厂家供应明康中锦正压通气面罩CF-10A
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品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)：湘械注准20222082146更新时间：2026/10/19 9:40:51
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厂家供应明康中锦正压通气面罩CF-10A
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别第二类
型号规格CF-10A(规格:S/M/L)；CF-10C(规格:S/M/L)
结构及组成/主要组成成分产品由面罩主体(主框架、硅胶垫、额垫、弯管、弯管连接头、卡扣)和头带组成。
适用范围/预期用途本产品适用于为成人使用者提供持续正压通气或双水平正压通气的界面连接装置。
1. 工作原理 Working Principle
中文：本面罩作为正压通气设备与患者口鼻之间的通气界面，通过硅胶垫与面部形成密闭贴合，将呼吸机输出的正压气流输送至患者口鼻；面罩弯管集成排气孔，排出患者呼出废气，完成通气回路，实现持续 / 双水平正压通气的气体传输。English：This mask serves as the ventilation interface between non‑invasive positive pressure ventilation device and patient’s nose‑mouth. It ｆorms an air‑tight seal with patient’s face via silicone cushion, delivers positive‑pressure airflow from ventilator to patient’s nose and mouth. Exhaust ports on elbow expel exhaled gas to complete ventilation circuit for CPAP / BiPAP gas delivery.
2. 功能 Function
中文：①作为呼吸机患者端连接界面，传递正压通气气流；②排出患者呼出废气；③配合头带实现面部密封固定，保障通气密闭性；④兼容符合标准接口的通气设备。English：①Patient‑side interface for non‑invasive ventilator to transmit positive‑pressure airflow；②Vent patient’s exhaled gas；③Seal and fix on patient face with headgear to maintain air‑tightness；④Compatible with standard‑interface non‑invasive ventilation devices.
3. 产品特点 Product Features
中文：①轻量化面罩框架，佩戴负担小；②医用柔软硅胶垫，面部贴合，降低压伤风险；③360° 旋转弯管，减少管路拉扯，睡姿活动自由度高；④弥散式排气孔，降低排气噪音；⑤额垫可调节，适配不同脸型；⑥拆装简单，便于清洗消毒；⑦具备 S/M/L 三种尺寸，适配不同成人面部轮廓；⑧头带透气，受力均匀。English：①Light‑weight ｆframe for low wearing burden；②Medical‑grade soft silicone cushion for facial fitting and reduced pressure injury risk；③360‑degree rotating elbow to reduce tube pulling and improve sleeping mobility；④Diffused exhaust ports for low noise；⑤Adjustable forehead pad for various face shapes；⑥Easy disassembly for cleaning & disinfection；⑦S/M/L sizes for different adult facial contours；⑧Breathable headgear with even stress distribution.
4. 技术参数 Technical Parameters
中文
型号：CF‑10A，规格 S/M/L（口鼻面罩）
连接接口：标准呼吸机管路接口
主要材质：PC 框架、医用硅胶、织物头带
适用通气压力范围：4‑30 cmH₂O
适用人群：成人（体重≥30kg）
排气方式：面罩弯管集成弥散排气孔
预期使用寿命：正常使用条件下建议 3‑6 个月更换
工作环境：温度 5℃‑40℃，相对湿度 15%‑95%，无凝露English
Model：CF‑10A, Size S/M/L (Oro‑nasal mask)
Connection：Standard ventilator tube interface
Main Material：PC ｆframe, medical‑grade silicone, textile headgear
Applicable ventilation pressure：4‑30 cmH₂O
Target user：Adults (body weight ≥30 kg)
Exhaust type：Diffused exhaust ports integrated on elbow
Expected service life：Suggested replacement every 3‑6 months under normal use
Operating environment：Temperature 5℃‑40℃, RH 15%‑95%, non‑condensing
5. 使用方法 Operation Method
中文
使用前检查面罩、硅胶垫、头带、弯管无破损、老化、开裂；选择合适尺寸。
组装面罩：硅胶垫、额垫、弯管卡扣装配到位，连接呼吸机管路。
将面罩对准口鼻，佩戴头带，调节头带松紧，松紧度以可插入 1‑2 根手指为宜，保证密封不漏气，不可过紧。
确认排气孔无堵塞，开启呼吸机，观察面罩密封情况，按需微调头带。
使用结束后，关闭呼吸机，取下面罩，拆卸各部件清洗消毒。
按说明书要求定期更换老化部件。English
Before use: Inspect mask, silicone cushion, headgear and elbow for damage, aging or crack; select proper size.
Assemble mask: Mount silicone cushion, forehead pad and elbow properly, connect ventilator tube.
Align mask over nose‑mouth, put on headgear and adjust tightness; allow 1‑2 fingers insertion under strap for proper seal, avoid over‑tightening.
Ensure exhaust ports are unblocked, start ventilator, check seal and fine‑tune headgear as needed.
After therapy: Power off ventilator, remove mask, disassemble components for cleaning and disinfection.
Replace worn components periodically per manual.
