Philips Respironics Amara, Respironics Amara Gel Instructions For Use Manual

Manufactured for:

Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA

Respironics Deutschland
Gewerbestrasse 17
82211 Herrsching, Germany

1077884 R14

©2015 Koninklijke Philips N.V. All rights reserved.

LZ 7/22/2015

Amara
Amara Gel

PT

PT-BR

INSTRUCTIONS FOR USEEN

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MODE D’EMPLOIFR

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ISTRUZIONI PER L’USOIT

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GEBRAUCHSANWEISUNGDE

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INSTRUCCIONES DE USOES

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INSTRUÇÕES DE UTILIZAÇÃO

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INSTRUÇÕES DE USO

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ΟΔΗΓΙΕΣ ΧΡΗΣΗΣEL

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BRUGSVEJLEDNINGDA

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GEBRUIKSAANWIJZINGNL

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BRUKSANVISNINGSV

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KÄYTTÖOHJEETFI

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BRUKSANVISNINGNO

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INSTRUKCJA UŻYCIAPL

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NÁVOD K POUŽITÍCS

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HASZNÁLATI UTASÍTÁSHU

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NÁVOD NA POUŽITIESK

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NAVODILA ZA UPORABOSL

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ZH-TW

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LIETOŠANAS INSTRUKCIJALV

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NAUDOJIMO INSTRUKCIJALT

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KASUTUSJUHISED ET

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INSTRUCŢIUNI DE UTILIZARERO

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ИНСТРУКЦИИ ЗА УПОТРЕБА

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УПАТСТВА ЗА УПОТРЕБАMK

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UPUTE ZA UPORABUHR

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使用说明

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PETUNJUK PENGGUNAANID

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ARAHAN UNTUK PENGGUNAANMS

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Instructions for Use

ENGLISH

Amara Full Face Mask

Intended Use

The Amara and Amara Gel Full Face Masks are intended to provide an interface for
application of CPAP or bi-level therapy to patients. The masks are for single patient use
in the home or multi-patient use in the hospital/institutional environment. The masks
are to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been
prescribed.

Note: An exhalation port is built into the mask so a separate exhalation port is not required.

Note: This mask is not made with natural rubber latex or DEHP.

Symbols

Warning or
Caution

Not Made With Natural
Rubber Latex

Note

System One Resistance
Control

Tip

Warnings:

• This mask is not suitable for providing life support ventilation.

• Hand wash prior to use. Inspect the mask for damage or wear (cracking, crazing, tears,
etc). Discard and replace any components as necessary.

• This mask is designed for use with CPAP or bi-level systems recommended by your health
care professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level
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
CPAP machine is turned on and functioning properly, new air from the CPAP machine flushes
the exhaled air out through the attached mask exhalation por t. However, when the CPAP
machine is not operating, enough fresh air will not be provided through the mask, and exhaled
air may be rebreathed.Rebreathing of exhaled air for longer than several minutes can in some
circumstances lead to suffocation. This warning applies to most models of CPAP systems.

• 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.

• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,
depending on the pressure settings, patient breathing pattern, mask selection, and the leak
rate. This warning applies to most types of CPAP and bi-level machines.

• At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to
clear all exhaled gas from the tubing. Some rebreathing may occur.

• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue
use and contact your healthcare professional.

• Consult a physician if any of the following symptoms occur: Unusual chest discomfort,
shor tness of breath, stomach distension, belching, severe headache, blurred vision, drying of
the eyes, eye pain or eye infections.

• This mask should not be used on patients who are uncooperative, obtunded, unresponsive, or
unable to remove the mask.

1

• This mask is not recommended if the patient is taking a prescription drug that may cause
vomiting.

• Consult a physician or dentist if you encounter tooth, gum, or jaw soreness. Use of a mask
may aggravate an existing dental condition.

• A minimum of 3cm H2O (hPa) must be maintained when using this mask.

• Attaching an exhalation device requires therapy pressure level adjustment to compensate for
increased leak.

• Do not block or seal off the entrainment
valve.

E

Contraindications

This mask may not be suitable for use on
patients with the following conditions:
recent eye surgery or dry eyes, hiatal hernia,
excessive reflux, impaired cough reflex,
impaired cardiac sphincter function; or on
patients unable to remove the mask by
themselves.

A

B

C

D

F

G

H

I

J

Before Use Read and Understand the
Instructions Completely

• Hand wash the mask.

• Wash your face. Do not use moisturizer/lotion on your
hands or face.

• Inspect the mask and replace it if the cushion has hardened
or is torn, or if any parts are broken.

