ΔΝΣΤΠΟ 8 ΣΔΥΝΙΚΔ ΠΡΟΓΙΑΓΡΑΦΔ

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1 ΔΝΣΤΠΟ 8 ΣΔΥΝΙΚΔ ΠΡΟΓΙΑΓΡΑΦΔ Αρ. Γηαγωληζκού: BOCOC2011 / 002 «Προκήζεηα Ραδηολοσθιηδίωλ / Ραδηοθαρκάθωλ θαη άιιωλ σιηθώλ απαραηηήηωλ γηα ηης αλάγθες ηες Πσρεληθής Ιαηρηθής ηοσ Ογθοιογηθού Κέληροσ ηες Σράπεδας Kύπροσ» Αρ. Γηαγωληζκού: BOCOC2011 / 002 Package Outline of Specifications The s must quote prices for all items for all groups in «ΔΝΣΤΠΟ 10 &10A» and specify which of the Optional items they can provide. The Bank of Cyprus Oncology Center reserves the right to purchase items from the Optional groups (radionuclides or cold kits etc.) from diferrent tenderes, on the basis of availability and cost. Supply and transportation conditions The production and transportation of all the radioactive materials and reagent kits must follow all the International and European Regulations for medically used radiopharmaceuticals. The requirements for keeping the above radiopharmaceuticals, such as temperature, humidity and other conditions must be provided by the manufacturers. Any accessories, tubing or special apparatus needed for the administration of these radiopharmaceuticals to patients, must be indicated and described clearly, and must be supplied in the proper quantities, together with the radiopaharmaceuticals. The transportation of the radiopharmaceuticals must be made by properly trained personnel Name: Date: Signature: 1

2 GROUP I : Radiopharmaceuticals (radionuclides and Cold Kits) needed for the uninterrupted operation of Nuclear Medicine- Required Items ΕΝΟΤΗΤΑ A1 : ΡΑΔΙΟΝΟΥΚΛΙΔΙΑ/ΡΑΔΙΟΦΑΡΜΑΚΑ (required) The s must specify if they can provide the Technetium Generators and other Radionuclides needed and included in this group. The tenderers must indicate both the cost per Unit / application and the cost for each individual radionuclide in Eληππν 10, based on the expected consumption per year. Delivery will be made once per week for all the items ordered for that week, and the weekly shipping costs must be indicated separately in Δληππν 11. It is expected that if any items of this group are ordered together with other items of another group, from the same for a given week, then shipping costs will be charged only once for that week and will be the same as the standard weekly shipping charge quoted in Δληππν 10 of this Tender. No. 1 2 The tenderers must indicate if they can provide Technetium 99m Sterile Generators with minimum activity of 12 GBq, or higher. (if the company does not provide 12 GBq generators, indicate the closest activity above 12 GBq. (Provide available generator activities and price for each generator of different activity in Δληππν 10). Also provide the total cost for 48 such generators in Δληππν 10. (anticipated number of generators needed per year) The tenderers must indicate if they can provide Sodium Iodide (I 131 ) Therapy Capsules. Please indicate available activities in capsule form and provide minimum and maximum activities. Provide corresponding cost in Δληππν 10. Expected consumption: 130 capsules per year, 100 of which will be of 3700 MBq (100 mci) activity, and the rest will be 5550 Mbq (150 mci) activity. Item provided by Reference to 2

3 3 3.1 The tenderers must indicate if they can provide I-131 sodium iodide in liquid form in vials, for whole body diagnostic tests. Please indicate available activities and provide minimum and maximum activities. Provide corresponding cost in Δληππν The tenderers must indicate if they can provide I-131 sodium iodide in capsules with activities e.g 3 mci, 5mCi, 10 mci. Please indicate available activities and provide the corresponding cost in Δληππν 10. Estimated number of whole body scans (approximately 3 mci I-131 each) = 100 patients per year The s must indicate if they can provide. Gallium (Ga 67 ) Citrate Injection ( MBq ). Estimated number = 5 studies per year The s must indicate if they can provide Iodine (I 131 ) Diagnostic MIBG, and indicate cost in Δληππν 10. Expected consumption: 3 patients/year The s must indicate if they can provide Iodine (I 123 ) Diagnostic MIBG, and indicate cost in Δληππν 10. Expected consumption: 2 patients/year The s must indicate if they can provide Iodine (I 131 ) Therapy MIBG. Estimated number : 2 studies per year (please indicate price in Δληππν 10) The tenderers must indicate if they can provide Indium (In 111 ) Octreoscan (122 MBq each). Expected consumption : 5 patients per year ( indicate cost in Δληππν 10) Number of items provided by this 3

