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厂商直销美国ZOLL卓尔除颤监护仪X Series

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厂商直销美国ZOLL卓尔除颤监护仪X Series
桂经理19117326863微xin同号
桂经理19117326863微xin同号

产品名称 除颤监护仪Defibrillator/Monitor

管理类别 第三类

型号规格 X Series

结构及组成/主要组成成分 该产品由主机和附件组成,详见附页。

适用范围/预期用途 该产品对新生儿、小儿和成人患者进行手动除颤、半自动体外除颤、同步心脏复律、体外起搏治疗,同时对新生儿、小儿和成人患者进行心电、脉搏血氧饱和度、血压、有创血压、呼气末二氧化碳、呼吸率、体温监护,并提供 12 导联心电分析和Real CPR Help功能,以及患者数据实时传输。该产品应由接受过设备操作培训的合格医务人员以及在基本生命支持、心脏支持和除颤方面培训合格的人员使用,由医师或遵医嘱使用。该产品可用于临床机构、救护车、飞行器、急救现场或者患者转运过程中。手动除颤用于终止无脉搏、无呼吸、无意识患者的室颤和快速室性心动过速症状;半自动体外除颤用于无脉搏、无呼吸、无意识的疑似心脏骤停患者;同步心脏复律用于治疗房颤和室性心动过速患者;体外起搏用于治疗症状性心动过缓、心跳骤停患者。心电监护预期用于 ECG 波形和心率监护,12导联心电分析功能适用于 18 岁以上的成人患者;脉搏血氧饱和度监护预期用于血氧饱和度、碳氧血红蛋白、高铁血红蛋白、脉搏率、总血红蛋白、血氧含量、灌注变化指数和灌注指数监护;血压监护预期用于式的动脉压和心率监护;有创血压监护预期用于动脉血压、中心静脉压、颅内压监护;呼气末二氧化碳监护预期用于二氧化碳浓度和呼吸率监护;体温监护预期用于直肠、食道或体表温度监护。 Real CPR Help 功能可以为急救人员在做心肺复苏时提供胸外按压信息反馈。

中文名称:除颤监护仪English Name: X Series Monitor / Defibrillator品牌厂商:ZOLL Medical 美国卓尔医疗型号:X Series国内注册类别:第三类有源医疗器械,国械注进20163082088,系统组成:主机、锂电池、多功能除颤电极片 / 电极板、心电电缆、各类监护传感器、热敏打印机;支持选配体外起搏模块、EtCO₂、Masimo 血氧、12 导联心电分析模块核心技术:专利 Rectilinear Biphasic™双相方波;Real CPR Help® 实时心肺复苏反馈、See-Thru CPR

一、工作原理 Working Principle

中文

  1. 心电监护原理:体表电极采集心肌微弱电活动,经放大、滤波、模数转换,实时显示心电图波形,识别心律失常;

  2. 除颤原理:内置储能电容充能,释放双相方波直流电,电流穿过胸壁心肌,使全部心肌细胞同步去极化,终止室颤 / 无脉室速,恢复窦房结主导的有序心律;设备自适应胸壁阻抗动态调节输出波形能量;

    • 异步除颤:用于室颤、无脉室速;

    • 同步复律:依靠 R 波同步触发电击,避免电击落入 T 波易损期,用于房颤、室上速、稳定室速;

  3. 体外起搏(选配):输出周期性电脉冲刺激心肌,维持有效心室率,治疗症状性心动过缓、心脏停搏过渡支持;

  4. CPR 反馈系统:多功能电极内置压力传感,实时检测按压深度、频率,提供声光指引;See-Thru CPR 技术在胸外按压期间滤除按压伪迹,持续显示 underlying 心电;

  5. 多参数监护:外接传感器同步采集血氧、呼末二氧化碳、血压、有创压力、体温等生命体征,整合多维度循环监测。

English

  1. ECG Monitoring: Surface electrodes capture weak myocardial bioelectrical signals. After amplification, filtering and A/D conversion, real-time ECG waveforms are displayed for arrhythmia identification.

  2. Defibrillation: Internal capacitor stores energy and delivers Rectilinear Biphasic™ DC current across the chest wall. The electric shock synchronously depolarizes massive myocardium to terminate ventricular fibrillation / pulseless ventricular tachycardia and restore organized sinus rhythm. The waveform dynamically adapts to thoracic impedance.

    • Asynchronous mode: For VF / pulseless VT;

    • Synchronized cardioversion: Shock triggered upon R-wave to avoid vulnerable T-wave period, indicated for atrial fibrillation, SVT, stable VT.

