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厂家供应施曼诺多导睡眠记录系统SleepSymphonia,SleepPortato
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厂家供应施曼诺多导睡眠记录系统SleepSymphonia,SleepPortato
桂经理19117326863微xin同号
· 型号规格
· Sleep Symphonia，Sleep Portato
· 结构及组成/主要组成成分
· 由主机、头盒、DOMINO软件（发布版本：2.9.0）、配套的探头、运动绑带和底座（电源适配器和USB线缆）组成。
· 适用范围/预期用途
· 本产品可记录、显示和保存睡眠时各种生理参数，包括持续气道正压（CPAP）、脑电信号（EEG）、眼动信号（EOG）、肌电信号（EMG)、心电信号（ECG）、胸部呼吸、腹部呼吸、口鼻气流、脉率、鼾声、脉搏血氧饱和度（SpO2）、环境光强、腿动和体位。对睡眠呼吸暂停低通气综合征进行分析、辅助诊断。
· 一、工作原理（Working Principle）
· 中文
· 系统由主机、头盒、DOMINO 2.9.0软件及配套传感器组成，通过医用级电极与生理传感器（EEG/EOG/EMG/ECG电极、胸腹呼吸带、口鼻气流、SpO₂、鼾声、体位、腿动、环境光强），同步采集睡眠期脑电、眼电、肌电、心电、胸腹呼吸、口鼻气流、血氧饱和度、脉率、鼾声、体位、腿动、环境光强、CPAP压力等生理信号。信号经24位高精度A/D转换、低噪放大、抗干扰滤波后，由主机实时存储并传输至DOMINO软件；软件内置AI算法自动完成睡眠分期、呼吸事件识别、AHI计算、PLM分析、CPAP同步分析，为睡眠障碍提供客观诊断数据。
· English
· The system consists of a host unit, headbox, DOMINO 2.9.0 software, and supporting sensors. It synchronously collects physiological signals during sleep, including EEG, EOG, EMG, ECG, thoraco‑abdominal respiration, nasal‑oral airflow, SpO₂, pulse rate, snoring, body position, leg movement, ambient light intensity, and CPAP pressure, via medical‑grade electrodes and physiological sensors.Signals undergo 24‑bit high‑precision A/D conversion, low‑noise amplification, and anti‑interference filtering, then are stored in real‑time by the host and transmitted to the DOMINO software. The built‑in AI algorithm automatically perｆorms sleep staging, respiratory event detection, AHI calculation, PLM analysis, and CPAP synchronization analysis, providing ｏbjective diagnostic data for sleep disorders.
· 二、产品特点（Product Features）
· 中文
· 双型号定位：Sleep Symphonia为台式临床旗舰，适配睡眠中心全参数诊断；Sleep Portato为便携式无线，支持家庭/床旁/转运监测。
· 全参数同步采集：覆盖15 +项核心指标，支持CPAP同步监测，满足OSA/CSA/混合性呼吸暂停分型。
· DOMINO智能分析：自动睡眠分期、呼吸事件识别、AHI/ODI计算、PLM/RLS分析，生成结构化报告，支持医生手动编辑。
· 高保真信号处理：24位A/D转换，采样率最高4096Hz，抗干扰强，信号精度达 µV级，符合AASM标准。
· 无线便携（Portato）：内置锂电池，续航≥12小时；蓝牙/ Wi‑Fi传输，无束缚线缆，提升患者舒适度。
· 临床级安全可靠：医用级低敏电极，IPX4防水，符合IEC 60601‑1、GB 9706.1医疗安全标准。
· 全流程数据管理：实时显示、本地存储、云端同步、多终端查看，数据导出兼容DICOM/HL7标准。
· English
· Dual‑Model Precise Positioning: Sleep Symphonia is a desktop clinical flagship for full‑parameter diagnosis in sleep centers; Sleep Portato is portable and wireless, supporting home/bedside/transport monitoring.
· Full‑Parameter Synchronous Acquisition: Covers 15+ core indicators and supports CPAP synchronization monitoring, enabling precise classification of OSA/CSA/mixed apnea.
· DOMINO Intelligent Analysis: Automatic sleep staging, respiratory event detection, AHI/ODI calculation, PLM/RLS analysis, structured report generation, and manual editing support.
