SPEC-IDX-01Cross-system

Combined Specification Index

Flattened view of every published parameter, tolerance, and reference value across the RAS and BHF subsystems. Use this index as a single source of truth for downstream design reviews and requirement-trace matrices.

Autonomous Robotic Implantation SystemRAS · 9 subsystems

RAS-017-DOF Surgical ManipulatorREV B.2

Parameter	Value	Unit	Note
Degrees of freedom	7		Redundant S-R-S
Cartesian repeatability	±50	µm	ISO 9283-3
Joint pos. resolution	21	bit abs.	Output side
Motor encoder	23	bit abs.	Motor side
Max joint velocity	120	°/s	Joints 1–4
Max TCP velocity	500	mm/s	Software-limited to 80 mm/s in procedure mode
Payload at TCP	3.0	kg
Workspace radius	600	mm	Spherical
Harmonic drive ratio	100:1 / 50:1		J1–4 / J5–7
Servo type	Frameless BLDC		Slot-less for low cogging
Control loop rate	4	kHz	EtherCAT DC-sync
Structural alloy	7075-T6 Al		Hard-anodized Type II Class 2
IP rating	IP54		Procedure side

RAS-02Force-Feedback Micro-ActuationREV A.4

Parameter	Value	Unit	Note
Actuator type	Voice-coil (VCA)		Custom Lorentz coil
Carriage mass	8.4	g
Stroke length	15	mm
Peak force	6.0	N
Continuous force	2.4	N
Position resolution	0.5	µm	Linear optical scale
F/T sensor axes	6		Fx, Fy, Fz, Tx, Ty, Tz
Force resolution (Fz)	5	mN
F/T sample rate	8	kHz
Insertion depth tolerance	±50	µm
Closed-loop bandwidth	350	Hz
Skin-tension threshold	0.6	N	Triggers force-mode handoff

RAS-03Cranial Fixation Ring & Ergonomic FrameREV C.1

Parameter	Value	Unit	Note
Halo material	Ti-6Al-4V ELI (Grade 23)		ASTM F136
Halo mass	380	g
Contact stations	6		60° spacing
Pad material	Polyurethane Shore 30A
Max contact pressure	4.5	N/cm²
Fiducial diameter	9.5	mm
Fiducial sphericity	<100	µm
Registration RMS error	<120	µm
Drift over 4 h	<0.20	mm
Frame torque	8.5	N·m	All articulating joints
Sterilization	Autoclave 134 °C / 18 min		Halo + frame

RAS-048K Optical & ToF LiDAR ModuleREV B.0

Parameter	Value	Unit	Note
Sensor	IMX661-class CMOS		Global shutter, mono
Resolution	8192 × 4320		33.2 MP
Pixel pitch	3.45	µm
Max frame rate	60	fps	Full-frame, 10-bit
Lens	F/2.4, fixed 250 mm WD
Illumination	Cross-polarized LED ring		940 nm + 450/520/630 nm
LiDAR modality	Indirect ToF		64 × 64 array
Depth map output	4K @ 30	Hz
Surface accuracy	<200	µm
Cross-calibration	30 µm / 0.05°		Tsai-Lenz
Reprojection limit	0.25	px	Cal-reject threshold

RAS-05AI Follicle Classification & Matrix GenerationREV D.1

Parameter	Value	Unit	Note
Detection backbone	YOLOv8-seg		Custom 5-class head
Classification head	3-stage MLP		FU1/FU2/FU3/FU4 + reject
Training corpus	~1.4 M tiles		Fitzpatrick I–VI
Inference latency	60	ms	TensorRT FP16
[email protected] (detection)	0.93		Hold-out test set
FU classification F1	0.91
Angle MAE	4.7	°
Min inter-implant spacing	0.8	mm
Target density	25–40	FU/cm²
Sampler	Poisson-disk + vMF KDE

RAS-06Micro-Needle Injector & Follicle CartridgeREV B.3

Parameter	Value	Unit	Note
Needle gauge	27 G		Thin-wall
Needle OD	0.413	mm
Needle ID	0.21	mm
Bevel angle	12	°	Back-bevel
Tip Ra	<0.2	µm	Electropolished
Reservoir cells	200		Rotary indexer
Well dimensions	Ø0.9 × 4	mm
Preservation medium	Hypothermosol-FRS		3.5 µL / well
Coupling repeatability	±10	µm	Kinematic 3-ball
Sterilization	Gamma 25–40 kGy		Per ISO 11137
Shelf life	18	months	RFID-verified expiry
Class	IIa		EU MDR

RAS-07Safety, Redundancy & Standards AlignmentREV A.6

Parameter	Value	Unit	Note
Functional safety target	PL d		ISO 13849-1
Hardware fault tolerance	1		HFT
Safety MCU	Dual-channel lockstep		SIL-2 micro-kernel
E-stop category	1		IEC 60204-1
Brake engage time	<25	ms
Collision threshold (F/T)	0.4	N
Capacitive prox. range	5–20	mm
Encoder redundancy	2× abs. per joint
Standards	IEC 60601-1, 60601-2-77, ISO 13482, ISO 14971
Cyber-security	IEC 81001-5-1		Premarket

