Laboratory devices and equipment

PHO Center for Public Health - Skopje

More details in the tender documentation.

Рок

Рокот за прием на понудите беше 2023-01-26. Набавката беше објавена на 2022-12-27.

Кој?

• PHO Center for Public Health - Skopje

Што?

Каде?

• Северна Македонија › Северна Македонија

Историја на набавките

Датум	Документ
2022-12-27	Оглас за договор

Оглас за договор (2022-12-27)
Предмет
Опсег на набавката
Наслов: Medical equipments
Референтен број: 0507-5148/2022
Краток опис: More details in the tender documentation.
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема 📦
Дополнителен CPV: Микробиолошки култури 📦
Вакцини против полио 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️
Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Тело уредено со јавно право
Име на органот кој доделува: PHO Center for Public Health - Skopje
Поштенска адреса: Nr.18, Third Macedonian Brigade str.
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.cph.mk 🌏
Е-пошта: info@cph.mk 📧
Телефон: +389 71248572 📞
Факс: +389 23298251 📠
URL за документи: https://e-nabavki.gov.mk/PublicAccess/Home.aspx#/home 🌏
URL за учество: https://e-nabavki.gov.mk/PublicAccess/Home.aspx#/home 🌏

Референца
Датуми
Датум на испраќање: 2022-12-27 📅
Рок за поднесување: 2023-01-26 📅
Датум на објавување: 2022-12-30 📅
Идентификатори
Број на огласот: 2022/S 252-734767
OJ-S издание: 252

Предмет
Опсег на набавката
Проценета вкупна вредност: 50 000 000 MKD 💰
Наслов на делот: A modern compact microbiological system for automated testing of the presence of microorganisms including Mycobacterium tuberculosis in blood cultures, sterile body fluids, blood and sputum:
Број на дел: 1
Краток опис:

• Technical and functional characteristics:

- Fully automated microbiological system with the principle of colorimetric technique, or equivalent for detecting the presence of microorganisms;

- The offered system should not need an additional computer and should be composed of one part in which the incubation and computer parts are located;

- The device should have a capacity of at least 120 cells located in two 2 independent drawers, each of which will have a minimum of 60 cells;

- Possibility to upgrade the device for at least 720 more cells;

- In order to avoid the possibility of contamination, the device should work with non-breakable plastic bottles;

- Possibility to incubate a minimum of 120 bottles at once;

- Minimum samples that can be incubated: blood, sterile body fluids, mycobacterium and sterility of platelets;

- Ability to detect the growth of bacteria, yeasts and molds from a minimum of 8 hours of incubation;- Да работи на принцип на колориметриска метода или еквивалент;

- To enable automatic recognition of the bottle that is placed;

- Advanced algorithm for a small amount of sampled blood;

- Every bottle should be checked automatically at least 100 times a day;

- The offered system should have visual and audio signaling during the detection of positive controls;

- The device should have automatic calibration and automatic quality control;

- The blood cultures that will be used in the device should contain an antibiotic inactivator;

- The device must have a CE IVD quality certificate.

Времетраење: 12 месеци
Наслов на делот: PCR cabinet
Број на дел: 2
Краток опис:

- The cabinet should be used for PCR for samples and molecular analysis;

- Is mandatory to have a UV lamp as a source for DNA inactivation between analyzes and white light.

- To have built-in panels specially designed to block UV waves below 400 nm;

- To have a UV timer and a safety switch to turn off the UV lamp when opening the front window;

- To have at least 2 built-in electrical sockets and at least two small shelves;

- The work surface should be made of antimicrobial non-rusting steel;

- The PCR cabinet should have the following external dimensions: maximum 80x60x65cm (WxDxH)

Наслов на делот: Type II Biosafety cabinet, safety class 2, or equivalent:
Број на дел: 3
Краток опис:

- The cabinet should have minimum internal working dimensions of 950 x 600 x 550 mm (WxDxH);

- Is Mandatory to be delivered with a suitable construction for installation;

- It must have a HEPA filter H14 or equivalent in accordance with EN1822 or equivalent, with a minimum efficiency of 99.995% MPPS and 99.999% DOP;

