Compliance to standards and regulations

Manufacturer

Company name: Dermus Ltd.

Address: Kanizsai utca 2-10 C/11, H-1114 Budapest, Hungary

Website: www.dermusvision.com

ISO 13485 compliance

Dermus Ltd. has established and maintains a comprehensive quality control system according to the requirements of the EN ISO 13485: 2016 + A11: 2021 standard.

This system and the technical documentation are reviewed periodically.

Certification body: DNV, Oslo, Norway, which participates in the conformity assessment.

CE compliance

Dermus SkinScanner-M complies with the general requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37 and of the regulation MDR.

Any customer comments related to the device or the user manual are received by Dermus Ltd. and handled with the necessary care.

If you have any questions, feel free to contact us at the following email address:

Open

Open

2460

EMC compliance

This device can generate and radiate radio frequency energy. The device can generate radio frequency noise to other medical and non-medical, and radio frequency communication equipment.

Test specification: EN 60601-1-2:2014 (Ed. 4)

Manufacturers’s Declaration – Electromagnetic Emissions

The Dermus SkinScanner-M is intended for use in the electromagnetic environment specified below. The customer or the user of the Dermus SkinScanner-M should assure that it is used in such an environment

Manufacturers’s Declaration – Electromagnetic Immunity

The Dermus SkinScanner-M is intended for use in the electromagnetic environment specified below. The customer or the user of the Dermus SkinScanner-M should assure that it is used in such an environment.

Immunity to RF wireless communications equipment

Copyrights

Copyright belongs to Dermus Ltd. All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Dermus Ltd.

Availability and provision of this document

This User Guide is provided as a softcopy, in electronic form, in accordance with the regulation 2021/2226/EU. It is electronically available on the Dermus Wiki public website, and maintained by the manufacturer, Dermus Ltd: https://dermus.atlassian.net/wiki/spaces/DOC/pages/3181805625.

Upon user request sent by email to

or stated during the ordering process, Dermus Ltd provides this document in paper form (hardcopy) at no additional cost for the user.

This document is originally written and published in English language. Upon user request sent by email to

or stated during the ordering process, Dermus Ltd undertakes to prepare a translation of this User Guide to any official language of any Member State of the European Union.

Symbol Descriptions

Symbols used in this User Guide

Special attention!

It draws attention to situations that, if not avoided, could result in an injury or damage to the examiner, patients, patient data, or the device.

Attention!

It draws attention to situations that, if not avoided, could affect the usability and applicability of the device, but do not affect the safety of the investigator, patients, patient data, or of the device itself.

Symbols used on the ME equipment

Device labeling

IP21: Protected from touch by fingers and objects greater than 12 millimeters. Protected from condensation

Safety precautions

Implementation of the ALARA principle: Since shielding is irrelevant for ultrasound imaging of the skin with the Dermus SkinScanner-M device, and a fixed minimal distance of 19 mm is structurally kept between the ultrasound transducer surface and the surface of the skin, the ALARA principle is implemented and maintained by keeping the number of examinations on a specific skin area of a specific patient as low as reasonably achievable, as cautioned in the Contraindications (see below).

Indications (intended patient population and medical conditions)

Indications for Use: The Dermus Skinscanner-M is a handheld and portable ultrasound device, thus it can be easily used to visually check skin conditions under current protocols of current standard-of-care procedures by healthcare professionals for various skin-related applications. (Contraindications: to examine bleeding or purulent skin surfaces and to examine the skin of the eyelid)

Any adult patient may be examined with the device. The device may be used to examine layers and lesions of human skin. The only exceptions to the above are the skin of the eyelids, which are contraindicated to be examined with the present device, and to examine bleeding or purulent skin surfaces.

Contraindications

Training Materials

The use of the Dermus SkinScanner-M device described in detail throughout this User Guide is shown in practice in the following series of training videos: https://dermus.atlassian.net/l/cp/YAJ1vPj2.

