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Gastroenterology X-ray System

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					INVITATION TO TENDER
            NO. 14286

          A C-arm R/F
Digital X –Ray Imaging System

                 For

 The Department of Gastroenterology at

    Landspítali-University Hospital
        in Reykjavik, ICELAND




                Reykjavík
                April 2007
                                         Abstract
Rikiskaup (The State Trading Centre), which is the Centre for governmental purchase of
goods and services in Iceland, on behalf of Landspitali – University Hospital (LSH), The
Department of Gastroenterology, invites tenders for a
                                  C-arm R/F Digital X-ray Imaging System
for interventional gastrointestinal endoscopy as further specified in these tender
specifications.
The technical specification concerns the supply of a C-arm R/F Digital X -ray Imaging
System for interventional gastrointestinal endoscopy for the Department of
Gastroenterology and Gastrointestinal Surgery at Landspítali – University Hospital at the
Hringbraut Campus in Reykjavik, Iceland. The imaging system is mainly intended for
Gastrointestinal (GI) radiographic and fluoroscopic assisted procedures of patients of all
ages.
The purpose of the information provided in this invitation and the technical specifications
regarding the system and equipment tendered, is to give prospective Tenderers a clear and
informative idea on what the purchaser is asking for and thus increase the likelihood for a
valid tender and a successful contract for both purchaser and supplier.
Total budget-plan for this project as specified is to the amount of approx. ISK 38 million,
excl. VAT, for the system, including installation, training and all other cost.
Commissioning of the system is foreseen in the 3rd – 4th quarter of the year 2007.




 Tender specification no. 14286              2/29       C-ARM R/F Digital X-ray Imaging System
                                      TABLE OF CONTENTS:
1.     GENERAL INFORMATION AND CONDITIONS FOR TENDERING AND CONTRACTING.... 5
     1.1     GENERAL INFORMATION ..................................................................................................................... 5
     1.2     THE ADDRESS OF THE CONTRACTING AUTHORITY ............................................................................. 5
     1.3     TENDER OVERVIEW:............................................................................................................................ 5
     1.4     TENDER DOCUMENTS ......................................................................................................................... 6
     1.5     USE OF SHALL AND SHOULD ............................................................................................................... 6
     1.6     LEGAL REFERENCE ............................................................................................................................. 6
     1.7     TENDERERS LEGAR REMEDIES ........................................................................................................... 6
     1.8     INQUIRIES AND COMMENTS DURING THE TENDER PERIOD ................................................................. 6
     1.9     INFORMATION MEETING ...................................................................................................................... 7
     1.10    LANGUAGE .......................................................................................................................................... 7
     1.11    CONDITIONS FOR TENDERING............................................................................................................. 7
     1.12    TENDER'S APPEARANCE ..................................................................................................................... 9
     1.13    LABELLING OF TENDER ..................................................................................................................... 10
     1.14    DELIVERY OF TENDERS ..................................................................................................................... 10
     1.15    REVOKING OF TENDERS.................................................................................................................... 10
     1.16    POSTPONEMENT OF OPENING .......................................................................................................... 11
     1.17    OPENING OF TENDERS ...................................................................................................................... 11
     1.18    VALIDITY OF TENDERS ...................................................................................................................... 11
     1.19    ALTERNATIVE TENDERS .................................................................................................................... 11
     1.20    PRESENTATION OF TENDER .............................................................................................................. 11
     1.21    QUALIFICATION CRITERIA ................................................................................................................. 12
     1.22    CRITERIA FOR EVALUATION OF TENDER AND AWARD OF CONTRACT ............................................... 12
     1.23    PURCHASE CONTRACT ..................................................................................................................... 13
     1.24    COMMUNICATION DURING THE CONTRACT PERIOD .......................................................................... 13
     1.25    PENALTY FOR DELAY ........................................................................................................................ 14
     1.26    NON-PERFORMANCE......................................................................................................................... 14
     1.27    GUARANTEE AND INSURANCE ........................................................................................................... 14
     1.28    MEDICAL DEVICE ALERT................................................................................................................... 14
     1.29    ASSIGNMENT OF RIGHTS................................................................................................................... 14
     1.30    TRANSFER OF OBLIGATIONS TO OTHER PARTIES – SUB-CONTRACTORS ........................................ 15
     1.31    JURISDICTION AND LAWS APPLICABLE .............................................................................................. 15
2.     PRICES AND TERMS OF PAYMENT ................................................................................................ 16
     2.1     PRICES AND PRICE ADJUSTMENTS ................................................................................................... 16
     2.2     TERMS OF PAYMENT ......................................................................................................................... 16
3.     CLINICAL AND TECHNICAL REQUIREMENTS .............................................................................. 17
     3.1     GENERAL INFORMATION AND CLINICAL REQUIREMENTS ................................................................. 17
     3.2     CLINICAL REQUIREMENTS ................................................................................................................. 18
     3.3     TECHNICAL REQUIREMENTS ............................................................................................................. 18
4.     DELIVERY AND COMMISSIONING ................................................................................................... 21
     4.1     DELIVERY .......................................................................................................................................... 21
     4.2     PACKING AND TRANSPORT ............................................................................................................... 21
     4.3     PARTS AND ACCESSORIES ................................................................................................................ 21
     4.4     HOSPITAL ACCESS ............................................................................................................................ 21
     4.5     INSTALLATION ................................................................................................................................... 21
     4.6     ACCEPTANCE TESTING ..................................................................................................................... 22
     4.7     NEW PRODUCTS, UPGRADES AND RENEWAL OF HARDWARE AND SOFTWARE ................................ 22
     4.8     TOOLS AND TEST EQUIPMENT ........................................................................................................... 22
5.     CUSTOMER TRAINING AND SUPPORT .......................................................................................... 23
     5.1     DOCUMENTATION AND MANUALS ...................................................................................................... 23
     5.2     USER TRAINING AND SUPPORT ......................................................................................................... 23
     5.3     SERVICE TRAINING AND SUPPORT .................................................................................................... 23

 Tender specification no. 14286                                         3/29                 C-ARM R/F Digital X-ray Imaging System
     5.4       SPARE PARTS.................................................................................................................................... 24
6.     WARRANTY, NORMS AND STANDARDS ....................................................................................... 25
     6.1       W ARRANTY ....................................................................................................................................... 25
     6.2       NORMS AND STANDARDS .................................................................................................................. 25
IDENTIFICATION OF THE TENDERER ..................................................................................................... 26

T E N D E R S H E E T ................................................................................................................................... 27

DECLARATION ............................................................................................................................................... 28

APPENDIX 1 .................................................................................................................................................... 29




 Tender specification no. 14286                                          4/29                 C-ARM R/F Digital X-ray Imaging System
                1. GENERAL INFORMATION AND
                CONDITIONS FOR TENDERING AND
                        CONTRACTING

1.1          General information
         Ríkiskaup (The State Trading Centre), which is the centre for governmental
         purchases of goods and services in Iceland, invites tenders for delivery of
                                    A C-arm R/F Digital X-ray Imaging System
         for interventional gastrointestinal endoscopy as further specified in these tender
         specifications.
         The following tender specifications concern the supply of a C-arm R/F X-ray
         Digital Imaging System for interventional gastrointestinal endoscopy for the
         Department of Gastroenterology and Gastrointestinal Surgery at Landspítali –
         University Hospital (LSH) at the Hringbraut Campus in Reykjavik, Iceland. The
         imaging system is mainly intended for Gastro-Intestinal (GI) X-ray examination and
         fluoroscopic assisted procedures of patients of all ages.
         Conditions for pricing and terms of payment are specified in chapter 2 and clinical
         and technical requirements for the system are specified in chapter 3.


