Medical equipments

‘Victor Babeș’ University of Medicine and Pharmacy Timișoara

Specialised medical equipment for ophthalmic surgery:
Lot_1: Refractive surgery platform (Laser Excimer, Femtosecond laser, Topographic/ tomography Diagnosisofthe refraction unit);
Lot_2: Micropulse laser.

Termen limită

Termenul de primire a ofertelor a fost de 2017-09-19. Achiziția publică a fost publicată pe 2017-07-14.

Furnizori

Următorii furnizori sunt menționați în deciziile de atribuire sau în alte documente de achiziții publice:

• Romger general trade & consulting SRL
• Spectra Vision SRL

Cine?

• ‘Victor Babeș’ University of Medicine and Pharmacy Timișoara

Ce?

• Instrumente chirurgicale › Laser chirurgical

Unde?

• Vest › Timiş

Istoricul achizițiilor

Data	Document
2017-07-14	Anunţ de participare
2017-12-05	Anunt de atribuire

Anunţ de participare (2017-07-14)
Obiect
Domeniul de aplicare al achiziției
Titlu: Laser chirurgical
Număr de referință: RORS 11/ “Victor Babes“ University of Medicine and Pharmacy Timisoara/ 05
Scurtă descriere:

Specialised medical equipment for ophthalmic surgery: Lot_1: Refractive surgery platform (Laser Excimer, Femtosecond laser, Topographic/ tomography Diagnosisofthe refraction unit); Lot_2: Micropulse laser.

Metadate ale anunțului
Limba originală: engleză 🗣️
Tip de document: Anunţ de participare
Natura contractului: Bunuri
Reglementare: Uniunea Europeană, cu participarea ţărilor membre ACAP
Vocabular comun privind achizițiile publice (CPV)
Cod: Laser chirurgical 📦
Cod CPV suplimentar: Laser chirurgical 📦
Locul de desfășurare
Regiunea NUTS: Timiş 🏙️

Procedura
Tip de procedură: licitaţie deschisă
Tip de ofertă: Prezentare ofertă pentru toate loturile
Criterii de atribuire
Cel mai mic preţ

Autoritatea contractantă
Identitate
Țara: România 🇷🇴
Tip de autoritate contractantă: Altele
Numele autorității contractante: ‘Victor Babeș’ University of Medicine and Pharmacy Timișoara
Adresa poștală: Piața Eftimie Murgu, nr. 2
Cod poștal: 300041
Orașul poștal: Timișoara
Contact
Adresă internet: http://www.umft.ro/achizitii-proiecte_575 🌏
E-mail: hstanca@yahoo.com 📧
Telefon: +40 722761454 📞
Fax: +40 256221554 📠
URL al documentelor: http://www.romania-serbia.net/?page_id=1749&lang=en_GB 🌏

Referință
Date
Data trimiterii: 2017-07-14 📅
Termen-limită de depunere: 2017-09-19 📅
Data publicării: 2017-07-18 📅
Identificatori
Numărul anunțului: 2017/S 135-276438
Se referă la anunț: 2017/S 115-231204
Număr JO-S: 135
Informații suplimentare

1. The tender guarantee is set at Lot 01 — Refractive surgery platform = 16 000 EUR, and must be presented in the form specified in the annex to the tender dossier. It must remain valid for 45 days beyond the period of validity of the tender. 2. The successful tenderer will be required to provide a performance guarantee of 10 % of the amount of the contract at the signing of the contract.

Obiect
Domeniul de aplicare al achiziției
Scurtă descriere:

Specialised medical equipment for ophthalmic surgery:

Lot_1: Refractive surgery platform (Laser Excimer, Femtosecond laser, Topographic/ tomography Diagnosisofthe refraction unit);

Lot_2: Micropulse laser.

Valoarea totală estimată: 857142.86 EUR 💰
Numărul maxim de loturi pe ofertant: 2
Denumirea lotului: Refractive surgery platform
Numărul lotului: 1
Scurtă descriere:

Structure:

— Excimer laser — 1 piece;

— Femtosecond laser — 1 piece;

— Topography/ Tomography Diagnosis Refractive Unit — 1 piece.

