ECG · PPG · EDA · 二类创新Class II Innovative
指套式多模态生理监测设备Finger-sleeve Multimodal Physiological Monitor
SY‑F100 · 45项认证技术点 · 连续监测 · 家庭与临床双场景45 Certified Technical Points · Continuous Monitoring · Home & Clinical Use
45核心技术点Core Tech Points
8光学波长Optical Wavelengths
3同步模态Sync Modalities
SY‑F100 · 指套式设计Finger-sleeve Design
1550/1650nm
500Hz ECG
EDA
产品技术要求Technical Requirements
产品说明书Instructions for Use
产品综述Product Overview
临床应用指南Clinical Application Guide
数据展示Data Showcase
📋 产品技术要求Technical Requirements
SY‑F100 指套式多模态生理监测设备 · 二类创新医疗器械Finger-sleeve Multimodal Monitor · Class II Innovative Device
68项医用技术指标68 Medical Technical Indicators · ECG/PPG/EDA · 整机结构Device Structure & 检验方法Test Methods
版本 2.3 · 2026-06Version 2.3 · 2026-06
1. 型号规格 & 整机结构1. Model Specifications & Device Structure
型号规格Model Specifications
- 产品名称Product Name指套式多模态生理监测设备Finger-sleeve Multimodal Physiological Monitor
- 型号ModelSY‑F100
- 尺寸 (L×W×H)Dimensions (L×W×H)58×42×28 mm
- 重量Weight≈ 28 g (含电池)≈ 28 g (with battery)
- 电池Battery3.7V 150mAh 锂聚合物3.7V 150mAh Li-Po
- 防水等级Ingress ProtectionIP22 (生活防水)IP22 (splash resistant)
整机结构 · 组件清单Device Structure · Component List
- 面板Front PanelOLED 显示屏 · 触摸按键 · ECG/EDA电极 · MIC采集孔 · 温度采集OLED Display · Touch Key · ECG/EDA Electrodes · MIC Port · Temperature
- 主体 (主板)Main Body (Mainboard)主控 · USB (充电/U盘) · 2×PD · 电池 · ECG/EDA按键MCU · USB (Charge/USB drive) · 2×PD · Battery · ECG/EDA Key
- 接触手指上部分Upper Finger Contact硅胶 · ECG/EDA电极 · 温度采集Silicone · ECG/EDA Electrodes · Temperature
- 接触手指下部分Lower Finger Contact硅胶 · ECG/EDA电极 · 8个LED (多波长PPG)Silicone · ECG/EDA Electrodes · 8 LEDs (multi-wavelength PPG)
- 接触手指尖部分Fingertip ContactECG/EDA按键 · 温度采集ECG/EDA Key · Temperature
- 电极/传感器总数Electrode/Sensor Total4×ECG/EDA电极 · 3×温度采集4×ECG/EDA Electrodes · 3×Temperature Acquisition
面板Front PanelOLED · 触摸按键 · ECG/EDA电极 · MIC · 温度OLED · Touch Key · ECG/EDA Electrodes · MIC · Temperature
主体Main Body主控 · USB · 2×PD · 电池 · ECG/EDA按键MCU · USB · 2×PD · Battery · ECG/EDA Key
上接触Upper Contact硅胶 · ECG/EDA电极 · 温度Silicone · ECG/EDA Electrodes · Temperature
下接触Lower Contact硅胶 · ECG/EDA电极 · 8×LED (PPG)Silicone · ECG/EDA Electrodes · 8×LED (PPG)
指尖FingertipECG/EDA按键 · 温度采集ECG/EDA Key · Temperature
4×ECG/EDA电极 · 3×温度传感器 · 8波长LED (525/660/850/940/1050/1300/1550/1650nm)4×ECG/EDA Electrodes · 3×Temperature Sensors · 8-wavelength LED (525/660/850/940/1050/1300/1550/1650nm)
2. 医用技术指标 · 68项 (筛选后)2. Medical Technical Indicators · 68 Items (Selected)
45项 二类创新认证 (ECG/PPG/EDA)45 Class-II Innovative Certifications (ECG/PPG/EDA)
23项 不纳入 (温度/运动/音频调试)23 Excluded (Temperature/Motion/Audio Tuning)
整机医用功能仅ECG/PPG/EDAMedical functions: ECG/PPG/EDA only
| 序号No. | 技术类别Category | 核心技术点Core Technical Point | 数据策略 / 频率Data Strategy / Rate | 适用药物Applicable Drugs | 配套说明Supporting Note |
|---|---|---|---|---|---|
| 1 | 光学监测Optical Monitoring | 组织水合指数Tissue Hydration Index | 1550/1650nm PPG原始, 125Hz1550/1650nm PPG raw, 125Hz | 利尿剂/SGLT2Diuretics/SGLT2 | 纯PPG光学Pure PPG optical |
| 2 | 光学监测Optical Monitoring | 微循环灌注MPIMicrocirculation Perfusion MPI | 多波长PPG, 250HzMulti-wavelength PPG, 250Hz | 血管扩张剂Vasodilators | 多波长血流Multi-wavelength blood flow |
| 3 | 光学监测Optical Monitoring | Hb指数Hb Index | 光密度变化, 250HzOptical density change, 250Hz | 抗凝药Anticoagulants | PPG血红蛋白PPG hemoglobin |
| 4 | 光学监测Optical Monitoring | 餐后血流再分布Postprandial Blood Redistribution | 525/850/940nm, 250Hz | GLP‑1 | 餐后PPGPostprandial PPG |
| 5 | 光学监测Optical Monitoring | 血氧趋势SpO₂ Trend | SpO₂均值/谷值, 125HzSpO₂ mean/min, 125Hz | 支气管扩张剂Bronchodilators | 基础血氧Baseline SpO₂ |
| 6 | 光学监测Optical Monitoring | 组织氧合Tissue Oxygenation | 850/940/1050nm, 125Hz | 血管扩张剂Vasodilators | 多波长组织氧Multi-wavelength tissue oxygen |
| 7 | 光学监测Optical Monitoring | 夜间氧合稳定性Nocturnal Oxygen Stability | 夜间8-10h, 125HzNight 8-10h, 125Hz | 支气管扩张剂Bronchodilators | 连续PPG血氧Continuous PPG SpO₂ |
| 8 | 电生理监测Electrophysiological Monitoring | HRV昼夜节律HRV Circadian Rhythm | ECG 500Hz, LF/HF/SDNN | RAAS/β阻滞剂RAAS/β-blockers | 自主神经核心Autonomic core |
| 9 | 电生理监测Electrophysiological Monitoring | 压力反射敏感性BRSBaroreflex Sensitivity BRS | ECG+PPG同步, 事件触发ECG+PPG sync, event-triggered | RAAS/β阻滞剂RAAS/β-blockers | 专利双模态Patented bimodal |
| 10 | 电生理监测Electrophysiological Monitoring | 心率‑皮肤电导耦联Heart Rate–Skin Conductance Coupling | ECG+EDA, 500/250Hz | 胰岛素/抗抑郁Insulin/Antidepressants | 专利异构传感器Patented heterogeneous sensor |
完整68项指标清单：45项认证（含多模态融合、预警预测、依从性、替代有创等） + 23项不纳入（温度/运动/音频，硬件永久关闭）Full 68-item indicator list: 45 certified (multimodal fusion, alert/prediction, compliance, invasive-alternative, etc.) + 23 excluded (temperature/motion/audio, hardware permanently disabled)
ECG 心电ECG (Electrocardiogram)PPG 光学 (8波长)PPG Optical (8-wavelength)EDA 皮肤电EDA (Electrodermal Activity)
温度 7项Temperature 7 items运动/震颤 15项Motion/Tremor 15 items音频 1项Audio 1 item
3. 元器件标准 · 电气性能3. Component Standards · Electrical Performance
关键元器件 & 标准Key Components & Standards
- 主控 MCUMain MCUARM Cortex‑M4, 180MHz
- ECG 前端ECG Front EndADS1292 (TI) , 500Hz‑1000Hz
- PPG 光学PPG Optical8波长 LED + 光电二极管, 250Hz8-wavelength LED + photodiode, 250Hz
- EDA 模块EDA ModuleAFE4300, 双电极恒压AFE4300, dual-electrode constant voltage
- 温度传感器Temperature SensorNTC 3路 (±0.1°C) 仅调试NTC 3-channel (±0.1°C) tuning only
- USB/PDUSB/PDUSB‑C 2.0, PD 3.0 充电USB‑C 2.0, PD 3.0 charging
- 显示屏Display0.96” OLED 128×64
电气 & 性能指标Electrical & Performance Indicators
- 供电电压Supply Voltage3.3V ~ 4.2V (电池)3.3V ~ 4.2V (battery)
- ECG 输入范围ECG Input Range±1.5V, 共模抑制比 >100dB±1.5V, CMRR >100dB
- PPG 波长精度PPG Wavelength Accuracy±2nm, 采样率 125/250Hz±2nm, sampling rate 125/250Hz
- EDA 激励EDA Excitation0.5V, 10Hz 正弦, 精度±5%0.5V, 10Hz sine, accuracy ±5%
- 蓝牙BluetoothBLE 5.2, 2.4GHz
- 存储Storage8GB eMMC (原始波形)8GB eMMC (raw waveforms)
- 绝缘/耐压Insulation/Withstand VoltageBF型, 4000V 介电强度Type BF, 4000V dielectric strength
4. 检验方法 & 判定标准4. Test Methods & Acceptance Criteria
检验方法 (摘要)Test Methods (Summary)
• ECG性能ECG Performance：FLUKE PS‑420 模拟器，100µV/1mV 方波，误差≤±5% ；频率响应 0.05‑150Hz。: FLUKE PS‑420 simulator, 100µV/1mV square wave, error ≤±5%; frequency response 0.05‑150Hz.
