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.
Item
Number
2.
Specifications Required
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
Cell counter with providing differential leukocyte including haematopoietic progenitor cell and nucleated red blood cell
Quantity: 1
Manufacturer’s name:
1
1.
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
Product type, model:
1.1.
General specification
1.1.1.
Device
quantitative automated hematology
analyzer
1.1.1.1.
technology
flow and fluorescent cytometry
technology
1.1.1.2.
analysis
provides a leukocyte differential count
and reticulocyte count and body fluids
analysis for IVD use in clinical
laboratories
1.1.2.
Parameters of
analysis
1.1.2.1.
analysis of nucleated
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
2
1.
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
Identify and enumerate NRBCs without
manual intervention
analysis software that corrects the WBC
count for NRBT(C)
1.1.2.2.
sample volume in
manual mode:
≤175µL
1.1.2.3.
body fluid count
Body Fluid results: WBC-BF, RBCBF,MN#/%, PMN #/%
WBC
RBC
HGB
1.1.2.4.
1.1.2.5.
CBC results:
differential results (no
and %):
HCT
MCV
MCHC
CHCM
RDW
HDW
PLT
NEUT
LYMPH
MONO
EOS
BASO
3
1.
2.
Specifications Required
Item
Number
1.1.2.6.
platelet results:
1.1.2.7.
reticulocite results:
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
PLT
MPV
PDW
PCT
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
1.2.
Technical data
1.2.1.
Workstation
1.2.1.1.
PC
Ethernet connection
1.2.1.2.
Software
MS Windows or equivalent compatible
operational system
CBC/DIFF 120samples/hour
4
1.
2.
Specifications Required
Item
Number
1.2.1.3.
Display
LCD or LED screen 19”
1.2.2.
Data management
capacity for archiving 10 000 samples
(including scattergram and histogram)
1.2.3.
Printer
ink jet color printer with networking
option
1.2.4.
Bar code reader
equipped with compatible software
1.3.
Installation
Installation performed by contractor or
authorised service provider
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
All the equipment must include all
necessary parts and standards for its
installation
1.4.
Testing
1.5.
Education
Testing of all basic function of the
instrument on a set of producer’s
standard samples commonly used for the
corresponding instrument.
5
1.
2.
Specifications Required
Item
Number
Education
Theoretical education about basic
functions of instrument, software and
maintenance in Croatian or
interpretation should be provided for 2
biochemists during 2 days organized in
Croatia on-site upon instrument
installation.
1.5.2.
Start-up training
Practical start-up training for 4 end users
(2 biochemists, 2 technicians) after
installation and testing in all basic
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
1.5.1.
1.6.1.
Conform to EU/CE
standards
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
medical devices have to comply with
"essential requirements" as described in
Annex I of Directive 93/42/EEC,
according to which medical devices
have to be not only safe but also
function in a medical-technical way as
described in the manufacturer's
"intended purpose"
6
1.
2.
Specifications Required
Item
Number
1.6.2.
Conform to European
Union In Vitro
Diagnostic Medical
Device Directive
(IVD)
Directive 98/79/EC regarding in vitro
diagnostic medical devices
Warranty
One year after provisional acceptance in
accordance with the conditions laid
down in Article 32 of the General
Conditions
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
7
Shall read as new text:
Lot 3 Cell counter with providing differential leukocyte including haematopoietic progenitor cell and nucleated red blood cell
1.
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
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.
General specification
1.1.1.
Device
quantitative automated hematology
analyzer
1.1.1.1.
technology
flow or fluorescent cytometry
technology
1.1.1.2.
analysis
provides a leukocyte differential count
and reticulocyte count and body fluids
analysis for IVD use in clinical
laboratories
1.1.2.
Parameters of
analysis
8
1.
2.
Specifications Required
Item
Number
1.1.2.1.
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
analysis of nucleated
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)
1.1.2.2.
sample volume in
manual mode:
≤175µL
1.1.2.3.
body fluid count
Body Fluid results: WBC-BF, RBCBF,MN#/%, PMN #/%
9
1.
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
WBC
RBC
HGB
HCT
1.1.2.4.
