RequiredExperience with Government
RequiredCertificate (Requested in ATC)
RequiredOEM Authorization Certificate
RequiredOEM Annual Turnover Bid to RA enabled No Cardiac TMT Machine With Monitor And Printer ( 2 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description Cardiac TMT Machine with Monitor and Printer * Clinical Purpose To study cardiac abnormalities in patients under stress conditions by * 1/14 exercising the patient on a treadmill according to a standardized protocol Product components Heavyduty medical treadmill with online UPS for the whole system
RequiredComputer system
Requiredprinter
RequiredVoltage stabilizer and software along with trolley system to mount computer & printer * Facility
Requiredwhereby data should be able to be acquired and digitized near the patient
Requiredproviding better ECG signal Yes * TREADMILL SPECIFICATIONS Treadmill Type Four tier heavy duty noise less medical tread mill with coasters having locking arrangement * Compatible online UPS for the whole system with minimum 3 hrs back up time Yes * Rating of UPS (KVA) 3 3 Stop/start button on treadmill for emergency stop Yes * Emergency stop button(ESB) must have the ability to be located in the location of choice by the end user Yes * Tredmill should have zero start Yes * Automatic operation from the main unit as per test protocol Yes * Fold down hand rails on treadmill for allowing easy and convenient assemble and installation Yes * Length of Treadmill Floor (mm) 1900 1900.0 Width of Treadmill Floor (mm) 710 710.0 2/14 Length of walking area on treadmill (mm) 1321 1321.0 Width of walking area on treadmill (mm) 508 508.0 Patient Load Capacity of Treadmill (Kg) 200 200.0 Speed range of Treadmill 0.1 to 14 km/Hr or higher range * Inclination( continuously variable) 0-25 or more * Treadmill motor AC Motor * Power requirements 220 - 240 VAC @ 50-60 Hz * Double sided polish on walking surface of treadmill for prolonged product life span Yes * Remote keyboard operation to start
Requiredstop and increase or decrease elevation and speed of treadmill Yes * Self-aligning anti skid conveyor belt Yes * Communication/Conn ectivity RS232
RequiredRS232
RequiredWifi
RequiredBluet ooth RS232
RequiredWifi
RequiredBluetooth Enhanced tolerance to electrical changes for greater patient safety Yes * Self-calibrating system for speed Yes * Inbuilt digital control issues
Requiredprecise speed and grade control in the system Yes * Delivers high torque even at low speeds which ensures no lag when the foot strikes the belt Yes * Provide smooth power and accuracy even at slow speeds Yes * Normal
Requiredslow deceleration and emergency stop modes Yes * 3/14 on treadmill Voltage Stabilizer provided Yes * Rating of Stabilizer (KVA) 3 KVA 3 KVA COMPUTER SYSTEM SPECIFICATIONS Type of Monitor LCD LCD Touch Screen Monitor No No Size of Monitor (inch) 17 17.0 RAM size 2 GB 2 GB Hard disk space 500 GB 500 GB Processer Intel core i3 Intel core i3 Operating System Windows 10 or Higher * CD ROM Drive Yes * Number of serial port 2 2 Number of USB Ports 4 4 Alphanumeric multimedia PC keyboard with systems dedicated keypad Yes * Standard PC mouse Yes * Built in uninterrupted power supply for minimum of 3 minutes Yes * QRS triggered output Yes * Parameters Displayed by the system 12 Lead raw ECG
Required12 lead ST level & Slops
RequiredEnlarged QRS complex with maximum ST level
RequiredExercise time
RequiredTarget and Max Heart Rate with % of target achievement
RequiredHeart Rate & METS trends
RequiredNIBP Trends
RequiredSpeed of tredmill
RequiredProtocol Name
RequiredProtocol stage
RequiredPatient info * Built in thermal printer with compatible additional laser black and white printer to print report on A4 Size thermal and A4 size ordinary bond papers respectively Yes * 4/14 Minimum Printing Speed of laser printer 20 pages/minute * Minimum Paper tray capacity of laser printer 250 Sheets * Print Resolution 1200 x 600 dpi 1200 x 600 dpi Duplex Printing No No Connectivity interface of Laser printer USB
RequiredNetwork printing(Ethernet) USB
RequiredNetwork printing(Ethernet) Supported paper sizes A4
RequiredLetter
RequiredLegal A4
RequiredLetter
