DirectHome MEDICAL SleepWeaver Anew Manual Del Usuario

Technical Specifications (cont.)
4. Anti-Asphyxia Valve (AAV) operation:
Open to atmosphere @ 1.6 cm H
Close to atmosphere @ 2.1 cm H
5. Fixed leak rate (flow may vary due to manufacturing variation):
Pressure (cm H 0) 4 5
2
Flow (LPM) 16 18
6. Environmental storage and operating conditions are not expected to effect the
function of this device.
Cautions & Warnings
• Does not contain natural rubber latex. If you have any reaction to any part of this mask or
headgear discontinue use immediately.
• In the USA, federal law restricts this device to sale by, or on the order of, a physician.
• This system should be used only with the PAP system recommended by your physician or
respiratory therapist.
• This mask should not be used unless the PAP machine is turned on and operating properly.
• The vent holes should never be blocked.
• Please refrain from smoking while using this product.
• The SleepWeaver Anew should not be cleaned with unapproved cleaning and
disinfecting methods.
• The mask should be cleaned daily to prevent dirt and oil contamination from the skin
building up on the mask.
• The patient should clean their face prior to wearing the mask.
• Ensure the mask is put on correctly. The oral portion of the mask contains the
90 Elbow AAV.
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• The patient should not alter the design of the mask.
• Do not place the mask in a clothes dryer.
• Do not block or disable the AAV on the SleepWeaver Anew.
• The SleepWeaver Anew is not intended to be used on patients that are uncooperative,
obtunded, unresponsive, or unable to remove the mask without clinical supervision.
• If the SleepWeaver Anew is being used with supplemental oxygen, the oxygen flow must
be turned off if the machine is not operating because accumulated oxygen is a fire hazard.
• If the SleepWeaver Anew is being used with supplemental oxygen, the patient should
refrain from smoking.
• To minimize the risk of vomiting during sleep, the patient should avoid eating or drinking
for three hours before using the mask.
• The SleepWeaver Anew is for single patient re-use only and is not approved for clinical
cleaning and disinfecting methods.
• At low pressures the flow through the ventilation holes may be inadequate to clear all
exhaled gas from the tubing. Some rebreathing may occur.
Contraindications
• The SleepWeaver Anew should not be used in conjunction with a volume ventilator that
requires a non-vented mask.
• The SleepWeaver Anew is not intended to be used by those patients that are taking
prescription drugs that may cause vomiting.
• The SleepWeaver Anew may not be suitable for persons with the following conditions:
impaired cardiac sphincter, excessive reflux, impaired cough reflex, or hiatal hernia.
Limited Warranty
• www.circadiance.com/help
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Intended Use
The SleepWeaver Anew Soft Cloth Full Face PAP Mask is intended to provide an
interface for Positive Airway Pressure (PAP) therapy. This mask is intended for
single-patient reuse in the home and in the hospital/institutional environment.
This mask is to be used on patients greater than 66 lbs (30 kg).
Mask Orientation
1. Remove your SleepWeaver Anew from the package.
2. Understand the proper orientation of the mask:
a. Oral interface covers your mouth
1. Contains 90
2. Contains exhalation holes
3. Contains mask size (Small, Regular, Large)
b. Nasal interface covers your nose
a. / 1.
a. / 2.
a. / 3.
Elbow Anti-Asphyxia Valve (AAV)
o
b.