30
I. General provisions1 21. Terms used in the documents of competitive tender
The documents of competitive tender were developed in compliance with Law (2289-17). The terms used in these documents of competitive tender shall have the meaning defined by the Law
2. Tender customer’s details:Full name National Scientific Center “M.D.Strazhesko Institute of Cardiology”
Address 5, Narodnogo opolchennya Str. 03151, Kyiv, Ukraine Customer’s officer authorized to communicate to the bidders
Bokov Ihor Mykolayovych, chief engineer
тел. 8-044-501-30-78, факс: +38(044)249-70-33
3. Purchase object details:Purchase object description Code 33.10.* - medical, surgical and orthopedic equipment
(medical equipment for Electrophysiological Laboratory) – 2 lotsPurchase object type Lot #1 – code DK 016-97 – 33.10.12.300 – different (nonfluoroscopic
navigation system);Lot #2 - code DK 016-97-33.10.12 - electrodiagnostic equipment and apparatus for treatment
Place, amount and scope of commodity delivery (rendering of services, performance of works)
Place of delivery: DDP - Ukraine, 03151, Kyiv, 5, Narodnogo opolchenia str. (Incoterms – 2000 Quantity: lot # 1 – one system; lot #2 – one system.
Term of commodity delivery (rendering of services, performance of works)
October-December 2010
4. Purchasing procedure Open tender5. Non-discriminating of bidders
The national and international bidders shall participate in the tender on common grounds
6. Details of currency(-ies) in which the tender offer price shall be calculated and specified. Competitive tender offer price.
The currency of competitive tender shall be hryvnia. If the bidder is a non-resident, it can also specify the competitive tender offer price in US dollars/ meanwhile, upon opening of offers the price of such competitive tender offer shall be recalculated in hryvnia at the official UAH vs. USD rate established by the National Bank of Ukraine as of the date of opening of the competitive tender offers as shall be specified in the minutes of opening of the competitive tender offers. The formula (technique, way) of the said recalculation is as follows:PriceUAH=PriceUSD х К, wherePriceUAH is price per unit in UAH;PriceUSD is price per unit in USD as specified in the offer;К is official UAH vs. USD rate established by the National Bank of Ukraine as of the date of opening of the competitive tender offers.In the competitive tender offer form (Annex 2) the bidder shall specify the price per each lot.The price shall be specified in the Ukrainian national currency DDP – Ukraine, 03151, Kyiv, 5, Narodnogo opolchenia str. (Incoterms - 2000).The purchase shall be made at the prices which cannot exceed the limiting prices (markups) established by Ukrainian laws.
7. Details of the language in which the competitive tender offers shall be prepared
During the tender all documents prepared by the customer shall be stated in Ukrainian and in English. The texts are authentic but the Ukrainian version shall prevail.All documents related to the tender offer and prepared directly by the bidder shall be prepared in Ukrainian.All other documents (including the information confirming the compliance of goods with documented requirements), related to the offer, may be prepared both in Ukrainian and in Russian, and if these documents are filed in a foreign language, they shall be translated into Ukrainian or Russian. The translation shall be certified by signature and seal (if any) of the bidder’s authorized official.If the bidder is not the resident of Ukraine, it may file its tender offer in English
2
and provide a Ukrainian translation (or Russian in case of documents specified in paragraph 3 hereof) certified by signature and seal (if any) of the bidder’s authorized official.
II. Amending and clarification of tender documents 1. Clarification of tender documents
The bidder who received the tender documents shall be entitled within ten days prior to expiration of the term for filing of tender offers to ask for clarification of tender documents. The customer shall provide clarification by request within three days upon receipt of such request to all persons who received tender documents. The customer shall be entitled to amend the tender documents on its own initiative or by request and prolong the term for filing and opening of tender offers for at least seven days subject to notification of amendments to all persons who were issued the tender documents within one business day. In case of late provision of explanations on the tender documents content by the customer, or late amending, the customer shall prolong the term for filing and opening of tender offers for at least seven days and notify all persons to whom the tender documents were issued of the same. The said information shall be announced by the customer pursuant to Clause 10 of the Law (2289-17).The lack of any question or clarification as regards the content and presenting of documentary requirements on the part of the bidders who received the documents according to the established procedure shall mean that all bidders participating in the tender fully realize the content of these documents and requirements stated by the Customer upon preparation of this tender.During the tender the parties shall be entitled to transmit any information on the tender by facsimile subject to subsequent confirmation in writing.
