ResMed Ultra Mirage User manual

Ultra Mirage
™
NV Mask
CliNiCiaN’s
guide
Guía del Médico
Guia do Médico
Guide c
www.resmed.com

1
CoNtraiNdiCatioNs
.................................................................. 2
WarNiNgs
.............................................................................. 2
CautioNs
............................................................................... 3
additioNal iNforMatioN
........................................................... 3
Mask CharaCteristiCs
.............................................................. 4
Parts of the Mask
.................................................................. 4
fittiNg the Mask
..................................................................... 5
disasseMbliNg the Mask
........................................................... 5
CleaNiNg the Mask iN the hoMe
............................................... 6
reProCessiNg the Mask betWeeN PatieNts
.................................... 6
reasseMbliNg the Mask
............................................................ 7
aCCessories aNd rePlaCeMeNt Parts
........................................... 8
storage, disPosal aNd syMbols
................................................. 9

2
Ultra MiraGe
™
nV Mask
The
Ultra Mirage
™
NV Mask
system (non-vented) is
only indicated for the treatment of adult patients using
non-invasive ventilator systems that have an active
exhaust.
caution
In the USA, federal law restricts this device to sale by,
or on the order of, a physician.
contraindications
• The
Ultra Mirage NV Mask
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
• Itisexpectedthatiftheventilatorfails,the
mechanism of the ventilator will provide a low-
deadspace path to room air, so that significant
rebreathing does not occur. If the ventilator is
such that this is not the case:
• Preventionofrebreathingortotalairway
obstruction (depending on the ventilator) depends
on the ability of the patient to open his or her
mouth.
• Ifthepatientmightfailtorespondeffectivelyto
failure of the ventilator by opening his or her
mouth and breathing through the mouth, this
mask should not be used.
• Themouthshouldneverbetapedorotherwise
limited from opening to an extent which might
compromise the patient’s ability to open his or her
mouth.
• Themaskshouldnotbewornunlessthe
ventilator system is turned on and operating
properly.
• Ataxedrateofsupplementaloxygenow(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, nylon, and polyester.
• Usingamaskmaycausetooth,gumorjaw
soreness or aggravate an existing dental condition.
If symptoms occur, consult your physician or
dentist.

3
cautions
• 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ow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,signicant
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PCO2with no change in ventilator settings.
additional inforMation
• ResMedhastintedthe
Ultra Mirage NV Mask
frame
and elbow blue to help you identify it as a non-
vented mask for use with active-exhaust non-
invasive ventilator systems only.
• Themaskelbowhasastandardfemale22mm
taperedtting(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 allowances for mask
deadspace and leak, both directly from the mask
itself(primarilyattheelbow-maskframejunction),
andbetweenthefaceandmask.RefertotheMask
Characteristicssectionformoreinformation.
• Refertotherelevantventilatorsystemoperating
instructions for detailed information concerning
connecting the mask.

4
Mask characteristics
Mask deadsPace
Ultra Mirage NV Mask
100mL
Note: is value was obtained using a facial prole and
measuring the volume from the surface of the face to the end of
the elbow. e data is provided as an indication only. Actual
volumes may vary depending on individual facial features.
Mask iMPedance data
Ataowof60L/minthedifferenceinpressure
between the end of the elbow and inside the mask is
lessthan0.5cmH2O.
Mask leak
The leak from the mask, excluding leak between the
faceandthemask,islessthan6.0L/minupto20cm
H2O.
enVironMental conditions
Temperature Humidity
Operating +41°F to 104°F
(+5°C to +40°C)
15% to 95%
relative humidity
non-condensing
Storage and Transport -4°F to 140°F
(-20°C to +60°C)
up to 95%
relative humidity
non-condensing
Parts of the Mask
Forehead support
Headgear clip tab
Forehead support tab
Mask frame
Cushion clip
Mask cushion
Headgear clip
Ports cap
Elbow

5
fittinG the Mask
Note: Before tting the mask, refer to section on “Cleaning the
Mask in the Home”.
1 Connecttheventilator22mmmalettingtothe
mask elbow. Alternatively, do this after you have
ttedthemask(Step3).
2 Placethecushionoveryournose,pullthe
headgear over your head and make the side lower
Velcro®straps pass below your ears.
 UsetheVelcrostrapstoadjustthetofthe
headgear. Do not pull the straps too tightly.
3The pads of the forehead support should lightly
touch your forehead when the mask is in place.
 Adjusttheforeheadsupportbydepressingitstab
and moving it to one of the other slot positions.
4 Turntheventilatoron.Liedownandcheckthat
the mask is comfortable and there are no air leaks.
Ifthereareairleaks,youmayneedtoreadjustthe
Velcro straps (see Step 2) or forehead support (see
Step3).
To remove the mask, depress the tabs of the headgear
clips. This releases the headgear clips from the mask
frame.Pullthemaskandheadgearawayfromyour
head.
disasseMblinG the Mask
1Detach and separate the ventilator 22mm male
fitting, headgear, headgear clips, forehead pads,
cushion clip, cushion, and ports cap.
2Depress the forehead
support tab and move
it past the top slot
position. This allows
you to remove the
forehead support from
the mask frame.
Forehead
support