  3. Non-invasive Transcutaneous Pacing (Optional): Periodic electrical pulses stimulate myocardium to maintain effective ventricular rate for symptomatic bradycardia and transitional support during asystole.

  4. CPR Feedback System: Built-in pressure sensor within multifunction electrodes measures compression depth and rate with real-time audio-visual guidance. See-Thru CPR filters compression artifacts to visualize underlying ECG during chest compressions.

  5. Multi-parameter Monitoring: External sensors acquire SpO₂, EtCO₂, NIBP, invasive pressure, temperature and other vital signs for comprehensive circulatory assessment.

二、产品功能 Functions

中文

  1. 监护:3/5 导联心电、可选 12 导联心电自动分析、心率报警;选配 Masimo Rainbow 血氧、EtCO₂、血压、多通道有创血压、双通道体温;

  2. 治疗模式:

    • 异步手动除颤、同步电复律;AED 半自动分析除颤模式;

    • 选配体外按需 / 固定频率起搏;

  3. 复苏辅助:Real CPR Help® 按压深度 / 频率实时反馈、CPR 节拍音、See-Thru CPR 伪迹滤除;

  4. 数据管理:波形实时回放、事件存储、趋势回顾、热敏打印;支持 WiFi 数据传输、RescueNet 软件归档;

  5. 人机交互:彩色触控屏、中文界面、声光报警;成人 / 儿童 / 新生儿三档患者模式一键切换;

  6. 安全机制:阻抗监测、充电完成提示、放电安全锁定、电极接触不良报警、电池状态监测。

English

  1. Monitoring: 3/5-lead ECG, optional automated 12-lead ECG analysis, heart rate alarms. Optional Masimo Rainbow SpO₂, EtCO₂, NIBP, multi-channel invasive pressure, dual temperature channels.

  2. Therapeutic modes:

    • Asynchronous manual defibrillation, synchronized cardioversion; semi-automatic AED analysis mode;

    • Optional non-invasive transcutaneous pacing (demand / fixed rate).

  3. Resuscitation assistance: Real CPR Help® real-time depth & rate feedback, CPR metronome, See-Thru CPR artifact suppression.

  4. Data management: Real-time waveform review, event storage, trend recall, thermal printing; WiFi transmission compatible with RescueNet archiving software.

  5. HMI: Color touchscreen, Chinese user interface, audible & visual alarms; one-click switching between adult / pediatric / neonatal patient profiles.

  6. Safety mechanisms: Impedance detection, charge completion alert, shock interlock, poor electrode contact alarm, battery status monitoring.

三、产品特点 Product Features

中文

  1. 专利双相方波技术:自适应胸壁阻抗,高阻抗患者除颤成功率高,同等疗效下降低心肌电击损伤;

  2. 一体化多功能电极:同时实现心电采集、除颤放电、CPR 压力传感,简化抢救布线;

  3. See-Thru CPR 技术:按压过程持续显示心电,无需中断 CPR 再分析心律,缩短复苏中断时间;

  4. 整机轻量化(约 5.4kg),抗震防尘,满足院前急救、院内转运、手术室多场景;

  5. 模块化可升级平台,后期可增配 12 导联、EtCO₂、起搏、有创血压,保护设备投资;

  6. 大容量锂电池,支持长时间连续监护与多次电击,适合转运无市电场景;

  7. 屏幕强光可视,操作逻辑契合生命支持抢救流程;

  8. 完整事件日志,自动记录电击、CPR、生命体征,满足质控与取证需求。

English

  1. Patented Rectilinear Biphasic waveform adapts to thoracic impedance, improves success rate in high-impedance patients and reduces myocardial injury under equivalent efficacy.

  2. Integrated multifunction electrodes perform ECG acquisition, shock delivery and CPR force sensing simultaneously to simplify emergency wiring.

  3. See-Thru CPR enables continuous ECG visualization during compressions; rhythm analysis without mandatory CPR pause to minimize hands-off time.

  4. Lightweight (~5.4 kg), shockproof and dustproof design for pre-hospital EMS, intra-hospital transport and operating room usage.

  5. Modular upgradable platform; 12-lead, EtCO₂, pacing and invasive pressure can be added post-purchase.

  6. High-capacity lithium battery supports prolonged continuous monitoring and multiple shocks during transport without mains power.

  7. Sunlight-readable display; workflow optimized for advanced life support emergencies.

  8. Comprehensive event log automatically records shocks, CPR and vital signs for quality control and medical documentation.