2. Procedure of the meeting for the purpose of clarification of requests on the tender documents
In case of the meeting for the purpose of clarification of any requests on the tender documents, the customer shall provide for keeping of minutes of such meeting specifying therein all clarifications by requests and send it to all persons who were issued the tender documents regardless of whether they attend the meeting or not. The said information shall be announced by the customer pursuant to Clause 10 of the Law (2289-17)
III. Preparation of competitive tender offers 1. Execution of competitive tender offers *This requirement shall not apply to the bidders operating without seal pursuant to applicable documents, unless the original documents or notarized copies were issued to the bidder by the other organizations (companies, establishments)
The tender offer shall be submitted in writing signed by the bidder’s authorized official, filed, numbered and sealed* in a glued envelope. The bidder shall be entitled to submit only one tender offer. The bidders shall be entitled to submit tender offers both for the tender object on the whole and for the specified tender object parts, i.e. lots.All pages of the bidder’s tender offer shall be numbered and signed by the bidder’s authorized official and sealed*. The signatory powers of the bidder’s tender offer documents shall be certified by an excerpt from the founders’ minutes, order of appointment, power of attorney, commission or another document evidencing the signatory power of the bidder's official to sign these documents.The tender offer shall be placed in one envelope which must be sealed by the bidder at attached joints*. The envelope shall specify the customer’s full name and address; tender object description pursuant to the open tender announcement; bidder's full name (first, last and middle name) and its location (place of residence), identification code according to the Uniform Public register of Ukrainian Companies and Organizations, contact phone numbers; and label "Do not open before _________ (specifying the date and time of opening of the tender offers")If the envelope containing the tender offer is not executed, sealed and labeled pursuant to this paragraph, such envelope shall not be accepted and shall be returned to the sender.All pages of the tender offer containing postscripts or amendments shall be certified by signature of the bidder's authorized official and have an inscription "The amendment is trustworthy".The envelope shall contain the description of all submitted documents marked as Copy or Original.If, pursuant to these documents, the copies shall be provided, all copies included
3
in the tender offer shall have the "True copy" inscription and be certified by signature of the bidder's authorized official.In cases specifically stipulated hereby the written documents shall be submitted by the bidder's in the form of notarized copies. If the documents do not provide for submission of copies, the bidder shall submit the relevant original document.
2. Bidder’s tender offer content
To participate in the tender, the bidder shall prepare and submit to the customer an offer which must comply with these documents.The offer submitted by the bidder shall consist of:1. commercial part; 2. technical part.The commercial part of the tender offer shall contain:1. Tender offer form. The tender offer form shall be executed pursuant to Annex 2 hereto, filled in accordance with these documents and certified by signature of the bidder's authorized official.2. Documents evidencing the signatory powers of the bidder's official or representative to sign the tender offer documents. If a person acts on behalf of the bidder by virtue of the Articles of Association (or another constituent document), the bidder shall submit a copy of the Articles of Association, or a sealed excerpt from the Articles of Association or another constituent document; certified copy of the document evidencing the managers authorities (a copy of order on appointment of the company manager to the position or a copy of the minutes of owners’ or shareholders’ resolution on its appointment as a manages or an excerpt from the minutes of founders on appointment of a director, president, board chairman etc. or a copy of Power of Attorney of the member’s manager etc.). If the person’s authorities are evidenced by the Power of Attorney, the bidder shall issue the original Power of Attorney.3. Document evidencing the provision of tender offer guarantee by the bidder (if it was stipulated in the tender announcement);4. Documentary evidence of the bidder's compliance with qualification criteria set forth in Annex 1 hereto;5. Details of the management and other persons authorized to represent the bidder's interests presented in a random form (name, contact phone number);6. Major conditions to be included in the purchasing agreement executed pursuant to Annex 4 hereto and signed by the bidder's authorized official;The technical part of the tender offer shall contain the details of compliance of the offered commodities with established requirements pursuant to paragraph 7 hereof and Annex 5 hereto.The bidder's failure to prepare the tender offer properly shall be its sole risk. The lack of the documents stipulated in paragraph 2 section ІІІ hereof shall be deemed as offer incompliance with these documents. The offers which aren’t in compliance with these documents shall be rejected.
3. Tender offer guarantee. No tender guarantee is required. 4. Conditions of return or non-return of the tender offer guarantee
No tender guarantee is required.
5. Tender offers validity The tender offers shall be deemed valid for 90 days after opening of the tender offers. Prior to expiration of this term the customer shall be entitled to require from the bidders to prolong the tender offers validity. The bidder shall be entitled to reject such requirement without losing the tender offer guarantee provided by him (if any); accept the requirement and prolong the validity of his tender offer and provided tender offer guarantee (if any). The bidders who fail to prolong their tender offers validity shall be deemed to have rejected to the requirement to prolong their offers.