- The air quality should be class ISO 4, in accordance with ISO CD 14644-1 or equivalent with min values of: 353 part. ≥ 0.5 µm/m3; 10000 parts. ≥ 0.1 µm/m3;

- Laminar flow speed of at least 0.35 m/s;

- Air speed at the front entrance 0.55 m/s;

- Frequency in the minimum range of 50-60 Hz;

- Lighting ≥ 1000 lux;

- The cabinet should be made of 304 L stainless steel with rounded corners and hermetically sealed around the front glass;

- To have a safety anti-reflective front glass with UV protection, without visible obstacles on the lower part;

- Double integrated ergonomic armrest with recessed air vents positioned at the front of the work surface to avoid blocking the incoming air;

- Microprocessor control with filter compensation and the possibility to work in environmental mode;

- UV light and fans programmable with a timer;

- Control and setting of parameters through a main screen that will display the laminar flow, filter condition and status of the cabinet according to international color code, namely:

• Green screen: Cabinet is in a safe state

• Red screen: The cabinet is outside the specified operating parameters

• Yellow screen: Cabinet is decontaminated

- The possibility of access codes on two levels (user and technical) protected by a password;

- Acoustic and visual alarms with an informative message for:

• Excessive or insufficient laminar flow

• Insufficient air extraction

• The glass is not in working position (front window open)

• Activated UV lamp

- Easy access to all maintenance areas of the cabinet from the front, with the possibility that the front glass together with the movable and stationary parts can be opened completely for easy cleaning of the entire internal surface of the cabinet and entry of smaller equipment;

- Possibility to work at 1, 2 and 3 levels of biosecurity for working with pathogens;

- The biosafety cabinet must meet standard EN 12469 or an equivalent standard for Class II biological safety cabinets.

Наслов на делот: Analog vortex mixer with manual mixing speed adjustment:
Број на дел: 4
Краток опис:

- To have a speed adjustment from 0-2500 RPM;

- Possibility of continuous use;

- The instrument should function at an ambient temperature of 5-40°C;

- The instrument should work at operating humidity up to 80%;

- The instrument must have a protection certificate according to DIN EN 60529 – IP 21 or equivalent.

Наслов на делот: Mini centrifuge:
Број на дел: 5
Краток опис:

- Mini centrifuge with a rotor for centrifugation of 1.5 – 2 ml with a maximum number of revolutions of 15,000 RPM;

- The instrument should have an LCD display to enable easier setting and reading of the functional parameters;

- The instrument must have memory for saving at least 10 different programs.

Наслов на делот: Water bath:
Број на дел: 6
Краток опис:

- The capacity of the water bath should be from 35l to 49l;

- Made of stainless steel;

- Digital temperature setting and display showing the current and set temperature with RT100 temperature sensor or equivalent;

- Timer from 1-99 min with sound alarm and overheating protection.

Наслов на делот: A system for determining the optical density of a suspension of organisms in McFarland units:
Број на дел: 7
Краток опис:

- System for measuring turbidity of suspensions applicable to Vitek 2 or equivalent;

- Digital reading of the result;

- Minimum reading rank: 0-4 McFarland;

- Option to choose work with glass and plastic test tubes;

- Tare option;

- Resolution to at least second decimal place;

- Minimum sample for testing: 2 ml;

- The system should be delivered factory calibrated;

- Measurement source: LED light at 580 nm;

- the instrument must have a battery for mobile operation.

Наслов на делот: Laboratory autoclave for sterilization of hard materials (laboratory glassware, liquids and liquid nutrients, bagged waste and liquid waste) • Technical and functional characteristics:
Број на дел: 8
Краток опис:

- Vertically placed with top loading, with a nominal chamber volume of at least 150 liters and a total chamber volume of at least 165 liters;

- Chamber diameter of at least 50 cm. and chamber depth of at least 75 cm.;

- Operating parameters: temperature up to 140°C / pressure up to 4 Bar with the possibility of increasing the temperature up to 150°C/ and the possibility of increasing the pressure up to 5 Bar;

