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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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厂家供应诺诚插件式多参数监护仪NX3

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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):沪械注准20162070746更新时间:2026/10/16 11:11:09

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厂家供应诺诚插件式多参数监护仪NX3
桂经理19117326863微xin同号
桂经理19117326863微xin同号

管理类别

第二类

型号规格

NX3

结构及组成/主要组成成分

产品为插件形式,由带显示屏主机箱、型号为NX-6多参数模块、一次性使用心电电极、心电导联线、血氧饱和度传感器及延长线、血压袖套、体温传感器,主机电源线及软件(软件发布版本:V2.9)组成。

适用范围/预期用途

供医疗机构在监护过程中对心电、呼吸、血氧饱和度、脉搏、体温、血压生理参数的监测。

1 工作原理 Working Principle

中文本设备为插件模块化多参数病人监护仪。通过配套传感器、电极采集人体心电、呼吸阻抗、光电容积脉搏波、袖套气压、体温模拟生理信号;插件模块完成信号放大、滤波、模数转换;主机嵌入式软件对信号运算解析,得到心电、呼吸、血氧饱和度、脉率、血压、体温数值与波形;完成屏幕显示、数据存储、声光超限报警、数据回顾输出。插件式结构支持模块插拔更换,实现参数配置扩展。

EnglishThis device is a plug‑in modular multi‑parameter patient monitor. Physiological analog signals including electrocardiogram, thoracic respiratory impedance, photoplethysmography pulse wave, cuff air‑pressure and body temperature are collected via matched sensors and electrodes. Plug‑in modules realize signal amplification, filtering and analog‑to‑digital conversion. The host embedded software processes and interprets signals to obtain numerical values and waveforms of ECG, respiration, SpO₂, pulse rate, non‑invasive blood pressure and body temperature. It performs screen display, data storage, audio‑visual out‑of‑limit alarm and data review. The plug‑in architecture supports hot‑swap and replacement of modules for expanded parameter configuration.

2 产品功能 Product Functions

中文

  1. 心电 ECG 监护:采集心电波形,监测心率,心律失常提示,支持多监护模式;

  2. 呼吸 RESP 监护:通过胸阻抗法监测呼吸波形与呼吸频率;

  3. 血氧饱和度 SpO₂及脉率 PR 监测:光电容积法测血氧饱和度与脉搏速率;

  4. 血压 NIBP 测量:手动、自动间隔测量收缩压、舒张压、平均动脉压;

  5. 体温 TEMP 测量:采集人体体温参数;

  6. 声光报警:生理参数超限、传感器脱落、设备故障声光报警,报警阈值可设置;

  7. 波形与数值实时显示;趋势数据、报警事件历史存储与回顾;

  8. 系统参数设置、患者信息录入、屏幕参数配置;

  9. 插件模块即插即用,模块状态识别。

English

  1. ECG monitoring: acquire ECG waveform, monitor heart rate, arrhythmia prompt, multiple monitoring modes;

  2. RESP monitoring: measure respiratory waveform and respiratory rate by thoracic impedance method;

  3. SpO₂ & Pulse Rate monitoring: measure oxygen saturation and pulse rate via photoplethysmography;

  4. NIBP measurement: manual / auto‑interval measurement of systolic, diastolic and mean arterial pressure;

  5. Temperature monitoring: collect human body temperature;

  6. Audio‑visual alarm: trigger audio‑visual alert for physiological out‑of‑range, sensor disconnection and device failure; adjustable alarm limit thresholds;

  7. Real‑time waveform & numeric display; storage and review of trend data & alarm events;

  8. System configuration, patient information input, screen setting;

  9. Plug‑and‑play for plug‑in modules, module status identification.

3 产品特点 Product Features

中文

  1. 插件模块化设计,NX‑6 六参数模块可插拔,维护、升级便捷;

  2. 一体化彩色显示屏主机,波形、数值同屏直观展示;

  3. 支持成人、小儿、新生儿多患者模式切换;

  4. 完备声光报警体系,分级报警,报警阈值自定义;

  5. 可存储生命体征趋势、报警事件,支持历史数据回顾;

  6. 抗干扰心电处理,适配病房、手术室临床环境;

  7. 整机集成度高,床边安放,配套完整患者附件;

