ManoScan Catheter Cleaning and High Level Disinfection Instructions

CATHETER CARE PRECAUTIONS: 1. Given Imaging DOES NOT perform disinfection of gastrointestinal probes prior to shipment. Proper disinfection of a probe is the responsibility of the clinician prior to conducting the procedure. The following recommendations are intended to aid in the cleaning or disinfection of a Given Imaging catheter without causing damage. 2. DO NOT ultrasonically clean or other agitation, autoclave, use ionizing radiation, or use products containing glycerin while washing, cleaning, or disinfecting. This can permanently damage probes. 3. DO NOT clean the probes with strongly-alkaline cleaning agents such as Parson’s soap or strongly-oxidizing agents such as peracetic acid or hydrogen peroxide. Disinfectants such as Endo-Spor, Sporox and the Steris Washer use hydrogen peroxide as a primary agent in their formulation and will damage the probe. 4. DO NOT use synthetic detergents or petroleum-based soaps as these may be absorbed by the silicone and subsequently leach out during prolonged use. 5. DO NOT use silicone fluid or grease to lubricate the passage of the probe through the nares (nostril) or anus as these materials may swell and weaken the tubing and consequently compromise the integrity of the outer section of the probe. Water-based lubricants are acceptable for use. 6. DO NOT immerse the probe beyond the “Do Not Immerse” demarcation line near the proximal end of the probe (the end with the electrical connectors and vent orifice). This can permanently damage probes. 7. DO NOT pull on the outer sleeve of the catheter probe while cleaning. This can cause bunching of the outer sleeve and potentially damage the probe. 8. DO inspect for tears or damage in the exterior of the catheter. The inspection should be done before immersion of the catheter in reprocessing solutions to minimize further damage of the catheter to parts not designed for fluid exposure. 9. DO reference the ManoScan User Manual for additional information for catheter care precautions. 10.DO reference the ManoShield® Instructions for Use. 11. The ruled tubing and “Y” connector section of the probe may be cleaned with an antiseptic towelette or germicidal disposable Cloth. Adhere to the manufacturer’s guidelines when using antiseptic or germicidal towelette or cloth. Given Imaging recommends the following cleaning cloths and/or towelettes: Benzalkonium antiseptic (BZK) towelettes PDI, Sani-Cloth® Plus, germicidal disposable cloth PDI, Super Sani-Cloth® Plus, germicidal Wipes Accel PREVention™ surface disinfectant (applied to sterile wipe, cloth, or gauze) CLEANING VALIDATION REFERENCES: AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. AAMI TIR30:2003 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. ISO 10993-17:2002 – Biological evaluation of medical devices – Part 17: Method for the establishment of allowable limits for leachable substances. ISO 13485:2003 – Medical devices – Quality management systems – Requirements for regulatory purposes. ISO14971:2007 – Medical devices – Application of risk management to medical devices. ISO 17664:2004 – Sterilization of medical devices – information to be provided by the manufacturer for the processing of resterilizable medical devices. United States Pharmacopeia (USP), current edition.

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