厂家直供尚沃一氧化氮检测器ADNO系列
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厂家直供尚沃一氧化氮检测器ADNO系列
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
ADNONA00、ADNO-N100、ADNO-N300、ADNO-N500、ADNO-N1000、ADNO-N2000、ADNO-N3000、ADNO-N5000
结构及组成/主要组成成分
由外壳、硬件接口卡、一氧化氮传感器组成。
适用范围/预期用途
配合本公司生产的呼气分析仪使用，用于检测呼出气NO(一氧化氮)浓度。
1、工作原理 Working Principle
中文：产品采用纳库仑电化学传感技术，呼出气中的一氧化氮扩散进入电化学传感器催化电极表面发生氧化还原反应，产生与 NO 浓度成比例的电流信号；硬件接口卡采集信号，经算法换算得到呼出气一氧化氮实时浓度值，输出至配套呼气分析仪主机显示结果。English：Adopting nacoulomb electrochemical sensing technology. Nitric oxide in exhaled breath diffuses to the catalytic electrode of electrochemical sensor and generates redox reaction, producing current signal proportional to NO concentration. The hardware interface card collects signals, calculates real‑time exhaled NO concentration through algorithm, and outputs results to the matched exhaled breath analyzer。
2、功能 Function
中文：作为检测核心部件，配合尚沃呼气分析仪，检测患者呼出气中一氧化氮浓度，输出检测电信号，为呼吸道气道炎症评估提供量化检测数据；支持仪器自动质控、标定信号采集传输。仅做检测，不具备诊断功能，检测结果供医师参考。English：As core detecting component, matched with Sunvou exhaled breath analyzer, detect nitric oxide concentration in patient’s exhaled breath and output electrical signals, providing quantitative data for respiratory tract inflammation assessment. Support automatic quality control and calibration signal acquisition & transmission. For test only, no diagnostic function; test results are for physician reference only。
3、产品特点 Product Features
中文
高检测灵敏度，检测下限低，可捕捉低浓度 NO 变化；
测量重复性好，2 小时内测量漂移小，检测结果稳定；
专用纳库仑电化学传感器，抗部分干扰气体影响；
模块化部件，接口标准化，可快速拆装更换；
响应速度快，适配临床呼气采样流程；
传感器具备自标定适配能力，配合主机完成质控校验。
English
High detection sensitivity with low limit of detection for low‑level NO variation;
Excellent repeatability, low measuring drift within 2 hours for stable results;
Special nacoulomb electrochemical sensor with partial anti‑interference against gas disturbance;
Modular design with standardized interface for quick disassembly and replacement;
Fast response, compatible with clinical exhaled‑breath sampling procedure;
Sensor supports auto‑calibration adaptation for quality control with main unit。
4、技术参数 Technical Parameters
中文
测量范围：0ppb～3000ppb
最低检测限：3ppb
准确度：＜50ppb 时，误差≤±3ppb；≥50ppb 时，误差≤±10%
重复性：相对偏差 CV≤10%
2 小时稳定性漂移：≤±10%
适配采样体积：30mL
整机设计寿命：5 年或 50000 次检测（以先到为准）
工作环境温度：10℃‑35℃；相对湿度 30%‑80%，无凝露
供电：由配套呼气分析仪主机供电
组成：外壳、硬件接口卡、一氧化氮传感器
English
Measuring Range：0ppb～3000ppb
Limit of Detection：3ppb
Accuracy：≤±3ppb when ＜50ppb；≤±10% when ≥50ppb
Repeatability：Relative deviation CV ≤10%
2‑hour stability drift：≤±10%
Adapted sampling volume：30mL
Design service life：5 years or 50000 tests (whichever comes first)
Operating ambient：10℃‑35℃，RH 30%‑80%, non‑condensing
Power supply：Powered by matched exhaled breath analyzer
Components：Housing, hardware interface card, nitric oxide sensor
5、使用方法 Operating Method
中文
确认检测器型号与配套呼气分析仪型号匹配，断电状态下将检测器接口对准主机卡槽，完成物理安装连接；
开机，配套主机执行整机自检，确认检测器通讯正常，传感器状态无告警；
按照分析仪操作流程完成仪器质控、标定；
受检者按照规范完成呼气采样，检测器采集气体样本，输出信号至分析仪计算 NO 浓度；
检测完成，可继续下一例检测；出现传感器故障告警时，停机更换检测器模块；
本部件不可单独运行，所有操作必须在配套呼气分析仪整机系统完成。
English
Confirm detector model matches matched exhaled breath analyzer. Install detector into main‑unit slot under power‑off condition;
Power on main unit. Complete self‑test, confirm normal communication without sensor alarm;
Perｆorm quality control and calibration following analyzer procedure;
Subject perｆorms standardized exhalation sampling. Detector samples gas and sends signal for NO concentration calculation;
