ISO 9001:2015 Certified

OFFICE OF THE MANAGING DIRECTOR

ASSAM MEDICAL SERVICES CORPORATION LIMITED
Central Drug Ware House Campus, Patherquery, Narengi, Guwahati, Assam-781026
Email id: [email protected]

Corrigendum No.2

Tender No: AMSC-EQUI0PROC/27/2024-EQUP PRO-AMSC/2 ECF: 478930 Dated

21.11.2024
FOR PROCUREMENT OF FULLY AUTOMATED BIO-CHEMISTRY ANALYSER AND
SEMI AUTO ANALYSER.

This has reference to the tender no.: AMSC-EQUI0PROC/27/2024-EQUP PRO-AMSC/2 ECF:

478930 Dated 21.11.2024 for “Supply of FULLY AUTOMATED BIO-CHEMISTRY
ANALYSER AND SEMI AUTO ANALYSER.”. The following amendments may be taken
note prior to submission of bids.

5.4 Technical Specification and Quality Standard for FULLY

AUTOMATED BIO-CHEMISTRY ANALYSER AND SEMI AUTO
ANALYSER.
Sr. Tender Specifications To be read as
no.
SEMI-AUTOMATED BIOCHEMISTRY ANALYSER

Sl. Specification Requirements

No.

1 Clinical purpose A semi-automated laboratory A semi-automated laboratory

instrument intended to be used instrument intended to be used
for the qualitative and for the qualitative and
quantitative in vitro quantitative in vitro
determination of multiple clinical determination of multiple clinical
chemistry analytes in a clinical chemistry analytes in a clinical
specimen. Analytes detected may specimen. Analytes detected may
include electrolytes, specific include electrolytes, specific
proteins, lipids and kidney, liver proteins, lipids and kidney, liver

Page 31 of 13
 and cardiac function test and cardiac function test
analytes. analytes.

2 Used by clinical Clinical Diagnostic Laboratory. Clinical Diagnostic Laboratory.

department/ ward

3 Technical characteristics • Analyzer should have ability • Analyzer should have ability to
(specific to this type of to use external cuvettes and use external cuvettes and
device) integrated flow cell. integrated flow cell.
• Analyzer should have more • Analyzer should have 80 or
than 200 programmable more programmable
channels. channels.
• Open Ended system • Open Ended system
preferably. preferably.
• Analyzer should have 5 assay • Analyzer should have 5 assay
types: End point, Fixed time, types: End point, Fixed time,
Kinetic, absorbance and 1- Kinetic, absorbance and 1-
point calibration with option point calibration with option
for extended keyboard. for extended keyboard.
• Analyzer should have • Analyzer should have
calibration types: Linear calibration types: Linear
factor, multi-point, point to factor, multi-point, point to
point and Log-Log out point and Log-Log out
• Facility for kinetic assay • Facility for kinetic assay
measurement with multiple measurement with multiple
standard mode. standard mode.
• Should have minimum 10,000 • Should have minimum
Patient Result memory 100Patient Result memory
Storage Storage
• Should have light source with • Should have light source with
working life of more than working life of more than
2000 hrs. 2000 hrs.
• Should have complete visual • Should have complete visual
range. range.
• 2levels control with day-to- • 2levels control with day-to-
day Levey Jennings chart day Levey Jennings chart
stored and displayed. stored and displayed.
• Provision for Bar Code/QR • To be read as deleted
code reading should be • The equipment should have in-
available. built digital display unit.
• The equipment should have in- • 2.2 User’s interface
built digital display unit. Should have in-built
• 2.2 User’s interface thermal printer/dot
Should have in-built thermal matrix
printer
4 User’s interface • Facility for integration with PC • Facility for integration with PC
for LIS purpose for LIS purpose

Page 32 of 13
 • Provision for LIS/HIS interface • Provision for LIS/HIS interface
should be available. should be available.

5 Heat dissipation Heat Dissipation: Should Heat Dissipation: Should maintain

maintain nominal temperature nominal temperature and the
and the heat should be disbursed heat should be disbursed through
through a cooling mechanism. a cooling mechanism.

6 Power Requirements 220VAC +/- 10%, 50 Hz. 220VAC +/- 10%, 50 Hz.

7 Battery operated UPS system for backup of UPS system for backup of
minimum one hour. minimum one hour.

8 Power consumption To be specified by To be specified by

manufacturer/supplier manufacturer/supplier
9 Accessories (mandatory,
standard, optional); Spare 1. Light source/Lamp-1 no. 1. Light source/Lamp-1 no.
parts (main ones);
2. Micro pipettes - 2 variable (5- 2. Micro pipettes - 2 variable (5-
Consumables/reagents
50), (100-1000) 50), (100-1000)
(open, closed system)
3. Tips 500 - small and 500- big. 3. Tips 500 - small and 500- big.

