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厂商直销尚沃呼气分析仪Sunvou-TM1100,Sunvou-TM1102
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厂商直销尚沃呼气分析仪Sunvou-TM1100,Sunvou-TM1102
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-TM1100、Sunvou-TM1102
结构及组成/主要组成成分
由主机、一氧化氮检测器、电源适配器、嵌入式软件（Sunvou Firmware TM1100/TM1102,V2）、一次性使用呼气过滤嘴、
过滤器（选配）、采样器（选配）、采样气袋（选配）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：设备采用纳库仑电化学传感器技术，采集受检者呼出气样本，传感器与呼出气中的一氧化氮发生电化学反应，将气体浓度信号转化为电信号；主机采集电信号，经内置算法运算处理，输出呼出气一氧化氮（FeNO）检测结果，实现气道炎症标志物定量检测。English：The device adopts nano‑coulomb electrochemical sensor technology to collect exhaled breath samples from subjects. The sensor generates electrochemical reaction with nitric oxide in exhaled breath, converting gas concentration signal into electrical signal. The host collects electrical signals and calculates via built‑in algorithm to output fractional exhaled nitric oxide (FeNO) test results for quantitative detection of airway inflammatory biomarkersde.sunvou-...。
2、功能 Functions
中文
检测人体呼出气中一氧化氮（NO）浓度；
支持在线、离线采样检测模式；
受检者信息录入、检测结果显示、存储、查询；
环境 NO 自动检测、质控提示；
支持数据导出、外接打印；
触摸屏操作，配套嵌入式检测软件。English
Detect nitric oxide (NO) concentration in human exhaled breath;
Support on‑line and off‑line sampling test modes;
Subject inｆormation entry, test result display, storage and query;
Automatic ambient NO detection and quality‑control prompt;
Support data export and external printing;
Touch‑screen operation with ｅmbedded detection software.
3、产品特点 Product Features
中文
纳库仑电化学传感器，检测灵敏度高，抗气体干扰能力强；
支持成人、儿童不同呼气时长设置；
内置质控模块，1500 次免维护；
在线、离线双采样模式，适配病房、门诊、床旁多场景；
触摸屏交互，操作简便；可存储大量历史检测数据；
整机便携，内置电池，支持交直流两用。English
Nano‑coulomb electrochemical sensor with high detection sensitivity and strong anti‑interference capability;
Adjustable exhalation duration for adults and children;
Built‑in quality‑control module, 1500‑test maintenance‑free cycle;
Dual sampling modes (on‑line / off‑line), suitable for outpatient, ward and bedside scenarios;
User‑friendly touch‑screen interface, large‑volume historical data storage;
Portable design with built‑in battery, supporting AC and DC power supply.
4、技术参数 Technical Parameters
中文
检测对象：呼出气一氧化氮（NO）
测量范围：0‑3000 ppb
测量准确度：±3 ppb 或 ±10%（取较大值）
重复性：CV≤10%
线性相关系数：＞0.96
标准呼气流速：50 mL/s；呼气压力＞5 cmH₂O
呼气采样时间：成人 10 s；儿童 6 s
单次分析时间：≤2 min
供电：AC 适配器 / 内置可充电锂电池
采样方式：在线直接采样、离线气袋采样
软件版本：Sunvou Firmware TM1100/TM1102,V2English
Analyte: Nitric oxide (NO) in exhaled breath
Measuring range: 0‑3000 ppb
Accuracy: ±3 ppb or ±10%, whichever is greater
Repeatability: CV ≤10%
Linear correlation coefficient:＞0.96
Standard exhalation flow rate: 50 mL/s; exhalation pressure＞5 cmH₂O
Exhalation duration: 10 s for adults; 6 s for children
Single analysis time: ≤2 min
Power supply: AC adapter / built‑in rechargeable lithium battery
Sampling modes: on‑line direct sampling, off‑line sample bag sampling
Software version: Sunvou Firmware TM1100/TM1102,V2
5、使用方法 Operation Method
中文
开机：接通电源或开机，设备完成自检与环境 NO 检测；
安装配件：安装一次性呼气过滤嘴 / 采样手柄；
录入受检者信息：姓名、年龄、性别等；
采样模式选择：在线模式或离线气袋采样模式；
受试者配合：深吸气（仪器过滤环境 NO），按照屏幕提示以规定流速、压力平稳呼气；
仪器自动采样分析，屏幕输出 FeNO 结果；
保存或打印报告；测试完成，丢弃一次性耗材；
关机，设备闲置 15 分钟可自动关机。English
Power‑on: Switch on device, complete self‑test and ambient NO background check;
Assemble accessories: Install disposable breath filter mouthpiece / sampling handpiece;
Input subject inｆormation: name, age, gender etc.;
Select sampling mode: on‑line or off‑line sample‑bag mode;
Subject maneuver: Deep inspiration (ambient NO filtered by device), exhale steadily at required flow rate and pressure following on‑screen guidance;
Device perｆorms automatic sampling and analysis, FeNO result displayed on screen;
Save or print test report; discard disposable consumables after test;
Power‑off; auto‑power‑off after 15‑min idle status.
