ResMed Ultra Mirage Bedienungsanleitung

Global leaders in sleep and respiratory medicine www.resmed.com

Ultra Mirage™

NON-VENTED FULL FACE MASK

Clinical Guide

English •Deutsch •Français •Italiano

Español •Português •Nederlands

608138/2 06 11

Ultra Mirage NVFFM

CLINICAL

EUR 1

608138

608138 ROW-1 UMNVFFM Multi cover.qxp 02/11/2006 4:05 PM Page 1

ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA

ResMed (UK) Ltd (EU Authorized Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK

ResMed Offices Australia, Austria, Brazil, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands,

New Zealand, Singapore, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details).

Ultra Mirage Non-vented Full Face Mask

Protected by patents: AU 710733, AU 741003, AU 766623, AU 775051, CA 2261790, DE 29724224, EP 0956069,

EP 1187647, EP 1187650, EP 1479406, JP 3686609, NZ 513052, NZ 526165, NZ 526166, NZ 526168, US 6112746,

US 6119693 , US 6357441, US 6374826, US 6463931, US 6513526, US 6532961, US 6581602, US 6634358,

US 6701927, US 6860269, US 6871649, US 7069933. Other patents pending. Protected by design registrations:

AU 157902, AU 302719, CN 200330102703.8, CN 200330102704.2, EP 098348, JP 1212687, JP 1214582,

US D493885, US D519207.

Ultra Mirage and Mirage are trademarks of ResMed Ltd and Mirage is registered in U.S. Patent and Trademark

Office.

CIDEX and STERRAD are trademarks of Johnson & Johnson. Alconox is a trademark of Alconox Inc. Neodisher

Medizyme is a trademark of Chemische Fabrik Dr Weigert. Aniosyme and Anioxyde are trademarks of Laboratoires

Anios.

608138 ROW-1 UMNVFFM Multi cover.qxp 01/11/2006 9:42 AM Page 2

Mask Parts / Teile der Maske / Composants du masque / Parti della

maschera / Piezas de la mascarilla / Peças da máscara /

Maskeronderdelen

Forehead support / Stirnbauteil / Support

frontal / Supporto frontale / Apoyo para la

frente / Suporte da testa / Voorhoofdsteun

Luer lock ports cap /

Anschlusskappen für

Luer-Verbindungsstück / Bouchon(s)

