厂家直供尚沃呼气分析仪Sunvou-CA4458
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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)：苏械注准20182071292更新时间：2026/10/16 11:11:02
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厂家直供尚沃呼气分析仪Sunvou-CA4458
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-CA4458
结构及组成/主要组成成分
由主机（含二氧化碳检测器）、呼气甲烷检测器、氢气检测器、一氧化氮检测器（选配件）、电源适配器、Sunvou呼气检测软件（英文名Sunvou Detector,V4）、采样器、采样气袋、过滤器组成。
适用范围/预期用途
用于检测呼出气中H2（氢气）、CH4（甲烷）、CO2（二氧化碳）和NO（一氧化氮）浓度（选配一氧化氮检测器时）。
1、工作原理 Working Principle
中文：采用纳库仑电化学传感技术，采集受试者呼出气样本，传感器对呼出气内氢气 (H₂)、甲烷 (CH₄)、二氧化碳 (CO₂)、一氧化氮 (NO，选配) 气体分子发生电化学反应，将气体浓度信号转化为电信号；主机采集信号经软件算法运算处理，输出各气体标志物浓度检测结果，实现呼气气体浓度检测无锡市尚沃...。English：Adopt Nacoulon electrochemical sensing technology to collect exhaled breath samples from subjects. The sensor generates electrochemical reaction with gas molecules including hydrogen (H₂), methane (CH₄), carbon dioxide (CO₂) and nitric oxide (NO, optional). Gas‑concentration signals are converted into electrical signals. The host collects signals and processes them via software algorithm to output concentration results of each breath biomarker for non‑invasive breath gas detectionenweb.sunv...。
2、功能 Functions
中文
检测呼出气中氢气、甲烷、二氧化碳浓度，选配一氧化氮检测器可检测一氧化氮浓度；
支持在线直采、离线气袋采样两种检测模式；
自动校准、样本分析、结果计算、报告生成、数据存储、查询打印；
配套 Sunvou Detector V4 软件完成数据处理、质控管理、病例管理。English
Detect concentration of hydrogen, methane, carbon dioxide in exhaled breath; nitric oxide can be detected with optional NO detector；
Support two sampling modes: on‑line direct sampling and off‑line sampling via breath bag；
Realize auto‑calibration, sample analysis, result calculation, report generation, data storage, query and print；
Cooperate with Sunvou Detector V4 software for data processing, quality control and case management。
3、产品特点 Product Features
中文
多标志物联检，一台设备同时检测 H₂、CH₄、CO₂，选配 NO；
在线、离线双采样模式，适配门诊、床旁、异地采样场景；
自动校准，内置质控逻辑，保障检测重复性；
呼气检测，采样便捷，受试者伤；
软件集成病例管理，检测报告可导出、打印；
模块化检测器，可按需选配一氧化氮检测模块。English
Multi‑biomarker combined detection, simultaneously test H₂, CH₄, CO₂, NO is optional；
Dual sampling modes (on‑line / off‑line), suitable for outpatient, bedside and off‑site sampling；
Automatic calibration with built‑in quality control logic to ensure test repeatability；
Non‑invasive breath test, easy sampling without trauma for subjects；
Integrated case‑management software, test report can be exported and printed；
Modular detector, NO module can be optionally configured as required。
4、技术参数 Technical Parameters
中文
产品型号：Sunvou‑CA4458
检测气体：氢气 (H₂)、甲烷 (CH₄)、二氧化碳 (CO₂)；一氧化氮 NO（选配）
H₂测量范围：0‑200ppm
CH₄测量范围：0‑75ppm
采样方式：在线直采、离线气袋采样
软件版本：Sunvou Detector V4
结构组成：主机（含 CO₂检测器）、甲烷检测器、氢气检测器、一氧化氮检测器 (选配件)、电源适配器、检测软件、采样器、采样气袋、过滤器
设备分类：Ⅱ 类医疗器械English
Model: Sunvou‑CA4458
Test gas: Hydrogen(H₂), Methane(CH₄), Carbon dioxide(CO₂); Nitric oxide NO (optional)
H₂ measuring range: 0‑200ppm
CH₄ measuring range: 0‑75ppm
Sampling mode: on‑line direct sampling, off‑line breath‑bag sampling
Software version: Sunvou Detector V4
Components: main unit(with CO₂ detector), methane detector, hydrogen detector, NO detector(optional), power adapter, detection software, sampler, breath sampling bag, filter
Device classification: Class Ⅱ medical device
5、使用方法 Operation Method
中文
开机：连接电源适配器，接通电源，设备开机完成自检与自动校准；
受试者准备：按照检测项目要求完成空腹 / 检测前准备；
采样选择：选择在线模式：受试者佩戴采样器直接向设备呼气；选择离线模式：受试者向采样气袋采集呼气样本；
样本检测：将样本接入设备，启动检测程序，设备自动完成气体分析；
结果输出：软件显示各项气体浓度，生成检测报告，保存、打印报告；
检测结束：对采样配件进行清洁消毒，关闭设备电源。English
Power‑on: Connect power adapter, turn on device, finish self‑test and auto‑calibration；
Subject preparation: Complete fasting or pre‑test preparation according to test requirements；
Sampling selection: On‑line mode: subject exhales directly to device via sampler; Off‑line mode: subject collects breath sample into sampling bag；
Sample test: Connect sample to device, start test program, device perｆorms automatic gas analysis；
Result output: Software displays gas concentration values, generates, saves and prints test report；
