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Cortex DermaLab Combo-4 Instruction Manual

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Released 2024.07.24
Instruction Manual Combo 4 Z5010118 UK
®
DermaLab
Combo-4
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 Instruction Manual Combo 4 Z5010118 UK ® DermaLab Combo-4 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-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 ................8 3.1 P...
  • Page 4 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 8.3 T ....................... 31 LASTICITY SCREEN 8.4 M ..........................32 AINTENANCE 9 SEBUM ........................33 9.1 P ............................. 33 RINCIPLE 9.2 S ......................33 EBUM COLLECTING STRIP 9.3 T ..........................
  • Page 5 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 11.5 M ..........................48 AINTENANCE 12 SKIN TEMPERATURE ..................49 12.1 P ........................... 49 RINCIPLE 12.2 T ....................49 EMPERATURE ROBE 12.3 T ....................49 EMPERATURE CREEN 12.4 M ..........................

  • Page 6: 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 7: Intended Use And General Description

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 2 Intended use and general description 2.1 Intended purpose The DermaLab Combo is an investigational laboratory instrument for measuring skin parameters. ® Several probes can simultaneously be connected to the main unit to measure skin-related parameters such as TEWL, ultrasound, elasticity, hydration, pH, temperature, sebum, and skin color.

  • Page 8: Installation And Power-On

    The power supply must be connected to a wall outlet providing a protective ground terminal to ensure 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 9: Main Screen

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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.

  • Page 10: Introduction To The Skinlab Combo Screens

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 5 Introduction to the SkinLab Combo Screens All individual measurement screens use common control buttons located at the lower left side of the screens. Note: Not all buttons are shown in all screens.

  • Page 11: High Resolution Ultrasound Imaging

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 subcutaneous 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

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 6.3 Ultrasound unit selection The DermaLab® Single offers two different ultrasound probes depending on the application: Standard The ultrasound 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

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 14: The Ultrasound Standard Probe Screen

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS The front piece parts may be cleaned in solutions of mild detergents suitable for plastics or wiped off with alcohol for disinfection. Put the black ring back onto the scanning head without film for storage.

  • Page 15: Understanding The Ultrasound Image

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 im- age, the colors represent the intensity (strength) of the reflected ultrasound signal. Dark color repre- sents low intensity and white (yellowish) represents a high intensity.
  • Page 16 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Curve - Ultrasound image with superimposed Super A-scan. Interpretation of the Super A-scan: red left part of the curve indicates the intensity of the ultrasound passing through the water cham- ber in the probe.
  • Page 17 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 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 in enabled, as both grid intensity and grid distance is based on grid placement.

  • Page 18: The Ultrasound Subcutaneous Unit

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 6.5 The Ultrasound Subcutaneous unit 6.5.1 Preparing the Subcutaneous Ultrasound probe Subcutaneous Except for the physical dimensions and choice of transducer, the basic design of the Probe Standard Probe is similar to the design of the and, accordingly, the preparations are the same –...

  • Page 19: Using The Subcutaneous Ultrasound Probe

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 6.5.3 Using the Subcutaneous Ultrasound probe Before each ultrasound scan apply ultrasound gel to the film. Place the probe on the skin area to be scanned and spread the gel evenly to the thinnest possible layer with “massaging”...

  • Page 20: Understanding The Subcutaneous Ultrasound Image

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Subcutane Ultrasound main screen with one sample image. Two sets of measurements for each image relate to the use of the Measure and Intensity buttons, which will be explained later in this section under section 6.5.7.

  • Page 21: Measurements

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS low-intensity (black/greenish) areas due to a homogenous composition separated by layers (vertical lines) of col- ored connective tissue. 6.5.7 Measurements Subcutane Ultrasound features calculation of intensity and horizontal distance by use of the buttons Intensity (A) and Measure (B).