4 ΕΝΟΤΗΤΑ A2 : ΡΑΔΙΟΝΟΥΚΛΙΔΙΑ/ΡΑΔΙΟΦΑΡΜΑΚΑ (Required) ( Για Θεραπεία και Διάγνωση) The s must specify if they can provide the Radionuclides listed below for therapy applications and diagnostic tests. The tenderers must indicate both the cost per Unit / application and the cost for each individual radionuclide in Eληππν 10. The expected consumption is limited from one to five per year. Delivery should be made for the week ordered, and the shipping costs must be indicated separately in Δληππν 10. It is expected that if any items of this group are ordered together with other items of another group, from the same for a given week, then shipping cost will be charged only once for that week and will be the same as the standard weekly shipping charge quoted in Δληππν 10 of this Tender. The Bank of Cyprus Oncology Center reserves the right to purchase different radionuclides included in this group (Δλόηεηα) from different suppliers, on the basis of costs, relying on the prices given by the suppliers in their proposal for this Tender. See also attached Δηδηθνί όξνη γηα Δλόηεηα A and Δλόηεηα B No. 1 The tenderers must indicate if they can provide Strontium-89 for Palliation Therapy. (4-5 mci per patient, ie MBq) (Indicate cost for one patient in Δληππν 10) Item provided by Reference to The tenderers must indicate if they can 2 provide Samarium-153 for Palliation Therapy (1-1.5 mci per Kg of patient weight, ie 75, 100, and 150 mci units. Indicate cost for one patient treatment per year treatment in Δληππν 10) 3 The tenderers must indicate if they can provide Rhenium (35 40 mci per patient, ie approx MBq per treatment. (Indicate cost for one patient treatment per year in Δληππν 10) 4 The tenderers must indicate if they can provide injectable Chromium-51 EDTA. (please indicate cost for one patient treatment per year in Δληππν 10) Number of items provided by this 4

5 ΔΝΟΣΗΣΑ B1 : ΦΑΡΜΑΚΔΤΣΙΚΑ ΤΛΙΚΑ ΓΙΑ ΗΜΑΝΗ ΜΔ ΡΑΓΙΔΝΔΡΓΟ ΣΔΥΝΗΣΙΟ (COLD KITS) (required) The s must specify if they can provide the cold Kits needed with the materials for labeling with radioactive technetium. The tenderers must indicate the cost per Unit / application in Δληππν 10, based on the expected consumption per year. Delivery for all items ordered from the same for a given week, ( radionuclides, cold kits etc), should be made once per week. The weekly shipping costs should be indicated separately in Δληππν 10. See also attached Δηδηθνί όξνη γηα Δλόηεηα A and Δλόηεηα B No. 1 The s must specify if they can provide Technetium Agent for Pulmonary Perfusion Scintigraphy (ΜΑΑ) and indicate cost for 2 kits per year in Δληππν 10 Item provided by 2 The s must specify if they can provide the following kits, in the quantities indicated: Technetium Agent for Dynamic Kidney Scintigraphy (DTPA) (2 Kits per year) 3 The s must specify if they can provide Technetium Agent for Dynamic Kidney Scintigraphy 3.1 MAG3 (2 Kits per year) 3.2 EC 4 The s must specify if they can provide Technetium Agent for Bone Scintigraphy 4.1 MDP 4.2 HDP ( 15 Kits per year ) 5 The s must specify if they can provide Technetium Agent for Bone Marrow Scintigraphy 6 ( 1 kit per year) The s must specify if they can provide Technetium HSA Agent for Scintigraphy (2 kits/year) 5

6 ΔΝΟΣΗΣΑ B 1: ΦΑΡΜΑΚΔΤΣΙΚΑ ΤΛΙΚΑ ΓΙΑ ΗΜΑΝΗ ΜΔ ΡΑΓΙΔΝΔΡΓΟ ΣΔΥΝΗΣΙΟ (COLT KITS ) continued. No. Item provided by 7 The s must specify if they can provide Technetium Agent for Tumor Scintigraphy 7,1 depreotide : 1 kit (5 vials) per year 7,2 CEA 8 The s must specify if they can provide Technetium Agent for Deep Vein Thrombosis ( 2 kits /year ) 9 The s must specify if they can provide Technetium Agent for RBC Labelling stannous ( 2 kits per year) 6

7 GROUP II : OPTIONAL ITEMS : The items in GROUP II, Eλόηεηες Α3, Β2, Γ1, Γ2, θαη Γ3, are optional. Although for these items no expected consumption is indicated, however the tenderers must still provide the cost per unit in Δλησπο 11A, and these prices will remain fixed until the end of this tender. The Bank of Cyprus Oncology Center will rely on the prices offered, to order some of the optional items within two years from the announcement of this Tender. In particular, some of the items of Group Γ 1 will be needed within the first half of next year. For this reason, the s must indicate prices for all the optional items, and these prices will be binding for the s. The BOCOC reserves the right to order all such optional items from one or more manufacturers based on the price offered by each one. ΔΝΟΣΗΣΑ Α 3 : OPTIONAL ITEMS The s must specify if they can provide the following optional Radionuclides and other items needed. The tenderers must indicate both the cost per Unit / application and the cost for each individual optional radionuclide in Δλησπο 10A. Although for items labeled as optional, no expected consumption is indicated, the s must still provide the cost per unit in Δληππν 10A. It is expected that, if any items of this group are ordered together with other items of another group, from the same for a given week, then shipping cost will be charged only once for that week at the standard rate and will not be increased. No. The s must indicate if they can provide the following optional items, and provide the cost per unit in Δληππν 10Α: Item provided by (Page & 1.1 Indium (In 111 ) Chloride Injection 1.2 Indium (In 111 ) Myoscint 1.3 Other Radionuclides for Palliation Therapy, e.g. 1.3α. Y90 1.3β Erbium 1.4 Selenium-75 for Imaging 1.5 Iodine 123 DATSCAN 1.6 Iodine 123 IBZM 1.7 Sodium Iodine Other Labelled B emitters used for radionuclide Therapy e.g. 1.8α. Y90 Zevalin 1.8β. Y90 for labeling 1.9 Thallium Chloride (Tl 201 ) Injection (111 MBq-1.8 GBq). Number of items provided by this 7