Post‑test: Clean and disinfect sampling accessories, power off the device。
6、适应症 Indications
中文：用于检测人体呼出气中氢气、甲烷、二氧化碳浓度；选配一氧化氮检测器时可检测呼出气一氧化氮浓度，为临床评估消化道菌群、气道炎症提供气体标志物检测参考，适用于呼吸科、消化科、儿科、变态反应科、体检中心等科室使用无锡市尚沃...。English：It is used to detect the concentration of hydrogen, methane and carbon dioxide in human exhaled breath. When equipped with optional NO detector, it can detect exhaled nitric oxide. It provides biomarker reference for clinical evaluation of gastrointestinal flora and airway inflammation, applicable for respiratory, gastroenterology, pediatrics, allergy department, physical examination center and other departmentsenweb.sunv...。
7、禁忌症 Contraindications
中文
无法配合完成呼气采样的受试者禁用；
存在严重呼吸困难、咯血、活动性气道出血患者不适用本检测；
采样部位存在严重损伤、无法佩戴采样配件者禁止使用。
提示：本设备仅提供检测数据，不作为单一确诊依据。English
Contraindicated for subjects unable to cooperate with breath sampling；
Not applicable for patients with severe dyspnea, hemoptysis or active airway bleeding；
Contraindicated for patients with severe injury at sampling site who cannot wear sampling accessories。 Note: The device only provides test data and shall not be used as sole diagnostic evidence。
8、注意事项 Precautions
中文
本设备医疗机构内由经过培训的医务人员操作使用；
严格按照说明书开展开机自检、定期校准，保证检测准确性；
采样气袋、过滤器为耗材，按要求及时更换，避免交叉感染；
受试者检测前按要求禁食、禁烟酒、避免刺激性气体接触，防止干扰检测结果；
设备避免撞击、跌落，远离强电磁干扰源；
检测结果仅作临床参考，需结合患者症状、其他检查综合判断，不可单独作为确诊依据；
配件消毒按照说明书要求执行，不可高温烘烤主机；
若设备报警、自检失败，停止使用，联系厂家维修，禁止自行拆解维修。English
The device shall only be operated by trained medical staff in medical institutions；
Perｆorm power‑on self‑test and regular calibration strictly per manual to guarantee test accuracy；
Sampling bags and filters are consumables, replace timely to avoid cross‑infection；
Subjects shall fast, avoid tobacco, alcohol and irritant gas exposure before test to prevent result interference；
Prevent device from impact, drop and strong electromagnetic interference；
Test results are for clinical reference only, diagnosis shall combine patient symptoms and other examinations, cannot be used as sole diagnostic basis；
Disinfect accessories according to manual; do not bake main unit at high temperature；
Stop operation when alarm or self‑test failure occurs, contact manufacturer for maintenance; do not disassemble by yourself。
9、存储条件 Storage Conditions
中文：环境温度：5℃‑40℃；相对湿度：20%‑80%，无冷凝；大气压力：70kPa‑106kPa；存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体，远离热源。耗材单独按耗材说明书储存。English：Ambient temperature: 5℃‑40℃; Relative humidity:20%‑80%, non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in dry and ventilated indoor environment, avoid direct sunlight, dust, corrosive gas and heat source. Consumables shall be stored separately per consumable manual。
10、说明书核心摘要 Core Summary of Instruction Manual
中文：尚沃 Sunvou‑CA4458 呼气分析仪为 Ⅱ 类医疗器械，注册证苏械注准 20182071292；采用纳库仑电化学传感技术，采集人体呼出气，检测 H₂、CH₄、CO₂，选配模块可检测 NO；支持在线、离线两种采样模式，软件完成数据处理报告输出；用于医疗机构检测呼出气气体标志物，辅助临床评估菌群、气道炎症；设备必须由培训后医护人员操作，严格执行校准、耗材更换与消毒；检测结果仅供临床参考，不可单独作为诊断依据；设备储存避免高温高湿、撞击与强电磁干扰，故障禁止自行拆解维修。English：Sunvou‑CA4458 Breath Analyzer is Class Ⅱ medical device, registration No. Su Xie Zhu Zhun 20182071292. Adopt Nacoulon electrochemical sensing technology for non‑invasive human breath sampling. It detects H₂, CH₄, CO₂, and NO with optional module. Support on‑line and off‑line sampling modes, software processes data and generates reports. It is applied in medical institutions to detect breath biomarkers and assist clinical evaluation of flora and airway inflammation. The device must be operated by trained medical personnel; calibration, consumable replacement and disinfection shall be strictly followed. Test results are for clinical reference only and cannot serve as sole diagnostic evidence. Avoid high temperature, high humidity, impact and strong electromagnetic interference during storage. Do not disassemble for troubleshooting by yourselfenweb.sunv...。
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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