1. Introducing Dermus SkinScanner-M

1.1. See Deeper. Care Better 

Dermus SkinScanner-M is a portable medical skin ultrasound imaging device. The device is capable of creating a depth image of a skin section positioned with the aid of real-time optical image guidance showing the surface of the skin area to be examined. Imaging is based on the high-frequency ultrasound reflection properties of the structures of the tissue.

1.2. Intended Use

The Dermus SkinScanner-M is intended to visualize the layers and lesions of skin tissues.

1.3. Principles of Operation and Role of Software Component

The ultrasound imaging of the Dermus SkinScanner-M relies on the well-documented pulse-echo principle. The high-frequency, single-element transducer is moved by a motor to produce full-frame images. Optical guidance of the scanning is achieved by an LED-illuminated camera looking at the same position where the ultrasound imaging works. The device is USB-powered, and the main image processing is carried out on a third-party host computer (ie. Android-based device). Dermus SkinScanner-M technically comprises a web application software component as a display and annotation interface (https://www.dermus.app/capture), which was developed to receive ultrasound- and optical- framepairs and cineloops from the device through USB. It displays the captured skin record pairs and the user is able to step between the framepairs.

Note: while the Dermus.app/capture web-app is an essential component of the device to achieve its main function as an image displaying tool, it can be executed on any computing device with a browser and internet connection. It works in such a way, that network connection is necessary only to load the software, while captured data remains in the memory, without a bi-directional network communication. To archive the captured data, the user can download it from the memory as still images, cineloop video or a pdf report. Alternatively, the user can export and upload to a different image catalog and cloud storage software, called SkinAid, which is not part of this device, but an optional accessory.

Since the software component of Dermus SkinScanner-M is not offering cloud storage (but the separate SkinAid app), we do not store any data for long term in this product, image archiving is only achieved by exporting the data. In this way, captured images can be rewatched in this application only after the live capturing (examination), before starting a new capturing session. Furthermore, this software component is not storing any sensitive information or personal data.

No special network-connection- or cybersecurity-related compliance obligations apply (such as IEC 80001-2-2:2012) regarding the software component (Capture app) of Dermus SkinScanner-M.

1.4. Device parts, packaging and recommended accessories

The parts and recommended accessories of the product are presented in the scheme of Figure 1.

The Dermus SkinScanner-M device itself, including its removable applied part, and its display and management tool – dermus.app/capture web-application – form the parts of the CE-certified medical device. These parts are physically or technically separable from the recommended accessories and from the catalogue system web application (skinaid.app).

The packaging of the device, including the labels of the packaging, are standardized and tested to maintain safe shipping and storage of the device and its recommended accessories.

The recommended accessories (see Section 1.5 below) which are intended to be used in combination with the device are not parts of the CE-certified medical device but can be parts of the package sent to a user.

Button functionalities

The user can give the following control inputs via pressing the buttons of the device:

• Short press of the “start/freeze” (top) button: Scanning starts or stops (freeze).

• Short press of the “navigation” buttons (left and right): Select the previous (left button) or next (right button) frame for display.

• Long press of the “navigation” buttons (left and right): Step multiple frames back (left button) or forth (right button) for display. The speed of stepping increases with the time of the button being pushed.

• Short press of the “save frame” button (bottom): Select the frame (currently on display) for saving.

Feedback light states

The color of the feedback light (placed beside the control panel) provides visual feedback to the user about the state of the device:

• Cyan light: The device is currently connecting to the host, and getting power from the host.

• Green light: Scanning is in progress.

• Blue light: Scanning is frozen (stopped).

• Yellow light: Firmware update mode, user interaction is needed.

1.5. Recommended accessories

Additional accessories needed to use the device:

• Cardboard box – for storage and transport.

• Host device (PC / phone / tablet) – e.g. exclusively prepared host smartphone, called Mobile Computing Unit, bearing an USB connector complying at least USB 3.0 standard, optionally with a magnetic phone case for physical attachment. Host device is a user interface and energy source to be able to use and control the SkinScanner-M device and display the results of imaging. For required certifications, please see Section 1.7.

• USB cables – complying at least USB 3.0 with standard USB-C male connector is required to connect the device to the host.

• Refillable flask with distilled water – to fill the water chamber of the device.

