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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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厂家供应费森尤斯血红蛋白分析仪9034200

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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):国械注进20192220071更新时间:2026/10/16 11:11:02

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导管 管路

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反搏设备

注射泵 输液泵

高频电刀

起搏器

听力设备

吸引器

眼科器械

检测仪 测量仪

刺激器

耗材

排痰机

超声

止血设备

医学检验设备

床

肺功能仪

心脏设备

血压计

测试仪 测定仪

全科诊断壁挂系统

呼吸/麻醉设备

设备

分析系统/分析仪

成像仪

镜类设备

血液回收设备及耗材

血液透析设备及耗材

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详细内容

厂家供应费森尤斯血红蛋白分析仪9034200

桂经理19117326863微xin同号

管理类别

第二类

型号规格

9034200

结构及组成/主要组成成分

本产品由血红蛋白分析仪主机、USB连接线、电源适配器和适配器插头组成。软件版本号:0057。

适用范围/预期用途

本产品采用广谱分光光度法的原理,用于对人体血样进行总血红蛋白定量测定。



一、工作原理(Working Principle)

中文

采用 干式化学分光光度比色法 与 反射光度法 结合:

样本反应:微量全血(毛细血管 / 静脉血)滴加至专用干试条,试条内溶血剂破坏红细胞,释放血红蛋白;血红蛋白与显色底物发生氧化显色反应。

光学检测:仪器光源发射 特定波长(约 540nm/415nm) 光照射反应区,血红蛋白显色产物吸收部分光线,反射光强度与血红蛋白浓度成反比。

信号计算:光电传感器接收反射光信号,经微处理器换算,自动显示 Hb 浓度(g/L 或 g/dL)。

温度补偿:内置温度传感器,自动校准环境温度对反应的影响,确保结果稳定。

English

Adopts dry chemical spectrophotometry & reflectance photometry:

Sample Reaction: A drop of whole blood (capillary/venous) is applied to a dry reagent strip. Hemolytic agents lyse RBCs to release Hb, which reacts with chromogenic substrates to form a colored complex.

Optical Detection: Light of specific wavelength (≈540nm/415nm) illuminates the reaction zone. Absorbance by the colored product reduces reflected light intensity inversely proportional to Hb concentration.

Signal Calculation: Photosensor captures reflected light; microprocessor converts signal to display Hb concentration (g/L or g/dL).

Temp Compensation: Built-in temperature sensor auto-calibrates for environmental effects, ensuring stability.

二、核心功能(Core Functions)

表格

中文功能 English Function

血红蛋白定量检测:全血 Hb 浓度快速测定 Quantitative Hb Measurement: Rapid whole blood hemoglobin assay

双样本类型兼容:毛细血管血、静脉全血(EDTA 抗凝) Dual Sample Compatibility: Capillary blood & EDTA anticoagulated venous whole blood

快速出结果:检测时间 ≤10 秒 Fast Results: Test time ≤10 seconds

数据存储:内置存储 ≥500 组结果,可查询 / 打印 Data Storage: ≥500 results storage, recall/print capable

校准 / 质控:自动校准、质控液检测、偏差报警 Calibration/QC: Auto-calibration, control testing, deviation alarms

温度补偿:宽温环境自动校正 Temperature Compensation: Auto-correction across wide temp range

低电量提示:电池 / 电源状态监测 Low Battery Alert: Battery/power status monitoring

单位切换:g/L ↔ g/dL 自由切换 Unit Switch: Toggle between g/L and g/dL

三、产品特点(Product Features)

中文

干式化学,无需液体试剂:无废液、无污染、维护极低。

微量样本:仅需 10–20µL 全血,指尖采血即可。

快速便捷:10 秒出结果,即插即测,操作简单。

高精度高稳定:CV ≤2%,与全自动血细胞分析仪相关性 ≥0.98。

便携设计:体积小、重量轻、内置锂电池(续航≥30 小时)。

抗干扰强:抗黄疸、脂血、溶血干扰,适用危重 / 透析样本。

生物安全:封闭试条设计,防样本暴露、交叉污染。

适用广:临床、急诊、体检、妇幼、透析、野外筛查。

English

Dry Chemistry, No Liquid Reagents: No waste, no contamination, minimal maintenance.

Microsample: Only 10–20µL whole blood; fingerstick compatible.

Fast & Easy: Results in 10s, ready-to-test, simple operation.

High Precision & Stability: CV ≤2%, correlation ≥0.98 vs. hematology analyzers.

Portable: Compact, lightweight, built-in Li-ion battery (≥30h).