8 ΔΝΟΣΗΣΑ B2 : OPTIONAL ITEMS: ΦΑΡΜΑΚΔΤΣΙΚΑ ΤΛΙΚΑ ΓΙΑ ΗΜΑΝΗ ΜΔ ΡΑΓΙΔΝΔΡΓΟ ΣΔΥΝΗΣΙΟ (COLT KITS ) The s must specify if they can provide the optional cold Kits needed with the materials for labeling with radioactive technetium. The tenderers must indicate cost per Unit / application for these optional items in Δληππν 10Α. For items labeled as optional, no expected consumption is indicated. Delivery for all items ordered each week ( radionuclides, cold kits etc), should be made once per week. The s must indicate the shipping costs for these optional items in Δληππν 10A, so this cost can be considered in case one of these optional items has to be ordered separately from other items during a given week. No. 1 The s must specify if they can provide Technetium Agent for Hepatobiliary Scintigraphy (IDA) Item provided by 2 The s must specify if they can provide Technetium Agent for Kidney Scintigraphy (DMSA) 3 The s must specify if they can provide Technetium Agent for Brain Scintigraphy ( HM - PAO ) 4 The s must specify if they can provide Technetium Agent for Liver Scintigraphy - sulphur Colloid 5 The s must specify if they can provide Technetium Pyrophosphate Agent for Scintigraphy 6 The s must specify if they can provide Technetium Agent for Infection and Inflammation 6.1 leucoscan 6.2 Infecton 6.3 Scintimun 7 The s must specify if they can provide Technetium Agent for Lymphoscintigraphy 7.1 nanocolloid 7.2 antimony colloid 8 The s must specify if they can provide Technetium Agent for Myocardial Perfusion Scintigraphy 8.1 Myoview 8.2 MIBI Number of items provided by this 8

9 ΔΝΟΣΗΣΑ Γ : ΤΛΙΚΑ ΑΠΑΡΑΙΣΗΣΑ ΓΙΑ ΣΗ ΛΔΙΣΟΤΡΓΙΑ ΚΑΙ ΑΚΣΙΝΟΠΡΟΣΑΙΑ ΣΗ ΠΤΡΗΝΙΚΗ ΙΑΣΡΙΚΗ (ACCESSORIES ) Γ1. Σα είδε ηες οκάδας Γ1, εθόζολ παραγγειζούλ ζα πρέπεη λα παραδοζούλ κία θορά θαζ όιε ηε δηάρθεηα ηες ζύκβαζες, θαηα ηε δηάρθεηα ηοσ The s must specify if they can provide the following, and provide the cost in Δλησπο 10A: No See also attached Δηδηθνί όξνη γηα Δλόηεηα Γ Supply computer software and hardware system that is used for keeping records of the radionuclides used and records of the quality assurance of the daily, quarterly and annual quality assurance of the dose calibrator and other instrumentation used in Nuclear Medicine. The offer must be either one of the following two hardware and software systems, with two network users capability, namely : PINESTAR system from GE Healthcare or TRIAD system from Mallinkrodt. The system provided must come with an appropriate printer connected to the computer provided and three years full warranty, An Uninterruptible Power Supply (UPS) with sufficient capacity to support the necessary equipment in case of power failure, and guarantee against loss of information, must be included in the price. Injection Stand (e.g. Capintec Catalog 06, , p.68, Biodex ,p.18 ) or equivalent (provide copy of appropriate catalog page, with image, dimensions of the item offered, etc) Two Standard shielded Pedal Bins approximately litre, 6 mm thick lead (e.g. gammacare 2841/6, Britec 6BT-SPB6,p.19) or equivalent ( provide copy of catalog page, with image, dimensions of the item offered, etc) 4 One Large, approximately 40 litre shielded Pedal Bin, 6 mm thick lead (e.g. Britec 6BT-LPB6,p.19) or equivalent. (provide copy of catalog page, with image, dimensions of the item offered, etc). Item provided by 9

