厂商直供美国火山Volcano血管内超声诊断仪797403
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厂商直供美国火山Volcano血管内超声诊断仪797403
一、工作原理 Working Principle
中文本系统配合一次性血管内超声诊断导管使用，导管内置微型超声换能器送入血管腔；换能器定向发射高频超声波，超声波遇到血管内膜、中膜、外膜、粥样斑块、血栓等不同组织界面产生反射回波；设备接收回波信号，经信号处理、模数转换重建血管 360° 横截面实时超声图像。系统可同步接收压力导丝信号，采集血管两端压力，运算得出 FFR/iFR 生理学参数；虚拟组织学（VH-IVUS）通过频谱分析区分斑块组织成分；ChromaFlo 彩色血流功能识别管腔内血流信号，弥补造影仅显示血管轮廓、无法观察血管壁结构的缺陷。
EnglishThe system works with disposable intravascular ultrasound catheters. A miniaturized ultrasonic transducer integrated inside the catheter is delivered into the blood vessel lumen. The transducer emits high-frequency ultrasound waves. Reflected echoes are generated when ultrasound encounters tissue interfaces including intima, media, adventitia, atherosclerotic plaque and thrombus. The system receives echo signals and reconstructs real-time 360° cross-sectional vascular images after signal processing and analog-to-digital conversion.The system supports pressure guidewire input to acquire vascular pressure for calculating FFR and iFR. Virtual Histology (VH-IVUS) identifies plaque components via ultrasound spectrum analysis. ChromaFlo blood flow imaging visualizes intraluminal flow. It compensates the limitation of angiography which only displays vessel outline without vessel wall visualization.
二、产品功能 Product Functions
中文
IVUS 灰阶成像：实时显示血管横截面、长轴图像，提供管腔、血管壁解剖影像；
自动 / 手动测量：管腔面积、血管外弹力膜面积、斑块负荷、直径、病变长度等定量参数；
VH 虚拟组织学成像：区分纤维组织、纤维脂肪组织、钙化组织、坏死脂质核心；
ChromaFlo 彩色血流成像，识别夹层、分支血管、血流通道；
兼容压力导丝，检测血管压力，计算 FFR 血流储备分数、iFR 瞬时无波形比值；
自动回撤成像、影像存储、回放、报告生成；
支持影像与冠脉造影图像融合配准。
English
Grayscale IVUS imaging: Real-time cross-section and longitudinal view of vessel lumen and vascular wall;
Automatic & manual measurement: Lumen area, EEM area, plaque burden, diameter, lesion length and other quantitative metrics;
VH Virtual Histology: Differentiate fibrous tissue, fibrofatty tissue, calcium and necrotic lipid core;
ChromaFlo color flow imaging to identify dissection, side branches and flow channel;
Compatible with pressure guidewire for pressure recording, FFR and iFR calculation;
Automatic pullback acquisition, image storage, playback and report generation;
Image fusion registration with coronary angiography.
三、产品特点 Product Features
中文
一体化 IVUS + 冠脉生理学评估平台，一台设备同时实现影像解剖评估与功能学评估；
兼容 Volcano 全系列相控阵式 IVUS 导管（Eagle Eye Platinum 等），即插即用；
高清实时成像，自动回撤匀速稳定，保障图像连续性；
成熟 VH 虚拟组织学技术，斑块易损性评估临床应用广泛；
无菌区床边控制器，术者可直接操控，无需离开无菌区域；
图像测量算法，支持 PCI 术前评估、术中支架优化、术后随访；
模块化推车式工作站，布局适配导管室，兼容 DICOM 影像传输；
支持冠脉与外周血管诊疗评估。
English
Integrated platｆorm combining IVUS anatomical imaging and coronary physiological assessment;
Full compatibility with Volcano phased array IVUS catheters (Eagle Eye Platinum series), plug-and-play;
High-definition real-time imaging with stable automatic pullback for continuous image acquisition;
Validated VH-IVUS technology widely used for vulnerable plaque evaluation;
Sterile field bedside controller enables operator control without leaving sterile area;
Precise measurement algorithms for pre-procedure planning, intra-procedural stent optimization and post-procedure follow-up;
Modular cart-based workstation designed for cath lab, supporting DICOM transmission;
Applicable for coronary and peripheral vascular intervention.
