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Catalogue values for Fully Automated Nephelometer

Category Specification Bid Requirement (Allowed Values)
GENERAL Product Description Fully Automated Nephelometer
PRODUCT INFORMATION Working Principle Nephelometry
Analyzing Modes Endpoint, V-Lin Integral, Fixed Time kinetic
Type of tests IgG1, IgG2, IgG3, IgG4, IgA, Total IgG, IgM, Albumin, Prealbumin, A1 Acid Glycoprotein, Transferrin, Haptoglobin, Ceruloplasmin, Antithrombin, ASO, RF, CRP, Ultra Sensitive CRP, C3, C4, C1 Inactivator, α1 Macroglobulin, Apo A1, Apo B, k Light Chain, λ Light Chain, Urine MicroAlbumin, β2 microglobulin and Cystatin, IgE, β Trace Protein, CDT, k Free Light Chain, λ Free Light Chain, Ferritin, LP(a)
Minimum throughput >=60 tests per hour, >=100 tests per hour Or higher
Capacity of storing all the required reagents and controls on- board in refrigerated condition to ensure reagent stability Yes
Generating Levy- Jennings plots, from the stored data for efficient quality control Yes
Automated reagent cap-opener to prevent evaporation of reagents Yes
Samples loaded in Primary tubes, Bar-coded or uncoded tubes, Sample cups for running pediatric or low- volume samples.
Continuous loading Yes
Continuous /STAT capability at any available sample position Yes
Display LED/LCD
Touch screen interface Yes
Computer Workstation (Latest i7 or equivalent) NA(in case of inbuilt PC)
Printer Laser printer
Laser/LED light source of wavelength ≥800nm
Samples on- board with continuous loading and off loading facility ≥30
Temperature control mechanism Dry heater
Reagent type Wet Reagent
Calibration Multipoint Calibration using single standard/Calibrator
Bidirectional host interface to connect with LIMS/HIS Yes
Storage of calibration curves for different reagents Yes
Handheld barcode reader Yes
Reagents/Catridges to be supplied with the machine ASO, RF, CRP
Supply necessary pre-requisites and startup kits, free of cost with required reagents calibrators and controls for the selected tests, as per the mentioned quantity for each test 1
ELECTRICAL AND OPERATIONAL REQUIREMENT Power Requirement 200-240V,50Hz
CERTIFICATIONS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
Availability of valid Medical Device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
Certification for manufacturing unit ISO:13485 (Latest)
Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
Electrical Safety IEC 60601-1-2 or Equivalent BIS
MISCELLANEOUS REQUIREMENTS OEM/Reseller shall ensure uninterrupted availability of all spares, consumables and reagents for atleast 10 years Yes
Availability of toll free facility for technical support maintened by OEM or authorized agencies Yes
User/Technical/Maintenance manuals to be provided in English in hard and soft copy Yes
Details of equipments and procedures required for local calibration and routine maintenance to be provided and advanced maintenance task documentation also to be furnished Yes
Supplier to perform installation, safety and operation checks before handover Yes
Training of users in operation and basic maintenance shall be provided Yes
Contact details of manufacturer, supplier and local service agent to be provided Yes
Certificate of calibration from the manufacturer Yes
Supplier to provide the reagents/cartridges required to complete the installation, training and handover Yes
WARRANTY Warranty (Years) 2, 3, 5 Or higher