6. Bidders’ qualification The bidders shall have the qualification stipulated in Annex 1 hereto.The assessment of bidders' compliance with established qualification requirements shall be performed by virtue of written documents provided by the bidders in the commercial part of their offer. The list of documents required for assessment of members’ compliance with qualification criteria is given in Annex 1 hereto. If the bidder’s offer doesn’t contain the documents specified in Annex 1 hereto, the customer shall deem that the bidder failed to comply with required
4
qualification.The customer shall decide to refuse to allow the bidder to participate in the tender and reject the tender offer if:1) it has undeniable evidences of the fact that the bidder offers, gives or agrees to give directly or indirectly to any customer's official or another governmental authority a remuneration in any form (job offer, a valuable thing, service etc.) to influence on making of a decision while determining the tender winner;2) the bidder was brought to legal responsibility for commitment of a corruptive action in the segment of public purchasing;3) the bidder was found to be collusion;4) an individual bidder was condemned of a crime related to the breach of the tender procedure or any other crime committed for mercenary motives, the conviction of which has not been expunged or cancelled as stipulated by law;5) the bidder's official authorized by the bidder to represent its interest in the course of the tender was condemned of a crime related to the breach of the tender procedure or any other crime committed for mercenary motives, the conviction of which has not been expunged or cancelled as stipulated by law;6) the tender offer was submitted by a bidder, who is affiliate to the other bidders;7) the bidder failed to submit the documents evidencing its authority to enter into the purchasing agreement;8) the bidder was legally acknowledged bankrupt and liquidation proceedings were instituted against it.The customer may decide to refuse to allow the bidder to participate in the tender and reject the tender offer if:1) the bidder has arrears in taxes and dues (compulsory payments);2) the bidder or previous qualification bidder doesn’t carry on business pursuant to its Articles of Association.Pursuant to Clause 17 of the Law the bidders shall, in addition to the documents evidencing its compliance with qualification requirements, submit a copy of his Articles of Association, Memorandum of Association (of any), public registration certificate, certificate on inclusion in the Uniform Public Register of Ukrainian Companies and Organizations (if any).If the bidder is a non-resident, the relevant documents shall be legalized as stipulated by law (unless the applicable laws provides for exemption from legalization).
7. Information on the required technical qualitative and quantitative properties of the purchasing object
The properties of commodities offered by the bidder shall comply with the following requirements:- the medications must be registered in Ukraine;- the offered medical equipment shall comply with medical and technical requirements and bundling specified in Annex 5 hereto;- the warranty term shall be at least one year after installation;The information on compliance of offered commodities with medical and technical documents shall be evidenced by the following documents:- a copy certified by signature of the bidder’s official and seal (if any) of the certificate of public registration in Ukraine issued by the Department for regulation of medications and medical items circulation in health protection system of Health Ministry of Ukraine;- information materials for the offered products (manufacturer’s catalogues, booklets, leaflets, articles from scientific publications (can be in Russian), instructions for use) evidencing the compliance of the purchasing object with medical and technical requirements;- a copy of ISO production quality compliance certificate.The bidders shall include in their tender offer the documents certifying the bidder's tender offer with technical, qualitative and other requirements to the purchasing object, namely: - original manufacturer’s letter of guarantee (or its authorized official, representative office or branch, if their authorities are applicable in Ukraine), certifying the warranty service term (at least one year after installation),
5
availability of staff certified by the manufacturer, equipment installation guarantee and training of the customer’s staff by the manufacturer’s certified specialists in commodities, which are the purchasing subject at this tender. The manufacturer’s letter of guarantee shall include the member’s full name, announcement number and number of official publication for public purchases in which this announcement was published as well as purchasing object name according to the announcement.The tender offer which doesn’t contain the said documents and/or doesn’t comply with paragraph 7 of section ІІІ of these documents shall be deemed as non-complying with these documents.
8. Description of a separate part (parts) of the purchasing object (lot) on which the tender offers can be submitted
The bidders shall submit their tender offers on separate parts of the purchasing object (lots) specified in paragraph 3 section 1 hereof.
9. Amending or revocation of tender offer by the bidder
The bidder shall be entitled to amend or revoke its tender offer prior to expiration of its submission term without losing its tender offer guarantee (if any). Such tender offer amendments or revocation statement shall be taken into account, if they were received by the customer prior to expiration of the tender offers submission term
IV. Submission and opening of tender offers 1. Way, place and end date of tender offers submission: way of tender offers submission
Personally or by mail
Place of tender offers submission
5, Narodnogo opolchenia str.03151, Kyiv, Ukraine, planning-economical department
End date of tender offers submission (date and time)
September 29, 2010 till 10:00 a.m. according to Kyiv timeThe tender offers received by the customer after expiration of their end date shall not be opened and shall be returned to the bidders who sent them. By bidder's request the customer shall within one day after receipt of the request confirm the receipt of the tender offer specifying its date and time
2. Place, date and time of opening of tender offers
September 29, 2010 at 12:00 a.m. according to Kyiv time; Ukraine, 03151, Kyiv, 5, Narodnogo opolchenia str., academic council hall.
3. Opening procedure All bidders or their authorized representatives can attend the procedure of opening of tender offers by the customer. If the bidder or its authorized representative does not attend the procedure of opening of tender offers, it shall not be the grounds for refusal to open or rejection of its tender offer. The authorities of bidder's representative shall be evidenced by an excerpt from the founders’ minutes, order of appointment, Power of Attorney, commission or any other document evidencing the authorities of the bidder's official to attend the procedure of opening of the tender offer. To prove one’s identity, the representative shall produce its passport. While opening the tender offers the availability or lack of all required documents stipulated by tender documents is verified and the name and address of each bidder and price of each tender offer or a part of the purchasing object (lot) shall be announced. The said information shall be included in the minutes of tender offers opening. The minutes of tender offer opening shall be prepared on the date of opening of tender offers in the form approved by the Ministry of Economics of Ukraine. The minutes of opening of the tender offers shall be signed by the tender board members and bidders attending the procedure of opening of tender offers. A copy of minutes of opening of the tender offers signed by the tender board chairman and customer’s seal shall be issued to any bidder by its request within one business day after receipt of such request. The minutes of opening of the tender offers shall be announced pursuant to Clause 10 of Law (2289-17)The offer in compliance with document requirements shall be the offer which complies with all terms and conditions of these documents. If the offer was deemed incompliant with documents it shall be rejected and cannot by adjust at a later time.
