厂商直销尚沃呼气分析仪Sunvou-DA1103
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厂商直销尚沃呼气分析仪Sunvou-DA1103
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
Sunvou-DA1103
结构及组成/主要组成成分
由主机、过滤器、采样器、一氧化氮检测器、电源适配器、Sunvou呼气检测软件（英文名Sunvou Detector，V4）、采样气袋组成。
适用范围/预期用途
用于检测呼出气中NO（一氧化氮）浓度
1、工作原理 Working Principle
中文：仪器采用纳库仑电化学一氧化氮检测传感器，采集受试者标准流速下的呼出气样本，呼出气中的一氧化氮与传感器发生电化学氧化还原反应，传感器将气体浓度信号转换为电信号；主机采集电信号，经内置软件算法运算处理，换算得到呼出气一氧化氮（FeNO）浓度数值，用于气道炎症的辅助评估。English：The instrument adopts coulomb‑electrochemical nitric‑oxide sensor to collect exhaled breath samples under standard flow rate from subjects. Nitric oxide in exhaled breath triggers electrochemical redox reaction inside the sensor, which converts gas‑concentration signal into electrical signal. The host collects electrical signals, calculates and converts them into fractional exhaled nitric oxide (FeNO) concentration via built‑in software algorithm for auxiliary evaluation of airway inflammation.
2、功能 Functions
中文
采集受试者呼出气样本，检测呼出气一氧化氮（FeNO）浓度；
自动环境 NO 本底检测、仪器自检；
受试者信息录入、检测结果存储、查询；
检测结果显示、打印输出；
支持数据对外导出。English
Collect exhaled breath samples and detect fractional exhaled nitric oxide (FeNO) concentration;
Automatic ambient NO background detection and device self‑test;
Subject inｆormation input, test result storage and query;
Display and print test reports;
Support external data export.
3、产品特点 Product Features
中文
纳库仑电化学传感技术，检测响应速度快；
便携式整机设计，临床科室、门诊均可使用；
内置软件自动质控，执行标准呼气流量控制；
配套一次性呼气过滤器，避免交叉感染；
人机交互操作界面，结果直观显示；
具备数据存储、打印、导出功能。English
Coulomb‑electrochemical sensing technology with fast response;
Portable unit for clinic and outpatient‑department application;
Built‑in automatic quality‑control, standard exhalation‑flow control;
Disposable breath filter accessories to prevent cross‑infection;
Human‑machine interactive interface with intuitive result display;
Functions of data storage, printing and export.
4、技术参数 Technical Parameters
中文
检测对象：呼出气一氧化氮（FeNO）
测量范围：0‑3000 ppb
测量精度：±3 ppb 或 ±10% 读数，取较差值
标准呼气流量：50 mL/s
采样方式：直接呼气采样 / 气袋采样
工作电源：AC 适配器供电；可选内置电池
工作环境温度：10℃‑35℃；相对湿度：30%‑80% RH，无凝露
软件版本：Sunvou Detector V4
整机组成：主机、纳库仑一氧化氮检测器、过滤器、采样器、采样气袋、电源适配器、软件组件English
Analyte: Fractional exhaled nitric oxide (FeNO)
Measuring range: 0‑3000 ppb
Measurement accuracy: ±3 ppb or ±10% of reading (whichever is worse)
Standard exhalation flow rate: 50 mL/s
Sampling mode: direct breath sampling / breath‑bag sampling
Power supply: AC adapter; optional internal battery
Operating ambient temperature:10℃‑35℃; Relative humidity:30%‑80%RH, non‑condensing
Software version: Sunvou Detector V4
Components: main unit, coulomb‑electrochemical NO detector, filter, sampler, breath‑sampling bag, power adapter, ｅmbedded software module
5、使用方法 Operation Method
中文
使用前检查仪器外观、电源、传感器有效期，安装一次性呼气过滤器；
接通电源开机，仪器执行开机自检与环境 NO 本底检测；
录入患者编号、年龄、性别等信息；
指导受试者按规范完成呼气动作，维持标准呼气流量；
仪器自动采集样本、完成检测，屏幕显示 FeNO 检测结果；
保存结果，按需打印报告；
测试完成，取下废弃一次性耗材，关闭设备。English
Inspect device appearance, power supply and sensor expiry date before use; install brand‑new disposable breath filter.
Power‑on; device perｆorms self‑check and ambient‑NO background measurement.
Input patient ID, age, gender and other inｆormation.
Instruct subject to perｆorm standardized exhalation maneuver and maintain standard flow rate.