1.2          The address of the contracting authority
        Address of the contracting authority is:
                          Rikiskaup (The State Trading Centre)
                          Borgartun 7,
                          IS-105 Reykjavik              Phone: +354 530 1400
                          Iceland                       Fax:     +354 530 1414
                          Project Manager:                Pálmar Guðmundsson


1.3          Tender overview:
            EES tender: Yes
            Open tender: Yes
            Information meeting (§1.9): No
            Deadline for inquiries (1.8): May. 25th 2007
          Deadline for response to inquiries (1.8): June. 2nd 2007
            Opening of tenders (1.17): June. 8th 2007 at 14:00 GMT
            Place of opening (§1.17): Ríkiskaup, Borgartuni 7, 105 Reykjavik, Iceland.
            Tenders SHALL be valid for the minimum time of (§1.18): 5 months.
            A presentation of tender is scheduled after opening of tenders (§1.20).



Tender specification no. 14286                   5/29          C-ARM R/F Digital X-ray Imaging System
1.4         Tender documents
        Tender documents are these tender specifications no. 14286 including;
        “identification of the tenderer”, “tendersheet (two pages)”,”form for declaration on
        behalf of the tenderer” and “appendix”.



1.5         Use of shall and should
        In these tender documents when describing requirements, the word SHALL is used
        when a requirement or specification is mandatory, but the word SHOULD when a
        requirement is strongly preferred. If a requirement or specification that SHALL be
        fulfilled in a tender but is not, the tender can be rejected.



1.6         Legal reference
        This invitation to tender is subject to the provisions of Act no. 65/1993 on tender
        procedure and Act. no. 84/2007 on public procurement. In the event of the text of the
        tender documents contradicts the aforementioned laws the tender’s text SHALL be
        subordinate to the law.


1.7         Tenderers legal remedies
        Undir Art. 75 of Act no 84/2007, tenderers whose tenders have been rejected, have
        the right to receive justifications for the rejection, if the send a written request (letter,
        fax, email) to the State Trading Centre (Rikiskaup). The State Trading Centre
        (Rikiskaup) will answer the request no later than 15 days after receiving it.


        Chapter XIV of the Puclic Procurement Act, no. 84/2007, covers the Tender
        Complaints Committee. Art. 94, paragraph 1, states: “A complaint shall be lodged in
        writing to the Tender Complaints Committee within four weeks from where the
        complainant having learned, or should have been able to learn, of decision, action or
        failure to act he considers a violation of his rights.” However, it is always possible to
        send complaint to the Tender Complaints Committee within 15 days from the date a
        justification according to Art. 75 is given. For each complaint complainer shall pay
        fee of 50.000 ISK.


        The Public Procurement Act no. 84/2007 is accessible at the website of Althingi
        http://www.althingi.is/altext/133/s/1368.html


1.8         Inquiries and comments during the tender period
         If more detailed documentation or further explanations concerning tender
         documents are desired, Ríkiskaup must receive a written request no later than 9
         calendar days before the opening of tenders.
         The inquiry SHALL be marked with the tender name and number and addressed to:
Tender specification no. 14286                6/29         C-ARM R/F Digital X-ray Imaging System
                                  The Consultation Division
                                  Fax: +354 530 1414 or
                                  E-mail: utbod@rikiskaup.is
          Inquiries received later than the aforementioned time will not be accepted.
          If Ríkiskaup deems reasons to provide new documents or respond to an inquiry as
          provided for in the first paragraph, the documents or inquiry, together with response
          to it will not be sent to tenderers, but will be published on The State Trade
          Center’s webpage www.rikiskaup.is no later than 6 calendar days prior to the
          opening of tenders.
          All comments on tenders and their implementation SHALL be made in writing.


1.9          Information meeting
          Not applicable in this tender.


1.10         Language
          Information presented in the tender SHALL be written in Icelandic and/or English.


1.11         Conditions for tendering
1.11.1 Right to accept or reject tenders
       Completing the procedure of the call for tenders in no way imposes on Ríkiskaup an
       obligation to award the contract. Ríkiskaup reserves the right to accept or reject any
       Tender, and to annul the Tendering process rejecting all Tenders, at any time prior
       to the award of the Contract, without thereby incurring any liability to the affected
       Tenderer(s).

1.11.2 Evaluation group
       An evaluation group consisting of 3 or more professionals such as doctors, nurses,
       radiographers, laboratory assistants, medical engineers, lawyers etc. with expert
       knowledge in the clinical, technical and legal field related to the tender and the
       goods tendered will be appointed to evaluate the tenders. The evaluation group will
       on behalf of Ríkiskaup and the purchaser evaluate; (1) which tenders fulfil the
       minimum standard set by these tender specifications and thus are valid and which
       tenders will be rejected, (2) how the valid tenders meet the criteria for evaluation,
       adjust them for best solution if applicable (§1.11.3) and grade them, (3) put forward
       a proposal to the purchaser and Ríkiskaup, which tender(s) to accept and why.

1.11.3 Adjustment of tenders before evaluation
       Ríkiskaup reserves the right, when applicable and if necessary to adjust valid
       tenders to the clinical and technical requirements specified in the tender
       specification by selecting or deselecting those items in the tenders that are deemed
       necessary or unnecessary to fulfil the requirements. The aim of this adjustment is to
       optimize the tender to meet the tender requirements to the highest extent and for the
       highest score, for the best possible solution for the purchaser and for evaluation of
       equal solutions from all Tenderers. Thus optional items that are not included in the
       main tender will be added to the main tender or exchanged for other items if
       necessary and the item price or price difference added to/subtracted from the
       tendered total price before evaluation. Also items that are included in the main
       tender that are not necessary will be taken out of the main tender and the item price

 Tender specification no. 14286              7/29         C-ARM R/F Digital X-ray Imaging System
         subtracted from the tendered total price before evaluation. The evaluation group will
         do the adjustment of tenders described above.
         This right does not change Tenderers obligation to submit a meaningful and
         precise main tender intending to fulfil the tender requirement, both mandatory
         and preferred and giving a point-to-point response to the tender specification
         with the requested information.

