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产品总览与合规路径Product Overview & Regulatory Path

我们交付的不只是设备
还有可以直接引用的文件 We deliver more than a device
we deliver documents you can cite

对研发型科研团队来说，硬件只是起点。真正决定项目周期的是：这台设备的验证方法能不能写进方案、判定标准能不能写进论文、合规边界能不能被伦理委员会接受。我们把 SY-F100 的检验方法、判定标准、风险管理文件与软件描述文档整理成可直接引用的形式，让方案论证与伦理提交不必从零开始。 For a research-driven team, hardware is only the starting point. What actually determines the project timeline is whether the verification methods can go into a protocol, whether the acceptance criteria can go into a manuscript, and whether the regulatory boundary will pass an ethics board. We have organised SY-F100's test methods, acceptance criteria, risk-management file and software description into directly citable form, so protocol justification and ethics submission need not start from scratch.

产品矩阵Product portfolio 合规路径Regulatory path 资料包Dossier 联系我们Contact

一句话架构In one line

一套技术底座，三种佩戴形态，一份统一数据格式，一条合规路径。 One technical foundation, three wearable forms, one unified data format, one regulatory path.

1技术底座Foundation

3硬件产品Products

4BioZ 模式BioZ modes

10引用标准Standards

指套已定型Sleeve finalised 胸贴平台化Patch platform 戒指平台化Ring platform

01 三形态产品矩阵与注册状态Three Forms · Registration Status

形态不同，成熟度不同，定位也不同 Different forms, different maturity, different positioning

产品Product	形态定位Form factor	通道能力Channels	成熟度Maturity	当前注册状态Registration status
指套式多参数记录仪Finger-sleeve multi-parameter recorder SY-F100	手指佩戴，环形电极，单按键操作，LCD 本地显示Finger-worn, ring electrodes, single-button control, local LCD	ECG · PPG · EDA	已定型Finalised	中国二类有源，分类编码 07-04；技术要求已定稿，走免临床路径China Class II active, code 07-04; technical requirements finalised, clinical-exemption route
胸贴小主板Chest patch core board 1 board · 4 patches	主板不接触皮肤，SNAP 接口连接一次性贴片，按贴选通道Board never touches skin; SNAP interface to disposable electrodes, channels selected by patch	ECG · BioZ · PPG · TEMP	平台化Platform	主板为平台硬件；按具体贴型分别取证，可优先以科研用途导入Board is platform hardware; each patch variant certified separately, research-use import first
智能戒指 FPC 主板Smart-ring FPC core board 1 board · 3 rings	柔性板卷曲成型，内外电极同层分时复用，5–7 天续航Flex board rolled into shape; inner/outer electrodes time-multiplexed on one layer; 5–7 day battery	PPG · ECG · EDA · TEMP	平台化Platform	FPC 主板为平台硬件；三款面壳按功能分别定义与取证FPC board is platform hardware; three shells defined and certified per function

为什么指套先定型Why the sleeve matured first

手指是同时容纳 ECG 环形电极、PPG 反射光路与 EDA 双电极的最佳单一佩戴位点；面积与刚性也最适合做首次完整验证。 The finger is the single best wear site for combining ECG ring electrodes, a reflective PPG path and EDA electrode pairs; its area and rigidity also suit a first full validation.

为什么胸贴做成"一板四贴"Why the patch is "one board, four patches"

胸部位点决定通道组合。把主板与接触件解耦，一块主板通过贴片内嵌识别电阻自动切换通道，避免为每个适应症重做整机。 The chest site dictates the channel combination. Decoupling board from contact part lets one board auto-switch channels via an ID resistor in the patch — no new device per indication.

为什么戒指只做三类功能Why the ring supports only three functions

戒指的价值在"7×24 h 不间断"，而不是通道数量。克制的功能边界换来更长的续航，也换来更低的注册复杂度。 The ring's value is 7×24 h continuity, not channel count. A restrained feature boundary buys longer battery life and lower certification complexity.

02 合规路径与取证节奏Regulatory Path & Certification Rhythm

先立"采集"边界，再谈功能扩展 Establish the acquisition boundary first, then extend

路径 A · 中国市场（已规划）Path A · China market (planned)

产品定性Product classification — 第二类有源医疗器械，分类编码 07-04（生理参数监护设备）。 Class II active medical device, classification code 07-04 (physiological parameter monitoring).

