ResMed Ultra Mirage NVFFM User manual

Global leaders in sleep and respiratory medicine www.resmed.com
Ultra Mirage™
NON-VENTED FULL FACE MASK
Clinical Guide
English •Svenska •Dansk •Norsk •Suomi
608144/3 07 04
Ultra Mirage NVFFM
CLINICAL
EUR 2
608144
608144 ROW-2 UMNVFFM Multi cover.qxp 20/04/2007 7:31 AM 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, Norway, 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. Others pending.
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.
© 2007 ResMed Ltd.
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A
© 2007 ResMed Ltd.
Mask Parts / Delar i masken / Maskens dele / Maskedeler /
Maskin osat
Forehead support / Pannstöd /
Pandestøtte / Pannestøtte / Otsatuki
Luer lock ports cap / Luerportlock /
Hætte til luer-lock-porte / Lokk til
luerlock-åpninger / Luer-liitännän
korkki
Forehead support pad / Pannstödsdyna / Pandestøtteunderlag /
Pute til pannestøtte / Otsatuen pehmike
Mask frame / Maskram /
Maskeramme / Maskeramme /
Maskin runko-osa
Cushion clip / Kuddklämma /
Pudeklemme /Tetningsklemme /
Pehmikkeen kiinnike
Mask cushion / Maskkudde /
Maskepude / Masketetning /
Maskin pehmike
Upper Velcro
™
straps /
Övre sidans kardborreremmar /
Øverste Velcro stropper /
Øvre borrelåsstropper /
Ylemmät tarranauhat
Headgear clip /
Hättans klämma /
Maskeholderspænde /
Klemme på hodeutstyr /
Pääremmien kiinnike
Lower Velcro straps / Lägre sidans
kardborreremmar / Nederste Velcro
stropper / Nedre borrelåsstropper /
Alemmat tarranauhat
Elbow / Båge / Vinkelstykke /
Vinkelrør / Kulmakappale
Elbow retainer / Båghållare /
Vinkelstykkeholder / Vinkelrørholder /
Kulmakappaleen pidike
B
B-1 B-2
B-3 B-4
B-5 B-6
©2007 ResMed Ltd.
1
3
4
2
Forehead support tab / Pannstödsflik /
Pandestøttetap / Knapp på pannestøtte /
Otsatuen kieleke
Fitting the Mask / Maskinpassning /Tilpasning af masken /
Tilpasse masken / Maskin sovittaminen
C-2
C-3 C-4
C-6
C
C-1
L-shaped ridge / L-formad kant / Vinkelformet
kant / L-formet kant / L:n muotoinen kohouma
LIFT / LYFT / LØFT /
LØFT / NOSTA
Elbow retainer / Båghållare /
Vinkelstykkeholder /
Vinkelrørholder / Kulmakappaleen
pidike
PUSH / SKJUT / SKUB /
SKYV / TYÖNNÄ
a
b
Disassembling for Cleaning /Ta isär för rengöring / Adskillelse før
rengøring / Demontere masken før rengjøring / Purkaminen
puhdistusta varten
©2007 ResMed Ltd.
C-5
b
a
UM NV FFM Illos ROW-2.qxp 10/04/2007 4:06 PM Page 1

Note: For complete instructions, read the text section in conjunction with the illustrations on
this sheet.
Obs! Läs textavsnittet tillsammans med illustrationerna på det här bladet för fullständiga
anvisningar.
Bemærk: Komplet anvisning fås ved både at læse teksten og se på billederne på dette ark.
Merk: Hvis du vil ha fullstendige anvisninger, skal du lese kapitlene knyttet til illustrasjonene på
dette arket.
Huomautus: Saadaksesi hyvän käsityksen ohjeista lue teksti tutustuen samalla tämän
kuvasivun kuviin.
Illustrations Sheet / Illustrationsblad / Illustrationsark / Illustrasjonsark / Kuvasivu
Ultra Mirage
TM
NON-VENTED FULL FACE MASK
Component of: 608144/3
D-1
D-6
D-3
a
b
D-5
D-2
D-4
D
D-7
©2007 ResMed Ltd.
Reassembling the Mask / Montera masken / Samling af masken /
Montere masken igjen / Maskin kokoaminen
Luer lock ports cap / Luerlås, portlock /
Hætte til luer-lock-porte / Lokk til
luerlock-åpninger / Luer-liitännän korkki
Mask port / Maskport / Maskeport /
Åpning i maske / Maskin liitäntä Elbow / Vinkelstykke /
Vinkelrør / Kulmakappale
Elbow retainer / Båghållare /
Vinkelstykkeholder /
Vinkelrørholder / Kulmakappaleen
pidike
Pivot / Axelbult /
Drejetap /
Svingelement / Tappi
UM NV FFM Illos ROW-2.qxp 10/04/2007 4:06 PM Page 2

English
1
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
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2
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).
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3
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.
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4
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.
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5
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.
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6
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.
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