Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Summary of Contents for Scibase Nevisense
- Page 1 User Handbook Name:...
- Page 2 Nevisense is an objective diagnostic support tool for non-visual detection of malignant melanoma. Nevisense detects structural changes in the lesion as well as in relation to a reference area (healthy skin next to the suspicious lesion). HOW DOES IT WORK? Nevisense is based on Electrical Impedance Spectroscopy (EIS) technology which measures the electrical impedance in the tissue.
- Page 3 LESION SELECTION Only melanocytic lesions with a suspicion of malignant melanoma should be measured with Nevisense. Evaluation with Nevisense should always be initiated by a physician. MEASURE ON: • Lesions that are accessible by the Nevisense probe. • Lesions with a diameter between 2mm and 20mm.
- Page 4 The disposable electrode is for single person use. It has to be replaced when an examination of a patient is completed, and also whenever Nevisense issues a White side warning about a used electrode. This upwards is in order to minimize the risk of spreading infections and to prevent the electrode spikes from being worn out.
- Page 5 IMPORTANT TO REMEMBER BEFORE MEASURING Only use the wet swabs and dry compresses that are delivered along with the electrodes. Make sure that the patient is positioned in a way that ensures a stable measurement. Remove hair using scissors (do not use a razor).
- Page 6 PLAN YOUR MEASUREMENT Warning! Ensure that a sufficient number of measurements are performed for each lesion, since the degree of atypia may vary within the lesion. Use the Lesion Coverage Tool to determine the number of measurements needed. One square of the Lesion Coverage Tool is equal to one (1) measurement.
-
Page 7: User Interface
USER INTERFACE After log in, the Start screen will show the following options: Training. Under this section you will find training and instructions on how to measure correctly as well as the qualification process. Quick measurement. This function is used if only a quick measurement is desired. - Page 8 REFERENCE MEASUREMENT Choose suitable reference area and plan your measuerement using the coverage tool. Clean reference area with 5 firm strokes using the wet swab. Moisten reference area for a minimum of 30 seconds. Remember to apply some pressure against the skin. Tip: Squeeze out the remaining liquid in the swab on the skin at the end.
- Page 9 Measure on the lesion and repeat step 7-9 until lesion is covered. Make sure the lesion has been fully covered before pressing ”Done”. Read the Nevisense EIS score. Warning! Ensure that the preparation of the skin is performed accurately, including both moistening and wipe off. The skin preperation influences the measurement result.
- Page 10 The correlation between the score given and the Nevisense pivotal study results is presented in Table 1 as Negative Predictive Value and Positive Predictive Value.
- Page 11 64% of suspicious lesion were positive for melanoma in the pivotal study. The Nevisense result is one element of the overall clinical assessment and should be used in combination with clinical and historical signs of melanoma. 10 (14)
- Page 12 IMPORTANT TO REMEMBER Make sure that there is consistency of measurement technique between reference and lesion measurement, such as; The underlying structure needs to be the same for reference area and lesion. Moistening time needs to be at least 30 seconds but if more is necessary for the reference then the same time needs to be for the lesion.
- Page 13 Notes: 12 (14)
- Page 14 Notes: 13 (14)
- Page 15 Notes: 14 (14)
- Page 16 INSTRUCTION VIDEOS AND MORE MATERIAL AVAILABLE ON USB STICK AND ON WWW.SCIBASE.COM/EN/USERS LOG-IN: nevisense PASSWORD: melanoma LEARN MORE IN THE ”CLINICAL REFERENCE GUIDE” AND IN THE ”INSTRUCTIONS FOR USE”. 975-0200-01, June 2016...
Need help?
Do you have a question about the Nevisense and is the answer not in the manual?
Questions and answers