DeRoyal 8004-01 - User Manual

IMPORTANT INFORMATION
Please read all warnings and instructions
before use. Correct application is essential for
proper product function and to reduce the risk of
injury or re-injury inherent with the use of any brace.
INTENDED USE
The DeRoyal
®
Arm Sling is used for cast support,
injuries to the arm, wrist or hand, acromioclaviclular
sprains, and anterior glenohumeral dislocations.
CAUTIONS
• 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. Use only as directed.
• Prolonged usage can result in muscle atrophy
in the user. The user may require (1) a weaning
period from the brace to build muscle strength
(2) regular physical therapy exercises to maintain
the strength of the shoulder (3) a limitation on
duration of use or (4) some combination of these.
• Inspect brace for damaged or missing
components before use.
• Discontinue use and consult your prescriber if
the brace or its components break or become
damaged.
• Inspect the fit of the brace on the patient to
ensure fit is proper. DO NOT OVERTIGHTEN.
Check regularly to ensure circulation is not
compromised.
• Consult your prescriber immediately if you
experience sensation changes, unusual reactions,
swelling or increased pain while using this brace.
Discontinue use if pressure injuries develop.
• Wear clothing underneath this brace.
• Take special care if the user is diabetic or
has poor circulation. These users may have
decreased skin sensitivity and are at greater
risk for poor peripheral circulation and pressure
injuries.
INSTRUCTIONS FOR USE
1. Attach shoulder pad by
inserting strap through
openings (if applicable). Slide
strap to desired position so
that the foam sits comfortably
on the patient’s shoulder.
2. Place affected arm in sling so
that the arm rests in the fold
of the sling against. Patients
elbow should be pressed back
snuggling fitting in the sling.
3. Place thumb in thumb loop
to prevent wrist drop (if
applicable).
4. a.) Bring strap behind patient
neck and over opposite
shoulder. If hook and loop
closure - bring strap through
the O-ring(s), adjust to proper
height and secure b.) If buckle
closure, bring strap through
buckle and pull the strap to
adjust to proper height.
5. When applicable, use sliding
buckle in back to adjust for
proper fit.
6. Make sure sling supports arm
securely.
NOTE: If the arm sling is fit
properly, the pouch should extend
to the first joint on the little finger
(the P.I.P. Joint). The arm sling should also be slightly
elevated to help prevent edema.
CARE INSTRUCTIONS (IF APPLICABLE)
Hand wash in lukewarm water with a mild detergent.
Air dry completely prior to wearing.
STORAGE AND TRANSPORT CONDITIONS
KEEP DRY
KEEP AWAY FROM SUNLIGHT
ARM SLING
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.
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Summary

Important Information and Usage

Intended Use of Arm Sling

Defines the product's application for cast support and injuries to the arm, wrist, or hand.

Cautions and User Precautions

Lists critical precautions, risks, and advice for proper usage, including prolonged use and patient conditions.

Arm Sling Application Instructions

Sling Fitting and Adjustment Steps

Step-by-step guide for fitting the arm sling, including shoulder pad, arm placement, and strap adjustment.

Proper Sling Fit and Edema Prevention

Details on correct pouch extension and elevating the arm to help prevent edema.

Product Care and Handling

Sling Cleaning and Drying Procedures

Guidance on washing the sling with mild detergent and air drying it completely.

Storage and Transport Conditions

Specifies keeping the sling dry and away from direct sunlight during storage.

Product Warranty and Manufacturer

DeRoyal Product Warranty Terms

Details the ninety (90) day warranty on product quality and workmanship.

Manufacturer and Contact Information

Provides manufacturer details, address, phone number, and website for DeRoyal Industries.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features
5. Important Considerations and Warnings

This document describes the DeRoyal Arm Sling, a single-patient use, non-sterile device not made with natural rubber latex, intended for sale or use by or on the order of a physician or properly licensed practitioner.

Function Description:

The DeRoyal Arm Sling is designed to provide support for various upper extremity conditions. Its primary function is to immobilize and support the arm, wrist, and hand, facilitating healing and reducing discomfort. Specific indications for use include cast support, injuries to the arm, wrist, or hand, acromioclavicular sprains, and anterior glenohumeral dislocations. The sling helps to maintain the arm in a stable, elevated position, which can aid in reducing swelling and preventing further injury. The design incorporates features to prevent wrist drop and ensure a secure fit, contributing to effective patient recovery and comfort.

