EUROPEAN UNION CONTRACTING AUTHORITY`S
Contents
1. 68 Referring to ANNEX II HI in TECHNICAL SPECIFICATION section for LOT 2 DIGITAL MAMMOGRAPHY UNITS there are list of some Yes correct 15 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer parameters that are not in the table They are as follows Image display After the patient selection the folder automatically appears and images are loaded Image display chronologically including previous images Image folder widening when several previous images are available Image panel allowing a visual control of all mammo patient images differentiating standard examination magnification stereotacxis screenshot by date laterality Patient s collection creation possibility for next examination discussion or for presentation Multiple hanging protocol Autoprefetch of Priors based on patient worklist if RIS and PACS is available Fit to screen function for all images of FFDM CR and digitized films the system to recognize automatically the shape of the breast in the image for display Automatic symmetrical alignment of the image FFDM CR and digitized films Local contrast enhancement at the location of mouse cursor Possibility to put marker on the image We understand that all those parameters are also requested to be fulfilled and should belong to the same evaluation process as all others in other words to be treated in the same way as all others and to be in the2. dossier and to provide necessary documentation such as catalogues brochures booklets that inform of details of technical specifications that sufficiently define the equipments being offered Do you find manufacturer s written statement informing about technical details of the equipment sufficient In ANNEX II II TECHNICAL SPECIFICATION Yes manufacturers signed statement is accepted 48 TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT page 2 we found all items supplied shall 11 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer include full manufacturer warranty granted for a minimum of two 2 years Do you find manufacturer s statement regarding warranty sufficient 49 In ANNEX II HI TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT page 2 we found that all equipment should have ISO certificate Do you mean ISO 13485 2003 certificates for Manufacturer Is it necessary to submit copy of ISO 13485 2003 for the manufacturer and copy of CE certificate DOC for the equipment Correct 50 Also In ANNEX II II TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT page 2 we found that tenderers shall ensure conformity of the equipment with all applicable Serbian Medicines and Medical Devices Agency and EU technical regulations IS
3. II for Lot 2 Digital Mammography units are not changed 34 Autoprint One of advantages of Digital Radiology is the possibility is the possibility to eliminate the cost the pollution and storage related to the images printed on film Nowadays the X ray report can be done on the base of digital images on 5 Mpixels monitor in the Dicom world the DicomDir function is provided to supply the study to the patient on a small world and cheap CD Rom and the Hospital can reduce the physical archive space storing all the images by means of the electronic archive of the PACS For the above mentioned reasons Autoprint function can t be indentified as qualifying characteristics of a state of the art systems that in any case gives the possibility of printing the images if necessary only by means of a simple click The request for autoprint has to be removed Autoprint option is necessary because of local practician s demands especially outside of Capital city There is still strong end user pressure on making hard copies of X ray images Technical requirements specified in Annex II II for Lot 2 Digital Mammography units are not changed 35 Video Colonoscope Insertion tube outer dia lt 13 mm Please review if it could read max DialS5mm This is not acceptable 36 Video Colonoscope Working length approx 1700 mm This is an unusual length Please review if it could read minimum length 1400 mm
4. table Is it correct 69 Referring to TECHNICAL SPECIFIACTION for LOT 3 MAMMOGRAPHIC WORK STATION The relevant images can be specifically marked key image marking is requested This parameter is dedicated to CT and MR images and it is not relevant for mammographic images Is it acceptable to offer annotations of lesions It is similar technique as requested one but more accurate way of highlighting relevant information Yes this is acceptable 70 Referring to TECHNICAL SPECIFIACTION for LOT 3 MAMMOGRAPHIC WORK STATION the Software including basic rendering functions MIP MPR is the parameter that is not relevant for mammographic images Therefore our firm cannot offer such feature with mammographic dedicated workstation We think that this parameter will not be treated as substantial departure which affects the requested technical requirements Can you confirm this Yes this is confirmed 71 Referring to ANNEX II III TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 1 LOT 2 and LOT3 in section WARRANTY we understand that the full standard manufacturer warranty This is correct however if there are parts included which bear a warranty period beyond 2 years these have to be mentioned 16 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer will be sufficient to be granted for a minimum of 2 years for all items supplied in the Lot Wou
5. 35 kV Yes this is acceptable 19 Page 6 Automatic exposure control It is requested solid state detectors Do you mean AEC solid state detectors If not could you please explain what is it related to Yes this relates to AEC solid state detectors 20 Page 6 Automatic exposure control It is requested Location indication with LED display Is it acceptable that system has min 6 detectors locations but without LED display for location indication Yes this is acceptable Palle Page 6 Gantry It is requested Rotation min 180 135 Would you consider as equivalent request Rotation min 135 180 due to same range of rotation It is only up to producer technology labelling and direction of rotation but results are the same Yes this shall be considered equivalent 22 Page 7 Safety features It is requested Automatic motorized compression release in case of power loss Is it acceptable to change it in Automatic motorized or manual compression release in case of power loss Yes this is acceptable 23 Page 7 Recording system It is requested Bucky factor R 5 1 approx 36 lines cm Does it mean that system with Bucky factor R 5 1 and 31 lines cm is also acceptable and not eliminatory Yes this is also acceptable 24 LOT 3 Mammographic Workstation Page 6 Workstation Itis requested contrast at least 800 1 for 2x medical computer screen for mammography C
