Manual Surgical Instruments 手动外科手术器械 ... 3 Manual Surgical Instruments...

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  • Manual Surgical Instruments 手动外科手术器械 手動外科手術器械 Ručni instrumenti za kirurške zahvate Ruční chirurgické nástroje Manuelle kirurgiske instrumenter Handbediende chirurgische instrumenten Manuaaliset kirurgiset instrumentit Instruments chirurgicaux manuels Manuelle chirurgische Instrumente Strumenti chirurgici manuali 手動手術機器 Ręczne narzędzia chirurgiczne Instrumentos cirúrgicos manuais Instrumentos cirúrgicos manuais Ручные хирургические инструменты Instrumentos quirúrgicos manuales Manuella kirurgiska instrument

    Product Information and Instructions CN 产品信息和说明 TW 產品資訊及說明 HR Informacije o proizvodu i upute CS Informace o výrobku a pokyny DA Produktinformation og -vejledninger NL Productinformatie en instructies FI Tuotetta koskevat tiedot ja ohjeet FR Informations et instructions concernant le produit DE Produktinformation und Gebrauchsanweisung IT Informazioni sul prodotto e istruzioni per l’uso JA 製品情報および使用説明 PL Informacje o produkcie i instrukcje BR Informações e instruções do produto PT Informações e instruções acerca do produto RU Информация об изделии и инструкции ES Instrucciones e información sobre el producto SV Produktinformation och instruktioner

    Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 USA

    Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2020 Integra LifeSciences Corporation. All Rights Reserved. 68E3774 Rev KC 02/20 1490919-1

  • Manual Surgical Instruments Manual Surgical Instruments 21

    Federal (USA) law restricts this device to sale by or on the order of a physician or practitioner

    Intended Use Manual surgical instruments are intended for use in multiple surgical specialties to perform basic surgical tasks such as cutting, grasping, clamping, dissecting, probing, retracting, draining aspirating, suturing or ligating.

    Indications For Use The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures. They include instrument trays and suction devices designed to evacuate gas, fluid, tissue or other foreign materials. It is the responsibility of the surgical team to select the appropriate instrument for each case.

    Materials The instruments can consist of any of the following patient contacting materials: ceramic, titanium nitride, stainless steel, tungsten, thermoset polymers (including silicone), thermoplastic polymers, or chrome plated brass.

    Contraindications None known.

    Pre-use/Handling/Inspection • Most new instruments are provided with a protective lubrication film. Instruments must

    be cleaned and sterilized prior to first use. • Remove any tubing or other tip protection prior to cleaning and sterilization. • Clean new instruments separately to remove lubrication film. • Follow the information in the cleaning and sterilization sections. • Check the condition of instruments before and after each case. Remove from use any

    incomplete or poorly operating instruments . • Do not reuse or resterilize single use devices. • For instruments that incorporate fiberoptics, only an IEC 60601 compliant light source

    should be used. • Only sterilize clean instruments; sterilization is only effective on clean items. • Use only decontamination solutions, lubricants, and cleaning equipment approved

    for surgical instruments per the cleaning equipment, lubricant and decontaminant solution’s manufacturer. Comply with the cleaning equipment, lubricant and decontaminant solution manufacturer’s instructions for use, storage and maintenance.

    Warnings • Do not use these instruments for purposes other than those for which they are

    intended. • Do not allow conductive instruments to contact active cautery devices, or use in current

    paths, as patient or user burns may occur. • Do not bend, pry, or use excessive force; breakage or failure of the instrument could

    occur resulting in possible harm to the patient or user. • Use extreme care during handling and cleaning of delicate or sharp instruments as

    injury or damage could occur. • Use appropriate personal protection equipment when handling contaminated

    instruments. • For mouth gags, which include tooth liners, inspect the liners for signs of wear. If the

    condition of the liners is questionable, replace them before the next procedure. • As a preventative measure, we recommend that a spare clamp is available during

    surgery. • Keep instrument moist (for example, cover with a wet drape or saturate with tap water

    - do not use saline) after use and prior to decontamination, cleaning and sterilization to ensure adequate cleaning.

