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The Veraseal
3 Full Face Vented Mask is a disposable mask intended to be used with positive airway pressure devices, such as CPAP or bi-level,
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operating at or above 3 cm H
The mask is intended for SHORT TERM SINGLE PATIENT USE (maximum of 7 days) in the 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.
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 the positive
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pressure device does not work properly.
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Verify that the mask is the right size by using the sizing guide.
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.
In the 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 mask to temperatures above 140˚F (60˚C).
The mask is intended for SINGLE PATIENT USE ONLY. It is intended for short term use (not more than 7 days) and must not be used on
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multiple persons. Do not sterilize or disinfect.
Consult attending physician prior to using mask if the patient is 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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Use this mask with baseline pressure of 3 cm H
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
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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.
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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 may be used when oxygen is in use.
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This mask is not intended for patients without a spontaneous respiratory drive. This mask should not be used on patients who are
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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.
Any unusual skin irritation, chest discomfort, shortness of breath, gastric distension, abdominal pain, belching or flatulence from ingested air,
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or severe headache experienced by the patient during or immediately after use should be immediately reported to the attending healthcare
professional.
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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 the patient experiences 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 edges of the
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mask. Loosen headgear straps to alleviate symptoms.
Significant unintentional leak may occur without properly fitting the mask. Follow the MASK FITTING INSTRUCTIONS provided.
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The elbow and anti-asphyxia valve assembly have specific safety functions. The mask should not be used if the valve flapper is damaged,
distorted, or torn.
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At low pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may
occur.
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
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flow of air out of the mask.
The mask should not be used unless the positive airway pressure device is turned on and operating properly. When the positive airway
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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
circumstances, lead to suffocation. This warning applies to most models of CPAP machines and masks.
The mask has a service life of 7 days. Please dispose of the mask and accessories in accordance with local and regional guidelines. Per EU MDR
2017/745, please report serious incidents to manufacturer and EU Member State competent authority.
This mask is disposable and is intended for single patient short term use (maximum of 7 days) only. The mask should be discarded if heavily soiled.
The mask may be cleaned daily or as needed using a 70% isopropyl alcohol swab or by wiping with a damp, soapy cloth. If using a damp cloth, use
mild soap such as Ivory
. Rinse thoroughly and allow to air dry, out of direct sunlight.
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NOTE: The gel cushion, although silky to the touch, will not tear, leak, or detach from the mask under normal use. The gel cushion is not
indestructible. It will tear, cut, and rip if subjected to mishandling or abuse.
Resistance to air flow at 50 L/min: 0.23 cm H
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Veraseal
CONTENTS: Veraseal
Assembled in USA with US and imported parts
O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
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O or higher.
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O; at 100 L/min: 0.48 cm H
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3 Full Face Vented Mask
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3 Vented Mask with Headgear
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Rx Only
INTENDED USE
NOTES
CONTRAINDICATIONS
CAUTIONS
WARNINGS
GENERAL INFORMATION
CLEANING AND MAINTENANCE
TECHNICAL INFORMATION
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