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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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厂家席勒半自动体外除颤器AED-N1,AED-N2,AED-N3,AED-N4,AED-N5,AED-N6

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品牌名称:$brandModel.Title型号: 原产地:中国大陆 医疗器械注册号(批文):国械注准20253080946更新时间:2026/10/16 11:11:02

产品摘要:厂家席勒半自动体外除颤器AED-N1,AED-N2,AED-N3,AED-N4,AED-N5,AED-N6

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厂家席勒半自动体外除颤器AED-N1,AED-N2,AED-N3,AED-N4,AED-N5,AED-N6

桂经理19117326863微xin同号


半自动体外除颤器

管理类别

第三类

型号规格

AED-N1, AED-N2, AED-N3, AED-N4, AED-N5, AED-N6

结构及组成/主要组成成分

该产品由主机、电池、除颤电极片、选配件组成,详见产品技术要求。

适用范围/预期用途

该设备预期治疗疑似心脏骤停患者(无反应、无呼吸、无脉搏),适用于体重≥25kg的成人及儿童(使用成人电极片)以及体重<25kg(年龄小于8岁)的儿童(使用儿童电极片)。  该产品在公共场所、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,或者在急救中心调度人员指导下使用,或者由接受过基本生命支持和生命支持课程培训合格的医务人员使用。


一、工作原理(Working Principle)

中文设备通过一次性除颤电极片采集患者心电信号,自动分析是否为室颤(VF)、无脉室速(pVT)等可除颤心律。若判定需要除颤,自动充电并提示操作者按下放电键,释放双相指数截断波(BTE)电击,强制心肌同步除极、终止异常电活动,恢复窦性心律。

EnglishThe device collects ECG signals via disposable defibrillation pads, automatically analyzes for shockable rhythms (e.g., ventricular fibrillation, pulseless ventricular tachycardia). If a shock is advised, it charges automatically and prompts the operator to press the discharge button, delivering abiphasic truncated exponential (BTE)shock to synchronously depolarize myocardium, terminate abnormal electrical activity, and restore sinus rhythm.

二、产品特点(Product Features)

中文

  • 双相波技术,自动阻抗补偿,低能量高成功率

  • 成人 / 儿童模式一键切换(成人≥8 岁 / 25kg;儿童 < 8 岁 /<25kg)

  • 全程中文语音 + 图示 / 屏幕引导,非专业人员可操作

  • 快速充电(≤7–10 秒),自动心律分析

  • 内置 CPR 节拍与按压反馈,支持 2 分钟 CPR 循环

  • 便携、抗跌落(1.5 米)、IP55 防尘防水

  • 一次性锂电池,待机≥5 年,支持≥200 次除颤

  • 部分型号(N4/N5/N6)支持数据存储、远程监控、高清彩屏

English

  • Biphasic waveform with automatic impedance compensation, low energy, high success rate

  • One‑key adult/pediatric mode switch (adult ≥8y/25kg; pediatric <8y/<25kg)

  • Full‑processChinese voice + graphic/screenguidance, usable by non‑professionals

  • Fast charging (≤7–10s), automatic rhythm analysis

  • Built‑in CPR metronome and compression feedback, supports 2‑minute CPR cycles

  • Portable, drop‑resistant (1.5m), IP55 dust‑proof and water‑resistant

  • Disposable lithium battery, standby ≥5 years, supports ≥200 shocks

  • Selected models (N4/N5/N6): data logging, remote monitoring, high‑resolution color display

微信图片_20260330112552_696_5.jpg

三、技术参数(Technical Specifications)

表格

项目中文English
型号AED‑N1, N2, N3, N4, N5, N6AED‑N1, N2, N3, N4, N5, N6
除颤波形双相指数截断波(BTE)Biphasic Truncated Exponential Wave (BTE)
成人能量120J/150J → 200J(自动递增)120J/150J → 200J (automatic escalation)
儿童能量50J → 70J → 85J(自动递增)50J → 70J → 85J (automatic escalation)
充电时间≤7–10 秒≤7–10 seconds
阻抗范围0–300Ω0–300Ω
重量(含电池)≤1.5–2.5kg≤1.5–2.5kg
尺寸约 200×280×90mmApprox. 200×280×90mm
防护等级IP55IP55
电池一次性锂锰电池,12V/3000mAhDisposable Li‑MnO₂ battery, 12V/3000mAh
电池寿命待机≥5 年;≥200 次 200J 除颤Standby ≥5 years; ≥200 shocks at 200J
电极一次性除颤电极片(成人 / 儿童通用)Disposable defibrillation pads (adult/pediatric universal)
显示N1/N2:指示灯;N3/N4:单色屏;N5/N6:彩屏N1/N2: LED indicators; N3/N4: monochrome; N5/N6: color display
数据存储N4/N5/N6:支持N4/N5/N6: Supported
远程监控N5/N6:支持N5/N6: Supported


