厂商直销德国科泰斯心肺功能测试系统MetaLyzer 3B
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厂商直销德国科泰斯心肺功能测试系统MetaLyzer 3B
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
MetaLyzer 3B
结构及组成/主要组成成分
见附页。
适用范围/预期用途
该产品由具备医学专业知识的人员在室内对14岁以上的患者进行心肺功能测试，根据测量值和计算值也可预测肺功能参数，适用于压力测试、康复医学和运动医学。
1、工作原理 Working Principle
中文：采用逐次呼吸（Breath‑by‑Breath）测试技术，涡轮流量传感器采集受试者呼吸气流流量；电化学燃料电池氧气传感器检测氧浓度，NDIR 非色散红外传感器检测二氧化碳浓度；结合大气压、温湿度环境参数，实时计算摄氧量 VO₂、二氧化碳排出量 VCO₂、通气量、呼吸商等心肺代谢参数；可同步对接 ECG 心电、血氧、心率外设，综合评估静息及运动负荷状态下人体心肺与能量代谢水平。English：Adopts breath‑by‑breath measurement technology. The turbine flow sensor collects the subject’s respiratory airflow. The electrochemical fuel‑cell O₂ sensor detects oxygen concentration, and the NDIR non‑dispersive infrared sensor detects carbon dioxide concentration. Combined with ambient parameters including atmospheric pressure, temperature and humidity, it calculates cardiopulmonary‑ｍmbedbolic parameters such as oxygen uptake VO₂, carbon dioxide output VCO₂, ventilation volume and respiratory quotient in real‑time. It can synchronize with external ECG, SpO₂ and heart‑rate devices to comprehensively evaluate human cardiopulmonary function and energy ｍmbedbolism under resting and exercise‑load conditionsPMC。
2、功能 Functions
中文
静息、运动负荷下逐次呼吸气体代谢检测，输出最大摄氧量、无氧阈、呼吸商、分钟通气量等核心指标
支持对接运动负荷设备（跑步机、功率自行车），完成运动心肺负荷试验
可外接心电、血氧、心率模块，同步采集心血管生理信号
MetaSoft® Studio 软件完成数据存储、分析、报告生成、数据导出
具备压力、流量、气体多点校准功能，保障检测精度
支持 USB / 蓝牙无线数据传输，可实验室固定使用，也可场地移动测试。English
Breath‑by‑breath gas‑ｍmbedbolism measurement at rest and under exercise load, output key indicators including VO₂max, anaerobic threshold, respiratory quotient and minute ventilation.
Compatible with exercise load equipment (treadmill, cycle ergometer) for cardiopulmonary exercise testing.
Connectable with external ECG, SpO₂ and heart‑rate modules for synchronous cardiovascular signal acquisition.
MetaSoft® Studio software for data storage, analysis, report generation and data export.
Multi‑point calibration for pressure, flow and gas to guarantee measurement accuracy.
USB / Bluetooth wireless transmission; supports fixed lab use and field mobile testingCORTEX。
3、产品特点 Product Features
中文
便携式模块化整机，体积小巧，整机重量轻，兼顾实验室与户外场地测试
逐次呼吸高精度检测，传感器响应速度快，数据实时输出
O₂燃料电池传感器使用寿命长，校准周期长，维护工作量低
兼容一次性涡轮、可重复使用涡轮两种流量传感器
丰富外设接口，可对接多款 ECG、血氧、功率计设备
可选外置大容量电池，脱离市电可长时间工作
LED 状态指示灯，设备运行状态直观可见；符合 CE、ISO13485 医疗合规标准。English
Portable modular compact unit with light weight, suitable for both laboratory and field testing.
High‑precision breath‑by‑breath measurement with fast‑response sensors for real‑time data output.
Long‑life fuel‑cell O₂ sensor with long calibration intervals and low maintenance workload.
Supports both disposable and reusable turbine flow transducers.
Abundant peripheral interfaces, compatible with multiple ECG, SpO₂ and power‑meter devices.
Optional high‑capacity external battery for long‑time operation without mains power supply.
