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Summary of Contents for Cortexa Technology DermaLab Mini
- Page 1 Released 2024.11.14 Z66001.02 DermaLab Mini IFU EN ® DermaLab Mini Instructions For Use CORTEX TECHNOLOGY Niels Jernes Vej 6B 9220 Aalborg, Denmark www.cortex.dk cortex@cortex.dk...
- Page 2 CORTEX TECHNOLOGY ApS ® ERMA NSTRUCTIONS Copyright © Copyright 2024 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.
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Page 3: Table Of Contents
CORTEX TECHNOLOGY ApS Contents 1 WARNINGS ..........................6 2 INTENDED USE AND GENERAL DESCRIPTION ..............7 2.1 I ........................7 NTENDED PURPOSE 2.2 G ......................7 ENERAL DESCRIPTION 3 INSTALLATION AND POWER-ON ....................7 3.1 M ..........................7 AIN UNIT 3.2 C ............ - Page 4 CORTEX TECHNOLOGY ApS 8.4 M ........................29 AINTENANCE 9 SEBUM ............................30 9.1 P ..........................30 RINCIPLE 9.2 S ....................... 30 EBUM COLLECTING STRIP 9.3 T ......................... 30 EADER 9.4 T .............. 31 EBUM SCREEN AND MEASUREMENT PROCEDURE 9.5 M ........................
- Page 5 CORTEX TECHNOLOGY ApS 11.5 M ........................45 AINTENANCE 12 SKIN TEMPERATURE ......................46 12.1 P ..........................46 RINCIPLE 12.2 T ................... 46 EMPERATURE ROBE 12.3 T ..................46 EMPERATURE CREEN 12.4 M ........................46 AINTENANCE 13 TRANS EPIDERMAL WATER LOSS (TEWL) ................. 47 13.1 P ..........................
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Page 6: Warnings
CORTEX TECHNOLOGY ApS 1 Warnings • If the unit is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. • The unit is intended for indoor laboratory use only, at an altitude of less than 3048 m (10,000 feet) above sea level, within a temperature range of 10˚C to 35˚C and a relative humidity range of 10% to 90% non-condensing. -
Page 7: Intended Use And General Description
CORTEX TECHNOLOGY ApS 2 Intended use and general description 2.1 Intended purpose ® The DermaLab Mini is an investigational laboratory instrument for measuring skin parameters. Several probes can simultaneously be connected to the main unit to measure skin-related param- eters such as TEWL, ultrasound, elasticity, hydration, pH, temperature, sebum, and skin color. In addition, a Dermascope can be connected to the Windows-based computer system using a USB connector to capture optical images of skin. -
Page 8: Connection Type
CORTEX TECHNOLOGY ApS The following figure shows the connectors on the rear panel of the main unit. Figure 1. Connectors on the rear panel of the main unit. Table 1 lists how the probes are to be connected to the main unit. Connectors 1 and 2 are for the elasticity probe (both must be connected). Connector 3 is for the ultrasound probe (standard or subcutaneous). -
Page 9: Main Screen
CORTEX TECHNOLOGY ApS 4 Main screen Turn on the PC, activate the SkinLab software, and the main screen appears. The main screen provides buttons to be activated. Main screen. The TEWL, Ultrasound, Elasticity, Hydration, pH, Temperature, Dermascope, Sebum and Skin Color buttons are used to enter the specific measurement screens directly. See the follow- ing chapters for further details on each measurement function. -
Page 10: Introduction To The Skinlab Screens
CORTEX TECHNOLOGY ApS 5 Introduction to the SkinLab Screens All individual measurement screens use common control buttons located at the lower left side of the screens. Note: Not all buttons are shown on all screens. These buttons provide the following functions: Open: Open (load) measurement data from a file. -
Page 11: High Resolution Ultrasound Imaging
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 subcuta- neous 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 12: Ultrasound Unit Selection
CORTEX TECHNOLOGY ApS 6.3 Ultrasound unit selection ® The DermaLab Mini 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 13: Using The Probe
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. film with a quick Press the black downward move- ring down over... -
Page 14: The Ultrasound Standard Probe Screen
CORTEX TECHNOLOGY ApS 6.4.5 The Ultrasound Standard probe screen The screen facilitates simultaneous presentation of two images – e.g. a new image in comparison with a previously saved recording or two new recordings from different body areas. One of the image positions is considered the active window, indicated by the white borderline of the frame (A). -
Page 15: Understanding The Ultrasound Image
CORTEX TECHNOLOGY ApS 6.4.6 Understanding the ultrasound image By pressing Sample, an ultrasound image is recorded and visualized in the active window. In this image, the colors represent the intensity (strength) of the reflected ultrasound signal. Dark color represents low intensity and white (yellowish) represents a high intensity. The epidermis is highly reflective (white/yellowish) and the dermis is a mix of many colors. - Page 16 CORTEX TECHNOLOGY ApS Curve - Ultrasound image with superimposed Super A-scan. 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. The yellow part of the Super A-scan indicates the Low Echogenic Band (LEB) of the dermis (C, calculated in micrometers).
