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Cortex DermaLab Single Instruction Manual

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Released 2024.07.24
DermaLab Single SkinLab Z5110113 UK
®
DermaLab
Single
Instruction Manual
CORTEX TECHNOLOGY
Niels Jernes Vej 6B
9220 Aalborg, Denmark
www.cortex.dk
cortex@cortex.dk

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  • Page 1 Released 2024.07.24 DermaLab Single SkinLab Z5110113 UK ® DermaLab Single Instruction Manual CORTEX TECHNOLOGY Niels Jernes Vej 6B 9220 Aalborg, Denmark www.cortex.dk cortex@cortex.dk...
  • Page 2 2023 by Cortex Technology ApS. All rights reserved. No part of this publication may be reproduced, transmitted, stored © in a retrieval system, or translated into any language in any form by any means without the permission of Cortex Technology.

  • Page 3: Table Of Contents

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Contents 1. WARNINGS ......................5 2. INTENDED USE AND GENERAL DESCRIPTION ............. 6 2.1. I ..........................6 NTENDED USE 2.2. G ........................6 ENERAL DESCRIPTION 3. INSTALLATION AND POWER-ON ................7 3.1.
  • Page 4 IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 8.3. T ....................... 28 LASTICITY CREEN 8.4. M ..........................29 AINTENANCE 9. TRANS EPIDERMAL WATER LOSS (TEWL) ............30 9.1. P ............................30 RINCIPLE 9.2. T TEWL X P ........................31 ROBE 9.3.

  • Page 5: Warnings

    • Avoid exposure to water. If exposed to smaller amounts such a rain, allow for the device to completely dry and consider contacting Cortex support for aid in assessing if the exposure has affected the integrity of the device. •...

  • Page 6: Intended Use And General Description

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 2. Intended use and general description 2.1. Intended use The DermaLab Single is an investigational laboratory instrument for measuring skin parameters. ® DermaLab Single offers units for the measurement of the following parameters: ®...

  • Page 7: Installation And Power-On

    The power supply must be connected to a wall outlet providing a protective ground terminal to en- sure electrical safety. It may be connected to input voltages from 100 - 240 VAC, 50/60 Hz. Do not use any other power supply than supplied by Cortex Technology. 3.2. Main unit Connect the main unit to the +12 V output cable from the power supply.

  • Page 8: Main Screen

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 4. Main screen Turn on the tablet/PC, activate the DermaLab SkinLab software, and the main screen appears. ® The main screen provides buttons to be activated. Main screen showing connection to Ultrasound Subcutane unit.

  • Page 9: Introduction To The Dermalab Single Software Screens

    Only files with the .cmf file extension (Cortex Measurement File) generated by Cortex software can be opened this way. Any data already open will be lost if not saved before importing new data. A warning will be shown if data will be deleted.

  • Page 10: High Resolution Ultrasound Imaging

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 6. High Resolution Ultrasound Imaging 6.1. General principle Ultrasound skin imaging is based on detecting the acoustic response from the skin and subcutane- ous tissues when an acoustic pulse is transmitted into and reflected from the skin. The energy of the acoustic pulse is very low and will not affect the tissue in any way.

  • Page 11: Ultrasound Unit Selection

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 6.3. Ultrasound unit selection The DermaLab Single offers two different ultrasound probes depending on the application: ® The ultrasound Standard probe features high resolution scanning specifically developed for skin imaging. It offers a good balance between resolution and penetration with a scan length of 17,6 mm.

  • Page 12: Using The Probe

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS The ultrasound probe is now operational. Over time air bubbles may collect, however, when the probe is held correctly in an up-right position for scanning (probe front down/cable end up), air bubbles will normally not disturb.

  • Page 13: Understanding The Ultrasound Image

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Touching the Start button (B) will record a new ultrasound image. The gain (ultrasound sensitivity), used when recording the ultrasound image, may be adjusted us- ing the up/down arrows (C).

  • Page 14: Measurements

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS The Standard Probe ultrasound image – film plus epidermis to the left followed by dermis and subcutis. The dermis is characterized by varying intensities (different colors), subcutis by low-intensity areas due to a homogenous composition.
  • Page 15 IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Interpretation of the Super A-scan: The red left part of the curve indicates the intensity of the ultrasound passing through the water chamber in the probe. The high left peak originates from the combined film/epidermal reflection.

