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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂商直供​尚沃氢气检测器SV-eH2-03,ADH2-3478

价格:¥ 电议

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20182071294更新时间:2026/10/16 11:04:35

产品摘要:厂商直供​尚沃氢气检测器SV-eH2-03,ADH2-3478

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详细内容

厂商直供尚沃氢气检测器SV-eH2-03,ADH2-3478

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

SV-eH2-03、ADH2-3478、ADH2-4458、ADH2⁻⁷349

结构及组成/主要组成成分

由外壳、硬件接口卡、氢气传感器组成。 注:氢气检测器是呼气分析仪的耗材,必须与呼气分析仪配合使用。

适用范围/预期用途

配合呼气分析仪产品使用,用于检测呼出气H2(氢气)浓度。

1. 工作原理 Working Principle

中文:产品核心为电化学氢气传感器,呼出气样进入传感器后,氢气发生电化学反应产生对应电信号;硬件接口卡采集信号并传输至配套呼气分析仪主机,经算法换算输出呼出气氢气浓度数值。English:The core component is an electrochemical hydrogen sensor. When exhaled breath sample enters the sensor, hydrogen undergoes electrochemical reaction to generate corresponding electrical signals. The hardware interface card collects signals and transmits them to the matched breath analyzer host, and the hydrogen concentration of exhaled breath is calculated and output by algorithm.

2. 功能 Function

中文:配合尚沃呼气分析仪主机,采集呼出气样本,检测呼出气中氢气(H₂)浓度,将气体信号转换为电信号上传主机完成数据解析输出。English:Matched with Sunvou breath analyzer host, collect exhaled breath samples, detect hydrogen (H₂) concentration in exhaled breath, convert gas signal into electrical signal and upload to host for data analysis and output.

3. 产品特点 Product Features

中文

  1. 电化学检测,响应速度快,检测灵敏度高;

  2. 模块化插拔式耗材,拆装便捷,适配对应型号呼气分析仪;

  3. 抗部分气体干扰,测量重复性较好;

  4. 集成外壳 + 接口卡 + 传感器一体化结构,便于整机校准维护。

English

  1. Electrochemical detection, fast response and high‑detection sensitivity;

  2. Modular plug‑in consumable, easy installation and disassembly, compatible with corresponding breath analyzers;

  3. Resist partial gas interference with good measurement repeatability;

  4. Integrated structure of housing, interface card and sensor, convenient for calibration and maintenance.

4. 技术参数 Technical Parameters

中文1. 测量范围:0 ppm‑200 ppm; 2. 最低检出浓度:2 ppm; 3. 测量准确度:≤20ppm 时 ±2.0ppm;>20ppm 时 ±10% 读数; 4. 重复性:变异系数 CV≤10%; 5. 工作模式:连续检测; 6. 结构组成:外壳、硬件接口卡、氢气传感器; 7. 产品属性:二类医疗器械,配套耗材,不可单独使用。

English1.Measurement range: 0 ppm‑200 ppm; 2.Limit of detection: 2 ppm; 3.Measurement accuracy: ±2.0ppm for ≤20ppm; ±10% reading for >20ppm; 4.Repeatability: coefficient of variation CV ≤10%; 5.Operation mode: continuous detection; 6.Structure composition: housing, hardware interface card, hydrogen sensor; 7.Product attribute: Class Ⅱ medical device, matching consumable, cannot be used independently.


5. 使用方法 Operation Method

中文1. 确认呼气分析仪处于关机状态; 2. 将氢气检测器对准主机插槽,平稳插入到位,确认接口卡接触良好; 3. 开机,按照分析仪主机提示完成自检、零点校准; 4. 安装采样配件,按照主机操作流程采集受试者呼出气样本,执行氢气检测; 5. 检测结束,如需更换耗材,关闭主机电源,拔出检测器; 6. 按照说明书定期完成整机标定。

English1.Make sure the breath analyzer is powered off; 2.Align hydrogen detector with host slot, insert steadily in place, ensure good contact of interface card; 3.Power on, complete self‑test and zero‑calibration following host prompts; 4.Install sampling accessories, collect subject’s exhaled breath sample and perform hydrogen detection according to host workflow; 5.After test completion, power off host and pull out detector if consumable replacement is needed; 6.Perform regular calibration as specified in user manual.