10 Atmosphere/Ambiance (air To be read as deleted To be read as deleted

conditioning, humidity,
dust ...)

11 User’s care, Cleaning, Disinfection: Parts of the Device Disinfection: Parts of the Device
Disinfection & Sterility that are designed to come into that are designed to come into
issues contact with the patient or the contact with the patient or the
operator should either be operator should either be capable
capable of easy disinfection or be of easy disinfection or be
protected by a single protected by a single
use/disposable cover. use/disposable cover.

12 Certificates (pre-market, Should conform USFDA/ European Should conform USFDA/ European
sanitary, ..); Performance CE/CE-IVD, in case of non- CE/CE-IVD, in case of non-
and safety standards availability of BIS Standards. availability of BIS Standards.
(specific to the device
type);Local and/or
international

13 Pre-installation As indicated by Manufacturer As indicated by Manufacturer and

requirements: nature, and compatible electrical compatible electrical accessories
values, quality, tolerance accessories as per standard as per standard Indian set-up.
Indian set-up.

Page 33 of 13
14 Requirements for sign-off 1. Supplier to perform 1. Supplier to perform
installation, safety and operation installation, safety and operation
checks before handover. checks before handover.

2. Lab In-Charge to affirm 2. Lab In-Charge to affirm

completion of installation. completion of installation.

15 Training of staff (medical, Satisfactory training of users in Satisfactory training of users in

paramedical, technicians) operation and basic maintenance operation and basic maintenance
shall be provided on installation shall be provided on installation
and during Preventive and during Preventive
Maintenance visits and shall be Maintenance visits and shall be
documented. documented.

16 Warranty 1. 3 years, including all spares 1. 3 years, including all spares and
and calibration. State/UT to link calibration. State/UT to link with
with the existing Biomedical the existing Biomedical
Equipment Management and Equipment Management and
Maintenance Program under Maintenance Program under
NHM. NHM.

2. Preventive maintenance visits 2. Preventive maintenance visits

at least one in each quarter at least one in each quarter

17 Operating manuals, service Should provide 2 sets (hardcopy Should provide 2 sets (hardcopy
manuals, other manuals and soft-copy) of: - and soft-copy) of: -

1) User, technical and 1) User, technical and

maintenance manuals to be maintenance manuals to be
supplied in English/Hindi supplied in English/Hindi
language along with machine language along with machine
diagrams. diagrams.

2) List of equipment and 2) List of equipment and

procedures required for local procedures required for local
calibration and routine calibration and routine
maintenance. maintenance.

3) Service and operation manuals 3) Service and operation manuals

(original and copy) to be (original and copy) to be
provided. provided.

4) Advanced maintenance tasks 4) Advanced maintenance tasks

documentation. documentation.

5) Certificate of calibration and 5) Certificate of calibration and

inspection. inspection.

Page 34 of 13
18 Other accompanying To be read as deleted To be read as deleted
documents

19 Service Support Contact Contact details of manufacturer, Contact details of manufacturer,

details (Hierarchy Wise; supplier and local service agent supplier and local service agent to
including a toll to be provided. be provided.
free/landline number)

20 Recommendations or Any warning signs would be Any warning signs would be

warnings adequately displayed. adequately displayed.

21 Warranty Warranty- 3 Years Warranty- 3 Years

Page 35 of 13
Sr. Tender To be read as
no. Specifications
TECHNICAL SPECIFICATION OF FULLY
BIOCHEMISTRY ANALYZER

SYSTEM FUNCTION:

1.1 Description : The analyzer should be

automated, discrete, STAT
The analyzer should be automated,
sample priority, random
discrete, STAT sample priority,
access model, clinical
random access model, clinical
chemistry analyzer capable
chemistry analyzer capable of
of performing biochemistry
performing biochemistry and
and immunoturbidimetric
immunoturbidimetric assays. The
assays. The analyzer should
analyzer should have facility for
have facility for unlimited
unlimited number of programmable
number of programmable
profiles and calculation Item.
profiles and calculation
Item.

1.2 Measuring Spectrophotometry/colori Spectrophotometry/colorimetry,

metry, Immunoturbidometric
principle:
Immunoturbidometric

1.3 Methodology: The analyzer should be The analyzer should be capable of

capable of All Types of All Types of Assays, e.g.. End
Assays, e.g.. End point, point, Rate kinetic, Fixed - time,
Rate kinetic, Fixed - time, Single and double reagents
Single and double reagents chemistry,turbidometric &
chemistry,turbidometric & bichromatic assays, Linear and non-
bichromatic assays, Linear linear multipoint calibration.
and non-linear multipoint
calibration.

1.4 Samples: The analyzer should be able

to use different type of The analyzer should be able to use
Samples - Serum, Plasma, different type of Samples - Serum,
Urine, CSF and body fluid Plasma, Urine, CSF and body fluid
samples, Oral Fluid. samples, Oral Fluid.

