Codan IBPM DPT-6000 Gebrauchsanweisung Seite 60

Instructions for Use – English
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14 Disinfection instructions
14.1
14.2
CODAN pvb Critical Care pressure monitoring sets are developed and manufactured in such a way that when the above-mentioned
disinfectants are used and the product-specifi c contact and drying times and the maximum duration of use of the pressure monitoring set
14.3
are complied with (see section 15, page 60 – Duration of use), any number of disinfections can be carried out without reducing the
basic safety of the pressure monitoring set or damaging the affected component(s).
14.4
15 Duration of use
15.1
15.2
15.3
h
60
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13.5.3
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For disinfection, use iodine-containing disinfectants or standard 1-propanol, 2-propanol or ethanol-based disinfec-
tants. For reasons of user and patient safety, check with the manufacturer about the product-specifi c contact time of the
disinfectant that must be complied with after application in order to adequately kill or inactivate pathogens. Disinfection
without observing the required contact time may lead to the spread/transmission of pathogens and thus pose a danger to
patients, users and third parties.
Following disinfection, make sure that the applied disinfectant has completely evaporated before using the components. If
Luer interfaces are used without complete evaporation of the disinfectant, they may break, causing ingress/leakage of
liquids, air and/or pathogens.
Wetting the air separation membrane of the AeroGuard
before the component has been completely primed with saline solution can result in the AeroGuard
saline solution to pass through, thus making it impossible to prime and fl ush the pressure monitoring set. Before and during
fi lling, make sure that no liquids can wet the fi lter system in order to maintain the patency of the pressure monitoring set.
For reasons of hygiene, the pressure monitoring set must be changed at least every 96 hours and the cumulative dura-
tion of use of 30 days maximum should not be exceeded. Moreover, in the event of damage and/or any change in the per-
formance of the individual components, e.g. due to environmental conditions, the pressure monitoring set must be replaced
(see section 19, page 63 – Replacing the pressure monitoring set/sterile accessories IBPM).
Reusing or reprocessing the pressure monitoring set and sterile accessories is prohibited under all circumstances, since
this can lead to lasting health damage due to infection or allergic/toxic reactions, accompanied by chronic long-term damage
to tissues/organs. Reusing the blood sampling systems may result in clotting of the systems, which makes proper operation
impossible. Reuse can also result in distortion of blood values. In addition, compliance with the recommended service life
cannot be ensured if systems are reused. Moreover, material properties can be impaired by cleaning processes and as
a result, the correct display of measured values, the leak-tightness of adhesively bonded and screw connections and the
pressure resistance of the individual components, for example, can no longer be ensured. As a result, neither correct set-up
nor proper use of the pressure monitoring set without air pockets and/or leakage of liquids is possible.
Resterilisation of the pressure monitoring set, accessories and/or individual components is prohibited. Otherwise the basic
safety and essential performance characteristics of all components cannot be ensured, which will jeopardise patient safety.
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270°
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fi lter system with liquids (e.g. disinfectant or saline solution)
®
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270°
13.5.3
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not allowing any more
®
CODAN pvb Critical Care GmbH
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13.5.3
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