1.11.4 Limitation to adjustment of tenders
       The right to adjust valid tenders to the clinical and technical requirements as
       described in §1.11.3 can only be executed when the information regarding the
       tendered items and their pricing is presented in the tender, item by item.
         The right to adjust valid tenders to the clinical and technical requirements as
         described in §1.11.3 will not be executed if it leads to a change in total prices outside
         reasonable limits (10-20%).
         The right to adjust valid tenders to the clinical and technical requirements will only be
         executed if approved by Tenderer on tendershee

1.11.5 Tendersheet
       Ríkiskaup reserves the right to reject tenders that are not presented on the tender
       sheet(s) or identical sheet(s) or as otherwise specified for tenders appearance.

1.11.6 Terms of payment
       Tenders that do not comply with terms of payment will be considered as incomplete
       and discarded without further justification.

1.11.7 Error in price calculation
       If a tender appears to contain errors in price calculations, unit prices will be
       considered as valid.

1.11.8 Information request and submission of written material
       Ríkiskaup reserve the right to request other information that is pertinent to this
       invitation to tender at a later stage if necessary. The Tenderer is however prohibited
       to submit any written material after the opening of tenders unless requested in
       writing by Ríkiskaup.

1.11.9 Confidentiality
       All information from Tenderers provided with in the tender documents, other than the
       information read out aloud at the opening meeting (§1.17) will be treated as
       confidential information.




 Tender specification no. 14286              8/29        C-ARM R/F Digital X-ray Imaging System
1.12         Tender's appearance
          It is of paramount importance that Tenderers abide to requirements and requests set
          in this invitation in this paragraph for tender’s appearance and provide the requested
          information together with their tenders. Failure to comply will result in rejection of
          tenders.

1.12.1       The Tenderer SHALL give a point-by-point response to these specifications. The
          response SHALL indicate compliance with the specification where this is tendered.
1.12.2        All the information requested in this invitation SHALL accompany tenders.
1.12.3       A listing of all major system components, software components, and accessories
          tendered SHALL be included in the tender, preferably with prices.
1.12.4       Tenders SHALL include detailed product specification, illustrative material,
          descriptive text, etc. where necessary and all requested information in this
          document for each item tendered.
1.12.5      A detailed work- and time schedule for delivery, installation and acceptance test
          SHALL be delivered with the tender.
1.12.6       The tenders SHALL include information about user training and access to user
          support as specified in §5.2
1.12.7       The tenders SHALL include information about service training and access to
          service support as specified in §5.3
1.12.8       The tenders SHALL include information about the location of warehouse for
          spare parts, delivery method and terms and delivery time as specified in §5.4.
1.12.9       Information about estimated running cost, including information on consumables,
          regular replacement parts and spare parts necessary to purchase from the vendor
          on a regular basis, to run and/or maintain the system for the first 3 years of
          operation SHALL be included in the tender if applicable.
1.12.10 Estimated lifetime and/or replacement interval and replacement cost of specific
       parts of the system, if other than the lifetime of the system as a whole, SHALL be
       stated in the tender.
1.12.11 Description on after sales services and a service contract if available SHOULD
       be included in the tender.
1.12.12 The Tenderer SHALL declare in his tender any subcontractors whose services is
       intended to use in event of a Contract.
1.12.13 A representative of the tendering party, authorised to legally bind that party in
       Contract, SHALL sign the tender.




 Tender specification no. 14286             9/29         C-ARM R/F Digital X-ray Imaging System
1.13        Labelling of tender
        Tenders SHALL be presented on accompanying tender sheet(s). Tenders SHALL
        be dated and signed by Tenderers. Tenders SHALL be returned in sealed
        envelopes labelled:
                                 RIKISKAUP (THE STATE TRADING CENTRE)
                                             TENDER NO. 14286
                                  C-arm R/F Digital X-ray Imaging Systems
                                  for interventional gastrointestinal endoscopy
                        (Envelopes SHALL also be identified with the Tenderers name)

         Tenders and supporting documents SHALL be delivered in 2 full sets. The
         envelope containing the original tender SHOULD be marked “Original” and the
         envelope containing the copy SHOULD be marked “Copy”.


1.14        Delivery of tenders
         Tenders SHALL be submitted to the following address:
                       Ríkiskaup (the State Trading Centre),
                       Borgartun 7,
                       IS-105 Reykjavik,
                       Iceland
         in a sealed envelope. The name and address of the Tenderer SHALL be indicated
         on the envelope, together with the name and number of the tender.
         Tenders may be presented by fax, if they are received prior to the tender opening,
         provided that all the documents that are to accompany the tender have been posted
         by registered mail at least one day before the opening of tenders takes place. In
         order for such tender to be accepted as valid, the fax dispatch SHALL be
         accompanied by a confirmation of a post office for having received the registered
         mail.

         If tenders are sent by mail or telefax, the Tenderer is responsible for ensuring
         that they are delivered to the proper destination before the tender opening.

         The total amount may only be submitted if the Tenderer so decides if unit prices and
         other required documents accompany it, in a sealed envelope or have verifiably
         been mailed the day before tenders are opened. The Tenderer may subsequently
         request that the unit prices not be examined unless his tender is under
         consideration.


1.15        Revoking of tenders
         The Tenderer may revoke his tender prior to opening, provided this is done in
         writing or by other equally secure means.




Tender specification no. 14286                  10/29       C-ARM R/F Digital X-ray Imaging System
1.16        Postponement of opening
        If opening of tenders is postponed, Ríkiskaup will announce the postponement and
        the new date and time set, at least 4 days prior to the previous date set for opening
        of tenders. If postponement of opening of tenders becomes necessary less than 4
        days before opening of tenders, the opening meeting will take place as scheduled
        and tenders put forward. Tenderers at the meeting SHALL be registered, but
        tenders will not be opened but returned to Tenderers. Only those present at the
        opening meeting SHALL be invited to participate in the continuation of the tender
        procedure and to deliver tenders at a later date.


1.17        Opening of tenders
         The final time for receipt of tenders is given in article 1.3 “Tender overview” at which
         time tenders will be publicly opened and read aloud at the office of Ríkiskaup in the
         presence of Tenderers. Tenders received later than the aforementioned date and
         time will not be accepted (will be returned to the Tenderers unopened together with
         an explanation of the reason for their return.) At the opening of tenders, the
         following will be read out aloud:
                    a.   Tenderers name
                    b.   Total price of item 1 on tender sheet
                    c.   Currency (currency basket where applicable)
                    d.   Delivery time
                    e.   Name of manufacturer
                    f.   Name of equipment tendered
        Other information than listed above will not be disclosed to Tenderers or third parties
        but treated as confidential matter as specified in §1.11.9

1.18        Validity of tenders
        Minimum time of validity of tenders is given in article 1.3 “Tender overview” from the
        day of opening of tenders.