  • Page 22: The Ultrasound Image

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Measurement screen. Intensity visualizes a superimposed yellow intensity curve based on the accumulated average of all Super A-scan ultrasound A-scans within the image – the so-called (C). No numbers are presented 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 23: How To Record An Ultrasound Image

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Follicle Dermis. Film + Epidermis Subcutis Vein Nevus Standard probe ultrasound skin images. 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.
  • Page 24 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS does not reach the skin. Such air bubbles will block the signal and cause horizontal shadows through- out the image. To prevent this from happening, make sure the outside of the film on the probe is clean and has a thin layer of well distributed gel or a thin layer of water before making the scan.

  • Page 25: Maintenance

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 6.9 Maintenance The daily maintenance of DermaLab ultrasound scanning probes is limited to the removal of film and ® water to reduce bacteria growth inside the water chamber, and to allow the transducer to dry. Always remove the plastic film overnight.

  • Page 26: The Hydration Probes

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 7.2 The Hydration probes Depending on the application and personal preference, two different probe designs are available – PIN and FLAT probe. If just one hydration probe is connected, the selection of Hydration in the main screen will automati- cally open the relevant parameter screen (PIN or FLAT) as indicated in the upper left corner.

  • Page 27: Flat Probe

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 7.4 FLAT probe The FLAT probe offers a traditional design with three concentric, circular electrodes. This flat design is convenient when measuring on larger ar- eas of normal skin with no interference from hairs and scales etc.
  • Page 28 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 28/70...

  • Page 29: Elasticity

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 8 Elasticity 8.1 Principle The elasticity measurement of the SkinLab Combo is based on suction applied to the skin surface. 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 30: The Elasticity Probe

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS  E = 0.3125   The elasticity modulus E depends entirely on the height  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 31: The Elasticity Screen

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 thick- ness as measured using the ultrasound probe (see section 6 above).

  • Page 32: Maintenance

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 deformation or...

  • Page 33: Sebum

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 9 Sebum 9.1 Principle The SkinLab Combo sebum screen provides an instrumental approach to quick and accurate meas- urement of surface sebum by means of a sebum collecting device (Sebum Collector) and an inte- grated reader module.

  • Page 34: The Sebum Screen And Measurement Procedure

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 9.4 The Sebum screen and measurement procedure Sebum screen To perform a sebum measurement, proceed as follows: Pick up an unused sebum collecting strip and insert it into the Tape Reader slot with the se- bum colleting tape and the text side facing down.

  • Page 35: Skin Color

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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. Depend- ing on the amount of pigment, this may cause the skin to appear pale when compared to the surround- ing skin (blanching).

  • Page 36: Calibration

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Calibration 10.4 calibrator that contains working standards for w A calibration is performed using the supplied hite, 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.

  • Page 37: Top Menu

    The Open button allows for importing any previously saved datafiles created using the Skin Colori Probe software. Only files with the .cmf file extension (Cortex Measurement File) generated by Cortex soft- ware 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 38: Print

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 in- stalled printers on the system including options for printing directly to pdf.

  • Page 39: Change Sample Rate

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 num- ber of measurements required while in continuous mode.

  • Page 40: Extended View

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 41: Single Measurement Info Panel

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 se- lected from the measurement list.

  • Page 42: Average Calculator

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 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 43: Measurement List Functions

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 10.5.3.7 Measurement list functions The measurement list function panel includes information regarding the total number of measurements as well as the total number of se- lected measurements in the measurements list.

  • Page 44: Settings Menu

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 10.5.4 Settings Menu The settings menu can be opened by pressing the settings but- ton. 10.5.4.1 Settings The following settings can be changed in the settings menu: 10.5.4.2 Measurement type:...

  • Page 45: Maintenance

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS As .cmf files can be edited and files in general can become corrupted, it may be advantageous to store file in a safe location and potentially create backups if needed.

  • Page 46: Skin Ph

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 11 Skin pH 11.1 Principle The pH probe measures the pH potentiometrically on the skin surface using a glass probe especially developed for surface measuring. 11.2 The pH probe The pH glass probe is fragile and will easily be destroyed if not handled carefully.

  • Page 47: The P Hscreen

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 cali- bration, please empty the pH4 and pH7 sachet into two small plastic cups.

