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iQ
®
Nasal Mask
iQ®
Nasal Mask
CONTENTS:
iQ®
Nasal Mask, Tubing Assembly
Rx ONLY LATEX FREE MADE IN U.S.A.
The Sleepnet Corporation
iQ®
Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP, operating at or above 3 cm H
2
O for the
treatment of adult obstructive sleep apnea.
GENERAL INFORMATION - WARNINGS AND CAUTIONS
CAUTION:
U.S. Federal Law restricts this device for sale by or on the order of a physician.
CAUTION:
Do not expose the
iQ®
Nasal Mask to temperatures above 122°F (50°C).
CAUTION:
This mask may be cleaned and used repeatedly on the same person. Do not sterilize. USA ONLY: For multiple patients use, high level disinfection
protocol must be followed.
WARNING:
At low baseline pressure, the flow through the vent holes may be inadequate to clear all exhaled gas from the tubing. Some re-breathing may occur.
WARNING:
This mask should be used with the positive airway pressure device recommended by the manufacturer, your physician, or a respiratory therapist.
The mask should not be used unless the positive airway pressure device is turned on and operating properly. The mask’s vent holes should never be blocked.
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. However, when the positive airway pressure device is not operating, exhaled air may
be re-breathed. Re-breathing of exhaled air can, in some circumstances, lead to suffocation. This warning applies to most models of nasal positive airway
pressure devices and masks.
WARNING:
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.
WARNING:
No smoking or open flames such as candles may be used when oxygen is in use.
WARNING:
Do not use the
iQ®
Nasal Mask with baseline pressure less than 3 cm H
2
O or greater than 20 cm H
2
O.
WARNING:
Consult manufacturer for proper O
2
enrichment tubing.
Figure 1
Figure 2
VENT HOLE PRESSURE/FLOW CHARACTERISTICS (Approx.)
Vent Flow (L/min)
40
30
20
10
0
0 5 10 15 20
Mask Pressure (cm H
2
O)
1
!
Sleepnet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 USA
Tel: (603) 758-6600
Fax: (603) 758-6699
Toll Free: 1-800-742-3646
(USA AND CANADA ONLY)
www.sleepnetmasks.com
90160-W Rev. A
0123
EU Rep: Medical Product Services GmbH
Borngasse 20, 35619 Braunfels Germany