1.19        Alternative tenders
         Tenderers are encouraged to propose more than one solution that meets the
         minimum requirements described in these tender documents.
         Alternative tenders SHALL fulfil the general terms of this tender specification and
         the clinical requirements and they SHALL be labelled as such and presented on a
         similar tendersheet as the standard tenders to be evaluated.


1.20        Presentation of tender
        The Tenderers may be invited to make a formal presentation of their tenders at
        Ríkiskaup at their own expense. Participation by Tenderer in such a presentation is
        voluntary. If Tenderer wishes to participate he SHOULD be ready to do so within 12
        calendar days of notification.
        The Tenderers may not in their presentation, present or deliver any new information,
        not delivered with the tender before opening.

Tender specification no. 14286                11/29       C-ARM R/F Digital X-ray Imaging System
1.21           Qualification Criteria
1.21.1 A reference list SHALL be included in the tender, showing installations in Europe
       and North America of products of the same type to those tendered, where the
       products are used for same services. The list SHOULD however be limited to a
       maximum of fifty- (50) systems. Installation in University hospitals SHOULD be
       emphasised.
         The date, which the tendered system was first put on the market, SHALL be stated
         in the tender.
         For a tender to qualify, the above specified reference list SHALL contain at least five
         (5) sales of the tendered goods, where the system is installed and in clinical use.

1.21.2 A reference site that can be visited to review the tendered system SHALL be made
       available to the evaluation group from the purchaser after opening of tenders,
       mutually agreed upon by tenderer and purchaser. Information on such a reference
       site or sites SHALL be included in the tender.

          For economic reasons, reference sites in the Scandinavian countries are preferred,
          but if that is not available a reference site in North-Europe or North-America could
          be accepeted. More than one reference site should be included in the tender
          documentation. University hospitals are preferred as reference sites.


1.22           Criteria for evaluation of tender and award of
               contract
1.22.1 The contract will be awarded to the Tenderer who’s tender is the most economically
       advantageous, i.e. the Tenderer, which scores the highest grades in the evaluation
       based on the criteria set in §1.22.2, using the method described in §1.22.3-5.
       Tenders fulfilling the minimum requirements set by these tender specifications will
       be evaluated.

1.22.2 The criteria that will be used for evaluation of tenders is the following:
        Clinical and technical requirements and vendor service and support, split
          up into to the following quality parameters:                            60%

              System general technical requirements:                                             15%
              Evaluation of ergonomi and user friendliness based on site visit::                 15%
              Digital imaging, image quality, radiation dose efficiency:                         10%
              Software/system protocols/image management:                                            5%
              System networking and integration with RIS/PACS:                                       5%


           User education, training and support:                                                 4%
           Technical training and support to service organisation:                               4%
           Organisation and delivery of spare parts:                                             2%

               Total Purchase Price:                                                            40%


 Tender specification no. 14286                 12/29       C-ARM R/F Digital X-ray Imaging System
Tenders will be evaluated on grounds of the quality of the equipment tendered and
purchase price tendered on tendersheet.

1.22.3 The evaluation of tenders is based on how the tendered goods meet the criteria for
       evaluation specified in §1.22.2 above.
          The evaluation will be done solely on the basis of information delivered with the
          tender before opening or other material requested by Ríkiskaup, but universally
          available information for example information on Internet homepages of suppliers
         and vendors may also be used for evaluation. The tenders that best meets the
         requirements regarding the specifications will get the highest score.

1.22.4 A tender that will score lower than 75% of the highest score in each of the quality
       parameters in the criteria for the tender (§1.22.2) will be disqualified.
1.22.5 The results of the above evaluation for valid tenders regarding the quality
       parameters will be presented as grades in numbers on the scale of 0 - 10. The
       highest grade will be given to the tender presenting the best result in the evaluation
       and less result will score lower.
       The evaluation of prices tendered will also be presented as grades in numbers on
       the scale of 0 – 10. The lowest price tendered in a valid tender will score 10 and
       other tenders with higher prices will score lower according to the formula:
                                             Gn = 10 x Pl/Pn
          Where Pl is the lowest price, Gn is the grade for a tender n with the price Pn. Price
          evaluation will be based on the chosen currency’s Custom exchange rate as it
          stands on the day of opening of tenders.
               The final result for the total evaluation will be the sum of the grades given,
                weighted as specified in §1.22.2.


1.23           Purchase Contract
1.23.1 If a tender is accepted, a Purchase Contract in writing will be made by the purchaser
       with the successful Tenderer, with the approval of Ríkiskaup.
1.23.2 If delivered goods turn out to be defective in any way, their durability unusually low
       or delivery dates are not met, the purchaser reserves the rights to compensation
       and/or termination of the contract and removal of the equipment at the cost of the
       supplier without further notice.
       The purchaser reserves the right to compensation and/or termination of the contract
       and/or removal of the equipment at the expense of the supplier if major problems
       arise regarding the performance, safety, reliability or quality of the system.


1.24           Communication during the contract period
         When a Purchase Contract has been made, the buyer and the supplier SHOULD
         appoint their representatives to manage all communications with each other during
         the contract period. Their role will be to supervise, on behalf of the buyer and
         supplier, that the project is executed in accordance with the conditions of the
         contract.




 Tender specification no. 14286             13/29       C-ARM R/F Digital X-ray Imaging System
1.25        Penalty for delay
        SHOULD delivery of system and equipment be delayed beyond agreed date of
        delivery stated in the Purchase Contract, and this is not caused by the
        purchaser/lessee, compensation for delay of 0,1% of the agreed amount SHALL be
        calculated for each started calendar day during which the delivery is delayed beyond
        the agreed date of delivery. However, compensation for delay SHALL not amount to
        more than 10% of the agreed amount. In the event of compensation for delay, this
        SHALL be deducted from the final payment for the equipment.


1.26        Non-performance
        The supplier SHALL in all manners meet his contractual obligations according to the
        provisions of the tender and contract documents. In the event of serious non-
        performance by the supplier, the hospital SHALL be authorised to cancel the
        contract with one (1) month’s notice and demand refund of all payments, providing
        no remedy has been made within the appropriate time.
        If the hospital suffers any loss due to non-performance by supplier, the supplier
        SHALL take full responsibility for this, under the provisions of compensation law.
        If the supplier seeks composition with his creditors, a moratorium on his debts, or if
        he is declared bankrupt, or has been subject to an unsuccessful attachment of his
        property, the hospital SHALL be authorised to cancel the contract without notice.


