ASPEN 992510 Summit Lower Spine Braces Instruction Manual

June 4, 2024
ASPEN

ASPEN 992510 Summit Lower Spine Braces Instruction Manual
ASPEN 992510 Summit Lower Spine Braces

BELT SIZING

  • A. Fit male tabs of belt through proper sizing adjustment holes in sides of back panel.

  • B. For smaller sizes, slide side panel through sizing adjustment slot and then fit tabs through proper adjustment holes from the under side.
    BELT SIZING

  • C. Once proper size is achieved, pull taught to lock tabs in place.
    BELT SIZING

SIZING GUIDE

Size|

Circumference

X-SMALL

| 26 – 31 in| 66 – 78 cm
SMALL| 30 – 37 in|

76 – 94 cm

MEDIUM

| 36 – 43 in| 91 – 109 cm
LARGE| 42 – 49 in|

107 – 124 cm

X-LARGE

| 48 – 55 in| 122 – 140 cm
XX-LARGE| 54 – 60 in|

137 – 152 cm

PLACEMENT

  • A. Apply the fully stretched brace making sure the back panel is centered and low on the back.
    PLACEMENT

  • 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.
    PLACEMENT

TIGHTENING

  • A. Pull strongly away from body. Tighten more than you need and then loosen to achieve a proper fit. Pull left tab to tighten lower, pull right to tighten upper as needed.
    TIGHTENING

  • B. Mate the pull tabs to loop material to maintain compression.
    TIGHTENING

MODIFICATION OPTIONS

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

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 wash 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 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 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.

Symbols:

  • MEDICAL DEVICE

  • SINGLE PATIENT- MULTIPLE USE

  • CAUTION

  • EMERGO EUROPE
    Prinsessegracht 20 2514 The Hague The Netherlands.
    Symbols

Support

Pat. aspenmp.com/patents
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.
ST0087F revised 04/2021

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