厂家直供麦迪卡帕克乳房病灶旋切式活检设备BXS100
价格：￥ 电议
品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)：国械注进20253010507更新时间：2026/10/16 11:11:02
支付方式：
- 支付宝 微信 银行转账
产品完善度： 访问次数：254
企业档案
会员类型：旗舰版
已获得阿仪网信誉 等级评定
(0 -40)基础信誉积累，可浏览访问
(41-90)良好信誉积累，可接洽商谈
(91+ )优质信誉积累，可持续信赖
阿仪网旗舰版会员：1年
工商认证 【已认证】
最后认证时间：
注册号： 【已认证】
法人代表： 【已认证】
参观次数：137243
手机网站：http://wap.app17.com/c174616/
旗舰版网址：http://ksdy.app17.com
详细内容
厂家直供麦迪卡帕克乳房病灶旋切式活检设备BXS100
桂经理19117326863微xin同号
第三类
型号规格
BXS100
结构及组成/主要组成成分
由主机、驱动手柄、真空桶、脚踏开关和一次性使用真空桶（可选）组成。
适用范围/预期用途
与本公司生产的特定一次性使用乳房旋切活检针联合使用，在超声设备引导下用于全部或部分乳腺异常组织的活检取样。
产品储存条件及有效期
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，设备通过真空负压将乳腺病灶组织吸入旋切刀头，高速旋转的切割刀对病灶进行连续、多次微创切割；真空系统同步将切取的组织样本输送至样本仓，部分设备配备冲洗通道可冲洗样本与管路，实现一次穿刺、多次取样，完成乳腺病灶的活检或微创旋切切除。
EnglishUnder the guidance of ultrasound, mammographic stereotactic or MRI imaging, the device uses vacuum negative pressure to draw breast lesion tissue into the rotating cutter head. The high-speed rotating cutting blade perｆorms continuous and multiple minimally invasive cutting on lesions. The vacuum system synchronously transports the excised tissue samples to the sample chamber. Some devices are equipped with a flushing channel to rinse samples and tubing, enabling multiple samplings with a single puncture to complete biopsy or minimally invasive resection of breast lesions.
二、产品功能｜Product Functions
中文
乳腺可疑病灶微创组织活检，获取足量病理样本。
对乳腺良性病灶进行完整或部分旋切切除。
真空辅助连续取样，提高取样效率与样本完整性。
影像实时引导，定位，减少正常组织损伤。
部分机型具备冲洗、血凝块清除、样本净化功能。
支持超声、立体定位、MRI 等多模式引导。
English
Minimally invasive tissue biopsy of suspicious breast lesions to obtain sufficient pathological samples.
Complete or partial rotational resection of benign breast lesions.
Vacuum-assisted continuous sampling to improve sampling efficiency and sample integrity.
Real-time imaging guidance for precise positioning and reduced damage to normal tissue.
Some models support flushing, clot removal and sample purification.
Supports multi-mode guidance including ultrasound, stereotactic and MRI.
三、产品特点｜Product Features
中文
一次穿刺多次取样，创伤小、出血少、恢复快。
真空辅助抽吸，样本量大、连续完整，提高病理诊断准确率。
刀头锋利，切割顺畅，可处理钙化灶、纤维结节、微小病灶。
定位，全程影像引导，降低漏诊与误诊风险。
旋切与取样同步，操作流程简化，手术时间短。
一次性耗材无菌设计，避免交叉感染。
设备兼容性强，可适配不同规格旋切针。
切口微小，美容效果好，无需缝合。
English
Multiple samplings with one puncture, minimal trauma, less bleeding and fast recovery.
Vacuum-assisted aspiration provides large, continuous and complete samples, improving pathological diagnostic accuracy.
Sharp cutter head with smooth cutting, suitable for calcifications, fibrous nodules and small lesions.
Precise positioning with full imaging guidance, reducing the risk of missed diagnosis and misdiagnosis.
Synchronous cutting and sampling, simplified procedure and short operation time.
Sterile single-use consumables to avoid cross-infection.
