厂商直销诺诚插件式多参数监护仪X6-A,X6-B,X6-D,X6-E
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厂商直销诺诚插件式多参数监护仪X6-A,X6-B,X6-D,X6-E
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
X6-A,X6-B, X6-D,X6-E
结构及组成/主要组成成分
产品为插件式,由主机、显示器、型号为NX-6多参数模块、脑电模块、呼末CO2模块、一次性使用心电电极、心电导联线、脑电电极和电缆、血氧饱和度传感器及延长线、血压袖套、体温传感器、呼末CO2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、脑电生理参数和呼末CO2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设备。由各类生理传感器采集人体心电、阻抗呼吸、血氧饱和度、脉搏、血压、体温、(选配:脑电、呼末二氧化碳)生理信号,转换为模拟电信号;主机模块完成信号放大、滤波、A/D 模数转换,嵌入式系统运算处理后,将波形、数值实时显示于屏幕;超限触发声光报警;实现数据存储、回顾、打印、联网中央监护。插件式硬件架构,可按需插拔选配测量模块扩展监护项目。
EnglishThis is a modular plug‑in multi‑parameter patient monitor. Physiological sensors acquire human physiological signals including ECG, impedance respiration, SpO₂, pulse rate, non‑invasive blood pressure, temperature, (optional: EEG, EtCO₂), and convert them into analog electrical signals. Main unit modules perform signal amplification, filtering and A/D conversion. The embedded system processes data and displays real‑time waveforms and numerical values on screen. Audible‑visual alarms are triggered when parameters exceed thresholds. It supports data storage, review, printing and network‑connected central monitoring. Plug‑in architecture allows hot‑swap optional measurement modules to expand monitoring items.
2 产品功能|Functions
中文
实时监测:心电 ECG、心率 HR、阻抗呼吸 RESP、血氧饱和度 SpO₂、脉率 PR、血压 NIBP、体温 TEMP;可选脑电 EEG、呼末二氧化碳 EtCO₂监测。
波形与数值同屏显示,支持波形冻结、回放。
参数上下限声光报警,报警事件存储。
NIBP 支持手动 / 自动 / 连续测量模式。
病人数据存储、趋势图回顾、事件回顾。
可选内置打印输出生命体征报告。
支持局域网接入中央监护系统,床旁数据上传中央工作站。
支持成人、小儿、新生儿三种病人模式切换。
English
Real‑time monitoring: ECG, Heart Rate, Impedance Respiration, SpO₂, Pulse Rate, NIBP, Temperature; optional EEG, End‑tidal CO₂ (EtCO₂) monitoring.
Simultaneous display of waveforms and numerical values; waveform freeze & review function.
Audible‑visual alarm for out‑of‑limit parameters; alarm event storage.
NIBP supports manual / auto / continuous measurement modes.
Patient data storage, trend graph review, event log review.
Optional built‑in printer for vital‑sign report output.
Compatible with local‑area‑network central monitoring system for bedside data uploading to central workstation.
Three patient modes: Adult / Pediatric / Neonate selectable.
3 产品特点|Product Features
中文
插件模块化设计,可灵活选配多参数、脑电、呼末 CO₂模块,升级扩展方便。
彩色 TFT 液晶显示屏,波形、参数清晰可视。
全年龄段适用:成人、儿童、新生儿监护。
完善报警管理:分级声光报警,报警限可自定义。
大容量趋势数据存储,历史波形、事件可回溯查看。
NIBP 过压保护,不同人群过压阈值自动适配。
内置可充电锂电池,支持断电后短时继续监护。
支持有线网络接入中央监护系统,实现多床集中监护。
整机便携,支持床旁、手术室、急诊、ICU 多场景使用。
English
Modular plug‑in design; optional multi‑parameter, EEG and EtCO₂ modules for flexible function upgrade.
Color TFT‑LCD screen for clear visualization of waveforms and numerical parameters.
Full‑age‑group applicability: Adult, Pediatric and Neonate monitoring.
Comprehensive alarm management: multi‑level audible‑visual alarms with user‑configurable alarm limits.
Large‑capacity trend‑data storage for reviewing historical waveforms and events.
NIBP over‑pressure protection with auto‑adapted pressure thresholds for different patient populations.
Built‑in rechargeable lithium‑ion battery enables short‑term monitoring under power‑failure condition.
Wired‑network connectivity to central monitoring system for multi‑bed centralized supervision.
Compact & portable unit for bedside, operating‑room, emergency and ICU scenarios.
