To all potential ICB 2.1.8 Bidders

Bidding Documents item/page

The content of the relevant item of Bidding Documents of Purchaser’s Bidding

Changes to the Bidding Documents

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailed requirements and related services

Lot 2Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

 Related services

р.1

1.The Supplier must arrange in the city of Zaporizhzhia a one-time doctors’ training on the operation of a portable ultrasound machine with the possibility of examination of the heart and blood vessels (item 2. “List of Related Services and Completion Schedule”Section VII. “Shedle of Requirements”). The training should be conducted in Russian or Ukrainian (including all teaching materials).

1.The Supplier must arrange in the city of Zaporizhzhia a one-time doctors’ training on the operation of an ultrasound machine with the possibility of examination of the heart and blood vessels (item 2. “List of Related Services and Completion Schedule”Section VII. “Shedle of Requirements”). The training should be conducted in Russian or Ukrainian (including all teaching materials).

Section VII.  Schedule of Requirements

4.Technical Specifications

p.2.     Standards

Medical equipment standards:

All offered equipment shall be in possession of either CE Mark, active directive EEC, or FDA approval  or compliance to other internationally recognized medical devices regulatory systems or certificated in accordance of effective legislation of Ukraine. In case of electrical medical equipment, each offered device shall also be compliant to the following standards and/or regulations:

• IEC 60601-1 (Medical electrical equipment Part 1- General requirements for basic safety and essential performance);
• IEC 60601 Collateral Standards applicable to the specific type of offered device (refer to IEC list of Collateral Standards);

Copies of the original certifications, issued by authorized notified bodies, or declarations of compliance issued by the manufacturer of the medical device shall be included in the bid.

Medical equipment standards:

All offered equipment shall be in possession of either CE Mark, active directive EEC, or FDA approval  or compliance to other internationally recognized medical devices regulatory systems or certificated in accordance of effective legislation of Ukraine. In case of electrical medical equipment, each offered device shall also be compliant to the following standards and/or regulations:

• IEC 60601-1 (Medical electrical equipment Part 1 - General requirements for basic safety and essential performance);
• IEC 60601 Collateral Standards applicable to the specific type of offered device (refer to IEC list of Collateral Standards);
• IEC 61010-2-101: 2015: Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment(concerning in vitro diagnostic devices).

Copies of the original certifications, issued by authorized notified bodies, or declarations of compliance issued by the manufacturer of the medical device shall be included in the bid.

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailed requirements and related services

Lot 2

Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

р.9 Scan modes and visualization technologys 9.17

(Description of requirements)

(Bidding Documents  in English)

Automatic М-mode

Аnatomical M-mode

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailed requirements and related services

Lot 2

Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

р.10 Characteristics of existing sensors  10.2

Frequencies(The avilablity of a function, or the value of the parameter)

not less than 3-11 MHz

not less than 2-4 MHz

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailed requirements and related services

Lot 2

Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

р.10 Characteristics of existing sensors  10.9

Depth of scan(The avilablity of a function, or the value of the parameter)

not less than 175 mm

not less than 140 mm

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailedrequirementsandrelatedservices

Lot 2

Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

р.10 Characteristics of existing sensors  10.16

Depth of scan(The avilablity of a function, or the value of the parameter)

not less than 250 mm

not less than 240 mm

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailed requirements and related services

Lot 5

5.2 Consumables for collecting biological material

Section IV.  Bidding Forms

Form of Bid Security

(Bidding Documents  in English)

Form of Bid Security

(Bank Guarantee)

[The bank shall fill in this Bank Guarantee Form in accordance with the instructions indicated.]

[Guarantor letterhead or SWIFT identifier code]

Beneficiary:  Health Department of Zaporizhzhia Oblast State Administration,
Sobornyi ave., 164, Zaporizhzhia, 69107, Ukraine

IFB No.: ICB 2.1.8

Date:  [Insert date of issue]

BID GUARANTEE No.:  [Insert guarantee reference number]

Guarantor:  [Insert name and address of place of issue, unless indicated in the letterhead]

We have been informed that ______ [insert name of the Bidder, which in the case of a joint venture shall be the name of the joint venture (whether legally constituted or prospective) or the names of all members thereof] (hereinafter called "the Applicant") has submitted or will submit to the Beneficiary its bid (hereinafter called "the Bid") for the execution of Medical equipment for primary health care сenters Contract under Invitation for Bids No. ICB 2.1.8 (“the IFB”).

Furthermore, we understand that, according to the Beneficiary’s conditions, bids must be supported by a bid guarantee.

At the request of the Applicant, we, as Guarantor, hereby irrevocably undertake to pay the Beneficiary any sum or sums not exceeding in total an amount of ___________   (____________) upon receipt by us of the Beneficiary’s complying demand, supported by the Beneficiary’s statement, whether in the demand itself or a separate signed document accompanying or identifying the demand, stating that either the Applicant:

(a)     has withdrawn its Bid during the period of bid validity set forth in the Applicant’s  Letter of Bid (“the Bid Validity Period”), or any extension thereto provided by the Applicant; or

(b)     having been notified of the acceptance of its Bid by the Beneficiary during the Bid Validity Period or any extension thereto provided by the Applicant, (i) has failed to execute the contract agreement, or (ii) has failed to furnish the performance security, in accordance with the Instructions to Bidders (“ITB”) of the Beneficiary’s bidding document.