技术要求定稿Technical requirements finalised — 逐条给出性能指标、检验方法与判定标准，可直接用于注册检验送检。 Clause-by-clause performance specifications, test methods and acceptance criteria, ready for type testing.

免临床论证Clinical-exemption justification — 预期用途严格限定在"采集、显示、存储、传输"，不涉及自动分析与诊断，论证链条完整。 Intended use strictly limited to acquisition, display, storage and transmission — no automated analysis or diagnosis — giving a complete justification chain.

注册检验与体系核查Type testing and QMS audit — 电气安全、EMC、环境试验、生物相容性按标准全项覆盖。 Full coverage of electrical safety, EMC, environmental testing and biocompatibility to standard.

路径 B · 欧美研发型使用（推荐入口）Path B · EU/US research use (recommended entry)

科研用途定位Research-instrument positioning — 在取得目标市场注册前，以科研测量设备身份进入实验室，用于方法学验证与初步数据积累。 Before target-market registration, enter the lab as a research measurement instrument for methods validation and initial data collection.

证据积累Evidence accumulation — 用真实的信号质量、时间同步与数据完整性指标，支撑后续算法论文或临床方案。 Use real signal quality, time synchronisation and data-integrity metrics to underpin later algorithm papers or clinical protocols.

算法与软件路径Algorithm & software route — 科研团队自行开发的算法可独立作为医疗器械软件（SaMD）申报，硬件作为其数据源。 Algorithms built by the research team can be filed independently as software as a medical device (SaMD), with our hardware as the data source.

硬件注册升级Hardware registration upgrade — 在证据充分后，按 FDA 510(k) / De Novo 或欧盟 MDR 路径推进硬件注册。 Once evidence is sufficient, pursue hardware registration via FDA 510(k)/De Novo or EU MDR.

关于"硬件先行、认证随行"：On "hardware first, certification in step": 我们的定位是让科研团队不必等待完整的医疗器械注册证才能开始研究。硬件在信号质量、时间同步与数据完整性上按医疗器械标准设计与验证，而功能宣称保持克制——这使得同一套硬件既能服务科研，也能作为后续注册的工程基线。 Our aim is that research teams should not have to wait for a full medical-device certificate before starting work. The hardware is designed and verified to medical-device standards in signal quality, time synchronisation and data integrity, while functional claims stay restrained — so the same hardware serves research today and becomes the engineering baseline for registration later.

03 规范性引用标准Normative Standards Referenced

可直接用于伦理提交与方案论证 Directly usable in ethics submissions and grant justification

#	标准编号Standard	名称Title	适用产品Applies to
1	GB 9706.1-2020	医用电气设备第 1 部分：基本安全和基本性能通用要求Medical electrical equipment — Part 1: General requirements for basic safety and essential performance	三形态整机All three forms
2	YY 9706.102-2021	医用电气设备第 1-2 部分：电磁兼容要求和试验Medical electrical equipment — Part 1-2: EMC requirements and tests	三形态整机All three forms
3	GB/T 16886.1-2022	医疗器械生物学评价第 1 部分：风险管理过程中的评价与试验Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process	接触皮肤部件Skin-contact parts
4	GB/T 16886.5-2017	生物学评价第 5 部分：体外细胞毒性试验Biological evaluation — Part 5: Tests for in vitro cytotoxicity	电极、指套、贴片材料Electrodes, sleeve, patch materials
5	GB/T 16886.10-2017	生物学评价第 10 部分：刺激与皮肤致敏试验Biological evaluation — Part 10: Tests for irritation and skin sensitisation	长期接触皮肤部件（戒指）Long-contact parts (ring)
6	YY 9706.247-2021	医用电气设备第 2-47 部分：动态心电图系统专用要求Medical electrical equipment — Part 2-47: Particular requirements for ambulatory electrocardiographic systems	ECG 通道（指套、胸贴、戒指）ECG channel (all forms)
7	YY 9706.261-2023	医用电气设备第 2-61 部分：脉搏血氧设备专用要求Medical electrical equipment — Part 2-61: Particular requirements for pulse oximeters	SpO₂ 通道（指套、胸贴、戒指）SpO₂ channel (all forms)
8	ISO 20495:2018	传统医学 — 皮肤电阻测量设备Traditional Chinese medicine — Skin electrical resistance measurement devices	EDA 测量原理与性能测试框架EDA principle & performance test framework
9	GB/T 14710-2009	医用电器环境要求及试验方法Environmental requirements and test methods for medical electrical equipment	三形态整机All three forms
10	YY/T 0316-2016	医疗器械风险管理对医疗器械的应用Medical devices — Application of risk management to medical devices	三形态全生命周期Full lifecycle, all forms
11	IEC 60601-1	医用电气设备第 1 部分：基本安全和基本性能通用要求（国际版）Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (international)	海外注册与测试对齐Overseas registration alignment
12	IEC 60601-1-2	医用电气设备第 1-2 部分：电磁干扰要求和试验（国际版）Medical electrical equipment — Part 1-2: Electromagnetic disturbances (international)	海外 EMC 对齐Overseas EMC alignment

