DJO ULTRASLING II AB - User Manual

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SPANISHENGLISH

ENGLISH ESPAÑOL

BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND

CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.

ANTES DE UTILIZAR ESTE DISPOSITIVO, LEA POR FAVOR ESTAS INSTRUCCIONES COMPLETA

Y DETENIDAMENTE. EL USO CORRECTO ES FUNDAMENTAL PARA EL FUNCIONAMIENTO

APROPIADO DE ESTE DISPOSITIVO.

NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN STATE-OF-THE-ART TECHNIQUES

TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND

COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE

OF THIS PRODUCT.

AVISO: SI BIEN SE HAN HECHO TODOS LOS ESFUERZOS POSIBLES CON LAS TÉCNICAS MÁS

MODERNAS PARA OBTENER LA COMPATIBILIDAD MÁXIMA DE LA FUNCIÓN, RESISTENCIA,

DURABILIDAD Y COMODIDAD, NO EXISTE GARANTÍA ALGUNA DE QUE SE EVITARÁN LESIONES

DURANTE EL EMPLEO DE ESTE PRODUCTO.

ULTRASLING™ II AB

ULTRASLING II AB

CABESTRILLO ULTRASLING II AB

ÉCHARPE ULTRASLING II AB

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

DJO, LLC

5919 Sea Otter Place,

Suite 200

Carlsbad, CA 92010

USA

CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A

LICENSED HEALTH CARE PROFESSIONAL.

PRECAUCIÓN: LA LEY FEDERAL (EE.UU.) RESTRIGE LA VENTA DE ESTE DISPOSITIVO POR PARTE DE

O A PEDIDO DE PROFESIONALES DE ATENCIÓN MÉDICA MATRICULADOS.

INTENDED USER PROFILE:

The user should be able to:

• Read and understand the directions, warnings and cautions.

INTENDED USE/INDICATIONS: Postoperative rotator cuff repairs, Postoperative

Bankart procedures, Capsular shifts, Glenohumeral, dislocation/subluxation, Soft

tissue strains/repairs

CONTRAINDICATIONS: None.

WARNINGS AND CAUTIONS: If you experience any pain, swelling, sensation changes,

or any unusual reactions while using this product, consult your medical professional

immediately. Never wear the support over an open wound.

APPLICATION INFORMATION:

1. Detach shoulder strap and open front panel. Position elbow in the sling as far back as

possible. Loop the sling strap through the D-ring and secure. (Fig. 1)

2. Secure strap at the top of the sling. If the thumb strap is desired, attach strap at the front of

the sling. (Fig. 1)

3. Place shoulder strap over the opposite shoulder. Connect shoulder strap to the sling using

the quick release buckle. (Fig. 2)

4. Place the large pillow under the affected area with the

45°

angle facing up. Attach the sling

to the pillow, align the hook and loop strips. Wrap waist strap around the waistline and

pillow and attach.

Note: Pillow may be turned upside down to create a 60° abduction angle.

CLEANING INSTRUCTIONS:

Hand wash in cold water using mild soap, rinse thoroughly. AIR DRY.

Note: If not rinsed thoroughly, residual soap may cause irritation and deteriorate material.

The waist and shoulder strap may be trimmed by removing the Y-tab ( Ultrasling II/III

only).

WARRANTY: DJO, LLC will repair or replace all or part of the unit and its accessories

for material or workmanship defects for a period of six months from the date of sale.

To the extent the terms of this warranty are inconsistent with local regulations, the

provisions of such local regulations will apply.

RX ONLY.

INTENDED FOR SINGLE PATIENT USE.

NOT MADE WITH NATURAL RUBBER LATEX.

PERFIL DEL USUARIO OBJETIVO:

El usuario debe ser capaz de realizar lo siguiente:

• Leer y comprender las instrucciones, advertencias y precauciones

USO INDICADO / INDICACIONES: Postoperatorio de reparaciones del rotador del

hombro, Postoperatorio de procedimientos de Bankart, Desplazamientos capsulares,

Luxación/subluxación glenohumeral, Distensiones/reparaciones de tejidos blandos

CONTRAINDICACIONES: Ninguna.

ADVERTENCIAS Y PRECAUCIONES: Si experimenta dolores, hinchazón, cambios de

sensibilidad o cualquier reacción fuera de lo común mientras utiliza este producto,

consulte de inmediato con un profesional médico. Nunca lleve la sujeción sobre una herida

abierta.

INSTRUCCIONES DE COLOCACIÓN:

Retire la correa del hombro y abra el panel frontal Coloque el codo en el cabestrillo lo más

atrás posible. Pase la correa del cabestrillo por el anillo en “D” y fíjelo. (Fig. 1)

2. Fije la correa en la parte superior del cabestrillo. Si se desea colocar la correa para el

pulgar, fije la correa en la parte delantera del cabestrillo. (Fig. 2) Fije la correa en la parte

superior del cabestrillo. Si se desea colocar la correa para el pulgar, fije la correa en la

parte delantera del cabestrillo. (Fig. 1)

3. Pase la correa del hombro sobre el hombro opuesto. Utilizando la hebilla de liberación

rápida, conecte la correa del hombro al cabestrillo. (Fig 2)

4. Coloque la almohadilla grande bajo la zona afectada con un ángulo de 45° mirando

hacia arriba. Fije el cabestrillo a la almohadilla, alineando las tiras de velcro. Pase la

correa de la cintura alrededor de la cintura y de la almohadilla y fíjela.

