厂家特价供应巴德乳房旋切穿刺针及配件ECP017GV
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厂家特价供应巴德乳房旋切穿刺针及配件ECP017GV
桂经理19117326863微xin同号
管理类别
第三类
型号规格
见附页。
结构及组成/主要组成成分
本产品由探针（包括外套、探针顶部、组织采集器和外罩）、真空导管、生理盐水导管、真空连接器、真空导管套件、真空桶、导引定位装置（MRI套件）、导针器组成。
适用范围/预期用途
该产品主要用于乳房病变组织取样，供诊断使用。部分或完全切除影像下异常组织，供组织学检查使用。
一、工作原理｜Working Principle
中文
在超声、钼靶立体定位或 MRI 影像引导下，系统通过一体化封闭式高负压将乳腺病灶组织吸入旋切刀槽。采用扇形剪切模式，利用剪切力切断组织，无需停止点，避免刀头钝滞或中断。单通道大内腔持续负压同步将切取样本输送至集样盒，防堵塞且减少肿瘤细胞针道转移；支持术中冲洗、麻醉与止血剂注入，一次穿刺完成多次取样，实现乳腺病灶的微创活检或部分 / 完整旋切切除。
English
Under ultrasound, stereotactic X‑ray, or MRI guidance, the system uses integrated closed high vacuum to draw breast lesion tissue into the cutter slot. It employs a fan‑shaped shear mode that uses shear force to completely cut tissue without stopping points, preventing blade dulling or interruption. A single large‑bore channel with continuous high vacuum transfers excised samples to the collection chamber, preventing clogging and reducing tumor seeding; Intraoperative flushing, anesthetic, and hemostatic agent injection are supported, enabling multiple precise samplings with one puncture for minimally invasive biopsy or partial/complete lesion resection.
二、产品功能｜Product Functions
中文
乳腺病灶微创活检：获取足量、完整组织样本，用于影像学异常（肿块、钙化、结构扭曲）的病理确诊。
病灶旋切切除：对≤3cm 良性病灶或可疑恶性病灶进行部分 / 完整旋切，保留乳房外形。
多模式切割：全自动 / 手动、全切 / 半切、60°~360° 角度可调；支持正常 / 致密组织模式，钙化灶切割。
真空辅助取样：持续稳定负压保证样本连续、完整，提升病理诊断准确率。
术中处理：支持单独真空抽吸、麻醉 / 止血剂通道注入，360° 均匀分布药液。
多影像适配：兼容超声、立体定位、MRI 引导，满足不同病灶定位需求。
样本净化：集成冲洗功能，去除血液与碎屑，提升样本质量。
English
Minimally Invasive Biopsy：Obtain sufficient, intact tissue samples for pathological diagnosis of breast abnormalities (masses, calcifications, architectural distortion).
Lesion Resection：Perｆorm partial/complete resection of benign lesions ≤3cm or suspicious malignant lesions, preserving breast appearance.
Multi‑Mode Cutting：Auto/manual, full/half cut, 60°–360° adjustable angle; normal/dense tissue modes for precise calcification cutting.
Vacuum‑Assisted Sampling：Continuous stable vacuum ensures continuous, intact samples, improving diagnostic accuracy.
Intraoperative Management：Support independent vacuum aspiration, anesthetic/hemostatic agent injection with 360° uniｆorm distribution.
Multi‑Imaging Compatibility：Compatible with ultrasound, stereotactic, and MRI guidance for diverse lesion localization needs.
Sample Purification：Integrated rinse function removes blood and debris to improve sample quality.
三、产品特点｜Product Features
中文
三凹面针尖：专利设计，穿透致密组织阻力低，减少组织损伤。
单通道真空：大内腔、持续高负压，输送顺畅不堵塞，降低肿瘤细胞针道转移风险。
扇形剪切技术：剪切力切割无中断，适配钙化、纤维结节等坚硬组织。
多规格适配：支持 7G、10G、12G 等旋切针，满足不同病灶大小与深度需求。
智能操作：中文触摸屏实时显示切割状态 / 次数，刀槽方向可调；故障中文提示，学习曲线短。
便捷控制：手柄 + 脚踏双控制，术中可随时启停；手柄内置前灯，暗室操作清晰。
高效取样：精确模式下 360° 切割每圈可达 12 条组织，样本量较同类系统提升约 35%~40%。
安全防护：一次性无菌耗材辐照灭菌，避免交叉感染；全封闭系统减少术区污染。
English
TriConcave™ Tip：Patented design reduces tissue drag and damage when penetrating dense tissue.
Single‑Channel Vacuum：Large bore, continuous high vacuum for smooth sample transport, reducing tumor seeding risk.
