Specification for Biochemistry Department

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
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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
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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
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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
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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
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6.1
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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.
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PRE- BID
T.E. NO.:
GMSCL/EQ. PURCHASE/BIOCHEMISTRY-3/2015-16
Name of Item :
Colorimeter
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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]
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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