Auniontech Aut-S200 Fabry–Pérot Cavity Medical Pressure Sensor

Overview

The Auniontech Aut-S200 Fabry–Pérot Cavity Medical Pressure Sensor is a miniature, fiber-optic-based pressure transducer engineered for high-fidelity, real-time intracorporeal pressure monitoring in clinical, preclinical, and biomedical research settings. Unlike conventional piezoresistive or capacitive sensors, the Aut-S200 leverages optical interferometry within a micro-machined Fabry–Pérot cavity formed between two parallel reflective surfaces on a silicon-on-insulator (SOI) MEMS diaphragm. Pressure-induced axial deformation of the diaphragm alters the cavity length, resulting in a wavelength shift of the reflected interference fringe — a parameter measured with sub-picometer resolution by a dedicated optical interrogator. This all-optical architecture eliminates electrical signal paths at the sensing site, ensuring intrinsic safety, zero electromagnetic interference (EMI), and immunity to RF ablation, MRI, electrosurgery, and high-voltage environments. Its sub-260 µm outer diameter enables minimally invasive deployment via catheters, endoscopes, or needle-based delivery systems, supporting chronic and acute measurements in coronary arteries, intracranial ventricles, bladder, uterine cavity, and small-animal cardiovascular models.

Key Features

• Fabry–Pérot interferometric sensing principle with <0.01% full-scale (FS) resolution and ±1% FS absolute accuracy across 0–3000 mmHg range
• MEMS-fabricated silicon diaphragm integrated with single-mode polarization-maintaining (PM) fiber, enabling stable, drift-free operation over extended durations
• Ultra-miniaturized form factor: sensor tip diameter ≤260 µm; polyimide (PI) tubing outer diameter 330 ± 0.03 µm — compatible with 22G–27G cannulas and standard neurovascular catheters
• Full optical isolation: no metallic conductors or active electronics at the sensing site — compliant with IEC 60601-1 essential performance requirements for medical electrical equipment
• Operating temperature range from 0 °C to 200 °C, supporting sterilization via autoclaving (up to 134 °C, 3 min), ethylene oxide (EtO), or gamma irradiation (25 kGy)
• Robust overload tolerance: rated for 300% FS transient pressure without permanent calibration shift or mechanical failure
• FC/APC fiber connector interface ensures low back-reflection coupling and compatibility with commercial broadband light sources and spectrometer-based interrogators

Sample Compatibility & Compliance

The Aut-S200 is validated for direct contact with biological fluids including blood, cerebrospinal fluid (CSF), urine, and interstitial tissue fluid. Its biocompatible PI tubing and passivated silicon surface meet ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) requirements. The sensor is intended for single-use or reprocessed applications under validated cleaning and sterilization protocols. It supports regulatory pathways aligned with FDA 510(k) predicate logic for fiber-optic intravascular pressure sensors and complies with relevant clauses of ISO 80601-2-56 (non-invasive blood pressure monitoring) and EN 13721 (invasive pressure measurement devices). Documentation packages include traceable calibration certificates (NIST-traceable reference standards), material declarations (RoHS/REACH), and biocompatibility test reports.

Software & Data Management

The Aut-S200 operates with Auniontech’s proprietary optical interrogation platforms (e.g., AQ-2000 series), which provide real-time spectral acquisition, fringe tracking, and linearized pressure output at up to 2 kHz sampling rate. Raw interferogram data is exportable in HDF5 or CSV format, preserving full spectral fidelity for post-hoc analysis. Software supports configurable alarm thresholds, trend logging, and timestamp-synchronized multi-channel acquisition — critical for GLP-compliant preclinical studies. Audit trail functionality meets FDA 21 CFR Part 11 requirements when deployed with validated electronic lab notebook (ELN) integration. Interrogator firmware includes built-in self-diagnostics, wavelength calibration verification, and automatic thermal drift compensation algorithms.

Applications

• Intravascular pressure monitoring during cardiac catheterization, fractional flow reserve (FFR) assessment, and pulmonary artery wedge pressure measurement
• Chronic intracranial pressure (ICP) monitoring in neurocritical care and hydrocephalus management
• Urodynamic studies including bladder pressure-volume profiling and detrusor pressure analysis
• Preclinical cardiovascular phenotyping in murine, porcine, and non-human primate models — especially where MRI or RF-intensive interventions are employed
• Micro-environmental pressure mapping in organ-on-chip systems and 3D tissue constructs
• Integration into robotic surgical tools and smart endoscopic platforms requiring EMI-hardened sensing feedback

FAQ

What is the recommended optical interrogator for the Aut-S200?
Auniontech recommends the AQ-2000 series broadband interferometric interrogator with 1520–1570 nm tuning range and <1 pm wavelength resolution.
Can the Aut-S200 be reused after sterilization?
Yes — provided sterilization follows validated EtO or autoclave cycles (134 °C, 3 min); repeated autoclaving beyond 10 cycles requires recalibration verification.
Is the sensor suitable for long-term implantation?
It is designed for acute (<72 h) and short-term chronic (up to 14 days) implantation; extended indwelling requires additional biocompatibility validation per ISO 10993-6.
Does the system support multi-sensor multiplexing?
Yes — up to 8 Aut-S200 sensors can be wavelength-division multiplexed (WDM) on a single fiber using custom cavity-length encoding.
What documentation is provided for regulatory submissions?
Includes design history file (DHF) excerpts, risk analysis (ISO 14971), calibration SOPs, biocompatibility reports, and EMC test summaries per IEC 61326-1.