Indications for Use:
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
- When using a laser or electrosurgical device in conjunction with this or other tracheal tubes, care must be taken to avoid contact with the tube. Such contact, especially in the presence of oxygen-enriched mixtures or nitrous oxide containing 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).
- The tracheostomy tube, neck strap, and disposable inner cannula cannot be adequately resterilized by the user in order to facilitate safe reuse and are therefore intended for single patient use. Attempts to resterilize 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 resterilize. Do not store product at temperatures above 120˚F (49˚C). en ShileyTM Adult Flexible Tracheostomy Tube Cuffless Disposable Inner Cannula 4UN65A 6.5 mm 5UN70A 7.0 mm 6UN75A 7.5 mm 7UN80A 8.0 mm 8UN85A 8.5 mm 9UN90A 9.0 mm 10UN10A 10.0 mm 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. 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.
- 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.
- 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.