{"id":3849,"date":"2019-07-23T15:51:02","date_gmt":"2019-07-23T15:51:02","guid":{"rendered":"https:\/\/www.omnidermal.it\/?page_id=3849"},"modified":"2021-10-19T15:32:22","modified_gmt":"2021-10-19T15:32:22","slug":"faq-spec","status":"publish","type":"page","link":"https:\/\/www.omnidermal.it\/en\/faq-spec\/","title":{"rendered":"Faq & Spec"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”3.22.4″ background_color=”rgba(0,0,0,0.05)” height=”299px” height_tablet=”” height_phone=”” height_last_edited=”on|desktop” custom_padding=”1px||0px|||” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|phone” _builder_version=”3.25″ width=”85%” custom_padding=”154px||0px|||” custom_padding_tablet=”||2%” custom_padding_phone=”20%||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Bold||||||||” text_text_color=”#19bbab” text_font_size=”100px” text_line_height=”1em” header_font=”Barlow Bold||||||||” header_text_align=”left” header_text_color=”#19bbab” header_font_size=”110px” header_letter_spacing=”-4px” header_3_font=”||||||||” transform_scale_tablet=”” transform_scale_phone=”” transform_scale_last_edited=”on|phone” transform_translate_tablet=”” transform_translate_phone=”0%|-20%” transform_translate_last_edited=”on|desktop” transform_translate_linked_tablet=”off” transform_translate_linked_phone=”off” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|desktop” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|desktop” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|desktop” transform_styles_last_edited=”on|desktop” custom_margin_tablet=”-12%||2%|” custom_margin_phone=”0%|||” custom_margin_last_edited=”on|tablet” custom_padding=”||0px” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”35%” text_font_size_tablet=”14px” text_font_size_phone=”” text_font_size_last_edited=”on|tablet” header_font_size_tablet=”97px” header_font_size_phone=”57px” header_font_size_last_edited=”on|phone” header_letter_spacing_tablet=”-4px” header_letter_spacing_phone=”” header_letter_spacing_last_edited=”on|phone” header_line_height_tablet=”0.9em” header_line_height_phone=”1em” header_line_height_last_edited=”on|phone” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”]<\/p>\n

FAQ & Spec.<\/span><\/strong><\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ disabled_on=”on|off|on” admin_label=”Menu Grid” _builder_version=”3.22.4″ background_position=”top_left” background_blend=”multiply” width_tablet=”100%” width_phone=”” width_last_edited=”on|phone” module_alignment=”center” custom_margin=”4%|0px|4%|0px||” custom_padding=”0px|0px|0px|0px||” global_colors_info=”{}”][et_pb_row _builder_version=”3.25″ custom_padding=”||32px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Italic||||||||” text_font_size=”16px” header_font=”Barlow Bold||||||||” header_text_color=”#000000″ header_font_size=”50px” custom_padding=”||2px|||” animation_style=”slide” animation_direction=”left” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

Frequently Asked Questions<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ custom_padding=”3px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”WHAT IS WOUNDVIEWER?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular||||||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

WoundViewer is a class 1 medical device able to acquire and process automatically in two\u00a0<\/em>minutes the images of cutaneous ulcers by an algorithm of artificial intelligence (AI) that gives\u00a0<\/em>the physician the basic parameters of the lesions and organizes the information in digital\u00a0<\/em>health records. Thanks to its 4 G and WiFi connectivity, WoundViewer can be used for\u00a0<\/em>telemedicine services.<\/em><\/div>\n

[\/et_pb_toggle][et_pb_toggle title=”How long does it take to measure the parameters of the lesion with woundviewer?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

WoundViewer allows to calculate in 2 minutes the basic parameters of a skin lesions.<\/em><\/div>\n

[\/et_pb_toggle][et_pb_toggle title=”What are the parameters monitored?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” custom_padding=”||20px|||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