· High‑Fidelity Signal Processing: 24‑bit A/D conversion, sampling rate up to 4096Hz, strong anti‑interference,µV‑level signal accuracy, compliant with AASM standards.
· Wireless Portability (Portato): Built‑in lithium battery with≥12‑hour life; Bluetooth/Wi‑Fi transmission, no restrictive cables, improved patient comfort.
· Clinical‑Grade Safety & Reliability: Medical‑grade hypoallergenic electrodes, IPX4 waterproof, compliant with IEC 60601‑1 and GB 9706.1 medical safety standards.
· Full‑Process Data Management: Real‑time display, local storage, cloud synchronization, multi‑terminal viewing, data export compatible with DICOM/HL7 standards.
· 三、技术参数（Technical Parameters）
· 中文
· 型号：Sleep Symphonia（台式）、Sleep Portato（便携式）
· 采集参数：EEG、EOG、EMG、ECG、胸腹呼吸、口鼻气流、SpO₂、脉率、鼾声、体位、腿动、环境光强、CPAP压力
· 采样率：EEG/EOG/EMG：250–4096Hz；ECG：500Hz；呼吸/血氧：100Hz
· 信号精度：EEG/EMG：±1µV；ECG：±0.1mV；SpO₂：±2%（70%–100%）；脉率：±2bpm
· 续航（Portato）：内置锂电池，≥12小时（单次充电）
· 传输方式：Symphonia：有线USB /以太网；Portato：蓝牙5.0 + Wi‑Fi 2.4G
· 存储容量：内置64GB，可存储≥100次整夜监测数据
· 工作环境：温度5–40℃，湿度30%–85% RH，气压86–106kPa
· 防护等级：IPX4（Portato）；IP20（Symphonia）
· 安全标准：IEC 60601‑1、GB 9706.1‑2020、GB 9706.226‑2021、AASM标准
· 注册证号：国械注进20212070087
· 配套软件：DOMINO Sleep Analysis System V2.9.0
· English
· Models: Sleep Symphonia (Desktop), Sleep Portato (Portable)
· Acquisition Parameters: EEG, EOG, EMG, ECG, thoraco‑abdominal respiration, nasal‑oral airflow, SpO₂, pulse rate, snoring, body position, leg movement, ambient light intensity, CPAP pressure
· Sampling Rate: EEG/EOG/EMG: 250–4096Hz; ECG: 500Hz; Respiration/SpO₂: 100Hz
· Signal Accuracy: EEG/EMG:±1µV; ECG:±0.1mV; SpO₂:±2% (70%–100%); Pulse Rate:±2bpm
· Battery Life (Portato): Built‑in lithium battery,≥12 hours per charge
· Transmission: Symphonia: Wired USB/Ethernet; Portato: Bluetooth 5.0 + Wi‑Fi 2.4G
· Storage: Built‑in 64GB, stores≥100 full‑night recordings
· Operating Environment: Temp 5–40℃, Humidity 30%–85%RH, Pressure 86–106kPa
· Protection Class: IPX4 (Portato); IP20 (Symphonia)
· Safety Standards: IEC 60601‑1, GB 9706.1‑2020, GB 9706.226‑2021, AASM Standards
· Registration No.: Guo Xie Zhu Jin 20212070087
· Supporting Software: DOMINO Sleep Analysis System V2.9.0
· 四、使用方法（Instructions for Use）
· 中文
· 准备
· 患者清洁皮肤（去油脂/毛发），剃净胡须，禁用化妆品；24小时内避免酒精、。
· 安装电极（EEG/EOG/EMG/ECG）、胸腹呼吸带、口鼻气流、SpO₂指夹、鼾声/体位/腿动传感器。
· 连接主机与头盒，开机自检，确认信号正常、电量充足（Portato）。
· 佩戴与校准
· 固定传感器于标准位置，确保电极与皮肤紧密接触；完成眨眼、深呼吸、肢体移动等校准动作。
· 启动DOMINO软件，设置患者信息，开启实时监测。
· 监测
· 患者自然睡眠，避免剧烈活动、电磁干扰；系统自动记录，异常信号声光提示。
· 支持CPAP同步监测，实时同步压力数据。
· 结束与数据处理
· 晨起停止监测，取下设备与传感器，关闭电源。
· 数据自动上传至DOMINO软件，完成AI分析，生成诊断报告；一次性电极废弃，可复用部件消毒。
· English
· Preparation
· Patient cleans skin (removes oil/hair), shaves facial hair, no cosmetics; avoid alcohol and caffeine for 24 hours.