d'entrée de raccord Luer / Tappi porte

con connessione Luer / Tapas de

puerto Luer lock / Tampas das portas

com fecho do tipo Luer /

Poortkap(pen) met luer-vergrendeling

Forehead support pad / Stirnpolster / Tampon du support frontal /

Imbottitura del supporto frontale / Almohadilla del apoyo para la

frente / Almofada do suporte da testa / Kussentje van

voorhoofdsteun

Mask frame / Maskenhalter /

Entourage rigide / Telaio della

maschera / Armazón de la

mascarilla / Armação da máscara /

Maskerframe

Cushion clip / Clip des

Maskeneinsatzes / Clip de

la bulle / Fermaglio del

cuscinetto / Traba de la

almohadilla / Dispositivo de

fixação da almofada / Klem

voor kussentje

Mask cushion / Maskeneinsatz /

Bulle du masque / Cuscinetto della

maschera / Almohadilla de la mascarilla /

Almofada da máscara / Maskerkussentje

Upper Velcro

™

straps / Die oberen

Velcro-Bänder / Bandes Velcro

supérieures / Cinghie laterali

superiori (Velcro) / Correas laterales

superiores (Velcro) / Correias Velcro

laterais superiores / Bovenste Velcro

klittenbandbevestiging

Headgear clip /

Kopfbandclip / Clip du

harnais / Fermaglio del

copricapo / Broche del

arnés / Dispositivo de

fixação do arnês para a

cabeça / Hoofdbandklem

Lower Velcro straps / Die unteren

Velcro-Bänder / Bandes Velcro inférieures /

Cinghie laterali inferiori (Velcro) / Correas

laterales inferiores (Velcro) / Correias Velcro

laterais inferiores / Onderste Velcro

klittenbandbevestiging

Elbow / Kniestück / Coude /

Gomito / Codo / Cotovelo / Bocht

Elbow retainer / Kniestückhalter / Anneau

de retenue du coude / Fermo del gomito /

Retenedor del codo / Retentor do cotovelo /

Bochthouder

B-1 B-2

B-3 B-4

B-5 B-6

Forehead support tab / Stirnbauteillasche /

languette du support frontal / Linguetta del

supporto frontale / Lengüeta del apoyo para la

frente / Dispositivo de ﬁxação do suporte da

testa / Tab van de voorhoofdsteun

Fitting the Mask / Anlegen der Maske / Mise en place du masque /

Come indossare la maschera / Colocación de la mascarilla / Colocação

da máscara / Het masker opzetten

C-2

C-3 C-4

C-6

C-1

L-shaped ridge / L-förmige Leiste / Bord en L /

Costa sinistra a L / Borde en forma de L / Saliência

em forma de L / L-vormige rand

LIFT / HEBEN /

SOULEVER /

SOLLEVARE /

LEVANTE / LEVANTE /

OMHOOGDOEN

Elbow retainer / Kniestückhalter /

Anneau de retenue du coude /

Fermo del gomito / Retenedor del

codo / Retentor do cotovelo /

Bochthouder

PUSH / DRÜCKEN / POUSSER /

SPINGERE / EMPUJE /

EMPURRE / DUWEN

Disassembling for Cleaning / Demontage zu Reinigungszwecken /

Démontage pour le nettoyage / Smontaggio per la pulizia /

Desmontaje para la limpieza / Desmontagem para limpeza /

Demontage voor reiniging

C-5

Note: For complete instructions, read the text section in conjunction with the illustrations on

this sheet.

Hinweis: Vollständige Anweisungen ﬁnden Sie im Textabschnitt und in den Illustrationen auf

diesem Blatt.

Remarque : pour les instructions complètes, veuillez lire le texte du guide avec cette ﬁche

d'illustrations.

Nota: Per istruzioni complete, leggere la sezione con il testo insieme alle illustrazioni su questo

foglio.

Nota: Para tener instrucciones completas, lea el texto en conjunto con las ﬁguras de esta hoja.

Nota: Para obter as instruções completas, leia a secção de texto em conjunção com as

ilustrações deste folheto.

Opm.: Raadpleeg voor een volledige beschrijving het tekstgedeelte en de bijbehorende

illustraties op dit blad.

Illustrations Sheet / Illustrationsblatt / Fiche d'Illustrations / Fogolio delle Illustrazioni /

Hoja de Figuras / Folheto de Ilustrações / Illustratieblad

Ultra Mirage

NON-VENTED FULL FACE MASK

Component of: 608138/2

D-1

D-6

D-3

D-5

D-2

D-4

D-7

Reassembling the Mask / Wiederzusammenbau der Maske /

Remontage du masque / Riassemblaggio della maschera / Montaje de

la mascarilla / Montagem da máscara / Het masker opnieuw monteren

Luer lock ports cap /

Anschlusskappen für

Luer-Verbindungsstück / Bouchon(s)

d'entrée de raccord Luer / Tappi porte

con connessione Luer / Tapas de puerto

Luer lock / Tampas das portas com

fecho do tipo Luer / Poortkap(pen) met

luer-vergrendeling

Mask port / Anschlussöffnung /

Port(s) du masque / Porta della

maschera / Puerto(s) de la mascarilla /

Orifício da máscara / Masterpoort(en)

Elbow / Kniestück / Coude /

Gomito / Codo / Cotovelo /

Bocht

Elbow retainer / Kniestückhalter /

Anneau de retenue du coude /

Fermo del gomito / Retenedor del

codo / Retentor do cotovelo /

Bochthouder

Pivot / Zapfen / Pivot /

Perno / Pivote / Pino /

Scharnier

English

Ultra Mirage™

NON-VENTED FULL FACE MASK

The Ultra Mirage NV (non-vented) Full Face Mask is a non-invasive device used

for channelling air flow with or without supplemental oxygen.

Intended Use

The Ultra Mirage NV Full Face Mask is intended to be used with active-exhaust-

valve ventilator systems, to provide ventilatory assistance to patients with

respiratory insufficiency and respiratory failure.

The Ultra Mirage NV Full Face Mask is to be used on adult patients (>30 kg),

requiring non-life-support ventilatory assistance.

The Ultra Mirage NV Full Face Mask is intended for single-patient re-use in the

home or multipatient re-use in the hospital/institutional environment.

. WARNINGS AND CAUTIONS

•The Ultra Mirage NV Full Face Mask, must not be used without qualified

supervision for patients who are unable to remove the mask by themselves.