1.5 Sample volume: The analyzer should have

The analyzer should have sample
sample pipetting between
pipetting between 2–25 µl or wider
2–25 µl or wider range
range with increments of 0.1 µl
with increments of 0.1 µl

Page 36 of 13
1.6 Reagents/Sample Should have built in Cooled Should have built in Cooled reagent
reagent Compartment. The Compartment. The analyzer should
tray:
analyzer should accept test accept test tubes and micro cup .
tubes and micro cup . All positions on sample disk should
All positions on sample accept STAT samples, blanks,
disk should accept STAT controls, standards in the same
samples, blanks, controls, sample tray. The analyzer should
standards in the same have provision to use all open
sample tray. The analyzer position as STAT positions for
should have provision to emergency samples.
use all open position as
STAT positions for
emergency samples.

1.7 Reagents/Sample The analyzer should have

at least two separate The analyzer should have at least
sample probe:
probes: one for the sample two separate probes: one for the
and one for the reagents sample and one for the reagents
with mixer. with mixer.
The analyzer should include The analyzer should include the
the following features: following features:

-Liquid level detection. -Liquid level detection.

-Vertical and horizontal -Vertical and horizontal collision

collision protection. protection.

-Inventory checking. -Inventory checking.

1.8 Probe cleaning: Automatic washing. Automatic washing.

1.9 Throughput: At least 150 tests / hour

photometric At least 150 tests / hour photometric

2 Reaction Tray: Must have on board

capacity for
permanent/semidisposable
and numbered Must have on board capacity for
cuvettes/cuvette rotor .The permanent/semidisposable and
analyser should have numbered cuvettes/cuvette rotor
dedicated on board laundry .The analyser should have
system to wash and dry dedicated on board laundry system
cuvettes.. to wash and dry cuvettes..

Page 37 of 13
2.1 Automatic
dilution:
To be read as deleted To be read as deleted

2.2 Light source: Should have solid state light

source (LED Technology) with Should have solid state light source
a split reference beam with (LED Technology) with a split
working life of more than reference beam with working life of
2000 hrs./ Halogen tungsten more than 2000 hrs./ Halogen
lamp/Quartz Iodine tungsten lamp/Quartz Iodine

2.3 Wave length: Optical System should have Optical System should have
Wavelength range from 340 Wavelength range from 340 to 700
to 700 nm or wider nm or wider

2.4 Calibrator The system should be

having the facility of both The system should be having the
method:
auto- calibration and facility of both auto- calibration
manual. and manual.

2.5 Quality control Real-time, daily, monthly &

QC chart, Visual QC Real-time, daily, monthly & QC
method:
assessment , QC history chart, Visual QC assessment , QC
checking QC error analysis. history checking QC error analysis.

2.6 Control rules: Westgard multi-rule, L-J Westgard multi-rule, L-J

chart,Cumulative sum check. chart,Cumulative sum check.

ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2

3.1 Power Requirements 220VAC +/- 10%, 50 Hz. 220VAC +/- 10%, 50 Hz.

3.2 Online UPS system with

minimum one hour back Online UPS system with minimum
Battery operated up one hour back up

3.3 Protection NA NA

3.4 To be specified by
Power consumption manufacture To be specified by manufacture

3.5 Other Technical

• Provision for bi-
characteristic:
directional LIS/HIS • Provision for bi-directional
interface should be LIS/HIS interface should be
available. available.

Page 38 of 13
 1.The analyzer should
have provision to collect 1.The analyzer should have
biohazard waste in a provision to collect biohazard waste
separate container. in a separate container.
The analyzer should have
facility for Barcode/QR code The analyzer should have facility for
Reading and Scanning of the Barcode/QR code Reading and
sample . Scanning of the sample .

3..The analyzer should be

3..The analyzer should be supplied
supplied with 3 year
with 3 year warranty.
warranty.

4. The System Should be 4. The System Should be open

open System System

5.Should have minimum

50,000 Patient Result 5.Should have minimum 50,000
memory Storage. Patient Result memory Storage.

6. The equipment should 6. The equipment should have in-built

have in-built digital display digital display unit/Panel
unit/Panel PC/Dedicated PC/Dedicated Desktop PC interface
Desktop PC interface facility. facility.

7.Minimum carryover of
not more than 0.05 ppm. To be read as deleted

8.2000 nos of samples 8.2000 nos of samples cups should

cups should be supplied be supplied

9.Variable Micropipettes
of 10 to 100 and 100 to 9.Variable Micropipettes of 10 to
1000 microliters one each 100 and 100 to 1000 microliters
should be supplied. one each should be supplied.