Fan‑Shaped Shear：Shear‑force cutting without interruption, ideal for calcified and fibrous tissues.
Multi‑Gauge Compatibility：Supports 7G, 10G, 12G probes for diverse lesion sizes and depths.
Smart Interface：Chinese touchscreen displays real‑time cutting status/counts with adjustable slot direction; Chinese fault prompts for short learning curve.
Dual Control：Handpiece + footswitch for on/off control; built‑in front light for clear operation in dark rooms.
High‑Efficiency Sampling：Precision mode delivers ~12 strips per 360° rotation, with sample volume ~35–40% higher than comparable systems.
Safety Assurance：Irradiation‑sterilized single‑use consumables prevent cross‑infection; fully enclosed system reduces surgical site contamination.
四、技术参数｜Technical Parameters
中文
表格
参数项 详情
产品型号 ECP017GV（EnCor™）
系统组成 主机、真空系统、驱动手柄、脚踏开关、手术托盘、一次性旋切针、集样盒、真空导管、生理盐水导管、真空连接器、MRI 导引定位装置、导针器
真空压力 持续高负压，范围 17–29 inHg（约 57.6–98.2 kPa），可调
切割模式 全自动 / 手动；全切 / 半切；60°~360°（±10°）；正常 / 致密组织模式；精确模式
旋切针规格 7G（标配）、10G、12G（三凹面设计）
引导方式 超声、钼靶立体定位、MRI
操作界面 触摸式液晶屏（中文），实时显示切割状态 / 次数、刀槽方向
控制方式 手柄控制、脚踏开关控制，支持实时启停
噪音 ≤72 分贝，提升术中舒适度
供电 AC 220V 50Hz
灭菌方式 主机清洁消毒；旋切针一次性辐照灭菌
注册证号 国械注进 20173016309
English
表格
Parameter Details
Model ECP017GV (EnCor™)
System Components Host, Vacuum System, Handpiece, Footswitch, Procedure Tray, Single‑Use Probes, Collection Chamber, Vacuum Catheter, Saline Catheter, Vacuum Connector, MRI Localization Device, Introducer
Vacuum Pressure Continuous high vacuum, 17–29 inHg (≈57.6–98.2 kPa), adjustable
Cutting Modes Auto/Manual; Full/Half Cut; 60°–360° (±10°); Normal/Dense Tissue Mode; Precision Mode
Probe Gauges 7G (standard), 10G, 12G (TriConcave™ design)
Guidance Ultrasound, Stereotactic X‑ray, MRI
Interface Touchscreen LCD (Chinese), real‑time display of cutting status/counts and slot direction
Control Handpiece + footswitch, real‑time start/stop control
Noise ≤72 dB for patient comfort
Power AC 220V 50Hz
Sterilization Host: cleaning & disinfection; Probes: single‑use irradiation‑sterilized
Registration No. CN Medical Device Registration No. 20173016309
五、使用方法｜Instructions for Use
中文
术前准备：连接主机、真空源、电源，完成设备自检；检查一次性旋切针包装完好、在有效期内。
定位麻醉：影像定位病灶，行局部浸润麻醉；做 3–5mm 皮肤小切口。
穿刺进针：影像引导下将旋切针穿刺至病灶后方，确认刀槽位置对准病灶。
旋切取样：选择对应切割模式（正常 / 致密组织、全切 / 半切、角度）；启动真空与切割，系统自动取样，可多次操作直至样本满足病理要求。
术中处理：必要时开启冲洗清洁管路，或注入麻醉 / 止血剂；术腔积液时可单独真空抽吸。
样本处理：取出集样盒，整理样本并标注后送病理检查。
术后处理：退出旋切针，局部充分压迫止血，加压包扎；耗材按医疗废物规范处理。
设备处置：关闭主机，清洁消毒手柄、真空管路等；完成操作记录。
English
Preoperative Prep：Connect host, vacuum, and power; perｆorm self‑check; inspect probe packaging and expiry.
Localization & Anesthesia：Locate lesion under imaging; administer local anesthesia; make a 3–5mm skin incision.
Puncture：Advance probe to the rear of the lesion under imaging guidance; confirm slot alignment.
Cutting & Sampling：Select appropriate mode (normal/dense tissue, full/half cut, angle); activate vacuum and cutting; repeat until sufficient samples are obtained.
Intraoperative Care：Use flushing to clean tubing if needed; inject anesthetic/hemostatic agent; perｆorm independent vacuum aspiration for serous fluid.
Sample Handling：Retrieve collection chamber; label and send samples for pathology.
Postoperative Care：Withdraw probe; apply sufficient compression hemostasis and bandage; dispose of consumables as medical waste.
