厂商直销精锋一次性使用超声软组织手术刀头MP1500
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厂商直销精锋一次性使用超声软组织手术刀头MP1500
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
MP1500
结构及组成/主要组成成分
产品由器械盒、器械杆、器械末端和扭矩扳手组成。
适用范围/预期用途
产品在医疗机构中使用，与本公司生产的胸腹腔内窥镜手术系统（型号：MP1000、MP2000、MP2000Apex、MP2000power）以及厚凯（天津）医疗科技有限公司的超声切割止血刀（型号：USG10Plus，软件发布版本：V1.0）、换能器（型号：HP25）配合使用，在手术中用于软组织的切割止血，可闭合直径不超过5mm的血管。
1、工作原理 Working Principle
中文：配套超声主机输出高频电信号，经换能器转换为高频纵向机械振动，振动能量通过刀头波导杆传递至刀头末端；刀头高频机械振动使接触软组织内水分子汽化、蛋白变性凝固，实现软组织同步切割与血管闭合止血；依靠机械超声能量工作，无电流流经人体组织。English：The matched ultrasonic generator outputs high‑frequency electrical signals, which are converted into high‑frequency longitudinal mechanical vibration by the transducer. Vibration energy is transmitted to the distal end of the blade through the waveguide rod. High‑frequency mechanical vibration of the blade vaporizes intracellular water and denatures tissue protein, realizing simultaneous soft‑tissue cutting and vessel sealing. It works by mechanical ultrasonic energy without electric current passing through human tissues。
2、产品功能 Functions
中文：①外科手术中软组织切割；②软组织凝闭止血；③闭合直径≤5mm 血管；④腔镜下组织分离、解剖处理，仅可与规定兼容设备配套使用。English：①Soft‑tissue cutting in surgical procedures; ②Soft‑tissue coagulation and hemostasis; ③Seal blood vessels with diameter ≤5 mm; ④Endoscopic tissue dissection and manipulation. Shall only be used with designated compatible equipment。
3、产品特点 Product Features
中文：1. 一次性无菌设计，消除交叉感染风险；2. 腔镜适配细长杆体，适配微创胸腹腔手术；3. 钳口结构，夹持组织稳定；4. 超声能量，热损伤范围小；5. 无电流通过人体，减少电损伤风险；6. 仅适配指定型号主机及换能器，不可跨品牌随意混用。English：1. Single‑use sterile design to eliminate cross‑infection risk; 2. Slender shaft for minimally invasive thoracoscopic and laparoscopic surgery; 3. Jaw structure for stable tissue grasping; 4. Ultrasonic energy with limited thermal spread; 5. No electric current through human body to reduce electrical injury risk; 6. Only compatible with designated generator and transducer models, prohibited for arbitrary cross‑brand mixing。
4、技术参数 Technical Parameters
中文1. 型号：MP1500 2. 产品组成：器械盒、器械杆、器械末端、扭矩扳手 3. 灭菌方式：环氧乙烷灭菌 4. 无菌有效期：3 年 5. 适用最大闭合血管直径：≤5 mm 6. 适配设备：精锋胸腹腔内窥镜手术系统 MP1000、MP2000、MP2000Apex、MP2000Power；厚凯 USG10Plus 超声切割止血刀 + HP25 换能器 7. 使用方式：一次性使用，不可重复灭菌复用 8. 适用腔镜穿刺套管规格：5 mm 及以上English1.Model: MP1500 2.Composition: Instrument box, instrument shaft, distal end, torque wrench 3.Sterilization: Ethylene oxide sterilization 4.Shelf‑life (sterile): 3 years 5.Max. sealable vessel diameter: ≤5 mm 6.Compatible devices: Senfeng Endoscopic Surgical System MP1000, MP2000, MP2000Apex, MP2000Power; Houkai USG10Plus ultrasonic cutting‑coagulation system with HP25 transducer 7.Usage: Single‑use only, re‑sterilization and reuse prohibited 8.Compatible trocar size: ≥5 mm
5、使用方法 Operation Method
中文1. 术前：检查包装完整性、灭菌有效期；核对型号；无菌条件下取出刀头；使用扭矩扳手将刀头与换能器可靠锁紧；确认钳口开合顺畅。 2. 设备连接：将换能器连接至兼容超声主机，完成设备开机自检。 3. 术中：钳口张开，将目标软组织置入钳口之间；闭合钳口夹持组织；根据组织类型选择能量档位，触发能量输出，完成切割 / 凝闭；单次连续激发时间不宜过长，间歇操作；操作完成后释放钳口。 4. 进出穿刺套管时，必须闭合钳口；术中及时清除刀头组织焦痂。 5. 术后：产品使用完毕，按医疗废物处理规范丢弃，严禁重复使用。English1.Pre‑operation: Inspect package integrity and sterile expiry date; verify model; take out blade under sterile condition; fasten blade to transducer with torque wrench; confirm smooth jaw opening‑closing. 2.Connection: Connect transducer to compatible ultrasonic generator and complete power‑on self‑test. 3.Intra‑operation: Open jaws, place target soft tissue between jaws; close jaws to grasp tissue; select energy level according to tissue property, activate energy output for cutting / coagulation; avoid excessively long continuous activation, use intermittent operation; release jaws after completion. 4.Jaws must be closed when inserting / withdrawing from trocar; remove charred tissue debris during operation. 5.Post‑operation: Discard used device as medical waste. Reuse is strictly forbidden。