RequiredLegal TRAMSMISSION OF DATA Transmission of data available through Network
RequiredNetwork
RequiredUSB
RequiredP DF
RequiredDICOM(Bidirectional ) Network
RequiredUSB
RequiredPDF
RequiredDICOM(Bidirectional) Advanced signal processing algorithms to provide exceptional accuracy in beat detection and noise rejection resulting in superior identification of events Yes * Unique source consistency filter
Requiredreducing noise and baseline artifact while preserving a diagnostic quality ECG signal Yes * Provision to eliminate artifacts due to respiration
Requiredmuscle rub and AC interference
Requiredbaseline wandering without compromising and distortion in ST segment changes Yes * PROTOCOLS Test Protocols include Bruce
RequiredModified Bruce
RequiredBalke
RequiredEllestad
RequiredNaughton protocols Yes * Facility to add user defined protocols Yes * SYSTEM SOFTWARE FEATURES Licensed copy of windows operating system Yes * Provision to record resting ECG & Exercise ECG Yes * Resting ECG software with detailed automatic Yes * 5/14 interpretation statement for all 12 or 16 lead resting ECG should be present ECG data management software for storage and review Yes * Facility to review
Requirededit and add ECG from full discloser storage post exam Yes * 50mm sweep speed selection for ECG display in the system Yes * Enlarged QRS complexes with superimposition technique Yes * Automatic BP Measurement System integrated with the stress test system Yes * Provision of real time average complexes Yes * Provision of real time ST Analysis in bar graphs Yes * Provision of Re analysis of final summary report Yes * System should be able to present ST levels for 12 average complexes
Requiredslope for 12 average complexes and ST Profile Yes * Provision of online ST measurement adjustment Yes * Provision of reanalyzing the possibility of complete exercise test with ST/HR and NIBP trend graphically Yes * SCD predictive tools like T-wave alternans
RequiredST/HR hysteresis analysis Yes * The system should have a Borg scale
Requiredsymptom and point Yes * 6/14 criteria table Full disclosure review/playback/scroll back and addition of past ECG events Yes * ST level and slope data for lead and worst case average beat update should be available continuously during the test Yes * Beat by beat review mode to allow full disclosure review during and post exam Yes * QRS signal averaging software
RequiredQT dispersion software
RequiredXYZ vector- cardiography software provided as standard part of the unit Yes * Facility to do reanalysis of scored ECG by changing line measurement point title ST and J Yes * The system should present comprehensive final report on minute by minute record of ST segment trend Yes * Facility of automatic arrhythmia detection Yes * Auto calibration with digital micro process control in the system and should also be manually operable Yes * Facility of pacemaker rhythm detection Yes * System should be able to view comprehensive ST segment and morphology analysis in an anatomically intelligent format Yes * ST profile
RequiredST elevation
RequiredST depression
Requiredheart rate
RequiredMets
RequiredNIBP
RequiredST index should be able to be clearly analyzed Yes * 7/14 The unit should be able to quickly identify anomalies with the dynamic zoom ST display Yes * The system should be able to view ST maps
Requiredpatented visual anatomical representations of ST deviations in-frontal planes Yes * Monitoring of ST changes with auto comparison of current and reference beats Yes * The system should be able to display the traces incrementally Yes * Provision of updating ECG and ST segment changes and compare them on a pre-exercise and during exercise basis on a high resolution display Yes * Compact digital acquisition module that virtually eliminates non- cardiac electrical noises Yes * Provision of alarm on HR
RequiredBP & ST level Yes * Facility to mark the ECG strip to enter comments at any stage Yes * DATA ACQUISITION AND PROCESSING Data Acquisition 12 Leads ECG Simultaneously and Display 3x4
Required4x6
Required6x12
