ResMed Nebulizer 1 User Guide

Ultra Mirage™  
NoN-veNted full face mask  
Clinical Guide  
English  
 
Mask Parts /Teile der Maske / Composants du masque / Parti della  
maschera / Piezas de la mascarilla / Peças da máscara /  
Maskeronderdelen  
A
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  
TM  
Ultra Mirage  
NON-VENTED FULL FACE MASK  
Forehead support / Stirnbauteil / Support  
frontal / Supporto frontale / Apoyo para la  
frente / Suporte da testa / Voorhoofdsteun  
Mask cushion / Maskeneinsatz /  
Bulle du masque / Cuscinetto della  
maschera / Almohadilla de la mascarilla /  
Almofada da máscara / Maskerkussentje  
Illustrations Sheet / Illustrationsblatt / Fiche d'Illustrations / Fogolio delle Illustrazioni /  
Hoja de Figuras / Folheto de Ilustrações / Illustratieblad  
Mask frame / Maskenhalter /  
Entourage rigide /Telaio della  
maschera / Armazón de la  
mascarilla / Armação da máscara /  
Maskerframe  
Note: For complete instructions, read the text section in conjunction with the illustrations on  
this sheet.  
Hinweis: Vollständige Anweisungen finden Sie imTextabschnitt 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.  
Cushion clip / Clip des  
Maskeneinsatzes / Clip de  
la bulle / Fermaglio del  
cuscinetto /Traba de la  
almohadilla / Dispositivo de  
fixação da almofada / Klem  
voor kussentje  
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  
Elbow retainer / Kniestückhalter / Anneau  
de retenue du coude / Fermo del gomito /  
Retenedor del codo / Retentor do cotovelo /  
Bochthouder  
Elbow / Kniestück / Coude /  
Gomito / Codo / Cotovelo / Bocht  
UpperVelcro 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  
LowerVelcro straps / Die unteren  
Velcro-Bänder / Bandes Velcro inférieures /  
Cinghie laterali inferiori (Velcro) / Correas  
laterales inferiores (Velcro) / Correias Velcro  
laterais inferiores / Onderste Velcro  
klittenbandbevestiging  
Component of: 608323/1  
 
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  
Disassembling for Cleaning / Demontage zu Reinigungszwecken /  
Démontage pour le nettoyage / Smontaggio per la pulizia /  
Desmontaje para la limpieza / Desmontagem para limpeza /  
Demontage voor reiniging  
B
C
Forehead support tab / Stirnbauteillasche /  
languette du support frontal / Linguetta del  
supporto frontale / Lengüeta del apoyo para la  
frente / Dispositivo de fixação do suporte da  
PUSH / DRÜCKEN / POUSSER /  
C-2  
L-shaped ridge / L-förmige Leiste / Bord en L /  
SPINGERE / EMPUJE /  
em forma de L / L- vormige rand  
C-1  
Costa sinistra a L / Borde en forma de L / Saliência  
testa /Tab van de voorhoofdsteun  
EMPURRE / DUWEN  
B-1  
B-2  
LIFT / HEBEN /  
SOULEVER /  
SOLLEVARE /  
LEVANTE / LEVANTE /  
OMHOOGDOEN  
4
3
2
1
C-4  
C-3  
Elbow retainer / Kniestückhalter /  
Anneau de retenue du coude /  
Fermo del gomito / Retenedor del  
codo / Retentor do cotovelo /  
Bochthouder  
B-3  
B-4  
a
b
B-5  
B-6  
b
C-5  
C-6  
a
 
Reassembling the Mask / Wiederzusammenbau der Maske /  
Remontage du masque / Riassemblaggio della maschera / Montaje de  
la mascarilla / Montagem da máscara / Het masker opnieuw monteren  
D
Luer lock ports cap /  
D-1  
D-2  
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  
D-4  
D-3  
Elbow retainer / Kniestückhalter /  
Anneau de retenue du coude /  
Fermo del gomito / Retenedor del  
codo / Retentor do cotovelo /  
Bochthouder  
a
b
Pivot / Zapfen / Pivot /  
Perno / Pivote / Pino /  
Scharnier  
D-7  
D-5  
D-6  
 