- Page 17 CORTEX TECHNOLOGY ApS Maintaining the same curvature, a second line – the right side of the grid (C) – may be freely posi- tioned using the left/right arrows (D). The grid becomes visible over the dimmed image by touching the Grid button. The Arrows used when moving the grid are only visible when the grid is enabled, as both grid in- tensity and grid distance is based on grid placement.
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Page 18: The Subcutaneous Ultrasound Unit
CORTEX TECHNOLOGY ApS 6.5 The Subcutaneous Ultrasound unit 6.5.1 Preparing the Subcutaneous Ultrasound probe The Ultrasound Subcutaneous Probe accommodates an internal water chamber. This chamber must be filled with distilled or de-ionized water by following the instructions below. 6.5.2 Mounting the water barrier The water chamber in the probe must be filled with water, and the water barrier film is then used as a seal to ensure that the water will remain inside the probe, when used. -
Page 19: Cleaning
CORTEX TECHNOLOGY ApS 6.5.4 Cleaning Please refer to cleaning of the Standard Probe section 6.4.4. 6.5.5 The Subcutaneous Ultrasound imaging screen The screen facilitates simultaneous presentation of two images – e.g., a new image in comparison with a previously saved recording or two new recordings from different body locations. One of the image positions is considered the active window, indicated by the light green top bar (A). -
Page 20: Measurements
CORTEX TECHNOLOGY ApS highly reflective (white/yellowish). The subcutaneous fat and muscle fibers will return a low inten- sity signal (dark green and black). See example below: Subcutis with layers of fat and connective tissue Epidermis/dermis Low Intensity 40 mm (0.120 µm resolution) The Subcutaneous ultrasound image. -
Page 21: The Ultrasound Image
CORTEX TECHNOLOGY ApS Activate the Measure button to superimpose two white vertical cursor lines (D). With the arrows (E), these cursors may be positioned according to the position of peaks on the intensity curve to measure depth or distance between layers of tissue. The numerical display under the image up- dates accordingly. -
Page 22: How To Record An Ultrasound Image
CORTEX TECHNOLOGY ApS 6.8 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 frequency, high frequency ultrasound is subject to a high degree of attenuation, which limits the penetration drastically. -
Page 23: Maintenance
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 24: Hydration (Moisture)
CORTEX TECHNOLOGY ApS 7 Hydration (Moisture) 7.1 Principle ® The DermaLab Mini provides information about the hydration state by measuring the conducting properties of the very upper layers of the skin, when subject to an alternating voltage. Accordingly, the method is referred to as a conductance measurement and the output is presented in the unit of micro-Siemens (µS). -
Page 25: Flat Probe
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. Pin probe with ventilating spacer. -
Page 26: Maintenance
CORTEX TECHNOLOGY ApS 7.6 Maintenance Except for keeping the probes clean, there is no preventive maintenance associated with the use of the hydration probes. To clean the probe front, simply wipe it off using a dry cloth. Should more thorough cleaning be necessary, a drop of alcohol may be applied to the cloth. Instrument performance in terms of calibration may be checked by obtaining an optional calibra- tion checker (phantom). -
Page 27: The Elasticity Probe
CORTEX TECHNOLOGY ApS r = radius of the surface (0.005 m) s = thickness of surface (skin thickness, adjustable but set to 0.001 m by default) Inserting reasonable assumptions, known probe constants and a default skin thickness of 1 mm leads to: ����... -
Page 28: The Elasticity Screen
CORTEX TECHNOLOGY ApS As the suction principle applies mechanical stress to the measurement site, the measurement cannot be immediately repeated in the exact same position. Allow 30 - 60 minutes between meas- urements at the same position for the skin to recover. During the measurement, care should be taken to avoid body movement as muscle tension may impact the measurement. -
Page 29: Maintenance
