厂家供应卡尔迪雅子宫内膜消融仪CAG-100
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厂家供应卡尔迪雅子宫内膜消融仪CAG-100
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 子宫内膜消融仪
管理类别 第三类
型号规格 CAG-100
结构及组成/主要组成成分 子宫内膜消融仪由子宫内膜消融仪主机（型号：CAG-100）和一次性双极消融电极套件（型号：DKU2012）组成。其中，子宫内膜消融仪主机包含脚踏开关（型号：FS-100）和电源线；一次性双极消融电极套件包括一次性双极消融电极（型号：DBA-100）和集液瓶（型号：FB-100）。
适用范围/预期用途 在医疗机构中使用，用于妇女绝经前、无生育要求、由良性疾病引起的月经过多（过量出血）子宫内膜切除（消融）。
中文名称：子宫内膜消融仪English Name: Endometrial Ablation System品牌厂商：卡尔迪雅（天津）医疗器械有限公司型号：CAG-100注册证号：国械注准 20183011003（第三类有源手术器械）配套耗材：DKU2012 一次性双极消融电极套件（DBA-100 消融电极 + FB-100 集液瓶）、FS-100 脚踏开关系统组成：消融仪主机、电源线、脚踏开关；须搭配一次性双极消融电极套件联合使用
一、工作原理 Working Principle
中文主机输出可控高频双极射频电流，经一次性框架式消融电极送入宫腔。射频电流使子宫内膜组织内离子高速震荡摩擦，产生内生生物热效应；在系统温度、阻抗、消融时间三重实时监测闭环调控下，使子宫内膜功能层、基底层及浅层肌层发生蛋白凝固、变性、坏死，最终脱落。电极配套负压抽吸通路，术中持续排出宫腔内气体与渗出液，保障电极与内膜充分贴合；系统实时采集组织反馈参数，达到预设消融终点后自动断电停机，实现标准化内膜消融，减少异常子宫出血。
EnglishThe main unit outputs controllable high-frequency bipolar radiofrequency current, delivered into uterine cavity via disposable ｆｆｆframe-shaped ablation electrode. RF current drives rapid oscillation and friction of ions within endometrial tissue to generate endogenous biological thermal effect. Under closed-loop control with real-time triple monitoring (temperature, impedance and ablation duration), it precisely induces protein coagulation, degeneration and necrosis of endometrial functional ｌayer, basal ｌayer and superficial myometrium.The electrode is equipped with negative pressure suction channel to continuously evacuate intrauterine gas and exudate during operation, ensuring adequate contact between electrode and endometrium. The system collects tissue feedback parameters continuously and automatically cuts off power upon reaching preset ablation endpoint to achieve standardized endometrial ablation for alleviating abnormal uterine bleeding.
二、产品功能 Functions
中文
输出受控双极射频能量，对宫腔内膜实施均匀热消融，破坏内膜再生能力；
集成温度、阻抗、消融时长三重监测，动态调控能量输出，到达消融终点自动停机；
配套负压抽吸控制，清除宫腔气体、积液，稳定电极贴合状态；
可视化人机交互界面，分步操作指引，记录治疗关键参数；
脚踏开关控制消融启停，便于术者双手操作；
多重故障、超限安全报警，具备过温、阻抗异常保护机制。
English
Deliver controlled bipolar RF energy to perｆorm uniｆorm thermal ablation of uterine endometrium and destroy endometrial regenerative capacity;
Integrate triple monitoring of temperature, impedance and ablation time, dynamically regulate energy output and auto-stop at ablation endpoint;
Support negative pressure suction control to evacuate intrauterine gas and fluid and stabilize electrode contact;
Visual HMI with step-by-step operation guidance and recording of key treatment parameters;
Footswitch controls ablation start/stop to facilitate bimanual operation for surgeons;
Multi-channel fault and limit alarm, equipped with over-temperature and abnormal impedance protection.
