厂商直供厚凯一次性使用超声软组织手术刀头
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厂商直供厚凯一次性使用超声软组织手术刀头
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
HOC-T545、HOC-T536、HOC-T523、HOC-T514
结构及组成/主要组成成分
该产品由刀杆部分、手控握持部分和扭力扳手组成。其中刀杆由波导杆（包含涂层）、夹持臂、套筒、组织垫组成，手控握持由手控按键、手板机、波轮、手握外壳组成。
适用范围/预期用途
该产品在医疗机构中使用，与本公司生产的超声切割止血刀主机USG10（软件发布版本V1.0）或USG10Plus（软件发布版本V1.0）和手柄HP25配合使用，用于软组织的切割止血，可闭合不超过5mm的血管。
1、工作原理 Working Principle
中文：本刀头配合超声主机与手柄，将电能转换为高频机械振动，通过波导杆传递至刀头末端；高频振动使组织内水分子汽化、蛋白变性，在机械切割软组织的同时使血管壁蛋白凝固闭合，实现切割与止血同步完成；无电流流经人体，依靠超声机械效应完成手术操作。English：Cooperating with ultrasonic main unit and handpiece, the device converts electric energy into high‑frequency mechanical vibration, which is transmitted to the distal end via waveguide rod. High‑frequency vibration vaporizes intracellular water molecules and denatures tissue protein. It realizes simultaneous cutting of soft tissue and vascular closure by protein coagulation. No electric current passes through patient’s body; surgical effect is achieved by ultrasonic mechanical effect。
2、功能 Function
中文：对软组织进行抓持、分离、切割；闭合血管实现术中止血；可完成组织离断、血管凝闭，支持腹腔镜及开放手术操作；止血档位下可闭合更大管径血管。English：Grasp, dissect and cut soft tissues; achieve hemostasis by vessel sealing; perｆorm tissue transection and vascular occlusion for laparoscopic and open surgeries; seal larger‑diameter vessels under advanced hemostasis mode。
3、产品特点 Product Features
中文：①一次性使用，环氧乙烷灭菌，杜绝交叉感染风险；②侧向热损伤小，对周边组织保护好；③集抓持、分离、切割、止血多功能一体；④多长度刀杆型号适配不同手术深度；⑤手控按键，操作便捷；⑥兼容厚凯 USG10Plus 主机、HP25 手柄；⑦档位支持 7mm 血管闭合（需符合临床规范）。English：①Single‑use, EO sterilized to avoid cross‑infection; ②Minimal lateral thermal injury to protect surrounding tissues; ③Integrated functions of grasping, dissection, cutting and hemostasis; ④Multiple shaft lengths for different surgical depths; ⑤Hand‑control button for convenient operation; ⑥Compatible with HOKAI USG10Plus generator and HP25 handpiece; ⑦Advanced mode supports sealing of vessels up to 7 mm (comply with clinical specifications)。
4、技术参数 Technical Parameters
中文
振动频率：55.5kHz
刀杆有效长度：14cm/23cm/36cm/45cm（对应 HOC‑H714/H723/H736/H745）
最大闭合血管：常规档位≤5mm；止血档位≤7mm（需临床评估）
灭菌方式：环氧乙烷灭菌
产品状态：一次性使用，不可重复灭菌复用
组成：超声刀头本体 + 扭力扳手
适配：仅适配 USG10Plus 主机、HP25 手柄English
Vibration frequency:55.5 kHz
Effective shaft length:14cm/23cm/36cm/45cm（HOC‑H714/H723/H736/H745）
Max sealing vessel: ≤5 mm under normal mode; ≤7 mm under advanced hemostasis mode(clinical assessment required)
Sterilization:Ethylene oxide sterilization
Usage:Single‑use only, resterilization and reuse prohibited
Components:Ultrasonic blade unit + torque wrench
Compatibility:Only for HOKAI USG10Plus generator and HP25 handpiece
5、使用方法 Operation Method
中文
检查包装完整性、灭菌有效期，确认型号匹配；
使用扭力扳手将刀头锁紧装配至 HP25 手柄；
将手柄连接 USG10Plus 超声主机，开机自检；
夹持靶组织，选择切割 / 凝血档位，扣动扳机或按压手控按键执行操作；
血管闭合时保持合适夹持压力，等待组织充分凝固后再离断；
手术结束，断开连接，按医疗废物处置刀头，严禁重复使用。English
Inspect package integrity and sterilization expiry date, confirm model matching.
Fasten and assemble blade to HP25 handpiece with torque wrench.
Connect handpiece to USG10Plus generator and power‑on for self‑test.
Clamp target tissue, select cut / coag mode, pull trigger or press hand‑control button to operate.
Maintain proper clamping force for vessel sealing; transect tissue only after adequate coagulation.
After surgery, disconnect components, dispose blade as medical waste. Reuse is strictly prohibited.