CORTEX TECHNOLOGY ApS When all measurement cycles (1, 3 or 5) have been made, the average of the measurements is shown on the display. Use the buttons at the cycle counter (D) to select the specific measures for each cycle. A further feature is the extraction of the U-values (E) from the suction/retraction curve. -
Page 30: Sebum
CORTEX TECHNOLOGY ApS 9 Sebum 9.1 Principle The SkinLab sebum screen provides an instrumental approach to quick and accurate measure- ment of surface sebum by means of a sebum collecting device (Sebum Collector) and an inte- grated reader module. After applying the Sebum Collector to the skin, the strip is inserted into the reader and the amount of sebum is measured based on the change in translucency of the film. -
Page 31: The Sebum Screen And Measurement Procedure
CORTEX TECHNOLOGY ApS 9.4 The Sebum screen and measurement procedure Sebum screen To perform a sebum measurement, proceed as follows: 1) Pick up an unused sebum collecting strip and insert it into the Tape Reader slot with the sebum collecting tape and the text side facing down. The device automatically detects the presence of the strip and performs an offset calibration before it prompts the user to per- form the next step. -
Page 32: Skin Color
CORTEX TECHNOLOGY ApS 10 Skin Color 10.1 How to perform a measurement The measurement head is placed gently on the skin without applying force. If pressure is applied to the skin, the skin color may change because blood is forced away from the capillaries in the area. -
Page 33: Calibration
CORTEX TECHNOLOGY ApS Calibration 10.4 Calibration is performed using the supplied calibrator that contains working standards for white, zero, and gloss. It is not necessary to re-calibrate each time the unit is turned on. However, it is recommended to re-calibrate on a regular basis - e.g. daily or after 100 measurements. Different parts of the calibrator are used based on what measurement mode is currently set for the Skin Colori Probe. -
Page 34: Top Menu
CORTEX TECHNOLOGY ApS User-interface separated into 3 parts in orange 10.5.2 Top Menu The top menu consists of buttons for general interaction with the software and Colorimeter probes. 10.5.2.1 Open The Open button allows for importing any previously saved datafiles created using the Skin Colori Probe software. -
Page 35: Print
CORTEX TECHNOLOGY ApS 10.5.2.3 Print The Print button allows for printing of collected data. Pressing the print button will open a pop-up with options for printing. Printing options will be displayed based on currently installed printers on the system including options for printing directly to pdf. A maximum of 75 measurements can be printed this way at a time. -
Page 36: Change Sample Rate
CORTEX TECHNOLOGY ApS 10.5.2.9 Change sample rate 2: If Single is selected, the system will make just one measurement. If Continuous is selected, multiple measurements will be made until stopped manually. Use the “Max” field to indicate the maximum number of measurements required while in continuous mode. During continuous sam- pling a new measurement will be taken roughly every 2 seconds. -
Page 37: Extended View
CORTEX TECHNOLOGY ApS Normal View changed to only display Gloss values 10.5.3.2 Extended View This section will cover the Extended view of the Skin Colori Probe software user-interface which is seen in the following figure. The sections will be covered as follows: •... -
Page 38: Single Measurement Info Panel
CORTEX TECHNOLOGY ApS 10.5.3.3 Single Measurement Info panel The single measurement info panel covers info regarding a selected measurement as shown in 10.5.3.7.1. When a measurement is made it will automatically appear in the info panel until a new measurement is selected from the measurement list. -
Page 39: Average Calculator
CORTEX TECHNOLOGY ApS measurement list will be highlighted with a white circle instead. Hovering over a measurement in the ITA graph will also display the measurement name. Highlighted measurements and label Spectrum Graph: The color spectrum graph will display a graph for the last selected measurement displaying the color spectrum, based on raw measurement data as seen in the following figure. -
