Publication Ref: Europeaid/133631/D/SUP/HR

CORRIGENDUM No: 1

to the

TENDER DOSSIER Publication Ref: EuropeAid/133631/D/SUP/HR

Subject: Supply of equipment for Strengthening the Institutional Capacity for Blood, Tissues and Cells Location – Republic of Croatia

The following alterations are made to the Tender dossier:

Annex II: Technical Specifications + Technical Offer

The former text:

Lot 3 Cell counter with providing differential leukocyte including haematopoietic progenitor cell and nucleated red blood cell

1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes Cell counter with providing differential leukocyte including haematopoietic progenitor cell and nucleated red blood cell

Quantity: 1 Manufacturer’s name:

Product type, model:

1 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes 1.1. General specification

quantitative automated hematology 1.1.1. Device analyzer

1.1.1.1. technology flow and fluorescent cytometry technology provides a leukocyte differential count 1.1.1.2. analysis and reticulocyte count and body fluids analysis for IVD use in clinical laboratories 1.1.2. Parameters of analysis analysis of nucleated 1.1.2.1. red blood cells (NRBC) provides analysis of percent and absolute number NRBC accurate number of NRBC for samples containing minimum 2% NRBC NRBCs are automatically enumerated with every CBC/diff/CBC Identify and enumerate NRBCs without manual intervention analysis software that corrects the WBC count for NRBT(C)

2 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes sample volume in 1.1.2.2. ≤175µL manual mode: Body Fluid results: WBC-BF, RBC- 1.1.2.3. body fluid count BF,MN#/%, PMN #/% WBC RBC HGB HCT MCV 1.1.2.4. CBC results: MCHC CHCM RDW HDW PLT NEUT LYMPH differential results (no 1.1.2.5. MONO and %): EOS BASO PLT MPV 1.1.2.6. platelet results: PDW PCT

3 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes 1.1.2.7. reticulocite results:

4 parameters morphology differentiation of NRBC within RBC population 1.1.2.8. linear ranges: WBC up to 400 x 10e3/ul

RBC up to 7 x 10e6/ul

PLT up to 3000 x 10e3/ul

1.1.2.9. throughput CBC/DIFF 120samples/hour

1.2. Technical data

1.2.1. Workstation

1.2.1.1. PC Ethernet connection MS Windows or equivalent compatible 1.2.1.2. Software operational system 1.2.1.3. Display LCD or LED screen 19” capacity for archiving 10 000 samples 1.2.2. Data management (including scattergram and histogram) ink jet color printer with networking 1.2.3. Printer option

4 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes 1.2.4. Bar code reader equipped with compatible software Installation performed by contractor or 1.3. Installation authorised service provider All the equipment must include all necessary parts and standards for its installation Testing of all basic function of the instrument on a set of producer’s 1.4. Testing standard samples commonly used for the corresponding instrument. 1.5. Education Theoretical education about basic functions of instrument, software and maintenance in Croatian or 1.5.1. Education interpretation should be provided for 2 biochemists during 2 days organized in Croatia on-site upon instrument installation.

5 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes Practical start-up training for 4 end users (2 biochemists, 2 technicians) after installation and testing in all basic 1.5.2. Start-up training functions of the instrument on set of standard samples, commonly used for the corresponding instrument. Duration of training 1 day. 1.5.3. Manuals Instruction manual in Croatian

1.6. Certificates and documentation medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC, 1.6.1. Conform to EU/CE according to which medical devices standards have to be not only safe but also function in a medical-technical way as described in the manufacturer's "intended purpose" Conform to European Union In Vitro Directive 98/79/EC regarding in vitro 1.6.2. Diagnostic Medical diagnostic medical devices Device Directive (IVD)

6 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes One year after provisional acceptance in accordance with the conditions laid Warranty down in Article 32 of the General Conditions

7 Shall read as new text:

Lot 3 Cell counter with providing differential leukocyte including haematopoietic progenitor cell and nucleated red blood cell

1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes Cell counter with providing differential leukocyte including haematopoietic progenitor cell and nucleated red blood cell

Quantity: 1 Manufacturer’s name:

1.1. General specification

quantitative automated hematology 1.1.1. Device analyzer

1.1.1.1. technology flow or fluorescent cytometry technology provides a leukocyte differential count 1.1.1.2. analysis and reticulocyte count and body fluids analysis for IVD use in clinical laboratories 1.1.2. Parameters of analysis

8 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes analysis of nucleated 1.1.2.1. red blood cells (NRBC) provides analysis of percent and absolute number NRBC accurate number of NRBC for samples containing minimum 2% NRBC NRBCs are automatically enumerated with every CBC/diff/CBC Identify and enumerate NRBCs without manual intervention analysis software that corrects the WBC count for NRBT(C) sample volume in 1.1.2.2. ≤175µL manual mode: Body Fluid results: WBC-BF, RBC- 1.1.2.3. body fluid count BF,MN#/%, PMN #/%