V. Assessment of tender offers and determination of the winner 1. The list of criteria and The customer shall be entitled to ask the bidders to clarify the content of their
6
methodology of assessment of the tender offer specifying the criterion specific weight
tender offers to straightforward the consideration and assessment of offers. The customer and the bidders cannot initiate any negotiations on amending the content or price of the submitted tender offer.The first stage of assessment is verification of bidders’ compliance with qualification criteria listed in Annex 1 hereto. According to the results of this offer stage the bidders who do not comply with qualification criteria shall be rejected pursuant to paragraph 3 of section 4 hereof.At the following stage the compliance of offers submitted by the bidders with documents is verified. The working group of experts, the composition of which shall be approved by the customer’s company director by his order can be involved in assessment of offers. The working group recommendations shall be taken into account upon determination of the tender winner. The offers which are not in compliance with documents shall be rejected pursuant to Clause 29 of the Law.The customer shall assess all non-rejected offers pursuant to the criteria and assessment technique specified in Annex 3 hereto.
2. Correction of arithmetical errors
The customer shall be entitled to correct the arithmetical errors which occurred in the course of arithmetical operations and were detected in the submitted tender offer during its assessment as stipulated by tender documents subject to consent in writing of the bidder who submitted this offer.The detected arithmetical errors shall be corrected as follows:а) in case of divergence between amounts specified in figures and in words, the amount in words shall prevail;b) in case of divergence between the price per unit and total cost obtained by multiplying of the price per unit by the number of units, the price per unit shall prevail and the total cost shall be adjusted respectively;c) if in the price per unit there is an obvious displacement of the decimal point, the total cost shall prevail and the price per unit shall be adjusted respectively.If the bidder disagrees with correction of arithmetical errors, its tender offer shall be rejected
3. Miscellaneous The customer shall keep the information provided by the bidders confidential throughout the whole purchasing process. The information on consideration and assessment of offers shall be disclosed only to the authorized agency, bodies procuring the public regulation and control in the purchasing segment, appeal authority and court.All customers and bidders' notices and statements related to the tender procedure shall be stated in writing. In the course of the purchasing procedure the parties shall be entitled to transmit any information about the tender by facsimile subject to subsequent confirmation in writing.The customer shall be entitled to send any information on the tender to the bidders by email (to the electronic address specified by the bidders) subject to subsequent confirmation in writing.All other issued not stipulated herein shall be regulated by laws.The bidder shall be solely responsible for all costs related to preparation and submission of its offer. The customer shall in no case be responsible for the bidder's offer content and its costs for preparation of proposal regardless of the tender result.The bidder shall be responsible for reliability of information contained in its offer.An individual or an entity may seek the remedy at the appeal agency for protection of its rights and legitimate interests in case of actions, decision and omissions of the Customer which are in conflict with laws in the segment of state purchasing and as a result of which the right or legitimate interest of such person was infringed.The customer’s actions can be appealed against as stipulated by law.
4. Rejection of tender offers The customer shall reject the tender offer if:1) the bidder: doesn’t comply with qualification criteria stipulated in Annex 1 hereof; disagrees with correction of arithmetical error detected by the customer; failed to provide the tender offer guarantee if it was required by the customer;
7
2) there are the grounds specified in clause 17 and paragraph seven of clause 28 of this Law;3) the tender offer doesn’t comply with tender documents.The information on rejection of tender offer specifying the grounds for rejection shall be sent to the rejected bidder within three business days after making of such decision and shall be announced pursuant to Clause 10 of this Law (2289-17)
5. Cancellation of tender or declaration of its failure by the customer
The customer shall cancel the tender if: - there is no more need in purchasing of goods and works; - it is impossible to remedy the breaches which occurred as a result of detected violation of laws on public purchasing; - there was found the fact of collusion between bidders; - the procedure of publication of tender announcement, acceptance and/or declaration of results stipulated by this Law (2289-17) was infringed; - less than two tender offers were submitted; - all tender offers were rejected pursuant to this Law; - the offers of less than two bidders were allowed to assessment.
The tender can be cancelled partially (by lot).
The customer shall be entitled to declare that the tender failed if: the price of the most advantageous tender offer is higher than the amount stipulated by the customer for purchase financing; the purchase became impossible as a result of the force majeure. The notice on cancellation or failure of the tender shall be sent by the customer to the authorized agency and to all bidders within three business days after making of relevant decision by the customer and shall be declared pursuant to Clause 10 of this Law.