• Ultrasound gel – CE marked, biocompatible and non-expired; for conducting the ultrasound examination.

• Water refill stand – to guarantee convenient water refilling process.

• Cardstock quick start guide – one-pager handout, to help the user during first use of the device.

• Textile sac – to facilitate device storage and in-house transport.

• Paper towel and alcohol – to clean the device (usually not included).

Note that the above recommended accessories are separate devices from the Dermus SkinScanner-M, and are certified in their own right.

1.6. Packaging

Dermus Ltd. provides proper durable packaging, which also functions as a case. The user can use this case for storing and carrying the device until the end of its lifetime.

The user can also use the sac as a recommended accessory for carrying the device.

1.7. Host device

A host device is referred to a device that includes USB connection, power supply, user interface, internet connection and a WebUSB-compliant web-browser access (e.g. Google Chrome, Microsoft Edge). 

The device can be connected to SkinScanner-M both through USB port A and B (see Figure 2). It is not mandatory to use the host device and the SkinScanner as one unit. For instance you can place the host device apart from the Skinscanner-M body and perform the check up. 

USB-C ports (see Figure 2 in Section 1.4) located on the SkinScanner-M device can be used to charge a smartphone host device without disconnecting it from the SkinScanner-M device. Such charging utilizes both USB-C ports of the device. To charge the smartphone host through the SkinScanner-M device, the host device must be connected to USB-C port A (for connectivity) and the charging cable must be connected to USB-C port B (for power supply). Only a certified USB charger or USB connector of a certified device is allowed to use for charging.

Minimum requirements for personal computer host devices (for full mobility an Android-based, Dermus-certified ‘Mobile Computing Unit’ can be used as an optional accessory):

• Shielded long USB-C cable for PC connection

• USB 3.0 certified connector

• Windows 7 or later (Android 10 or later)

• Web browser with WebUSB compliance (e.g. Google Chrome, Microsoft Edge, Samsung Internet, Opera)

• Internet connection

• Intel Core i5-5200U CPU or similar (on Android max 8nm octa-core Snapdragon and at least Adreno 618 GPU)

• 8 GB of RAM (for PC at least DDR3)

• Min. FHD (1920x1080p) display resolution

• Certified according to IEC 60950 and/or IEC 62368
  
  

2. Recording Workflow

The SkinScanner-M device uses a web application as a user interface. This interface needs user registration and is directly connected to the SkinAid product of Dermus Ltd. For more detailed instructions regarding registration and login, please refer to Section 2 of our SkinAid User Manual. 

The registration is made via the SkinAid web application (skinaid.app). Users already registered on our SkinAid platform can log in to the user interface software with their credentials. 

2.1. Steps prior to examination

1. Please access our web application either by using www.skinaid.app/capture URL directly, or by pressing the “Capture” shortcut button in the SkinAid user interface (www.skinaid.app) – see highlight in yellow below. 

    

2. After logging in, plug in your device and select ‘OK' under ‘Plug and pair Dermus Device’ window.

    

3. Select ‘Dermus Camera’ and click ‘Connect’ on the pop-up window.

4. Allow Chrome access to Dermus Camera.

    

5. Repeat steps 3 and 4 for ‘Dermus Ultrasound’ connection.

2.2. Capture Screen Layout

In order to view the content in ‘Full screen’ mode, press the button located at the bottom-right corner.

To exit the ‘Full screen’ mode, press the button located at the bottom-right corner again.

2.3. Skin Ultrasound Image Recording 

The recording process is as follows:

1. For good recording quality, apply ultrasound gel to the membrane of the device's examination window.

2. Place the ultrasound-gel-lubricated examination window of the device to the skin area to be examined so that the area between the examination window and the skin surface is completely filled with the gel.

3. Start recording either by clicking on the ‘Unfreeze’ button in the application or by pushing the top 'Start/Freeze' button on the control panel of the device.

Use the real-time optical image displayed on the screen to position the device so that the top view axis of the depth section to be examined is aligned with the red line on the optical image as shown in the images below.

4. After aligning the red line on the lesion to be examined on the display, click on the red ‘Freeze’ button either in the Control Panel section of the web application screen (on the right side of the screen) or on the Control Panel of the device (top button).

