ResMed Nasal Mask Mirage Micro Bedienungsanleitung

Mirage Micro™

nasal mask

User Guide

English

Mirage Micro™

nasal mask

Thank you for choosing the Mirage Micro™.

Intended Use

The Mirage Micro channels airﬂow noninvasively to a patient from a positive

airway pressure device such as a continuous positive airway pressure (CPAP)

or bilevel system.

The Mirage Micro is:

to be used by adult patients (>66 lb/30 kg) for whom positive airway•

pressure has been prescribed

intended for single-patient re-use in the home environment and•

multipatient re-use in the hospital/institutional environment.

Before Using the Mask

WARNINGS

The vent holes must be kept clear.•

The mask should not be used unless the CPAP system is turned on and•

operating properly.

Follow all precautions when using supplemental oxygen.•

Oxygen ﬂow must be turned off when the ﬂow generator is not operating,•

so that unused oxygen does not accumulate within the ﬂow generator

enclosure and create a risk of ﬁre.

At a ﬁxed ﬂow rate of supplemental oxygen ﬂow, the inhaled oxygen•

concentration varies, depending on the pressure settings, patient breathing

pattern, mask, point of application and leak rate.

The technical speciﬁcations of the mask are provided for your clinician to•

check that they are compatible with the ﬂow generator. If used outside

speciﬁcation or if used with incompatible devices, the seal and comfort of

the mask may not be effective, optimum therapy may not be achieved, and

leak, or variation in the rate of leak, may affect the ﬂow generator function.

Discontinue using the Mirage Micro if you have ANY adverse reaction to•

the use of the mask, and consult your physician or sleep therapist.

Using a mask may cause tooth, gum or jaw soreness or aggravate an•

existing dental condition. If symptoms occur, consult your physician or

dentist.

As with all masks, some rebreathing may occur at low CPAP pressures.•

Rx Only

Parts of the Mask & Ordering Information

Complete system

S* 16333 M&L* 16334 LW&XL* 16335

Frame system (no headgear)

S* 16378 M* 16379 L* 16380 LW* 16381 XL* 16382

Frame assembly (no headgear, no cushion)

S* 16383 St* 16384

Elbow assembly (elbow, swivel)

16399

S* Small; M* Medium; L* Large; LW* Large-Wide; XL* Extra-Large; St* Standard

Refer to your ﬂow generator manual for details on settings and operational•

information.

Flow Generator Settings

Select ‘Standard’ (or ‘Vista’ for VPAP Adapt SV™) as the mask option when

using the Mirage Micro with ResMed ﬂow generators that have mask setting

options. For a full list of compatible devices for this mask, see the Mask/

Device Compatibility List on www.resmed.com on the Products page under

Service & Support. If you do not have internet access, please contact your

ResMed representative.

Forehead

support pad

Forehead support

16393

Dial

61289

Mask cushion

16388 (S*)

16389 (M*)

16390 (L*)

16391 (LW*)

16392 (XL*)

Ports cap

16570 (2)

16571 (10)

Elbow

16387

Swivel

16565

60123 (1)

60124 (10)

Mask frame

16395 (S*)

16394 (St*)

Headgear clip

16569 (2)

16734 (10)

Upper straps

Lower straps

Headgear

16118 (S*)

16117 (M)

16119 (L*)

12 3

654

English

Turn the dial, so that the

forehead support is fully

extended.

Hold the mask over your

nose and pull the headgear

over your head.

Bringing the lower straps

below your ears, connect

the headgear clip to the the

mask frame.

Unfasten the Velcro®,

pull the upper headgear

straps evenly until they are

comfortable and ﬁrm, and

reattach the Velcro.

Repeat step 4 with the

lower headgear straps.

Connect the main air

tubing to the swivel. Then

connect the free end of

the air tubing to your ﬂow

generator and turn the ﬂow

generator on.

Fitting the Mask

Lie down in your sleeping

position. Adjust the dial

until the mask is evenly

positioned on your face.

It should be comfortable,

with a satisfactory seal.

Adjust the headgear straps

if necessary.

The ﬁtted mask is shown

above.

Removing the Mask

Disconnect one of the

headgear clips and pull the

mask and headgear up over

your head.

12 3

Disassembling the Mask

Detach the air tubing. Unclip the headgear clips

and unthread the upper

headgear straps. It is not

necessary to remove the

headgear clips from the

headgear.

Remove the elbow

assembly from the mask

frame by pivoting from the

bottom edge.

67 8

Remove the forehead

support pads from the

forehead support.

Remove the ports cap

from the mask frame.

Remove the cushion

from the mask frame.

4 5

(a)

(b)

Note the position on the dial for the next time you use

the mask. Unscrew and remove the dial (a) then pull the

forehead support (b) out of the mask frame.

Remove the swivel from

the elbow.

English

Cleaning the Mask at Home

Notes:

The mask and headgear should be cleaned by handwashing.

•

The headgear may be washed without removing the headgear clips.•

WARNING

Do not use aromatic-based solutions or scented oils (eg, eucalyptus or

essential oils), bleach, alcohol or products that smell strongly (eg, citrus)

to clean any of the mask components. Residual vapours from these

solutions can be inhaled if not rinsed thoroughly.They may also damage

the mask, causing cracks.

CAUTION

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

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

replaced.

Avoid connecting ﬂexible PVC products (eg, PVC tubing) directly•

to any part of this mask. Flexible PVC contains elements that can

be detrimental to the materials of the mask, and may cause the

components to crack or break.

Daily/After Each Use

To optimize the mask seal, facial oils should be removed from the cushion

before use.

Handwash the mask by gently rubbing in warm (86°F/30°C) water using mild

soap.

