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厂家西门子糖化血红蛋白/尿微量白蛋白分析仪DCA Vantage
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厂家西门子糖化血红蛋白/尿微量白蛋白分析仪DCA Vantage
桂经理19117326863微xin同号
产品名称
糖化血红蛋白/尿微量白蛋白分析仪DCA Vantage Analyzer
管理类别
第二类
型号规格DCA Vantage
结构及组成/主要组成成分
该产品主要由试剂卡隔室（试剂卡放置及光学检测部件）、机载条码阅读器、 显示屏、打印机、电源控制部件及内部存储器、软件（发布版本号：V4.4）组成。
适用范围/预期用途
该产品基于分光光度法原理，与配套的检测试剂共同使用，在临床上用于对来源于人体的血液和尿液样本中的被分析物进行定量检测，包括血液中糖化血红蛋白 A1c 的百分比和尿液中低浓度的白蛋白（尿微量白蛋白）浓度、肌酐浓度和白蛋白/肌酐比值。
产品储存条件及有效期
附件
产品技术要求
批准日期
2025-02-19
生效日期
2025-07-13
有效期至
2030-07-12
工作原理 Working Principle
中文DCA Vantage 采用免疫比浊法与干式化学荧光免疫分析技术，通过微量全血 / 尿液样本与专用试剂条反应，检测糖化血红蛋白（HbA1c）和尿微量白蛋白（U-Alb）。样本在试剂条上发生抗原 - 抗体特异性结合，经光学系统检测反射光 / 荧光强度变化，由内置算法自动换算成浓度结果，实现床边快速定量检测。
EnglishDCA Vantage adopts immunoturbidimetry and dry chemical fluorescent immunoassay technology. It detects HbA1c and urine microalbumin (U-Alb) by reacting micro whole blood/urine samples with dedicated test strips. Specific antigen-antibody binding occurs on the strip; the optical system measures changes in reflected light/fluorescence intensity, and the built-in algorithm automatically converts to concentration results for rapid point-of-care quantitative testing.
二、产品特点 Product Features
中文
一机双测：同时支持糖化血红蛋白 HbA1c、尿微量白蛋白 U-Alb 检测。
快速出值：全流程 3～6 分钟，即时获得结果。
微量样本：全血仅需 1µL，尿液微量即可检测。
操作简单：傻瓜式插卡检测，无需专业培训。
稳定：批内 / 批间精密度高，符合 NGSP、IFCC 标准化。
数据管理：可存储上千条结果，支持数据传输与打印。
便携耐用：体积小巧，适合门诊、病房、体检中心使用。
抗干扰强：减少脂血、黄疸、溶血干扰，结果可靠。
English
Dual-test function: supports both HbA1c and urine microalbumin testing.
Rapid results: 3–6 minutes per test.
Microsample: only 1µL whole blood required.
Easy operation: insert strip to test, no professional training needed.
High accuracy: high precision, meets NGSP and IFCC standards.
Data management: stores thousands of records, supports transmission and printing.
Portable design: suitable for clinics, wards, and physical examination centers.
Strong anti-interference: resistant to lipemia, jaundice, hemolysis.
三、技术参数 Technical Parameters
中文
型号：DCA Vantage
检测项目：HbA1c（糖化血红蛋白）、尿微量白蛋白
检测方法：干式免疫荧光 / 免疫比浊法
HbA1c 范围：0～18%
尿微量白蛋白范围：0～300 mg/L
样本类型：静脉全血、指尖血、尿液
样本量：全血 1µL
检测时间：3～6 分钟
校准：内置校准，配套质控液
数据存储：≥2000 组
电源：AC 100–240V 或电池供电
工作环境：15～32℃，湿度≤85% RH
English
Model: DCA Vantage
Test items: HbA1c, Urine Microalbumin
Method: Dry fluorescent immunoassay / immunoturbidimetry
HbA1c range: 0–18%
U-Alb range: 0–300 mg/L
Sample type: venous whole blood, capillary blood, urine
Sample volume: 1µL whole blood
Test time: 3–6 minutes
Calibration: built-in calibration with control solution
Memory: ≥2000 records
Power: AC 100–240V or battery
Operating environment: 15–32℃, ≤85%RH
四、使用方法 Instructions for Use
中文
开机自检，确认仪器与试剂条在有效期内。
采集指尖血或静脉血，或收集新鲜尿液样本。
取出试剂条，插入仪器卡槽。
微量加样，将样本滴加于试剂条指定区域。
仪器自动识别、反应、检测并显示结果。
记录、打印或传输数据。
检测完毕，丢弃试剂条，清洁仪器表面。
English
Power on self-test; check instrument and strip expiry.
Collect capillary/venous blood or fresh urine sample.
Take out test strip and insert into the instrument.
Add micro-sample to the designated area.
Instrument automatically processes and displays results.
Record, print or transmit data.
Dispose of strip and clean the instrument.