6. LED display Question and request As our MammoDiagnost have unlimited variable positions please change to Location indication with LED display for models which have only min 6 fix detector locations This is acceptable 80 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 7 Safety features Automatic motorized compression release in case of power loss Question and request Please remove this characteristic as request Changed to read Automatic motorized or manual decompression release in case of power loss 81 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 7 Safety features Integrated quality control to compensate against changes in film processor and film Question and request The exposure parameters at MammoDiagnost needs to be adapted to every film and film processor used for the system The Service is able to calibrate the MammoDiagnost to the used film and film processor Please clarify what kind of Integrated quality control Any kind is acceptable 19 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer should be present on the mammo system 82 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 7 Recording system Bucky factor R 5 1 approx 36 lines cm Question and request Please change to B
7. The length of 1 400 mm is acceptable as the specifications provide for an approximate length 37 Emergency halogen lamp Halogen is quite outdated Please specify if other lamps are acceptable as well or if the entire specification of an emergency lamp is redundant This is not acceptable 38 Video system unit Digital outputs IEEE Fire wire DV Any of the output specified is acceptable CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer etc Firewire outputs are outdated Usually DV outputs are used 39 Video system unit Colour adjustment red blue etc Manual colour adjustment is overridden by the automatic white balance specification Please follow the technical specifications 40 Colour LCD monitor Input 2x RGB 4xBNC connectors 1 x Y C 4 pin mini DIN 1 x Composite BNC connectors RGB connectors are usually SUB D 15 connectors Please follow the technical specifications 41 System for capturing image and video documentation with the possibility of DICOM and HL 7 interface for integration in the hospital information system HIS and hospital network Language English and Serbian if available Is Serbian language compulsory Serbian language if available 42 User Manual English and Serbian if available Is Serbian language compulsory Serbian language if available 43 If all products offered in LO
8. dia gt 3 7 mm is this right or maybe typing mistake should be gt because colonoscopes usually have instrument channel inner diameter of 3 7 mm not gt 3J mm Please follow the technical specifications 95 Special Conditions Applicable to contract EuropeAld 129567 C SLrP RS LOT 4 Contents Article 16 Tax and customs arrangements second paragraph For supplies to be imported into the country of the Contracting Authority all duties and taxes applicable to their importation including VAT shall be excluded Please could you explain what mean all duties and taxes shall be excluded from In this case Contracting Authority is Delegation of the European Union to the Republic of Serbia GTC 19 Avenue Building Vladimira Popovica 40 11070 Belgrade Serbia and if Contractor import into that Country customs duties and taxes exist and present component of price structure All supplies and services under this contract will be exempt from Customs taxes and VAT Bids must therefore not include any import taxes into Serbia 96 Lot 1 1 1 Mammography unit The technical specifications of this unit can comply This is not accepted 22 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer with only one brand s product So we kindly request you to put some deviations to the technical specifications according to the following requirement for a more competitive bidding p
9. of the Contracting Authority The Contracting Authority will appoint a project manager with the necessary capacity 63 We would like to inquire about the termination clause 36 8 in the general conditions of the contract draft The clause 36 1 seems to include already a fairly extensive list of termination grounds What kind of situations could be foreseen to result in termination under 36 8 Is there a possibility to be more precise or and make sure the clause could not be used in bad faith Termination grounds are only those listed in article 36 1 Article 36 8 seems to reaffirm what is already foreseen in article 36 1 14 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer 64 Referring to ANNEX II III TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNITS AND INTEGRATED CR UNIT for LOT 2 DIGITAL MAMMOGRAPHY UNITS and for LOT 3 MAMMOGRAPHIC WORK STATION the Operator and Service Manual in English and Serbian language are requested Taking into consideration that service manuals are very huge set of many documents and is allowed to be used only by authorized trained service engineers is it acceptable that this requirement does not include Service manual and be corrected into Operator manuals in English and Serbian language Moreover Operator Manual itself includes some basic service manual data and maintenance instructions and troublesho
10. 150 000 If less than 60 of pre financing is requested in the offer and in the case that pre financing does not exceed EUR 150 000 does the Contractor still have to provide a financial guarantee for the full amount of the pre financing payment Yes it is possible No pre financing guarantee is needed for amounts lower than 150 000 EUR 12 In TECHNICAL SPECIFICATION for LOT 1 we found request for Mammography dedicated dry Imager In TECHNICAL SPECIFICATION for LOT 2 we found connectivity request for DIGITAL MAMMOGRAPHY UNITS Autoprint and DICOM Print Basic Grayscale Print User and for constituent Diagnostic Review Workstation DICOM Print but no Please just bid for the items and quantities requested CONTRACTING AUTHORITY S CLARIFICATIONS No 1 No Question Answer Mammography dedicated dry imager Do Institutes listed in Delivery installation and training list pg 11 of ANEX II UI TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 2 DIGITAL MAMMOGRAPHY UNITS already have imagers or we need to offer mammography dedicated dry imagers for LOT 2 as for LOT 1 Lot 4 Colonoscope There is no derogation on the rule of origin for Lot 5 Colonoscopy Simulator this tender because of the availability of products Item 4 1 Video Colonoscope with EU certificate of origin B Item 5 1 Colonoscope Simulator According to our market research these items which are specif
11. O 13485 2003 specifies requirements for a alty management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services CE Marking on a product is a manufacturer s declaration that the product complies with the essential requirements of the relevant European health safety and environmental protection legislation Tenderers cannot ensure this conformity Only Manufacturers can Do you mean tenderers shall prove conformity with all applicable Serbian Medicines and Medical Devices Agency and EU technical regulations with submission of copies of ISO certificate CE certificate and Marketing Authorization Certificate granted by Medicines and Medical Devices Agency of Serbia The ISO certificate is requested for the manufacturer of the device The CE mark is requested for each device offered Each device offered must have been approved by the Medicines and Medical Devices Agency of Serbia If not the device could not be operated in Serbian health institutions 51 In ANNEX II HI TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT page 3 we found that tenderers must have a local maintenance and technical support office or a company entrusted to solve any problem on site etc Is it necessary to prov
