ResMed Mirage SoftGel User manual

Mirage™ SoftGel
NASAL MASK
User Guide
English

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Fitting / 配戴步骤 / 配戴步驟
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Removal / 取下面罩 / 取下面罩
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MirageTM SoftGel

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Mirage SoftGel
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BC

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Mask components / 面罩组件 / 面罩組件
Item /
项目 / 項目
Description / 描述 / 描述 Part number /
配件编号 / 配件編號
1Mask frame / 面罩框架 / 面罩框架 60180 (St)
60193 (S)
2Dial / 微调器 / 微調器 61289
3Forehead support / 前额托架 / 前額托架 16393
4Forehead support pad / 前额托架垫 /
前額托架墊
60123 (1)
60124 (10)
5Cushion & clip / 护垫与护垫夹 /
軟墊與軟墊夾
61631 (S)
61632(M)
61633 (L)
61634 (LW)
6Cushion clip / 护垫夹 / 軟墊夾 60176 (St)
60197 (S)
7Headgear clip / 头带扣钩 /
頭帶扣鈎
16569 (2)
16734 (10)
8Headgear / 头带 / 頭帶 16118 (S)
16117 (M)
16119 (L)
9Ports cap / 端口帽 / 端口帽 16570 (2)
16571 (10)
10 Swivel / 万向轴 / 萬向軸 16565
11 Elbow / 弯头 / 彎頭 16387
12 Vent / 通气孔 / 通氣孔 -

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A Complete system / 完整系统 / 完整系統 ANZ APAC
61616 (S)
61617 (M)
61618 (L)
61619 (LW
61642 (S)
61643 (M)
61644 (L)
61645 (LW)
BElbow assembly / 弯头组合 / 彎頭組合 16399
Also available / 另外提供配件 / 另外提供配件
C Activa LT Cushion & Clip /
护垫与护垫夹 / 軟墊與軟墊夾
60198 (S)
60177 (M)
60178 (L)
60179 (LW
S Small / 小型 / 小型
M Medium / 中型 / 中型
L Large / 大型 / 大型
LW Large Wide / 大宽型 / 大寬型
St Standard / 标准型 / 標準型

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Disassembly / 拆卸 / 拆卸
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789

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Reassembly / 重新组装 / 重新組合

1
English
English
MirageTM SoftGel
NASAL MASK
Thank you for choosing the Mirage SoftGel.
The Mirage SoftGel is the first of ResMed’s masks offering a choice of two
high performance cushions (Mirage SoftGel and Mirage Activa LT) on the one
durable frame. For further information, refer to the Activa LT User Information
section in this User Guide
Intended use
The Mirage SoftGel channels airflow noninvasively to a patient from a positive
airway pressure (PAP) device such as a continuous positive airway pressure
(CPAP) or bilevel system.
The Mirage SoftGel is:
to be used by adult patients (> 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.
Using your mask
When using your mask with ResMed CPAP or bilevel devices that have mask
setting options, refer to the Technical specifications section in this user guide
for mask selection 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.
Note: If you experience nasal dryness or irritation, use of a humidifier is
recommended.
WARNING
The vent holes must be kept clear.•
The mask should not be used unless the CPAP or bilevel device is
•
turned on and operating properly.
Follow all precautions when using supplemental oxygen.
•
Oxygen flow must be turned off when the CPAP or bilevel device
•
is not operating, so that unused oxygen does not accumulate
within the CPAP or bilevel device enclosure and create a risk of
fire.

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At a fixed 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 CPAP or bilevel
device. 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 CPAP or bilevel device function.
Discontinue using this mask 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.
Refer to your CPAP or bilevel device manual for details on settings
•
and operational information.
Remove all packaging before using the mask.
•
Cleaning your mask in the home
Your mask and headgear should only be handwashed by gently rubbing in
warm (approximately 30°C) water using mild soap. All components should
be rinsed well with drinking quality water and allowed to air dry out of direct
sunlight.
Daily/After each use:
To optimize the mask seal, facial oils should be removed from the cushion•
after use.
Handwash the separated mask components (excluding headgear).•
If the vent requires cleaning use a soft bristle brush.•
Weekly:
Handwash the headgear. It may be washed without being disassembled.•

