Circulatory devices for cardiac support

JZU UK za drzavna kardiohirurgija

Circulatory devices for cardiac support
Heart rate monitors
Artificial parts of the heart
Heart stimulation devices

Рок

Рокот за прием на понудите беше 2022-07-20. Набавката беше објавена на 2022-06-22.

Кој?

• JZU UK za drzavna kardiohirurgija

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега › Медицинска опрема

Каде?

• Северна Македонија › Скопски

Историја на набавките

Датум	Документ
2022-06-22	Оглас за договор

Оглас за договор (2022-06-22)
Предмет
Опсег на набавката
Наслов: Medical equipments
Краток опис:

Circulatory devices for cardiac support Heart rate monitors Artificial parts of the heart Heart stimulation devices

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: Медицинска опрема 📦
Место на извршување
NUTS регион: 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: Друго
Име на органот кој доделува: JZU UK za drzavna kardiohirurgija
Поштенска адреса: ul. Majka Tereza br.17/zgrada br.8
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: https://www.e-nabavki.gov.mk/ 🌏
Е-пошта: f.stoilkovska@yahoo.com 📧
Телефон: +389 75389076 📞
Факс: +389 23113053 📠
URL за документи: https://www.bjn.gov.mk/ 🌏

Референца
Датуми
Датум на испраќање: 2022-06-22 📅
Рок за поднесување: 2022-07-20 📅
Датум на објавување: 2022-06-27 📅
Идентификатори
Број на огласот: 2022/S 121-345556
OJ-S издание: 121

Предмет
Опсег на набавката
Краток опис:

Circulatory devices for cardiac support

Heart rate monitors

Artificial parts of the heart

Heart stimulation devices

Проценета вкупна вредност: 73 100 000 MKD 💰
Краток опис:

1 Centrifugal pump for mechanical support of the left ventricle in adolescents and adults,flow from 2.5l/min to 10l/min;the operation of the pump is based on full magnetic levitation technology(even at zero speed-the rotor in the pump is fully supported only by electromagnetic forces)designed for implantation in the pericardial space,to have a pulsating mode and centrifugal flow.

2 HeartMate 3 system backup device or eq.an external control unit that uses lights,sounds and text messages on the screen to communicate with the patient about the operation of the pump itself,as well as the status of the alarms,to display the type of alarm while giving clear instructions on how to fix the problem that triggered the alarm,direct access to the alarm history via the controller without the need for external hardware (a monitor),it also contains memory with the operating parameters of the pump, which can be further processed later, it also shows the status of charging of the backup battery

3 Battery charger for HeartMate3 system or eq.with four slots–pockets for simultaneous charging of HeartMate3 14V lithium-ion batteries, with option for calibration and diagnostics of batteries,with the capacity to register battery faults and report them through alarm codes as well as charger errors and informing via alarm codes.

4 14V lithium-ion battery connector (set with 2 connectors) for HeartMate3 system or eq.with a length 80 mm,width 92 mm and 32 mm height.

5 Batteries suitable for the HeartMate3 system or eq. 14V lithium-ion battery,4.8 each Ah or 71 Wh,length 160 mm,width 76 mm,height 25 mm.

6 Mobile power unit for the HeartMate3 system or eq. with functionality for detection of errors and activation of alarms for them, activation of alarms and warning pressure level alarms (SPL), power supply 100-240 V AC 50-60 Hz.

7 Shoulder bag for carrying control device and battery packs for HeartMate3 system or eq. with pockets suitable for the items it is intended to carry, with an outlet for the modular cable on the right or left side depending on which shoulder it is carried on

8 Shower bag (2-piece set) for HeartMate3 system or eq.impervious to protection of system components from moisture,including system control device,batteries and connectors for batteries.

