厂商直供安保半自动体外除颤仪i3,i5
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厂商直供安保半自动体外除颤仪i3,i5
桂经理19117326863微xin同号
管理类别
第三类
型号规格
i3，i5
结构及组成/主要组成成分
该产品由主机、电池和一次性使用除颤电极片组成，详见附页。
适用范围/预期用途
该产品预期用于对无反应、无呼吸、无脉搏的疑似心脏骤停患者进行体外除颤治疗。年龄不低于8岁患者适用成人模式，8岁以下或体重不足25kg的患者适用儿童模式。该产品在公共场所或医疗场所使用，应由接受过心肺复苏和半自动体外除颤器使用培训合格的人员使用，或者接受过基本生命支持/生命支持课程培训合格的医务人员使用，或者在急救中心调度人员指导下使用。
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，自动分析识别心室颤动（VF）、无脉性室性心动过速（pVT）等可除颤心律。采用双相指数截断波（BTe）技术，根据患者胸阻抗自动补偿能量与波形参数。若判定需要除颤，设备自动充电并提示操作者按下放电键，释放可控电击使心肌细胞同步除极，终止恶性心律失常，帮助恢复有效窦性心律。
EnglishThe device collects ECG signals via disposable defibrillation pads and automatically analyzes for shockable rhythms such as ventricular fibrillation (VF) and pulseless ventricular tachycardia (pVT). It usesbiphasic truncated exponential (BTe)waveｆorm technology with automatic impedance compensation based on patient chest resistance. If a shock is advised, the device charges automatically and prompts the operator to press the discharge button, delivering a controlled shock to synchronously depolarize myocardial cells, terminate malignant arrhythmias, and restore effective sinus rhythm.
二、产品特点 Product Features
中文
双相波智能除颤：自适应阻抗补偿，成人 / 儿童双模式，能量自动递增
全程语音 + 视觉引导：i3 指示灯 + 语音；i5 4.3 英寸彩屏 + 动画 + 语音，非专业可操作
快速响应：开机至放电＜8 秒，心律分析＜5 秒
CPR 实时反馈：指导按压频率（100 次 / 分）与深度，支持 30:2/15:2 / 仅按压
开盖即开机，成人 / 儿童一键切换
坚固耐用：IP55 防尘防水，1.5 米六面抗跌落
长寿命耗材：一次性锂电池待机≥5 年，电极片有效期 5 年
数据记录：i5 支持存储≥1000 条急救日志与 ECG 数据（可选）
便携设计：整机约 2.3kg，体积小巧，适合公共场所部署
English
Smart Biphasic Defibrillation: Automatic impedance compensation, dual adult/pediatric modes with automatic energy escalation
Full Voice + Visual Guidance: i3: LED indicators + voice; i5: 4.3” color screen + animation + voice, usable by non-professionals
Fast Response: <8s from power-on to first shock; ECG analysis <5s
Real-time CPR Feedback: Guides compression rate (100 bpm) and depth; supports 30:2/15:2/hands-only CPR
Lid-open Power-on, one-key adult/pediatric mode switch
Rugged Durability: IP55 dust/water resistant, 1.5m six-sided drop-proof
Long-life Consumables: Disposable lithium battery standby ≥5 years; pads valid for 5 years
Data Recording: i5 stores ≥1000 rescue logs and ECG data (optional)
Portable Design: ~2.3kg total weight, compact size for public deployment
三、技术参数 Technical Specifications
| 项目 Item | 中文 Chinese | English |
|---|---|---|
| 型号 Model | i3 / i5 | i3 / i5 |
| 除颤模式 Defib Mode | 半自动（需人工确认放电） | Semi-automatic (manual shock confirmation) |
| 除颤波形 Waveｆorm | 双相指数截断波（BTe）+ 阻抗补偿 | Biphasic truncated exponential (BTe) + impedance compensation |
| 成人能量 Adult Energy | 200J → 300J → 360J（自动递增） | 200J → 300J → 360J (automatic escalation) |
| 儿童能量 Pediatric Energy | 50J → 70J → 100J（自动递增） | 50J → 70J → 100J (automatic escalation) |
| 分析时间 Analysis Time | ＜5 秒 | ＜5 seconds |
