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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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厂家直供迈柯唯呼吸机SERVO-U

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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20193082113更新时间:2026/10/16 11:11:02

产品摘要:厂家直供迈柯唯呼吸机SERVO-U

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详细内容

厂家直供迈柯唯呼吸机SERVO-U

桂经理19117326863微xin同号

管理类别

第三类

型号规格

SERVO-U

结构及组成/主要组成成分

产品组成包括:用户界面、病人装置(主机)、空气压缩机(Compressor Mini)、NAVA组件(包括Edi模块、线缆、测试插头)、二氧化碳组件、Y型传感器组件。

适用范围/预期用途

本产品用于为新生儿、儿童和成人患者提供呼吸支持、监测和治疗。


一、工作原理 (Working Principle)

中文

SERVO-U 采用微处理器闭环控制与涡轮驱动 + 独立氧阀双路供气系统。主机通过高精度压力、流量、氧浓度传感器实时监测气道数据,微处理器动态调节涡轮转速与氧气阀门,控制输出潮气量、压力、流量及氧浓度。核心特色是NAVA(神经调节辅助通气)技术,通过专用导管监测膈肌电信号(Edi),以患者自身神经触发同步送气,实现人机同步。同时集成 ** 跨肺压监测、Open Lung Tool、Servo Compass?** 等肺保护工具,提供个性化、肺保护性通气策略。

英文

The SERVO-U utilizes a microprocessor closed-loop control system with a turbine-driven air supply and independent oxygen valve. High-precision pressure, flow, and O? sensors monitor airway parameters in real time. The CPU dynamically adjusts turbine speed and O? flow to precisely deliver tidal volume, pressure, flow, and FiO?. Its flagship feature is NAVA (Neurally Adjusted Ventilatory Assist), which uses a specialized catheter to monitor Electrical Activity of the Diaphragm (Edi), triggering breaths synchronously with the patient’s neural drive for unparalleled patient-ventilator synchrony. It also integrates advanced tools like Transpulmonary Pressure, Open Lung Tool, and Servo Compass? for personalized, lung-protective ventilation.

二、功能 (Functions)

中文

通气模式(全年龄段)

有创:VC、PC、PRVC、SIMV(PC/VC/PRVC)+PS、APRV/Bi-Vent、VS、NAVA、NPS

:NIV-PC、NIV-PS、NIV-NAVA、NIV-NPS、HFNC(高流量湿化)

智能:Automode?、容量保证(VG)、窒息后备、手动通气

肺保护与监测

Servo Compass?:实时显示 VT/PBW、驱动压、应力指数

Open Lung Tool:引导肺复张与最佳 PEEP 滴定

跨肺压(Ptp)监测:评估真实肺泡压力

NAVA/Edi:监测膈肌功能,指导撤机,减少人机不同步

安全与辅助

分级声光报警、双路超压保护、电池后备

一体化 Aerogen? 雾化、智能吸痰、屏气功能

72 小时波形 / 参数趋势、屏幕指导、Safety Scale

英文

Ventilation Modes (All Ages)

Invasive: VC, PC, PRVC, SIMV(PC/VC/PRVC)+PS, APRV/Bi-Vent, VS, NAVA, NPS

Non-Invasive: NIV-PC, NIV-PS, NIV-NAVA, NIV-NPS, HFNC

Smart: Automode?, Volume Guarantee (VG), Apnea Backup, Manual Breath

Lung Protection & Monitoring

Servo Compass?: Real-time VT/PBW, Driving Pressure, Stress Index

Open Lung Tool: Guided recruitment and optimal PEEP titration

Transpulmonary Pressure (Ptp): Assesses true alveolar pressure

NAVA/Edi: Monitors diaphragm function, guides weaning, reduces asynchrony

Safety & Tools

Graded alarms, dual overpressure protection, battery backup

Integrated Aerogen? nebulization, smart suction, breath hold

72hr trends, on-screen guidance, Safety Scale

三、产品特点 (Product Features)

中文

NAVA 领先技术:商用神经通气模式,不受漏气影响,优化人机同步

全能一体化:覆盖成人 / 儿童 / 新生儿,支持有创 / / 高频 / 雾化 / 转运

:潮气量最低 2mL(新生儿),触发响应 <40ms

智能决策:Servo Compass、Open Lung Tool、Edi 趋势,辅助临床决策

操作高效:15.6 英寸可旋转触摸屏,模块化界面,一键快速设置

安全可靠:符合 IEC 60601-2-12,IP21 防护,热插拔电池(最长 3 小时)

模块化升级:支持 EtCO?、NFC、HL7、床边监护系统对接

英文

Leading NAVA Technology: Only commercial neural mode, immune to leaks, superior synchrony

All-in-One Platform: Adult/pediatric/neonatal; invasive/NIV/HFNC/nebulization/transport