•This mask is not for use 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 size selection and the mask leak.

•If oxygen is used with the ventilator, the oxygen flow must be turned off

when the ventilator is not operating.

Explanation: When the ventilator is not in operation, and the oxygen flow

is left on, oxygen delivered into the ventilator tubing may accumulate within

608138r2.book Page 1 Thursday, November 2, 2006 3:27 PM

the ventilator enclosure. Oxygen accumulated in the ventilator enclosure

will create a risk of fire. This warning applies to most types of ventilators.

•Please refrain from smoking while oxygen is in use.

About the Mask

•The mask system does not contain latex, PVC or DEHP materials. If the

patient has ANY reaction to any part of the mask system, discontinue use

and investigate the possible causes.

•ResMed has tinted the Ultra Mirage NV Full Face Mask elbow blue to

identify it as a non-vented mask for use with active exhaust non-invasive

ventilator systems only.

•The mask has a standard female 22 mm tapered fitting (ISO5356-1) for

external connection to the ventilator.

•Refer to the section “Technical Specifications” of this guide for information

about mask leak, dead space and resistance.

CAUTION

The mask must be cleaned and disinfected/sterilized if it is used between

patients. Refer to the section “Cleaning the Mask between Patients” for

details.

Parts of the Mask

See section Aon the illustrations sheet.

Fitting the Mask

Note: Refer to the relevant ventilator system operating instructions for detailed

information about connecting the mask.

See section Bon the illustrations sheet.

The Ultra Mirage NV Full Face Mask is supplied fully assembled.

1Move the forehead support tab to Position 3. (Refer illustration B-1 for

location of Positon 3.)

2Disconnect one lower headgear clip. Place the mask on the face and pull the

headgear over the patient’s head (B-2). Ensure that the upper straps pass

across the forehead and the lower straps below the ears.

3Reattach the headgear clip to the mask frame.

4Gently tighten the upper headgear straps (B-3).

5Gently tighten the lower headgear straps (B-4).

608138r2.book Page 2 Thursday, November 2, 2006 3:27 PM

English

The pads of the forehead support should sit comfortably on the forehead

when the mask is in place. If the pads are at an angle and not completely

seated on the forehead, change the position of the forehead support tab.

Note: Do not overtighten the headgear straps as this may cause discomfort,

cushion creases and mask leak. The Ultra Mirage NV Full Face Mask has

been designed to provide a comfortable seal without the need to

overtighten the headgear.

6The fitted mask should look like this (B-5).

7Connect the main air tubing to the elbow (B-6). Then connect the free end

of the air tubing to the ventilator and turn the ventilator on. If the patient

experiences air leaks around the cushion, it may be necessary to gently

tighten the headgear straps.

8If the patient is unable to get a proper seal:

•reposition the mask by lifting it and placing the cushion comfortably on

the face.

•adjust the position of the forehead support tab by testing all four

positions and finding the one that best prevents leaks.

•gently tighten the headgear straps.

Notes:

•If it is not possible to resolve any leaks, your patient may require another

mask frame and/or another cushion size.

•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.

Removing the Mask

To remove the Ultra Mirage NV Full Face Mask, disconnect one of the lower

headgear clips and pull the mask and headgear up over the patient’s head.

Note: The headgear clips are easy to locate and disconnect. They allow the

quick removal of the mask from the face in the event of an emergency.

608138r2.book Page 3 Thursday, November 2, 2006 3:27 PM

Disassembling for Cleaning

See section Con the illustrations sheet.

1Detach the mask from the air tubing.

2Disconnect the headgear clips to release them from the mask frame. It is

not necessary to remove the headgear clips from the headgear.

3Remove the ports caps from the mask frame.

4Detach the cushion assembly from the mask frame by depressing the

cushion clip at the base of the mask frame and gently pulling it off. This

releases the cushion and cushion clip.

Then, separate the cushion from the cushion clip.

5To detach the elbow from the frame, lift (C-1) and push (C-2) the right wing

of the elbow retainer over the right L-shaped ridge on the mask frame.

6Rotate the elbow retainer to the position shown in C-3. The elbow retainer

is now in the correct position for removal.

7To remove the elbow retainer, hold one wing of the elbow retainer down,

and firmly pull the other wing out (C-4a) and then up (C-4b) over the top of

the elbow. Remove the elbow retainer and elbow from the mask frame.