CBC results:
MCV
MCHC
CHCM
RDW
HDW
PLT
1.1.2.5.
differential results (no
and %):
NEUT
LYMPH
MONO
EOS
BASO
1.1.2.6.
platelet results:
PLT
MPV
PDW
PCT
1.1.2.7.
reticulocite results:
4 parameters
10
1.
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
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
1.2.
Technical data
1.2.1.
Workstation
1.2.1.1.
PC
Ethernet connection
1.2.1.2.
Software
MS Windows or equivalent compatible
operational system
1.2.1.3.
Display
LCD or LED screen 19”
1.2.2.
Data management
capacity for archiving 10 000 samples
(including scattergram and histogram)
1.2.3.
Printer
ink jet color printer with networking
option
1.2.4.
Bar code reader
equipped with compatible software
CBC/DIFF 120samples/hour
11
1.
2.
Specifications Required
Item
Number
1.3.
Installation
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
Installation performed by contractor or
authorised service provider
All the equipment must include all
necessary parts and standards for its
installation
1.4.
Testing
1.5.
Education
1.5.1.
1.5.2.
Testing of all basic function of the
instrument on a set of producer’s
standard samples commonly used for the
corresponding instrument.
Education
Theoretical education about basic
functions of instrument, software and
maintenance in Croatian or
interpretation should be provided for 2
biochemists during 2 days organized in
Croatia on-site upon instrument
installation.
Start-up training
Practical start-up training for 4 end users
(2 biochemists, 2 technicians) after
installation and testing in all basic
functions of the instrument on set of
standard samples, commonly used for
the corresponding instrument. Duration
of training 1 day.
12
1.
2.
Specifications Required
Item
Number
1.5.3.
Manuals
1.6.
Certificates and
documentation
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
Instruction manual in Croatian
1.6.1.
Conform to EU/CE
standards
medical devices have to comply with
"essential requirements" as described in
Annex I of Directive 93/42/EEC,
according to which medical devices
have to be not only safe but also
function in a medical-technical way as
described in the manufacturer's
"intended purpose"
1.6.2.
Conform to European
Union In Vitro
Diagnostic Medical
Device Directive
(IVD)
Directive 98/79/EC regarding in vitro
diagnostic medical devices
Warranty
One year after provisional acceptance in
accordance with the conditions laid
down in Article 32 of the General
Conditions
13
The former text:
Lot 4 CO2 incubator
1
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
CO2 incubator
Quantity: 2
Manufacturer’s name:
Product type, model:
1.1.
General specification
1.1.1.
power supply
1.1.2.
Control functions
display screen
1.1.3.
microprocessor
control
microprocessor control of temperature,
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
220-240V, 50/60 Hz
inner stainless steel
14
1
2.
Specifications Required
Item
Number
1.1.5.2.
inner casing
stainless steel inner chamber with
smooth inner casing and rounded
corners
1.1.5.3.
inner volume
210-240 L
1.1.5.4.
number of inner
shelves
6
1.1.5.5.
number of inner glass
doors
6
1.1.5.6.
exterior door
hinged right
1.1.5.7.
inner fan
placed on the top of the chamber
1.1.5.8.
humidity water
reservoir
with inclined and rounded corners
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
constant humidity (95%)
1.1.6.
temperature range
1.1.7.
CO2 control
1.1.7.1.
range and accuracy
5ºC above room temperature up to 55
ºC (room temperature 20-25C; average
23C)
range 1-21%; accuracy ±0.1%
15
1
2.
Specifications Required
Item
Number
1.1.7.2.
measurement system
IR-CO2 measurement system
1.1.7.3.
CO2 regulator
CO2 regulator with manometer,
connection equipment and appropriate
valve
1.1.7.4.
5% CO2 recovery time
5 min
1.1.8.
1.1.8.1.
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
alarm system
Type
optical and acoustic alarm system
1.1.8.2.
alarm conditions
for temperature change of ±1ºC, for
change of CO2 level ±1%, for low
relative humidity (low water level in the
chamber container)
1.1.9.
decontamination
method
automated heat decontamination system
which does not require removal of
incubator including parts (CO2 sensor)
Installation
Installation performed by contractor or
authorised service provider
1.2
3.
