Respironics ComfortFull 2 Manual de usuario

1067749

JDH 03/31/2010

ComfortFull 2

INSTRUCTIONS FOR USE

ComfortFull 2

Full Face Mask

2 Package Contents

4 Intended Use

5 Warnings

7 Contraindications and Disposal

8 Symbols

9 Before Use

10 Cleaning Instructions

12 System One Resistance Control

13 Removing and Attaching the Headgear

15 Achieving the Right Fit

20 Removing the Headgear and Mask

20 Tubing Quick Release

21 Troubleshooting Leaks

22 Replacing the Forehead Pad

23 Specifications

26 Reorder Information

27 Limited Warranty

Table of Contents

ComfortFull 2

Package Contents

ComfortFull 2 mask•

Headgear•

Mask assembly•

Instructions for use•

Quick Start fitting tips•

Note: Not all packages contain listed items. Please

contact your Home Care Provider or Respironics for

additional items or replacement parts.

INSTRUCTIONS FOR USE

ComfortFull 2

Full Face Mask

Figure 1

A = StabilitySelector

B = Exhalation Port

(Do not block)

C = Entrainment Valve

D = Elbow Swivel

E = Tubing Quick Release

F = Quick Clip Socket

G = Port Cap

H = Cushion

I = Forehead Support

ComfortFull 2

Intended Use

The ComfortFull 2 Full Face 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 (>66 lbs/30 kg) for whom

CPAP or bi-level therapy has been prescribed.

Important Note: An exhalation port is built into the ComfortFull 2 Full

Face Mask so a separate exhalation port is not required.

Caution: US federal law restricts this device to sale by or on the order of

a physician.

INSTRUCTIONS FOR USE

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. This warning applies to most

models of CPAP systems. Rebreathing of exhaled

air for longer than several minutes can, in some

circumstances, lead to suffocation.

If oxygen is used with this device, the oxygen•

flow must be turned off when the machine 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

Warning:

Indicates the possibility

of injury to the user

or operator

Caution:

Indicates the possibility of

damage to the device

Note:

A note places an

emphasis on an

operating characteristic.

ComfortFull 2

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, mask selection, and the leak rate.This warning applies to most types of

CPAP or bi-level machines.

Some users may experience skin redness, irritation, or discomfort. If this•

happens, discontinue use and contact your healthcare professional.

The patient’s physician should be contacted if the patient experiences the•

following symptoms while using the masks or after removing it: Unusual chest

discomfort, shortness of breath, stomach distension, belching, or sever headache;

drying of the eyes, eye pain, or eye infections; blurred vision. (Consult an

ophthalmologist if symptoms persist.)

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.

A minimum of 3 cm H•

O (hPa) must be maintained when using this mask.

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

If an additional exhalation device is added to the patient circuit, you may•

need to adjust the pressure level to compensate for the additional leak of the

exhalation device.

INSTRUCTIONS FOR USE

Hand wash prior to first use. Inspect the mask for damage or wear (cracking,•

crazing, tears, etc). Discard and replace any components as necessary.

Use of a nasal or full face mask may cause tooth, gum, or jaw soreness or•

aggravate an existing dental condition. Consult your physician or dentist if

symptoms occur.

Do not block or try to seal the entrainment valve.•

Contraindications

This mask may not be suitable for persons with the following conditions:

impaired cardiac sphincter function, excessive reflux, impaired cough reflex, and

hiatal hernia. It should not be used if the person is uncooperative, obtunded,

unresponsive, or unable to remove the mask by themselves.

Disposal

Dispose of in accordance with local regulations.

ComfortFull 2

Symbols

Symbol Description

Consult instructions for use

General caution or warning

Note

Tip

System One Resistance Control

INSTRUCTIONS FOR USE

Before Use

Hand wash the mask to remove particles that may have accumulated•

during shipping or storage.

Read and understand the instructions completely.•

Verify that the entrainment valve functions correctly.•

Wash face.•

Remove the quick fit tips.•

Comfort Tip

If you have sensitive skin, you can condition the mask before use. To condition,

create a bath of warm, soapy water and soak the mask for 30-60 minutes. Use

a mild detergent free of conditioners, moisturizers, or bleaching agents. Rinse

thoroughly and air dry.

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