厂家供应美林肺评估仪ErgoTOP
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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)：粤械注准20222070166更新时间：2026/10/16 11:11:09
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厂家供应美林肺评估仪ErgoTOP
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
ErgoTOP
结构及组成/主要组成成分
由主机、电源适配器及电源线、流量传感器及气路组件、呼吸面罩及接口和头带、3L定标桶及转接管、
气体校准管、USB数据线、WebCPT软件组成。
适用范围/预期用途
适用于临床肺功能检测，以测定肺容量。
1、工作原理 Working Principle
中文：采用每口气压差式气体分析技术，受检者通过呼吸面罩完成平静呼吸、用力呼吸或运动负荷下呼吸，流量传感器采集通气流量，气体分析模块实时检测氧气、二氧化碳浓度；系统计算摄氧量、二氧化碳排出量、通气量、肺容量等参数，结合 WebCPT 软件完成数据运算、存储与报告输出，实现静态及运动状态下肺功能评估。English：Adopts breath‑by‑breath differential‑pressure gas analysis technology. The subject breathes through a mask under resting, forced or exercise‑loaded conditions. The flow sensor acquires ventilation flow, while the gas‑analysis module detects real‑time O₂ and CO₂ concentration. The system calculates oxygen uptake, carbon‑dioxide output, ventilation, lung volume and other parameters. WebCPT software perｆorms data computation, storage and report generation for pulmonary function evaluation at rest and during exercise。
2、产品功能 Functions
中文
静态肺容量、通气功能检测；
运动负荷下气体代谢参数测定（VO₂、VCO₂、VE、呼吸熵 RER 等）；
支持选配心电、血压、血氧模块，同步采集生命体征；
数据自动采集、运算、曲线实时显示；
测试报告生成、存储、查询、打印输出；
设备定标、气体校准功能。
English
Static lung volume and ventilation function measurement;
Gas‑ｍmbedbolism parameter measurement under exercise load (VO₂, VCO₂, VE, RER, etc.);
Optional ECG, blood pressure and SpO₂ modules for synchronous vital‑sign acquisition;
Automatic data acquisition & calculation, real‑time curve display;
Test report generation, storage, query and printout;
System volume calibration and gas calibration function.
3、产品特点 Product Features
中文
每口气压差法检测，运动状态下测量精度高；
一体化移动台车，集成气路、主机、显示终端；
WebCPT 智能分析软件，内置专家辅助判读系统；
可对接功率自行车、运动踏车，完成心肺运动试验；
模块化扩展，可增配 12 导心电、血压、血氧；
3L 定标桶 + 标准气体双重校准，保障数据可靠性；
非侵入式面罩呼吸，受试者依从性好；
报告格式标准化，支持导出打印。
English
Breath‑by‑breath differential‑pressure measurement with high accuracy under exercise;
Integrated mobile cart with gas circuit, main unit and display terminal;
WebCPT intelligent analysis software with built‑in expert‑aided interpretation system;
Compatible with ergometer for cardiopulmonary exercise test;
Modular expandable with 12‑lead ECG, NIBP and SpO₂;
Dual calibration by 3L calibration syringe and standard reference gas to ensure data reliability;
Non‑invasive mask breathing for good subject compliance;
Standardized report ｆormat supporting export and printout.
4、技术参数 Technical Parameters
中文
流量测量范围：0‑15L/s；
容积测量：0‑10L；
O₂测量范围：0‑100%；
CO₂测量范围：0‑10%；
采样模式：每口气逐次采样；
定标器具：3L 定标桶；
工作电源：AC 100‑240V，50/60Hz；
工作环境温度：10℃‑35℃；相对湿度 30%‑80%；
软件版本：WebCPT；
选配模块：心电模块、血压、血氧饱和度。
English
Flow measurement range: 0‑15 L/s;
Volume measurement: 0‑10 L;
O₂ measurement range: 0‑100%;
CO₂ measurement range: 0‑10%;
Sampling mode: breath‑by‑breath sampling;
Calibration syringe: 3 L;
Power supply: AC 100‑240V, 50/60Hz;
Operating ambient temperature:10℃‑35℃; relative humidity 30%‑80%;
Software version: WebCPT;
Optional modules: ECG module, non‑invasive blood pressure, SpO₂.
