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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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当前位置: 阿仪网 > 医疗器械 > 化验设备 > 病理分析前处理设备 > 上海康世达医疗器械有限公司 > 产品展示 > 医学检验设备 > 血气分析仪 > 厂家理邦血气生化分析仪i15系列

厂家理邦血气生化分析仪i15系列

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厂家理邦血气生化分析仪i15系列

桂经理19117326863微xin同号


型号规格 i15、i15A、i1506、i1508、i1505

结构及组成/主要组成成分 由主机、打印机、扫描仪和电子仿真器组成。

适用范围/预期用途 分析仪与理邦仪器生产的血气生化试剂盒(干式电化学法/交流阻抗法)、血气生化试剂包配套使用,适用于测量人体全血样本中的pH、pCO2、pO2、Na+、K+、Cl-、Ca++、Hct、Glu、Lac的含量。

型号规格

i15、i15A、i1506、i1508、i1505

结构及组成/主要组成成分

由主机、打印机、扫描仪和电子仿真器组成。

适用范围/预期用途

分析仪与理邦仪器生产的血气生化试剂盒(干式电化学法/交流阻抗法)、血气生化试剂包配套使用,适用于测量人体全血样本中的pH、pCO2、pO2、Na+、K+、Cl-、Ca++、Hct、Glu、Lac的含量。

血气生化分析仪i15、i15A、i1506、i1508、i1505

小巧便捷,即时检测

操作简便,只需三步即可完成检测内置热敏打印机,随时随地打印结果内置电池,可待机24小时或可连续测试50个标本

准确可靠

仪器无液路,便于维护保养完整的溯源体系以及质控体系单次抛弃型测试卡,无交叉感染可获得与传统大电极测量法相媲美的结果有线/无线无缝连接LIS/HIS,数据实时共享

测试菜单:

灵活多样的测试卡,满足不同临床科室使用需求

pHpCO2PO2NaKCICaHctGlu










一、工作原理(Working Principle)

中文

采用干式电化学法+交流阻抗法+微流控一次性测试卡,30–70秒完成10项实测+ 18项计算参数:

干式电化学法(Potentiometry/Amperometry):测试卡内置离子选择电极(ISE)、酶电极,样本与干试剂反应,通过电位/电流变化定量pH、pCO₂、pO₂、Na⁺、K⁺、Cl⁻、Ca²⁺、Glu、Lac。

交流阻抗法(AC Impedance):检测血液阻抗变化,计算血细胞比容(Hct)。

微流控自动吸样:仪器自动水平吸样,样本在测试卡内微流控通道均匀分配,无液路、免维护。

自动定标+电子质控:内置电子仿真器+定标质控体系,全程溯源,结果可靠。

English

Adopts dry electrochemical method + AC impedance method + disposable microfluidic test card, completes 10 measured + 18 calculated parameters in 30–70 seconds:

Dry Electrochemistry (Potentiometry/Amperometry): Ion-selective electrodes (ISE) & enzyme electrodes in test card; sample reacts with dry reagents; potential/current change quantifies pH, pCO₂, pO₂, Na⁺, K⁺, Cl⁻, Ca²⁺, Glu, Lac.

AC Impedance: Blood impedance change→hematocrit (Hct) calculation.

Microfluidic Auto-Sampling: Auto horizontal sampling; sample distributed in microfluidic channels; no fluid path, zero maintenance.

Auto-Calibration + Electronic QC: Built-in electronic simulator + calibration/QC system; full traceability, reliable results.

二、产品特点(Product Features)

中文

极速微量:30–70秒出结果,仅需80–100µL全血,新生儿/微量样本友好。

干式免维护:无液路、无气瓶、免清洗,单次抛弃式测试卡,杜绝交叉污染。

多参数覆盖:10项实测(pH/pCO₂/pO₂/Na⁺/K⁺/Cl⁻/Ca²⁺/Hct/Glu/Lac)+18项计算(HCO₃⁻/BE/sO₂/AnGap等),≥28项总参数。

便携床旁:内置电池(待机24h /连续测50次)、热敏打印、WiFi /蓝牙,急诊/ ICU /手术室/转运适用。

智能质控:电子仿真器+自动定标+内置质控,三重保障,溯源完整。

操作极简:全触摸+图形向导+教学视频,三步完成检测,新手快速上手。

数据互联:无缝对接LIS/HIS,数据实时传输,内置条码扫描。


三、技术参数(Technical Specifications)

表格

项目(Item)中文(Chinese)英文(English)

检测原理干式电化学法、交流阻抗法Dry Electrochemistry, AC Impedance

实测参数10项:pH、pCO₂、pO₂、Na⁺、K⁺、Cl⁻、Ca²⁺、Hct、Glu、Lac10 Measured: pH, pCO₂, pO₂, Na⁺, K⁺, Cl⁻, Ca²⁺, Hct, Glu, Lac

计算参数18项:cH⁺、HCO₃⁻act、HCO₃⁻std、BE (ecf)、BE (B)、sO₂(est)、AnGap等18 Calculated: cH⁺, HCO₃⁻act, HCO₃⁻std, BE(ecf), BE(B), sO₂(est), AnGap, etc.

