ResMed MIRAGE NV 2 Series Bedienungsanleitung

MIRAGE® NV FULL FACE MASK SERIES 2

CLINICIAN’S

GUIDE

www.resmed.com

GUIDE CLINIQUE

GUÍA DEL MÉDICO

GUIA DO MÉDICO

RESMED

CLINICIAN’S GUIDE (ENGLISH) .............................................................................................1

GUIDE CLINIQUE (FRANÇAIS) ............................................................................................. 13

GUÍA DEL MÉDICO (ESPAÑOL) ............................................................................................ 25

GUIA DO MÉDICO (PORTUGUÊS) ........................................................................................ 37

CONTRAINDICATIONS ..................................................................... 2

WARNINGS..................................................................................... 2

PRECAUTIONS ................................................................................. 2

ADDITIONAL INFORMATION ............................................................ 3

PARTS OF THE MASK...................................................................... 4

FITTING THE MASK ........................................................................ 4

FOREHEAD PAD CLIP ASSEMBLY..................................................... 6

REMOVING THE MASK .................................................................... 6

QUICK RELEASE TAB ..................................................................... 6

CLEANING THE MASK IN THE HOME .............................................. 7

CLEANING AND DISINFECTING/STERILIZING THE MASK

BETWEEN PATIENTS ........................................................................ 7

REASSEMBLING THE MASK ............................................................ 10

MASK CHARACTERISTICS...............................................................1 1

ACCESSORIES AND REPLACEMENT PARTS.......................................1 1

MIRAGE® NV FULL FACE

MASK SERIES 2

The MIRAGE® NV FULL FACE MASK SERIES 2 system (non-

vented) is only indicated for the treatment of adult

patients using non-invasive ventilator systems that have

an active exhaust.

PRECAUTION

In the USA, federal la restricts this device to sale by,

or on the order of, a physician.

CONTRAINDICATIONS

• The MIRAGE NV FULL FACE MASK SERIES 2 must not

be used ithout appropriately qualified supervision

either hen the patient is at risk of not responding

to severe hypoxia or hypercapnia by arousal, or

hen the patient, having aroused, is unable to

remove the mask.

WARNINGS

• The mask must not be used on patients ith

impaired laryngeal reflexes or other conditions

predisposing to aspiration in the event of

regurgitation or vomiting.

• The mask should not be orn unless the ventilator

system is turned on and operating properly.

• At a fixed rate of supplemental oxygen flo (if

used), the inhaled oxygen concentration ill vary

depending on the pressure settings, patient

breathing pattern, mask selection, and the leak rate.

• The mask must not be used if the patient is kno n

to be allergic to any of the follo ing mask

component materials: polycarbonate, silicone

rubber, polyurethane rubber, nylon, polyester, and

cotton.

PRECAUTIONS

• The mask is not for use ith ventilators hich have

a combination of:

a) little or no ability to compensate for mask leak

and variation in mask leak (eg volume-cycled

ventilators ith no compensation for leak, or

pressure-cycled ventilators hich are unable to

deliver adequate extra flo in the presence of

increased leak); and

b) no expired ventilation alarms.

If a ventilator ith poor leak compensation is used,

special reliance is placed on the expired ventilation

alarm.

• As ith all mask ventilation systems, significant leak

may occur bet een the mask and the patient’s

face. The leak may vary depending on such factors

as the patient’s position and sleep stage. Variation

in leak may significantly affect patient ventilation,

potentially producing profound hypoventilation or

hyperventilation. The magnitude of this effect

depends on the ventilator’s ability to compensate

for leak.

• Leak or variation in the leak may cause

mistriggering of the ventilator.

• Increased face-to-mask leak ill reduce effective

deadspace by ashing out expired gases. In a

pressure-cycled ventilator hich tolerates moderate

leak, the effect may be a reduction in arterial PCO2

ith no change in ventilator settings.

ADDITIONAL INFORMATION

• ResMed has tinted the MIRAGE NV FULL FACE MASK

SERIES 2 blue to help you identify it as a non-

vented mask for use ith active-exhaust non-

invasive ventilator systems only.