The Refractive surgery platform is a surgical and diagnosis equipment intended for advanced corneal laser treatments.

The Refractive surgery platform should include the Excimer laser (1 piece), the Femtosecond laser (1 piece) and the Topography/Tomography/Aberrometry Diagnosis Refractive Unit (1 piece).

The femtosecond laser is cutting the cornea and is used to produce different kinds of very specialized cuts into the cornea in order to provide corneal flaps for FemtoLasik, intracorneal channels for intracorneal rings, antiastigmic relaxing incisions, intracorneal pockets for corneal inlays, grafts for lamellar and penetrating keratoplasties and/or other possible procedures.

The excimer laser is sculpting the cornea and is used to produce different kinds of corneal shapping patterns in order to treat myopia, hyperopia, astigmatism and even presbyopia by aspherical, aberration-free, topography guided and/or wavefront guided corneal stromal ablations.

The topography/tomography/aberrometry Diagnosis Refractive Unit is a diagnostic tool which comprehensively evaluates the corneal profile in order to properly select the patients which could be treated with corneal lasers (femtosecond and excimer lasers) and to precisely plan the laser cornea refractive surgery according with the particularities of each patient's cornea. This diagnosis system is providing detailed maps of the anterior and posterior surface of the cornea, of the cornea thickness, of the optical aberration of the cornea (corneal wavefront maps) or the entire eye (ocular wavefront maps).

The refractive laser surgery platform is evaluating and treating the patients with different kinds of corneal diseases like refractive errors (myopia, hyperopia, astigmatism), corneal ectasias, and corneal opacities by shaping and reshaping the corneal tissue according with several treatment patterns and strategies.

The Refractive Surgery Platform is a surgical and diagnosis equipment intended for advanced corneal laser treatments which includes the Excimer laser, the Femtosecond laser and the Topography/Tomography/Aberrometry Diagnosis Refractive Unit.

The Refractive Surgery Platform should be offered as a single item because:

1. All the contained items should be able to work with the same software, mainly the excimer laser and the diagnosis refractive unit, in order to be able to provide customised wave-front ablations (corneal and ocular) for our patients. If they will be acquired as independent units each of them will have it's own software which is not compatible with other equipments and we'll be able just to analyze the patients, but not to individualize the treatments by customized surgery. Having all these elements together in one big item should include the guarantee of the supplier that they can work together sharing informations in order to offer a fluent surgery for our patients.

2. The femtosecond laser and the excimer laser should share the same operating table which should be integrated with the software for surgery in order to adapt the patient position to the specificity of the surgery. If they will be acquired as independent units each of them will have it's own operating table which means that we'll need to mobilize the patients from one item to the other during the surgery, which is interfering with the quality of the surgery and the patient's comfort.

Valoarea estimată fără TVA: 806722.69 EUR 💰
Durata: 30 zile
Denumirea proiectului sau a programului finanțat de UE: Interreg-IPA Cross-border Cooperation Romania-Serbia Programme; Project: Regional Centre for Advanced Laser Therapies in Ophthalmology — RECALT; Cod eMS project: RORS 11.
Informații suplimentare:

2. The successful tenderer will be required to provide a performance guarantee of 10 % of the amount of the contract at the signing of the contract.

Denumirea lotului: Micropulse laser
Numărul lotului: 2
Scurtă descriere:

The micropulse 577 nm laser system is a surgical equipment intended for advanced retinal treatments. The device is used to produce a therapeutic treatment without inducing intraretinal damage detectable on clinical examination during or after treatment. The controlled laser delivery of micropulse technology affords treatment options for diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), central serouschorioretinopathy (CSR), macular edema secondary to branch retinal vein occlusion (BRVO), and evenglaucoma.