• PPG血氧PPG SpO₂：模拟手指 (波长校验) ，SpO₂ 70%‑100% 误差≤±2% ；灌注指数测试。: Simulated finger (wavelength calibration), SpO₂ 70%‑100% error ≤±2%; perfusion index test.
• EDA皮肤电EDA Galvanic Skin Response：精密电阻箱 (10kΩ‑1MΩ) ，恒压模式，线性度>0.98。: Precision resistance box (10kΩ‑1MΩ), constant-voltage mode, linearity >0.98.
• 温度采集Temperature Acquisition (仅调试) ：恒温水槽 25°C‑45°C，误差≤±0.2°C (不用于医用) 。 (Tuning only): thermostatic bath 25°C‑45°C, error ≤±0.2°C (not for medical use).
• 整机安全Device Safety：GB 9706.1‑2020, 漏电流≤100µA, 介电强度 4000V。: GB 9706.1‑2020, leakage current ≤100µA, dielectric strength 4000V.
• ECG性能ECG Performance：FLUKE PS‑420 模拟器，100µV/1mV 方波，误差≤±5% ；频率响应 0.05‑150Hz。: FLUKE PS‑420 simulator, 100µV/1mV square wave, error ≤±5%; frequency response 0.05‑150Hz.
• PPG血氧PPG SpO₂：模拟手指 (波长校验) ，SpO₂ 70%‑100% 误差≤±2% ；灌注指数测试。: Simulated finger (wavelength calibration), SpO₂ 70%‑100% error ≤±2%; perfusion index test.
• EDA皮肤电EDA Galvanic Skin Response：精密电阻箱 (10kΩ‑1MΩ) ，恒压模式，线性度>0.98。: Precision resistance box (10kΩ‑1MΩ), constant-voltage mode, linearity >0.98.
• 温度采集Temperature Acquisition (仅调试) ：恒温水槽 25°C‑45°C，误差≤±0.2°C (不用于医用) 。 (Tuning only): thermostatic bath 25°C‑45°C, error ≤±0.2°C (not for medical use).
• 整机安全Device Safety：GB 9706.1‑2020, 漏电流≤100µA, 介电强度 4000V。: GB 9706.1‑2020, leakage current ≤100µA, dielectric strength 4000V.
判定标准Acceptance Criteria
• 全部医用指标 (ECG/PPG/EDA) 需满足AAMI/ISO 80601‑2‑61, 80601‑2‑30 及产品技术要求附录A。All medical indicators (ECG/PPG/EDA) shall meet AAMI/ISO 80601‑2‑61, 80601‑2‑30 and Appendix A of Technical Requirements.
• 电气安全：符合GB 9706.1‑2020, 电磁兼容 YY 9706.102‑2021。Electrical safety: complies with GB 9706.1‑2020; EMC: YY 9706.102‑2021.
• 软件验证：数据完整性、预警阈值 (低血糖/出血/COPD等) 经临床模拟验证，误报率＜5%。Software verification: data integrity and alert thresholds (hypoglycemia/bleeding/COPD, etc.) validated by clinical simulation, false alarm rate <5%.
• 整机环境：温度 10°C‑40°C, 湿度 30%‑75% 无凝结。Device environment: temperature 10°C‑40°C, humidity 30%‑75% non-condensing.
• 全部医用指标 (ECG/PPG/EDA) 需满足AAMI/ISO 80601‑2‑61, 80601‑2‑30 及产品技术要求附录A。All medical indicators (ECG/PPG/EDA) shall meet AAMI/ISO 80601‑2‑61, 80601‑2‑30 and Appendix A of Technical Requirements.
• 电气安全：符合GB 9706.1‑2020, 电磁兼容 YY 9706.102‑2021。Electrical safety: complies with GB 9706.1‑2020; EMC: YY 9706.102‑2021.
• 软件验证：数据完整性、预警阈值 (低血糖/出血/COPD等) 经临床模拟验证，误报率＜5%。Software verification: data integrity and alert thresholds (hypoglycemia/bleeding/COPD, etc.) validated by clinical simulation, false alarm rate <5%.
• 整机环境：温度 10°C‑40°C, 湿度 30%‑75% 无凝结。Device environment: temperature 10°C‑40°C, humidity 30%‑75% non-condensing.
主板元器件Mainboard Components 主控 · USB (充电/U盘) · 2×PD · 电池 · ECG/EDA按键MCU · USB (Charge/USB drive) · 2×PD · Battery · ECG/EDA Key
温度采集Temperature Acquisition 3路 NTC (仅调试，固件关闭)3-channel NTC (tuning only, firmware disabled)
LED阵列LED Array 8波长: 525/660/850/940/1050/1300/1550/1650nm8 wavelengths: 525/660/850/940/1050/1300/1550/1650nm
整机含4个ECG/EDA电极 (共用) ，3个温度采集点 (手指上/下/尖) ，硅胶包覆，IP22。Device includes 4 shared ECG/EDA electrodes, 3 temperature acquisition points (upper/lower/fingertip), silicone covered, IP22.
📖 产品说明书 · 样稿Instructions for Use · Sample
SY‑F100 指套式多模态生理监测设备 · 二类创新医疗器械Finger-sleeve Multimodal Monitor · Class II Innovative Device
ECG · PPG · EDA · 仅医用三模态Medical-grade Three-modalities Only
版本 1.1 · 2026-06Version 1.1 · 2026-06
1. 预期用途 & 禁忌症1. Intended Use & Contraindications
预期用途Intended Use
SY‑F100 指套式设备用于连续或间歇采集成人患者的 The SY‑F100 finger‑sleeve device is used for continuous or intermittent acquisition of 心电 (ECG)electrocardiogram (ECG)、多波长光电容积脉搏波 (PPG)multi‑wavelength photoplethysmogram (PPG) 及 and 皮肤电活动 (EDA)electrodermal activity (EDA) 信号，供专业医护人员或经培训的用户在家庭及临床环境中进行生理监测。设备提供心率、血氧趋势、HRV、皮肤电导等参数，辅助评估自主神经功能、血流动力学及药物效应，不替代诊断。 signals in adult patients, for physiological monitoring by professional healthcare personnel or trained users in home and clinical environments. The device provides parameters such as heart rate, blood oxygen trend, HRV, and skin conductance to assist in assessing autonomic function, hemodynamics, and drug effects; it does not replace diagnosis.
禁忌症Contraindications
- · 已知对硅胶或电极材料过敏者Individuals with known allergy to silicone or electrode materials
- · 佩戴部位有破损、感染或严重皮炎Broken skin, infection, or severe dermatitis at the wearing site
- · 植入式心脏起搏器或除颤器患者 (ECG信号可能受干扰)Patients with implanted pacemakers or defibrillators (ECG signals may be interfered)
- · 严重凝血功能障碍或出血倾向 (指套压力风险)Severe coagulation disorders or bleeding tendency (risk from finger‑sleeve pressure)
- · 不可用于MRI环境Not for use in MRI environments
2. 操作步骤2. Operation Steps
- 充电Charging — 使用配套USB‑C充电器 (5V/1A) ，充电时OLED显示电量，充满约2小时。 — Use the supplied USB‑C charger (5V/1A); the OLED shows battery level while charging, and a full charge takes about 2 hours.
- 佩戴Wearing — 将指套佩戴于左手食指或中指，确保下部分8个LED窗口紧贴指腹，上部分电极与指背接触。 — Wear the finger sleeve on the left index or middle finger, ensuring that the 8 LED windows on the lower part are close to the fingertip pad and the electrodes on the upper part contact the back of the finger.
- 开机Power On — 长按触摸按键 (面板) 3秒，OLED亮起，设备自动进入待测模式。 — Press and hold the touch button (panel) for 3 seconds; the OLED lights up and the device automatically enters ready‑to‑measure mode.
- 连接APP/数据Connect App / Data — 通过BLE 5.2与配套移动应用配对，或通过USB‑C连接PC (U盘模式) 读取原始数据。 — Pair with the companion mobile app via BLE 5.2, or connect to a PC via USB‑C (USB mass‑storage mode) to read raw data.
