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厂家供应浦讯迈柯唯热稀释导管包及压力监测套装PV2014L16A,PV8215等型号
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厂家供应浦讯迈柯唯热稀释导管包及压力监测套装PV2014L16A,PV8215等型号
桂经理19117326863微xin同号
结构及组成/主要组成成分 该产品由热稀释导管（PiCCO导管）包和压力监测套装组成，两者均为独立包装，详见附件。热稀释导管（PiCCO导管）包含有热稀释导管（PiCCO导管）、导丝、穿刺针和/或扩张器。压力监测套装含有压力传感器、压力连接管和注射液温度感受器。
适用范围/预期用途 该产品配合PULSION监护仪使用，利用经肺热稀释技术和脉搏波形轮廓分析技术，预期用于测量手术和危重病人的心输出量和血流动力学参数。热稀释导管（PiCCO导管）可测量动脉血压和血温，也可获取动脉血液样本；压力监测套装可测量血压和血温。
一、产品基本信息
1. 热稀释导管包（PiCCO Arterial Catheter Kit）
PV2014L16A：4Fr × 16cm，成人肱动脉 / 小体型股动脉
PV2015L20‑A：5Fr × 20cm，成人股动脉
2. 压力监测套装（Pressure Monitoring Kit）
PV8215：含压力传感器、150cm 红色压力连接管、注射液温度感受器（PV4046）
二、工作原理（Working Principle）
中文
产品基于经肺热稀释（TPTD） 与动脉脉搏轮廓分析（Pulse Contour Analysis） 双技术，配套 PiCCO 监护仪使用。
热稀释法（间断校准）：经中心静脉注入冷盐水（0‑4℃，10‑20mL），动脉导管热敏电阻记录温度变化曲线，按 Stewart‑Hamilton 公式计算心输出量（CO），并校准全心舒张末期容积（GEDVI）、血管外肺水（EVLWI）等容量参数。
脉搏轮廓法（连续监测）：通过动脉压力波形实时分析每搏输出量（SV），实现 CO、每搏量变异（SVV）、脉压变异（PPV）等参数的连续动态监测。
English
Based on Transpulmonary Thermodilution (TPTD) and Arterial Pulse Contour Analysis, used with PiCCO monitors.
Thermodilution (Intermittent Calibration): Cold saline (0‑4°C, 10‑20mL) is injected via central vein; arterial thermistor records temperature decay curve. Cardiac Output (CO) is calculated by Stewart‑Hamilton equation, calibrating volume parameters like Global End‑Diastolic Volume Index (GEDVI) and Extravascular Lung Water Index (EVLWI).
Pulse Contour (Continuous Monitoring): Real‑time analysis of arterial pressure waveｆorm to derive Stroke Volume (SV), enabling continuous CO, Stroke Volume Variation (SVV), Pulse Pressure Variation (PPV), etc.
三、产品特点（Product Features）
中文
双技术融合：热稀释校准 + 脉搏轮廓连续监测，兼顾与动态。
微创动脉置管：无需肺动脉导管，经股 / 肱动脉置入，创伤小、并发症低。
参数：可测 CO、ITBV、GEDVI、EVLWI、SVV、PPV、SVR、dPmx 等，覆盖循环、容量、肺水、心肌收缩力。
导管设计：镍钛合金导丝（超弹抗折）、不透射线、热敏电阻、多腔设计（测压 + 采血 + 输液）。
套装集成：PV8215 含压力传感器与温度感受器，即拆即用，减少连接误差。
适用人群：成人 / 儿童多规格，ICU、手术室、麻醉科通用。
English
Dual‑Technology Integration: Thermodilution calibration + pulse contour continuous monitoring for accuracy and real‑time data.
Minimally Invasive: Arterial catheterization (femoral/brachial) without pulmonary artery catheter, lower trauma and complications.
Comprehensive Parameters: Measures CO, ITBV, GEDVI, EVLWI, SVV, PPV, SVR, dPmx, covering circulation, volume, lung water, and contractility.
Catheter Design: Nitinol guidewire (kink‑resistant), radiopaque, precise thermistor, multi‑lumen for pressure, sampling, infusion.
Integrated Kit: PV8215 includes pressure transducer and thermistor, ready‑to‑use, reduces connection errors.
Broad Indications: Multiple sizes for adult/pediatric, suitable for ICU, OR, anesthesia.
四、技术参数（Technical Specifications）
1. 热稀释导管（PV2014L16A / PV2015L20‑A）
| 参数项 | PV2014L16A | PV2015L20‑A |
|---|---|---|
| 规格（French × Length） | 4Fr × 16cm | 5Fr × 20cm |
| 置入部位 | 肱动脉 / 小体型股动脉 | 成人股动脉 |
| 导管材料 | 不透射线 PVC | 不透射线 PVC |
| 热敏电阻精度 | ±0.1℃ | ±0.1℃ |
| 压力监测范围 | 0‑300mmHg | 0‑300mmHg |
| 导丝 | 镍钛合金，超弹抗折 | 镍钛合金，超弹抗折 |
| 包装 | 无菌独立包装，5 套 / 盒 | 无菌独立包装，5 套 / 盒 |
2. 压力监测套装（PV8215）
压力传感器：精度 ±1% FS，响应时间 < 10ms
压力连接管：150cm，红色，防扭结
注射液温度感受器（PV4046）：测量范围 0‑40℃，精度 ±0.1℃
适用监护仪：Pulsion PiCCO、Philips 等兼容模块
English (Key Specs)
Catheter: 4Fr/5Fr, radiopaque PVC, thermistor ±0.1°C, pressure 0‑300mmHg, nitinol guidewire.
