UNITED ORTHO Step-thru NoVel User manual

RANGE OF MOTION – HINGE ADJUSTMENT
The brace is shipped with a 0° hinge extension stop installed.
Additional extension (EXT) and flexion (FLEX) stops are included with
each brace, as well as the tools required to change the stops.
When changing FLEX or EXT stops, be sure that the screws are
tightened securely and that both medial and lateral hinge stops are
identical. The following EXT & FLEX stops are included:
EXT: 0°, 10°, 20°, 30°, 40°, 50°
FLEX: 45°, 60°, 75°, 90°, LOCKOUT
ADJUSTING FLEX & EXT STOPS
1. REMOVING CONDYLE PAD
Remove the condyle pads by detaching them from the inside of
the hinge.
2. REMOVE SCREW
Remove the EXT stop screw by using the Allen wrench provided
(turn counter-clockwise to remove). Remove the pre-installed 0°
EXT stop.
3. INSTALL STOP & REPLACE SCREW
Choose the proper EXT or FLEX stop and screw into place as
illustrated below. NOTE: The FLEX stop must be inserted between
the hinge plates.
IMPORTANT: Replace the medial and lateral hinge with the same
degree EXT or FLEX stops. Do not over-tighten screws.
4. NOTE: A Lockout Stop is included and can be used in combination
with the 0° EXT Stop to immobilize the knee.
Condyle Pad Removal
EXT Stop Adjustment
FLEX Stop Adjustment
Lockout Stop
BRACE CARE
Liners and pads must be removed and cleaned regularly depending
upon your activity level and perspiration.
All liners and pads are held in place by hook fasteners and can easily
be removed from the frames, hinges and straps. Wipe or HAND WASH
with a MILD anti-bacterial soap, rinse well, then AIR DRY. Replace and
position properly by pressing firmly against the fasteners.
CLEANING HINGES
The hinges on your brace are pre-lubricated. If sand, dirt or water gets
inside the hinges, they may require cleaning and lubrication. Remove
the condyle pad, open the hinge screws with the provided Allen
wrench, and clean the hinge thoroughly and re-lubricate with any
common synthetic lubricant (grease) from a hardware store. Check
that the hinge is gliding smoothly and reassemble.
PARTS, SERVICE, & WARRANTY
Straps, liners and other comfort pads may need to be replaced due to
normal wear and tear. If your brace requires replacement parts, you
should contact the professional who assisted you in ordering and
fitting the brace.
Under normal use and conditions, the frames and hinges on your
brace are covered by a one year warranty against defects in
craftsmanship and breaking. Straps, liners and other comfort pads are
backed by a six month warranty.
U.S. Patent No: Patent Pending
PART NUMBERS: 300851-XX; 300852-XX, 300853-30.
-XX -01 -03 -05 -07 -08 -09
XS SM MD LG XL XXL
United Ortho Enterprises
2235 Pennsylvania St. Fort Wayne, IN 46803
www.United-Ortho.com
Phone: [phone]
Fax: [phone]
PN PL0065 REV B 0814
FKB
NōVel
Step Thru
Frame
Brace Fitting Instructions
RANGE OF MOTION – HINGE ADJUSTMENT
The brace is shipped with a 0° hinge extension stop installed.
Additional extension (EXT) and flexion (FLEX) stops are included with
each brace, as well as the tools required to change the stops.
When changing FLEX or EXT stops, be sure that the screws are
tightened securely and that both medial and lateral hinge stops are
identical. The following EXT & FLEX stops are included:
EXT: 0°, 10°, 20°, 30°, 40°, 50°
FLEX: 45°, 60°, 75°, 90°, LOCKOUT
ADJUSTING FLEX & EXT STOPS
1. REMOVING CONDYLE PAD
Remove the condyle pads by detaching them from the inside of
the hinge.
2. REMOVE SCREW
Remove the EXT stop screw by using the Allen wrench provided
(turn counter-clockwise to remove). Remove the pre-installed 0°
EXT stop.
3. INSTALL STOP & REPLACE SCREW
Choose the proper EXT or FLEX stop and screw into place as
illustrated below. NOTE: The FLEX stop must be inserted between
the hinge plates.
IMPORTANT: Replace the medial and lateral hinge with the same
degree EXT or FLEX stops. Do not over-tighten screws.
4. NOTE: A Lockout Stop is included and can be used in combination
with the 0° EXT Stop to immobilize the knee.
Condyle Pad Removal
EXT Stop Adjustment
FLEX Stop Adjustment
Lockout Stop
BRACE CARE
Liners and pads must be removed and cleaned regularly depending
upon your activity level and perspiration.
All liners and pads are held in place by hook fasteners and can easily
be removed from the frames, hinges and straps. Wipe or HAND WASH
with a MILD anti-bacterial soap, rinse well, then AIR DRY. Replace and
position properly by pressing firmly against the fasteners.
CLEANING HINGES
The hinges on your brace are pre-lubricated. If sand, dirt or water gets
inside the hinges, they may require cleaning and lubrication. Remove
the condyle pad, open the hinge screws with the provided Allen
wrench, and clean the hinge thoroughly and re-lubricate with any
common synthetic lubricant (grease) from a hardware store. Check
that the hinge is gliding smoothly and reassemble.
PARTS, SERVICE, & WARRANTY
Straps, liners and other comfort pads may need to be replaced due to
normal wear and tear. If your brace requires replacement parts, you
should contact the professional who assisted you in ordering and
fitting the brace.
Under normal use and conditions, the frames and hinges on your
brace are covered by a one year warranty against defects in
craftsmanship and breaking. Straps, liners and other comfort pads are
backed by a six month warranty.