Page 40: Measurement List Functions
CORTEX TECHNOLOGY ApS 10.5.3.7 Measurement list functions The measurement list function panel includes information regard- ing the total number of measurements as well as the total number of selected measurements in the measurements list. By default, all new measurements will be named “Measure X” where X represents the total number of measurements with that naming scheme. -
Page 41: Settings Menu
CORTEX TECHNOLOGY ApS 10.5.4 Settings Menu The settings menu can be opened by pressing the settings button. 10.5.4.1 Settings The following settings can be changed in the settings menu: 10.5.4.2 Measurement type: The following measurement types are available: All: This will show CIELAB and CIELCh values along with Ery- thema, Melanin, ITA and Gloss values from measurements. -
Page 42: Maintenance
CORTEX TECHNOLOGY ApS As .cmf files can be edited and files in general can become corrupted, it may be advantageous to store files in a safe location and potentially create backups if needed. Printing layout 10.6 Maintenance For normal cleaning use a dry lint free cloth. For more thorough cleaning the cloth can be soaked in a mild liquid detergent (soap). -
Page 43: Skin Ph
CORTEX TECHNOLOGY ApS 11 Skin pH 11.1 Principle The pH probe measures the pH potentiometrically on the skin surface using a glass probe espe- cially developed for surface measuring. 11.2 The pH probe The pH glass probe is fragile and will easily be destroyed if not handled carefully. The probe is made of different layers of glass and thereby it can easily break. -
Page 44: The P Hscreen
CORTEX TECHNOLOGY ApS Always calibrate the probe at pH 7.0 first and then at pH 4.0. One sachet with pH4 and one with pH7 reference solution are included with the pH probe. Before calibration, please empty the pH4 and pH7 sachet into two small plastic cups. A third plastic cup with tap water should be prepared for cleaning the probe before and in between the calibrations. -
Page 45: Maintenance
CORTEX TECHNOLOGY ApS The pH screen. 11.5 Maintenance To maximize the lifetime of the pH probe it is very important to make sure the probe is always in contact with the storage buffer solution when not in use. The probe shall always be placed in the holder and the tip of the probe shall be covered by the storage buffer solution. -
Page 46: Skin Temperature
CORTEX TECHNOLOGY ApS 12 Skin Temperature 12.1 Principle The temperature probe measures the skin temperature by infrared temperature sensing. 12.2 The Skin Temperature Probe Infrared temperature measurement is a non-contact principle. Ac- cordingly, the probe should not be placed on the skin but kept at a distance of approx. -
Page 47: Trans Epidermal Water Loss (Tewl)
CORTEX TECHNOLOGY ApS 13 Trans Epidermal Water Loss (TEWL) 13.1 Principle ® Water loss as measured by the DermaLab Mini 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 48: The Tewl Screen
CORTEX TECHNOLOGY ApS To minimize possible cross-contamination, a disposable TEWL-probe protector is available to be placed on the skin side of the probe. The sensors in the probe are delicate, do not touch and handle the probe carefully. The sensors inside the probe shall not get in close contact with volatile chemicals such as solvents or other organic compounds used for e.g. -
Page 49: Maintenance
CORTEX TECHNOLOGY ApS Pressing (A) toggles between normal and extended view. Detailed settings are only shown in ex- tended view. Touching the Sample button initiates the TEWL measurement, and the graph for the /h as a function of time. After the TEWL has stabilized after typically 30 – TEWL is shown in g/m 40 sec., the measurement stops automatically upon reaching a preset stop-criterion (F). - Page 50 CORTEX TECHNOLOGY ApS Re-calibration is recommended at a 1-year interval depending on the use of the probe - a shorter interval if the probe is used extensively in very wet conditions (RH80%), or longer intervals at lower RH values. Within normal RH/T operating range, the typical long-term humidity drift of the sensors is <0,25 %RH/year, while the maximum long-term drift of the temperature sensors is <0,03 °C/year.