检测时间30–70秒/样本30–70 seconds/sample

样本量80–100µL全血80–100µL whole blood

样本类型动脉/静脉/毛细血管/混合动静脉血Arterial/Venous/Capillary/Mixed Blood

测试卡一次性微流控干式卡,常温保存Disposable microfluidic dry card, room temp storage

电池续航内置锂电,待机24h /连续测50次Li-ion battery, 24h standby/50 continuous tests

数据存储≥10,000条结果≥10,000 results

接口WiFi、蓝牙、USB、RS232、LIS/HISWiFi, Bluetooth, USB, RS232, LIS/HIS compatible

尺寸/重量315×238×153mm;<4kg(带电池)315×238×153mm; <4kg (with battery)

电源AC 100–240V,50/60HzAC 100–240V, 50/60Hz

操作环境15–30℃,20%–80% RH(无冷凝)15–30°C, 20%–80%RH (non-condensing)




四、使用方法(Operation Instructions)

中文

开机准备:检查电源/电池,开机自检;仪器自动定标+电子质控,预热完成。

样本处理:肝素抗凝全血,无凝块/气泡,10分钟内检测;条码扫描录入信息。

测试卡加载:取出一次性测试卡,插入仪器卡槽,仪器自动识别。

样本吸样:将样本靠近吸样口,仪器自动水平吸样,无需手动操作。

检测启动:选择测试项目,仪器自动分配、反应、检测;30–70秒显示结果。

结果审核:自动质控校验,异常标记(凝块/气泡/质控失控),人工复核后打印/传输。

关机维护:完成测试后,取出废弃测试卡;清洁表面;关机断电;长期不用取出电池。


五、适应症(Indications)

中文

急诊/ ICU:呼吸衰竭、休克、酸碱失衡、电解质紊乱快速评估。

手术麻醉:术中/术后血气、电解质、代谢监测,指导通气与补液。

新生儿/儿科:早产儿呼吸窘迫、窒息、代谢性酸中毒筛查。

呼吸科:COPD、哮喘、肺栓塞、ARDS病情监测与疗效评估。

心内科:心梗、心衰、心律失常、电解质(K⁺/Ca²⁺)紊乱监测。

内分泌科:糖尿病酮症酸中毒(Glu/Lac/pH)、乳酸酸中毒诊断。

急诊科:创伤、中毒、脓毒症、多器官功能衰竭快速诊断。

English

ED/ICU: Rapid assessment of respiratory failure, shock, acid-base imbalance, electrolyte disorders.

OR/Anesthesia: Intra-/post-op blood gas, electrolyte, mmbedbolite monitoring; guide ventilation & fluid therapy.

Neonatal/Pediatric: Screening for RDS, asphyxia, mmbedbolic acidosis in preterm infants.

Respiratory: Monitoring COPD, asthma, PE, ARDS; evaluate treatment response.

Cardiology: Monitoring MI, heart failure, arrhythmia, electrolyte (K⁺/Ca²⁺) disorders.

Endocrinology: Diagnosis of DKA (Glu/Lac/pH), lactic acidosis.

Emergency: Rapid diagnosis of trauma, poisoning, sepsis, MODS.




六、禁忌症(Contraindications)

中文

样本禁忌:严重溶血、脂血、凝块、气泡、非肝素抗凝样本禁用(结果不可靠)。

试剂禁忌:使用非EDAN原厂测试卡/定标液/质控液,结果无效且损坏仪器。

环境禁忌:易燃易爆、强电磁干扰、温湿度超标环境禁用。

人员禁忌:未培训人员严禁操作,避免误操作致结果错误/仪器故障。

用途禁忌:体外诊断,不可用于治疗、动物检测或非诊断用途。

English

Sample: Severe hemolysis, lipemia, clots, bubbles, non-heparinized samples (unreliable results).

Reagent: Non-EDAN test cards/calibrators/controls invalidate results & risk instrument damage.

Environment: Flammable/explosive, strong EMI, out-of-range temp/humidity.

Personnel: Untrained staff prohibited; avoid misuse causing errors/failure.

Use: For in vitro diagnostic use only; no therapeutic, veterinary, or non-diagnostic applications.




