三种佩戴形态覆盖从"高保真锚点"到"7×24 h 连续"的完整测量谱；四种 BioZ 工作模式在同一套硬件上按需切换；四道硬件级质量门控让数据可信度可量化、可报告。这不是一台设备，是一套可以直接写进研究方案的采集基础设施。 Three wearable forms span the full measurement spectrum from high-fidelity anchor points to 7×24 h continuous coverage; four BioZ operating modes switch on demand within one hardware set; and four hardware-level quality gates make data credibility quantifiable and reportable. This is not a device — it is acquisition infrastructure you can write directly into a protocol.
| BioZ 模式 / 信号BioZ mode / signal | 关键配置特征Key configuration | 指套Sleeve | 戒指Ring | 胸贴Patch | 科研用途Research use |
|---|---|---|---|---|---|
| GSR / EDA | 0.5 V 恒压直流、高增益、高通旁路、双电极0.5 V constant-voltage DC, high gain, high-pass bypassed, two electrodes | ★★★ 指端黄金位gold-site |
★★ 连续无感unobtrusive |
★★ 胸段连续thoracic |
自主神经功能、应激反应、小纤维神经病变Autonomic function, stress response, small-fibre neuropathy |
| ICG 心阻抗图Impedance cardiography |
≈100 kHz 高频、四电极法、高增益带宽≈100 kHz, four-electrode, wide gain bandwidth | — | — | ★★★ 唯一载体only vehicle |
每搏量、心输出量、射血前期/左室射血时间、胸腔液体含量Stroke volume, cardiac output, PEP/LVET, thoracic fluid content |
| Respiration | 平衡方波电流、极低频、可与 ECG 共用同一对电极Balanced square-wave current, very low frequency, can share the ECG electrode pair | ★ | — | ★★★ 最优optimal |
呼吸率、潮气量趋势、心肺耦合分析Respiration rate, tidal-volume trend, cardiopulmonary coupling |
| BIA / BIS 阻抗谱Impedance spectroscopy |
5 kHz – 500 kHz 多频扫描，需精确校准5 kHz – 500 kHz sweep, precise calibration required | ★ 小视野small field |
— | ★★★ 胸腔阻抗谱thoracic spectrum |
阻抗谱参数、体液分布、细胞膜完整性Spectroscopy parameters, fluid distribution, membrane integrity |
| ECG | 四电极 / 单导联 / 指间导联Four-electrode / single lead / finger-to-finger | ★★ | ★ | ★★★ | 心率变异性、心律事件、心脏电活动参考Heart-rate variability, rhythm events, cardiac electrical reference |
| PPG / SpO₂ | 多波长光学（最长 8 通道）Multi-wavelength optics (up to 8 channels) | ★★★ | ★★★ | ★★ | 血氧、脉率、外周灌注、脉搏传导时间SpO₂, pulse rate, peripheral perfusion, pulse transit time |
| 温度 / IMUTemperature / IMU | 四路温度（每电极 1 路）+ 六轴惯性Four temperature channels (one per electrode) + 6-axis inertial | ★★★ | ★★★ | ★★ | 皮温趋势、体位活动、运动伪影剔除Skin-temperature trend, posture and activity, motion-artifact rejection |
| VPT 振动感知阈值Vibration perception threshold |
振动执行器 + 患者响应按键Vibration actuator + patient response key | ★★★ 唯一only |
— | — | 大纤维功能评估、神经病变筛查Large-fibre assessment, neuropathy screening |
| 辅助模式Auxiliary modes Utility / BIST / Lead-Off / Lead-On |
直流偏置诊断 / 内部标准电阻 / 导联脱落 / 佩戴唤醒DC-offset diagnostics / internal reference / lead-off / wear-on wake | ★★★ | ★★★ | ★★★ | 数据质量门控，贯穿所有研究方向Data-quality gating, applicable to every research direction |
可穿戴设备数据的最大质疑是"怎么知道信号是可信的"。我们的做法是：所有进入科研数据集的数据，必须通过四道硬件级门控，且每一道门控的结果都以质量位的形式随数据落盘。审稿人问起来，你能给出通过率，而不是"我们目视检查过"。 The central objection to wearable data is "how do you know the signal is trustworthy?". Our answer: every sample entering a research dataset must pass four hardware-level gates, and each gate's result is logged alongside the data as a quality bit. When a reviewer asks, you can quote a pass rate instead of saying "we inspected the traces visually".
检测电极-皮肤界面的直流偏置是否落在可用范围内。偏置异常通常意味着电极干涸、接触不良或极化严重——这类数据在后续处理中会产生难以察觉的畸变。 Checks whether the electrode-skin DC offset falls within a usable range. Anomalous offsets usually mean a dried-out electrode, poor contact or excessive polarisation — data that produces subtle, hard-to-detect distortion downstream.
