Covidien Shiley Gebrauchsanweisung Seite 6

• Prior to use, handle with due care to prevent user contamination.
• The reusable inner cannula is designed for single patient use and should not be cleaned
for reuse on another patient.
• When using a reusable inner cannula, it can only be replaced by a Shiley reusable inner
cannula of the same size.
• It is recommended that a spare reusable 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 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.
• 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
regulations 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.
• 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.
Contents of Package: 1 tracheostomy tube with pliable neck plate; 2 reusable inner cannulae;
1 obturator; 1 neck strap. Reference page 2 for sizes and dimensions.
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 Trays. The items listed in the Cleaning section are sold separately.
Reference www.covidien.com.
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 center line).
Tube Preparation and Insertion Using the Obturator or a Percutaneous Loading Dilator
The tube sizes that have a compatible loading dilator available (reference page 2) can be used in
percutaneous dilatational tracheotomy (PDT) procedures.
NOTE: As this tracheostomy tube can be placed percutaneously, sterile technique should be
followed for the handling and placement of the tracheostomy tube.
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