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DROIT D'AUTEUR
Toutes les informations contenues dans ce manuel ne peuvent pas être
utilisées à d'autres fins que celles d'origine. Ce manuel est la propriété de
Air Liquide Medical Systems S.r.l. Il ne peut être
reproduit, totalement ou partiellement, sans l'autorisation écrite préalable de
l'entreprise. Tous droits réservés.
MISE À JOUR DES CARACTÉRISTIQUES TECHNIQUES
Afin d'améliorer en permanence les performances, la sécurité et la fiabilité,
tous les dispositifs médicaux fabriqués par Air Liquide Medical Systems
S.r.l. sont périodiquement soumis à des révisions et des modifications.
Les manuels d'instructions sont donc modifiés pour assurer leur cohérence
constante avec les caractéristiques des dispositifs mis sur le marché. Si le
manuel d'instructions accompagnant cet
appareil est perdu, il est possible d'obtenir du fabricant une copie de la
version correspondant à l'appareil fourni, en indiquant les références
indiquées sur l'étiquette.
ENGLISH
1 - INTENDED USE
ALNEST N1 is a reusable nasal mask with calibrated exhalation orifices
(Vented), intended to be used at home or in a hospital setting by multiple
adult patients (weighing more than 30 kg) who have been prescribed for
a non-invasive positive pressure ventilation therapy (NPPV), for example
a continuous positive airway pressure therapy (CPAP) or Bilevel positive
airway pressure therapy (BiPAP).
WARNINGS
• The mask should be used exclusively with positive pressure equipment
recommended by your doctor or respiratory therapist supplying a
minimum pressure of 4 cmH
evacuation through the exhalation orifices is not guaranteed and so a
partial re-inhalation may occur.
• Before using the mask, it needs to check that the exhalation orifices
are not occluded, even partially, to not jeopardize the safety and the
quality of the therapy.
• In case of discomfort, irritation or allergic reactions to any component of
the mask, consult your doctor or respiratory physiotherapist.
• In case of additional oxygen administration, smoking or using open
flames is prohibited.
• When using oxygen and the equipment is not in operation, turn off the
oxygen dispenser.
• Do not use the mask in case of vomiting or nausea.
• Keep away from light.
• It is recommended to wash the mask before the first use.
• The mask shall be cleaned after each use.
• Frequency of cleaning, methods of cleaning or the use of cleaning
agents other than those specified in this user manual, or exceeding
the recommended number of regeneration cycles, can jeopardize the
safety and the quality of the therapy.
• Before use, check the integrity of the mask. If damaged during
transport, notify your dealer.
• In case of visible deterioration (cracks, tears, etc.), it needs to eliminate
and replace the damaged mask component.
• Do not leave the components of the mask unattended, some of these
may be swallowed by children.
• Contact your dealer as a healthcare professional in case of functional
problems, size problems or questions regarding the application of the
medical device.
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
12
ENGLISH
O: at lower pressures, exhaled air safety
2