Integra LifeSciences Corporation

Integra Surgical Instruments Instructions for Use

3 Pages

Integra surgical instruments are designed to perform a specific function, such as cutting, grasping, clamping, dissecting, probing, retracting, draining, aspirating, suturing, or ligating. For use by, or as directed by, a surgeon. Instruments should be used only for the purpose for which they are designed. The proper surgical technique for the use of instruments is the responsibility of the surgeon.  and sterilized as described below. Handle the instrument with care. The instrument must be inspected to assure proper functioning prior to each use with particular attention paid to the condition of all moving parts, tips, box locks, ratchets and cutting edges. Each instrument with a screw must be inspected before and after use to ensure that the screws do not move when operating the instrument. Screws can loosen and back out of an instrument as a result of normal operation and/ or the vibration during ultrasonic cleaning. Failure to make a complete inspection to assure the proper operation and function of the instrument may result in unsatisfactory performance, perhaps because a part is missing. Do not use if the instrument does not appear to be functioning properly. 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. In order to insure warranties and guarantees, instruments in need of repair should be sent to Integra.  CONTRAINDICATION  DECONTAMINATION AND STERILIZATION PROCEDURES  Instruments should not be used for anything other than their intended use.  As with any decontamination procedure, personnel should follow accepted guidelines for hand washing, the use of protective attire, etc. as recommended by A.A.M.I. Standards and Recommended Practice, “Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Non-Clinical Settings”, ANSI/AAMI ST35:2003.  ENGLISH INDICATIONS FOR USE ®  WARNING Consult individual national infection control/prevention protocols for specific guidance regarding processing medical devices with suspected exposure to Creutzfeldt-Jakob Disease (CJD).  CAUTION After cleaning, especially ultrasonic cleaning, check screws on instruments because the vibration from the ultrasonic cleaning may cause them to loosen or fall out. For electrosurgical instruments, use the least amount of power appropriate for the application. For electrosurgical cables, disconnect from the generator or instrument by grasping the connector only. Do not pull the cable by the cord. Do not use instrument or cable if insulation is not fully intact. Integra surgical instruments are supplied non-sterile and must be cleaned, lubricated and sterilized prior to use according to hospital protocol and the procedures outlined in this document. Failure to follow these procedures will invalidate the instrument’s warranty and can cause the instrument to fail. Inappropriate use of instruments will lead to damage that is usually not repairable; for example, a hemostat that is used to clamp tubing can become misaligned and quickly break.  INSPECTION OF ALL INSTRUMENTS All instruments are carefully inspected before shipment. Because damage may occur during transit, the instruments should be thoroughly inspected upon receipt. All instruments must be inspected prior to use. Handling and Operating Instruments: Instruments should be handled and operated by personnel completely familiar with their use, assembly and disassembly. Before a new instrument is used and prior to each surgical procedure, the instrument must be decontaminated, lubricated  Decontamination is a two step process: 1) Thorough cleaning and rinsing. 2) Sterilization or disinfection. A. MANUAL DECONTAMINATION PRECLEANING: Remove gross debris from surgical instruments with a lap sponge and sterile water routinely during the procedure to prevent drying on of blood and body fluids, etc. It is important to rinse instruments that have been exposed to blood and saline solution before these substances dry. Blood and body fluids as well as saline solutions are highly corrosive. In addition, blood can produce a stain that is difficult to remove. CLEANING: To prevent the formation of biofilm, cleaning should occur as soon as possible after instrumentation is used. Biofilm is an accumulation of a biomass of bacteria and extracellular material that tightly adheres itself to the surface of the instruments. It cannot be easily removed, and protects microorganisms from being easily removed by ordinary cleaning/decontamination methods used in hospitals. It is particularly problematic in lumened medical devices. Step 1. Maintain moisture: Immediately after the surgical procedure, place the instruments in an instrument tray/container and cover with a towel moistened with sterile distilled water. Foam, spray or gel products, specifically intended for use with surgical instruments, are available to keep the soil moist. Transport tray of soiled instruments in an impervious plastic bag or container with a tight lid to the decontamination environment (keep the outside of the containment clean). Step 2. Enzymatic Soak: Immerse fully opened and/or disassembled instruments in an enzymatic solution, specific for use with surgical  instruments. Prepare the solution and use per enzyme manufacturer’s recommendations, paying special attention to instructions for correct dilution, temperature and soak time. Flush air from lumens and fill them with enzymatic solution for full contact with this inner surface during the soak time. Step 3. Rinse: Remove from enzymatic soak after the time period recommended by the enzymatic manufacturer and rinse thoroughly with tap water. Flush lumens until rinse water runs clear. Step 4. Cleaning Instruments: Choose a cleaning solution appropriate for surgical instruments and follow the manufacturer’s instructions for use. The use of neutral pH detergents is vital to the maintenance of surgical instruments. Contact with acidic or alkaline solution will remove the instruments’ protective barrier of chromium oxide, often leading to corrosion, pitting, and breakage. You may find that depending on the type of soil, a detergent that is a little more or less acid or alkaline may be more appropriate. The ideal cleaning agent is nonabrasive, lowfoaming and free-rinsing. Using a small clean hand-held brush, remove soil from all surfaces of the instrument while fully immersed in the solution. During manual cleaning, never use steel wool, wire brushes, scalpel blades or highly abrasive detergent or cleansers to remove soil from surgical instruments. These will damage the instruments’ protective surface and lead to corrosion. Use a clean soft bristled brush to clean instruments with an accessible channel. Remove the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument must be thoroughly cleaned after each use. A build-up of soil, debris, lubricants, etc. in these areas, will make it difficult to use the instrument and eventually irreparably damage it. Vigorously flush channels with the cleaning solution. Deionized water is recommended and preferred because it is free of the many compounds which exist in ordinary tap water. These substances, alone, cause stains and when tap water is combined with some detergents it will form insoluble deposits on the instruments. Manual cleaning should remove all visible residue. It is essential to keep the box locks and hinges open during any manual or automated cleaning process. Step 5. Rinse: Thoroughly rinse instruments by immersing in tap water and wiping with a clean, soft cloth. Flush lumens until water runs clear. Step 6. Ultrasonic Cleaning and Rinsing: Follow the recommendations of the ultrasonic manufacturer regarding cycle times, detergents, proper placement of the instrument tray, and conditioning (“degassing”) of the cleaning solution, etc. Use an ultrasonic cleaner to remove soil from hard to reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc., after gross soil has been removed. Open or disassemble instruments as appropriate. Place instruments in a mesh bottom stainless steel instrument tray. Place the tray into the ultrasonic cleaner. Flush air out of lumens and fill them with the ultrasonic cleaning solution (under the solution level in the chamber) for effective removal of soil from that inner surface by the ultrasonic activity. Step 7. FINAL RINSE should be with “treated water”. Softened or deionized water should be used for the final rinse to better remove detergents etc. Softening water removes calcium and magnesium
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File Name: Integra LifeSciences Corporation - JL-00032 - Integra Surgical Instruments Instructions for Use - 2021-04 - Rev F.pdf

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