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  
1
 
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.  
Using a mask may cause tooth, gum or jaw soreness or aggravate an  
existing dental condition. If symptoms occur, consult your physician or  
dentist.  
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/sterilised if it is used between  
patients. Refer to the section “Cleaning the Mask between Patients” for  
details.  
Parts of the Mask  
See section A on the illustrations sheet.  
Fitting the Mask  
Note: Refer to the relevant ventilator system operating instructions for detailed  
information about connecting the mask.  
See section B on the illustrations sheet.  
The Ultra Mirage NV Full Face Mask is supplied fully assembled.  
1 Move the forehead support tab to Position 3. (Refer illustration B-1 for  
location of Positon 3.)  
2 Disconnect one lower headgear clip. Place the mask on the face and pull the  
headgear over the patients head (B-2). Ensure that the upper straps pass  
across the forehead and the lower straps below the ears.  
3 Reattach the headgear clip to the mask frame.  
4 Gently tighten the upper headgear straps (B-3).  
2
 
5 Gently tighten the lower headgear straps (B-4).  
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.  
6 The fitted mask should look like this (B-5).  
7 Connect 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.  
8 If 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  
Normal Release  
To remove the Ultra Mirage NV Full Face Mask, squeeze one of the lower  
headgear clips and pull the mask and headgear up over the patient’s head.  
Emergency Release Cord  
The Emergency Release Cord (Figure 1) allows the mask to come away from  
the face quickly in the event of an emergency.  
3
 
Simply pull the Emergency Release Cord and the two part clip separates,  
allowing you to remove the mask from the face.  
Figure 1: Emergency Release Cord.  
Note: The Emergency Release Cord should only be used to remove the mask  
in the event of an emergency. Overuse of the Emergency Release Cord may  
result in the deterioration of the two part clip mechanism.  
Disassembling for Cleaning  
See section C on the illustrations sheet.  
1 Detach the mask from the air tubing.  
2 Disconnect the headgear clips to release them from the mask frame. It is  
not necessary to remove the headgear clips from the headgear.  
3 Remove the ports caps from the mask frame.  
4 Detach 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.  
5 To 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.  
6 Rotate the elbow retainer to the position shown in C-3. The elbow retainer  
is now in the correct position for removal.  
7 To 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.  
8 To 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).  
9 Pull firmly at the base of the forehead support pad plugs to release the pads  
from the forehead support (C-6).  
4
 
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 (approximately 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 (approximately 30ºC) water using mild soap  
or detergent. Rinse well and allow to air dry out of direct sunlight.  
CAUTION  
Do not use bleach, chlorine, alcohol, or aromatic-based solutions,  
moisturising 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.  
Reprocessing the Mask between Patients  
The mask should be reprocessed when used between patients.  
Cleaning, disinfection and sterilisation instructions are available from the  
If you do not have Internet access, please contact your ResMed  
representative.  
Reassembling the Mask  
See section D on the illustrations sheet.  
1 Twist the luer lock port caps onto the mask ports (D-1).  
2 Hold the mask frame and the elbow firmly together (D-2).  
5
 
3 To 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 it clicks into place (D-3b).  
4 Rotate the elbow retainer to its original position (D-4).  
5 Check 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.  
6 Fit 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).  
7 Attach 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.  
8 Connect 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.  
9 Insert the headgear clips into the slots on the mask frame. The headgear  
label should face outward and be near the patients neck when fitted.  
Note: The Emergency Release Cord must be attached to one of the bottom  
headgear straps in order to function correctly.  
Disposal  
The Ultra Mirage NV Full Face Mask does not contain any hazardous  
substances and may be disposed of with your normal household refuse.  
Technical Specifications  
When determining ventilator settings, and in particular the tidal volume for  
volume cycled ventilators, make appropriate allowances for mask dead space  
and leak.  
Unintentional Mask Leak  
The Unintentional Mask Leak comprises leak between the cushion-frame and  
elbow-frame interfaces.  
6
 
