厂家供应Masimo迈心诺麻醉深度监护仪SedLine
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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20243070027更新时间：2026/10/16 11:11:02
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厂家供应Masimo迈心诺麻醉深度监护仪SedLine
桂经理19117326863微xin同号
管理类别
第三类
型号规格
SedLine
结构及组成/主要组成成分
该产品由脑电模块（型号：SedLine）、主机（型号：Root）和患者导联线（RD SedLine）组成。
适用范围/预期用途
该产品临床用于成人和儿童（1岁及以上）脑电信号采集及处理，成人麻醉深度和镇静状态监测。
一、工作原理 (Working Principle)
中文
迈心诺 SedLine 通过4 通道双侧前额脑电图（EEG）监测技术工作。RD SedLine 传感器采集大脑额叶的微弱电信号，系统经自适应信号处理引擎去除肌电（EMG）等伪迹干扰，通过多域线性与非线性算法计算患者状态指数（PSi）。同时生成密度谱阵列（DSA），实时显示左右脑半球脑电波的频率、功率变化及对称性，综合评估麻醉药物对大脑的抑制程度，量化麻醉与镇静深度MasimoMasimo。
英文
Masimo SedLine operates on 4-channel bilateral frontal electroencephalogram (EEG) monitoring. The RD SedLine sensor captures faint electrical signals from the patient's frontal lobes. An adaptive signal processing engine removes artifacts (e.g., EMG). Advanced multi-domain linear/non-linear algorithms compute the Patient State Index (PSi). It also generates a Density Spectral Array (DSA) to visualize real-time frequency, power, and symmetry of bilateral brain activity, quantifying anesthetic effects and sedation depthMasimoMasimo.
二、功能 (Functions)
中文
患者状态指数（PSi）：0-100 量化麻醉深度（25-50 为全麻理想范围）。
四通道 EEG 波形：同步显示左右脑原始脑电，评估活动对称性。
密度谱阵列（DSA）：彩色图谱显示 0-30Hz 脑电功率，直观反映麻醉进程。
爆发抑制比（SR）：0-100% 量化大脑电活动抑制程度，预警过深麻醉。
肌电指数（EMG）：0-100% 评估面部肌肉活动，排除干扰。
信号质量指数（ARTF）：0-100% 提示 EEG 信号可靠性。
趋势回顾：PSi、SR 等参数长时趋势记录与回放。
报警功能：参数超限、电极脱落、信号质量低自动报警。
英文
Patient State Index (PSi): 0-100 scale (25-50 optimal for general anesthesia).
4-Channel EEG Waveｆorms: Simultaneous bilateral raw EEG for symmetry assessment.
Density Spectral Array (DSA): Color map of 0-30Hz EEG power showing anesthetic progression.
Suppression Ratio (SR): 0-100% measure of electro-cortical suppression.
EMG Index: 0-100% for facial muscle activity artifact detection.
Artifact Index (ARTF): 0-100% for EEG signal quality indication.
Trend Review: Long-term trending and playback of PSi, SR, etc.
Alarms: Automatic alerts for out-of-range values, poor signal, electrode disconnect.
三、产品特点 (Features)
中文
四通道双侧监测：4 电极采集，比单通道更，可发现脑活动不对称。
自适应信号处理：强抗干扰，分离 EEG 与 EMG，提升低功率信号准确性。
高清 DSA 显示：支持标准 / 多窗谱阵列，清晰显示爆发抑制与脑电变化Masimo。
PSi 算法：受肌电干扰小，适用于老年、低脑电功率患者。
便捷传感器：预涂凝胶、免剃毛，软泡沫垫，佩戴舒适固定牢固。
模块化集成：作为 Masimo Root 模块，可与血氧、血压等多参数整合。
临床导向：辅助预防术中知晓、术后谵妄，优化麻醉用药。
英文
4-Channel Bilateral Monitoring: 4-electrode array for comprehensive, symmetricity detection.
Adaptive Signal Processing: Superior artifact rejection, isolates EEG from EMG reliably.
High-Resolution DSA: Standard/Multitaper options, clearly visualizes burst suppressionMasimo.
Robust PSi Algorithm: Less susceptible to EMG, perｆorms well in low-power EEG.
Easy Sensor Application: Pre-gelled, no-shave, soft foam for comfort & secure fit.
Modular Integration: Plugs into Masimo Root platｆorm, combining with SpO2, NIBP, etc..
Clinical Focus: Aids in preventing awareness, delirium, optimizing anesthetic titration.
四、技术参数 (Specifications)
中文
监测通道：4 通道（左 / 右前额）Masimo
EEG 频率范围：0.5-30Hz（可调至 40Hz）
参数范围
PSi：0-100
SR：0-100%
EMG：0-100%
ARTF：0-100%
传感器：RD SedLine 一次性电极
主机：Masimo Root 监护平台
尺寸（模块）：3.3 × 10.2 × 2.0 cm
电源：Root 主机供电（锂电池 / 交流）
显示：Root 高分辨率触摸屏
数据输出：DICOM、USB、网络传输
注册证：国械注进 20243070027
英文
EEG Channels: 4-channel (bilateral frontal)Masimo
EEG Frequency: 0.5-30Hz (adjustable to 40Hz)
Parameters
PSi: 0-100
SR: 0-100%
EMG: 0-100%
ARTF: 0-100%
Sensor: RD SedLine disposable electrode
Host: Masimo Root monitor platｆorm
Module Dimensions: 3.3 × 10.2 × 2.0 cm
Power: Via Root platｆorm (Li-ion battery/AC)
Display: Root high-resolution touchscreen
Connectivity: DICOM, USB, Network
China Registration: 国械注进 20243070027
五、使用方法 (Instructions)
中文
准备：连接 SedLine 模块至 Root 主机，开机自检Masimo。
皮肤准备：酒精清洁前额皮肤，待干。
粘贴传感器：
中央电极对准鼻根上方
外侧电极贴于两侧太阳穴上方无发区
轻压固定，勿直接按压凝胶处
启动监测：选择患者类型（成人 /≥1 岁儿童），启动 EEG 采集。
参数观察：监测 PSi、DSA、SR、EMG，评估麻醉深度Masimo。
记录与报警：确认报警限，自动记录数据与趋势。
结束：监测完毕，撕除传感器，清洁模块，关机Masimo。
英文
Setup: Connect SedLine module to Root, perｆorm self-testMasimo.
