CooperSurgical Advincula Arch Handle Mode D'emploi page 3

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.
Advincula Arch Handle 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.
Crevices and Grooves
Inspect the surface crevices and grooves closely for signs of trapped soil. Inspect the edges of the grooves for signs of worn or damaged surfaces as the edges
are more likely to show damage first. Signs of damage to the surface may indicate a need to replace the instrument.
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.
5. STERILIZATION - MOIST HEAT (STEAM)
Individually packaged instruments using legally marketed sterile barriers with labeling consistent with the following parameters may be sterilized prior to use and
between subsequent uses. Legally marketed (FDA-cleared and/or CE-marked) moist heat (steam) sterilizers should be used. The following parameters have
been validated for use with the instruments within the scope of this document:
6. STORAGE
Individually packaged instruments should be cooled to a safe handling temperature following moist heat sterilization prior to final storage. Individually
packaged instruments should be transported to a clean, temperature and humidity controlled, sterile supply storage area. If instrument packaging is
compromised during storage (becomes wet, torn, or seals are open), the instrument must be reprocessed through cleaning, inspection, and sterilization
prior to use. Do not stack instruments or allow other product or instruments to be stacked on top of them. Protection from dust and moisture is
recommended. Ensure that traceability and identity is maintained throughout storage and up to subsequent use.
7. VALIDATION OF PROCESSES
CooperSurgical, Inc. performed validations for the cleaning of the instruments. The following detergents were used in the validations demonstrating efficacy:
Klenzyme , Manu-Klenz , ENZOL
® ™
CooperSurgical, Inc. does not endorse the use of the identified products in lieu of other similar products designed for use with medical devices, however,
this information may provide a basis for comparing the formulations to select an appropriate alternate in facilities or locations where these detergents are not
readily available.
The parameters listed in the automated cleaning section as the minimum parameters for automated cleaning are identical to the parameters used in the
validation, with the exception of the dry time. Post-cleaning dry time was eliminated for the cleaning process validation to facilitate detection of soil residuals,
if present, in order to reduce the potential for a false negative result.
WARRANTY
The Advincula Arch Uterine Manipulator Handle is warrantied by CooperSurgical, Inc. for a period of 120 days from shipment. This warranty applies only to the
original purchaser and only against defects in workmanship or materials, which under normal use render the instrument inoperable.
, Neutrad , Prolystica Ultra-Concentrate Neutral Detergent and Prolystica
® ® ®
*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.
3
Ultra-Concentrate Alkaline Detergent.
®