四、技术参数 Technical Specifications

中文English
型号:X SeriesModel: X Series
除颤波形:Rectilinear Biphasic™双相方波Defibrillation Waveform: Rectilinear Biphasic™
能量档位:1~200J 多档可调;AED 模式 120/150/200JEnergy Selection: 1~200J adjustable; AED sequence 120/150/200J
充电时间:200J ≤7 秒Charge Time: ≤7 s at 200J
心电:3/5 导联,可选 12 导联自动分析ECG: 3/5-lead; optional auto 12-lead analysis
起搏(选配):固定 / 按需 VVI 模式;电流 0~140mAPacing (Optional): Fixed / demand VVI; 0~140mA
患者模式:成人 / 儿童 / 新生儿Patient Profile: Adult / Pediatric / Neonatal
电池:内置可充锂电池Battery: Built-in rechargeable Li-ion
整机重量:≈5.4kgUnit Weight: ≈5.4 kg
显示屏:彩色高对比度触控 LCDDisplay: High-contrast color touch LCD
运行环境温度:4℃~40℃Operating Temp: 4℃~40℃
可选监护:SpO₂、EtCO₂、NIBP、有创血压、体温Optional Monitoring: SpO₂, EtCO₂, NIBP, invasive BP, temperature
打印:内置热敏记录仪Recording: Built-in thermal printer
预期使用寿命:8 年Expected Service Life: 8 years

五、使用方法 Operation Instructions

中文

  1. 开机自检,确认电池电量充足;选择成人 / 儿童模式;连接心电电缆或粘贴多功能除颤电极;

  2. 心电监护:电极规范粘贴,确认波形清晰,设置心率报警阈值;按需连接血氧、呼末 CO₂等传感器;

  3. 除颤 / 电复律

    • 室颤 / 无脉室速:选择异步模式,设置能量,启动充电;充电完成确认所有人离开患者后放电;

    • 房颤 / 室上速复律:开启SYNC 同步模式,观察 R 波同步标记,充电后放电;

  4. AED 半自动模式:粘贴电极,设备自动分析心律;遵从语音提示,必要时电击;持续 CPR;

  5. 起搏(选配):粘贴起搏电极,设置起搏频率、输出电流,观察夺获波形与脉搏;

  6. 复苏全程启用 CPR 反馈,遵循屏幕指引规范胸外按压;

  7. 抢救结束,停止治疗,存储 / 打印事件记录;关机、清洁设备。⚠️每次电击前确认无人接触患者病床。

English

  1. Power on and complete self-test; verify sufficient battery level; select adult/pediatric profile. Attach ECG cable or multifunction defibrillation electrodes.

  2. ECG Monitoring: Apply electrodes properly for clear traces; configure heart rate alarms. Connect SpO₂, EtCO₂ and other sensors as required.

  3. Defibrillation / Cardioversion

    • VF / pulseless VT: Select asynchronous mode, set energy and initiate charge. Confirm all personnel clear of patient before shock delivery.

    • AF / SVT cardioversion: Activate SYNC mode, verify R-wave marker, charge and deliver synchronized shock.

  4. AED semi-automatic mode: Attach electrodes; unit analyzes rhythm automatically. Follow voice prompts; deliver shock if advised and continue CPR.

  5. Non-invasive pacing (Optional): Apply pacing electrodes, set rate and output current; capture and peripheral pulse must be verified.

  6. Activate CPR feedback during resuscitation and follow on-screen guidance for compressions.

  7. After intervention, terminate therapy, save and print event log; power off and clean equipment.⚠️ Ensure no physical contact with patient or bed before every shock.

六、适应症 Indications

中文

  1. 除颤 / 同步复律

    • 心室颤动、无脉性室性心动过速(异步除颤);

    • 药物无效的心房颤动、心房扑动、阵发性室上速、稳定持续性室速(同步电复律);

  2. 体外起搏:症状性心动过缓、房室传导阻滞、心脏停搏过渡性循环支持;

  3. 心电与多参数监护:围手术期、急救转运、危重症持续心电及生命体征监测;

  4. 心脏骤停抢救,配合 CPR 实施生命支持;⚠️本设备为急救治疗设备,不能心脏原发疾病。

English

  1. Defibrillation / Synchronized Cardioversion

    • Ventricular fibrillation, pulseless ventricular tachycardia (asynchronous shock);

    • Drug-refractory atrial fibrillation, atrial flutter, PSVT, stable sustained VT (synchronized cardioversion).