四、使用方法(Operating Instructions)

中文

  1. 开机:打开设备电源,语音启动

  2. 贴电极:成人贴右胸锁骨下、左乳头外侧;儿童贴前胸 / 后背

  3. 分析:设备自动分析心律,所有人远离患者

  4. 除颤:若提示 “建议电击”,确认无人接触后按放电键

  5. CPR:无需电击或除颤后,立即按提示做 CPR(30 次按压 + 2 次通气)

  6. 循环:每 2 分钟自动重新分析,重复至急救人员到达

English

  1. Power on: Turn on the device; voice guidance starts

  2. Apply pads: Adult: right upper chest, left lateral chest; Pediatric: anterior/posterior chest

  3. Analyze: Device analyzes rhythm automatically;all clear patient

  4. Shock: If “Shock Advised”, confirm no contact then press discharge button

  5. CPR: If no shock advised or after shock, perform CPR (30 compressions + 2 ventilations) as prompted

  6. Cycle: Re‑analyze every 2 minutes; repeat until EMS arrives



五、适应症(Indications)

中文适用于无意识、无正常呼吸、无脉搏的疑似心脏骤停患者,用于体外除颤治疗。

  • 成人模式:≥8 岁或体重≥25kg

  • 儿童模式:<8 岁或体重 < 25kg

EnglishFor external defibrillation ofunresponsive, non‑breathing, pulselesssuspected cardiac arrest patients.

  • Adult mode: ≥8 years or ≥25kg

  • Pediatric mode: <8 years or <25kg

六、禁忌症(Contraindications)

中文

  • 患者有意识、有呼吸、有脉搏

  • 胸部有开放性伤口、严重烧伤、植入式起搏器 / ICD(电极避开)

  • 水中或潮湿环境(擦干胸部)

  • 电极片无法良好接触皮肤(如多毛、大量汗液)

  • 易燃易爆环境(如氧气、天然气聚集处)

English

  • Conscious, breathing, pulseless patient

  • Open chest wounds, severe burns, implanted pacemaker/ICD (pad placement avoidance)

  • In water or wet environment (dry chest thoroughly)

  • Poor pad‑skin contact (e.g., excessive hair, heavy perspiration)

  • Flammable/explosive environment (e.g., oxygen, natural gas)


七、注意事项(Cautions)

中文

  • 除颤时严禁任何人接触患者,大声警示 “远离”

  • 电极片必须贴紧干燥皮肤,避免褶皱、气泡

  • 儿童必须使用儿童模式或儿童电极片

  • 远离火源、电磁干扰

  • 电池 / 电极片过期禁止使用

  • 仅用于急救,不可替代专业医疗

  • 定期自检,确保设备可用

English

  • No one touches patientduring shock; loudly announce “Clear”

  • Pads must adhere firmly to dry skin; avoid wrinkles/bubbles

  • Pediatric mode or pediatric pads mandatory for children

  • Keep away from fire sources and electromagnetic interference

  • Do not use expired batteries/pads

  • For emergency use only; not a substitute for professional care

  • Perform regular self‑tests to ensure readiness


八、存储条件(Storage Conditions)

中文

  • 温度:-40℃~+70℃

  • 湿度:0%~95%(非冷凝)

  • 避免阳光直射、潮湿、腐蚀气体

  • 存放于干燥、通风、易取用的固定位置

  • 定期自检(设备自动或手动),确保可用

English

  • Temperature: -40℃ to +70℃

  • Humidity: 0%–95% (non‑condensing)

  • Avoid direct sunlight, moisture, corrosive gases

  • Store in dry, ventilated, easily accessible location

  • Perform regular self‑tests (automatic/manual) to ensure readiness



九、说明书核心信息(Manual Key Information)

中文

  • 产品名称:半自动体外除颤器(AED)

  • 型号:AED‑N1, N2, N3, N4, N5, N6

  • 组成:主机、一次性电池、一次性电极片、便携包

  • 管理类别:第三类医疗器械

  • 适用人群:成人 / 儿童心脏骤停急救

  • 操作:半自动,语音引导,需人工确认放电

  • 维护:定期自检,更换过期电池 / 电极

  • 安全:双相波,自动放电保护,防误触

  • 质保:主机质保 5 年,电池 / 电极片按有效期

  • 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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