CooperSurgical RUMI II Handle Manual Del Usario página 3

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
trigger/grip and the snap drum on the RUMI II Handle. Scrub regions with crevices and lumens on the sides of the handles and near the tips. Actuate the
moving parts of the RUMI II Handle while submerged to ensure contact between the instrument surfaces and the brush/detergent.
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. Actuate
the moving parts of the RUMI II Handle during rinsing.
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. Actuate the moving parts of the RUMI II Handle during rinsing.
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.
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 washer or medical washer-disinfector, using a hold-down screen if indicated by the
washer/washer-disinfector manufacturer.
4. Load the rack with the instruments into the washer/washer-disinfector and close the door.
5. Select a cycle intended for instruments that has the following parameters at a minimum:
PARAMETER TOLERANCE
Detergent Neutral or Alkaline medical device detergent
Pre-wash rinse Minimum of one
Minimum of 00:15 (mm:ss)
Cold tap water or better quality
Wash Minimum of one repetition
Minimum of 02:00 (mm:ss)
Warm tap or purified water (minimum of 140°F/60°C)
Minimum concentration per detergent manufacturer's IFU
Post-wash rinse Minimum of one
Minimum of 00:15 (mm:ss)
Warm tap or purified water (minimum of 110°F/43.3°C)
Thermal rinse* Minimum of one
Minimum of 01:00 (mm:ss)
Purified water (minimum of 180°F/82.2°C)
Drying** Minimum of default cycle setting
6. Start the cycle and allow it to run through conclusion.
7. Medical washer-disinfector default cycles often use high heat during the final stages of the processing cycle. Use caution and heat-protective gloves
when opening and removing the wash rack at the end of the cycle.
8. Examine the instruments for signs of residual soil. If there are any signs of residual soil on the instrument, repeat the cleaning process.
9. If the instruments are not thoroughly dry following the automated process, dry the instruments with low-lint or lint-free towels or wipes.
3. INSPECTION
All instruments must be inspected for signs of damage, wear or residual soil each time they are reprocessed. If residual soil is observed during inspection, the
cleaning process must be repeated for the instrument. Remaining soils can impede effective sterilization by shielding remaining microorganisms and can lead to
tissue reactions in subsequent patients.
Surface Finish
Inspect the surface of the instrument; the surface should be smooth. Some staining and discoloration may occur depending on the exact formulation of the
detergents used and the water quality. Staining will not impact performance of the handles as long as there are no signs of corrosion or surface pitting.
Grooves and Mated Surfaces
Carefully inspect the grooved and recessed areas of the shaft, particularly between the shaft and the guide pins, for signs of trapped soil. Inspect the mated
surfaces near the snap drum and near the grip for potential trapped soil.
Articulations
Fully articulate the moving components of the handle using the trigger and grip. The motion should be smooth. Jerking and catching within the range of motion
may be signs of damage or retained material between the mated surfaces. Ensure that the trigger moves easily when depressed and that it automatically drops
down when released. The un-actuated position should be locked into the articulating dial end of the shaft. When the trigger is engaged in the articulating end of
the shaft, the instrument should not shift or rotate. Damage to the trigger locking mechanism may allow slippage during a procedure. Corrosion may weaken the
materials leading to a break under normal load. Signs of damage or poor motion quality may indicate a need to replace the instrument or have it repaired.
Debris
Look carefully at any areas that appear to be a different color than the overall instrument as these may be signs of residual soil adhered to the surface.
4. WRAPPING
Prior to terminal sterilization, the instruments must be packaged to preserve sterility after processing during storage. Legally marketed sterilization packaging
(e.g. CSR wrap) that is compatible with and labeled for use with the chosen sterilization method should be used. CooperSurgical, Inc. has not evaluated the
sterilization efficacy of the processes recommended in this document using containment systems (e.g. procedure/case trays, cassettes, rigid reusable sterilization
containers), therefore, users who choose to use a containment system in the sterilization of these instruments should verify that the process is effective under
these conditions. Containment systems can impede the ingress and egress of sterilant (moist heat). CooperSurgical, Inc. recommends individually wrapping the
instruments prior to sterilization. The instruments should be wrapped using one of the common closure techniques, using properly sized material and secured with
tape or adhesive designed and labeled for use with the sterilization process chosen. Instruments should be labeled with identifying information and sterilization
date to facilitate selection for use after processing.
*Only heat-based medical device washer-disinfectors will include a thermal rinse. Medical device
washers that do not include a thermal disinfection phase should be set to have a minimum of a
01:00 (mm:ss) rinse following the post-wash rinse using purified water.
** Drying time will be variable dependent on the size and composition of the load, altitude,
environmental conditions, and air temperature and source characteristics.
NOTE: automated wash processes that include additional phases or longer
phase durations are anticipated to deliver equivalent or better cleaning efficacy
as the minimal validated parameters. Additional phases and longer phase
durations may be added if they are within the healthcare facility's normal
procedures.
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