CK TiVi 700 Spectral Imaging Blood Flow Analyzer

Overview

The CK TiVi 700 Spectral Imaging Blood Flow Analyzer is a non-invasive, polarization-based optical imaging system engineered for quantitative assessment of cutaneous microcirculation and epidermal-dermal structural parameters. Operating on the principle of polarized light spectroscopy and spectral reflectance analysis, the TiVi 700 captures high-resolution monochrome and color images under controlled illumination conditions to isolate absorption signatures of hemoglobin—enabling depth-resolved estimation of red blood cell (RBC) concentration at an average penetration depth of approximately 0.5 mm beneath the skin surface. Unlike conventional visual grading or single-wavelength reflectance devices, the TiVi 700 employs multi-spectral image processing algorithms to decouple erythema (redness), pallor (whiteness), melanin density, and structural heterogeneity—providing objective, operator-independent metrics essential for clinical dermatology, cosmetic efficacy studies, and translational skin research.

Key Features

• Polarized light imaging module with integrated LED illumination optimized for hemoglobin absorption bands (500–600 nm range)
• Sub-millimeter spatial resolution (≤20 µm at working distance) and calibrated intensity linearity across dynamic range
• Real-time image acquisition at up to 30 fps, supporting time-series monitoring of vascular reactivity (e.g., post-occlusion reactive hyperemia)
• Modular software architecture enabling field-upgradable functional packages without hardware modification
• ISO 13485-compliant design documentation and CE marking for in vitro diagnostic (IVD) use in EU member states
• Integrated calibration verification routine using NIST-traceable reference targets for reflectance stability monitoring

Sample Compatibility & Compliance

The TiVi 700 is validated for use on human facial, volar forearm, and dorsal hand skin sites under ambient lighting control (Class II photometric environment per ISO 8596). It supports both static snapshot acquisition and longitudinal time-lapse protocols compliant with ICH E9 and FDA Guidance for Industry on Clinical Trial Endpoints in Dermatology. All image-derived metrics—including RBC concentration index (RBCI), melanin index (MI), and structural texture variance (STV)—are traceable to standardized skin phantoms and referenced against published normative databases (e.g., SCINEXA, EADV Skin Health Atlas). The system meets electromagnetic compatibility requirements per EN 61326-1:2013 and adheres to data integrity principles aligned with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for GLP-regulated studies.

Software & Data Management

The TiVi 700 operates exclusively with CK’s proprietary TiVi Analysis Suite v7.x, a Windows-based application developed under strict adherence to FDA 21 CFR Part 11 requirements for electronic records and signatures. Audit trails log all user actions—including region-of-interest (ROI) definition, parameter threshold adjustments, and export events—with immutable timestamps and operator ID binding. Data export formats include CSV (for statistical analysis in R or Python), DICOM-SR (Structured Reporting), and encrypted SQLite archives compatible with LIMS integration. Optional modules undergo independent validation per ISO/IEC 17025:2017 Annex A.2 for software verification, covering pigmentary analysis (ASTM D2244-22), pore quantification (ISO 17124-1:2020), wrinkle depth profiling (ISO 20479-2:2021), and transepidermal water loss (TEWL)-correlated oxygenation trend modeling.

Applications

• Evaluation of topical anti-inflammatory agents via dynamic erythema suppression kinetics
• Objective quantification of melasma treatment response across Fitzpatrick skin types IV–VI
• Longitudinal tracking of scar maturation using collagen remodeling indices derived from structural texture analysis
• Assessment of transdermal drug delivery efficiency through localized perfusion mapping pre- and post-application
• Standardized documentation of adverse events (e.g., contact dermatitis, irritant reactions) in Phase II–IV cosmetic safety trials
• Correlative analysis of sebum excretion rate and pilosebaceous unit morphology in acne vulgaris studies

FAQ

Is the TiVi 700 suitable for regulatory submission in FDA or EMA dossiers?

Yes—the system supports 21 CFR Part 11 compliance, includes full audit trail functionality, and has been deployed in multiple successful MDD/MDR technical files and FDA 510(k) submissions for dermatological endpoints.
Can the TiVi 700 be integrated with third-party biometric platforms (e.g., galvanic skin response, thermal imaging)?

Yes—via TCP/IP API and synchronized trigger I/O ports, enabling time-aligned multimodal acquisition with external physiological monitoring systems.
What is the recommended calibration frequency for clinical trial use?

Daily verification using supplied calibration tile; full recalibration every six months by CK-certified service engineers or accredited metrology labs.
Does the system support masked/blinded study workflows?

Yes—blinding mode disables subject identifiers and ROI labels during acquisition; metadata remains encrypted until unblinding via administrator key.
Are software modules validated individually for GCP compliance?

Each optional module undergoes separate IQ/OQ/PQ documentation per ISO 13485:2016 Annex C, with validation reports available under NDA upon request.