厂商直供火山IVUS血管内超声诊断导管88900,88901
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厂商直供火山IVUS血管内超声诊断导管88900,88901
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
88900，88901
结构及组成/主要组成成分
由圆柱型超声换能器、导管管体组成，于配合美国VOLCANO CORPORATION 公司生产的型号为S5
(807300-001)和S5i(807400-001)血管内超声波诊断仪使用。一次性使用产品，环氧乙烷灭菌，有效期3
年。
适用范围/预期用途
通过提供外周血管的横断面图像在血管内评估血管的形态，作为传统血管造影的辅助手段提供血管腔和
管壁的图像并进行尺寸测量。
注册证：国械注进 20193061625；一次性使用、环氧乙烷灭菌，配套 Volcano S5 / S5i IVUS 诊断主机
一、工作原理 Working Principle
中文导管远端搭载 64 阵元圆柱形数字超声换能器，经导丝送入血管腔内；换能器发射高频超声波，声波穿透血液抵达血管壁、斑块组织，不同组织产生反射回波；换能器接收回声信号并传输至 IVUS 主机，系统将信号重建为血管横断面实时二维灰阶超声图像，实现血管腔、血管壁、动脉粥样硬化斑块的腔内成像，辅助血管造影进行定量与定性评估。EnglishThe distal tip of the catheter is equipped with a 64-element cylindrical digital ultrasound transducer, which is delivered into the blood vessel lumen over a guidewire. The transducer emits high-frequency ultrasound waves that travel through blood to the vascular wall and plaque tissue; echoes are generated at tissue interfaces. The transducer receives echo signals and transmits them to the IVUS console. The system reconstructs signals into real-time 2D grayscale cross-sectional images of vessels, enabling intraluminal visualization of vessel lumen, vascular wall and atherosclerotic plaques, supporting quantitative and qualitative assessment as an adjunct to angiography.
二、产品功能 Product Functions
中文
获取外周血管横断面实时超声影像；
测量管腔面积、血管直径、斑块负荷等参数；
显示血管壁三层结构、斑块形态、钙化、血栓；
作为血管造影补充手段，指导外周血管介入诊疗；
记录、存储腔内超声影像用于术后复盘分析。English
Acquire real-time cross-sectional ultrasound images of peripheral blood vessels;
Measure lumen area, vessel diameter, plaque burden and other parameters;
Display three-ｌayer structure of vessel wall, plaque morphology, calcification and thrombus;
Serve as an adjunct to angiography to guide peripheral vascular interventional diagnosis and treatment;
Record and store intravascular ultrasound images for post-procedure review and analysis.
三、产品特点 Product Features
中文
数字式 64 阵元换能器，图像信噪比高，成像清晰度；
兼容 0.035”~0.038” 标准导丝，90cm 有效工作长度；
导管外壁亲水涂层，推送顺滑，降低血管损伤风险；
锥形软头端，通过迂曲血管能力更强；
一次性无菌使用，杜绝交叉感染；
配套 Volcano S5/S5i IVUS 系统，支持自动回撤成像；
8.2F 成像探头外径，最低适配 8.5F 鞘管。English
Digital 64-element transducer with high signal-to-noise ratio and superior image clarity;
Compatible with 0.035”~0.038” standard guidewire, 90 cm usable working length;
Hydrophilic coating on catheter shaft for smooth delivery and lower risk of vessel injury;
Soft tapered tip for improved trackability across tortuous vasculature;
Single-use sterile device to prevent cross-contamination;
Designed for Volcano S5 / S5i IVUS systems, supporting automatic pullback imaging;
8.2F imaging transducer outer diameter, minimum compatible sheath size 8.5F.
四、技术参数 Technical Specifications
中文
型号：88900、88901（Visions PV .035）
成像换能器尺寸：8.2F（2.73 mm）
导管杆最大外径：7.0F（2.33 mm）
有效工作长度：90 cm
适配导丝：0.035 inch ~ 0.038 inch（0.89–0.97 mm）
最小鞘管 / 导入鞘：8.5F
超声中心频率：9 MHz
灭菌方式：环氧乙烷（EO）灭菌
有效期：自灭菌起 3 年
使用方式：一次性使用，禁止重复灭菌复用
适用主机：Volcano S5 (807300-001)、S5i (807400-001) 血管内超声诊断仪English
Model: 88900, 88901 (Visions PV .035)
Transducer outer diameter: 8.2F (2.73 mm)
Maximum shaft outer diameter: 7.0F (2.33 mm)
Usable working length: 90 cm
Compatible guidewire: 0.035 inch ~ 0.038 inch (0.89–0.97 mm)
Minimum introducer sheath: 8.5F
Ultrasound center frequency: 9 MHz
Sterilization: Ethylene Oxide (EO)
Shelf life: 3 years after sterilization
Usage: Single use only, re-sterilization and reuse prohibited
Compatible console: Volcano S5 (807300-001), S5i (807400-001) IVUS System
五、使用方法 Operation Method
中文
术前检查 IVUS 主机运行正常，核对导管外包装完好、在有效期内；
无菌操作打开包装，置于无菌台；经 Y 接头冲洗导丝腔，肝素生理盐水擦拭导管全长；
移除导管 PIM 连接器保护帽，连接至患者接口模块，确认图像输出正常；
将导管穿入血管内已到位的导丝，肝素生理盐水浸润激活亲水涂层；
沿导丝缓慢推送导管至目标成像血管段；
启动成像，可手动或自动回撤采集连续血管横断面影像，完成测量与记录；
成像结束后，沿导丝缓慢撤出导管；
按医疗废物规范处置一次性导管。English
Verify normal operation of IVUS console; confirm catheter package intact and within expiry date;
Open package under sterile technique and place on sterile field. Flush guidewire lumen via Y-connector, wipe full catheter length with heparinized saline;
Remove protective cap of PIM connector, connect to patient interface module and confirm image output;
Thread catheter over the in-situ intravascular guidewire; activate hydrophilic coating with heparinized saline;
Advance catheter slowly over guidewire to target vascular segment for imaging;
Activate imaging; acquire continuous cross-sectional images via manual or automatic pullback, perｆorm measurement and recording;
After imaging, withdraw catheter slowly over guidewire;
Dispose of single-use catheter as regulated medical waste.