6、适应症 Indications
中文：医疗机构中，与配套主机、手柄配合，用于外科手术中软组织切割止血；常规可闭合直径≤5mm 血管；止血档位可闭合最大 7mm 血管，用于普外科、妇科、泌尿外科、胸外科、头颈乳腺外科等开放及腹腔镜手术，实现软组织分离、切割、血管闭合止血。English：Used in medical institutions with matched generator and handpiece for soft‑tissue cutting and hemostasis in surgical procedures. Routine sealing for vessels ≤5 mm; up to 7 mm under advanced hemostasis mode. Applied in general surgery, gynecology, urology, thoracic surgery, head‑neck and breast surgery for open and laparoscopic operations for soft‑tissue dissection, cutting and vascular sealing hemostasis。
7、禁忌症 Contraindications
中文
禁止用于骨组织、硬钙化组织切割；
不可用于心脏大血管、主动脉等生命高危大血管的闭合；
禁止用于对环氧乙烷过敏患者直接接触部位；
不可用于除配套 USG10Plus+HP25 以外其他品牌 / 型号主机手柄；
不适合无合适手术视野、无法安全夹持靶组织的术野。English
Not for cutting bone or heavily calcified tissue.
Do not seal major vital vessels such as aorta and cardiac great vessels.
Avoid direct contact with patients sensitive to ethylene oxide.
Forbidden to use with generators / handpieces other than matched USG10Plus and HP25.
Not applicable for surgical field without adequate view and safe tissue‑clamping condition.
8、注意事项 Precautions
中文
一次性使用，包装破损、过期严禁使用；
7mm 血管闭合仅在止血档位使用，需医师结合患者凝血、血压、抗凝状态综合评估；
操作时避免刀头接触金属器械，防止刀头损坏、能量异常；
夹持组织不可过载，避免刀杆断裂；
刀头工作末端温度较高，防止灼伤周围脏器、组织；
装配必须使用配套扭力扳手，保证锁紧到位；装配不到位会导致能量输出异常；
术中留意刀头工作噪音与振动，出现异常立即停止使用；
不得冲洗、浸泡、重复灭菌刀头；
严格遵循临床外科操作规范与说明书全部要求。English
Single‑use only. Do not use if package damaged or expired.
7 mm‑vessel sealing shall only be perｆormed under advanced hemostasis mode. Physician shall comprehensively evaluate patient’s coagulation status, blood pressure and anticoagulation therapy.
Prevent blade tip from touching ｍmbedl instruments to avoid blade damage and abnormal energy output.
Do not overload clamping force to prevent shaft fracture.
Distal tip gets hot during activation; avoid thermal burn to adjacent organs and tissues.
Assemble with matched torque wrench to ensure full locking; improper assembly causes abnormal energy output.
Stop operation immediately if abnormal noise or vibration occurs.
Do not rinse, immerse or resterilize the blade.
Strictly comply with clinical surgical specifications and full instructions for use.
9、存储条件 Storage Conditions
中文：环境温度：‑20℃～+45℃；相对湿度：10%‑80%；无腐蚀性气体，通风干燥，避免阳光直射、重压、跌落；远离热源。English：Ambient temperature:‑20℃～+45℃; Relative humidity:10%‑80%. Store in dry, ventilated environment without corrosive gas. Avoid direct sunlight, heavy pressure, drop and heat source.
10、说明书核心摘要 Core Summary of IFU
中文：厚凯一次性使用超声软组织手术刀头为 Ⅲ 类无源手术耗材，环氧乙烷灭菌，与 USG10Plus 主机、HP25 手柄配套使用；用于外科手术软组织切割、分离、血管闭合止血；常规最大闭合 5mm 血管，档位最大 7mm 血管，7mm 血管闭合需医师综合评估患者情况；一次性使用，禁止复用、重复灭菌；装配使用配套扭力扳手；存储保持干燥通风；出现包装破损、过期禁止使用；操作注意热损伤与刀头过载风险，废弃按医疗废物处理，全部操作遵从外科临床规范与完整说明书。English：HOKAI single‑use ultrasonic soft‑tissue surgical blade is Class‑Ⅲ passive surgical consumable, EO‑sterilized. It shall only be used with matched USG10Plus generator and HP25 handpiece. It is intended for soft‑tissue cutting, dissection and vascular sealing hemostasis in surgeries. Max sealing diameter is 5 mm under normal mode and up to 7 mm under advanced mode, and 7 mm‑vessel sealing requires comprehensive clinical evaluation by surgeons. Single‑use only; reuse and resterilization are prohibited. Assemble with matched torque wrench. Store in dry and ventilated place. Reject product with damaged package or expired shelf‑life. Pay attention to thermal injury and over‑load risk during operation. Dispose as medical waste. All operations shall comply with surgical clinical specifications and complete Instructions for Use.
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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