Strong compatibility, adaptable to different gauges of biopsy probes.
Tiny incision with excellent cosmetic outcome and no suturing required.
四、技术参数｜Technical Parameters
中文
工作模式：真空辅助旋切活检
驱动方式：电动驱动 / 气动驱动
真空压力：可调，通常 -60～-95kPa
旋切刀转速：可调
适用探针规格：7G、8G、9G、10G、11G、12G 等
引导方式：超声 / 钼靶立体定位 / MRI
取样方式：连续自动取样
冲洗功能：可选配冲洗管路
供电：AC 220V 50Hz 或内置电池
设备尺寸：台式 / 便携式
灭菌方式：主机常规清洁消毒，探针一次性辐照灭菌
English
Working Mode: Vacuum Assisted Breast Biopsy
Drive Mode: Electric / Pneumatic
Vacuum Pressure: Adjustable, typically -60～-95kPa
Cutter Rotation Speed: Adjustable
Compatible Probe Gauges: 7G, 8G, 9G, 10G, 11G, 12G etc.
Guidance Mode: Ultrasound / Mammographic Stereotactic / MRI
Sampling Mode: Continuous Automatic Sampling
Irrigation Function: Optional flushing line
Power Supply: AC 220V 50Hz or built-in battery
Device Type: Desktop / Portable
Sterilization: Host routine cleaning & disinfection; Probes single-use irradiation sterilized
五、使用方法｜Instructions for Use
中文
术前准备：连接设备电源、真空源，检查设备运行状态；准备一次性旋切针，确认包装完好、在有效期内。
定位麻醉：超声 / 影像定位病灶，局部浸润麻醉。
穿刺进针：皮肤小切口，将旋切针穿刺至病灶后方。
旋切取样：开启真空与旋切模式，设备自动切割并输送样本；可多次取样直至满足病理需求。
样本处理：取出样本仓，整理组织样本送病理检查。
术后处理：退出穿刺针，局部压迫止血，加压包扎。
设备处置：关闭主机，清洁消毒；耗材按医疗废物处理。
English
Preoperative Preparation: Connect power and vacuum source, check device status. Prepare single-use probe, confirm intact package and valid expiry.
Localization & Anesthesia: Locate lesion under ultrasound/imaging, perｆorm local anesthesia.
Puncture: Make a small skin incision, advance the probe to the rear of the lesion.
Cutting & Sampling: Activate vacuum and cutting mode; the device automatically excises and transfers samples. Multiple samplings can be perｆormed until pathological requirements are met.
Sample Handling: Remove sample chamber, collect tissue specimens for pathological examination.
Postoperative Management: Withdraw the probe, apply compression hemostasis and pressure bandage.
Device Disposal: Turn off the host, clean and disinfect. Dispose of consumables as medical waste.
六、适应症｜Indications
中文
乳腺影像学（超声、钼靶、MRI）提示 BI-RADS 3～5 类可疑病灶的组织学活检。
乳腺微小钙化灶、结构扭曲、不对称密度灶的确诊取样。
乳腺良性肿瘤（如纤维腺瘤）的微创旋切切除。
临床可触及或不可触及的乳腺病灶活检。
术后可疑灶、假体旁异常病灶的活检。
English
Histological biopsy of suspicious breast lesions (BI-RADS 3–5) detected by imaging (ultrasound, mammography, MRI).
Diagnostic sampling of microcalcifications, architectural distortion and asymmetric density in breast.
Minimally invasive resection of benign breast tumors (e.g., fibroadenoma).
Biopsy of palpable or non-palpable breast lesions.
Biopsy of suspected recurrent lesions and abnormal lesions adjacent to implants.
七、禁忌症｜Contraindications
中文
严重凝血功能障碍、出血倾向，无法压迫止血者。
病灶位置过深、过小，无法影像定位或安全穿刺者。
妊娠期、哺乳期不建议行微创旋切（特殊情况由医师评估）。
局部皮肤感染、破溃或乳腺急性炎症期。
对设备耗材材质过敏者。
无法耐受俯卧 / 侧卧体位及局麻手术者。
怀疑为血管瘤、血管畸形等高出血风险病灶。
English
Severe coagulation disorders, bleeding tendency, inability to achieve hemostasis by compression.