用芯片内部的精密标准电阻对整条模拟链路做自检，验证增益与偏移是否符合出厂标定。这把"设备本身是否漂移"从主观判断变成可验证的数值。 Runs the entire analogue chain against the chip's internal precision reference resistor to verify gain and offset match factory calibration — turning "has the device drifted?" from a judgement call into a verifiable number.
持续监测每个电极的电气连续性。电极脱落的时间段被精确标记，可在分析中剔除而不必丢弃整段记录。 Continuously monitors electrical continuity at every electrode. Detached intervals are precisely flagged so they can be excluded in analysis without discarding an entire record.
区分"设备未佩戴"与"佩戴但信号弱"。两者在原始数据中极难区分，但含义完全不同——前者应排除，后者可能是重要的生理发现。 Distinguishes "device not worn" from "worn but weak signal". The two are nearly indistinguishable in raw data yet mean opposite things — the first should be excluded, the second may be a genuine physiological finding.
免疫检查点抑制剂相关心肌炎的发病率低但致死率极高，诊断为"窗口极窄"的典型难题：射血分数正常不能排除，活检假阴性率高。核心假设是外周信号偏离早于心肌损伤的可检测阶段。 Immune-checkpoint-inhibitor myocarditis is rare but highly lethal, a textbook narrow-window diagnostic problem: preserved ejection fraction does not exclude it and biopsy has a high false-negative rate. The central hypothesis is that peripheral signal deviation precedes detectable myocardial injury.
硬件支撑要点：三形态同时上，提供"7×24 h 不间断 + 中心血流动力学 + 指端自主神经"的组合，单一设备无法覆盖。 Hardware requirement: all three forms together supply uninterrupted 7×24 h coverage plus central haemodynamics plus fingertip autonomic signals — a combination no single device can achieve.
多频阻抗谱目前的主战场是体成分分析；把它做到心胸连续监测是罕见路径，而单芯片集成阻抗谱、心阻抗与心电的能力让分时互斥测量成为可能。核心假设是阻抗谱参数（细胞膜电容、特征频率）的连续趋势比单频阻抗更早反映肺间质水肿。 Multi-frequency spectroscopy is currently dominated by body-composition analysis; applying it to continuous cardiothoracic monitoring is a rare path, and single-chip integration of spectroscopy, impedance cardiography and ECG makes time-exclusive measurement feasible. The hypothesis: the trend of spectroscopy parameters (membrane capacitance, characteristic frequency) reflects pulmonary interstitial oedema earlier than single-frequency impedance.
硬件支撑要点：外部精密电阻与内部基准电阻双路径校准，是阻抗谱绝对值可比的先决条件。 Hardware requirement: dual-path calibration via an external precision resistor and the internal reference, a prerequisite for comparable absolute spectroscopy values.
门静脉压力梯度的有创测量无法重复，术后又缺少无创高频监测手段。核心思路是把"心肺耦合"的心阻抗方法迁移到全身—门脉耦合：用胸贴的心阻抗搏动分量联合指套的外周血流动力学参数做反推，并与影像学血流参数对照。 Invasive portal pressure gradient measurement cannot be repeated, and post-procedure non-invasive high-frequency monitoring is lacking. The approach migrates the cardiopulmonary-coupling impedance method to a systemic-to-portal coupling model: combining the patch's pulsatile impedance component with the sleeve's peripheral haemodynamic parameters, then validating against imaging-derived flow parameters.
硬件支撑要点：胸贴与指套必须时间对齐到毫秒级，这是"中心—外周"联合反推能够成立的前提。 Hardware requirement: patch and sleeve must align to millisecond precision — the precondition for any central-peripheral joint inference.
化疗诱导周围神经病变同时累及大纤维、小纤维与自主神经三条通路，而现有研究几乎都是单通道评估。核心假设是：连续的自主体征趋势可能早于振动阈值阳性出现——即存在"亚临床期自主神经先行"。 Chemotherapy-induced peripheral neuropathy involves large-fibre, small-fibre and autonomic pathways simultaneously, yet existing studies are almost all single-channel. The hypothesis: continuous autonomic trends may deviate before vibration threshold turns positive — a subclinical autonomic-first phase.
硬件支撑要点：三通道必须在同一受试者上同步采集，"大纤维 + 小纤维 + 自主神经"三通道同步评估此前缺少可行的硬件方案。 Hardware requirement: all three channels must acquire synchronously on the same subject; a simultaneous large-fibre / small-fibre / autonomic assessment has previously lacked a workable hardware solution.