9 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes WBC RBC HGB HCT MCV 1.1.2.4. CBC results: MCHC CHCM RDW HDW PLT NEUT LYMPH differential results (no 1.1.2.5. MONO and %): EOS BASO PLT MPV 1.1.2.6. platelet results: PDW PCT 1.1.2.7. reticulocite results:

4 parameters

10 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes morphology differentiation of NRBC within RBC population 1.1.2.8. linear ranges: WBC up to 400 x 10e3/ul

RBC up to 7 x 10e6/ul

PLT up to 3000 x 10e3/ul

1.1.2.9. throughput CBC/DIFF 120samples/hour

1.2. Technical data

1.2.1. Workstation

1.2.1.1. PC Ethernet connection MS Windows or equivalent compatible 1.2.1.2. Software operational system 1.2.1.3. Display LCD or LED screen 19” capacity for archiving 10 000 samples 1.2.2. Data management (including scattergram and histogram) ink jet color printer with networking 1.2.3. Printer option 1.2.4. Bar code reader equipped with compatible software Installation performed by contractor or 1.3. Installation authorised service provider

11 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes All the equipment must include all necessary parts and standards for its installation Testing of all basic function of the instrument on a set of producer’s 1.4. Testing standard samples commonly used for the corresponding instrument. 1.5. Education Theoretical education about basic functions of instrument, software and maintenance in Croatian or 1.5.1. Education interpretation should be provided for 2 biochemists during 2 days organized in Croatia on-site upon instrument installation. Practical start-up training for 4 end users (2 biochemists, 2 technicians) after installation and testing in all basic 1.5.2. Start-up training functions of the instrument on set of standard samples, commonly used for the corresponding instrument. Duration of training 1 day. 1.5.3. Manuals Instruction manual in Croatian

12 1. 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes 1.6. Certificates and documentation medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC, 1.6.1. Conform to EU/CE according to which medical devices standards have to be not only safe but also function in a medical-technical way as described in the manufacturer's "intended purpose" Conform to European Union In Vitro Directive 98/79/EC regarding in vitro 1.6.2. Diagnostic Medical diagnostic medical devices Device Directive (IVD) One year after provisional acceptance in accordance with the conditions laid Warranty down in Article 32 of the General Conditions

13 The former text:

Lot 4 CO2 incubator

1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes CO2 incubator

Quantity: 2

Manufacturer’s name:

1.1.1. power supply 220-240V, 50/60 Hz Control functions 1.1.2. display screen

microprocessor microprocessor control of temperature, 1.1.3. control humidity, CO2 and O2 (0,1%-5,0% O2) concentration 1.1.4. heating system air jacketed heating system

1.1.5. interior construction

1.1.5.1. Material inner stainless steel

14 1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes stainless steel inner chamber with 1.1.5.2. inner casing smooth inner casing and rounded corners

1.1.5.3. inner volume 210-240 L

number of inner 1.1.5.4. 6 shelves

number of inner glass 1.1.5.5. 6 doors

1.1.5.6. exterior door hinged right

1.1.5.7. inner fan placed on the top of the chamber

humidity water 1.1.5.8. with inclined and rounded corners reservoir

constant humidity (95%)

5ºC above room temperature up to 55 1.1.6. temperature range ºC (room temperature 20-25C; average 23C)

1.1.7. CO2 control

1.1.7.1. range and accuracy range 1-21%; accuracy ±0.1%

1.1.7.2. measurement system IR-CO2 measurement system

15 1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes CO2 regulator with manometer, 1.1.7.3. CO2 regulator connection equipment and appropriate valve 1.1.7.4. 5% CO2 recovery time 5 min 1.1.8. alarm system

1.1.8.1. Type optical and acoustic alarm system for temperature change of ±1ºC, for 1.1.8.2. alarm conditions change of CO2 level ±1%, for low relative humidity (low water level in the chamber container) decontamination automated heat decontamination system 1.1.9. method which does not require removal of incubator including parts (CO2 sensor) 1.2 Installation Installation performed by contractor or authorised service provider All the equipment must include all necessary parts and standards for its installation Testing of all basic function of the 1.3 Testing instrument on a set of producer’s standard samples commonly used for the corresponding instrument. 1.4. Manuals Instruction manual in Croatian

16 1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes Certifications and 1.5. declarations

medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC, Conform to EU/CE 1.5.1. according to which medical devices standards have to be not only safe but also function in a medical-technical way as described in the manufacturer's "intended purpose" One year after provisional acceptance in Warranty accordance with the conditions laid down in Article 32 of the General Conditions

