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The Mojo
2 Full Face Non Vented Mask is intended to provide a patient interface for application of noninvasive ventilation. The
®
mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are
intended to administer positive pressure ventilation. It is intended for use on adult patients (>30kg) who are appropriate candidates
for noninvasive ventilation in the hospital or institutional environment.
This mask requires a separate exhalation device.
The mask system does not contain DEHP or phthalates.
This product is not manufactured with natural rubber latex.
If the patient has ANY reaction to any part of the mask system, discontinue use.
The mask does not include an anti-asphyxia valve (air entrainment valve).
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.
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical
contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples
include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips,
metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter,
implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact
lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic
metallic implants/electrodes/valves placed in upper limbs, torso, or higher, etc. If you have any questions regarding the
implant, consult your physician or the manufacturer of your implant.
U.S. Federal Law restricts this device for sale by or on the order of a physician.
Do not expose the Mojo
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.
Consult physician prior to using mask if using any medications or devices to remove deep secretions.
This mask is not suitable for providing life support ventilation.
This mask should be used with a POSITIVE PRESSURE VENTILATOR WITH AN EXHALATION VALVE
recommended by the manufacturer or by your physician or respiratory therapist. The mask should not be used unless the
positive pressure ventilator is turned on and operating properly. When the ventilator is functioning properly, the exhalation
valve allows exhaled air to escape to ambient. When the ventilator is not operating, exhaled air may be re-breathed.
Re-breathing of exhaled air can, in some circumstances, lead to suffocation.
Do not use the Mojo
This mask must be used with VENTILATORS WHICH HAVE ADEQUATE ALARMS AND SAFETY SYSTEMS in the
event of a ventilator failure. In the event of ventilator failure, use of this mask requires the same level of attention and
assistance as the use of a tracheal tube.
No smoking or open flames such as candles may be used when oxygen is in use.
If using O
enrichment, turn off oxygen supply when not in use. When using a fixed flow rate of supplemental oxygen, the
2
inhaled oxygen percentage will vary, depending on pressure settings, patient breathing pattern, mask size, and leak rate.
To minimize the risk of vomiting during sleep, avoid eating or drinking for three (3) hours before using the mask.
Any unusual skin irritation, unusual chest discomfort, shortness of breath, gastric distention, abdominal pain, belching or
flatulence from ingested air, or severe headache during or immediately after use should be immediately reported to physician.
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 you experience any of the following symptoms 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.
Significant unintentional leak may occur without properly fitting the mask. Follow the MASK FITTING INSTRUCTIONS
provided.
This mask does not include an anti-asphyxia valve (air entrainment valve) that would allow a patient to breathe if the
ventilator failed. This mask is not intended for patients without a spontaneous respiratory drive. This mask should not be
Mojo
2 Full Face Non Vented Mask
®
CONTENTS: Mojo
2 Full Face Non Vented Mask with Headgear
®
Assembled in USA with US and imported parts
CONTRAINDICATIONS
®
2 Full Face Non Vented Mask to temperatures above 122°F (50°C).
2 Full Face Non Vented Mask with baseline pressure less than 3 cm H
®
Rx Only
INTENDED USE
NOTES
CAUTIONS
WARNINGS
ENGLISH
!
O.
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