Expression Of Interest (Eoi) For Maldi-Tof System, parel-Maharashtra

Expression of Interest (EOI) for MALDI-TOF System; 1 MALDI-TOF Mass Spectrometry (MS)-based IVD system with database, software, workstation, and accessories for microbial identification including Fungi (Filamentous and yeast) and Bacteria (Gram Negative, Gram Positive, Aerobic, Anaerobic Bacteria), Mycobacteria including Mycobacterium tuberculosis and NTM, Actinomycetes etc 2 Instrument should have capability to hold high throughput sample size. Please mention throughput. 3 System should be compatible with disposable/reusable (target slides) 4 System should be equipped with a suitable Laser. Please specify life of laser 5 Should be capable of acquiring spectra from 2,000 – 20,000 daltons 6 Equipped with database to identify clinically relevant bacterial and fungal isolates in a tertiary care diagnostic facility, supporting most recent/wide range of microbes including rare emerging pathogen . 7 The library update for the same must be free and regularly done. 8 The system should be able to detect ~105 or lower input cells. 9 System should be able to identify microbes from positively flagged blood culture bottles 10 Should be able to identify microbes up to species level 11 Should have simplified workflow with minimum steps to load and start a run. 12 System should have internal control or calibration control to monitor the quality of testing in same run 13 Should have suitable middleware software to integrate data of existing systems with the MALDI TOF to have benefits of data consolidation and stat analysis. 14 Vendor has to supply software for data consolidation of ID, antibiogram with tool of stat analysis for data free and any software upgradation hence forth. 15 Equipment software should be windows based, versatile, easy to use for instrument control. 16 The database should be wide with robustness in database to capture variability 17 Should have IVD Mycobacteria database for both MTB and NTM. Number of species should be specified. 18 Should have the flexibility to add gram staining information and other manual AST details of baterial specimen in the middle ware software. 19 Should have database of clinically relevant yeast species. Number of species should be specified. 20 Should have database of clinically relevant fungal species. Number of species should be specified. 21 Should have the feature of automated fine tuning to increase uptime. 22 Should be accompanied with workstation having latest version of windows and Monitors 23 All required software for machine and PC to be provided by the vendor 24 It should be BIS/ICMED/ FDA/ IVD / CE approved 25 Uptime guarantee and Penalty clause for Hi End medical Equipment. a) The supplier and / or its Indian agent will be required to maintain the equipment and all its bought out items (including software updates and various licenses) used for the functionality of the system in good working condition during the warranty/ CMC period with 96% uptime guarantee. b) Equipment shall be fully functional to be considered as the uptime. In case of partial functionality, the proportion of functionality shall be determined and downtime shall be adjusted by such proportion (i.e. if the equipment is 70% functional, 30% downtime shall be applicable). In cases where it is not possible to definitely determine the proportion of functionality, the downtime shall be considered as 100%. c) The decision of the TMC management or its representative in determining the % of the downtime shall be final and binding. d) Essential period to shut down the equipment entirely or partially during warranty/CMC period shall also be included in the downtime while calculating the guaranteed uptime i.e. all features as per specifications in purchase order should be functional for uptime. e) The penalty applicable for downtime shall be calculated on an hourly basis and will be at the rate of 0.004% per hour (0.1% per day) of the total cost of the equipment (excluding works), during and up to the period of warranty/ CMC. There shall be a permissible down time of 360 hours per year, beyond which the down time penalty will be applicable. f) However, in case of the downtime exceeding seven days (i.e. 168 hrs) at a stretch, the downtime beyond these 168 hours will be considered for calculation of downtime penalty. g) The levy of this penalty shall be at the discretion of director TMC irrespective of the overall up time of the equipment throughout the period of the warranty or CMC. h) This clause is to ensure maximum uninterrupted service to patients and hence Director, TMC’s decision in enforcing / invoking this clause will be final and binding for all. i) For CMC, W.O. issued by TMC shall be final as per D.A.E. Norms. TMC & its units shall not sign separate legal contract as per vendor’s format. 27 Should perform yearly calibration/Validation and preventive maintenance (2nos) during warranty & if entered into AMC(includes unlimited breakdown calls) /CMC (which will include spare replacement, consumable spares,breakdown calls) Testing & measuring equipment used should be traceable to SI units through National/international standards( As per NABL norms). To submit SOPs for PMS at the time of installation/commissioning. Also to provide neccessary accessories , including turnkey work for the lab. 28 Should be supplied with standard make UPS with atleast 30 mins backup. 29 Please submit the technical data sheet along with the brochure as a tender document with reference to the quoted make & model. 30 Please specify list of consumables/consumable Spares( i.e.spares need to be replaced at regular intervals, maybe quarterly/half yearly/yearly such as annual maintenance kit etc.) 31 Please specify pre installation requirements [electrical, HVAC, Compressed air ( please specify required air pressure), water requirement (RO/DI/Distilled water with its pressure, flow rate per hour) ; if any of the above is essential] 32 Please specify footprint size & weight. 33 Demo of the quoted model , will be required if so desired by the user, after the opening of the technical bid and prior to opening of financial bid. This is for technical evaluation. 34 Please visit the site to check whether quoted model can be accomodated in the available space. 35 Please specify power consumption. 36 Local Service Support: Should have local office and service support/service engineer for attending the breakdown calls. 37 Response Time: Should not be more than 12 hrs from lodging a breakdown complaint on toll free or by email. 38 Warranty- 5 years 39 CMC- for 5 years after warranty 40 Back to back assurance to be taken by the supplier from OEM to supply spares for minimum 10 years and to be submitted.

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