6、适应症 Indications
中文：在医疗机构内，与指定兼容设备配套，用于外科手术中软组织切割止血，可闭合直径不超过 5 mm 的血管，适用于腔镜及开放外科手术软组织处理。English：Used in medical institutions with designated compatible equipment, for cutting and hemostasis of soft tissue in surgical procedures; capable of sealing blood vessels up to 5 mm diameter, for soft‑tissue manipulation in endoscopic and open surgery。
7、禁忌症 Contraindications
中文：1. 不可用于骨组织、钙化坚硬组织；2. 不可用于大血管（＞5 mm 直径）直接闭合；3. 不可用于心脏、大血管等不允许热损伤的高危组织；4. 禁止在非兼容主机 / 换能器条件下使用；5. 禁止用于不适合超声外科器械的组织部位。English：1.Not for bone or heavily calcified hard tissue; 2.Not for direct sealing of vessels＞5 mm diameter; 3.Not for high‑risk tissues such as heart and great vessels where thermal injury is unacceptable; 4.Prohibited to use with non‑compatible generator / transducer; 5.Not for anatomical sites unsuitable for ultrasonic surgical devices.
8、注意事项 Notes & Warnings
中文1. 本产品为一次性无菌耗材，包装破损、过期禁止使用；严禁重复使用、再次灭菌。 2. 仅可使用注册载明的兼容主机、换能器，错配将造成刀头损坏、手术风险。 3. 仅可闭合≤5 mm 血管，对闭合效果必须肉眼观察确认，止血不满意应采取缝合等其他止血手段。 4. 避免刀头接触金属器械、骨骼，防止刀头断裂、损坏。 5. 单次连续超声激发不宜长时间持续，防止刀头过热、组织碳化；及时清理刀头焦痂。 6. 进出穿刺器套管前务必闭合钳口，防止钳口受损。 7. 不可过度暴力夹持组织，避免器械损坏或组织撕裂。 8. 使用后刀头尖端温度较高，避免烫伤周围正常组织。 9. 操作环境注意电磁兼容，远离强电磁干扰设备。 10. 手术中如刀头发生异常振动、异响，立即停止能量输出，检查整套系统。English1.Single‑use sterile device. Do not use if package damaged or expired. Reuse and re‑sterilization are strictly prohibited. 2.Only use with generator and transducer specified in registration; mismatched equipment may cause blade failure and surgical hazard. 3.Only seal vessels ≤5 mm. Visually verify hemostasis. If unsatisfactory, adopt alternative hemostasis measures such as suture. 4.Avoid contact with ｍmbedl instruments or bone to prevent blade fracture or damage. 5.Avoid prolonged continuous ultrasonic activation to prevent overheating and tissue carbonization; remove charred debris timely. 6.Close jaws before inserting or withdrawing from trocar to avoid jaw damage. 7.Do not apply excessive grasping force to prevent instrument damage or tissue laceration. 8.Distal tip may stay hot after activation; prevent thermal burn to adjacent normal tissue. 9.Observe EMC requirements; keep away from strong electromagnetic interference equipment. 10.If abnormal vibration or noise occurs during surgery, stop energy output immediately and inspect the whole system.
9、存储条件 Storage Requirements
中文：环境温度 5℃‑40℃；相对湿度 10%‑80%；无腐蚀性气体、通风干燥室内存放；避免挤压、阳光直射；在原包装内保存。English：Storage temperature: 5℃‑40℃; relative humidity 10%‑80%; store in dry, ventilated room without corrosive gas; avoid extrusion and direct sunlight; keep in original package.
10、说明书核心摘要 Core Summary
中文：MP1500 为一次性使用超声软组织手术刀头，环氧乙烷灭菌，有效期 3 年；必须与注册证载明的兼容超声主机、换能器配套使用；用于手术软组织切割止血，最大闭合血管直径 5 mm；一次性使用，禁止复用复灭；使用时控制单次激发时长，确认血管闭合效果；远离骨骼金属；按医疗废弃物处置；储存于干燥通风常温环境。English：MP1500 is single‑use ultrasonic surgical blade, ethylene‑oxide sterilized with 3‑year shelf‑life. Must be used with generator and transducer specified in registration. Intended for soft‑tissue cutting and hemostasis, max sealable vessel diameter 5 mm. Single‑use only; reuse and re‑sterilization forbidden. Control single activation duration intra‑operatively and verify vessel sealing effect. Avoid contact with bone and ｍmbedl. Dispose as medical waste. Store in dry, ventilated ambient‑temperature environment.
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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