  8. 嵌入式软件 V2.9,运行稳定,操作界面简洁。

English

  1. Plug‑in modular design, swappable NX‑6 six‑parameter module for easy maintenance and upgrade;

  2. Integrated host with color display, simultaneous visualization of waveforms and numeric values;

  3. Multi‑patient mode switch: adult, pediatric, neonate;

  4. Complete hierarchical audio‑visual alarm system with customizable alarm thresholds;

  5. Storage of vital‑sign trends and alarm events, historical data review available;

  6. Anti‑interference ECG processing, suitable for ward and operating‑room clinical environment;

  7. High‑integration bedside unit, complete patient accessories included;

  8. Embedded software V2.9, stable performance and user‑friendly interface.

4 主要技术参数 Main Technical Specifications

中文

  1. 心电 ECG

  • 模式:监护 / 手术 / 诊断模式;监护模式带宽 0.5Hz‑35Hz;诊断模式 0.05Hz‑130Hz;手术模式 1Hz‑20Hz;共模抑制比≥90dB;心率测量范围:20‑300bpm

  1. 呼吸 RESP

  • 成人:0‑120 rpm;小儿 / 新生儿:0‑150 rpm;胸阻抗检测方式

  1. 血氧饱和度 SpO₂

  • 测量范围 50%‑100%;脉率 20‑300bpm

  1. 血压 NIBP

  • 测量压力范围 0‑300 mmHg;支持成人、儿童、新生儿袖套适配;手动 / 自动测量模式

  1. 体温 TEMP

  • 测量范围 25℃‑45℃

  1. 软件版本:V2.9;结构:主机箱 + NX‑6 多参数插件模块 + 配套患者附件

English

  1. ECG ‑ Modes: Monitor / OR / Diagnostic; Monitor mode bandwidth:0.5Hz‑35Hz; Diagnostic mode:0.05Hz‑130Hz; OR mode:1Hz‑20Hz; CMRR ≥90dB; Heart rate:20‑300bpm

  2. RESP ‑ Adult:0‑120 rpm; Pediatric / Neonate:0‑150 rpm; Thoracic impedance measurement

  3. SpO₂ ‑ Measuring range:50%‑100%; Pulse rate:20‑300bpm

  4. NIBP ‑ Pressure measuring range:0‑300 mmHg; Compatible with adult / pediatric / neonate cuffs; Manual / Auto measurement mode

  5. Temperature ‑ Measuring range:25℃‑45℃

  6. Software Version: V2.9; Construction: Main unit + NX‑6 multi‑parameter plug‑in module + patient accessories.


5 使用方法 Operating Instructions

中文

  1. 放置监护仪于平稳床边台面,接通交流电源;确认模块正确插入主机插件槽;

  2. 根据患者类型(成人 / 小儿 / 新生儿)选择对应模式与配套附件:心电电极贴于患者体表,连接心电导联线;血氧传感器固定于合适部位;匹配规格血压袖套绑扎上臂;连接体温传感器;

  3. 开机自检,等待设备完成上电自检测,确认无硬件报错;

  4. 设置患者信息、报警上下限、血压测量间隔等参数;

  5. 确认各波形、数值正常后开始连续监护;观察屏幕波形、数值及报警提示;

  6. 需要时调取趋势、报警历史进行查阅;

  7. 使用结束:先移除患者端全部传感器、电极,关机,断开电源;

  8. 重复使用附件按规范清洁消毒;一次性电极禁止重复使用。

English

  1. Place monitor on stable bedside surface, connect AC power; ensure plug‑in module is fully inserted into host slot.

  2. Select corresponding patient mode (Adult / Pediatric / Neonate) and accessories. Apply ECG electrodes onto patient skin and connect ECG cable; fix SpO₂ sensor on proper site; fit correct‑size NIBP cuff on upper arm; connect temperature sensor.

  3. Power‑on and wait for self‑test; confirm no hardware error reported.

  4. Configure patient information, alarm high/low limits, NIBP measurement interval and other settings.

  5. Start continuous monitoring after valid waveforms and values are obtained; observe screen waveforms, numeric readings and alarm prompts.

  6. Review trend data and alarm history as needed.

  7. After use: remove all patient‑side sensors and electrodes, power‑off device and disconnect mains supply.

  8. Clean and disinfect reusable accessories per specification. Do NOT reuse single‑use electrodes.

6 适应症 / 预期用途 Indications / Intended Use

中文供医疗机构在监护过程中,对患者的心电、呼吸、血氧饱和度、脉搏、体温、血压生理参数进行连续或间歇监测;适用于成人、小儿、新生儿床边监护;仅用于生命体征监护,不用于治疗,不做自动诊断。

EnglishIntended for medical institutions to continuously or intermittently monitor patient physiological parameters: electrocardiogram, respiration, SpO₂, pulse rate, body temperature and non‑invasive blood pressure. For bedside monitoring of adults, pediatric and neonatal patients. For vital‑sign monitoring only. Not for therapy or automatic medical diagnosis.

