Chest Patch Core Board · One Board, Many Patches

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产品 02 · 一板配多贴 Platform 02 · One board, many patches

胸贴小主板
一块主板，四款贴片 Chest Patch Core Board
one board, four patch types

主板只负责计算、电源、无线与标准接口，所有与皮肤接触的电极、凝胶与光学窗全部放进一次性贴片。主板可复用、可消毒，注册时主机与耗材分离申报。同一个 BioZ 通道分时复用 ICG、呼吸阻抗与 EDA——换贴即换模式，固件自动识别，临床零配置。 The core board handles only compute, power, radio and a standard interface; every skin-contacting electrode, gel and optical window lives in the disposable patch. The host is reusable and disinfectable, and host/patch are registered separately. A single BioZ channel is time-multiplexed across ICG, respiration impedance and EDA — swap the patch, switch the mode, with automatic identification and zero clinical configuration.

四款贴片矩阵Patch matrix SNAP 接口定义SNAP interface

≤28×38主板尺寸 mmBoard size mm

≤8mm主板厚度Board thickness

72h+全通道续航Full-channel runtime

4.0mm标准公扣接口Standard snap

Chest patch with disposable electrode patch worn on body — real photo

主板模块清单Core board modules

模块Module	器件 / 规格Part / spec
AFE	MAX86178 · ECG 三电极 + BioZ（激励/采集）+ PPG 双通道 + 恒流转 0.5 V EDAECG three-electrode + BioZ (drive/sense) + dual-channel PPG + 0.5 V constant-current EDA
主控MCU	MAX32690GWE+ · Arm Cortex-M4F · 大容量 RAM 适配多通道实时处理large RAM for multi-channel real-time processing
第二采集链2nd acquisition chain	ADS131A02 + REF3325 + AD8628（选配焊位：3 导联 ECG 升级，或 EEG/EOG/EMG 通用科研前端）ADS131A02 + REF3325 + AD8628 (optional footprint: 3-lead ECG upgrade, or a general EEG/EOG/EMG research front-end)
USB	MAX3207 + MAX9062 + PS7A21 + MAX20356 · U 盘直读 + 边充边传 + 功率路径mass-storage readout + charge-and-transfer + power path
传感辅助Auxiliary sensing	3 轴 IMU + 皮温 NTC3-axis IMU + skin-temperature NTC
存储Storage	1 Gb NAND
电池Battery	250 mAh Li-Po

01 设计原则：一个通道，三种用途 Design Principle: One Channel, Three Uses

主机不接触皮肤Host never touches skin

所有电极、凝胶、光学窗都进一次性贴片。主板可复用、可消毒，且不进注册的"与患者接触部件"清单——这大幅简化了主机的生物相容性与消毒验证负担。 All electrodes, gel and optical windows live in the disposable patch. The host is reusable, disinfectable and excluded from the registered patient-contacting parts list — greatly simplifying biocompatibility and disinfection validation for the host.

BioZ 通道分时复用BioZ channel time-multiplexed

同一个 BioZ 前端按固件时序在三职之间切换：ICG 血流动力学 → 呼吸阻抗 → 0.5 V 恒流 EDA。硬件零改动，这是"一板配多贴"能成立的物理基础。 One BioZ front-end switches between three duties under firmware timing: ICG haemodynamics → respiration impedance → 0.5 V constant-currnt EDA. No hardware change required — this is the physical basis that makes "one board, many patches" work.

贴片自动识别Automatic patch identification

贴片内嵌一颗编码电阻，第五扣位空闲时复用。主板读取阻值即可判定贴片类型并载入对应采集时序。错位或误配的贴片会报"贴片不匹配"并拒绝采集。 Each patch embeds a coding resistor, multiplexed onto the fifth snap when free. The board reads its value, identifies the patch type and loads the matching acquisition sequence. Misaligned or mismatched patches report "patch mismatch" and refuse to acquire.

