Technical feasibility

1 Has the R & D result been tested?  
1a In what mode has the result been tested?

•             Prototype

•             Pilot Application

•             Alpha/BETA testing

Prototype units were tested and are still in use for patients treatment in the premises of University of Medicine, Sofia, Bulgaria and Prophylactic, rehabilitation and relaxation complex in town of Varshets, Bulgaria .

The experiment started in January 2009 and is still on and is held in a special office for electro sleep.  The prototypes are used 6 hours per day, 5 days per week , and in one hour 2 patients are treated.

1b. Please describe and discuss the testing results
The system ESS for Cranial Electrotherapy has been tested  and is in use for treatment of patients in order to improve their sleep after stress caused by different reasons. It is used for therapeutic reasons, including the treatment of anxiety, depression, insomnia, and chemical dependency.

The Electro Sleeping System consists of two parts, a hat and electrical unit. The hat with electrodes is put on the head of the patient, while the electrical unit generates an adjustable current of 80 to 600µA that flows through electrodes. The physician chooses  a certain mode of operation (software program) depending on the particular case (disease). The treatment lasts about 20-30 minutes and during the treatment the patient is sleeping. This procedure is repeating each day for two weeks. As a result after two week treatment  the patient has a normal sleep at least half a year.

1c. To what extend does the result corespond the initially defined task?
The results of the testing correspond to a great extent to the initially defined.

The physicians are satisfied by the results  of the treatment of sick people.


1f. What is the cost needed for testing?
The cost needed for testing includes:

-cost for equipment

- cost for human resources, etc.

SECTION 2: Current Stage of Development

2a To what extent does the development team have technical resources for supporting the production of a new product[1]? (Researchers, human resources, hardware, etc. )
The product, Electro Sleeping System, is a collective result of a team consisting of electronic, software and chemical engineers, IT specialists, technicians. The development team has technical resources for the production of small series of the product.

The developers have resources to consult and advice for research, technical and organizational issues and to answer any questions while the product is producing.


2b What are the technical issues that need to be tackled for full deployment, if needed?
-Survey on the last medical studies on cranial electrotherapy stimulation;

-mathematical model according the ideas of the physician;

-computer model;

-engineering model;

-prototype of the system;

-standardizing of each unit;

-technical tests;

-clinical tests.


2c What additional technical resources are needed for the production of this new product?

-measuring systems;

-Software for visualization and optimization of space-temporal configuration of electro therapy field .


2d Overall assessment of the current stage of technical development.
Prototype and small series are produced by the research team and are used in some hospitals in Bulgaria.

SECTION 3: Deployment

3a Define the demands for large scale production in terms of
  • Materials
Special electronic component, switches and plates for medical application, special plastic boxes for medical application, electrodes ( conductors ),  special rubbers with characteristics like thermal stability, chemical and technical resistance.

Assemblage, bandaging

  • technologies, tools, machineries
Machines for producing electrodes with different sizes.

Machines for production and assemblages of plates for medical application. It is necessary to ensure very high reliability.

  • Staff effort
-Electrical engineers;

-Software engineers;

-Chemical engineers,



SECTION 4: Overall Assessment

1 What is your overall assessment of the technical feasibility of the research result?
The research result  is on world level although there is no patent.

[1] Throughout this section by “new product” we mean a product or a service or a technology


Adequacy of testing activity undertaken so far 1 2 3 4 5√
Adequacy and availability of technical resources of the development team 1 2 3 4 5√
Current development stage 1 2 3 4 5√
Overall technical feasibility 1 2 3 4 5√

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