Medtronic COVIDIEN Shiley Mode D'emploi page 3

en
Identification of a substance that
is contained or present within the
product or packaging.
Identification of a substance that
is not contained or present within
the product or packaging.
This product cannot be adequately cleaned and/or sterilized by the user in order to
facilitate safe reuse, and is therefore intended for single use. Attempts to clean or
sterilize these devices may result in a bio-incompatibility, infection or product failure
risks to the patient.
This product contains DEHP. When used as indicated, very limited exposure to trace
amounts of DEHP may occur. There is no clear clinical evidence that this degree of
exposure increases clinical risk. However, in order to minimize risk of DEHP exposure in
children and nursing or pregnant women, this product should only be used as directed.
This instruction insert applies to the following Shiley™ Tracheostomy products:
LPC Tracheostomy Tube Cuffed with Inner Cannula
FEN Tracheostomy Tube Cuffed with Inner Cannula Fenestrated
CFS Tracheostomy Tube Cuffless with Inner Cannula
CFN Tracheostomy Tube Cuffless with Inner Cannula Fenestrated
LGT Laryngectomy Tube
Instructions for Use
WARNINGS:
CAREFULLY READ THESE INSTRUCTIONS PRIOR TO USE. THESE INSTRUCTIONS
ARE APPLICABLE ONLY TO THE SHILEY DOUBLE CANNULA TRACHEOSTOMY
TUBES (LPC, FEN, CFS, CFN) AND SHILEY LARYNGECTOMY TUBE (LGT) WITH
REUSEABLE INNER CANNULAE.
STERILE ONLY IF THE PROTECTIVE BAG IS NOT OPEN, DAMAGED OR BROKEN.
DO NOT RESTERILIZE. DO NOT EXPOSE TO TEMPERATURES ABOVE 120°F (49°C).
WHEN USING A LASER IN CONJUNCTION WITH THESE DEVICES, CARE MUST
BE TAKEN TO AVOID CONTACT OF THE LASER BEAM WITH THE TUBE. SUCH
CONTACT, ESPECIALLY IN THE PRESENCE OF OXYGEN-ENRICHED MIXTURES,
COULD RESULT IN RAPID COMBUSTION OF THE TUBE WITH HARMFUL THERMAL
EFFECTS AND WITH EMISSION OF CORROSIVE AND TOXIC COMBUSTION
PRODUCTS, INCLUDING HYDROCHLORIC ACID (HCl).
DURING AN MRI SCAN THE PILOT BALLOON SHOULD BE SECURED NEAR THE
Y CONNECTOR OF THE VENTILATOR CIRCUIT AT LEAST 3 CM FROM THE AREA
OF INTEREST TO PREVENT MOVEMENT AND IMAGE DISTORTION.
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