1.27        Guarantee and insurance
           –The supplier is responsible for the project and its execution, including the work of
             subcontractors, as well as damage the purchaser or a third party may sustain
             upon its execution.
           –The supplier SHALL take out all statutory insurance as stipulated by law and
             regulations.


1.28        Medical Device Alert
      In case of medical device alert from the supplier regarding goods covered by the
      Purchase Contract, the purchaser SHALL be informed without any delay in written
      and formal way.
      If any of the items or group of items covered by this contract are recalled by the
      producer or Supplier or by a Competent Authority within the EEA, the Purchaser can
      immediately postpone the execution of the Purchase Contract for the period of 3
      months or cancel it in total if the Purchaser deems that his patients are at a risk by
      use of the items recalled. Such a postponement of execution or cancellation SHALL
      be made in writing to Seller within 7 days.


1.29        Assignment of rights
        The supplier SHALL not be permitted to assign or mortgage its right under this
        contract without the written consent of the hospital.




Tender specification no. 14286              14/29       C-ARM R/F Digital X-ray Imaging System
1.30         Transfer of obligations to other parties – Sub-
             contractors
         The supplier SHALL not be permitted, without the purchaser’s consent, to entrust
         another party to make a tender on the same terms or take over, in part or wholly, the
         obligations in its place under this contract. If the supplier entrusts a sub-contractor
         with individual aspects of this contract with the consent of the purchaser/lessee, this
         SHALL in no manner alter the supplier’s obligations to the purchaser/lessee.




1.31         Jurisdiction and laws applicable
1.31.1 Any contract placed as a result of this tender invitation SHALL be made under
       Icelandic law and regulations and SHALL take precedence over foreign law and
       regulations.
1.31.2 If any disputes SHOULD arise they SHALL be resolved according to Icelandic law
       and regulations by the District Court of Reykjavik, Iceland (Héraðsdómur
       Reykjavíkur).




 Tender specification no. 14286             15/29       C-ARM R/F Digital X-ray Imaging System
           2. PRICES AND TERMS OF PAYMENT

2.1         Prices and price adjustments
2.1.1 Tendered prices
        Prices tendered for the Digital C-ARM R/F X-ray Imaging System SHALL be
        presented on the tender sheet or similar sheet. If more than one technical solution is
        tendered, additional tendersheets SHALL be delivered, one for each additional
        solution or tender.

2.1.2 Total purchase prices
         The tendered prices SHALL be total prices in Icelandic krónur (ISK) for the
         equipment installed and fully operational at the Dept. of Gastroenterology and
         Gastrointestinal Surgery at Landspítali – University Hospital, at the Hringbraut
         Campus in Reykjavík, including insurance cost, transportation cost, financial cost,
         installation cost, user training, service and support, levies, duties, taxes and all other
         relevant cost, but excluding 24,5% Icelandic VAT.

2.1.3 Currency
        The tendered price for goods may be linked to a foreign currency or currency basket,
        stated by the Tenderer on the tendersheet. Thus the purchase price can change
        over the contract period in accordance with changes in the Icelandic Custom
        Exchange Rate for the specified currency or currency basket from the day of
        opening of tenders until payment is due.


2.2         Terms of payment
2.2.1 Purchase payments
         Tenderers SHALL base their purchase price tenders on the terms of payments that
         are described below.
        Seventy percent (70%) of contract value will be paid at delivery of the system to
        purchaser after installation and acceptance test (§4.6.1), ready for clinical use
        Thirty percent (30%) of contract value will be paid after final acceptance (§4.6.2).

2.2.2 Invoices
        Invoices SHALL be sent to Landspitali – University Hospital, Office of Invoices,
        Eiriksgötu 5, 101 Reykjavik or other location agreed upon. Invoices SHALL be
        marked with contract name and number if applicable.The approved invoice will be
        paid no later than 30 days after the end of the month of presentation if acceptance
        test has been past.


Please notice that tenders that do not comply with above mentioned payment terms
will be considered as incomplete and discarded without further justification.




Tender specification no. 14286               16/29        C-ARM R/F Digital X-ray Imaging System
                      3. CLINICAL AND TECHNICAL
                             REQUIREMENTS

3.1         General Information and Clinical Requirements
         The goods requested in this tender invitation is a C-ARM R/F Digital X-ray
         Imaging System for interventional gastrointestinal endoscopy as specified in §3.2
         below. at the Department of Gastroenterology and Gastrointestinal Surgery at
         Landspítali – University Hospital (LSH) at the Hringbraut Campus in Reykjavik,
         Iceland.
         The systems SHALL be fully digital for film-less working environment.
         Landspítali – University Hospital was founded in the year 2000 by the merger of the
         two largest hospitals in Iceland, Landspítalinn (The National University Hospital) and
         Sjúkrahús Reykjavíkur (The Reykjavík City Hospital) forming one Landspítali -
         University Hospital in Iceland, owned and funded by the Icelandic Government. The
         hospital is placed in Reykjavik, the capital of Iceland. Landspítali - University
         Hospital provides multidisciplinary specialised medical services to the Icelandic
         people currently a population of approximately 300.000. The hospital main functions
         are centred at the two campuses at Fossvogur and at Hringbraut, but many of the
         hospital institutes and departments are spread through out the city of Reykjavik.
         The Landspitali – University Hospital is responsible for the procurement, installation
         and operation of the X-ray equipment.
        The Department of Gastroenterology and Gastrointestinal Surgery is centred at the
        Hringbraut campus and are the only highly specialised hospital departments in
        Iceland for general and specialised diagnosis and treatment of Gastrointestinal
        diseases and play an important role in the services offered by the hospital.
        Landspitali-University Hospital has earned a good reputation for interventional
        gastrointestinal endoscopy providing both in-house and outpatient services.
         The system tendered SHALL in general comprise the latest technology in the field
         of C-arm R/F Digital X-ray Imaging System for interventional gastrointestinal
         endoscopy and offer very ergonomic, flexible and reliable operation with good
         patient access and high patient throughput. Very important factors are excellent
         image quality, high resolution but with low patient dose and dose rates. The unit will
         serve patients of all ages from young children to elderly patients, but the majority will
         be adult patients. The equipment SHOULD be modular in construction and be
         upgradeable in both hardware and software and offer durable technology, excellent
         image quality and image documentation on CD and/or DVD. The systems SHALL
         be fully DICOM 3.0 compliant and offer full digital image working environment,
         including a fast Ethernet network connection to the hospital RIS system (Kodak
         2010) for patient information communication and DICOM modality work-list
         management and to the hospital PACS system (Agfa Impax) for image
         communication and archiving.
        The C-arm R/F Digital X-ray Imaging System will be installed in The Department
        of Gastroenterology and Gastrointestinal Surgery at Landspítali –



Tender specification no. 14286              17/29        C-ARM R/F Digital X-ray Imaging System
        University Hospital (LSH) at the Hringbraut Campus in Reykjavik, Iceland. The room
        layout is described in the architectural drawings and technical plans accompanying
        this tender material in appendix 1. The equipment tendered SHALL fit into the
        locations intended for its use. A detailed site-planning proposal and installation plan
        SHOULD be supplied with the tender. A site-planning manual SHOULD also be
        supplied with the tender.
        All available options, not specified or requested specially, but could be
        advantageous or beneficial for this project SHOULD be specified by Tenderer and
        listed in the tender with prices.
        More detailed information on clinical requirements, technical description and
        specifications regarding the system tendered are presented in §3.2-3.3.