Specifications Offered
All the equipment must include all
necessary parts and standards for its
installation
16
1
2.
Specifications Required
Item
Number
1.3
Testing
Testing of all basic function of the
instrument on a set of producer’s
standard samples commonly used for the
corresponding instrument.
1.4.
Manuals
Instruction manual in Croatian
1.5.
Certifications and
declarations
1.5.1.
Conform to EU/CE
standards
medical devices have to comply with
"essential requirements" as described in
Annex I of Directive 93/42/EEC,
according to which medical devices
have to be not only safe but also
function in a medical-technical way as
described in the manufacturer's
"intended purpose"
Warranty
One year after provisional acceptance in
accordance with the conditions laid
down in Article 32 of the General
Conditions
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
17
Shall read as new text:
Lot 4 CO2 incubator
1
2.
Specifications Required
Item
Number
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
CO2 incubator
Quantity: 2
Manufacturer’s name:
Product type, model:
1.1.
General specification
1.1.1.
power supply
1.1.2.
Control functions
display screen
1.1.3.
microprocessor
control
microprocessor control of temperature,
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
220-240V, 50/60 Hz
inner stainless steel
18
1
2.
Specifications Required
Item
Number
1.1.5.2.
inner casing
stainless steel inner chamber with
smooth inner casing and rounded
corners
1.1.5.3.
inner volume
210-240 L
1.1.5.4.
number of inner
shelves
6
1.1.5.5.
number of inner glass
doors
6
1.1.5.6.
exterior door
hinged right
1.1.5.7.
inner fan
placed on the top of the chamber
1.1.5.8.
humidity water
reservoir
with inclined and rounded corners
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
constant humidity (95%)
1.1.6.
temperature range
1.1.7.
CO2 control
1.1.7.1.
range and accuracy
5ºC above room temperature up to 55
ºC (room temperature 20-25C; average
23C)
range 0-20%; accuracy ±0.1%
19
1
2.
Specifications Required
Item
Number
1.1.7.2.
measurement system
IR-CO2 measurement system
1.1.7.3.
CO2 regulator
CO2 regulator with manometer,
connection equipment and appropriate
valve
1.1.7.4.
4% CO2 recovery time
5 min
1.1.8.
1.1.8.1.
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
alarm system
Type
optical and acoustic alarm system
1.1.8.2.
alarm conditions
for temperature change of ±1ºC, for
change of CO2 level ±1%, for low
relative humidity (low water level in the
chamber container)
1.1.9.
decontamination
method
automated heat decontamination system
which does not require removal of
incubator including parts (CO2 sensor)
Installation
Installation performed by contractor or
authorised service provider
1.2
3.
Specifications Offered
All the equipment must include all
necessary parts and standards for its
installation
20
1
2.
Specifications Required
Item
Number
1.3
Testing
Testing of all basic function of the
instrument on a set of producer’s
standard samples commonly used for the
corresponding instrument.
1.4.
Manuals
Instruction manual in Croatian
Warranty
One year after provisional acceptance in
accordance with the conditions laid
down in Article 32 of the General
Conditions
3.
Specifications Offered
4.
Notes, remarks,
ref to documentation
5.
Evaluation
Committee’s
notes
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”
1
[…]
[……………………]
2
[…]
[……………………]
3
[…]
[……………………]
4
[…]
[……………………]
Certificates and
documentation
Manuals
Testing
Description
Installation
qty
Unloading
Item
Beneficiary: ………………………………
……………………
…………………….
Delivery
Contractor: …………………………
……………………..
……………………..
Remarks
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
Name
Signature…………………………..
Date of acceptance:…………………
The Beneficiary
Name
Signature…………………………..
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”
1
[…]
[……………………]
2
[…]
[……………………]
3
[…]
[……………………]
4
[…]
[……………………]
Manuals
Testing
Description
Installation
qty
Unloading
Item
Beneficiary: ………………………………
……………………
…………………….
Delivery
Contractor: …………………………
……………………..
……………………..
Remarks
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
Name
Signature…………………………..
Date of acceptance:…………………
The Beneficiary
Name
Signature…………………………..
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.
25