Cardiac TMT Machine with Monitor and Printer

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Description

GENERAL FEATURES

Product DescriptionCardiac TMT Machine with Monitor and Printer
Clinical PurposeTo study cardiac abnormalities in patients under stress conditions by exercising the patient on a treadmill according to a standardized protocol
Product componentsHeavyduty 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 signalYes

TREADMILL SPECIFICATIONS

Treadmill TypeFour 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 timeYes
Rating of UPS (KVA)6
Stop/start button on treadmill for emergency stopYes
Emergency stop button(ESB) must have the ability to be located in the location of choice by the end userYes
Tredmill should have zero startYes
Automatic operation from the main unit as per test protocolYes
Fold down hand rails on treadmill for allowing easy and convenient assemble and installationYes
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 Treadmill0.1 to 14 km/Hr or higher range
Inclination( continuously variable)0-25 or more
Treadmill motorAC Motor
Power requirements220 – 240 VAC @ 50-60 Hz
Double sided polish on walking surface of treadmill for prolonged product life spanYes
Remote keyboard operation to start, stop and increase or decrease elevation and speed of treadmillYes
Self-aligning anti skid conveyor beltYes
Communication/ConnectivityRS232,USB,Wifi,Bluetooth
Enhanced tolerance to electrical changes for greater patient safetyYes
Self-calibrating system for speedYes
Inbuilt digital control issues, precise speed and grade control in the systemYes
Delivers high torque even at low speeds which ensures no lag when the foot strikes the beltYes
Provide smooth power and accuracy even at slow speedsYes
Normal, slow deceleration and emergency stop modes on treadmillYes
Voltage Stabilizer providedYes
Rating of Stabilizer (KVA)6 KVA

COMPUTER SYSTEM SPECIFICATIONS

Type of MonitorLED
Touch Screen MonitorNo
Size of Monitor (inch)24 inch
RAM size4 GB
Hard disk space500 GB
ProcesserIntel core i3
Operating SystemWindows 10 or Higher
CD ROM DriveYes
Number of serial port2
Number of USB Ports4
Alphanumeric multimedia PC keyboard with systems dedicated keypadYes
Standard PC mouseYes
Built in uninterrupted power supply for minimum of 3 minutesYes
QRS triggered outputYes
Parameters Displayed by the system12 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 respectivelyYes
Minimum Printing Speed of laser printer20 pages / minute
Minimum Paper tray capacity of laser printer250 Sheets
Print Resolution1200 x 600 dpi
Duplex PrintingNo
Connectivity / interface of Laser printerUSB,WiFI Direct,Network printing(Ethernet)
Supported paper sizesA4,Letter,Legal

TRAMSMISSION OF DATA

Transmission of data available throughNetwork,USB,PDF,XML,DICOM(Bidirectional)
Advanced signal processing algorithms to provide exceptional accuracy in beat detection and noise rejection resulting in superior identification of eventsYes
Unique source consistency filter, reducing noise and baseline artifact while preserving a diagnostic quality ECG signalYes
Provision to eliminate artifacts due to respiration, muscle rub and AC interference, baseline wandering without compromising and distortion in ST segment changesYes

PROTOCOLS

Test Protocols include Bruce, Modified Bruce, Balke, Ellestad, Naughton protocolsYes
Facility to add user defined protocolsYes

SYSTEM SOFTWARE FEATURES

Licensed copy of windows operating systemYes
Provision to record resting ECG & Exercise ECGYes
Resting ECG software with detailed automatic interpretation statement for all 12 or 16 lead resting ECG should be presentYes
ECG data management software for storage and reviewYes
Facility to review, edit and add ECG from full discloser storage post examYes
50mm sweep speed selection for ECG display in the systemYes
Enlarged QRS complexes with superimposition techniqueYes
Automatic BP Measurement System integrated with the stress test systemYes
Provision of real time average complexesYes
Provision of real time ST Analysis in bar graphsYes
Provision of Re analysis of final summary reportYes
System should be able to present ST levels for 12 average complexes, slope for 12 average complexes and ST ProfileYes
Provision of online ST measurement adjustmentYes
Provision of reanalyzing the possibility of complete exercise test with ST/HR and NIBP trend graphicallyYes
SCD predictive tools like T-wave alternans, ST /HR hysteresis analysisYes
The system should have a Borg scale, symptom and point criteria tableYes
Full disclosure review/playback/scroll back and addition of past ECG eventsYes
ST level and slope data for lead and worst case average beat update should be available continuously during the testYes
Beat by beat review mode to allow full disclosure review during and post examYes
QRS signal averaging software, QT dispersion software, XYZ vector-cardiography software provided as standard part of the unitYes
Facility to do reanalysis of scored ECG by changing line measurement point title ST and JYes
The system should present comprehensive final report on minute by minute record of ST segment trendYes
Facility of automatic arrhythmia detectionYes
Auto calibration with digital micro process control in the system and should also be manually operableYes
Facility of pacemaker rhythm detectionYes
System should be able to view comprehensive ST segment and morphology analysis in an anatomically intelligent formatYes
ST profile, ST elevation, ST depression, heart rate, Mets, NIBP, ST index should be able to be clearly analyzedYes
The unit should be able to quickly identify anomalies with the dynamic zoom ST displayYes
The system should be able to view ST maps, patented visual anatomical representations of ST deviations in-frontal planesYes
Monitoring of ST changes with auto comparison of current and reference beatsYes
The system should be able to display the traces incrementallyYes
Provision of updating ECG and ST segment changes and compare them on a pre-exercise and during exercise basis on a high resolution displayYes
Compact digital acquisition module that virtually eliminates non-cardiac electrical noisesYes
Provision of alarm on HR, BP & ST levelYes
Facility to mark the ECG strip to enter comments at any stageYes