WoundViewer allows the user to measure, in a matter of minutes and automatically, all the\u00a0<\/em>main parameters that characterize skin lesions:<\/em><\/div>\n
Perimeter of the wound<\/em><\/div>\n
Area of the wound<\/em><\/div>\n
Depth of the wound<\/em><\/div>\n
Granulation tissue<\/em><\/div>\n
Ulcer classification according to international protocols<\/em><\/div>\n
Exudate and degree of infection (under development)<\/em><\/div>\n

[\/et_pb_toggle][et_pb_toggle title=”what languages are available?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

WoundViewer is currently available in Italian and English. Other languages will be supported in the coming months.<\/em><\/div>\n

[\/et_pb_toggle][et_pb_toggle title=”is data protection guaranteed?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

Security is one of our priorities. All data is transferred according to the SSL\/TLS security\u00a0<\/em>protocol to avoid malicious actions. The access to WoundViewer account is safe on the Web as\u00a0<\/em>on your phone to prevent patient data to fall into the wrong hands.<\/em><\/div>\n

[\/et_pb_toggle][et_pb_toggle title=”do you have a privacy policy?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

All personal and patients\u2019 information will be kept confidential and will not be sold to third parties, nor will be added to the mailing list. WoundViewer respects the GDPR, the European\u00a0regulation on data protection and privacy.<\/em><\/div>\n

[\/et_pb_toggle][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Italic||||||||” text_font_size=”16px” header_font=”Barlow Bold||||||||” header_text_color=”#000000″ header_font_size=”50px” custom_margin=”10%||” custom_padding=”||2px|||” animation_style=”slide” animation_direction=”left” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

Technical Specifications<\/h1>\n

[\/et_pb_text][et_pb_image src=”https:\/\/www.omnidermal.it\/wp-content\/uploads\/2021\/10\/Wound-Viewer-120_19-2-copia-2.png” align=”center” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”4.11.2″ hover_enabled=”0″ global_colors_info=”{}” title_text=”Wound-Viewer-120_19-2-copia” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”3.25″ width=”70%” global_colors_info=”{}” column_structure=”1_3,1_3,1_3″][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”DISPLAY” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

    \n
  • LCD interface capacitive<\/span><\/li>\n
  • Touch Screen<\/span><\/li>\n
  • 2 USB Plugs<\/span><\/li>\n<\/ul>\n

    [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”CAMERA” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

      \n
    • 1 x CMOS Camera<\/span><\/li>\n
    • 16 x IR Sensors<\/span><\/li>\n
    • 4 x White LEDs<\/span><\/li>\n
    • Microphone<\/span><\/li>\n
    • Geo-localization<\/span><\/li>\n
    • microSD<\/span><\/li>\n<\/ul>\n

      [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”COMMUNICATION” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        \n
      • WiFi interface<\/span><\/li>\n
      • 4G interface<\/span><\/li>\n
      • Bluetooth<\/span><\/li>\n
      • Micro – nano SIM<\/span><\/li>\n<\/ul>\n

        [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”3.25″ width=”70%” width_tablet=”80%” width_phone=”” width_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”REGULATORY STANDARDS REQUIRED” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”35px” title_letter_spacing=”-2px” body_font=”Barlow Regular||||||||” body_text_align=”left” body_font_size=”15px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        Regulatory standards to achieve CE certification are those contained in the family CE93\/42<\/strong><\/div>\n
        (47\/2007).\u00a0In order to protect the future marketing of the device, WoundViewer was designed and built in<\/strong><\/div>\n
        \n

        compliance with the following standards:<\/strong><\/p>\n

        <\/strong><\/p>\n

        <\/strong><\/p>\n<\/div>\n

        [S1] EN ISO 13485 Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes.<\/span><\/p>\n

        [S2] EN 60601-1 Medical electric equipment Part 1: General requirements for safety.<\/span><\/p>\n

        [S3] EN 60601-1-11 Medical electrical equipment General requirements for basic safety and essential performance \u2014 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/span><\/p>\n

        [S4] EN 60601-1-2 Medical electric equipment Part 1: General requirements for safety 2- Collateral Standard: Electromagnetic compatibility- Requirements and tests.<\/span><\/p>\n

