Data on sensitivity, specificity and accuracy of the method compared to X-ray mammography
Minimum amount of benign and malignant tumours, which can be detected
According to the data of electrochemical and biological tests, MEIK has the following detection limit: for objects with high electrical conductivity (typical for malignant tumours) 1-3 mm, for objects with low electrical conductivity (typical for inflammations) 3-5 mm.
Level of competence of the personnel necessary for using MEIK
Screening can be done by paramedical personnel, assessment should be done by a doctor. The device can be used by an ultrasonographer, gynecologist, breast physician.
Consumables for MEIK electrical impedance mammograph
Single-use button-type gel electrodes. The manufacturer has included 50 Skintact FS single-use button-type gel electrodes in the base kit. A doctor uses four electrodes per one examination.
Is any special equipment required in the room for electrical impedance mammography?
No special equipment is required in the room where MEIK mammograph will be used. The room should be equipped with a doctor’s desk and chair, chair for the patient, examination table and printer.
Availability of Russian and European licenses and certificates
MEIK mammograph is manufactured under license No. FS-99-04-002439, Registration Certificate No.RZN 2014/2264 of 03/02/2015, Declaration of Conformity of 02 March 2020. Computerized electrical impedance mammograph has a patent, Eurasian patent No.012006 of 2007.
Grounds for application of MEIK electrical impedance mammograph:
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According to Order No.744 of 01 December 2005 of the Ministry of Health and Social Development of the RF, Electrical Impedance Mammography became a part of standard of medical care for patients with malignant breast tumours.
- Electrical impedance mammography is included in the National Mammology Guidelines: Chapter 2 ‘Methods of Diagnostics of Breast Diseases’: 2.1. ‘Methods of Selection of Women to Be Included in Risk Groups’; and Chapter 8. ‘System of Breast Examination. Diagnostic Algorithms’
Can MEIK mammograph be used by mobile teams?
Yes, electrical impedance mammography doesn’t require a specially equipped room, only an examination table, a desk and a chair are needed. The mammograph weighs 2 kg.