Thuasne GenuStart L1820 User manual

Instructions for Use
Indications
• Conservative treatment of knee ligament injuries.
• Joint instability/laxity.
• Knee pain and/or swelling management.
• Sport activities resumption.
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 knee
ligament injuries and/or in sport activities resumption.
The patient’s thigh and calf circumferences must
correspond to the fitting range.
• 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


• The product is made of aluminum, stainless steel,
polyamide, elastane, polyester, synthetic rubber,
polyoxymethylene, 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. Metal uprights/stays
7. TM5 hinge
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
GenuStart 
Hinged Ligament Knee Brace
Also available in short
length and/or sleeve
style application
Figure A
Figure B
L-0118 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.
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 USA warrants 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)
GenuStart 
Hinged Ligament Knee Brace


Medical Device
L-0118 Rev. A