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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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厂家直供卓尔自动体外除颤器FullyAutomaticAEDPlus

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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): 国械注进20163083103更新时间:2026/10/16 11:11:02

产品摘要:厂家直供卓尔自动体外除颤器FullyAutomaticAEDPlus

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厂家直供卓尔自动体外除颤器FullyAutomaticAEDPlus

桂经理19117326863微xin同号

结构及组成/主要组成成分 该产品由主机、一次性二氧化锰锂电池(型号:123A)、除颤电极片(型号:CPR-D padz, Stat-padz II, Pedi-Padz II)组成。

适用范围/预期用途 该产品用于治疗无意识、无正常呼吸、无脉搏跳动或者无循环迹象的疑似心脏骤停患者。当患者年龄小于8岁或者体重不足25公斤时,应使用ZOLL儿童除颤电极片,但不应为了判断患者的确切年龄或体重而延误治疗。心肺复苏反馈功能提供胸外按压的声音节拍器和深度测量显示,指导急救人员按照AHA/ERC推荐的频率和深度进行胸外按压。该功能适用于年龄8岁以上(含8岁)的患者。该产品预期安装于公共场所,应由接受过心肺复苏与自动体外除颤器使用培训的人员使用,或者接受过基本生命支持、生命支持培训的人员使用,或者在其他医师授权下针对心脏骤停患者的急救人员使用。



一、工作原理

Working Principle

中文设备通过电极片采集患者心电信号,内置算法自动识别心室颤动(VF)、无脉性室性心动过速(VT)等可除颤心律。若判定需除颤,设备全自动完成充电、、放电,无需手动触发电击键。采用双相方波技术,按预设能量等级(成人 120/150/200J,儿童 50/70/85J)释放电击,通过胸壁传递至心脏,终止异常电活动,恢复窦性心律。全程由 **Real CPR Help®** 提供按压深度与频率反馈,配合全中文语音 / LED 指引,非专业人员可按提示完成操作。

EnglishThe device collects ECG signals via electrode pads and uses built-in algorithms to automatically identify shockable rhythms such as ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT). If defibrillation is indicated, it automatically charges, counts down, and discharges without requiring a manual shock button press. Utilizing biphasic waveform technology, it delivers shocks at preprogrammed energy levels (120/150/200J for adults, 50/70/85J for pediatrics) through the chest wall to terminate abnormal electrical activity and restore sinus rhythm. Real CPR Help® provides real-time feedback on compression depth and rate, while Chinese voice/LED guidance directs untrained users through the process.

二、产品特点

Product Features

中文

全自动操作:识别可除颤心律后自动放电,无需手动按键,简化抢救步骤。

Real CPR Help® 实时反馈:语音 + 视觉提示按压深度、频率与回弹,指导高质量 CPR。

双相方波除颤:能量(120/150/200J 自动预选),心肌损伤小,除颤效率高。

儿童模式自动适配:连接儿童电极片自动下调能量(50/70/85J),覆盖全年龄段。

商用电池长续航:10 节 3V 123 锂锰电池,待机约 5 年或 300 次放电,红色 “X” 提示剩余能量。

快速充电:新电池下 200J 充电≤10 秒,缩短抢救间隔。

全中文语音 + 图形引导:清晰步骤提示,低视力友好,操作零门槛。

IP55 防护:防尘防水抗摔,耐受 - 30℃至 70℃极端环境,适合多场景。

多级自检:可设置每周 / 每日自检,实时监测电池、电极、电路与 CPR 功能。

数据存储:记录 50 分钟 ECG 与 CPR 数据,支持追溯与培训评估。

English

Fully Automatic Operation: Automatically delivers shocks when shockable rhythms are detected, no manual button press needed.

Real CPR Help® Real-Time Feedback: Audio/visual prompts for compression depth, rate, and recoil to guide high-quality CPR.

Biphasic Waveform Defibrillation: Precise energy (120/150/200J auto-selection) with minimal myocardial damage.

Pediatric Mode Auto-Selection: Automatically reduces energy (50/70/85J) when pediatric pads are attached.

Long-Lasting Commercial Batteries: 10×3V 123 lithium manganese dioxide batteries; 5-year standby or 300 shocks; red "X" indicates remaining energy.

Rapid Charging: ≤10 seconds to charge to 200J with new batteries.

