Catalogue values for 5 Part Automated Hematology Analyser (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | 5 Part Automated Hematology Analyser |
| PRODUCT INFORMATION | Type of Configuration | Benchtop |
| Type of system offered | Closed system | |
| Type of automation | Fully Automatic | |
| Equipment should have automatic start up,shut down and sample analysis | Yes | |
| Analysis principle | Laser based scatter analysis | |
| Type of cell counting | 5 part WBC differential with Retics and NBRC enumeration capability | |
| Should have multi channel analysis for better resolution and reproductability | Yes | |
| Analysis available | WBC, Lympho#, Lympho%, Neutrophil#, Neutrophil %, Basophil#, Basophil%, Easinophil #, Easinophil%, Monocyte#, Monocyte%, RBC, HGB, MCV, PCV, MCH, MCHC, RDW-SD, RDW CV, PLT, MPV, PDW, PLT, PLCR, PLCC, HCT, PCT, RET#, RET%, NRBC# | |
| NRBC% | Yes | |
| IPF analysis | Yes | |
| PLT-0 Analysis | Yes | |
| PLT-F Analysis | Yes | |
| IG % analysis | Yes | |
| IG# analysis | Yes | |
| RET-HE analysis | Yes | |
| HFR analysis | Yes | |
| LFR analysis | Yes | |
| MFR analysis | Yes | |
| IRFanalysis | Yes | |
| Discrete analysis modes available | CBC,CBC+DIFF,CBC+RETIC,CBC+RETIC+DIFF | |
| Analysis method for WBC | Tri-angle Laser flow cytometry | |
| Method for platelet measurement | Electrical impedance | |
| RBC Measurement method | Electrical Impedance | |
| Hb measurement | Cyanide free colorimetry | |
| Retic measurement | On board light scatter (fluorescent dye/retic stain based) for reticulocytes | |
| Maximum sample Aspiration volume needed in all modes | 50µl or less | |
| Minimum sample volume required in all modes | 20µl or less | |
| Throughput capacity in CBC/Differential | 80-90 | |
| Throughput capacity in Retic mode | 45 or more | |
| Type of modes of sample running | Closed vial | |
| 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 | |
| Retic linearity | 0 to 24.5 | |
| 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 | |
| Clot detection facility | Yes | |
| Automatic probe wipe | Yes | |
| Extended Analyses for cytopenic samples | Yes | |
| Quality assurance system with calibration and controls | Yes | |
| Number of quality control programs | Atleast 3 | |
| Type of Calibration | Both manual and automatic | |
| Direct aspiration for capillary blood from finger prick | No | |
| Floating discriminator for platelets and RBC counting for reliable RBC and PLT data | Yes | |
| Separate diluting nozzles for RBC and WBC | Yes | |
| Double bathing mechanism | Yes | |
| Upgradable to integrate with attachment | No | |
| Data Management and Display | Type of data management | In-built system |
| Display | LCD, LED Or higher | |
| PC hard disk | NA | |
| Inbuilt monitor size in inches | NA (for PC based) | |
| Processor of PC Provided with system | NA (If PC not provided) | |
| RAM | NA (If PC not provided) | |
| HDD | NA (If PC not provided) | |
| PC Monitor size if PC provided externally | NA (for Inbuilt based) | |
| The processor and RAM of the board system should be latest version | Yes | |
| Number of USB Port provided | 2 | |
| Type of printer unit | External | |
| Printer type | Thermal 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 | |
| L J Plot facility | Yes | |
| Delta check for cumulative review | Yes | |
| On-line QC option | Yes | |
| Patient moving average | Yes | |
| QC File management | Yes | |
| Facility for workload recording | Yes | |
| Flagging in event of unacceptable control data | Yes | |
| Ability to transmit results to host computer | Yes | |
| Type of user Interface or data entry | Touchscreen, Handheld barcode reader facility, Manual | |
| Have auto cleaning function in the analyser’s software | Yes | |
| POWER REQUIREMENTS | Type of power supply | 100-240 VAC,50-60 Hz |
| Power Backup facility | UPS | |
| Type of UPS | Online | |
| Back up time in minutes | 30, 60, 90, 120 Or higher | |
| Availability of Sufficient Number of Quality control files which store 100 or more XB Analysis | Yes | |
| ACCESSORIES, SPARE PARTS AND CONSUMABLES | Offered equipment unit to be supplied with sufficient consumables (with at least 2/3rd of total shelf life) required for, sufficient to carry out haematological testing of samples" | 500 |
| Should have on board reagent facility and automatic reagent inventory management | Yes | |
| Net work integration with lab information system feature | Yes | |
| 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 | |
| CERTIFICATION AND REPORTS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid drug 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 | |
| Manufacturing unit certification | ISO:13485 (Latest) | |
| Availability of Test Report for product as per Medical Device Rules (MDR) 2017 as amended till date | Yes | |
| Electrical Safety Standards | IEC/EN 60601-1 or equivalent BIS Standard | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement | Yes | |
| WARRANTY | Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 5 Or higher |
| MISCELLANEOUS REQUIREMENTS | OEM/Reseller shall ensure uninterrupted availability of all spares for 10 years | Yes |
| Availability of toll free facility for technical support maintened by OEM or authorized agencies | Yes | |
| User/Technical/Maintenance manuals to be supplied in English in hard and soft copy | Yes | |
| 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, with 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 | |
| Calibration certificates as per NABH requirement | Yes | |
| Time to attend breakdown calls | within 48 hrs | |
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