ResMed n30 ユーザーガイド

English

简体中文

繁體中文

한국어

日本語

Bahasa

Melayu

Indonesia

ภาษาไทย

User guide

USER GUIDE

English 1

ENGLISH

A

Split-band headgear

3

End cap

B

Cushion

4

Stabilizer

C

QuietAir™ / standard frame

5

QuietAir vent

1

Buckle

6

Vent

2

Buttonhole

7

Mask tubing

Intended Use

The AirFit N30 nasal cradle mask is intended to be used by patients

weighing more than 66 lb (30 kg) who have been prescribed non-invasive

positive airway pressure (PAP) therapy such as CPAP or bi-level therapy.

The mask is intended for single patient re-use in the home and multi-

patient re-use in the hospital/institutional environment.

QuietAir frame

The QuietAir frame is intended for single patient re-use in the home and

hospital/institutional environment.

2

Fitting your mask

1. While holding the cushion away from your nose, make sure that the

cushion size, left (L) and right (R) indicators are facing towards you.

Place the cushion under your nose.

2. Pull the headgear bands over your head by holding the bottom band

and stretching it around the back of your head. The top band should sit

comfortably on the crown of your head.

3. Briefly pull your mask away from your nose and place it back to

ensure that the cushion fits comfortably.

English 3

Adjusting your mask

• To achieve a comfortable fit, adjust the split bands by spreading them

apart to loosen or draw them closer together to tighten.

• To fix any mask leak, adjust the headgear by pulling the headgear

through the buckle. Adjust only enough for a comfortable seal and do

not overtighten. You may need to adjust the headgear as it stretches

over time.

Your mask is now fitted and ready to use. While lying down and the

device is running, a light breeze should be felt near the venting area

around the tube connection. To inspect the vent, place a finger close to

the connection area and feel for air. Do not allow the venting area to

become blocked.

Removing your mask

To take off your mask system, pull the mask

and headgear by the split-band up and over your

head.

4

Disassembling your mask for cleaning

1. Firmly pinch one side of the cushion and pull away from the frame.

2. Unhook the headgear from the stabilizer by pulling on the end cap to

reveal the buttonhole.

3. Slide the headgear off the end of the stabilizer.

Cleaning your mask

After each use: Cushion

Weekly: Headgear and frame

1. Soak the components in warm water with a mild liquid detergent.

2. Hand wash the components with a soft bristle brush. Pay particular

attention to the vent.

3. Thoroughly rinse the components under running water.

4. Shake the frame to remove any excess water from the vent. Leave

the components to air dry out of direct sunlight.

If the mask components are not visibly clean, repeat the cleaning steps.

Make sure that the vent is clean and clear.

English 5

Reassembling your mask

1. With the gray side of the headgear facing out, insert each end of the

headgear band over the stabilizers through the buttonholes.

2. Secure the headgear by pulling the buttonholes over the ends of the

stabilizers.

3. Holding the mask frame, stretch the headgear lightly to ensure it is

securely attached. Ensure that the headgear band is not twisted.

4. Align the notch in the cushion to the tab on the mask frame. Firmly

push one side of the cushion onto the frame, then repeat on the other

side. Push down all the edges of the cushion onto the frame to ensure

that the edges are completely flat.

6

WARNING

• Remove all packaging before using the mask

• To avoid affecting the safety and quality of therapy, the mask

vents must be kept clear to protect against rebreathing. Regularly

inspect the vents to ensure they are kept clean, undamaged and

clear of blockages

• Only use compatible CPAP or bi-level therapy devices. The

technical specifications of the mask are provided for healthcare

professionals to determine compatible devices. Use in

combination with incompatible medical devices can decrease the

safety or alter the performance of the mask.

• The mask is not suitable for patients requiring life support

ventilation.

• Regularly clean your mask and its components to maintain the

quality of your mask and to prevent the growth of germs that can

adversely affect your health.

• The mask must be used under qualified supervision for patients

who are unable to remove the mask by themselves. The mask

may not be suitable for those prone to aspiration.

• The mask should not be used unless the device is turned on. Once

the mask is fitted, ensure the device is blowing air to reduce risk

of rebreathing exhaled air.

