厂商直销思雅全胸振荡排痰机YSQ01B,YSQ01C-W
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厂商直销思雅全胸振荡排痰机YSQ01B,YSQ01C-W
桂经理19117326863微xin同号
全胸振荡排痰机
管理类别
第二类
型号规格
YSQ01J、YSQ01B、YSQ01C、YSQ01C-W
结构及组成/主要组成成分
全胸振荡排痰机由主机、手控器、导气软管、充气背心和（或）压缩空气式雾化器组成。其中压缩空气式雾化器仅由压缩泵组成。仅YSQ01C-W组成中具有压缩空气式雾化器。导气软管采用PVC材料。充气背心采用TPU高强度复合面料；充气背心分标准全胸充气背心及简易半胸充气胸带。按结构分为标准台式、便携式和柜机推车式；按功能分为标准全胸振荡排痰型和全胸振荡排痰雾化型两种
适用范围/预期用途
适用于肺部分泌物排出困难或由粘液阻塞肺部引起的肺膨胀不全患者，起到促进气道清除排痰或改善支气管引流的作用。
产品储存条件及有效期
有源产品不适用
附件
产品技术要求
其他内容
无
备注
原注册证号：苏械注准20172262294
审批部门
江苏省药品监督管理局
批准日期
2022-01-25
生效日期
2022-11-21
有效期至
2027-11-20
一、工作原理（Working Principle）
中文
采用 ** 高频胸壁振荡（HFCWO）** 技术：
主机产生高频脉冲气流，通过双导气软管驱动全胸充气背心快速、同步充放气。
使胸壁产生5Hz～30Hz的高频、节律性振荡，能量穿透胸壁传导至肺部。
振荡在气道内形成剪切力与微气流，松动、液化呼吸道壁及肺深部黏稠痰液。
增强气道纤毛摆动功能，模拟生理咳嗽机制，推动痰液向主气管移动，最终通过咳嗽或吸痰排出。
English
Adopts High-Frequency Chest Wall Oscillation (HFCWO) technology:
The main unit generates high-frequency pulsed air flow, driving the full-chest inflatable vest to inflate and deflate rapidly and synchronously via dual air hoses.
Creates high-frequency, rhythmic oscillations (5Hz–30Hz) in the chest wall, transmitting energy deep into the lungs.
Oscillations produce shear force and micro-airflow in the airways, loosening and liquefying thick sputum on airway walls and deep in the lungs.
Enhances ciliary movement, mimics the physiological cough mechanism, propels sputum toward the trachea for expulsion via coughing or suction.
二、产品功能（Functions）
中文
深部痰液清除：有效松动、液化并排出呼吸道及肺部深部分泌物
肺不张防治：改善黏液阻塞引发的肺膨胀不全，恢复肺部通气功能
支气管引流：促进痰液定向移动，辅助支气管分泌物引流
雾化辅助治疗（W 型）：集成雾化功能，药物直达病灶，增强排痰效果
多模式适配：手动 / 自动 / 自定义模式，满足不同年龄、体型及病情需求
安全排痰：替代人工叩背，降低医护强度，减少患者痛苦
English
Deep Sputum Clearance: Effectively loosens, liquefies and removes secretions from deep respiratory tract and lungs
Atelectasis Prevention & Treatment: Improves mucus plug-induced atelectasis and restores lung ventilation
Bronchial Drainage: Promotes directional sputum movement and assists bronchial secretion drainage
Nebulization Therapy (W Type): Integrated nebulization delivers medication directly to lesions, enhancing expectoration
Multi-Mode Adaptation: Manual/Auto/Custom modes for all ages, body types and conditions
Safe Non-Invasive Therapy: Replaces manual percussion, reduces staff workload and patient discomfort