VI. Entering into the purchase agreement 1. Terms of entering into the purchase agreement
On the date of determination of the winner the customer shall accept the tender offer which was found the most feasible according to assessment results. Within one business day after making of a decision on determination of the winner the customer shall send to the tender winner a notice on acceptance of its offer and a notice on tender results specifying the name and address of the winner, whose offer was acknowledged the most feasible in the course of assessment to the rest of the bidders.The notice on offer acceptance shall be published pursuant to the Law.The customer shall enter into the purchase agreement with the bidder whose tender offer was accepted within 30 days after acceptance of offer pursuant to the tender documents and accepted offer, but at lease in 14 days after publishing of a notice on acceptance of the tender offer in the official public printed media for state purchasing
2. Material terms and conditions to be included in the purchase agreement
Supplier undertakes timely delivery and transfer ownership of Customer Goods in assortment, quantities and prices that are listed in the specifications developed on the basis of acceptance of tender offer and is an integral part of this Contract, and Customer has to accept and pay for "Good."
Amount of goods supplied under this Contract shall be reduced depending on the actual funding of the Customer. Supplier transfers to the ownership of Customer the goods according with DDP-Ukraine (Incoterms 2000).
2. Contract currency is hryvnia Ukraine.
3. Conditions of the Contract must not be changed after signing to full implementation of commitments by the parties, except occurrences of purchase volume reducing depending of real funding expenditures and agreed by the parties of Contract reduce of purchase Contract cost.
Note: The price at the time of the contract conclusion shall not vary from the 8
price specified in the tender offer of the purchase procedure winner.4. Payment is made according to legislation. In case of delaying of budget financing calculations are made upon receipt of delivery or within 14 days of receipt of funds at the account for specified purposes. 5. Supplier shall deliver the goods to the Customer within 30 days after applying. 6. Place of goods delivery: 5, Narodnogo opolchenia str.03151, Kyiv, Ukraine7. Delivery time: October-December 2010. 8. Shelf life of a good (if any) - not less than 12 months at the time of delivery. 9. Warranty service is less than a year since installation moment.10. In case of delaying of goods deliveries or supply incomplete consignment declared by the Customer, Supplier shall pay a penalty in the amount of double rate of National Bank of Ukraine of the amount of undelivered goods for each day of delay. 11. Delivered goods must meet the highest level of technology and standards existing in the country of manufacture for similar goods, norms and standards, established by law in Ukraine, as well as documentation requirements of competitive bidding. 12. Medical equipment must be registered in Ukraine. 13. Delivered goods must have the necessary certificates, certificates of registration, instruction in Ukrainian or Russian, accompanied by instruments on the number, warranty terms, name and manufacturer.14. This Contract shall enter into force upon signing moment and is valid till 31.12.2010r., but the full implementation of commitments. 15. Customer has the right to control the supply of goods in the terms set in this Contract. 17. Participant shall ensure the delivery of goods within the terms established by this Contract. 18. Budgetary obligations of the Customer arising under a contract in the case of availability and within the relevant budgetary allocations.
3. Customer’s actions if the tender winner refuses to sign the purchase agree
If the tender winner refuses in writing to enter into the purchase agreement pursuant to the tender documents or fails to enter into the purchase agreement through the tender winner’s fault within the term stipulated by Law (2289-17), the customer shall once again determine the most feasible tender offer among those which haven’t expired yet.
4. Purchase contract enforcement
Enforcement of purchase contract is not required.
9
Annex 1QUALIFICATION CRITERIA
The bidders shall comply with the following qualification criteria:
Qualification criteria List of documents required for assessment of bidders’ compliance with qualification criteria *
1. Availability of equipment and logistic base
Copies of documents certifying the availability of own1 or leased2 motor vehicles by the bidder and warehouses. Notes:1 Holding of own motor vehicles by the bidder can be certified by copies of vehicles state registration certificates or license cards.2 Holding of leased motor vehicles by the bidder can be certified by copies of vehicle lease agreements or agreements on rendering of freight services subject to compulsory documentary certification of holding of the vehicles by the other party to the agreement.
2. Availability of personnel with relevant qualification having the required knowledge and experience
List of employees’ names with secondary medical, technical, economic and legal education in random form.
3. Availability of documented experience in performance of similar agreements.
Table in a random form signed by the bidder's authorized official and sealed listing the major agreement with Ukrainian medical establishment on delivery of medical items for the past three years.
4. Financial stability 1. A copy of the balance sheet and income statement for the past reporting period (Form 1 and Form 2) signed by the bidder's authorized official and sealed (if any).2. A copy of the cash flow statement for the past reporting period (Form 3) signed by the bidder's authorized official and sealed (if any).4. Original bank certificate on the lack of credit arrears issued within two weeks prior to opening of the tender offers
* The bidder may at its sole discretion provide some additional materials evidencing its compliance with qualification criteria.*** If the bidder submits some of the documents in a foreign language, they shall be translated into Ukrainian. The translation shall be signed by the bidder’s authorized official and sealed (if any).**** The non-resident bidder shall submit the documents specified in the table in view of the legal peculiarities of its country of origin. If such documents have no analogues, the non-resident bidder shall provide the letter explaining the lack of the relevant document instead.