This guarantee will expire: (a) if the Applicant is the successful bidder, upon our receipt of copies of the contract agreement signed by the Applicant and the performance security issued to the Beneficiary in relation to such contract agreement; or (b) if the Applicant is not the successful bidder, upon the earlier of (i) our receipt of a copy of the Beneficiary’s notification to the Applicant of the results of the bidding process; or (ii)twenty-eight days after the end of the Bid Validity Period.

Consequently, any demand for payment under this guarantee must be received by us at the office indicated above on or before that date.

This guarantee is subject to the Uniform Rules for Demand Guarantees (URDG) 2010 Revision, ICC Publication No. 758.

_____________________________

[Signature(s)]

Note:  All italicized text is for use in preparing this form and shall be deleted from the final product.

Form of Bid Security

(Bank Guarantee)

[The bank shall fill in this Bank Guarantee Form in accordance with the instructions indicated.]

 [Guarantor letterhead or SWIFT identifier code]

Beneficiary:  Health Department of Zaporizhzhia Oblast State Administration,
Sobornyi ave., 164, Zaporizhzhia, 69107, Ukraine

IFB No.: ICB 2.1.8

Date:  [Insert date of issue]

BID GUARANTEE No.:  [Insert guarantee reference number]

Guarantor:  [Insert name and address of place of issue, unless indicated in the letterhead]

We have been informed that ______ [insert name of the Bidder, which in the case of a joint venture shall be the name of the joint venture (whether legally constituted or prospective) or the names of all members thereof] (hereinafter called "the Applicant") has submitted or will submit to the Beneficiary its bid (hereinafter called "the Bid") for the execution of Procurement of medical diagnostic equipment and consumables  Contract under Invitation for Bids No. ICB 2.1.8 (“the IFB”).

Furthermore, we understand that, according to the Beneficiary’s conditions, bids must be supported by a bid guarantee.

At the request of the Applicant, we, as Guarantor, hereby irrevocably undertake to pay the Beneficiary any sum or sums not exceeding in total an amount of ___________   (____________) upon receipt by us of the Beneficiary’s complying demand, supported by the Beneficiary’s statement, whether in the demand itself or a separate signed document accompanying or identifying the demand, stating that either the Applicant:

(a)     has withdrawn its Bid during the period of bid validity set forth in the Applicant’s  Letter of Bid (“the Bid Validity Period”), or any extension thereto provided by the Applicant; or

(b)     having been notified of the acceptance of its Bid by the Beneficiary during the Bid Validity Period or any extension thereto provided by the Applicant, (i) has failed to execute the contract agreement, or (ii) has failed to furnish the performance security, in accordance with the Instructions to Bidders (“ITB”) of the Beneficiary’s bidding document.

This guarantee will expire: (a) if the Applicant is the successful bidder, upon our receipt of copies of the contract agreement signed by the Applicant and the performance security issued to the Beneficiary in relation to such contract agreement; or (b) if the Applicant is not the successful bidder, upon the earlier of (i) our receipt of a copy of the Beneficiary’s notification to the Applicant of the results of the bidding process; or (ii)twenty-eight days after the end of the Bid Validity Period.

Consequently, any demand for payment under this guarantee must be received by us at the office indicated above on or before that date.

This guarantee is subject to the Uniform Rules for Demand Guarantees (URDG) 2010 Revision, ICC Publication No. 758.

_____________________________

[Signature(s)]

Note:  All italicized text is for use in preparing this form and shall be deleted from the final product.

Section II.  Bid Data Sheet(BDS)

ITB 16.4

Period of time the Goods are expected to be functioning (for the purpose of spare parts):  3 years for each device

Period of time the Goods are expected to be functioning (for the purpose of spare parts):  12 monthsfor each device

Section VII.  Schedule of Requirements

4.Technical Specifications

8. Detailed requirements and related services

1.         General Requirements

1.5 The Supplier should provide a complex software support during 36 months from the delivery date (including free access to upgrades and corrections) that is part of the following goods:

LOT 1:

1. Daily blood pressure monitoring apparatus – 100 pcs.

2. Daily electrocardiography registration apparatus – 10 pcs.

LOT2:

1. Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

LOT3:

1. Biochemical analyzer with  – 3 pcs.

2. Immunochemyluminescent analyzers – 3pcs.

1.5 The Supplier should provide a complex software support during 12 months from the delivery date (including free access to upgrades and corrections) that is part of the following goods:

LOT 1:

1. Daily blood pressure monitoring apparatus – 100 pcs.

2. Daily electrocardiography registration apparatus – 10 pcs.

LOT2:

1. Apparatus for ultrasound diagnostics with the possibility of examination of the heart and blood vessels – 7 pcs.

LOT3:

1. Biochemical analyzer with  – 3 pcs.

 2. Immunochemyluminescent analyzers – 3pcs.

Section IX.  Special Conditions of Contract

GCC 28.3

Par.1

The period of validity of the Warranty shall be not less than 36 months from the date of Acceptance for all goods.

The period of validity of the Warranty shall be not less than 12 months from the date of Acceptance for all goods.