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ENGLISH
This device has been designed for single use only. Reusing this medical
device bears the risk of cross‑patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body
fluids or tissues with potential pyrogenic or microbial contamination have
had contact with the medical device for an indeterminable period of time.
The residue of biological material can promote the contamination of the
device with pyrogens or microorganisms which may lead to infectious
complications.
Do not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical
device increases the probability that the device will malfunction due to
potential adverse effects on components that are influenced by thermal
and/or mechanical changes.
Di(2‑ethylhexyl)phthalate (DEHP) is a plasticizer used in some polyvinyl
chloride medical devicesDEHP has been shown to produce a range
of adverse effects in experimental animals, notably liver toxicity and
testicular atrophy. Although the toxic and carcinogenic effects of DEHP
have been well established in experimental animals, the ability of this
compound to produce adverse effects in humans is controversial. There is
no evidence that neonates, infants, pregnant and breast feeding women
exposed to DEHP experience any related adverse effects. However, a
lack of evidence of causation between DEHP‑PVC and any disease or
adverse effect does not mean that there are no risks.
FRANÇAIS
Ce dispositif est conçu exclusivement pour un usage unique. La
réutilisation de ce dispositif médical comporte un risque de contamination
entre les patients car les dispositifs médicaux – en particulier ceux
dotés de lumières longues et petites, de joints et/ou de fentes entre les
composants – sont difficiles ou impossibles à nettoyer après avoir été en
contact pendant une période indéterminable avec des liquides ou des
tissus corporels susceptibles d'être contaminés par des pyrogènes ou
des microbes. Les résidus de matériau biologique peuvent favoriser la
contamination du dispositif par des pyrogènes ou des micro‑organismes,
ce qui peut conduire à des complications infectieuses.
Ne pas restériliser. Après restérilisation, la stérilité du produit n'est pas
garantie en raison d'un degré indéterminable de contamination pyrogène
ou microbienne potentielle pouvant conduire à des complications
infectieuses. Le nettoyage, le retraitement et/ou la restérilisation de ce
dispositif médical augmente le risque de dysfonctionnement dû aux
éventuels effets indésirables sur les composants influencés par les
changements thermiques et/ou mécaniques.
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