Internet connection during examination

If the internet access is lost during the data acquisition process, the following message will appear at the bottom of the screen.

If the connection is restored, the following message will appear. The message will automatically disappear after 6 seconds of successful internet establishment, however you can manually close the message before that by clicking on the 'x' button at the right end of the message window.

Image Adjustments during data acquisition

In order to perform an image adjustment, please click on the Image adjustment button. Please note that both the Ultrasound and the Optical Images can be adjusted, separately. Select the modality you want to make adjustments on by clicking on it. The selection is indicated by a thin light blue frame around the selected image. Note that the Ultrasound image is selected by default for image adjustments. If you would like to adjust the brightness of the Optical image, please select the Optical image before moving the slider.

Brightness level

Brightness level can be modified for both the Ultrasound and the Optical image. It can be modified for one of them at a time. It can be increased or decreased by moving the slider up or down on the scale having 9 levels in total.

Color Switch

By pressing the “Color switch” button, the display of the Ultrasound image can be switched between colorized and grayscale representation.

(The colormap switch function is specific for – only applicable on – the Ultrasound image.)

Echo Intensity

It is possible to display or hide the echo intensity label of the Ultrasound image by pressing the button at the bottom of the adjustment panel.

(The echo intensity label is again specific for the Ultrasound image.)

2.4. Other Functionalities

As shown on Figure 5 in Section 2.2 Capture screen layout, image analysis tools can be found below the Optical image. These tools are also available on the SkinAid platform, so that you will be able to later analysis on the images if they were saved. The results of distance measurements and annotations will be saved and shown in SkinAid if the corresponding frame pair is saved. 

Thickness measurement

This option allows the user to measure the distance between two specified points on the ultrasound image or on the optical image, independently from each other. Please note that the results are demonstrated in three different values: True Distance, Vertical and Horizontal projections (components) in millimeters.

In order to execute the measurement, tap the ‘Thickness measurement’ button, then select two points on the Optical or on the Ultrasound image. The distance measurement results can be displayed simultaneously for both the Optical and the Ultrasound image. It is possible to simultaneously have at most three measurements on the same optical or ultrasound image. Distance measurements can be modified by dragging and dropping the markers which indicate the selected points.

The numerical results of distance (thickness) measurements are displayed in panels on the modalities they were made on. Results of a measurement made on a particular frame can be hidden and displayed again by tapping on the ‘Thickness measurement’ button.

Any distance (thickness) measurement result can be deleted by dragging the marker onto the bin icon which appears when a marker is moved.

The results and coordinates of the last three performed measurements will be saved in the SkinAid database and can be viewed on the Lesion page if you save that particular frame (see Section 2.5 for saving frames).

Annotation

The user can mark out lesion borders or any other structures on the given image by using the annotation functionality of our SkinAid software. 

In order to select annotation points, tap the ‘Annotation’ button, then select points on the Optical or on the Ultrasound image. Selected points are indicated with markers. When a point is selected on the Ultrasound image, a corresponding marker appears on the red Ultrasound image slice position indicator line on the Optical image. It is possible to simultaneously have at most seven annotation points on the same Optical or Ultrasound image. Annotation results can be modified by dragging and dropping the annotation markers.

Results of annotation made on a particular frame can be hidden and displayed again by tapping on the ‘Annotation’ button.

Any annotation marker can be deleted by dragging it onto the bin icon which appears when a marker is moved.

The results of annotation will be saved in the SkinAid database and can be viewed on the Record Review page if you save that particular frame (see Section 2.5 for saving frames).

Download Images

By selecting this option, the optical and ultrasound images currently on display will be downloaded automatically, in two separate (.png) files. The image file names will contain patient ID, lesion ID and recording ID information. 

The downloaded images will have the same adjustments as the displayed images, meaning that color/grayscale display, echo intensity label display of the Ultrasound image and brightness level of both downloaded images will be the same as on display at the time of pressing the ‘Download images’ button.

If Distance measurement and/or Annotation results are displayed at the time of pressing the ‘Download images’ button, the downloaded images will also contain these markers and results.

