厂商供应厚凯超声高频外科集成系统超声刀头HOC-345
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厂商供应厚凯超声高频外科集成系统超声刀头HOC-345
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
HOC-345、HOC-336、HOC-323、HOC-314
结构及组成/主要组成成分
刀头由刀杆部分、手控握持部分两大部分组成；刀杆部分由波导杆、夹持臂、套筒、组织垫、减震管组成，手控握持部分由手控按钮、手扳机、提示音弹片、外壳、拨轮、波形弹簧组件、复位弹簧、导线架组件、传动连杆组成。
适用范围/预期用途
预期与本公司生产的超声切割止血刀主机USG10 Plus和手柄HP25配合使用，用于辅助实现超声手术设备功能，最大可闭合直径3mm及以下的血管。
1、工作原理 Working Principle
中文：超声主机输出高频电信号，经手柄压电换能器转换为高频机械振动，通过刀头波导杆传递至刀头尖端；刀头高频机械振动使接触的软组织内蛋白氢键断裂、组织水汽化变性，实现软组织切割，同时使血管壁蛋白凝固闭合，完成止血；无电流流经患者人体。English：The ultrasonic main unit outputs high‑frequency electrical signals, which are converted into high‑frequency mechanical vibration by the piezoelectric transducer of handpiece, and transmitted to the tip of blade via waveguide rod. High‑frequency mechanical vibration of blade breaks protein hydrogen bonds, vaporizes tissue moisture and denatures soft tissue to realize cutting; meanwhile, it coagulates vessel wall protein for vessel closure and hemostasis. No electric current passes through patient’s body。
2、功能 Functions
中文：①手术中软组织的切割；②软组织及血管凝闭止血；③最大可闭合直径 3mm 及以下血管；④配合主机实现腔镜、开放手术下组织分离处理。English：①Soft tissue cutting during surgery; ②Coagulation and hemostasis for soft tissue and blood vessels; ③Closure of blood vessels up to 3 mm in diameter; ④Perｆorm tissue dissection for laparoscopic and open surgery when matched with main unit。
3、产品特点 Product Features
中文：①一次性使用，环氧乙烷灭菌，避免交叉感染；②枪式操作手柄，扳机、手控双模式输出；③刀杆 45° 工作角度，适配腔镜狭小操作空间；④热损伤范围可控，减少周边组织副损伤；⑤刀头夹持臂带组织垫，提升夹持稳定性；⑥与 USG10 Plus 主机、HP25 手柄配套识别。English：①Single‑use, ethylene‑oxide sterilized to avoid cross‑infection; ②Gun‑style handle with dual trigger‑manual activation modes; ③45° working angle of shaft, suitable for narrow laparoscopic working space; ④Controllable thermal injury range to reduce collateral tissue damage; ⑤Jaw with tissue pad for stable grasping; ⑥Automatic recognition when matched with USG10 Plus main unit and HP25 handpiece。
4、技术参数 Technical Parameters
中文1. 型号：HOC‑345 2. 使用方式：一次性使用，环氧乙烷灭菌 3. 配套设备：超声切割止血刀主机 USG10 Plus、手柄 HP25 4. 最大闭合血管直径：≤3mm 5. 刀杆工作角度：45° 6. 结构组成：刀杆部分（波导杆、夹持臂、套筒、组织垫、减震管）；手控握持部分（手控按钮、手扳机、外壳、拨轮、弹簧组件、传动连杆等） 7. 灭菌有效期：见产品外包装 8. 管理类别：Ⅱ 类医疗器械English1.Model:HOC‑345 2.Usage:Single‑use,ethylene‑oxide sterilization 3.Compatible device:Ultrasonic cutting and hemostasis main unit USG10 Plus,handpiece HP25 4.Maximum sealable vessel diameter:≤3 mm 5.Shaft working angle:45° 6.Structure:Shaft assembly(waveguide rod,jaw assembly,sleeve,tissue pad,damping tube);hand‑grip assembly(manual button,trigger,housing,adjust wheel,spring assembly,transmission linkages etc.) 7.Sterilization validity:Refer to outer package 8.Device class:Class Ⅱ medical device
5、使用方法 Operation Method
中文1. 术前检查包装完整性、灭菌有效期，包装破损或过期禁止使用。 2. 将刀头与 HP25 手柄进行机械装配，确认装配到位；手柄连接 USG10 Plus 主机。 3. 开机完成主机自检，确认系统识别刀头。 4. 术中将目标组织置于夹持臂之间，扣动扳机或按压手控按钮，选择合适能量档位，执行组织切割、凝闭操作。 5. 操作结束，停止能量输出；手术完成后，按医疗废弃物规范处置，严禁重复使用。English1.Check package integrity and sterilization expiry date before surgery. Do not use if package is damaged or expired. 2.Mechanically assemble blade to HP25 handpiece and ensure full engagement; connect handpiece to USG10 Plus main unit. 3.Power‑on and complete self‑test, confirm the system recognizes the blade. 4.Place target tissue between jaws, pull trigger or press manual button, select appropriate energy level to perｆorm tissue cutting and coagulation. 5.Stop energy output after operation. Dispose of used blade as medical waste after surgery. Reuse is strictly prohibited.