The instrument automatically samples and completes measurement; FeNO result is displayed on screen.
Save results and print report if required.
Remove discarded disposable consumables and power‑off the device after test.
6、适应症 / 预期用途 Indications /Intended Use
中文：用于医疗机构检测人体呼出气中的一氧化氮浓度，辅助评估气道炎症状态，为呼吸道相关疾病诊疗提供参考依据。本设备仅用于检测，不作为独立确诊依据。English：For medical‑institution use to measure nitric‑oxide concentration in human exhaled breath, to assist evaluation of airway‑inflammation status and provide reference for diagnosis and treatment of respiratory‑tract diseases. This device is only for measurement and shall not be used as sole diagnostic evidence.
7、禁忌症 Contraindications
中文
无法配合完成标准呼气动作的受试者，不适用本检测方式；
存在严重呼吸困难、呼吸衰竭无法执行规范呼气操作者；
口腔、气道活动性大出血患者禁止测试。
注：本仪器无绝对药物相关禁忌症，临床由医师评估受试者是否适合呼气检测。English
Subjects unable to complete standardized exhalation maneuver are not suitable for this test.
Subjects with severe dyspnea or respiratory failure incapable of standardized exhalation.
Subjects with active massive oral or airway hemorrhage shall not perｆorm test. Note: No absolute drug‑related contraindications. Physicians shall evaluate subject suitability for breath test clinically.
8、注意事项 Precautions
中文
必须使用原厂配套合格过滤器、采样耗材，一次性耗材严禁重复使用，防止交叉感染；
传感器为消耗件，必须在有效期内使用，按期更换；
检测前受试者避免吸烟、饮酒、进食、漱口剂，建议静置 20 分钟以上再检测，避免干扰结果；
避免在 NO 浓度偏高的污染环境开展检测；
仪器避免撞击、跌落、进水，禁止非授权人员拆机；
严格按照仪器要求执行定期校准与质控；
检测结果仅作临床辅助参考，需结合患者症状、其他检查综合判断，不可单独作为确诊或排除疾病的依据；
设备工作时远离强电磁干扰源。English
Only original‑qualified filters and sampling consumables shall be used. Disposable consumables must not be reused to avoid cross‑infection.
Sensor is consumable component; use within validity period and replace on schedule.
Subjects shall avoid smoking, drinking, eating and mouthwash before test; rest for at least 20 min to prevent result interference.
Do not perｆorm test in environment with high ambient‑NO pollution.
Avoid impact, drop and water ingress. Unauthorized disassembly is prohibited.
Perｆorm periodic calibration and quality‑control as required.
Test result is for clinical reference only; comprehensive judgement combining patient symptoms and other examinations is required, and shall not serve as sole diagnostic basis.
Keep away from strong electromagnetic interference during operation.
9、存储条件 Storage Conditions
中文温度：‑10℃ ~ +45℃；相对湿度：10%‑90% RH，无凝露； 环境：干燥通风，避光，避免腐蚀性气体、粉尘；远离强震动挤压；长期存储建议取出电池；传感器需按单独包装存储要求保管。EnglishTemperature:‑10℃ ~ +45℃; Relative humidity:10%‑90%RH, non‑condensing. Environment: dry, ventilated, away from direct sunlight, corrosive gas and dust; avoid heavy vibration and compression. Remove battery for long‑term storage. Store sensor following its separate‑packaging requirements.
10、说明书核心摘要 Core Summary of Instructions
中文：Sunvou‑DA1103 纳库仑呼气分析仪为二类医用检测设备，利用纳库仑电化学传感器检测呼出气一氧化氮 FeNO 浓度，用于医疗机构气道炎症辅助评估；整机由主机、检测器、过滤器、采样配件、电源及软件组成；需规范执行受试者呼气操作，使用合格一次性耗材，传感器按期更换，定期质控校准；检测结果仅为临床辅助参考，不能单独用于疾病确诊；做好设备防护与规范存储。English：Sunvou‑DA1103 is Class‑Ⅱ medical testing device. It adopts coulomb‑electrochemical sensor to measure FeNO concentration in exhaled breath for auxiliary airway‑inflammation evaluation in medical institutions. The system consists of main unit, NO detector, filters, sampling accessories, power adapter and ｅmbedded software. Standardized subject exhalation maneuver, qualified disposable consumables, timely sensor replacement and regular QC‑calibration are required. Test results are only clinical reference and cannot be used for sole disease diagnosis. Device protection and standardized storage shall be maintained.
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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