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English
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 system component is apparent•
(cracking, crazing, tears or cushion damage resulting in gel
exposure, etc), the component should be discarded and replaced.
Avoid connecting flexible PVC products (eg, PVC tubing) directly
•
to any part of the mask. Flexible PVC contains elements that can
be detrimental to the materials of the mask, and may cause the
components to crack or break.
Reprocessing the mask between patients
This mask should be reprocessed when used between patients.
Cleaning, disinfection and sterilization instructions are available from the
ResMed website, www.resmed.com/masks/sterilization.
If you do not have internet access, please contact your ResMed
representative.
Troubleshooting
Problem/possible cause Solution
Mask is uncomfortable
Headgear straps are too tight. Adjust straps evenly. The forehead
support ‘anchors’ your mask and
should sit firmly on your forehead.
Fit is too tight. Wind out dial.
Mask is too noisy
Cushion clip is not inserted correctly. Remove cushion from frame and
reinsert starting at the top.
Check that the cushion clip is correctly
inserted into the cushion and that
the cushion is correctly clipped to the
frame. If the problem persists, talk to
your clinician.

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Troubleshooting
Problem/possible cause Solution
Ports cap or elbow incorrectly inserted. Remove the ports cap or elbow from
the mask, then reassemble according
to the instructions.
Vent is blocked or partially blocked. If the vent requires cleaning, use a soft
bristle brush.
Mask leaks around the face
Mask not positioned correctly. Gently pull the cushion away from the
face to reinflate. Reposition your mask
according to the instructions.
Air leaking around the bridge of the
nose.
Wind the dial in.
Air leaking around the top of the lip. Wind the dial out and or tighten the
bottom straps.
The mask does not fit properly
Cushion could be the wrong size. Talk to your clinician.
Mask is incorrectly assembled. Disassemble the mask, then
reassemble according to the
instructions.
Cushion may be dirty. Clean cushion according to the
instructions.
Cannot insert forehead support into mask frame
The dial has been inserted into the
frame before the forehead support.
Push the end of the dial onto a hard
surface until the dial comes out of the
frame. Reassemble according to the
instructions.

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English
Technical specifications
Pressure–flow
curve
The mask contains passive venting to protect against
rebreathing. As a result of manufacturing variations, the vent
flow rate may vary.
Dead space
information
Physical dead space is the empty volume of the mask to the end
of the swivel. Using the large cushions it is 145 mL.
Therapy pressure 4 to 20 cm H2O
Resistance Drop in pressure measured (nominal)
at 50 L/min: 0.3 cm H2O
at 100 L/min: 0.9 cm H2O
Sound DECLARED DUAL NUMBERED NOISE EMISSION VALUES IN
ACCORDANCE WITH ISO 4871
The A weighted sound power level of the mask is 29 dBA, with
uncertainty 3 dBA.
The A-weighted sound pressure level of the mask at a distance
of 1m is 22 dBA, with uncertainty 3 dBA.
Environmental
conditions
Operating temperature: +5°C to +40°C)
Operating humidity: 15% to 95% relative humidity
non-condensing
Storage and transport: -20°C to +60°C)
Storage and transport humidity: up to 95% relative humidity
non-condensing
Gross dimensions Mask fully assembled – no headgear
L: 155 mm (H) x 91 mm (W) x 118 mm (D)
Mask setting
options
Select ‘ACTIVA’ (if available), otherwise select ‘STANDARD’ as
the mask option.
Notes:
The mask system does not contain latex, PVC or DEHP materials.•
The manufacturer reserves the right to change these specifications•
without notice.
0
10
20
30
40
50
60
4 6 8 10 12 14 16 18 20
Mask pressure (cm H20)
Vent flow rate (L/min)
Pressure
(cm H2O)
Flow
(L/min)
419
8 28
12 34
16 40
20 45

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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
Lot number;
REF
Part
number; Temperature limitation; Humidity limitation; Does not
contain 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 (Asia Pacific/ANZ)
ResMed Pty 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 merchantability or fitness for a particular purpose. Some
regions or states do not allow limitations on how long an implied warranty
lasts, so the above limitation may not apply to you.

