Spinal Kinetics M6 Surgical Instruments Instructions

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Spinal Kinetics M6 Surgical

Description

Spinal Kinetics instruments and instrument cases are generally composed of aluminum, stainless steel, and/or polymeric materials. The cases may be multi- layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing a sterilization and drying cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap to maintain sterility.
These instructions are provided in accordance with AAMI TIR12, AAMI TIR30, DIN EN ISO 17664, and ISO 17665-1.

Indications for Use
Manual surgical instruments are intended for use in a wide variety of surgical procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures. The instrument cases include instrument trays, which may be used to hold the instruments during steam sterilization cycles. It is the responsibility of the surgical team to select the appropriate instrument for each case and be familiar with Spinal Kinetics’ surgical technique guidelines.

Contraindications

• None known
• Materials
• Aluminum
• Stainless Steel
• Polymeric Materials

Disclaimer
Spinal Kinetics instrument cases are intended to protect the instrumentation and facilitate the sterilization process by allowing steam penetration and drying.
Spinal Kinetics has verified through laboratory testing that its instrument cases are suitable for the specific sterilization methods and cycles for which they have been tested. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. Testing should be conducted in the health care facility to ensure that conditions essential to sterilization can be achieved. Spinal Kinetics does not accept responsibility or liability arising from a lack of cleanliness or sterility of any medical devices supplied by Spinal Kinetics that should have been properly cleaned and/or sterilized by the end-user prior to use.

Recommendations

• The instruments are provided non-sterile. Clean instruments before each use. After cleaning, sterilize as directed prior to use.
• As soon as possible after surgery, instruments should be cleaned and sterilized.
• Clean the instruments per the instructions below. Strictly follow the dosage, temperature, exposure time, and material compatibility specifications for the cleaning agent.
• Sterilize the instruments using the steam sterilizer operating conditions below.
• Stainless steel instruments can become stained or corroded if the cleaning and sterilization instructions are not followed. If excessive staining is observed use demineralized water for cleaning and sterilization. Staining may be eliminated by scrubbing the device following standard cleaning procedures. Instruments with corrosion should be removed from use.
• Repeated reprocessing on the instruments has minimal effect. End of life is normally determined by wear and damage due to use.
• After each use inspects all instruments for any damage. Discard and replace instruments as necessary.
• After cleaning and sterilization, verify functionality prior to use.
• Instruments are compatible with Alkaline cleaning solutions up to a pH of 11.

CAUTION:

• If sterilizing for the first time, remove all vinyl caps and packing foam prior to autoclaving.
• The condition of all instruments must be checked before use.
• Soak or rinse instruments immediately after use. To avoid the risk of corrosion or staining, DO NOT exceed 15 minutes of soaking time.
• Whenever possible, disassemble the instruments.
• Disassemble the instruments prior to commencement of the cleaning, disinfection, and sterilization process.
• 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.
• 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.
• Store instruments in a clean, dry area.

WARNING:

• Only trained personnel should clean and sterilize instruments as described in these Instructions for Use. Use appropriate personal protection equipment when handling contaminated instruments.
• To avoid a higher risk of corrosion and contamination, treat instruments immediately after use. Instruments must be dried after cleaning and after any exposure to water.
• Take care to avoid contamination to prevent debris from drying when transporting instruments to the cleaning area.
• Only sterile instruments may be used for surgery.
• Do not use these instruments for purposes other than those for which they are intended.
• 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.

Responsibilities of the User

General. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material is suitable for use in sterilization processing and sterility maintenance.

Cleaning/Decontamination. The health care facility is responsible to ensure that conditions essential to safe handling and decontamination can be achieved. ANSI/AAMI ST35 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings and ISO 15883-1 Washer-disinfectors – Part 1: General requirements, terms and definitions and tests provide relevant guidelines.

Sterility. Users should conduct testing in the health care facility to ensure that conditions essential to sterilization can be achieved and that specific configuration of the container contents is acceptable for the sterilization process and for the requirements at the point of use. ANSI/AAMI ST33 Guidelines for the Selection and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities and ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices provide relevant guidelines.

Sterilization and Cleaning Methods

Instruments should be placed in the designated location for each instrument in the sterilization case.
Universal instrument trays and cases without defined, preconfigured layouts or containing undefined universal spaces or compartments should only be used under the following conditions:

• Any device capable of disassembly must be disassembled prior to placement in the case.
• All devices must be arranged to ensure steam penetration to all instrument surfaces. Instruments should not be stacked or placed in close contact.
• The user must ensure that the instrument case is not tipped or the contents shifted once the devices are arranged in the case. Silicone mats may be used to keep devices in place.