Strong Anti-Interference: Resists icterus, lipemia, hemolysis; suitable for critical/dialysis samples.

Bio-safe: Sealed strips prevent exposure and cross-contamination.

Wide Application: Clinics, ER, physical exams, OB/GYN, dialysis, field screening.







四、技术参数(Technical Specifications)

表格

中文参数 英文参数

产品型号 Model

9034200 血红蛋白分析仪 9034200 Hemoglobin Analyzer

检测原理 Principle

干式化学分光光度比色法(反射光度法) Dry Chemical Spectrophotometry (Reflectance Photometry)

检测范围 Measurement Range

0–260 g/L(0–26.0 g/dL) 0–260 g/L (0–26.0 g/dL)

样本类型 Sample Type

毛细血管全血、静脉全血(EDTA-K2/K3) Capillary whole blood, venous whole blood (EDTA-K2/K3)

样本量 Sample Volume

10–20 µL 10–20 µL

检测时间 Test Time

≤10 秒 ≤10 Seconds

准确度 Accuracy

±3 g/L(≤100g/L);±3%(>100g/L) ±3 g/L (≤100g/L); ±3% (>100g/L)

精密度(CV) Precision (CV)

≤2% ≤2%

数据存储 Data Memory

≥500 组检测结果 ≥500 Results

电源 Power Supply

锂电池(3.7V/1200mAh)+ USB 电源适配器 Li-ion Battery (3.7V/1200mAh) + USB Adapter

工作环境 Operating Conditions

温度 10–35℃;湿度 20%–80% RH(无冷凝) Temp 10–35°C; Humidity 20%–80%RH (non-condensing)

尺寸 / 重量 Dimensions/Weight

约 120×80×50mm;约 250g Approx. 120×80×50mm; ~250g

认证 Certifications

医疗器械注册证(NMPA)、CE NMPA, CE Certified

保质期 Shelf Life

仪器:2 年;试条:24 个月(2–8℃冷藏) Instrument: 2 years; Strips: 24 months (2–8°C)

五、使用方法(Usage Instructions)

中文

开机准备

长按电源键开机,自检完成后进入主界面。

插入专用干试条,仪器自动识别试条代码。

样本采集

指尖采血:75% 酒精消毒,待干后穿刺,弃去滴血,取 10–20µL 全血。

静脉血:EDTA 抗凝全血,混匀后取微量样本。

加样检测

仪器提示 “滴血” 时,将血样均匀滴加至试条反应区,避免气泡。

仪器自动检测,10 秒内显示 Hb 浓度。

数据处理

记录 / 打印结果,取出试条丢弃。

连续检测可直接插入新试条。

关机维护

检测完毕,长按电源键关机。

清洁光学窗口与试条插槽,定期质控校准。

English

Power-On Prep

Press power button to start; self-test completes, ready screen appears.

Insert dry strip; instrument auto-detects strip code.

Sample Collection

Fingerstick: 75% alcohol disinfect, dry, puncture; discard first drop, apply 10–20µL whole blood.

Venous: EDTA anticoagulated blood, mix well before sampling.

Testing

When “Apply Blood” appears, add sample to strip; avoid air bubbles.

Auto-analyzes; displays Hb in ≤10 seconds.

Data Handling

Record/print results; discard used strip.

For consecutive tests, insert new strip directly.

Shutdown & Care

Press power button to turn off.

Clean optical window and strip port; perform QC/calibration regularly.

六、适应症(Indications)

中文

贫血诊断与分型:缺铁性、巨幼细胞性、溶血性、再生障碍性、地中海贫血等。

贫血治疗监测:补铁、促红素、透析、化疗后 Hb 动态观察。

术前 / 术后评估:手术前后贫血筛查、失血监测。

透析患者管理:肾性贫血常规监测(透析前后 Hb 对比)。

健康体检 / 普查:人群贫血筛查、高原 / 孕期 / 儿童贫血监测。

急诊 / 重症:快速评估失血、休克、缺氧状态。

English

Anemia Diagnosis & Classification: Iron-deficiency, megaloblastic, hemolytic, aplastic, thalassemia, etc.

