Thuasne Sleeq Max TLSO User manual

SLEEQ MAX™TLSO
INSTRUCTIONS FOR USE
4615 Shepard Street, Bakersfield, CA 93313, USA
800.432.3466 • ThuasneUSA.com
© 2018 ThuasneUSA All rights reserved.
Warnings
• Carefully read use/care instructions and warnings prior to use.
• If increased pain, swelling, sensation changes, or any adverse reactions are experienced
while using this product, immediately consult your medical professional.
• For single patient use only.
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 Limited Warranty is
effective from the date of delivery to the original purchaser for up to 6
months.
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 warranty 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. User
should seek advice from their healthcare provider immediately if user
encounters any kind of adverse reaction related to the use of this product.
User should consult with their healthcare provider with any questions or
concerns relating to the proper use of this product for their specific medical
condition. IMPORTANT- Read all Instructions for Use (IFU) and any other
associated materials to ensure proper use.
Premium Post-Op/Post-Injury TLSO
PDAC Approved L0464
The rigid back panel, anterior panel, lateral panels and wing shells can be trimmed and heat modified
to adjust lordosis, add scapula reliefs or create flares. The steel upright can be bent to match
anatomical contours and the wings can be attached to the Crescent Connectors at up to 5 degree
angles up or down to accommodate various waist to hip ratios.
INTERIOR SHELLS:
BACK PANEL REMOVAL FOR MODIFICATION:
Separate the cover at the base of the back panel (1). Lift cover (2). Remove the LSO assembly (3).
© 2018 Thuasne USA – All rights reserved. L-0005 Rev.D
Care Instructions:
4.0 MODIFICATIONS
5.0 RESET
TRIM
HEAT
FORM
1
4
REMOVE
SEPARATE
LIFT
Remove plastic panel from material sleeve (4).
2
2
3REMOVE When removing the brace, always replace Pull Tabs to ready position (5.1) Lay brace on a flat
surface then pull each Wing outward to reset the tightening mechanism (5.2).
4.1
4.2
4.3
5.2
5.1
REPLACE
PULL PULL
ADJUST FOR UNDER AXILLA STRAPPING OPTION
The posterior clip attachment piece can be detached and repositioned to acommodate proper
postioning for over the shoulder strap placement (A) or the under axilla strapping option (B).
A B
(Also see Section 3.4 for anterior view)
ANTERIOR
PANEL WITH SCISSORS
CAUTION:
DO NOT TRIM TOP
CENTER TABS ON
ANTERIOR PANEL

CRESCENT
CONNECTOR
LATERAL
PANEL
(2)
ANTERIOR
PANEL
ASSEMBLY
S LEEQ MAX™TLSO
38 - 44
44 - 54 32 - 38
26 - 32
80 - 95
65 - 80
95 - 110
110 - 136
4
3
2
1 1
2
34
Sizing Arqs
™
Sizing Arqs
™
PULL TAB
1.1
1.0 SIZING
Indications:
Sagittal/coronal/transverse plane motion restriction; increased intracavitary pressure to reduce spine
& disc loading; mechanical or discogenic thoracic/lumbar & extremity pain; post-operative spinal
stabilization/fusion; degenerative disc disease; post-injury to facilitate healing; spondylolysis; spinal
stenosis; spondylolisthesis; spondylosis; laminectomy; discectomy; facet syndrome; spinal muscle
weakness; arthritis; low back sprains and strains; prophylactic back support.
Contraindications:
• SLEEQ braces are contraindicated for women who are pregnant.
• SLEEQ braces are contraindicated for persons with circulatory, pulmonary, cardiovascular or other
conditions where increased abdominal pressure would be of concern.
Prepare to Fit: Unclip straps (1) from sternal plate and remove anterior panel
assembly (2) from wing.
2.1 3.1
3.2
3.3
3.4
2.0 ATTACH WING SHELLS & LATERAL PANELS 3.0 ADJUST & FIT
•ALIGN wing shell on wing with sew line Arq on shell aligned to sew line Arc on
wing where crescent connector is attached from step 1.2 (see arrows below).
1.2
Adjust Circumference: Measure waist circumference and reference size chart
above for proper alignment.
2
REMOVE
PUSH
1
SIZE
REFERENCE
RECEIVER
CLIP
WING SHELL
(2)
IN. CM.
Move right wing in or out and align Crescent Connector to appropriate Sizing Arq.
Repeat on left wing.
Scan To View
Instructional Fitting
Video
LIFT
1. ALIGN
2. TUCK 3. SECURE
WRAP WRAP
(A)
• Position the brace with lower edge of back panel at coccyx level.
• Position the anterior panel with lower edge just above symphysis pubis level.
• Wrap the left wing (1) and attach to Velcro on the anterior panel, then wrap
right wing (2).
41
2
34
LIFT
SLIDE
SYMPHYSIS
PUBIS
STERNAL
NOTCH
STERNAL BAR CLIP
Note: When fitting in
standing position, patient
should hold wings at
their sides to allow
practitioner to place
anterior panel centered
at midsagittal line.
Tighten brace: Detach pull-tabs, pull out & away from the body then
re-attach anywhere onto the wings. (See section 5.0 for resetting the
tighening mechanism)
UNDER AXILLA STRAPPING OPTION
(Also see MODIFICATIONS section 4.3)
COCCYX
FOLD
(A)
1
2
• Attach strap clips into sternal plate and adjust straps so that strap padding
is centered on the anatomy.
• The strap ends should be tucked into the anterior strap clips and posterior
strap loops. Strap ends can also be cut and heat sealed.
Sternal Bar: Open sternal bar clip to telescope sternal bar to desired
height, then close clip to lock in place.
– Standard practice is to have sternal plate 1 to 2” below sternal notch
when standing and 1/2” below when seated or supine.
– If there is a gap between sternal pad and chest or there is too much
pressure on the chest, the sternal bar can be bent to achieve proper
positioning with bending irons or over the edge of a table. Note: Bend
sternal bar above toothed area.
EXT Extension Panel
(Sold Separately)
Extends SLEEQ Max to 50”-60”
(127-152 cm)
• Attach wing shell Velcro to inside of wing and secure Velcro tab (A) at inner end of
wing inside back panel.
• TUCK and attach wing shell inside back panel as shown above.
• SECURE Velcro tab (A) to inner end of wing inside back panel.
• Repeat on other side.
Note: For sizes 1, 2, 3, use center Arq on wing shell, and for size 4 use posterior
Arq near Velcro tab (A).
ATTACH LATERAL PANELS