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iQ
Ventilation Nasal Mask
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CONTENTS: iQ
Ventilation Nasal Mask with iQ StableFit Headgear
Rx ONLY DESIGNED AND BUILT IN THE U.S.A.
!
THIS PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX
The iQ Ventilation Nasal mask is to be used as an accessory to CPAP/bi-level positive pressure systems
that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product
is indicated for use with CPAP/BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION
VALVES. The iQ Ventilation Nasal Mask is intended for single patient, multi-use in the home and hospital/
institutional environment. It is intended for use on adult patients > 30 kg.
GENERAL INFORMATION - WARNINGS AND CAUTIONS
CAUTION: U. S. Federal Law restricts this device for sale by or on the order of a physician.
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CAUTION: Do not expose the iQ
Ventilation Nasal Mask to temperatures above 122°F (50°C).
WARNING: This mask should be used with a POSITIVE PRESSURE DEVICE WITH AN EXHALATION
VALVE recommended by the manufacturer or by your physician or respiratory therapist. This mask
should not be used unless the positive pressure device is turned on and operating properly. When the
device is functioning properly, the exhalation valve allows exhaled air to escape to ambient. However,
when the device is not operating, exhaled air may be re-breathed. Re-breathing of exhaled air can, in
some circumstances, lead to suffocation.
WARNING: This mask must be used with a device which has ADEQUATE ALARMS AND SAFETY
SYSTEMS in the event of a device failure. In the event of device failure, use of this mask requires the
same level of attention and assistance as the use of a tracheal tube.
CAUTION: Consult manufacturer for proper O2 enrichment tubing.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.
WARNING: If oxygen is used with the mask, the oxygen flow must be turned off when the device is not
operating. When the device is not in operation, and the oxygen flow is left on, oxygen delivered into the
tubing may accumulate within the device enclosure. Oxygen build-up will create a risk of fire.
WARNING: No smoking or open flames (such as candles) may be used when oxygen is in use.
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WARNING: The iQ
Ventilation Nasal Mask must be used with non-conductive tubing.
WARNING: If skin irritation or any other adverse reaction develops, discontinue use and contact your
health care professional.
GENERAL INFORMATION
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The iQ
Ventilation Nasal Mask has a 3 month warranty for manufacturing defects. If a manufacturing
defect is suspected, contact your supplier.
NOTE: Please dispose of the mask and accessories in accordance with local and regional guidelines. The
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iQ
Ventilation Nasal Mask and its accessories do not contain natural rubber latex.
NOTE: The iQ Ventilation Mask is provided clean, non-sterile, and ready to use. No additional processing
is required prior to the initial use.
CLEANING AND MAINTENANCE
NOTE: Inspect mask prior to each use. Replace the mask if parts are damaged or gel is exposed due
to tears or punctures.
NOTE: The gel cushion, although silky to touch, will not tear, leak or detach from the mask under normal
use and following recommended cleaning and maintenance protocols. However, the gel cushion is not
indestructible. It will tear, cut and rip if subjected to mishandling or abuse. Do not clean in a dishwashing
machine. The warranty does not cover these types of product failures. Therefore, please handle your
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new iQ
Ventilation Nasal Mask with care.
For Home Use: Cleaning is recommended on a daily basis. Wash the mask and components in warm
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INTENDED USE
water using a mild shampoo or dish detergent. Rinse thoroughly after washing. Visually verify that the
swivel elbow is not obstructed and allow the mask to air dry.
TECHNICAL INFORMATION
Deliverable pressure range: 3 to 20 cm H 2 O
Dead space: 120 ml
Pressure drop: 0.31 @ 30 lpm, 1.28 @ 60 lpm
Recommended operating conditions:
Temperature 60°F to 90°F
Humidity 0°F to 85% RH
Recommended storage conditions:
Temperature 10°F to 90°F
Humidity 0°F to 50% RH
USER INSTRUCTIONS FOR IQ® STABLEFIT HEADGEAR
1. Attach tubing to mask, if not already assembled.
2. Thread upper straps through forehead slots as illustrated, and affix Velcro tabs lightly.
3. Thread lower straps through slots in the mask headgear connector. Thread center bridge strap through
top slot on the headgaer connector.
4. Place the mask and headgear assembly on head with blue fabric facing outward. Adjust uppper and
lower headger straps; unhook the Velcro tabs and pull forward to center the mask over face, and adjust
strap tension and length. Affix tabs.
5. Adjust center bridge strap. Attach tubing to headgear with loop strap, if preferred.
NOTE: The mask should rest comfortably against the face and still provide an effective air seal. Pulling
the straps too tight can cause skin irritation. The mask should not constrict your nose; you should be
able to breathe freely and comfortably. If the mask and headgear are adjusted correctly and a problem
persists, contact your healthcare professional.
6. Attach mask tubing to device tubing; turn device on and verify airflow through mask.
7. Gently bend pliable ring embedded inside mask shell to change mask shape to create a comfortable
fit, and reduce leaks.
REMOVING THE MASK AND HEADGEAR
8. Open one of the horizontal straps and detach from headgear connector on the mask.
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iQ
is a trademark of Sleepnet Corporation.
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Visit our website at www.sleepnetmasks.com.
Máscara nasal de ventilación iQ
ESPAÑOL
CONTENIDO: Máscara nasal de ventilación iQ® con casco StableFit™ iQ
!
Sólo Rx Diseñado y fabricado en los EE.UU.
ESTE PRODUCTO NO CONTIENE LÁTEX DE CAUCHO NATURAL
La máscara de ventilación nasal iQ debe usarse como accesorio de los sistemas de presión positiva de
tipo CPAP o binivel que dispongan de alarmas y sistemas de seguridad adecuados en caso de fallo del
suministro de presión positiva. Utilícese con SISTEMAS DE PRESIÓN POSITIVA DE TIPO CPAP O
BINIVEL QUE CONTENGAN VÁLVULAS DE ESPIRACIÓN. La máscara de ventilación nasal iQ está
diseñada para un único paciente, para usos sucesivos en el hogar y en el entorno hospitalario o sanitario. Está
prevista para ser utilizada en pacientes adultos > 30 kg.
INFORMACIÓN GENERAL - ADVERTENCIAS Y PRECAUCIONES
PRECAUCIÓN: Las leyes federales de EE. UU. restringen el empleo de este dispositivo para un médico
o bajo su prescripción facultativa.
PRECAUCIÓN: No exponga la Máscara de ventilación nasa iQ
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USO PREVISTO
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a temperaturas superiores a 50°C (122°F).
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