ResMed AirFit N30i User manual

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User guide
USER GUIDE
P

English 1
ENGLISH
A
Elbow
1
Vent
B
Elbow ring
2
QuietAir vent
C
Headgear
3
Sleeve
D
Frame
4
Side buttons
E
P30i pillows cushion
F
N30i nasal cushion
Intended use
The AirFit N30i and AirFit P30i masks are is intended to be used by
patients weighing more than 30 kg who have been prescribed non-
invasive positive airway pressure (PAP) therapy such as CPAP or bi-level
therapy. The masks are intended for single patient re-use in the home and
multi-patient re-use in the hospital/institutional environment.
Please read the entire guide before use.
Before using your mask
Remove all packaging and inspect each mask component for visible
deterioration.
Use the fitting template to assist in selecting the right size cushion and
frame.

2
Fitting your mask
1. Pull the frame and headgear over your head until the elbow is
positioned on top and the headgear is behind your head.
2. Place the cushion under your nose.
For the AirFit P30i mask, align the pillows into your nostrils.
3. Tighten or loosen the headgear until the cushion fits comfortably
under your nose.
4. Squeeze the side buttons on the elbow and detach from the frame.
Connect the air tubing from your device to the elbow, then reattach to
the frame.
Adjusting your mask
•When using the mask, air will flow out of the vents in the cushion and
elbow. If air leaks from the side or top of the cushion, adjust the mask
fitting to improve the seal.
•You can position the top of the frame forward or backwards over your
head until the mask feels comfortable.

English 3
Sizing the mask frame
If the mask frame falls back over your head or sits too close to your ears,
try a small frame size. If the mask falls forward on your head or sits too
close to your eyes, try a standard frame size.
Disassembling your mask for cleaning
If your mask is connected to a device, disconnect the device air tubing
from the mask elbow.
1. Pull the cushion from the frame.
2. Undo the fastening tabs on the headgear strap and pull it from the
frame.
3. Squeeze the side buttons on the elbow and detach from the frame.
Note: The QuietAir vent can be removed to allow inspection of the vent
holes.
Cleaning your mask
After each use: Cushion
Weekly: Headgear, frame and elbow
1. Soak the components in warm water with a mild liquid detergent.
Ensure that there are no air bubbles while soaking.
2. Hand wash the components with a soft bristle brush. Pay particular
attention to the vent holes.

4
3. Thoroughly rinse the components under running water.
4. For the frame sleeves, squeeze with a clean towel to remove excess
water. Shake the QuietAir vent to remove any excess water. Leave
the components to air dry out of direct sunlight.
If the mask components are not visibly clean, repeat the cleaning steps.
Reassembling your mask
1. Connect the elbow into the top of the frame until it clicks.
2. Insert the headgear strap into the frame and fold the fastening tabs
backwards.
3. Insert the ends of the frame into the cushion, ensuring that the arrows
on the cushion and frame are aligned.
Note: If the elbow ring detaches, re-insert into the top of the frame.
Removing/inserting the QuietAir vent
1. To remove the vent, gently pull the cushion away and slide the vent
out.
2. To insert the vent, align the tab (a) on the cushion with the notch (b)
on the vent, and then gently pull the cushion over the vent.

English 5
WARNING
•The mask is not suitable for patients requiring life support ventilation.
•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.
•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.
•Regularly clean your mask to maintain the quality of your mask and to prevent the
growth of germs that can adversely affect your health.
•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.
•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 with incompatible devices may affect the performance or safety of the mask.
•Discontinue using the mask if you have ANY adverse reaction and consult your
physician or sleep therapist.
•The mask is not intended to be used simultaneously with nebulizer medications that
are in the air path of the mask/tube.
•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.
CAUTION
•Remove all packaging before using 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.
•When fitting the mask, do not overtighten the headgear as this may lead to skin
redness or sores around the mask cushion.

6
•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.
•As with all masks, some rebreathing may occur at low pressures.
•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.
•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 product, these should be
reported to ResMed and the competent authority in your country.
Technical specifications
Compatible devices
For a full list of compatible devices for this mask, see the Mask/Device Compatibility List
at ResMed.com/downloads/masks. SmartStop may not operate effectively when using this
mask with some CPAP or bi-level devices.
Pressure-flow curve:
Pressure
(cm H2O)
Flow
(L/min)
4
20
9
31
15
41
20
49
25
55
AirFit N30i
AirFit P30i
Mask setting options:
For AirSense, AirCurve or S9
Therapy Pressure:
Pillows
4 to 25 cm H
2
O
Pillows
4 to 25 cm H
2
O
Resistance: Drop in pressure measured (nominal)
at 50 L/min
0.5 cm H
2
O
0.4 cm H
2
O
at 100 L/min
1.7 cm H2O
1.5 cm H2O
Sound: Declared dual-number noise emission values in accordance with ISO4871:1996
and ISO3744:2010. A-weighted sound power level and A-weighted sound pressure level at
a distance of 1 m, with uncertainty of 3 dBA, are shown
Sound power level
Sound pressure level
21 dBA
14 dBA
21 dBA
14 dBA
Environmental conditions:
Operating temperature: 5°C to 40°C
Operating humidity: 15% to 95% non-condensing

