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厂商供应美国波科心脏脉冲电场消融系统61M401
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厂商供应美国波科心脏脉冲电场消融系统61M401
桂经理19117326863微xin同号
产品由脉冲电场消融仪、记录模块及附件电缆组成，具体型号规格详见附页。
适用范围/预期用途
该产品与本公司生产的一次性使用心脏脉冲电场消融导管（型号规格：41M401，41M402）及连接线缆配合使用，用于药物难治性、性、症状性的阵发性房颤或药物难治性、症状性的持续性房颤（发作持续时间小于1年）患者的治疗。
厂商供应美国波科心脏脉冲电场消融系统61M401
一、产品特点（Product Features）
中文
· 非热消融原理：利用陡脉冲电场产生不可逆电穿孔效应，选择性破坏心肌细胞，实现肺静脉电隔离，避免热损伤周围组织（如食管、膈神经）。
· 双相交变脉冲：输出1800/1900/2000V三档固定电压，脉冲参数预设，操作简便
同步/非同步双模式：同步模式配合电生理记录仪在心肌不应期放电；非同步模式直接按固定频率输出。
· 三重安全控制：电压闭环调节（波动＜±3%）、导管位移＞2mm自动熔断、组织温升≤1℃实时监测。
· 高效：单次消融**≤90秒**，肺静脉隔离即刻成功率100%，术后12个月成功率约70%。
· 兼容配套导管：与FARAWAVE 41M401/41M402一次性消融导管（花瓣/网篮电极）。
English
· Non-thermal Ablation Principle: Uses steep pulsed electric fields to induce irreversible electroporation, selectively ablating myocardial cells for pulmonary vein isolation, minimizing thermal damage to surrounding tissues (e.g., esophagus, phrenic nerve)。.
· Biphasic Alternating Pulses: Delivers 1800/1900/2000V fixed voltage levels with preset parameters for simplified operation。.
· Dual Modes (Sync/Async): Sync mode discharges during the myocardial refractory period with an electrophysiology recorder; Async mode outputs at fixed intervals directly。.
· Triple Safety Controls: Closed-loop voltage regulation (variation <±3%), auto-shutdown if catheter displacement > 2mm, real-time tissue temperature monitoring (≤1°C).
· High Efficiency & Precision: Single ablation≤90 seconds, 100% acute pulmonary vein isolation success rate, ~70% 12-month freedom from atrial fibrillation.
· Compatible Catheters: Works with FARAWAVE 41M401/41M402 single-use ablation catheters (petal/basket electrodes)。
二、技术参数（Technical Specifications）
中文
· 型号：61M401（主机）、61M407（记录模块）
· 脉冲类型：双相交变脉冲（Biphasic Alternating Pulses）
· 输出电压：1800V、1900V、2000V（三档固定，不可调）
· 脉冲宽度：预设（不可调）
· 脉冲频率：同步/非同步模式下固定频率
· 消融时间：单脉冲序列**≤90秒**
· 安全机制：电压闭环、位移监测、温度监测、阻抗突变（＞20Ω）立即停止
· 电气安全：符合GB 9706.1-2020、GB 9706.202-2021、YY 9706.102-2021。
· 使用期限：主机3年，软件版本V4。
English
· Model: 61M401 (Generator), 61M407 (Recording Module)
· Pulse Type: Biphasic Alternating Pulses
· Output Voltage: 1800V, 1900V, 2000V (3 fixed, non-adjustable levels)
· Pulse Width: Preset (non-adjustable)
· Pulse Frequency: Fixed in Sync/Async modes
· Ablation Duration: Single pulse sequence≤90 seconds
· Safety Features: Closed-loop voltage, displacement monitoring, temperature monitoring, immediate stop on impedance spike (>20Ω)
· Electrical Safety: Complies with GB 9706.1-2020, GB 9706.202-2021, YY 9706.102-2021。
· Service Life: Generator 3 years, Software Version V4。
三、使用方法（Instructions for Use）
中文
1.
术前准备
2.
o 患者评估：排除左心房血栓、机械瓣膜、严重主动脉瓣狭窄（压差＞40mmHg）。
o 设备自检：开机自检，连接导管、记录模块、脚踏开关，确认阻抗正常。
o 麻醉：全麻/深度镇静，构建左心房三维模型（精度0.3mm）。
3.
导管操作
4.
o 经8.5F鞘管送入FARAWAVE 41M401/41M402导管至左心房肺静脉开口。
o 展开花瓣/网篮电极，贴靠压力5–20g，确保电极与组织充分接触。
5.
消融执行
6.
o 选择电压档位（1800/1900/2000V）与模式（同步/非同步）。
o 脚踏触发脉冲序列，单次**≤90秒**，实时监测阻抗、温度、位移。
o 后壁消融需食道温度监测，避免损伤。
7.
效果验证
8.
o 消融后用腺苷诱发，验证肺静脉双向传导阻滞（达标率100%）。
o 术后48小时心电监护，监测房扑转化风险（约8%）。
English
1.