10 No. 5 Group Γ 1 continued Sharps Container Shield for beta and gamma radiation (e.g.biodex , p.20) or equivalent Item provided by (provide copy of catalog page, with image and dimensions of the item offered, etc). 6 Lead or Tungsten Syringe Shields with release of the syringe at the press of a button (Capintec, catalog , Biodex , Britec 1BT-AL01,p.7) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). A) 6 X 1cc B) 6 X 2cc C) 6 X 5cc D) 2 X 10cc Acrylate Beta syringe Shields 1, 2, 5 and 10cc (for 7 beta radiation) (Britec IBT-BS01-BS10, p.8) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Α) 2 X 1cc Β) 2 X 2cc C) 2 X 5cc D) 2 X 10cc Tungsten vial shield (Gamacare GC2848, Britec 8 2BT-TVST, p.10) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). 9 Medium size Syringe Carrier (6 mm lead) with handle for gamma emitters (e.g.gammacare GC 2845, Britec 4BT-MCBF6, p.12) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). 10

11 No. Group Γ 1 continued Item provided by (Page and 10 Acrylate Syringe Carrier for beta emitters, able to accept a loaded 10 ml syringe in acrylate syringe shield, fitted with a capped needle. (provide copy of catalog page, with image and dimensions of the item offered, etc). Mobile leaded dispensing trolley 3mm lead, (Britec 11 SBT-MSDU3, p.17) or equivalent. (provide copy of catalog page, with image and dimensions of the item offered, etc). 12 Mobile leaded trolley for therapy, 6 mm lead (Britec SBT-MSDU6,p.17) ) or equivalent. (Provide copy of catalog page, with image and dimensions of the item offered, etc). 13 Lead-shielded trolley (6mm) for moving/storing large volume waste with lockable lid (Britec 6BT- PERAMB6, p.20) or equivalent. (Provide copy of catalog page, with image and dimensions of the item offered, etc). 14 Portable contamination/radiation monitors with thin plastic scintillation detector for α-,β- and γ-radiation and carrying case ( a) Model ASM 990-Advanced Survey meter, and b) Model 451B-DE-SI-RYR ion chamber Survey meter with beta guide Personal pocket radiation monitor with 15 semiconductor detector, for gamma radiation 20 KeV and above, with audible alarm (Capintec PDM 117,p.130,) or equivalent. (Provide copy of catalog page, with image and dimensions of the item offered, etc). 11

12 No. 16 Group Γ 1 continued Dose calibrator with molybdenum breakthrough set and extra dipper Choice between Item provided by a) Britec 10VDC-404 or b) equivalent Capintec CRC-15R, The system provided must come with an appropriate printer connected to the system provided and three years full warranty, 17 Easy mover *transfer of patients from table to table (Biodex , p.99) or equivalent. (Provide copy of catalog page, with image and dimensions of the item offered, etc). Number of items provided by this 12

13 ΔΝΟΣΗΣΑ Γ : ΤΛΙΚΑ ΑΠΑΡΑΙΣΗΣΑ ΓΙΑ ΣΗ ΛΔΙΣΟΤΡΓΙΑ ΚΑΙ ΑΚΣΙΝΟΠΡΟΣΑΙΑ ΣΗ ΠΤΡΗΝΙΚΗ ΙΑΣΡΙΚΗ (ACCESSORIES ) Γ2. Σα είδε ηες οκάδας Γ2, εθόζολ παραγγειζούλ, ζα πρεπεη λα παραδοζούλ κία θορά θαζ όιε ηε δηάρθεηα ηες ζύκβαζες, θαηα ηε δηάρθεηα ηοσ Δηδηθά ηα είδε 6, 7, 8, θαη 9 ζα παραγγειζούλ κηα θορα, περί ηο ηέιος ηοσ έηοσς 2012 ή αρτές ηοσ Γ2 ΓΔΝΙΚΑ ΥΑΡΑΚΣΗΡΙΣΙΚΑ The s must specify if they can provide the following, and provide the cost in Δλησπο 10A See also attached Δηδηθνί όξνη γηα Δλόηεηα Γ No. 1 2 LEUKOKIT (single use kit for the isotopic labelling procedure of autologous Leucocytes) Disposable ΜIBG Therapy dilution set (Amersham Code no.n 60), or Mallinkrott etc. 3 Disposable ΜIBG Therapy vial connector set (Amersham Code No.N 61)or Mallincrott etc 4 MIBG Therapy needle guide (Amersham Code No.N 63) or Mallinkrott etc. Item provided by 5 Technetium elution Vials, if such vials do not come with each delivered generator 6 Rectangular flood Source (Co 57 ) for dual headed γ-camera, supplied in a stable, easy to handle, lead-lined roller case for safe transport and storage (740 MBq).(Capintec C-Thru Co-57 Flood Source, p.38 7 Mixture of reference sources for dose calibrator calibration (combination of Co-57, Cs137 and Ba133) and source decay schedule for at least one year (Capintec , p.33) Co 57 pen marking source (gammacare GC ,Biodex p.88 ) Radioactive ruler flexible from Co-57, 9 approx.100 κci (Biodex ,Capintec 0975-FR57, p.35) Decontamination liquid (Capintec RAD CON, p.66, Britec Radiacwash spray.p.46,biodex ,p.146) 13