- 开始监测Start Monitoring — 在APP或设备端选择“连续监测”或“事件模式”，设备自动采集ECG/PPG/EDA数据。 — Select "Continuous Monitoring" or "Event Mode" in the app or on the device; the device automatically acquires ECG/PPG/EDA data.
- 结束 & 数据导出End & Data Export — 长按按键关机，数据自动保存至内置存储；可通过USB或蓝牙导出。 — Press and hold the button to power off; data are automatically saved to internal storage and can be exported via USB or Bluetooth.
3. 警示 & 注意事项3. Warnings & Precautions
通用警示General Warnings
· 本设备非急救设备，出现严重不适请立即就医。This device is not intended for emergency use; seek immediate medical attention if severe discomfort occurs.
· 设备仅用于生理参数采集，临床判读须由专业医护进行。The device is only for physiological parameter acquisition; clinical interpretation must be performed by professional healthcare personnel.
· 避免在强电磁干扰源 (如微波炉、高频手术设备) 附近使用。Avoid use near strong electromagnetic interference sources (e.g., microwave ovens, high‑frequency surgical equipment).
· 每次使用前检查电极/硅胶完整性，如有破损请勿使用。Check electrode/silicone integrity before each use; do not use if damaged.
· 本设备非急救设备，出现严重不适请立即就医。This device is not intended for emergency use; seek immediate medical attention if severe discomfort occurs.
· 设备仅用于生理参数采集，临床判读须由专业医护进行。The device is only for physiological parameter acquisition; clinical interpretation must be performed by professional healthcare personnel.
· 避免在强电磁干扰源 (如微波炉、高频手术设备) 附近使用。Avoid use near strong electromagnetic interference sources (e.g., microwave ovens, high‑frequency surgical equipment).
· 每次使用前检查电极/硅胶完整性，如有破损请勿使用。Check electrode/silicone integrity before each use; do not use if damaged.
电池 & 维护Battery & Maintenance
内置锂聚合物电池，不可拆卸。若长期不使用，建议每3个月充电至50%存放。清洁时使用软布蘸取75%酒精擦拭硅胶及电极，禁止浸泡。Built-in lithium-polymer battery, non-removable. If not used for a long time, it is recommended to charge to 50% every 3 months for storage. When cleaning, wipe the silicone and electrodes with a soft cloth dampened with 75% alcohol; do not immerse.
内置锂聚合物电池，不可拆卸。若长期不使用，建议每3个月充电至50%存放。清洁时使用软布蘸取75%酒精擦拭硅胶及电极，禁止浸泡。Built-in lithium-polymer battery, non-removable. If not used for a long time, it is recommended to charge to 50% every 3 months for storage. When cleaning, wipe the silicone and electrodes with a soft cloth dampened with 75% alcohol; do not immerse.
4. 医用与非医用硬件说明4. Medical & Non-medical Hardware Description
医用功能Medical Functions ECG · PPG (8波长) · EDA · 主控 · OLED ECG · PPG (8 wavelengths) · EDA · main control · OLED
调试预留Debug Reserved 温度传感器 (3路) · 六轴IMU · 振动激励 · 音频MIC Temperature sensor (3 channels) · 6-axis IMU · vibration actuator · audio MIC
重要说明：Important Note:设备内置的温度、六轴IMU、振动及音频采集硬件仅为PCB调试预留组件，The temperature, 6-axis IMU, vibration, and audio acquisition hardware built into the device are reserved components for PCB debugging only; 出厂固件已永久关闭the factory firmware has permanently disabled上述模块的采集、运算及输出功能。这些硬件不参与任何医疗监测、诊断或治疗，不属于本医疗器械预期用途。产品标签及说明书已明确区分，不宣传任何基于上述模块的医疗功效。the acquisition, processing, and output functions of the above modules. These hardware components are not involved in any medical monitoring, diagnosis, or treatment and do not belong to the intended use of this medical device. The product label and instructions for use clearly distinguish them, and no medical efficacy based on the above modules is claimed.
5. 最小销售单元标签 (样稿)5. Minimum Sales Unit Label (Sample)
VitalinkDX
SY‑F100 指套式多模态生理监测设备SY‑F100 Finger-sleeve Multimodal Physiological Monitor
91450300MAK2F9NT5W · ECG/PPG/EDA 二类91450300MAK2F9NT5W · ECG/PPG/EDA Class II
内含: 指套主机 ×1 · USB线 ×1 · 充电器 ×1 · 快速指南Contents: Finger-sleeve main unit ×1 · USB cable ×1 · Charger ×1 · Quick guide
SN: SYF100‑2406XXX 生产日期 2026‑06Mfg. Date 2026‑06
标签明确标注“仅ECG/PPG/EDA医用功能”，温度/IMU/振动/音频为调试硬件，无诊疗用途。The label clearly states "ECG/PPG/EDA medical functions only"; temperature/IMU/vibration/audio are debug hardware with no diagnostic or therapeutic purpose.
6. 维护 & 存储6. Maintenance & Storage
清洁与维护Cleaning & Maintenance
- · 使用软布蘸取70%异丙醇或中性清洁剂擦拭表面。Wipe the surface with a soft cloth dampened with 70% isopropyl alcohol or neutral detergent.
- · 禁止使用研磨剂、有机溶剂或高压水流。Do not use abrasives, organic solvents, or high-pressure water streams.
- · 电极及硅胶部分建议每周清洁一次。It is recommended to clean the electrodes and silicone parts once a week.
存储条件Storage Conditions
- · 温度: -10°C ~ 50°CTemperature: -10°C ~ 50°C
- · 湿度: 30% ~ 75% 无凝结Humidity: 30% ~ 75% non-condensing
- · 避免阳光直射及强磁场Avoid direct sunlight and strong magnetic fields
📋 产品综述资料Product Overview Materials
SY‑F100 指套式多模态生理监测设备 · 二类创新医疗器械Finger-sleeve Multimodal Monitor · Class II Innovative Device
ECG · PPG (8波长)(8 Wavelengths) · EDA · 三层异构架构Three-layer Heterogeneous Architecture
版本 2.0 · 2026-06Version 2.0 · 2026-06
1. 产品概述1. Product Overview
SY‑F100 是一款指套式多模态生理监测设备，集成is a finger-sleeve multimodal physiological monitoring device integrating ECG心电ECG、, 多波长PPG光学Multi-wavelength PPG Optics (8个LED) 及(8 LEDs) and EDA皮肤电EDA Galvanic Skin Response 三模态同步采集。设备基于three-modal synchronous acquisition. The device is built on 45项二类创新认证技术点45 Class-II innovative certification technical points，涵盖血流动力学、自主神经、药物依从性及预警预测等核心医用指标。整机采用医用级硅胶与柔性电极，适用于家庭及临床连续监测。, covering core medical indicators such as hemodynamics, autonomic nervous function, medication adherence, and early warning/prediction. The device uses medical-grade silicone and flexible electrodes for continuous monitoring at home and in clinical settings.
二类创新医疗器械Class II Innovative Medical Device
8波长 PPG (525~1650nm)8-Wavelength PPG (525~1650nm)
ECG 500Hz/1000Hz
EDA 10Hz 恒压激励EDA 10Hz Constant-Voltage Excitation
2. 结构组成 & 整机三层架构2. Structure & Three-layer Architecture
结构组成Structure Composition
- 面板Face Panel：OLED显示屏 · 触摸按键 · ECG/EDA电极 · MIC孔 · 温度采集: OLED Display · Touch Buttons · ECG/EDA Electrodes · MIC Port · Temperature Acquisition
- 主体 (主板)Main Body (Mainboard)：主控 · USB (充电/U盘) · 2×PD · 电池 · ECG/EDA按键: Main Controller · USB (Charging/USB Drive) · 2×PD · Battery · ECG/EDA Buttons
- 上接触Upper Contact：硅胶 · ECG/EDA电极 · 温度采集: Silicone · ECG/EDA Electrodes · Temperature Acquisition
- 下接触Lower Contact：硅胶 · ECG/EDA电极 · 8个LED (多波长PPG): Silicone · ECG/EDA Electrodes · 8 LEDs (Multi-wavelength PPG)
- 指尖Fingertip：ECG/EDA按键 · 温度采集: ECG/EDA Buttons · Temperature Acquisition
- 4×ECG/EDA电极 · 3×温度 (调试)4×ECG/EDA Electrodes · 3×Temperature (Debug)
应用层 (APP/云端)Application Layer (APP/Cloud)
BLE 5.2 · 数据可视化 · 预警推送BLE 5.2 · Data Visualization · Alert Push核心算法层 (固件)Core Algorithm Layer (Firmware)
ECG/PPG/EDA 同步采集 · 45项指标 · 专利融合ECG/PPG/EDA Synchronous Acquisition · 45 Metrics · Patent Fusion硬件传感层Hardware Sensing Layer
8波长LED · ECG前端 · EDA · 硅胶电极8-Wavelength LED · ECG Front End · EDA · Silicone Electrodes 3. 核心专利工作原理3. Core Patent Working Principle
专利核心 · 三模态同步Patent Core · Tri-modal Synchronization
ECG+PPG+EDA 异构传感器同步架构ECG+PPG+EDA Heterogeneous Sensor Synchronization Architecture：设备通过: The device uses 4个共用电极4 shared electrodes 同时采集心电 (ECG) 和皮肤电 (EDA)，并利用to simultaneously acquire ECG and EDA signals, and uses 8波长LED8-wavelength LED 同步获取光电容积脉搏波 (PPG)。三模态数据在时域上严格对齐，实现to synchronously obtain photoplethysmography (PPG). The three-modal data are strictly aligned in the time domain, enabling 压力反射敏感性 (BRS)Baroreflex Sensitivity (BRS)、, 心率-皮肤电导耦联Heart Rate–Skin Conductance Coupling 及and 药物生理指纹Drug Physiological Fingerprint 等专利核心指标。温度、IMU、振动模块仅作调试预留，不参与医用计算。and other patent core metrics. Temperature, IMU, and vibration modules are reserved for debugging only and do not participate in medical calculations.