        [S5] EN 62304 Medical device software \u2013 Software life-cycle processes.<\/span><\/p>\n

        [S6] EN ISO 14971 Medical devices \u2013 Application of risk management to medical devices.<\/span><\/p>\n

        [S7] 1907\/2006 Regulation (EC) of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh), establishing a European Chemicals Agency<\/span><\/p>\n

        [S8] 2011\/65\/EU Directive of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment (recast).<\/span><\/p>\n

        [S9] EN ISO 14971 Medical devices \u2013 Application of risk management to medical device<\/span><\/p>\n

        [S10] EN 62366-1 Medical devices. Application of usability engineering to medical devices<\/span><\/p>\n

        [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ disabled_on=”on|on|off” admin_label=”Menu Grid” _builder_version=”3.22.4″ background_position=”top_left” background_blend=”multiply” width_tablet=”90%” width_phone=”” width_last_edited=”on|phone” module_alignment=”center” custom_margin=”4%|0px|4%|0px||” custom_padding=”0px|0px|0px|0px||” global_colors_info=”{}”][et_pb_row _builder_version=”3.25″ width=”70%” custom_padding=”||32px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Italic||||||||” text_font_size=”16px” header_font=”Barlow Bold||||||||” header_text_color=”#000000″ header_font_size=”50px” custom_padding=”||2px|||” animation_style=”slide” animation_direction=”left” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

        Frequently Asked Questions<\/h1>\n

        [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ width=”70%” custom_padding=”3px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”WHAT IS WOUNDVIEWER?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular||||||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        WoundViewer is a class 1 medical device able to acquire and process automatically in two\u00a0<\/em>minutes the images of cutaneous ulcers by an algorithm of artificial intelligence (AI) that gives\u00a0<\/em>the physician the basic parameters of the lesions and organizes the information in digital\u00a0<\/em>health records. Thanks to its 4 G and WiFi connectivity, WoundViewer can be used for\u00a0<\/em>telemedicine services.<\/em><\/div>\n

        [\/et_pb_toggle][et_pb_toggle title=”HOW LONG DOES IT TAKE TO MEASURE THE PARAMETERS OF THE LESION WITH WOUNDVIEWER?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        WoundViewer allows to calculate in 2 minutes the basic parameters of a skin lesions.<\/em><\/div>\n

        [\/et_pb_toggle][et_pb_toggle title=”WHAT ARE THE PARAMETERS MONITORED?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        WoundViewer allows the user to measure, in a matter of minutes and automatically, all the\u00a0<\/em>main parameters that characterize skin lesions:<\/em><\/div>\n
        Perimeter of the wound<\/em><\/div>\n
        Area of the wound<\/em><\/div>\n
        Depth of the wound<\/em><\/div>\n
        Granulation tissue<\/em><\/div>\n
        Ulcer classification according to international protocols<\/em><\/div>\n
        Exudate and degree of infection (under development)<\/em><\/div>\n

        [\/et_pb_toggle][et_pb_toggle title=”WHAT LANGUAGES ARE AVAILABLE?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        WoundViewer is currently available in Italian and English. Other languages will be supported in the coming months.<\/em><\/div>\n

        [\/et_pb_toggle][et_pb_toggle title=”IS DATA PROTECTION GUARANTEED?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        Security is one of our priorities. All data is transferred according to the SSL\/TLS security\u00a0<\/em>protocol to avoid malicious actions. The access to WoundViewer account is safe on the Web as\u00a0<\/em>on your phone to prevent patient data to fall into the wrong hands.<\/em><\/div>\n

        [\/et_pb_toggle][et_pb_toggle title=”DO YOU HAVE A PRIVACY POLICY?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

        All personal and patients\u2019 information will be kept confidential and will not be sold to third parties, nor will be added to the mailing list. WoundViewer respects the GDPR, the European\u00a0regulation on data protection and privacy.<\/em><\/div>\n