10
Appendix 2COMPETITIVE TENDER OFFER FORM1. We, being familiarized with tender documentation, submit our offer for participation in tender:1. Full name of the bidder (title must be stated on the basis of statutory documents) 2. Legal and actual address of the bidder3. USREOU code (if available)4. telephone (fax), е-mail5. The number of note on scheduled purchase, published in official state publishing house on issues relating to scheduled purchases 6. Warranty period of the product from the date of installation Lot No____ -
Then a bidder should fill in the table given belowLot No _____(name of equipment according to competitive tender documentation
No Catalogue code Description of a purchase item
Commercial name, manufacturer, country
Unit of measurement
Quantity
Total value of lot (without VAT)_________________________________________UAH __kopecks
2. We undertake to follow the terms of this offer not less than within 90 days from the date of its consideration, determined by You. Our tender offer is compulsory for us.3. If our offer will be accepted, we undertake to sign the Contract on purchase within 30 days from the date of acceptance of our offer, but not earlier than 14 days from the date of publishing of note about acceptance of the competitive tender offer in official state print edition on proceedings of state purchase and fulfill all conditions stated in the purchase Contract.
4. By this signature ____________________ unconditionally acknowledges its agreement with all(point the title of bidder)provisions of documentation (including their compliance with current legislation) and agrees to meet all requirements, stipulated by documentation.
Authorized person ___________ __________________ (signature) (initials and surname)
11
Appendix 3
Criteria and technique of assessment of bidders’ competitive tender offers
Evaluation of tender offer is executed on the basis of the following criteria:
The price of tender offer in case of achieving of claimed characteristics of the product. The term "price" is considered as a price per lot on offered product.
Maximal possible amount of grades in terms of price equals 100.The evaluation is executed on the basis of the following methods:The amount of grades in terms of "price" is determined by the following way: tender offer, lot price of which is the most profitable (the least price), has the maximal possible amount of grades. The amount of grades for the rest tender offers is determined on the basis of formula:G. calc. = P.min/P calc. *100, whereG. calc. is calculated amount of grades;P.min is the lowest price;P. calc. is the price of proposition, for which the amount of grades is calculated;100 is maximal possible amount of grades in terms of price
All tender offices, evaluated on the basis of evaluation criteria, are arranged as the indexes of total sum increase. In case of equal value of indexes, the winner is determined via voting by not less than two-thirds of the members of Competitive Tender Committee on the basis of majority of votes. If the amounts of votes for both candidates are equal, the Head of Competitive Tender Committee has a full voting status.The winner is determined by resolution of Competitive Tender Committee.
12
Appendix 4Purchase object:
Code – 33.10.* Medical equipment for Electrophysiological Laboratory
Lot №1 (Code - 33.10.12.300) - Nonfluoroscopic navigation system
General requirements Confirmed document
1. The system must be registered in Ukraine. Availability2. The availability of detailed technical description of the
system on paper and electronic media in Russian or Ukrainian language.
Availability
3. Warranty maintence, clinical and technical support must be provided by certified specialists of the manufacturer. Clinical and technical experts should be in Ukraine or Russia.
Availability
4. The possibility of training doctors for procedures at this navigation system.
Availability
5. Possibility to get a service contract on any terms. AvailabilityNonfluoroscopic navigation system kit:
1. RAM module and an image processing based PC with the software.
Availability
2. Patient Interface Unit for registration of the information which comes during the diagnostic process and treatment.
Availability
3. Electromagnetic field generator. Availability4. Bracket for installation of the electromagnetic field
generator.Width not less than 600 mm
5. Electrical transformer for the patient safety. Availability
6. External electrophysiological tools unit Availability7. External reference patch unit Availability8. LCD Monitors for the operating and control rooms. Not less than 24 inches9. The set of pedals for remote control Availability10. The set of cables for compatible components and
systems.Availability
11. The set of cables for surface ECG and intracardiac signals registration.
Availability
12. Radiofrequency generator to perform radiofrequency ablations.
Availability
13. Irrigaton pump for irrigation ablations. Availability14. The set of cables for the different electrodes Availability15. The set of electrodes for electrophysiology
investigations and ablation of rhythm disorders.Availability
The main technical requirements for nonfluoroscopic navigation system
1. The system block: 1
1.1. Processor, not less than Intel® Core™2 Duo 525W, E6750 (2.66ГГц, 1333 МГЦ FSB, 4MB L2 Cache, Dual Core)Pentium IV, 2.66 Ггц
13
Intel® Core™2 Duo 525W, E6750 (2.66GHz, 1333 MHz FSB, 4MB L2 Cache, Dual Core)Pentium IV, 2.66 GHz
1.2. RAM, not less than 2 Gb
1.3 Hard Drive, not less than 320Gb
1.4 Archive memory, not less than 160 Gb1.5 Access to the network - Ethernet, TCP / IP protocol,
speed 100 Mb / sAvailability
1.6 Operating system Microsoft® Windows® XP Professional
1.7 Media drive DVD+/-RW16x max2. Patient interface module: Interface module for
catheters connection, system unit connection and electrophysiology system connection . Unit serves to collect to filterand to process surface ECG and intracardiac signals; also it serves to determine catheter`s site.