7 禁忌症 Contraindications

中文本设备无绝对禁忌症。 ⚠️不可直接用于胸腔内、心脏内部侵入式测量;不可用于核磁共振 MRI 环境;不可用于体外循环术中直接接触强高能除颤以外特殊高危场景;当患者皮肤存在严重破损、烧伤时,评估后谨慎使用体表电极与传感器。

注:监护仪本身无疾病禁忌症,禁忌症主要来自附件应用场景。

EnglishNo absolute contraindications for the device itself. ⚠️ Shall NOT perform invasive intra‑thoracic or intra‑cardiac measurement. Not for MRI environment. Not for special high‑risk scenarios other than defibrillation protection. Use surface electrodes and sensors cautiously upon assessment for patients with severe skin damage or burn. Note: No disease‑specific contraindications for monitor unit; contraindications are related to accessory application scenarios.


8 注意事项 Precautions

中文

  1. 本设备仅由医疗机构经培训合格医护人员操作;监护仪仅作辅助监护,不能替代临床医师诊断;

  2. 严格使用原厂或符合规格的配套电极、袖套、传感器;一次性心电电极严禁重复使用;

  3. 避免强电磁干扰设备附近使用(高频电刀等),防止波形失真与误报警;

  4. NIBP 袖套规格必须匹配上臂周长,袖套不可包扎在输液肢体上;

  5. SpO₂探头避免强光直射,定期更换佩戴位置,防止局部皮肤压伤;

  6. 出现频繁误报警,优先检查传感器、电极、接触状态,再调整报警阈值,不得随意关闭报警;

  7. 不可在 MRI 环境下运行整机;设备遇液体泼溅立即断电检查;

  8. 设备故障时停止使用,联系厂家维修,严禁自行拆机;

  9. 高频电刀使用时,注意电极安放位置,避免电刀回路灼伤风险;

  10. 定期按维护周期完成设备校验、清洁、消毒。

English

  1. Operated only by trained clinical staff in medical institutions. The monitor serves as auxiliary monitoring tool and cannot replace physician clinical diagnosis.

  2. Only use original or compatible qualified electrodes, cuffs and sensors. Single‑use ECG electrodes must not be reused.

  3. Avoid operating close to strong electromagnetic interference sources such as HF electrosurgical unit to prevent waveform distortion and false alarms.

  4. NIBP cuff size shall match upper‑arm circumference. Do not apply cuff on limbs with intravenous infusion.

  5. Protect SpO₂ sensor from intense ambient light; rotate attachment site periodically to prevent local skin pressure injury.

  6. For frequent false alarms: inspect sensors / electrodes / skin contact status prior to adjusting alarm thresholds. Do NOT disable alarms arbitrarily.

  7. Do NOT operate under MRI environment. Cut off power supply immediately if liquid spills onto device and perform inspection.

  8. Cease operation upon device malfunction; contact manufacturer for service. Do NOT disassemble unit by yourself.

  9. Pay attention to electrode placement during electrosurgery to avoid ESU‑related burn hazard.

  10. Perform periodic calibration, cleaning and disinfection according to maintenance schedule.

9 存储条件 Storage Conditions

中文存储环境:环境温度‑20℃~+55℃;相对湿度 10%‑93%(无凝露);大气压力 70kPa‑106kPa;存放于干燥通风室内,避免阳光直射、粉尘、腐蚀性气体;设备断电存放,附件分类收纳,避免挤压损坏。

EnglishStorage environment: Ambient temperature:‑20℃~+55℃; Relative humidity:10%‑93% non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in dry and ventilated indoor location, avoid direct sunlight, dust and corrosive gas. Store unit under power‑off status; store accessories separately and prevent mechanical crush damage.


10 结构组成 Composition

中文插件式结构,由带显示屏主机箱、NX‑6 多参数模块、一次性心电电极、心电导联线、血氧饱和度传感器及延长线、血压袖套、体温传感器、主机电源线及软件(V2.9)组成。

EnglishPlug‑in configuration: Main unit with display screen, NX‑6 multi‑parameter module, single‑use ECG electrodes, ECG patient cable, SpO₂ sensor & extension cable, NIBP cuff, temperature sensor, AC power cord and embedded software V2.9.免责提示 Disclaimer。

免责声明:以上产品详情仅供参考,临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品,所有产品均来自产品的生产厂家,代理商,经销商,如有侵权请联系我们,会尽快处理!The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.

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