DeRoyal MLP30-15 Maxalign LSO Spine Brace Instruction Manual
- June 12, 2024
- DeRoyal
Table of Contents
**Improving Care Improving Business
**
INSTRUCTIONS FOR USE
SIZING
NOTE: Brace sizing is determined by circumferential waist measurement
taken at the navel.
| Zone| Zone| Zone| Zone| Zone| Zone
---|---|---|---|---|---|---
| 1| | 2| | 3| | 4| | 5| | 6|
Measurement| 25″-| 34″| 30″-| 39″| 34″-| 43″| 40″-| 49″| 44″-| 53″| 50″-| 60″
NOTE: For best results and ease of adjustment, brace sizing should be conducted on a large bed or table.
BRACE SIZING ADJUSTMENT:
-
Pull out both Boa ® Fit System dials to release lacing and release the front hook and loopclosure to open the brace beltcompletely.
-
Place the back of the brace flawith the outside of the back panel facing upward. Ensure the left and right belt arms arespread outward evenly and arenon-impinged.
-
Unfasten the back-panel hookclosures and flip over the backpanel and belt arms to revealthe belt sizing adjustment mechanism.
-
Pull up on the two (2) belt security hook flaps located oneach side of the adjustment mechanism until they reach a45-degree angle upward fromthe belt.
-
Place one hand under the Belt
Pull Strap near the hand indicator and use the other hand to pull up on the Belt Pull Strap until the appropriate sizezone is reached on the left and right side of the belt. NOTE: Ensure that the sizing zones are even on both sides. Reapply the belt security hook flapsto secure the belt. -
Align the Belt Pull Strap with the middle of the belt adjustment mechanism panel, ensure excess belt length is even and press down firmly. Fold theback-panel and belt over and reattach the backflap hook closures at the top of the back panel.
BRACE APPLICATION:
- To apply the brace in the supine position, roll the patient on their side. Tuck the side closure behind the posterior panel and slide the closure and lateral panel under the patient’s lower back so the panels are accessible and can be retrieved on the opposite side.
- The inferior (lower) portion of the posterior panel should be positioned just above the patient’s coccyx.
- Roll the patient back into the supine position.
- Retrieve the brace belt and lateral panel from under the patient. Wrap the left side of the belt around the body and position just above the pubicbone. NOTE: Ensure both Boa ® Fit System dials are in the released (pulled-out) position and the lateral panels have not migrated below the belt.
- Close the belt by attaching the right side of the belt evenly over the left side of the belt. Ensure the oval shape of the right side of the belt is evenly aligned to the oval shape of the left side of the belt and the lateral panels.
- Tighten the brace belt by pushing in on the Boa ® Fit System dials on each side of the brace and turning evenly to apply compression. Each dial should be turned in the same direction (clockwise) and at the same time to achieve even compression. Tighten until desired compression is achieved. NOTE: Ensure the orthosis is in a midline position with the spine and that it has not migrated upwards or downwards.
PANEL MODIFICATION FOR BRACE CUSTOMIZATION
NOTE: See customization worksheet for further details and documentation
of brace customization for patient.
- The posterior panel of the brace can be modified using a regulated heat gun. Position the posterior panel in the appropriate lordotic curvature, apply heat, and allow to cool in that position. Modification is only recommended above the B and D ports as indicated on the inside of the posterior panel. The adhered hook may be removed during modification and reapplied once material has cooled. Let panel cool completely before applying brace to patient.
- The lateral panels on each side of the back panel can be trimmed or removed for a more customized and comfortable fit.
CARE INSTRUCTIONS
Remove panels from the brace and clean all soft goods by hand washing with mild soap and let air dry completely prior to reapplication. Anterior and posterior panels can be cleaned by wiping down witha disinfectant wipe.
STORAGE AND TRANSPORT CONDITIONS
| KEEP DRY
---|---
| KEEP AWAY FROM SUNLIGHT
In addition to the competent authority in the country where the patient resides, serious incidents must be reported to DeRoyal Industries, Inc.
WARRANTY
DEROYAL ® PRODUCTS ARE WARRANTED FOR NINETY (90) DAYS FROM THE DATE OF
SHIPMENT FROM DEROYAL AS TO PRODUCT QUALITY AND WORKMANSHIP. DEROYAL’S WRITTEN
WARRANTIES ARE GIVEN IN LIEU OF ANY
IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
MAXALIGN ® LSO SPINE BRACE
| SINGLE PATIENT USE
---|---
| NON-STERILE
| NOT MADE WITH NATURAL RUBBER LATEX
RX ONLY| FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR
ON THE ORDER OF A PHYSICIAN OR PROPERLY LICENSED PRACTITIONER.
IMPORTANT INFORMATION
**** Please read all instructions, warnings, and precautions before use. Correct application is essential for proper functioning of product.
INTENDED USE
The DeRoyal ® MAXAlign ® LSO Spine Brace powered by the Boa ® Fit System is intended to provide support and immobilization of the spinal column in the sagittal and coronal planes. The device is also intended to aid in relief and recovery following spinal surgery or an injury.
CAUTIONS
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A physician or properly licensed practitioner (a “prescriber”) who is familiar with the use and purpose of this brace must fit it to the user.
The prescriber has a duty to provide wearing instructions and risks related to the use of this brace to other healthcare practitioners treating the users and the users themselves, including duration of use. The instructions provided in this sheet do not supersede hospital protocol or direct orders of the prescriber. -
Inspect product for damage and/or missing components before use.
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Inspect the fit of the brace on the patient to ensure fit is proper. DO NOT OVERTIGHTEN.
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Prolonged usage can result in muscle atrophy in the user.
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Consult your prescriber immediately if you experience sensation changes, unusual reactions, swelling or increased pain while using this brace.
**** Manufactured by: DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 USA
888.938.7828 or (001) 865.938.7828
www.deroyal.com
Part#0-1992 Revised 9/2021
©2021 DeRoyal Industries, Inc.
All Rights Reserved. MAXAlign, DeRoyal, the DeRoyal
logo and Improving Care. Improving Business. are trademarks or registered
trademarks of DeRoyal
Industries, Inc.
Boa is a registered trademark of Boa Technologies Inc.