Lesions too deep or too small to be imaged or safely punctured.
Minimally invasive resection is not recommended during pregnancy or lactation (evaluated by physician in special cases).
Local skin infection, ulceration or acute mastitis.
Allergy to device or consumable materials.
Inability to tolerate prone/lateral position or local anesthesia.
Lesions with high bleeding risk such as suspected hemangioma or vascular malｆormation.
八、注意事项｜Precautions
中文
必须由具备资质的医师操作，严格遵循影像引导规范。
一次性旋切针严禁重复使用、重复灭菌，防止交叉感染。
使用前检查耗材包装、灭菌有效期，破损或过期禁用。
操作中避免损伤血管、神经、胸膜，防止气胸、大出血等并发症。
术后必须充分压迫止血，观察有无血肿、感染、疼痛加剧。
真空压力、切割速度根据病灶质地合理调节。
冲洗液仅用于样本与管路清洁，不可注入病灶深部。
病理结果与影像不符时，应重新评估或补充取样。
设备使用前自检，异常报警立即停机排查。
English
Must be operated by qualified physicians, strictly following imaging guidance protocols.
Single-use probes are strictly prohibited from reuse or re-sterilization to prevent cross-infection.
Inspect package and sterilization expiry before use; do not use if damaged or expired.
Avoid injury to blood vessels, nerves and pleura during operation to prevent complications such as pneumothorax and massive bleeding.
Sufficient compression hemostasis is mandatory postoperatively. Monitor for hematoma, infection and increasing pain.
Adjust vacuum pressure and cutting speed appropriately according to lesion texture.
Irrigation fluid is only for cleaning samples and tubing, not for deep injection into lesions.
Re-evaluate or re-sample if pathological results are inconsistent with imaging.
Perｆorm self-test before use; stop immediately and troubleshoot if alarm occurs.
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：常温避光、干燥保存，温度 10℃～30℃，避免挤压、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，过期禁止使用。
运输过程避免剧烈震动、雨淋、暴晒。
English
Host: Store in dry, ventilated and clean environment, temperature 5℃～40℃, relative humidity ≤80%, no corrosive gas.
Single-use consumables: Store at room temperature, away from light and moisture, temperature 10℃～30℃, avoid extrusion and dropping.
Keep away from heat sources, fire, direct sunlight and strong electromagnetic interference.
Use consumables within sterilization expiry; expired products are prohibited.
Avoid severe vibration, rain and direct exposure during transportation.
十、说明书核心信息｜Core Manual Inｆormation
中文
产品名称、型号规格、注册证编号、生产企业、生产日期、有效期。
适用范围与禁忌症，明确乳腺病灶使用。
一次性耗材标识：无菌、一次性使用，禁止复用。
安全警示：专业医务人员操作，非培训人员禁用。
电气安全：符合医用电气安全标准，接地可靠，防止漏电。
维护保养：主机定期清洁、功能检测；管路无堵塞、无漏气。
废弃处理：使用后耗材按医疗废物管理条例处置。
责任声明：未按说明书操作导致不良事件，厂商不承担相关责任。
English
Product name, model, registration number, manufacturer, production date, expiry date.
Indications and contraindications; clearly for breast lesions only.
Single-use label: sterile, single patient use only, no reuse.
Safety warning: for use by qualified medical personnel only.
Electrical safety: comply with medical electrical safety standards, reliable grounding to prevent leakage.
Maintenance: regular cleaning and function test of host; ensure no blockage or air leakage in tubing.
Disposal: dispose used consumables in accordance with medical waste regulations.
Liability statement: manufacturer is not liable for adverse events caused by improper use.
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.
热门标签：厂家直供麦迪卡帕克乳房病灶旋切式活检设备BXS100,麦迪卡帕克乳房病灶旋切式活检设备,乳房病灶旋切式活检