三、产品特点（Features）
中文
智能操作：9.7 英寸彩色触摸屏，全中文界面，直观便捷
宽频振荡：频率5～30Hz、压力0.5～3.2kPa连续可调，适配
多模式：5 种自动程序（儿童 / 成人分型）+ 手动 + 自定义，参数记忆
双管均衡：双软管同步充气，全胸受力均匀柔和，舒适度高
安全设计：手控紧急泄压、过压保护、故障自检、治疗结束报警
卫生便捷：背心外套可拆卸清洗消毒，可选配一次性背心
低噪稳定：工作噪音≤50dB，运行稳定，适合病房 / ICU 使用
双效合一（W 型）：排痰 + 雾化一体化，治疗连续高效
English
Smart Operation: 9.7-inch color touch screen, Chinese interface, intuitive and convenient
Wide Range Oscillation: 5–30Hz frequency, 0.5–3.2kPa pressure, continuously adjustable
Multiple Modes: 5 Auto (child/adult) + Manual + Custom, with parameter memory
Balanced Inflation: Dual hoses for synchronous inflation, uniｆorm chest pressure, high comfort
Safety Features: Handheld emergency deflation, over-pressure protection, self-test, end-of-treatment alarm
Hygienic Design: Detachable/washable vest cover, optional disposable vests
Low Noise: ≤50dB during operation, stable, suitable for wards/ICU
2-in-1 (W Type): Sputum clearance + nebulization integration for continuous therapy
四、技术参数（Technical Specifications）
表格
参数项（Item） YSQ01C / YSQ01C-W
振荡频率 5Hz～30Hz，连续可调，步距 1Hz
治疗压力 0.5kPa～3.2kPa，10 档可调，步距 0.3kPa
定时范围 1min～99min，步距 1min；自动档：5/10/15/20min
工作模式 手动模式、5 种自动模式、自定义模式
显示屏 9.7 英寸彩色触摸屏
噪音 ≤50dB(A)
电源 AC 220V±10%，50Hz，输入功率 150W
主机重量 ≤14kg（柜机推车式）
背心尺寸 胸围 43～175cm（成人 / 儿童适配）
雾化参数（W） 最大压强≥0.2MPa，雾化量≥0.20mL/min
安全保护 紧急泄压、过压保护、漏气监测、故障报警
五、使用方法（Instructions for Use）
中文
准备：检查设备；患者穿棉质内衣，坐位 / 半卧位，穿戴充气背心，松紧适宜。
连接：双软管连接主机与背心，确保无漏气；手控器置于患者可及处。
开机：接通电源，设备自检，进入主界面。
设参：选择模式（自动 / 手动 / 自定义）→ 调节频率、压力、时间。
初始：低频率（5-10Hz）、低压力（0.5-1.0kPa） 起始
启动：按 “开始”，背心循环振荡；指导患者正常呼吸、咳嗽。
监护：观察反应，不适按手控器紧急泄压；咳嗽时可暂停。
结束：时间到自动停机；关机、拆卸、清洁背心。
English
Preparation: Inspect device; patient wears cotton undergarment, sitting/semi-reclined, fits inflatable vest snugly.
Connection: Attach dual hoses to main unit and vest (no leaks); place hand controller within reach.
Power On: Connect power, self-test completes, enter main interface.
Settings: Select mode (Auto/Manual/Custom) → set frequency, pressure, time.
Initial: Start low (5–10Hz, 0.5–1.0kPa)
Start: Press 'Start'; vest cycles; instruct patient to breathe and cough normally.
Monitor: Observe response; press emergency deflate for discomfort; pause for coughing.
Finish: Auto-stop; power off, disconnect, clean vest.
