Public procurement notice: Contract Notice
Published: 2017-03-22
Buyer: Ss. Cyril and Methodius University Faculty of Medicine Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33100000 | 33122000: Ophthalmological equipment | 33124100 | 33128000 | 38341300
Estimated value:  MKD
Submission deadline: 2017-05-04
Award criteria: Lowest price

Technical requirements: Ss. Cyril and Methodius University, Faculty of Medicine Skopje, 50 Divizija No 6, 1000 Skopje, Republic of Macedonia.
Reading minimum range of 0,3 to 5,0 McFarland units i.e., 100x10 6 *150x10 to * 7 cells / ml; modicum test: 2 ml; the result of the measurement of the optical density to show how numerical value expressed in McFarland units of LED display with at least one decimal place; factory calibrated for glass tubes with a diameter of 16 mm; to maintain calibration and without voltage electricity; can be calibrated in the laboratory with standard solutions and suspensions; measurement speed: 1 second; measurement precision: ± 3 %; dimensions for use on laboratory table in a small space, with a minimum warranty period of one year, power supply 120V to 230V and a frequency of 50Hz to 60Hz, output voltage of 12 VDC.
With a gross volume of at least 100 liters to a maximum of 160 liters; luminous display indicating the temperature; automatic defrost; with a minimum warranty period of one year, power supply 220V to 230V.
Capacity of at least 90 samples at once, with automatic dilution without manually pipetrianje and retestiranje; automatic detection of clot, cooling reagents, waste, monitoring of performance in real time; have involved compatible PC, printer and uninterrupted power supply; in the range of analysis include markers of at least 15 infectious diseases (Clostridium difficile GDH, Clostridium toxin A & B, Procalcitonin B.R.A.H.M.S PCT, HbsAg ultra, Anti-HAV Total, HbsAg ultra confirmation, HIV duo Quick, Lyme IgM, Lyme IgG, CMV IgG, CMV IgM avidity II, Anti-Hbs total quick, HBc IgM II, Varicella-Zoster IgG, H.pylori IgG), with a minimum warranty period of three years, power supply 220-240V / 50Hz.
Adjustable; self-defrosting; with external digital temperature display; minimum 5 perforated metal shelves, all individually adjustable; light inside; with a lock; with a minimum warranty period of one year, power supply 220-240V / 50Hz.
With adapter for horizontal installation, with protective head tube and a platform for multiple tubes; Digital control and display speed rotation time; run by pressing the button (from 1 to 99 seconds) and non-manual functioning (for 1 to 60 minutes); compatible to work with Diversilab system or equivalent with a minimum warranty period of one year, power supply 220 V-230 V, 50-60Hz.
Semi-automated inoculation of petri plates with a diameter of 90mm (+/- 1 %); at least three adapter sizes petri plate; with the possibility of selecting the speed of rotation with external potentiometer minimum 0 to 500rpm; a temperature range of 15 to 35 ° C; humidity (no condensation agar) 15 to 85 %; switching on and off with a button; a minimum standard for conformity with EMCD 89/336 / EEC and LVD 73/23 / EEC or equivalent with a minimum warranty period of one year, power supply 100V — 240 V / 50 — 60Hz.
From the amount no more than 0.5 μl sample able to measure low concentrations of DNA (2ng / μl), to measure accurately and reproducibilno low concentration DNA (2ng / μl), highly concentrated sample (50 times higher than standard) without dilution, in the full range (from 220 to 750 nanometers); with a minimum warranty period of one year, power supply 110 V — 220 V, 50-60 Hz.
With a lid that provides protection against the spread of aerosols and opens automatically at the end of operation, small tubes of 1.5 to 2 ml; minimum capacity of 12 tubes; at least 8000 up to 15 000rpm; during acceleration to maximum speed of 13-15 seconds; a timer for measuring time of centrifugation; dimensions laboratory table; intensity of noise at work no more than 50 db; with a minimum warranty period of one year, power supply 220 V — 230 V, 50-60Hz.
Conical tubes with at least 30 positions with a minimum speed of 100rpm up to 6000rpm; size for laboratory work table, power supply 220 V — 230 V 50-60Hz.
With optical part with a limit of detection of color with maximum 1nm, with reactive part of amplification calibrated to ± 1,0 ° C with thermal control at least 16 independently controlled reaction points; heating range of a maximum of 10 ° C / sec on a scale of at least 50 ° Cdo maximum 95 ° C and cooling range of from 2,5 ° C / sec on a scale of up to 95 ° C to at least 50 ° C; support carrying at least 20 different tests for the detection of diagnostic, prognostic and predictive molecular markers for ER1, PR, HER2, Ki67, CYFIP1, UPK1B, IGF2, CRH, ANXA10, ABL1, BCR-ABL, EGFR, KRAS, BRAF, NRAS, HRAS, BRCA1, PDGFRA, PIK3CA, PTEN, with a minimum warranty period of three years, appliance to be able to work a minimum input voltage of 220V up to 230V and a frequency of at least 50Hz to 60Hz maximum.
