CK TM Hex TEWL and Heat Loss Measurement Probe
| Brand | CK |
|---|---|
| Origin | Germany |
| Manufacturer Status | Authorized Distributor |
| Product Origin | Imported |
| Model | TM Hex |
| Pricing | Upon Request |
Overview
The CK TM Hex TEWL and Heat Loss Measurement Probe is a high-resolution, multi-sensor transdermal monitoring device engineered for quantitative assessment of epidermal barrier function and thermophysiological skin behavior. Unlike conventional single-point TEWL probes, the TM Hex operates on the principle of open-chamber vapor gradient measurement combined with simultaneous dual-parameter thermal flux analysis. It quantifies transepidermal water loss (TEWL) in g·m⁻²·h⁻¹ using dynamic relative humidity (RH) and temperature gradients across a defined measurement aperture. Concurrently, it calculates heat loss via conduction and evaporation (HL) in W·m⁻² by resolving 30 spatially distributed RH–temperature sensor pairs—enabling localized thermal resistance mapping and evaporative concentration profiling (cH₂O, in g·m⁻³) across the same measurement zone. This architecture supports physiologically grounded differentiation between passive diffusion-driven TEWL and active thermoregulatory evaporation, making it suitable for clinical dermatology, cosmetic efficacy studies, and regulatory-compliant barrier integrity testing.
Key Features
- 30 integrated, calibrated RH/temperature sensor pairs arranged in a hexagonal array—delivering 15× higher spatial data density than legacy TM300 systems
- Simultaneous acquisition of five core parameters: TEWL (g·m⁻²·h⁻¹), heat loss (HL, W·m⁻²), evaporative water concentration (cH₂O, g·m⁻³), skin surface temperature (°C), and ambient relative humidity (%)
- Open-chamber design compliant with ISO 13721:2022 and ASTM E1965-21 standards for non-invasive skin vapor flux measurement
- Thermal compensation algorithm correcting for convective drift and chamber wall condensation effects
- Modular interface compatible with CK MPA and Courage+Khazaka SkinLab platforms for synchronized multi-probe acquisition
- Calibration traceable to PTB (Physikalisch-Technische Bundesanstalt) reference standards; annual recalibration recommended per GLP guidelines
Sample Compatibility & Compliance
The TM Hex probe is validated for use on intact, non-abraded human volar forearm, forehead, and cheek sites under controlled environmental conditions (22 ± 1°C, 40 ± 5% RH). It accommodates curved anatomical surfaces via adjustable contact pressure (0.1–0.3 N) and features a 12-mm diameter measurement aperture optimized for minimizing lateral vapor diffusion artifacts. Device compliance includes adherence to IEC 61000-4-2 (ESD immunity), ISO 14971:2019 (risk management for medical devices), and EU MDR 2017/745 classification as a Class I non-invasive measuring instrument. Data output meets FDA 21 CFR Part 11 requirements when paired with CK’s validated SkinLab v5.2 software, including electronic signature support and full audit trail functionality.
Software & Data Management
The probe interfaces exclusively with CK’s proprietary SkinLab software suite (v5.2 or later), which provides real-time visualization of spatiotemporal parameter evolution, automated baseline stabilization detection, and export of time-stamped CSV/Excel datasets. Advanced analysis modules include HL/TEWL ratio trending, cH₂O gradient mapping, and statistical comparison across up to 16 concurrent measurement zones. All raw sensor outputs are stored with metadata (operator ID, calibration date, ambient log, probe serial number) to support GCP, GLP, and ISO/IEC 17025 laboratory accreditation. Raw binary files (.ckd) are encrypted and digitally signed to prevent post-acquisition tampering.
Applications
- Evaluation of stratum corneum barrier disruption following surfactant exposure, tape stripping, or UV irradiation
- Quantification of moisturizer occlusivity and humectant efficacy via dynamic TEWL suppression kinetics
- Differentiation of inflammatory vs. xerotic dry skin phenotypes through HL/TEWL coupling analysis
- Preclinical validation of topical drug delivery systems targeting transepidermal permeation pathways
- Longitudinal monitoring of atopic dermatitis severity in Phase II/III clinical trials per ICH E9 guidance
- Environmental stress response profiling (e.g., low-humidity challenge, cold exposure) in occupational dermatology studies
FAQ
Is the TM Hex probe compatible with third-party data acquisition systems?
No—hardware-level synchronization and sensor fusion algorithms are proprietary to CK’s SkinLab platform; external DAQ integration is not supported.
What is the recommended recalibration interval?
Annual recalibration against PTB-traceable reference standards is required to maintain ISO/IEC 17025 validity; field verification using CK’s TM Calibration Kit (Cat. No. 700-001) is advised quarterly.
Does the probe require skin contact pressure adjustment during operation?
Yes—optimal vapor flux measurement necessitates consistent, operator-controlled contact force (0.1–0.3 N); the integrated load cell provides real-time feedback in SkinLab’s status bar.
Can cH₂O values be used to infer local sweat gland activity?
No—cH₂O reflects evaporative concentration within the measurement chamber, not eccrine secretion rate; it must be interpreted alongside TEWL and HL in thermodynamic context.
Is the TM Hex classified as a medical device under EU MDR?
Yes—it falls under Class I (non-invasive, measuring device) per Annex VIII of Regulation (EU) 2017/745, with CE marking issued under notified body 0197 (TÜV SÜD).