14 Γ2 ΓΔΝΙΚΑ ΥΑΡΑΚΣΗΡΙΣΙΚΑ No. 11 Decontamination towelettes (Biodex p.147) Item provided by Reference to Disposable coverall, medium and large size (Biodex , p.150) Wipe tests smears (Biodex , p.149) Complete decontamination kit (Capintec p.67, Biodex p.147) Minor spill emergency kit (Capintec p.67) 16 Absorbent paper roll (Biodex , p.151) 17 Lead vinyl rolls or lead foil (Britec 3LVSI,Capintec ,p.62) 18 Tc99m-Radiopharmaceutical quality control kits (Britec ,110,220, 440, ,950,980,550 and780 p.42, Biodex Tec Control chromatography systems, p.91) Number of items provided by this 14

15 ΔΝΟΣΗΣΑ Γ : ΤΛΙΚΑ ΑΠΑΡΑΙΣΗΣΑ ΓΙΑ ΣΗ ΛΔΙΣΟΤΡΓΙΑ ΚΑΙ ΑΚΣΙΝΟΠΡΟΣΑΙΑ ΣΗ ΠΤΡΗΝΙΚΗ ΙΑΣΡΙΚΗ (ACCESSORIES ) Γ3. OPTIONAL ITEMS / ACCESSORIES Σα είδε ηες οκάδας Γ3 ζα παραγγειζούλ κόλο εάλ τρεηαζζούλ, θαη εθόζολ παραγγειζούλ, ζα πρέπεη λα παραδοζούλ εληός ηαθηού δηαζηήκαηος κεηά ηελ παραγγειία. No. Γ3 ΓΔΝΙΚΑ ΥΑΡΑΚΣΗΡΙΣΙΚΑ - OPTIONAL ITEMS / ACCESSORIES The s must indicate if they can provide the following items and provide the cost in Δλησπο 10A High handle step stool, (Britec 16BT- 1 HHSS1-p.48, Biotex ) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Mobile leaded screen (Britec VLS-201) 2 about 120cmW x 160cm H(lead cm H and the rest leaded window,p.28) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Acrylic beta shield about 40 cm H x 35 cm 3 W (Capintec , p.43) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). 4 Radioaerosol administration system (Britec, p.58) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). 5 Radioaerosol system lead shield (britec p.58) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). 6 Disposable Radioaerosol sets with approximately 68 cm extended tube length(britec p.58) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Item provided by 15

16 No. Γ 3 Continued _ Optional items 7 Nuclear Medicine injection/resting chair with footrests (Britec 19BT-ICNF, p.61, Biodex , p. 19) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Item provided by 8 Cardiac stress system with full adjustments to the back rest, leg section and ergometer (Britec 21CST-101B, p.65) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Anthropomorhic 3-D Brain Phantom (Biodex , p.88, Britec 22Jb005 p.78, Capintec p.139) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Neck phantom (Biodex p.94) or 10 equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). 11 Cost of Mobile Thyroid uptake system with 2 x2 NaI(Tl) detector, 1024 channels and Well Counter with 2 lead shielding (Biodex p.70-71, Capintec p.90) or equivalent (provide copy of catalog page, with image and dimensions of the item offered, etc). Number of items provided by this 16

17 ΔΝΟΣΗΣΑ Γ ΔΝΟΣΗΣΑ Γ. ΠΔΡΑΙΣΔΡΩ ΑΠΑΙΣΗΔΙ ΣΗ ΠΡΟΦΟΡΑ 1 Operations 1,1 The s should include in their proposal a complete description of the items offered, particularly the components of computer hardware and software and the dose calibrator included in their offer. Item provided by (Page & 2 Warranty 2.1 The warranty period for any hardware offered (Dose calibrator, computer system etc.,) must start on the date of successful completion of the acceptance test as agreed on by the and the Oncology Center. 2.2 The warranty period must last a minimum of 36 months The warranty must cover all the accessories, software upgrades, labour, and all associated parts and costs, (prorata warranty is not accepted), with a commitment for uptime to at least 97%, calculated on 300 days per year during warranty. 2.5 During the warranty period, the tenderer must replace components as needed for 100% proper function, and shall sign a commitment that the system as a whole be fully functional during the above periods, with downtime not to exceed 3% The s must indicate that, during the warranty period, in case their service engineer cannot repair the equipment within two days from the time the problem was reported, they undertake to ship the equipment to the manufacturer and have it repaired and returned without undue delay Name: Date: Signature: 17