Valoarea estimată fără TVA: 50420.17 EUR 💰
Informații suplimentare:

1. The tender guarantee is set at Lot 02 — Micropulse laser = 1 000 EUR, and must be presented in the form specified in the annex to the tender dossier. It must remain valid for 45 days beyond the period of validity of the tender.

Vocabular comun privind achizițiile publice (CPV)
Cod CPV suplimentar: DA42
FA04
Locul de desfășurare
Locul principal sau locul de desfășurare:

‘Victor Babeș’ University of Medicine and Pharmacy Timișoara,

Department of Surgery I,

Ophthalmology Discipline,

Piața Martir Belici Radian, nr. 3,

Timișoara 300011,

Timiș County, Romania.

Informații juridice, economice, financiare și tehnice
Condiții de participare
Capacitatea de exercitare a activității profesionale:

Professional capacity of tenderer (based on i.a. items 4 and 5 of the Tender Form for a Supply Contract). The reference period which will be taken into account will be the last three years from submission deadline.

Criteria for legal persons:

1- The tenderer is authorized to perform the activities covered by this contract.

Criteria for natural persons:

1- Currently works / has worked in the past 3 years as a manager / team leader with at least 1 collaborator in fields related to this contract.

Situația economică și financiară:

Economic and financial capacity of tenderer (based on i.a. item 3 of the Tender Form for a Supply Contract). In case of tenderer being a public body, equivalent information should be provided. The reference period which will be taken into account will be the last three years for which accounts have been closed.

Nivel(uri) minim(e) al(e) standardelor:

Criteria for legal persons:

1- The average annual turnover of the tenderer must exceed the maximum budget of the contract;

Criteria for natural persons:

1- The available financial resources of the tenderer must exceed the maximum budget of the contract.

Capacitatea tehnică și profesională:

Technical capacity of tenderer (based on i.a. items 5 and 6 of the Tender Form for a Supply Contract). The reference period which will be taken into account will be the last three years from submission deadline.

This means that the contract the tenderer refers to could have been started or completed at any time during the indicated period but it does not necessarily have to be started and completed during that period, nor implemented during the entire period. Tenderers are allowed to refer either to projects completed within the reference period (although started earlier) or to projects not yet completed. In the first case the project will be considered in its whole if proper evidence of performance is provided (statement or certificate from the entity which awarded the contract, final acceptance). In case of projects still on-going only the portion satisfactorily completed during the reference period will be taken into consideration. This portion will have to be supported by documentary evidence (similarly to projects completed) also detailing its value.

An economic operator may, where appropriate and for a particular contract, rely on the capacities of other entities, regardless of the legal nature of the links which it has with them. Some examples of when it may not be considered appropriate by the Contracting Authority are when the tender rely in majority on the capacities of other entities or when they rely on key criteria. If the tender rely on other entities it must prove to the Contracting Authority that it will have at its disposal the resources necessary for performance of the contract, for example by producing an undertaking on the part of those entities to place those resources at its disposal. Such entities, for instance the parent company of the economic operator, must respect the same rules of eligibility and notably that of nationality, as the economic operator. Furthermore, the data for this third entity for the relevant selection criterion should be included in the tender in a separate document. Proof of the capacity will also have to be furnished when requested by the Contracting Authority.

Nivel(uri) minim(e) al(e) standardelor:

1- the tenderer has delivered supplies under at least 1 contract with a budget of at least: Lot 01 = 400 000 EUR; Lot 02 = 25 000 EUR in the field of surgical lasers which were implemented during the following period: 3 years from the submission deadline, 19.9.2017 respectively.

Procedura
Ora de primire a ofertelor: 12:00
Limbile în care pot fi prezentate ofertele sau cererile de participare: engleză 🗣️
Perioadă de valabilitate a ofertei: 2017-12-18 📅
Data deschiderii ofertelor: 2017-09-20 📅
Ora deschiderii ofertelor: 10:00
Locul: ‘Victor Babes’ University Of Medicine And Pharmacy Timisoara, Piata Eftimie Murgu No. 2A, Timisoara 300041, Timis country, Romania, Grant Research and Management Department.
Informații suplimentare:

The tender opening session is a formal, public process. The evaluation committee opens the tenders in public at the place and time set in the tender dossier. Although it is public, participation in the tender opening session is restricted to representatives of the companies that are tendering for the contract. (PRAG ver. 2015.0, 4.3.9.3. Tender opening session).