· Apply electrodes (EEG/EOG/EMG/ECG), thoraco‑abdominal belts, nasal‑oral airflow, SpO₂finger clip, snoring/position/leg movement sensors.
· Connect host and headbox, power on for self‑test; confirm normal signals and sufficient battery (Portato).
· Application & Calibration
· Secure sensors in standard positions, ensure tight electrode‑skin contact; perｆorm calibration (blinking, deep breathing, limb movement).
· Launch DOMINO software, enter patient info, start real‑time monitoring.
· Monitoring
· Patient sleeps naturally; avoid vigorous movement and electromagnetic interference; system records automatically with audible/visual alerts for abnormalities.
· Supports CPAP synchronization monitoring with real‑time pressure data.
· Completion & Data Processing
· Stop monitoring in the morning, remove device and sensors, power off.
· Data auto‑uploads to DOMINO for AI analysis and report generation; dispose of single‑use electrodes, disinfect reusable parts.
· 五、适应症（Indications）
· 中文
· 睡眠呼吸暂停综合征（OSA/CSA/混合性）的诊断、分型、严重程度评估
· 失眠症、发作性睡病、异态睡眠的客观睡眠结构分析
· 周期性肢体运动障碍（PLMD）、不宁腿综合征（RLS）的辅助诊断
· 睡眠相关癫痫、昼夜节律紊乱、肥胖/高血压/糖尿病合并睡眠障碍监测
· CPAP/Auto‑CPAP /口腔矫治器治疗效果评估与滴定
· 成人/儿童家庭睡眠监测、临床睡眠中心全参数诊断、转运监测
· English
· Diagnosis, classification, and severity assessment of sleep apnea syndromes (OSA/CSA/mixed)
· Objective sleep architecture analysis for insomnia, narcolepsy, and parasomnias
· Auxiliary diagnosis of periodic limb movement disorder (PLMD) and restless legs syndrome (RLS)
· Monitoring of sleep‑related epilepsy, circadian rhythm disorders, and sleep disorders comorbid with obesity/hypertension/diabetes
· Treatment efficacy evaluation and titration for CPAP/Auto‑CPAP/oral appliances
· Home sleep monitoring for adults/children, full‑parameter diagnosis in clinical sleep centers, and transport monitoring
· 六、禁忌症（Contraindications）
· 中文
· 严重呼吸衰竭、心力衰竭、肝肾功能衰竭未控制者
· 皮肤破损、感染、炎症或对电极/传感器材质过敏者
· 无法配合佩戴、意识障碍、躁动不配合者
· 需紧急抢救、生命体征不稳定者
· 儿童＜3岁（需专业人员操作）
· English
· Uncontrolled severe respiratory failure, heart failure, or hepatic/renal failure
· Skin breakdown, infection, inflammation, or allergy to electrode/sensor materials
· Inability to cooperate with application, impaired consciousness, or agitation
· Patients requiring emergency resuscitation or with unstable vital signs
· Children <3 years (professional operation required)
· 七、注意事项（Precautions）
· 中文
· 医护人员或经培训人员操作，使用前阅读完整说明书。
· 仅使用原厂电极/传感器，禁止混用非兼容配件，避免信号干扰。
· 皮肤清洁干燥后粘贴，确保电极与皮肤紧密接触，防止脱落导致数据缺失。
· 监测期间远离手机、路由器等强电磁源，关闭无关蓝牙/ Wi‑Fi设备。
· Portato防水溅（IPX4），禁止浸泡、淋水；Symphonia避免液体接触。
· 一次性电极单人单次使用；可复用部件用75%酒精擦拭消毒。
· 儿童/老年患者需家属陪护，防止电极脱落、误吞或缠绕。
· 监测中出现皮肤红肿、瘙痒、呼吸困难等不适，立即停止并处理。
· 定期校准传感器（建议每6个月），确保数据准确性。
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.
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