    • To ensure proper functioning of dismantable devices and devices with accessories, check the assembly and functionality of all elements of the device before use.

    • Do not Reuse Single use Devices. • Do no re-sterilize sterile packaged devices • Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure; these

    instruments have not been validated to withstand the chemical and thermal exposures recommended to eradicate prions.

    • DO NOT flash sterilize these instruments. These instruments have not been validated for flash sterilization.

    Precautions • Do not process instruments of different metals during sterilization, oxidation due to

    electrolytic effects may occur. • Do not use Glutaraldehyde, Chlorine, or Ammonium for soaking, this may cause damage

    to the instrument finish. • Do not use dry heat sterilization, as this may damage the instrument finish.

    Reprocessing Instructions for Reusable Instruments When applying dry times to Integra LifeSciences instrument trays and their accessories, dry times outside the standard healthcare prevacuum parameters may be required.

    Drying Time: Instruments Only and Aluminum/Stainless Steel Instrument Trays : 15 to 30 minutes and visual inspection for dryness. Polymer-based (plastic) Instrument Trays: Minimum drying time 40 minutes and visual inspection for dryness Reprocessing Instructions Cleaning and Sterilization instructions are subject to change.

    Warnings / Precautions To prevent stains, use distilled or demineralized water, and use a neutral detergent, to reprocess these instruments. Do not cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry sterilize, as damage to the instrument finish may occur.

    Limitations After cleaning and sterilization, verify functionality prior to re-use. Point of Use This product is provided non-sterile and must be cleaned and

    sterilized before the first use and any reuse. Rinse instrument immediately after use in distilled or demineralized water. Keep instrument moist (for example, cover with a wet drape or saturate with tap water - do not use saline) after use and prior to decontamination, cleaning and sterilization to ensure adequate cleaning. Instruments with cleaning ports and/or suction tubes shall be flushed with neutral pH enzymatic detergent, followed by a tap water rinse.

    Containment and Transportation

    It is recommended that instruments are reprocessed as soon as is practical following use.

    Preparation for decontamination

    Fully disassemble modular designed instruments for effective cleaning. Remove any cap covering the cleaning port, if applicable. For instruments with lumens, and instruments equipped with cleaning ports, inject cleaning solution through the instrument with an irrigation syringe. When cleaning suction tubes with holes to control suction, place gloved finger over the control hole to flush though the tube. Open any articulated instruments before positioning in the soaking solution. Place instruments so they do not touch each other. Note: Flushing in running water is essential between decontamination and cleaning to prevent any risk of reaction between the two solutions.

    Cleaning: Automated All instruments shall be thoroughly rinsed with tap water prior to placement in the automatic washer. Remove instruments and equipment from any sterilization trays before placing into washer baskets. Orient devices following recommendations of washer/disinfector manufacturers. Use alkaline or neutral pH detergent recommended by washer/ disinfector or detergent manufacturers. These products have been validated for effective cleaning using an automatic washer/disinfector cycle consisting of the following:

    Phase Recirculation Time

    Water temperature

    Detergent type

    Pre-wash 1 3 minutes cold tap water


    Enzyme Wash

    5 minutes hot tap water neutral pH enzymatic detergent

    Wash 1 5 minutes 66°C set point

    neutral pH detergent

    Rinse 1 3 minutes hot tap water N/A

    Thoroughly examine instruments for any residual soil. A rigid MIS (minimally invasive surgery) rack should be used to clean rigid MIS instruments and instruments with lumens to maximize efficiency of cleaning. Suction ports and flush ports should be connected to the MIS Rack to allow a constant flow of solution inside hard-to-reach areas of the instruments.

    English English

    Storage • Store instruments in a clean, dry, area.

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    Reprocessing Instructions for Reusable Instruments Cleaning: Manual Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5), enzymatic