18 ΔΙΓΙΚΟΙ ΟΡΟΙ ΓΙΑ ΣΙ ΔΝΟΣΗΣΔ A θαη Β A1 θαη B1 Characteristics specifications terms Ο πξνζθνξνδόηεο πξέπεη λα θαηέρεη Άδεηα Δηζαγωγής Ραδηοθαρκάθωλ από ηε Τπεξεζία Αθηηλνπξνζηαζίαο ηνπ Τπνπξγείνπ Δξγαζίαο, ζύκθσλα κε ηνπο πεξί Πξνζηαζίαο από Ινλίδνπζα Αθηηλνβνιία Νόκνπο ηνπ 2002 θαη Reply Response offer Reference ΠΑΡΑΓΟΗ: Σα ξαδηνλνπθιίδηα ηεο ελόηεηαο Α θαη ηα είδε ηεο Δλόηεηαο Β, ζα παξαδίλνληαη ζύκθσλα κε ηηο εβδνκαδηαίεο παξαγγειίεο θαζ όιε ηε δηάξθεηα ηεο ζύκβαζεο θαη ζύκθσλα κε ηηο αλάγθεο ηνπ Σκήκάηνο Ππξεληθήο Ιαηξηθήο ηνπ Ογθνινγηθνύ Κέληξνπ ηεο Σξάπεδαο Κύπξνπ (ΟΚΣΚ ) (Bank of Cyprus Oncology Center_ BOCOC ). A2 θαη B2 A3 θαη B3 Σα ξαδηνλνπθιίδηα ηεο ελόηεηαο Α θαη ηα είδε ηεο ΔΝΌΣΗΣΑ Β, ζα πξέπεη λα θζάλνπλ ζην αεξνδξόκην Λάξλαθαο θαη λα παξαδίδνληαη ζηo ηκεκα Ππξεληθήο Ιαηξηθήο ηνπ OKTK, θάζε Παξαζθεή ή άββαην απόγεπκα ηεο εβδνκάδνο πνπ έγηλε ε παξαγγειία (ή ην αξγόηεξν Κπξηαθή βξάδπ κέρξη ηηο 08:00κκ). Οη ελεξγόηεηεο (activities) πνπ αλαγξάθνληαη ζηνλ θαηάινγν είλαη νη απαηηνύκελεο θαηα ηελ εκέξα ρξήζεο εληόο ηεο εβδνκάδνο πνπ αθνινπζεί, θαη απηέο ζα ιακβάλεη ππόςε ε ελδηαθεξόκελε ππεξεζία γηα ζθνπνύο αμηνιόγεζεο ηεο νκάδαο Α (ξαδηνλνπθιίδηα) θαη ζύγθξηζεο ησλ ηηκώλ. Δπίζεο, νη ηηκέο ησλ εηδώλ ηεο Δλόηεηαο Β, ζα ιακβάλνληαη ππόςε από ηελ επηηξνπή αμηνιόγεζεο. Η εκέξα βαζκνλόκεζεο ηνπ θάζε ξαδηνλνπθιηδίνπ πξέπεη λα παξνπζηαζηεί κε ηελ πξνζθνξά ΣΟΠΟ ΠΑΡΑΓΟΗ : ην ζεξκό εξγαζήξην ηνύ Ογθνινγηθνύ Κέληξνπ ηεο Σξάπεδαο Κύπξνπ ζηε Λεσθόξν Αθξνπόιεσο 32, ηξόβνινο, Λεπθσζία Γηα θάζε είδνο ηεο νκάδαο Α θαη ηεο νκάδαο Β, ν πξνζθνξνδόηεο ζα πξέπεη λα ππνβάιεη MA (manufacturing authorization) License of tracer (License of colt kit, αληίζηνηρα) από κία από ηηο Δπξσπατθέο ρώξεο. Με ηελ παξνπζίαζε ηεο ΜΑ άδεηαο δελ ρξεηάδεηαη ε Δγγξαθή ηνπ ξαδηνλνπθιηδίνπ/ξαδηνθαξκάθνπ ή ηνπ ζθεπάζκαηνο ζηε Κύπξν. A4 ΠΙΣΟΠΟΙΗΣΙΚΑ : Όια ηα πην θάησ απαηηνύκελα πηζηνπνηεηηθά πξέπεη λα επηζπλάπηνληαη ζηε πξνζθνξά) 1, Όια ηα πξντόληα πνπ ζα πξνζθεξζνύλ πξέπεη λα ζπλάδνπλ κε ηα κνλνγξάκκαηα ηεο Δπξσπατθήο (EP) ή Βξεηαληθήο (BP) ή Ακεξηθάληθεο ( USP) θαξκαθνπνηίαο. 18

