Current STEP-backed mechanical reference · 2026-07-19
Every part retained. Every clearance inspectable.
The CBM G1 engineering package now includes the actual populated Biocoin envelope, upstream-exact dock headers, a full guarded daughterboard, retained cartridge connector, offset battery cradle and harness, board clips, hard stops, gaskets, latches, source materials, and the gates that prevent nominal CAD from becoming a medical claim.
A passed stage unlocks only the next engineering stage. It never automatically unlocks skin wear.
Gate E
Electrical truth
≤0.5 mV loading error at 1 GΩ; settled cross-talk, temperature, humidity, BLE, and charge checks.
Gate C
Chemistry
Three independent commercial arrays; ladders, residuals, interference, drift, and post-run calibration.
Gate Q
Quality behavior
Every induced fault suppresses the intended output while retaining the labeled raw trace.
Gate M / W0
Mechanical + integrated
Contact, ingress, insertion, fracture, isolation, and full artificial-ISF repeat on the real cartridge.
CP-01
Guarded interface daughterboard
Custom PCB
Frozen specification
EnvelopeØ38 × 0.8 mm full disc
ChannelsNa, K, pH, blank, RE-A, RE-B
Front end6 × LMP7721 + ADS124S08
Upward2×10 + 2×8 Mill-Max 855 dock headers
Downward12-position Mill-Max 817 connector
Release gate: 1.25 mm nominal package edge clearance; ≤0.5 mV loading at 1 GΩ; 6.08 mm Biocoin and 2.24 mm cartridge working heights; reviewed schematic/layout before RFQ.
Manufacturing sequence
Route six guarded islands at radius 15.8 mm and keep each unbuffered run under 8 mm.
Place LMP7721 followers, central ADS124S08, four published dock footprints, and the retained cartridge connector.
Assemble, ionically clean, bake, and verify header/connector coplanarity.
Seat Biocoin in four shell-supported edge clips, compressing J3/J4/J7/J8 by 0.70 mm.
Measure loading, crosstalk, humidity, radio, and charge-state behavior after full mating.
PANI: 0.1 M aniline in 0.1 M HCl; CV −0.2→+1.0 V, 100 mV/s, 30 cycles.
The blank matches the physical stack relevant to the validated use while omitting recognition chemistry.
No single blank is allowed to “correct” every analyte without a dedicated experiment.
Method boundary: the dopamine–hyaluronic-acid hydrogel ketone route and a P4VP patent embodiment are separate. G1 does not blend them and call the hybrid published.
Release: 0.81 mm battery/component gap, 1.05 mm ceiling gap, 2.31 mm full-Raytac-body keepout, no ingress or insertion-load transfer.
Prototype sequence
Import and center the actual populated Biocoin STEP, not a board envelope.
Print the lower chassis, four clips, hard stops, battery cradle, and top cap in Tough 1500 for fit only.
Install tabbed CP1240 leads through JST ACHR-02V-S; never solder the cell.
Run 500 mate/demate, shell closure, motion, ingress, latch-load, and phantom-insertion tests.
Select production material and sterilization only through the device biological-risk program.
Live sourced BOM
Catalog, open, RFQ, or custom.
Search the engineering CSV. Links point to the manufacturer or primary open-hardware source; prices are intentionally not presented as live quotes.
Phase
Part / function
Manufacturer / part
Status
Critical specification
Source
Loading BOM…
Primary anchors
Methods trace back to sources.
The full evidence ledger is downloadable with the package.
BiocoinOpen multimodal reader, hardware, firmware, software, and STEP.npj Biosensing 2026 ↗eMPatch2×3 PS microneedle tiles, six-analyte rat platform, fabrication methods.Nano-Micro Letters 2026 ↗Human ketone microneedlepoly-TBO / HBD / NAD+ / CNT / chitosan / PVC process.ACS Sensors 2024 ↗Ketone drift warningSeven-person randomized study with progressive 14-day signal decline.JMIR Diabetes 2026 ↗Control-heavy human arrayEight cortisol molecular switches plus eight controls; n=3 + n=3.Diabetes 2026 ↗FDA investigational deviceIDE, NSR, exemption, and IRB decision framework.FDA guidance ↗
Non-negotiable boundary
Exact manufacturing notes are not a self-test protocol.
Bench work stops at artificial ISF, mechanical phantoms, and approved ex-vivo fixtures. A human microneedle study requires IRB review, the correct IDE/NSR or exemption determination, investigational labeling, informed consent, device-level biological evaluation, sterilization and packaging evidence, electrical and battery safety, comparators, monitoring, and adverse-event stop rules. Passing Gate W0 does not waive any of that.