ResMed Mirage NV Full Face Mask Series 2 Bedienungsanleitung

MIRAGE™ NV FULL FACE MASK SERIES 2

CLINICIAN’S

GUIDE GUÍA DEL USUARIO

GUIA DO USUÁRIO

BRUKSANVISNING

GUIDA PER L’UTENTE

MODE D’EMPLOI

GEBRAUCHSANWEISUNG

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

GEBRAUCHSANWEISUNG (DEUTSCH)................................................................................... 13

MODE D’EMPLOI (FRANÇAIS) ............................................................................................. 24

GUIDA PER L’UTENTE (ITALIANO)......................................................................................... 35

GUÍA DEL USUARIO (ESPAÑOL)........................................................................................... 46

GUIA DO USUÁRIO (PORTUGUÊS)....................................................................................... 57

BRUKSANVISNING (SVENSKA) ............................................................................................. 68

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

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

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

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

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

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

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

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

CLEANING THE MASK IN THE HOME .............................................. 6

CLEANING AND DISINFECTING/STERILISING THE MASK

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

REASSEMBLING THE MASK .............................................................. 9

MASK CHARACTERISTICS............................................................... 10

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.

CONTRAINDICATIONS

• The MIRAGE NV FULL FACE MASK SERIES 2 must not

be used without appropriately qualified supervision

either when the patient is at risk of not responding

to severe hypoxia or hypercapnia by arousal or

when the patient having aroused is unable to

remove the mask.

WARNINGS

• The mask must not be used on patients with

impaired laryngeal reflexes or other conditions

predisposing to aspiration in the event of

regurgitation or vomiting.

• The mask should not be worn unless the ventilator

system is turned on and operating properly.

• At a fixed rate of supplemental oxygen flow (if

used) the inhaled oxygen concentration will 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 known

to be allergic to any of the following mask

component materials: polycarbonate silicone

rubber polyurethane rubber nylon polyester and

cotton.

PRECAUTIONS

• The mask is not for use with ventilators which have

a combination of:

a) little or no ability to compensate for mask leak

and variation in mask leak (eg volume-cycled

ventilators with no compensation for leak or

pressure-cycled ventilators which are unable to

deliver adequate extra flow in the presence of

increased leak); and

b) no expired ventilation alarms.

If a ventilator with poor leak compensation is used

special reliance is placed on the expired ventilation

alarm.

• As with all mask ventilation systems significant leak

may occur between 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 will reduce effective

deadspace by washing out expired gases. In a

pressure-cycled ventilator which tolerates moderate

leak the effect may be a reduction in arterial PCO2

with 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 with 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 allowance 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 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

following 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 below the lower lip and the top

of the cushion on the bridge of the nose between

the eyes.

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

sure the side lower Velcro® straps pass below the

patient’s ears and that the side upper Velcro straps

pass over their forehead.

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 2: Headgear

4Tighten the side lower (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) with 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 away 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 system is delivering positive

pressure, the irage cushion inflates to float gently on

the patient’s face, forming a secure and comfortable

seal without the need for tight headgear. Pulling the

headgear too tightly may reduce the effectiveness of

the mask.

Figure: 3 Figure: 4

Figure: 5

Figure: 6

REMOVING THE MASK

To remove the MIRAGE NV FULL FACE MASK SERIES 2

release the lower 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 only in the event of an emergency.

QUICK RELEASE TAB

The Quick Release Tab (Fig. 7) allows the mask to

come away 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 allowing you to

remove the mask from the face.

Note: The Quick Release Tab should be used to remove

the mask only in the event of an emergency. Overuse

of the Quick Release Tab will result in the

deterioration of the Velcro opening.

CLEANING THE MASK IN THE HOME

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

dye may run. It is important to always handwash the

headgear.

1Detach the mask from the ventilator and separate

the headgear luer lock port caps cushion clip and

mask cushion.

2Handwash the headgear in warm soapy water. Use

a mild detergent such as pure soap. Rinse well and

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

least once per week.

3Handwash the mask components in warm soapy

water. Use a mild detergent such as pure soap.

Rinse the components well and allow them to air

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

PRECAUTION

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

based solutions moisturising 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.

Figure: 7

CLEANING AND DISINFECTING/STERILISING

THE MASK BETWEEN PATIENTS

The following are the recommended and validated

procedures for cleaning disinfection and sterilisation of

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

each healthcare facility consult its own procedures

before carrying out the following instructions.

WARNING : ResMed cannot give any assurance

that deviations from the procedures listed below and

their effect on the performance of the product will

be acceptable.

1Detach the mask from the ventilator. Disassemble

the mask by separating the headgear luer lock port

caps cushion clip and mask cushion.

2After disassembly thoroughly clean the mask

components according to the following cleaning

procedure:

CLEANING PRIOR TO DISINFECTION OR STERILISATION

aHandwash the headgear in warm water using a

mild detergent such as pure soap. Rinse well

and allow it to air dry out of direct sunlight.

bClean the individual parts of the mask with a

soft bristle brush for one minute while soaking

them in detergent. Pay particular attention to all

crevices and cavities.

cRinse the components twice by agitating them

vigorously in one litre of water and allow 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 sterilise the headgear. This

part cannot be disinfected or sterilised.

3After disassembly and cleaning disinfect the

reusable mask components according to the

following procedure for chemical or thermal

disinfection.

After disassembly and cleaning sterilise the mask

according to the following procedure for the

STERRAD® Sterilisation Process.

Note: The mask must be disassembled and cleaned

prior to disinfection or sterilisation.

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%

(eg CIDEX PA®) or orthopthalaldehyde 0.55%

(eg CIDEX OPA®) as described in the

manufacturer’s instructions.

bRinse the mask components as described in the

manufacturer’s instructions and allow 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. Yellow discolouration of the cushion

may occur. This discolouration is acceptable.

Testing by Res ed has shown that the mask

components can withstand 15 cycles using

solutions of glutaraldehyde 3.4% (eg CIDEX Plus®),

peracetic acid 0.08% (eg CIDEX PA®) or

orthopthalaldehyde 0.55% (eg CIDEX OPA®) when

following the manufacturer’s instructions.

OPTION 2: THERMAL DISINFECTION

aUsing a certified hot water disinfection system

soak the mask components for one of the

following times:

• 70°C for 100 minutes or

• 75°C for 30 minutes or

• 80°C for 10 minutes.

• 90°C for 1 minute.

bPerform 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. Yellow discolouration of the cushion

may occur. This discolouration is acceptable.

Testing has shown that the mask components can

withstand 15 cycles of disinfection using the above

time-temperature combinations.

OPTION 3: STERRAD® 100S STERILISATION

PROCESS

aSterilise the mask components as described in

the manufacturer’s instructions for the

STERRAD 100S Sterilisation System.

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