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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂家直供久心半自动体外除颤器iAED-M1-SEN

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厂家直供久心半自动体外除颤器iAED-M1-SEN

桂经理19117326863微xin同号

供应型号规格iAED-M1-SEN,iAED-M1-SEB,iAED-M1-SEW,iAED-M1-SEG

结构及组成/主要组成成分 该产品由主机、电池、一次性除颤电极片组成。

适用范围/预期用途 该产品预期治疗疑似心脏骤停患者(无反应、无脉搏或无循环迹象、无呼吸或呼吸不正常),其中儿童模式适用于0至7岁的患者,成人模式适用于8岁及以上的患者。该产品在公共场所、家庭或医疗场所使用,应由接受过心肺复苏和自动体外除颤器使用培训合格的人员使用,或由接受过基础生命支持和生命支持课程培训合格的医务人员使用,或在急救中心调度人员指导下使用。

iAED-M1
专为家庭及个人用户设计的“家庭宝”AED
适用于个人家庭、运动健身、休闲旅行等场景
产品参数:
• 整机仅重1.1kg,方便携带
• 成人/儿童模式一键切换
• 全程语音指导,三步完成除颤
• 150J低能量双相波除颤技术
• 抗起搏干扰,识别安装起搏器人群
• 覆盖全年龄段人群,基于阻抗进行动态补偿
• 抗跌落高度≥1.2
• IP55级防尘防水
• 每周日/周/月自检
• 主机寿命十年




一、工作原理

Working Principle

中文iAED‑M1 系列采用双相指数截尾波(BTE)+ 实时阻抗自动补偿 + 心律分析与预充电同步核心技术。通过预连接一次性电极片采集患者心电信号,内置基于 20 年国人心电数据库的智能算法,识别心室颤动(VF)、无脉性室性心动过速(VT)等可除颤心律。设备为半自动模式:自动完成心律分析并语音 / 图文提示,由操作者确认后手动触发放电。放电时输出低能量、低心肌损伤、高成功率的双相波,自动根据患者胸阻抗动态调节电流,成人最大输出 150J、儿童 50J,快速终止心脏异常电活动、恢复窦性心律。同时集成CPR 辅助、自动自检、数据存储,实现 “快速分析 — 除颤 —CPR 辅助 — 数据追溯” 一体化急救流程。

EnglishThe iAED‑M1 series adopts biphasic truncated exponential wave (BTE) + real‑time automatic impedance compensation + synchronized rhythm analysis and pre‑charging as core technology. It collects ECG signals via pre‑connected disposable pads, and its built‑in intelligent algorithm based on a 20‑year Chinese ECG database accurately identifies shockable rhythms such as ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT). The device operates in semi‑automatic mode: it automatically analyzes rhythms and provides voice/graphic prompts, with shock delivery manually triggered by the operator after confirmation. It delivers low‑energy, low‑myocardial‑damage, high‑success‑rate biphasic waves, automatically adjusting current based on thoracic impedance with a maximum output of 150J for adults and 50J for pediatrics, rapidly terminating abnormal cardiac electrical activity and restoring sinus rhythm. It also integrates CPR assistance, automatic self‑tests, and data storage, realizing an integrated emergency workflow of “rapid analysis—precise defibrillation—CPR assistance—data traceability”.

二、产品特点

Product Features

中文

小巧便携:尺寸与乒乓球拍相仿,厚度 4.7cm,重量仅 1.1kg,轻薄易携,适配居家、车载、户外场景

极简操作:三步操作(开机 — 贴电极 — 除颤),全程语音 + CPR 节拍音指导,预连接电极,开机即用

高效低损除颤:150J 低能量双相指数截尾波,阻抗自动补偿,除颤成功率超 98%,心肌损伤更小

抗干扰分析:20 年心电数据库,抗运动 / 起搏器干扰,心律识别准确率≥98.5%

极速响应:心律分析与预充电同步,充电≤5 秒,黄金 4 分钟快速施救

全人群适配:成人(≥8 岁 /≥25kg)/ 儿童(0–7 岁 /<25kg)一键切换,自动衰减能量

坚固耐用:IP55 防尘防水,抗 1.2 米跌落,适配复杂环境

智能守护:每日 / 周 / 月自动自检,开机录音,数据可导出复盘

长寿命耗材:一次性锂电池待机≥5 年 /≥200 次除颤;电极片有效期≥30 个月

安全可靠:防误触放电、电极粘连检测、低电量报警,多重安全保障


三、技术参数

Technical Parameters

中文

型号:iAED‑M1‑SEN、iAED‑M1‑SEB、iAED‑M1‑SEW、iAED‑M1‑SEG

除颤波形:双相指数截尾波(BTE),实时阻抗自动补偿

能量范围:成人 150J;儿童 50J(自动衰减)

