3.3 Intended use
The operational safety of the unit is only assured when used for the purpose it is intended
for, as specified in the instructions for use.
The Kröber O2 concentrates the oxygen that the ambient air contains by the so-called
pressure swing adsorption process (PSA). Pressure swing adsorption processes rely on the
fact that if air is passed under pressure through a vessel containing an adsorbent bed of
zeolite that attracts nitrogen more strongly than it does oxygen, part or all of the nitrogen will
stay in the bed, and the gas coming out of the vessel will be enriched with oxygen (refer to
Chapter 5 O2-Concentration).
The Kröber O2 is solely intended for use within the scope of a non-life sustaining medical
therapy for the additional supply of oxygen. The unit may thereby be used in hospitals,
homes or at home.
The patient is intended to be the operator, whereby the device may only be operated by a
previously instructed adult. The device may be used by toddlers (at least 2 years) up to
adults.
WARNING! Danger of damage to health!
Newborns and infants are not allowed to use the device!
ATTENTION: Danger of damage to health due to phtalate-containing
accessory components!
With many phthalates an impairment of the male reproduction is either proven or
there is a strong suspicion. Damage to the liver, the nervous and immune
systems and increased occurrence of overweight and insulin resistance cannot
be ruled out.
Phthalates can penetrate the placental barrier and damage a child in the womb.
Children in particular, whose organisms are still developing, are increasingly
absorbing phthalates from toys or floor coverings.
If children and pregnant or nursing women use this medical device, it is
recommended to use phthalate-free accessory components such as O2 tubes or
nasal cannulas. Phthalates also increase the risk of allergies and asthma in
pregnant women and children.
The unit must only be used according to the medical indication and only in accordance with
the doctor's prescription by following these instructions for use
NOTE!
To ensure the success of the therapy, the effectiveness of the therapy in relation to the
set volume flow should be checked regularly by the attending physician.
Intended use also includes following the assembly instructions and the instructions for
cleaning and maintenance of the device.
Any further and/or different use of the device is stated below and is not considered as
intended use! Claims of any kind against the manufacturer and/or his authorised
representatives for damage resulting from improper use of the device are excluded. The
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