2.5. Saving results into SkinAid

The user can save the recordings frame-by-frame and/or save the whole series of frames ('cine loop') into the database of the SkinAid system SkinAid 4.0 Instructions for Use (04.08.2022) , using the following buttons with the following functionalities:

Save Frame

It is possible to select any of the recorded frames for saving either using the ‘Save frame’ button of the screen or with the corresponding physical (bottom) button on the control panel of the device. It is possible to unselect the previously selected frame by pushing either of these buttons again when that particular frame is on display.

When a frame is selected, the ‘Save frame’ button of the application will be displayed in red, and if it is unselected, the button will be displayed in gray again.

Save Cine-loop

Selecting the cine-loop for saving is possible in the ‘Close Exam’ step. It is possible to select the whole cine-loop or only a section of it for saving. Cropping of the cineloop can be done by moving the two markers (start and end marker) located on the slider above the image pair. The start marker is located at the beginning of the slider, and the end marker is located at the end of the slider by default. They can be moved by clicking and holding down the left mouse button.

Move the start marker to the position of the first, and the end marker to the position of the last frame you want to include in the cineloop region selection (cropped region).

Close Exam

A pop-up window with options to deselect/select frames chosen and/or cine-loop for saving will appear when the examination is closed with the ‘Close Exam’ button of the Capture screen. The selected items will be saved only after pressing the ‘Close Exam’ button of the pop-up window and then successfully designating the recording to a specific lesion of a patient (see below).

The “multi-frame cine-loop” option will always appear on this window, and is unselected by default. Saving the selected cine-loop section is possible by ticking the checkbox. The single frames only appear if they were selected at least once during the session.

Saving frames/cine-loop (records) to a Patient

After closing the exam, the application automatically directs you into the SkinAid system. Here you need to select a patient and then a lesion of that patient to which the recordings will be saved. Either existing patient/lesion can be selected or a new one can be added.

In summary, there are three options for assigning patient/lesion to recordings (frames/cine loop) to be saved:

• Select an existing patient and its existing lesion (in the database);

• Select an existing patient and add a new lesion to him/her;

• Add a new patient with a new lesion.

Add records to an existing lesion

1. Select a specific patient from the Patients list.

2. By selecting the lesion of choice the saved frames/cine loop will be attached to that lesion.

Add records to a new lesion of an existing patient

1. Select a specific patient from the Patients list.

2. Add a new lesion by clicking on the red plus icon at the right bottom corner of the screen.

3. After selecting the lesion area on the following body schematic, the saved frames/cine loop will be attached to that newly created lesion.

Add frames/cine loop to a new Patient

1. Add a new patient by clicking on the plus icon at the right bottom corner of the screen.

2. Provide details of the patient.

3. In this case, the application progresses directly to the “Add new lesion” screen. After selecting the lesion area on the following body schematic, the saved frames/cine loop will be attached to the newly added lesion and patient.

Providing diagnosis information

After selecting or registering a patient and a lesion, the application asks to provide information about the diagnosis of the examined lesion. A pop-up window appears with an ICD code search field and a free text field to describe the diagnosis, and radio buttons to select the basis of the diagnosis. You have the options to either give the ICD code or fill the free text field or do both (supplementing each other).

The title of the pop-up window is ‘Add diagnosis’ or ‘Confirm / Update diagnosis’. It has a button with ‘Add diagnosis’ text at the bottom.

If a new lesion is registered, the fields in the pop-up window are empty and none of the radio buttons is selected. If the recordings are saved to an already existing lesion, previously saved diagnosis information is displayed in the pop-up window. In the latter case, you are free to either update it, or leave it as is.

After you start typing an ICD code in the search field, options will be displayed in a drop-down menu and you can choose one by clicking on it. It is possible to provide additional information in the free text field.

If you click the ‘Add diagnosis’ button, the application saves the recordings and the corresponding diagnosis information to the selected lesion.

Feedback about saving and option to cancel saving

After you click ‘Add diagnosis’, the pop-up window is closed and the uploading of the recordings will start automatically. The application provides feedback about the progress of saving by displaying a progress bar in a pop-up window.

