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Cortexa Technology DermaLab Aesthetic Instructions For Use Manual
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Cortexa Technology DermaLab Aesthetic Instructions For Use Manual

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Released 2024-10-11
Instructions for Use DermaLab Aesthetic
Z65001.03 EN
®
DermaLab
Aesthetic
Instructions for Use
CORTEX TECHNOLOGY
Niels Jernes Vej 6B
9220 Aalborg, Denmark
www.cortex.dk cortex@cortex.dk

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  • Page 1 Released 2024-10-11 Instructions for Use DermaLab Aesthetic Z65001.03 EN ® DermaLab Aesthetic Instructions for Use CORTEX TECHNOLOGY Niels Jernes Vej 6B 9220 Aalborg, Denmark www.cortex.dk cortex@cortex.dk...
  • Page 2 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY ® DermaLab Aesthetic Instructions for Use 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.
  • Page 3 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Contents 1 Before you start ........................5 1.1 Warnings .............................5 1.2 Intended purpose ........................5 1.3 General description ........................5 2 Getting started ........................6 2.1 Connect power supply .........................6 2.2 Connect main unit ........................6 2.3 Connect computer to main unit ....................6...
  • Page 4 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 4.1.2.1 Cleaning ..........................25 4.1.3 Performing a collagen measurement ..................26 4.1.4 Understanding the collagen measurement ................. 27 4.1.5 Avoiding Artifacts ........................27 4.1.6 Gel layer thickness ........................28 4.1.7 Maintenance ..........................28 4.2 Moisture ............................
  • Page 5 Several probes can simultaneously be connected to the main unit to measure skin-related parameters such as collagen, elasticity, moisture (hydration), pH, and skin oiliness (sebum). The DermaLab Aesthetic is intended to be connected to a Windows-based computer system using a USB cable.
  • Page 6 CORTEX TECHNOLOGY 2 Getting started To ensure trouble-free and safe operation of the DermaLab Aesthetic please follow the instructions for use and maintenance as described in this document. The following figure shows the connectors on the rear panel of the main unit.
  • Page 7 2.6.2 Software installation instructions To install and run the DermaLab Aesthetics Software, run the DermaLab Aesthetics software installation msix package provided with the DermaLab Aesthetic. On first install, you may be asked to install USB-drivers to access the DermaLab Aesthetic hardware. 7/42...
  • Page 8 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 3 How to use the software When starting the software, the first page presented is the “Client menu” as shown in Figure 3. Figure 3 The “Client menu” At first startup, you will be prompted to input company information. Access the Company settings page through the “Company settings”...
  • Page 9 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 4 The “Company settings” page 3.1.2 Company and system settings From the top menu you can access further settings and information regarding the system. 3.1.3 Change info text This page allows you to change the text of the about sections that each of the measurement pages contain.
  • Page 10 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 5 The “Treatments” page The page is divided into three sections:  “Search”: Search for treatments that have been added.  “Add treatment”: Give the treatment a name and select the icon that would match the treatment.
  • Page 11 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 6 The “Common values” page pH: The common value for pH is based on multiple research studies using the pH Probe from Cortex Technology and is between 4.4 and 6.3 Moisture: The moisture score ranges from 0 to 400 µS.
  • Page 12 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 7 “System info” page This page is useful when you are concerned about whether a probe is enabled, if you want to ensure that you have the latest version of the software, etc.
  • Page 13 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY  Treatments All treatments  All Data All of the above Before importing, users will also have to select the import method:  Overwrite Any data selected for import will overwrite current values on system (e.g. if clients and...
  • Page 14 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Register new client Press the “Register new client" shown in Figure 3 to enter the “Register new client” page. Here you can enter the client ID (as assigned by you), age and gender of the client, and you can register the practitioner.
  • Page 15 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY If the client is not present in the list and needs to be registered as a new client, click the button in the bottom left corner to go to the “Register new client” page.
  • Page 16 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 3.4.1 Session options You can start measurements by clicking on the measurement indicators on the screen. More information about each measurement can be found in section 4. The top menu of the ”Main menu” provides functionalities for the session: ...
  • Page 17 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 3.4.3 Compare measurements Measurement results from previous sessions can be compared on the “Compare results” page shown in Figure 13. Baseline values can be enabled or disabled using the switch in the lower left corner.
  • Page 18 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY In the “All treatments” section, you can view all the treatments you have added in “Company settings”. Select a treatment by clicking on the treatment in the section “All treatments”. The treatment will then be displayed in the “Selected treatment”...
  • Page 19 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Examples of printout can be seen in Figure 16, Figure 17, Figure 18 and Figure 19. Figure 16 Printout with all measurements Figure 17 Printout with only 3 measurements selected.