If the vent requires cleaning use a soft bristle brush.

Rinse all components well with drinking quality water and allow them to air

dry out of direct sunlight. Do not soak the mask.

Weekly

Handwash the headgear in warm (approx. 86°F/30°C) water using mild soap.

Reprocessing the Mask between Patients

This mask should be reprocessed when used between patients.

Cleaning, disinfection and sterilisation 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.

31 2

6 7

(a)

(b)

(c)

Push the forehead pads

ﬁrmly into the forehead

support.

Insert the forehead support (a) into the mask frame and

screw (b) the dial clockwise onto the pole. Turn the dial

until it clicks (c). Ensure the dial sits ﬂush against the

frame.

Insert the cushion into the

mask frame. Ensure that

the arrows at base of the

cushion and mask frame

are aligned.

Insert the ports cap.

Reattach the top headgear

straps by threading them

through the loops.

Insert the swivel into the

end of the elbow.

Insert the assembled

elbow into the mask frame.

Reassembling the Mask

English

Troubleshooting

Problem Possible reason Possible solution

Mask won’t seal

properly

or is uncomfortable

Mask may have been

ﬁtted incorrectly or is

incorrectly adjusted.

Carefully follow instructions

in “Fitting the Mask”. Check

headgear and dial are not over-

tightened. Extend dial to apply

more force to upper lip. Shorten

dial to increase force at nose

bridge.

Mask is wrong size. Talk to your clinician.

Mask cushion is

skewed in mask frame.

Check insertion of cushion

and reinsert correctly

according to the instructions in

“Reassembling the Mask”.

Mask cushion is

misaligned or creased

on face.

Ensure cushion is properly

aligned according to the

instructions in “Reassembling

the Mask”. Make sure the

cushion has no creases in it:

undo headgear clip, check

cushion and reposition the mask

over your nose.

Mask cushion may be

dirty.

Clean cushion according to

instructions in “Cleaning the

Mask at Home”.

Mask is too noisy Mask is assembled

incorrectly.

Reassemble mask.

Vents are blocked or

partially blocked.

Clean vents according to

instructions in “Cleaning the

Mask at Home”.

Dial inserted into mask

frame before forehead

support

Misassembly. Push dial base onto a hard

surface until the dial comes out

of the frame.

Symbols

Caution, consult accompanying documents;

L O T

Lot number;

REF

Part

number; Temperature limitation; Humidity limitation; Does not

contain latex; 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.

Limited Warranty

ResMed warrants that your ResMed mask system, including its components:

mask frame, cushion, headgear, tubing and other accessories (“Product”) shall

be free from defects in material and workmanship for a period of ninety (90)

days from the date of purchase by the initial consumer.

For further details refer to the Warranty.

Technical Speciﬁcations

Note: The mask system does not contain latex, PVC or DEHP materials.

Pressure–Flow

Curve

The mask contains passive venting to protect

against rebreathing. As a result of manufacturing

variations, the vent ﬂow rate may vary.

468101214161820

Pressure

(cm H2O)

Flow

(L/min)

419

8 28

12 34

16 40

20 45

Vent Flow Rate (L/min)

Mask Pressure (cm H2O)

Dead Space

Information

The dead space of the mask varies according to cushion size. It is

128 mL for the Extra Large size.

Therapy Pressure 4 to 20 cm H2O

Resistance Drop in pressure measured (nominal)

at 50 L/min: 0.1 cm H2O

at 100 L/min: 0.7 cm H2O

Environmental

Conditions

Operating temperature: +41°F to 104°F (+5°C to +40°C)

Operating humidity: up to 95% non-condensing

Storage and transport temperature: -4°F to 140°F (-20°C to +60°C)

Storage and transport humidity: up to 95% non-condensing

Gross

dimensions

S: 140 mm (H) x 91 mm (W) x 93 mm (D)

M, L, LW, XL: 155 mm (H) x 91 mm (W) x 98 mm (D)

Mask fully assembled – no headgear.

Note: The manufacturer reserves the right to change these speciﬁcations

without notice.

Storage

Ensure that the mask is thoroughly clean and dry before storing it for any

length of time. Store the mask in a cool dry place out of direct sunlight.

Disposal

The Mirage Micro does not contain any hazardous substances and may be

disposed of with your normal household refuse.

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 Authorised Representative) 96 Milton Park Abingdon Oxfordshire OX14

4RY UK

ResMed Ofﬁces Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Greece,

Hong Kong, India, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway,

Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com

for contact details).

Mirage Micro Nasal Mask

Protected by patents: AU 710733, AU 741003, AU 766623, AU 775051, AU 777033, AU 785376,

CA 2261790, EP 0956069, EP 1187647, EP 1187648, EP 1187649, EP 1187650, EP 1314445, EP

1479406, HK 1057714, JP 3686609, NZ 513052, NZ 526165, NZ 526166, NZ 526167, NZ 526168,

US 6112746, US 6119693, US 6357441, US 6374826, US 6439230, US 6463931, US 6532961, US

6557556, US 6581594, US 6581602, US 6634358, US 6691708, US 6823865, US 6860269, US

6871649, US 6997188, US 7011090, US 7159587, US 7178527, US 7188620, US 7216647, US

7234466, US 7243651. Other patents pending.

Protected by design registrations: AU 304309, CN 200530117106.1, EP 366844, JP 1264474, NZ

406357, US D532512, US D547439, US D545960. Others pending.

AutoSet CS, Mirage and Mirage Micro are trademarks of ResMed Ltd. AutoSet CS and Mirage are

registered in U.S. Patent and Trademark Ofﬁce.

Velcro is a registered trademark of Velcro Industries B.V.

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