12. Procurement Notice Section 16 Selection and Award Criteria are those projects which are related to Diagnostic imaging equipment Please confirm if this understanding is correct Similar project in nature means projects for the supply of similar equipment as in this tender 60 We would like to inquire about the readiness of the sites to receive the equipment The tender documents or the contract draft does not discuss any pre installation work to be done Are we correct in assuming that the sites are all ready for installation The sites will be ready at the time of delivery of the goods 6l We would like to inquire more detail about the insurance policies required Would a customary transportation insurance generally used in international trade qualify as the transport insurance required to cover ALL risk as specified in the Special terms What coverage specifically is required from the full comprehensive installation insurance It is up to the supplier to decide which insurance policy complies with the requirements of the General and Special conditions in this respect 62 A project manager will be appointed to monitor the contract performance with fairly extensive authorization on behalf of the Contracting Authority We would like to inquire how the project manager will be selected what are the qualifications of such project manager and if the person will be a third party etc a consultant or an employee
13. RC this tender because of the availability of products prevention program in Serbia with EU certificate of origin As a leading European wide supplier of such FOB test i system based on the state of the art quantitative Please refer to Art 2 3 1 of EU Practical Guide immunochemical analysis of human hemoglobin as a marker of CRC which is recommended by the report http ec europa eu europeaid work procedures im European Guidelines for Quality Assurance in plementation practical_guide index_en htm 10 Colorectal Cancer Screening of the European Commission see Chapter 4 the list of suppliers we would like to raise the following issue and address the question The system we Supply support and service is OC Sensor produced by Eiken Chemical Industries Ltd in Japan but distributed supported and serviced European wide by MAST group in Germany UK and France and in Serbia by LKB Vertriebs GmbH from CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer Vienna Austria FOB test system we supply is perfect for cancer screening projects and it meets and exceeds all criteria described under your test specifications except the origin of product Nevertheless OC sensor is recommended by EU Commission see report European Guidelines for Quality Assurance in Colorectal Cancer Screening of the European Commission see Chapter 4 the list of suppliers and it is already accepted as a basis for nationwide s
14. T 4 and LOT 7 must originate as indicated I Instruction for tenderers in a Member State of EU or a country covered by the IPA programme Could the products which do not originate in EU or IPA programme countries be offered as well in this tender Does this mean that supplies from the non European manufacturers are excluded from this procurement All supplies must comply with the rule of origin The eligible countries covered by the IPA programme are the following Member States Austria Belgium Bulgaria Czech Republic Cyprus Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom Beneficiaries of this Regulation Croatia The former Yugoslav Republic of Macedonia Turkey Albania Bosnia Montenegro Serbia including Kosovo Beneficiary of the European Neighbourhood and Partnership Instrument 10 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 No Question Answer Algeria Armenia Azerbaijan Belarus Egypt Georgia Israel Jordan Lebanon Libya Moldova Morocco Palestinian Authority of the West Bank and Gaza Strip Russian Federation Syria Tunisia Ukraine Member State of the European Economic Area Iceland Lichtenstein Norway Tender Guarantees Both options are acceptable Could you kindly indicate if it is possible to provid
15. acceptable Please be informed that the specifications contain certain Except for the automatic motorized or manual lock outs in favour of one particular brand This will make decompression release in case of power loss it impossible for bidders to offer other brands thus creating monopolies which is not allowed according to The keyboard shall be in Serbian Latin letters tender procedures That is why we would like to ask you to confirm whether the following specs would be ig acceptable as well so alternative brands could be offered i Microprocessor controlled up to 50 or 80kHz Compression auto mode only fine tuned Min 3 detector locations Manual compression release in case of power failure Is it really necessary to supply the operator key board console with Serbian characters because normally speaking these consoles have regular letters LOT Ne2 Digital Mammograph This is not acceptable Please be informed that the specifications contain certain Thick breasts and thin breasts have very different lock outs in favour of two particular brands This will absorption characteristics Therefore it is needed make it impossible for bidders to offer other brands thus to use different X ray spectra to optimise image creating monopolies which is not allowed according to quality at lowest possible dose Dual track anode tender procedures That is why we would like to ask you ig the best way to optimize the x ray spectrum 109 to confirm wh
16. allow all European manufacturers to compete on this tender According to the tender document and the specifications any eligible manufacturer from all countries eligible under the IPA programme and any eligible distributor can take part to the tender 74 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 4 Service and operation manuals in English and Serbian language Page 8 General system inclusions Operator manual English Serbian Tech documentation English only Pre installation guide English only 3 of 7 Question and request Please change to Page 4 Service manual in English and operation manuals in This is acceptable 17 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer English and Serbian language 75 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 4 DOCUMENTS The following documents shall be delivered for all equipment Service and operation manuals in English and Serbian language Execution guidance installation drawings Certificates of compliance to safety norms and standards and or trial test results at the manufacturer s facility Question and request Please change to The following documents shall be delivered for all equipment during equipment delivery Service manual in English and operation manuals in English and Serbian lan