6
3From the inside of
the mask frame,
hold one side of
the elbow clip in
place and release
the other side of
theclip.Remove
the clip and elbow
from the mask
frame.
cleaninG the Mask in the hoMe
Note: Wash the headgear before rst time use, as the dye may
run. It is important to always hand wash the headgear.
1 Handwash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.
2 Handwash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.
caution
• Donotusebleach-,chlorine-,alcohol-,or
aromatic-based solutions, moisturizing or
antibacterial soaps, or scented oils to clean the
cushion, mask frame, forehead pads, or headgear.
These solutions may cause damage and reduce
the life of the product.
• Donotexposeanypartofthemasksystemto
direct sunlight as it may cause the product to
deteriorate.
reProcessinG the Mask betWeen Patients
The mask should be reprocessed when used between
patients.
Cleaning,disinfectionandsterilizationinstructions
areavailablefromtheResMedwebsite,www.resmed.
com/masks/sterilization/americas.
If you do not have Internet access, please contact
yourResMedrepresentative.
Elbow clip

7
reasseMblinG the Mask
1 Inserttheportscapintotheports.Makesurethe
tabs of the ports cap face away from the mask.
2 Insert the elbow into the mask frame and secure
it with the elbow clip on the inside of the frame.
Theatsideoftheelbowclipmustfacethemask
frame. If you have fitted the elbow correctly, it
should not move when you try to firmly pull it
away from the frame.
3 Replacetheforeheadpadsbyslidingthecentre
division of the pads onto the forehead pad
holders.
4 Reconnecttheforeheadsupporttothemask
frame. Depress the tab and move the forehead
support into one of the four slot positions.
Elbow
clip
Elbow
Forehead
pad
Forehead
support

8
5Fit the grooved edge of the nasal 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.Pushthecushionclipoverthecushion
onto the mask frame, ensuring it clicks into place
in all locations.
6 Connecttheheadgearclipstothemaskframe.
Thread the headgear straps through the slots on
the forehead support and the headgear clips. The
Ultra Mirage
headgear label should face outwards
and be near your neck when fitted. Fasten the
Velcro straps.
accessories and rePlaceMent Parts
Description Quantity Part
per pack Number
Cushion(Standard)  1 16556
Cushion(Large)  1 16557
Cushion(Shallow)  1 16558
CushionClip  1 16563
ElbowAssembly(includesElbowClip) 1 60916
ElbowClip  1 16572
ElbowClip  10 16573
ForeheadPad  2 16561
ForeheadPad  10 16574
ForeheadSupport  1 16562
Headgear  1 60917
HeadgearClips  2 16569
HeadgearClips  10 16734
Mask/AirTubingConnector  1 60913
(Male22mmtaper/Male22mmbarbed) 
Mask/AirTubingConnector  10 60914
(Male22mmtaper/Male22mmbarbed) 
MaskFrame  1 60915
PortsCap  2 16570
PortsCap  10 16571
Mask cushion
Cushion clip

9
storaGe
Ensure that the mask is thoroughly clean and dry
before storing it for any length of time. Store the mask
in a dry place out of direct sunlight.
disPosal
This mask does not contain any hazardous substances
and may be disposed of with your normal household
refuse.
syMbols
Caution,consultaccompanyingdocuments;
LOT
BatchCode;
REF
CatalogueNumber;
EuropeanAuthorisedRepresentative;
Temperature limitation; Humiditylimitation;
Does not contain natural rubber latex;
Manufacturer; 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;
Keep away from rain; This way up;
Fragile, handle with care.
liMited Warranty
ResMedLtd(hereafter’ResMed’)warrantsthatyour
ResMedmasksystem(includingmaskframe,cushion,
headgear and tubing) shall be free from defects in
material and workmanship from the date of purchase
fortheperiodof90daysorinthecaseofdisposable
masks the maximum use period.
This warranty is only available to the initial consumer.
It is not transferable.
If the product fails under conditions of normal use,
ResMedwillrepairorreplace,atitsoption,the
defective product or any of its components.
This limited warranty does not cover: a) any
damage caused as a result of improper use, abuse,
modification or alteration of the product; b) repairs
carried out by any service organization that has not
beenexpresslyauthorizedbyResMedtoperformsuch
repairs; and c) any damage or contamination due to
cigarette, pipe, cigar or other smoke.
Warranty is void on product sold, or resold, outside
the region of original purchase.
Warranty claims on defective product must be made
by the initial consumer at the point of purchase.
This warranty replaces all other expressed or implied
warranties, including any implied warranty of