Integra Omni-Tract Instrucciones De Uso

Integra Omni-Tract
®
Table Mounted Retractor Systems
Instrument Cleaning, Sterilization and Care Instructions
Instructions for Use/English
Indications for Use
Integra Omni-Tract Table Mounted Retractors are intended to provide stable retraction during invasive surgery to enable temporary
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retraction and direct visualization of target tissues and organs.
Warning
DO NOT flash sterilize the Integra Omni-Tract Instruments. The instruments have not been validated for flash sterilization.
Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure.
Pre-Use, Handling, and Inspection of Instruments
• Read the Instructions for Use and keep them in a safe place.
• Use the product only in accordance with its intended use, see Indications.
• Use of an instrument for a task other than that for which it is intended could result in a damaged or broken instrument, or one which
provides an unsatisfactory performance.
• Instruments should be handled and operated by personnel completely familiar with their use, assembly, and disassembly.
• Instruments must be rendered safe for handling, inspection, and assembly while wearing appropriate personal protection
equipment (PPE) as promulgated by OSHA and AORN.
• Inappropriate use of instruments will lead to damage that is usually not repairable.
• Instruments must be thoroughly inspected upon receipt and prior to use to assure proper functioning. Failure to make a complete
inspection to assure proper operation and function of instrument may result in unsatisfactory performance.
• Integra Omni-Tract instruments are supplied non-sterile and must be pre-cleaned, cleaned, visually examined, lubricated, and
sterilized prior to use. Please see pre-cleaning, cleaning, visual examination, lubrication, and sterilization procedures below.
• Check screws on instruments after ultrasonic cleaning. Vibration from ultrasonic cleaning may cause them to loosen or fall out.
• Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components.
• Do not use the product if it is damaged or defective.
• Replace any damaged components immediately.
• Store products in a dry, clean and safe place.
Point of Use
Remove any excess body fluids and tissue with a, non-shedding wipe and cover with a damp cloth. Body fluids and tissue should not be
allowed to dry on the instruments prior to cleaning.
Containment/Transportation
Standard precautions for handling contaminated/biohazardous materials should be observed.
Pre-Cleaning, Cleaning and Sterilization Procedures
Pre-Cleaning should occur as soon as possible after instrumentation is used.
Holding/Presoak
Never hold instruments in a dry container. Doing so allows blood and debris to dry onto instrument surfaces and makes
cleaning more difficult.
If rinsing and decontamination processes are not immediately available, pre-treat instruments or hold them in a neutral pH holding/
presoak enzymatic solution (low foaming) such as Integra
Prepare solutions according to manufacturer's recommendations/instructions for correct dilution and temperature.
*Validated with Prolystica 2x Enzyme Cleaner
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Miltex Instrument Prep Enzyme Foam* or Integra Miltex EZ-Zyme®*.
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