USER GUIDE - Stealth Nasal Pillow CPAP Mask with Headgear

NASAL PILLOW MASK
NASAL PILLOW MASK
4 Sizes of pillows available:
Super Small, Small, Med & Lg
REF NO.: 7901
Intended Use
The nasal pillow mask is intended to provide
an interface for Continuous Positive Airway
Pressure (CPAP) or bilevel system.
The mask to be used by adult patients
for whom positive airway pressure has been
prescribed. The mask is for single-patient re-use
in the home environment and multi-patient re-use
in the hospital/ institutional environment.
Features
*Easy to fit, assemble, and maintain.
*4 Pillow Cradles with 4 different pillow sizes.
(Super Smail. Small, Medium & Large)
*Pillows can be independently changed on a
cradle to accommodate nostril asymmetry.
*Quick release floating elbow with 360 degree
rotation and extended silicone tube.
*Quiet vent design.
LATEX
- 1 -
Parts of the Nasal Pillow
2
10
1
9
8
3
4
6
5
7
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Description
Top headgear
Rear headgear
Pillows (Super Smail, Small, Med & Lg)
Pillow Cradle
Slicone Base
Quick Release Connector Ring
Elbow connector
Silicone tube
Swivel connector
Tubing connector
Optional over-the-head tube strap
- 2 -
11
Outline of assembled Nasal Pillow Mask
Slot A1
Front View
B2
Lateral View
B1
Headgear
- 3 -
Assembling your Nasal Pillow Mask
First - insert the small
upper Tab on the Pillow
Cradle into the slot on
the Silicone Base
Next - while holding
the small upper tab
in place, Insert the
large tab on the right
side of the Pillow
Cradle into the side
slot on the Silicone
Base
Last - while continuing
to hold the small upper
tab in place, insert the
other large tab on the
left side of the Pillow
Cradle into the left
side slot on the
Silicone Base.
Note: It is important that the small upper tab on the Pillow Cradle remains
properly inserted into its slot in the Silicone Base to ensure a proper
seal with no leaks.
- 4 -
Connecting & Disconnecting the
Quick Release Elbow.
To disconnect the
Quick Release Elbow,
squeeze the small
tabs on the connector
ring and pull it from
the Silicone Base.
To connect the Quick
Release Elbow, push
it into the Silicone
Base until it snaps into
place.
Inserting Nasal Pillows into the Cradle
Insert the pillows into
the Cradle.
The pillows and cradle
are shaped to only fit
one way.
XS
Line the pillows up
accordingly and be
sure that the pillow's
first groove is properly
seated into the cradle
- 5 -
FITTING YOUR STEALTH NASAL PILLOWS MASK
hold the pillows at
your nose, and pull
the headgear over
your head.
Adjust the Nasal
pillows to the most
comfortable position
Adjust the side
straps of the
headgear upward
to the most optimal
fit
- 6 -
Adjust the rear straps
to the best fit.
Notes:
1) Over tightening of your headgear straps may cause excess pressure on
your nose and can actually cause leaking.
2) Further adjustment of the side and back headgear straps after connected
to the CPAP or BiLevel may be necessary to ensure an optimal fit.
USING THE OPTIONAL OVER-THE-HEAD STRAP
Fasten the air tubing
through tube holder
strap B2 , the tubing
can be positioned in
the center of head.
B2
Complete.
- 7 -
Caution
US federal law restricts this device to sale by or on the order of a
physician.
Warnings
This mask is designed for use with CPAP or bilevel systems
recommended by your health care professional or respiratory
therapist. Do not wear this mask unless the CPAP or bilevel system
is turned on and operating properly. Do not block or try to seal the
exhalation port.
Explanation of the Warning:
CPAP systems are intended to be used with special masks with
connectors which have vent holes to allow continuous flow of air out
of the mask. When the device is turned on and functioning properly,
new air from the device flushes the exhaled air out through the
attached mask exhalation port. However, when the device is not
operating, enough fresh air will not be provided through the mask,
and exhaled air may be re-breathed. At low pressures, the airflow
through the exhalation port may not be enough to clear all of the
exhaled gas (CO2) from the mask. You may breathe in some of the
air that you have exhaled.
*If oxygen is used with the device, the oxygen flow must be turned
off when the device is not operating.
Explanation of the Warning:
When the device is not in operation, and the oxygen flow is left on,
oxygen delivered into the ventilator tubing may accumulate within
the device enclosure. Oxygen accumulated in the device enclosure
will create a risk of fire.
*Oxygen supports combustion. Oxygen should not be used while
smoking or in the presence of an open flame.
*At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen
concentration will vary, depending on the pressure settings, patient
breathing pattern, nasal interface selection, and the leak rate.
*Some users may experience skin redness. If this happens, contact
your health care professional.
Cleaning the Interface:
The pillows, cradle, silicone base and tubing should be cleaned daily or
as needed.
*Hand wash in warm water with a mild liquid dishwashing detergent.
Do not use bleach, alcohol, or cleaning solutions containing alcohol.
Do not use cleaners containing conditioners or moisturizers.
*Rinse thoroughly. Pat with a towel and air dry completely before use.
*Inspect all parts for damage or wear; replace if necessary.
Cleaning the Headgear:
Hand wash the headgear weekly or as needed. Lay the headgear flat
or line dry.
Disposal:
The nasal pillow mask does not contain any hazardous substances
and may be disposed of with your normal household refuse.
- 8 -
Technical specifications
Note: The mask contains passive
venting that meets the requirements
for protection against rebreathing
as specified in ISO 17510-2. As a
result of manufacturing variations,
the vent flow rate may vary.
Pressure-Flow
Curve
4 cmH2O
8 cmH2O 12 cmH2O 16 cmH2O 20 cmH2O
4
8
40
35
30
25
20
15
10
5
0
12
16
20
cmH2O cmH2O cmH2O cmH2O cmH2O
Standards
CE designation in accordance with EC directive
93/42/EEC, class Iia. ISO 14971, ISO13485,
ISO 10993-1 and ISO 17510-2.
Therapy
Pressure
4 to 20cmH2O.
Resistance
Drop in pressure measured
at 50L/min: 2.1cmH2O & 100L/min: 8.0cmH2O
Sound
27.2 dBA @ 10cmH2O; 34.6 dBA @ 20cmH2O
Environmental
Conditions
Operation temperature: -18°C~50°C
Storage temperature: -40°C~60°C
Storage relative humidity: <85%
- 9 -
PART NUMBERS
Part No.
7901
Description
STEALTH
Nasal Pillow
Interface
7905 Replacement Headgear
7906 Replacement Nasal Pillows & Cradle - Super Small
7907
7908
7909
Replacement
Replacement
Replacement
Nasal Pillows & Cradle - Small
Nasal Pillows & Cradle - Medium
Nasal Pillows & Cradle - Large
Probasics
15 S. Main Street
Marlboro, NJ 07746
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