  • Page 48: Maintenance

    The typical lifetime for a well-maintained pH probe is 2 years. When the pH measurement takes long time to stabilize then the probe is defective and needs to be replaced. A replacement pH probe can be purchased from Cortex Technology by contacting cor- tex@cortex.dk or your local Cortex distributor.

  • Page 49: Skin Temperature

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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. Accord- ingly, the probe should not be placed on the skin but kept at a distance of approx.

  • Page 50: Trans Epidermal Water Loss (Tewl)

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 13 Trans Epidermal Water Loss (TEWL) 13.1 Principle Water loss as measured by the SkinLab Combo 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 51: The Tewl Screen

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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. do not touch The sensors in the probe are delicate, and han- dle the probe carefully.

  • Page 52: Maintenance

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 TEWL is shown in g/m /h as a function of time.
  • Page 53 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Re-calibration is recommended at a 1-year interval depending on the use of the probe - a shorter inter- val if the probe is used extensively in very wet conditions (RH80%), or longer intervals at lower RH values.

  • Page 54: Dermascope

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 14 Dermascope 14.1 Principle The videoscope probe provides a magnified surface image of the skin using polarized or non-polar- ized white LED light as the light source. The videoscope probe needs to be connected to an USB connector on the computer.

  • Page 55: The Videoscope Probe

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Non-polarized (surface reflections – typically fine lines - are visible). 14.2 The Videoscope 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.

  • Page 56: 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 57: Data Extractor

    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 58 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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 59: Extractor Output

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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.

  • Page 60: 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 instal- lation or incorrect use of the device.

  • Page 61: Technical Specifications

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Due to the nature of the humidity sensors used in the TEWL probes and the use of these probes, re-calibration may be needed within the one-year warranty period. Such re-calibra- tion is not covered by the warranty.

  • Page 62: Hydration Probe

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS • Standard uncertainty: 2.5% • Stop criteria: standard deviation, time, and linearity of the vapor gradient (slope target) of moving average filtered data (5 s window). • Recommended operating conditions: 18-26°C •...

  • Page 63: Sebum Strip Reader

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 21.9 Sebum Strip Reader • Principle: Optical assessment of collected sample. • Sebum collector: Microporous polymer film mounted on light absorbing substrate. • Sebum score: 0 – 99.

  • Page 64: Combo Parts

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 22 Combo parts Name Picture Item number Combo Main C64000.01 Calibrator for skin color D22214.01 probe Color probe for Combo 4 C09600.01 Film for ultrasound probe V01005.01 Outer ring for foil M09007.01...
  • Page 65 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Hydration flat probe for Combo 4 C03600.01 Moisture flat calibrator C03006.01 Hydration pin probe for Combo 4 C06600.01 Hydration pin calibrator C06006.02 Stand-off for hydration pin M21010.01 Dermascope C10001.01...
  • Page 66 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Skin temperature probe for Combo 4 C02600.01 TEWL X probe C04445.01 TEWL probe protectors M20010.01 Ultrasound probe C08600.01 Power supply (Adapter C44703.01 Tech., ATM036T-P120) 66/70...

  • Page 67: Faq

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS 23 FAQ In the FAQ below please find answers to questions not to be found elsewhere in this manual. General: In the main screen, some buttons are lit although no probe is connected.
  • Page 68 IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx CORTEX TECHNOLOGY ApS Specifically Sebum: Why is offset calibration on each strip necessary? - The offset calibration eliminates batch-to-batch variation on the strip in order to increase accuracy/re- producibility. For how long do I need to press the sebum collecting strip against the skin? - The time is less important as long as all of the absorbing area on the strip is exposed.

  • Page 69: List Of Symbols

    IFU-10815 IFU Z5010118 DermaLab Combo 4 v2 (ID 55108).docx 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.

  • Page 70: Declaration Of Conformity

    Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on tronic equipment (WEEE). Name of product: Dermalab ® Combo 4 Name and address of manufacturer: Cortex Technology Aps, Niels Jernes vej 6B 9220 Aalborg Ø, Denmark. Tel.: +45 98574100 E-mail: cortex@cortex.dk Implemented standards: DS/EN 61000-6-1:2019...

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