Intended Use; Contraindications; Important Parts; Before Use - DeVilbiss Innova 50848 Guía De Instrucciones

• If oxygen is used with this CPAP mask, the oxygen flow must be turned off when the CPAP machine is not
operating. Explanation of the warning: When the CPAP device is not in operation, and the oxygen flow is left
on, oxygen delivered into the device tubing may accumulate within the CPAP machine enclosure. Oxygen
accumulated in the CPAP machine enclosure will create a risk of fire.
• NOTE: At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary, depending
on pressure settings, patient breathing, and leak rate.
• No smoking or open flames such as candles may be used when oxygen is in use.
• To minimize the risk of vomiting during sleep, avoid eating or drinking for three (3) hours before using the
mask.
• Any unusual skin irritation, chest discomfort, shortness of breath, gastric distension, abdominal pain,
belching or flatulence from ingested air, or severe headache experienced during or immediately after use
should be reported to a healthcare professional.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms
occur, consult a physician or dentist.
• Consult a physician if you experience any of the following symptoms while using the mask: Drying of the
eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
• Do not overtighten the headgear straps. Signs of overtightening include: excessive redness, sores, or
bulging skin around the edges of the mask. Loosen headgear straps to alleviate symptoms.
• Significant unintentional leak may occur without properly fitting the mask.

INTENDED uSE

The Innova Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel
operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure
therapy has been prescribed. The mask is intended for single patient use in the home, hospital or institutional environment.

coNTRaINDIcaTIoNS

Do not use this product if you are experiencing nausea, vomiting, taking a prescription drug that may cause vomiting, or if
you are unable to remove the mask on your own.

IMpoRTaNT paRTS

Innova Mask
1. Flexible Spacebar
2. Vent Holes
3. Oxygen Port
4. Airgel™ Cushion
5. Quick Release Headgear Connector
6. Elbow Assembly
7. Mask Shell

BEFoRE uSE

• Inspect mask and valve prior to each use. Replace the mask if parts are damaged or gel is exposed due to tear or
punctures.
• Check the anti-asphyxia valve. With the positive pressure device turned off, verify that the valve flapper is positioned
so that room air can flow through the large openings in the valve (Figure 1a). Turn on the system; the flapper should
close, and system air should flow through the mask (Figure 1b). If the flapper does not close or does not function
properly, replace the mask. Do not block the opening on the anti-asphyxia valve or the vent holes. Ensure that the
valve is not blocked with secretions and that the flapper is dry.
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