Autoritatea contractantă
Identitate
Numărul național de înregistrare: 4269215
Alt tip de autoritate contractantă: Higher Education — University of Medicine and Pharmacy
Contact
Punct de contact: Dr. Horia Stanca
Adresa profilului de cumpărător: http://www.romania-serbia.net/?page_id=1749&lang=en_GB 🌏
Documente URL: http://www.romania-serbia.net/?page_id=1749&lang=en_GB 🌏

Referință
Informații suplimentare

1. The procurement procedure is in line with PRAG, version 2015.0 (The Practical Guide explains contractingprocedures for EU external aid contracts financed by the EU general budget (Budget) and the 10th EuropeanDevelopment Fund (EDF).) — http://ec.europa.eu/europeaid/prag/previousVersions.do — version 2015.0.

2. Tenderers must comply with the rules of nationality and origin in accordance with PRAG, ver. 2015.0, chapter 2.3.1.

3. The tender dossier is available from the following Internet address: http://www.romania-serbia.net/?page_id=1749&lang=en_GB and http://www.umft.ro/achizitii-proiecte_575. The tender dossier is also available from the Contracting Authority. Tenders must be submitted using the standard Tender Form for a Supply Contract included in the tender dossier, whose format and instructions must be strictly observed.

Tenderers may submit questions in writing to the following address up to 21 days before the deadline for submission of tenders, 28/08/2017 respectively, specifying the publication reference and the contract title:

RORS 11/ ‘victor Babes’ University Of Medicine And Pharmacy Timisoara/ 05

Medical equipments

Adress: ‘VICTOR BABES’ UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA, Piata Eftimie Murgu No. 2A, Timisoara 300041, Timis country, Romania

Fax: 0040 (0)256 221 554

e-mail: hstanca@yahoo.com & achizitii@umft.ro

The Contracting Authority has no obligation to provide clarifications after this date.

Any clarification of the tender dossier will be published on the website at http://www.romania-serbia.net/?page_id=1749&lang=en_GB and http://www.umft.ro/achizitii-proiecte_575 at the latest 11 days before the deadline for submission of tenders, 7.9.2017 respectively.

Any prospective tenderers seeking to arrange individual meetings with either the Contracting Authority and/or the European Commission during the tender period may be excluded from the tender procedure.

4. The successful tenderer will be asked to provide a performance guarantee of 10 % of the amount of the contract at the signing of the contract. This guarantee must be provided together with the return of the countersigned contract no later than 30 days after the tenderer receives the contract signed by the Contracting Authority. If the selected tenderer fails to provide such a guarantee within this period, the contract will be void and a new contract may be drawn up and sent to the tenderer which has submitted the next cheapest compliant tender.

Informații complementare
Revizuirea organismului
Nume: ‘Victor Babeș’ University of Medicine and Pharmacy Timișoara
Adresa poștală: Piața Eftimie Murgu, nr. 2
Orașul poștal: Timisoara
Cod poștal: 300041
Țara: România 🇷🇴
Telefon: +40 722761454 📞
E-mail: hstanca@yahoo.com 📧
Fax: +40 256221554 📠
Adresă internet: www.umft.ro 🌏
Informații privind termenele de introducere a căilor de atac:

1. Complaints to the contracting authority

Without prejudice to other remedies and, in particular, without altering the time-limits for bringing actions set out in paragraphs 2.4.15.3 (PRAG Ver 2015.0), where a candidate, tenderer or applicant believes he has been adversely affected by an error or irregularity allegedly committed as part of a selection or procurement procedure, or that the procedure was vitiated by any maladministration, he may file a complaint to the contracting authority.

