MEDICAL AND TECHNICAL REQUIREMENTS FOR THE SUBJECT OF PROCUREMENT
Automatic biochemical analyzer (EHS code DK 021:2015:38430000-8 Detectors and analyzers (38432000-2) (code NK 024:2019:56669 - IVD automatic biochemical analyzer of metabolic profile, stationary))
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№ |
Medical and technical requirements | Compliance with the requirements (indicate yes/no) of the user manual |
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1 |
Automatic biochemical analyzer, with free access to patients and tests (Random Access) and with discrete access - test-by-test system (Bench Top) - 1 set |
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2 |
Open system |
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3 |
The fully automatic measurement system |
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4 |
Measured parameters - designed to determine the biochemical parameters of blood - substrates (glucose, urea, cholesterol, triglycerides, protein, uric acid, and others), enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, alpha-amylase, and others) and ions (iron, copper, calcium, magnesium, phosphorus, and others), specific proteins (transferrin, immunoglobulins, C-reactive protein, and others). |
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5 |
Sample type: serum, plasma, cerebrospinal fluid, urine |
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6 |
Productivity up to 200 tests/hour (up to 400 tests/hour with electrolyte determination unit). |
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7 |
Number of tests on board (up to 50) |
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8 |
Number of positions for samples - 50 positions |
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9 |
Number of positions for reagents - 50 positions |
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10 |
The minimum volume of the reaction mixture - is 180 µl (180-550 µl) |
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11 |
Sample dosing volume 2-70 µl (in 0.1 µl increments) |
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12 |
Reagent dosing volume: Reagent 1: 50-300 µl (in 1 µl increments); Reagent 2: 10-200 µl (in 1 µl increments) |
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13 |
Incubation time - 1 stage of analysis (using R1) max 648 seconds; For 2 stages of analysis (using R1 and R2) 1st reaction 306 seconds + 2nd reaction 324 seconds |
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14 |
Analyzer operating cycle - no more than 18 seconds |
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15 |
Automatic dilution of samples when exceeding the permissible range during measurements. Possibility to increase or decrease the dosed volume after the restart. Ability to perform dilution from 2 to 150 times |
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16 |
Reaction carousel: 45 reusable quartz glass cuvettes, temperature 37±0.2°C |
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17 |
The optical system of 8 light filters: 340, 405, 505, 546, 578, 600, 660, and 700 nm |
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18 |
Analysis methods: endpoint with reagent and sample blank, kinetics, two-point kinetics, direct potentiometry, immunoturbidimetric, differential, mono- and bichromatic methods. |
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19 |
Measurement principle: absorption photometry, immunoturbidimetry, potentiometry |
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20 |
Urgent analyses are processed without interrupting the planned analysis |
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21 |
Cooled reagent rotor on board |
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22 |
Calibration type: by standard (calibrator), by calculation factor, multicalibration: linear, nonlinear |
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23 |
Primary rinsing, automatic rinsing, probe washing, cuvette rinsing |
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24 |
Option to save the history of auto wash |
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25 |
Automatic preliminary and final sample dilution |
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26 |
Sample dispenser with built-in liquid level detector and breakage protection |
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27 |
Reagent dispenser with built-in liquid level detector and breakage protection |
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28 |
Built-in barcode reader for samples and reagents |
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29 |
Cuvette washing: On-board washing station, with continuous washing and drying cycle |
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30 |
Water consumption: up to 7.5 l per hour |
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31 |
Photometric range 0-3 opt. units |
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32 |
Light source - halogen lamp 12V/20W |
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33 |
Detector - silicone photodiode |
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34 |
Communication with external computer - USB interface for Pentium IV and higher |
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35 |
Dimensions not less than - 810 mm (H) x 700 mm (L) x 600 mm (W) |
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36 |
Weight not less than 120 kg |
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37 |
Power supply Alternating current 220 V±10, 50±1 Hz |
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38 |
Quality control - graphing and verification of results according to Westgard rules |
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39 |
The complete set: |
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39.1 |
Starter kit of reagents: ALT - 1 pc, AST - 1 pc, Total bilirubin - 1 pc, Direct bilirubin - 1 pc, Multicalibrator - 1 pc, Wash solution - 1 pc, Normal control - 1 pc, Pathology control - 1 pc, Sample cups, pack - 1 pc. |
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39.2 |
Water purification system not worse than deionized water of II class: |
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39.2.1 |
water purification methods - carbon filtration, mechanical filtration, reverse osmosis (thin-film composite membrane), filtration on ion exchange resins (deionization), for final mechanical filtration of deionized water, 0.2 microns, to remove bacterial contaminants; |
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39.2.2 |
class of produced water -2 class according to DSTU ISO 3696; |
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39.2.3 |
quality of the received water - resistivity of clean water of class II - not less than 10 Mohm*cm (conductivity - not more than 0.1 μS/cm); |
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39.2.4 |
system productivity - not less than 7 l/h of purified water; |
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39.2.5 |
system placement - desktop or wall-mounted; |
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39.2.6 |
preliminary mechanical and carbon filters, reverse osmosis membrane, the deionization module with a resource of 1 cubic meter; |
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39.2.7 |
backlit display showing the quality of the water received, the operating status of the equipment, information on the remaining service life of the preliminary filters (residual nominal life), and water level in the tank; |
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39.2.8 |
it should be possible to replace the cleaning modules of the system by the user without the use of special tools. |
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39.3 |
PC with uninterruptible power supply, printer. |
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General requirements |
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40 |
Declaration of conformity |
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41 |
Operating manual in the Ukrainian language |
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42 |
Manufacturer's certificate for service maintenance |
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43 |
Putting into operation |
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44 |
Training of technical and medical personnel |
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45 |
Warranty for at least 12 months from the date of commissioning |
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46 |
Post-warranty service |
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47 |
The Tenderer must confirm the possibility of supplying the goods offered by it, in the quantity and within the terms specified in this Documentation and the Tenderer's offer. As a confirmation, the Tenderer shall provide the original letter of the manufacturer or a notarized copy (representative offices, branches of the manufacturer - if their respective powers extend to the territory of Ukraine), or a representative, dealer, distributor officially authorized by the manufacturer, which confirms the possibility of supplying the goods that are the subject of this procurement procedure, in the quantity and within the terms specified in this Documentation and the Tenderer's offer. The letter must include the name of the Tenderer, the number of the announcement published on the web portal of the Authorized Body for Public Procurement, as well as the name of the subject of procurement in accordance with the announcement of the procurement procedure. Availability of a service center in the region of equipment installation for quick response to all technical issues regarding this equipment, service engineers must have the necessary permits provided by the manufacturer or official representative office. |
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(с) 2024