Skin Prep: Clean forehead with alcohol, dry thoroughly.
Sensor Application:
Center electrodes above nose bridge
Place outer electrodes on hairless area above temples
Press gently; avoid direct pressure on gel pads
Initiate Monitoring: Select patient type (adult/≥1yo), start EEG acquisition.
Monitor: Observe PSi, DSA, SR, EMG to assess depthMasimo.
Record & Alarm: Set alarm limits; data/trends auto-recorded.
Completion: Stop monitoring, remove sensor, clean module, power offMasimo.
六、适应症 (Indications)
中文
成人（≥18 岁）：手术室全麻 / 镇静深度监测Masimo。
儿童（≥1 岁）：脑电信号采集与处理。
ICU：重症患者镇静水平监测Masimo。
临床研究：麻醉 / 镇静药物脑效应研究Masimo。
适用药物：丙泊酚、七氟烷、地氟烷、、、笑气等Masimo。
英文
Adults (≥18yo): Monitoring anesthesia/sedation depth in ORMasimo.
Pediatrics (≥1yo): EEG signal acquisition & processing.
ICU: Sedation level monitoring for critical care patientsMasimo.
Research: Clinical studies on anesthetic/sedative effectsMasimo.
Agents: Propofol, Sevoflurane, Desflurane, , , N?O, etc.Masimo.
七、禁忌症 (Contraindications)
中文
年龄：1 岁以下婴儿（尚无安全有效性数据）Masimo。
传感器过敏：对电极片、粘合剂或凝胶过敏者Masimo。
破损皮肤：前额皮肤破损、感染、炎症时Masimo。
MRI 环境：不可在 MRI 扫描中或强磁场区域使用Masimo。
易燃环境：不可在可燃性麻醉气体环境中使用Masimo。
英文
Age: Infants <1 year (no safety/efficacy data)Masimo.
Allergy: Hypersensitivity to sensor adhesive, gel, or materialsMasimo.
Broken Skin: Forehead lacerations, infections, or inflammationMasimo.
MRI Zone: Prohibited in MRI or strong electromagnetic fieldsMasimo.
Flammables: Not for use with flammable anesthetics/agentsMasimo.
八、注意事项 (Precautions)
中文
专业操作：受过培训的医护人员使用Masimo。
信号干扰：电刀、除颤仪可能暂时影响信号，不损伤设备。
传感器使用：一次性使用，禁止重复消毒、复用。
设备维护：不可拆解、浸泡、高压灭菌；仅表面清洁。
电磁兼容：远离高频设备，保持安全距离Masimo。
临床判断：PSi/DSA 为辅助工具，不能替代临床综合判断。
电池安全：长期存放需定期充电，防止过放损坏。
英文
Qualified Use: For trained medical personnel onlyMasimo.
Interference: Electrocautery/defibrillation may temporarily distort signals.
Sensor: Single-use only; do not reprocess/sterilize.
Maintenance: Do not disassemble, submerge, or autoclave; external wipe only.
EMC: Maintain distance from high-frequency equipmentMasimo.
Clinical Decision: PSi/DSA are aids, not substitutes for clinical judgment.
Battery: Charge periodically if stored long-term to prevent damage.
九、存储条件 (Storage Conditions)
中文
模块
温度：-20°C ～ +50°C
湿度：10% ～ 90% RH，无冷凝
传感器（未开封）
温度：5°C ～ 30°C（常温）
湿度：30% ～ 70% RH
环境：避光、干燥、通风，远离腐蚀性气体
运输：防震、防潮、防暴晒；原包装运输
英文
Module
Temp: -20°C to +50°C
Humidity: 10%–90% RH, non-condensing
Unopened Sensors
Temp: 5°C to 30°C (ambient)
Humidity: 30%–70% RH
Environment: Dry, dark, ventilated; corrosive gas-free
Transport: Shockproof, moisture-proof, avoid sunlight; original packaging
十、说明书核心信息 (Manual Core Info)
中文
产品组成：SedLine 脑电模块、Root 主机、RD SedLine 导联线 / 传感器。
适用人群：成人（≥18 岁）麻醉监测；儿童（≥1 岁）EEG 监测Masimo。
安全分类：CF 型应用部分，防除颤，连续运行。
电磁兼容：符合 IEC 60601-1-2，医用环境安全。
质保：模块标准18 个月有限保修。
使用期限：模块5 年；传感器有效期见包装标注。
废弃处理：按医疗废弃物与电子垃圾法规分类处理。
英文
Components: SedLine EEG module, Root monitor, RD SedLine cable/sensor.
Indications: Adults (≥18yo) anesthesia; Pediatrics (≥1yo) EEGMasimo.
Safety: Type CF, defibrillation-proof, continuous operation.
EMC: Complies with IEC 60601-1-2 for medical environments.
Warranty: 18-month limited warranty for module.
Service Life: Module 5 years; Sensor expiry per package.
Disposal: Dispose per medical waste & 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.
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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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