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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Technical Construction File — Neura Vital Patch
Status
Draft
Applicable Regulations to Evaluate
- FCC Part 15 intentional radiator
- CE RED
- ISED Canada
- UKCA
- IEC 60601-1 / IEC 60601-1-2 if medical electrical equipment
- EU MDR / FDA pathway depending claims
Product Description
Skin-worn wireless biosensing patch with BLE telemetry, LiPo charging, ECG/PPG/contact/electrochemical sensing, and flexible electrode/microfluidic interfaces.
Wireless Technology Summary
Table
| Module | MPN | Technology | Frequency Band | Pre-certified? | Notes |
|---|---|---|---|---|---|
| U1 | MDBT50Q-1MV2 | BLE / 2.4 GHz multiprotocol nRF52840 module | 2.4 GHz ISM | Vendor certification expected; verify exact grant for purchased variant | Antenna keepout and final host-product testing still required. |
Required Documentation Checklist
- Draft schematic in Flux.
- Draft BOM in Flux.
- Block diagram in Project Specification.
- RF module selection and antenna-placement notes.
- Preliminary FMEA.
- Final PCB layout / Gerbers.
- RF module datasheet and certification grant file archived.
- Accredited EMC/RF test reports.
- User manual and labeling.
- Final Declaration of Conformity.
RF Design Notes
- Place MDBT50Q antenna at an outer board/flex edge.
- Maintain vendor antenna keepout: no copper, battery, components, electrodes, or ground under antenna region.
- Validate BLE range on-body, with sweat/adhesive stack, and with battery installed.
- Use secure BLE pairing/bonding/encryption for health data.
Draft Declaration of Conformity Text
Aumevia declares that the draft product concept Neura Vital Patch is intended to conform to applicable radio and safety requirements when finalized and tested. This draft is not a legal declaration and cannot be used for product release before accredited testing and regulatory review.
Authorized signatory: TBD
Date: TBD
Date: TBD
Open Items / Action Required
- Confirm exact module certification IDs for MDBT50Q-1MV2 lot/variant.
- Determine final medical/wellness claims and applicable regulatory pathway.
- Produce final user warnings: not for diagnosis, no sensing while charging unless isolated, battery/skin temperature warnings.
2026-07-27 Regulatory / Safety Architecture Update
- Hardware USB-forced patient disconnect has been added at schematic level using Q1/R25/R26/R27/R28 to force PATIENT_SW_CTRL low whenever USB_VBUS is present.
- LiPo charge current is now conservatively set to ~100 mA using R4 = 8.87 kΩ on BQ24074 ISET; RT1 10 kΩ NTC is now the active TS sensing element.
- This does not establish IEC 60601 compliance: patient leakage, single-fault behavior, USB attach/detach transients, ESD, thermal rise, and applied-part classification still require formal testing.
- Final layout is not manufacturing-ready: 26 airwires remain and J1 USB-C same-net pad geometry requires manufacturer review.
2026-07-27 Manufacturing Readiness Update
- A 6-layer rigid-flex routing assumption was applied and the AD5940 island was re-placed with bottom-side support capacitors.
- Final export was not generated because DRC still reports 24 airwires.
- Manufacturer review required before next routing freeze: 6-layer rigid-flex stackup, 75 µm trace/space capability, 0.45/0.20 mm via baseline, laser microvia/via-in-pad options for AD5940, USB-C same-net pad geometry, and bottom-side passives near the skin/enclosure stack.
Status
Applicable Regulations to Evaluate
Product Description
Wireless Technology Summary
Required Documentation Checklist
RF Design Notes
Draft Declaration of Conformity Text
Open Items / Action Required
2026-07-27 Regulatory / Safety Architecture Update
2026-07-27 Manufacturing Readiness Update