| 开机至放电 Time to Shock | ＜8 秒（200J，新电池） | ＜8 seconds (200J, new battery) |
| 阻抗范围 Impedance Range | 15–200Ω | 15–200Ω |
| 显示 Display | i3：LED 指示灯 + 语音；i5：4.3 英寸彩色 LCD | i3: LED indicators + voice; i5: 4.3” color LCD |
| 防护等级 Protection | IP55 | IP55 |
| 抗跌落 Drop Resistance | 1.5 米六面 | 1.5m six-sided |
| 电池 Battery | 一次性锂锰电池（4200mAh） | Disposable Li-MnO₂ battery (4200mAh) |
| 电池寿命 Battery Life | 待机≥5 年；≥350 次 200J 除颤 | Standby ≥5 years; ≥350 shocks at 200J |
| 电极 Pads | 一次性成人 / 儿童通用 | Disposable adult/pediatric universal |
| 重量 Weight（含电池 / 电极） | 约 2.3kg | Approx. 2.3kg |
| 尺寸 Dimensions | 289×217×91mm | 289×217×91mm |
| 存储容量 Memory | i3：无；i5：≥16G，≥1000 条日志 | i3: None; i5: ≥16G, ≥1000 logs |
| 管理类别 Classification | 第三类医疗器械 | Class III Medical Device |
| 质保 Warranty | 主机 5 年 | 5-year unit warranty |
四、使用方法 Operating Instructions
中文
开机：打开机盖，设备自动开机并语音提示
贴电极：成人贴右胸锁骨下、左乳头外侧；儿童贴前胸 / 后背
分析：设备自动分析心律，所有人远离患者
除颤：若提示 “建议电击”，确认无人接触后按闪烁放电键
CPR：无需电击或除颤后，立即按提示做 CPR（30:2，100 次 / 分）
循环：每 2 分钟自动重新分析，重复至急救人员到达
English
Power On: Open lid; device powers on automatically with voice prompts
Apply Pads: Adult: right upper chest, left lateral chest; Pediatric: anterior/posterior chest
Analyze: Device analyzes rhythm automatically;all clear patient
Shock: If “Shock Advised”, confirm no contact then press flashing discharge button
CPR: If no shock advised or after shock, perｆorm CPR (30:2 at 100 bpm) as prompted
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（电极需避开）
水中或潮湿环境（需擦干胸部）
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：-30℃～+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
定期自动自检，确保可用
English
Temperature: -30℃ to +70℃
Humidity: 0%–95% (non-condensing)
Avoid direct sunlight, moisture, corrosive gases
Store in dry, ventilated, easily accessible location
Perｆorm regular automatic self-tests to ensure readiness
九、说明书核心信息 Manual Key Inｆormation
中文
产品名称：BeneHeart i3 /i5 半自动体外除颤仪
型号：i3（基础版，指示灯 + 语音）；i5（进阶版，彩屏 + 数据记录）
组成：主机、一次性锂电池、预连接电极片、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，开盖开机，语音 + 视觉引导，人工确认放电
维护：自动自检，更换过期电池 / 电极
安全：双相波 + 阻抗补偿，防误触，IP55 防护
质保：主机 5 年，电池 / 电极片按有效期
English
Product Name: BeneHeart i3 / i5 Semi-Automatic External Defibrillator
Model: i3 (Basic: LED + voice); i5 (Advanced: color screen + data recording)
Components: Main unit, disposable lithium battery, pre-connected pads, carry case
Classification: Class III Medical Device
Intended Use: Adult/pediatric cardiac arrest emergency
Operation: Semi-automatic, lid-open power-on, voice+visual guidance, manual shock confirmation
Maintenance: Automatic self-tests, replace expired batteries/pads
Safety: Biphasic wave + impedance compensation, anti-accidental shock, IP55 protection
Warranty: 5-year unit warranty; battery/pads per expiration 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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