厂商直供先亚呼气分析仪ETCO-01
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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20252070223更新时间：2026/10/19 9:40:51
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厂商直供先亚呼气分析仪ETCO-01
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
ETCO-01
结构及组成/主要组成成分
产品由分析仪主机、一氧化碳气体传感器、电源适配器（带电源线）、采样气袋套装（包括：采样气袋和吹气嘴）、过滤器、采气前端及样品气进气接头组件组成。
适用范围/预期用途
用于检测呼出气体中的一氧化碳浓度。
1、工作原理 Working Principle
中文：仪器采用电化学一氧化碳传感检测技术。人体血红素代谢生成胆红素过程中等摩尔产生内源性一氧化碳，该物质随呼气排出体外；采集受试者呼气样本送入仪器，传感器感应呼气中一氧化碳浓度，将气体信号转换为电信号，经系统运算得到呼气末校正一氧化碳 ETCOc 数值，间接反映体内溶血与胆红素生成速率。English：The instrument adopts electrochemical carbon monoxide sensing detection technology. Endogenous carbon monoxide is produced in equimolar quantity during the ｍmbedbolism of human heme into bilirubin and exhaled with breath. The exhaled sample of subject is collected and sent into the instrument. The sensor detects carbon‑monoxide concentration, converts gas signal into electrical signal, and calculates end‑tidal corrected carbon monoxide (ETCOc) value, so as to indirectly reflect in‑vivo hemolysis and bilirubin production rate。
2、功能 Function
中文：1. 采集人体呼气样本，检测呼气中一氧化碳浓度，输出 ETCOc 检测结果；2. 检测数据本地存储、显示；3. 支持数据查阅；4. 配套采样气袋完成样本收集；5. 结果辅助评估溶血程度，为新生儿高胆红素血症风险预警提供参考依据。English：1.Non‑invasively collect human breath samples, test carbon‑monoxide concentration in exhaled gas and output ETCOc results; 2.Local storage and display of test data; 3.Historical data query; 4.Sample collection with matched sampling gas bag; 5.Assist to evaluate hemolysis degree and provide reference for risk warning of neonatal hyperbilirubinemia.
3、产品特点 Product Features
中文：①呼气检测，无需采血；②操作流程简洁，检测速度快；③整机台式，触摸屏显示，结果直观；④配套专用采样气袋、过滤器，降低水汽与杂质干扰；⑤内置数据存储，便于溯源；⑥专为临床新生儿溶血风险筛查设计；⑦二类医用设备，临床合规。English：①Non‑invasive breath test, no blood sampling required; ②Simple workflow with fast test speed; ③Desktop unit with touch‑screen for intuitive result display; ④Equipped with dedicated sampling bags and filters to reduce interference of water vapor and impurities; ⑤Built‑in data storage for traceability; ⑥Specially designed for clinical neonatal hemolysis risk screening; ⑦Class II medical device with clinical compliance.
4、技术参数 Technical Parameters
中文1. 检测对象：人体呼出气体一氧化碳 2. 检测方式：电化学传感器 3. 采样方式：气袋离线采样 4. 显示指标：ETCOc（呼气末校正一氧化碳），单位 ppm 5. 工作环境温度：10℃‑35℃；相对湿度 30%‑80%，无凝露 6. 电源：AC100‑240V，50/60Hz；主机直流供电 7. 数据存储：可存储多条患者检测记录 8. 整机尺寸：台式机，适配新生儿科室操作台 9. 配件：采样气袋、一次性吹气嘴、过滤器、采气接头English1.Test ｏbject: Carbon monoxide in human exhaled breath 2.Detection method: Electrochemical sensor 3.Sampling mode: Off‑line sampling via gas bag 4.Display index: ETCOc (End‑tidal corrected carbon monoxide), unit: ppm 5.Operating ambient: Temperature 10℃‑35℃; RH 30%‑80%, non‑condensing 6.Power supply: AC100‑240V,50/60Hz; DC power for main unit 7.Data storage: Multiple patient test records storable 8.Unit dimension: Desktop type, suitable for neonatal ward console 9.Accessories: Sampling gas bag, disposable mouthpiece, filter, gas sampling connector
5、使用方法 Operation Method
中文1. 开机预热：接通电源开机，完成仪器自检与传感器预热； 2. 样本采集：受试者使用一次性吹气嘴，将呼气收集至专用采样气袋； 3. 装接样本：将充满呼气的采样气袋连接仪器采气前端； 4. 启动检测：触摸屏启动检测程序，仪器抽取气袋内呼气样本进行分析； 5. 读取结果：检测完成屏幕显示 ETCOc 数值，保存或打印报告； 6. 收尾：卸下耗材，丢弃一次性部件，做好仪器清洁； 7. 下一次检测前确认过滤器、吹气嘴全部更换为一次性配件。English1.Power‑on preheating: Switch on power, complete self‑test and sensor warm‑up. 2.Sample collection: Subject exhales through disposable mouthpiece to collect breath into dedicated sampling gas bag. 3.Sample connection: Connect gas bag filled with breath to instrument sampling port. 4.Start measurement: Trigger test procedure on touch‑screen; instrument extracts breath sample for analysis. 5.Read results: ETCOc value displayed on screen after measurement; save or print report. 6.Post‑operation: Disconnect accessories, discard disposable parts and clean equipment. 7.Before next test: Replace filter and mouthpiece with brand‑new disposable accessories.
