Technical Specifications - Circadiance SleepWeaver 3 Guia De Inicio Rapido

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Intended Use
The SleepWeaver 3D Nasal Mask is intended to
provide an interface for Continuous Positive Airway
Pressure (CPAP) or Bi-Level therapy. This mask is
intended for single-patient reuse in the home and
single-patient reuse in the hospital / institutional
environment. This mask is to be used on patients
greater than 66 lbs (30 kg).
Fitting the Mask & Adjusting for Leaks:
1. Remove mask from packaging. If you have
removed the mask from the headgear, re-attach
the headgear straps through the slits in the mask
wings. The black tabs will pass through the slits
with a black arrow (picture 1).
2. Put mask on by pulling the headgear over your
head so that the cup of the mask is centered over
the nose (picture 2).
3. The neck support of the headgear should sit
comfortably on the lower part of your neck
(picture 3).
4. Adjust the bottom straps first so that the bottom
of the mask is comfortably resting on your
upper lip just below your nostrils (picture 4).
5. Adjust the top straps to pull the mask comfortably
against your nose (picture 5).
6. Ensure headgear is not overly tightened, you
should be able to easily fit one finger under each
strap of the headgear (picture 6).
7. Connect the tubing from the machine to the
plastic hose connector on the front of the mask
(picture 7).
8. Turn on the machine (picture 8).
9. If there are leaks, push the white interface
material down into the mask and release the
fabric. Allow the white material to blow out
towards your nose to achieve a seal (picture 9).
10.You may also try to shift the mask and/or white
fabric around so that the fabric is able to form
a seal against your skin. Slightly tightening or
loosening the headgear straps may also aid in
obtaining a seal (picture 10).
11.Lie down in a normal sleeping position and
read just the mask as necessary (picture 11).
Cleaning the Mask
• Hand wash the mask every other day with a mild,
nonabrasive soap in warm water. Air dry out of
direct sunlight.
• Hand wash the headgear weekly.
Warnings
• The device is a vented mask and should
not be used with a dual limb ventilation circuit.
• If there are any reactions to any part of this mask
or headgear, discontinue use immediately.
• This system should be not be used unless the
therapy device is turned on and is operating
properly.
• The vent holes should never be blocked.
• The SleepWeaver 3D Mask is for single patient
reuse only and is not approved for reprocessing
(cleaning and disinfecting methods) in the clinical
setting. For both the home and clinical setting,
only the cleaning methods outlined in these
instructions should be utilized.
• Ensure the mask is put on correctly. Ensure the
mask and headgear are assembled and positioned
as shown in the Quick Start Guide.
English
• If any visible deterioration of a system component
is apparent (cracking, broken parts, tears, etc.),
or if after cleaning any components remain
unclean, the component should be discarded and
replaced.
• Please refrain from smoking while using this
product.
• Varying the frequency, method, or cleaning agent
to clean this product other than what is detailed
in these instructions may have an adverse effect
on Sleepweaver 3D and consequently the safety
or quality of the therapy.
Limited Warranty: www.circadiance.com/help
Cautions
• Refer to your therapy device manual for details on
settings and operational information.
• The technical specifications of the mask are
provided for your clinician to check that they are
compatible with the therapy device. If used
outside specification, the seal and comfort of the
mask may not be effective, optimum therapy
may not be achieved, and leak or variation in the
leak rate may affect device function.
• The SleepWeaver 3D mask should not be cleaned
with unapproved cleaning and disinfecting
methods.
• The mask should be cleaned every other day to
prevent dirt and oil contamination from the skin
building up on the mask.
• The user should clean their face prior to wearing
the mask.
• The user should not alter the design of the mask.
• Do not place the mask in a clothes dryer.
• In the USA, federal law restricts this device to
sale by, or on the order of, a physician.
Contraindications
• None

Technical Specifications

1. Therapy Pressure range
4 to 20 cm H2O
2. 22mm swivel connection
3. Resistance (pressure drop)
@ 50 lpm = 0.3 cm H2O
@ 100 lpm = 0.5 cm H2O
4. Fixed leak rate (flow may vary due to
manufacturing variation):
Pressure (cm H
0)
2
Flow (lpm)
5. Environmental storage and operating conditions
are not expected to effect the function of this
device.
6. Sound Levels
A-weighted Sound Power Level, 26dBA
A-weighted Sound Pressure Level @ 1m, 18dBA
7. The Sleepweaver 3D is expected to remain
suitable for use under normal usage and cleaning
conditions for a time period of at least 90 days.
8. This device is not made with natural rubber latex.
Watch the SleepWeaver
3D Quick Fit Video Online:
www.circadiance.com/3dvideos
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