RequiredOEM Authorization Certificate Bid to RA enabled Yes Automated Hematology Analyser ( 5 Part ) ( 2 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Standards Certifications for the product US FDA * Certification number and date - * Confirmity to quality management standards ISO 9001 & ISO 13485 * Confirmity to electrical safety standards IEC 61010-1
RequiredIEC 61010-2-081
RequiredIEC 61010-2-101 or BIS equivalent * 1/9 Performance Parameters UMDNS Name and Code "Analyzers
RequiredLaboratory
RequiredHematology
RequiredCell Counting
RequiredAutomated [17-741] Analyzers
RequiredLaboratory
RequiredHematology
RequiredCell Counting
RequiredSemiautomated [17-742] Analyzers
RequiredPoint-of-Care
RequiredWhole Blood
RequiredHematology [18-513] Computer Aided Detection Systems
RequiredPathology Slide
RequiredBlood Cell Classification [24-248]" * Clinical Purpose Hematology Analyzers are used to count and characterize blood cells for disease detection and monitoring. Basic analyzers return a complete blood count(CBC) with a 5-part differential white blood cell(WBC) count.Sophisticated analyzers measure cell morphology and can detect small cell populations to diagnose rare blood conditions. * Type of Configuration benchtop * Type of system offered closed system Open system
Requiredclosed system Type of automation fully automatic * Equipment should have automatic start up
Requiredshut down and sample analysis Yes * Analysis principle LASER based scatter analysis LASER based scatter analysis Type of cell counting "5 part WBC differential without Retic and NRBC enumeration capability" "5 part WBC differential without Retic and NRBC enumeration capability" Should have multi channel analyssi for better resolution and reproductability Yes * Analysis available WBC
RequiredLympho#
RequiredLympho %
RequiredNeutrophil#
RequiredNeutrop * 2/9 hil %
RequiredBasophil#
RequiredBasoph il%
RequiredEasinophil #
RequiredEasino phil%
RequiredMonocyte#
RequiredMono cyte%
RequiredRBC
RequiredHGB
RequiredMCV
RequiredP CV
RequiredMCH
RequiredMCHC
RequiredRDW- SD
RequiredRDW CV
RequiredPLT
RequiredMPV
RequiredP DW
RequiredPLT
RequiredPLCR
RequiredPLCC
RequiredHCT
RequiredPCT
RequiredRET#
RequiredRET%
RequiredNRBC #
RequiredNRBC% Yes Yes
RequiredNo Availability of body f luid(CSF
Requiredsynovial
Requiredser ous) parameters like WBC-BF
RequiredRBC-BF
RequiredMN #
RequiredMN%
RequiredPMN%
RequiredPMN#
RequiredTC-BF# No Yes
RequiredNo IPF analysis No Yes
RequiredNo PLT-0 Analysis Yes Yes
RequiredNo PLT-F Analysis Yes Yes
RequiredNo IG % analysis Yes Yes
RequiredNo IG# analysis Yes Yes
RequiredNo RET-HE analysis No Yes
RequiredNo HFR analysis No Yes
RequiredNo LFR analysis No Yes
RequiredNo MFR analysis No Yes
RequiredNo IRFanalysis No Yes
RequiredNo Discrete analysis modes available CBC
RequiredCBC+DIFF CBC
RequiredCBC+DIFF Analysis method for WBC Tri angle Laser flow cytometry Tri angle Laser flow cytometry method for platelet measurement electrical impedance electrical impedance RBC Measurement method electrical impedance light scatter measuring technique
Requiredelectrical impedance Hb measurement cyanide free colorimtery cyanide free colorimtery Retic measurement not provided on board light scatter(flouroscent dye/retic stain based) for reticulocyres
Requirednot provided no of sample racks to cater to different tube sizes 1 1
Required4
Required6 Maximum sample Aspiration volume 20µl or less 20µl or less 3/9 needed in all modes Minimum sample volume required in all modes 20µl or less 20µl or less Throughput capacity in CBC/Differential 50-60 50-60 Throughput capacity in Retic mode NA 45 or more
RequiredNA Type of modes of sample running Open vial Open vial
Requiredcapillary/Pre dilute
RequiredClosed vial
RequiredSTAT Linearity of Platelet " 0 to 3000 * 10 3 cells micro litres" * RBC Linearity 0 to 8 x 10^6 per micro litre or more * Hemoglobin linearity 0 to 25 gm per litre 0 to 25 gm per litre
Required0 to 22 gm per litre Rectic linearity NA 0 to 24.5
RequiredNA WBC linearity " 0 to 300 * 1000 cells micro litres" * Directly measures MCV Yes * Time taken by the analyser to produce the test results(Analysis time) in seconds 40-60 * Availability of Auto dilution Yes Yes
RequiredNo should have clot detection facility Yes Yes
RequiredNo Automatic probe wipe Yes * Extended Analyses for cytopenic samples Yes * Number of reagents 4 * Quality assurance system with calibration and controls Yes * Atleast 3 quality control programs Yes * Type of Calibration Both manual and automatic Both manual and automatic Direct aspiration for capillary blood from finger prick Yes Yes
RequiredNo Floating discriminator for platelets and RBC counting for reliable Yes * 4/9 RBC and PLT data Separate diluting nozzles for RBC and WBC Yes Yes