• Verify that the therapy device, i.e., ventilator, including the
alarms and safety systems, has been validated prior to use.

• Verify therapy device pressure(s).

Verify the Entrainment Valve

Figure 1
A Top Headgear Straps
B Integrated Cushion/Faceplate
C Bottom Headgear Straps
D Entrainment Valve Air Inlet (Do

Not Block)
E Push Button Adjuster
F Forehead Pad Support
G Frame with Elbow
H Exhalation Port (Do Not Block)
I Headgear Clips
J Quick Release Swivel

The entrainment valve consists of an air inlet and a flapper.
With the airflow turned off, verify that the elbow with the
flapper is lying flat (Figure 2A) so that room air can flow in and
out through the air inlet. Next, with the airflow on, the flapper
should now cover the air inlet and air from the CPAP or bi­level device should flow into the mask (Figure 2B). If the flapper
does not close or does not function properly, replace the mask.

Warning: Do not block or seal the entrainment valve.

2A

2B

Figure 2

2

Cleaning Instructions

Hand wash the mask before first use and daily. The headgear should be hand washed
weekly, or as needed. The headgear does not need to be removed for daily cleaning of
the mask.

1. Hand wash mask in warm water with liquid dishwashing detergent.

2. Rinse thoroughly. Air dry completely before use. Make sure the mask is dry before
use. Lay the headgear flat or line dry. Do not place the headgear into the dryer.

Caution: Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol,

o r cl e a n i n g s o l u t i o ns co n t a i n i n g c o n di t i o n e r s o r m o i s t u r i ze r s .
Caution: Any deviation from these instructions may impact the performance of the
product.

Caution: Inspect the mask for damage or wear (cracking, crazing, tears, etc). Discard

and replace any components as necessary.

Institutional Disinfection

For multi-patient use in the hospital/institutional environment, use the Disinfection Guide to reprocess
the mask between patients. These instructions can be obtained by visiting us online at www.philips.com/
respironics or by contacting Philips Respironics Customer Service at 1-800-345-6443 (USA or Canada) or
at 1-724-387-4000.

Dishwashing Instructions

In addition to hand washing, the mask may be cleaned in the dishwasher once a week.

Caution: Use a mild liquid dish washing detergent only to wash the mask.

1. Remove the headgear. Do not wash the headgear in the dishwasher.

2. Separate the cushion and the faceplate and wash in the top shelf of the dishwasher.

3. Air dry. Make sure the mask is dry before use.

4. Inspect all parts for damage or wear; replace any parts that have visibly deteriorated
(cracking, crazing, tears, etc). Replace the mask if the cushion becomes hardened.

Philips Respironics System One Resistance Control

Your mask when combined with a Philips Respironics System One device, provides optimal
resistance compensation. This mask value is

and should be set by your provider.

Notes:

• Compare the mask to the device. See your device manual if the values do not match.

• System One is not compatible with masks that use a separate exhalation device.

3

Achieving the Right Fit

Before putting on the mask:

1. Headgear clips - Grip and twist away from the frame

to disconnect.

2. Headgear - L o o s e n t o a l a r g e s e t t i n g .

Adjusting the mask:

1. Pull the mask over your head. Hold the mask against your

face.

2. Headgear clips - Press into place to connect.(Figure 3).

3. Headgear - Pull back the tabs to evenly adjust the top

and bottom straps (Figure 4).

4. Forehead adjuster button - Press and hold to slide the

frame toward or away from your face to adjust pressure
(Figure 5). This will decrease or increase the pressure on
the bridge of your nose and chin.

The mask should rest comfortably against your face. The
forehead pad will touch your forehead lightly. The bottom
of the mask cushion should rest just above your chin with
your mouth slightly open.

Figure 3

4

Using the mask:

1. Connect the flexible tubing (included with your CPAP or bi-level

device) to the elbow swivel on the mask.

2. Lie down. Turn the therapy device on. Breathe normally. Keep your

mouth slightly open.

3. Assume different sleeping positions. Move around until

comfortable. If there are any excessive air leaks, make final
adjustments. Some air leaking is normal.

Comfort Tips

• The most common mistake is overtightening
the headgear. The headgear should fit loose and
comfortable. If your skin bulges around the mask or if
you see red marks on your face, loosen the headgear.

• Adjust the bottom headgear straps to reduce leaks at
the sides of your mouth.

Removing the Mask

Disconnect the headgear clips and pull over the top of your
head (Figure 6).

Figure 4

Figure 5

Figure 6

4