E-Tender for Rate Contract for Supply of Diagnostic Equipment- Blood Gas Analyzer (ABG) Under Reagent Rental Scheme for U. N. Mehta Institute of Cardiology and Research Centre (Affiliated to B. J. Medical College & NABH Accredited) Ahmedabad, Gujarat, India

System for measuring PH, Pco2,Po2, HCo3¯, SO2%, Glucose, Lactate, Complete Haemogolobin & four Electrolytes (Na+, K+, Ca+, Cl-), O2 Hb, HHb, CoHb, MetHb, Billirubin in blood and related calculated parameters like Aniongap, HCo3, Ctco2, Cto2, HCT, etc. All should be measured in a single Injection/aspiration of sample.

ABG analyzer should be Cartridge-based system or a High-capacity Reagent Pack system essential to minimize downtime

Should be able to analyze all parameters using low blood volume directly from syringe or capillaries.

Fast and accurate result of test made available in 120 sec or less.

Data display on well-illuminated Screen/ Display.

The bidder must provide the latest version of their Middleware/Data Management Software including all licenses as part of the CPRT package at no additional cost. Middleware must have following but not limited to: -Automated QC Tracking: The system must automatically plot Levey-Jennings (L-J) charts and apply Westgard Rules -Electronic Audit Trail: Every change, calibration, and test result must be time-stamped and linked to a specific operator ID -Non-Conformity Alerts: Real-time email or SMS alerts to the designated person if a machine fails QC or goes offline. -Remote Monitoring: Ability to view the analyzer screen, check reagent levels, and perform remote troubleshooting from the central lab -LIS Interfacing: Bidirectional communication with the LIS for seamless data flow without manual entry (to eliminate transcription errors)

Automatic calibration with flexible and programmable time schedule.

The machine should have inbuilt thermal printer.

Barcode Scanner: Integrated barcode reader for patient ID, reagent and QC.

Easily Retrievable Internal memory of sample results and controls.

System supply with compatible online UPS with battery back up of at least 30 minute.

The machine should have In built data management system to store patient results, QC results, Calibration reports & self diagnosis.

Machine should be HL7 Ready and also provide Communication protocol for HL7

ABG machine should be USFDA and European CE approved and certificate should be submitted.

Company has to provide minimum no. of ABG machines as mentioned in e-tender document. New ABG Machine for the present sample load and upgrading bed capacity of Institute. Company should install additional ABG machine as per institute requirement.

The contract shall include all consumables to run the full machine i.e. reagent, all spares, consumables, electrodes, QC,Initial and ongoing verification, Lot verification of reagent and QC material, middlwear,Thermal paper roll, Engineering services, UPS, battery etc.

Only Correct report of patient sample will be counted, Tests consumed because of Quality check, false reading, or any other error will not count in billing.

Bidder must perform complete protocol for validation of the system in relation to Installation that includes Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) which must include Precision, Comparision and Linearity check for each instrument.

Ongoing Device verification and Inter-Instrument comparison shall be done on six monthly basis which must include Precision, Comparision with a minimum of three specimens with low, medium and high concentration and Linearity check for each instrument.

For Ahmedabad Centre- New reagent lot evaluation shall be verified three times using each level of QC material. New Quality control material lot to lot evaluation shall be done by comparing three times for each quality control level.

The System must have Auto-QC facility with a programmable interval feature for automatic QC.

For Ahmedabad Centre- Automated Internal quality control for All Parameter: Bidder has to provide QC for Automated internal quality control.One level of QC should be performed per shift for three shifts in a day in each machine and same to be documented after verifying for acceptance. In each shift different level of QC must be used (different level in all three shifts in a day in each equipment).

For Gandhinagar Centre- Automated Internal quality control for All Parameter: Bidder has to provide QC for Automated internal quality control. One level of QC should be performed in a day in each machine same to be documented after verifying for acceptance.

Cold Chain must be maitain for reagents from the original manufacturing company to its authorized distributor or dealer till delivery at UNMICRC store with each shipment.

For Ahmedabad Centre-Cold Chain Maintenance record (Continous temperature monitoring data loggers) should be provided from the original manufacturing company to its authorized distributor or dealer till delivery at UNMICRC store with each shipment.

Bidder has to replace spares like membrane, sensors, electrodes, modules etc. as per maintenance/service/user manual of manufacturer with out any additional cost.

Submit service manual and user manual along with the bid document.

Bidder has to do electrical safety test of equipment and UPS (supplied along with machine) on yearly basis with out any additional cost.