English 7
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% 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 ‘Warning’ 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.
Disposal
This mask and packaging do not contain any hazardous substances and may be disposed of
with your normal household refuse.
Reprocessing the mask between patients
This mask should be reprocessed when used between patients. Cleaning, disinfection and
sterilisation instructions are available on ResMed.com/downloads/masks. If you do not
have internet access, please contact your ResMed representative.

8
Symbols
The following symbols may appear on your product or packaging:
Nasal cradle mask Nasal pillows mask
QuietAir vent Device setting - Pillows
Cushion size - small Cushion size - medium
Cushion size - large Cushion size - wide
Cushion size - small wide Standard frame
Small frame Importer
Medical device
Not made with natural
rubber latex
Caution, consult accompanying documents.
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
弯头
1
通气孔
B
弯头环
2
QuietAir通气孔
C
头带
3
套
D
框架
4
侧按钮
E
P30i枕垫
F
N30i鼻枕
设计用途
AirFit N30i和AirFit P30i 面罩适用于体重超过30千克的患者。 这些患者已
接受了无创气道正压通气（PAP）治疗，如CPAP或双水平治疗。这些面罩
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。
使用前请阅读手册的全部内容。
在使用您的面罩之前
取下所有包装并检查每个面罩组件是否有明显的损坏。
使用佩戴模板来帮助选择合适尺寸的护垫和框架。

2
配戴面罩
1. 将框架和头盔拉过头部，直到弯头位于顶部，头带位于头部后面。
2. 将护垫放在鼻子下端。
对于AirFit P30i面罩，将鼻枕对准您的鼻孔。
3. 拧紧或松开头带，直至护垫舒适地放在鼻子下面。
4. 挤压弯头的侧按钮并从框架上拆下。将空气管从您的装置连接至弯头，
然后重新连接到框架。
调整您的面罩
•使用面罩时，空气会从护垫和弯头的通气孔流出。如果空气从护垫的侧
面或顶部泄漏，请调整面罩配件以改善密封。
•您可以将框架顶部向前或向后移动，直到感觉面罩佩戴舒适为止。

简体中文 3
调整面罩框架的大小
如果面罩框架在您的头上下坠或太靠近您的耳朵，请尝试使用较小的框架
尺寸。如果面罩在头上向前下坠或太靠近您的眼睛，请尝试使用标准的框
架尺寸。
拆卸面罩进行清洁
如果面罩连接到装置，请从弯头处断开装置空气管。
1. 把护垫拔出面罩框。
2. 松开头带上的固定片并将其从框架中拉出。
3. 按下弯头上的侧按钮并从框架上拆下。
备注：可以拆下QuietAir通气孔以检查通气孔。

4
清洗面罩
每次使用后：护垫
每周清洁：头带、框架和弯头
1. 在温水和温和的洗涤液中浸泡组件。确保浸泡时没有气泡。
2. 用软毛刷刷洗组件。特别注意通气孔。
3. 用流水彻底冲洗组件。
4. 对于框架套，用干净的毛巾挤压以除去多余的水分。摇晃QuietAir通气
孔以除去多余的水。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。
重新组装您的面罩
1. 将弯头连接到框架的顶部，直到发出喀哒声。
2. 将头带绑带插入框架并向后折叠固定片。
3. 将框架的两端插入护垫，确保护垫和框架上的箭头对齐。
备注：如果弯头环脱落，请重新插入框架顶部。
拆下/插入QuietAir通气孔
1. 要拆下通气孔，请轻轻拉开护垫并将其滑出。
2. 要插入通气孔，请将护垫上的卡舌（a）与通气孔上的凹口（b）对齐，
然后将护垫轻轻拉过通气孔。

简体中文 5
警告
•面罩不适合需要生命支持通气的患者。
•为避免影响治疗的安全性和质量，必须保持面罩通气孔通畅以防止
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
除堵塞物。
•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。此面
罩不适合容易发生误吸情况的患者使用。
•定期清洁面罩，保持面罩的质量，防止滋生影响身体健康的细菌。
•产品检查的目测标准︰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。
•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。使用不兼容的设备可能会影
响面罩的性能或安全性。
•若出现任何不良反应，请停止使用面罩，并咨询您的医生或睡眠治
疗师。
•该面罩的设计不能与面罩/通气管内的雾化药物同时使用。
•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。
注意事项
•使用面罩前请先除去所有包装。
•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询问治疗方法。
•佩戴面罩时，头带不要束得过紧，否则可能会导致面罩护垫周围皮
肤发红或疼痛。
•装置启动后才能使用面罩。面罩配戴好后，确保装置正在输送空气
以降低吸入排放气体的风险。

