INVOTEC SOFT-FORM AL Guia De Inicio Rapido

FÉRULA NASAL EXTERNA DE ALUMINIO
Por Favor Leer Atentamente:
NOTA: EL PROFESIONAL MÉDICO ES RESPONSABLE DE LAS ADECUADAS
TÉCNICAS Y PROCEDIMIENTOS QUIRÚRGICOS. LAS SIGUIENTES
INSTRUCCIONES SÓLO SON DE INFORMACIÓN. EL CIRUJANO, DEBERÁ
EVALUAR LA APROBACIÓN DEL PROCEDIMIENTO BASANDOSE EN SU
PROPIA FORMACIÓN Y EXPERIENCIA PROFESIONAL.
Instrucciones para su Aplicación
Paso 1: IMPORTANTE - Limpiar y secar la piel de la nariz y el área
de aplicación.
Paso 2: Enjuagar el área limpiada con alcohol y secar completamente.
Paso 3: Rápido edema del área de aplicación.
Paso 4: Preparar la piel del área de aplicación y - MUY
IMPORTANTE - SECAR COMPLETAMENTE.
Paso 5: Aplicar un ancho de 1/2 pulgada de esparadrapo en la piel
empezando desde la parte inferior de la nariz y colocando las
tiras cuidadosamente hasta que quede cubierta toda el área
de aplicación. (Ver Figura 1)
Paso 6: Despegue la tira adhesiva por ambos lados del Dorsum Pad y
aplicar sobre las tiras desde la base hacia la zona superior del
área. El adhensivo del Pad Dorsum no debe tomar contacto
con la piel. (Ver Figura 2)
Paso 7: Moldee la férula de aluminio al área de aplicación. La férula
debe quedar en perfecto estado ajustado.
Paso 8: Despegue el papel de la cinta adhensiva e hipoalérgica de las
alas de la férula y aplique el lado de espuma sobre la cinta
adhensiva de ambos lados. Moldee la férula de modo que la
forma y la presión sean las adecuandas. (Ver Figura 3)
Paso 9: La férula debe retirarse pasados siete y ocho dias.
* Incluido en un solo kit completo.
Instrucciones de Extracción
Paso 1: Retirar la férula cortando sus alas con tijera y levantar suavemente
Paso 2: Volver a tapar la nariz durante 3 o 4 dias mas, si el médico lo estima oportuno.
Garantia
Invotec Internacional, Inc. garantiza que sus productos están libres de defectos tanto
en el material como en la elaboración del mismo. Invotec remplazará o reembolsará
cualquier producto siempre y cuando se devuelva bajo las condiciones de "Material
Devuelto" indicadas en las intrucciones del apartado de politica de venta. Invotec
no se hará responsable de este producto por el resultado de una pérdida, del daño
o deteriodo producido directa o indirectamente del uso del producto o por la
incapacidad derivada de uso, LA PRESENTE GARANTIA EXCLUYE CUALQUIER
OTRO TIPO DE GARANTIA, EXPRESADA, TÁCITA O SURGIDA DE MODO
ALGUNO, YA SEA COMERCIAL, POR CONVENIENCIA DE UN OBJETIVO
PARTICULAR, POR INFRACCIÓN O DE CUALQUIER OTRA MANERA,
Invotec Internacional, Inc. no asume ni autoriza a ninguna persona que asuma
cualquier otro riesgo adicional o responsabilidad con respecto a este producto.
Soft-Form™ y Custom Cut son marcas registradas por Invotec Internacional, Inc.
INVOTEC INTERNATIONAL, INC.
6833 Phillips Industrial Blvd. • Jacksonville, Florida 32256 U.S.A.
Tel: 800-998-8580 / 904-880-1229 • Fax: 904-886-9517 • www.invotec.net
MDSS GmbH
Schiffgraben 4130175 • Hannover, Germany
SOFT-FORM AL™
Symbols and definitions:
Figura #1
Figura #2
Figura #3
6833 Phillips Industrial Blvd. • Jacksonville, Florida 32256 U.S.A.
Tel: 800-998-8580 / 904-880-1229 • Fax: 904-886-9517 • www.invotec.net
Manufacturer: Indicates the medical device manufacturer,
as defined in EU directives 90/385/EEC, 93/42/EEC, and
98/79/EC.
Authorized representatives in the European Community.
