厂商供应德国ERT易瑞康肺功能仪MasterScope
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厂商供应德国ERT易瑞康肺功能仪MasterScope
桂经理19117326863微xin同号
管理类别
第二类
型号规格
MasterScope
结构及组成/主要组成成分
MasterScope由MasterScope 软件（发布版本4.0）、仪器包和配件组成，配件包括肺活量计手柄（706235）（包括传感器（709554-CT）和弯头（852352））、指纹传感器（992008）、电源线。
适用范围/预期用途
MasterScope用于对人体呼气和吸气的流量和体积进行测量。本产品须由医疗专业人员操作，受试者必须能够理解并执行医师的指示。适用于3岁以上的儿童及成人。
产品储存条件及有效期
附件
一、工作原理（Working Principle）
中文
MasterScope 肺功能仪采用高精度压差式流量传感器（JAEGER? Pneumotach），检测呼吸气流的压力差变化，经信号转换与微处理器计算，获取流速、流量数据，并通过积分运算得出肺活量、用力呼气量等容量参数。设备内置蓝牙无线传输模块，可将数据实时发送至电脑端 SentrySuite 专业软件，自动完成BTPS 修正（体温、气压、水汽饱和校正）与质量控制，确保测量符合 ATS/ERS 国际标准。
English
MasterScope Spirometer adopts high-precision differential pressure flow sensor (JAEGER? Pneumotach) to detect pressure difference changes of respiratory airflow. Through signal conversion and microprocessor calculation, it obtains flow velocity and flow data, and calculates volume parameters such as vital capacity and forced expiratory volume via integral operation. The device has a built-in Bluetooth wireless transmission module, which can send data to the SentrySuite professional software on the computer in real time, and automatically complete BTPS correction (body temperature, barometric pressure, water vapor saturation correction) and quality control to ensure measurements meet ATS/ERS international standards.
二、产品功能（Functions）
中文
常规通气功能：慢肺活量（SVC）、用力肺活量（FVC）、第 1 秒用力呼气量（FEV1）、FEV1/FVC、峰流速（PEF）、用力呼气中段流量（FEF25%⁻⁷5%）、最大通气量（MVV）
肺容量测定：功能残气量（FRC）、残气量（RV）、肺总量（TLC）（搭配体描箱模块）
气道阻力检测：脉冲振荡（IOS）、阻断法阻力（Rocc）、气道传导率
特殊试验：支气管舒张试验、药物 / 冷激发试验、呼吸肌力（MIP/MEP）、P0.1 呼吸驱动力
数据管理：多语言界面、中文报告、数据存储 / 回放、质控评级、趋势分析、蓝牙 / USB 传输
扩展功能：可选配 12 导联心电图（ECG）、FeNO（呼出气一氧化氮）、婴幼儿潮气呼吸模块
English
Routine ventilation function: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC), Forced Expiratory Volume in 1s (FEV1), FEV1/FVC, Peak Expiratory Flow (PEF), Forced Expiratory Flow 25%⁻⁷5% (FEF25%⁻⁷5%), Maximal Voluntary Ventilation (MVV)
Lung volume measurement: Functional Residual Capacity (FRC), Residual Volume (RV), Total Lung Capacity (TLC) (with body box module)
Airway resistance detection: Impulse Oscillometry (IOS), Occlusion resistance (Rocc), Airway conductance
Special tests: Bronchodilator test, Drug/cold challenge test, Respiratory muscle strength (MIP/MEP), P0.1 respiratory drive
Data management: Multilingual interface, Chinese reports, data storage/review, quality control, trend analysis, Bluetooth/USB transmission
Extended functions: Optional 12-lead ECG, FeNO (Fractional Exhaled Nitric Oxide), pediatric tidal breathing module
三、产品特点（Features）
中文
德国 JAEGER 原厂传感器：测量、稳定性强，自带滤菌膜，降低交叉感染风险
无线蓝牙设计：摆脱线缆束缚，操作灵活，支持远距离测试
