Respironics Amara View Instructions For Use Manual

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Amara View minimal contact full-face mask

Instructions for Use

Intended Use

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

Caution: U.S. Federal law restricts this device to sale by or on the order of a

physician.

Note:

• An exhalation port is built into this mask so a separate exhalation port is not required.

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

Symbols

Warning or Caution

Note

Tip

Consult Instructions for
Use

Not Made with Natural
Rubber Latex

X1 System One Resistance Control

Warnings

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

• 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 port. 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.

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• 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,
shortness 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.

• 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 overtighten the headgear straps. Watch for signs of overtightening, such as
excessive redness, sores or bulging skin around the edges of the mask. Loosen the
headgear straps to alleviate symptoms.

• Do not block or seal the anti-asphyxia valve or exhalation ports.

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Figure a
AMask Cushion with Exhalation Ports

(Do not block)

BMask Frame
CElbow with Anti-Asphyxia Valve

(Do not block)

DQuick Release Tabs
EQuick Release Tube with swivel
FHeadgear Crown Strap
GHeadgear Top Side Strap
HHeadgear Bottom Side Strap

IHeadgear Clip

A

C

F

G

H

I

1

B

D

E

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Verify the Anti-Asphyxia Valve

The anti-asphyxia valve consists of an air inlet and a flapper b. With the airflow
turned off, verify that the elbow with the flapper is lying flat 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 bi-level device should flow into the
mask . If the flapper does not close or does not function properly, replace the
mask.

Warning: Do not block or seal the anti-asphyxia valve.

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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.

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 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).

Cleaning Instructions

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

1. Hand wash mask and headgear 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,

or cleaning solutions containing conditioners or moisturizers.

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

Refer to the Disinfection Guide for Professional Users to reprocess between patients in
a clinical setting. Access the latest version of the Disinfection Guide at www.healthcare.
philips.com or by contacting customer service at 1-800-345-6443 (USA or Canada only) or
[phone].