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厂家直供美国Hologic豪洛捷乳房活检与旋切系统ATEC Sapphire
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厂家直供美国Hologic豪洛捷乳房活检与旋切系统ATEC Sapphire
桂经理19117326863微xin同号
结构及组成/主要组成成分
产品由控制台（含脚踏开关及电源线）、旋切探针、抽吸罐、组织收集器延长管（可选）、组织收集器（可选）、ATEC适配器（可选）和ATEC导针器（可选）组成，具体型号见附页。
适用范围/预期用途
ATEC(R)乳房活检与旋切系统预期用于在组织学检查时获取乳腺组织样品。乳房活检与旋切系统 ATEC Sapphire（Hologic）
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，ATEC Sapphire 主机产生持续高负压，通过一次性手柄与旋切针将乳腺病灶组织吸入针槽。采用旋转剪切 + 真空同步输送模式，内刀高速旋转切割组织，单通道大内腔负压将切取样本连续输送至后置组织过滤器，全程封闭防污染、减少针道转移。系统支持术中冲洗、麻醉 / 止血剂注入与独立抽吸，一次穿刺可多次取样，实现微创活检或良性病灶旋切切除。
English
Under ultrasound, stereotactic X‑ray, or MRI guidance, the ATEC Sapphire console generates continuous high vacuum to draw breast lesion tissue into the needle aperture via the disposable handpiece. It uses a rotary shear + vacuum‑assisted transport mechanism: the inner cutter rotates at high speed to excise tissue, and a single large‑bore channel with continuous vacuum transfers samples to the rear tissue filter. The fully closed system prevents contamination and reduces tumor seeding. Intraoperative lavage, anesthetic/hemostatic injection, and independent aspiration are supported, enabling multiple samplings with one puncture for minimally invasive biopsy or benign lesion resection.
二、产品功能｜Product Functions
中文
乳腺微创活检：获取足量组织样本，用于 BI‑RADS 3~5 类可疑病灶（肿块、钙化、结构扭曲）病理确诊。
病灶旋切切除：对≤3cm 良性病灶（如纤维腺瘤）进行微创旋切，保留乳房外形。
高速取样：每 4.5 秒获取 1 条组织，全程取样通常＜30 秒，效率显著提升。
术中处理：支持生理盐水冲洗、麻醉 / 止血剂注入、独立真空抽吸，清洁术腔、控制出血。
多影像兼容：适配超声、立体定位、MRI 引导，满足不同定位需求。
样本保障：全封闭集样，冲洗净化样本，提升病理诊断准确率。
便捷操作：脚踏 + 手柄双控，一键切换活检 / 冲洗 / 抽吸模式，无需编程。
English
Minimally Invasive Biopsy：Obtain sufficient tissue samples for pathological diagnosis of BI‑RADS 3–5 suspicious lesions (masses, calcifications, architectural distortion).
Lesion Resection：Minimally invasive resection of benign lesions ≤3cm (e.g., fibroadenoma) while preserving breast appearance.
High‑Speed Sampling：1 tissue strip every 4.5 seconds; total procedure typically <30 seconds for improved efficiency.
Intraoperative Management：Supports saline lavage, anesthetic/hemostatic injection, and independent vacuum aspiration for cavity cleaning and hemostasis.
Multi‑Imaging Compatibility：Compatible with ultrasound, stereotactic, and MRI guidance.
Sample Quality：Fully enclosed collection with lavage to purify samples and improve diagnostic accuracy.
Easy Operation：Footswitch + handpiece control; one‑touch mode switching (biopsy/lavage/aspiration); no programming required.
三、产品特点｜Product Features
中文
全封闭系统：一次性手柄 + 管路，全程封闭，降低污染与交叉感染风险。
高速高效：4.5 秒 / 样本，MRI 引导流程较同类缩短约 10 分钟。
轻便手柄：仅 204g，直径 4.2cm、长 26.8cm（不含针），操作灵活、患者舒适度高。
多规格针型：9G/12G，长度 9/12/14cm，孔径 12/20mm，适配不同病灶大小与深度。
一键模式：活检 / 冲洗 / 抽吸一键切换， setup＜1 分钟，无需复杂编程。
持续给药：术中不间断注入麻醉 / 止血剂，提升操作安全性与患者耐受度。
安全设计：真空就绪指示灯、故障报警，操作状态可视化；一次性耗材辐照灭菌。
多影像适配：兼容超声、立体定位、MRI，一站式满足各类引导需求。
English
Fully Closed System：Disposable handpiece + tubing; fully enclosed to reduce contamination and cross‑infection risk.