Chinese Voice + Graphic Guidance: Clear step-by-step prompts for easy use.

IP55 Ruggedness: Dust/waterproof, shock-resistant; operates from -30°C to 70°C.

Multi-Level Self-Tests: Configurable weekly/daily checks for battery, electrodes, circuits, and CPR functions.

Data Storage: Logs 50 minutes of ECG/CPR data for traceability and training evaluation.




三、技术参数

Technical Parameters

表格

项目 Item 参数 Specification

型号 Model Fully Automatic AED Plus

除颤波形 Defibrillation Waveform 双相方波(Rectilinear Biphasic)

能量范围 Energy Range 成人:120/150/200J;儿童:50/70/85J(自动预选)

充电时间 Charging Time 新电池≤10 秒(至 200J)

心律分析 Rhythm Analysis 自动识别,适配 VF / 宽 QRS 室速

电池类型 Battery Type 3V 123 锂锰电池,10 节

电池寿命 Battery Life 待机约 5 年或 300 次放电;红色 “X” 为寿命提示

工作温度 Operating Temp 0℃~50℃

存储温度 Storage Temp -30℃~70℃

相对湿度 Humidity 10%~95%(无冷凝)

防护等级 Protection IP55 防尘防水

尺寸 Dimensions 13.3×24.1×29.2cm(高 × 宽 × 深)

重量 Weight 约 3.1kg(含电池)

显示 Display LCD,实时显示 ECG、CPR 反馈、电池状态

语音 Voice 全中文真人语音,音量可调

自检 Self-Test 每日 / 每周自动自检,电池 / 电极 / 电路 / CPR 功能监测

数据存储 Data Storage 50 分钟 ECG+CPR 数据

兼容电极 Compatible Electrodes ZOLL CPR-D-padz、pedi-padz® II、stat-padz® II

四、使用方法

Instructions for Use

中文

评估与呼救:确认患者无意识、无正常呼吸、无脉搏,立即呼救并取 AED。

开机与准备:打开设备盖自动开机,按提示去除患者胸部衣物,擦干皮肤,必要时修剪胸毛。

粘贴电极:撕开成人 CPR-D-padz 电极,按图示贴于右上胸(锁骨下)、左乳头外侧,连接主机接口。(儿童用 pedi-padz® II,自动切换能量)。

自动分析:设备提示 “不要触碰患者”,自动分析心律,全程无需操作。

自动除颤:若识别可除颤心律,设备自动→充电→放电;无需手动按键。

CPR 配合:放电后立即进行2 分钟高质量 CPR(按压深度 5-6cm,频率 100-120 次 / 分),设备实时反馈提示。

重复循环:CPR 结束后设备自动再次分析,按需重复除颤 + CPR,直至专业人员到场或患者恢复意识 / 呼吸。

术后处理:抢救结束,关闭设备盖,耗材按医疗废物处理,记录事件数据。

English

Assess & Call for Help: Confirm patient is unresponsive, not breathing normally, and pulseless; call for help and retrieve AED.

Power On & Prepare: Open device lid to auto-power on; remove chest clothing, dry skin, and trim chest hair if needed.

Apply Pads: Tear open adult CPR-D-padz; apply to right upper chest (below clavicle) and left lateral to nipple, connect to device. (Use pedi-padz® II for children; energy auto-adjusts).

Auto-Analysis: Device prompts "Don’t touch the patient" and analyzes rhythm automatically.

Auto-Shock: If shockable rhythm detected, device automatically counts down → charges → discharges; no manual button press needed.

CPR Support: Immediately perform 2 minutes of high-quality CPR (5-6cm depth, 100-120 compressions/min) with real-time feedback.

Repeat Cycle: After CPR, device re-analyzes automatically; repeat shock+CPR until EMS arrives or patient recovers.

Post-Rescue: Close lid; dispose consumables as medical waste; record event data.

五、适应症

Indications

中文适用于 ** 突发心脏骤停(SCA)** 患者,需同时满足:

无意识、无正常呼吸、无脉搏 / 循环体征。

心电显示心室颤动(VF)或无脉性室性心动过速(VT)(可除颤心律)。

成人及儿童(8 岁以下 / 体重<25kg 优先用儿童电极)。

场景:医院、急救车、公共场所(机场、学校、商场)、家庭等院前 / 院内急救。

EnglishIndicated for patients with sudden cardiac arrest (SCA) meeting:

Unresponsive, not breathing normally, pulseless/no circulation signs.