专利号: CN2024XXXXXXPatent No.: CN2024XXXXXX
同步精度 < 1msSynchronization Accuracy < 1ms
8波长 PPG 血流分析8-Wavelength PPG Blood Flow Analysis
4. 预期用途 · 适用人群 · 禁忌症4. Intended Use · Target Population · Contraindications
预期用途Intended Use
连续或间歇采集ECG、PPG、EDA信号，用于自主神经功能、血流动力学、药物效应评估及预警 (低血糖/出血/COPD等)。辅助临床决策，不替代诊断。Continuously or intermittently acquire ECG, PPG, and EDA signals for autonomic function, hemodynamics, drug effect evaluation, and early warning (hypoglycemia/bleeding/COPD, etc.). Aids clinical decision-making; not a substitute for diagnosis.
适用人群Target Population
- · 心血管疾病患者 (高血压、心衰)· Cardiovascular disease patients (hypertension, heart failure)
- · 代谢性疾病 (糖尿病、肥胖)· Metabolic diseases (diabetes, obesity)
- · 自主神经功能紊乱、焦虑/抑郁· Autonomic dysfunction, anxiety/depression
- · 药物疗效监测 (抗凝、降压、GLP‑1)· Drug efficacy monitoring (anticoagulation, blood pressure lowering, GLP‑1)
禁忌症Contraindications
- · 对硅胶/电极过敏· Allergy to silicone/electrodes
- · 佩戴部位破损/感染· Broken/infected wearing site
- · 植入式起搏器/除颤器· Implanted pacemaker/defibrillator
- · 严重凝血障碍· Severe coagulation disorder
- · MRI环境· MRI environment
5. 整机创新概述5. Device Innovation Overview
三模态异构融合Tri-modal Heterogeneous Fusion
ECG+PPG+EDA 同步，专利时序对齐ECG+PPG+EDA synchronization with patent time-series alignment8波长 PPG 光学8-Wavelength PPG Optics
525~1650nm，Hb/水合/灌注多维评估525~1650nm, Hb/Hydration/Perfusion Multi-dimensional Assessment45项认证指标45 Certified Metrics
含预警预测、依从性、替代有创等Including early warning, adherence, invasive-alternative, etc.医用/调试硬件分离Medical/Debug Hardware Separation
温度/IMU/振动/音频固件永久关闭Temperature/IMU/Vibration/Audio Firmware Permanently Disabled 6. 附件 · 样机 / 硬件图纸 / 软件截图6. Attachments · Prototype / Hardware Drawings / Software Screenshots
样机实拍 (指套)Prototype Photo (Finger Sleeve)
SY‑F100 佩戴示意SY‑F100 Wearing Diagram
硬件PCB图纸Hardware PCB Drawings
主板布局 · 8LED · ECG前端Mainboard Layout · 8LED · ECG Front End
APP 截图APP Screenshots
实时波形 · HRV · 预警Real-time Waveform · HRV · Alerts
3D结构图3D Structure Diagram
三层架构 · 电极布局Three-layer Architecture · Electrode Layout
原始数据示例Raw Data Sample
ECG+PPG+EDA 同步ECG+PPG+EDA Synchronization
完整附件包 (PDF/STEP/APP录屏) 随注册资料提交Full attachment package (PDF/STEP/APP screen recording) submitted with registration materials
VitaLink Pharma 21大药物评估超值应用21 Major High-Value Drug Evaluation Applications of VitaLink Pharma
基于VitaCore平台的21类药物评估能力，为制药企业提供超越传统评估维度的深度洞察，加速药物研发与价值验证Leveraging the 21-category drug evaluation capability of the VitaCore platform to provide pharmaceutical companies with in-depth insights beyond traditional evaluation dimensions, accelerating drug R&D and value validation
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21大超值应用21 Premium Applications
这些应用不仅提供疗效数据，更能揭示药物作用机制、预测长期预后、实现个体化治疗，为药物提供独特的临床价值主张These applications not only provide efficacy data, but also reveal drug mechanisms, predict long-term prognosis, and enable personalized therapy, delivering unique clinical value propositions.
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1. 利尿剂1. Diuretics
袢利尿剂、噻嗪类、保钾利尿剂Loop diuretics, thiazides, potassium-sparing diuretics
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 容量状态Volume Status | 体重、水肿临床检查（滞后）Body weight, edema clinical exam (delayed) | 组织水合动态连续监测（提前1-2h预警）Continuous tissue hydration monitoring (1-2h early warning) |
| 电解质平衡Electrolyte Balance | 血电解质检查（间歇）Blood electrolyte testing (intermittent) | 电解质紊乱早期预警（自主神经兴奋性监测）Early warning of electrolyte disorders (autonomic excitability monitoring) |
| 血流动力学Hemodynamics | 血压、肾功能（单点）Blood pressure, renal function (single-point) | 循环状态综合评估（肾灌注+全身循环平衡）Integrated circulatory assessment (renal perfusion + systemic circulation balance) |
核心临床意义Core Clinical Significance
容量状态精准导航，在体重变化前1-2h检测利尿反应，区分有效利尿与利尿剂抵抗。Precise volume navigation: detect diuretic response 1-2h before body-weight changes and distinguish effective diuresis from diuretic resistance. 为急性心衰患者提供ICU级别容量监测能力，同时规避有创风险。Provides ICU-grade volume monitoring for acute heart-failure patients while avoiding invasive risks.
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2. RAAS抑制剂2. RAAS Inhibitors
ARB/ACEI (氯沙坦、赖诺普利、缬沙坦等)ARB/ACEI (losartan, lisinopril, valsartan, etc.)
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 血压控制Blood Pressure Control | 诊室/家庭血压计（单点测量）Office/home sphygmomanometer (single-point measurement) | 24小时血压全景图（昼夜节律+血压变异性）24-hour blood-pressure panorama (circadian rhythm + BPV) |
| 血管健康Vascular Health | 无法常规评估Not routinely assessable | 动脉僵硬度连续追踪（脉搏波传导速度动态变化）Continuous arterial stiffness tracking (dynamic PWV changes) |
| 神经调节Neuroregulation | 无常规评估No routine assessment | 压力反射敏感性优化（自主神经平衡指数改善）Optimized baroreflex sensitivity (improved autonomic balance index) |
核心临床意义Core Clinical Significance
区分“仅降压”与“降压且改善血管功能”的治疗。Distinguishes treatment that merely lowers blood pressure from treatment that also improves vascular function. 在心血管事件发生前数年即提供靶器官保护的客观证据，为药物差异化定价和临床优选提供科学依据。Provides objective evidence of target-organ protection years before cardiovascular events occur, supporting differentiated pricing and clinical preference.
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3. 钙通道阻滞剂3. Calcium Channel Blockers
硝苯地平、氨氯地平、非洛地平等Nifedipine, amlodipine, felodipine, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 血压控制质量Blood Pressure Control Quality | 平均血压值Average blood pressure value | 24小时平滑指数+血压变异性24-hour smoothness index + BPV |
| 晨峰血压Morning BP Surge | 难以捕捉Difficult to capture | 晨峰血压动态监测（清晨6-10点连续追踪）Dynamic morning-surge monitoring (continuous tracking 6-10 a.m.) |
| 血管舒缩功能Vascular Vasomotor Function | 无法常规评估Not routinely assessable | 外周血管阻力动态（血管舒缩节律分析）Dynamic peripheral vascular resistance (vasomotor rhythm analysis) |
核心临床意义Core Clinical Significance
将高血压评估从“降压达标”升级为“血压质量管控”。Upgrades hypertension assessment from “reaching BP targets” to “blood-pressure quality management.” 晨峰血压控制、夜间节律恢复、血管弹性改善——这些是真正决定患者长期预后的核心指标。Morning-surge control, nocturnal rhythm recovery, and improved vascular elasticity—these are the core determinants of long-term patient prognosis.