  • Page 16: The Ultrasound Subcutaneous Unit

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Grid - Ultrasound image with superimposed grid. The measurement algorithm calculates the Distance between left and right side of the grid in mi- crometers as well as the average Intensity (ultrasound reflection strength) inside the grid. This may be used to quantify specific features within certain areas –...

  • Page 17: Using The Subcutaneous Ultrasound Probe

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Black, press-fit Inject water into the ring holds the empty chamber. water barrier film Gently shake the in place. probe to eliminate air bubbles, top-up with water. Place film over Snap off excess the probe tip.

  • Page 18: Understanding The Subcutaneous Ultrasound Image

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Select the active position by clicking inside the window. New recordings as well as previously saved images being opened will appear in the active window. Activating the Start button (B) will record a new ultrasound image.

  • Page 19: Measurements

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Subcutis with layers of fat and connective tissue Epidermis/dermis Low Intensity 40 mm (0.120 µm resolution) The Subcutane ultrasound image. Dermis is characterized by varying intensities (different colors), subcutis by low-intensity (black/greenish) areas due to a homogenous composition separated by layers (vertical lines) of colored connective tissue.

  • Page 20: The Ultrasound Image

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS as a result, but a concentration of high intensities appears as peaks on the curve and this way serves as an indicator for the in-depth positioning of layers in the tissue.

  • Page 21: How To Record An Ultrasound Image

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 6.6.2. How to record an ultrasound image Setting the correct Gain Most importantly, the amplification of the signal should be set correctly. As the focused sound beam travels through the tissue, it gets attenuated. Since attenuation increases with the frequency, high frequency ultrasound is subject to a high degree of attenuation, which limits the penetration drastically.

  • Page 22: Maintenance

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS A tiny air-bubble be- tween film and epider- mis will create a black shadow in the ultra- sound image. Re-apply gel or water and make new image.   It is important to ensure a good acoustic contact between the tip of the probe and the skin.

  • Page 23: Hydration (Moisture)

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 7. Hydration (Moisture) 7.1. Principle The DermaLab Single provides information about the hydration state by measuring the conduct- ® ing properties of the very upper layers of the skin, when subject to an alternating voltage. Accord- ingly, the method is referred to as a conductance measurement and the output is presented in the unit of micro-Siemens (µS).

  • Page 24: Flat Probe

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS The probe features spring-loaded action, which will initiate a measurement when the probe is pressed against the skin. The probe comes with a ventilating spacer to facilitate application of constant meas- urement pressure and reduce accumula- tion of water in the measurement area.

  • Page 25: Maintenance

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 7.4. Maintenance Instrument performance in terms of calibration may be checked by obtaining an optional calibra- tion checker (phantom). Press the phantom against the probe making sure to establish good electri- cal contact to the probe face (two pins in case of pin-probe) and perform a normal measurement.

  • Page 26: Elasticity

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 8. Elasticity 8.1. Principle The elasticity measurement of the DermaLab Single is based on suction applied to the skin sur- ® face. The probe provides a suction chamber and uses adhesive tape to prevent creeping and folding of the skin under the edge surrounding the measurement chamber.

  • Page 27: The Elasticity Probe

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS The elasticity modulus E depends entirely on the height x measured by the probe at the end of the elevation phase and the applied vacuum. Young´s modulus (E) carries the unit MPa (mega Pascal).

  • Page 28: The Elasticity Screen

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 8.3. The Elasticity Screen Elasticity screen. The y-axis shows the elevation (mm), the x-axis is time (seconds). The default skin thickness (A) is set to 1.00 mm. Optionally, it may be changed to the actual skin thickness as measured using the ultrasound probe (see section 6 above).

  • Page 29: Maintenance

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Calendula Extract: Effects On Mechanical Parameters Of Human Skin; Akhtar et al, Acta Poloniae – Drug Research, Vol. 68 No. 5 pp. 693-701, 2011. The figure shows how the U-values are extracted from the elasticity measurement. The immediate...

  • Page 30: Trans Epidermal Water Loss (Tewl)

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 9. Trans Epidermal Water Loss (TEWL) 9.1. Principle Water loss as measured by the Dermalab Single is based ® on Nilsson’s Vapor Pressure Gradient method, which is an open chamber method with minimal impact on the skin being examined and, accordingly, very low bias to the reading.