• The mask has a standard female 22mm tapered

fitting (ISO5356-1) for external connection to the

ventilator.

• In determining the initial ventilator settings, and in

particular the tidal volume for volume-cycled

ventilators, make appropriate allo ance for mask

dead space and leak. Refer to the Mask

Characteristics section of these instructions for more

information.

• Refer to the relevant ventilator system operating

instructions for detailed information concerning

connecting the mask.

PARTS OF THE MASK

Figure 1: Mask Parts

Mask

frame

Tapered

fitting

Luer lock

port cap/s

Mask

port

Mask

cushion

Cushion

clip

Top Velcro strap

Side

upper

Velcro

straps

Side

lower

Velcro

straps

Quick

Release

Tab

Figure : Headgear

FITTING THE MASK

The MIRAGE NV FULL FACE MASK SERIES 2 is supplied

fully assembled.

Fitting the mask correctly is essential to optimum

therapy delivery. Use the ResMed Mask Fitting

Template to help you choose the best mask size for

your patient.

1Connect the mask to the ventilator system by

follo ing the ventilator system operating

instructions and/or physician’s prescription.

2Seat the mask cushion over the patient’s nose and

mouth. On most patients, the bottom of the

cushion should rest belo the lo er lip and the top

of the cushion on the bridge of the nose, bet een

the eyes.

Note: The MIRAGE NV FULL FACE MASK SERIES 2 offers

two cushion sizes: standard and shallow. The shallow

cushion is designed to better fit those patients who

have a lower nasal bridge, higher cheek bones, or

receded jaw lines.

3Pull the headgear over the patient’s head. Make

sure the side lo er Velcro® straps pass belo the

patient’s ears, and that the side upper Velcro straps

pass over their forehead.

4Tighten the side lo er (Fig. 3) and then the side

upper Velcro straps (Fig. 4) to achieve a secure and

comfortable fit.

5Adjust the top Velcro strap (Fig. 5) ith very slight

tension to add stability to the fit of the mask. The

mask should be secure but not overly tight.

6The fitted mask should look like this (Fig. 6):

Note: The top of the mask frame should not touch the

patient’s forehead. In most cases, the top of the mask

frame should be some distance awa from the patient’s

forehead.

7Turn the ventilator on. If you detect air leaks

around the cushion, reposition the mask on the

patient’s face to achieve a better seal. You may

also need to readjust the Velcro straps.

Note: When the ventilator s stem is delivering positive

pressure, the Mirage cushion inflates to float gentl on

the patient’s face, forming a secure and comfortable

seal without the need for tight headgear. Pulling the

headgear too tightl ma reduce the effectiveness of

the mask.

Figure: 3 Figure: 4

Figure: 5

Figure: 6

FOREHEAD PAD CLIP ASSEMBLY

The MIRAGE NV FULL FACE MASK SERIES 2 is supplied

ith a forehead pad clip assembly kit. This kit is an

optional accessory. It is for the minority of patients ho

may require additional support and stability. For

assembly instructions, see section on Reassembling the

Mask (step 3).

WARNING

The forehead pad clip assembly is for single-patient

use only.

Note: When the mask is fitted with a forehead pad clip

assembl attached, the forehead pad should lightl

touch the patient’s forehead without the mask putting

pressure on the bridge of the nose.

REMOVING THE MASK

To remove the MIRAGE NV FULL FACE MASK SERIES 2,

release the lo er Velcro straps and pull the mask and

headgear up over the patient’s head.

Note: The Quick Release Tab should be used to remove

the mask onl in the event of an emergenc .

QUICK RELEASE TAB

The Quick Release Tab (Fig. 8)

allo s the mask to come a ay

from the face quickly in the

event of an emergency.

Simply pull the Quick Release

Tab and the rear Velcro

opening of the headgear

separates, allo ing you to

remove the mask from the

face.