四、技术参数 Technical Specifications
中文
产品型号：797403（IntraSight Integrated System）
组成：工作站、隔离变压器、床边控制器 TSM、患者接口模块 PIM、接线盒 BUB，可选 LOMAP 组件
适配导管：Eagle Eye Platinum、89900、85900PST、88901 等一次性 IVUS 超声导管
适配压力导丝：10185P、10185JP、89185、89185J 系列
成像模式：灰阶 IVUS、VH 虚拟组织学、ChromaFlo 彩色血流
生理学功能：FFR、iFR 运算分析
显示：医用彩色液晶显示器；支持 DICOM 3.0
自动回撤速度：0.25–1.0 mm/s 可调
供电：交流 100–240V，50/60Hz
运行系统：专用医用嵌入式系统
管理类别：第三类医疗器械
English
Model: 797403 (IntraSight Integrated IVUS System)
Components: Workstation, isolation transｆormer, TSM bedside controller, PIM patient interface module, BUB junction box, optional LOMAP module
Compatible catheters: Disposable IVUS catheters including Eagle Eye Platinum, 89900, 85900PST, 88901
Compatible pressure guidewires: 10185P, 10185JP, 89185, 89185J series
Imaging modes: Grayscale IVUS, VH Virtual Histology, ChromaFlo color flow
Physiological function: FFR & iFR calculation and analysis
Display: Medical color LCD monitor; DICOM 3.0 compliant
Automatic pullback speed: Adjustable 0.25–1.0 mm/s
Power supply: AC 100–240V, 50/60Hz
Operation system: Dedicated medical ｅmbedded system
Device classification: Class III medical device
五、使用方法 Operation Method
中文
术前检查设备、电源线、连接线完整性，开机自检；确认 IVUS 导管 / 压力导丝在有效期内、包装完好无菌；
将患者接口模块与主机连接，安装无菌床边控制器；
介入常规穿刺建立血管通路，置入导引导丝，沿导丝送入 IVUS 超声导管至目标病变远端；
导管接头连接患者接口模块，系统识别导管，启动实时成像；
确认图像清晰后启动自动回撤，同步记录全程影像；
如需生理学检测，更换压力导丝连接系统，完成压力采集、FFR/iFR 测算；
术中对目标血管段进行图像测量、斑块分析，指导介入操作；
检查完成，停止采集，保存影像与报告；撤出导管，规范处置一次性耗材；
关闭设备，清洁消毒操作台及控制器外表面。
English
Inspect equipment, cables before use; power on and complete self-test. Verify IVUS catheter/pressure guidewire sterility and expiry date.
Connect patient interface module to main unit; install sterile bedside controller.
Establish vascular access via standard percutaneous technique. Advance guidewire and deliver IVUS catheter distally to target lesion over guidewire.
Connect catheter hub to PIM, system automatically identifies catheter and activates live imaging.
Initiate automatic pullback and continuous image recording once satisfactory image quality is obtained.
For physiological assessment, connect pressure guidewire to record pressure signals and compute FFR/iFR.
Perｆorm vascular measurement and plaque analysis to guide interventional treatment.
Terminate acquisition, save images and procedure report. Retract catheter and dispose single-use devices properly.
Power off system, clean and disinfect external surfaces of controller and workstation.
六、适应症 Indications
中文本设备配合 IVUS 导管：用于冠状动脉、外周血管血管壁与管腔成像，作为血管造影辅助手段，评估血管形态结构；配合压力导丝：冠状动脉造影及介入术中，测定血管压力，计算 FFR、iFR，评估冠脉狭窄血流动力学意义。临床适用场景：
冠脉造影结果模棱两可，明确狭窄真实严重程度；
评估粥样斑块形态、斑块负荷、斑块易损性；
指导支架尺寸选择、支架植入优化，判断支架贴壁、扩张情况；
识别血管夹层、血栓、钙化病变、血管重构；
慢性完全闭塞病变（CTO）介入策略指导；
外周动脉疾病介入术前规划与术后评估；
介入术后中长期随访评估。
EnglishWhen used with IVUS catheters: Perｆorm lumen and vessel wall imaging for coronary and peripheral arteries, as adjunct to angiography to evaluate vascular morphology.When used with pressure guidewire: Measure vascular pressure during coronary angiography and intervention to calculate FFR and iFR for hemodynamic evaluation of stenosis.Clinical applications:
Evaluate intermediate lesions with ambiguous angiographic findings;
Assess atherosclerotic plaque morphology, plaque burden and plaque vulnerability;
Guide stent sizing, optimize stent deployment, evaluate stent apposition and expansion;
Identify vascular dissection, thrombus, calcification and vascular remodeling;
Guide intervention for chronic total occlusion (CTO);
Pre-procedure planning and post-procedure assessment for peripheral arterial disease;
Long-term follow-up after endovascular intervention.
七、禁忌症 Contraindications
中文
脑血管内禁止使用配套 IVUS 导管；
无法耐受抗凝治疗、存在严重出血风险患者；
目标血管存在活动性夹层、大量新鲜血栓，导管推送易加重血管损伤；
血管严重迂曲、极度狭窄，导管无法安全送达目标区域；
对导管材料、肝素、造影剂存在严重过敏；
严重血流动力学不稳定、无法耐受介入操作；
妊娠患者仅在获益显著大于风险时谨慎评估使用。
English
Compatible IVUS catheters shall NOT be used in cerebral vessels;
Patients who cannot receive anticoagulation therapy with high bleeding risk;
Active vessel dissection or massive fresh thrombus at target site where catheter advancement may aggravate vascular injury;
Severe vessel tortuosity or extreme stenosis preventing safe catheter delivery;
Severe allergy to catheter materials, heparin or contrast media;
Severe hemodynamic instability intolerant to interventional procedure;
Pregnant patients: Use only when clinical benefit outweighs risks.