上表 12 项中，1–10 为国内注册路径的规范性引用；11–12 为国际版对应标准，用于海外测试报告与方案对齐。全部标准编号与名称均为原文引用，可直接写入伦理申请与基金申请的方法学章节。 Of the 12 entries above, 1–10 are the normative references for the China registration path; 11–12 are the international counterparts used to align overseas test reports and protocols. All standard numbers and titles are quoted verbatim and can be written directly into the Methods section of ethics and grant applications.

04 可提供的注册与验证资料包Registration & Verification Dossier Available

按需提供，签署保密协议后交付 Provided on request under NDA

A · 产品技术要求（完整版）A · Product technical requirements (full)

第 3 章结构组成：整机分层结构、元器件清单、佩戴分区定义。 Ch. 3 Structure: layered assembly, bill of components, wear-zone definitions.
第 4 章硬件规范：关键器件参数与选型依据。 Ch. 4 Hardware: key component parameters and selection rationale.
第 5–8 章通道指标：整机通用性能、ECG、PPG、EDA 逐条指标 + 检验方法 + 判定标准。 Ch. 5–8 Channels: general performance, ECG, PPG, EDA — clause-level specification + test method + acceptance criterion.
第 9 章同步性：跨通道时间对齐指标与验证方法。 Ch. 9 Synchronisation: cross-channel time-alignment metrics and verification.
第 10–16 章：电气安全、EMC、软件、环境、外观、包装、检验规则。 Ch. 10–16: electrical safety, EMC, software, environment, appearance, packaging, inspection rules.

B · 配套技术文件B · Supporting technical documents

文件Document	内容Contents
统一数据格式规范 V3.0Unified Data Format Spec V3.0	三层架构、四种帧型、通道注册表、时间戳体系、PC 端解析接口Three-layer architecture, four frame types, channel registry, timestamp system, PC-side parsing API
单按键与 UI 设计说明Button & UI Design Description	按键状态机、四种角色定义、界面命名规范、UART 命令集Button state machine, four roles, UI naming convention, UART command set
风险管理文件Risk Management File	按 YY/T 0316-2016 编制的危害分析、风险控制措施与验证记录Hazard analysis, risk-control measures and verification records per YY/T 0316-2016
软件描述文档Software Description Document	软件安全性级别、体系结构、开发环境、验证与确认方法Software safety class, architecture, development environment, V&V methods
检验方法要点说明Test Method Notes	每项指标对应的测试装置、测试条件与重复次数Test setup, conditions and repeat counts for each specification
标准化数据样例集Standardised sample dataset	V3.0 格式的真实多通道样例数据，可用于解析器开发与算法调试Real multi-channel sample data in V3.0 format, for parser development and algorithm debugging

对科研团队的实用价值：Practical value for research teams: 上述文件可直接支撑三类场景——① 伦理申请中"测量设备"章节的描述；② 论文方法学部分的设备与信号质量说明；③ 自研算法作为医疗器械软件申报时的硬件数据源依据。我们不需要你重新验证硬件，只需要你专注在算法与研究问题上。 These documents directly support three scenarios — (1) the "measurement device" section of an ethics application; (2) the device and signal-quality description in a manuscript's Methods; (3) the hardware data-source basis when filing a self-developed algorithm as SaMD. You do not need to re-validate the hardware; you only need to focus on the algorithm and the research question.

05 预期用途与合规边界Intended Use & Regulatory Boundary

与产品技术要求保持完全一致 Fully consistent with the product technical requirements

预期用途：Intended use: 用于医疗机构或家庭对患者进行无创心电信号（ECG）、脉搏血氧饱和度（SpO₂）、皮肤电导信号（EDA）的采集、显示、存储及传输。 Non-invasive acquisition, display, storage and transmission of ECG, SpO₂ and EDA signals for patients in clinical or home settings.

