Manual Surgical Instruments Product Infomation and Instructions

English

English

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.

Storage

• Store instruments in a clean, dry, area.

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:

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

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

Limitations Point of Use

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.

Containment and Transportation Preparation for decontamination

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.

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Cleaning: Automated

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. After cleaning and sterilization, verify functionality prior to re-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. It is recommended that instruments are reprocessed as soon as is practical following use. 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. 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 Pre-wash 1

Recirculation Time 3 minutes

Enzyme Wash Wash 1

5 minutes

Rinse 1

3 minutes

5 minutes

Water Detergent type temperature cold tap N/A water hot tap water neutral pH enzymatic detergent 66°C set neutral pH detergent point 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.

Manual Surgical Instruments

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English Returns

Reprocessing Instructions for Reusable Instruments Cleaning: Manual

Disinfection Packaging

Sterilization (Temperatures are minimum required; times are minimum required)

Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5), enzymatic detergent and deionized water for a minimum of 2 minutes. For instruments with lumens, and instruments equipped with cleaning ports, inject cleaning solution through the instrument with an irrigation syringe and allow to soak for a minimum of 2 minutes. Use a soft instrument brush to scrub instruments while submerged in cleaning solution to remove organic matter. Rinse with deionized water, then clean ultrasonically in a lukewarm (less than 43°C), mild (pH 7.0 - 8.5), detergent and deionized water for 10 minutes. Rinse thoroughly with deionized water, utilizing a syringe to thoroughly rinse cleaning solution from lumens and cleaning ports. Clean in this manner until no visible soil remains on the instrument. Dry with compressed air, or wipe dry with a lint-free cloth. Examine instruments for any staining or deterioration; remove from use as appropriate. Note: When using an ultrasonic cleaner or a spray washing machine, follow the manufacturers recommendations, particularly with regard to articulated instruments and positioning of instruments. Following cleaning, lightly lubricate instruments with movable parts. Use a lubricant intended for sterilizable instruments such as a watersoluble instrument milk. Do not use silicone spray. Note: Do not cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilize, as damage to the instrument finish may occur. A standard, sterilization wrap may be used. In the US, an FDA cleared surgical wrap is required. In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays. Ensure that cutting edges are protected. Wrap trays using appropriate method. Check the cleanliness and operation of the instrument. Clean again if debris is present and remove from use any damaged instrument. Close instruments with catches and racks on the first notch. Arrange the instruments in sterilization containers with perforations on the top and bottom, and on supports such as those used in microsurgery. Follow the appropriate cycle listed in the table below. All steam cycles have been validated in the wrapped configuration and can be sterilized wrapped or unwrapped. These devices have only been validated for steam sterilization methods. Instruments Only

Instruments Only or Instruments in Instrument Trays Pre-vac Pre-vac Pre-vac (FR/WHO) (UK) 132°C 134°C 134°C

Cycle

Gravity

Gravity

Temperature

121°C

132°C

Time

30 10 4 18 3 minutes minutes minutes minutes minutes • Instruments Only and Aluminum/Stainless Steel Instruments 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.

Drying

Maintenance, Inspection Inspect components for any damage before and after each use. If and Testing damage is observed do not use the instrument until it is repaired. After cleaning and sterilization, verify functionality prior to re-use. Storage Store instruments in a clean, dry area. Additional Information Note: Additional cleaning methods may be warranted, including presoaking in 3% hydrogen peroxide.

Contact Integra LifeSciences Customer Service to obtain a Return Goods Authorization number (RGA#) prior to shipping the product back to Integra LifeSciences. The RGA# should be prominently displayed on the outside of the return packaging and included on all paperwork enclosed with the return. All product returned should be decontaminated and cleaned, and all products should be safely packed in protective wrapping. Please have the original invoice number or purchase order number available to assist in verifying warranty information.

Customer Service Information

For further information regarding the use of this product or to report any problems, please contact Integra LifeSciences at 1-800-654-2873 with each device; or contact your local distributor.

Limited Warranty

A. This LIMITED WARRANTY provides assurance for the customer who purchases an Integra Product (hereinafter the “Product”) that should the Product fail to function to Integra’s published specifications during the term of this LIMITED WARRANTY (one year from the date of shipment for new Product), Integra will either replace, repair, or issue a credit (adjusted to reflect the age of the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from Integra or from its affiliate or its authorized distributor or representative. B. To qualify for this LIMITED WARRANTY, the following conditions must be met: (1) The Product must be used on or before its “Use By” or “Use Before” date, if applicable. (2) The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. (3) Integra must be notified in writing within thirty (30) days following discovery of a defect. (4) The Product must be returned to Integra within thirty (30) days of Integra receiving notice as provided for in (3) above. (5) Upon examination of the Product by Integra, Integra shall have determined that: (i) the Product was not repaired or altered by anyone other than Integra or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product. C. This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Integra be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise. D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. The information contained in this document is accurate at time of publication. Integra LifeSciences reserves the right to make changes to the product described in this manual without notice and without incorporating those changes to products already sold.

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. They are NOT APPLICABLE to single use devices or single use accessories, which must be destroyed after use in accordance with applicable local regulations. It remains the responsibility of the processor to ensure that the reprocessing is performed using validated equipment to achieve the desired result. This normally requires validation and routine monitoring of the process. Some devices have specific assembly instructions. In this case, refer to the assembly insert provided with the device for additional instructions. All validations performed per current AAMI TIR12, “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.”

Troubleshooting And Repairs Integra LifeSciences disclaims all responsibility in cases of improper user handling, unauthorized repairs, or lack of maintenance by the user.

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