English; Descriptive Information; Intended Use; Description Of The Device - Atos Medical ProTrach XtraCare Instrucciones De Uso

The Instructions for Use, which accompanies this product, may be revised
from time to time and must therefore be reviewed prior to each procedure in
which the product is used.

1. Descriptive information

1.1 Intended use

ProTrach ® XtraCare
electrostatic filter (HMEF) that conditions and filters inhaled air in patients
spontaneously breathing through a tracheostoma.
1.2 CONTRAINDICATIONS
ProTrach XtraCare is 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.
• use the device on a single lumen tube (tube without an inner tube), unless the
patient or caregiver is able to reinsert the tube themselves after emergency or
accidental removal.
• cannot tolerate the added dead space.

1.3 Description of the device

The ProTrach 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. NOTE: Since there are other pathways for pathogens to enter the
human body, ProTrach XtraCare can never guarantee total protection. ProTrach
XtraCare has a 15 mm ISO connector for connection to a tracheostomy tube.
ProTrach XtraCare can be connected to oxygen tubing using the ProTrach O
Adaptor. See section 3.
1.4 WARNINGS
DO NOT reuse ProTrach XtraCare on another patient. The device and all its
accessories are intended for single use only. Reuse in another patient may
cause cross contamination.

ENGLISH

is a single use Heat and Moisture Exchanger with
™
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