系统框图System block diagram

                     ┌────────────────────────────────────────────┐
   Disposable patch  │        Chest patch core board (≤28×38×8 mm)    │
   (3/4/5-electrode) │                                            │
 ┌───────────┐      │ ┌──────────┐    ┌──────────────────────┐  │
 │ Ag/AgCl   │◄────┼─►│ SNAP     │───►│ MAX86178 AFE        │  │
 │ electrodes│ 4–5 │ │ 4–5 snap │    │ ECG_EL1/2/3 · BioZ   │  │
 │ 4.0 mm    │ snaps│ │ + optical│    │ · PPG · EDA (0.5 V)  │  │
 │ + optic win│      │ └──────────┘    └──────────┬───────────┘  │
 └───────────┘      │ ┌──────────┐               │ SPI      │
                    │ │MAX20356  │    ┌──────────▼──────────┐  │
 Type-C ◄───────────┼─┤ charger +│    │ MAX32690GWE+        │  │
 (charge + U-disk)│ │ PS7A21    │    │ Arm Cortex-M4F ·     │  │
                    │ └──────────┘    │ USB · firmware stack │  │
 Key / LED ◄─────────┼─┐               └──────────┬──────────┘  │
                    │ ┌──────────┐               │             │
 Optional ◄──────────┼─┤ADS131A02 │◄──────────────┘             │
 (3-lead ECG /    │ │ 24-bit ΔΣ│    MAX3207 · MAX9062          │
  EEG / EMG)     │ └──────────┘    VBUS detect                 │
                    │  IMU (3-axis) · skin temp · Li-Po · NAND    │
                    └────────────────────────────────────────────┘

02 SNAP 标准接口定义SNAP Standard Interface

主板底面 · 5 个 4.0 mm 镀金公扣 + 光学窗 Board underside · five 4.0 mm gold-plated snaps + optical window

扣位Snap	信号Signal	3 电极贴3-electrode patch	4 电极贴4-electrode patch	5 电极贴5-electrode patch	EDA 专用贴EDA patch
S1	ECG_EL1 / BioZ IN+	ECG RAL	ECG1 / IN+	ICG IN+	EDA A
S2	ECG_EL2 / BioZ IN−	ECG LL	ECG2 / IN−	ICG IN−	EDA B
S3	ECG_EL3 / BioZ 激励1drive 1	参考 RLReference RL	激励1Drive 1	ICG 激励1drive 1	空扣 / 定位spare / alignment
S4	BioZ 激励2drive 2	—	激励2Drive 2	ICG 激励2drive 2	空扣 / 定位spare / alignment
S5	共地 / 屏蔽（可选）Common / shield (optional)	—	—	ECG 第 3 导参考3rd-lead reference	编码电阻Coding resistor
光窗Window	PPG	—	留光学窗Optical window	留窗Window	—

Chest patch core board underside with five gold snaps S1-S5 and optical window, plus the three disposable patch SKUs (3/4/5-electrode) and EDA pair

主机图（底面五扣 + 光窗）与三种一次性电极贴（3 / 4 / 5 电极）及 EDA 专用贴。点击查看大图。 Core board underside (five snaps + optical window) with the three disposable patch SKUs (3 / 4 / 5-electrode) and the EDA pair. Open full size.

四种贴片的用法How each patch is used

3 电极贴：3-electrode patch: 标准动态心电（RAL/LL/RL），走 MAX86178 ECG 通道。适配常规动态心电筛查场景。 standard ambulatory ECG (RAL/LL/RL) via the MAX86178 ECG channel — suited to conventional Holter-style screening.
4 电极贴：4-electrode patch: 2 电极 ECG + 2 激励 + IN± 复用 = 呼吸阻抗（RR）+ PPG 光窗，多体征一体化。 two ECG electrodes plus two drive electrodes with IN± reuse gives respiration impedance (RR) plus a PPG window — multimodal in one patch.
5 电极贴：5-electrode patch: ICG 四电极法（IN± + 激励±）+ ECG 双/三导，用于血流动力学胸贴。 four-electrode ICG (IN± plus drive±) with dual/triple-lead ECG for the haemodynamic chest patch.
EDA 专用贴：EDA patch: S1/S2 经 BioZ 通道跑 0.5 V 恒压 EDA，双乳晕区外胸骨旁位点布置。 S1/S2 run 0.5 V constant-current EDA through the BioZ channel, positioned parasternal outside the areolar regions.