4 主要技术参数|Main Technical Specifications
X6‑A / X6‑B 共用 NX‑6 基础多参数模块,X6‑B 扩展可选脑电 / 呼末 CO₂模块
表格
| 项目 Item | 中文参数 | English Specifications |
|---|---|---|
| 心电 ECG | 导联:3/5 导联;心率范围:15‑300bpm;灵敏度可调;心律失常分析 | Lead: 3‑lead /5‑lead; HR range:15‑300bpm; adjustable gain; arrhythmia analysis |
| 呼吸 RESP | 阻抗式呼吸;呼吸率 7‑120 次 / 分 (成人),7‑150 次 / 分 (小儿 / 新生儿);窒息报警可选 10‑40s | Impedance respiration; RR 7‑120BrPM(Adult),7‑150BrPM(Ped/Neo); apnea alarm 10‑40s selectable |
| 血氧 SpO₂ | 测量范围 0‑100%;70‑100% 精度 ±1%;脉率 30‑250bpm | SpO₂ 0‑100%; Accuracy ±1%(70‑100%); Pulse Rate 30‑250bpm |
| 血压 NIBP | 成人:SYS60‑270,DIA30‑210mmHg;儿童、新生儿分档;过压保护;手动 / 自动 / 连续模式 | Adult:SYS60‑270,DIA30‑210mmHg; separate range for pediatric/neonate; over‑pressure protection; manual/auto/continuous mode |
| 体温 TEMP | 测温范围 0‑50℃;精度 ±0.1℃ | Temperature range 0‑50℃; Accuracy ±0.1℃ |
| 呼末 CO₂(选配) | 测量范围 0‑99mmHg;适用于各年龄段 | EtCO₂(optional):0‑99mmHg; applicable for all ages |
| 脑电 EEG(选配) | 采集通道,用于脑电监测、生物反馈康复 | EEG(optional): acquisition channels for EEG monitoring & biofeedback rehabilitation |
| 显示屏 | 彩色 TFT 液晶屏 | Color TFT‑LCD display |
| 电源 | AC 100‑240V 50/60Hz;内置锂电池备用 | Power supply AC100‑240V 50/60Hz; built‑in backup lithium‑ion battery |
| 软件版本 | V2.9(主机) | Software Version V2.9 |
| 分类 | Ⅱ 类医用电气设备,BF 型应用部分 | Class II medical electrical equipment, BF‑type applied parts |

5 使用方法|Operation Method
中文
安放设备,接通交流电源,开机自检,等待自检完成。
根据患者选择:成人 / 小儿 / 新生儿病人模式。
连接配套附件:心电电极及导联线贴于患者体表;血氧探头固定于手指 / 对应部位;选择合适尺寸血压袖带绑扎上臂;连接体温探头;选配模块接对应传感器。
设置各参数报警上下限;设置 NIBP 测量间隔。
监护仪实时显示波形与生命体征,观察屏幕,发生报警及时处置患者。
需要时执行手动测压、趋势查看、波形冻结、打印。
使用结束:摘除全部患者附件,关机;断开电源。
可接入局域网,接入中央监护工作站。
English
Place the unit properly, connect AC power, power‑on for self‑test and wait for completion.
Select patient mode: Adult / Pediatric / Neonate according to subject.
Connect accessories: apply ECG electrodes & leads on patient skin; attach SpO₂ sensor to finger or appropriate site; fit properly‑sized NIBP cuff on upper‑arm; connect temperature probe; connect sensors for optional modules.
Configure upper/lower alarm limits for each parameter; set NIBP measurement interval.
Monitor real‑time waveforms and vital‑sign values. Respond promptly whenever alarms activate.
Perform manual NIBP measurement, trend review, waveform freeze or printing as required.
After use: remove all patient accessories, power‑off and disconnect mains power.
Connect to local‑area‑network for central‑monitoring workstation access if needed.

6 适应症|Indications for Use
中文供医疗机构对成人、小儿、新生儿患者进行床旁生命体征监护,监测心电、阻抗呼吸、血氧饱和度、脉率、血压、体温;选配模块可监测脑电、呼末二氧化碳。可用于生物反馈康复治疗。配套中央监护系统可实现多床生命体征集中监护。本设备仅用于监护,不用于治疗,不能作为诊断依据。
EnglishIntended for bedside vital‑sign monitoring of adult, pediatric and neonate patients in medical institutions. Monitors ECG, impedance respiration, SpO₂, pulse rate, NIBP and body temperature. Optional modules enable EEG and EtCO₂ monitoring. Applicable for biofeedback rehabilitation therapy. Matching central‑monitoring system supports multi‑bed centralized vital‑sign supervision. This device is for monitoring only, NOT for therapy and shall NOT serve as sole diagnostic basis.