Above the progress bar, a text is displayed about the number of frame pairs and/or about cine-loop being under uploading.

If the uploading of the optical-ultrasound frame pairs is finished and the uploading of the cine-loop is still in progress, the text changes to ‘We are uploading the cine-loop (n frame pairs are already uploaded)’.

There is an option to cancel the saving of the recordings by clicking the button with text ‘Cancel saving’ at the bottom of the pop-up window. The text on the button changes to ‘Cancel cine-loop saving’ If the uploading of the optical-ultrasound frame pairs is finished and the uploading of the cine-loop is still in progress.

If the ‘Cancel’ button is clicked, the saving stops and the application returns to the Capture screen with the recording being in frozen state. The results of the previous examination are displayed and the frame and/or cine-loop selections are still present. Recordings that got fully uploaded to SkinAid will remain saved, other recordings will not be saved.

Finishing the saving workflow

When the uploading is finished, the application presents two options for the user:

1. Go back to the Capture screen: the application returns to the Capture screen with the recording being in frozen state, as left when the ‘Close exam’ button was pushed. The results of the previous examination are displayed and the frame and/or cine-loop selections are still present.

2. Review the saved recordings: the application progresses to the SkinAid system where the uploaded recordings can be viewed. From here, there is no returning to the Capture screen with the previous recording on display.

2.6. Access to Capture Screen directly from SkinAid

By selecting the USB symbol (Add new record with SS-M/U) on the page of a lesion of a patient on the SkinAid platform, you will be prompted directly to the capture screen.

In this case, there will be no need to select patient and lesion during saving the recordings when closing the capture session. They will be automatically assigned to the lesion from which the capture session was initiated. Also, once the application redirects to the Capture screen, the selected patient ID and lesion ID will be displayed at the top (navigation bar) of the screen.

2.7. Completing the examination

Steps to follow each patient examination:

1. Remove the gel from the examination window

2. Clean the examination window

2.8. Interpretation of the ultrasound images

The ultrasound images recorded of the skin by the Dermus SkinScanner-M usually present reflections from the following structures:

• Structures of the imaging window:

  • Membrane

• Structures of the skin:

  • Epidermis

  • Dermis

  • Subcutis

• There is ideally a reflection-free gel area in between the membrane of the imaging window and the epidermis of the skin.

Reflections seen in the gel area are usually representing hair or air bubbles, both of which may also cause an acoustic shadow on the image of the skin.

3. Troubleshooting and Support

3.1. Common Troubleshooting Steps

Failed connection between device and host

If the connection between the device and the host is lost or in other cases of the device not working properly, please reset the connection between the device and the host via the following steps:

1. Unplug the device from the host.

2. Wait for 5 seconds.

3. Plug in again the USB connector to the host device.

4. Refresh the Capture screen of the web application (SkinAid).

Multiple failed connection attempts

An error message will appear after multiple unsuccessful connection attempts. The message will show an option to reset the device so that it can be used normally again.

Optical image not appearing

If a recording has been started and only ultrasound images appear on the screen, with no optical images next to them, please stop the recording (freeze) and restart it (unfreeze). In most of the cases, both the optical and the ultrasound images should appear after restarting the recording. If the issue still occurs and the two images do not appear simultaneously after the recording has been restarted, please contact the support team of the manufacturer.

3.2 How to view firmware versions in the web application

In case our support team is asking for such information, you can check the actual firmware versions of your device by opening www.skinaid.app/usb-settings on a host device connected to it. The versions are listed under the title “Current device version table”.

3.3. Support Options

If the above steps do not solve the problem, or in any other cases of malfunctions, please contact our Support Team at:

How to access 'Support page' from Capture Screen

The instructions below will help you to locate our support page on the SkinAid platform.

1. Open www.skinaid.app/capture

2. Click on the 'question mark' icon located on the top left corner of the page as highlighted below.

    

3. Three options appear: ‘About’, ‘Release notes’ and ‘Support’.

4. Clicking ‘About’ opens a page with information about Dermus Ltd.
   Clicking ‘Release notes’ opens the list of notes of all releases so far.
   Clicking ‘Support’ redirects to Dermus Wiki which has a range of support options.

