{"id":26,"date":"2020-11-10T18:55:04","date_gmt":"2020-11-10T18:55:04","guid":{"rendered":"http:\/\/engprojects.tcnj.edu\/dvt-detection\/?p=26"},"modified":"2020-11-10T18:55:04","modified_gmt":"2020-11-10T18:55:04","slug":"device-requimrents-specifications","status":"publish","type":"post","link":"https:\/\/engprojects.tcnj.edu\/dvt-detection\/2020\/11\/10\/device-requimrents-specifications\/","title":{"rendered":"Device Requimrents & Specifications"},"content":{"rendered":"\n
  1. The device must be able to detect inflammation presented on the skin surface for all different skin tones<\/li><\/ol>\n\n\n\n

    Justification:-<\/strong> <\/p>\n\n\n\n

    Skin discoloration is a symptom of reduced blood flow, which is a correlate for DVT. <\/p>\n\n\n\n

    Specifications:-<\/strong> <\/p>\n\n\n\n

    1.1) The device correctly identifies  presentation of erythema from digital images regardless of skin tone over 85% of the time.3<\/sup><\/p>\n\n\n\n

    Verifications:-<\/strong><\/p>\n\n\n\n

    1.1) Test the algorithm using a new dataset of skin images and verify that 85% of true positives are identified.<\/p>\n\n\n\n

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

    1. The device must be able to obtain the patient\u2019s Hemoglobin bound Oxygen Levels.<\/li><\/ol>\n\n\n\n

      Justification:- <\/strong><\/p>\n\n\n\n

      Systemic O2<\/sub> levels are related to blood clot formation.<\/p>\n\n\n\n

      Hemoglobin bound Oxygen accounts for 97% of Systemic Oxygen.<\/p>\n\n\n\n

      Specifications:-<\/strong><\/p>\n\n\n\n

      2.1) Obtains measurement at 1Hz from hospital oximeter.5<\/sup><\/p>\n\n\n\n

      Verifications:-<\/strong><\/p>\n\n\n\n

      2.1) Find the frequency at which the oximeter is taking measurements to ensure it\u2019s no less than 1Hz.<\/p>\n\n\n\n

      1. The device must accommodate a wide range of sizes to match the user.<\/li><\/ol>\n\n\n\n

        Justification:- <\/strong><\/p>\n\n\n\n

        A wide range of sizes will allow the device to be worn comfortably as well as prevent the device interfering with DVT assessment.<\/p>\n\n\n\n

        Specifications:-<\/strong><\/p>\n\n\n\n

        3.1) Ankle (Mean \u00b1 SD)<\/p>\n\n\n\n

        Male: 23.5 cm \u00b1 1.5 cm (19.0 – 28.0 cm) <\/p>\n\n\n\n

        Female: 21.9 cm \u00b1 1.3 cm (18.0 – 25.8 cm)<\/p>\n\n\n\n

        3.2) Must be able to adjust circumference to accommodate the location\u2019s size<\/p>\n\n\n\n

        Verifications:-<\/strong><\/p>\n\n\n\n

        3.1 & 3.2) Verify that the size of the device will be incrementally changeable to accommodate the desired ranges by measuring the device\u2019s length\u2019s. <\/p>\n\n\n\n

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

        1. The device must have sufficient battery life to monitor the patient\u2019s stats for long periods of time.<\/li><\/ol>\n\n\n\n

          Justification:- <\/strong><\/p>\n\n\n\n

          A long battery life will allow for continuous monitoring of patients without disruption.<\/p>\n\n\n\n

          Specifications:-<\/strong><\/p>\n\n\n\n

          4.1) More than 12 hours to allow changing of nurse shifts.<\/p>\n\n\n\n

          Verifications:-<\/strong><\/p>\n\n\n\n

          4.1) Measure power consumption of the device and its constituent parts using a LabView model and\/or test the physical parts specifications.<\/p>\n\n\n\n

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

          1. Device must cause little to no reaction to the skin of the patient.<\/li><\/ol>\n\n\n\n

            Justification:- <\/strong><\/p>\n\n\n\n

            Reactions to the skin can cause interferences with monitoring results and can change patient DVT detection.<\/p>\n\n\n\n

            Specifications:-<\/strong><\/p>\n\n\n\n

            5.1) The power delivered to the skin from the LEDs is less than 180 mW\/cm2<\/sup> at a rate of 0.2 mJ\/cm2<\/sup>.6<\/sup><\/p>\n\n\n\n

            5.2) The material used that contacts skin should be compliant with ISO 10993-10:2010(E)7<\/sup>.<\/p>\n\n\n\n

            Verifications:-<\/strong><\/p>\n\n\n\n

            5.1) Measure the power output from the LED\u2019s dedicated device to ensure it remains within desired range. <\/strong><\/p>\n\n\n\n

            5.2) Place material on participant skins and check for discoloration, damage, and inflammation. <\/p>\n\n\n\n

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

            1. The device must be able to alert healthcare workers when DVT risk reaches threshold level set by healthcare workers.<\/li><\/ol>\n\n\n\n

              Justification:- <\/strong><\/p>\n\n\n\n

              Alerting healthcare workers will allow for preventive measures to be taken and prevent further clot formation and damage to the blood vessels.<\/p>\n\n\n\n

              Specifications:-<\/strong><\/p>\n\n\n\n

              6.1) Trigger alarm within <1s when the threshold is reached.<\/p>\n\n\n\n

              6.2) SpO2<\/sub> threshold can be set between 95% and 98% with 1% resolution.<\/p>\n\n\n\n

              6.3) Erythema threshold can be set between 10-25% of the area of the skin displaying inflammation with 1% resolution.<\/p>\n\n\n\n

              Verifications:-<\/strong><\/p>\n\n\n\n

              6.1) Time the delay between the artificial triggering of the device and the triggering of the alarm. <\/p>\n\n\n\n

              6.2) Test that the device SpO2<\/sub> threshold can be altered by a user within the given ranges and resolution.<\/p>\n\n\n\n

              6.3) Test that the device erythema threshold can be altered by a user within the given ranges and resolution.<\/p>\n\n\n\n

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

              1. The device must remain comfortable to wear.<\/li><\/ol>\n\n\n\n

                Justification:- <\/strong><\/p>\n\n\n\n

                User comfortability is important as the user will be wearing the device for long periods of times, at least 12 hours. <\/p>\n\n\n\n

                <\/p>\n","protected":false},"excerpt":{"rendered":"

                The device must be able to detect inflammation presented on the skin surface for all different skin tones Justification:- Skin discoloration is a symptom of reduced blood flow, which is a correlate for DVT.  Specifications:- 1.1) The device correctly identifies  presentation of erythema from digital images regardless of skin tone over 85% of the time.3 … <\/p>\n

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