6、适应症 Indications
中文：用于检测人体呼出气中一氧化氮浓度，作为气道炎症的辅助评估指标，供临床用于哮喘等气道炎症相关疾病的辅助评估、随访观察。English：For detecting nitric oxide concentration in human exhaled breath. It serves as auxiliary evaluation index of airway inflammation for clinical auxiliary assessment and follow‑up observation of airway inflammatory diseases such as asthma.
7、禁忌症 Contraindications
中文
受检者无法配合完成规范呼气动作；
口腔、面部损伤无法正常含住采样嘴；
无绝对医学禁忌症，检测结果仅作临床辅助参考，不可单独作为确诊依据。English
Subjects cannot complete standardized exhalation maneuver;
Oral / facial injury preventing normal mouthpiece sealing;
No absolute medical contraindications. Test result is only for clinical auxiliary reference and shall not be used as sole diagnostic evidence.
8、注意事项 Notes
中文
测试前受检者避免吸烟、剧烈运动、饮酒、浓茶咖啡，按临床要求空腹或避开饮食；
必须使用原厂配套一次性过滤嘴耗材，禁止重复使用；
测试环境避免 NO 污染源，环境 NO 超标会干扰结果；
传感器有使用寿命，需按说明书定期维护更换；
仪器仅用于体外检测，不可用于人体治疗；
检测结果需结合临床症状、其他检查综合判读，不可单独用于确诊或排除疾病；
避免液体进入主机内部，防止设备损坏；
禁止非授权人员拆机维修。English
Before test, subjects shall avoid smoking, strenuous exercise, alcohol, strong tea and coffee; follow clinical requirements for fasting condition;
Only use original disposable mouthpiece filters; reuse is prohibited;
Avoid NO‑polluted testing environment; excessive ambient NO will interfere with results;
Sensor has limited service life and shall be maintained / replaced per user manual;
The device is for in‑vitro test only, not for human therapy;
Test results shall be interpreted together with clinical symptoms and other examinations; cannot be solely used for disease diagnosis or exclusion;
Prevent liquid ingress into main unit to avoid equipment damage;
Unauthorized disassembly and repair are forbidden.
9、存储条件 Storage Conditions
中文环境温度：‑10℃～+55℃； 相对湿度：10%～85%（无冷凝）； 大气压力：70 kPa‑106 kPa； 存放于干燥通风室内，避免阳光直射、腐蚀性气体、剧烈震动。EnglishAmbient temperature:‑10℃～+55℃; Relative humidity:10%‑85% (non‑condensing); Atmospheric pressure:70 kPa‑106 kPa; Store in dry and ventilated indoor environment, avoid direct sunlight, corrosive gas and violent vibration.
10、说明书核心摘要 Core Summary
中文：尚沃呼气分析仪 Sunvou‑TM1100、Sunvou‑TM1102 为 Ⅱ 类医疗器械，由主机、一氧化氮检测器、电源适配器、嵌入式软件、一次性呼气过滤嘴及选配采样配件组成；采用纳库仑电化学传感器检测呼出气 NO 浓度，用于气道炎症辅助评估；具备在线 / 离线两种采样模式；测试结果仅作临床辅助参考，不能单独作为诊断依据；需使用原厂一次性耗材，按要求维护传感器；在规定温湿度环境存储使用。English：Sunvou‑TM1100 / Sunvou‑TM1102 breath analyzer is Class Ⅱ medical device, composed of main unit, NO detector, power adapter, ｅmbedded software, disposable breath filter mouthpiece and optional sampling accessories. It adopts nano‑coulomb electrochemical sensor to measure exhaled NO for auxiliary evaluation of airway inflammation, supporting on‑line and off‑line sampling modes. Test results are for clinical reference only and shall not serve as sole diagnostic basis. Original disposable consumables shall be used; sensor shall be maintained as required. Store and operate within specified temperature‑humidity range.
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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