Important Technical Specifications:

• Material: Non-sterile, not made with natural rubber latex. This specification is crucial for patients with latex allergies, ensuring the device is safe for a broader population.
• Usage: Single patient use. This indicates that the device is intended for one individual patient and should not be reused by others, which helps maintain hygiene and product integrity.
• Regulatory Status: RX ONLY, meaning it is restricted by federal U.S.A. law to sale or use by or on the order of a physician or properly licensed practitioner. This highlights the medical nature of the device and the need for professional oversight in its application.
• Fit: The pouch should extend to the first joint on the little finger (the P.I.P. Joint) when properly fitted. This precise measurement guideline ensures optimal support and function, preventing the arm from slipping or being improperly positioned.
• Elevation: The arm sling should be slightly elevated to help prevent edema. This design consideration is important for managing swelling, a common issue with arm injuries.

Usage Features:

The DeRoyal Arm Sling is designed with several features to ensure ease of application, comfort, and effective support:

• Shoulder Pad: The sling includes a shoulder pad that can be attached by inserting the strap through openings. This pad is designed to sit comfortably on the patient's shoulder, distributing pressure and preventing discomfort from the strap.
• Arm Placement: The affected arm is placed in the sling so that it rests in the fold of the sling, with the patient's elbow pressed back snugly into the sling. This ensures proper positioning and support for the entire arm.
• Thumb Loop: A thumb loop is incorporated to prevent wrist drop, a common complication in arm injuries where the wrist may sag due to lack of support. This feature helps maintain the wrist in a neutral or slightly extended position.
• Adjustable Straps: The sling features adjustable straps with different closure mechanisms depending on the model:
  • Hook and Loop Closure: For models with hook and loop, the strap is brought behind the patient's neck and over the opposite shoulder, then threaded through O-ring(s) to adjust to the proper height and secure. This allows for precise and customizable fit.
  • Buckle Closure: For models with buckle closure, the strap is threaded through the buckle and pulled to adjust to the proper height. This provides a secure and stable adjustment.
  • Sliding Buckle: When applicable, a sliding buckle in the back can be used for further adjustment, ensuring a snug and comfortable fit across the back and shoulder.
• Secure Support: The instructions emphasize ensuring the sling supports the arm securely. This is critical for effective immobilization and patient safety.
• Proper Fit Guidance: The document provides a clear guideline for proper fit, stating that the pouch should extend to the first joint on the little finger (P.I.P. Joint). This detail helps practitioners and users confirm correct application.
• Edema Prevention: The sling is designed to be slightly elevated, which is a key feature for helping to prevent or manage edema (swelling) in the injured limb.

Maintenance Features:

Proper maintenance is essential for the longevity and hygiene of the DeRoyal Arm Sling:

• Washing Instructions: The sling can be hand washed in lukewarm water with a mild detergent. This gentle cleaning method helps preserve the material and structural integrity of the device.
• Drying Instructions: After washing, the sling should be air dried completely prior to wearing. Air drying prevents damage that could be caused by heat and ensures the material is fully dry, reducing the risk of skin irritation or bacterial growth.
• Storage Conditions:
  • KEEP DRY: The sling should be stored in a dry environment to prevent material degradation, mold growth, or other damage from moisture.
  • KEEP AWAY FROM SUNLIGHT: Storage away from direct sunlight helps prevent UV damage to the materials, which can cause fading, weakening, or brittleness over time.

Important Considerations and Warnings:

• Professional Fitting: The brace must be fitted by a physician or properly licensed practitioner ("prescriber") who is familiar with its use and purpose. The prescriber is responsible for providing wearing instructions and informing users of risks.
• Inspection: Users should inspect the brace for damaged or missing components before use and discontinue use if components break or become damaged. Regular inspection of the fit is also necessary to ensure it is proper and not overtightened, checking regularly to ensure circulation is not compromised.
• Patient Monitoring: Users should consult their prescriber immediately if they experience sensation changes, unusual reactions, swelling, or increased pain. Discontinue use if pressure injuries develop.
• Skin Protection: Wearing clothing underneath the brace is recommended. Special care is advised for diabetic users or those with poor circulation, as they may have decreased skin sensitivity and are at greater risk for pressure injuries.
• Prolonged Usage: Prolonged usage can lead to muscle atrophy. Users may require a weaning period, regular physical therapy, or limitations on duration of use to maintain shoulder strength.

This comprehensive description covers the essential aspects of the DeRoyal Arm Sling, providing a clear understanding of its function, technical specifications, usage, and maintenance requirements.

DeRoyal 8004-01 Specifications

General

Brand	DeRoyal
Model	8004-01
Category	Sling
Language	English