Required12 lead data indicate significant changes * A/D 12 bits or more * Sampling Rate 300/Sec/channel or more * Input impedance should be more than 90M Ohms Yes * CMRR Should be more than 100 dB Yes * Frequency response 0.05Hz to 100Hz * 8/14 Patient leakage Should be less then 100μA Yes * The system should have baseline correction Yes * Digital filters 50Hz
Required20Hz
Required35Hz * REPORTING Facility to get system generated auto report Yes * Analysis should work on toal of atleast 5 protocols Yes * No startup delay in the system ie instant ECG Reports at the push of a button should be available Yes * Final report with configurable lead groups Yes * Patient report include protocol
RequiredIndications
Requiredmedications
Requiredtarget heart rate reasons for end
Requiredsymptoms
Requireddiagnosis
Requirednotes and conclusions with space for personnel and physician electronic signature Yes * Examination summary include heart rate/BP/Workload trends page
RequiredST level trends/ST slope trends
RequiredAverage QRS by stage or by minute
RequiredMets
RequiredMaximum predicted heart rate
RequiredTHR formula selection Yes * Ability to select final report segments including patient information
Requiredexam summary
Requiredrate
RequiredBP
Requiredwork trends
RequiredST level trends
RequiredST slope trends
Requiredaverage QRS and events should be provided in the system Yes * Events should include 12 lead ECG analysis for arrhythmias and Yes * 9/14 user added ECGs Provision of customizable system generated summary report to determine the contents of report with data storage facility Yes * Provision of Password protection Yes * Option to create network review workstations for viewing
Requiredediting and report printing of the stress test examinations should be there Yes * ACCESSORIES Standard Accessories
Requiredconsumables provided 2 sets of 12 lead ECG patient cables
Required100 Electrodes
Required10 rim A4 Reporting papers * Detachable/replaceable cables and leads Yes * Minimum warranty(months) on accessories i e lead set 6 Months 6 Months Appropriate sized cuffs of small
Requiredmedium and large should be provided with the system Yes * Trolley system to mount computer & printer Yes * Dimensions of Trolley (L x W x H) in mm - * Other standard accessories
Requiredif any - * STORAGE OF RECORDS Storage of atleast 100 patients records Yes * Full disclosure archive to external drive Yes * Events/12 lead ECGs/Full disclosure Yes * ENVIRONMENTAL CONDITIONS Operating Temperature +10°C to + 40°C * Operating Relative Humidity 10% to 95%
RequiredNon condensing * Storage temperature - 40°C to + 70°C * 10/14 Storage Relative Humidity 10% to 95%
RequiredNon condensing * Operation/Storage atmospheric pressure 500 hPa to 1060 hPa * CERTIFICATIONS Certifications for Tredmill System ISO 13485 ISO 13485 Certifications for BP Measurement System ISO 13485
RequiredEU-CE ISO 13485
RequiredEU-CE Conformity to all electrical safety guidelines/criteria as lay down by Diagnostic Electrocardiograph Devices Yes * Conformity to standards for electrical safety IEC-60601-1 :1988 General requirements including all amendments Yes * Conformity to standards IEC-60601-2-25 Safety of Electrocardiograms including all amendments Yes * Conformity to council directive 93/42/EEC of 14 June 1993 concerning medical devices Yes * Availability of Test report from Central GOVT/NABL/ILAC accredited Lab or manufacturer's inhouse Test Report to prove the conformity to the declared specification Yes * Submission of all the certifications
Requiredlicenses and test reports at the time of supply to the buyer Yes * INSTALLATION & TRAINING Supplier to perform installation
Requiredsafety and operation checks before handover Yes * Onsite training for all operating staff and Yes * 11/14 basic maintenance shall be provided WARRANTY & MAINTENANCE Warranty (Yrs) on complete system 2 2 User technical
Requiredoperational and maintenance manual detailing complete maintaining schedule with routine maintenance should be provided Yes * Response time for attending breakdown/repair of the system (in days) 1 * Remote service network connecting and online phone support facility Yes * Contact details of manufacturer
Requiredsupplier and local service agent to be provided Yes * * Bold specifications 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.