7 禁忌症|Contra‑indications
中文
无绝对禁忌症。
不可直接用于核磁共振 MRI 环境,不可在高压氧舱内使用。
不可用于体外循环术中直接作为监护手段。
破损皮肤、烧伤创面不可直接粘贴心电电极。
提示:本设备不能替代专业临床诊断。
English
No absolute contra‑indications.
NOT for use in MRI environment or hyperbaric‑oxygen chamber.
Shall NOT be used as sole monitoring means during extracorporeal circulation procedures.
Do NOT attach ECG electrodes directly onto broken skin or burn wounds.
Note: This device cannot replace professional clinical diagnosis.

8 注意事项|Precautions
中文
设备仅由经过培训的医护人员操作使用。
使用原厂配套电极、袖带、探头、导联配件;非原厂配件可能造成测量错误、安全风险。
定期检查电源线、导联线有无破损,防止漏电风险。
NIBP 袖带尺寸必须匹配患者肢体,袖带绑扎过松过紧会造成血压测量不准。
血氧探头避免强光直射,强光干扰会降低血氧测量准确度。
报警功能开启,请勿随意关闭报警;定期校验报警阈值。
锂电池避免深度亏电,长期不用应定期充放电。
设备表面使用医用消毒剂擦拭清洁,禁止液体直接泼淋主机与模块接口。
请勿自行拆解主机与插件模块;维修由厂家授权人员执行。
电磁环境:远离大功率射频设备,避免电磁干扰造成波形失真。
出现设备故障,立即停止使用,改用其它监护手段监护患者。
English
Operate only by trained medical‑care personnel.
Use original‑manufacturer electrodes, cuffs, probes and leads. Non‑original accessories may cause erroneous measurements and safety hazards.
Periodically inspect power cord and patient cables for damage to prevent electric‑leakage risk.
NIBP cuff size must match patient limb; improper tightness will lead to inaccurate BP readings.
Keep SpO₂ sensor away from intense ambient light which degrades SpO₂ accuracy.
Keep alarm function enabled; do NOT disable alarms arbitrarily; verify alarm limits periodically.
Avoid deep discharge of built‑in battery; perform regular charge‑discharge cycles for long‑term storage.
Wipe unit surface with medical disinfectant. Do NOT pour liquid directly onto main‑unit or module connectors.
Do NOT disassemble main‑unit or plug‑in modules; repair shall be performed only by manufacturer‑authorized personnel.
Electromagnetic environment: keep away from high‑power RF equipment to prevent waveform distortion from EMI.
In case of equipment malfunction, discontinue use immediately and switch to alternative patient‑monitoring means.
9 存储条件|Storage Conditions
中文存储环境温度:‑10℃~+55℃;相对湿度:10%~93%,无冷凝;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、剧烈震动。长期存放前,摘除全部患者附件。
EnglishStorage ambient temperature:‑10℃~+55℃; Relative humidity:10%‑93%, non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in dry and ventilated indoor space; avoid direct sunlight, dust, corrosive gas and severe vibration. Remove all patient accessories before long‑term storage.

10 说明书核心提示|Core IFU Remarks
中文
产品型号:X6‑A、X6‑B;注册证:赣械注准 20182070177;软件版本 V2.9。
整机组成:主机、NX‑6 多参数模块,可选脑电模块、呼末 CO₂模块、中央监护系统;配套耗材:心电电极、导联线、血氧探头、血压袖套、体温探头等。
用途定位:生命体征监护,仅做监护,不作为诊断依据,无治疗功能。
维护:定期设备性能检测,电池定期维护;配件按耗材寿命更换。
报废处置:遵循当地医疗电子废弃物处置法规。
English
Model: X6‑A, X6‑B; Registration Certificate: Gan Xie Zhu Zhun 20182070177; Software Version V2.9.
System composition: Main unit, NX‑6 multi‑parameter module; optional EEG module, EtCO₂ module, central monitoring system. Consumables: ECG electrodes, patient cables, SpO₂ sensor, NIBP cuff, temperature probe etc.
Intended use: Vital‑sign monitoring ONLY, NOT sole diagnostic reference; no therapeutic function.
Maintenance: Periodic performance inspection and battery maintenance; replace consumables according to service‑life specification.
Disposal: Comply with local regulations for medical‑electronic waste.
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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