PV8215 Kit: Transducer ±1% FS, 150cm tubing, thermistor ±0.1°C, compatible with PiCCO monitors.
五、使用方法（Instructions for Use）
中文（核心步骤）
术前准备：无菌操作，评估穿刺部位（股 / 肱动脉），检查产品包装与有效期。
置管（Seldinger 技术）：
局部麻醉，穿刺动脉，置入导丝。
沿导丝送入扩张器与导管，确认回血通畅。
固定导管，连接 PV8215 压力传感器与温度感受器。
系统校准：监护仪归零，执行热稀释校准（冷盐水注射）。
监测与维护：
连续监测动脉压与血流动力学参数。
每 6‑8 小时用肝素盐水（1‑5U/mL）冲洗管路防血栓。
按需重复热稀释校准（病情波动时）。
拔管：病情稳定后无菌拔管，局部压迫止血≥15 分钟。
English
Prep: Sterile field, assess puncture site, inspect package and expiry.
Catheter Insertion (Seldinger): Local anesthesia, arterial puncture, guidewire placement, dilator/catheter insertion, secure, connect PV8215.
Calibration: Zero monitor, perｆorm thermodilution calibration with cold saline.
Monitoring: Continuous pressure/hemodynamics; flush q6‑8h with heparinized saline; recalibrate as needed.
Removal: Sterile removal, manual compression ≥15min for hemostasis.
六、适应症（Indications）
中文
危重患者（ICU、术后、休克、脓毒症）血流动力学监测。
心功能不全、肺水肿、ARDS 患者容量管理与肺水评估。
重大手术（心脏、腹部、血管）术中 / 术后循环监测。
容量反应性评估（SVV/PPV 指导液体治疗）。
心肌收缩力与后负荷评估（dPmx、SVR）。
English
Hemodynamic monitoring in critically ill patients (ICU, post‑op, shock, sepsis).
Volume management and lung water assessment in heart failure, pulmonary edema, ARDS.
Intra‑/post‑operative monitoring for major surgery (cardiac, abdominal, vascular).
Fluid responsiveness evaluation (SVV/PPV‑guided therapy).
Myocardial contractility and afterload assessment (dPmx, SVR).
七、禁忌症（Contraindications）
中文
绝对禁忌：穿刺部位感染、严重凝血功能障碍（INR > 3.0 或血小板 < 50×10⁹/L）、动脉闭塞 / 夹层、外周血管疾病致置管禁忌、对导管材料过敏。
相对禁忌：严重外周血管疾病、近期动脉介入史、无法配合患者。
English
Absolute: Local infection, severe coagulopathy (INR >3.0, platelets <50×10⁹/L), arterial occlusion/dissection, peripheral vascular disease precluding cannulation, hypersensitivity to catheter materials.
Relative: Severe PVD, recent arterial intervention, uncooperative patient.
八、注意事项（Warnings & Precautions）
中文
Ⅲ 类医疗器械，专业医护操作，严格无菌。
置管 / 拔管动作轻柔，避免血管损伤、血栓、出血、血肿。
持续监测穿刺部位血运、皮温、感觉，警惕缺血 / 栓塞。
管路必须无气泡、无扭曲，压力传感器定期归零。
热稀释注射需匀速（3‑5 秒），避免过快 / 过慢影响结果。
留置时间≤7 天，预防感染与血栓。
不可用于肺动脉压监测，不可替代肺动脉导管。
出现心律失常、出血、感染、肢体缺血立即处理。
English
Class III device, only by trained staff, strict asepsis.
Gentle insertion/removal to avoid vascular injury, thrombosis, bleeding, hematoma.
Monitor distal perfusion, temperature, sensation for ischemia/embolism.
No air bubbles/kinks; transducer zeroed regularly.
Thermodilution injection over 3‑5s for accuracy.
Indwelling ≤7 days to reduce infection/thrombosis.
Not for pulmonary artery pressure; not a replacement for PAC.
Treat arrhythmia, bleeding, infection, ischemia immediately.
九、存储条件（Storage Conditions）
中文
温度：15‑25℃
湿度：30‑70% RH
避免阳光直射、高温、潮湿、腐蚀性气体
无菌包装有效期：3 年（以包装标注为准）
运输：符合医疗器械运输规范，避免剧烈震动
English
Temperature: 15‑25°C
Humidity: 30‑70% RH
Protect from direct sunlight, heat, moisture, corrosive gases
Sterile shelf life: 3 years (per package label)
Transportation: Comply with medical device regulations, avoid shock
十、说明书核心信息摘要（Summary）
产品组成：动脉热稀释导管包（导管 + 导丝 + 穿刺套件）+ 压力监测套装（传感器 + 管路 + 温度探头）。
核心技术：经肺热稀释 + 脉搏轮廓分析，实现连续血流动力学监测。
临床价值：微创、、动态，指导容量、心功能、肺水管理，改善危重患者预后。
合规要求：Ⅲ 类进口医疗器械，凭注册证采购与使用，操作人员需专项培训。
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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