3.2         Clinical requirements
         The R/F C-arm Digital X-ray Imaging System is intended for use for interventional
         gastrointestinal   endoscopy    and    GI     examinations     and     other   R/F
         (Radiographic/fluoroscopic) dependent clinical activities and services provided by
         The Departments of Gastroenterology and Gastrointestinal Surgery including:
              1. ERCP (Endoscopic Retrograde Cholangio- and Pancreatography) with or
                 without sphinctoerotomy, stone extraction, stent placement or extraction etc.
              2. EUS (Endoscopic UltraSound) with tissue sampling, cyst drainage etc.
              3. Endoluminal stent placement, esophageal, biliary, pancreatic, gastro-
                 duodenal, colo-rectal, and across fistulas
              4. Dilatations of esophageal, pyloric, pancreatic, biliary and colorectal strictures
              5. Mucosal ablations in particular of the esophagus
              6. Endoscopic mucosal resection
        Activities planned for the near future include:
                  Balloon based-circumpherential ablation system (f.ex. BARRX HALO360)
                  NOTES (Natural orifice transluminal endoscopic surgery)
         The annual number of ERCP´s in Iceland has been around 330 and the associated
         interventions listed 2-6 above around 150 and both categories are expected to
         increase. The near future activities and the NOTES developments in particular are
         expected to expand.
         The Departments conducting these interventions are the Departments of
         Gastroenterology and Gastrointestinal Surgery and other sub-specialities within The
         Department of Medicine at Landspitali – University Hospital.


3.3         Technical requirements
          The following are minimum technical requirements and specifications for the
                                    equipment tendered.
         The technical requirements and specifications reflect the interpretation of the clinical
         requirements into technical specifications and demands needed to fulfil the goals
         laid out in the clinical requirements.



Tender specification no. 14286                18/29       C-ARM R/F Digital X-ray Imaging System
         The requested X-ray system is a C-arm R/F digital X-ray imaging system ready to
         perform the examinations and clinical activities described in §3.2 with efficiency and
         quality outcome.
         The unit SHALL be a fully digital radiography and fluoroscopy unit, with a high
         resolution/high DQE image intensifier and TV-chain and/or a direct digital receptor
         (FPD – Flat Panel Detector) technology and the unit SHALL be remote controlled
         and shall also fully and easily controlled at tableside, preferably with a independent
         mobile control unit.
         It will be emphasised here that detailed description of the systems tendered as well
         as their individual units as defined in paragraphs 3.3.1 – 3.3.7 SHALL accompany
         the tender material.

3.3.1 Generator
        The generator SHOULD be a microprocessor controlled high frequency inverter
        generator, with adjustable 40-150 kV output and with sufficient power output for
        continuous/pulsed use with full accuracy and reproducibility with digital readouts of
        all appropriate data as well as other parameters for the described clinical use,
        ensuring high temporal resolution even for obese patients (fulfilling EN 60601-2-7).
        The generator SHALL allow pulsed fluoroscopy and dose optimisation. It SHOULD
        be ergonomic in operation with pre programmed exposure technique for routine
        procedures and fully automatic exposure control. A dose monitoring system
        providing real-time patient dose and dose-rate information SHALL be included.

3.3.2 X-ray tube and collimator
        X-ray tubes SHALL be a low noise type (preferably silent), high speed, with
        necessary heat capacity and cooling rate for continuous operation. The tubes
        SHOULD have high performance dual or multi-focal spots approx. 0.6 - 1.0 mm or
        less for optimum image quality. It SHALL at least have 3.0 mm Al total filtration or
        equivalent and preferably also additional user-adjustable filtration. A starting device
        for high-speed tube rotation SHALL be included and the necessary high-tension
        cables.     Square collimators and Iris diaphragm for fluoroscopy and digital
        radiography for the table, SHALL be included. Available special dose reduction
        filtration SHOULD be described.

3.3.3 C-arm
         The C-arm SHALL be stable, but light and flexible in use, with rotation and
         angulation capabilities for all necessary examinations. It SHALL be possible to
         individually position the C-arm at a corresponding iso-centric height and and
         angulate and rotate it without moving the patient. All movements of the C-arm
         SHALL be motorised.

3.3.4 Patient table
        The patient table requested is a examination table with a floating tabletop. The table
        SHALL be tiltable, preferably at least +90°/-30° and with automatic position towards
        the C-arm. Adjustable table height, SHOULD offer low loading position for easy
        patient access. The tabletop SHOULD be made of a low absorption material and
        SHOULD be able to carry patient weight of up to at least 180 kg. All movements of
        the patient table SHALL be motorised. All necessary controls for the patient table
        SHALL be available and easily accessable at tableside or preferrably in an
        independent mobile control unit that can be used at tableside. The patient table


Tender specification no. 14286             19/29        C-ARM R/F Digital X-ray Imaging System
        SHOULD be delivered with a mattress and all necessary handgrips and straps for
        clinical use.

3.3.5 Image receptor, television system and monitors
         The image receptor SHOULD be an image intensifier with high resolution, regarding
         both spatial and contrast resolution, with approx. 40 cm nominal diameter, and it
         SHOULD have at least 3 zoom modes. The television system SHOULD be at least
         1k x 1k matrix resolution with a high quality and reliable CCD based camera.
         Monitors SHOULD be high quality, flicker free with high resolution and high contrast,
         preferably flat panel monitors and SHOULD be able to display multiple images.


         The system tendered can also be a direct digital imaging system with a flat panel
         detector, at least a 35 cm x 43 cm in size, with at least the acquisition and image
         reconstruction resolution of 2K x 2K image matrix size or better and SHOULD offer
         at least 12 bit greyscale resolution or better.
         Monitors SHOULD be high quality, flicker free with high resolution, high brightness
         and high contrast, preferably flat panel monitors meeting or exceeding the current
         standards for diagnostic monitors (AAPM TG18).
         All the necessary information for evaluation of the FPD and the digital imaging
         system’s capability, image quality including spatial and contrast resolution,
         DQE (according to IEC-62220-1-3) and dose usage for patient imaging SHALL
         be delivered with tender.