- Error alarms shown on the display for interrupted cycle, cycle error, open door, etc.;

- Waste sterilization program with pulsed temperature increase in order to effectively remove air from the chamber;

- Temperature retention function after completing a program when autoclaving liquids;

- Automatic locking of the door depending on the temperature and pressure in the chamber, as well as safety provided by a minimum of two safety valves on the autoclave;

- Automatic opening of the door after completion of the program;

- Integrated separate steam generator, without heating elements and without a tank for dirty water in the chamber;

- Automatic supply of demineralized water for steam production;

- Built-in exhaust gas / steam condensation system;

- At least 23 work programs for different work modes, of which at least 10 are programmable for individual programming by the user;

- Flexible temperature sensor PT100 or equivalent;

- Additional temperature sensor in the exhaust condensate;

- LCD screen and full automatic microprocessor control of working parameters that at least display and control steam pressure, temperature and sterilization time;

- At least RS232 and RS485 interfaces for connecting to a computer and transferring data from the process;

- Built-in memory for data storage of at least 500 sterilization cycles;

- Passwords for accessing the menu for changing the parameters of work processes;

- Possibility to complete with a printer to print the protocol of the process;

- The construction and body should be made of stainless steel;

- The sterilization chamber should be made of stainless steel minimum AISI316 Ti or equivalent;

- Possibility of validation according to the requirements of "Good Manufacturing Practice" (GMP);

- Ability to provide DQ/ IQ / OQ / PQ documentation for validation;

- Calculation of F0 value

- Equipped with at least one mesh basket made of stainless steel and at least one basket, made of stainless steel, perforated only in the upper part, with a closed lower part, for waste sterilization;

- According to 2014/68/EU pressure equipment directive for pressure vessels, or equivalent directives;

- CE certification of the equipment.

Наслов на делот: Laboratory incubator with natural convection with a capacity of at least 110 l.:
Број на дел: 9
Краток опис:

- Temperature range from at least +5°C above ambient temperature to +100°C;

- Temperature variation at +37°C maximum +/-3K;

- Temperature fluctuation at +37°C maximum +/- 0.1K;

- Required heating time up to +37°C of a maximum of one hour;

- Time required to reach a temperature of +37°C again after opening the door for 30 seconds - maximum 15 minutes;

- Ability to disinfect at +100°C;

- Electromechanical control of exhaust opening;

- Controller with LCD display;

- Inner door made of tempered glass for protection;

- At least two chrome shelves with the possibility of adding at least three more shelves;

- Load capacity of at least 30 kg. per shelf;

- Temperature protection with alarm according to DIN 12880 or equivalent;

- USB port;

- Electricity consumption at 37°C of a maximum of 25Wh/h;

- Internal dimensions of at least 500x400x500mm (WxDxH);

- External dimensions with all connections and accessories of a maximum of 720x680x740mm (WxDxH).

Наслов на делот: Upgrade of an existing molecular system for polymerase chain reaction in real time, qualitative and quantitative analysis of DNA/RNA sequences of interest and automatic interpretation of results...
Број на дел: 10
Краток опис:

- Thermal plate - monoblock for a maximum of 96 test tubes of 0.2 mL (standard micro tubes 0.2 ml for real-time PCR with the possibility of 8 tubes in a strip or individually, as well as the possibility of a PCR plate with 96 positions of 0.2 ml.), with the possibility of upgrading the thermal block up to 384 positions and automatic adjustment of the sample tubes;

- The instrument must have integrated software, compatible with the software of the existing system (DtLite or equivalent) – DT Master or equivalent, from the equipment manufacturer, which is validated for the interpretation of the results of the used kits by issuing a final qualitative and quantitative interpreted result, with an included template for issuing the results in English or Macedonian and an open prepared template for the analyzes that are being performed;

- The temperature range of the thermal unit should be at least from 0 to 100°C;

- Temperature accuracy of the thermal unit ± 0.2 °С, maximum temperature increase speed 3.5 °С / sec., maximum cooling speed 2.5 °С / sec.;

- The instrument should have the ability to actively heat/cool the thermal unit using 6 peltier thermoelectric elements, automatic extraction of the thermal block, have a factory calibration of the instrument;

- The instrument must have the ability to simultaneously detect the amplified products using 5 detection channels, LED excitation sources for each channel individually, CCD camera detector or equivalent with the following spectral range: Fam 470/40 – 515/30; Hex 530/20 – 560/20; Rox 580/30 – 620/30; Cy5 630/20 – 660/20; Cy5.5 687/20 – 731/30;

- The instrument should have the following analysis capabilities: quantification, melting curves, gene expression, SNP, automatic retest function.