DATA ACQUISITION AND PROCESSING

Data Acquisition12 Leads ECG Simultaneously and Display 3×4, 4×6, 6×12, 12 lead data indicate significant changes
A/D12 bits or more
Sampling Rate300/Sec/channel or more
Input impedance should be more than 90M OhmsYes
CMRR Should be more than 100 dBYes
Frequency response0.05Hz to 100Hz
Patient leakage Should be less then 100μAYes
The system should have baseline correctionYes
Digital filters50Hz, 20Hz, 35Hz

REPORTING

Facility to get system generated auto reportYes
Analysis should work on toal of atleast 5 protocolsYes
No startup delay in the system ie instant ECG Reports at the push of a button should be availableYes
Final report with configurable lead groupsYes
Patient report include protocol, Indications, medications, target heart rate reasons for end, symptoms, diagnosis, notes and conclusions with space for personnel and physician electronic signatureYes
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 selectionYes
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 systemYes
Events should include 12 lead ECG analysis for arrhythmias and user added ECGsYes
Provision of customizable system generated summary report to determine the contents of report with data storage facilityYes
Provision of Password protectionYes
Option to create network review workstations for viewing, editing and report printing of the stress test examinations should be thereYes

ACCESSORIES

Standard Accessories, consumables provided2 sets of 12 lead ECG patient cables, 100 Electrodes, 10 rim A4 Reporting papers
Detachable/replaceable cables and leadsYes
Minimum warranty(months) on accessories i e lead set6 Months
Appropriate sized cuffs of small, medium and large should be provided with the systemYes
Trolley system to mount computer & printerYes
Dimensions of Trolley (L x W x H) in mm85X69X95
Other standard accessories, if anyNA

STORAGE OF RECORDS

Storage of atleast 100 patients recordsYes
Full disclosure archive to external driveYes
Events/12 lead ECGs/Full disclosureYes

ENVIRONMENTAL CONDITIONS

Operating Temperature+10°C to + 40°C
Operating Relative Humidity10% to 95%, Non condensing
Storage temperature– 40°C to + 70°C
Storage Relative Humidity10% to 95%, Non condensing
Operation/Storage atmospheric pressure500 hPa to 1060 hPa

CERTIFICATIONS

Certifications for Tredmill SystemISO 13485,EU-CE
Certifications for BP Measurement SystemISO 13485,EU-CE
Conformity to all electrical safety guidelines/ criteria as lay down by Diagnostic Electrocardiograph DevicesYes
Conformity to standards for electrical safety IEC-60601-1 :1988 General requirements including all amendmentsYes
Conformity to standards IEC-60601-2-25 Safety of Electrocardiograms including all amendmentsYes
Conformity to council directive 93/42/EEC of 14 June 1993 concerning medical devicesYes
Availability of Test report from Central GOVT/NABL/ILAC accredited Lab or manufacturer’s inhouse Test Report to prove the conformity to the declared specificationYes
Submission of all the certifications, licenses and test reports at the time of supply to the buyerYes

INSTALLATION & TRAINING

Supplier to perform installation, safety and operation checks before handoverYes
Onsite training for all operating staff and basic maintenance shall be providedYes

WARRANTY & MAINTENANCE

Warranty (Yrs) on complete system2
User technical , operational and maintenance manual detailing complete maintaining schedule with routine maintenance should be providedYes
Response time for attending breakdown/repair of the system (in days)6
Remote service network connecting and online phone support facilityYes
Contact details of manufacturer, supplier and local service agent to be providedYes

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