17. creening programs within those EU countries that has established such programs As a result we have excellent references all over the EU Scotland Austria Netherlands Germany Slovenia Hungary etc demonstrating that our test system perfectly fits various CRC screening programs and fulfils the conditions requested in your tender as well The automated analyzer OC Sensor is rapidly measuring and precisely quantifying human hemoglobin level in stool specimens in a highly specific manner and without interferences System has already been evaluated in many European pilot and screening studies and is the only system passing RCT randomized controlled trials studies giving us the lead in scientific proof Additionally the very stable sampling device which has been optimized during more than 10 years of development and use corresponds to UN 3373 standard demonstrating sample stability of 12 days which is far longer than requested in your tender Therefore we would kindly ask you to consider granting us derogation from the rule of origin and giving us an opportunity to participate in this tender This would place Serbia in a position to start an innovative prevention program in accordance to EU Commission recommendations in a proper way and it would make justification of expenditure of EU money given for such a program far simpler 11 Is it possible to ask less than 60 of pre financing in order this pre financing not to exceed EUR
18. e one 44 single tender guarantee covering the total of tender guarantee amounts for all lots we intend to bid or if bidders have to submit separate tender guarantees for each lot Lot 7 Microscopes There is a printing error in the technical The technical specifications indicate Long life LED specification illumination 100 000 hours 45 10 000 h ten thousand hours is correct Based on 8 hour workdays this corresponds with approx 50 year bulb life Please confirm 100 000 is a typo and the LED illumination lifetime should be 10 000 hours which is industry standard for these types of microscopes Annex II III documents Technical specifications Proof of compliance with technical standards shall Technical offer for Lots 1 2 and 3 page 2 section be included in the technical documentation for STANDARDS it is written Tenderers shall ensure each product offered 46 conformity of the equipment with all applicable Serbian Medicines and Medical Devices Agency Should tenderer submit the valid licence issued by Medicines and Medical Devices Agency of Republic Serbia in tender as a proof of above mentioned request In ANNEX II HI TECHNICAL SPECIFICATION See answer n 17 TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT page 1 we found that tenderers are required to demonstrate that specifications of items that they offer 47 are responsive to the requirements set out in the tender
19. e technical capacity of local maintenance and technical support office with list of service engineers fully employed in a local office or local entrusted company Technical specifications request only the following The tenderer must have a local maintenance and technical support office or a company entrusted to solve any problem on site The response time must not be more than 24 hours The name of the company address telephone and fax numbers e mail address must be mentioned in the bid The technical capacity of the local maintenance and technical support office doesn t need to be proved 12 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer 52 In ANNEX II HI TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT page 3 we found that tenderers shall confirm the availability of spare parts for a period of 5 years beyond the warranty period Only manufacturer can confirm spare parts availability Do you ask Manufacturer s statement about availability of spare parts A tenderer s declaration in this respect is sufficient 53 In ANNEX IV FINANCIAL OFFER PUBLICATION REFERENCE for LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT we found in a table column D that unit costs with delivery should be DDP Also we need to express costs for training and maintenance Taking into consideration local legislative and that
20. ents page 4 for Lots 1 2 and 3 In mandatory requirements you requested The following documents shall be delivered for all equipment service and operation manuals in English and Serbian language execution guidance installation drawings and certificates of compliance to safety norms and standards and or trial test results at the manufacturer s facility Please confirm whether this relates to delivery of these documents along with the equipment upon the selection of the best bidder and award of the contract Yes this is meant to be handed in only by the winner at the time of delivery or where necessary at the time of pre shipment inspection 29 Question 1 Articles 7 2 and 21 5 of the Instructions to Tenderers If the tenderer is awarded with the agreement covering more than one lot could the tenderer provide the performance guarantee for each lot respectively or is it mandatory to provide one performance guarantee for the entire contract covering more than one lot In addition if the provision of the single performance guarantee is mandatory in the case of one contract covering more than one lot what are the guidelines for the Contracting Authority when deciding whether to conclude one or more contracts with the tenderer awarded with one or more lots Yes the tenderer shall present separate performance guarantee for each lot of the contract also due to the different implementation periods 30 Question 2 Ar
21. er warranty conditions in accordance to the requirement for Warranty stated in Annex II III of each lot Please see answers to questions n 54 and 55 57 According to our market research regarding the LOT 7 of the above Tender we find that microscopes specified as items 7 1 7 2 and 7 3 do not have their origin in EU Please make exceptions to the rule on There is no derogation on the rule of origin for this tender because of the availability of products with EU certificate of origin 13 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer origin in this case and approve a derogation We would like to emphasize that by such derogation the dominant part of the total value of the LOT 7 will remain with EU origin 58 We would like to clarify the paragraph regarding economic operator in the Supply Procurement Notice Section 16 Selection and Award Criteria We understand that legal entities bidding in the tender could be supported by other companies e g entities within the same group of companies in the selection criteria based on a specific understanding regarding the resources in question without the need to create a formal consortium Kindly confirm if this understanding is correct Yes this is correct A letter of undertaking from these other companies shall be provided in the tender 59 Our understanding of similar projects in nature requested in Supply
