Description
GENERAL FEATURES
| Product Description | Cardiac TMT Machine with Monitor and Printer |
| Clinical Purpose | To study cardiac abnormalities in patients under stress conditions by exercising the patient on a treadmill according to a standardized protocol |
| Product components | Heavyduty medical treadmill with online UPS for the whole system, Computer system, printer, Voltage stabilizer and software along with trolley system to mount computer & printer |
| Facility, whereby data should be able to be acquired and digitized near the patient, providing 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) | 6 |
| 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 millimeter |
| Width of Treadmill Floor (mm) | 720 millimeter |
| Length of walking area on treadmill (mm) | 1550 millimeter |
| Width of walking area on treadmill (mm) | 550 millimeter |
| Patient Load Capacity of Treadmill (Kg) | 190 kilogram |
| 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, stop and increase or decrease elevation and speed of treadmill | Yes |
| Self-aligning anti skid conveyor belt | Yes |
| Communication/Connectivity | RS232,USB,Wifi,Bluetooth |
| Enhanced tolerance to electrical changes for greater patient safety | Yes |
| Self-calibrating system for speed | Yes |
| Inbuilt digital control issues, precise 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, slow deceleration and emergency stop modes on treadmill | Yes |
| Voltage Stabilizer provided | Yes |
| Rating of Stabilizer (KVA) | 6 KVA |
COMPUTER SYSTEM SPECIFICATIONS
| Type of Monitor | LED |
| Touch Screen Monitor | No |
| Size of Monitor (inch) | 24 inch |
| RAM size | 4 GB |
| Hard disk space | 500 GB |
| Processer | Intel core i3 |
| Operating System | Windows 10 or Higher |
| CD ROM Drive | Yes |
| Number of serial port | 2 |
| Number of USB Ports | 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, 12 lead ST level & Slops, Enlarged QRS complex with maximum ST level, Exercise time, Target and Max Heart Rate with % of target achievement, Heart Rate & METS trends, NIBP Trends, Speed of tredmill, Protocol Name, Protocol stage, Patient 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 |
| Minimum Printing Speed of laser printer | 20 pages / minute |
| Minimum Paper tray capacity of laser printer | 250 Sheets |
| Print Resolution | 1200 x 600 dpi |
| Duplex Printing | No |
| Connectivity / interface of Laser printer | USB,WiFI Direct,Network printing(Ethernet) |
| Supported paper sizes | A4,Letter,Legal |
TRAMSMISSION OF DATA
| Transmission of data available through | Network,USB,PDF,XML,DICOM(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, reducing noise and baseline artifact while preserving a diagnostic quality ECG signal | Yes |
| Provision to eliminate artifacts due to respiration, muscle rub and AC interference, baseline wandering without compromising and distortion in ST segment changes | Yes |
PROTOCOLS
| Test Protocols include Bruce, Modified Bruce, Balke, Ellestad, Naughton 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 interpretation statement for all 12 or 16 lead resting ECG should be present | Yes |
| ECG data management software for storage and review | Yes |
| Facility to review, edit 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, slope 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, ST /HR hysteresis analysis | Yes |
| The system should have a Borg scale, symptom and point criteria table | Yes |
| 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, QT dispersion software, XYZ 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, ST elevation, ST depression, heart rate, Mets, NIBP, ST index should be able to be clearly analyzed | Yes |
| 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, patented 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, BP & 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 3×4, 4×6, 6×12, 12 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 |
| Patient leakage Should be less then 100μA | Yes |
| The system should have baseline correction | Yes |
| Digital filters | 50Hz, 20Hz, 35Hz |
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, Indications, medications, target heart rate reasons for end, symptoms, diagnosis, notes and conclusions with space for personnel and physician electronic signature | Yes |
| Examination summary include heart rate/BP/Workload trends page, ST level trends/ST slope trends, Average QRS by stage or by minute, Mets, Maximum predicted heart rate, THR formula selection | Yes |
| Ability to select final report segments including patient information, exam summary, rate, BP, work trends, ST level trends, ST slope trends, average QRS and events should be provided in the system | Yes |
| Events should include 12 lead ECG analysis for arrhythmias and user added ECGs | Yes |
| 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, editing and report printing of the stress test examinations should be there | Yes |
ACCESSORIES
| Standard Accessories, consumables provided | 2 sets of 12 lead ECG patient cables, 100 Electrodes, 10 rim A4 Reporting papers |
| Detachable/replaceable cables and leads | Yes |
| Minimum warranty(months) on accessories i e lead set | 6 Months |
| Appropriate sized cuffs of small, medium 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 | 85X69X95 |
| Other standard accessories, if any | NA |
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%, Non condensing |
| Storage temperature | – 40°C to + 70°C |
| Storage Relative Humidity | 10% to 95%, Non condensing |
| Operation/Storage atmospheric pressure | 500 hPa to 1060 hPa |
CERTIFICATIONS
| Certifications for Tredmill System | ISO 13485,EU-CE |
| Certifications for BP Measurement System | ISO 13485,EU-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, licenses and test reports at the time of supply to the buyer | Yes |
INSTALLATION & TRAINING
| Supplier to perform installation, safety and operation checks before handover | Yes |
| Onsite training for all operating staff and basic maintenance shall be provided | Yes |
WARRANTY & MAINTENANCE
| Warranty (Yrs) on complete system | 2 |
| User technical , operational 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) | 6 |
| Remote service network connecting and online phone support facility | Yes |
| Contact details of manufacturer, supplier and local service agent to be provided | Yes |
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