PRE- BID T.E. NO.: GMSCL/EQ. PURCHASE/BIOCHEMISTRY-1/2015-16 Name of Item : Automatic Biochemistry Analyzer [A] DATE: 27/05/2015 TIME: 11.00 Hrs. Required Specifications Fully Automated Biochemistry Analyzer [1] 1.1 [2] 2.1 2.2 2.3 2.4 2.5 2.6 [3] 3.1 3.2 3.4 3.5 3.6 3.7 Description of function Fully Automated Random Access Biochemistry Analyzer Operational requirements Fully open programmable system Floor standing model Able to perform atleast 45 chemistries simultaneously for each sample in random or batch mode Stat sample (priority testing) facility Photometric throughput of not less than 300 tests/ hour Assay Type/Methodology: End point, Rate reaction (Fixed time), Kinetic, Single and dual reagent chemistries, Monochromatic/ Bichromatic, Linear/ Non linear with one point or multipoint calibration Technical specifications Reagent Requirements: • Minimum 50 refrigerated positions for reagents on board in a built in compartment to maximize reagent stability • Reagent bottles of size 20 mL -50 mL • Reagent dispensing volumes should be programmable in the steps of 1 μL • It should have level monitoring and refill message for all reagents on-board Reaction Conditions: • Minimum reading volume of reaction mixture should be 200 μL or less • At least 70 or more reusable optical glass/quartz cuvettes having service life of not less than 3 years with current work-load of 1000 tests per day. Spare set of optical glass/quartz cuvettes to be provided. • Temperature of the reaction mixture should be maintained at 37 ± 0.2 ˚C • It should have facility of automatic dilution and automatic rerun of diluted sample for out of range samples • Dilution ratio 1: 100 or better Photometric Requirements: • Spectral range must be 340-800 nm or better • At least 12 wavelengths or more covering all the most commonly used wavelengths for biochemical tests • Diffraction grating optics or long life glass filters • Absorption Range 0.1-3.0 ABS or better. Resolution:0.001 abs or better • Halogen or xenon lamp should have low cost and long service life of at least 1500 working hours with automatic stand by on non-working mode Sample and regent pipetting: • Dedicated sample probe capable of collecting and dispensing low volumes of 2 μL - 50μL with increments of 0.2 μL or better • Sample probe should have liquid level detectors, clot detectors and collision detector • Two separate reagent probes for Reagent 1 and Reagent 2 • Reagent probes should be programmable in the steps of 1 μL and have level detection capability with dispensing volumes of 10 to 400 μL • Both internal and external probe wash facility • Facility of mixing the reaction mixture in cuvettes with stirrer Programming: • Facility to store at least 75 open and modifiable programs for photometric and 1 PRE- BID T.E. NO.: GMSCL/EQ. PURCHASE/BIOCHEMISTRY-1/2015-16 Name of Item : Automatic Biochemistry Analyzer [A] DATE: 27/05/2015 TIME: 11.00 Hrs. Required Specifications Fully Automated Biochemistry Analyzer 3.8 3.9 3.10 3.11 [4] 4.1 4.2 [5] 5.1 5.2 5.3 5.4 5.5 5.6 5.7 calculated parameters Washing station • On board laundry system with 8 or more steps of automatic washing, cleaning and drying • Automatic cuvettes quality check by photometer after washing cycles. Self-diagnosis tests with error-message & on-line display • Water consumption should be low and not more than 30 liters per day • Equipment to be supplied and quoted with one good quality and compatible Water Treatment System/External Deionizer for providing the required quality of de-ionized Type I water with conductivity meter. Technical bid should contain the details of this external device (make, model, manufacturer & specifications) being supplied with the analyzer. Deionizer to be supplied with two years warranty followed by 3 years of CMC that includes change of resin/cartridge or recharging and replacement of any other parts if required. Quality Control • Real time QC program with L-J graphs, Westgard rules with facility to print out QC reports and charts. QC data should be easily retrievable when required. Software/ User Interface • User friendly, easy to operate and show the status of all operations from the first to last step • Display of reaction curves and calibration curves • Facility for back-up of instrument calibration data, analyte chemistry parameters and patient reports • System should have compatible internal or external PC facility with large 17” Screen LCD monitor, data storage of more than 100 GB, standard printer for printing lab reports, keyboard, and optical mouse etc. • To be provided with licensed software for management of patient data and for printing lab reports compatible with operating interface of the analyzer. Barcode Reader – Both for samples and reagents (Optional) Power supply The equipment should operate on power supply of 220V±10% AC, 50-60 Hz fitted with Indian plug with built in/external stabilizer if required for the operation of the equipment Analyzer should be supplied with one compatible on-line UPS having maintenance free batteries and one-hour back-up time. Maintenance System must have easily replaceable parts and a list of necessary maintenance spares and consumables for a period of two years must be attached and supplied with the machine. During warranty and CMC periodic preventive maintenance services (minimum four per year) should be given. To be supplied with 2 years of warranty beginning from the date of installation followed by CMC for 3 years. Cost of CMC for three years must be quoted. Replacement of photometer lamp, probes, tubing and washing station parts should be included in CMC contract. Periods of breakdown of machine will be excluded from warranty/CMC period. Calibration to be done on twice in a year bases and certificate of the same to be provided Permanent service engineer should be available in Gujarat for attending service contracts and 2 PRE- BID T.E. NO.: GMSCL/EQ. PURCHASE/BIOCHEMISTRY-1/2015-16 Name of Item : Automatic Biochemistry Analyzer [A] DATE: 27/05/2015 TIME: 11.00 Hrs. Required Specifications Fully Automated Biochemistry Analyzer [6] 6.1 6.2 6.3 6.4 rectification within 24 hours including free replacement of any defective part during warranty period. Name and address of service engineer should be provided with details of after sales support. Standard, safety and training Equipment manufacturer must bear valid FDA/CE/ISO certification as well as other all certification as per NABL accreditation requirement. Complete circuit diagram, operating and service manuals, manufacturer original calibration report, original factory certification of new equipment, proof of date and place of manufacturing of the supplied equipment should be given at the time of delivery. Comprehensive free and full training of one week for end-users to be arranged by supplier for operating the equipment at the installation site. Measurement of quality The quoted system with exact model shall be demonstrated in working conditions to the technical committee. During demonstration, 25 identical samples of internal quality control sera of normal range and 25 identical samples of internal quality control sera of abnormal range shall be analyzed. The equipment for demonstration can be pre-calibrated as required. The internal quality control sera must be of human origin and from internationally accepted manufacturer of supplier's choice. During analysis, at any time three STAT samples shall be introduced to the equipment. Glucose, Creatinine, ALT, Total Bilirubin and Ca2+ shall be measured in all non-stat samples with first-come-first-analysed algorithm. Glucose, ALT, Creatinine, Calcium, Na+, K+, Cl- shall be measured in STAT samples. Time from starting of analysis of the batch to completion of all results and achieving idle state (53 samples) must be less than 60 minutes. Time for completion of each STAT sample from introduction must be within 15 minutes. At the end of analysis, SD and CV% of each analysis is calculated. [4xCV%] shall not exceed HCFA/CLIA proficiency testing criteria for acceptable performance for each analyte at normal as well as abnormal level sera. Warranty for 2 years & CMC price next 5 years, which should include cost of labour spares, entire equipment. The CMC cost will be taken into consideration for price comparision. 3 PRE- BID T.E. NO.: GMSCL/EQ. PURCHASE/BIOCHEMISTRY-3/2015-16 Name of Item : Colorimeter [A] 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 DATE: 27/05/2015 TIME: 11.00 Hrs. Required Specifications Photoelectric Digital Colorimeter The instrument should cover wavelengths ranging from 400 nm to 800 nm Should have 8 optical filters: 7 occupied positions and one blank position for optional filter Must have 430/440 nm, 490/500 nm, 520 nm, 540 nm, 570 nm and 600/630 nm. The instrument must have %Transmission, Absorption and Concentration modes . % transmission ratio range should be from 0.0 to 100.0 Absorbance range should be from 0.000 to 1.999 Photometric resolution should be 0.1% Transmission or 0.001 Absorption Wave length accuracy should be ±10 nm or better Spectrum bandwidth should be 20 nm or less The instrument should have 4 digit LCD/LED display Reading volume should be 500 μL or less in 1 mL cuvette; and 1 mL or less in 4 mL cuvette. The equipment is to be supplied with 10 cuvettes of both types. Light source should be long life halogen lamp (expected lamp life more than a year with daily use of approximately 3 hours). The equipment is to be supplied with 2 extra lamps. The light detector should be a sealed spill proof photocell. The instrument must come with the warranty of two years. Periods of breakdown of machine will be excluded from warranty period. Calibration of instrument is to be done and certificate of the same to be provided. Permanent service engineer should be available in Gujarat for rectification of problem and free replacement of any defective part during warranty period. Name and address of service engineer should be provided with details of after sales support. The equipment should work on 230±10V AC, 50 Hz power supply. Instrument should accompany with documentary proof of quality and regulatory certification and date and place of manufacture of the equipment. Warranty for 2 years & CMC price next 5 years, which should include cost of labour spares, entire equipment. The CMC cost will be taken into consideration for price comparision. 1 PRE- BID T.E. NO.: GMSCL/EQ. PURCHASE/BIOCHEMISTRY-2/2015-16 Name of Item : ISE based Electrolyte Analyzer [A] 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 DATE: 27/05/2015 TIME: 11.00 Hrs. Required Specifications Fully automated Ion Selective Electrode (ISE) based electrolyte analyser capable of accurate and speedy analysis of Sodium and Potassium in serum, plasma, urine or CSF. The Analyzer should be able to complete the measurement in about 60 seconds time. Analyzer should be able to measure the parameters in low volume of samples not exceeding 150 micro litres. The Analyzer should have long life sensor assembly not requiring any routine maintenance or frequent change of membranes or refilling. Warranty period of electrodes should be at least 3 years. The analyzer is to be supplied with complete warranty for 3 years. Warranty includes the complete machine including all sensor assemblies and their parts. Any breakdown complain under warranty is to be attended within 24 hours. Supplier will have to replace all the parts as well as consumables (except reagents and printer rolls) under warranty free of any cost and on urgent bases. Periods of breakdown (more than 24 hours) of the analyzer will be deducted from the warranty period. . CMC RATES of 4th and 5th year are to be quoted. The cost of reagent/ pack system should be specified with the cost of equipment. Quote the cost of the reagent ( Per cost test ) at rate of minimum number of tests per day. The analyzer must be provided with rate contract of 3 years for reagents and other consumables. It should be able to analyze undiluted urine, CSF and other body fluids without recalibrating or separate programming for each. Resolution for sodium should be 1 mmol/L and resolution for potassium should be 0.1 mmol/L or better. CV for sodium and potassium should be less then 1.5%. The instrument should have automatic self calibration and on demand calibration facility. It must be able to store at least 100 patient test results in memory. The instrument must have user controlled active and economy mode. It should have good quality control program with QC memory storage of 3 levels and automatic calculation of mean, CV, SD, LJ graphs. Reagent packs/ bottles should be low in cost and biohazard free. Preferably the analyzer should have individually replaceable reagent bottles to prevent wastage. The equipment to be supplied with one set of standard spares. Bidder must give original documentary proof for the date and place of manufacture of the quoted equipment. Equipment should be capable to operate continuously between temperatures of 20⁰ -35⁰C and power supply of 220-230 V AC, 50 Hz fitted with Indian plug. Servo Voltage stabilizer must be supplied for protection. Suitable online UPS with maintenance free batteries for minimum 1 hour backup time should be supplied with the equipment. Servo voltage stabilizer and online UPS are also to be supplied with 3 years complete warranty. Any complain under warranty is to be attended under 24 hours. It should be FDA/CE/ISI approved product and ISO compliant. Complete circuit diagram, user manual, service/technical manual and certificate of calibration and inspection from factory must be supplied. List of important spare parts and accessories with their costing be enclosed in both technical and commercial bids for proper scrutiny. Logbook with instructions for daily, weekly, monthly and quarterly maintenance, checklist/support to be provided. The job description of the hospital technician and company service engineer should be clearly spelt out. Warranty for 2 years & CMC price next 5 years, which should include cost of labour spares, entire equipment. The CMC cost will be taken into consideration for price comparision. 1
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