22. ether the following specs would be avoiding un necessary radiation This results in acceptable as well so alternative brands could be offered dose reduction and that is why this tender X ray tube dual track this can only be provided by two requirement must remain unchanged brands who will offer themselves making it impossible for other bidders to participate Can you remove this feature from the specs or change it to single track to allow other bidders to participate as well 110 Can the feature Focal spots 4 four two on each target be The changes that you suggest are not acceptable changed to 2 focal spots which is part of single track tube oe X ray tube target material This is not acceptable Is Molybdenum material for the X ray tube also 24 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer acceptable 112 Item 4 1 Requested Insertion tube outer dia lt 13 mm Is it possible to offer solution 13 2mm because this scope type can be used with the working channel 4 2mm This is not acceptable 113 Requested 300 W Xenon lamp 500 hrs life time Is it possible to offer 300W x lamp BUT with 400 hrs lifetime stated in technical characteristics as minimum This is not acceptable 114 Requested Emergency halogen lamp Is it possible to offer LED lamp This is not acceptable 25
23. guage Execution guidance installation drawings Certificates of compliance to safety norms and standards and or trial test results at the manufacturer s facility This is acceptable 76 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 5 Generator kV range min 22 35 Question and request Please confirm that following figures can be accepted kV range min 23 35 This is acceptable 77 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 5 mAs range 4 500 with timer range 0 04 5s Question and request Please confirm that following figures can be accepted mAs range 4 500 with timer range 0 04 7s or mAs range 4 500 with timer range large focus 10ms 4s small focus 10ms 7s This is acceptable 18 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer 78 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 5 X Ray tube assembly Focal spot 0 1 mm small and 0 3 mm large Question request Please confirm that following figures can be accepted Focal spot 0 1 mm star pattern or 0 15 IEC small and 0 3 mm large This is acceptable 79 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 6 Automatic exposure control Location indication with
24. his is acceptable 91 Page 8 Connectivity DICOM Query Retrieve User Question and request This is not accepted 21 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer Please remove as request 92 Page 10 Multiple hanging protocol Fit to screen function for all images of FFDM CR and digitized films the system to recognize automatically the shape of the breast in the image for display Question and request Please remove as request This is not accepted 93 Instruction for tenderers on page 3 paragraph Origin Unless otherwise provided in the contract supplies must originate in a Member State of the European Union or a country covered by the IPA programme The origin of the goods must be determined according to the Community Customs Code or the international agreements to which the country concerned is a signatory Please could you explain in details statement Unless otherwise provided in the contract does this means that offered supplies can be originate also out of European Union for example if there are no suppliers from EU or leading manufacturers for that kind of equipment are no in EU Please read answers n 8 and 43 94 Concerning tender with publication reference EuropeAid 129567 C SUP RS in technical specification for LOT 4 Colonoscopes for technical specification of colonoscopes is characteristic Instrument channel inner
25. ical specifications 102 Can you please inform us if X Ray tube target material is only tungsten or tungsten rhenium is acceptable This is not acceptable 103 Rotation speed is required min 8 500 rpm does it acceptable to be offered 3 000 rpm This is not acceptable 104 Collimator beam filter is required Mo und Rh Can you please clarify if Rh and Ag is acceptable or not This is not acceptable 105 For digital acquisition System exposure to exposure time is required lt 30s can you please inform us if exposure time 40s is acceptable or not This is not acceptable 23 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 No Question Answer Connectivity Auto print is required we kindly request This cannot be omitted 106 you to omit this requirement for the technical specifications According to our market research regarding the LOT 7 of There is no derogation on the rule of origin for the above Tender we find that microscopes specified as this tender because of the availability of products items 7 1 7 2 and 7 3 do not have their origin in EU with EU certificate of origin 107 Please make exceptions to the rule on origin in this case and approve derogation We would like to emphasize that by such derogation the dominant part of the total value of the LOT 7 will remain with EU origin LOT Ne 1 Analogue Mammograph The changes that you suggest are not
26. ics about FOBT required and details characteristics than those mentioned in the how to obtain that documentation specifications is available When and on what account tender guarantee 1 000 E A tender guarantee amounting to Euro 1 000 for lot 9 is to be given must be made out by your financial institution as 4 per template No 10 Tender guarantee in the i tender dossier and has to be included in the tender as per article 11 of the Instructions to tenderers Our company is representative of the renowned There is no derogation on the rule of origin for manufacturer of medical equipment and currently this tender because of the availability of products only company that has a certification with EU certificate of origin Si Mammographic Type Test of EUREF European Reference Organization EUREF http www euref org Council for Quality Assured Breast Screening and Diagnostic Services which represents top of pyramid experts in that field Concerning software please read answer n 7 Vladimira Popovica Street 40 V GTC Avenue building block 19a 11070 New Belgrade Tel 381 11 3083 200 Fax 381 11 3083 201 E mail delegation serbia ec europa eu 1 3 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer Mammographic Type Test include http ikrweb uni muenster de aqs Richtlinien qualitaet_mammo qualit aet_mammo html The manufacturer is from the United States but the crucial parts a
27. ied in technical specifications are not originated in European Union countries So we kindly request you to give derogation for these items Document A Instructions to tenderers point 3 5 What Please read article 3 4 and 21 1 of the instructions did you mean by tenderers must prove that they comply to tenderers as well as the relevant parts of the with necessary legal technical and financial PRAG at the following link 14 requirements Is it acceptable to provide only the statement or do you require some additional documents http ec europa eu europeaid work procedures im If you require some additional documents please state plementation practical_guide index_en htm which ones Document A Instructions to tenderers point 24 It is The purpose of a tender is to collect offers from explained in the Cancelation of the tender procedure tenderers and award a contract to the most that one of criteria for cancelation is if all technically advantageous technically compliant bidder 15 compliant tenders exceed the financial resources Therefore no budget estimate shall be provided available In order not to exceed planned tender value to the bidders at any stage could you please provide us with financial resources available evaluated tender value for LOT 1 2 and 3 Document A Instructions to tenderers point 9 It is Since the language of this tender is English all stipulated that the language of the tender is English and documentation has