3.3.6 Digital imaging system
        A digital imaging system for image acquisition and processing SHOULD include
        acquisition resolution and display of at least 10 bits, 1k x 1k matrix size for an II
        solution, but 2kx2k with the FPD solution. Frame rate for serial radiography
        SHOULD be at least 2-6 f/s. Local image storage SHOULD allow storing of at least
        10.000 DICOM images (1k x 1k).
         An independent digital video-loop for storage of fluoroscopic scenes SHOULD be
         included. It SHOULD be possible to record radiography and fluoroscopy images and
         image series on to CD’s or DVD’s. The system SHOULD also include a video
         output connection for videotape backup of all fluoroscopy scenes done on a
         standard S-VHS 625 line, 50 Hz VCR (PAL) for recording f.ex. swallowing
         examinations of dysphagia patients. For review/reading of the exams a frame-by-
         frame display (jogger wheel function) either in a VCR or WS software is required. A
         unit for image processing operations in the examination room SHOULD be included
         and delivered with the system.
         The digital imaging system SHALL be fully DICOM 3 compliant and connectable
         over network with future PACS and RIS for DICOM 3.0 work-list management. The
         system SHALL include a fast Ethernet network connection that complies with the
         100 Base TX standard for DICOM image transfer to a diagnostic radiology
         workstation and PACS.

3.3.7 System Connectivity requirements
         The following DICOM 3.0 connectivity must be fully supported by the X-ray system;
         work-list management, archiving, query retrieve.




Tender specification no. 14286             20/29       C-ARM R/F Digital X-ray Imaging System
              4. DELIVERY AND COMMISSIONING

4.1          Delivery
          Time of delivery at the hospital of all items tendered SHALL be clearly stated in the
          tender in terms of weeks, from date of order. Delivery is defined here as delivery of
          the equipment fully installed and accepted for use (see §4.6.1). Any delays in
          delivery of the equipment due to purchaser, is the sole responsibility of the
          purchaser.


4.2          Packing and transport
4.2.1     The Tenderer is responsible for the packing, transportation and delivery to the
          location of installation at Landspitali – University Hospital at Hringbraut Campus in
          Reykjavík, Iceland.
4.2.2     The Tenderer is responsible for the equipment during the time of installation until the
          equipment has been fully installed, accepted and delivered to the purchaser fully
          operational according to the purchase contract.


4.3          Parts and accessories
4.3.1     All parts and accessories required for installation, implementation, acceptance
          testing and operation of the equipment system and its subsystem, SHALL be
          included in the tender.

4.4          Hospital access
4.4.1     The purchaser SHALL grant the supplier the necessary access to the hospital
          premises during normal working hours for pre-installation work, system installation,
          system implementation and user training.


4.5          Installation
4.5.1     The equipment SHALL be installed and operated in The Department of
          Gastroenterology at Landspitali – University Hospital at Hringbraut Campus in
          Reykjavík, Iceland
4.5.2     Installation and implementation of the system on site, including all cost, SHALL be
          included in the tender.
4.5.3     The purchaser, at own cost, will assist the supplier during installation of the system
          by providing manpower for construction work and cable pulling and termination, and
          by providing experienced service engineers to assist in any way possible to assure
          a quick and efficient system installation and implementation.
4.5.4     The purchaser is responsible for the pre-installation work. Before delivery, the seller
          can make a site visit to check compliance with the seller’s site specifications. The
          site SHOULD be accepted as fully compliant before the date of delivery.




 Tender specification no. 14286             21/29        C-ARM R/F Digital X-ray Imaging System
4.6          Acceptance testing
4.6.1 A representative of purchaser, the Department of Gastroenterology at Landspitali –
      University Hospital in co-operation with the supplier, will conduct an acceptance test
      before first clinical use. This test SHALL verify compliance with standards, tender
      requirements and specifications. The results from these tests SHALL be in writing
      and approved and signed by official representatives of both parties.
4.6.2 Final acceptance SHALL be after three months of trouble-free clinical use. The final
      acceptance will be based upon technical and clinical evaluation of the uptime and
      performance of the system during that period of time. The result of the final
      acceptance SHALL be the basis for payments as described in chapter 2
4.6.3 The supplier SHALL also perform a performance and quality test shortly before the
      end of the warranty period. This test SHALL verify compliance with the acceptance
      test and equipment specifications.


4.7          New products, upgrades and renewal of hardware
             and software
4.7.1 For the duration of the contract, the supplier SHALL inform the purchaser on all
      alterations, improvements, upgrades and modifications of the system tendered,
      hardware and software.
4.7.2 Upgrades and modifications intended for increasing the equipment and system
      operational safety and reliability, especially regarding patient safety, SHALL be
      reported to the purchaser and supplied free of charge including necessary parts and
      components for the lifetime of the equipment.
4.7.3 Information on new products as well as information on incidences related to the
      contracted goods and items and other relevant information on safe use of the
      equipment SHOULD be provided to user for the lifetime of the equipment.


4.8          Tools and test equipment
4.8.1 Tools, equipment and service software
          Special tools, measurement equipment, service software and access keys for
          performing necessary maintenance and service on the equipment and systems,
          SHALL be included in the tender and delivered with the system.

4.8.2 Tools for QA
         A list of special test equipment and measurement devices necessary to perform
         quality assurance and quality tests SHOULD be delivered with the tender including
         prices.




 Tender specification no. 14286          22/29       C-ARM R/F Digital X-ray Imaging System
        5. CUSTOMER TRAINING AND SUPPORT

5.1          Documentation and manuals
5.1.1    Language
         All documents delivered with the equipment SHALL be in Icelandic and/or English.

5.1.2     Quality and quantity of enclosed material
         All documentation, manuals, plans diagrams, software and passwords necessary for
         maintenance, adjustment, control, service and quality management (QC) procedure
         of the equipment SHALL be included in the tender and supplied in electronic form
         (CD) or in a paper copy and delivered with the goods.

5.1.3    Product labelling
         Product labelling SHALL be provided for each delivered system component.

5.1.4    Operator manuals
         Operator manuals SHALL be provided for each delivered system component.

5.1.5 Version of manuals
         All manuals etc SHALL be updated appropriately to reflect new hardware and
         software releases.


5.2          User training and support
5.2.1 User training
         Training for operators and staff by an application specialist during the commissioning
         of the equipment SHALL be included in the tender.
5.2.2 User education program
          Educational courses and user training for radiographers and doctors SHALL be
          provided. A detailed description of the user educational and training plan, prior to,
          during or after installation of the equipment SHALL be included in the tender,
          including information on the content of courses and seminars on or off site.
5.2.3 User assistance
         Information on user support and contact person(s), available at working hours (8.00-
         17.00) in Iceland and by vendor, SHALL be included in the tender.