八、注意事项 Precautions
中文
主机与一次性 IVUS 导管、压力导丝必须型号匹配；严禁重复使用一次性导管；
超声导管不得与高频电刀同时靠近患者，避免干扰与安全风险；
导管推送全程透视监视，禁止暴力推送，防止血管夹层、穿孔；
严格按照导管说明书进行冲洗，排除导管内气泡，避免图像伪影；
设备属于精密医用电子仪器，避免碰撞、液体泼溅；
影像仅供医师综合临床信息诊断，不可单独作为诊断依据；
出现图像异常、设备报错立即停止操作，排查故障；
定期执行设备预防性维护；
所有连接线缆避免过度弯折；
操作人员必须经过 Volcano IVUS 系统正规培训。
English
Ensure compatibility between main unit, disposable IVUS catheters and pressure guidewires. Single-use catheters must not be reused.
Do not operate IVUS catheter simultaneously near high-frequency electrosurgical devices to avoid interference and hazards.
Advance catheter under continuous fluoroscopy; avoid forceful manipulation to prevent dissection or perforation.
Flush catheter strictly per IFU guidelines to eliminate air bubbles and imaging artifacts.
The system is precision medical electronic equipment; protect from impact and liquid spillage.
Images shall be interpreted by physicians combined with full clinical data; not to be used as sole diagnostic evidence.
Stop operation immediately in case of abnormal image or system error.
Perｆorm regular preventive maintenance.
Avoid excessive bending of all connecting cables.
Operators must receive ｆormal training on Volcano IVUS system.
九、存储条件 Storage Conditions
中文
环境温度：10℃～35℃；
相对湿度：30%～75%，无凝露；
大气压力：700hPa～1060hPa；
存放环境：干燥、通风、无尘，避免阳光直射、腐蚀性气体、剧烈震动；
长期闲置时断开电源，盖防尘罩；配套一次性耗材单独按照耗材说明书储存。
English
Ambient temperature: 10℃～35℃
Relative humidity: 30%～75%, non-condensing
Atmospheric pressure: 700hPa～1060hPa
Storage environment: Dry, ventilated and dust-free; avoid direct sunlight, corrosive gas and severe vibration.
Disconnect power and cover dust cover for long-term idle storage. Store disposable consumables separately per catheter IFU.
十、说明书核心信息 Summary of IFU Core Content
中文797403 为 Volcano IntraSight 一体化血管内超声诊断系统，第三类进口医疗器械，可整合 IVUS 解剖成像与冠脉生理学 FFR/iFR 检测；必须搭配原厂合规一次性超声导管、压力导丝使用；具备介入资质医师在导管室使用；一次性导管严禁复用；操作全程遵守介入放射防护规范；设备输出图像用于辅助血管病变评估，不能替代临床综合判断；需定期维护校准；运输、使用、存储避免剧烈冲击；出现不良事件按照法规上报；配套耗材灭菌有效期见外包装。
EnglishModel 797403 is Volcano IntraSight integrated IVUS system, Class III imported medical device integrating IVUS anatomical imaging and coronary physiological FFR/iFR measurement. It shall be used with original approved disposable IVUS catheters and pressure guidewires. Only operated by qualified interventional physicians in cardiac catheterization laboratory. Single-use catheters are prohibited from reprocessing/reuse. Follow radiation protection standards throughout procedure. Acquired images serve as auxiliary reference for vascular lesion assessment and cannot replace comprehensive clinical judgment. Regular maintenance and calibration are required. Avoid severe impact during transportation, operation and storage. Adverse events shall be reported in accordance with regulatory requirements. Shelf life of sterile consumables is marked on outer package.
管理类别
第三类
型号规格
797403
结构及组成/主要组成成分
该产品由隔离变压器、工作站、床边控制器（TSM）、患者接口模块（PIM）、接线盒（BUB）和可选组
件Lomap组成。其中患者接口模块（PIM）包含SA-PIM，PIMr和FM-PIM。
适用范围/预期用途
该产品在医疗机构中使用，与一次性使用血管内超声诊断导管（型号：89900，Eagle Eye Platinum，
85900PST，88901）配合使用，用于对血管壁、血管腔进行成像，为诊断提供信息。与一次性使用压力
导丝（型号：10185P，10185JP，89185，89185J）配合使用，用于在冠状动脉血管造影术和（或）介入
手术中显示冠状动脉病变血管压力和主动脉压并计算血流储备分数（Fractional Flow Reserve, FFR）
和瞬时无波型比率（Instantaneous Wave-free Ratio, iFR）。
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