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English
ResMed shall not be responsible for any incidental or consequential damages
claimed to have resulted from the sale, installation or use of any ResMed
product. Some regions or states do not allow the exclusion or limitation of
incidental or consequential damages, so the above limitation may not apply to
you.
This warranty gives you specific legal rights, and you may also have other
rights which vary from region to region. For further information on your
warranty rights, contact your local ResMed dealer or ResMed office.

1
Mirage Activa™ LT
NASAL MASK / 鼻面罩 / 鼻面罩
User information
English•简体中文•繁體中文
English
Please read this information in conjunction with your MirageTM SoftGel User
Guide when changing your Mirage SoftGel cushion to the Mirage Activa LT
cushion.
Intended use
The Mirage Activa LT 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 Activa LT is:
to be used by adult patients (> 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.
Cushion & clip /
护垫与护垫夹 /
護墊與護墊夾
60198 (S)
60177 (M)
60178 (L)
60179 (LW)
Cushion clip /
护垫夹 / 護墊夾
60176 (St
60197 (S)

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Troubleshooting
Problem/possible cause Solution
Mask is uncomfortable
Cushion incorrectly inflated With the air turned off, adjust the straps so that you can
insert two fingers between your cheek and the lower
headgear strap.
Technical specifications
Dead space information The dead space of the mask varies according to
cushion size. It is 185 mL for the Medium size.
Resistance Drop in pressure measured (nominal)
at 50 L/min: 0.1 cm H2O
at 100 L/min: 0.7 cm H2O
Sound DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The
A-weighted sound power level of the mask is 30
dBA, with uncertainty 3 dBA. The A-weighted sound
pressure level of the mask at a distance of 1 m is
22 dBA, with uncertainty 3 dBA.
Gross dimensions
S:
M, L, LW:
Mask fully assembled – no headgear.
141 mm (H) x 91 mm (W) x 107 mm (D)
154 mm (H) x 95 mm (W) x 117 mm (D)
Mask setting options Select ‘Activa’ (if available) or ‘Standard’ as the mask
option when using the Mirage Activa LT with ResMed
devices that have mask setting options.
简体中文
将Mirage SoftGel(梦幻软胶)鼻面罩护垫换成Mirage Activa LT(梦幻动态LT)鼻
面罩护垫时，请合并详阅此信息与您的MirageTM SoftGel用户指南。
设计用途
Mirage Activa LT鼻面罩的用途在于将持续气道正压(CPAP)或双水平系统的气道
正压装置所产生的气流，以无创方式输送给患者。
Mirage Activa LT鼻面罩适合：
供体重超过30公斤，按医嘱须接受气道正压治疗的成年患者使用， •
供单一患者在家中重复使用，以及供多位患者在医院/诊所中重复使用。 •

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故障排除
问题/可能原因 解决方法
面罩不舒服
护垫充气不当 关闭空气，将束带调整为能在面颊与下部头带束带间插
入两指的松紧度。
技术规格
死腔信息 面罩的死腔会因护垫的尺寸而有所差异。中型尺寸容积
为185毫升。
阻力 测量到的压力下降(标称值)
50公升/分钟时﹕0.1 cm H2O
100公升/分钟时﹕0.7 cm H2O
声音 依照ISO 4871标准公布的双数噪音排放值
面罩的A加权声音功率程度为30调整分贝，不确定值为3
调整分贝。
在1米的距离时，面罩的A加权音压程度为22调整分贝，
不确定值为3调整分贝。
外部尺寸
S(小型):
M(中)、L(大)、LW(大宽):
完全组装面罩 – 无头带。
141毫米(高) x 91毫米(宽) x 107毫米(厚)
154毫米(高) x 95毫米(宽) x 117毫米(厚)
面罩设定选项 搭配具有面罩设定选择的瑞思迈装置使用Mirage Activa
LT鼻面罩时，面罩选择请选‘Activa’(若提供)
或‘Standard’。
繁體中文
將Mirage SoftGel(夢幻軟膠)鼻面罩護墊換成Mirage Activa LT(夢幻動態LT)鼻面
罩護墊時，請合併詳閱此資訊與您的MirageTM SoftGel用戶指南。
設計用途
Mirage Activa LT鼻面罩的用途在於將持續氣道正壓(CPAP)或雙陽壓系統的氣道
正壓裝置所產生的氣流，以非侵入方式輸送給患者。
Mirage Activa LT鼻面罩適合:
供體重超過30公斤，按醫囑須接受氣道正壓治療的成年患者使用， •
供單一患者在家中重複使用，以及供多位患者在醫院/診所中重複使用。 •