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4. β受体阻滞剂4. Beta Blockers
美托洛尔、比索洛尔、卡维地洛等Metoprolol, bisoprolol, carvedilol, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 心率控制Heart Rate Control | 静息心率单点测量Single-point resting heart-rate measurement | 24小时心率分布图谱+运动-心率响应曲线24-hour heart-rate distribution map + exercise-heart-rate response curve |
| 自主神经平衡Autonomic Balance | 无法常规评估Not routinely assessable | 心率变异性昼夜节律重塑（交感-迷走平衡）Circadian HRV remodeling (sympathetic-vagal balance) |
| 运动耐量Exercise Tolerance | 运动试验（门诊单次）Exercise test (single outpatient session) | 真实世界活动耐力（活动-心率耦合效率）Real-world activity endurance (activity-heart-rate coupling efficiency) |
核心临床意义Core Clinical Significance
从“单纯降心率”升级为“优化心率-活动-自主神经平衡”。Upgrades from “simply lowering heart rate” to “optimizing heart-rate-activity-autonomic balance.” 识别β阻滞剂对心衰患者的真正获益——交感-迷走平衡的重塑，而非简单的心率压制。Identifies the true benefit of beta blockers in heart-failure patients—remodeling of sympathetic-vagal balance rather than simple heart-rate suppression.
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5. 血管扩张剂5. Vasodilators
硝酸酯类、硝普钠、肼屈嗪等Nitrates, sodium nitroprusside, hydralazine, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 血管阻力Vascular Resistance | 有创血流动力学（ICU专属）Invasive hemodynamics (ICU only) | 外周血管阻力连续追踪（基于PPG波形）Continuous peripheral vascular-resistance tracking (based on PPG waveform) |
| 微循环灌注Microcirculatory Perfusion | 毛细血管镜、乳酸（定性或采血）Capillaroscopy, lactate (qualitative or blood sampling) | 微循环灌注指数动态（多波长PPG组织灌注分析）Dynamic microcirculatory perfusion index (multi-wavelength PPG tissue-perfusion analysis) |
| 反射性激活Reflex Activation | 心率监测（片面）Heart-rate monitoring (one-sided) | 交感-血管耦联分析（代偿阈值预警系统）Sympathetic-vascular coupling analysis (compensatory-threshold early-warning system) |
核心临床意义Core Clinical Significance
将血管活性药物评估从ICU有创监测扩展至普通病房。Expands vasoactive-drug assessment from ICU invasive monitoring to general wards. 在组织损伤发生前预警灌注不足，实现从“血压导向”到“灌注导向”的治疗范式跃迁。Warns of hypoperfusion before tissue injury occurs, enabling a paradigm shift from “pressure-guided” to “perfusion-guided” therapy.
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6. 抗心律失常药6. Antiarrhythmic Drugs
胺碘酮、普罗帕酮、索他洛尔等Amiodarone, propafenone, sotalol, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 心律失常负荷Arrhythmia Burden | 动态心电图（24-48小时）Holter ECG (24-48 hours) | 连续7-14天心电监测+心律失常负荷趋势Continuous 7-14-day ECG monitoring + arrhythmia-burden trends |
| 心电稳定性ECG Stability | QT间期（单次测量）QT interval (single measurement) | QT间期动态与离散度+T波交替幅度追踪Dynamic QT interval and dispersion + T-wave alternans tracking |
| 致心律失常风险Proarrhythmic Risk | 发生严重事件后回顾Retrospective review after serious events | 尖端扭转型室速前兆模式识别+QT-心率关系异常预警Torsades-de-pointes precursor pattern recognition + abnormal QT-heart-rate relation warning |
核心临床意义Core Clinical Significance
在严重心律失常事件发生前预警，在致心律失常副作用出现前停药。Warns before serious arrhythmic events and enables drug discontinuation before proarrhythmic side effects appear. 让这类“高风险-高获益”药物的使用更安全、更精准。Makes the use of these “high-risk-high-benefit” drugs safer and more precise.
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7. 抗凝/抗血小板药7. Anticoagulant/Antiplatelet Drugs
华法林、阿司匹林、氯吡格雷、利伐沙班等Warfarin, aspirin, clopidogrel, rivaroxaban, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 出血风险Bleeding Risk | INR检测（每周/月）INR testing (weekly/monthly) | 微出血事件连续监测（组织微循环状态异常检测）Continuous micro-bleeding monitoring (abnormal tissue microcirculation detection) |
| 凝血稳态Coagulation Homeostasis | 单点凝血指标Single-point coagulation indices | 凝血稳态指数+昼夜节律分析Coagulation homeostasis index + circadian-rhythm analysis |
| 用药依从性Medication Adherence | 患者自述、药片计数Patient report, pill count | 药物生理指纹识别（服药后特定生理信号变化）Drug physiological fingerprinting (specific physiological signal changes after dosing) |
核心临床意义Core Clinical Significance
在严重出血事件前数天预警，让抗凝治疗实现真正的“安全窗口”动态管理。Warns days before serious bleeding events, enabling true dynamic “safety-window” management of anticoagulation. 微出血预警系统让医生在严重出血事件发生前及时调整剂量。The micro-bleeding early-warning system lets clinicians adjust doses before serious bleeding occurs.
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8. SGLT2抑制剂8. SGLT2 Inhibitors
达格列净、恩格列净、卡格列净等Dapagliflozin, empagliflozin, canagliflozin, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 容量状态Volume Status | 体重、尿量（粗略、滞后）Body weight, urine output (rough, delayed) | 组织水合动态+夜间排尿模式分析Tissue hydration dynamics + nocturnal voiding pattern analysis |
| 代谢改善Metabolic Improvement | HbA1c（3个月/次）HbA1c (every 3 months) | 水合-代谢耦合指数+基础代谢率趋势Hydration-metabolism coupling index + basal metabolic rate trend |
| 血管健康Vascular Health | 无法常规评估Not routinely assessable | 动脉僵硬度动态+血管内皮功能指数+血压节律重塑Arterial stiffness dynamics + vascular endothelial function index + blood pressure rhythm remodeling |
核心临床意义Core Clinical Significance
首次实现容量-代谢-血管三重效应同步量化评估。For the first time, simultaneous quantitative assessment of volume-metabolism-vascular triple effects. 揭示SGLT2抑制剂真实作用机制，为心衰、糖尿病、CKD患者提供全景式治疗监测。Revealing the true mechanism of SGLT2 inhibitors and providing panoramic therapeutic monitoring for patients with heart failure, diabetes, and CKD.
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9. GLP-1受体激动剂9. GLP-1 Receptor Agonists
司美格鲁肽、利拉鲁肽、度拉糖肽等Semaglutide, liraglutide, dulaglutide, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 胃排空功能Gastric Emptying Function | 胃排空闪烁扫描（复杂、昂贵）Gastric emptying scintigraphy (complex, expensive) | 餐后血流再分布模式+胃排空速度指数Postprandial blood flow redistribution pattern + gastric emptying velocity index |
| 自主神经调节Autonomic Regulation | 无法常规评估Not routinely assessable | 迷走神经活性动态+胃-脑轴功能指数Vagal activity dynamics + gut-brain axis function index |
| 食欲调控Appetite Regulation | 主观食欲评分Subjective appetite score | 进食行为生理标记+饱腹感持续时间量化Physiological markers of eating behavior + satiety duration quantification |
核心临床意义Core Clinical Significance
首次实现GLP-1药物对胃肠道-自主神经-中枢轴作用的连续、无创监测。First continuous, non-invasive monitoring of GLP-1 drug effects on the gastrointestinal-autonomic-central axis. 从主观的“食欲感受”到客观的“餐后生理反应”，为肥胖症和糖尿病的精准治疗提供全新评估工具。From subjective "appetite perception" to objective "postprandial physiological response," providing a novel assessment tool for precision treatment of obesity and diabetes.
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10. 胰岛素10. Insulin
各类胰岛素制剂Various insulin preparations
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 低血糖风险Hypoglycemia Risk | 血糖仪（点刺、间断）Glucometer (fingerstick, intermittent) | 低血糖早期预警系统（提前15-30分钟预警）Early hypoglycemia warning system (15–30 min advance warning) |
| 胰岛素敏感性Insulin Sensitivity | HOMA-IR（采血）HOMA-IR (blood draw) | 胰岛素敏感性动态指数（每日追踪）Dynamic insulin sensitivity index (daily tracking) |
| 血糖控制质量Glycemic Control Quality | 糖化血红蛋白（3个月平均）Glycated hemoglobin (3-month average) | 血糖稳定性全景（波动幅度+夜间谷值分析）Panoramic glycemic stability (fluctuation amplitude + nocturnal nadir analysis) |
核心临床意义Core Clinical Significance
将糖尿病管理从“血糖监测”升级为“低血糖风险主动防控+胰岛素敏感性动态追踪”。Upgrading diabetes management from "glucose monitoring" to "proactive hypoglycemia risk prevention + dynamic insulin sensitivity tracking." 在低血糖发生前采取行动，真正实现“安全降糖”。Take action before hypoglycemia occurs, truly achieving "safe glucose lowering."
