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cleaning/disinfection and sterilization, and that the validated
parameters are adhered to during every cycle.
4.2 Please also observe the applicable legal requirements
in your country as well as the hygiene regulations of the
hospital or clinic. This applies especially with regard to the
additional requirements for the inactivation of prions.
5. POST-OPERATIVE TREATMENT
The post-operative treatment must be carried out
immediately, no later than 30 minutes after the completion
of the operation. Additional information, while necessary,
is provided in the respective product-specific usage
instructions.
Steps:
1.Rinse away any surface soiling on the product with
distilled deionized water or with a cleaning agent.
2.Rinse through all lumina (E.g. irrigation and aspiration
connection) at least 3 times in the normal direction of flow
(no back rinsing) using a disposable syringe (min. volume
50 ml) filled with distilled/deionized water applied to the
back nozzle.
3.An aldehyde-free cleaning and disinfection solution that
is compatible with the products may also be used as an
alternative rinsing solution. In such cases, it is necessary to
rinse thoroughly afterwards at least 3 times with distilled, or
deionized water.
6. CLEANING/DISINFECTION:
6.1 MECHANICAL REPROCESSING
Disinfection must be performed no later than 2 hours after
the cleaning phase.
A machine cleaning and disinfection method should always
be used for cleaning / disinfection because of the increased
effectiveness of this method.
6.2 MECHANICAL CLEANING AND DISINFECTION
6.2.1 Thermal disinfection should be used if this function is
available on your disinfector. Use if possible a disinfecting
cycle compliant with the standard EN ISO 15883.
6.2.2 Note that there is a risk of disinfectant residue on
products when using chemical disinfectants.
6.2.3 Ensure the following criteria are met when selecting a
disinfector system:
•Disinfector is proven effective through testing (E.g. FDA
approved or CE marked / EN ISO 15883 compliant).
•Disinfector has suitable baskets to hold small fragile
products and has rinsing connections for the attachment to
product lumina.
•The cleaning program is suitable for products to be
processed and the rinsing cycle is sufficient.
•Only low microbe count (<10 cfu/ml) distilled or deionized
water is used for all rinsing steps. (E.g. Aqua purificata, as
per the specifications of Pharm. Eur. or USP).
•Air used for drying is HEPA filtered.
•Disinfector is serviced and checked on a regular basis.
