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Symbols
Vapotherm Inc. has declared that this product conforms with the European
Council Directive 93/42/EEC Medical Device Directive when it is used in
accordance with the instructions provided in the Operation Manual.
This symbol indicates that the waste of electrical and electronic equipment
must not be disposed as an unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the manufacturer for
information concerning the decommissioning of your equipment.
Vapotherm tubing products contain DEHP [Di-(2-Ethylhexyl) Phthalate] which
is the most frequently used plasticizer to add flexibility to medical tubing. The
medical tubing is intended for the transport of medical breathing gases and not for
the storage of substances that have chemical extraction properties. The European
Commission has issued the following statement:
“The Scientific Committee on Emerging and Newly Identified Health Risks
(SCENIHR) has evaluated the exposure to DEHP for the general population and
patients during medical procedures. In some cases the exposure is significant and
exceeds the toxic doses observed in animal studies. There is a reason for some
concern for prematurely born male neonates for which the DEHP exposure may
be transiently above the dose inducing reproductive toxicity in animal studies. So
far, there is no conclusive scientific evidence that DEHP exposure via medical
treatments has harmful effects in humans. But, it is recognized that especially
the potentially high exposure during medical treatments may raise a concern,
even in the absence of clinical or epidemiological evidence, for harmful effects in
humans.” – SCENIHR 2008
Pregnant and nursing women should consider the effects on a child that may
occur from medical respiratory treatments. The general population is exposed
to phthalates daily from dietary sources and the inhalation of air. The extent of
medical treatment exposure largely depends upon the medical treatments given
and the duration of the treatment
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