6
•和所有的面罩一样，在压力过低时可能会出现某种程度的再吸入。
•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。
•不得熨烫头带，因为头带的材料对热度敏感，会被损坏。
备注：对于与本产品有关的任何严重事件，应向瑞思迈和贵国的主管部门
报告。
技术规格
兼容装置
本款面罩的兼容装置完整清单，请见ResMed.com/downloads/masks。
与一些具有SmartStop功能的气道正压或双水平装置并用时，SmartStop功能可
能无法有效运作。
气流压力曲线
压力
(cmH2O)
气流
(L/min)
4 20
9 31
15 41
20 49
25 55
AirFit N30i AirFit P30i
面罩设定选项：
AirSense、AirCurve或S9
治疗压力：
鼻枕
4至25 cm H2O
鼻枕
4至25 cm H2O
阻力：
测量到的压力下降（标称值）
处于50升/分钟 0.5 cm H2O 0.4 cm H2O
处于100升/分钟 1.7 cm H2O 1.5 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加权噪音压力，含3分贝的不确定性。
声强级
声压级
21分贝
14分贝
21分贝
14分贝

简体中文 7
环境条件：
工作温度：摄氏5度至40度
工作湿度：15%至95%，非凝结
存放和运输温度：摄氏-20度至60度
存放和运输湿度：至95%，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“警告”部分中的“产品检查的目测
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
储存前，无论储存时间长短，都需彻底清洁面罩，并保持干燥。面罩需储
存于干燥避光处。
废弃
此面罩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
此面罩用于不同患者前应予以再次处理。清洗、消毒与灭菌说明均在
ResMed.com/downloads/masks网站提供。如果您无法上网，请与您的瑞思迈销
售代表联系。

8
符号
产品上或包装上可能出现下列符号：
鼻托型鼻罩 鼻枕面罩
QuietAir通气孔 设备设置 - 鼻枕
护垫尺寸 - 小 护垫尺寸 - 中
护垫尺寸 - 大 护垫尺寸 - 宽
护垫尺寸 - 小宽 标准面罩
小框架 进口商
医疗设备 不使用天然乳胶制造
注意事项，请参阅随附文件。
请参阅ResMed.com/symbols上的符号词汇表。
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
繁体中文
A
彎頭
1
通氣孔
B
彎頭環
2
QuietAir
通氣孔
C
頭帶
3
套
D
面罩框
4
側按鈕
E
P30i
枕墊
F
N30i
鼻枕
設計用途
AirFit N30i和AirFit P30i面罩適用於體重超過30公斤的患者。這些患者
接受規定的非侵入性氣道正壓通氣（PAP）治療，如CPAP或雙陽壓治療。
這些面罩供單一患者在家中重複使用，以及供多位患者在醫院/公共機構中
重複使用。
使用前請閱讀手冊的全部內容。
在使用您的面罩之前
取下所有包裝並檢查每個面罩元件是否有明顯的損壞。
使用佩戴模板來幫助選擇合適尺寸的軟墊和框架。

2
佩戴面罩
1. 將框架和頭帶拉過頭部，直到彎頭位於頂部，頭帶位於頭部後面。
2. 將軟墊放在鼻下。
對於AirFit P30i面罩，將鼻枕頭對準您的鼻孔。
3. 擰緊或鬆開頭帶，直至軟墊舒適地放在鼻子下面。
4. 擠壓彎頭上的側按鈕並從框架上拆下。將空氣管路從裝置連接至彎
頭，然後重新連接到框架。
調整面罩
•使用面罩時，空氣會從軟墊和彎頭的通氣孔流出。如果空氣從軟墊的
側面或頂部洩漏，請調整面罩配件以改善密封。
•您可以將框架頂部向前或向後移動，直到感覺佩戴面罩舒適爲止。

繁體中文 3
調整面罩框架的大小
如果面罩框架在您的頭上下墜或太靠近您的耳朵，請嘗試使用較小的框架
尺寸。如果面罩在頭上向前下墜或太靠近您的眼睛，請嘗試使用標準的框
架尺寸。
拆卸面罩進行清潔
如果面罩仍然連接裝置，請先從面罩彎頭處斷開裝置空氣管。
1. 把軟墊從框架拉出。
2. 鬆開頭帶上的緊固片並將其從框架中拉出。
3. 擠壓彎頭上的側按鈕並從框架上拆下。
備註：可以拆下QuietAir通氣孔以檢查通氣孔。