充电时间:≤5 秒(150J)

心律分析:4–6 秒,VF 阈值 0.2mV,心搏停止阈值<0.2mV

语音指导:中 / 英双语,音量自适应(≥80dB)

CPR 辅助:实时节拍音指导(100–120 次 / 分)

电池:一次性锂电池,待机≥5 年 /≥200 次 150J 除颤

电极片:成人 / 儿童二合一,预连接,有效期≥30 个月

防护等级:IP55

工作温度:0℃~50℃

存储温度:-20℃~60℃

相对湿度:10%~95%(无冷凝)

尺寸:约 220×180×47mm(长 × 宽 × 高)

重量:约 1.1kg(含电池)

适用人群:成人(≥8 岁 /≥25kg)、儿童(0–7 岁 /<25kg)



四、使用方法

Instructions for Use

中文

开机:打开设备盖,自动开机并启动自检,语音提示就绪

模式选择:按 “儿童键” 切换儿童模式(0–7 岁 /<25kg),默认成人模式

贴电极片:暴露患者胸部,按图示贴右锁骨下、左乳头外侧;儿童可前后位贴法

心律分析:连接电极后,设备自动分析,提示 “不要触碰患者”,期间禁止接触

除颤操作:提示 “建议除颤”→确认周围安全→按 “除颤键” 放电;提示 “无需除颤”→立即 CPR

CPR 配合:除颤后立即 CPR,按节拍音规范按压,遵循 “30:2” 循环

数据记录:全程自动录音、存储操作数据,支持导出复盘

重复流程:每 5 个循环(≈2 分钟)自动再次分析,重复除颤 / CPR

急救结束:患者恢复自主循环或专业人员到达后,关机并整理设备

English

Power on: Open device cover, auto‑power‑on and self‑test, voice prompt for readiness

Mode selection: Press “Child” key for pediatric mode (0–7y/<25kg); default adult mode

Apply pads: Expose patient’s chest, apply pads to right upper chest below clavicle and left lateral to nipple per diagram; anterior‑posterior placement for pediatrics

Rhythm analysis: After pad connection, device analyzes automatically with prompt “Do not touch the patient”; no contact during analysis

Defibrillation operation: If “Shock advised” → confirm safety → press “Shock” button; if “No shock advised” → start CPR immediately

CPR coordination: Start CPR immediately after shock, follow metronome for standardized compressions, follow “30:2” cycle

Data recording: Full audio and operation data auto‑stored, supports export for review

Repeat cycle: Auto‑reanalyzes after every 5 cycles (≈2 minutes), repeat defibrillation/CPR

End rescue: After ROSC or arrival of professionals, power off and organize equipment




五、适应症

Indications

中文

心脏骤停急救:无反应、无呼吸 / 呼吸异常、无循环迹象的成人 / 儿童疑似心脏骤停患者

可除颤心律:心室颤动(VF)、无脉性室性心动过速(VT)的半自动体外除颤

适用人群:成人(≥8 岁或体重≥25kg);儿童(0 岁以上 7 岁以下或体重不足 25kg)

使用场景:家庭、车载、社区、小型公共场所、户外旅行、运动场所(经培训人员操作)

English

Sudden cardiac arrest emergency: For adult/pediatric patients with suspected SCA who are unresponsive, not breathing or breathing abnormally, and have no signs of circulation

Shockable rhythms: Semi‑automatic external defibrillation for ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT)

Target users: Adults (≥8y or ≥25kg); Pediatrics (0–7y or <25kg)

Application scenarios: Home, vehicle, community, small public places, outdoor travel, sports venues (operated by trained personnel)



六、禁忌症

Contraindications

中文

非心脏骤停:患者有意识、有正常呼吸、可触及脉搏者

非可除颤心律:窦性心律、房室传导阻滞、稳定房颤、血流动力学稳定室上速等

胸部禁忌:胸部皮肤严重破损、感染、烧伤、出血;电极无法紧密粘贴

环境禁忌:患者处于水中 / 潮湿环境(触电风险);易燃易爆 / 高氧环境

设备禁忌:自检失败、电池亏电、电极过期 / 破损、硬件故障

人群禁忌:新生儿(<0 岁)禁用;无意识儿童禁用成人模式

植入物禁忌:电极覆盖起搏器 / ICD 部位(至少避开 10cm),避免设备故障

English

Non‑cardiac arrest: Conscious patient with normal breathing and palpable pulse

Non‑shockable rhythms: Sinus rhythm, AV block, stable atrial fibrillation, hemodynamically stable SVT, etc.