工程约束与红线Engineering constraints

公扣位置公差Snap position tolerance± 0.3 mm
主机防护等级Host ingress protectionIP54
接触面处理Contact finish镀金触点 + 顶面密封Gold-plated contacts + sealed top face
EDA 限流EDA current limit≤ 10 µA
错配保护Mismatch protection识别电阻兜底，报错并拒绝采集Coding resistor fallback: error and refuse to acquire

胸部 EDA 的固有挑战：Inherent challenge of chest EDA: 胸骨区汗腺密度低于掌跖与指端，信号幅度更小。我们依靠直流恒压高灵敏度体系（比交流法高约一个数量级）补偿，并把电极重润与漂移控制 SOP 固化到耗材说明书中。建议先做科研验证，再讨论医疗取证。 Sweat-gland density at the sternal region is lower than on palms, soles and fingertips, so signal amplitude is smaller. We compensate with the DC constant-voltage high-sensitivity scheme (roughly an order of magnitude above AC methods) and embed electrode rehydration and drift-control SOPs into the consumable instructions. Scientific validation should precede any medical certification discussion.

03 一板四贴：产品线矩阵One Board, Four Patches: Product Matrix

同一块 PCB · 差异仅在固件配置与选配位是否贴片 One PCB · differences limited to firmware config and optional footprints

SKU-A

3 电极心电贴3-electrode ECG patch

核心指标Core metrics3 导联 ECG · HRV · EDR3-lead ECG · HRV · EDR
目标场景Target动态心电筛查、术后心律失常、房颤筛查Ambulatory screening, post-op arrhythmia, AF screening
定位Positioning主流 · 现金流Mainstream · cash flow

SKU-B

4 电极多体征贴4-electrode multimodal patch

核心指标Core metricsECG + RR(BioZ) + SpO₂ + 皮温 + 体位ECG + RR (BioZ) + SpO₂ + skin temp + posture
目标场景Target住院 RPM、出院过渡期、慢病居家Inpatient RPM, discharge transition, home chronic care
定位Positioning主流 · 规模Mainstream · scale

SKU-C

5 电极血流动力学贴5-electrode haemodynamic patch

核心指标Core metricsSKU-B 全部 + ICG（SV/CO/TFC/PEP/LVET）All of SKU-B + ICG (SV/CO/TFC/PEP/LVET)
目标场景Target心衰院外管理、透析容量、休克早期预警Outpatient HF management, dialysis volume, early shock warning
定位Positioning差异化 · 高值（全球无成熟量产竞品）Differentiated · high value (no established commercial competitor)

SKU-D

EDA 双电极贴Dual-electrode EDA patch

核心指标Core metrics胸部 EDA（0.5 V 恒流）+ ECG 心电参考Chest EDA (0.5 V const.) + ECG reference
目标场景Target精神科自主神经剖面、化疗相关自主神经病变、应激科研Psychiatric autonomic profiling, chemotherapy-related autonomic neuropathy, stress research
定位Positioning差异化 · 学术与取证先导Differentiated · academic and regulatory pioneer

硬件规模效应：Hardware scale effect: 四款 SKU 使用同一块 PCB。差异仅在于固件配置切换，以及 ADS131A02 第二采集链是否贴片（仅 SKU-C/D 需要）。这意味着你可以先上一条产线，覆盖四个市场。 All four SKUs share one PCB. Differences are limited to firmware configuration and whether the ADS131A02 second acquisition chain is populated (needed only by SKU-C/D). One production line therefore covers four markets.

