厂家直供惠雨恩红细胞寿命测定呼气分析仪WY-2201
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厂家直供惠雨恩红细胞寿命测定呼气分析仪WY-2201
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
WY-2201
结构及组成/主要组成成分
产品由红细胞寿命测定呼气分析仪、气体检测软件、USB连接线、采气装置、采样气袋、环境气袋组成。其中红细胞寿命测定呼气分析仪包括主机、一氧化碳气体传感器、过滤盒、开关电源适配器（带电源线）。
适用范围/预期用途
适用于红细胞寿命测定。
1、工作原理 Working Principle
中文：基于内源性一氧化碳代谢原理，采用电化学传感器检测技术检测受试者呼气末一氧化碳（ETCOc）浓度；红细胞破坏降解血红蛋白会生成内源性 CO，仪器结合受检者血红蛋白检测值，通过内置算法计算得出红细胞平均寿命，实现定量评估红细胞破坏程度。English：Based on endogenous carbon monoxide ｍmbedbolism principle, electrochemical sensor technology is adopted to detect end‑tidal carbon monoxide (ETCOc) concentration in subjects’ exhaled gas. Endogenous CO is generated from hemoglobin degradation during red blood cell destruction. Combined with subject’s hemoglobin value, the instrument calculates average red‑blood‑cell life span via built‑in algorithm to realize non‑invasive quantitative evaluation of red blood cell destruction degree。
2、功能 Functions
中文：①检测呼气末一氧化碳浓度；②结合血红蛋白数据计算输出红细胞寿命；③存储、查询检测数据；④显示、打印检测报告；⑤支持离线采样，适配成人、儿童、新生儿样本检测wellyearn....。English：①Detect end‑tidal carbon monoxide concentration; ②Calculate and output red‑blood‑cell life span combined with hemoglobin data; ③Store and query test data; ④Display and print test reports; ⑤Support off‑line sampling for adults, children and newborn sampleswellyearn....。
3、产品特点 Product Features
中文：1）呼气检测，无需抽血；2）离线采样，新生儿、ICU 卧床患者均可采样；3）检测速度快，进气后 2‑3 分钟输出结果；4）亚 ppm 级检测灵敏度，全年龄段适用；5）整机便携，床旁可开展检测；6）触控显示屏，操作简便；7）配套专用采样气袋、过滤盒，保障样本可靠性。English：1）Non‑invasive breath test, no blood drawing required; 2）Off‑line sampling, available for newborns and ICU bedridden patients; 3）Fast test, results available within 2‑3 minutes after sample intake; 4）Sub‑ppm detection sensitivity, suitable for all age groups; 5）Portable unit for bedside testing; 6）Touch‑screen display for simple operation; 7）Equipped with dedicated sampling bags and filter cartridges to guarantee sample reliability。
4、技术参数 Technical Parameters
中文1. 型号：WY‑2201 2. 检测对象：呼气中一氧化碳 3. 检测方式：离线气袋进样 4.CO 测量范围：0ppm‑10ppm 5. 检测精度：亚 ppm 级 6. 样本类型：成人、儿童、新生儿呼气样本 7. 显示屏：触控液晶显示屏 8. 供电：AC 100‑240V，50/60Hz 电源适配器 9. 整机组成：主机、CO 传感器、过滤盒、气体检测软件、USB 线、采气装置、采样气袋、环境气袋 10. 输出指标：ETCOc 数值、红细胞寿命（天）English1.Model: WY‑2201 2.Test target: Carbon monoxide in exhaled breath 3.Test mode: Off‑line bag sampling 4.CO measuring range: 0ppm‑10ppm 5.Detection precision: Sub‑ppm level 6.Sample type: Breath samples from adults, children and newborns 7.Display: Touch LCD screen 8.Power supply: AC 100‑240V, 50/60Hz power adapter 9.Composition: Main unit, CO sensor, filter cartridge, gas detection software, USB cable, gas sampling device, sampling bag, ambient‑air bag 10.Output indicators: ETCOc value, red‑blood‑cell life span (days)
5、使用方法 Operation Method
中文： 1. 样本采集：成人使用采样气袋 + 过滤盒采集肺泡呼气；新生儿搭配鼻氧管、过滤盒完成离线采样；同步采集环境空白气样本wellyearn....。 2. 仪器准备：开机预热，完成仪器自检。 3. 样本检测：将采样气袋、环境气袋依次接入仪器气路接口，启动检测程序。 4. 录入受检者血红蛋白、基础信息，仪器自动完成检测运算。 5. 读取 ETCOc、红细胞寿命结果，保存或打印报告。 6. 检测结束，清洁气路，收纳耗材。English： 1.Sample collection: Collect alveolar breath from adults using sampling bag and filter cartridge; perｆorm off‑line sampling for newborns with nasal oxygen tube and filter cartridge; collect ambient blank gas sample at the same timewellyearn..... 2.Instrument preparation: Power on, warm‑up and complete self‑check. 3.Sample testing: Connect sampling bag and ambient‑air bag sequentially to instrument gas ports, start test program. 4.Input subject’s hemoglobin and basic inｆormation; instrument automatically completes detection and calculation. 5.Read ETCOc and red‑blood‑cell life‑span results, save or print reports. 6.After test, clean gas path and store consumables.
