Thuasne GenuStart ROM L1832 User manual

Instructions for Use
Indications
• Functional treatment of the knee during the pre- or
post-operative period, as well as the rehabilitation period
(including following moderate or severe cruciate ligament
and/or collateral ligament sprains).
• Conservative treatment of knee ligament injuries
and/or ruptures.
• Knee instability.
Contraindications
Patients with severe arterial insufficiency and/or spider veins
inducing skin at risk with the regular wearing of compression
orthosis or a known reaction or allergy to any of the material
ingredients
Warning and Precautions
Read all instructions prior to use. If increased pain, swelling,
change in sensation, or any adverse reactions are experienced
while using this product, immediately consult your medical
professional. This product is intended to be applied by

healthcare practitioner. For single patient use only.
Precautions
• Closely follow your healthcare professional’s prescription
and recommendations for use.
• Check the product is not damaged before use.
• Do not apply the product directly over broken skin or an
open wound without an appropriate dressing.
• 
sensations, remove the product and seek the advice of a
healthcare professional.
• In the event of a change in product performance, contact
the healthcare professional who prescribed or supplied the
product.
• This product is intended for the treatment of a given
condition. Its duration of use is limited to this treatment only.
• For hygiene and performance reasons, do not re-use the
product for another patient.
• Do not apply the device in direct contact with a greasy
substance (ointment, cream, etc.).
• Remove the product before any imaging exams.
• Store at room temperature, preferably in its original packaging.
• The product should be disposed of as per local regulations.
Description
• Purpose: the product is aimed at patients with a moderate
to severe knee ligament injury and/or in postoperative
treatment. The patient’s thigh and calf circumferences
must correspond to the fitting range.
• Properties/Mechanism of action: Stabilization of knee
joint ligaments provided by the rigid hinged side uprights.
- Extension can be adjusted to 10° and 20°.
- Flexion can be adjusted to 0°, 45°, 60° and 90°.
• The product is available in 4 forms: 2 versions
(open and closed), each available in 2 lengths (short and
long) to meet the needs of patients (example of open long
version in figure A and closed short version in gure B).
Each version is available in 7 sizes.
• The product is composed of:
- a fabric part consisting of a 3D knit at the front and a
thin, elastic knit at the back;
- 
- the TM5+ hinge mimicking the knee’s natural

- 2 anterior half-straps and 2 posterior half-straps

- 4 anterior half-straps and 3 posterior half-straps

- a patellar insert to enable correct positioning of the


• 
be used without tools.
• The design of the frame enables limitation of extension
to 0° by default.
• 
the hinge
of the knee brace, is included in the packaging.
• The product is made of aluminum, stainless steel,
polyamide, elastane, polyester, synthetic rubber,
polyoxymethylene, TPU, and PVC.
Unwanted side eects
• This device can cause skin reactions (redness, itching,
blistering, burns, blisters, etc.)
• Any serious incidents occurring related to the device
should be reported to the manufacturer and to the
competent authority of the country in which the user and/or
patient is resident.
Brace Components & Sizing
Size
Circumference Measurement At:
6" Above
Knee Center Knee Center 6" Below Knee Center
XS   
SM   
MD   
LG   
XL   
2XL   
3XL   
Components
1. Patella buttress
2. Wrap opening
3. Upper straps
4. Lower straps
5. Posterior straps
6. TM5 hinge and metal uprights/stays
7. 
 
9. Flexion/Extension Pins (six included)
GenuStart ROM 
Hinged Ligament Knee Brace With Flexion/Extension Control
Also available in short
length and/or sleeve
style application
Figure A
Figure B
Remove stays and
hand wash 30°C
with mild detergent
Do not Iron
Do not
tumble
Do not
dry clean
Lay sleeve
flat to dry
Do not
bleach
Do not submerge
uprights and
hinge in water
single patient,
multiple use
L-0133 Rev. A

Fitting Instructions
For optimum wear and fit it is recommended to apply the brace against
bare skin (except in the case contraindicated). To improve comfort and
fit, the metal uprights/stays may be formed to more closely align with

to the size chart (available on the box and at the start of the instruction
sheet). If the measurements taken do not correspond to the same size,
favor the size corresponding to thigh circumference measurement.
3. To remove hinge-cap, push the fastener
from underneath the hinge and peel back
upon release (D).
4. To replace the hinge-cap, hook the anchor
under the front of the hinge and snap the
fastener back in place (E).
5. Six flexion/extension pins are included
with the brace. To set flexion/extension,
insert pin into desired degree (F). Be sure
both hinges are set to match. Extension
can be limited to 10° and 20°. Flexion can
be limited to 0°, 45°, 60° and 90° Pins can
be removed at any time to adjust settings.
1. Unfasten all anterior and posterior straps
and open anterior Velcro closure. Position
open brace under leg (A) with patella
buttress at knee center.
2. Wrap the sleeves around the thigh and
calf, stretching the material until the
Velcro adheres (B). Your knee cap should
fit snugly in the patella buttress and the
hinges should be at knee center.
3. Individually tighten each anterior and
corresponding posterior strap, starting
with the lower straps and finishing with
the upper straps (C). The brace should
be snug, but not so tight your circulation
is restricted. If you feel any tingling or
severe discomfort remove and contact
the medical professional who fit the brace.
Warranty: Aluminum hinge, straps and sleeve are
covered under standard warranty for six months from
date of purchase. If you experience a problem with
the fit or function of the brace, please call the medical
provider who t your brace.
Limited Warranty: Thuasne USAwarrants to the original
purchaser that this product is free from defects in
materials and workmanship. Normal wear and tear
during the use of a product is not considered a defect.
This warranty does not apply if this product; (1) has
been altered in any way; (2) was not purchased from
Thuasne USA or one of its authorized distributors;
(3) is not used in accordance with Thuasne USA’s
Instructions for Use (IFU). Under this Limited Warranty
Thuasne USA’s sole obligation shall be to repair or
replace the defective product or associated part(s)
at no charge. This Limited Warranty does not cover
damage as a result of mishandling, accidents,improper
use or alteration of the product. This is in place of all
other warranties, either express or implied, including
but not limited to warranties of merchantability or
fitness for a particular purpose. Thuasne USA shall
not be liable under this or any implied warranty for
any personal injury, property damage, or special,
incidental, or consequential damages arising out of,
related, or incidental to the use of the product even
if Thuasne USA has been informed of the prospect
of such possible loss or damage, unless state law
otherwise prohibits this exclusion.
Distributed by
Townsend Design/Thuasne USA
4615 Shepard Street, Bakersfield, CA 93313

ThuasneUSA.com
(A) (B)
(C)
(D)
+
20¡
10¡
0¡
60¡
45¡
90¡
FLX
EXT
0¡
60¡
90¡
45¡
20¡
10¡
+
(F)
GenuStart ROM 
Hinged Ligament Knee Brace With Flexion/Extension Control
Thuasne - 120, rue Marius Aufan -
92300 Levallois-Perret -France
Medical Device
* The product’s default position is limitation of flexion to 90°.
Additional pins are supplied with the product.
L-0133 Rev. A