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CooperSurgical Advincula Arch Handle Mode D'emploi page 2

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  • FRANÇAIS, page 5
Reusable instruments must be rinsed thoroughly after use and after cleaning to ensure removal of gross soil and residual cleaners and solvents. Gross soil is
damaging to instrument surfaces and inhibits thorough cleaning and subsequent sterilization. Residual cleaners and solvents can impede further processing and
may affect the surface finish of the instrument over time.
2. CLEANING
There are two methods for cleaning that have been validated by CooperSurgical, Inc. Any healthcare facility should be able to perform the manual cleaning
process. For those facilities that use automated washer-disinfectors, an automated method has also been validated.
Personnel are cautioned to use personal protective apparel due to the unknown and potentially hazardous nature of biological fluids and soils present. Specific
detergents or cleaning solutions vary in requirements for concentrations and temperatures required for optimal cleaning performance. Use temperatures in
this document as guidance, to be superseded by the detergent/cleaner manufacturer's directions for use. Any processes outside the recommendations in this
document must be validated before use.
The quality of water used to prepare solutions and rinse reusable instruments can affect the efficacy of the process and the instrument reuse life.
CooperSurgical, Inc. recommends the use of freshly prepared purified water or sterile water for dilutions of solution and rinsing of instruments. Non-purified
water can add mineral deposits and recontaminate instruments with microorganisms. Mineral deposits can impede sterilization and affect the condition of the
instrument, resulting in staining, corrosion, and/or other damage.
Equipment and Materials Required for Manual Cleaning
• Personal protective apparel/equipment as recommended by cleaning solution supplier.
• Cleaning bath, sink, or other vessel large enough to accommodate full immersion of instruments.
• Freshly prepared cleaning solution intended for manual cleaning (use enzymatic, neutral, or alkaline detergents).
• Soft-bristled brushes and sponges.
• Clean, low-lint or lint-free cloth.
Equipment and Materials Required for Automated Cleaning
• Personal protective apparel/equipment as recommended by cleaning solution supplier.
• Legally marketed (FDA-cleared and/or CE-marked) medical device washer or washer-disinfector.
• Cleaning solution intended for automated cleaning (use enzymatic, neutral, or alkaline detergents).
• Racks and accessories to hold and support instruments during processing.
Point of Use
During and immediately after the clinical procedure, instruments should be treated to reduce and remove gross soil materials. Instruments should be wiped
with low-lint or lint-free absorptive materials, such as low-lint or lint-free wipes to remove solid tissues and the majority of bodily fluids. Immediately after use,
all disposable single-use accessories should be removed and discarded into appropriate biohazardous waste containers. Instruments should be placed into a
transport container that will protect them from damage during transport and should be kept moist.
Transport to Processing Area
Transport the instruments to the processing area as soon as practical. Minimize holding time before removing organic debris. Ensure that lighter instruments are
not mixed with heavier instruments to avoid damage to the instruments due to mechanical abrasion. Seal or enclose the transport container to prevent fluid loss
and the potential for cross-contamination of other areas.
Preparation
Remove all single-use accessories such as the RUMI Tips or Koh-Efficient and discard in an appropriate waste container designed for
biohazardous materials if this has not been performed at point of use.
The only accessory for the Advincula Arch Handle that is reusable is the Koh Cup device and specific reprocessing instructions for the Koh Cup are included
with packaging for that device.
Cleaning
Cleaning should take place as soon after use as practical. Soils should not be allowed to dry onto the instrument surfaces. The manual process and the
automated process were validated independently and are considered equivalently effective when performed according to the instructions in this document.
Do not use metal-bristled brushes on the instruments.
Manual Cleaning Processes
1. Ensure that all single-use tips and colpotomy attachments are removed from the instruments and discarded in an appropriate biohazardous waste container.
2. Detach the Koh Cup from the Advincula Arch Handle.
3. Prepare a neutral or alkaline enzymatic detergent specifically designed for manual cleaning of medical instruments. Prepare a fresh solution of detergent at
the detergent manufacturer's recommended concentration using water at the detergent manufacturer's recommended temperature.
4. Ensure that the instruments are fully immersed in the prepared solution. Soak the instrument for a minimum of ten (10) minutes at room temperature
(68-77°F/20-25°C) or longer if indicated on the detergent manufacturer's instructions for use.
5. After the soak time, scrub the handle with a soft sponge for large surfaces. Using a soft-bristled brush, scrub the regions with mated surfaces, such as the
grip and the snap drum on the Advincula Arch Handle. Scrub regions with crevices and lumens on the sides of the handles and near the tips.
6. Rinse the instrument in warm tap water (100-120°F/ 38-49°C) for one (1) minute. Ensure that all crevices, lumens and mated surfaces are flushed.
7. Place the instrument into a prepared ultra-sonicator containing a neutral or alkaline detergent specifically designed for manual cleaning of medical
instruments and labeled for use with an ultra-sonicator. Ultra-sonicate the instrument in the detergent solution for ten (10) minutes.
8. Rinse the instrument with purified or sterile water for one (1) minute or until all visible signs of detergent residue are removed, whichever is longer. Ensure
that all crevices, lumens and mated surfaces are flushed.
9. Examine the instrument for signs of residual soil. If there are any signs of residual soil on the instrument, repeat the cleaning process.
10. Dry the instrument with a low-lint or lint-free towel or wipe.
• Examine the instrument for signs of residual soil. If there are any signs of residual soil on the instrument, repeat the cleaning process.
• Dry the instrument with a low-lint or lint-free towel or wipe.
Automated Cleaning Process
1. Ensure that all gross soil has been wiped or rinsed from the surfaces of the instruments.
2. Use only a legally marketed (FDA-cleared and/or CE-marked) medical device washer or medical device washer-disinfector. Industrial use and household
use dishwashers are not acceptable for the cleaning of medical devices.
3. Place the instruments loosely within a rack designed for the medical device washer or medical device washer-disinfector, using a hold-down screen if
indicated by the washer/washer-disinfector manufacturer.
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Umh750