三、产品特点 Product Features
中文
微创入路：消融电极导管外径 5.5mm，多数患者无需宫颈充分扩宫，麻醉需求更低；
框架型柔性电极，适配不同形态子宫腔形态，内膜贴合均匀，消融范围完整；
三重参数闭环监控，消融深度可控，平均消融深度可达 6.5mm，疗效稳定；
双极射频模式，电流局限于电极之间，降低周边脏器热损伤风险；
标准化治疗流程，单次消融平均射频作用时间约 85 秒，整体手术周期短；
内置负压通路，避免宫腔积气造成局部消融不足；
程序引导式操作，降低人为操作差异，终点自动终止，减少过度消融；
耗材一次性无菌使用，整机操作简洁，适合日间妇科手术开展。
English
Minimally invasive access: electrode outer diameter 5.5 mm; cervical dilatation is unnecessary for most patients with reduced anesthesia requirement;
Flexible ｆｆｆframe electrode adapts to diverse uterine cavity geometry for uniｆorm contact and complete ablation coverage;
Closed-loop triple-parameter monitoring enables controllable ablation depth (average 6.5 mm) with consistent efficacy;
Bipolar RF design confines current between electrodes to lower risk of thermal injury to adjacent viscera;
Standardized workflow: average RF activation time ~85 seconds with short overall procedural duration;
Built-in suction channel prevents insufficient ablation caused by intrauterine gas accumulation;
Program-guided operation reduces operator variability; automatic termination avoids over-ablation;
Single-use sterile consumables, user-friendly workflow suitable for gynecological day surgery.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品型号：CAG-100 | Model：CAG-100 |
| 能量类型：双极射频能量 | Energy Type：Bipolar Radiofrequency Energy |
| 配套耗材：DKU2012（DBA-100 消融电极套件） | Matched Consumable：DKU2012 (DBA-100 ablation electrode set) |
| 监测项目：组织温度、组织阻抗、消融计时 | Monitoring Items：Tissue temperature, tissue impedance, ablation timer |
| 电极导管外径：5.5 mm | Electrode Outer Diameter：5.5 mm |
| 控制方式：主机触屏操作 + 脚踏启停 | Control Mode：Touchscreen + footswitch trigger |
| 安全机制：超温、阻抗异常、超时自动停机报警 | Safety Mechanism：Auto stop & alarm for overtemperature, abnormal impedance and overtime |
| 供电电源：AC 220V 50Hz | Power Supply：AC 220V 50Hz |
| 运行环境温度：10℃～30℃ | Operating Ambient Temp：10℃～30℃ |
| 设备类别：Ⅲ 类有源医疗器械 | Device Class：Class Ⅲ Active Medical Device |
| 耗材灭菌方式：环氧乙烷 EO | Consumable Sterilization：Ethylene Oxide (EO) |
| 耗材使用属性：一次性使用，禁止复用 | Consumable：Single-use only, reuse prohibited |
五、使用方法 Operation Instructions
中文
术前完善妇科超声、宫腔镜等评估，确认适应症，排除禁忌症；
连接主机电源，开机完成整机自检；连接脚踏开关；拆开无菌消融电极套件；
将电极线缆与主机射频输出接口对接，负压管路连接集液瓶；
患者取膀胱截石位，常规外阴、阴道、宫颈消毒；轻柔将消融电极送入宫腔，展开框架电极；
主机录入宫腔测量参数，启动负压抽吸，确认电极与内膜贴合良好；
确认参数无误后，踩踏脚踏启动射频消融；系统持续监测温度、阻抗；
到达预设消融终点，设备自动停止能量输出；必要时按规范评估补充消融；
消融结束，收回框架电极，缓慢撤出导管；按术后流程观察患者生命体征与阴道出血；
一次性电极套件使用完毕，按感染性医疗废弃物规范处置；主机清洁、待机。
English
Complete preoperative evaluation including gynecologic ultrasound/hysteroscopy to confirm indication and rule out contraindications;
Connect mains power and power on for system self-test; connect footswitch and unpack sterile electrode set;
Link electrode cable to RF output port and connect suction tubing to collection bottle;
Place patient in lithotomy position, perｆorm standard vulvar, vaginal and cervical disinfection; advance electrode gently into uterine cavity and deploy ｆｆｆframe electrode;
Input uterine cavity dimensions on the unit, activate negative pressure and verify adequate electrode-endometrium contact;
Confirm parameters, depress footswitch to initiate RF ablation. The system continuously monitors temperature and impedance;
Device automatically ceases energy delivery upon reaching ablation endpoint; supplementary ablation may be perｆormed per protocol if needed;
Retract ｆｆｆframe electrode after treatment and withdraw catheter slowly; monitor vital signs and vaginal bleeding post-procedure;
Dispose used single-use electrode as infectious medical waste; clean main unit and set to standby.