6、适应症 Indications
中文：用于医疗机构内红细胞寿命测定；辅助评估溶血程度，辅助鉴别贫血病因、新生儿高胆红素血症、溶血性相关疾病，适用于血液科、新生儿科、产科、肾内科、肿瘤科、体检科等临床使用。English：For red‑blood‑cell life‑span measurement in medical institutions; auxiliary evaluation of hemolysis severity, auxiliary differentiation of anemia etiology, neonatal hyperbilirubinemia and hemolytic‑related diseases. Applied in hematology, neonatology, obstetrics, nephrology, oncology, physical‑examination departments, etc。
7、禁忌症 Contraindications
中文：无绝对禁忌症；无法配合呼气采样、气道严重损伤、存在大量漏气无法获取合格肺泡呼气样本的受试者，不适用本检测。本设备仅为检测设备，不能单独作为确诊依据。English：No absolute contraindications. Not applicable for subjects unable to cooperate with breath sampling, suffering severe airway injury or massive air leakage where qualified alveolar breath samples cannot be obtained. This device is only for testing and shall not be used as sole basis for diagnosis.
8、注意事项 Precautions
中文1. 本仪器为二类医用设备，医疗机构由经培训医护人员操作。 2. 必须使用原厂配套采样气袋、过滤盒，禁止混用其他耗材，避免数据偏差。 3. 采样需避开室内 CO 污染源（吸烟、燃气、尾气等），同步采集环境气做基线校正。 4. 传感器避免撞击、潮湿、污染，定期按说明书开展校准。 5. 检测结果仅供临床辅助参考，需结合患者临床症状、其他检验综合判读，不可单独用于确诊。 6. 气路管路定期清洁维护，防止水汽、分泌物污染传感器。 7. 新生儿采样严格按新生儿操作流程，保证样本合格。 8. 设备故障时禁止自行拆机维修，联系厂家售后。English1.This is Class II medical device, only operated by trained medical staff in medical institutions. 2.Only use original matching sampling bags and filter cartridges; mixing other consumables is prohibited to avoid data deviation. 3.Avoid indoor CO pollution sources (smoking, gas combustion, vehicle exhaust etc.) during sampling; collect ambient gas for baseline correction. 4.Prevent sensor from impact, moisture and contamination; perｆorm calibration periodically per manual. 5.Test results are only for clinical auxiliary reference; comprehensive interpretation combining clinical symptoms and other lab tests, cannot be used for independent diagnosis. 6.Regularly clean and maintain gas path to prevent sensor contamination by moisture and secretions. 7.Follow dedicated neonatal sampling procedure to guarantee valid samples. 8.Do not disassemble for repair upon failure; contact manufacturer after‑sales service.
9、存储条件 Storage Conditions
中文：环境温度：5℃‑40℃；相对湿度：10%‑80%，无凝露；大气压力 70kPa‑106kPa；远离腐蚀性气体、粉尘、强磁场、阳光直射；断电存放，耗材单独避光干燥保存。English：Ambient temperature: 5℃‑40℃; Relative humidity: 10%‑80%, non‑condensing; Atmospheric pressure:70kPa‑106kPa. Keep away from corrosive gas, dust, strong magnetic field and direct sunlight. Store with power off; store consumables separately under dry and light‑shielded condition.
10、说明书核心摘要 Core Manual Summary
中文：惠雨恩 WY‑2201 红细胞寿命测定呼气分析仪为二类医疗器械，注册证粤械注准 20242221344，通过检测呼气内源性一氧化碳，结合血红蛋白计算红细胞寿命，用于临床红细胞寿命测定，辅助溶血相关疾病评估。采用离线气袋采样，支持成人、新生儿检测；检测输出呼气末 CO 浓度及红细胞寿命；操作需使用原厂耗材，规避环境 CO 干扰；结果为临床辅助指标，需结合其它检查综合诊断；设备需定期维护校准，按要求环境存储运输。English：WellYearn WY‑2201 Red‑Blood‑Cell Life‑Span Breath Analyzer is Class II medical device, registration No. Yue Xie Zhun 20242221344. It calculates red‑blood‑cell life‑span by detecting endogenous breath CO combined with hemoglobin value, for clinical red‑blood‑cell life‑span measurement and auxiliary evaluation of hemolytic‑related diseases. Adopt off‑line bag sampling, support adult and neonatal testing. Output end‑tidal CO concentration and red‑blood‑cell life‑span. Original consumables must be used and environmental CO interference shall be avoided. Test results serve as clinical auxiliary indicators and shall be interpreted with other examinations. The device requires regular maintenance, calibration and shall be stored and transported under specified conditions。
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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