6. 适应症 Indications
中文：适用于成人使用者，作为持续正压通气（CPAP）或双水平正压通气（BiPAP）治疗时，通气设备与患者之间的界面连接装置；用于阻塞性睡眠呼吸暂停、慢性阻塞性肺疾病等需要正压通气治疗的成人患者（本产品仅通气界面，不具备治疗主机功能）。English：Intended for adult patients as patient interface for Continuous Positive Airway Pressure (CPAP) or Bi‑level Positive Airway Pressure (BiPAP) non‑invasive ventilation therapy, for patients with obstructive sleep apnea, COPD and other conditions requiring non‑invasive positive‑pressure ventilation. This product is only patient interface, not therapeutic host device.
7. 禁忌症 Contraindications
中文
面部严重创伤、面部畸形、面部皮肤破溃感染，无法实现面罩密封者；
自发性气胸、纵隔气肿未处理；
无法配合通气、意识障碍、呕吐高风险且无气道保护；
对产品硅胶、织物等材质过敏者；
禁止用于生命支持用途。English
Severe facial trauma, facial deｆormity, facial skin ulcer / infection preventing proper mask sealing；
Untreated spontaneous pneumothorax or mediastinal emphysema；
Poor compliance, unconsciousness, high vomiting risk without airway protection；
Known allergy to silicone, textile or other mask materials；
Shall NOT be used for life‑support purpose.
8. 注意事项 Precautions
中文
本产品仅为通气界面，不能单独作为治疗设备，不能用于生命支持，必须配合合规呼吸机使用。
排气孔严禁堵塞，堵塞会造成二氧化碳重复吸入，引发窒息风险。
头带不可过紧，防止面部、鼻梁压疮；出现皮肤发红压痛及时调整或更换配件。
禁止酒精、强腐蚀性溶剂清洗硅胶部件，避免材质老化损坏。
每次使用后清洗，定期消毒；硅胶垫出现硬化、发白、开裂立即更换。
需在医生指导下使用，通气参数由医务人员设定，不可自行更改。
面罩仅个人专用，禁止多人共用，防止交叉感染。
睡眠使用中若出现憋气、胸闷、不适，应立即停止使用并咨询医师。
不可用于儿童（本型号为成人款）。English
This is only ventilation interface, NOT standalone therapy device, NOT for life‑support; must be used with qualified non‑invasive ventilator.
Never block exhaust ports; blockage may cause CO₂ rebreathing and suffocation risk.
Do not over‑tighten headgear to avoid facial / nasal bridge pressure injury; adjust or replace parts when skin redness or pain occurs.
Do not clean silicone parts with alcohol or strong corrosive solvents to prevent material degradation.
Clean after each use and disinfect periodically; replace silicone cushion immediately if hardened, whitened or cracked.
Use under physician guidance; ventilation parameters shall be set by medical staff, do not modify by yourself.
For single‑patient use only; multi‑person sharing is forbidden to avoid cross‑infection.
Stop use immediately and consult doctor if suffocation, chest tightness or discomfort occurs during sleep therapy.
Not intended for pediatric patients (adult‑only model).
9. 存储条件 Storage Conditions
中文：存放于阴凉干燥通风处；环境温度‑20℃～+55℃；相对湿度 10%‑95%，无凝露；远离阳光直射、高温热源、臭氧、腐蚀性气体；避免挤压、尖锐物划伤。English：Store in cool, dry and well‑ventilated place; ambient temperature‑20℃～+55℃, relative humidity 10%‑95% non‑condensing. Keep away from direct sunlight, high‑temperature heat source, ozone and corrosive gas. Avoid squeezing and scratch by sharp ｏbjects.
10. 说明书核心摘要 Core Summary of Instructions
中文：CF‑10A 为明康中锦口鼻型正压通气面罩，Ⅱ 类医疗器械，注册证湘械注准 20222082146，作为成人 CPAP/BiPAP 通气的患者界面；依靠硅胶垫实现面部密封，弯管排气排出废气；含 S/M/L 三种成人尺寸；必须配套合规呼吸机，严禁堵塞排气孔，不可用于生命支持；单人专用，定期清洗消毒，硅胶件老化及时更换；储存避高温日晒；禁忌症包含面部损伤、材质过敏、未处理气胸等；出现不适及时就医。English：CF‑10A is oro‑nasal positive‑pressure ventilation mask, Class Ⅱ medical device, Registration No. Xiang Xie Zhu Zhun 20222082146. It acts as patient interface for adult CPAP / BiPAP non‑invasive ventilation. Silicone cushion provides facial seal; elbow exhaust ports remove exhaled gas. Available in S/M/L adult sizes. Must be used with qualified non‑invasive ventilator. Exhaust ports must not be blocked. Not for life‑support. Single‑patient use only. Clean and disinfect regularly; replace aged silicone components timely. Store away from high temperature and sunlight. Contraindicated for facial injury, material allergy, untreated pneumothorax etc. Seek medical advice in case of discomfort。
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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