19 θαη Β4 A5 θαη Β5 2. Πξντόληα πνπ ζεσξνύληαη θάξκαθα ζύκθσλα κε ηηο πξόλνηεο ηνπ Πεξί Φαξκάθσλ Αλζξώπηλεο Υξήζεο «Έιεγρνο ηεο πνηόηεηαο, πξνκήζεηαο θαη ηηκώλ» Νόκνπ 70(Ι) ηνπ ζα ιακβάλνληαη ππόςε όηαλ: Κπθινθνξνύλ ζηε Κύπξν ή άιιε ρώξα ηεο Δπξσπατθήο Έλσζεο. 3. Γηα πξντόληα πνπ ζα πξνζθεξζνύλ θαη δελ θπθινθνξνύλ ζηε Κύπξν πξέπεη λα πξνζθνκίδεηαη πηζηνπνηεηηθό θαξκαθεπηηθνύ πξντόληνο ( CoPP ) ή ζρεηηθό πηζηνπνηεηηθό ειεύζεξεο θπθινθνξίαο ( FSC ) ή αληίγξαθν ηεο ηζρύνπζαο άδεηαο θπθινθνξίαο πνπ λα απνδεηθλύνπλ όηη ην πξντόλ θπθινθνξεί ζε ηνπιάρηζην κία από ηηο ρώξεο ηεο Δπξσπατθήο Έλσζεο. Αλαβάζκηζε ηνπ πξντόληνο Δάλ, θαηά ηε δηάξθεηα ρξήζεο, ππάξμεη νπνηαδήπνηε αλαβάζκηζε ηνπ πξντόληνο, ηόηε ν επηηπρώλ πξνζθνξνδόηεο, ζα είλαη ππόρξενο λα ην αληηθαηαζηήζεη κε ην λέν, ζηελ ίδηα ηηκή. Ννείηαη όηη ζα ππάξμεη αμηνιόγεζε ηνπ λένπ πξντόληνο κε δείγκαηα, πνπ ζα ππνβιεζνύλ. Αλ ν πξνζθνξνδόηεο πξνκεζεύεη ηα πξντόληα από εξγνζηάζην παξαζθεπήο ζηε Κύπξν πξέπεη λα έρεη άδεηα παξαζθεπήο Φαξκαθεπηηθώλ Πξντόλησλ θαη πηζηνπνηεηηθό GMP ( θαλόλεο νξζήο παξαζθεπαζηηθήο πξαθηηθήο) από ηηο Φαξκαθεπηηθέο Τπεξεζίεο ηεο Κππξηαθήο Γεκνθξαηίαο. A6 θαη Β6 Αλ ν πξνζθνξνδόηεο πξνκεζεύεη ηα πξντόληα από εξγνζηάζην παξαζθεπήο άιιεο Δπξσπατθήο ρώξαο πξέπεη λα έρεη άδεηα παξαζθεπήο Φαξκαθεπηηθώλ Πξντόλησλ θαη πηζηνπνηεηηθό GMP ( θαλόλεο νξζήο παξαζθεπαζηηθήο πξαθηηθήο) από ηηο Φαξκαθεπηηθέο Τπεξεζίεο ηεο αληίζηνηρεο ρώξαο θξάηνπο κέινπο. Αλ ν πξνκεζεπηήο εηζάγεη ηα πξντόληα θαη ε ρώξα θαηαζθεπήο δελ είλαη ρώξα ηεο Δπξσπατθήο Έλσζεο πξέπεη λα δηαζέηεη πηζηνπνηεηηθό GMP ( θαλόλεο νξζήο παξαζθεπαζηηθήο πξαθηηθήο) πνπ εθδόζεθε από ρώξα θξάηνο κέινο ηεο Δπξσπατθήο Έλσζεο, ε νπνία επηζεώξεζε θαη πηζηνπνίεζε ηηο εγθαηαζηάζεηο. Αλ ν πξνκεζεπηήο εηζάγεη ηα πξντόληα από ρώξα ηεο Δπξσπατθήο Έλσζεο ή άιιε, πξέπεη λα δηαζθαιίδεηαη ε αζθαιήο κεηαθνξά ζύκθσλα κε ηηο νδεγίεο ηνπ θαηαζθεπαζηή. 19