六、适应症 Indications
中文依据注册预期用途：用于绝经前、无生育要求、良性疾病所致月经过多患者，实施子宫内膜消融治疗。临床适用：药物保守治疗效果不佳、拒绝或不适合子宫切除的异常子宫出血（良性病因）患者。⚠️ 治疗后几乎丧失自然妊娠能力，术前必须充分告知。
EnglishAccording to registered intended use: indicated for premenopausal women without fertility desire suffering from menorrhagia caused by benign disorders to perｆorm endometrial ablation.Clinical application: patients with abnormal uterine bleeding (benign etiology) refractory to medical management, who decline or are unsuitable for hysterectomy.⚠️ Natural pregnancy capacity is almost eliminated after treatment; adequate preoperative inｆormed consent is mandatory.
七、禁忌症 Contraindications
中文
有生育意愿、计划后续妊娠女性；
妊娠期、可疑宫内妊娠；
急性盆腔炎、活动性生殖道感染未控制；
可疑或确诊子宫内膜恶性病变、癌前病变；
严重子宫畸形、宫腔形态不适合电极放置；
子宫穿孔病史、活动性盆腔出血；
严重凝血功能障碍，无法耐受微创操作；
已知对电极高分子材料、环氧乙烷灭菌残留物过敏。
English
Patients with fertility desire or planned future pregnancy;
Pregnancy or suspected intrauterine gestation;
Uncontrolled acute pelvic inflammatory disease or active genital tract infection;
Suspected or confirmed endometrial malignancy or premalignant lesions;
Severe uterine malｆormation preventing proper electrode deployment;
History of uterine perforation or active pelvic hemorrhage;
Severe coagulopathy intolerant to minimally invasive procedure;
Known allergy to electrode polymer materials or EO sterilization residuals.
八、注意事项 Precautions
中文
具备妇科内镜 / 宫腔手术资质、接受本设备专项培训医师操作；
必须使用原厂配套 DKU2012 消融电极套件；禁止搭配第三方电极；
电极为一次性无菌耗材，严禁清洗、重复使用；包装破损、过期禁止使用；
术前规范测量宫腔深度、宽度，参数设置不当易造成消融不足或子宫穿孔风险；
术中持续关注阻抗、温度曲线，出现异常报警立即停止消融；
严格把控负压状态，防止空气大量进入宫腔；
术后规范随访，告知患者闭经、经量减少、分泌物增多等常见术后表现；
不可替代组织病理活检；可疑内膜病变者先行宫腔镜活检排除恶性疾病；
主机避免液体泼溅、暴力碰撞；定期执行厂家预防性维护；
远离大功率射频、电刀等强电磁干扰设备。
English
Operation limited to physicians qualified for gynecologic intrauterine surgery and dedicated equipment training;
Only original DKU2012 electrode set is permitted; third-party electrodes are prohibited;
Electrode is single-use sterile consumable; cleaning and reuse are forbidden. Do not use if package damaged or expired;
Measure uterine cavity depth and width preoperatively. Improper parameter setting increases risk of incomplete ablation or uterine perforation;
Continuously monitor impedance and temperature trace intraoperatively; stop ablation immediately upon abnormal alarm;
Maintain proper negative pressure to prevent massive air entry into uterine cavity;
Arrange standardized post-op follow-up; inｆorm patients of common outcomes including amenorrhea, reduced menstrual flow and increased discharge;
This device cannot replace histopathologic biopsy; perｆorm hysteroscopic biopsy first for patients with suspected endometrial lesions to rule out malignancy;
Prevent liquid spillage and heavy impact on main unit; carry out scheduled preventive maintenance per manufacturer requirement;
Keep away from high-power RF generators, electrosurgical units and other strong electromagnetic interference sources.
九、存储条件 Storage Conditions
中文主机存放环境温度：10℃～30℃；相对湿度：30%～75%，无凝露；环境：干燥通风、防尘；避免阳光直射、剧烈撞击、重压；远离腐蚀性气体、液体；一次性消融电极套件：5℃～30℃储存，禁止冷冻；保持原装密封包装；长期闲置：主机断电，线缆整理收纳；耗材按效期先出管理。
EnglishMain Unit Storage Temperature：10℃～30℃;Relative Humidity：30%～75%, non-condensing;Environment：Dry, ventilated and dust-free; avoid direct sunlight, heavy impact and compression; keep away from corrosive gas and liquid;Disposable electrode set storage：5℃～30℃, freezing prohibited; remain in original sealed package;Long-term standby: power off main unit and organize cables; implement FIFO stock management for consumables based on expiry date.
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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