6、适应症 Indications
中文：用于检测人体呼出气体中的一氧化碳浓度，临床可辅助评估溶血状态，辅助新生儿高胆红素血症、溶血风险筛查，供医疗机构临床使用。English：For detecting carbon‑monoxide concentration in human exhaled breath. Clinically used to assist evaluation of hemolysis status and screen neonatal hyperbilirubinemia and hemolysis risk for medical institutions.
7、禁忌症 Contraindications
中文：无绝对禁忌症；不能用于不能配合呼气采样、严重呼吸困难无法完成规范呼气动作的受试者；本设备仅作辅助检测，不可单独作为确诊依据。English：No absolute contraindications. Not applicable for subjects who cannot cooperate with breath sampling or suffer severe dyspnea unable to perｆorm standardized exhalation. This device is for auxiliary test only and shall not be used as sole diagnostic basis.
8、注意事项 Notes
中文1. 本仪器为医用辅助设备，检测结果仅供临床参考，不可单独作为诊断依据，需结合临床体征、其他检验综合判断； 2. 吹气嘴、过滤器为一次性使用，严禁重复使用，防止交叉感染； 3. 避免外界一氧化碳环境干扰，采样环境禁止吸烟、远离尾气、燃气； 4. 保持传感器干燥，水汽、分泌物会造成检测偏差； 5. 仪器应定期按说明书进行校准维护； 6. 请勿在强电磁干扰环境下使用； 7. 采样气袋不可泄露，漏气将直接造成结果错误； 8. 设备故障时停止使用，联系厂家维修，禁止自行拆机； 9. 新生儿操作需医护人员全程监护。English1.This instrument is medical auxiliary equipment. Test results are for clinical reference only. Diagnosis shall be made combined with clinical signs and other lab examinations instead of relying solely on this test. 2.Mouthpieces and filters are disposable. Reuse is forbidden to avoid cross‑infection. 3.Avoid ambient carbon‑monoxide interference; no smoking, keep away from vehicle exhaust and fuel gas during sampling. 4.Keep sensor dry; water vapor and secretions will cause measurement deviation. 5.Calibrate and maintain instrument periodically per user manual. 6.Do not operate under strong electromagnetic interference. 7.Sampling gas bag shall be leak‑tight; air leakage directly leads to wrong results. 8.Stop operation in case of malfunction; contact manufacturer for repair, do not disassemble by yourself. 9.Neonatal sampling shall be fully supervised by medical staff.
9、存储条件 Storage Conditions
中文：环境温度‑10℃～+45℃；相对湿度 20%‑85%，无凝露；避免阳光直射、远离腐蚀性气体、粉尘；断电存放；一次性耗材单独存放，避免挤压破损。English：Storage temperature:‑10℃～+45℃; Relative humidity:20%‑85%, non‑condensing. Keep away from direct sunlight, corrosive gas and dust. Store with power off. Store disposable accessories separately to prevent crush damage.
10、说明书核心摘要 Core Manual Summary
中文：先亚 ETCO‑01 呼气分析仪属于 Ⅱ 类医疗器械，通过电化学传感器检测人体呼气一氧化碳浓度，输出 ETCOc 指标，间接反映溶血、胆红素生成速率，多用于新生儿溶血与高胆红素血症风险辅助筛查；采用离线气袋采样，一次性耗材防止交叉感染；检测结果仅作辅助参考，不能独立诊断；应规避环境 CO 干扰，定期校准；一次性部件严禁复用；故障不可自行拆解，遵照说明书开展操作、维护与储存，注册证粤械注准 20252070223。English：The Seata ETCO‑01 Breath Analyzer is Class II medical device. It detects carbon‑monoxide concentration in human exhaled breath by electrochemical sensor and outputs ETCOc index to indirectly reflect hemolysis and bilirubin production rate, mainly used for auxiliary screening of neonatal hemolysis and hyperbilirubinemia risk. It adopts off‑line gas‑bag sampling with disposable consumables for cross‑infection prevention. Test results are for auxiliary reference only and cannot serve as independent diagnostic evidence. Avoid ambient CO interference and perｆorm regular calibration. Disposable components must not be reused. Do not disassemble unit upon failure. Operation, maintenance and storage shall follow user manual. Registration No.: Yue Xie Zhun 20252070223。
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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