ONKOCET Ltd. has exhibited the devices from its portfolio on the MEDTEC UK exhibition in Birmingham, April 2011 through our partner Medical & Partners.
Product: Electroimpedance Computer Mammograph “MEIK”®
Model/type: version 5.0
Classification: medical device class IIa
The electrical impedance computer mammograph "MEIK®".
The mammograph makes it possible to visualize distribution of biological tissues electrical conductivity in several lateral sections of patient's body and to detect on the images tumors as regions with abnormal values of electrical conductivity. The main advantages of electrical impedance methods of diagnostics are absolute safety of examination, comprehensiveness, connected with significant level of correlation of electrical conductivity (electrical impedance) of biological tissues and their physiological state, compactness, reasonable price and simplicity of examination procedure.
Benefits
The electrical impedance diagnosis can be performed for patients of all sex (for women from the first ovulation period up to death), ages and can be used for screening of breast cancer diseases. Therefore the doctor can perform repeated examinations, monitor the disease dynamics as well as effects of changes of tissue conductivity during drug therapy.
Side Effects
During the scanning process the device, utilizing one out of 256 electrodes of the matrix successively injects into the patient's body weak alternative electric current (0,5 mA) with the frequency of 50 kHz and registers corresponding distributions of electric potentials on its surfaces. It is absolutely harmless for the patients as well as for the medical staff. By usage of the electro impedance mammograph MEIK there are no side effects.
Patents for the invention
The electrical impedance mammograph "MEIK®" is protected by the Eurasian patent of the for the invention # 012006.
Approval documentations
The product, an electrical impedance computer mammograph "MEIK®", is manufactured according to the Technical Conditions TU 9442-001-21702999-2013.
On the decision of the "Committee for Equipment and Technical Instrumentation, Utilized in Oncology and Medical Radiology" the device has been recommended for batch production and application in medical practice. It is registered in the State Register of Medical Goods. (registration certificate # 29/05010303/5420-03 dated July 2003), OKP 94 4220, class 2 b.
The electrical impedance mammograph "MEIK®" possesses the Conformance Certificate # ROSS RU.IM02.?14247 of the Government Standard of Russian and CE1023 ?07 0681 QS/NB.
The electrical impedance mammograph "MEIK®" corresponds to sanitary norms, that are confirmed by sanitary-and-epidemiologic conclusion #77.99.34.944.D.007393.08.06.
Requirement for technician
The electrical impedance computer mammograph "MEIK®" is intended for noninvasive measuring conductivity in biological tissues especially breast tissue.
It is utilized in oncology; the monitoring of treatment as well as drugs and physiotherapy procedure effects. Doctor should be specialized in radiology, oncology, gynecology, immunology and surgery, with training in electrical impedance in biological tissues (MEIK certificate).
Conclusion
Medical device mammograph MEIK can be used by the doctor specialists graduated through training in using electrical impedance mammograph and received certificate for the training published by producer company SIM-technika Ltd., Yaroslavl, Russia or by its representative on territory of the European Union company ONKOCET Ltd., Bratislava, Slovakia, www.onkocet.eu .
The device specifications are the following:
The electrical impedance computer mammograph "MEIK®" is recommended for using in medicine practice for oncology screening; at specialized oncology and mammology centers for detection of cancer and the monitoring of treatment.
Storage
For short term of storage the radiometer must be stored indoors at 10-35°C temperature, and relative humidity must be less 70% at room temperature of 25°C. Long term storage of the radiometer should be provided in warehouse of a manufacturer or customer in accordance with storage conditions of the national standards GOST 15.150.
Service & Warranty
The manufacturer guarantees that the radiometer corresponds to indicated specifications when all conditions of use, technical service, transporting and storing requirements indicated in the device documents are met.
The warranty period is 24 months, it begins once the radiometer is set to be used.