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11. 甲状腺激素11. Thyroid Hormones
左甲状腺素、碘塞罗宁等Levothyroxine, liothyronine, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 代谢状态Metabolic Status | 甲状腺功能血检（仅反映激素水平）Thyroid function blood test (reflects hormone levels only) | 基础代谢率精准调校（结合体温与静息血流）Precise basal metabolic rate calibration (combining body temperature and resting blood flow) |
| 血管舒缩症状Vasomotor Symptoms | 患者症状日记（主观，不精确）Patient symptom diary (subjective, imprecise) | 血管舒缩症状客观量化（潮热的频率/强度）Objective quantification of vasomotor symptoms (frequency/intensity of hot flashes) |
| 治疗目标Treatment Goal | 实验室指标正常化Laboratory index normalization | 生理功能与感受最优化Optimization of physiological function and well-being |
核心临床意义Core Clinical Significance
将治疗目标从“激素水平正常化”提升到“生理功能与感受最优化”。Elevating treatment goals from "hormone level normalization" to "optimization of physiological function and well-being." 实现真正的个体化精准剂量，解决“指标正常但症状仍在”的临床困境。Achieving true individualized precision dosing and resolving the clinical dilemma of "normal indices but symptoms persist."
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12. 抗抑郁药12. Antidepressants
SSRI/SNRI（舍曲林、帕罗西汀、文拉法辛等）SSRI/SNRI (sertraline, paroxetine, venlafaxine, etc.)
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 情绪状态Emotional State | HAMD、PHQ-9量表（主观）HAMD, PHQ-9 scales (subjective) | 睡眠结构重塑分析（深睡/REM比例变化）Sleep architecture remodeling analysis (deep sleep/REM ratio changes) |
| 自主神经功能Autonomic Function | 无法常规评估Not routinely assessable | 心率变异性昼夜节律+晨间迷走张力恢复Heart rate variability circadian rhythm + morning vagal tone recovery |
| 应激反应Stress Response | 实验室应激测试Laboratory stress test | 真实世界应激反应衰减指数+恢复速度Real-world stress response attenuation index + recovery speed |
核心临床意义Core Clinical Significance
将抗抑郁疗效评估从“主观量表”升级为客观生理指标。Upgrading antidepressant efficacy assessment from "subjective scales" to objective physiological indicators. 早于情绪改善2-3周捕捉生理变化，为药物起效提供早期信号，指导治疗方案的及时优化。Capturing physiological changes 2–3 weeks before emotional improvement, providing early signals of drug response and guiding timely optimization of treatment plans.
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13. 抗焦虑药13. Anxiolytics
阿普唑仑、劳拉西泮、丁螺环酮等Alprazolam, lorazepam, buspirone, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 焦虑水平Anxiety Level | HAMA量表（主观）HAMA scale (subjective) | 自主神经基线动态+自发性SCR频率Autonomic baseline dynamics + spontaneous SCR frequency |
| 应激反应Stress Response | 实验室应激测试Laboratory stress test | 日常应激反应衰减指数（真实世界）Daily stress response attenuation index (real-world) |
| 日间功能影响Daytime Functional Impact | 主观嗜睡评分Subjective somnolence score | 认知负荷生理响应+日间警觉性指数Cognitive load physiological response + daytime alertness index |
核心临床意义Core Clinical Significance
首次实现抗焦虑药物在真实世界环境中的客观疗效评估。First objective efficacy assessment of anxiolytics in real-world environments. 测量药物对日常应激反应的真实衰减效果，同时客观量化日间功能影响。Measuring the true attenuation effect of medication on daily stress responses while objectively quantifying daytime functional impact.
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14. 抗精神病药14. Antipsychotics
奥氮平、利培酮、氯氮平等Olanzapine, risperidone, clozapine, etc.
超值评估维度Premium Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Methods | VitaLink超值评估VitaLink Premium Assessment |
|---|---|---|
| 锥体外系反应Extrapyramidal Symptoms | AIMS量表（主观）AIMS scale (subjective) | 运动-自主神经耦合异常预警（提前数天预警）Motor-autonomic coupling abnormality early warning (days in advance) |
| 代谢副作用Metabolic Side Effects | 定期体重/血糖（数月）Periodic weight/blood glucose (every few months) | 代谢趋势连续监测+体动-能耗效率指数Continuous metabolic trend monitoring + movement-energy expenditure efficiency index |
| 静坐不能Akathisia | 主观报告Subjective report | 微动模式+静息-活动转换频率Micro-movement pattern + rest-activity transition frequency |
核心临床意义Core Clinical Significance
在严重副作用出现临床症状前数天即可通过生理信号变化早期预警。Early warning through physiological signal changes days before clinical symptoms of severe side effects appear. 实现真正的“治疗获益-副作用风险”动态平衡管理。Achieving true dynamic balance management of "therapeutic benefit–side effect risk."
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15. 助眠药Hypnotics
唑吡坦、右佐匹克隆、褪黑素等Zolpidem, Eszopiclone, Melatonin, etc.
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 入睡评估Sleep Onset Assessment | 睡眠日记（主观）Sleep Diary (Subjective) | 入睡时间客观量化（心率-体动模式分析）Objective Quantification of Sleep Onset (Heart Rate-Body Movement Pattern Analysis) |
| 睡眠结构Sleep Architecture | 多导睡眠图（单夜）Polysomnography (Single Night) | 连续睡眠分期+深睡比例与稳定性Continuous Sleep Staging + Deep Sleep Ratio and Stability |
| 次日残留效应Next-Day Residual Effects | 主观嗜睡评分Subjective Sleepiness Score | 次日自主神经恢复评估+晨峰心率变异性Next-Day Autonomic Recovery Assessment + Morning Peak HRV |
核心临床意义Core Clinical Significance
从“睡了几小时”升级为睡眠质量与次日功能恢复全维度评估。From "how many hours slept" to a comprehensive assessment of sleep quality and next-day functional recovery. 次日晨间自主神经恢复程度是判断助眠药安全性的关键指标。The degree of next-day morning autonomic recovery is a key indicator for evaluating hypnotic safety.
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16. 支气管扩张剂Bronchodilators
沙丁胺醇、噻托溴铵、福莫特罗等Salbutamol, Tiotropium, Formoterol, etc.
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 肺功能Pulmonary Function | 肺功能仪（门诊单次）Spirometry (Single Clinic Visit) | 呼吸-心率相位同步+呼吸效率连续分析Respiration-Heart Rate Phase Synchronization + Continuous Respiratory Efficiency Analysis |
| 夜间症状Nocturnal Symptoms | 夜间憋醒报告Nocturnal Breathlessness Awakening Report | 夜间呼吸事件自动识别+氧合稳定性Automatic Nocturnal Respiratory Event Detection + Oxygenation Stability |
| 运动耐受Exercise Tolerance | 6分钟步行试验6-Minute Walk Test | 日常活动耐力连续监测+活动-血氧耦合曲线Continuous Daily Activity Endurance Monitoring + Activity-SpO2 Coupling Curve |
核心临床意义Core Clinical Significance
在急性加重发生前24-48小时预警，将评估从“门诊单次肺功能”扩展至“真实世界连续监测”。Provides 24-48 hour early warning before acute exacerbation, expanding assessment from "single clinic spirometry" to "real-world continuous monitoring". 为COPD和哮喘的精细化治疗提供客观依据。Provides objective evidence for refined treatment of COPD and asthma.
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17. 肺动脉高压靶向药PAH Targeted Therapies
波生坦、西地那非、利奥西呱、曲前列尼尔等Bosentan, Sildenafil, Riociguat, Treprostinil, etc.
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 右心后负荷Right Heart Afterload | 右心导管（有创，无法常做）Right Heart Catheterization (Invasive, Not Routinely Repeatable) | 右心后负荷动态评估（通过脉搏波形态）Dynamic Right Heart Afterload Assessment (via Pulse Wave Morphology) |
| 功能容量Functional Capacity | 6分钟步行试验（单次，受状态影响大）6-Minute Walk Test (Single, Highly Status-Dependent) | 日常活动耐力连续监测（替代6分钟步行试验）Continuous Daily Activity Endurance Monitoring (Alternative to 6MWT) |
| 氧合状态Oxygenation Status | 心脏超声（间歇性）Echocardiography (Intermittent) | 氧合趋势（连续无创监测）Oxygenation Trend (Continuous Non-invasive Monitoring) |
核心临床意义Core Clinical Significance
将评估从有创/门诊单点，扩展到无创/家庭连续。Expands assessment from invasive/clinic single-point to non-invasive/home continuous monitoring. 能更灵敏地反映病情波动和治疗反应，提前预警恶化，实现真正的肺动脉高压全程管理。More sensitively reflects disease fluctuations and treatment response, provides early warning of deterioration, and enables true whole-journey management of pulmonary arterial hypertension.
