Sleepnet Mojo 2, Instructions Manual

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Mojo ® 2 Full Face AAV Non Vented Mask
CONTENTS: Mojo ® 2 Full Face AAV Non Vented Mask with Headgear
Assembled in USA with US and imported parts
Rx Only
INTENDED USE
The Mojo ® 2 Full Face AAV 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.
NOTES
¾
This mask requires a separate exhalation device.
¾ The mask system does not contain DEHP or phthalates.
¾
This product is not manufactured with natural rubber latex.
¾ If the patient has ANY reaction to any part of the mask system, discontinue use.
¾
The mask includes an anti-asphyxia valve (air entrainment valve) to help reduce rebreathing of exhaled air in
the event that the positive pressure device does not work properly.
¾
Verify that the mask is the right size by using the sizing guide.
CONTRAINDICATIONS
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.
CAUTIONS
¾ U.S. Federal Law restricts this device for sale by or on the order of a physician.
¾ Do not expose the Mojo
®
2 Full Face AAV Non Vented Mask to temperatures above 122°F (50°C).
¾ 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.
¾ Consult physician prior to using mask if using any medications or devices to remove deep secretions.
WARNINGS
¾ This mask is not suitable for providing life support ventilation.
¾ 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.
¾ Do not use the Mojo ® 2 Full Face AAV Non Vented Mask with baseline pressure less than 3 cm H2O.
¾ 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.
¾ No smoking or open flames such as candles may be used when oxygen is in use.
¾ If using O
2
enrichment, turn off oxygen supply when not in use. When using a fixed flow rate of supplemental
oxygen, the inhaled oxygen percentage will vary, depending on pressure settings, patient breathing pattern,
mask size, and leak rate.
¾ To minimize the risk of vomiting during sleep, avoid eating or drinking for three (3) hours before using the
mask.
¾ 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
im¬mediately reported to physician.
¾ Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms
occur, consult a physician or dentist.
¾ 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.
¾ 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.
¾ Significant unintentional leak may occur without properly fitting the mask. Follow the MASK FITTING
INSTRUCTIONS provided.
¾ The elbow and anti-asphyxia valve (air entrainment valve) assembly have specific safety functions. The mask
should not be used if the valve is damaged. The mask should be discarded if the valve is damaged, distorted, or
torn. This mask is not intended for patients without a spontaneous respiratory drive. This mask should not be
!
37
NOT:
I. Kay ı ş lar ı a ş ı r ı s ı kmay ı n. A ş ı r ı s ı kma, s ı z ı nt ı lar ı n artmas ı na sebep olab l r. Opt mum oturma ve konfor ç n,
maske tam oturmal ı ancak s ı k ı olmamal ı d ı r.
MASKE VE BA Ş LI Ğ IN HIZLICA ÇIKARILMASI
13. Manyet k kl psler ay ı r ı n ve yüzünüzden kald ı r ı n. Maskey ve ba ş l ı k tert bat ı n ı ç ı kar ı n.
Mojo
®
Sleepnet Corporat on’ ı n t car markas ı d ı r.
Web s tem z www.sleepnetmasks.com’u z yaret ed n.
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