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Circadiance SleepWeaver Elan User Manual

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100673 REV 7
Intended Use
This SleepWeaver 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 multi-patient,
multi-use in the hospital/institutional environment.
This mask is to be used on patients greater than
66 lbs (30 kg).
Cautions
Refer to your therapy device manual for details on settings and operational
information.
Thetechnicalspecicationsofthemaskareprovidedforyourcliniciantocheck
thattheyarecompatiblewiththetherapydevice.Ifusedoutsidespecication,
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 mask should be cleaned every other day to prevent dirt and oil
contamination from the skin building up on the mask.
The mask should not be cleaned with unapproved cleaning or disinfecting methods.
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
Limited Warranty
www.circadiance.com/help
White hook tab
attaches to the
top of mask
Feather
Weight
Tube
90 Degree
Elbow Swivel
Blue hook tab attaches
to the Bottom of mask
Exhalation
Holes
Size
Identication
Printing
Bottom of
Mask
Adjustment
Tab
1 2 3
4
5
Fitting the Mask
Mask Orientation
Technical Specications
1. Therapy Pressure Range: 4 to 20 cmH
2
O
2. 22mm Swivel Connection
3. Resistance (pressure drop)
@ 50 lpm = 0.4 cmH
2
O
@ 100 lpm = 0.7 cmH
2
O
4. Fixedleakrate(owmayvaryduetomanufacturingvariation):
5. Environmental storage and operating conditions are not expected to effect
the function of this device.
6. Sound Levels
A-weighted Sound Power Level, 27 dBA
A-weighted Sound Pressure Level @ 1m, 19 dBA
7. This device is expected to remain suitable for use under normal
usage and cleaning conditions for a time period of at least 90 days.
8. The device is not made with natural rubber latex.
Pressure (cmH
2
0) 4 5 10 15 20
Flow (lpm) 14 16 27 37 45
English
Instructions for Use
Soft Cloth Masks
Élan
Mailing Address: PO Box 17480, Pittsburgh PA 15235
Physical Address: 1300 Rodi Road Turtle Creek PA 15145
Phone: 888-825-9640 or +1 724-858-2837
cservice@circadiance.com www.sleepweaver.com
www.circadiance.com/help
Watch the Fitting Video
®
EMERGO EUROPE
Prinsessegracht 20,
2514 AP The Hague,
The Netherlands
0459
For patents and trademarks applicable to Circadiance products, please visit www.Circadiance.com/IP
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Circadiance SleepWeaver Elan Specifications

General IconGeneral
CategoryMedical Equipment
Size OptionsSmall, Medium, Large
TypeCPAP Mask
MaterialSoft Fabric
CompatibilityCompatible with most CPAP and BiPAP machines
Intended UseSleep Apnea Treatment
WeightLightweight (specific weight not specified)

Summary

Cautions and Contraindications

General Cautions

Provides precautions for mask use, cleaning, and handling.

Contraindications

States that there are no contraindications for the mask's use.

Technical Specifications

Pressure and Flow Specifications

Details therapy pressure range, resistance, and fixed leak rate.

Mask Features and Performance

Includes connection type, sound levels, and material information.

Instructions for Use

Intended Use and Patient Suitability

Defines the mask's purpose and suitability for patients over 30 kg.

Mask Fitting Guide

Illustrates mask orientation and step-by-step fitting instructions.

Mask Fitting and Leak Adjustment

Fitting the Mask Continued

Provides detailed steps for headgear and mask adjustment for a seal.

Adjusting for Leaks

Offers techniques to eliminate leaks by tightening straps and wiggling the mask.

Attaching Mask Components

Guides on connecting headgear, elbow swivel, and tether strap.

Cleaning and Maintenance

Cleaning the Mask in the Home

Instructions for daily hand washing with mild soap and water.

Cleaning Between Patients

Directs users to the website for specific instructions for multi-patient use.

Safety Warnings

Ventilation and Usage Warnings

Warns against dual limb circuits, blocked vents, and proper setup.

Usage with Supplemental Oxygen

Advises against smoking and turning off oxygen flow when not in use.