9 Hospital's PowerMate 3 system power supply module or eq.to provide isolated system power supply during operation, communication interface between the control device system and system monitor,with backup battery that provides system operation for 30 minutes,to provide a two-way data transmission connection to the monitor for hospital use,isolated dual-channel analog connection for power failure alarm,warning/danger alarm for internal backup battery,yellow key system failure alarm,operates at 100-240 V of alternating current 50-60 Hz

10 Monitor compatible with the Hospital HeartMate 3 system power supply module or eq. backlit color LCD interface,640x480 pixel resolution, display function on: clinical parameters(speed, flow(liters per minute),pulsatility index,power, fixed mode),settings–system setup, alarms, data storage, history and administration of date and time.

11 Acute circulatory support system with flow based on full magnet technology levitation, intended for application in LVAD/BiVAD procedures,ECMO/ECLS, wean/bridge to recovery,bridge to decision, bridge to transplantation/bridge to durable VAD (console 2 no, probe 2 no, motor 2 no,engine holder 2 no, \monitor 1 no, oxygenator holder small 1 no, oxygen holder large 1 no,trolley 1 no,gas blender 1,heating/cooling unit 1 no)

12 Consumables for Acute Circulatory Support System - pump with full Maglev technology flow, the parts that come in contact with the blood are made of polycarbonate, with a volume of charge 31 ml,maximum flow 9.9 l/min, connector (3/8"input-output ports),with maximum working pressure 600 mmHg,with hose set - inlet 200 cm, 3/8 x 3/32 PVC,marked in blue and output 200 cm, 3/8 x3/32 PVC

Проценета вредност без ДДВ: 73 100 000 MKD 💰
Времетраење: 12 месеци
Заеднички речник на набавки (CPV)
Дополнителен CPV код: LA52
Место на извршување
Главна локација или место на извршување: PHI University Clinic for State Cardiac Surgery – Skopje, Mother Theresa 17/8

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:

- statement of the economic operator that no effective verdict has been pronounced against the economic operator within the past five years for a committed crime stated in Art. 88, paragraph 1 of the LPP;

- certificate stating that no bankruptcy procedure has been initiated by a competent body;

- certificate stating that no liquidation procedure has been initiated by a competent body;

- certificate of paid taxes, contributions and other public duties issued by a competent body in the country where the economic operator is registered;

- certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty -…

… ban on participating in open call procedures, awarding public procurement contracts and contracts on public - private partnership has been pronounced;

… temporary or permanent ban on performing particular activity has been pronounced;

- certificate stating that no misdemeanour sanction - ban on the performance of the profession, activity or duty, i.e. temporary ban on the performance of a particular activity has been pronounced with an effective verdict.

Техничка и професионална способност:

- samples, description and/or photographs of products that are subject to delivery, and whose reliability the economic operator is obliged to confirm if requested by the contracting authority: Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

- certificates and reports issued by competent quality control bodies with recognized competence, and which test the suitability of the products which has been clearly established by the references to the specifications and standards: Decision for placing a medical device on the market, with precisely marked positions that are subject of procurement, in accordance with the Law on Medicines and Medical Devices

Минимално ниво(а) на стандарди:

- “DRA”-sample – Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered. – Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 13:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Датум на отворање на понудите: 2022-07-20 📅
Време на отворање на понудите: 13:00
Место: PHI University Clinic for State cardiac Surgery – Skopje, Mother Theresa 17/8

Договорен орган
Идентитет
Друг вид договорен орган: Public Health Institution
Контакт
Контактна точка: Frosina Stoilkovska
Адреса на профилот на купувачот: http://kardiohirurgija.mk/mk/ 🌏
URL на документи: https://www.bjn.gov.mk/ 🌏

Дополнителни информации
Тело за преглед
Име: Ministry of Finance – Public Procurement Bureau
Поштенска адреса: Mother Theresa 17/building no. 8
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Телефон: +389 75389076 📞
Е-пошта: f.stoilkovska@yahoo.com 📧
Интернет-адреса: https://www.e-nabavki.gov.mk/ 🌏
Информации за роковите за приговор: 12.07.2022; 15:30
Орган од каде што може да се добијат информации за постапката за ревизија
Исто како: Тело за преглед
Извор: OJS 2022/S 121-345556 (2022-06-22)

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