厂家直供东方电子心脏电生理刺激仪DF-5A
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厂家直供东方电子心脏电生理刺激仪DF-5A
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
DF-5A
结构及组成/主要组成成分
产品由主机、食道电极和充电器三部分组成。电极导管为聚氨酯导管，电极头采用奥氏体不锈钢材料制造。
适用范围/预期用途 供心脏调搏刺激用。
1、工作原理 Working Principle
中文 仪器依据心脏电生理特性，通过食道 / 心内电极向心脏发放可控电脉冲刺激；可 R 波同步触发，在心动周期特定时刻施加基础刺激、程控早搏刺激、猝发刺激，同步采集心电信号，观察心脏传导、起搏、折返等电生理反应，以此评估心脏传导系统功能，诱发或终止心律失常，完成电生理检查与保护性起搏治疗。
English Based on cardiac electrophysiological characteristics, the device delivers controllable electrical pulse stimuli to the heart via trans‑esophageal or intracardiac electrodes. It supports R‑wave synchronous triggering to deliver basic stimulation, programmed premature stimulation and burst stimulation at specific phases of cardiac cycle. Synchronously collect ECG signals to observe cardiac responses including conduction, pacing and re‑entry, so as to evaluate cardiac conduction system function, induce or terminate arrhythmias for electrophysiological examination and protective pacing therapyAgência Na...。
2、产品功能 Product Functions
中文
经食管心房调搏、心内电生理刺激；
基础刺激、S1S2/S2S3 程控早搏刺激、Burst 猝发高频刺激；
R 波同步触发刺激输出；
窦房结、房室传导功能检测；
诱发、终止室上性心动过速；
保护性起搏、心脏负荷试验；
配合心电设备记录体表及食道导联心电波形，辅助心律失常鉴别诊断与药物疗效评估。
English
Trans‑esophageal atrial pacing and intracardiac electrophysiological stimulation;
Basic stimulation, S1S2/S2S3 programmed premature stimulation, Burst high‑frequency stimulation;
R‑wave synchronized trigger stimulation output;
Detection of sinoatrial node and atrioventricular conduction function;
Induction and termination of supraventricular tachycardia;
Protective pacing and cardiac stress test;
Cooperate with ECG equipment to record surface and esophageal lead ECG waveｆorms, assist arrhythmia differential diagnosis and drug efficacy evaluation。
3、产品特点 Product Features
中文
支持食道、心内两种刺激模式，脉冲参数连续可调；
R 波同步触发，可避开心脏易损期，提升操作安全性；
具备程控早搏、猝发刺激多种临床刺激模式；
便携式内置充电电池，适合床旁检查；
刺激间期、频率、电压调节范围宽，适配不同患者；
操作界面简洁，可快速切换刺激模式，紧急起搏一键启动。
English
Support both trans‑esophageal and intracardiac stimulation modes with continuously adjustable pulse parameters;
R‑wave synchronous triggering to avoid cardiac vulnerable period and improve safety;
Multiple clinical stimulation modes including programmed premature and burst stimulation;
Portable with built‑in rechargeable battery for bedside examination;
Wide adjustable range of stimulation interval, frequency and voltage for different patients;
Simple operation interface, quick mode switching, one‑key emergency pacing functionAgência Na...
4、技术参数 Technical Parameters
中文
刺激频率：30‑1000 次 / 分；
脉冲幅度：心内 0.2V‑8V，食道 0.6V‑40V 连续可调；
脉冲脉宽：心内 1ms，食道 10ms；
S1S1 间期：10‑1999ms；S1S2/S2S3 间期：10‑999ms；
供电：内置可充电电池；
设备分类：CF 型防除颤应用部分，短时连续工作模式。
English
Stimulation frequency: 30‑1000 beats/min;
Pulse amplitude: intracardiac 0.2V‑8V, trans‑esophageal 0.6V‑40V continuously adjustable;
Pulse width: intracardiac 1ms, trans‑esophageal 10ms;
S1S1 interval:10‑1999ms; S1S2/S2S3 interval:10‑999ms;
Power supply: built‑in rechargeable battery;
Device classification: CF‑type defibrillation‑proof applied part, short‑term continuous operation modeAgência Na...。
5、使用方法 Operation Method
中文
术前检查仪器电量、电极、连接线完好；
将食道电极经鼻腔置入食道合适位置（左心房后方），连接主机刺激输出端；心内模式连接心内电极；
连接体表心电采集，确认 R 波感知正常；
根据临床需求设置刺激模式：基础刺激 / 程控 S1S2 早搏刺激 / Burst 猝发刺激，设置频率、电压、间期参数；
启动刺激输出，同步观察心电波形，完成电生理检测；
出现心动过速时，使用猝发刺激终止心律失常；遇长间歇立即开启保护性起搏；
检查结束，停止刺激输出，取出电极，关闭设备电源，整理配件。
English
Check battery power, electrodes and connecting cables before operation;
Insert trans‑esophageal electrode through nasal cavity to proper position behind left atrium, connect to host stimulation output terminal; connect intracardiac electrode for intracardiac mode;
Connect surface ECG acquisition and confirm normal R‑wave sensing;
Set stimulation mode (basic / programmed S1S2 premature / Burst), configure frequency, voltage and interval parameters according to clinical requirements;
Activate stimulation output, observe ECG waveｆorm synchronously and complete electrophysiological test;
