ASPEN 9923X0 Summit 637 Back Brace Instruction Manual

ASPEN 9923X0 Summit 637 Back Brace

installation instructions

PREPARATION

Place the pull tabs 2 inches from the plastic in the back of the Summit. Pull the ends of the Summit away from each other ensuring that it is fully extended.

PLACEMENT

• A. Center over your lower back and apply the brace tightly around the abdomen, the right side overlapping the left.
  B. When applied properly, the Summit Logo will be visible. (The rigid anterior panels do not need to align perfectly in front of the brace.)

ANGLING ENDS

• A. For patients with a larger hip-to-waist ratio, the ends of the Summit should meet at a downward angle to fit properly and limit migration.
• B. For patients with pendulous abdomens, the ends of the Summit should meet at an upward angle to fit properly and limit migration.

TIGHTENING

• A. Slip your thumbs through the holes in the pull tabs. Pull away from your body.
• B. The right pull tab controls the upper compression and the left pull tab controls the lower compression. Adjust the compression as needed.
• C. When tightened, secure the pull tabs to the hook-and-loop in front of the brace.

ADJUSTMENT

Adjust the upper and/or lower compression by loosening or tightening the pull tabs as needed.

MODIFICATION OPTIONS

This product may be substantially modified by an individual with expertise. For more information, please visit www.aspenmp.com/education/product- modifications.

INTENDED USE

To provide motion restriction and stability of the lumbar-sacral spine.
INDICATIONS
Postoperative support, Deconditioned trunk musculature, Post laminectomy syndrome, Surgical Decompression procedures, Non-surgical Decompression procedures, Degenerative disc disease, Bulging or herniated disc, Non-specific low back pain, Chronic low back pain, Fracture management, Spondylolysis, Spondylolisthesis, Spinal stenosis , Ligament sprains / Muscle strains, Spondylosis (Osteoarthritis/Degenerative Joint Disease), Facet syndrome, SI dysfunction, Sacroiliitis, Radiculopathy, Injections, Radiofrequency Ablation, Lumbar Multifidus Muscle Atrophy

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.

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