28. ilability of products case these conditions do not apply we ask for reasons with EU certificate of origin ror hata ClamnCauOM OF Meke tason Please refer to Art 2 3 1 of EU Practical Guide http ec europa eu europeaid work procedures im plementation practical_guide index_en htm Does the software vendors out of the EU Member States There is no derogation on the rule of origin for may participate in the tender If vendors of Software this tender because of the availability of products outside EU Member States can not participate in this with EU certificate of origin tender we are asking for clarification of these reasons taking into account the fact that one of the required Please refer to Art 2 3 1 of EU Practical Guide software is manufactured in USA The intention of such a request for clarification is to http ec europa eu europeaid work procedures im 9 provide situation for manufacturer of mammography plementation practical_guide index_en htm with proven best features and currently the only certified by the EUREF A Hologic Inc to participate make their offer in order to provide equipment for the implementation of the National Programme for breast cancer screening in Serbia with goal to be appropriate and in accordance with the norms and conditions that are recommended in the European Union As mentioned in LOT 9 there is a requirement for 40 There is no derogation on the rule of origin for 000 FOB Test units which will be used in C
29. ld you be kind to confirm this 72 TENDER DOCUMENT page 6 of 10 TENDERER S DECLARATION S In paragraph 8 We confirm that we are not tendering for the same contract in any other form Does it indicate that we as a bidder can submit only one offer per lot Since we are distributor of a specific manufacturer does it mean that other companies worldwide can also offer same manufacturer s equipment Please clarify Yes only one bid per Lot Any company fulfilling the terms and conditions of the tender may submit a bid There can be several bids offering the same brand of equipment 73 Clarifications for Lot 1 According to our information only one firm has CR System and Medical Dry Technology Imager with European origin Because of that firm have monopolistic position which is opposite to the fair competition aim of the open tender procedure To secure our monopolistic claim we further state that only that firm as European origin manufacturer has a registered product in Serbian medicines and medical devices Agency for the territory of Serbia In this way we conclude that only the bidder that unites with Agfa distributor as a joint venture bidders or similar qualifies as an appropriate bidder In this way transparency of tender process and competitiveness between manufacturers is fully ruined Question and request Therefore PLEASE restructure the tender requirement with respect to this demand and
30. le such features 85 Clarifications for Lot 2 ANNEX II HI TECHNICAL SPECIFICATIONS TECHNICAL OFFER LOT 2 DIGITAL MAMMOGRAPHY UNITS MANDATORY All manuals shall be supplied in English and in Serbian if available 20 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer REQUIREMENTS FOR LOT 2 Page 4 Service and operation manuals in English and Serbian language Question and request Please change to Service manual in English and operation manuals in English and Serbian language 86 Page 5 X ray Generator Power min 5kW Question and request Please confirm that following figure can be accepted Power min 4 7kW This is not accepted 87 Page 7 Collimator FOV to be modified manually Question and request Please remove as request This is not accepted 88 Page 7 Flat panel detector Size min 24 x 30 cm Question and request Please confirm that following figure can be accepted Size min 23 9 x 30 cm This is acceptable 89 Page 7 Flat panel detector Image depth gt 13 bit Question and request Please confirm that following figure can be accepted Image depth gt 13 bit This is acceptable 90 Page 8 Digital acquisition system Exposure to exposure time lt 30 seconds Question and request Please confirm that following figure can be accepted Exposure to exposure time lt 30 seconds T
31. linical practice has shown that 500 1 contrast is sufficient for mammography purpose So is it acceptable to offer contrast 500 1 Yes this is acceptable 25 Page 8 It is requested Display of several series on the computer screen and Display of several series on several computer screens Do you consider under this request display of images from series in full resolution on both monitors and their comparing Otherwise there is no sense to display different series because there is no diagnostic possibility in such way Yes the display of images from series in full resolution on both monitors and their comparison is here requested 26 Page 8 The relevant images can be specifically marked key image marked What did you mean by this request Could you please be so kind to explain in more detailed way This is a filming tag It is used for the marking of certain images that can be written to a laser camera CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer 27 Page 9 Could you please clarify and explain following for Magnify Pan Extended Monitor Display Magnify Rectangle Magnify Pan reset Magnify glass Interactive Magnification Magnify Glass 1 1 not shown Pixels options These provisions depict the possibilities of digital image zooming 28 LOT 1 2 and 3 Annex II II Technical specifications Technical offer Mandatory requirements Docum
32. n Technological innovation and taking care of Patients protection minimizing the Dose It s our opinion that mammography devices can provide highest quality without this feature Conclusion also a single target tungsten tube has to be admitted especially important for younger women with radiographically dense breasts Technical requirements specified in Annex II II for Lot 2 Digital Mammography units are not changed 33 Rotation speed minimum 8500 RPM In analog mammography with Mo tube High Speed Rotation was useful to enhance tube loading reducing exposure time and related possible artefacts due to patient displacement but there is a cost to pay for High Speed Rotation in terms of higher tube assembly High speed rotation generally increases the power capacity of a tube by approximately 60 There are Manufacturers of Mammography units with 10 000 rpm anode rotation rate CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer thermal loading and life reduction due to higher mechanical stress Tungsten tubes representing the state of the art for Digital Mammography have two times the loading capabilities of Molybdenum tubes without high Speed Rotation It s our opinion that this feature is not qualifying and mammography devices can provide highes quality without it Conclusion Rotation speed minimum 8500 RPM has to be removed Technical requirements specified in Annex II