Ultra-Precision: VT down to 2mL (neonate), trigger response <40ms

Smart Decision Support: Servo Compass, Open Lung Tool, Edi trending

Intuitive Operation: 15.6" rotating touchscreen, modular UI, 1-touch setup

Safe & Robust: IEC 60601-2-12, IP21, hot-swappable batteries (up to 3hr)

Modular Upgrade: EtCO?, NFC, HL7, bedside monitor integration




四、技术参数 (Technical Specifications)

表格

参数项 (Parameter) 规格 (Specification)

适用人群 新生儿、婴幼儿、儿童、成人

潮气量 VT 新生儿:2–50mL;儿童:10–350mL;成人:100–4000mL

呼吸频率 RR 常频:1–150bpm;高频:3–15Hz

吸气压力 1–120cmH?O;压力限:16–125cmH?O

PEEP/CPAP 1–50cmH?O

氧浓度 FiO? 21%–100%,精度 ±3%

触发灵敏度 流量:0–200L/min;Edi 触发(NAVA):自动

屏幕 15.6 英寸 TFT 触摸屏,1366×768

电池 2–6 块热插拔锂电,续航 60–180 分钟

电源 AC 100–240V, 50/60Hz;DC 24V

尺寸 / 重量 主机:82.6×36.8×20.5cm;约 23kg(不含台车)

噪音 <45dB(A)

五、使用方法 (Instructions for Use)

中文

术前准备

连接电源、气源(O? 2.0–6.0bar),安装管路、湿化器、传感器

开机自检,执行漏气测试与功能校验

输入患者信息(体重、身高),选择人群类别(新生儿 / 儿童 / 成人)

模式与参数设置

常规:PRVC/PC+VG,VT 6–8mL/kg,PEEP 5–12cmH?O

重症 / ARDS:APRV、Open Lung Tool 复张,优化 PEEP

撤机 / 膈肌保护:NAVA/PS,监测 Edi,Automode? 自动切换

:NIV-PS/NAVA,开启漏气补偿,固定面罩

设置报警上下限

通气与监测

连接气道,启动通气,观察波形、Edi 信号、人机同步性

每 30–60 分钟核查参数、血气、肺顺应性、跨肺压

吸痰 / 雾化:使用内置功能,保持通气连续

停机与维护

转待机→关机→断气源 / 电源→拆卸管路

消毒呼气盒、传感器(禁高温高压)

清洁机身,充电备用,记录维护日志

英文

Pre-Use Setup

Connect power/gas (O? 2.0–6.0bar), install circuit, humidifier, sensors

Power on self-test; perform leak test & function check

Enter patient data (weight, height), select patient category

Mode & Parameter Settings

Routine: PRVC/PC+VG, VT 6–8mL/kg, PEEP 5–12cmH?O

Severe/ARDS: APRV, Open Lung Tool recruitment, optimize PEEP

Weaning/Diaphragm: NAVA/PS, monitor Edi, Automode?

NIV: NIV-PS/NAVA, enable leak compensation, secure mask

Set alarm limits

Ventilation & Monitoring

Connect airway, start ventilation; check waveforms, Edi, synchrony

Verify parameters, ABG, compliance, Ptp q30–60min

Suction/nebulize via integrated functions

Shutdown & Maintenance

Standby → Power off → Disconnect gas/power → Dismantle circuit

Disinfect expiratory cassette/sensors (no autoclaving)

Clean unit, charge batteries, log service

六、适应症 (Indications)

中文

急性呼吸衰竭:ARDS、重症肺炎、AECOPD、重症哮喘、心源性肺水肿

新生儿呼吸支持:RDS、胎粪吸入、早产儿 / 有创通气

慢性呼吸衰竭:神经肌肉疾病、慢阻肺稳定期、胸廓畸形

术后呼吸支持:心胸 / 腹部 / 颅脑术后呼吸监护

通气:AECOPD、心源性肺水肿、免疫抑制患者肺炎、拔管后序贯

特殊场景:NAVA 适用—— 人机不同步、膈肌无力、困难撤机、小体重儿

院内转运:ICU、手术室、检查科室途中通气保障

英文

Acute Respiratory Failure: ARDS, severe pneumonia, AECOPD, status asthmaticus, cardiogenic pulmonary edema

Neonatal Support: RDS, meconium aspiration, preterm invasive/NIV

Chronic RF: Neuromuscular disease, stable COPD, thoracic deformity

Post-Op Support: Cardiothoracic/abdominal/neuro surgery monitoring

NIV: AECOPD, cardiogenic edema, immunocompromised pneumonia, post-extubation

NAVA Specific: Asynchrony, diaphragm dysfunction, difficult weaning, small infants

Intra-Hospital Transport: Ventilation during ICU/OR/radiology transfer

七、禁忌症 (Contraindications)

中文

绝对禁忌

未引流的张力性气胸

严重气道梗阻 / 大量咯血 / 误吸

面部严重创伤 / 畸形(无法 NIV)