5.3          Service training and support
          For clarification: Landspítali – University hospital operates a (in-house) Clinical
          Engineering Service Department with highly specialised and skilled service
          engineers that service vast majority of the medical equipment in the hospital.
          Hospital service engineers attend courses held by manufacturers/vendors and are
          qualified and licensed to perform service and maintenance.




 Tender specification no. 14286             23/29       C-ARM R/F Digital X-ray Imaging System
5.3.1 Training of engineers
         Technical service training for two experienced hospital service engineers SHALL be
         included in the tender. The training SHALL take place shortly before or soon after
         installation of the equipment.

5.3.2 Technical service support
         Information about the location and delivery of technical service support and
         assistance in Iceland and by the vendor SHALL be included in the tender.

5.3.3 Service contract
         A service contract on a yearly basis, including acute and preventive maintenance
         including or not including spare parts is not a requirement but is welcomed with
         tender. A service contract in co-operation with the hospital Clinical Engineering
         Dept. for preventive maintenance alone is also welcomed. Detailed information
         about the contents of such contract SHOULD be submitted with the tender.

5.3.4 Remote connection to system
        It SHALL be possible to connect the system via modem or VPN Internet connection
        to suppliers or vendors central service organisation for quick remote technical fault
        analysis, diagnostic service tests and system quality control. Access to such a
        service organisation SHALL be included in the tender.


5.4         Spare parts
5.4.1 Spare part availability
         Spare parts SHALL be available for a minimum of 7 years from the time of
         installation.

5.4.2 Lifetime and replacement cost
         Lifetime and/or replacement interval and replacement cost of any specific parts of
         the equipment, if other than the lifetime of the equipment as a whole, SHALL be
         clearly stated in the tender.

5.4.3 Pricelist
         A pricelist of all major spare parts for the equipment SHOULD be submitted with
         tender.

5.4.4 Location of warehouse and delivery
         The tenders SHALL include information about the location of warehouse for spare
         parts, delivery method and terms and delivery time to Landspítali – University
         Hospital.




Tender specification no. 14286            24/29       C-ARM R/F Digital X-ray Imaging System
     6. WARRANTY, NORMS AND STANDARDS

6.1          Warranty
6.1.1     The warranty period for the system as a whole as well as for all individual units
          SHALL be a minimum of 12 months from the time of acceptance (see §4.6.1).
6.1.2     Special warranty terms and period for individual parts and components of the
          contracted goods, if different from the warranty period for the unit as a whole,
          SHALL be stated in the tender.


6.2          Norms and standards
6.2.1 MD legal references
         The equipment tendered SHALL fulfil Icelandic law on medical devices no.16/2001
         and regulation no. 892/2004 on medical devices in Iceland.

6.2.2 CE and EN markings
         The goods SHALL be CE marked and fulfil any and all EU – directives on medical
         devices, safety and technical norms, standards and regulations mandatory in Iceland
         for medical equipment at the date of installation, such as, but not limited to EU
         Council Directive 93/42/EBE on Medical Devices (MDD) and EN – 60601-01: Safety
         on Medical Electrical Equipment etc.

6.2.3 DICOM 3.0
          The equipment SHALL comply with the Digital Imaging and Communication in
          Medicine 3.0 Standard (DICOM 3.0). A DICOM conformance statement SHALL be
          submitted electronically with the tender explaining in detail what information objects,
          service classes and data encoding are supported by the X-ray systems.

6.2.4 Electricity
         The equipment SHALL be wired for single-phase/three phase 230/400 volt AC, 50
         Hz power.

6.2.5 Icelandic characters
         The equipment and systems SHOULD be able to use and handle all Icelandic
         characters as defined in ISO 8859/1 for all patient demographic data.

6.2.6 Quality standard certification
         The manufacturing of the goods SHALL be certified according to ISO quality system
         standards such as ISO 9000 or similar. A copy of the quality standard certificate
         SHALL be delivered with the tender.

6.2.7 FDA status
         Information on the manufacturers and/or sellers status regarding FDA approval
         SHALL be included in the tender, if available.




 Tender specification no. 14286             25/29        C-ARM R/F Digital X-ray Imaging System
             IDENTIFICATION OF THE TENDERER
                                   (to be filled in by the Tenderer)

                                                                               Answer:
         Identity:
Name of Tenderer ……………........
ID number ……......…….

         Address:
Tenderers administrative address for
the purpose of this invitation, if
applicable


         Contact Person:
Contact person for this invitation to
tender
   a) Surname: …………………………
   b) Forename: ……………………...
   d) Position (e.g. manager): …………
   e) Telephone number: ……………….
   f) Fax number: ………………………
   g) E-mail address: …………………..



Declaration by                    an   authorised            representative                  of       the
organisation:
I, the undersigned, certify that the information given in this tender is correct and that the tender is
valid.
                 a) Surname……………………
                 b) Forename…………………..
                 d) Position (e.g. manager) ……
                 e) Telephone number ……….
                 f) Fax number…………………
                 g) E-mail address ……………..
         Date and place
SIGNATURE:



 Tender specification no. 14286                26/29         C-ARM R/F Digital X-ray Imaging System
                                  TENDERSHEET
TENDER NO. 14286. Digital C-ARM R/F X-ray Imaging System

                        Name of item or service:                   No:        Total price in Icelandic kronur, ISK,
                                                                                          EXCL.. VAT:

  1. Purchase Contract for a led C-ARM R/F                       1 pcs.
  Digital X-ray System for interventional
  gastrointestinal endoscopy


Name:___________________________________
  2. Test equipment according to §4.8.2: (Optional)


  3. Service contract according to §5.3.3: (Option)



Tenders for other solutions compliant to the tender specifications are welcomed but SHALL be tendered
separately as alternative tenders.

4. State the name of currency (currency basket where applicable):

__________________________________________________

5. Country of origin:

____________________________________________________

6. Delivery time (see 4.1)



7. Name of manufacturer:

____________________________________________________
8. Location of spare part depot:

_____________________________________________________

9. Delivery method:

________________________________________________________

10. Delivery time of spare parts to LSH:

______________________________________________________


Signature: _____________________________________________


Date:______________

 Tender specification no. 14286                    27/29       C-ARM R/F Digital X-ray Imaging System
                                      DECLARATION

Declaration:
I, the undersigned, declare that the evaluation group may optimize this tender to the tender
requirements before evaluation as described in §1.9.


Date:..............................    Signature: ..............................................




 Tender specification no. 14286               28/29             C-ARM R/F Digital X-ray Imaging System
                                 APPENDIX 1
                      Architectural drawings and technical plans
 A.1.1 The drawing shows the available room/area for a led C-ARM R/F Digital X-ray
 System for interventional gastrointestinal endoscopy at the Dept. of Gastroenterology at
 Landspítali - University Hospital at the Hringbraut Campus in Iceland.




Tender specification no. 14286         29/29       C-ARM R/F Digital X-ray Imaging System

				
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