This symbol shall be accompanied by the name and
address of the authorized representative in the European
Community, adjacent to the symbol.
Use by date: Indicates the date after which the medical device
is not to be used.
Batch code: Indicates the manufacturer's batch code so that
the batch or lot can be identified.
Catalog Number: Indicates the manufacturer's catalog
number so that the medical device can be identified.
Do not use if package is damaged: Indicates a medical device
that should not be used if the package has been damaged
or opened.
Do not re-use: Indicatees a medical device that is intended
for one use, or for use on a single patient during a single
procedure.
Consult instructions for use: Indicates the need for the user
to consult instructions for use.
Caution: Indicates the need for the user to consult the
instructions for use for important cautionary information
such as warnings and precautions that cannot, for a variety
of reasons, be presented on the medical device itself.
REV 112618
INVOTEC INTERNATIONAL, INC.
MDSS GmbH
Schiffgraben 4130175 • Hannover, Germany
EXTERNAL ALUMINUM NASAL SPLINT
Please Read Carefully:
NOTE: THE MEDICAL PROFESSIONAL IS RESPONSIBLE FOR PROPER
SURGICAL PROCEDURES AND TECHNIQUES.
INSTRUCTIONS ARE FOR INFORMATION ONLY. THE ATTENDING
SURGEON MUST EVALUATE THE APPROPRIATENESS OF THE PROCEDURE
BASED ON HIS/HER OWN MEDICAL TRAINING AND EXPERIENCE.
This product is intended for single use only. Reuse of this device may expose the patient to
infection or contamination risks.
Application Instructions
Step 1: IMPORTANT! Cleanse and dry skin on nose and application
area.
Step 2: Wipe cleansed area with Isopropyl Alcohol Wipe* and dry
throughtly.
Step 3: Express edema from application area.
Step 4: Apply skin preparation* to application area and DRY
THROUGHLY (Extremely IMPORTANT!)
Step 5: Apply 1/2 inch wide skin closure tape* starting at the bottom
of the nose being careful to overlap each strip to be assured
that all the skin in the application area is covered. (See Figure
#1)
Step 6: Remove release paper from Dorsum Pad and apply over skin
closure tape from Radix to Supratip area if desired. Dorsum
Pad adhesive should not contact skin. (See Figure #2)
Step 7: Shape the Soft-Form AL splint to fit the application area.
Step 8: Remove the release paper from the hypoallergenic adhesive
on the back of the splint wings and apply foam side to nose
over the Dorsum Pad and skin closure tape. Mold the Soft-
Form Aluminum Splint to achieve proper fit and pressure. (See Figure #3)
Step 9: Splint should be removed in seven to eight days.
*Included in the complete kit only.
Removal Instructions
Step 1: Remove by cutting wings off with scissors, and gently lifting.
Step 2: Retaping for three or four days is optional by the physician
Disposal
When disposing the product, take all steps necessary to avoid risk of injury and infection.
Contaminated products must be disposed of as hazardous waste and handled so as to avoid
contamination of third parties.
Reporting
Any serious incident that has occured in relation tot he device should be reported to Invotec In
ternational, Inc, MDSS GmbH, and thew competent authority of the Member State in which the
user and/or patient is established.
Warranty
Invotec International, Inc. warrants that the product is free from defects in material
and workmanship. Invotec will replace or provide a refund for any product found
to be defective so long as the product is returned according to the Returned Goods
instructions in the Sales Policy. Invotec shall not be liable for any consequential loss,
damage or expense directly or indirectly arising from the use of, or inability to use,
this product. THE FOREGOING WARRANTY IS IN LIEU OF AND EXCLUDES
ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, HOWEVER ARISING,
INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
AGAINST INFRINGEMENT OR OTHERWISE. Invotec International neither
assumes, nor authorizes any person to assume for it, any other additional liability or
responsibility with respect to this product.
Soft-Form AL™ is a trademark of Invotec International, Inc.
INVOTEC INTERNATIONAL, INC.
6833 Phillips Industrial Blvd. • Jacksonville, Florida 32256 U.S.A.
Tel: 800-998-8580 / 904-880-1229 • Fax: 904-886-9517 • www.invotec.net
MDSS GmbH
Schiffgraben 4130175 • Hannover, Germany
SOFT-FORM AL™
THE FOLLOWING
Figure #1
Figure #2
Figure #3