6. 适应症 Indications

中文:配合呼气分析仪,用于检测人体呼出气中氢气浓度;检测结果辅助临床评估小肠细菌过度生长、碳水化合物吸收不良等消化系统相关检查,仅作辅助诊断参考,不单独作为确诊依据。English:Used with breath analyzer to detect hydrogen concentration in human exhaled breath. Test results assist clinical evaluation of small intestinal bacterial overgrowth, carbohydrate malabsorption and other digestive‑system related examinations. It is only for auxiliary reference and shall not be used alone for definitive diagnosis.

7. 禁忌症 Contraindications

中文:无绝对禁忌症;本耗材本身无直接人体接触,不用于人体侵入性操作;不可用于非人体呼出气检测。English:No absolute contraindications. This consumable has no direct human‑body contact and shall not be used for invasive human procedures. Not applicable for non‑human‑breath sample testing


8. 注意事项 Notes

中文1. 本检测器为专用配套耗材,必须匹配尚沃对应型号呼气分析仪,禁止跨品牌、跨型号混用; 2. 传感器对环境温湿度、污染气体敏感,避免油污、水汽、腐蚀性气体进入检测器; 3. 达到使用寿命后必须及时更换,超期使用会造成检测结果偏差; 4. 拆装避免暴力插拔,防止接口卡损坏; 5. 检测结果仅为辅助参考,临床诊断结合患者症状、其他检查综合判断; 6. 不可拆解检测器外壳,拆解将造成失效、丧失保修; 7. 避免跌落、撞击、强光暴晒。

English1.This detector is dedicated matching consumable. It must be used with corresponding Sunvou breath analyzer. Cross‑brand or cross‑model mixed use is prohibited. 2.The sensor is sensitive to ambient temperature‑humidity and polluted gas. Prevent oil stain, water vapor and corrosive gas from entering detector. 3.Must replace timely upon end‑of‑service‑life. Overdue use will cause test deviation. 4.Avoid violent plug‑and‑pull during assembly and disassembly to prevent interface card damage. 5.Test result is only auxiliary reference. Clinical diagnosis shall combine patient symptoms and other examinations comprehensively. 6.Do not disassemble housing; disassembly will cause failure and void warranty. 7.Avoid dropping, impact and strong sunlight exposure.

9. 存储条件 Storage Conditions

中文:环境温度:5℃‑40℃;相对湿度:10%‑80% RH,无冷凝;干燥通风,远离腐蚀性气体、热源,避光存放;按照包装标识有效期管理。English:Ambient temperature:5℃‑40℃; Relative humidity:10%‑80%RH, non‑condensing. Store in dry and ventilated place, keep away from corrosive gas and heat source, avoid light. Follow expiration date marked on package.


10. 说明书核心摘要 Manual Core Summary

中文:SV‑eH2‑03、ADH2‑3478 氢气检测器属于第二类医疗器械,为呼气分析仪配套电化学气体检测耗材,由外壳、硬件接口卡、氢气传感器组成。仅可与适配的尚沃呼气分析仪配套使用,实现呼出气氢气浓度检测;检测结果用于消化系统疾病辅助筛查。使用时严格匹配主机型号,定期校准,到期更换;禁止私自拆解,避免环境因素干扰传感器性能。存储需控温防潮避光。检测结果不能单独作为确诊疾病依据。English:SV‑eH2‑03 and ADH2‑3478 hydrogen detectors are Class Ⅱ medical devices, which are electrochemical gas‑testing consumables matched for breath analyzers. Composed of housing, hardware interface card and hydrogen sensor. It shall only be used with compatible Sunvou breath analyzer to realize hydrogen concentration detection of exhaled breath. Test results are for auxiliary screening of digestive‑system diseases. Strictly match host model during operation, perform regular calibration and replace upon end‑of‑life. Unauthorized disassembly is forbidden. Prevent environmental factors from interfering sensor performance. Store under temperature‑controlled, moisture‑proof and light‑avoiding condition. Test results cannot be independently used for disease definitive diagnosis.

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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