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18. 抗生素Antibiotics
β-内酰胺类、喹诺酮类、万古霉素等β-lactams, Quinolones, Vancomycin, etc.
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 感染控制Infection Control | 体温（单点）、血常规Body Temperature (Single Point), CBC | 炎症-体温-心率三联征消退模式Inflammation-Temperature-Heart Rate Triad Regression Pattern |
| 药物热鉴别Drug Fever Differentiation | 难以鉴别Difficult to Differentiate | 体温昼夜节律分析（区分感染热与药物热）Body Temperature Circadian Rhythm Analysis (Differentiating Infectious Fever from Drug Fever) |
| 组织灌注Tissue Perfusion | 乳酸（采血）Lactate (Blood Draw) | 微循环灌注趋势（基于PPG）Microcirculation Perfusion Trend (Based on PPG) |
核心临床意义Core Clinical Significance
首次实现抗生素疗效的24小时内早期预测。First to enable early prediction of antibiotic efficacy within 24 hours. 在CRP尚未下降前，提前判断抗生素是否有效，指导及时换药，降低耐药风险。Determines antibiotic effectiveness before CRP declines, guiding timely switching and reducing resistance risk.
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19. JAK抑制剂JAK Inhibitors
托法替布、巴瑞替尼、乌帕替尼等Tofacitinib, Baricitinib, Upadacitinib, etc.
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 炎症控制Inflammation Control | CRP、ESR（采血）CRP, ESR (Blood Draw) | 炎症-活动-睡眠多维模式+活动-炎症耦联分析Inflammation-Activity-Sleep Multidimensional Pattern + Activity-Inflammation Coupling Analysis |
| 疲劳量化Fatigue Quantification | FACIT-F量表FACIT-F Scale | 疲劳-活动-自主神经耦合指数+活动节律紊乱程度Fatigue-Activity-Autonomic Coupling Index + Activity Rhythm Disruption Degree |
| 晨僵评估Morning Stiffness Assessment | 主观报告Subjective Report | 晨间活动启动模式+夜间心率变异性Morning Activity Initiation Pattern + Nocturnal HRV |
核心临床意义Core Clinical Significance
客观量化真实世界功能改善，为生活质量获益提供证据。Objectively quantifies real-world functional improvement, providing evidence for quality-of-life benefits. 通过活动-睡眠-自主神经多维耦合分析，客观量化患者的日常功能改善。Through multidimensional activity-sleep-autonomic coupling analysis, objectively quantifies patients' daily functional improvement.
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20. 非甾体抗炎药NSAIDs
布洛芬、萘普生、COX-2选择性抑制剂Ibuprofen, Naproxen, COX-2 Selective Inhibitors
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 炎症活动Inflammatory Activity | 血沉、CRP、主观疼痛评分ESR, CRP, Subjective Pain Score | 组织微炎症热图（短波红外PPG监测局部温度升高）Tissue Micro-inflammation Heatmap (Local Temperature Elevation via Short-Wave Infrared PPG) |
| 疗效验证Efficacy Verification | 患者自我报告“疼痛减轻”Patient Self-Reported "Pain Relief" | 疼痛-功能客观关联（日常活动-疼痛阈值分析）Objective Pain-Function Correlation (Daily Activity-Pain Threshold Analysis) |
| 安全分层Safety Stratification | 定期肾/肝功能检查Periodic Renal/Hepatic Function Tests | 肾灌注指数动态追踪+胃肠道微出血早期预警Dynamic Renal Perfusion Index Tracking + Early Gastrointestinal Microbleeding Warning |
核心临床意义Core Clinical Significance
将抗炎治疗从“症状管理”升级为“组织微炎症动态监控”。Upgrades anti-inflammatory treatment from "symptom management" to "dynamic tissue micro-inflammation monitoring". 在关节结构损伤发生前预警，在肾损伤前识别风险，在胃肠道出血前发现微出血信号。Warns before joint structural damage, identifies risk before renal injury, and detects microbleeding signals before gastrointestinal bleeding.
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21. 肿瘤支持治疗药物Oncology Supportive Care Drugs
EPO、G-CSF、抗恶病质药物EPO, G-CSF, Anti-cachectic Drugs
超值评估维度High-Value Assessment Dimensions
| 评估维度Assessment Dimension | 传统方法Traditional Method | VitaLink超值评估VitaLink High-Value Assessment |
|---|---|---|
| 癌因性疲乏Cancer-Related Fatigue | 量表评分Scale Score | 疲乏-活动-自主神经动态+活动节律紊乱指数Fatigue-Activity-Autonomic Dynamics + Activity Rhythm Disruption Index |
| 贫血改善Anemia Improvement | 血常规（间断）CBC (Intermittent) | 组织氧合趋势+氧输送-利用效率Tissue Oxygenation Trend + Oxygen Delivery-Utilization Efficiency |
| 化疗耐受性Chemotherapy Tolerability | 不良反应报告Adverse Event Report | 化疗前后生理储备评估+恢复速度指数Pre/Post-Chemotherapy Physiological Reserve Assessment + Recovery Speed Index |
核心临床意义Core Clinical Significance
在患者主观报告疲乏之前，通过活动-自主神经-睡眠多维耦合指数识别生理储备下降；连续追踪组织氧合趋势与氧输送-利用效率，客观量化 EPO/G-CSF 等支持治疗的贫血改善效果；在化疗周期前后评估生理储备与恢复速度指数，为剂量调整、支持治疗介入时机和个体化化疗方案提供客观依据，并在心脏毒性等关键器官损伤发生前提供预警。Identifies physiological reserve decline through activity-autonomic-sleep multidimensional coupling indices before patients subjectively report fatigue; continuously tracks tissue oxygenation trends and oxygen delivery-utilization efficiency to objectively quantify anemia improvement from supportive therapies such as EPO/G-CSF; evaluates physiological reserve and recovery-speed indices before and after chemotherapy cycles to provide objective evidence for dose adjustment, timing of supportive care intervention, and individualized chemotherapy regimens, while providing early warning before cardiotoxicity and other critical organ injuries.
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6个标准应用6 Standard Applications
除超值应用外，VitaLink平台还支持以下药物类别的标准疗效与安全性评估In addition to premium applications, the VitaLink platform also supports standard efficacy and safety assessments for the following drug categories.
💊 22. 非甾体抗炎药Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
示例：Examples: 布洛芬、萘普生、COX-2抑制剂Ibuprofen, Naproxen, COX-2 inhibitors
- 局部炎症/水肿监测（组织水合度）Local inflammation/edema monitoring (tissue hydration)
- 疼痛缓解效果评估（活动水平恢复）Pain relief efficacy assessment (activity level recovery)
- 胃肠道副作用风险提示Gastrointestinal side-effect risk alert
🧬 23. 免疫抑制剂Immunosuppressants
示例：Examples: 甲氨蝶呤、JAK抑制剂、生物制剂Methotrexate, JAK inhibitors, biologics
- 全身炎症负荷监测（HRV与心率趋势）Systemic inflammatory load monitoring (HRV and heart rate trends)
- 感染风险早期预警Early warning of infection risk
- 疲劳与生活质量客观评估Objective assessment of fatigue and quality of life
🚹 24. 前列腺疾病药物Prostate Disease Drugs
示例：Examples: α受体阻滞剂、5α还原酶抑制剂Alpha-blockers, 5-alpha reductase inhibitors
- 体位性低血压风险监测Orthostatic hypotension risk monitoring
- 夜尿频率客观记录Objective recording of nocturia frequency
- 焦虑相关症状改善评估Assessment of anxiety-related symptom improvement
🫁 25. 哮喘/COPD药物Asthma/COPD Drugs
示例：Examples: 吸入性糖皮质激素、LABA/LAMAInhaled corticosteroids, LABA/LAMA
- 夜间呼吸模式监测Nocturnal breathing pattern monitoring
- 急性加重早期预警Early warning of acute exacerbation
- 药物依从性客观评估Objective assessment of medication adherence
🩸 26. 抗凝/抗血小板药物Anticoagulant/Antiplatelet Drugs
示例：Examples: 阿司匹林、氯吡格雷、DOACsAspirin, Clopidogrel, DOACs
- 微循环灌注改善评估Assessment of microcirculatory perfusion improvement
- 出血风险早期迹象监测Monitoring of early bleeding risk signs
- 药物相互作用风险提示Drug interaction risk alert
🦠 27. 抗癫痫/神经痛药物Antiepileptic/Neuropathic Pain Drugs
示例：Examples: 加巴喷丁、普瑞巴林、卡马西平Gabapentin, Pregabalin, Carbamazepine
- 神经兴奋性抑制效果评估Assessment of neuronal excitability suppression
- 镇静副作用量化监测Quantitative monitoring of sedative side effects
- 发作性事件预警Paroxysmal event warning
CPIN振动模块 · 5大扩展应用CPIN Vibration Module · 5 Extended Applications
基于振动马达 + 温度传感器 (3路) + ICM42688 (6轴运动姿态) 硬件组合的可扩展监测场景Scalable monitoring scenarios based on the hardware combination of vibration motor + temperature sensors (3 channels) + ICM42688 (6-axis motion attitude).