6、适应症 Indications
中文：医疗机构内，配合 USG10 Plus 主机、HP25 手柄，用于外科手术中软组织切割、组织分离、血管闭合止血；适用于普外科、妇科、胸外科、泌尿外科等开放及腔镜手术，仅用于闭合直径≤3mm 血管。English：Used in medical institutions together with USG10 Plus main unit and HP25 handpiece, for soft‑tissue cutting, dissection and blood‑vessel closure & hemostasis in surgical procedures. Applicable for open and laparoscopic surgeries in general surgery, gynecology, thoracic surgery, urology and other departments, only for vessels ≤3 mm diameter。
7、禁忌症 Contraindications
中文1. 禁止用于闭合＞3mm 直径血管； 2. 禁止用于骨组织、硬质钙化组织切割； 3. 禁止用于眼部、神经等不耐受热损伤的精细高危组织直接操作； 4. 不可用于对环氧乙烷灭菌残留物过敏患者的直接接触部位； 5. 不可与非原厂指定主机、手柄搭配使用。English1.Should not be used for vessels over 3 mm diameter; 2.Not for cutting bone or hard calcified tissue; 3.Direct operation on heat‑vulnerable high‑risk tissues such as eyes and nerves is prohibited; 4.Should not be applied to direct‑contact sites of patients allergic to ethylene‑oxide residues; 5.Do not use with non‑original designated main unit or handpiece.
8、注意事项 Precautions
中文1. 本品为一次性使用，严禁重复使用、重复灭菌；重复使用会造成机械失效、止血失败、交叉感染风险。 2. 只能与厚凯原厂 USG10 Plus 主机、HP25 手柄配套使用，其它品牌主机手柄会导致性能失效、手术风险。 3. 仅可闭合≤3mm 血管，超出规格血管禁止使用本刀头闭合。 4. 能量输出时刀头尖端温度高，避免触碰周围非目标组织，防止热灼伤。 5. 操作中避免刀头与金属器械、钛夹等硬质硬物直接撞击，防止波导杆损伤断裂。 6. 刀头装配必须到位，装配不良将引发振动异常、输出不足。 7. 术中若出现异常异响、报警，立即停止使用，更换刀头。 8. 废弃刀头按感染性医疗废物处置。 9. 操作人员须经过超声外科设备规范化培训。English1.This is single‑use device. Reuse or re‑sterilization is strictly forbidden, which may cause mechanical failure, hemostasis failure and cross‑infection risk. 2.Must be used with original HocerMed USG10 Plus main unit and HP25 handpiece. Mismatched third‑party devices may lead to perｆormance failure and surgical hazard. 3.Only for vessels ≤3 mm diameter. Do not seal vessels exceeding specification. 4.The tip gets high temperature during energy delivery. Avoid touching non‑target surrounding tissue to prevent thermal burn. 5.Avoid collision with hard ｏbjects such as ｍmbedl instruments and titanium clips to prevent waveguide rod damage or fracture. 6.Complete assembly is mandatory; improper assembly causes abnormal vibration and insufficient energy output. 7.Stop using immediately and replace blade if abnormal noise or alarm occurs during operation. 8.Dispose used blade as infectious medical waste. 9.Operators shall receive standardized training for ultrasonic surgical equipment.
9、存储条件 Storage Conditions
中文：环境温度‑20℃～+55℃；相对湿度 10%～80%，无冷凝；通风干燥，避免阳光直射、腐蚀性气体、重压撞击；原包装存放。English：Ambient temperature:‑20℃～+55℃; relative humidity:10%‑80%, non‑condensing. Store in ventilated and dry place, avoid direct sunlight, corrosive gas, heavy pressure and impact; keep in original package.
10、说明书核心摘要 Core Summary
中文：厚凯 HOC‑345 超声高频外科集成系统超声刀头为一次性环氧乙烷灭菌耗材，必须配套本公司 USG10 Plus 主机与 HP25 手柄；依靠超声高频机械振动实现软组织切割、血管闭合止血，最大闭合血管直径 3mm；用于多科室开放及腔镜外科手术；严禁重复使用，严禁闭合超规格血管，注意防范术中热损伤；按医疗废物处理使用后产品，在规定温湿度环境原包装储存。English：HocerMed HOC‑345 Ultrasonic High‑Frequency Surgical Integrated System Blade is single‑use EO‑sterilized consumable. It must be matched with original USG10 Plus main unit and HP25 handpiece. It realizes soft‑tissue cutting and vessel hemostasis by high‑frequency ultrasonic mechanical vibration, maximum sealable vessel diameter 3 mm. It is applied in open and laparoscopic surgeries of multiple departments. Reuse is strictly prohibited. Do not seal over‑specification vessels. Prevent intra‑operative thermal injury. Dispose used products as medical waste, store in original package under specified temperature‑humidity range。
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。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. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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