Assessments - 3, GPA: 3.3
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1 GEBRAUCHSANWEISUNG ( DEUTSCH) ................................................................................... 13 MODE D’EMPLOI ( FRANCAIS) ............................................................................................. 24 GUIDA PER L’UTENTE ( ITALIANO) ......................................................................................... 35 GUIA DEL USUARIO ( ESPANOL) ........................................................................................... 46 GUIA DO USUARIO ( PORTUGUES) ....................................................................................... 57 BRUKSANVISNING ( SVENSKA) ............................................................................................. 68 CONTRAINDICATIONS ..................................................................... 2 WARNINGS ..................................................................................... 2 PRECAUTIONS ................................................................................. 2 ADDITIONAL INFORMATION ............................................................ 3 PARTS OF THE MASK ...................................................................... 4 FITTING THE MASK ........................................................................ 4 REMOVING THE MASK .................................................................... 6 QUICK RELEASE TAB ..................................................................... 6 CLEANING THE MASK IN THE HOME .............................................. 6 CLEANING AND DISINFECTING/STERILISING THE MASK BETWEEN PATIENTS ........................................................................ 7 REASSEMBLING THE MASK .............................................................. 9 MASK CHARACTERISTICS ............................................................... 10 ACCESSORIES AND REPLACEMENT PARTS....................................... 1 1 MIRAGE ™ NV FULL FACE MASK SERIES ™ The MIRAGE NV FULL FACE MASK SERIES 2 system (nonvented) is only indicated for the treatment of adult patients using non-invasive ventilator systems that have an active exhaust. CONTRAINDICATIONS • The MIRAGE NV FULL FACE MASK SERIES 2 must not be used without appropriately qualified supervision either when the patient is at risk of not responding to severe hypoxia or hypercapnia by arousal, or when the patient, having aroused, is unable to remove the mask. WARNINGS • The mask must not be used on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting. • The mask should not be worn unless the ventilator system is turned on and operating properly. • At a fixed rate of supplemental oxygen flow (if used), the inhaled oxygen concentration will vary depending on the pressure settings, patient breathing pattern, mask selection and the leak rate. • The mask must not be used if the patient is known to be allergic to any of the following mask component materials: polycarbonate, silicone rubber, polyurethane rubber, nylon, polyester and cotton. PRECAUTIONS • The mask is not for use with ventilators which have a combination of: a) little or no ability to compensate for mask leak and variation in mask leak (eg volume-cycled ventilators with no compensation for leak, or pressure-cycled ventilators which are unable to deliver adequate extra flow in the presence of increased leak); and b) no expired ventilation alarms. If a ventilator with poor leak compensation is used, special reliance is placed on the expired ventilation alarm. • As with all mask ventilation systems, significant leak may occur between the mask and the patient’s face. The leak may vary depending on such factors as the patient’s position and sleep stage. Variation in leak may significantly affect patient ventilation, potentially producing profound hypoventilation or hyperventilation. The magnitude of this effect depends on the ventilator’s ability to compensate for leak. • Leak or variation in the leak may cause mistriggering of the ventilator. • Increased face-to-mask leak will reduce effective deadspace by washing out expired gases. In a pressure-cycled ventilator which tolerates moderate leak, the effect may be a reduction in arterial PCO2 with no change in ventilator settings. ADDITIONAL INFORMATION • ResMed has tinted the MIRAGE NV FULL FACE MASK SERIES 2 blue to help you identify it as a non- vented mask for use with active-exhaust noninvasive ventilator systems only. • The mask has a standard female 22mm tapered fitting (ISO5356-1) for external connection to the ventilator. • In determining the initial ventilator settings, and in particular the tidal volume for volume-cycled ventilators, make appropriate allowance for mask dead space and leak. Refer to the Mask Characteristics section of these instructions for more information. • Refer to the relevant ventilator system operating instructions for detailed information concerning connecting the m...