Наслов на делот: Carrier system for the counting of coliforms, Legionella, E. Coli, enterococci, pseudomonas and heterotrophs in drinking and surface water with the MPN method with detection and enumeration with semi:
Број на дел: 11
Краток опис:

- The system should enable easy, fast and precise counting of bacteria, should allow easy manipulation and should not require the hiring of additional personnel;

- To enable quantitative detection of Coliforms, E. coli, Faecal Coliforms, Enterococci, P. aeruginosa, L. pneumophila and Heterotrophic bacteria;

- There is no need to use media;

- To have the possibility of a minimum level of detection of 1 microorganism per 100ml;

- To have the possibility of enumeration of 1-2,419 MPN/100 mL without dilution;

- There is no need to use additional glass consumables for analysis and nutrient media;

- That there is no need for confirmation;

- The system does not require annual preventive maintenance;

- The instrument must work in accordance with the ISO standard (ISO 9308-2:2012) or equivalent.

Наслов на делот: The automated system for the preparation and pouring of nutrient media should consist of a minimum of an automated system for preparing media, a peristaltic pump and an automated system for pouring...
Број на дел: 12
Краток опис:

- The substrate preparation system should have a volume of at least 1 L to 20 L;

- To have a built-in temperature probe;

- Accuracy of the temperature during the sterilization steps to be a minimum of +/- 0.5 °C;

- Sterilization temperature from minimum 25 to 125 °C;

- Pouring temperature from minimum 25 to 78 °C;

- To have at least one removable magnetic stirrer inside the container intended for better homogenization of the nutrient medium;

- To have a TFT resistant screen, a built-in printer and a cart intended for transporting the instrument;

- To have the possibility of delayed start of the cycle - automatic start;

- To have a light indicator to inform the user about the status of the instrument;

- To have an audible and visual alarm with the display of alarm messages;

- A peristaltic pump with a dosing volume from a minimum of 1 ml to a maximum of 20 l and a minimum of the following characteristics:

• To be accurate from at least 0.1 ml to 9 ml;

• To have the ability to adjust the dosing speed at a minimum of 3 levels;

• Minimum pump opening (mm): 1.6 3.2 4.8 - 6.4;

• Possibility of traceability of date, batch, user, media name, dose;

• Connection: Two-way (LIMS);

• Data consistency: Printer, USB or FTP server;

• Data format: XML, CSV, JSON;

• Communication: Internet, USB, WIFI;

• Possibility of setting: volume, cycle, delay of the number of doses between each dosing;

- A system for pouring nutrient medium into petri plates with a capacity of at least 560 plates, with the possibility of pouring more plates by connecting to a turbo pump and at least the following features:

• Dosing capacity from a minimum of 1 to 50 ml;

• Compatible for Petri plates with a diameter of 90mm and/or 50mm, with optional putty;

• Built-in peristaltic pump;

• Built-in UV lamp;

• Integrated plate cooling system;

• The pouring system must contain a minimum of 20 programs

• The pump should be able to fill test tubes and flasks;

• Detection of defective plates;

• Possibility to connect to the Internet;

• USB port;

• Possibility to connect an InkJet printer to petri plates.

