2
4
1
2
5
3
MiniMe 2
™
Mask
1.Touchless Spacebar
™
2.Mask Shell
3.Airgel
™
Cushion
4.Headgear Connector
5.Vented Elbow Assembly
VENT HOLE PRESSURE/FLOW CHARACTERISTICS (Approx.)
MiniMe 2
TM
Nasal Vented Mask
CONTENTS: MiniMe 2
TM
Nasal Vented Mask, tubing, and headgear
THIS PRODUCT IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX
Rx ONLY MADE IN U.S.A.
The MiniMe 2 Pediatric Nasal Vented Mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory
to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and <12 years old. It is intended for single patient, multi-use in the home, hospital, or
institutional environment.
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 mask to temperatures above 122°F (50°C).
WARNING:
Do not use the Mask with baseline pressure less than 4 cm H
2
O or greater than 20 cm H
2
O.
CAUTION:
The mask is designed to provide a stable, effective air seal with minimum headgear tension. Excessive headgear tension may lead to facial deformities with
long-term use. Regular clinical review is recommended.
CAUTION:
If skin irritation or any other adverse reaction develops, discontinue use and contact your health care professional.
CAUTION:
This mask may be cleaned and used repeatedly on the same person. Do not sterilize.
WARNING:
This mask is not suitable for providing life support ventilation.
WARNING
: Do not block or try to seal the vent holes.
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 is intended for use on children >2 years of age and <12 years of age. The mask is designed to seal over the child’s nose. Ensure that the nasal mask
cushion does not block the nostrils at any time during fitting or use.
WARNING:
Children should be attended at all times during therapy.
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. 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:
Consult manufacturer for proper O
2
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:
Using a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
WARNING:
Significant unintentional leak may occur without properly fitting the mask. Follow the USER INSTRUCTIONS FOR MINIME 2 NASAL MASK provided.
WARNING:
If the mask is prescribed for children with serious congenital conditions or cognitive impairments then the positive pressure device must have the appropriate
alarms. The device, mask, and alarms must be tested before starting therapy.
GENERAL INFORMATION
The mask has a non-transferable three month limited warranty for manufacturer’s defects from the date of purchase by the initial consumer. If a mask used under normal
conditions should fail, Sleepnet will replace the mask or its components. For additional information about the Sleepnet Warranty, please visit http://www.sleepnetmasks.com/
products/our-promise.cfm.
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