MicroFrance Laparoscopic Instruments
 

Indications, Safety, and Warnings

MicroFrance Manual Surgical Instruments

Intended Use
Manual surgical instruments are intended for use in a wide variety of surgical procedures including otorhinolaryngology, head and neck, otoneurological, ophthalmic, and various laparoscopic and endoscopic surgeries.

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: glass, ceramic, titanium nitride, stainless steel, tungsten, thermoset polymers (including silicone), thermoplastic polymers, sterling silver, or chrome-plated brass.

Contraindications
None known.

Instrument Use

  • 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.


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 preventive 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.
  • To avoid patient or user burn when using light source, be sure you follow the light source manufacturer instructions for preventing excessive heat.


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.


Recommendations

  • 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.


Reprocessing Instructions For Reusable Instruments (Per ISO17664:2004)

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 heat sterilize, as damage to the instrument finish may occur.
Limitations After cleaning and sterilization, verify functionality prior to re-use.
Instructions
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.
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 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 a minimum 44 minutes total time, including a pre-wash, main wash and rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.Thoroughly examine instruments for any residual soil.
Cleaning: Manual 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 water-soluble instrument milk or a sterile Vaseline. Do not use silicone spray.
Disinfection Note: Do not cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilize, as damage to the instrument finish may occur.
Packaging A standard, sterilization wrap may be used. In the US, an FDA-approved surgical wrap must be used. Ensure that the pack is large enough to contain the instrument without stressing the seals. 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.
Sterilization
(Temperatures are minimum required; times are minimum required)
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.
Sterilization
(Temperatures are minimum required; times are minimum required)
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.
Cycle: Gravity: Gravity Pre-vac Pre-vac (FR-WHO) Pre-vac (UK)
Temp: 121°C 132°C 132°C 134°C 134°C
Time: 30 min 10 min 4 min 18 min 3 min
Drying: 15 – 30 minutes, or until visibly dry
Maintenance, Inspection, and Testing Inspect components for any damage before and after each use. If 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.

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for reuse. 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 AAMI TIR12:2004, Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers.

Note: In France, soaking the device in one mole of Soda (NaOH) per liter of solution is the recommendation of French Circular 138 in order to prevent Creutzfeld-Jakob Disease transmission.

Last updated: 9 Jan 2013