Hygienic Re-Use In The Professional Environment; General; Processing Limits - Pari VORTEX Instrucciones De Uso

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HYGIENIC RE-USE IN THE PROFESSIONAL ENVIRONMENT

The cleaning regulations for use of the product at home are available on the internet
(www.pari.com) or from the PARI Service Center [see: Contact, page 29].

4.1 General

CAUTION
Risk of infection in the case of a change in patients. The VORTEX must be
cleaned, disinfected and sterilised before a change of patients. If they are not steril-
ised, the mouthpiece and any mask used must be disposed of.
The "Ladybug" baby mask and the "Frog" child mask are not sterilisable and must
be disposed of in any case before a change of patients.
CAUTION
Ensure that the components are allowed to dry sufficiently after each processing
step. Condensation or residual wetness can present an increased risk of bacterial
growth.
NOTICE
Ensure that the system is processed for re-use only with the application of ad-
equately validated device- and product-specific procedures, and that the validated
parameters are maintained during each cycle. The equipment used must be main-
tained regularly.
PARI products must be processed for re-use with the application of suitable, validated
methods in such manner that the success of these methods can be monitored reliably
and the safety and health of patients is not threatened.
The following text describes the methods validated by PARI, with which the product
components can be processed effectively. If you have any questions about pro-
cessing for re-use, please contact the PARI Service Center [see: Contact, page 29].
Processing cycles
Observe the following cycle for hygienic processing of the VORTEX and the accessor-
ies used:
– Single patient use:
Clean and disinfect all product components and the accessories used
– once a day in the case of acute infection of the airways,
– at least once a week,
– whenever there is visible soiling.
– Multiple patient use:
Clean, disinfect and sterilise all product components before every change in
patient.
Sterilisation may be omitted if a new mouthpiece (and mask if applicable) is used.

4.2 Processing limits

The VORTEX can be processed for re-use up to 30 times and used for up to one year.
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