LED status indicators for intuitive equipment status monitoring; compliant with CE and ISO13485 medical standardsCORTEX。
4、技术参数 Technical Parameters
中文
O₂传感器：电化学燃料电池；测量范围 0‑25% Vol；精度 ±0.1% Vol；响应 T90≤100ms
CO₂传感器：NDIR 非色散红外；测量范围 0‑13% Vol；精度 ±0.1% Vol；响应 T90≤100ms
可复用涡轮流量：≤20 L/s；精度 ±2%；一次性涡轮流量：≤14 L/s；精度 ±3%
压力传感器：300‑1100 mbar
通讯：USB、蓝牙 BLE
供电：AC 100‑250V，50‑60Hz；选配外置电池最长 12h 续航
整机尺寸：240×210×90 mm；整机重量：940 g
工作环境温度：10℃‑35℃；相对湿度：0‑100%（无冷凝）；大气压 500‑1050 mbar
配套软件：MetaSoft® Studio；兼容 Windows 操作系统
合规：ISO13485、IEC60601‑1、CE 认证CORTEX。English
O₂ Sensor: Electrochemical fuel cell; measuring range 0‑25%Vol; accuracy ±0.1%Vol; T90 response ≤100 ms
CO₂ Sensor: NDIR non‑dispersive infrared; measuring range 0‑13%Vol; accuracy ±0.1%Vol; T90 response ≤100 ms
Reusable turbine flow: ≤20 L/s; accuracy ±2%; Disposable turbine flow: ≤14 L/s; accuracy ±3%
Pressure sensor: 300‑1100 mbar
Communication: USB, Bluetooth BLE
Power supply: AC 100‑250V, 50‑60Hz; optional external battery, max.12‑hour operation
Dimension: 240×210×90 mm; Weight: 940 g
Operating ambient temperature: 10℃‑35℃; relative humidity: 0‑100% (non‑condensing); atmospheric pressure 500‑1050 mbar
Software: MetaSoft® Studio; Windows‑compatible
Compliance: ISO13485, IEC60601‑1, CE certificationCORTEX。
5、使用方法 Operation Method
中文
设备开机预热，按照规范依次完成大气压校准、流量容积校准、标准气体校准。
连接主机、电脑，按需连接 ECG、血氧、心率等外设；根据受试者脸型匹配密封呼吸面罩，佩戴固定。
设置受试者基础信息，选择测试模式：静息测试或运动负荷测试；运动模式下对接跑步机 / 功率自行车设置负荷方案。
指导受试者保持正常呼吸，启动测试；运动测试按方案逐级递增负荷，全程实时采集呼吸代谢、生命体征数据。
测试结束，停止运动，保存原始数据；软件自动运算生成心肺代谢报告，查看、编辑、导出报告。
测试完成，拆卸面罩、涡轮组件；一次性涡轮直接废弃；可复用涡轮完成清洁消毒，收纳设备。
每日测试前做流量校准；按周期执行气体传感器校准维护。English
Power on and warm‑up the device. Perｆorm atmospheric‑pressure calibration, volume‑flow calibration and reference‑gas calibration in specified sequence.
Connect main unit and PC; attach external ECG, SpO₂ or heart‑rate modules as required. Fit and fasten a well‑sealed breathing mask matching subject’s facial contour.
Input subject baseline inｆormation; select test mode: resting test or exercise‑load test. For exercise test, set load protocol on treadmill / cycle ergometer.
Instruct subject to breathe normally and start measurement. Increase exercise load step‑by‑step according to protocol; collect respiratory‑ｍmbedbolic and vital‑sign data in real‑time.
Terminate exercise upon test completion, save raw data. The software automatically calculates and generates cardiopulmonary‑ｍmbedbolism reports for review, editing and export.
Dismantle mask and turbine assembly. Discard disposable turbines directly; clean and disinfect reusable turbines before storage.
Perｆorm flow calibration before daily testing; conduct periodic gas‑sensor calibration and maintenanceatendiment...。
6、适应症 Indications
中文
心肺疾病患者运动耐量评估，辅助诊断呼吸困难、心功能不全、肺功能损伤病因。
心血管、肺部疾病治疗效果评估、康复运动方案制定。
术前心肺风险评估，评估手术耐受能力。
运动医学：运动员有氧能力、最大摄氧量、无氧阈测试，训练方案制定。
肥胖、代谢综合征人群能量代谢评估。
职业健康、科研教学开展人体运动代谢研究。
健康人群健康体检，心肺储备功能筛查。English
Exercise‑tolerance evaluation for cardiopulmonary patients; assist differential diagnosis for dyspnea, cardiac insufficiency and pulmonary impairment.
Therapeutic‑effect evaluation and rehabilitation exercise planning for cardiovascular and pulmonary diseases.
Pre‑operative cardiopulmonary risk assessment for surgical tolerance evaluation.
Sports medicine: aerobic capacity, VO₂max and anaerobic‑threshold testing for athletes; training‑program ｆormulation.
Energy‑ｍmbedbolism assessment for obese and ｍmbedbolic‑syndrome populations.
Occupational health assessment and human exercise‑ｍmbedbolism research for scientific and educational purposes.
Cardiopulmonary reserve screening for healthy subjects in physical examination。
7、禁忌症 Contraindications
中文
不稳定型心绞痛、急性心肌梗死发病急性期。
严重未控制心律失常、重度心力衰竭。
急性肺栓塞、严重肺动脉高压、急性呼吸衰竭。
严重高血压未控制，收缩压＞200mmHg 或舒张压＞110mmHg。
急性感染、高热；严重躯体损伤无法完成运动。
精神障碍无法配合完成呼吸测试。
面罩接触部位皮肤严重破损、过敏。
运动负荷测试需要临床医师评估受试者整体风险，判断是否适合开展负荷试验。English
Unstable angina; acute phase of myocardial infarction.