七、注意事项(Precautions)

中文

人员资质:仅由经培训医护操作,熟悉SOP与电子质控流程。

样本规范:严格肝素抗凝,无凝块/气泡,10分钟内检测;避免剧烈震荡。

测试卡管理:测试卡常温保存,开封后7天内用完;严禁冷冻/高温。

仪器维护:每日执行电子质控;每周清洁吸样口/表面;每月检查电池/接口;每季度性能验证。

干扰防控:远离手机、射频设备;避免液体渗入;温湿度严格控制在15–30℃、20%–80% RH。

急诊管理:床旁快速检测,结果及时审核;异常结果立即通知临床。

数据安全:定期备份结果;LIS对接验证数据完整性;质控失控立即暂停检测并排查。

安全防护:操作戴手套,样本按生物安全处理;废弃测试卡分类处置。

English

Personnel: Operated only by trained staff familiar with SOP & electronic QC workflow.

Sample Protocol: Strict heparinization; no clots/bubbles; test within 10 minutes; avoid vigorous mixing.

Test Card Management: Store at room temp; use within 7 days of opening; no freezing/heating.

Instrument Maintenance: Daily electronic QC; weekly sample port/surface cleaning; monthly battery/interface check; quarterly performance verification.

Interference Control: Keep away from phones/RF equipment; prevent liquid ingress; maintain 15–30°C, 20%–80%RH.

Emergency Management: POC rapid testing; timely result review; notify clinicians of critical values immediately.

Data Security: Regular result backup; verify LIS integration; suspend testing if QC out-of-control.

Safety: Wear gloves; handle samples per biosafety; dispose of used cards properly.

八、存储条件(Storage Conditions)

中文

仪器:温度- 20℃~+50℃;湿度≤85%(无冷凝);远离磁场、腐蚀性气体、直射阳光;水平放置,避免震动。

测试卡:未开封/开封后均常温(15–30℃)保存,避光密封;开封后7天内使用;严禁冷冻/高温。

定标液/质控液:2–8℃冷藏,避光密封;有效期内使用;严禁冷冻。

配件/耗材:室温(15–30℃),干燥密封;有效期2年;开封后尽快使用。

English

Instrument: -20°C to +50°C;≤85%RH (non-condensing); away from magnetic fields, corrosive gases, direct sunlight; store level, avoid vibration.

Test Cards: Unopened/opened stored at 15–30°C, light-proof & sealed; use within 7 days of opening; no freezing/heating.

Calibrators/Controls: 2–8°C refrigerated, light-proof & sealed; use before expiry; no freezing.

Accessories/Consumables: 15–30°C, dry & sealed; 2-year shelf life; use promptly after opening.

九、说明书核心信息(Manual Core Information)

中文

适用范围:体外诊断,对人全血进行血气、电解质、代谢物定量检测,辅助临床酸碱失衡、呼吸/循环功能、代谢紊乱诊疗与监测。

安全标准:IEC 60601-1、IEC 60601-2⁻⁷6、FDA 510 (k)、CE认证。

标准配置:主机、热敏打印机、条码扫描仪、电子仿真器、电源适配器、电池、USB线、说明书、清洁工具。

报警提示:温度异常、样本不足、测试卡过期、凝块/气泡检测、质控失控、溶血/脂血干扰、电池低电量、通讯异常。

数据管理:≥10,000条结果存储;LIS/HIS对接;质控数据统计与趋势分析。

维护周期:每日电子质控/清洁;每周吸样口清洁;每月电池/接口检查;每季度性能验证;每年校准与维护。

故障处理:结果异常→重测+检查样本/测试卡/定标;仪器报警→查看提示+排查耗材/接口/传感器;无法开机→检查电源/电池。

English

Intended Use: In vitro diagnostic; quantitative testing of blood gas, electrolyte, mmbedbolite in human whole blood; aids diagnosis/monitoring of acid-base imbalance, respiratory/circulatory function, mmbedbolic disorders.

Safety Standards: IEC 60601-1, IEC 60601-2⁻⁷6, FDA 510(k), CE marked.

Standard Configuration: Main unit, thermal printer, barcode scanner, electronic simulator, power adapter, battery, USB cable, manual, cleaning tools.

Alarms: Temp error, low sample, expired card, clot/bubble detected, QC out-of-control, hemolysis/lipemia interference, low battery, communication error.

Data Management:≥10,000 results; LIS/HIS integration; QC statistics & trend analysis.

Maintenance Schedule: Daily electronic QC/cleaning; weekly sample port cleaning; monthly battery/interface check; quarterly performance verification; annual full calibration & service.

Troubleshooting: Abnormal result→retest + check sample/card/calibration; instrument alarm→follow message + check consumables/interface/sensor; no power→check power/battery.




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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