2.1. Number of channels of surface ECG, at least 122.2. Number of channels of navigational catheter, at least 42.3. Number of intracardiac channels at least 782.4. Intracardiac ECG amplitude 10 mkV - 300 mlV
2.5. Breakdown voltage, at least 4 kV
2.6. Automatic disconnection of the mapping electrode from RF generator during the stimulation of M1-M2.
Availability
2.7. Autodetection of the surface ECG or catheter disconnection and voltage errors detection.
Availability
2.8. The number of simultaneously visualized catheters At least 82.9. Attached catheters autoidentification. Catheter recognition:
4-20 poles4-8 FrTypes of bending:Deflectable / not deflectableGeometry Type:Direct catheter / catheter-loop
2.10. Ability to edit the connected catheters list. Availability2.11. Pole visualization during the stimulation. Availability3 Nonfluoroscopic 3-D navigation technology: Electromagnetic
navigation3.1. The ability to use for diagnosis and treatment of all
forms of tachycardias.Availability
14
3.2. Source of electromagnetic fields Electromagnetic field generator with the function of determining spatial position of the catheter inside the heart
3.3. The number and the type of coils that generate electromagnetic fields.
Not less than 9 coils
3.4. Mapping Accuracy Not more than 1 mm3.5. Mapping zone Not less than 300 mm
(X axis) x 400 mm (axis Y) x 460 mm (axis Z).
3.6. The electric field location principle Availability 4. The system should operate on two principles of
location: using a sensor in electromagnetic field, and using sensors that record low high-intensive electric field, registering position of electrodes inside the heart chambers
Availability
5. With the system should be possible to fast construction of anatomical maps using one cycle endocardial mapping technology to decrease the timeof fluoroscopy.
System`s location zone, at least 200х200х200 mm,point aquiring speed at least 60/sec
6. With the system should be possible to build electroanatomic maps using ultrasound catheter mapping, which helps to decrease the time of fluoroscopy.
Availability
7. Catheters visualization should be able to tune by the user (swithon/off of appropriate catheters,ablaton electrode marking, any electrode marking, the direction of bending marking, electrodes numbering)
Availability
8. The navigation system must have an electrophysiology system compatible interface to "combine" two systems into a coherent whole.
Availability
9. The navigation system must have an ultrasound system compatible interface to "combine" two systems into a coherent whole.
Availability
10. The navigation system must have an pacemaker system compatible interface to "combine" two systems into a coherent whole.
Availability
11. The navigation system must have a radiofrequency generator compatible interface to "combine" two systems into a coherent whole.
Availability
12. The navigation system must have a program to build local activation maps, isopotential maps and propagation maps.
Availability
13. Possibility to clearly define the area of postinfarction and / or postoperative scar using isopotential maps.
Availability
14. The navigation system must have a program to map “zones of interest” in separate chambers of the heart.
Availability
15. The navigation system must have possibility to measure the distance between any points on the map.
Availability
16. The navigation system must have possibility to measure the volume of the map.
Availability
17. The navigation system must have the function of mapping based on anatomical maps that were built earlier.
Availability
18. The navigation system must have possibility to Availability
15
visualize of three-dimensional model of the heart in any projection.
19. The ability to create directed cuts of any maps in any projection at any angle.
Availability
20. Ability to record and view video clips and images taken during the procedure..
Availability
21. The navigation system must have possibility to build and save not less than 20 maps per procedure.
Availability
22. The navigation system must have analysis buffer for at least 10 cardiac beats.
Availability
23. Ability to visualize the activation wave front on the detailed anatomy of the heart chambers.
Availability
24. Possibility of three-dimensional modeling of major vessels of the heart.
Availability
25. Possibility to mark major anatomical landmarks such as large vessels, valves and others
Availability
26. Possibility to save electrograms of the each point of the map.
Availability
27. Ability to create, edit and save electroanatomical maps. Availability28. Ability to register points of ablation. Availability29. Ability to register unipolar and bipolar signals as well. Availability30. Ability to create local activation maps isopotential maps
and isochronal maps.Availability
31. Ability to register low potentials in any chamber of the heart and visualize the scar area using color mapping.
Availability
32. Ability to identify and mark areas of scarring on sinus rhythm and during the pacemapping.
Availability
33. Ability to display all channels which can be necessary for electrophysiology investigation
Availability
34. The possibility of stimulation of any pair of electrodes on referent catheter.
Availability
35. The possibility of stimulation of any pair of electrodes on mapping catheter.
Availability
36. Ability to create an adequate reconstruction of the heart chamber by several points.
Availability
37. Можливість архівації отриманих під час дослідження даних.Ability to archive data received during the study.
НаявністьAvailability
38. Ability to register intracardiac signals before, during and after the process of ablation.
Availability
39. Ability to output parameters of ablation on the navigation system monitor.
Availability
40. Ability to build maps of several heart chambers, and display them on the screen simultaneously.
Availability
41. Catheters used for the navigation system should be diagnostic and ablative as well.
Availability
The main technical requirements for radiofrequency generator
1. Output power 100 W Availability2. Ability to use catheters from different manufacturers Availability3. Ability to use irrigated catheters Availability4. Ability to use catheters with 8-mm tip and two built-in
