Respironics Profile Lite Manuel utilisateur

1067778

JDH 04/9/2010

Profile Lite

INSTRUCTIONS FOR USE

ProleLite

Nasal Gel Mask

3 Intended Use

4 Warnings

6 Symbols

7 Cleaning Instructions

8 System One Resistance Control

8 Putting on the Mask and Headgear

9 Removing the Mask and Headstrap

10 Replacing the Gel Spacer

10 Reforming the Mask

12 Comfort Tips

12 Disposal

12 Specifications

15 Limited Warranty

16 Reorder Information

Table of Contents

ProfileLite

ProleLite

Nasal Gel Mask

Figure 1

A = Gel Forehead Spacer

B = Mask Cushion

C = Exhalation Port

(Do not block)

D = Removable Port Cap

INSTRUCTIONS FOR USE

Intended Use

The Profile Lite Nasal Gel 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 or bi-level therapy has

been prescribed.

Important Note: An exhalation port is built into the Profile Lite Nasal

Gel 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.

ProfileLite

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 the device, the oxygen•

flow must be turned off when the device is

Warning

A warning indicates the

possibility of injury to

the user or operator.

Caution

A caution indicates the

possibility of damage to

the device.

Note

A note places an

emphasis on an

operating characteristic.

INSTRUCTIONS FOR USE

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, mask selection, and the leak rate. This warning

applies to most types of CPAP and bi-level machines.

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

If this happens, discontinue use and contact your healthcare

professional.

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.

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.

Hand wash prior to first use. Inspect the mask for damage or wear•

(cracking, crazing, tears or cushion damage resulting in gel exposure,

etc). Discard and replace any components as necessary.

Carefully touch the mask cushion to be sure that it has cooled•

enough to prevent irritation or burning.

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.

ProfileLite

Symbols

Symbol Description

General Caution or Warning

Consult instructions for use

System One Resistance Control

Note

Tip

Does not contain natural rubber latex

INSTRUCTIONS FOR USE

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.

Hand wash the mask and headgear in warm water with a mild1.

liquid dish washing detergent.

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

or alcohol, or cleaning solutions containing conditioners or moisturizers.

Rinse thoroughly with drinking quality water and air dry out of2.

direct sunlight. Make sure the mask is dry before use. Lay the

headgear flat or line dry. Do not place the headgear into the

dryer.

Inspect all parts for damage or wear; replace any parts that have3.

visibly deteriorated (cracking, crazing, tears, etc). Replace the

mask if the cushion becomes hardened.

For multi-patient use in the hospital/institutional environment,

use the Mask Cleaning and Disinfection Instructions to reprocess

the mask between patients. These instructions can be obtained by

visiting www.sleepapnea.com or contacting Respironics Customer

Service at 1-800-345-6443 (USA or Canada) or 1-724-387-4000.

ProfileLite

Figure 2

System One Resistance Control

This mask uses the System One Resistance Control setting .This

symbol may appear on your therapy device.This symbol represents the level of

mask resistance compensation. Match the setting to the mask if appropriate.

Important Notes:

Verify the System One setting if the mask or mask cushion changes.•

The System One setting is not compatible with masks requiring a separate/•

additional exhalation device.

If your provider has locked the resistance compensation setting, you can view

the setting but cannot change it, and the screen will display a lock symbol.

If your provider has disabled the resistance compensation, you will not see

this setting.

Putting on the Mask and

Headgear

Hold the mask lightly against your face, and1.

slide the headstrap over your head

(Figure 2).

Connect the flexible tubing to the2.

INSTRUCTIONS FOR USE

exhalation elbow. Turn the CPAP or

bi-level system on.

Lie down and breathe normally through3.

your nose, keeping your lips closed.

Unhook the straps and gradually tighten

them until the mask has minimal leaks and

fits comfortably.

Note: The headstrap has two sets of tabs for

better adjustment. For larger size heads, use

the black tabs. For smaller head sizes, use the

blue tabs (Figure 3). The extra tabs can be

removed using a pair of scissors.

DO NOT overtighten the straps.4.

Overtightening can cause or worsen leaks.

Removing the Mask and

Headstrap

Because the entire headstrap stretches, you

should not need to unfasten the straps to

remove the headstrap. Simply slide the mask

and headstrap over your head. If necessary,

unfasten either of the neck straps.

Figure 3

A = Use blue tabs for

smaller sized heads

B = Use black tabs for

larger sized heads

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