Complete test and proceed next sample. Shut down and replace detector upon sensor fault alarm;
Cannot operate standalone. All operations must be perｆormed on complete matched exhaled breath analyzer system。
6、适应症 Indications
中文：配合尚沃呼气分析仪，用于检测人体呼出气一氧化氮浓度；临床用于辅助评估气道炎症水平，可为哮喘、过敏性呼吸道炎症、慢性咳嗽等呼吸道疾病气道炎症评估提供检测参考，仅提供检测数据，不作为独立确诊依据。English：Matched with Sunvou exhaled breath analyzer for detecting human exhaled nitric oxide concentration. Clinically used to assist evaluation of airway inflammation level, provide reference data for asthma, allergic respiratory inflammation, chronic cough and other respiratory diseases. Test data cannot be used as sole diagnostic evidence。
7、禁忌症 Contraindications
中文：该部件为气体检测模块，无直接人体接触，无绝对禁忌症；但无法配合完成标准呼气动作的受试者，不适用该检测方案。不可用于体外、体内直接侵入人体测量。English：This is gas‑detecting module without direct human‑body contact, no absolute contraindications. Subjects unable to perｆorm standardized exhalation are not applicable. Not for in‑vivo invasive measurement.
8、注意事项 Precautions
中文
本检测器仅可与尚沃指定型号呼气分析仪配套使用，禁止混用其他品牌主机；
传感器避免撞击、跌落、液体泼溅，不可拆解检测器外壳；
避免高浓度腐蚀性气体、油烟、有机溶剂环境，会造成传感器不可逆损伤；
必须按照周期完成仪器标定与质控，否则检测结果不可采信；
出现告警、漂移超标、达到设计寿命时应及时更换检测器；
检测前受检者遵循呼气测试准备规范，避免吸烟、浓茶咖啡、剧烈运动干扰结果；
属于二类医用部件，医疗机构由经过培训人员操作；
传感器性能会随使用次数、时间衰减，按要求定期校验；
不可用于直接诊断疾病，检测结果结合临床症状、其他检查综合判断。
English
Only compatible with designated Sunvou exhaled breath analyzer. Do not use with other brand equipment;
Prevent impact, drop and liquid splash. Do not disassemble detector housing;
Keep away from high‑concentration corrosive gas, oil fume and organic solvent to avoid irreversible sensor damage;
Perｆorm periodic calibration & quality‑control, otherwise test results are invalid;
Replace detector upon alarm, excessive drift or end of service life;
Subjects shall comply with pre‑test preparation: avoid smoking, strong tea, coffee and strenuous exercise before test;
Class II medical component. Operated only by trained personnel in medical institutions;
Sensor perｆormance degrades over usage time and counts; periodic verification required;
Not for direct disease diagnosis; results shall be interpreted combined with clinical symptoms and other examinations.
9、存储条件 Storage Conditions
中文：存储环境温度：5℃‑40℃；相对湿度 20%‑85%，无凝露；避免阳光直射，远离腐蚀性气体、热源、潮湿；运输存储防止剧烈振动撞击。English：Storage temperature:5℃‑40℃；Relative humidity 20%‑85%, non‑condensing. Keep away from direct sunlight, corrosive gas, heat source and dampness. Avoid violent vibration and impact during transportation and storage.
10、说明书核心摘要 Core Summary
中文：尚沃 ADNO 系列一氧化氮检测器为第二类医疗器械，模块化电化学传感部件，不能单独使用，必须搭配尚沃呼气分析仪整机系统；通过纳库仑电化学原理检测呼出气 NO 浓度，输出电信号由主机换算结果，辅助临床气道炎症评估；需定期标定质控，避免腐蚀、摔碰，达到寿命或故障时及时更换；仅供医疗机构专业人员操作，结果仅供医师综合评估参考，不单独作为确诊依据。English：Sunvou ADNO series nitric oxide detector is Class II medical device, modular electrochemical sensing component. Cannot work standalone; must be used with complete Sunvou exhaled breath analyzer system. Detect exhaled NO concentration via nacoulomb electrochemistry and output electric signal for main‑unit calculation to assist clinical airway‑inflammation evaluation. Periodic calibration and QC required. Avoid corrosion and mechanical damage. Replace at end‑of‑life or fault status. Operated by trained medical‑staff only. Test results serve for comprehensive clinical reference instead of sole diagnostic basis。
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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