硬件组合：Hardware Combination: 振动马达 (主动可控振动) · 温度传感器×3 (精度0.1℃) · ICM42688 (6D运动追踪)Vibration motor (active controllable vibration) · 3× temperature sensors (0.1℃ accuracy) · ICM42688 (6D motion tracking)
| 扩展场景Extended Scenario | 市场规模Market Size | 监管路径清晰度Regulatory Clarity | 与现有专利协同Patent Synergy | 技术难度Technical Difficulty | 优先级建议Priority |
|---|---|---|---|---|---|
| 糖尿病周围神经病变Diabetic Peripheral Neuropathy | ⭐⭐⭐⭐⭐ 巨大⭐⭐⭐⭐⭐ Huge | ⭐⭐⭐⭐ 清晰⭐⭐⭐⭐ Clear | ⭐⭐⭐ 中等⭐⭐⭐ Medium | ⭐⭐⭐ 中等⭐⭐⭐ Medium | 第一优先Top Priority |
| 帕金森病监测Parkinson's Disease Monitoring | ⭐⭐⭐⭐ 较大⭐⭐⭐⭐ Large | ⭐⭐⭐ 中等⭐⭐⭐ Medium | ⭐⭐⭐⭐⭐ 高⭐⭐⭐⭐⭐ High | ⭐⭐⭐ 中等⭐⭐⭐ Medium | 第二优先Second Priority |
| 康复医学Rehabilitation Medicine | ⭐⭐⭐⭐ 较大⭐⭐⭐⭐ Large | ⭐⭐⭐ 中等⭐⭐⭐ Medium | ⭐⭐ 较低⭐⭐ Lower | ⭐⭐⭐⭐ 较高⭐⭐⭐⭐ Higher | 第三优先Third Priority |
| 神经损伤定位Nerve Injury Localization | ⭐⭐⭐ 中等⭐⭐⭐ Medium | ⭐⭐⭐⭐ 清晰⭐⭐⭐⭐ Clear | ⭐⭐ 较低⭐⭐ Lower | ⭐⭐⭐ 中等⭐⭐⭐ Medium | 配合CIPNAlign with CIPN |
| 精神心理评估Mental/Psychological Assessment | ⭐⭐⭐ 中等⭐⭐⭐ Medium | ⭐⭐ 模糊⭐⭐ Unclear | ⭐ 很低⭐ Very Low | ⭐⭐⭐⭐ 较高⭐⭐⭐⭐ Higher | 长期探索Long-term Exploration |
场景说明：Scenario Note: 糖尿病周围神经病变（DPN）市场规模最大（中国超1.4亿患者），监管路径清晰，为第一优先方向；帕金森病监测与现有专利7（抗精神病药副作用预警）高度协同。Diabetic peripheral neuropathy (DPN) has the largest market size (over 140 million patients in China), a clear regulatory path, and is the top priority; Parkinson's disease monitoring is highly synergistic with existing patent 7 (antipsychotic side-effect early warning).
数据展示Data Showcase
设备存储 · 实时导出Device Storage · Real-time Export U盘目录结构 · 原始数据USB Directory Structure · Raw Data
目录按日期组织，文件命名规则：数据缩写 + 日期 + 开始时间（例：PPG_20260627_0830.dat）Directories are organized by date; file naming convention: data abbreviation + date + start time (e.g., PPG_20260627_0830.dat).
- 2026-06-27 (今日)(Today)
- PPG_20260627_0830.dat (PPG 原始波形, 125HzPPG Raw Waveform, 125Hz)
- ECG_20260627_0830.dat (ECG 原始波形, 500HzECG Raw Waveform, 500Hz)
- EDA_20260627_0830.dat (EDA 皮肤电, 10HzEDA Electrodermal Activity, 10Hz)
- HRV_20260627_0830.dat (HRV 摘要数据HRV Summary Data)
- BPV_20260627_0830.dat (血压变异性Blood Pressure Variability)
- EVENT_20260627_0830.log (事件标记日志Event Marker Log)
- 2026-06-26
- PPG_20260626_0915.dat (PPG 原始, 125HzPPG Raw, 125Hz)
- ECG_20260626_0915.dat (ECG 原始, 500HzECG Raw, 500Hz)
- EDA_20260626_0915.dat (EDA 皮肤电EDA Electrodermal Activity)
- PWV_20260626_0915.dat (脉搏波传导速度Pulse Wave Velocity)
- ALERT_20260626_0915.log (预警事件日志Alert Event Log)
- 2026-06-25
- PPG_20260625_1400.dat (PPG 原始, 125HzPPG Raw, 125Hz)
- ECG_20260625_1400.dat (ECG 原始, 500HzECG Raw, 500Hz)
- EDA_20260625_1400.dat (EDA 皮肤电EDA Electrodermal Activity)
- BRS_20260625_1400.dat (压力反射敏感性Baroreflex Sensitivity)
- 2026-06-24
- PPG_20260624_0730.dat (PPG 原始, 125HzPPG Raw, 125Hz)
- ECG_20260624_0730.dat (ECG 原始, 500HzECG Raw, 500Hz)
- EDA_20260624_0730.dat (EDA 皮肤电EDA Electrodermal Activity)
- SpO2_20260624_0730.dat (血氧趋势SpO₂ Trend)
- SCR_20260624_0730.dat (皮肤电导反应Skin Conductance Response)
总存储: 6.2GB / 8GB · 文件数: 47Total Storage: 6.2GB / 8GB · Files: 47
摘要数据 · 每日CSV文件Summary Data · Daily CSV Files
每日生成一个CSV文件：AbDataYYYYMMDD.csv （例：AbData20260627.csv）One CSV file is generated daily: AbDataYYYYMMDD.csv (e.g., AbData20260627.csv).
AbData20260627.csv (最新 · 今日)(Latest · Today)
| 时间Time | 数据名称Data Name | 数据1Data 1 | 数据2Data 2 | 数据3Data 3 | 数据4Data 4 | 数据5Data 5 |
|---|---|---|---|---|---|---|
| 08:30:00 | HRV_LF/HF | 0.82 | 1.34 | 45.2 | 38.7 | 0.61 |
| 08:30:00 | SpO2 | 98.2 | 97.8 | 99.1 | — | — |
| 08:30:00 | BPV_SI | 0.42 | 0.38 | 0.51 | 0.33 | — |
| 08:30:00 | SCL | 2.45 | 2.67 | 2.31 | 2.88 | — |
| 08:30:00 | PWV | 7.2 | 7.4 | 7.0 | 7.6 | — |
| 09:00:00 | HRV_LF/HF | 0.91 | 1.21 | 48.3 | 35.6 | 0.58 |
| 09:00:00 | SpO2 | 98.0 | 97.5 | 98.8 | — | — |
| 09:00:00 | BPV_SI | 0.45 | 0.41 | 0.48 | 0.36 | — |
| 09:00:00 | SCL | 2.52 | 2.73 | 2.40 | 2.92 | — |
| 09:00:00 | PWV | 7.3 | 7.5 | 7.1 | 7.7 | — |
| … 共 144 行 (每10分钟一条) …… 144 rows total (one every 10 min) … | ||||||
2026-06-272026-06-27
00:00 – 23:5000:00 – 23:50
记录数: 144Records: 144
数据波形展示 · 实时/历史回放Waveform Display · Real-time / Historical Playback
基于原始数据生成的波形图，支持缩放与标注。Waveforms generated from raw data, supporting zoom and annotation.
ECG 心电 (500Hz)ECG Electrocardiogram (500Hz)
PPG 光电容积 (125Hz)PPG Photoplethysmography (125Hz)
EDA 皮肤电 (10Hz)EDA Electrodermal Activity (10Hz)
多模态融合 (ECG+PPG+EDA)Multimodal Fusion (ECG+PPG+EDA)
ECG
PPG
EDA
时间轴: 10秒Timeline: 10 s
点击波形可放大Click Waveform to Zoom
广西桂林守月科技有限公司Guilin Shouyue Technology Co., Ltd. · vitalinkdx co. ltd
桂林市临桂区桂林经开区华为信息生态产业合作区创新大厦第三层405号405, 3/F, Innovation Building, Huawei Info-Eco Park, Guilin Economic Zone, Lingui District, Guilin, China
Sydneyzhong@digitalring.top · 91450300MAK2F9NT5W
桂林市临桂区桂林经开区华为信息生态产业合作区创新大厦第三层405号405, 3/F, Innovation Building, Huawei Info-Eco Park, Guilin Economic Zone, Lingui District, Guilin, China
Sydneyzhong@digitalring.top · 91450300MAK2F9NT5W
SY‑F100 · 二类创新医疗器械Class II Innovative Medical Device
版本 2.0 · 2026-06Version 2.0 · 2026-06