33. ocurement is as EC Reg No 1085 2006 IPA that strongly promotes the business within the European Community d As INSTRUCIONS TO TENDERERS 09 SER 01 05 21 art 3 Participation e As INSTRUCTIONS TO TENDERERS 09 SER 01 05 21 art 4 Origin Granted all the above mentioned specifically referring to the Lot No 2 Digital mammography units It is our opinion that the participation of European manufacturers in this tender is strongly limited considering that only two international manufacturers CAN OFFER PRODUCTS EXAXTLY CORRESPONDING to the technical characteristics specified in the tender invitation More precisely two of the technical characterises specified in the tender invitation are highly restrictive and disputable and they should be amended for the following REASONS X ray tube dual track tubes X ray tube dual track tubes are a technological heritage of Analog Mammographhy when the evolution of Digital Mammography makes the actual state of the art in terms of Lower Dose and enhanced image quality based on Tungsten target with Rhodium or silver filtrations The higher dose released to the patient with Mo target makes a double target tube only more expensive and delicate withour any Clinical Benefit For the above reasons a double target tube can t be indentified as qualifying characteristics vs those units having a slingle Tungsten target tube This requirement is obsolete and penalizes those Manufacturers investing i
34. oting This is acceptable 65 Referring to ANNEX II HI in TECHNICAL SPECIFICATION for LOT 1 ANALOGUE MAMMOGRAPHY UNITS AND INTEGRATED CR UNIT the Operator key board console must include all Serbian characters is stated in section for mammography unit Bearing in mind that there is no standard keyboard having complete set of characters in analog mammography unit and from other hand such keyboard exists in CR unit is it acceptable that such requirement be the part of CR section 66 Referring to ANNEX II II TECHNICAL SPECIFICATION TECHNICAL OFFER for LOT 2 DIGITAL MAMMOGRAPHY UNITS technical specification includes Diagnostic Mammography Review Workstation Bearing in mind that such workstation is treated as separate medical device in accordance to the EU s and Serbian law regulations the Marketing Authorization Certificate Registration Sales License issued by Medicines and Medical Devices Agency of Serbia is needed Therefore to our understanding the tenderer should submit such document in order to comply the tender s request related to the conformity Is it correct The tenderer shall prove that this device is approved by the Medicines and Medical Devices Agency of Serbia 67 Referring to ANNEX II HI in TECHNICAL SPECIFICATION section for LOT 2 DIGITAL MAMMOGRAPHY UNITS the LCD monitor resolution of 1289x1024 is requested Is 1280 x 1024 acceptable Yes this is acceptable
35. re produced in the EU This equipment is in Serbia already installed on the most important and the highest frequency of patients tertiary health care facilities where he undoubtedly proved their unmatched quality Regarding the subject of procurement under this tender is equipment for implement the National Programme of screening for breast cancer we believe that it is necessary to get the only one certified by EUREF a manufacturer of analog and digital mammography units our company be provided the opportunity to participate in this tender Does our company as a representative of the manufacturer and the manufacturer itself meet the requirement of the origin of the equipment as necessary qualifications for participation in this tender Also refer the request for clarification regarding the conditions for participation TERMS OF PARTICIPATION 1 Eligibility and rules of origin Participation is open to all legal persons participating either individually or in a grouping consortium of tenderers which are established in a Member State of the European Union or in a country or territory of the regions covered and or Authorised by the specific instruments applicable to the program under which the contract is Financed see item 22 below All goods supplied under this contract must originate in one or more of these countries Participation is also open to international organizations Participation of natural persons is directly governed by
36. rocedure Tube current is required as 100 mA we kindly request yon to change this specification as 90 100 mA 97 For Automatic exposure control min 6 detector locations is required can you please clarify if 3 fields electronically selectable will be acceptable or not They will not be acceptable 98 For Gantry digital display for kV mAs and exposure time required can you please clarify if digital display for kV and mAs will be enough and acceptable This is not acceptable 99 1 2 CR System and Medical Technology Imager There is only one CR system which can be used for mammography BUT being a semi automatic CR system it is not suitable for breast cancer screening and diagnostics therefore there is not solution for this application So please change the specifications as semi automatic or application of this unit This is not acceptable 100 Lot 2 2 1 Digital mammography units The technical specification of this unit can comply with only one brand s product So we kindly request you to put some deviations to the technical specifications according to the following requirement for a more competitive bidding procedure Can you please clarity if display parameters of kV mAS target filter will be enough or not They will not be enough Please follow the technical specifications 101 Can you please clarify the focal spot 0 1 0 3 is acceptable or not Please refer to techn
37. the specific instruments applicable to the program under which the contract is Financed The required specification for the third lot ANNEX II WI TECHNICAL SPECIFICATIONS TECHNICAL OFFER Lot 3 technical specifications Item number 3 1 workstation The required software for the operating system workstations Licensed MS Windows XP MS 7 or 6 manufacturers Microsoft USA Are any of the special operation conditions for the participation of U S manufacturers is applied in this case There is no derogation on the rule of origin for this tender because of the availability of products with EU certificate of origin Please refer to Art 2 3 1 of EU Practical Guide http ec europa eu europeaid work procedures im CONTRACTING AUTHORITY S CLARIFICATIONS No 1 No Question Answer plementation practical_guide index_en htm What are the conditions when it comes to eligibility and An EU certificate of origin to be issued by a tules of origin applied in this case and the required relevant authority doesn t take into account only software from the U S the country of production manufacture of the 16 product Some products have no equivalents and are produced only by a single manufacturer Do these conditions applied in this case can be applied There is no derogation on the rule of origin for in case the company Hologic Inc also from the U S In this tender because of the ava