Preoperative Preparation
2.
o Patient Evaluation: Exclude left atrial thrombus, mechanical valves, severe aortic stenosis (gradient >40mmHg).
o System Check: Power-on self-test; connect catheter, recording module, footswitch; verify normal impedance.
o Anesthesia: General/deep sedation; 3D left atrial modeling (0.3mm precision).
3.
Catheter Placement
4.
o Advance FARAWAVE 41M401/41M402 catheter via 8.5F sheath to pulmonary vein ostia in left atrium.
o Deploy petal/basket electrodes; maintain 5–20g contact pressure for optimal tissue apposition.
5.
Ablation Delivery
6.
o Select voltage (1800/1900/2000V) and mode (Sync/Async).
o Trigger pulse sequence via footswitch; single application≤90 seconds; real-time monitoring of impedance, temperature, displacement.
o Esophageal temperature monitoring required for posterior wall ablation to prevent injury.
7.
Effect Verification
8.
o Post-ablation: Adenosine challenge to confirm bidirectional pulmonary vein block (100% success rate).
o 48-hour post-op ECG monitoring for atrial flutter conversion risk (~8%).
四、适应症（Indications）
中文
· 用于药物难治性、性、症状性阵发性房颤患者的肺静脉电隔离治疗。
· 医疗机构内使用，与FARAWAVE 41M401/41M402一次性消融导管配套。
English
· For pulmonary vein isolation in patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation。.
· For use in medical facilities, in conjunction with FARAWAVE 41M401/41M402 single-use ablation catheters。.
五、禁忌症（Contraindications）
中文
· 绝对禁忌：左心房血栓、机械心脏瓣膜、严重主动脉瓣狭窄（跨瓣压差＞40mmHg）。
· 相对禁忌：未控制的出血倾向、严重肝肾功能不全、妊娠、左心房内径显著扩大、既往食管手术史。
English
· Absolute Contraindications: Left atrial thrombus, mechanical heart valves, severe aortic stenosis (transvalvular gradient >40mmHg).
· Relative Contraindications: Uncontrolled bleeding diathesis, severe hepatic/renal dysfunction, pregnancy, significantly enlarged left atrium, prior esophageal surgery.
六、注意事项（Warnings & Precautions）
中文
· 操作红线：单点消融**≤90秒**、贴靠压力5–20g、阻抗突变＞20Ω 立即停止。
· 食道保护：后壁消融必须监测食道温度，避免过热损伤。
· 迷走反射：术中可能出现严重迷走反射，建议预置心室起搏电极，必要时用阿托品（排除前列腺肥大/青光眼）。
· 冠脉痉挛：二尖瓣/三尖瓣峡部消融时，冠心病患者需加强监测，术前可预防性用。
· 术后监测：48小时心电监护，复查血常规、凝血、肾功能（警惕溶血/ AKI）。
· 设备维护：主机使用期限3年，定期校准，仅用原厂配件。
English
· Hard Limits: Single ablation≤90 seconds, contact pressure 5–20g, immediate stop on impedance spike >20Ω.
· Esophageal Protection: Mandatory esophageal temperature monitoring for posterior wall ablation to avoid thermal injury.
· Vagal Response: Severe vagal reactions may occur; recommend ventricular pacing backup, atropine if needed (exclude prostatic hypertrophy/glaucoma).
· Coronary Spasm: Increased risk during mitral/tricuspid isthmus ablation in CAD patients; monitor closely, consider prophylactic nitroglycerin.
· Post-op Monitoring: 48-hour ECG surveillance; CBC, coagulation, renal function tests (monitor for hemolysis/AKI).
· Device Maintenance: Generator service life 3 years; periodic calibration; use only original accessories.
七、存储条件（Storage Conditions）
中文
· 环境温度：+10℃～+30℃
· 相对湿度：30%～75%（无冷凝）
· 大气压力：700hPa～1060hPa
· 存储要求：干燥、通风、无腐蚀性气体、避免阳光直射与剧烈震动
· 包装：原包装密封存储，防止受潮与污染
English
· Ambient Temperature: +10°C to +30°C
· Relative Humidity: 30% to 75% (non-condensing)
· Atmospheric Pressure: 700hPa to 1060hPa
· Storage Requirements: Dry, ventilated area; no corrosive gases; avoid direct sunlight and severe vibration
· Packaging: Store in original sealed packaging to prevent moisture and contamination
八、说明书核心信息（Key Manual Inｆormation）
· 产品名称：心脏脉冲电场消融系统（FARASTAR Pulsed Field Ablation Generator System）
· 型号：61M401（消融仪）、61M407（记录模块）
· 管理类别：第三类医疗器械
· 生产企业：FARAPULSE, Inc.（美国）
· 适用范围：药物难治性、性、症状性阵发性房颤的肺静脉电隔离
· 配套耗材：一次性使用心脏脉冲电场消融导管（41M401、41M402）
· 使用期限：主机3年，软件版本V4
· 电气安全：GB 9706.1-2020、GB 9706.202-2021、YY 9706.102-2021
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.
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