8To remove the forehead support from the mask, press the tab (C-5a) and

move it upwards until it is possible to slide it off the mask frame (C-5b).

9Pull firmly at the base of the forehead support pad plugs to release the pads

from the forehead support (C-6).

Cleaning the Mask in the Home

Notes:

•Wash your hands before cleaning the mask.

•It is important to always handwash the headgear.

•The headgear may be washed without being disassembled from the

headgear clips.

Daily/After each use

Handwash the mask components in warm (approx 30ºC) water for one minute

using mild soap or detergent. Rinse the components well with drinking quality

water and allow them to air dry out of direct sunlight.

Weekly

Handwash the headgear in warm (approx. 30ºC) water using mild soap or

detergent. Rinse well and allow to air dry out of direct sunlight.

608138r2.book Page 4 Thursday, November 2, 2006 3:27 PM

English

CAUTION

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

moisturizing or antibacterial soaps, or scented oils to clean any of the mask

components. 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.

•The headgear is sensitive to heat and must not be ironed.

•If any visible deterioration of a mask component is apparent (cracking,

crazing, tears, etc), the mask component should be discarded and replaced.

Cleaning the Mask between Patients

All mask components can be disinfected/sterilized using validated procedures.

The following table presents a summary of the validated procedures for

disinfection/sterilization of the system. Refer to the website

www.resmed.com/masks/sterilization for details.

To clean the headgear between patients use the method described in the

previous section “Cleaning the Mask in the Home”.

Methods Pre-disinfection/

sterilization Disinfection/Sterilization

Chemical Detergent

eg, Aniosyme™DDI or

Alconox™

Solution (any one)

•Peracetic acid 0.15% (eg, Anioxyde™1000)

•Ortho-phthalaldehyde 0.55% (eg, CIDEX™OPA)

•Glutaraldehyde 3.4% (eg, CIDEX Plus™)

Thermal Detergent

eg, Neodisher™Medizyme

or Alconox

Temperature-time (any one)

•70°C for 100 minutes

•75°C for 30 minutes

•80°C for 10 minutes

•90°C for 1 minute

•93°C for 10 minutes

STERRAD™Detergent

eg, Alconox System

STERRAD Sterilization System

Notes:

•Testing by ResMed has shown that the components can withstand 15 cycles of

disinfection/sterilization for the methods listed in the table.

•When using detergents, disinfectants or sterilization agents, always follow the

manufacturer’s instructions.

608138r2.book Page 5 Thursday, November 2, 2006 3:27 PM

Reassembling the Mask

See section Don the illustrations sheet.

1Twist the luer lock port caps onto the mask ports (D-1).

2Hold the mask frame and the elbow firmly together (D-2).

3To attach the elbow retainer, fit one side of the elbow retainer against the

groove of the elbow. While holding one wing of the elbow retainer down

(D-3a), press the other wing down until the elbow retainer clicks into place

(D-3b).

4Rotate the elbow retainer to its original position (D-4).

5Check that you have fitted the elbow and elbow retainer correctly by firmly

pulling the elbow away from the frame. If the elbow is fitted correctly, it

should not separate from the frame.

If the elbow comes away from the frame, try refitting the elbow retainer as

described in Steps 3 and 4. If the elbow still comes away from the frame

when you pull on it, you may need to replace the elbow retainer with a new

one.

6Fit the grooved edge of the mask cushion to the mask frame. Fit the top

section first, then work your way around the mask, pushing the cushion

onto the frame, ensuring a good seal has been achieved.

Then push the cushion clip over the cushion and onto the mask frame,

ensuring it clicks into place in all locations (D-5).

7Attach the forehead pads to the forehead support by inserting the pad plugs

into the two holes on the back of the forehead support (D-6). Push the pads

firmly against the forehead support to ensure that the pads fit securely into

the forehead support.

8Connect the forehead support to the mask frame. Slide the pivots into the

pivot slot on the mask frame (D-7). Depress the forehead support tab and

move it into any of the tab positions.

9Insert the headgear clips into the slots on the mask frame. The headgear

label should face outward and be near the patient’s neck when fitted.

Disposal

The Ultra Mirage NV Full Face Mask does not contain any hazardous

substances and may be disposed of with your normal household refuse.

608138r2.book Page 6 Thursday, November 2, 2006 3:27 PM

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