General Information - Sleepnet MiniMe 2 Bedienungsanleitung

CONTENTS: MiniMe
THIS PRODUCT IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX
The MiniMe 2 Pediatric Nasal Non-Vented Mask is intended to provide an interface for application of positive
pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems
CONTAINING EXHALATION VALVES. 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.
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
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: The mask does not have exhalation holes and must be used with a patient circuit that incorporates an
exhalation valve.
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 vent holes in the patient circuit 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, air from the device flushes the exhaled air out through the vent
holes in the patient circuit. 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
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.
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 www.
sleepnetmasks.com. Per EU MDR 2017/745, please report serious incidents to manufacturer and EU Member
State competent authority.
NOTE: The mask has a service life of 6 months.
NOTE: Please dispose of the mask and accessories in accordance with local and regional guidelines.
NOTE: THIS PRODUCT IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX
NOTE: The mask without vent holes can only be used with positive pressure devices that have an exhaust valve.
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MiniMe 2 Nasal Non-Vented Mask
®
2 Pediatric Nasal Non-Vented Mask, Tubing, and Headgear
®
Rx ONLY
GENERAL INFORMATION - WARNINGS AND CAUTIONS

GENERAL INFORMATION

MADE IN U.S.A.
enrichment tubing. At a fixed rate of supplemental oxygen
2
O or greater than 20 cm H
2
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2