4. Storage and maintenance

4.1. Storage

The safe use and storage of the device requires a dry place at room temperature, protected from direct sunlight. The device shall be stored with empty water chamber.

Temperature range permitted for max one week delivery time: 0... +45 ºC

4.2. Maintenance

Dermus SkinScanner-M is maintenance-free in addition to cleaning and bubble discharging (described in Section 4.3 below). Do not leave the same distilled water in the chamber for more than 1 day. It could cause significant degradation in the optical and ultrasound image quality.

For safety reasons, it is important to maintain the integrity of the device.

If any malfunction occurs or safe use of the device is not certain anymore for any reasons, please contact the manufacturer forthwith.

4.3. Refilling the water chamber

The chamber behind the examination window is filled with distilled water for acoustic coupling required for proper ultrasound wave propagation. Since this coupling medium tends to evaporate, it is required to refill the chamber regularly. The refilling is performed via the  “bubble discharge” process.

Tools and materials used for bubble discharge 

Tools: 

• Dropper bottle

Material:

• Distilled water

Bubble discharge process

The dropper bottle is intended to refill the inner chamber with distilled water. 

The device stand is meant to hold the device securely parallel to the ground as shown in the image below.

1. After placing the device on the stand, remove the applied part cap closing the water chamber by turning it counter clockwise by ~45°.

2. Use the dropper bottle for refilling. Aspirate approximately 18 ml of deaerated (as treated with a vacuum chamber or via boiling) distilled water.

3. Distilled water should be added to the inner chamber until a dome-shaped pool of water forms on top.

4. Apply a small amount of gel around the edges of the chamber as a lubricator to eliminate friction of the cap while closing the vent.

5. If there are no more bubbles in the chamber, close the vent by carefully fitting and tightening the cap via turning it 45° clockwise.

4.4. Disposal

In the case of an intended disposal, the user should send the device back and Dermus Ltd. will dispose of the device properly. 

4.5. Cleaning the device

Agents and tools used for cleaning

Agents: ethanol or isopropyl alcohol (at least 95% concentration)

Tools: paper towel

Process of cleaning:

The imaging window and its neighborhood (the parts being in indirect contact with the patient, through ultrasound gel) should be cleaned in the following way, after finishing the examination of each patient.

1. Remove the gel completely from the relevant parts of the device surface (imaging window and its neighborhood, if necessary) using a paper towel. 

2. Cover the entire area that was previously in contact with the gel preferably using a spray of the cleaning agent. In the absence of spray, use a paper towel instead to evenly distribute the cleaning agent on the surface area.

3. Leave the surface area treated with the cleaning agent untouched for 2–3 minutes. During this time, the alcohol substance exerts its effect, the majority of the alcoholic component evaporates, and the cleaning finishes. 

4.6. Environmental condition

Application and long-term storage

Temperature range: +10 ... +45 ºC

Relative humidity: 0 ... 100% non-condensing

Short-term (< 24 hours time) ratings for storage and transport

Temperature range: +5 ºC ... +50 ºC

Relative humidity: 0 ... 100% non-condensing

5. Technical Data

5.1. Working principle

The Dermus SkinScanner-M uses high-frequency ultrasound waves for imaging of the subsurface structures of human skin. The ultrasound pulses generated by the device get scattered and reflected on the inhomogeneities of the structural elements of the skin. The reflected waves are received and their data are processed by the device. The device uses a one-element transducer moved on a linear stage by a stepper motor. The data are converted into two-dimensional images by recognition of stepper motor position (for forth and back movement as well). During capturing the ultrasound image, optical imaging aids the guidance of where the ultrasound image should be taken. The relative spatial position of the ultrasound image cross-section is indicated with a red line superimposed on the optical image. A series of corresponding optical-ultrasound image frame pairs can be recorded of which a number of selected frame pairs or the whole loop of frames can be saved for storage and further analysis.

5.2. Technical specification

The examination window may come into contact with type “B” patient parts.