厂商供应希克玛一氧化氮检测器iFeNO-NC-N系列
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厂商供应希克玛一氧化氮检测器iFeNO-NC-N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
iFeNO-NC-N100,iFeNO-NC-N300,iFeNO-NC-N500,iFeNO-NC-N800,iFeNO-NC-N1000,iFeNO-NC-N1500,iFeNO-NC-N2000
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
本产品配套公司I2C接口的呼气分析仪使用,用于检测呼出气中一氧化氮浓度。
1、工作原理 Working Principle
中文:基于电化学传感器检测原理,人体呼出气样本进入检测气室后,一氧化氮与电化学传感器发生电化学反应,传感器将气体浓度信号转化为电信号;主机采集电信号经算法运算,输出呼出气一氧化氮(FeNO)浓度数值,以此反映气道炎症水平。English:Based on the electrochemical sensor detection principle. After human exhaled breath sample enters the detection chamber, nitric oxide triggers electrochemical reaction with the electrochemical sensor. The sensor converts gas concentration signal into electrical signal. The host collects and calculates electrical signal via algorithm, outputs fractional exhaled nitric oxide (FeNO) concentration value to reflect airway inflammation level。
2、产品功能 Product Functions
中文
检测人体呼出气中一氧化氮浓度 FeNO,单位 ppb;
支持在线呼气检测,选配鼻呼套件可开展鼻腔一氧化氮检测;
自动控制呼气流量,实时呼气引导提示;
检测结果显示、存储、查询、导出;
设备自检、开机自动校准;
支持 USB 数据传输,配套软件完成数据管理。
English
Detect FeNO (fractional exhaled nitric oxide) concentration in human exhaled breath, unit: ppb;
Support on‑line exhalation test; nasal nitric oxide detection available with optional nasal breath kit;
Automatic exhalation flow control with real‑time breathing guidance prompt;
Display, store, query and export test results;
Equipment self‑test and power‑on auto‑calibration;
USB data transmission, supporting data management by matched software。
3、产品特点 Product Features
中文
电化学检测模块,响应速度快;
恒定流量闭环控制,保障呼气条件符合 ATS/ERS 标准;
可视化呼气引导,提升检测成功率;
内置锂电池,支持交直流两用,适合门诊、病房使用;
模块化一氧化氮检测器,可更换;
配置一次性过滤嘴,避免交叉感染;
人机交互界面简洁,支持数据本地存储与导出。
English
Electrochemical detection module with fast response;
Closed‑loop constant flow control, complying with ATS/ERS testing standards;
Visual exhalation guidance to improve test success rate;
Built‑in lithium‑ion battery, AC/DC dual‑purpose, suitable for outpatient and ward;
Modular replaceable nitric oxide detector;
Disposable filter nozzle to prevent cross‑infection;
User‑friendly interface, supporting local data storage and export。
4、技术参数 Technical Parameters
中文
检测原理:电化学传感器
测量范围:0~3800ppb
分辨率:0.1ppb
示值误差:<60ppb 时≤±3ppb;≥60ppb 时≤±5% 读数
重复性:≤5%
标准呼气流量:50mL/s±10%
检测时间:单次检测≤60s
工作环境:温度 10℃‑40℃;相对湿度 20%‑80%,无冷凝
供电:AC 适配器 / 内置可充电锂电池
数据存储:可存储多组检测报告
配件:主机、呼气手柄、一次性过滤嘴、一氧化氮检测器、电源适配器、USB 线;鼻呼套件(选配)
English
Detection principle: Electrochemical sensor
Measuring range: 0~3800ppb
Resolution: 0.1ppb
Indication error: ≤±3ppb when <60ppb; ≤±5% of reading when ≥60ppb
Repeatability: ≤5%
Standard exhalation flow:50mL/s±10%
Test time: ≤60s per test
Operating environment: Temperature 10℃‑40℃; RH 20%‑80%, non‑condensing
Power supply: AC adapter / built‑in rechargeable lithium‑ion battery
Data storage: Multi‑group test reports storable
Accessories: Main unit, breath handle, disposable filter nozzles, NO detector, power adapter, USB cable; nasal breath kit (optional)

5、使用方法 Operation Method
中文
设备开机,完成自检与预热校准;
安装一次性过滤嘴;
受试者按规范要求准备,手持呼气手柄,按屏幕提示完成吸气、匀速呼气;设备自动控制呼气流量;
检测完成,屏幕显示 FeNO 检测结果,保存报告;
取下废弃过滤嘴;可导出打印报告;
检测结束关闭设备,做好清洁维护;
鼻呼检测:加装选配鼻呼套件,按套件操作流程执行检测。
English
Power on the device, finish self‑test, warm‑up and calibration;
Install brand‑new disposable filter nozzle;
Subject makes preparation as specification, hold breath handle, inhale and exhale steadily following on‑screen prompt; device automatically controls exhalation flow;
After test finished, FeNO result is displayed on screen, save report;
Remove and discard used filter nozzle; export or print report as needed;
Power off device after test, complete cleaning and maintenance;
For nasal NO test: install optional nasal breath kit and operate according to kit procedure。