• Discontinue using or replace this mask if the patient has ANY

adverse reaction to the use of the mask. Consult your physician or

sleep therapist.

• 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 device enclosure and create a risk of fire.

• Oxygen supports combustion. Oxygen must not be used while

smoking or in the presence of an open flame. Only use oxygen in

well ventilated rooms.

• 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. This

warning applies to most types of CPAP or bilevel devices.

English 7

WARNING

• Refer to your CPAP or bilevel device manual for details on

settings and operational information.

• Always follow cleaning instructions and only use a mild liquid

detergent. Some cleaning products may damage the mask, its

parts and their function, or leave harmful residual vapours. Do not

use a dish washer or washing machine to clean the mask

• 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 pressures.

• The mask is not intended to be used simultaneously with

nebulizer medications that are in the air path of the mask/tube.

CAUTION

• Visual criteria for product inspection: If there is any visible

deterioration of a mask component (cracking, crazing, tears etc.),

the component should be discarded and replaced.

• When fitting the mask, do not overtighten the headgear as this

may lead to skin redness or sores around the mask cushion.

• 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.

• Do not iron the headgear as the material is heat sensitive and will

be damaged.

Note: For any serious incidents that occur in relation to this device, these

should be reported to ResMed and the competent authority in your

country.

Technical specifications

Mask setting options: For AirSense: Select 'Pillows'.

Compatible devices: For a full list of compatible devices for this mask, see the

Mask/Device Compatibility List at ResMed.com/downloads/masks.

8

Pressure-flow curve

Pressure

(cm H2O)

Flow

(L/min)

4

20

8

29

12

37

16

43

20

49

Therapy pressure: 4 to 20 cm H20

Resistance: Drop in pressure measured (nominal)

at 50 L/min: 0.4 cm H2O

at 100 L/min: 1.7 cm H2O

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996

and ISO3744:2010. The A-weighted sound power level and the A-weighted pressure level

at a distance of 1 m, with uncertainly of 3 dBA, are shown.

Power level (with QuietAir Frame): 25 dBA

Pressure level (with QuietAir frame): 18 dBA

Power level (with standard frame): 28 dBA

Pressure level (with standard frame): 21 dBA

Environmental conditions

Operating temperature: 5°C to 40°C

Operating humidity: 15% to 95% RH non-condensing

Storage and transport temperature: -20°C to +60°C

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

Service life: The service life of the mask system is dependent on the intensity of usage,

maintenance, and environmental conditions to which the mask is used or stored. As this

mask system and its components are modular in nature, it is recommended that the user

maintain and inspect it on a regular basis, and replace the mask system or any

components if deemed necessary or according to the 'Visual criteria for product inspection'

in the ‘Caution’ section of this guide.

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 dry place out of direct sunlight.

English 9

Disposal

This product and packaging do not contain any hazardous substances and

may be disposed of with your normal household refuse.

Reprocessing the mask between patients

Reprocess this mask when using between patients. Reprocessing instructions are

available on ResMed.com/downloads/masks.

Symbols

The following symbols may appear on your product or packaging:

Nasal cradle mask Device setting - Pillows

QuietAir vent Size - small

Size - medium Size - small wide

Not made with natural rubber latex

See symbols glossary at ResMed.com/symbols.

Consumer Warranty

ResMed acknowledges all consumer rights granted under the EU

Directive 1999/44/EC and the respective national laws within the EU for

products sold within the European Union.