U.S. Patent No: Patent Pending
PART NUMBERS: 300851-XX; 300852-XX, 300853-30.
-XX -01 -03 -05 -07 -08 -09
XS SM MD LG XL XXL
United Ortho Enterprises
2235 Pennsylvania St. Fort Wayne, IN 46803
www.United-Ortho.com
Phone: [phone]
Fax: [phone]
PN PL0065 REV B 0814
FKB
NōVel
Step Thru
Frame
Brace Fitting Instructions
FKB No¯VEL
STEP-THRU
Brace Fitting Instructions
RANGE OF MOTION—HINGE ADJUSTMENT
ADJUSTING FLEX AND EXT STOPS
BRACE CARE

APPLICATION INSTRUCTIONS
A:
UNFASTEN BUCKLES
Release the four straps by
depressing the Quick Release
Buttons on the medial frame.
Strap #5 should only be
adjusted once during the initial
fitting. If this is the initial
fitting, loosen strap #5.
C:
STEP THRU & POSITION
Step thru the brace and sit with
the knee bent between a 30°-
45° angle. Position the brace so
that the center of the hinge
aligns with the top of the patella.
D:
STRAPS #1 & #2
Engage Strap #1 by inserting the
Strap Tab into the Quick Release
Buckle. Add tension to the strap
by turning the dial, (clockwise on
a right knee, counterclockwise
on a left, until a snug fit is
achieved.
Follow the same steps for Strap
#2.
E:
STRAP #3
Engage Strap #3 by inserting the
Strap Tab into the Quick Release
Buckle. Tightening Strap #3 will
cause the hinges to be pulled
toward the back of the knee.
Tighten until the centers of the
hinges are approximately .5”
behind the centers of the
condyles.
F:
STRAP #4
Insert Strap #4 into the Quick
Release Buckle.Tightening
strap #4 will cause the hinges
to be realigned with the center
of the knee. Tighten until the
centers of the hinges align with
the centers of the condyles.
Do not pull beyond midline of
the leg.
G:
STRAP #5
Strap #5 does not have a Quick
Release Buckle or cinching knob.
Tighten Strap #5 until snug.
Strap #5 should only be adjusted
once during initial fitting.
Patient should not adjust once it
has been set by fitter.
H:
FINAL CHECK
Stand up with the leg in
full extension and check
to ensure the center of
the hinges aligns with the
center of the patella.
Straps should be
retightened during
activities to ensure a snug
fit.
CONDYLE PAD
The medial and lateral
condyle pads should
make full contact with the
knee. In case of a gap or
irregular fitting between
the medial or lateral side,
use the extra 5mm or
15mm condyle pads
provided to achieve a
perfect fit for both sides
(10mm condyle pads are
installed).
ADJUSTING PAD
LENGTH
For optimal fit and
comfort, ensure Strap
Pads are centered on
the leg when straps
are tightened. If a
Strap Pad is too long,
remove the pad from
strap and trim excess
with scissors.
B:
LOOSEN STRAPS
Depress the release button
in the center of all four dials.
The straps can now pulled on
to increase the length as
needed during the fitting
process.
IMPORTANT: STRAP ORDER
FOLLOW CORRECT
STRAP ORDER
All straps are numbered
in numerical order (with
the exception of Strap #5
which is not labeled). It
is important to apply the
brace according to the
numerical order to
ensure optimal
protection and fit.
INDICATIONS: ACL, ACL/PCL Deficiencies; ACL, ACL/PCL reconstructions;
Collateral ligament deficiencies; Collateral ligament deficiencies with ACL
involvement; MCL and/or LCL sprains; Hyperextension. This product was
designed to complement the variety of medical treatments common to the
above afflictions. The frequency and duration of use should be determined by
your prescribing healthcare professional.
WARNING: CAREFULLY READ FITTING INSTRUCTIONS AND WARNINGS PRIOR TO USE. TO ENSURE PROPER PERFORMANCE OF THE BRACE, FOLLOW ALL INSTRUCTIONS. FAILURE TO PROPERLY POSITION
THE BRACE AND FASTEN EACH STRAP WILL COMPROMISE PERFORMANCE AND COMFORT.
WARNING: IF YOU EXPERIENCE INCREASED PAIN, SWELLING, SKIN IRRITATION, OR ANY ADVERSE REACTIONS WHILE USING THIS PRODUCT, IMMEDIATELY CONSULT YOUR MEDICAL PROFESSIONAL.
WARNING: THIS DEVICE WILL NOT PREVENT OR REDUCE ALL INJURIES. PROPER REHABILITATION AND ACTIVITY MODIFICATION ARE ALSO AN ESSENTIAL PART OF A SAFE TREATMENT PROGRAM.
CONSULT YOUR LICENSED HEALTH CARE PROFESSIONAL REGARDING SAFE AND APPROPRIATE ACTIVITY LEVEL WHILE WEARING THIS DEVICE.
CAUTION: CARE AND CLEANING OF THIS PRODUCT IS ESSENTIAL TO ITS CONTINUING STRENGTH AND PERFORMANCE. FOLLOW REMOVAL AND CLEANING PROCESS DESCRIBED IN INSTRUCTIONS.
CAUTION: FOR SINGLE PATIENT USE ONLY.
CAUTION: THIS BRACE IS INTENDED TO INCREASE SUPPORT AND PROPRIOCEPTION ON A PREVIOUSLY INJURED OR HEALING KNEE.
FITTING TIPS
APPLICATION INSTRUCTIONS CONT.
#2
#1
#3
#4
#5
APPLICATION INSTRUCTIONS
FITTING TIPSIMPORTANT: STRAP ORDER