厂商供应万联达13C呼气分析仪WLD600C
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厂商供应万联达13C呼气分析仪WLD600C
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
WLD600C
结构及组成/主要组成成分
13C呼气分析仪主要由主机、计算机、电源软电线、打印机组成，其中主机包括光学信号采集部分、样品采集部分、控制/分析部分。
适用范围/预期用途
本产品和胃幽门螺杆菌检测试剂盒配合使用，用于临床机构通过13C呼气试验体外检测胃幽门螺杆菌。
1、工作原理 Working Principle
中文：基于红外吸收光谱法，检测受试者服用 ¹³C 标记尿素试剂前后呼出气体中 ¹³CO₂与 ¹²CO₂丰度比值的差值（DOB/Delta 值）。若胃内存在幽门螺杆菌，尿素酶会将 ¹³C‑尿素分解生成 ¹³CO₂进入呼出气体，仪器通过红外探测器测定同位素比值变化，判定幽门螺杆菌感染情况。English：Based on infrared absorption spectroscopy, the instrument measures the difference (DOB/Delta value) of ¹³CO₂/¹²CO₂ abundance ratio in exhaled air before and after subject taking ¹³C‑urea reagent. If Helicobacter pylori exists in stomach, urease decomposes ¹³C‑urea into ¹³CO₂ which is exhaled. The infrared detector detects isotopic ratio variation to judge H.pylori infection status。
2、功能 Functions
中文：①采集、检测呼气样本，计算 DOB 检测值；②患者信息录入、存储、查询；③仪器自检、曲线校正；④检测报告生成、打印，支持报告模板定制；⑤历史数据统计、备份与恢复；⑥支持对接 HIS 系统；⑦固件在线升级；⑧显示实时测量状态。English：①Collect and analyze breath samples, calculate DOB value; ②Patient inｆormation input, storage and query; ③Instrument self‑test and curve calibration; ④Generate and print test reports with customizable templates; ⑤Historical data statistics, backup & recovery; ⑥HIS system interface support; ⑦Online firmware upgrade; ⑧Real‑time measurement status display。
3、产品特点 Product Features
中文：10 通道并行检测；开机预热≤20min，单组样品检测＜3min；无需标准气体校正，维护简单；一键式操作，图形化软件界面；PbSe 高灵敏红外探测元件；测量精密度高、重复性好；整机体积小、重量轻，方便移动摆放；无放射性，适用人群广；数据存储量大，支持导出备份继圣(上海...。English：10‑channel parallel testing; warm‑up ≤20 min, single‑pair sample analysis＜3 min; no standard gas calibration required, easy maintenance; one‑key operation with graphic software interface; high‑sensitivity PbSe infrared detector; high precision and good repeatability; compact size and light weight for easy movement; non‑radioactive, wide applicable population; large‑capacity data storage with export & backupiamconsult...。
4、技术参数 Technical Parameters
中文1. 通道数：10 通道 2. 预热时间：≤20 min 3. 分析速度：＜3 min / 每对样品 4.CO₂检测浓度范围：1%‑6% 5. 精密度 δsd：≤0.3‰；C.V.≤±2% 6. 孔间差△δ：≤0.4‰ 7. 光源工作温度：950℃ 8. 探测器：PbSe 红外光敏元件 9. 电源：AC220V，50Hz；功耗 100VA 10. 外形尺寸：320×565×225 mm 11. 整机重量：15±1 kg 12. 配置：主机、计算机、电源线、打印机；主机含光学采集、样品采集、控制分析单元
English1.Number of channels:10 channels 2.Warm‑up time: ≤20 min 3.Analysis speed:＜3 min per sample pair 4.CO₂ concentration range:1%‑6% 5.Precision δsd ≤0.3‰; C.V.≤±2% 6.Channel‑to‑channel deviation △δ ≤0.4‰ 7.Infrared source temperature:950℃ 8.Detector:PbSe infrared photosensitive element 9.Power supply:AC220V,50Hz; Power consumption:100VA 10.Dimension:320×565×225 mm 11.Weight:15±1 kg 12.Composition:main unit, computer, power cord, printer; main unit includes optical acquisition, sample sampling, control‑analysis module
5、使用方法 Operation Method
中文1. 开机，仪器预热 20 分钟，完成自检； 2. 受检者空腹，采集服药前基础呼气样本； 3. 受试者服用 ¹³C‑尿素试剂，静坐 20 分钟； 4. 采集服药后呼气样本； 5. 将两组采气袋连接仪器通道； 6. 软件启动检测，仪器自动分析，输出 DOB 结果； 7. 生成并打印检测报告，保存数据； 8. 完成检测，清理气路，关闭设备。
English1.Power on, warm‑up for 20 min until self‑test completes; 2.Subject fasts, collect baseline breath sample before reagent intake; 3.Subject takes ¹³C‑urea reagent and sits quietly for 20 min; 4.Collect post‑dose breath sample; 5.Connect two sample bags to instrument channels; 6.Start test via software, instrument automatically analyzes and outputs DOB value; 7.Generate, print report and save data; 8.Complete test, clean gas path and power off the equipmentiamconsult...。