17 Shall read as new text:

Lot 4 CO2 incubator

1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes CO2 incubator

Quantity: 2

Manufacturer’s name:

1.1.1. power supply 220-240V, 50/60 Hz Control functions 1.1.2. display screen

microprocessor microprocessor control of temperature, 1.1.3. control humidity, CO2 and O2 (0,1%-5,0% O2) concentration 1.1.4. heating system air jacketed heating system

1.1.5. interior construction

1.1.5.1. Material inner stainless steel

18 1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes stainless steel inner chamber with 1.1.5.2. inner casing smooth inner casing and rounded corners

1.1.5.3. inner volume 210-240 L

number of inner 1.1.5.4. 6 shelves

number of inner glass 1.1.5.5. 6 doors

1.1.5.6. exterior door hinged right

1.1.5.7. inner fan placed on the top of the chamber

humidity water 1.1.5.8. with inclined and rounded corners reservoir

constant humidity (95%)

5ºC above room temperature up to 55 1.1.6. temperature range ºC (room temperature 20-25C; average 23C)

1.1.7. CO2 control

1.1.7.1. range and accuracy range 0-20%; accuracy ±0.1%

1.1.7.2. measurement system IR-CO2 measurement system

19 1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes CO2 regulator with manometer, 1.1.7.3. CO2 regulator connection equipment and appropriate valve 1.1.7.4. 4% CO2 recovery time 5 min 1.1.8. alarm system

1.1.8.1. Type optical and acoustic alarm system for temperature change of ±1ºC, for 1.1.8.2. alarm conditions change of CO2 level ±1%, for low relative humidity (low water level in the chamber container) decontamination automated heat decontamination system 1.1.9. method which does not require removal of incubator including parts (CO2 sensor) 1.2 Installation Installation performed by contractor or authorised service provider All the equipment must include all necessary parts and standards for its installation Testing of all basic function of the 1.3 Testing instrument on a set of producer’s standard samples commonly used for the corresponding instrument. 1.4. Manuals Instruction manual in Croatian

20 1 5. 4. 2. 3. Evaluation Item Notes, remarks, Specifications Required Specifications Offered Committee’s Number ref to documentation notes One year after provisional acceptance in Warranty accordance with the conditions laid down in Article 32 of the General Conditions

21 Provisional / Final Acceptance Certificate for Lot 4

The former text: PROVISIONAL / FINAL ACCEPTANCE CERTIFICATE for Lot 4 Contract No °2009-0303-1102 Title “Supply of equipment for Strengthening the Institutional Capacity for Blood, Tissues and Cells”

Contractor: ………………………… Beneficiary: ……………………………… …………………….. …………………… …………………….. ……………………. d n n o n a i g

t s y o n s l g a i r i t t e a n e t d a i n u v l t a a e i l n s

Item qty Description c l o a i a l e m e t f n s i T u Remarks t M D n c r U I o e d C

1 […] [……………………] 2 […] [……………………] 3 […] [……………………] 4 […] [……………………] Provisional: All of the above mentioned items have been delivered, installed, tested and found compliant with the Technical Specifications of the supply contract.

Final: The Supplier has remedied any defect or damage occurred during the warranty period, as specified in the contract.

The Contractor The Beneficiary Name Name Signature………………………….. Signature………………………….. Date of acceptance:………………… Date of acceptance:…………………

The Project Manager (Contracting Authority) Name

22 Signature………………………….. Date of acceptance:………………… Shall read as new text:

PROVISIONAL / FINAL ACCEPTANCE CERTIFICATE for Lot 4 Contract No °2009-0303-1102 Title “Supply of equipment for Strengthening the Institutional Capacity for Blood, Tissues and Cells”

Contractor: ………………………… Beneficiary: ……………………………… …………………….. …………………… …………………….. ……………………. n g s y o n l g i r i t a n e d a i u v l t a l i n Item qty Description s l o a a l e e t n s T Remarks M D n U I

1 […] [……………………] 2 […] [……………………] 3 […] [……………………] 4 […] [……………………] Provisional: All of the above mentioned items have been delivered, installed, tested and found compliant with the Technical Specifications of the supply contract.

Final: The Supplier has remedied any defect or damage occurred during the warranty period, as specified in the contract.

The Contractor The Beneficiary Name Name Signature………………………….. Signature………………………….. Date of acceptance:………………… Date of acceptance:…………………

The Project Manager (Contracting Authority) Name Signature…………………………..

23 Date of acceptance:…………………

24 All other terms and conditions of the Tender Dossier remain unchanged. The above alterations to the Tender Dossier are integral part of the Tender Dossier.