五、适应症 Indications
中文
糖尿病患者长期血糖控制水平评估（HbA1c）
糖尿病肾病早期筛查与监测（尿微量白蛋白）
高血压、肥胖、代谢综合征人群肾损伤筛查
门诊、病房、体检中心快速血糖与肾功能筛查
孕期糖尿病血糖监测
慢病管理、随访疗效评估
English
Long-term glycemic control evaluation in diabetics (HbA1c)
Early screening and monitoring of diabetic nephropathy (U-Alb)
Renal injury screening for hypertension, obesity, ｍmbedbolic syndrome
Rapid blood glucose and renal function screening
Gestational diabetes monitoring
Chronic disease management and follow-up evaluation
六、禁忌症 Contraindications
中文
严重溶血、脂血、黄疸样本会导致结果异常，禁止使用。
样本被细菌污染、放置过久、反复冻融禁止检测。
试剂条受潮、破损、过期禁止使用。
极端环境温度下禁止开机检测。
休克、重度水肿、严重贫血患者结果仅供参考，不用于单独诊断。
English
Do not use severely hemolyzed, lipemic, or icteric samples.
Do not test contaminated, expired, or repeatedly frozen-thawed samples.
Do not use damp, damaged, or expired strips.
Do not operate under extreme temperature.
Results for shock, severe edema, severe anemia are for reference only.
七、注意事项 Precautions
中文
样本必须新鲜，采集后尽快检测。
试剂条需冷藏保存，使用前恢复室温。
避免手指直接触碰试剂反应区。
仪器避免震动、阳光直射、水淋、高温高湿。
定期使用质控液验证准确度。
不可用于诊断新生儿、极危重患者依据。
检测结果不能替代临床医师综合判断。
一次性试剂条不可重复使用。
English
Samples must be fresh and tested promptly.
Store strips refrigerated; equilibrate to room temperature before use.
Do not touch the reaction area of strips.
Protect the instrument from vibration, sunlight, water, heat and humidity.
Regularly verify accuracy with control solution.
Not intended as sole diagnostic basis for neonates or critical patients.
Results do not replace clinical judgment.
Single-use strips cannot be reused.
八、存储条件 Storage Conditions
中文
仪器存储温度：-20℃～+55℃
试剂条存储：2～8℃冷藏，避免冷冻
环境湿度：≤85% RH，无冷凝
避光、干燥、通风，无腐蚀性气体
避免重压、摔落、剧烈震动
未开封试剂有效期：18～24 个月
开机使用环境温度：15～32℃
English
Instrument storage: -20℃～+55℃
Test strips: 2–8℃ refrigerated, do not freeze
Humidity: ≤85%RH, non-condensing
Keep away from light, dry and ventilated
Avoid heavy pressure, dropping, vibration
Unopened strip shelf life: 18–24 months
Operating temperature: 15–32℃
九、说明书核心信息 Core Manual Inｆormation
中文产品名称：糖化血红蛋白 / 尿微量白蛋白分析仪型号：DCA Vantage用途：体外快速定量检测 HbA1c 和尿微量白蛋白适用科室：内分泌科、肾内科、体检科、门诊、社区医疗样本：全血、尿液注册分类：Ⅱ 类医疗器械结果单位：HbA1c（%）、尿微量白蛋白（mg/L）警示：仅供体外诊断使用；结果需结合临床；严格按说明书操作
EnglishProduct Name: HbA1c/Urine Microalbumin AnalyzerModel: DCA VantagePurpose: In vitro rapid quantitative test for HbA1c and U-AlbDepartments: Endocrinology, Nephrology, Physical Examination, ClinicSample: Whole blood, urineClass: Class II Medical DeviceUnits: HbA1c (%), U-Alb (mg/L)Warning: For in vitro diagnostic use only; results for clinical reference only; follow instructions strictly.
新型DCAVantage，
超强病人管理
有1省管实验字成者Pi(即时检测)
定向测定
HbA1c"
尿白蛋白
尿肌酐
尿白蛋白/尿肌酐
比值(ACR)
NGSP认
HbA1cCLIA许可
EME
有了DCAVantage
您可以前所未有的尝试准确地，
轻松地监控糖尿病病人的血糖水平。
DCAVantage新增功能一患病趋势图能让您有能力:
掌握病情发现HbA1c的细微变化推荐有效的治疗方案大大改善治疗决策的制定
DCA Vantage
服务于糖尿病管理
定量检测
·六分钟报告全血中的糖化血红蛋白(HbA1c)七分钟报告尿液白蛋白，肌酐，和两者比值(ACR
使用简单
自动定标
自动计算ACR比值
操作简单，只需三步:取样，定标，插入试剂盒没有样本准备，样本贮存，或者试剂准备等手工程序独立试剂盒，内带取样器，无需试管等
灵活的数据管理
通过触摸屏或者可选的条码阅读器输入病人和操作员ID/姓名
机内储存4000组资料和强大的数据搜索功能
USB接口连接PC，轻松输出数据
灵活的数据报告方式:机上显示;自动打印;外接打印和/或传输至LIS/HIS
与专业实验室一致的检测数据
灵活的质控操作:定期提醒或者检测关闭
实现管理员或POCT协调员的远程访问
用户能自行调整与参考方法的相关性系数
用户根据种群自定义参考范围
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
热门标签：厂家西门子糖化血红蛋白/尿微量白蛋白分析仪DCA,Vantage,糖化血红蛋白/尿微量白蛋白分析仪,DCA,Vantage
