ASPEN SUMMIT™ 456 TLSO
THORACIC LUMBAR SACRAL ORTHOSIS
Instruction Manual
ASPEN SUMMIT 456 TLSO Thoracic Lumbar Sacral Orthosis
MEDICAL DEVICE
SINGLE PATIENT- MULTIPLE USE
CAUTION
EMERGO EUROPE
Prinsessegracht 20 2514 AP The Hague The Netherlands
Pat. aspenmp.com/patents
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BACK PANEL
If necessary, custom form back panel to properly fit patient anatomy.
PLACEMENT
A. Apply the fully stretched brace making sure the back panel is centered and low on the back.
B. Overlap the ends of the brace so the hook material grips the opposite side loop as tightly as possible.
C. Ends may be angled to accommodate for different anatomies.
TIGHTEN AND ADJUST
A. Adjust the vertical height of the posterior adjustment strap so that the yoke rests at C7 or 2” below the shirt collar.
B. Slip each thumb into the pull tabs. Extend the tabs out and away from the brace. When the desired compression is achieved, place the hook side of the pull tabs down onto the loop material to secure.
C. Pull and tighten the shoulder straps until properly fit.
D. Fasten and tighten the chest buckle to secure the shoulder straps.
MODIFICATION OPTIONS
This product may be substantially modified by an individual with expertise. For more information, please visit www.aspenmp.com/education/product-modifications.
SIZING GUIDE
| Size | Circumference | |
| SMALL | 26 – 34 in | 66 – 86 cm |
| MEDIUM | 33– 42 in | 84 – 107 cm |
| LARGE | 41 – 51 in | 104 – 130 cm |
| X- ARGE | 50 – 60 in | 127 – 152 cm |
INTENDED USE
To provide motion restriction and stability of the Thoracic-lumbar-sacral spine.
INDICATIONS
Postoperative support, Degenerative disc disease, Bulging or herniated disc, Fracture management, Spondylolysis, Spondylolisthesis, Spinal stenosis, Kyphosis, Spondylosis (Osteoarthritis/Degenerative Joint Disease).
CONTRAINDICATIONS
Hypersensitivity or allergies to any of the materials from which the brace is made. Swelling of the lymphatic tissue caused by circulatory disorders. Patients who are not allowed to wear a brace according to medical instructions.
PRECAUTIONS
READ INSTRUCTIONS BEFORE USE. Proper training in the use of this device should take place before it is applied. These directions are guidelines only and are not offered as medical recommendations. If you suffer from a serious medical condition, we strongly suggest that you consult with a licensed health care professional before using this product. Proper fitting is required for this product to be effective. Under some circumstances, this product may be prescribed by a physician. Please see the limited
warranty for further information.
CARE INSTRUCTIONS
Hand washes only at 30° C; Wash with mild detergent; Air dry; Do not use bleach or other chemicals.
MATERIALS
Nylon, Polyester, HDPE, PVC, Polyurethane, UHMWPE.
NOT MADE WITH NATURAL RUBBER LATEX.
DISPOSAL
Product may be safely disposed of in accordance with local laws.
REPORTING
Please report any serious incident involving the use of this device to both the Competent Authority in your state and to the manufacturer (listed on this document).
LIMITED WARRANTY
Aspen Medical Products, LLC, Irvine, CA 92618, warrants to the user who originally purchases this product that it is free from defects in material and workmanship. The sole obligation of Aspen Medical Products, LLC in the event of a breach of warranty shall be to repair or replace the defective product or part(s).
Aspen Medical Products, LLC shall have no obligation under this limited warranty in the event:
(a) The product was not purchased from Aspen Medical Products, LLC or through its authorized channels of distribution;
(b) The product is altered;
(c) Any parts not supplied by Aspen Medical Products, LLC are inserted into the product; or
(d) The product is not used in accordance with the Aspen Medical Products, LLC Instructions for Use.
THE FOREGOING IS THE SOLE AND EXCLUSIVE REMEDY FOR FAILURE IN SERVICE OF, OR DEFECT IN, THE PRODUCT. ASPEN MEDICAL PRODUCTS, LLC SHALL NOT BE LIABLE UNDER THIS OR ANY IMPLIED WARRANTY FOR ANY DIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, AND ALL OBLIGATIONS OR LIABILITIES ON THE PART OF ASPEN MEDICAL PRODUCTS FOR DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE USE OF THE PRODUCTS, WHICH ARE HEREBY DISCLAIMED AND EXCLUDED BY ASPEN MEDICAL PRODUCTS, LLC.
This warranty gives you specific legal rights and you may have other rights which vary from location to location.
A listing of authorized distributors in your area is available upon request.
Aspen Medical Products, LLC
6481 Oak Canyon, Irvine, CA 92618-5202 USA
aspenmp.com
+1-800-295-2776
+1-949-681-0200
©2021 Aspen Medical Products, LLC. All Rights Reserved.
ST0060K revised 04/2021
Documents / Resources
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Aspen ASPEN SUMMIT 456 TLSO Thoracic Lumbar Sacral Orthosis [pdf] Instruction Manual ASPEN SUMMIT 456, TLSO Thoracic Lumbar Sacral Orthosis, ASPEN SUMMIT 456 TLSO Thoracic Lumbar Sacral Orthosis, Thoracic Lumbar Sacral Orthosis, Lumbar Sacral Orthosis, Sacral Orthosis |