Nota: La almohadilla puede invertirse para crear un ángulo de abducción de 60°.

INSTRUCCIONES DE LIMPIEZA:

El lavado se realiza a mano con jabón suave en agua fría, enjuague exhaustivamente.

SECADO AL AIRE.

Nota: Si no se enjuaga exhaustivamente, los restos de jabón pueden provocar irritación y

deteriorar el material.

Las correas del hombro y de la cintura pueden recortarse retirando la orejeta en “Y” (sólo

con el cabestrillo Ultrasling II/III).

GARANTÍA: DJO, LLC se compromete a reparar o sustituir la totalidad o parte del

producto y sus accesorios, por defectos del material o de la fabricación, durante

los seis meses siguientes a la fecha de venta. Si los términos de esta garantía son

incompatibles con la normativa local, se aplicarán las disposiciones de la normativa

local.

SOLO CON RECETA MÉDICA.

INDICADO PARA SU USO EN UN SOLO PACIENTE.

NO CONTIENE LÁTEX DE CAUCHO NATURAL.

Need help?

Do you have a question about the DJO ULTRASLING II AB and is the answer not in the manual?

This document describes the DJO Ultrasling II/III, a medical device designed for post-operative support and immobilization of the shoulder and arm. It is intended for single-patient use and is not made with natural rubber latex.

Function Description

The Ultrasling II/III is a shoulder and arm support system primarily used for post-operative recovery and immobilization. It provides a stable and comfortable position for the arm, helping to protect the surgical site and facilitate healing. The device features a sling that cradles the elbow and forearm, a shoulder strap for support, and a large pillow that positions the arm at a specific abduction angle. The design aims to reduce stress on the shoulder joint and surrounding soft tissues, which is crucial for conditions like rotator cuff repairs, Bankart procedures, capsular shifts, glenohumeral dislocation/subluxation, and soft tissue strains/repairs. The device's modular design allows for adjustment of the abduction angle, offering flexibility based on the patient's specific recovery needs.

Important Technical Specifications

Intended Use/Indications: Postoperative rotator cuff repairs, Postoperative Bankart procedures, Capsular shifts, Glenohumeral dislocation/subluxation, Soft tissue strains/repairs.
Contraindications: None specified in the manual.
Material: Not made with natural rubber latex.
Abduction Angle: The large pillow can position the arm at a 45° abduction angle. The pillow can also be inverted to create a 60° abduction angle, offering versatility in post-operative positioning.
Fasteners: Utilizes hook and loop strips for secure attachment and a quick-release buckle for the shoulder strap.
Adjustability: Features trimmable waist and shoulder straps (Ultrasling II/III only) by removing a Y-tab, allowing for a customized fit.

Usage Features

The Ultrasling II/III is designed for ease of application and patient comfort, with several features that enhance its usability:

Step-by-step Application: The manual provides clear, illustrated instructions for application, ensuring correct placement.
1. Sling Placement: Detach the shoulder strap and open the front panel. The elbow is positioned as far back as possible in the sling, and the sling strap is looped through a D-ring and secured.
2. Thumb Strap (Optional): A thumb strap can be attached at the front of the sling if desired, providing additional support for the hand.
3. Shoulder Strap Connection: The shoulder strap is placed over the opposite shoulder and connected to the sling using a quick-release buckle. This ensures the weight of the arm is distributed comfortably across the back and shoulder.
4. Pillow Attachment and Waist Strap: The large pillow is placed under the affected area with the 45° angle facing up. The sling is then attached to the pillow using hook and loop strips. A waist strap wraps around the waistline and pillow, securing the entire assembly and preventing unwanted movement.
Adjustable Abduction: The ability to switch between 45° and 60° abduction angles by inverting the pillow is a key feature, allowing healthcare professionals to tailor the arm's position to the specific requirements of the patient's recovery protocol.
Customizable Fit: The waist and shoulder straps can be trimmed by removing a Y-tab, which helps achieve a more precise and comfortable fit for different body types, reducing bulk and improving patient compliance.
User Profile: Intended for users who can read and understand directions, warnings, and cautions, emphasizing the importance of patient education for safe and effective use.
Quick Release Buckle: The shoulder strap's quick-release buckle allows for easy donning and doffing, which is beneficial for patient comfort and for healthcare providers assisting with application or removal.
Secure Fastening: The use of hook and loop strips ensures that the sling and pillow remain securely attached, preventing slippage and maintaining the desired arm position.

Maintenance Features

Proper maintenance is essential for the longevity and hygiene of the Ultrasling II/III:

Cleaning Instructions: The device is designed for easy cleaning to maintain hygiene and prevent material deterioration.
- Hand Wash: It should be hand washed in cold water using mild soap.
- Rinsing: Thorough rinsing is crucial to remove all soap residue. The manual explicitly warns that if not rinsed thoroughly, residual soap may cause irritation and deteriorate the material.
- Air Dry: After rinsing, the device should be air-dried.
Durability: The materials and construction are designed for durability, ensuring the device can withstand repeated use and cleaning cycles throughout the patient's recovery period.
Warranty: DJO, LLC provides a six-month warranty from the date of sale, covering material or workmanship defects. This warranty underscores the manufacturer's confidence in the product's quality and provides assurance to the user. The warranty terms are subject to local regulations, ensuring compliance with regional consumer protection laws.

The Ultrasling II/III is a prescription-only device, highlighting its medical nature and the need for professional guidance in its application and use. Its design prioritizes both effective immobilization and patient comfort, making it a valuable tool in post-operative shoulder and arm care.