The V3 Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at
or above 3 cm H
O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
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The mask is intended for single-patient multi-use in the home, hospital or institutional environment.
The mask system does not contain PVC, DEHP, or phthalates.
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This product is not manufactured with natural rubber latex.
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If the patient has ANY reaction to any part of the mask system, discontinue use.
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An exhalation port is built into this mask so a separate exhalation port is not required.
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The mask includes an anti-asphyxia valve (air entrainment valve) to help reduce rebreathing of exhaled air in the event that
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the positive pressure device does not work properly.
Verify that the mask is the right size by using the sizing guide.
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This product should not be used if the patient is experiencing nausea, vomiting, taking a prescription drug that may cause vomiting,
or if they are unable to remove the mask on their own.
U.S. Federal Law restricts this device for sale by or on the order of a physician.
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Do not expose the V3 Full Face Vented Mask to temperatures above 140˚F (60˚C).
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This mask is intended for single patient use only. It may be cleaned and used re¬peatedly on the same person but must not be
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used on multiple persons. Do not sterilize or disinfect.
Consult a physician prior to using mask if using any medications or devices to remove deep secretions.
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This mask is not suitable for providing life support ventilation.
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If the patient has respiratory insufficiency, they should wear this mask ONLY when therapy is being delivered.
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Do not use the V3 Full Face Vented Mask with baseline pressure less than 3 cm H
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If oxygen is used with this CPAP mask, the oxygen flow must be turned off when the CPAP machine is not operating.
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Explanation of the warning: When the CPAP device is not in operation, and the oxygen flow is left on, oxygen delivered
into the ventilator tubing may accumulate within the CPAP machine enclosure. Oxygen accumulated in the CPAP machine
enclosure will create a risk of fire.
At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings,
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patient breathing pattern, mask selection, and the leak rate.
No smoking or open flames such as candles may be used when oxygen is in use.
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To minimize the risk of vomiting during sleep, avoid eating or drinking for three (3) hours before using the mask.
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Any unusual skin irritation, chest discomfort, shortness of breath, gastric distension, abdominal pain, belching or flatulence
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from ingested air, or severe headache experienced by the patient during or immediately after use should be immediately
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
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physician or dentist.
Consult a physician if any of the following symptoms occur while using the mask: drying of the eyes, eye pain, eye
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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
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edges of the mask. Loosen headgear straps to alleviate symptoms.
Significant unintentional leak may occur without properly fitting the mask. Follow the MASK FITTING INSTRUCTIONS
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provided.
The elbow and anti-asphyxia valve assembly have specific safety functions. The mask should not be used if the valve flapper
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is damaged, distorted, or torn.
At low CPAP pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas from the tubing.
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Some rebreathing may occur.
This mask should be used with the positive airway pressure device recommended by a physician or respiratory therapist.
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The mask should not be used unless the positive airway pressure device is turned on and operating properly. Do not block or
try to seal the exhalation port (vent holes) or anti-asphyxia valve (air entrainment valve). The vent holes allow a continuous
flow of air out of the mask. When the positive airway pressure device is turned on and functioning properly, new air from the
device flushes the exhaled air out through the mask's vent holes. When the positive airway pressure device is not operating,
exhaled air may be rebreathed. Rebreathing of exhaled air can, in some circum¬stances, lead to suffocation. This warning
applies to most models of CPAP machines and masks.
This mask is not intended for patients without a spontaneous respiratory drive. This mask should not be used on patients who
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are uncooperative, obtunded, unresponsive, or unable to remove the mask. This mask may not be suitable for persons with
the following conditions: impaired cardiac sphincter function, excessive reflux, impaired cough reflux, and hiatal hernia.
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V3 Full Face Vented Mask
CONTENTS: V3 Full Face Vented Mask with Headgear
Rx ONLY MADE IN U.S.A.
DOES NOT CONTAIN NATURAL RUBBER LATEX
INTENDED USE
NOTES
CONTRAINDICATIONS
CAUTIONS
WARNINGS
GENERAL INFORMATION
O.
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ENGLISH
!