38. this is Donation project and according to Article 8 of General Conditions is it possible to obtain requisite permits and licenses in order not to pay custom fee and VAT at the customs Is it possible not to pay VAT for training and maintenance In other words do we need to fill in an Annex IV table prices with or without VAT and customs fees All supplies and services under this contract will be exempt from Customs taxes and VAT 54 In Article 32 3 of ANNEX I General Conditions it is specified that The Contractor shall at his own cost make good the defect or damage as soon as practicable The warranty period for all items replaced or repaired shall recommence from the date on which the replacement or repair was made to the satisfaction of the Project Manager Does the recommencement mean that warranty shall begin again or resume Resume The warranty period is fixed and starts from provisional acceptance 55 Should the warranty be applied only for replaced or repaired spare part or to be applied for complete system that consist that particular defective or damaged spare part The warranty resume only for the parts either replaced or repaired 56 If the warranty is applied to particular replaced or repaired spare part does this warranty should be valid for the same duration of warranty requested in the Tender or it would be applied as separate warranty for replaced part according to general manufactur
39. ticles 21 1 and 21 2 of the Instructions to Tenderers and Article 2 4 11 of the Practical Guide Should the documentary proofs confirming the tenderer s eligibility and its capacity under the section 2 3 3 and section 2 4 11 of the Practical Guide be submitted together with the offer or these documentary proofs are to be provided upon the receipt of notification of award What you write is correct Please see answer n 14 31 Question 3 Mandatory requirements for Lots 1 2 and 3 Warranty All items supplied in these Lots shall include full manufacturer warranty granted for minimum of two years Is it acceptable to provide full tenderers two year warranty instead for the offered systems If a tenderer is not the manufacturer of the goods offered such tenderer has to provide the proof that the manufacturers warranty is valid at least for a period of two years If manufacturers warranty is longer than two years it is of course acceptable 32 Referring to the public procurement procedure by Ordering Party we expose as follows Granted that Dual track X ray tube ensures the lowest possible dose to suit specific breast characteristics CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer a These supply contracts are financed by the European Community with European funding program b Ordering Party is European Union Delegation to the Republic of Serbia c This Public pr
40. to be presented in this that all supporting documents should be translated into language Documentation in other languages 16 the language of the call for tenders Is it obligatory to should be translated into English There is no provide translations verified by an official court need for an authorised or official translation translator registered at the Ministry of Justice of Republic of Serbia LOT 1 and 3 documents Annex I II Technical All products characteristics and features specifications Technical offer page 1 tt is requested requested have to be proved by supporting or from Bidder to provide necessary documentation such technical documents Declarations of compliance as catalogues brochures booklets that inform of details are not sufficient to verify compliance with the 17 of technical specifications that sufficiently define the technical specifications equipments being offered If all relevant data are not listed in above mentioned documents is it acceptable to submit Original Statement of producer or offerer s detailed technical proposal where such system technical features and parameters are stated CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Question Answer 18 LOT 1 Analogue Mammography Unit and Integrated CR Unit in Annex IHI document Technical specifications Technical offer Page 5 Generator It is requested kV range 22 35 kV Is it acceptable to offer generator with kv range 23
41. ucky factor R 5 1 approx 31 lines cm This is acceptable because the specification provided is an approximate figure 83 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 8 General system inclusions Operator key board console must include all Serbian characters Question and request Please change to Operator key board console must include all Serbian Latin characters This is acceptable 84 LOT 1 ANALOGUE MAMMOGRAPHY UNIT AND INTEGRATED CR UNIT MANDATORY REQUIREMENTS FOR LOT 1 Page 11 CR system Automatic display of the following image attributes kVp exposure time target and filter material compression force breast thickness magnification factor estimated source to detector distance exposure control method sensor position organ doze device ID and device type Question and request It is not possible to transfer from MammoDiagnost to CR and to automatic display asked image attributes According to our information there is no any mammo system on the market that enables this feature Please remove as request This is not accepted This feature is very important for clinical use and is therefore mandatory Information that there are no mammography systems on the market enabling this feature is not correct There is a minimum of five manufacturers with European origin on the market producing the mammography units which enab
42. x xt kik XANI EUROPEAN UNION gt yt DELEGATION TO THE REPUBLIC OF SERBIA Belgrade 01 11 2010 CONTRACTING AUTHORITY S CLARIFICATIONS No 1 Supply of equipment for the Implementation of the National screening programme for colorectal cervical and breast cancer Publication ref EuropeAid 129567 C SUP RS Tender no 09SERO1 05 21 Question Answer We re writing to you after reading the call for tender concerning the Supply of equipment for the Implementation of the National screening programme for colorectal cervical and breast cancer published on the Tenders Electronic Daily web site in order to ask for a clarification on our possibility to take part in Yes you can bid for only one lot Tender Documents are available at the following addresses https webgate ec europa eu europeaid online 1 one lot only of the mentioned supply oes ee ene mee Should your response be positive we would request mE amp orderby upd amp orderbyad Desc amp searchty you please to forward us a copy of the LOT 8 pe RS amp aofr 129567 specifications office and lab furniture and www curopa rs We would like to bid for Lot 9 FOB Tests for cancer See answer n 1 2 screening programme only Please can you advise if this is possible and how we should go about this Do you have additional separate documentation with No additional separate documentation with more 3 detailed characterist
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