INSTRUCTIONS FOR USE 

This device is part of a group of manually operated minimally invasive surgical instruments to include Clamps, Curettes, Dilators, Elevators, Forceps, Knot Tiers, Needle Holders, Hooks, Knot Pushers, Knives, Osteotomes, Pliers, Rasps, Retractors, Saws, Scissors, Speculums, Suction Tips, Wire Benders and Twisters. These reusable devices are packaged non-sterile and are steam sterilizable. 

 

INDICATIONS 

Elixir Surgical are manually operated instruments designed to perform specific functions such as aspirating, clamping, cutting, dilating, dissecting, draining, grasping, ligating, probing, retracting or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy. 

CONTRAINDICATION These instruments should not be used for anything other than their intended use.

 

CAUTION: Normal repeated use has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. 

CAUTION: Use of this instrument for any purpose, or in any manner other than those described here may cause instrument damage or failure which could result in serious patient injury or death. If needed, all metal products or fragments thereof can be located by means of an X-Ray. 

CAUTION: The World Health Organization recommends the longest exposure times when there is concern regarding HIV, TSE, CJD, etc. contamination. It is the user’s responsibility to determine what contamination exists and what procedure is appropriate to ensure proper sterilization.

 

Every surgical instrument must be properly inspected, cleaned, lubricated and sterilized before the initial use and all subsequent uses. Carefully examine each surgical instrument for proper function and damage of any sort prior to and after each use. It is extremely important to check all working parts including blades, locks, points, stops, ratchets, screws, etc. Instruments that show any sign of damage or corrosion should be repaired or replaced prior to further use. 

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Instruments may only be used for their intended purpose in their respective surgical specialties by properly trained and qualified personnel. The surgeon (qualified user) shall be responsible for the proper instrument selection for each application, for obtaining the appropriate training for use, for insuring the proper care and sterilization, and for their operative use. 

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Elixir Surgical, Inc. does not have any control over the ultimate use of the surgical instruments and therefore,

 cannot accept any responsibility or liability for any damages caused by inappropriate application and use or by inappropriate sterilization and maintenance of the instruments. 

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Cleaning and Sterilizing Guidelines: Elixir Surgical, Inc. has no control over the conditions or contaminants the user will subject the instruments to, therefore, it is the ultimate responsibility of the user to determine what cleaning and sterilizing methods and additional steps might be needed to properly remove all known and unknown organisms or contaminants. In all circumstances the user should closely follow the recommendations provided by the manufacturers of the cleaning/ sterilizing products and equipment used.

The following are the essential steps that Elixir Surgical recommends.

First and Foremost – Never allow organic materials or other contaminants to dry or get encrusted on the instrument.

 

Important – Always process dissimilar metals separately including different grades of the same metals. Do not allow instruments to stand while touching each other. 

Always – Wear appropriate safety protection and observe applicable safety procedures when handling, cleaning, and sterilizing surgical instruments. 

 

Pre-cleaning/Holding –Thoroughly rinse instruments with warm distilled water immediately after use. If not possible to start cleaning process immediately after use, apply a neutral pH enzymatic solution for holding following the manufacturer’s instructions, and then rinse thoroughly before continuing disinfecting and cleaning. 

 

Disinfecting – Immerse instruments in a suitable disinfectant approved for use on surgical instruments following the manufacturer’s instructions. Rinse instruments thoroughly after disinfecting. 

 

Cleaning – Instruments must be thoroughly cleaned before sterilization and have all organic materials, stains, rust, corrosion, and other contaminants completely removed. Regardless of the cleaning method used, stubborn particles will need to be removed manually by soaking in a suitable enzymatic cleaner following the manufacturer’s instructions and then brushing. All instruments should be cleaned in the open and/or disassembled position. Most rust, pitting, stains, and corrosion can be removed using a suitable surgical instrument rust and stain remover following the manufacturer’s instructions. Black coated and color anodized components may be negatively affected if aggressive cleaning mediums or appliances (e.g. extreme acidic/alkaline, abrasives) are used. A pH neutral cleaner, which may or may not contain enzymes. Exposure to chlorides or hydrogen peroxide may negatively affect the coating or colorization of components. Ultrasonic or automatic washer using suitable instrument cleaners and following the manufacturer's instructions is preferred over manual cleaning alone. In all instances care should be taken to always use clean, fresh solutions and finish by thoroughly rinsing the instruments. Instruments should be completely dry before storage.

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Manual Cleaning Instructions:

• Rinse and/or flush under warm flowing distilled water to remove visible debris for a minimum of 30 seconds.

• Ultrasonically clean using a detergent solution prepared according to the manufacturer's instructions for a minimum of 10 minutes.

• Completely immerse the instruments in a detergent solution prepared according to the manufacturer's instructions.

• Scrub all instruments with an appropriately sized soft nylon bristle brush for a minimum of one minute, paying particular attention to crevices and hard to clean areas.

• Scrub cannulated instruments with an appropriately sized soft nylon bristle brush for a minimum of 30 seconds.

• Flush cannulated instruments at least three times with a syringe (50 ml.).

• Rinse with flowing purified (deionized) water for a minimum of 30 seconds.

• Dry the instruments using absorbent, low-lint wipes to remove excess water. Automated Cleaning Instructions:

• Use only washer/disinfector machines that have been validated in accordance with ISO 15883.

• Perform pre-cleaning to remove gross contaminants as follows:

  • Submerge and soak in a pH neutral detergent solution prepared according to the manufacturer's instructions for a minimum of 1 minute.

  • Flush any cannulated instruments that may be present.

  • While still submerged, remove visible soil by scrubbing with an appropriately sized soft nylon bristle brush d. Rinse with flowing purified(deionized) water for a minimum of 30 seconds.

  • Load instruments into washer/disinfector in accordance with the manufacturer's instructions.

  • Arrange Instruments with curved surfaces and cannulated facing downward to prevent pooling of water.

 

• Operate the washer/disinfector cycle according to the manufacturer's Instructions. a. Recommended minimal washer/disinfector parameters:

  • Heated Wash at 140F° (60°C) for 2 minutes

• Heated Distilled Water Rinse at 140°F (60°C ) for 20 seconds

• Heated purified Water Rinse at 180°F (82°C) for 1 minute

• Forced Air Drying at 240° F (116°C) for 9minutes

 

 

Lubrication – Thoroughly lubricate all working parts and joints of instruments prior to inspection and sterilization with a lubricant suitable for use on surgical instruments that will withstand the temperature used during sterilization. For instruments with moving parts, lubricate joints with a steam-permeable, water soluble instrument lubricant prior to sterilization. 

 

Sterilization - The most common method of sterilization is by autoclaving as per the autoclave manufacturer's instructions.

 

CAUTION: Autoclave temperatures should not exceed 137°C (280°F), handles, insulation or

other non-metallic parts may be damaged. (Note: Contact your steam autoclave manufacturer to confirm appropriate temperatures and sterilization times.)

Storage: Instruments should be stored in a clean dry area with tip protectors. Please examine instrument prior to use for functionality and damage. Dispose of at end of life in accordance with national regulations and approved hospital practices for surgical instrumentation disposal.

 

Warning/Precautions:

Load size, atmospheric, and other conditions may alter specifications. If stricter specifications are required by the user, then those specifications should be used. Instruments should be open and/or disassembled and carefully prepared for sterilization following the sterilization equipment

manufacturer's guidelines. Equipment and procedures used for sterilization should be in compliance with ANSI/AAMI ST79, AST-MF1744 and ISO 17665.