简体中文 1

简体中文

A

对开式头带

3

终端盖

B

护垫

4

稳定组件

C

QuietAir™/

标准框架

5

QuietAir

通气孔

1

搭扣

6

通气孔

2

扣眼

7

面罩管路

设计用途

AirFit N30鼻托型鼻罩适用于接受无创气道正压通气(PAP)治疗，如CPAP或

双水平治疗的患者，且患者体重须超过30千克。面罩供单一患者在家中重

复使用，也可供多位患者在医院或公共机构中重复使用。

QuietAir框架

QuietAir框架供单一患者在家中和医院/公共机构中重复使用。

2

配戴面罩

1. 将护垫拿到鼻子前，确保护垫的尺寸、左(L)右(R)指示标记面朝您。将护

垫放在鼻子下端。

2. 握住下部束带并把它箍在脑后，然后把头带拉过头顶。上部头带应舒适

地套在头顶。

3. 将面罩稍微拉离您的鼻子，然后重新放置，确保护垫能舒适佩戴。

简体中文 3

调整面罩

• 若要保持配戴舒适，请调整对开的束带，拉开即松开束带，或拉近即将

其收紧。

• 面罩如有泄漏，请将头带穿过带扣进行调整。调整头带松紧至舒适服贴

即可，无需过紧。头带随着使用而发生拉伸，您可能需要不时调整头

带。

现在已配戴好面罩并准备就绪。在您躺下并使用装置的过程中，管路连接

处的出气孔附近应能感觉到有微风。想要检查出气孔，将手指放到连接处

附近，感受下是否有气流。不要让出气孔堵塞。

取下您的面罩

若要取下面罩系统，把面罩和头带的对开束带向

上拉过头顶即可。

4

拆卸面罩进行清洁

1. 用力捏住护垫一侧，并往外拉出面罩框。

2. 拉开终端盖，露出扣眼，然后从稳定组件上解开头带。

3. 将头带从稳定组件末端滑出。

清洗面罩

每次使用后：护垫

每周清洁：清洗头带和框架

1. 在温水和温和的洗涤液中浸泡头带。

2. 用软毛刷刷洗组件。特别注意所有缝隙和通气孔。

3. 用流水彻底冲洗组件。

4. 晃动框架，从通气孔排出多余的水。组件自然晾干，避免阳光直射。

如果面罩组件仍显得不干净，请重复清洁步骤。务必将通气孔清洁干净。

简体中文 5

重新组装面罩

1. 头带灰色一侧朝外，把头带束带的每个末端插入稳定组件的扣眼。

2. 拉紧稳定组件终端的扣眼，固定头带。

3. 扶住面罩框，轻轻拉伸头带，确保已经固定。确保头带没有扭曲。

4. 将护垫上的凹槽对准框架上的袢扣。将一侧护垫用力推进框架，另一侧

重复同样步骤。将护垫的所有边缘向下按，确保边缘完全平整。

警告

•

使用面罩前请先除去所有包装。

• 为避免影响治疗的安全性和质量，必须保持面罩通气孔清洁以防止

再次吸入。定期检查通气孔，确保它们保持清洁，完好无损并且清

6

警告

除堵塞物。

• 只能使用兼容的CPAP或双水平治疗设备。请让医疗保健专业人员

知悉面罩技术规格，以使用兼容装置。配合不兼容的医疗设备使

用，会降低面罩的安全性或影响其性能。

• 面罩不适合需要生命支持通气的患者。

• 定期清洁面罩及其组件，保持面罩的品质，防止有害细菌生长。

• 不能自行摘除面罩的患者，使用面罩时必须有合格人员监护。面罩

不适合容易发生误吸的患者使用。

• 装置启动后才能使用面罩。面罩配戴好后，确保装置输送空气，避

免重复吸入所呼出的气体。

• 如果病人使用面罩出现相关的不良反应，请停止使用或加以更换。

咨询您的医生或睡眠治疗师。

• 输送氧气时，须遵循所有安全保护措施。

• CPAP或双水平装置未运行时，必须关闭供氧气流。只有这样做，

未使用的氧气才不会在装置内部聚集，从而产生火灾危险。

• 氧气会助燃。吸烟或面对明火时，严禁使用氧气。仅在通风条件良

好的屋内使用氧气。

• 在补充供氧流量固定不变的情况下，由于压力设置、患者的呼吸模

式、面罩、配戴位置和泄漏程度的不同，吸入的氧气浓度可能会有

所不同。此警告适用于大多数型号的CPAP或双水平装置。

• 有关设定的详细内容与操作信息，请参阅您的CPAP或双水平装置

手册。

• 始终遵循清洁说明，只使用温和的液体清洁剂。某些清洁产品可能