        [\/et_pb_toggle][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Italic||||||||” text_font_size=”16px” header_font=”Barlow Bold||||||||” header_text_color=”#000000″ header_font_size=”50px” custom_margin=”10%||” custom_padding=”||2px|||” animation_style=”slide” animation_direction=”left” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

        Technical Specifications<\/h1>\n

        [\/et_pb_text][et_pb_image src=”https:\/\/www.omnidermal.it\/wp-content\/uploads\/2021\/10\/Wound-Viewer-120_19-2-copia-2.png” align=”center” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”4.11.2″ hover_enabled=”0″ global_colors_info=”{}” title_text=”Wound-Viewer-120_19-2-copia” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”3.25″ width=”70%” global_colors_info=”{}” column_structure=”1_3,1_3,1_3″][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”DISPLAY” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

          \n
        • LCD interface capacitive<\/span><\/li>\n
        • Touch Screen<\/span><\/li>\n
        • 2 USB Plugs<\/span><\/li>\n<\/ul>\n

          [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”CAMERA” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

            \n
          • 1 x CMOS Camera<\/span><\/li>\n
          • 16 x IR Sensors<\/span><\/li>\n
          • 4 x White LEDs<\/span><\/li>\n
          • Microphone<\/span><\/li>\n
          • Geo-localization<\/span><\/li>\n
          • microSD<\/span><\/li>\n<\/ul>\n

            [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”COMMUNICATION” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              \n
            • WiFi interface<\/span><\/li>\n
            • 4G interface<\/span><\/li>\n
            • Bluetooth<\/span><\/li>\n
            • Micro – nano SIM<\/span><\/li>\n<\/ul>\n

              [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”3.25″ width=”70%” width_tablet=”90%” width_phone=”” width_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”REGULATORY STANDARDS REQUIRED” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”35px” title_letter_spacing=”-2px” body_font=”Barlow Regular||||||||” body_text_align=”left” body_text_color=”#000000″ body_font_size=”15px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              Regulatory standards to achieve CE certification are those contained in the family CE93\/42<\/strong><\/div>\n
              (47\/2007).\u00a0In order to protect the future marketing of the device, WoundViewer was designed and built in<\/strong><\/div>\n
              \n

              compliance with the following standards:
              <\/strong><\/p>\n<\/div>\n

              [S1] EN ISO 13485 Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes.<\/span><\/p>\n

              [S2] EN 60601-1 Medical electric equipment Part 1: General requirements for safety.<\/span><\/p>\n

              [S3] EN 60601-1-11 Medical electrical equipment General requirements for basic safety and essential performance \u2014 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/span><\/p>\n

              [S4] EN 60601-1-2 Medical electric equipment Part 1: General requirements for safety 2- Collateral Standard: Electromagnetic compatibility- Requirements and tests.<\/span><\/p>\n

              [S5] EN 62304 Medical device software \u2013 Software life-cycle processes.<\/span><\/p>\n

              [S6] EN ISO 14971 Medical devices \u2013 Application of risk management to medical devices.<\/span><\/p>\n

              [S7] 1907\/2006 Regulation (EC) of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh), establishing a European Chemicals Agency<\/span><\/p>\n

              [S8] 2011\/65\/EU Directive of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment (recast).<\/span><\/p>\n

              [S9] EN ISO 14971 Medical devices \u2013 Application of risk management to medical device<\/span><\/p>\n

              [S10] EN 62366-1 Medical devices. Application of usability engineering to medical devices<\/span><\/p>\n

              [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ disabled_on=”off|on|on” admin_label=”Menu Grid” _builder_version=”3.22.4″ background_position=”top_left” background_blend=”multiply” width_tablet=”90%” width_phone=”99%” width_last_edited=”on|phone” module_alignment=”center” custom_margin=”4.1%|0px|4%|0px||” custom_padding=”0px|0px|0px|0px||” global_colors_info=”{}”][et_pb_row _builder_version=”3.25″ custom_padding=”||32px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Italic||||||||” text_font_size=”16px” header_font=”Barlow Bold||||||||” header_text_color=”#000000″ header_font_size=”45px” custom_padding=”||2px|||” animation_style=”slide” animation_direction=”left” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