sensor catheters.Availability
5. Ability to work with different types of thermosensor ( thermistor and thermocouple)
Availability
6. Ability to register intracardiac signals before, during and after the process of ablation.
Availability
16
7. Ability to program setting mode (at least 4 programming modes).
Availability
8. Ability to control the irrigation pump working using a special interface.
Availability
9. Ability to display ablation parameters on the electrophysiology system monitor.
Availability
10. Ability to work with nonfluoroskopic navigation system mapping catheters.
Availability
11. Generator must have a connection cable with irrigation pump.
Availability
The main technical requirements for irrigation pump
1. Ability to supply saline solution for irrigation catheters. Availability2. Ability to program the solution flow speed from 2 to 40
ml per minute.Availability
3. Ability to connect with the generator and ability to be programmed with the generator.
Availability
4. Ability to use special tubes for saline supply. Availability
Lot №2 (kode - 33.10.12) – Electrophysyological laboratoryGeneral requirements Confirmed
document1. Registration in the territory of Ukraine availability
2.Recording and registration of high-frequency small-amplitude signals for no less than 184 channels
availability
3. Invasive treatment and diagnostic electro-cardiac stimulation availability4. Radio frequency impacts on the cardiac conduction system availability5. 3D mapping of the dominant frequency (DF), monitoring of
fibrillation cycles length availability
Mandatory technical characteristics Name of parameter Document,
str.#1. Customized interface for every user availability2. Special design keyboard for management optimization availability3. High quality no less than 184 channel amplifier – no less than
4000 events per second availability
4. Number of intra-cardiac channels – no less than 160 availability5. Maximum signal resolution – no less than 16 bit availability
6. Template analysis availability7. T-wave subtraction (P-wave visualization at its transposition
over T-wave)availability
8. ECG signal filter – no less than 5 degrees (low frequency, high frequency, network interference 50-60 Hz with the tuning possibility with the precision of up to 0.1 Hz, filter for interference from the radio frequency generator and the adapted filter)
availability
9. Fourier series dominant frequencies analysis availability10. Automatic spectrology of dominants frequencies (frequencies
with the largest amplitude) of fibrillation, incl. from the coronal sinus
availability
11. Automatic calculation of the dominant frequency, regularity index and organization index for every point
availability
12. Construction of a 3D map of fibrillation dominant frequencies in real time
availability
13. Voltage maps availability
17
14. Definition of local activation time availability15. Automatic calculation of fibrillation cycles availability16. ECG form analysis availability17. Data centralization (stimulator, generator, fluoroscopy) availability18. Report in a Microsoft open format compatible with Microsoft
Word availability
19. DVD recording availability20. Real-time data collection availability21. Grabbing fluoroscopy availability22. Stimulator interface availability
Software requirements Name of parameter Document, str.#
1. Entering into the computer simultaneously up to 12 standard ECG outputs, 4 invasive pressure channels, 4 stimulation channels, 4 channels for high-amplitude signals and 160 intra-cardiac EGs with monitoring on the real time screen of any channels with different scales by amplitude and monitoring of R-R intervals
availability
2. Measuring of time and amplitude ECG and EG parameters (with a keyboard or the "mouse" manipulator);
availability
3. Saving results of registration and processing in the patients database
availability
4. Work with the patients database – search, select, delete, print patients records from one catalogue into another, printing patients lists, etc.;
availability
5. In-depth managing of the process of printing cardiac curves, measurement and analysis results;
availability
6. Autonomous cardiac stimulator availability7. Managing operation of the device for radio frequency
destruction of cardiac conduction paths availability
8. Interface with different devices for radio frequency destruction of cardiac conduction paths
availability
9. Microsoft Windows operational system availability
Hardware technical requirementsName of parameter Confirmed
document1. Strain feeding 220±22B2. Frequency (50± 0.5) Hz3. Number of intracardial channels No less than 1604. Number of standard ECG outputs No less than 125. Number of blood pressure outputs No less than 46. Number of High level inputs No less than 47. Range of U input voltage, mV Range no less
than: from +/-1 to +/-100
8. In-phase signal depression coefficient No less than 96 dB.
9. Sampling rate 16 bit10. Sampling frequency 4000 Hz11. Availability of an autonomous cardiac stimulator availability12. TouchScreen for ECS management availability13. Number of stimulation channels No less than 414. Availability of bi-ventricular stimulation availability
Including the following components18
EquipmentQuantity in
pcs.
Availability
1. Digital Processor ncluding software Mapping & Analysis Suite with 3D Mapping
1
2. Monitor no less than 20 inch 4 3. 184 channel amplifier 1 4. Junction Box cabel 2 5. junction box support bracket 2 6. Cable ECG 2 7. ECG Leadwires, Grabble-style, IEC color-coded 3 8. CABLE Ethernet, SHIELDED 1 9. Power Cord 7 10. Blood pressure cable 1
11 Null Modem Cable, FF 1 12 Equipotential Ground Cable 1 13 CABLE STIMulator 1 14 CABLE Analog OUT 1 15 CABLE RF filter 1 16 Blood pressure transducers 1 17 VGA extension cable 218 Printer 1 19 Isolation Transformer 2 20 System Cart 2 21 VGA IMAGE Capture Hardware Kit 1 22 LCD Monitor 2
23 VGA VIDEO SPLITTER 1
23 STIMULATOR including TouchScreen 1
23 Installation Suite of catheters and cables: - diagnostic catheters with 1 cable- ablative catheters with 1 cable
22
19
