CK ST500 Non-Contact Infrared Skin Surface Thermometer
| Brand | CK |
|---|---|
| Origin | Germany |
| Model | ST500 |
| Type | Handheld Infrared Thermometric Probe for Cutaneous Temperature Mapping |
| Measurement Principle | Passive Infrared Radiometry (8–14 µm spectral band) |
| Accuracy | ±0.2 °C (within 25–40 °C range) |
| Repeatability | <0.1 °C |
| Response Time | <250 ms |
| Spot Size Ratio | 12:1 |
| Operating Distance | 30–150 mm |
| Output Interface | Analog voltage (0–5 V) / Optional RS232 or USB digital output |
Overview
The CK ST500 Non-Contact Infrared Skin Surface Thermometer is an ISO 13485–certified, CE-marked medical-grade thermal probe engineered for precise, non-invasive quantification of cutaneous surface temperature in dermatological research, cosmetic efficacy testing, and clinical trial settings. It operates on the principle of passive infrared radiometry—detecting naturally emitted mid-wave infrared radiation (8–14 µm wavelength band) from the stratum corneum without physical contact or thermal perturbation. This ensures measurement integrity during dynamic physiological assessments, such as post-application thermal response profiling of topical actives, vasoactive compounds, or cooling/warming agents. The device complies with IEC 60601-1 safety standards for medical electrical equipment and meets essential requirements for Class IIa devices under the EU MDR (Regulation (EU) 2017/745), enabling integration into GLP-compliant study protocols.
Key Features
- High-resolution thermal sensing using a calibrated thermopile detector with spectral response optimized for human skin emissivity (ε = 0.97–0.98)
- Fixed-focus optical system with 12:1 distance-to-spot ratio, enabling consistent 5-mm diameter measurement zones at 60 mm working distance
- Real-time analog output (0–5 V DC) synchronized to temperature readings; optional digital interface supports RS232 or USB 2.0 for direct acquisition into LabVIEW, MATLAB, or custom LIMS platforms
- Integrated ambient temperature compensation and automatic emissivity correction to minimize drift across laboratory environmental fluctuations (15–30 °C ambient range)
- Rugged aluminum housing with IP54-rated ingress protection, designed for repeated use in cleanroom environments (ISO Class 7/8) and clinical examination rooms
- Factory-calibrated traceable to PTB (Physikalisch-Technische Bundesanstalt) reference standards; calibration certificate included with each unit
Sample Compatibility & Compliance
The ST500 is validated for use on intact, dry, non-occluded skin surfaces—including facial, forearm, and volar wrist regions—without requiring coupling gels or surface preparation. It is unsuitable for use over occlusive dressings, wet skin, or highly reflective surfaces (e.g., metallic tattoos or silicone-based barrier films). Device compliance includes adherence to ASTM E1965-16 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature), ISO 80601-2-56:2017 (Medical electrical equipment – Part 2-56: Particular requirements for clinical thermometers), and relevant clauses of ICH E8(R1) for temperature endpoint collection in dermatological clinical studies. Data logging workflows support audit-ready documentation per FDA 21 CFR Part 11 when paired with validated software modules.
Software & Data Management
The ST500 interfaces natively with CK’s proprietary SkinScan Control Suite (v4.2+), which provides time-synchronized multi-channel acquisition, baseline subtraction, thermal gradient mapping, and export in CSV, HDF5, or .mat formats. All raw measurements include embedded metadata: timestamp (UTC), operator ID, subject ID, anatomical site code (based on FDB Body Map taxonomy), ambient RH/T, and probe serial number. Audit trails record all parameter changes, calibration events, and user logins—fully compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Third-party integration is supported via DLL SDK and documented REST API endpoints for enterprise LIMS or ePRO systems.
Applications
- Quantitative assessment of transient thermal responses following application of cosmeceuticals (e.g., niacinamide-induced flushing, menthol-triggered cooling, capsaicin-mediated vasodilation)
- Objective evaluation of transdermal delivery efficiency via localized thermal signature shifts correlated with permeation kinetics
- Monitoring microcirculatory changes in atopic dermatitis, rosacea, or psoriatic plaques during therapeutic intervention
- Validation of thermal regulation claims in sunscreens, anti-redness formulations, and post-procedure soothing products
- Supporting ISO 10993-23 biocompatibility testing through controlled thermal stress profiling of medical adhesives and wearable sensor interfaces
FAQ
Is the ST500 suitable for measuring core body temperature?
No. It is strictly validated for cutaneous surface temperature only and must not be used as a diagnostic tool for systemic fever or hypothermia.
Can the probe be sterilized between subjects?
Yes—wipe disinfection with 70% isopropyl alcohol is approved; autoclaving, UV-C exposure, or immersion are prohibited.
Does the device require annual recalibration?
CK recommends recalibration every 12 months or after 5000 measurement cycles, whichever occurs first, using accredited service centers traceable to national metrology institutes.
What is the minimum measurable temperature difference (thermal resolution)?
The system resolves differences ≥0.05 °C under stable ambient conditions, verified per ISO/TR 29997:2021 Annex B protocols.
Is training provided for GCP-compliant data collection?
Yes—CK offers certified SOP development workshops and on-site operator qualification (OQ) support aligned with ICH-GCP E6(R3) Annex 11 requirements.