会损坏面罩及其组件和功能，或者会残留有害气体。请勿使用洗碗

机或洗衣机清洁面罩。

• 使用面罩可能会导致牙齿、牙龈或面颊疼痛或加重现有牙齿病症。

如果出现这些症状，请向您的医生或牙医咨询。

• 和所有的面罩一样，如果压力过低则可能会发生一定的再吸入。

• 该鼻面罩的设计不能与面罩/通气管内的雾化药物同时使用。

简体中文 7

注意事项

•

产品检验的目测标准︰面罩组件若出现明显变质（例如破裂、纹裂

或撕裂等），则应予以抛弃并更换组件。

• 佩戴面罩时，头带不要束得过紧，否则面罩护垫周围皮肤可能发红

或疼痛。

• 避免将柔性聚氯乙烯产品（例如柔性聚氯乙烯软管）直接连接到面

罩的任何部分。柔性聚氯乙烯包含对面罩原料可能有害的成分，并

可能导致组件破裂或碎裂。

• 不得熨烫头带，因为头带的材料对热度敏感，会因而损坏。

技术规格

面罩设定选项：对于AirSense：选择“鼻枕”。

兼容装置：本款面罩的兼容装置完整清单，请见

ResMed.com/downloads/masks。

气流压力曲线

压力

(cm H

2

O)

气流

（升

/

分钟）

4

20

8 29

12

37

16

43

20

49

治疗压力：4至20 cm H20

阻力：测量到的压力下降（标称值）

处于50升/分钟时：0.4 cm H2O

处于100升/分钟时：1.7 cm H2O

噪声：根据ISO4871:1996和ISO3744:2010声明的双数噪声值。以下所示为在1米

距离内的A加权噪音功率和A加权压力，含3分贝的不确定性。

功率水平（带QuietAir框架）：25分贝

压力水平（带QuietAir框架）：18分贝

功率水平（带标准框架）：28分贝

压力水平（带标准框架）：21分贝

8

环境条件

运行温度：摄氏5度至40度

运行湿度：15%至95%，RH非凝结

存放和运输温度：摄氏-20度至+60°度

存放和运输湿度：最高95%，RH非凝结

使用寿命：面罩装备使用寿命视使用强度、维护以及面罩使用或存放的环

境条件而定。由于此面罩及其组件都是模块化性质，我们建议用户定期维

护和检查面罩，必要时根据此用户指南的“注意事项”部分中的“产品检验的

目测标准”更换面罩系统或任何组件。

备注：制造商保留修改这些规格的权利，恕不另行通知。

储存

无论储存时间长短，面罩储存前都需彻底清洁并风干。面罩需储存于干燥

避光处。

废弃

此产品和包装不含任何有害物质，可当作一般家庭废物处置。

不同患者共用面罩的再处理方式

病人之间使用时，重新处理此面罩。重新处理说明可见

ResMed.com/downloads/masks网页。

符号

产品上或包装上可能出现如下图标：

鼻托型鼻罩

设备设置-鼻枕

QuietAir通气孔

尺寸-小号

尺寸-中号

尺寸-小宽

不使用天然乳胶制造

注意事项，参见随附文件。

请参阅ResMed.com/symbols上的符号词汇表。

简体中文 9

顾客保证

瑞思迈承认根据欧盟理事指令1999/44/EG以及欧盟组织内个别国家法对于

在欧盟地区内销售之产品所定的全部消费者权利。

繁體中文 1

繁體中文

A

對開式頭帶

3

末端環

B

軟墊

4

穩定器

C

QuietAir™ /

標準面罩框

5

QuietAir

通氣孔

1

帶扣

6

通氣孔

2

扣眼

7

面罩管路

設計用途

AirFit N30 面罩適用於接受非侵入性氣道正壓通氣 (PAP)

治療，例如單陽壓或雙陽壓治療的患者，且患者體重超出 30

公斤。本面罩可供一名患者在家中重複使用，亦可供多名患者在醫院或公

共機構重複使用。

QuietAir 面罩框

QuietAir 面罩框適合單一患者在家中及在醫院或醫療機構中重複使用。

ページが読み込まれています...

ResMed n30 ユーザーガイド

ResMed n30 ユーザーガイド

関連論文

その他のドキュメント