RequiredNo Double bathing mechanism Yes Yes
RequiredNo Upgradable to integrate with attachment No "Fully automated slidemaker & slide stainer"
RequiredNo Data Management and Display Type of data management PC based PC based
Requiredinbuilt system Display TFT LCD
RequiredLED
RequiredTFT PC hard disk NA >500 GB
RequiredNA Inbuilt monitor size in inches NA (for PC based) >5
RequiredNA (for PC based) Processor of PC Provided with system NA (If PC not provided) I 5 or more
RequiredNA (If PC not provided) RAM NA (If PC not provided) 4 GB
Required8 GB
RequiredNA (If PC not provided) HDD NA (If PC not provided) 500 GB
Required1 TB
RequiredNA (If PC not provided) PC Monitor size in inches if PC provided externally NA (for Inbuilt based) 17 INCHES OR MORE
RequiredNA (for Inbuilt based) The processor and RAM of the board system should be latest version Yes * HIS/LIS Interface HL7 RS232
RequiredEthernet
RequiredHL7 Type of external storage USB USB
RequiredSD Card No of USB Port provided 4 2
Required3
Required4 Printer facility Yes Yes
RequiredNo Type of printer unit External Inbuilt
RequiredExternal Printer type Thermal printer LASER printer
RequiredThermal printer Display and print provided scatter plot and histograms * Auto loader facility Yes * Facility for user defined flagging Yes * "Database capability of storing sets of results and graphics" >= 50000 >= 2000 to 5000
Required" >=5000 to 10000"
Required" >=10000 to 20000"
Required">= 20000 to 50000"
Required5/9 >= 50000 L J Plot facility Yes Yes
RequiredNo delta check for cumulative review Yes Yes
RequiredNo On line QC option Yes Yes
RequiredNo patient moving average Yes Yes
RequiredNo QC File management Yes Yes
RequiredNo Facility for workload recording Yes * "Flagging in event of unacceptable control data" Yes * Ability to transmit results to host computer Yes * Make of PC provided (Reputed make PC to be provided ) - * Type of user Interface or data entry touchscreen touchscreen
Requiredhandheld barcode reader facility
Requiredmanual
Requiredall three Have auto cleaning function in the analyser’s software Yes * Power Requirements Type of power supply in VAC
RequiredHz 100-240 VAC
Required50-60 Hz * Power Backup facility UPS * Type of UPS Online * Rating of UPS in KVA 1 KVA 0.5 KVA
Required1 KVA
Required0.6 KVA Back up time in minutes 30 min 30 min
Required60 min
Required90 min
Required120 min AVAILABILITY OF Sufficient Number of Quality control fileswhich store 100 or more XB Analysis Yes * ACCESSORIES
RequiredSPARE PARTS AND CONSUMABLES "Offered equipment unit to be supplied with sufficient consumables (with at least 2/3rd of total shelf life) required for
Requiredsufficient to carry out haematological testing of samples" 500 500
Required1000
Required10000 6/9 Should have on board regent facility and automatic reagent inventory management Yes * Net work integration with lab information system feature Yes Yes
RequiredNo Operating temperature and humidity "Capable of operating continuously in ambient temperature of 10 to 35 deg C and relative humidity of 15 to 85% in ideal circumstances" * Miscellaneous Parameters Warranty in years 3 3 Number of installations in Central/State/PSU Govt Hospitals ( Hint: Seller should supply a performace certificate of the device to the buyer incase demaneded after placement of order) More than 3 0
RequiredLess than 3
RequiredMore than 3 OEM/Reseller ( if supplied by reseller shall ensure uninterputed availabilty of all spares for 10 years) Yes * Availability of toll free facility for technical support maintened by OEM or authorised agencies Yes Yes
RequiredNo During the warranty period it shall be ensured that all the break down calls are attended with in 48 hrs and the complete details of service agents/contact details should be furnished to buyer and consignee at time of supplies Yes * User/Technical/Mainten ance manuals to be supplied in English in hard and soft copy Yes * 7/9 Details of equipments and procedures required for local calibration and routine maintenance to be supplied and advanced maintenance task documentation also to be furnished Yes * List of important spares and accessories
Requiredwith their part numbers to be supplied to the buyer at the time of supplying the equipment Yes * Installation and Demonstration of equipment and training to be provided after completing supplies before acceptance Yes * The Principal Manufacturer must have direct Presence/approved service center In India Yes * Copies of reports and certifications to be furnished to buyer on demand at time of supplies Yes * Calibration certificates as per NABH requirement Yes * * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