合规边界（重要）：Regulatory boundary (important): SY-F100 为第二类有源医疗器械（分类编码 07-04 生理参数监护设备）。本产品不具备自动分析、自动诊断或临床评估功能，所采集的数据仅供临床医师结合其他检查结果综合解读，不单独作为临床诊断或治疗决策的依据。胸贴与戒指主板为平台化硬件设计，具体功能与宣称以对应注册证为准。 SY-F100 is a Class II active medical device (classification code 07-04, physiological parameter monitoring equipment). It performs no automated analysis, diagnosis or clinical assessment; acquired data must be interpreted by a clinician alongside other findings and must not serve alone as the basis for diagnosis or treatment decisions. The chest-patch and ring core boards are platform hardware designs; their features and claims are governed by their respective registrations.

我们做What we do

信号的采集、显示、存储、传输Acquire, display, store, transmit signals
硬件级信号质量控制与标记Hardware-level signal-quality control and marking
统一时间戳与统一数据格式Unified timestamps and data format

我们不做What we do not do

自动诊断或病情判读Automated diagnosis or condition interpretation
治疗或干预输出Therapy or intervention output
在方法学中充当"评估工具"Act as an "assessment tool" in Methods

论文写作建议Manuscript writing note

方法学中建议表述为"多通道信号采集设备（finger-sleeve multimodal acquisition device）"，并给出采样率、同步精度与质量门控位图的使用方式。 In Methods, describe it as a "finger-sleeve multimodal acquisition device" and report sample rates, synchronisation accuracy and how the quality-gate bitmap was used.

对研究设计的三点实际影响Three practical implications for study design

伦理审查更顺畅：设备不产生诊断性结论，属于测量工具范畴，审查关注点集中在数据安全与受试者权益，而非临床有效性。 Smoother ethics review: the device produces no diagnostic conclusion and falls under measurement instruments; review focuses on data security and subject rights rather than clinical efficacy.
方法学可复用：统一数据格式使不同采样率、不同设备的信号可以在同一时间轴上融合，方案中的同步描述不必逐设备重写。 Reusable methodology: the unified format lets signals at different rates and from different devices fuse on one timeline, so the synchronisation description need not be rewritten per device.
后续申报不冲突：研究阶段的科研用途使用不会妨碍后续硬件注册；反之，研究积累的证据正是注册时最有价值的支撑材料。 No conflict with later filing: research-use deployment does not hinder later hardware registration; on the contrary, the evidence gathered is the most valuable support material for it.

06 商务与样品Business & Samples

评估套件可提供，资料包签署保密协议后交付 Evaluation kits available; dossier delivered under NDA

评估套件（Evaluation Kit）Evaluation Kit

面向研发型科研团队的入门通道。包含已完成定型的指套整机、V3.0 数据格式规范、标准化样例数据集与 PC 端解析接口示例代码，开箱即可开始信号采集与算法调试。 The entry channel for research-driven teams. Includes a finalised finger-sleeve device, the V3.0 data-format specification, a standardised sample dataset and PC-side parsing reference code — start acquiring and debugging out of the box.

内容物Contents指套整机 × 1、数据规范、样例数据、解析代码1 × sleeve device, data spec, sample data, parser code
适用对象For高校课题组、科研院所、算法团队University groups, research institutes, algorithm teams
交付周期Lead time按项目排期，请先沟通Scheduled per project — please enquire first

开始对话时请告诉我们When you get in touch, please tell us

研究问题与场景Research question and setting — 关注哪一类生理信号或人群，预期在什么场景下采集。 Which physiological signals or population, and in what setting you expect to acquire.

所需形态与通道Required form and channels — 指套 / 胸贴 / 戒指，以及需要的通道组合。 Sleeve / patch / ring, and the channel combination needed.

合规需求Compliance needs — 是否用于伦理申请、是否需要出具测试报告或标准符合性说明。 Whether it feeds an ethics application, and whether test reports or standards-conformance statements are needed.

时间预期Timeline expectations — 项目阶段、样本规模与关键节点。 Project stage, sample scale and key milestones.

公司的研发与制造基地：R&D and manufacturing base: 广西桂林守月科技有限公司。硬件设计、生产与底层软件开发在同一团队内闭环，因此接口调整、固件适配与批量交付可以快速响应。 Guangxi Guilin Shouyue Technology Co., Ltd. Hardware design, production and low-level software development close the loop within one team, so interface changes, firmware adaptation and volume delivery respond quickly.