High Speed & Efficiency：4.5‑second sample cycle; MRI workflow ~10 minutes faster than comparable systems.
Lightweight Handpiece：Only 204g, 4.2cm diameter, 26.8cm length (excl. needle); ergonomic and patient‑friendly.
Multi‑Gauge Needles：9G/12G, 9/12/14cm lengths, 12/20mm apertures for diverse lesion sizes and depths.
One‑Touch Modes：Biopsy/lavage/aspiration switching; setup <1 minute; no complex programming.
Uninterrupted Medication：Continuous anesthetic/hemostatic delivery during procedure for safety and comfort.
Safety Features：Vacuum ready indicator, fault alarms, visual status; single‑use consumables irradiation‑sterilized.
Multi‑Modality Ready：Works with ultrasound, stereotactic, and MRI guidance in one platｆorm.
四、技术参数｜Technical Parameters
中文
表格
参数项 详情
产品型号 ATEC Sapphire（Hologic）
系统组成 主机、一次性手柄（含旋切针）、组织过滤器、脚踏开关、管路套件
真空压力 约 71cmHg（≈28inHg，海平面），持续高负压
取样周期 每 4.5 秒获取 1 条组织，全程通常＜30 秒
旋切针规格 9G/12G；长度 9/12/14cm；孔径 12/20mm
手柄参数 重量 204g，直径 4.2cm，长度 26.8cm（不含针）
引导方式 超声、钼靶立体定位、MRI
操作模式 活检（Biopsy）、冲洗（Lavage）、手动抽吸（Manual Aspiration）
主机尺寸 63×53×93cm（W×D×H），带 360° 脚轮
主机重量 约 50kg（110lbs）
供电 AC 220V/50Hz
环境条件 温度 15℃~40℃，相对湿度 30%~75%
灭菌方式 主机清洁消毒；一次性耗材辐照灭菌
English
表格
Parameter Details
Model ATEC Sapphire (Hologic)
System Components Console, disposable handpiece (with needle), tissue filter, footswitch, tubing set
Vacuum Pressure ~71cmHg (≈28inHg at sea level), continuous high vacuum
Sampling Cycle 1 tissue strip every 4.5 seconds; total procedure typically <30 seconds
Needle Specs 9G/12G; lengths 9/12/14cm; apertures 12/20mm
Handpiece 204g, 4.2cm diameter, 26.8cm length (excl. needle)
Guidance Ultrasound, stereotactic X‑ray, MRI
Operating Modes Biopsy, Lavage, Manual Aspiration
Console Dimensions 63×53×93cm (W×D×H), 360° casters
Console Weight ≈50kg (110lbs)
Power AC 220V/50Hz
Environment 15°C–40°C, 30%–75% RH
Sterilization Console: cleaning & disinfection; Consumables: single‑use irradiation‑sterilized
五、使用方法｜Instructions for Use
中文
术前准备：连接主机电源、真空与管路；开机自检，进入 Setup 模式，待 “Vacuum Ready” 绿灯常亮；安装一次性手柄与旋切针，测试循环正常。
定位麻醉：影像定位病灶，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，确认针槽对准病灶。
旋切取样：切换至 Biopsy 模式，踩脚踏启动真空与切割，系统自动取样；可多次循环直至样本足量。
术中处理：切换 Lavage 模式冲洗管路 / 术腔；切换 Manual Aspiration 模式独立抽吸积液；必要时注入麻醉 / 止血剂。
样本处理：取出组织过滤器，转移样本并标注，送病理检查。
术后处理：退出旋切针，局部压迫止血≥15 分钟，加压包扎；一次性耗材按医疗废物处理。
设备处置：关机，清洁消毒主机、脚踏等；记录操作信息。
English
Preoperative Prep：Connect power, vacuum, and tubing; power on and self‑test; enter Setup mode until “Vacuum Ready” is solid green; install disposable handpiece and needle; run test cycle.
Localization & Anesthesia：Image‑guided lesion localization; local anesthesia; 3–5mm skin incision.
Puncture：Advance needle to lesion under imaging; confirm aperture alignment.
Cutting & Sampling：Switch to Biopsy mode; activate via footswitch; repeat cycles until sufficient samples are obtained.
