
Pilot hole
Insert laces into smallest end of pass through on
spool. Tie double overhand knots on each end.
Leave 8cm of lace
on both ends
8 cm
Feed lace:
How to remove dial:
Locate tab (see above)
Lock on to housing of dial with needle nose vise grips. Rotate clockwise to remove
Tab location:
Finished!
Push towards center of reel
1/4 turn - Turn the
housing not the dial itself
Pull dial to open
Inline
Depending on the location,
either at 4 o’clock or 11o’clock. Always at 8:30.
Remote
- Fit patient
- Tune in t, by rening pad shape... if necessary.
- Provide IFU's and replacement lace pack to patient
a. Open dial
b. Use tool to press inward on tab
c. Simultaneously turn housing clockwise
If you inserted the reel PRIOR to drilling an access hole use vise grip
instructions below. Once dial is removed, drill pilot hole.
Lamination Instructions Continued:

PEL, LLC
ph: 800-321-1264
www.pelservice.com
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