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The iQ
®
2 Nasal 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
positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use
in the home, hospital or institutional environment.
This product is not manufactured with natural rubber latex.
If the patient has ANY reaction to any part of the mask system, discontinue use.
An exhalation port is built into this mask, so a separate exhalation port is not required.
U.S. Federal Law restricts this device for sale by or on the order of a physician.
Do not expose the iQ
This mask is intended for single patient use only. It may be cleaned and used repeatedly on the same
person but must not be used on multiple persons. Do not sterilize or disinfect.
This mask is not suitable for providing life support ventilation.
Do not use the iQ
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 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, 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.
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 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 physician or dentist.
Consult a physician if any of the following symptoms occur 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.
At low CPAP pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas
from the tubing. Some rebreathing may occur.
This mask should be used with the positive airway pressure device recommended by a physician or
respiratory therapist. 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). 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 circumstances, 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 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.
Significant leak may occur without properly fitting the mask.
Magnets are used in the swivel frame/tube set and the headgear clips. The magnetic field strength is
380 mT. Ensure that the magnets are kept at least 2.25 inches (6 cm) away from any active medical
implant or medical device that can be impacted by the magnetic field (e.g., pacemaker, defibrillators,
neurostimulators, cochlear implants, hearing aids) to avoid possible effects from localized magnetic
fields.
iQ
2 Nasal Vented Mask User Instructions
®
®
2 Nasal Vented Mask to temperatures above 122˚F (50˚C).
2 Nasal Vented Mask with baseline pressure less than 3 cm H
®
O. The mask is to be used on adult patients (>30kg) for whom
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NOTES
CAUTIONS
WARNINGS
O.
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