Intraoperative Care：Lavage mode for tubing/cavity cleaning; Manual Aspiration for fluid removal; administer anesthetic/hemostatic as needed.
Sample Handling：Remove tissue filter; transfer and label samples for pathology.
Postoperative Care：Withdraw needle; apply compression hemostasis ≥15 minutes and bandage; dispose of consumables as medical waste.
Device Care：Power off; clean and disinfect console/footswitch; document procedure.
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、结构扭曲、不对称密度灶的确诊取样。
临床可触及 / 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.
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 recurrences or peri‑implant abnormalities.
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，无法压迫止血者。
病灶过深 / 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。
对耗材材质（不锈钢、高分子）过敏者。
无法耐受俯卧 / 侧卧及局部麻醉者。
怀疑血管瘤、血管畸形等高出血风险病灶。
医师评估经皮切除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
经培训医师操作，严格遵循影像引导与无菌原则。
一次性手柄 / 针严禁重复使用 / 灭菌，防止交叉感染。
术前检查耗材包装与灭菌有效期，破损 / 过期禁用。
操作避开血管、神经、胸膜，警惕气胸、大出血。
术后充分压迫止血≥15 分钟，观察血肿、感染、疼痛加剧等并发症。
根据病灶质地调节真空与模式，致密组织优先高速模式。
冲洗液、麻醉剂仅用于术腔 / 管路，严禁注入病灶深部。
病理与影像不符时，重新评估或补充取样。
主机可靠接地，使用医用电源线，禁用延长线 / 转接头。
故障报警立即停机排查，未修复前禁用。
English
Operator Qualification：For trained physicians only; follow imaging guidance and aseptic technique.
Single‑Use Only：No reuse/re‑sterilization of handpiece/needle to prevent cross‑infection.
Pre‑Use Check：Inspect packaging and sterilization expiry; do not use damaged/expired products.
Safety Protection：Avoid vessels, nerves, and pleura; monitor for pneumothorax and massive bleeding.
Postoperative Care：Compression hemostasis ≥15 minutes; monitor for hematoma, infection, and increased pain.
Parameter Adjustment：Adjust vacuum and mode based on lesion texture; use high‑speed mode for dense tissue.
Medication/Fluid：Lavage/anesthetic for cavity/tubing only; no deep injection into lesions.
Re‑Evaluation：Re‑assess 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 resolved.
九、存储条件｜Storage Conditions
中文
主机：干燥、通风、清洁环境，温度 15℃~40℃，相对湿度 30%~75%，无腐蚀性气体 / 强电磁干扰。
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，防潮、防尘。
耗材在灭菌有效期内使用，过期禁用。
运输避免剧烈震动、雨淋、暴晒。
English
Console：Dry, ventilated, clean environment; 15°C–40°C, 30%–75% RH; no corrosive gases or strong electromagnetic interference.
Consumables：Store at 10°C–30°C, away from light and moisture; avoid crushing, impact, and dropping.
Keep Away：From heat sources, open flames, direct sunlight; protect from moisture and dust.
Expiry：Use consumables within sterilization validity; do not use expired products.
Transport：Avoid severe vibration, rain, and direct sunlight.
十、说明书核心信息｜Manual Core Inｆormation
中文
核心用途：超声 / 立体定位 / MRI 引导下乳腺病灶真空辅助旋切活检与良性病灶微创切除。
操作核心：Setup 自检→真空就绪→穿刺→Biopsy 取样→Lavage 冲洗→Manual Aspiration 抽吸→样本送检→术后止血包扎。
安全要点：一次性耗材严禁复用；全程无菌；术后充分压迫；故障立即停机。
维护要点：主机清洁消毒；耗材一次性使用；定期检查真空与管路通畅。
合规声明：本产品为三类医疗器械，需持证医师操作，遵循当地法规与说明书要求。
English
Core Purpose：Vacuum‑assisted breast biopsy and minimally invasive benign lesion resection under ultrasound, stereotactic, or MRI guidance.
Operating Flow：Setup self‑test → Vacuum ready → Puncture → Biopsy sampling → Lavage → Manual Aspiration → Sample submission → Postoperative hemostasis & bandaging.
Safety Highlights：Single‑use consumables only; strict asepsis; sufficient postoperative compression; immediate stop on fault.
Maintenance：Console cleaning & disinfection; single‑use consumables; regular vacuum and tubing checks.
Compliance：Class III medical device; for use by licensed physicians only; follow local regulations and manual instructions.
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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