Explanation Of Symbols - CooperSurgical RUMI II Handle Manual Del Usario

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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 RUMI II 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. The original purchaser shall prepay the

shipping costs for returning a CooperSurgical, Inc. instrument for warranty service. CooperSurgical, Inc. will, at its option and without charge, either repair or replace

any instrument, which CooperSurgical, Inc. determines to be defective in material or workmanship. Instrument damage caused by misuse or accident, shall void

this warranty.

CooperSurgical, Inc. disclaims any liability for special, incidental, consequential, punitive or exemplary damages arising out of the use of any CooperSurgical,

Inc. instrument. CooperSurgical, Inc.'s liability in all events is limited to, and shall not exceed, the purchase price paid. Except as expressly provided in this limited

warranty section, CooperSurgical, Inc. makes no representations or warranties, expressed or implied, as to the instruments, including warranties of merchantability

and fitness for a particular purpose, all of which are hereby expressly disclaimed and excluded. No warranty or affirmation of fact, express or implied, other than as

set forth in this limited warranty, is made or authorized by CooperSurgical, Inc.