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Україна єдина #UAРАЗОМ

Attention: Prices for services and service codes can be found on the website of the institution in the section Paid services and by phone (04622) 5-32-91 (room 223)

Software and hardware complex of psychophysiological diagnostics

The information is published following the requirements of the Resolution of the Cabinet of Ministers of Ukraine No. 710 dated 11.10.2016

                                                                

TECHNICAL REQUIREMENTS FOR THE SUBJECT OF PROCUREMENT

 

Hardware and software complex of psychophysiological diagnostics "Psycholot-1" (code according to EZS DK 021:2015:33120000-7 - Medical information registration systems and research equipment)

 

Requirements: Compliance:

1. PACPFD is designed to equip psychophysiological examination rooms that conduct psychophysiological examinations during mandatory preliminary (during hiring) and periodic (during employment) medical examinations of employees employed in jobs where there is a need for professional selection, and form conclusions of psychophysiological examination on the suitability of employees to perform work requiring professional selection (Order of the Ministry of Health of Ukraine No. 246 of 21.05.2007).

 

2. Composition:

 

2.1. specialized psychodiagnostic keyboard (SPK)

 

2.2. personal computer (PC) of "Notebook" type (NME 1);

 

2.3. printer (PME 3);

 

2.4. power supply unit (PSU) of PC (NME 2);

 

2.5. multi-socket network connector (MSNC) (NME 4), which is a separate product.

 

2.6. standard cable type "AM-VM".

 

3.PACPFD should be designed to assess the level of such psychological qualities of a person as:

 

- reaction;

- memory;

- attention (stability, distribution, switching, volume, concentration)

- functional mobility of nervous processes;

- psychomotor qualities;

- the balance of nervous processes;

- orientation in space;

- spatial and temporal extrapolation;

- resistance to monotony and other qualities that meet the requirements of regulatory acts.

 

3.1 The PCPFD should evaluate the level of psychological qualities of a person using a set of methods for determining the level of psychophysiological indicators of employees according to the "List of works where there is a need for professional selection" (Order of the Ministry of Health of Ukraine and the State Committee of Ukraine on Supervision of Labor Protection of 23.09.1994 No. 263/121), which is recommended for use in the units of the psychophysiological examination system.

 

4. Classification

 

4.1. The outer surfaces of the PCS must be resistant to multiple disinfection according to GOST 42-21-2 with a three percent hydrogen peroxide solution according to GOST 177-88 with the addition of a half percent synthetic detergent according to GOST 25644-96.

 

4.2. by the degree of protection against the danger of electric shock, the complex must meet the requirements of DSTU EN - 60601-1: 2015, for products of class II type BF;

 

4.3. the degree of protection of the SPC against the penetration of solid particles and water - IP30 according to IEC 60529:1989

 

4.4. SCC must meet the requirements of DSTU EN ISO 10993-1:2015 for biocompatibility.

 

PACPFD should provide the measurement of time intervals in the range from 0.10 to 600 s.

The relative error of measuring time intervals should be in the range from 0.1 to 0.5 s no more than ± 15%, in the range from 0.5 to 1 s no more than ± 5% and in the range from 1 to 600 s no more than ± 1%.

 

The PACPFD must operate under the Windows 7, 8, and 10 operating systems.

 

The software of the PACPFD must implement:

- PC response to pressing and releasing the keys of the FCS;

- reception of signals from the FCS via USB interface;

- displaying the corresponding functionality on the monitor screen when receiving signals;

- formation of the employee's test results and their transfer to the printer;

- saving the results of the tests to the PC memory;

- printing of the saved results.

 

PACPFD must maintain technical characteristics in the following operating conditions

- in the range of ambient temperatures from 10 to 35 ºC;

- at relative humidity up to 80% at a temperature of 25 °C without moisture condensation;

- at atmospheric pressure (100 ± 4) kPa or (750 ± 30) mm Hg.

 

The warranty period of PACPFD operation should be at least one year from the date of its commissioning.

 

Date of issue not earlier than 2020

 

Certificate Quality management system following the requirements of DSTU EN ISO 13485:2015 in the field: design, development, production, implementation, and repair of software and hardware complex of psychophysiological diagnostics "Psycholot-1"

 

Declaration of conformity to the Technical Regulations on medical devices approved by the Cabinet of Ministers of Ukraine dated 02.10.2013 № 753 (Annex 8). Additionally, the products must comply with the following harmonized standards: DSTU EN 60601-1:2015, DSTU EN 60601-2:2015, DSTU EN 980:2007

 

Certificate of conformity of technical documentation complies with the requirements of Annex No. 8 of the Technical Regulations on medical devices approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 753

 

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