With temperature control in the range of at least 37 ° C to a maximum 95° C; climbing rate of the temperature cycle of at least 4.4 ° C / sec and cooling rate of at least 2.2 ° C / sec, with specific thermal layer for uniform heating and cooling throughout the plate; detection system camera with a resolution at least 1024x1344 pixels, sensitivity 0,2 nmol / l +/- 1 % and the coefficient of variation of less than 0.15 % in the number of copies to be produced with a lamp as a light source with a minimum range 240 to 2000 nanometers and at least 1000 hours, a minimum of 6 filters for excitation and at least 6 emission filters; control software for automated in vitro diagnostic interpretation of results, automatic verification and validation of consistency of the reaction curve, full monitoring of the reaction, and automatic printing of standardized reports, possibility of high-resolution melting analysis with genotyping in endpoint and intercalation; opportunity for amplification and detection and the ability to add new records to an existing menu of tests; with factory calibration certificate confirming and putting into operation, including maintenance issues of minimum 3 years borne by the bidder.
With chambers temperature range of minimum 60 to maximum 65 ° C, with a capacity for continuous charging and discharging of a minimum of 40 cartridges every 40 minutes showing the color touch screen software through process control monitor; possibility of manual and automatic switching system for control and management of reagents: The counter of cassettes and cycles, with factory certificate confirming calibration of speed and time warranty least three years. The device to be able to work with the input voltage of minimum of 220V to 230V maximum and minimum frequency of 50Hz up to 60Hz.
With manual and automatic control, waste container, with the possibility of orientation reference zero point, turnaround button on / off switch and two mechanisms to secure work by blocking the lever system for cutting in any position, with the possibility of cutting large tissue samples with a minimum size 50x66mm with knife holder, ability of horizontal displacement of the sample of at least 30mm and vertical movement of at least 70mm with possibility of orientation of the sample in x- axis and y-axis angle of minimum 8 °, minimum warranty period of one year, the device to be able to work with a minimum input voltage of 220V up to 230V and a frequency of at least 50Hz to 60Hz maximum.
Opportunity for two-way connection with laboratory information system, the device to perform preparation, reading and printing of bar-codes on microscopic glass with a capacity of at least 48 windows and a minimum of 42 positions for bar-coded reagents with obligatory option for the separation of toxic waste, with calibration certificate on time, with possibility of connection to device for pre-preparation of tissue sections with a minimum warranty period of three years. The device to be able to work with minimum input voltage of 220V up to 230V and a frequency of at least 50Hz to 60Hz maximum.

Eligibility requirements: Statement by the economic operator that it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organization, corruption, fraud or money laundering; Certificate that it is not subject to bankruptcy procedure issued by competent authority; Certificate that it is not subject to liquidation procedure issued by competent authority; Certificate for paid taxes, contributions and other public dues by the competent authority in the country where that economic operator is established; Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — prohibition to participate in public competitions, public procurement contract award and public-private partnership contract award procedures; Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity; Certificate that it is not being sanctioned for misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain business activity. Ability for performing professional activity of the economic operator: Document for registered business activity. Certificate for wholesale of medical devices in accordance with the Law on medicines and medical devices. Approval for sale of the medical device or temporary or permanent authorization for parallel imports, in accordance with the Law on Medicines and Medical Devices issued by the Agency for medicines and medical devices for Lots. No: 3, 5, 6, 7, 10, 11, 14, 18, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 and 32. The economic operator needs to have an Approval for sale of the medical device or temporary or permanent authorization for parallel imports, in accordance with the Law on Medicines and Medical Devices issued by the Agency for medicines and medical devices for Lots. No: 3, 5, 6, 7, 10, 11, 14, 18, 21, 22, 23, 24,25, 26, 27, 28, 29, 30, 31 and 32.
Approval for sale of the medical device or temporary or permanent authorization for parallel imports, in accordance with the Law on Medicines and Medical Devices issued by the Agency for medicines and medical devices for Lots. No: 3, 5, 6, 7, 10, 11, 14, 18, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 and 32. The economic operator needs to have an Approval for sale of the medical device or temporary or permanent authorization for parallel imports, in accordance with the Law on Medicines and Medical Devices issued by the Agency for medicines and medical devices for Lots. No: 3, 5, 6, 7, 10, 11, 14, 18, 21, 22, 23, 24,25, 26, 27, 28, 29, 30, 31 and 32.
Approval for sale of the medical device or temporary or permanent authorization for parallel imports, in accordance with the Law on Medicines and Medical Devices issued by the Agency for medicines and medical devices for Lots. No: 3, 5, 6, 7, 10, 11, 14, 18, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 and 32.
The economic operator needs to have an Approval for sale of the medical device or temporary or permanent authorization for parallel imports, in accordance with the Law on Medicines and Medical Devices issued by the Agency for medicines and medical devices for Lots. No: 3, 5, 6, 7, 10, 11, 14, 18, 21, 22, 23, 24,25, 26, 27, 28, 29, 30, 31 and 32.