Pressure  
(cm H2O)  
Maximum Leak  
(L/min)  
4–20  
6
Dead Space  
Dead space is the empty volume of the mask up to the elbow.  
The dead space of the mask varies according to cushion sizes but is less than  
260 mL.  
Standards  
CE designation in accordance with EC directive 93/42/EEC, class IIa.  
EN ISO 14971, ISO 5356-1, ISO 594-1, ISO 10993-1 and ISO 13485.  
Operating Pressure  
0 to 40 cm H O  
2
Resistance  
Drop in pressure measured  
at 50 L/min: 0.5 cm H O  
2
at 100 L/min: 1.5 cm H O  
2
Dimensions  
The dimensions of the mask (Medium) are:  
H = 200 mm, W = 100 mm and D = 100 mm  
Symbols  
System and Packaging  
Caution, consult accompanying documents  
Batch Code  
LOT  
Catalogue Number  
REF  
European Authorised Representative  
Humidity limitation  
7
 
Temperature limitation  
Does not contain natural rubber latex  
Manufacturer  
Clinical Guide  
Indicates a Warning or Caution and alerts you to a possible injury or  
explains special measures for the safe and effective use of the device.  
Ordering Information  
Part No. Item  
System  
60643  
60642  
60645  
60644  
60647  
60646  
UM NVFFM System Small, Standard – Europe 1  
UM NVFFM System Small, Shallow – Europe 1  
UM NVFFM System Medium, Standard – Europe 1  
UM NVFFM System Medium, Shallow – Europe 1  
UM NVFFM System Large, Standard – Europe 1  
UM NVFFM System Large, Shallow – Europe 1  
Replacement Parts  
Cushion, Small, Standard (1 pk.)  
16604  
16671  
16605  
16672  
16606  
16673  
16674  
16675  
16676  
60678  
60683  
60681  
60682  
60115  
60116  
60123  
Cushion, Small, Shallow (1 pk.)  
Cushion, Medium, Standard (1 pk.)  
Cushion, Medium, Shallow (1 pk.)  
Cushion, Large, Standard (1 pk.)  
Cushion, Large, Shallow (1 pk.)  
Cushion clip, Small (1 pk.)  
Cushion clip, Medium (1 pk.)  
Cushion clip, Large (1 pk.)  
Elbow (1 pk.)  
Elbow retainer (1 pk.)  
Luer lock ports caps (2 pk.)  
Luer lock ports caps (10 pk.)  
Headgear clip (2 pk.)  
Headgear clip (10 pk.)  
Forehead pad (1 pk.)  
8
 
Part No. Item  
60124  
60675  
60676  
60677  
60673  
60917  
60618  
60619  
Forehead pad (10 pk.)  
Mask Frame, Small (1 pk.)  
Mask Frame, Medium (1 pk.)  
Mask Frame, Large (1 pk.)  
Forehead Support (1 pk.)  
Headgear (1 pk.)  
Emergency Release Cord assembly (1 pk.)  
Emergency Release Cord assembly (10 pk.)  
Europe 1 - English, German, French, Italian, Spanish, Portuguese, Dutch.  
Consumer Warranty  
ResMed acknowledges all consumer rights granted under the EU Directive  
1999/44/EG and the respective national laws within the EU for products sold  
within the European Union.  
Note: Translations are based on the English version in this guide. However, there  
may be minor variations based on the disinfection/sterilisation procedures  
applicable in some countries. ResMed has reviewed these changes and all  
procedures included here have been validated.  
9
 
Manufacturer:  
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia  
Distributed by:  
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA  
ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK  
See www.resmed.com for other ResMed locations worldwide.  
Ultra Mirage and Mirage are trademarks of ResMed Ltd and Mirage is registered in the U.S. Pat-  
ent 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.  
© 2011 ResMed Ltd.  
 
608323/1  
2011-12  
Ultra Mirage NVFFM  
CLINICAL  
EUR 1 - ENG  
608323  
 
Global leaders in sleep and respiratory medicine www.resmed.com  

QSC Audio Stereo Amplifier CX1102 User Guide
Razor Motorcycle MX350 15128050 User Guide
RCA Camcorder ProV600 User Guide
RCA Flat Panel Television HD50LPW163 User Guide
RCA MP3 Player M41 User Guide
Russound Stereo Amplifier R275HC User Guide
Ryobi Outdoor Trimmer RPT2543C, RY7011 User Guide
Samsung DVD Player AK68 01808C User Guide
Seagate Computer Drive 9TN158 510 User Guide
Sebo Yard Vacuum C31 User Guide