The complaint shall be substantiated and its sole subject shall not be to obtain a second evaluation for no reason other than the complainant disagrees with the final award decision.

2. Complaints to the European Ombudsman Without prejudice to other remedies and, in particular, without altering the deadlines laid down for the appeals set out in paragraphs 2.4.15.3 (PRAG Ver 2015.0), any citizen of the European Union or any natural or legal person residing or having its registered office in a Member State has the right to complain to the Ombudsman for any instance of maladministration by the European Union institutions (Article 228 of the Treaty on the Functioning of the European Union (TFEU)). More information may be found on the website http://www.ombudsman.europa.eu/en/home.faces.

3. Ordinary Actions

When a candidate, tenderer or applicant believes he has been adversely affected by an error or irregularity allegedly committed as part of a selection procedure or procurement, he may also file ordinary actions, provided the conditions are met.

Ordinary action shall be launched in accordance with the conditions and deadlines fixed by the national legislation of the contracting authority.

PRAG Ver 2015.0, 2.4.15. Legal remedies — http://ec.europa.eu/europeaid/prag/previousVersions/document.do?num=2015.0&lang=en

Serviciul de la care se pot obține informații privind procedura de reexaminare
La fel ca: Revizuirea organismului
Sursa: OJS 2017/S 135-276438 (2017-07-14)

Anunt de atribuire (2017-12-05)
Obiect
Domeniul de aplicare al achiziției
Număr de referință: RORS 11/ “VICTOR BABES“ UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA/ 05
Scurtă descriere:

Specialised medical equipment for ophthalmic surgery: Lot_1: Refractive surgery platform (Laser Excimer, Femtosecond laser, Topographic/ tomography Diagnosis of the refraction unit); Lot_2: Micropulse laser.

Valoarea totală a achiziției: 855420.17 EUR 💰
Metadate ale anunțului
Tip de document: Anunt de atribuire

Procedura
Tip de ofertă: Nu se aplică

Autoritatea contractantă
Identitate
Numele autorității contractante: "Victor Babeș" University of Medicine and Pharmacy Timișoara

Referință
Date
Data trimiterii: 2017-12-05 📅
Data publicării: 2017-12-06 📅
Identificatori
Numărul anunțului: 2017/S 234-485999
Se referă la anunț: 2017/S 135-276438
Număr JO-S: 234
Informații suplimentare

1. The tender guarantee is set at Lot 01 - Refractive surgery platform = 16 000.00 EUR, and must be presented in the form specified in the Annex to the tender dossier. It must remain valid for 45 days beyond the period of validity of the tender. 2. The successful tenderer will be required to provide a performance guarantee of 10 % of the amount of the contract at the signing of the contract.

Obiect
Domeniul de aplicare al achiziției
Scurtă descriere:

Lot_1: Refractive surgery platform (Laser Excimer, Femtosecond laser, Topographic/ tomography Diagnosis of the refraction unit);

Denumirea lotului: Refractive surgery platform.
Scurtă descriere:

— Excimer laser - 1 piece,

— Femtosecond laser - 1 piece,

— Topography/ Tomography Diagnosis Refractive Unit - 1 piece.

The Refractive surgery platform is a surgical and diagnostic equipment intended for advanced corneal laser treatments.

The excimer laser is sculpting the cornea and is used to produce different kinds of corneal shaping patterns in order to treat myopia, hyperopia, astigmatism and even presbyopia by aspherical, aberration-free, topography-guided and/or wavefront-guided corneal stromal ablations.

The topography/tomography/aberrometry Diagnosis Refractive Unit is a diagnostic tool which comprehensively evaluates the corneal profile in order to properly select the patients which could be treated with corneal lasers (femtosecond and excimer lasers) and to precisely plan the laser cornea refractive surgery according to the particularities of each patient's cornea. This diagnosis system is providing detailed maps of the anterior and posterior surface of the cornea, of the cornea thickness, of the optical aberration of the cornea (corneal wavefront maps) or the entire eye (ocular wavefront maps).