  • Page 31: The Tewl X Probe

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 9.2. The TEWL X Probe The probe is connected to the input connector on the rear panel. Place the probe on the skin as indicated by the arrow on the front of the probe.

  • Page 32: Maintenance

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Extended view showing additional details, such as stop criteria (F), and sensor data (G, I). Pressing (A) toggles between normal and extended view. Detailed settings are only shown in ex- tended view.

  • Page 33: Calibration

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS get in close contact with volatile chemicals such as solvents or other organic compounds. Especially high concentration and long exposure must be avoided. Ketenes, Acetone, Ethanol, Isopropyl Alco- hol, Toluene, etc. are known to cause drift of the humidity reading – irreversibly in most cases.

  • Page 34: Files And Formats Of Saved Data

    ® filename - but using different file type extension: Filename.cmf: The .cmf file is the Cortex Measurement File. It is an ASCII text file with all measurement data separated by the horizontal TAB character (ASCII value 09). The .cmf file can be imported to Excel or other spread sheet programs or opened in any word processing editor (e.g.

  • Page 35: Data Extractor

    11. Data extractor DermaLab SkinLab version 2.5.0.0 and onwards provides built-in capabilities for ex- tracting data from several cortex measurement files and combining the results into a .csv file. The Data extractor can be accessed on the main menu through the respective but- ton in the top row of the screen.
  • Page 36 IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Data Filtering Before starting the data extractor, it is possible to filter what information should be included in the output file. Only selected measurement types and related information will be included in the output file.

  • Page 37: Extractor Output

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 11.1. Extractor output The output of the data extractor is a file in the format .csv (comma separated file). This file can be imported into Excel or similar software for easy viewing of data.

  • Page 38: General Maintenance

    Do not use any other power supply than provided by Cortex Technology. Cortex Technology ApS cannot be held responsible for any damage or loss caused by improper in- stallation or incorrect use of the device.

  • Page 39: Technical Specifications

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 16. Technical specifications • IP-class: IP20 (EN60529) • Environment: Indoor use • Temperature: 10 to 35 °C • Relative humidity: 10 to 90 percent relative humidity, non-condensing • Altitude: 3048 m (10,000 feet) maximum •...

  • Page 40: Elasticity Probe

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS • Optional calibration checker available. • Measurement uncertainty: ±5% 16.4. Elasticity probe The elasticity probe utilizes a well-established method to evaluate the (visco)-elastic properties of the skin using controlled mechanical deformation. The measured elevation/retraction curves pro- vide information about skin aging and the collagen/elastin content of the skin.

  • Page 41: Dermalab Single Parts

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 17. DermaLab Single parts Name Picture Item number Dermalab Single C02228.05 Elasticity probe for C05600.xx  DermaLab Single Elasticity double adhesive V02001.01 patch Hydration flat probe for C03600.xx  DermaLab...
  • Page 42 IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Stand-off for hydration pin M21010.01 TEWL X probe C04600.0x TEWL probe protectors M20010.01 Ultrasound standard probe C08900.xx Ultrasound subcutaneous C01660.xx probe Film for ultrasound probe V01005.01 Outer ring for foil M09007.01...
  • Page 43 IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Power supply (Adapter Tech., C44703.01 ATM036T-P120) 43/46...

  • Page 44: Faq

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS 18. FAQ In the FAQ below please find answers to questions not to be found elsewhere in this manual. Specifically TEWL: Why does the measurement not stabilize and stop? - There may be a leak between probe and skin surface. Reposition the probe to align with skin sur- face.
  • Page 45 CORTEX TECHNOLOGY ApS Specifically Hydration: The DermaLab Single measures skin conductance. What is the difference to skin capacitance? - Skin conductance is the skins ability to conduct an electrical, alternating current as opposed to skin capacitance, which is the ability to accumulate an electrical charge.

  • Page 46: Appendix A - List Of Symbols

    IFU-10849 DermaLab Single Z5110113 v2 (ID 55167) CORTEX TECHNOLOGY ApS Appendix A – List of symbols The following symbols are used: WARNING or CAUTION information to avoid personal injury or damage to the product. ELECTRICAL SHOCK HAZARD. Indicates that an electrical shock could or might occur.

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