04 BioZ 四模式在胸贴上的分工 How the Four BioZ Modes Map onto the Patch

模式Mode	关键配置特征Key configuration	胸贴上的用途Use on the patch	适用 SKUSKUs
ICG 心阻抗图Impedance cardiography	≈100 kHz 高频激励、四电极法、高增益带宽≈100 kHz drive, four-electrode, wide gain bandwidth	每搏量 SV、心输出量 CO、胸液含量 TFC、射血前期 PEP、左室射血时间 LVETStroke volume SV, cardiac output CO, thoracic fluid content TFC, pre-ejection period PEP, left ventricular ejection time LVET	C
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	呼吸率 RR、潮气量趋势、心肺耦合分析Respiration rate RR, tidal-volume trend, cardiopulmonary coupling	B / C
GSR / EDA	0.5 V 恒流直流体系、双电极激励测量共用、高增益、高通旁路0.5 V constant-current DC, shared drive/sense electrodes, high gain, high-pass bypassed	胸段皮肤电导水平 SCL 与反应 SCR，反映交感-汗腺活动Thoracic skin conductance level SCL and responses SCR, reflecting sympathetic-sudomotor activity	D
BIA / BIS 阻抗谱Impedance spectroscopy	5 kHz – 500 kHz 多频扫描，需精确校准5 kHz – 500 kHz multi-frequency sweep, precise calibration required	胸腔阻抗谱参数（细胞外液电阻、细胞内液电阻、细胞膜电容、特征频率），用于体液与容量状态观察Thoracic impedance spectroscopy parameters (extracellular resistance, intracellular resistance, membrane capacitance, characteristic frequency) for fluid and volume-state observation	B / C
辅助模式Auxiliary Utility / BIST / Lead-Off / Lead-On	ECG 直流偏置诊断 / 内部标准电阻自检 / 导联脱落检测 / 佩戴唤醒ECG DC-offset diagnostics / internal reference self-test / lead-off detection / wear-on wake	全部数据质量门控的硬件基础（见科研平台页）The hardware basis for all data-quality gating (see the Research Platform page)	A–D

分时互斥是关键：Time-division exclusivity is the key: 阻抗谱扫描与搏动采样在时序上互斥，需固件精细调度。单芯片集成 BIS + ICG + ECG 的能力，使这种调度成为可能——分立器件方案很难做到严格的时序隔离与串扰抑制。 Impedance-spectrum sweeps and beat-by-beat sampling are mutually exclusive in time and require careful firmware scheduling. Single-chip integration of BIS, ICG and ECG makes this possible — discrete-component designs struggle to achieve strict timing isolation and crosstalk suppression.

05 注册与合规路径Regulatory & Compliance Path

事项Item	安排Approach
主机（中国） China — host	按第二类管理（心电类先行，走"动态心电记录仪"成熟分类）。ICG 与 EDA 功能以"辅助参考"措辞先行，持证后按需扩展。 Class II, ECG first along the established "ambulatory ECG recorder" classification. ICG and EDA functions are introduced with "adjunctive reference" wording, expanding after certification.
耗材（贴片） China — consumables	电极贴按第二类医用耗材单独注册；ISO 10993 生物相容性由贴片厂提供配套报告。 Electrode patches registered separately as Class II consumables; ISO 10993 biocompatibility reports supplied by the patch manufacturer.
安全标准 Safety standards	IEC 60601-1 + 60601-2-47（动态心电）。BioZ/EDA 引脚限流：EDA ≤ 10 µA，在 IEC 60601-1 直流限值内；BioZ 激励限流按芯片手册叠加保护元件。 IEC 60601-1 plus 60601-2-47 (ambulatory ECG). BioZ/EDA pin current limiting: EDA ≤ 10 µA, within IEC 60601-1 DC limits; BioZ drive limited per datasheet plus protection components.
海外路径 Overseas	FDA 510(k)：SKU-A/B 预测器械（predicate）充足；SKU-C 需明确阻抗心功能 + 动态心电的组合检索策略，备选 De Novo 路径。 FDA 510(k): SKU-A/B have ample predicates; SKU-C requires a defined combined-search strategy across impedance cardiography and ambulatory ECG, with a De Novo route as fallback.
软件 Software	按医疗器械软件注册审查指导原则；固件栈与 U 盘存储模式互斥设计沿用既有量产经验。 Follows medical device software review guidance; the firmware stack and its mutually-exclusive mass-storage mode design carry over proven production experience.