免维护预校准传感器：无需每日定标，减少操作步骤，提升效率
SentrySuite 专业平台：符合 21 CFR Part 11，支持多方案、中心化管理、智能质控
多语言触控界面：中文 / 英文一键切换，操作简便，适合 4 岁以上患者
模块化扩展：可升级体描、弥散、IOS、CPX 等模块，满足全维度肺功能检测
医用级安全：Ⅱ 类医疗器械，无电击、无辐射，适配医院 / 诊所 / 临床研究场景
数据安全传输：支持 Wi-Fi/USB/ 以太网，加密传输，符合临床试验数据规范
English
Original German JAEGER sensor: High precision, strong stability, built-in bacterial filter, reduces cross-infection risk
Wireless Bluetooth design: Cable-free, flexible operation, supports long-distance testing
Maintenance-free pre-calibrated sensor: No daily calibration required, simplifies operation, improves efficiency
SentrySuite professional platｆorm: Compliant with 21 CFR Part 11, supports multi-protocol, centralized management, intelligent quality control
Multilingual touch interface: One-key switch between Chinese/English, easy operation, suitable for patients over 4 years old
Modular expansion: Upgradable with body box, diffusion, IOS, CPX modules for comprehensive pulmonary function testing
Medical-grade safety: Class II medical device, no electric shock, no radiation, suitable for hospital/clinic/clinical trial scenarios
Secure data transmission: Supports Wi-Fi/USB/Ethernet, encrypted transmission, complies with clinical trial data standards
四、技术参数（Technical Specifications）
中文
流量范围：0.1~14 L/s
流量精度：0.1~16 L/s：±10% 或 ±0.3 L/s；0.1~14 L/s：±5% 或 0.2 L/s
容量范围：0~8 L
容量精度：0.1~8 L：±2.5% 或 ±0.050 L
分辨率：PEF：<5 mL/s；FEV1/FVC：1 mL
时间分辨率：1 ms
传感器类型：压差式（Pneumotach），预校准免维护
显示：彩色触控 LCD（电脑端）
电源：AC 220V 50Hz / 内置可充电锂电池
尺寸 / 重量：手柄：20×10×5 cm，<0.8 kg；主机：35×25×15 cm，3.5 kg
工作环境：温度 10~40℃，湿度 15~90%（无冷凝）
存储环境：温度 - 20~50℃，湿度 10~95%（无冷凝）
English
Flow range: 0.1~14 L/s
Flow accuracy: 0.1~16 L/s: ±10% or ±0.3 L/s; 0.1~14 L/s: ±5% or 0.2 L/s
Volume range: 0~8 L
Volume accuracy: 0.1~8 L: ±2.5% or ±0.050 L
Resolution: PEF: <5 mL/s; FEV1/FVC: 1 mL
Time resolution: 1 ms
Sensor type: Differential pressure (Pneumotach), pre-calibrated maintenance-free
Display: Color touch LCD (computer)
Power: AC 220V 50Hz / Built-in rechargeable Li-ion battery
Dimensions/Weight: Handle: 20×10×5 cm, <0.8 kg; Main unit: 35×25×15 cm, 3.5 kg
Operating environment: Temp 10~40℃, humidity 15~90% (non-condensing)
Storage environment: Temp -20~50℃, humidity 10~95% (non-condensing)
五、使用方法（Operation）
中文
准备阶段
设备开机，连接电脑，启动 SentrySuite 软件
患者取坐位，放松，测量身高、体重、年龄，录入系统
佩戴鼻夹，含紧一次性咬嘴，确保不漏气
示范测试动作：平静呼吸→最大吸气→快速呼气→最大吸气
FVC 测试
平静呼吸 3 次 → 最大深吸气至肺总量
立即以最快、最大力持续呼气≥6 秒至完全排空
快速最大吸气，完成 1 次测试
重复 2~3 次，取最佳值（变异率 < 5%）
MVV 测试
指令下最快最深呼吸 12 秒，自动计算 1 分钟最大通气量
特殊测试（IOS / 激发）
IOS：正常平静呼吸，双手贴紧脸颊减少信号损耗，记录 4 个稳定呼吸周期
激发试验：按软件指令梯度给药，对比用药前后肺功能变化
结束流程
自动生成报告，存储 / 打印数据
更换咬嘴，传感器用专用消毒液（Descogen）消毒
English
Preparation
Power on, connect to computer, launch SentrySuite software