Note: The Quick Release Tab should be used to remove

the mask onl in the event of an emergenc . Overuse

of the Quick Release Tab will result in the

deterioration of the Velcro opening.

Figure: 8

Forehead

pad clip

Forehead

pad

Figure 7: Forehead Pad Clip Assembly

CLEANING THE MASK IN THE HOME

Note: Wash the headgear before first time use, as the

d e ma run. It is important to alwa s handwash the

headgear.

1Detach the mask from the ventilator and separate

the headgear, luer lock port caps, cushion clip,

mask cushion, and forehead pad clip assembly (if

attached).

2Hand ash the headgear in arm, soapy ater. Use

a mild detergent such as pure soap. Rinse ell and

allo it to air dry out of direct sunlight. Do this at

least once per eek.

3Hand ash the mask components in arm, soapy

ater. Use a mild detergent such as pure soap.

Rinse the components ell and allo them to air

dry out of direct sunlight. Do this after each use.

PRECAUTION

• Do not use bleach-, chlorine-, alcohol-, or aromatic-

based solutions, moisturizing or antibacterial soaps,

or scented oils to clean any part of the mask

system, including headgear. These solutions may

cause damage and reduce the life of the product.

• Do not expose any part of the mask system or

tubing to direct sunlight as it may cause the

product to deteriorate.

CLEANING AND DISINFECTING/STERILIZING

THE MASK BETWEEN PATIENTS

The follo ing are the recommended and validated

procedures for cleaning, disinfection, and sterilization of

the MIRAGE NV FULL FACE MASK SERIES 2. We advise that

each healthcare facility consult its o n procedures

before carrying out the follo ing instructions.

WARNING : ResMed cannot give any assurance

that deviations from the procedures listed belo , and

their effect on the performance of the product, ill

be acceptable.

1Detach the mask from the ventilator. Disassemble

the mask by separating the headgear, luer lock port

caps, cushion clip, mask cushion, and forehead pad

clip assembly (if attached).

2After disassembly, thoroughly clean the mask

components according to the follo ing cleaning

procedure:

CLEANING PRIOR TO DISINFECTION OR STERILIZATION

aHand ash the headgear in arm ater using a

mild detergent, such as pure soap. Rinse ell

and allo it to air dry out of direct sunlight.

bClean the individual parts of the mask ith a

soft bristle brush for one minute hile soaking

them in detergent. Pay particular attention to all

crevices and cavities.

cRinse the components t ice by agitating them

vigorously in ater and allo them to air dry

out of direct sunlight.

PRECAUTION

• Do not expose any part of the mask system or

tubing to direct sunlight as it may cause the

product to deteriorate.

• Do not disinfect or sterilize the headgear and

forehead pad clip assembly. This part cannot be

disinfected or sterilized.

3After disassembly and cleaning, disinfect the

reusable mask components according to the

follo ing procedure for chemical or thermal

disinfection.

After disassembly and cleaning, sterilize the mask

according to the follo ing procedure for the

STERRAD® Sterilization Process.

Note: The mask must be disassembled and cleaned

prior to disinfection or sterilization.

OPTION 1: CHEMICAL DISINFECTION

aSoak the reusable mask components in a

commercially available solution of glutaraldehyde

3.4% (eg CIDEX Plus®), peracetic acid 0.08%, or

ortho-phthalaldehyde 0.55% (eg CIDEX OPA®)

as described in the manufacturer’s instructions.

bRinse the mask components as described in the

manufacturer’s instructions and allo them to

air dry out of direct sunlight.

cPerform a visual inspection of each mask

component. If any visible deterioration of a mask

component is apparent (eg cracking, tears etc),

the mask component should be discarded and

replaced. Yello discoloration of the cushion

may occur. This discoloration is acceptable.

Testing b ResMed has shown that the mask

components can withstand 15 c cles using

solutions of glutaraldeh de 3.4% (eg CIDEX Plus®),

peracetic acid 0.08%, or ortho-phthalaldeh de

0.55% (eg CIDEX OPA®) when following the

manufacturer’s instructions.

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