The Refractive Surgery Platform is a surgical and diagnostic equipment intended for advanced corneal laser treatments which include the Excimer laser, the Femtosecond laser and the Topography/Tomography/Aberrometry Diagnosis Refractive Unit.

1. All the contained items should be able to work with the same software, mainly the excimer laser and the diagnosis refractive unit, in order to be able to provide customised wave-front ablations (corneal and ocular) for our patients. If they will be acquired as independent units each of them will have its own software which is not compatible with other equipment and we’ll be able just to analyze the patients, but not to individualize the treatments by customized surgery. Having all these elements together in one big item should include the guarantee of the supplier that they can work together sharing information in order to offer a fluent surgery for our patients.

2. The femtosecond laser and the excimer laser should share the same operating table which should be integrated with the software for surgery in order to adapt the patient position to the specificity of the surgery. If they will be acquired as independent units each of them will have its own operating table which means that we’ll need to mobilize the patients from one item to the other during the surgery, which is interfering with the quality of the surgery and the patient’s comfort.

Denumirea proiectului sau a programului finanțat de UE: Interreg-IPA Cross-border Cooperation Romania-Serbia Programme; Project: Regional Centre for Advanced Laser Therapies in Ophthalmology – RECALT; Cod eMS project: RORS 11
Informații suplimentare:

Denumirea lotului: Micropulse laser.
Scurtă descriere:

The micropulse 577 mm laser system is a surgical equipment intended for advanced retinal treatments.The device is used to produce a therapeutic treatment without inducing intraretinal damage detectable on clinical examination during or after treatment. The controlled laser delivery of micropulse technology affords treatment options for diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), central serous chorioretinopathy (CSR), macular edema secondary to branch retinal vein occlusion (BRVO), and even glaucoma.

Informații suplimentare:

1. The tender guarantee is set at Lot 02 - Micropulse laser = 1 000.00 EUR, and must be presented in the form specified in the Annex to the tender dossier. It must remain valid for 45 days beyond the period of validity of the tender.

Locul de desfășurare
Locul principal sau locul de desfășurare:

"Victor Babeș" University of Medicine and Pharmacy Timișoara,

Piața Martir Belici Radian, no. 3,

”Victor Babeș” University of Medicine and Pharmacy Timișoara,

Atribuirea contractului
Data încheierii contractului: 2017-11-06 📅
2017-11-03 📅

Autoritatea contractantă
Identitate
Alt tip de autoritate contractantă: Higher Education - University of Medicine and Pharmacy

Referință
Informații suplimentare

1. The procurement procedure is in line with PRAG, version 2015.0 (The Practical Guide explains contracting procedures for EU external aid contracts financed by the EU general budget (Budget) and the 10th European Development Fund (EDF).) - http://ec.europa.eu/europeaid/prag/previousVersions.do - version 2015.0.

RORS 11/ “VICTOR BABES“ UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA/ 05.

Medical equipment.

Adress: “VICTOR BABES“ UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA, Piata Eftimie Murgu No. 2A, Timisoara 300041, Timis country, Romania.

Fax: 0040 (0)256 221 554.

Informații complementare
Revizuirea organismului
Nume: "Victor Babeș" University of Medicine and Pharmacy Timișoara
Informații privind termenele de introducere a căilor de atac:

2. Complaints to the European Ombudsman Without prejudice to other remedies and, in particular, without altering the deadlines laid down for the appeals set out in paragraphs 2.4.15.3 (PRAG Ver 2015.0), any citizen of the European Union or any natural or legal person residing or having its registered office in a Member State has the right to complain to the Ombudsman for the instance of maladministration by the European Union institutions (Article 228 of the Treaty on the Functioning of the European Union (TFEU)). More information may be found on the website http://www.ombudsman.europa.eu/en/home.faces.

PRAG Ver 2015.0, 2.4.15. Legal remedies - http://ec.europa.eu/europeaid/prag/previousVersions/document.do?num=2015.0&lang=en.

Sursa: OJS 2017/S 234-485999 (2017-12-05)

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