  • Page 20 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 18 Treatment recommendations printout. Figure 19 Printout with all measurements - including information about sections. Printing from the “Compare results” page will include all measurements selected for comparison. Baseline values will only be present in the printout if selected beforehand.
  • Page 21 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 20 “Compare results” printout. 3.4.6 Sending email Dermalab Aesthetics software allows the user to send email to the client with the same data that can be printed. When the user sends an email, the software creates a .PDF file that will be attached to the email and the software opens the user’s default email client, where the user can send the email from.
  • Page 22 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 2. The user should then navigate to the top row of the page and click the “Send as mail” button. Figure 21 Main measurement page top row buttons. 3. In the popup, the user should input the user’s own mail address for a test email.
  • Page 23 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 6. The user is now ready to send email to clients using the Dermalab Aesthetics software. When the test mail has been sent, the user can navigate to the start page of the software by pressing “End session”.
  • Page 24 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Step 7: Check if Thunderbird opens with a new mail. If Thunderbird opens, you are now ready to send mails using the DermaLab Aesthetics software. Troubleshooting: If Thunderbird does not prompt you to make it the default mail client or thunderbird does not open a mail when the “Open Mail”...
  • Page 25 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Use the syringe Check for air with the bubbles (more attached tip to information fill the chamber below). with water. Ultrasound Probe is ready for use. Remove as much air as possible from the water chamber during filling. Minor air bubbles will typically not disturb the collagen measurement.
  • Page 26 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 4.1.3 Performing a collagen measurement Measurements are performed in order from left to right, beginning with the reference measurements. See Figure 25. Figure 25 “Collagen” page with no measurements. Apply ultrasound gel on the tip of the probe before each scan to couple the probe to the skin.
  • Page 27 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 4.1.4 Understanding the collagen measurement In the ultrasound 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 28 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY It is important to ensure good acoustic contact between the tip of the probe and the skin. Artifacts in the form of shadows may also be a result of collected air bubbles inside the water chamber.
  • Page 29 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 32 “Moisture” page with T-zone measurement indicator. Figure 33 “Moisture” page with U-zone measurement indicator. All results can be cleared by clicking “Delete” in the top menu. The last measurement performed can be cleared by clicking “Clear last result”.
  • Page 30 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Elasticity The Elasticity Probe provides information regarding the skin’s elasticity by measuring the retraction time of the skin. Retraction time (R) is the time in milliseconds it takes for the skin to retract from the peak elevation to 33% of the peak elevation.
  • Page 31 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 4.3.2 Maintenance Except for keeping the Elasticity Probe clean there is no preventive maintenance associated with the use of the probe. To clean the probe front, simply wipe it off using a dry cloth. Should more thorough cleaning be necessary, a drop of isopropyl alcohol may be applied to the cloth to remove residual glue.
  • Page 32 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 39 The “Skin oil” page. The measurement result is presented on the screen as a sebum score of saturation of the film from 0 to 100, where 100 indicates very oily skin. See Figure 39.
  • Page 33 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Figure 40 The “pH” page. 4.5.2 Calibration A Calibration can be Initialized by pressing the “Calibrate” button at the top of the “pH” page and a pop- up will appear as shown in Figure 41.
  • Page 34 “Calibrate pH4” button and wait for the button to get back to its original state. Please note each calibration can take up to 20 seconds. After calibration, the calibration values are stored in the DermaLab Aesthetic and will be used until the next time a calibration is performed.
  • Page 35 7 Safety The external power supply for the DermaLab Aesthetic forms an integral part of the electrical safety features of the device and must not be tampered with. Do not use any other power supply than provided by Cortex Technology.
  • Page 36 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 9 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 37 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 10 DermaLab Aesthetic parts Name Picture Item number DermaLab Aesthetic main unit C65001.xx Elasticity Probe for DermaLab Aesthetic C05600.xx Elasticity double adhesive patch V02001.xx Hydration Probe for DermaLab Aesthetic C06445.xx Hydration pin calibrator C06006.xx...
  • Page 38 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Sebum strips V02002.xx Aesthetic Ultrasound Probe C08600.xx Ultrasound Probe Head C08601.xx Ultrasound Probe Fill Valve M26038.xx Filling adapter M08610.xx O-ring for Ultrasound Probe Head N16032.xx 38/42...
  • Page 39 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY Power supply (Adapter Tech., C44703.xx ATM036T-P120) 39/42...
  • Page 40 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 11 FAQ In the FAQ below please find answers to questions not to be found elsewhere in this manual. General: In the ”Main menu”, some buttons are greyed out and it is not possible to perform a measurement.
  • Page 41 IFU-10593 Dermalab Aesthetic Z65001.03 EN v3 (ID 54659) CORTEX TECHNOLOGY 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 42 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 harmonisation of the laws of the Member States relating to electromagnetic compatibility. Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits.