Technical Evaluation and Physical Verification Report Of Fully Automated Bio-

Immuno Chemistry Analyzer Machine

Technical Secifications Name of the awarded bidder
Name of the bidder: Labline Traders Pvt. Ltd.
Manufacturer: Abbott laboratories
Made In: Singapore
Country Of Origin Singapore
Model No. I1000Sr
Brand: Architect
1. For analysis of Hormones, cancer markers, cardiac markers, Yes, Verified
infectious markers and other special immune assay from
serum and plasma samples

2. Fully automated, latest and bench top analyzer capable of Yes, Verified
performing the qualitative and quantitative analysis of
hormones, cancer markers, cardiac markers, infectious
markers and other special immune assay from serum and
plasma samples.

3. Fully Selective Random Access Analyzer with STAT testing Yes, Verified
capacity.

4. System should be using the latest ECLIA principle for Yes, Verified
measuring the assays with very high sensitivity and linearity

5. System should be brand new & Supplier must provide Yes, Verified
original documentary proof of date of manufacturing along
with factory calibration certificate.

6. System should have facility for on board programs for Yes, Verified
approximately 100 different test parameters with
approximately 50heterogeneous tests and the reagent
should be provided from the same manufacturer.

7. Should have Onboard sample capacity approximately for 30 Yes, Verified

or more at one time with a provision for continues loading.

8. Must have self-diagnostic tests with error message and Yes, Verified
online display.

9. Incubation time for the assays must not exceed 15 minutes Yes, Verified
for fast reporting

10. The label used in reagent should be highly stable and Yes, Verified
should not be present in body fluids to avoid interference
11. System should have on board cooling facility to maintain the Yes, Verified
temperature of the reagent

12. Should have flexibility to use different sample containers like Yes, Verified
primary tubes with different sizes, sample cups for easy
processing.

13. Sample volume requirement should not be more than 50 Yes, Verified
microliters per test to control excessive cost in control.

14. System should have a routine throughput of approximately Yes, Verified

50 test/hr

15. System should have provision of using disposable cups and Yes, Verified
tips for pipetting sample and reagent for all immune assays
test to prevent any carry over contamination to have
relaiable patient results.

16. System should use latex mixing probe or better technology Yes, Verified
to mix the samples and reagent to have a complete
uniformity with clot detection facility.

17. System should have reagent slots for a minimum of 15-20 Yes, Verified
assays

18. Test Menu should be:Systems must have the facility to test Yes, Verified as the tender evaluation
Immunosuppressive drugs panel commonly used in document.
transplant medicine- Tacrolimus, Cyclosporine, Sirolimus ,
Everolimus and other innovative markers like : hsTroponin
T, NTpro BNP, S100, DHEAS, Vit D, CYFRA 21-1, Anti TG,
Anti TPO , B-Crosslaps , P1NP, PLGF, SFLT, ACTH, anti
TSHR, anti CCP, anti HCV, Pro-calcitonin, Hepatitis B
Marker, CMV , HIV assays besides the other routine
immunology parameters

19. On-board reagent stability should be up to two months and Yes, Verified
calibration of the parameter should be typically lot based. No
daily calibration should be required by the system to save
the reagents

20. Calibration for the Parameter must be “Two Point” Yes, Verified

21. System should have on-board windows based data control Yes, Verified
work station with approximately 12” TFT LCD color touch
screen monitor or better for programming the tests and
entering the patient data.
22. System should have the facility to store approximately of Yes, Verified
2000 test results

23. External Printer to take printout of patient results and QC Yes, Verified
reports should be provided

24. Patient samples and Reagents should be scanned with on- Yes, Verified
board barcode scanner for easy operation.

25. System should have 2 x RS 232 or better bi-directional Yes, Verified

interface and in-built modem for remote diagnostics

26. The system offered shall be designed to operate normally Yes, Verified
under the conditions of the purchaser's country. The
conditions include Power Supply, Climate, Temperature,
Humidity, etc.

27. Power supply: 220 – 240 VAC, 50Hz fitted with appropriate Yes, Verified
plug. The power cable must be at least 2 meter in length.

Terms and Condition

28. Must submit ISO13485:2003/AC:2007 for Medical Devices Yes, Verified

AND

29. CE approved AND should be USFDA approved system, Yes, Verified

brand new with each reagent carrying USFDA510K
certificate cleared.

30. Shall meet IEC 61010-2-081safety requirements for Yes, Verified

electrical equipment for measurement, control, and
laboratory use - Part 2-081: Particular requirements for
automatic and semiautomatic laboratory equipment for
analysis and other purposes.

31. Must provide formal user training (including how to use and Yes, Verified
maintain the equipment) to at least two technical staffs and
service training to biomedical staffs for at least 3 days by the
company’s trained engineer.

32. Comprehensive warranty should be 2 years from the date of Yes, Verified
 installation of the machine.

33. Bidders must submit the commitment letter from the Yes, Verified
manufacturer regarding the period of warranty, availability of
spare parts and other related issues.

34. During the warranty period supplier must ensure planned Yes, Verified
preventive maintenance (PPM) and corrective/breakdown
maintenance whenever required.

35. The bidder must arrange for the equipment to be installed Yes, Verified
and commissioned by certified or qualified personnel; any
prerequisites for installation to be communicated to the
purchaser in advance, in detail.

36. Bidder must submit the manufacturer’s authorization letter. Yes, Verified

37. Should provide original brochure of the instrument. Yes, Verified

38. User (Operating) manual in English Yes, Verified

39. Service (Technical / Maintenance) manual in English Yes, Verified

40. List of all spare parts and accessories with their part number Yes, Verified
and costing.

41. The spare parts, which are not mentioned in the spare part Yes, Verified
list, should be bear by the bidder himself.

42. Certificate of calibration and inspection from factory. Yes, Verified

43. Technical Status of the Offer: Brand New Machine is supplied as

per the tender technical
specification and the machine is on
normal working condition till date.