ACCESSORIES, SPARE PARTS, CONSUMABLES

Page 39 of 13
4.1 Accessories Suitable water plant Suitable water plant /Purification
(mandatory, standard, /Purification system should system should be provided by only
optional); Spare parts be provided by only those those bidders who are quoting
(main ones); bidders who are quoting equipment which consumes more
equipment which consumes than 1 L/hour of water. If the
Consumables/reagents
more than 1 L/hour of consumption is more than 1 litre then
(open, closed system)
water. If the consumption is the bidder should provide suitable
more than 1 litre then the water plant/Purification system like
bidder should provide CLSI Type II Deionized water plant of
suitable water higher capacity. The entire servicing,
plant/Purification system maintenance, repairs, change of
like CLSI Type II Deionized consumables and complaints need to
water plant of higher be handled by the bidder for the time
capacity. The entire of equipment warranty.
servicing, maintenance, However if bidder offers machine
repairs, change of whose water consumption is less than
consumables and complaints 1 Litre then the water plant is not
need to be handled by the required.
bidder for the time of 2. External printer( Laser)
equipment warranty. 3.Online UPS for atleast 1 hour
However if bidder offers backup.
machine whose water
consumption is less than 1
Litre then the water plant is
not required.
2. External printer( Laser)
3.Online UPS for atleast 1
hour backup.

ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS

5.1 Atmosphere/Ambiance
(air conditioning,
humidity, dust ...) To be read as deleted To be read as deleted

5.2 User’s care, Cleaning, To be specified by To be specified by manufacturer

Disinfection & Sterility manufacturer
issues

STANDARDS AND SAFETY

6.1 Certificates (pre 1 Should conform USFDA/ Should conform USFDA/ European
market, sanitary, ..); European CE/CE-IVD, in CE/CE-IVD, in case of non-
Performance and safety case of non-availability of availability of BIS Standards.
standards (specific to BIS Standards.
the device type);Local
.
and/or international

Page 310 of 13
 TRAINING AND INSTALLATION

7.1 Pre-installation As indicated by

requirements: nature, Manufacturer and
values, quality, compatible electrical As indicated by Manufacturer and
tolerance accessories as per compatible electrical accessories as
standard Indian set-up. per standard Indian set-up.

7.2 Requirements for sign- Supplier to perform

of installation, safety and Supplier to perform installation,
operation checks before safety and operation checks before
handover. handover.

7.3 Training of staff Satisfactory training of

(medical, paramedical, users in operation and Satisfactory training of users in
technicians). basic maintenance shall operation and basic maintenance
be provided on installation shall be provided on installation
and during Preventive and during Preventive
Maintenance visits and Maintenance visits and shall be
shall be documented. documented.

WARRANTY AND MAINTENANCE

8.1 Warranty 1. 3 years, 1. 3 years, including

including all all spares and calibration.
spares and 2. Preventive
calibration. maintenance visits at least
2. one in each quarter
Preventive
maintenance visits
at least one in
each quarter
DOCUMENTATION

9.1 Operating manuals, Should provide 2 sets Should provide 2 sets (hardcopy
service manuals, other (hardcopy and soft-copy) and soft-copy) of: - 1) User,
manuals. of: - 1) User, technical and technical and maintenance
maintenance manuals to manuals to be supplied in
be supplied in English/Hindi language along with
English/Hindi language machine diagrams. 2) List of
along with machine equipment and procedures
diagrams. 2) List of required for local calibration and
equipment and routine maintenance. 3) Certificate
procedures required for of calibration and inspection
local calibration and
routine maintenance. 3)

Page 311 of 13
 Certificate of calibration
and inspection

NOTES

Service Support Contact Contact details of Contact details of manufacturer,

details (Hierarchy Wise; manufacturer, supplier supplier and local service agent to
including a and local service agent to be provided.
10. tollfree/landline be provided.
1 number)

10. Recommendations or Any warning signs should Any warning signs should be
2 warnings be adequately displayed adequately displayed

Additional Point

1. Reagents to be supplied with machine as FOC: -

In System pack (prefilled and disposable bottles) for 500 tests each:-
Creatinine, Urea, Uric Acid, Triglycerides, HDL, LDL, Glucose, Cholesterol, Total
Protein, Total Calcium, Albumin, SGOT, SGPT, Alkaline Phosphatase, Bilirubin
(Total & Direct), Amylase ,GGT,Microalbumin,CRP and RA factor.

2.

All above FOC reagents shall be supplied along with Calibrator - 4 number And
Quality Control -5 Nos Each For Normal And Abnormal and all other necessary
accessories like sample cups, cleaning solution, cuvettes, reagent bottles etc. in
sufficient quantity so as to perform abovementioned number of tests from
FOC reagents supplied.

All other terms and conditions of the above referred tender shall
remain unchanged.

Sd/-
Managing Director, AMSCL, Assam

Page 312 of 13
Page 313 of 13