20 Characteristics specifications terms ΔΙΓΙΚΟΙ ΟΡΟΙ ΓΙΑ ΣΗΝ ΔΝΟΣΗΣΑ Γ Reply Response - offer Reference Γ1 ΠΑΡΑΓΟΗ: Σα είδε ηεο νκάδαο Γ1, εθόζνλ παξαγγειζνύλ, ζα παξαδνζνύλ κία θνξά θαηα ηε δηάξθεηα ηεο ζύκβαζεο (εληόο ηνπ 2012), θαη ζύκθσλα κε ηηο αλάγθεο ηνπ Σκήκάηνο Ππξεληθήο Ιαηξηθήο ηνπ Ογθνινγηθνύ Κέληξνπηεο Σξάπεδαο Κύπξνπ. Σα είδε ηεο νκάδαο Γ2, εθόζνλ παξαγγειζνύλ, ζα πξέπεη λα παξαδνζνύλ κία θνξά θαζ όιε ηε δηάξθεηα ηεο ζύκβαζεο (εληόο ηνπ 2012 ). Δμαίξεζε απνηεινύλ ηα είδε 6, 7, 8, θαη 9 πνπ, εθόζνλ παξαγγειζνύλ, ζα πξέπεη λα παξαγγειζνύλ πεξί ην ηέινο ηνπ ΝΑΙ Γ2 Γ3 ΣΟΠΟ ΠΑΡΑΓΟΗ ζην Σκήκα Ππξεληθήο Ιαηξηθήο ηνπ Oγθνινγηθνύ Κέληξνπ ηεο Σξάπεδαο Κύπξνπ ΠΙΣΟΠΟΙΗΣΙΚΑ: Όια ηα πην θάησ απαηηνύκελα πηζηνπνηεηηθά πξέπεη λα επηζπλάπηνληαη ζηε πξνζθνξά ήκαλζε CE ζρεηηθό πηζηνπνηεηηθό λα επηζπλάπηεηαη ) The trade reference numbers quoted are only to indicate the physical dimensions and to show an overall idea of what is wanted. ΝΑΙ. I. Britec 2003/2004 edition, II.Capintec catalog 06 and III.Nuclear Medicine Supplies and Accesorries, Biodex ΙV. Gammacare V. Fluke Biomedical, Γ4 Γ5 Σα Δίδε 2, 3 θαη 4 ηεο ελόηεηαο Γ2 πξέπεη λα πξνέξρνληαη από ηνλ ίδην θαηαζθεπαζηή θαη ζα θαηαθπξσζνύλ ζαλ έλα είδνο Σα Δίδε 4, 5 θαη 6 ηεο ελνηεηαο Γ3 πξέπεη λα πξνέξρνληαη από ηνλ ίδην θαηαζθεπαζηή θαη ζα θαηαθπξσζνύλ ζαλ έλα είδνο NAI ΗΜΔΙΩΔΙ: 1. Δίλαη ππνρξεσηηθή ε απάληεζε ζε όια ηα ζεκεία ηνπ Πίλαθα. ε πεξίπησζε πνπ δελ έρεη απαληεζεί νπνηνδήπνηε ζεκείν, ε απάληεζε ζεσξείηαη αξλεηηθή. 2. ηε ηήιε «ΥΑΡΑΚΣΗΡΙΣΙΚΑ-ΠΡΟΓΙΑΓΡΑΦΔ» ή «ΑΠΑΙΣΗΔΙ-ΠΡΟΓΙΑΓΡΑΦΔ», πεξηγξάθνληαη αλαιπηηθά νη αληίζηνηρνη ηερληθνί όξνη, ππνρξεώζεηο ή επεμεγήζεηο γηα ηα νπνία ζα πξέπεη λα δνζνύλ αληίζηνηρεο απαληήζεηο. 3. Αλ ζηε ζηήιε «ΑΠΑΙΣΗΗ» έρεη ζπκπιεξσζεί ε ιέμε «ΝΑΙ», πνπ ζεκαίλεη όηη ε αληίζηνηρε πξνδηαγξαθή είλαη ππνρξεσηηθή γηα ηνλ ππνςήθην Αλάδνρν ή έλαο αξηζκόο πνπ ζεκαίλεη ππνρξεσηηθό αξηζκεηηθό κέγεζνο ηεο πξνδηαγξαθήο θαη απαηηεί ζπκκόξθσζε, ζεσξνύληαη σο απαξάβαηνη όξνη θαη νη Πξνζθνξέο πνπ δελ θαιύπηνπλ ηέηνηεο απαηηήζεηο απνξξίπηνληαη σο απαξάδεθηεο. 4. ηε ζηήιε «ΑΠΑΝΣΗΗ» ζεκεηώλεηαη ε απάληεζε ηνπ Πξνζθέξνληα πνπ είηε είλαη ην ζπγθεθξηκέλν πξντόλ πνπ πξνζθέξεη είηε έρεη ηε κνξθή ΝΑΙ/ΟΥΙ εάλ ε αληίζηνηρε 20

21 πξνδηαγξαθή πιεξνύηαη ή όρη από ηελ Πξνζθνξά ή έλα αξηζκεηηθό κέγεζνο πνπ δειώλεη ηελ πνζόηεηα ηνπ αληίζηνηρνπ ραξαθηεξηζηηθνύ ζηελ Πξνζθνξά. 5. ηε ζηήιε «ΠΑΡΑΠΟΜΠΗ» ζα θαηαγξαθεί ε ζαθήο παξαπνκπή ζε Παξάξηεκα ηεο Σερληθήο Πξνζθνξάο ην νπνίν ζα πεξηιακβάλεη αξηζκεκέλα Σερληθά Φπιιάδηα θαηαζθεπαζηώλ, ή αλαιπηηθέο ηερληθέο πεξηγξαθέο ησλ πξνζθεξόκελσλ πξντόλησλ, πνπ θαηά ηελ θξίζε ηνπ Πξνζθέξνληα ηεθκεξηώλνπλ ηα δεινύκελα ζηνλ Πίλαθα ηνηρα. Οη παξαπνκπέο πξέπεη λα είλαη ζπγθεθξηκέλεο (π.ρ. Σερληθό Φπιιάδην 3, ει. 4 Παξάγξαθνο 4, θ.ι.π.), ελώ αληίζηνηρα ζην ηερληθό θπιιάδην ή ηελ αλαθνξά ζα ππνγξακκίδεηαη ην ζεκείν ηεθκεξίσζεο θαη ζα ζεκεηώλεηαη ε αληίζηνηρε παξάγξαθνο ηνπ Πίλαθα ζηελ νπνία θαηαγξάθεηαη ην δεηνύκελν ραξαθηεξηζηηθό. 21