Cardiac TMT Machine with Monitor and Printer

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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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