Descriptive Information; Intended Use; Description Of The Device - Atos Medical FREEVENT XtraCare Manual Del Usuario

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1. Descriptive information

1.1 Intended use

™ ™
Freevent ® XtraCare and Freevent ® XtraCare Mini are single use Heat
and Moisture Exchangers with electrostatic filter (HMEF) that condition and
filter inhaled air in patients spontaneously breathing through a tracheostoma.
1.2 CONTRAINDICATIONS
Freevent XtraCare and Freevent XtraCare Mini are contraindicated for
patients who:
• are under any form of mechanical ventilation.
• are unable to handle or remove the device themselves when needed, and who
are not under constant supervision of a clinician or a trained caregiver.
• cannot tolerate the added dead space.
Freevent XtraCare and Freevent XtraCare Mini are contraindicated if
single lumen tracheal tube cannot be reinserted by patient or caregiver after
accidentally removed.

1.3 Description of the device

The device is available in two versions:
• Freevent XtraCare.
• Freevent XtraCare Mini
Both devices are included when referenced as Freevent XtraCare below.
Freevent XtraCare is a Heat and Moisture Exchanger combined with an
electrostatic filter (HMEF). The HME is impregnated with a hygroscopic salt
and conditions the inhaled air. The electrostatic filter reduces the inhalation of
particles such as viruses, bacteria, pollen and other particulate matter through
the tracheostoma. The electrostatic filter provides effective filtration of small
airborne particles, e.g. bacteria, viruses, dust and pollen, irrespective of the
direction of airflow through the device. NOTE: Since there are other pathways
for pathogens to enter the human body, Freevent XtraCare can never guarantee
total protection. Freevent XtraCare has a 15 mm ISO connector for connection
to a tracheostomy tube. For supplemental oxygen the compatible O adaptor
2
can be connected to Freevent XtraCare. See section 3.
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