              Frequently Asked Questions<\/h1>\n

              [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ custom_padding=”3px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”WHAT WOUNDVIEWER?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular||||||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              WoundViewer is a class 1 medical device able to acquire and process automatically in two\u00a0<\/em>minutes the images of cutaneous ulcers by an algorithm of artificial intelligence (AI) that gives\u00a0<\/em>the physician the basic parameters of the lesions and organizes the information in digital\u00a0<\/em>health records. Thanks to its 4 G and WiFi connectivity, WoundViewer can be used for\u00a0<\/em>telemedicine services.<\/em><\/div>\n

              [\/et_pb_toggle][et_pb_toggle title=”HOW LONG DOES IT TAKE TO MEASURE THE PARAMETERS OF THE LESION WITH WOUNDVIEWER?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              WoundViewer allows to calculate in 2 minutes the basic parameters of a skin lesions.<\/em><\/div>\n

              [\/et_pb_toggle][et_pb_toggle title=”WHAT ARE THE PARAMETERS MONITORED?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              WoundViewer allows the user to measure, in a matter of minutes and automatically, all the\u00a0<\/em>main parameters that characterize skin lesions:<\/em><\/div>\n
              Perimeter of the wound<\/em><\/div>\n
              Area of the wound<\/em><\/div>\n
              Depth of the wound<\/em><\/div>\n
              Granulation tissue<\/em><\/div>\n
              Ulcer classification according to international protocols<\/em><\/div>\n
              Exudate and degree of infection (under development)<\/em><\/div>\n

              [\/et_pb_toggle][et_pb_toggle title=”WHAT LANGUAGES ARE AVAILABLE?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              WoundViewer is currently available in Italian and English. Other languages will be supported in the coming months.<\/em><\/div>\n

              [\/et_pb_toggle][et_pb_toggle title=”IS DATA PROTECTION GUARANTEED?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              Security is one of our priorities. All data is transferred according to the SSL\/TLS security\u00a0<\/em>protocol to avoid malicious actions. The access to WoundViewer account is safe on the Web as\u00a0<\/em>on your phone to prevent patient data to fall into the wrong hands.<\/em><\/div>\n

              [\/et_pb_toggle][et_pb_toggle title=”DO YOU HAVE A PRIVACY POLICY?” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#000000″ title_font=”Barlow Regular|||on|||||” body_font=”Barlow Italic||||||||” body_font_size=”16px” body_line_height=”1.3em” custom_margin=”-1%||” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

              All personal and patients\u2019 information will be kept confidential and will not be sold to third parties, nor will be added to the mailing list. WoundViewer respects the GDPR, the European\u00a0regulation on data protection and privacy.<\/em><\/div>\n

              [\/et_pb_toggle][et_pb_text _builder_version=”3.27.4″ text_font=”Barlow Italic||||||||” text_font_size=”16px” header_font=”Barlow Bold||||||||” header_text_color=”#000000″ header_font_size=”45px” custom_margin=”10%||” custom_padding=”||2px|||” animation_style=”slide” animation_direction=”left” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

              Technical Specifications<\/h1>\n

              [\/et_pb_text][et_pb_image src=”https:\/\/www.omnidermal.it\/wp-content\/uploads\/2021\/10\/Wound-Viewer-120_19-2-copia-2.png” align=”center” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”4.11.2″ hover_enabled=”0″ global_colors_info=”{}” title_text=”Wound-Viewer-120_19-2-copia” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”3.25″ custom_padding=”||4px|||” global_colors_info=”{}” column_structure=”1_3,1_3,1_3″][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”DISPLAY” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

                \n
              • LCD interface capacitive<\/span><\/li>\n
              • Touch Screen<\/span><\/li>\n
              • 2 USB Plugs<\/span><\/li>\n<\/ul>\n

                [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ custom_margin=”||-5%” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”CAMERA” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