未纠正的先天性膈疝、气管食管瘘

心跳呼吸骤停(需先复苏)

相对禁忌(慎用)

严重肺大疱 / 重度肺气肿(高压风险)

血流动力学不稳定(休克、严重心律失常)

意识障碍、不合作、频繁呕吐(NIV)

严重颅内压增高(慎用高 PEEP)

英文

Absolute

Tension pneumothorax (undrained)

Severe airway obstruction/hemoptysis/aspiration

Severe facial trauma/anomalies (NIV impossible)

Uncorrected congenital diaphragmatic hernia, TEF

Cardiopulmonary arrest (resuscitation first)

Relative (Caution)

Severe bullae/emphysema (rupture risk)

Hemodynamic instability (shock, severe arrhythmias)

Altered mental status, uncooperative, vomiting (NIV)

Severe intracranial hypertension (high PEEP caution)

八、注意事项 (Precautions)

中文

专业操作:受过专业培训医护人员,严禁无人值守

NAVA 使用:Edi 导管正确定位(胃内 7–10cm),确认信号质量

肺保护:潮气量 ≤6–8mL/kg,控制驱动压 <15cmH?O

管理:优化面罩密封,警惕胃胀气、误吸、皮肤压伤

湿化安全:温度 32–37℃,及时倾倒冷凝水,防气道烫伤 / 感染

安全检查:每小时查管路、漏气、报警、电池、气源

感染控制:一次性管路单人使用;可复用部件高水平消毒

应急准备:备复苏囊、备用电池、氧气筒,应对突发故障

英文

Professional Use: Only by trained staff; no unattended operation

NAVA Care: Correct Edi catheter placement (7–10cm in stomach), verify signal quality

Lung Protection: VT ≤6–8mL/kg, Driving Pressure <15cmH?O

NIV Care: Optimize mask seal; monitor gastric distension, aspiration, skin breakdown

Humidification: Temp 32–37℃, drain condensate, prevent burns/infection

Safety Checks: Hourly circuit, leak, alarms, battery, gas supply

Infection Control: Single-use circuits; high-level disinfection for reusables

Emergency Prep: Keep resuscitator, backup battery, O? cylinder handy

九、存储条件 (Storage Conditions)

中文

环境:温度 5–40℃,相对湿度 30–75%RH,无冷凝

长期存储:温度 -20–+55℃,湿度 ≤85%RH,防尘、防震、防潮、防腐蚀气体

部件存储:

传感器 / 呼气盒:清洁干燥,密封避光

电池:50–60% 电量存储,每 3 个月充放电一次

耗材:在有效期内,阴凉干燥、避光保存

运输:原包装防震,环境 -20–+60℃,避免剧烈震动 / 雨淋

英文

Environment: 5–40°C, 30–75%RH, non-condensing

Long-Term: -20–+55°C, ≤85%RH, dust/shock/moisture/corrosion-free

Component Storage:

Sensors/cassette: Clean, dry, sealed, dark

Batteries: Store at 50–60% charge, cycle q3 months

Consumables: Within expiry, cool, dry, dark

Transport: Original shockproof packaging, -20–+60°C, avoid vibration/rain

十、说明书核心信息 (Manual Core Information)

中文

组成:主机(涡轮 / 阀 / 传感器)、15.6 寸触摸屏、呼气盒、NAVA 模块、湿化器、台车、电池、管路

分类:三类医疗器械,符合 IEC 60601-1/2-12,BF 型

适用:新生儿至成人的有创 / 呼吸支持、监测、转运

质保:主机 2 年;传感器 / 电池 / 滤器按周期更换

安全:双回路超压保护(125cmH?O)、窒息后备、过充 / 过流保护

关键声明:

NAVA/Edi 为专利技术,需专用 Edi 导管

严格按适应症 / 禁忌症使用,错误应用致严重伤害

维护 / 校准需原厂配件 / 工具,非授权改装失效

废弃:按医疗电子废弃物法规处理

英文

Components: Main unit (turbine/valve/sensors), 15.6" touchscreen, expiratory cassette, NAVA module, humidifier, trolley, batteries, circuits

Classification: Class III, IEC 60601-1/2-12, Type BF

Intended Use: Neonatal to adult invasive/NIV support, monitoring, transport

Warranty: 2yr main unit; scheduled replacement for sensors/batteries/filters

Safety: Dual overpressure protection (125cmH?O), apnea backup, overcharge/overcurrent protection

Key Statements:

NAVA/Edi is patented; requires specialized Edi catheter

Use strictly per indications/contraindications to avoid harm

Service/calibration with original parts/tools; unauthorized mods void safety

Disposal: Per medical e-waste regulations



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.




热门标签:厂家直供迈柯唯呼吸机SERVO-U,迈柯唯呼吸机SERVO-U,迈柯唯呼吸机

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