Наслов на делот: Mass Spectrometer for Automated Identification of Microorganisms in Clinical Routine (MALDI-TOF):
Број на дел: 13
Краток опис:

- Benchtop system with integrated computer and screen or equivalent;

- To possess CE-IVD mark for software and device;

- The device must have FDA approval;

- The system should have the possibility of…

… reliable identification in the IVD database of at least gram+/gram-bacteria, mycobacteria, nocardia, yeasts and molds up to species level;

… continuously inserting samples into the device up to 16 at the same time according to the "load and go" model or equivalent;

- The capacity of the device is at least 767 positions for samples;

- Identification of more than 100 samples per hour;

- To have the ability to place an emergency slide in the priority of the work;

- The system should be easy to maintain, without the need to clean the ionization source;

- The lifetime of the laser should be at least 100 billion guaranteed shots;

- The system is compatible and confirmed for different substrates;

- The reference database for identification should contain at least 2,000 species of microorganisms, of which at least 1,000 IVDs are of clinically relevant species;

- The IVD database must contain a minimum of reference spectra for the reliable identification of bacteria and yeasts, as well as the possibility of identifying clinically relevant species of molds and microbacteria;

- To have an open research base for easy upgrade with strains relevant to the user or equivalent;

- To have at least a computer application (Middleware) or equivalent, based on WEB technology that enables monitoring of related work processes in the laboratory with the possibility of software consolidation of existing compatible automated systems in the microbiological laboratory as well as unification of sample preparation and reading of the results for identification and antibiogram;

- To have the possibility of minimum archiving of data and reporting of the results per patient and statistical epidemiological monitoring of the results;

- To have at least the ability to connect the software with LIS as well as an Internet connection that enables remote management and servicing of devices;

- Free regular software updates;

- To have at least all the necessary software and hardware needed for work (computer TFT monitor, printer, UPS);

- To work as a minimum on disposable barcode slides (CE and IVD) or equivalent;

A minimum of the following reagents are required for smooth operation of the instrument: Matrix solution and formic acid ready for use with the CE-IVD.

- The instrument should allow the application of bacteria without prior extraction, while for mold fungi and mycobacteria there should be minimal prior preparation

For mold, mycobacteria/nocardia identification to have a minimum of commercial (CE-IVD) kits.

Наслов на делот: Laboratory microscope:
Број на дел: 14
Краток опис:

- LED, Kohler lighting;

- Optical system with a field of view not less than 22 mm;

- Light techniques - light field;

- Double-sided focusing mechanism, with temperature compensation, adjustment of the required focusing power, adjustment and fixation of the maximum focus height - stop focus. Possibility of height adjustment with micro and macro screws for better ergonomics;

- Rotating head for no less than 6 lenses;

- Ergonomic X, Y work table with no less than 110 ° rotation and anti-scratch ceramic coating. Telescopic X, Y screw to adjust the force of movement of the table and the possibility to easily change the position of X, Y - screw for working with left or right hand. Minimum table movement of 76mm x 25mm;

- Holder for two microscope slides for changing with one hand;

- Binocular viewing head with an output for the camera, with a field of view not less than 22 mm and light distribution between the eyepiece and the camera 50/50%.;

- Angle of observation no greater than 30 °;

- Abbe-condenser for operation in bright field, phase contrast, dark field. Vertical focusing of the condenser, with a double-sided focusing mechanism. Color coding of final aperture positions relative to lens coding;

- Eyepiece with 10x magnification and field number not less than 22 mm, focused

- Polarization of light - polarizer and analyzer;

- Panchromatic lenses with magnification and N.A.: 5x / 0.12; 10x / 0.25; 20x / 0.40; 40x / 0.65; 100x / 1.25 immersive;

- Color digital microscope camera with CMOS sensor (1/2.3)". Sensor resolution min. 4000 x 3000;

- Ability to work independently on a monitor, without the need for a personal computer. 4K live image at no less than 60 fps;

- Recording images in JPG with a resolution of at least 12 Mpixels and MP4 video;

- Controlling the camera directly through a wireless "mouse" that communicates with the camera;

- Record photos or video directly to a USB memory stick connected to the camera. No less than 4 USB 2.0 ports as well as at least: USB 3.0 type C, HDMI, LAN, C-Mount adapter;

- Software for camera control, recording, measurements and other annotations;

- The software should recognize the microscope and the configured optical components, as well as the camera and enable automatic calibration of the live image, as well as recorded images when changing lenses;