现有睡眠呼吸暂停诊断只看呼吸事件计数（AHI），不做自主神经表型分型。核心假设是：胸阻抗变化与呼吸努力的解耦可区分阻塞性与中枢性事件；而戒指整夜皮肤电反应与交感激活表型相关，后者可能与心血管风险更直接相关。 Current sleep apnoea diagnosis relies on event counting (AHI) and does not phenotype autonomic state. The hypothesis: decoupling of thoracic impedance change from respiratory effort distinguishes obstructive from central events, while overnight electrodermal responses on the ring correlate with a sympathetic-activation phenotype that may map more directly to cardiovascular risk.
硬件支撑要点：呼吸阻抗可与心电共用同一对电极，不增加佩戴负担；整夜连续采集依赖戒指形态的续航与舒适度。 Hardware requirement: respiration impedance shares the ECG electrode pair, adding no wearing burden; overnight acquisition depends on the ring's endurance and comfort.
以上只是我们基于硬件能力推演出的方向。如果你的研究问题需要"多模态、长时间、可对照金标准"的生理信号——无论属于神经、心血管、精神、代谢还是睡眠领域——我们都可以一起评估硬件是否支撑、如何配置。 The five directions above are simply what we infer from the hardware's capabilities. If your research question needs multimodal, long-duration, gold-standard-comparable physiological signals — in neurology, cardiology, psychiatry, metabolism or sleep — we can assess together whether and how the hardware supports it.
讨论你的研究问题 →Discuss your research question →不同研究方向不共用同一批被试数据——样本池化会在多个期刊同时受到质疑。唯一可接受的复用是同一批数据回答不同研究问题、不同主要终点，且必须在各自的研究方案中明确声明。 Different research directions do not share subject data — pooled samples draw simultaneous scrutiny from multiple journals. The only acceptable reuse is when the same dataset answers different research questions with different primary endpoints, and it must be declared explicitly in each protocol.
凡是具备新颖性的方法学（多设备多模态预警、阻抗谱连续监测、自主神经分型等），都建议先完成专利申请再公开数据与结论。我们会在合作早期就提出这个时间线，避免不可逆的公开。 For any methodologically novel element (multi-device multimodal warning, continuous spectroscopy monitoring, autonomic phenotyping), we recommend completing the patent filing before public disclosure of data or conclusions. We raise this timeline early in any collaboration to avoid irreversible disclosure.
硬件是信号采集设备，在取得相应注册之前，任何功能都以"采集、显示、存储、传输"为界。论文方法学中同样应据实描述，不把采集设备写成评估工具——这既是合规要求，也是审稿人越来越关注的点。 The hardware is a signal-acquisition device; until the relevant registration is obtained, every function is bounded by acquisition, display, storage and transmission. Manuscript Methods should describe it as such, never as an assessment tool — both a compliance requirement and an increasingly common reviewer concern.
四道门控的通过率必须在每篇论文中报告实际数值，而不是统一引用一个通用数字。不同人群、不同佩戴时长、不同季节的通过率会有差异，这本身就是有价值的方法学信息。 Gate pass rates must be reported at their actual per-study values, never replaced by a generic figure. Rates vary with population, wear duration and season — and that variation is itself valuable methodological information.
提供工程样机 + 底层软件 + 数据解析 API。适用于可行性验证、预实验、以及撰写研究方案前的技术摸底。 Engineering prototypes, low-level software and the parsing API. Suited to feasibility validation, pilot work, and technical due diligence before writing a protocol.
双方共同确定研究设计，我们提供硬件、固件定制与数据管道支持，承担硬件侧的迭代与维护；你主导科学问题、入组与终点评估。 Both parties define the study design together. We supply hardware, firmware customisation and pipeline support, and own hardware-side iteration and maintenance; you lead the scientific question, enrolment and endpoints.
当方法验证成熟、需要走注册或规模化制造时，我们承担硬件量产、注册文件编制与供应链组织，你负责临床证据与适应症定义。 Once a method is validated and needs registration or scaled manufacturing, we take on hardware production, registration documentation and supply-chain organisation, while you own clinical evidence and indication definition.
有这四项信息，我们就能在第一次沟通中判断硬件是否匹配、需要哪些配置、以及大致的开发工作量。 With these four items we can assess hardware fit, required configuration and the approximate development effort in a first conversation.
三层架构、四种帧型、通道注册表、元数据快照与统一解析接口。 Three-layer architecture, four frame types, the channel registry, metadata snapshots and a unified parsing interface.
查看数据格式 →View the data format →IEC 60601-1、YY 9706 系列、ISO 20495、ISO 10993，以及检验方法与判定标准。 IEC 60601-1, the YY 9706 series, ISO 20495, ISO 10993, with test methods and acceptance criteria.
查看合规资料 →View compliance material →