4
故障排除
問題/可能原因 解決方法
面罩不舒服
護墊充氣不當 關閉空氣，將束帶調整為能在面頰與下部頭帶束帶間插
入兩指的鬆緊度。
技術規格
死腔資訊 面罩的死腔會因護墊的尺寸而有所差異。中型尺寸容積
為185毫升。
阻力 測量到的壓力下降(標稱值)
50公升/分鐘時: 0.1 cm H2O
100公升/分鐘時: 0.7 cm H2O
聲音 依照ISO 4871標準公佈的噪音排放值
面罩的A加權聲音功率程度為30分貝，誤差值為3分貝。
在1米的距離時，面罩的A加權音壓程度為22分貝，誤差
值為3分貝。
外部尺寸
S(小型):
M(中)，L(大)，LW(大寬):
完全組裝面罩 – 無頭帶。
141毫米(高) x 91毫米(寬) x 107毫米(厚)
154毫米(高) x 95毫米(寬) x 117毫米(厚)
面罩設定選項 搭配具有面罩設定選擇的瑞思邁裝置使用Mirage
Activa LT鼻面罩時，面罩選擇請選 'Activa' (若提供)或
'Standard'。

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Manufacturer:ResMedPtyLtd1 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.Mirage SoftGelProtected by patents: AU 741003, AU 766623, AU 775051, AU 777033, AU 785376, DE 20122844.0, EP 1187647, EP 1187649, EP 1187650, EP 1314445, EP 1582230, EP 1621225, EP 1640034, HK 1057714, JP 3686609, NZ 513052, NZ 526165, NZ 526166, NZ 526167, NZ 526168, NZ 542849, NZ 543939, US 6119693, US 6374826, US 6439230, US 6463931, US 6532961, US 6557556, US 6581594, US 6691708, US 6823865, US 6860269, US 6997188, US 7159587, US 7216647, US 7234466. Other patents pending. Protected by design registrations: AU 156663, AU 156665, AU 321676, DE 40301991.5, FR 031425, FR 031430, JP 1192859, JP 1197930, NZ 411222, US D486227, US D487510, US D493521, US D493522, US D545960, US D567935. Others pending.Mirage is a trademark of ResMedPty Ltdand is registered in U.S. Patent and Trademark Office. © 2009 ResMed. Mirage Activa LT Protected by patents: AU 2001267133, AU 2002301370, AU 710733, AU 741003, AU 766623, AU 775051, AU 777033, AU 785376, CA 2261790, CA 2470671, DE 20122844.0, EP 0956069, EP 1187647, EP 1187649, EP 1187650, EP 1314445, EP 1334742, EP 1479406, EP 1582230, EP 1621225, EP 1640034 , HK 1057714, HK 1071083, JP 3686609, JP 3802872, JP 4031422, NZ 513052, NZ 526165, NZ 526166, NZ 526167, NZ 526168, NZ 542849, NZ 543939, US 6112746, US 6119693, US 6357441, US 6374826, US 6412487, US 6439230, US 6463931, US 6532961, US 6557556, US 6581594, US 6581602, US 6634358, US 6691708, US 6772760, US 6796308, US 6823865, US 6823869, US 6860269, US 6871649, US 6986352, US 6997188, US 7021311, US 7107989, US 7159587, US 7178527, US 7216647, US 7234466, US 7243651, US 7318439, US 7487777. Other patents pending. Protected by design registrations: AU 156663, AU 156665, AU 321676, DE 40301991.5, EU 985601, FR 031425, FR 031430, JP 1192859, JP 1197930, JP 1367396, NZ 411222, US D486227, US D487510, US D493521, US D493522, US D545960, US D567935, US D597661. Others pending.Mirage and Activa are trademarks of ResMedPty Ltdand are registered in U.S. Patent and Trademark Office. © 2009 ResMed.