Apply burst stimulation to terminate tachycardia; enable protective pacing immediately in case of long cardiac pause;
Stop stimulation output after examination, remove electrode, power off device and organize accessoriesAgência Na...。
6、适应症 Indications
中文
窦房结功能检测；
房室传导功能评估；
预激综合征、房室结双径路等心律失常电生理检查；
阵发性室上性心动过速诱发、分型及终止；
缓慢心律失常保护性起搏；
经食管心房起搏心脏负荷试验；
抗心律失常药物疗效评价；
射频消融术前电生理评估。
English
Sinoatrial node function assessment;
Atrioventricular conduction function evaluation;
Electrophysiological examination for arrhythmias such as Wolff‑Parkinson‑White syndrome and atrioventricular nodal dual pathways;
Induction, classification and termination of paroxysmal supraventricular tachycardia;
Protective pacing for bradyarrhythmia;
Trans‑esophageal atrial pacing cardiac stress test;
Efficacy evaluation of anti‑arrhythmic drugs;
Pre‑radiofrequency‑ablation electrophysiological assessment。
7、禁忌症 Contraindications
中文
严重心功能衰竭、不稳定型心绞痛、急性心肌梗死急性期；
严重电解质紊乱、未控制的恶性心律失常；
食管病变：食管穿孔、食管重度静脉曲张、食管急性炎症；
严重凝血功能障碍；
生命体征不稳定，不能耐受电生理检查患者；
对电极材料过敏者；
病态窦房结伴反复晕厥，无抢救保障条件禁止做窦房结恢复时间测定。
English
Severe heart failure, unstable angina, acute phase of myocardial infarction;
Severe electrolyte disturbance, uncontrolled malignant arrhythmia;
Esophageal lesions: esophageal perforation, severe esophageal varices, acute esophagitis;
Severe coagulation disorders;
Unstable vital signs and patients intolerant to electrophysiological examination;
Patients allergic to electrode materials;
Sinoatrial node syndrome with recurrent syncope; sinoatrial node recovery time test is prohibited without rescue guarantee conditions。
8、注意事项 Precautions
中文
具备心脏电生理资质医师操作，场地必须配备除颤仪、抢救药品；
检查前确认设备、电极完好，电池电量充足；
刺激参数由低向高逐步上调，密切监护心电与患者生命体征；
严格规避心脏易损期，R 波同步模式优先使用；
术中出现恶性心律失常、严重胸闷头晕，立即停止刺激，实施抢救；
食道电极一次性使用，禁止重复使用；
设备不可与高频手术设备同时靠近患者使用，避免干扰；
定期设备校准维护，禁止自行拆解主机；
操作中出现长 RR 间期，立刻启动保护性起搏功能。
English
Operated only by physicians with cardiac electrophysiology qualification; defibrillator and rescue drugs must be available on site;
Confirm intact device and electrodes with sufficient battery power before examination;
Gradually increase stimulation parameters from low level, closely monitor ECG and patient vital signs;
Strictly avoid cardiac vulnerable period; R‑wave synchronization mode is preferred;
Immediately stop stimulation and perｆorm rescue in case of malignant arrhythmia, severe chest tightness or dizziness during examination;
Trans‑esophageal electrode is disposable; re‑use is forbidden;
Do not operate simultaneously with high‑frequency surgical equipment near patient to prevent interference;
Regular calibration and maintenance; do not disassemble host by yourself;
Activate protective pacing immediately when long RR interval occurs during operationAgência Na...。
9、存储条件 Storage Conditions
中文 环境温度：0℃～+40℃；相对湿度：20%‑80%；无腐蚀性气体，避免潮湿、阳光直射、剧烈震动；电池长期存放前需充足电；电极导管防尘避光存放。
English Ambient temperature: 0℃～+40℃; Relative humidity:20%‑80%; Store in environment without corrosive gas, avoid moisture, direct sunlight and violent vibration. Fully charge battery before long‑term storage; store electrode catheter away from dust and light.
10、说明书核心摘要 Core Summary
中文 DF‑5A 心脏电生理刺激仪为 Ⅲ 类医疗器械，用于经食道及心内心脏调搏刺激，开展心律失常电生理诊断、心动过速诱发终止、保护性起搏；必须由专业医师操作，现场具备全套抢救设备；严格把控适应症禁忌症，食道电极一次性使用；设备需定期维护校准，妥善存储充电电池，防范恶性心律失常风险。
English DF‑5A Cardiac Electrophysiology Stimulator is Class Ⅲ medical device, applied for trans‑esophageal and intracardiac cardiac pacing stimulation, arrhythmia electrophysiological diagnosis, tachycardia induction/termination and protective pacing. It shall be operated by professional physicians with complete on‑site rescue equipment. Strictly comply with indications and contraindications. Trans‑esophageal electrode is disposable. Perｆorm regular maintenance and calibration, properly store rechargeable battery, prevent malignant arrhythmia risks
以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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