Patient seated, relaxed; measure height, weight, age and input into system
Apply nose clip, seal tightly with disposable mouthpiece to prevent leaks
Demonstrate test: Quiet breathing → Max inspiration → Forceful fast expiration → Max inspiration
FVC Test
Breathe quietly 3 times → Max deep inspiration to TLC
Immediately exhale as fast and forcefully as possible for ≥6 seconds until fully empty
Rapid max inspiration to complete 1 test
Repeat 2~3 times, accept best result (variability <5%)
MVV Test
Breathe as fast and deep as possible for 12 seconds on command; auto-calculate 1-minute ventilation
Special Tests (IOS/Challenge)
IOS: Breathe normally, press cheeks to reduce signal loss; record 4 stable breathing cycles
Challenge test: Administer drugs gradiently per software, compare pre/post medication changes
Finish
Auto-generate report, save/print data
Replace mouthpiece, disinfect sensor with special solution (Descogen)
六、适应症（Indications）
中文
COPD、哮喘的诊断、分级与病情监测
咳嗽、胸闷、气短、喘息的病因筛查
胸腹部手术术前肺功能风险评估
肺纤维化、间质性肺病、尘肺病的诊断与随访
支气管舒张 / 激发试验，鉴别气道高反应性
药物疗效评价（慢阻肺、哮喘、间质性肺病）
长期吸烟、粉尘暴露、有害气体接触者肺功能普查
4 岁以上儿童及成人肺功能评估、临床研究
English
Diagnosis, staging and monitoring of COPD, asthma
Etiology screening for cough, chest tightness, dyspnea, wheeze
Preoperative pulmonary risk assessment for thoracic/abdominal surgery
Diagnosis and follow-up of pulmonary fibrosis, interstitial lung disease, pneumoconiosis
Bronchodilator/provocation test to identify airway hyperresponsiveness
Treatment efficacy evaluation (COPD, asthma, interstitial lung disease)
Pulmonary function screening for long-term smokers, dust/harmful gas exposed 人群
Pulmonary function assessment and clinical trials for children over 4 years and adults
七、禁忌症（Contraindications）
中文
绝对禁忌
近 3 个月心肌梗死、脑卒中、休克
近 4 周不稳定心绞痛、严重心衰
未控制高血压（SBP>200/DBP>100 mmHg）
活动性气胸、巨大肺大疱（未手术）
主动脉 / 脑动脉瘤（未治疗）
近 1 个月大咯血、眼部 / 胸腔 / 腹腔手术
癫痫发作期、严重认知障碍无法配合
相对禁忌
心率 > 120 次 / 分、严重心律失常
妊娠晚期、鼓膜穿孔
近 4 周急性呼吸道感染
严重呼吸困难、晕厥史、无法耐受用力呼吸
English
Absolute Contraindications
Recent myocardial infarction, stroke, shock (within 3 months)
Recent unstable angina, severe heart failure (4 weeks)
Uncontrolled hypertension (SBP>200/DBP>100 mmHg)
Active pneumothorax, large bullae (untreated)
Aortic/cerebral aneurysm (untreated)
Recent massive hemoptysis, eye/thoracic/abdominal surgery (1 month)
Active epilepsy, severe cognitive impairment unable to cooperate
Relative Contraindications
HR>120 bpm, severe arrhythmia
Late pregnancy, tympanic membrane perforation
Recent acute respiratory infection (4 weeks)
Severe dyspnea, syncope history, unable to tolerate forced breathing
八、注意事项（Precautions）
中文
测试前停药：短效支气管扩张剂停 12 小时，停 24~48 小时（遵医嘱）