5、使用方法 Operation Method
中文
设备准备：连接主机、显示器、气路组件，接通电源开机；使用 3L 定标桶完成容积定标，执行气体校准；
受试者信息录入：录入身高、体重、年龄、性别等基础信息；
受试者准备：佩戴呼吸面罩及头带，确认面罩密闭无漏气；选配模块粘贴心电电极、佩戴血压袖带；
测试模式选择：根据临床需求选择静态肺功能模式或心肺运动模式；运动模式下连接运动功率设备；
执行检测：指导受试者按提示完成平静呼吸、用力呼吸或分级运动负荷呼吸，设备自动采集数据；
结束测试：停止采集，摘除面罩及配件；软件自动分析生成报告，复核数据后保存、打印；
测试完毕：清洁面罩、管路，设备待机或关机。
English
Device preparation: Connect main unit, monitor and gas‑circuit components, power on. Perｆorm volume calibration with 3 L syringe and gas calibration;
Subject inｆormation entry: Input height, weight, age, gender and other basic data;
Subject preparation: Fit breathing mask and headband, ensure mask sealing without leakage. Attach ECG electrodes and blood‑pressure cuff if optional modules are used;
Test mode selection: Select static pulmonary‑function mode or cardiopulmonary‑exercise mode as clinical requirement; connect ergometer for exercise test;
Test execution: Guide subject to perｆorm quiet breathing, forced breathing or graded‑load exercise breathing per prompts; device acquires data automatically;
Test completion: Stop acquisition, remove mask and accessories. Software generates report automatically; review, save and print results;
Post‑test: Clean mask and tubing; set device to standby or power off
6、适应症 Indications
中文：适用于临床肺功能检测，测定肺容量；可开展静态肺功能检查及心肺运动试验，用于评估肺通气、气体代谢储备能力，辅助呼吸系统、心血管系统疾病筛查、功能评估、康复疗效评价。English：Intended for clinical pulmonary‑function examination and lung‑volume measurement. Supports static pulmonary‑function test and cardiopulmonary exercise test to evaluate pulmonary ventilation and gas‑ｍmbedbolism reserve, assisting screening, functional assessment and rehabilitation‑effect evaluation for respiratory and cardiovascular diseases.
7、禁忌症 Contraindications
中文
严重胸痛、急性心肌梗死、不稳定心绞痛；
严重心律失常、重度心力衰竭；
急性大咯血、气胸、活动性肺结核；
严重高血压未控制；
认知障碍，无法配合完成呼吸指令；
急性感染发热期；
医生评估不适合做运动负荷试验的患者。
English
Severe chest pain, acute myocardial infarction, unstable angina pectoris;
Severe arrhythmia, severe heart failure;
Massive acute hemoptysis, pneumothorax, active pulmonary tuberculosis;
Uncontrolled severe hypertension;
Cognitive disorder unable to follow breathing instructions;
Acute febrile infection;
Subjects assessed by physician unfit for exercise‑load test.
8、注意事项 Precautions
中文
本设备仅用于临床辅助诊断，不可单独作为确诊依据，检测结果需医师综合判读；
每次检测前必须完成容积定标与气体校准，定标桶、气体校准管需完好；
呼吸面罩需保证密闭，漏气会直接造成检测数据失真；
运动测试全程需有医护人员监护，配备急救设备；出现胸闷、头晕、心悸等不适应立即终止测试；
面罩、接触人体配件按院感要求清洁消毒，避免交叉感染；一次性配件严禁重复使用；
远离强电磁干扰源，避免与大功率设备同回路供电；
设备出现报错、异常报警，停止使用，联系厂家维修，禁止自行拆解；
受试者检测前 2 小时禁止剧烈运动，禁止吸烟、大量进食；
软件仅使用原厂 WebCPT，禁止安装第三方修改程序。
English
This device is for clinical auxiliary diagnosis only and shall not be used as sole diagnostic basis; test results shall be comprehensively interpreted by physicians;
Volume calibration and gas calibration must be perｆormed before each test; calibration syringe and gas tube shall be intact;
Ensure mask sealing; air leakage will cause data distortion;
Exercise test shall be monitored by medical staff with emergency equipment available. Immediately terminate test if chest tightness, dizziness, palpitations or other discomfort occurs;
Masks and patient‑contact accessories shall be cleaned and disinfected per hospital‑infection control requirements to prevent cross‑infection. Disposable parts shall not be reused;
Keep away from strong electromagnetic interference sources; avoid sharing power circuit with high‑power equipment;
Stop operation upon error or abnormal alarm; contact manufacturer for maintenance. Do not disassemble the unit by yourself;
Subjects shall avoid strenuous exercise, smoking and heavy meals within 2 hours before test;
Only original WebCPT software shall be used; third‑party modified programs are prohibited.
9、存储条件 Storage Conditions
中文：环境温度‑10℃～+45℃；相对湿度 10%‑90%，无冷凝；避免阳光直射、粉尘、腐蚀性气体；设备平放，避免剧烈震动；面罩、管路配件防尘存放。English：Ambient temperature ‑10℃～+45℃; relative humidity 10%‑90%, non‑condensing. Avoid direct sunlight, dust and corrosive gas. Store horizontally without violent vibration. Keep masks and tubing dust‑proof.
10、说明书核心摘要 Core Summary
中文产品名称：肺评估仪；型号：ErgoTOP；注册证：粤械注准 20222070166；二类医疗器械；原理为每口气压差法气体分析；用于临床肺容量、通气及运动气体代谢检测；需定期定标校准；需医护人员操作；仅做辅助诊断；运动测试做好急救监护；按规范消毒配件；异常故障联系原厂，禁止私自拆机。EnglishProduct Name: Pulmonary Function Evaluator; Model: ErgoTOP; Registration No.: Yue Xie Zhu Zhun 20222070166; Class Ⅱ medical device. Adopts breath‑by‑breath differential‑pressure gas‑analysis principle for clinical lung‑volume, ventilation and exercise gas‑ｍmbedbolism measurement. Regular calibration required. Operated by medical personnel for auxiliary diagnosis only. Emergency monitoring shall be ready for exercise test. Disinfect accessories per specification. Contact manufacturer for faults; disassembly by unauthorized personnel is forbidden.
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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