6、适应症 Indications
中文：与胃幽门螺杆菌 ¹³C 尿素呼气检测试剂盒配套使用，医疗机构通过 ¹³C 呼气试验，体外检测人体胃内幽门螺杆菌感染情况，适用于幽门螺杆菌感染筛查、诊断及治疗后复查寰熙医疗。English：Used together with ¹³C‑urea breath test kit for Helicobacter pylori. For in‑vitro detection of gastric Helicobacter pylori infection in medical institutions via ¹³C breath test. Apply to H.pylori screening, diagnosis and post‑eradication follow‑up test寰熙医疗。
7、禁忌症 Contraindications
中文：本仪器本身无绝对禁忌症；受检者无法配合呼气采气、严重呼吸衰竭、严重呕吐无法服用试剂者，不适合该项检测；试剂相关禁忌症参照配套试剂盒说明书。English：The instrument itself has no absolute contraindications. Subjects incapable of cooperating with breath collection, severe respiratory failure, severe vomiting and unable to take reagent are not suitable for this test. For reagent contraindications, refer to matched test kit manual.
8、注意事项 Precautions
中文1. 仪器必须由经培训医务人员操作； 2. 检测环境避免强电磁干扰、阳光直射、粉尘潮湿； 3. 严格遵守采样时序，服药后静坐满 20min 再采样； 4. 检测前受试者需空腹，检测前停用抗生素、铋剂、抑酸药物（遵临床要求）； 5. 定期维护气路系统，检查气泵、电磁阀； 6. 不可使用超出 1%‑6% CO₂浓度范围的样本； 7. 仅使用原厂配套采气袋与试剂盒； 8. 出现故障立即停机，请勿自行拆机维修； 9. 定期备份检测数据，防止数据丢失； 10. 设备接地良好，保证用电安全。
English1.Operation must be perｆormed by trained medical staff; 2.Avoid strong electromagnetic interference, direct sunlight, dust and humid environment; 3.Follow sampling timeline strictly; collect breath sample exactly 20 min after reagent intake; 4.Subject shall fast before test; discontinue antibiotics, bismuth agents and acid‑suppressing drugs as clinical requirement; 5.Maintain gas path regularly, inspect air pump and solenoid valve; 6.Do not test samples with CO₂ out of 1%‑6% range; 7.Only use original matched sample bags and test kits; 8.Shut‑down immediately in case of malfunction; do not disassemble for self‑repair; 9.Backup test data regularly to avoid data loss; 10.Ensure reliable equipment grounding for electrical safety。
9、存储条件 Storage Conditions
中文：环境温度：5℃～40℃；相对湿度：30%‑80%，无冷凝；大气压力 70kPa‑106kPa；存放于干燥通风室内，远离腐蚀性气体、热源，避免剧烈震动与撞击；长期闲置应断电，做好防尘防护。English：Ambient temperature:5℃～40℃; Relative humidity:30%‑80%, non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in dry and ventilated room, away from corrosive gas and heat source; avoid severe vibration and impact. Power off and implement dust‑proof protection for long‑term storage.
10、说明书核心摘要 Core Manual Summary
中文：WLD600C 为二类红外光谱法 ¹³C 呼气分析仪，10 通道，配套 ¹³C 尿素试剂盒，用于体外检测胃幽门螺杆菌感染。仪器预热≤20min，单组样品检测小于 3 分钟，无需标准气体校准；具备样本检测、病人档案管理、报告打印、数据备份统计、HIS 对接功能。操作需规范执行呼气采样流程；操作人员需培训；远离潮湿粉尘电磁干扰；定期维护气路；按环境条件存储；故障禁止自行拆解维修。检测判读以 DOB 值为依据，配套试剂盒说明书协同使用。English：WLD600C is Class‑II infrared‑spectroscopy ¹³C breath analyzer with 10 channels. It works with matched ¹³C‑urea kit for in‑vitro detection of gastric Helicobacter pylori infection. Warm‑up ≤20 min, analysis＜3 min per sample pair, no standard‑gas calibration required. Functions include sample measurement, patient file management, report printing, data backup & statistics and HIS interface. Breath‑sampling procedure shall be strictly followed. Operators must receive professional training. Keep away from moisture, dust and electromagnetic interference. Maintain gas‑path regularly and store under specified environmental conditions. Do not disassemble unit when malfunction occurs. Test interpretation is based on DOB value, refer to matched kit manual simultaneously.
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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