Wearable Health Patch
Worked for 30 sec
Prepared the PCBWay DFM submission materials and regenerated the STEP model. I can’t submit to PCBWay directly from Flux, but these files are ready for you to upload to PCBWay’s rigid-flex/HDI quote channel for engineering feedback.
Project files:
Upload package:
- neura-vital-patch-gerbers.zip
- pcbway-dfm-review-request-neura-vital-patch.md
3D Model (STEP)
Failed to load 3D model
Open items:
- Final assembly is still incomplete: DRC has unresolved airwires.
- Use these files for PCBWay engineering review only, not fabrication release.
- After PCBWay provides the approved stackup/via table, manually finish AD5940/ADS1292 fanout, clear airwires, rerun DRC, then regenerate final exports.
Start Auto-Layout
Thought for 13 sec
I’ll inspect the current PCB state, determine whether placement, routing, or both need work, then run the appropriate auto-layout operations and verify the applied result.
Thought for 22 sec
Blocked: your account currently has no available ACUs, so AI inspection and auto-layout operations are unavailable.
Current known project state:
- 6-layer rigid-flex working layout.
- AD5940 support placement previously reorganized.
- PCBWay HDI-oriented rules applied.
- Last verified state had 24 unresolved airwires.
No PCB changes were made in this session. Remaining work is to inspect the latest board state, determine whether placement and/or routing is needed, run auto-layout, apply the result, and verify DRC once ACUs are available.
Check ACU balance
List airwires
Check DRC/ERC
Manual placement review
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Design History File — Neura Vital Patch
Status
Draft
Applicable Standards / Frameworks to Evaluate
- FDA 21 CFR Part 820 / QMSR
- ISO 13485 quality management
- ISO 14971 risk management
- IEC 60601-1 medical electrical safety
- IEC 60601-1-2 EMC
- IEC 60601-1-11 home healthcare environment, if applicable
- IEC 62304 software lifecycle
- IEC 62366 usability engineering
- ISO 10993 biocompatibility for skin-contacting materials
- Cybersecurity/privacy requirements for BLE medical data
Device Classification
TBD. The hardware includes patient-contact electrodes and wireless telemetry. Likely classification depends on claims:
- Wellness/research physiological data collection: lower risk but still safety-critical.
- ECG monitoring, glucose/lactate quantification, SpO2, or blood-pressure claims: higher regulatory burden and likely clinical validation.
Intended Use
Skin-worn battery-powered multimodal biosensing patch for ECG/PPG/contact/electrochemical research and development. Diagnostic, treatment, blood-pressure, and blood-glucose claims are not validated in this revision.
Design Inputs
Table
| ID | Requirement | Current Implementation | Status |
|---|---|---|---|
| DI-001 | BLE wireless telemetry | MDBT50Q-1MV2 nRF52840 module | Draft |
| DI-002 | Battery-powered operation | LiPo connector + BQ24074 + buck-boost rails | Draft |
| DI-003 | USB charging | USB-C sink + BQ24074 | Draft |
| DI-004 | ECG acquisition | ADS1292R + FPC electrodes + protection | Draft |
| DI-005 | PPG heart-rate acquisition | MAX30102 | Draft |
| DI-006 | Lactate/glucose electrochemical acquisition | AD5940 + FPC electrodes | Research only |
| DI-007 | Contact/pressure sensing | Honeywell MPRLS0300YG00001B | Draft |
| DI-008 | Motion artifact data | KX022-1020 | Draft |
| DI-009 | Patient safety during USB | Analog switches + firmware control; hardware USB-force-disconnect still open | Incomplete |
| DI-010 | Battery safety | Charger TS net provisioned; battery protection/NTC finalization open | Incomplete |
Risk Analysis Summary
See the separate Preliminary FMEA. Highest risks are patient leakage during USB connection, LiPo thermal/safety, invalid clinical claims from sweat glucose/lactate and cuffless BP, and high-impedance biosignal susceptibility.
Design Outputs
- Draft schematic architecture in Flux.
- Component selection and power budget document.
- Draft project specification.
- Preliminary regulatory/safety documentation.
- Final PCB layout and routing.
- Production BOM with finalized passives/MPNs.
- Firmware verification package.
- Clinical/bench validation protocols.
- Biocompatibility material stack.
Verification & Validation Plan
Table
| Requirement | Verification Method | Status |
|---|---|---|
| Power rails | Bench bring-up, DMM/scope ripple | Planned |
| BLE telemetry | SWD flash + BLE advertising + data notify | Planned |
| ECG | ECG simulator + lead-off/contact tests | Planned |
| PPG | Optical fixture + motion/pressure tests | Planned |
| Electrochemical | Dummy cell + calibrated chemistry samples | Planned |
| Pressure/contact | Pressure source/calibrator | Planned |
| Battery charging | USB current limit, thermal rise, charge profile | Planned |
| USB patient safety | Leakage/current path test in USB attached and fault states | Planned |
Traceability Matrix
Table
| Requirement | Schematic Output | Verification | Status |
|---|---|---|---|
| DI-001 | U1, J5, BLE antenna placement constraint | Firmware BLE test | Draft |
| DI-002 | J2, U2, U3, U4, C/L/R support | Power rail test | Draft |
| DI-004 | U5, J3, R16–R18, D3, U11 | ECG simulator | Draft |
| DI-006 | U7, J4, R19–R24, D3, U12/U13 | Dummy cell/calibration | Research |
| DI-009 | U11–U13, PATIENT_SW_CTRL | USB attached safety test | Incomplete |
Open Items
- Decide exact medical claim category and regulatory path.
- Add hardware USB-forced patient disconnect if sensing while USB attached is physically possible.
- Finalize skin-contact materials and single-use/reusable strategy.
- Validate electrode chemistry, pressure-contact mechanics, and optomechanical PPG stack.
2026-07-27 Design Decision Record
- DI-009 status updated: hardware USB-forced disconnect is now implemented with Q1/R25/R26/R27/R28. Verification remains open until bench leakage/current-path testing proves patient switch paths are disabled with USB attached.
- DI-010 status updated: RT1 10 kΩ NTC added on BQ24074 TS; R4 ISET set to 8.87 kΩ for ~100 mA charging. Final LiPo cell capacity, protected-pack choice, NTC placement, and thermal validation remain open.
- Layout verification status: partial routing only; 26 airwires remain after cleanup. Final PCB layout output remains incomplete.
2026-07-27 Layout Decision Record Update
- Decision: move from 4-layer routing concept to a 6-layer rigid-flex routing assumption because the AD5940 0.4 mm pitch BGA/WLCSP and mixed analog/digital routing remained congested.
- Decision: allow selected bottom-side 0402 passives in the AD5940 rigid island to improve fanout and reference/decoupling loop placement.
- Verification result: final reroute still has 24 airwires, so final PCB output remains incomplete and manufacturing export is blocked.
- Open design input: select a fabricator and lock supported trace/space, via, microvia, via-in-pad, flex bend, and bottom-side assembly constraints.
Status
Applicable Standards / Frameworks to Evaluate
Device Classification
Intended Use
Design Inputs
Risk Analysis Summary
Design Outputs
Verification & Validation Plan
Traceability Matrix
Open Items
2026-07-27 Design Decision Record
2026-07-27 Layout Decision Record Update