六、适应症（Indications）
中文
呼吸道分泌物黏稠潴留、排痰困难
黏液阻塞引起的肺不张、肺膨胀不全
COPD、支气管扩张、肺炎、囊性纤维化
胸腹部术后咳痰无力、疼痛拒咳
老年、卧床、神经肌肉疾病咳嗽功能减弱
重症监护（ICU）人工气道、机械通气患者气道管理
小儿肺炎、新生儿肺透明膜病等儿科排痰困难
English
Thick retention and difficulty expectorating respiratory secretions
Atelectasis and incomplete lung expansion due to mucus plugging
COPD, bronchiectasis, pneumonia, cystic fibrosis
Weak cough and pain-induced refusal to cough post thoracic/abdominal surgery
Impaired cough function in elderly, bedridden and neuromuscular disease patients
Airway management for intubated/ventilated patients in ICU
Pediatric sputum retention: pediatric pneumonia, neonatal hyaline membrane disease
七、禁忌症（Contraindications）
中文
绝对禁忌：
未控制的气胸、纵隔气肿、肺大疱
近期胸壁 / 肋骨骨折、肺挫伤、未愈合胸部手术
胸壁感染、开放性伤口、恶性肿瘤
活动性咯血、肺出血、凝血功能障碍
严重心肺功能衰竭、血流动力学不稳定、急性心梗
颅内压增高、癫痫、带心脏起搏器患者
相对禁忌：
严重骨质疏松、低血压、休克
胸壁畸形、皮肤过敏
English
Absolute Contraindications:
Uncontrolled pneumothorax, pneumomediastinum, bullae
Recent chest wall/rib fracture, pulmonary contusion, unhealed chest surgery
Infection, open wounds, malignancy on chest wall
Active hemoptysis, pulmonary hemorrhage, coagulopathy
Severe cardiopulmonary failure, hemodynamic instability, acute MI
Increased ICP, epilepsy, pacemaker carriers
Relative Contraindications:
Severe osteoporosis, hypotension, shock
Chest wall deｆormity, skin allergy
八、注意事项（Precautions）
中文
必须医护指导使用，个体化参数
治疗前空腹 2 小时（防反流呕吐）
低参数起始，逐步上调至耐受（酸胀）
背心松紧适度，不影响呼吸循环
治疗中监测血氧、心率、呼吸、皮肤，异常立即停机
咯血、气胸、低血压、休克时立即停用
儿童、老年、虚弱者降参数、严密监护
背心专人专用、定期清洗消毒，防交叉感染
设备故障、漏气、异响立即检修
不可替代吸痰、药物、手术等核心治疗
English
Use under medical supervision with individualized parameters
NPO 2 hours before treatment (prevent reflux/vomiting)
Start low, titrate up to tolerance (aching, no pain)
Vest fit snugly, do not impair breathing/circulation
Monitor SpO2, HR, RR, skin; stop immediately for abnormalities
Stop immediately for hemoptysis, pneumothorax, hypotension or shock
Lower parameters & close monitoring for children, elderly, frail
Vest single-patient use, clean/disinfect regularly to prevent cross-infection
Repair immediately for malfunction, air leak, abnormal noise
Do not replace core treatments (suction, medication, surgery)
九、存储条件（Storage Conditions）
中文
环境温度：5℃～40℃（工作）；-10℃～+50℃（存储）
相对湿度：30%～85%，无冷凝
大气压力：86kPa～106kPa
存放于干燥、通风、清洁、无腐蚀性气体环境
避免阳光直射、高温、潮湿、震动、挤压、跌落
长期存放：每月通电自检一次
English
Temperature: 5°C–40°C (operation); -10°C–+50°C (storage)
Relative Humidity: 30%–85%, non-condensing
Atmospheric Pressure: 86kPa–106kPa
Store in dry, ventilated, clean, non-corrosive environment
Avoid direct sunlight, heat, moisture, shock, crush, drop
Long-term: Self-test monthly
十、说明书核心信息（Manual Core Summary）
中文
YSQ01C（YSQ01C-W）为高频胸壁振荡排痰系统（二类医疗器械），通过全胸背心高频充放气实现深部排痰。
核心优势：9.7 寸触屏、5-30Hz 宽频、多模式、双管均衡、低噪安全；W 型集成雾化功能。
适用于分泌物潴留、肺不张、术后 / 老年 / ICU 排痰困难。禁忌症含气胸、胸壁损伤、出血、严重心肺疾病。
使用需医护指导、低参数起始、严密监护。设备适用于呼吸科、ICU、康复科、儿科及长期护理，高效替代人工叩背。
English
YSQ01C (YSQ01C-W) is a high-frequency chest wall oscillation sputum clearance system (Class II medical device)
providing non-invasive deep expectoration via full-chest vest inflation/deflation. Key features: 9.7-inch touchscreen,
5–30Hz range, multi-mode, dual-hose balance, low noise, safety; W-type integrates nebulization. Indicated for
secretion retention, atelectasis, post-op/elderly/ICU impaired clearance. Contraindications: pneumothorax
chest wall injury, bleeding, severe cardiopulmonary disease. Use under medical supervision, start low,
monitor closely. Ideal for respiratory, ICU, rehab, pediatrics and long-term care, efficiently replacing manual percussion.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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