- Fluorescent equipment:

• Rotating (revolving) mechanism for a minimum of 5 fluorescent filters

• Fluorescence intensity control of a minimum of 3 filters

• Fluorescence source - mercury lamp with intensity not less than 100W

- Fluorescent filters with parameters:

• UV excitation 340-380 nm, emission 425 nm

• UV excitation 450-490 nm, emission 515 nm

• UV excitation 515-560 nm, emission 590 nm

Наслов на делот: Apparatus ULV- for cold fogging:
Број на дел: 15
Краток опис:

- Fuel: diesel;

- Engine: minimum 35 HP;

- Fuel tank: minimum 30 liters;

- Solution tank: minimum 500 liters;

- Adjuster for droplet sprayer: 0-130 liters/hour;

- Spraying of solution: height min. 25 meters, distance min. 30 meters;

- Rotation of the sprinkler head on the main body: up-down minimum 250Cº, left-right minimum 250Cº;

- Atomizer nozzles: a minimum of 14 (of which a minimum of 7 for ULV spraying and a minimum of 7 for interrogation);

- Hand spray gun: length minimum 40 meters;

- Handgun spraying: short spray minimum 2 meters, long spray minimum 10 meters;

- Droplet regulation: for ULV atomizer from 20 to 50 microns, for interrogator from 50 to 100 microns, for hand gun atomizer from 70 to 350 microns;

- Weight: maximum 500 kg;

- Water cooling;

- Remote control;

- Regulating the sprayer's operating speed;

- The sprinkler nozzles can be individually regulated and individually turned off if necessary;

- The spray hose is corrosion resistant.

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност: More details in the tender documentation
Техничка и професионална способност:

- the economic operator should train the medical personnel who will handle the equipment;

- the economic operator is authorized by the manufacturer…

… of the equipment for its distribution;

… and/or authorized distributor of the equipment to participate in the tender procedure.

- the economic operator must provide a guarantee for the offered products of at least 1 (one) year, i.e. at least 2 (two) years for the item with serial number 15 and

- the bidders must submit a document with the technical specification of the offered product with their bid.

Минимално ниво(а) на стандарди:

- the bidder, together with the offer, must submit a statement that if he is selected as the most favorable bidder, he will carry out training of the personnel in handling the device;

- an authorization document from the manufacturer of the equipment confirming that the economic operator is an authorized distributor for it;

- authorization document for the participation of the economic operator in the tender procedure, issued by the manufacturer and/or the authorized distributor of the equipment;

- a statement with which the economic operator will guarantee that if he is selected as the most favorable bidder, he will provide a guarantee period for the offered product of at least 1 (one) year, i.e. a minimum of 2 (two) years for the item with serial number 15 and

- bidders must submit with their bid a Catalog with precisely and unambiguously marked pages and a marked product for the offered catalog number. The catalog can be uploaded through the ESJN available through the following web address: https://www.e-nabavki.gov.mk, together with the offer, if they can be scanned and uploaded to the ESJN. The catalog can also be submitted to the archive of the PHI Center for Public Health-Skopje, no later than the date and time determined as the deadline for submitting offers at the following location, ul. "3rd Macedonian Brigade" No. 18 Skopje.

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 11:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 2 месеци
Датум на отворање на понудите: 2023-01-26 📅
Време на отворање на понудите: 11:00
Место: PHO Center for public health Skopje

Договорен орган
Контакт
Контактна точка: Sector for public procurements
URL на документи: https://e-nabavki.gov.mk/PublicAccess/Home.aspx#/home 🌏

Дополнителни информации
Тело за преглед
Име: State commission for appeals on public procurements
Поштенска адреса: No. 63a, bul.„Ilinden“
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Телефон: +389 23251251 📞
Е-пошта: dkzjn@gs.gov.mk 📧
Факс: +389 23251250 📠
Интернет-адреса: http://dkzjn.mk 🌏
Орган од каде што може да се добијат информации за постапката за ревизија
Исто како: Тело за преглед
Извор: OJS 2022/S 252-734767 (2022-12-27)

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