Covidien Shiley 4CN65A Instrucciones De Uso página 5

this device may result in product failure and increased risks to the patient.
• Sterile only if the protective tray and cover are not open, damaged, or broken. Do not resteril-
ize. Do not expose to temperatures above 120˚F (49˚C).
• 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.
• As a further precaution for ventilator-dependent patients, cuff inflation should be checked on
a regular basis, and replacement tracheostomy tubes should be kept at bedside.
• Syringes, three-way stopcocks, or other devices should not be left inserted in the inflation
valve for an extended period of time. The resulting stress could crack the valve housing and
allow the cuff to deflate.
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 time frame. 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.
• To ease insertion and to guard against cuff perforation from sharp edges of cartilage, taper back
the cuff by deflating the cuff and gently moving it away from the distal tip of the cannula toward
the neck plate as the residual air is removed by deflation. When tapering the cuff, do not use sharp
instruments that would damage the cuff, such as forceps or hemostats.
• Avoid pulling or manipulation of the inflation line, as it is designed to conduct and hold air as part
of the cuff inflation system.
• Prevent lint or other particulates from entering the luer valve of the pilot balloon.
• Extremes of movement may result in mucosal abrasion and transient disruption of cuff seal.
• The use of Lidocaine Topical Aerosol has been associated with the formation of pin holes in PVC
cuffs. Lidocaine hydrochloride solution has been reported not to have this effect.
• Do not use solutions or chemical agents other than those recommended in these instructions to
clean any part of the tracheostomy tube, 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 regula-
tions for biologically hazardous waste.
notes
• The tracheostomy tube and accessories are safe to use for X-ray, ultrasound, Positron Emission
Tomography (PET), and Radiation Therapy.
• 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.
• The tracheostomy tube and accessories are composed of medical grade plastics which do not
contain and have not been manufactured with natural rubber latex material.
• Sterilized with ethylene oxide.
contents of Package: 1 tracheostomy tube with cuff and pliable neck plate; 1 disposable inner can-
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