Covidien Shiley Instrucciones De Uso página 6

• Prior to use, handle with due care to prevent user contamination.
• The disposable inner cannula is designed for single use and should not be cleaned or reused.
• When using a disposable inner cannula, it can only be replaced by a Shiley disposable inner
cannula of the same size.
• It is recommended that a spare disposable inner cannula be with the patient at all times.
• When using a water-soluble lubricant, verify that the lubricant does not enter and occlude the
tube lumen, which may restrict ventilation.
• Patients in the home care environment should be carefully instructed by a home health care
provider in the proper use and handling of the tracheostomy tube and accessory products.
CAUTIONS
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• The tracheostomy tube and obturator are single patient use medical devices. Duration of single
patient use should not exceed twenty-nine (29) days. Covidien does not recommend and has not
substantiated use of these devices beyond the 29-day timeframe. Decisions about tracheostomy
tube changes should be made by the responsible physician or designate using accepted medical
techniques and judgment.
• Clinicians placing this device percutaneously should be competent in the procedure prior to using
this tube.
• Prior to use, check that the obturator can be inserted and removed without difficulty.
• To ease placement of the tracheostomy tube, generously lubricate the surface of the loading dilator.
• Do not use solutions or chemical agents other than sterile saline, hydrogen peroxide, or water and
mild detergent, as this may result in tube damage.
• Precautions should be taken when discarding the tracheostomy tube and accessories. Disposal
should be made in accordance with current institutional standards and applicable national
regulations for biologically hazardous waste.
• Duration of use should not exceed twenty-nine (29) days.
NOTES
• The tracheostomy tube and accessories are safe to use for X-ray, ultrasound, Positron Emission
Tomography (PET), and Radiation Therapy.
• The tracheostomy tube and accessories are composed of medical grade plastics which do not
contain and have not been made with natural rubber latex material or DEHP.
• Sterilized with ethylene oxide.
• The product can be thermally cleaned in water at a temperature of 65 degrees Celsius without the
addition of chemical additives.
Contents of Package: 1 tracheostomy tube with pliable neck plate; 1 disposable inner cannula;
1 obturator; 1 neck strap. Reference page 2 for sizes and dimensions.
Accessories Available from Covidien: CAP, Disposable Inner Cannula (reference 10006780 for
part numbers).
Accessories Available Separately: Some of the tube sizes (reference page 2) are compatible with
the Percutaneous Dilatational Loading Dilator from the Cook® Critical Care Ciaglia Percutaneous
Introducer Sets and Trays.
NOTE: The sizing dimensions listed on page 2 refer to the ID (the inside diameter of the tube or
inner cannula at its narrowest point), the OD (the outside diameter of the tube), and the length
(the distance from the neck plate to the distal tip on the tube's or inner cannula's centerline).
6