Anemia Treatment Monitoring: Post-iron/EPO, dialysis, chemotherapy Hb follow-up

Pre/Post-Op Assessment: Pre-op screening, intra/post-op blood loss monitoring

Dialysis Patient Management: Renal anemia routine monitoring (pre/post-dialysis Hb)

Physical Exams/Screening: General population, high-altitude, pregnancy, pediatric anemia screening

ER/Critical Care: Rapid evaluation of hemorrhage, shock, hypoxia

七、禁忌症(Contraindications)

中文

非体外诊断使用:严禁用于人体体内、动物检测或非医疗用途。

严重溶血样本:样本明显溶血(Hb 游离)导致结果假性升高。

严重脂血 / 黄疸样本:重度脂血(TG>11.3mmol/L)、重度黄疸(TBIL>85µmol/L)干扰检测。

非配套试条:使用其他品牌 / 型号试条,结果无效。

样本凝固:采血后未及时检测、样本凝固,结果偏低。

English

Non-In Vitro Use: Forbidden for in vivo, veterinary, or non-medical use.

Severely Hemolyzed Samples: Causes falsely elevated results.

Severe Lipemia/Icterus: TG >11.3mmol/L or TBIL >85µmol/L interferes with assay.

Non-Compatible Strips: Use of other brands/models invalidates results.

Clotted Samples: Delayed testing leads to falsely low Hb.

八、注意事项(Precautions)

中文

体外诊断专用:医疗专业人员使用,严禁家用。

试条管理:试条 2–8℃冷藏,开封后 1 个月内用完;取出后 30 秒内加样。

温度要求:使用环境 10–35℃,温度过低结果偏低。

采血规范:酒精消毒后必须擦干;避免酒精稀释样本。

加样要求:一次性滴足量,禁止补样;避免气泡、分层。

质控校准:每日开机做 质控液检测;定期校准仪器。

清洁维护:定期清洁光学头,防灰尘、血渍干扰。

电池安全:勿拆解、短路、高温;长期不用每月充电一次。

结果复核:异常结果需 重复检测或与全自动分析仪比对。

废物处理:使用后试条按 感染性医疗废物 处置。

English

In Vitro Diagnostic Only: For professional use only; not for home use.

Strip Storage: 2–8°C refrigerated; use within 1 month of opening; apply sample within 30 seconds.

Temperature: Operate at 10–35°C; low temp causes low results.

Sampling: Dry skin completely after alcohol; avoid alcohol dilution.

Application: Apply full volume at once; no re-dosing; avoid bubbles/layering.

QC/Calibration: Run control solution daily; calibrate periodically.

Maintenance: Clean optical window regularly to avoid dust/blood interference.

Battery Safety: No disassembly, short-circuit, or heat; recharge monthly if unused.

Result Verification: Repeat or compare with hematology analyzer for abnormal values.

Waste Disposal: Discard strips as infectious medical waste.

九、存储条件(Storage Conditions)

中文

仪器存储

温度:-10℃~45℃;湿度:≤80%RH(无冷凝)

环境:干燥、通风、无尘、无腐蚀性气体、避光、防震动

试条存储

未开封:2–8℃ 冷藏,避免冷冻、阳光直射

已开封:15–30℃ 干燥密封,1 个月内用完

远离热源、潮湿、化学挥发物

English

Instrument Storage

Temp: -10°C to 45°C; Humidity: ≤80%RH (non-condensing)

Environment: Dry, ventilated, dust-free, no corrosive gases, light-proof, shock-resistant

Strip Storage

Unopened: 2–8°C refrigerated; avoid freezing & direct sunlight

Opened: 15–30°C dry sealed; use within 1 month

Keep away from heat, moisture, chemical fumes

十、说明书核心信息(Manual Key Information)

中文

产品信息:名称、型号、注册证号、生产厂家、批号、有效期。

原理与结构:干式化学比色法、光学系统、微处理器、显示屏、试条插槽。

功能参数:检测范围、样本量、时间、精度、存储、电源。

操作流程:开机、试条插入、采血、加样、检测、数据、关机。

适应症 / 禁忌症:临床应用、干扰因素、无效样本场景。

注意事项:质控、校准、维护、安全、废物处理。

存储运输:仪器与试条温湿度、有效期、运输防护。

故障处理:常见报警(试条错误、温度异常、电量低、样本错误)及排除。

责任声明:持证医护使用;未按规范操作导致结果误差责任自负。

English

Product Info: Name, model, registration, manufacturer, lot, expiry.

Principle & Structure: Dry chemistry, optics, microprocessor, display, strip port.

Specifications: Range, volume, time, precision, memory, power.

Operation: Power-on, strip loading, sampling, testing, data, shutdown.

Indications/Contraindications: Clinical use, interferences, invalid samples.

Precautions: QC, calibration, maintenance, safety, waste disposal.

Storage/Shipping: Temp/humidity, expiry, transport protection.

Troubleshooting: Common alarms (strip error, temp, low battery, sample error) & fixes.

Liability: For trained personnel only; user responsible for errors from improper use.


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.


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