Chest contraindications: Severe skin damage, infection, burns, bleeding on chest; poor electrode adhesion

Environmental contraindications: Patient in water/wet environment (electric shock risk); flammable/explosive/high‑oxygen environment

Device contraindications: Failed self‑test, low battery, expired/damaged electrodes, hardware malfunction

Population contraindications: Prohibited for neonates (<0y); adult mode prohibited for unconscious children

Implant contraindications: Electrodes over pacemaker/ICD site (keep ≥10cm away) to avoid device failure

七、注意事项

Precautions

中文

安全操作:分析 / 放电时严禁触碰患者、病床或导电物品,确保周围人员安全

电极使用:电极片必须完整贴紧,避开毛发、伤口、起搏器 / ICD(≥10cm);儿童必须用儿童模式

CPR 优先:除颤不能替代高质量 CPR,严格遵循 “分析 — 除颤 —CPR” 循环

环境安全:禁止在水中、易燃易爆、高浓度氧气环境使用;患者先转移至干燥地面

耗材管理:一次性电极不可重复使用;定期检查电池电量、电极有效期、设备状态

设备维护:不可自行拆卸维修;故障由久心医疗授权人员处理;保持清洁干燥

操作资质:接受过 CPR 与 AED 培训的人员操作,或在急救调度 / 远程指导下使用

儿童规范:0–7 岁儿童必须使用儿童模式,禁止直接用成人能量除颤



八、存储条件

Storage Conditions

中文

温度:工作 0℃~50℃;存储 - 20℃~60℃

湿度:10%~95%,无冷凝水

环境:干燥、通风、清洁,远离腐蚀性气体、粉尘、强光、热源、强电磁干扰

物理防护:避免重压、摔落、剧烈震动、弯折;水平放置,固定牢固

耗材存储:电极片密封保存,防潮、防晒、防污染,在有效期内使用

运输:防震、防雨、防摔,温度控制在 - 20℃~60℃;固定牢固,避免挤压

电池:一次性电池不可充电;存储于阴凉干燥处,避免高温 / 潮湿




九、说明书核心信息

Core Manual Information

中文

产品名称:半自动体外除颤器(iAED‑M1 系列)

型号:iAED‑M1‑SEN、iAED‑M1‑SEB、iAED‑M1‑SEW、iAED‑M1‑SEG

结构组成:主机、一次性锂电池、成人 / 儿童二合一电极片、急救包(剪刀 / 手套 / CPR 面罩)

适用人群:成人(≥8 岁 /≥25kg)、儿童(0–7 岁 /<25kg)

核心功能:半自动除颤、心律分析、CPR 节拍指导、自动自检、数据存储 / 导出、语音指导

安全特性:IP55 防护、防误触放电、电极粘连检测、低电量报警、定期自检

操作模式:半自动(自动分析 + 手动放电);成人 / 儿童双模式

配套耗材:成人 / 儿童二合一电极片、一次性锂电池、急救包

维护要求:定期自检,清洁消毒,禁止私自拆解;电池 / 电极到期立即更换

有效期:设备质保 5 年;一次性电池待机≥5 年;电极片有效期≥30 个月

使用资质:经 CPR 与 AED 培训人员操作,或在急救调度 / 远程指导下使用

注册证号:国械注准 20233081026

English

Product name: Semi‑Automated External Defibrillator (iAED‑M1 Series)

Model: iAED‑M1‑SEN, iAED‑M1‑SEB, iAED‑M1‑SEW, iAED‑M1‑SEG

Composition: Main unit, disposable Li‑battery, 2‑in‑1 adult/pediatric pads, emergency kit (scissors/gloves/CPR mask)

Target users: Adults (≥8y/≥25kg), Pediatrics (0–7y/<25kg)

Core functions: Semi‑automatic defibrillation, rhythm analysis, CPR metronome guidance, automatic self‑tests, data storage/export, voice guidance

Safety features: IP55 protection, anti‑accidental shock, pad adhesion detection, low battery alarm, regular self‑tests

Operation modes: Semi‑automatic (auto‑analysis + manual shock); adult/pediatric dual modes

Consumables: 2‑in‑1 adult/pediatric pads, disposable Li‑battery, emergency kit

Maintenance: Regular self‑tests, cleaning and disinfection, no unauthorized disassembly; immediate replacement of expired batteries/pads


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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