测试前1 小时禁剧烈运动、吸烟、咖啡 / 浓茶、大量进食
环境温度20~25℃，避免气流直吹、电磁干扰
确保咬嘴密封、鼻夹夹紧，防止漏气导致数据偏差
严重患者缩短测试时长，出现头晕、胸闷立即暂停
一次性咬嘴一人一换，传感器每次用 Descogen 消毒 15 分钟
设备避免摔落、进水、高温暴晒，专人操作维护
测试结果需结合临床症状、影像学综合判断
English
Medication withdrawal before test: Short-acting bronchodilators for 12h, long-acting for 24~48h (per physician)
No strenuous exercise, smoking, coffee/strong tea, heavy meal 1h before test
Room temp 20~25℃, avoid direct draft and electromagnetic interference
Ensure tight mouthpiece seal & nose clip to prevent data deviation from leaks
Shorten test for severe patients; pause immediately if dizziness, chest tightness occurs
Disposable mouthpieces for single patient use; disinfect sensor with Descogen for 15min each time
Protect device from drops, water, high temperature; operated by trained staff
Test results need comprehensive judgment with clinical symptoms and imaging
九、存储条件（Storage Conditions）
中文
温度：-20℃ ~ +50℃
湿度：10% ~ 95%（无冷凝）
避免阳光直射、潮湿、粉尘、腐蚀性气体、强电磁干扰
传感器、咬嘴干燥密封存放，防止污染
长期存储：锂电池每月充电 1 次，防止亏电损坏
软件授权、数据线、说明书分类存放，便于取用
English
Temp: -20℃ ~ +50℃
Humidity: 10% ~ 95% (non-condensing)
Avoid direct sunlight, moisture, dust, corrosive gases, strong electromagnetic interference
Store sensors and mouthpieces dry & sealed to prevent contamination
Long-term storage: Recharge Li-ion battery monthly to avoid damage from over-discharge
Store software license, cables, manual separately for easy access
十、说明书核心信息（Manual Core Summary）
中文
产品名称：MasterScope 肺功能仪（德国 JAEGER/ERT）
注册证号：国食药监械 (进) 字 2012 第 2214578 号
适用人群：4 岁及以上可配合患者
检测原理：压差式流量传感 + 无线传输 + BTPS 自动校正
核心标准：符合 ATS/ERS、21 CFR Part 11、GCP 临床规范
安全等级：Ⅱ 类医疗器械，、无辐射、低感染风险
维护要求：每日检查传感器，每次测试后消毒，定期软件升级
质控标准：测试重复 2~3 次，变异率 < 5% 为有效数据
报告内容：FVC、FEV1、PEF、流速容量环、质控评级、中文诊断结论
保修服务：原厂 1 年保修，终身维护，专业技术支持
English
Product Name: MasterScope Spirometer (German JAEGER/ERT)
Registration No.: SFDA(Import) 2012 No.2214578
Applicable Population: Patients aged 4 years and above who can cooperate
Detection Principle: Differential pressure flow sensing + wireless transmission + automatic BTPS correction
Core Standards: Compliant with ATS/ERS, 21 CFR Part 11, GCP clinical specifications
Safety Level: Class II medical device, non-invasive, no radiation, low infection risk
Maintenance Requirements: Daily sensor check, disinfection after each test, regular software upgrade
QC Standard: 2~3 test repeats; valid data if variability <5%
Report Content: FVC, FEV1, PEF, flow-volume loop, QC rating, Chinese diagnostic conclusion
Warranty: 1-year original factory warranty, lifelong maintenance, professional technical support
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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