Precautions

• When handling sharp instruments use extreme caution to avoid injury.
• Consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact.
• Unless otherwise indicated, instrument sets are NOT Sterile and must be thoroughly cleaned and sterilized prior to use.
• Unwrapped instrument cases DO NOT maintain sterility.

Cleaning and Disinfection Process

• Disassemble any instrument capable of being disassembled prior to cleaning.

• Promptly and thoroughly rinse instruments with deionized water after use.

• Open any articulated instruments before positioning in the soaking solution.

• Users may choose to perform either the manual cleaning and disinfection method or the automated cleaning and thermal disinfection method.

• Manual Cleaning – Method 1

  • Prepare the Enzol® detergent per the manufacturer’s instructions. Fully immerse the instruments in the prepared detergent and allow them to soak for a minimum of two minutes.
  • Use a soft bristle brush to thoroughly clean any crevices or other difficult-to-clean areas of the instruments. Flush lumens and small spaces with a syringe.
  • Rinse the instruments in running tap water for a minimum of one minute. Use a syringe to assist in rinsing lumens and small spaces.
  • Dry the instruments with a clean, soft, lint-free single-use cloth to avoid damage to the surface.

• Manual Cleaning – Method 2

  • Prepare a cleaning solution of 1.0% neodisher® MediClean forte (or equivalent) with 20-25°C water.
  • Soak instruments in the cleaning solution for 20 min.
  • After the 20 min soak, brush surfaces of instruments for 1 min with a nylon-bristled brush (or equivalent).
  • Rinse instruments in 20-25°C water for 30 sec.
  • Submerge instruments in deionized water for 30 sec.
  • Dry instruments with a clean, soft, lint-free single-use cloth to avoid damage to the surface.

• Disinfection

  • Submerge the instruments in a vessel or tray containing 20-25°C Cidex® OPA.
  • Soak instruments in 20-25°C Cidex® OPA (or equivalent) for 12 min.
  • Use a syringe to flush lumens and mechanical joints (e.g., thumb screws, spring-loaded detents, hinges, etc.) with Cidex® OPA.
  • While submerged, manipulate the device through its full range of motion.
  • After the soak, rinse in sterile deionized water for 1 min. Repeat two additional times, replacing the sterile deionized water each time.
  • Dry instruments with a clean, soft, lint-free single-use cloth to avoid damage to the surface.

• Automated Cleaning and Thermal Disinfection
  Method 1:

  • Place the instruments into the washer/dryer.
  • Run the validated cycle parameters below.
  • Upon removal from the washer/dryer, dry the instruments with a clean, soft, lint-free single-use cloth to avoid damage to the surface.

Validated Automated Cleaning Cycle

Method 2:

• Place the instruments into a Steris Reliance 444 Washer Disinfector (or equivalent) using neodisher ® Mediclean forte detergent (or equivalent).
• Run the validated cycle parameters below.
• Upon removal from the washer/dryer, dry the instruments with a clean, soft, lint-free single-use cloth.

Validated Automated Cleaning and Thermal Disinfection Cycle

Sterilization Process
Since Spinal Kinetics is not familiar with individual hospital handling procedures, cleaning methods, bioburden levels, and other conditions, Spinal Kinetics assumes no responsibility for sterilization of products by a hospital even if the general above guidelines are followed.
The following sterilization cycle parameters were validated by Spinal Kinetics under laboratory conditions; however, these cycles must be re-validated by the end-user to ensure that sterility can be achieved on-site.

Storage and Shelf Life

Instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture. Care must be exercised in handling wrapped cases to prevent damage to the sterile barrier. The health care facility should establish a shelf life for wrapped instrument cases based upon the type of sterile wrap used and the recommendations of the sterile wrap manufacturer. The user must be aware that maintenance of sterility is event-related and that the probability of occurrence of a contaminating event increases over time, with handling, and whether woven or non-woven materials, pouches, or container systems are used as the packaging method.

Limited Warranty

Spinal Kinetics LLC, an Orthofix company, warrants that reasonable care has been used in the manufacture of this device. There are no express or implied warranties, including fitness for a particular purpose, for these manual instruments. Any description or specifications provided are solely to describe the product at the time of manufacture and do not constitute any express or implied warranties. Spinal Kinetics LLC, an Orthofix company, is not responsible for any direct, incidental, special, or consequential loss, damage, or expense based on any defect, failure, or malfunction of this product, other than as expressly provided by mandatory provisions of applicable law. No person has the authority to bind Spinal Kinetics LLC, an Orthofix company, to any representation or warranty, except as provided in this Limited Warranty.

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