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Page 51: Dermascope
CORTEX TECHNOLOGY ApS 14 Dermascope 14.1 Principle The Dermascope probe provides a magnified surface image of the skin using polarized or non- polarized white LED light as the light source. The Dermascope probe needs to be connected to a USB connector on the computer. 14.1.1 Magnification The probe provides two focus ranges. -
Page 52: The Dermascope Probe
CORTEX TECHNOLOGY ApS Non-polarized (surface reflections – typically fine lines - are visible). 14.2 The Dermascope Probe When using the probe bring the image in focus at one of the two focus areas by turning the black dial on the side of the camera. Once the image is in focus at the desired magnification, press Freeze Image to capture the image on the screen. -
Page 53: Files And Formats Of Saved Data
CORTEX TECHNOLOGY ApS 15 Files and Formats of Saved Data When pressing the Save button in the measurement screens SkinLab software proposes to save the data at the folder used last time for saving data. It also proposes a default filename with the actual date and time (a time stamp). -
Page 54: Data Extractor
CORTEX TECHNOLOGY ApS 16 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 by clicking “Extract data” in the top row of the screen. - Page 55 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. Extracting data When folder and filters have been selected, click the “Extract data”...
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Page 56: Extractor Output
CORTEX TECHNOLOGY ApS 16.1 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. When importing using Excel or similar software, note that the output file is separated using Semi- colon “;”... -
Page 57: General Maintenance
CORTEX TECHNOLOGY ApS 17 General maintenance Maintaining the main unit is limited to cleaning the exterior of the instrument as necessary. Check the cables and connectors regularly to ensure trouble-free operation. Maintenance of application probes is described in the relevant application module chapter. 17.1 Calibration &... -
Page 58: Technical Specifications
CORTEX TECHNOLOGY ApS 21 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 • Dimensions: 452x106x131 mm •... -
Page 59: Hydration Probe
CORTEX TECHNOLOGY ApS • The temperature and humidity at the skin surface is calculated based on the vapor gra- dient inside the measurement chamber. 21.4 Hydration Probe The hydration probe measures the hydration level of the stratum corneum down to around 15 micrometers using the conductance method. -
Page 60: Dermalab Mini Parts
CORTEX TECHNOLOGY ApS ® 22 DermaLab Mini parts Name Picture Item number ® DermaLab Mini main unit C66001.xx Skin Color Probe C09600.xx Calibrator for skin Color probe D22214.xx Ultrasound Probe C08601.xx Ultrasound Probe Head C08601.xx Ultrasound Probe Fill Valve M26038.xx 60/66... - Page 61 CORTEX TECHNOLOGY ApS O-ring for Ultrasound Probe N16032.xx Head Elasticity probe C05600.xx Elasticity double adhesive V02001.xx patch Hydration flat probe C03600.xx Moisture flat calibrator C03006.xx Hydration pin probe C06600.xx Hydration pin calibrator C06006.xx Stand-off for hydration pin M21010.xx Dermascope C10001.xx 61/66...
- Page 62 CORTEX TECHNOLOGY ApS pH probe C07444.xx Buffer for pH probe (4 and 7 C17441.xx (pH 4) pH + storage) C17443.xx (pH 7) C17442.xx (storage) Sebum strips V02002.xx Skin temperature probe C02600.xx TEWL X probe C04445.xx TEWL probe protector M20010.xx Power supply (Adapter Tech., C44703.xx ATM036T-P120) 62/66...
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Page 63: Faq
Specifically Hydration: The DermaLab Mini measures skin conductance. What is the difference to skin capacitance? - Skin conductance is the skin’s ability to conduct an electrical, alternating current as opposed to skin capacitance, which is the ability to accumulate an electrical charge. - Page 64 - Skin thickness is a parameter in the equation for calculating elasticity. By default it is preset to 1 mm, but if the real thickness is known, it is possible to obtain a more correct elasticity measurement by adjusting this setting. Depending on configuration, the DermaLab Mini features high resolution ul- trasound to accurately measure skin thickness.
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Page 65: List Of Symbols
CORTEX TECHNOLOGY ApS 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. Class 2 equipment (IEC 60601-1). Alternating current, single phase. -
Page 66: Declaration Of Conformity
CORTEX TECHNOLOGY ApS B. Declaration of Conformity EU – DECLARATION OF CONFORMITY We hereby declare that the product mentioned below conforms to the requirements of: Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the har- monisation of the laws of the Member States relating to electromagnetic compatibility.
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