                  \n
                • 1 x CMOS Camera<\/span><\/li>\n
                • 16 x IR Sensors<\/span><\/li>\n
                • 4 x White LEDs<\/span><\/li>\n
                • Microphone<\/span><\/li>\n
                • Geo-localization<\/span><\/li>\n
                • microSD<\/span><\/li>\n<\/ul>\n

                  [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ custom_margin=”||-5%” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”COMMUNICATION” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”26px” title_letter_spacing=”-2px” body_font=”Barlow Thin||||||||” body_text_align=”left” body_font_size=”20px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

                    \n
                  • WiFi interface<\/span><\/li>\n
                  • 4G interface<\/span><\/li>\n
                  • Bluetooth<\/span><\/li>\n
                  • Micro – nano SIM<\/span><\/li>\n<\/ul>\n

                    [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_divider color=”#000000″ _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”3.25″ width=”70%” width_tablet=”90%” width_phone=”80%” width_last_edited=”on|tablet” custom_padding=”5px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_toggle title=”REGULATORY STANDARDS REQUIRED” closed_toggle_background_color=”rgba(0,0,0,0.03)” icon_color=”#19bbab” _builder_version=”3.22.4″ title_text_color=”#19bbab” title_font=”Barlow Thin||||||||” title_text_align=”left” title_font_size=”35px” title_letter_spacing=”-2px” body_font=”Barlow Regular||||||||” body_text_align=”left” body_font_size=”15px” body_line_height=”1.3em” custom_margin=”||2%” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n

                    Regulatory standards to achieve CE certification are those contained in the family CE93\/42<\/strong><\/div>\n
                    (47\/2007).\u00a0In order to protect the future marketing of the device, WoundViewer was designed and built in<\/strong><\/div>\n
                    \n

                    compliance with the following standards:
                    <\/strong><\/p>\n<\/div>\n

                    [S1] EN ISO 13485 Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes.<\/span><\/p>\n

                    [S2] EN 60601-1 Medical electric equipment Part 1: General requirements for safety.<\/span><\/p>\n

                    [S3] EN 60601-1-11 Medical electrical equipment General requirements for basic safety and essential performance \u2014 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/span><\/p>\n

                    [S4] EN 60601-1-2 Medical electric equipment Part 1: General requirements for safety 2- Collateral Standard: Electromagnetic compatibility- Requirements and tests.<\/span><\/p>\n

                    [S5] EN 62304 Medical device software \u2013 Software life-cycle processes.<\/span><\/p>\n

                    [S6] EN ISO 14971 Medical devices \u2013 Application of risk management to medical devices.<\/span><\/p>\n

                    [S7] 1907\/2006 Regulation (EC) of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh), establishing a European Chemicals Agency<\/span><\/p>\n

                    [S8] 2011\/65\/EU Directive of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment (recast).<\/span><\/p>\n

                    [S9] EN ISO 14971 Medical devices \u2013 Application of risk management to medical device<\/span><\/p>\n

                    [S10] EN 62366-1 Medical devices. Application of usability engineering to medical devices<\/span><\/p>\n

                    [\/et_pb_toggle][et_pb_divider divider_weight=”8px” _builder_version=”3.22.4″ global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

                    FAQ & Spec.Frequently Asked QuestionsWoundViewer is a class 1 medical device able to acquire and process automatically in two\u00a0minutes the images of cutaneous ulcers by an algorithm of artificial intelligence (AI) that gives\u00a0the physician the basic parameters of the lesions and organizes the information in digital\u00a0health records. Thanks to its 4 G and WiFi connectivity, […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-3849","page","type-page","status-publish","hentry"],"yoast_head":"\nFaq & Spec - Omnidermal<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.omnidermal.it\/en\/faq-spec\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Faq & Spec - Omnidermal\" \/>\n<meta property=\"og:description\" content=\"FAQ & Spec.Frequently Asked QuestionsWoundViewer is a class 1 medical device able to acquire and process automatically in two\u00a0minutes the images of cutaneous ulcers by an algorithm of artificial intelligence (AI) that gives\u00a0the physician the basic parameters of the lesions and organizes the information in digital\u00a0health records. 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