六、适应症 Indications
中文用于评估外周血管血管形态；作为常规血管造影辅助手段，提供血管腔与血管壁结构影像并进行尺寸测量；适用于外周动脉疾病介入术中评估病变斑块、管腔狭窄程度，指导介入方案选择、评估术后支架 / 球囊治疗效果。EnglishIntended to evaluate vascular morphology in peripheral blood vessels. As an adjunct to conventional angiography, it provides images of vessel lumen and wall structure and dimensional measurement. Indicated for interventional procedures of peripheral arterial disease to assess atherosclerotic plaques and luminal stenosis, guide interventional strategy and evaluate post-procedural stent / angioplasty outcomes.
七、禁忌症 Contraindications
中文
禁止用于脑血管系统；
严重血管痉挛、重度血管钙化、血管严重迂曲难以输送导管；
血管内存在大面积活动性血栓；
无法充分抗凝、存在肝素严重过敏患者；
存在血管破裂、夹层高风险，导管操作极易造成组织 / 血管严重损伤；
未经培训医师操作。English
Not for use in cerebral vasculature;
Severe vasospasm, heavy vascular calcification, extreme vessel tortuosity preventing safe catheter delivery;
Large active intraluminal thrombus;
Patients unable to receive adequate anticoagulation or with severe heparin allergy;
High risk of vessel dissection or rupture where catheter manipulation may cause severe vascular injury;
Operation by untrained personnel.
八、注意事项 Precautions
中文
仅一次性使用，严禁重复使用、二次灭菌；包装破损、受潮禁止使用；
仅可配套指定 Volcano IVUS 主机使用，不可兼容其他品牌超声系统；
推送 / 回撤导管全程轻柔，禁止暴力操作，防止血管夹层、穿孔；
全程维持有效抗凝，降低导管相关血栓风险；
不可与高频电刀设备同时靠近导管工作，避免干扰或器械损坏；
导管不可弯折、挤压超声探头段；
术中持续监测患者生命体征，警惕血管损伤、栓塞、造影剂不良反应；
仅允许接受正规 IVUS 操作培训的介入医师使用；
若图像异常，停止输送，排查连接或导管故障。English
Single use only. Reuse and re-sterilization are strictly prohibited. Discard if package is damaged or moist;
Only compatible with designated Volcano IVUS consoles; incompatible with other brand imaging systems;
Advance and withdraw catheter gently at all times. Avoid forceful manipulation to prevent dissection or perforation;
Maintain adequate anticoagulation throughout procedure to reduce catheter-related thrombosis risk;
Do not operate high-frequency electrosurgical equipment adjacent to catheter to avoid interference or device damage;
Do not bend or squeeze the ultrasound transducer segment;
Continuously monitor patient vital signs during procedure, watch for vascular injury, embolism and contrast media adverse reactions;
Device shall only be operated by interventional physicians ｆormally trained in IVUS technique;
Stop catheter advancement if imaging abnormality occurs; inspect connection and catheter integrity.
九、存储条件 Storage Conditions
中文存放环境：温度 10℃ ~ 30℃；相对湿度 30%～75%；无腐蚀性气体、通风干燥；避免阳光直射、重压、弯折、剧烈震动；水平或竖直放置，不可堆叠重物；在原包装内保存，直至使用前开封。EnglishStorage environment: Temperature 10℃ ~ 30℃; relative humidity 30%～75%; well ventilated, dry, free of corrosive gas. Avoid direct sunlight, heavy compression, bending and severe vibration. Store horizontally or vertically, do not stack heavy ｏbjects. Keep inside original packaging until use.
十、说明书核心信息 Summary of IFU Core Content
批准文号国械注进20193061625
中文本品为第三类一次性无菌血管内超声诊断导管，型号 88900、88901（Visions PV .035），配套 Volcano S5/S5i IVUS 诊断系统，用于外周血管腔内超声成像，辅助血管造影完成病变评估。依靠 64 阵元数字超声换能器生成血管横断面图像，支持管腔、斑块定量测量。外周血管使用，严禁脑血管应用；一次性 EO 灭菌，有效期 3 年。操作必须由培训合格介入医师实施，严格遵循无菌操作，轻柔输送导管预防血管并发症。出现包装破损、超期禁止使用，不可复用。按照规定条件避光干燥储存。EnglishThis is Class III single-use sterile intravascular ultrasound catheter, model 88900 / 88901 (Visions PV .035), compatible with Volcano S5/S5i IVUS system for peripheral intravascular imaging to assist angiographic lesion assessment. A 64-element digital transducer generates cross-sectional vessel images and enables quantitative measurement of lumen and plaque. For peripheral vasculature only;cerebral use is forbidden. Single-use EO sterilized, shelf life 3 years. Operation must be perｆormed by trained interventional physicians under strict sterile conditions; gentle catheter delivery is required to reduce vascular complications. Discard if package damaged or expired; reuse is prohibited. Store in dry, light-protected environment as specified.
以上产品详情仅供参考，上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理!The above product details are for reference only. Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical products. All products are sourced from respective manufacturers, agents and distributors. Please contact us in case of any infringement, and we will handle it promptly.
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