Severe uncontrolled arrhythmia; severe heart failure.
Acute pulmonary embolism; severe pulmonary hypertension; acute respiratory failure.
Uncontrolled severe hypertension: SBP＞200 mmHg or DBP＞110 mmHg.
Acute infection with high fever; severe physical injury preventing exercise perｆormance.
Mental disorder preventing subject cooperation for respiratory test.
Severe skin damage or allergy at mask‑contact area.
Exercise‑load testing shall be perｆormed only after clinical physician’s overall risk assessment for subject eligibility.
8、注意事项 Precautions
中文
运动心肺测试存在运动诱发心血管事件潜在风险，测试现场必须配备急救设备与急救药品，由具备资质医护人员操作监护。
每次测试前完成设备预热与全套校准；校准气体、校准注射器需要定期校验。
面罩必须保证密封良好，漏气会直接造成检测结果失真。
一次性涡轮不可重复使用；可复用涡轮每次使用后必须规范清洁消毒，避免交叉感染。
传感器避免水汽、液体渗入；禁止撞击、摔落主机与传感器组件。
严格按照周期执行传感器校准；O₂、CO₂传感器属于消耗件，寿命到期及时更换。
测试过程中受试者出现胸痛、严重胸闷、头晕、显著心律失常等危险信号，立即终止测试，开展临床处置。
不可在易燃易爆环境使用设备。
软件数据定期备份，防止检测数据丢失。 10. 设备维修、内部元件更换必须由厂家授权工程师执行，禁止自行拆机。English
Cardiopulmonary exercise testing carries potential risk of exercise‑induced cardiovascular events. First‑aid equipment and medicines shall be available on‑site; test shall be monitored by qualified medical staff.
Complete device warm‑up and full calibration before every test. Calibration gas and calibration syringe shall be verified periodically.
Ensure good mask sealing; air leakage will cause severe measurement deviation.
Disposable turbines shall not be reused. Reusable turbines must be properly cleaned and disinfected after each use to avoid cross‑infection.
Prevent water vapor or liquid ingress into sensors; avoid impact or dropping of main unit and sensor assemblies.
Perｆorm sensor calibration on scheduled cycles. O₂ and CO₂ sensors are consumables and shall be replaced upon end‑of‑service‑life.
Immediately terminate test and provide clinical intervention if subject develops chest pain, severe dyspnea, dizziness, significant arrhythmia or other warning signs.
Do not operate device in flammable‑explosive atmosphere.
Back‑up software data regularly to prevent data loss.
Maintenance and internal component replacement must be perｆormed by manufacturer‑authorized engineers. Unauthorized disassembly is prohibitedatendiment...。
9、存储条件 Storage Conditions
中文存储温度：‑20℃ ~ +45℃；存储相对湿度：10‑90%，无冷凝；存储大气压 500‑1100 mbar；远离腐蚀性气体、粉尘；避免阳光直射；主机、传感器组件防震存放；一次性耗材阴凉干燥避光保存。EnglishStorage temperature:‑20℃ ~ +45℃; relative humidity:10‑90% non‑condensing; atmospheric pressure 500‑1100 mbar. Keep away from corrosive gas and dust; avoid direct sunlight. Store main unit and sensor assemblies with shock protection. Store disposable consumables in cool, dry and shaded environmentCORTEX。
10、说明书核心摘要 Core Summary of Instructions
中文：MetaLyzer 3B 为德国 CORTEX 科泰斯便携式运动心肺功能测试系统，采用逐次呼吸气体分析技术，采集静息及运动负荷下人体通气、氧气、二氧化碳代谢数据，配套软件完成心肺运动试验，用于医院、康复科、运动医学机构开展心肺功能评估。使用前必须完成预热、压力‑流量‑气体三级校准；运动测试必须有医护监护，备好急救物资；严格区分一次性与可复用涡轮，做好消毒；传感器为消耗件定期校准更换；禁忌人群禁止运动负荷测试；设备储存防潮湿、防撞击，维修需授权工程师操作。English：MetaLyzer 3B is a portable cardiopulmonary exercise‑testing system manufactured by CORTEX (Germany). It adopts breath‑by‑breath gas‑analysis technology to collect ventilation, O₂ and CO₂ ｍmbedbolic data under resting and exercise‑load conditions. Matching software completes cardiopulmonary exercise tests for cardiopulmonary assessment in hospitals, rehabilitation departments and sports‑medicine institutions. Complete warm‑up plus three‑level calibration (pressure‑flow‑gas) before use. Exercise testing must be medically supervised with first‑aid supplies ready. Distinguish disposable / reusable turbines strictly and implement proper disinfection. Sensors are consumables requiring periodic calibration and replacement. Exercise‑load test shall be prohibited for contraindicated subjects. Store device against moisture and impact; maintenance must be carried out by authorized engineers.
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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