6、适应症 Indications
中文:用于临床检测人体呼出气一氧化氮浓度,辅助评估气道嗜酸性炎症水平;辅助哮喘、慢性咳嗽、嗜酸粒细胞性支气管炎、过敏性鼻炎等呼吸系统疾病评估,辅助监测抗炎治疗效果;本仪器不能单独作为确诊依据,需结合临床其他检查综合判断北京市中医...。
English: Clinically used to detect fractional exhaled nitric oxide concentration of human body, for auxiliary evaluation of eosinophilic airway inflammation; assist assessment for asthma, chronic cough, eosinophilic bronchitis, allergic rhinitis and other respiratory diseases, and monitor anti‑inflammatory therapeutic effect. This device cannot be used for independent diagnosis; comprehensive judgement shall combine with other clinical examinations北京市中医...。
7、禁忌症 Contraindications
中文
活动性咯血患者;
未经胸腔引流的气胸;
严重呼吸困难、无法配合完成规范呼气动作的受试者;
口鼻严重损伤、无法正常呼气受试者;
临床不适合进行呼气测试的其他情况。
English
Patients with active hemoptysis;
Pneumothorax without thoracic drainage;
Subjects with severe dyspnea who cannot complete standardized exhalation maneuver;
Subjects with severe oral‑nasal injury unable to exhale normally;
Other conditions where exhalation test is clinically inadvisable。

8、注意事项 Precautions
中文
受检者检测前 1 小时禁止吸烟、进食、喝咖啡、茶、碳酸饮料;检测前 3 小时避免食用富含硝酸盐食物(西兰花、莴苣、腌制熏制食品);
检测前避免剧烈运动,避免雾化、吸入药物;
每位受试者必须使用一次性过滤嘴,严禁重复使用,防止交叉感染;
设备需定期校准,按照说明书维护更换一氧化氮检测器模块;
避免在 NO 污染环境下开展检测;
仅供医疗机构专业人员操作;
传感器避免水汽、液体进入气室;
本设备结果仅为辅助参考,不可单独作为诊断依据;
锂电池避免过充过放,长期存放需定期补电;
勿自行拆解设备,维修由厂家授权人员执行北京市中医...。
English
Subjects shall not smoke, consume coffee, tea or carbon‑drinks 1 hour before test; avoid nitrate‑rich food (broccoli, lettuce, pickled or smoked food) 3 hours before test.
Avoid strenuous exercise, nebulization and inhaled medication before test.
Brand‑new disposable filter nozzle must be used for each subject; re‑use is strictly forbidden to prevent cross‑infection.
Calibrate device periodically; replace nitric oxide detector module following user manual.
Do not perform test under environment polluted by nitric oxide gas.
Only operated by qualified medical personnel in medical institution.
Prevent moisture or liquid from entering sensor chamber.
Test result is for auxiliary reference only, shall not be used as sole diagnostic basis.
Prevent lithium‑ion battery from over‑charge or over‑discharge; recharge periodically for long‑term storage.
Do not disassemble device by yourself; repair shall be completed by manufacturer‑authorized personnel北京市中医...。
9、存储条件 Storage Conditions
中文:环境温度‑20℃~+55℃;相对湿度 10%‑90%,无冷凝;避免阳光直射,远离腐蚀性气体、粉尘;锂电池长期存储,建议每 3 个月补充一次电量。English: Ambient temperature‑20℃~+55℃; relative humidity 10%‑90%, non‑condensing; avoid direct sunlight, corrosive gas and dust. For long‑term lithium‑ion battery storage, recharge every 3 months recommended.

10、说明书核心摘要 Core Summary of Instructions
中文:iFeNO‑NC‑N 系列一氧化氮检测器(呼气分析仪)属于第二类医用设备,采用电化学传感器检测呼出气一氧化氮 FeNO 浓度,用于医疗机构辅助评估气道嗜酸性炎症。设备具备自动校准、流量闭环控制、呼气引导、数据存储导出功能。操作时严格执行受试者检测前准备,一人一用一次性过滤嘴。结果仅作为临床辅助参考,不可单独用于疾病确诊。定期维护、更换检测器模块,按规定温湿度存放。医疗机构由专业医护人员使用。English: iFeNO‑NC‑N series nitric oxide detector (exhaled breath analyzer) is Class Ⅱ medical device. It adopts electrochemical sensor to measure FeNO concentration for auxiliary evaluation of eosinophilic airway inflammation in medical institutions. It supports auto‑calibration, closed‑loop flow control, breath guidance, data storage & export. Strictly follow subject pre‑test preparation; one disposable filter nozzle per subject. Test result is clinical auxiliary reference only and cannot be used for independent disease diagnosis. Perform regular maintenance and detector module replacement, store under specified temperature & humidity. For professional medical personnel use in medical institutions only。
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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