Device Disposal：Power off; clean and disinfect handpiece and vacuum lines; document the procedure.
六、适应症｜Indications
中文
乳腺影像学（超声、钼靶、MRI）发现的 BI‑RADS 3~5 类可疑病灶的组织学活检。
乳腺微小钙化、结构扭曲、不对称密度灶的确诊取样。
临床可触及或不可触及的乳腺良性病灶（如纤维腺瘤）的微创旋切切除。
乳腺术后可疑灶、假体旁异常病灶的微创活检。
需获取足量、高质量组织样本的乳腺病灶诊断与治疗。
English
Histological Biopsy：For BI‑RADS 3–5 suspicious breast lesions detected by ultrasound, mammography, or MRI.
Diagnostic Sampling：For microcalcifications, architectural distortion, and asymmetric density in breast.
Benign Lesion Resection：Minimally invasive resection of palpable/non‑palpable benign breast lesions (e.g., fibroadenoma).
Recurrent/Peri‑Implant Lesion Biopsy：Minimally invasive biopsy of suspected recurrent lesions or abnormalities adjacent to implants.
Diagnosis & Treatment：For breast lesions requiring sufficient, high‑quality tissue samples.
七、禁忌症｜Contraindications
中文
严重凝血功能障碍、出血倾向，无法通过压迫止血者。
病灶位置过深、过小，无法影像定位或安全穿刺者。
局部皮肤感染、破溃或乳腺急性炎症期。
对设备耗材材质（不锈钢、高分子材料）过敏者。
无法耐受俯卧 / 侧卧体位及局部麻醉手术者。
怀疑为血管瘤、血管畸形等高出血风险病灶。
医师评估经皮切除会显著增加并发症风险者。
English
Severe Coagulopathy：Bleeding tendency with inability to achieve hemostasis by compression.
Deep/Small Lesions：Inability to image or safely puncture.
Local Infection：Skin infection, ulceration, or acute mastitis.
Material Allergy：Allergy to consumable materials (stainless steel, polymers).
Anesthesia/Position Intolerance：Inability to tolerate prone/lateral position or local anesthesia.
High‑Bleeding‑Risk Lesions：Suspected hemangioma or vascular malｆormation.
High Complication Risk：Percutaneous resection with significantly increased complication risk per physician judgment.
八、注意事项｜Precautions
中文
经培训的执业医师操作，严格遵循影像引导规范与无菌原则。
一次性旋切针严禁重复使用、重复灭菌，防止交叉感染。
术前检查耗材包装完整性与灭菌有效期，破损、过期产品禁止使用。
操作中需避开血管、神经、胸膜，警惕气胸、大出血等并发症。
术后必须充分压迫止血，密切观察有无血肿、感染、疼痛加剧等并发症。
根据病灶质地合理调节真空压力与切割模式，致密组织优先选用 “致密模式”。
冲洗液、麻醉剂、止血剂仅用于术腔与管路清洁 / 治疗，严禁注入病灶深部。
病理结果与影像不符时，需重新评估病灶或补充取样。
设备必须可靠接地，使用医用专用电源线，禁止使用延长线 / 转接头。
出现故障报警时立即停机排查，未解决前禁止继续使用。
English
Operator Qualification：For trained physicians only; strictly follow imaging guidance and aseptic principles.
Single‑Use Probes：No reuse/re‑sterilization to prevent cross‑infection.
Preoperative Check：Inspect packaging integrity and sterilization expiry; do not use damaged/expired products.
Safety Protection：Avoid blood vessels, nerves, and pleura; monitor for pneumothorax and massive bleeding.
Postoperative Monitoring：Sufficient compression hemostasis is mandatory; watch for hematoma, infection, and increased pain.
Parameter Adjustment：Adjust vacuum pressure and cutting mode based on lesion texture; use "dense mode" for hard tissue.
Medication/Fluid：Anesthetic, hemostatic agent, and flushing fluid are for surgical site/tubing cleaning only; no deep injection into lesions.
Re‑Evaluation：Re‑evaluate the lesion or re‑sample if pathology and imaging are discordant.
Electrical Safety：Ensure proper grounding; use medical‑grade power cord; no extensions/adapters.
Troubleshooting：Stop immediately on alarm; do not reuse until the issue is resolved.
九、存储条件｜Storage Conditions
中文
主机：存放于干燥、通风、清洁环境，温度 5℃~40℃，相对湿度≤80%，无腐蚀性气体。
一次性耗材：常温（10℃~30℃）、避光、干燥保存，避免挤压、碰撞、跌落。
远离热源、火源、直射阳光及强电磁干扰。
耗材在灭菌有效期内使用，过期禁用。
运输避免剧烈震动、
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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