ResMed Ultra Mirage Bedienungsanleitung

Ultra Mirage

™

NV Mask

CliNiCiaN’s

guide

Guía del Médico

Guia do Médico

Guide c

www.resmed.com

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

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.

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.

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

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

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

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

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

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

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