  2. Non-invasive pacing: Symptomatic bradycardia, AV block, transitional circulatory support during asystole.

  3. ECG & multi-parameter monitoring: Perioperative, transport and critical care continuous vital sign surveillance.

  4. Advanced life support during cardiac arrest combined with CPR.⚠️ This device provides emergency intervention and cannot cure underlying cardiac disease.

七、禁忌症 Contraindications

中文

除颤 / 电复律相对禁忌

  1. 无法纠正的严重电解质紊乱未纠正前;

  2. 洋地黄中毒诱发心律失常;

  3. 慢性房颤未抗凝、血栓高风险(复律需充分评估);

  4. 终末期疾病无复苏意愿患者。

起搏相对禁忌

  1. 严重胸壁创伤、大面积烧伤无法安放电极;

  2. 无法建立有效循环、不可逆死亡患者。

English

Relative Contraindications for Shock Therapy

  1. Severe uncorrected electrolyte disturbance.

  2. Arrhythmia induced by digitalis toxicity.

  3. Chronic AF with high thromboembolic risk without adequate anticoagulation (requires full risk assessment prior to cardioversion).

  4. Terminal disease with no resuscitation intent.

Relative Contraindications for External Pacing

  1. Severe thoracic trauma or extensive burns preventing electrode placement.

  2. Irreversible terminal patients unable to achieve effective circulation.

心脏骤停属于急症,不设置绝对禁忌症,按复苏流程处置。

八、注意事项 Precautions

中文

  1. 操作人员必须取得生命支持培训资质,熟悉设备操作、心律失常判读;

  2. 除颤电极紧密贴合皮肤,毛发过多需剃除;禁止电极下存在导电膏堆积、空气气泡,避免皮肤灼伤;

  3. 放电前大声警示,确保所有人脱离患者、病床、输液金属管路;

  4. 同步复律务必确认屏幕出现 R 波同步标记,防止易损期电击诱发室颤;

  5. 起搏治疗需同时监测体表脉搏,仅依靠心电波形不能确认有效夺获;

  6. 设备远离氧气高浓度区域,防止电火花诱发燃烧;

  7. 仅使用 ZOLL 原厂电极片、传感器、电池;第三方耗材可能导致电击失效、设备损坏;

  8. 定期执行设备自检、电池充放电维护;出现故障立即停用报修;

  9. 转运前确认电池电量;优先使用交流市电,电池作为应急备用;

  10. 妥善保存复苏数据,遵守医疗隐私法规。

English

  1. Operators shall complete formal advanced life support training and master rhythm interpretation.

  2. Defibrillation electrodes must adhere closely to skin; excessive chest hair should be shaved. Avoid conductive gel pooling and air bubbles beneath electrodes to prevent skin burns.

  3. Verbally alert staff before shock; guarantee no contact with patient, bed or mmbedl IV tubing.

  4. Confirm visible R-wave marker on screen during synchronized cardioversion to avoid shock within cardiac vulnerable period and triggering VF.

  5. Always verify peripheral pulse during pacing; ECG waveform alone cannot confirm effective myocardial capture.

  6. Keep unit away from high-concentration oxygen to avoid ignition hazard from electric spark.

  7. Only genuine ZOLL electrodes, sensors and batteries are permitted; third-party consumables may cause shock failure or hardware damage.

  8. Perform periodic self-test and battery maintenance; cease operation and arrange service upon fault alerts.

  9. Check battery level before transport; AC mains power preferred; battery for emergency backup.

  10. Securely archive resuscitation data and comply with medical privacy regulations.

九、存储条件 Storage Conditions

中文主机闲置存放温度:-30℃~50℃;运行温度:4℃~40℃;相对湿度:15%~95%,无凝露;环境:干燥、防尘、避光;避免剧烈跌落、撞击;远离腐蚀性气体、液体;一次性电极耗材:5℃~30℃避光存放,禁止冷冻;长期存放:主机断电,电极单独存放;锂电池建议每 3 个月充放电一次养护。

EnglishStandby Storage Temperature: -30℃~50℃;Operating Temperature: 4℃~40℃;Relative Humidity: 15%~95%, non-condensing;Environment: Dry, dust-free, protected from light; avoid heavy drop and impact; keep away from corrosive gas and liquid.Disposable electrodes: Store at 5℃~30℃ away from light; freezing prohibited.Long-term storage: Power off main unit and separate consumables; perform charge-discharge cycle for lithium battery every 3 months.


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