RAS-08Sterilization Workflow & Sterile FieldREV A.2

Parameter	Value	Unit	Note
Autoclave cycle	134 °C / 18 min		ISO 17665, halo + frame + shroud
VHP cycle	STERRAD 100NX std		Sensor head + electronics shroud
Gamma dose	25–40	kGy	Cartridges only
Validated SAL	10⁻⁶		Per ISO 11137 / 17665
Bellows leak threshold	0.5	kPa
Reprocessing cycles	≥ 200		Mechanical hardware lifecycle

RAS-09Maintenance Access & Service StrategyREV A.0

Parameter	Value	Unit	Note
Joint LRU swap time	<90	s
Harmonic drive service interval	10 000	h
Flex-spline backlash limit	0.05	°
Telemetry channels	142		Prometheus, 2 Hz
MTBF target	20 000	h
Annual PM duration	4	h
Brake torque (min)	14	N·m

Bio-Engineered Hair FollicleBHF · 8 subsystems

BHF-01Bulge Epithelial Stem CellsREV C.0

Parameter	Value	Unit	Note
Source	Autologous occipital		2 mm punch
Sort markers	CD200⁺ / K15⁺ / K19⁺ / α6ʰⁱ		FACS
Yield	1.2–2.0 × 10⁴	cells/FU
Expansion medium	KSFM + EGF/bFGF/Y-27632
Feeder layer	Irradiated 3T3-J2		±60 Gy
Passage limit	≤ P4
Doubling time	24–30	h
Clonogenicity	≥ 12	% holoclones	P4

BHF-02Dermal Papilla Cells & Inductive SignalingREV C.2

Parameter	Value	Unit	Note
Source	Autologous donor follicles
Spheroid size	180	µm	3000 cells/well, 72 h
Inductive markers	ALP, versican, corin, α-SMA
Inductivity restoration	≥ 70	% native signature
Co-graft validation	≥ 8 shafts / chamber		NSG mouse, day 21
Passage limit	≤ P3 (2D) / P6 (spheroid)

BHF-03Epithelial–Mesenchymal Co-cultureREV B.4

Parameter	Value	Unit
Aggregate composition	8–10k eHFSCs + 1 DP spheroid
Wnt activator	CHIR99021 3 µM
BMP inhibitor	LDN-193189 100 nM
FGF	FGF7 10 ng/mL
Shh agonist	SAG 50 nM
Cocktail window	0–6	days
Day-7 QC threshold	≥ 60 % LEF1⁺/SOX9⁺

BHF-04Crosslinked Hyaluronan Hydrogel ECMREV B.1

Parameter	Value	Unit	Note
Base polymer	Methacrylated HA		Methacrylation DS ≈ 25 %
Crosslinker	4-arm PEG-dithiol
Photoinitiator	LAP 0.05 % w/v
Cure	405 nm / 5 mW/cm² / 60 s
Storage modulus G′	1.2	kPa	1 Hz, 37 °C
Loss tangent (tan δ)	<0.10		1 Hz
RGD density	1.5	mM
Degradation t½	~14	days	Hyaluronidase mediated
Cell viability post-cure	>95	%

BHF-05PLGA/PCL Micro-scaffold with Gradient StiffnessREV D.0

Parameter	Value	Unit	Note
Polymer system	PLGA 75:25 + PCL		Gradient ratio
Fabrication	Melt-electrowriting (MEW)		In-house 8-axis MEW
Scaffold dim.	Ø0.9 × 4	mm
Fiber diameter	18 ± 3	µm
Pore size	50–150	µm	µCT-validated
Apical modulus	1.8	MPa	Compressive
Basal modulus	0.18	MPa
PLGA t½ in vivo	~6	weeks
PCL persistence	>12	weeks
Endotoxin	<0.5	EU/device	LAL test

BHF-06Angiogenic & Immunomodulatory CargoREV B.0

Parameter	Value	Unit	Note
Microsphere polymer	PLGA 50:50
Microsphere diameter	12 ± 2	µm
VEGF-165 loading eff.	78–85	%
PDGF-BB loading eff.	81	%
TGF-β3 loading eff.	72	%
IL-10 loading eff.	84	%
24 h burst	22	%
Cumulative day 21	85	%
Local VEGF target	50–100	ng/mL	Day 3–10
Macrophage polarization	>65 % M2		Day 10

BHF-07Implantation, Vascularization & Maturation TimelineREV B.3

Parameter	Value	Unit	Note
Implant depth	1.4	mm	Below surface, reticular dermis
Capillary sprouting	D3–7
Anastomosis	D10–14
Full perfusion	D14–21
First shaft emergence	26.4 ± 1.8	d	n = 12 large-animal
Engraftment rate	≥ 92	%	Day 28

BHF-08Immune Compatibility & BiocompatibilityREV A.5

Parameter	Value	Unit	Note
Rejection risk	Minimal		Autologous cellular fraction
Biocomp. standard	ISO 10993-1		+ subordinate -5/-6/-10/-11/-23
Endotoxin limit	<0.5	EU/device
Pyrogenicity	MAT (Ph. Eur. 2.6.30)
M2 macrophage ratio	>65	%	Day 10 local infiltrate
Capsule thickness	<80	µm	Day 28 histology