ECG shows ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT).

Adults and children (<8 years/<25kg: use pediatric pads).

Settings: hospitals, ambulances, public areas (airports, schools, malls), homes, etc..




六、禁忌症

Contraindications

中文

患者有意识、有正常呼吸、有脉搏,无需除颤。

心电为非可除颤心律:窦性心律、房扑 / 房颤、室上速、房室传导阻滞等。

胸部皮肤破损、感染、烧伤,或电极覆盖植入式起搏器 / ICD(需避开植入物)。

患者浸泡在水中、接触导电物体,存在触电风险。

电极片过期、破损、未贴牢,或电池 / 设备自检未通过,禁止使用。

English

Patient is responsive, breathing normally, and pulsing; no defibrillation needed.

ECG shows non-shockable rhythms: sinus rhythm, atrial flutter/fibrillation, SVT, AV block, etc..

Chest skin with breaks, infection, burns, or over implanted pacemaker/ICD (avoid implant area).

Patient in water or touching conductive objects; risk of electric shock.

Electrode pads expired, damaged, or poorly attached; or device/battery failed self-test; do not use.

七、注意事项

Precautions

中文

安全:分析 / 放电时严禁触碰患者,避免触电;周围无导电连接。

电极规范:使用原装电极,检查有效期与完整性;贴紧皮肤,避开毛发、伤口、植入物。

儿童使用:儿童电极片必须使用,禁止成人电极高能量直接用于儿童。

电池管理:定期自检,红色 “X” 提示电池寿命;每 5 年或设备提示时更换电池。

环境安全:禁止在 / 富氧环境中使用;远离电磁干扰,关闭手机等无线设备。

CPR 配合:除颤后立即 CPR,遵循 “分析→除颤→CPR” 循环,不可仅等待设备操作。

设备维护:定期自检,勿自行拆卸;故障联系厂家售后,定期清洁消毒主机。

特殊场景:水中患者先移至干燥处再操作;孕妇电极贴于胸部,避开腹部。

English

Safety First: Do not touch the patient during analysis/shock to avoid electric shock; ensure no conductive contacts around.

Electrode Compliance: Use authentic pads; check expiration and integrity; adhere firmly to skin, avoid hair, wounds, and implants.

Pediatric Use: Pediatric pads mandatory; no high-energy adult pad use for children.

Battery Care: Perform regular self-tests; replace batteries every 5 years or when prompted by device.

Environment Safety: Do not use in flammable gas/oxygen-rich areas; keep away from EMI; turn off wireless devices.

CPR Integration: Immediate CPR after shock; follow "analyze → shock → CPR" cycle; do not wait passively.

Device Maintenance: Regular self-tests; do not disassemble; contact manufacturer for faults; clean and disinfect regularly.

Special Scenarios: Move wet patients to dry area first; for pregnant patients, apply pads on chest, avoid abdomen.

八、存储条件

Storage Conditions

中文

设备存储:环境温度 **-30℃~70℃,相对湿度10%~95%(无冷凝)**,通风干燥,远离腐蚀性气体、粉尘与阳光直射。

耗材存储:电极片密封、避光、防潮,在有效期内使用;存储温度与设备一致,避免重压、弯折。

电池存储:未使用电池单独存放,远离高温、潮湿,避免与金属物品接触。

运输要求:温度 **-30℃~70℃**,防震、防潮、防摔,避免剧烈震动与挤压。

放置规范:设备水平放置,避免儿童接触;定期检查包装完整性与自检状态,确保随时可用。





九、说明书核心信息(中英文)

Manual Core Information

中文

产品名称:自动体外除颤器

型号:Fully Automatic AED Plus

生产厂家:ZOLL(卓尔)

核心技术:双相方波除颤、Real CPR Help® 实时反馈、全自动除颤、IP55 防护

核心功能:自动识别可除颤心律、全自动放电、CPR 按压指导、数据存储、多级自检

适用范围:成人 / 儿童突发心脏骤停(无意识、无呼吸、无脉搏)的体外除颤

关键参数:能量 120/150/200J(成人)/50/70/85J(儿童),充电≤10 秒,电池 5 年 / 300 次,IP55 防护

操作流程:评估→开机


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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