Catalogue values for Electrocardiography (ECG) Machine (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL FEATURES | Product Description | ECG Machine |
| PRODUCT INFORMATION | Operating modes of ECG Machine | Automatic, Manual and Rhythm |
| ECG machine should have ECG lead annotation facility | Yes | |
| Leads which is in ECG machine should be able to acquire simultaneously and interpret them | 12 | |
| Number of channels | 12 Channel | |
| ECG machine should acquire lead ECG for both adult and pediatric patients | Yes | |
| The ECG machine should have facility to show lead fail indication | Yes | |
| The ECG machine should have facility to show lead reversal indication | Yes | |
| The ECG machine should have facility to show the impedance to quality check of connection | Yes | |
| Acquisition time for ECG Machine in sec | 10 sec | |
| Digital sampling rate for Pacemaker spike detection | 8000 s/sec/channel | |
| Recording of digital sampling for pacemaker | 500 s/sec/channel | |
| ECG machine should have real time colour backlit display of ECG waveforms with signal qualify indication for each lead | Yes | |
| ECG machine should have frequency filters | Artifact, AC and low and high pass frequency filters | |
| Number of ECGs which can be store in ECG Machine | 151 to 200 | |
| ECG machine should have full screen preview of ECG report for quality assessment checks prior to print | Yes | |
| Type of inbuilt screen | LCD | |
| Size of screen in inches | 7 | |
| Display resolution of ECG machine in pixels | 640 x 480 | |
| ECG machine should have interpretation facility of the amplitudes, duration and morphologies of ECG waveforms and associated rhythm for adult and pediatric patient | Yes | |
| ECG machine should have alphanumeric keyboard for patient data entry | Hard keys | |
| Availability of latest interpretation software | Yes | |
| Wireless acquisition module with RF technology | No | |
| System should have the dedicated software to download the ECG form machine in PDF format | Yes | |
| PRINTER | Printer Type | Thermal Printer |
| Recorder Paper Size | 105 mm x 20 Meter | |
| Recorder Speed | 5 mm/sec | |
| Resolution of digital array printer | 200 dpi x 500 dpi | |
| Number of Thermal paper | 500, 1000 Or higher | |
| ECG machine report format | Report formats of 3x4, 6x2, Rhythm for up to selected leads, 12 lead extended measurement, 1 minute of continuous waveform data for 1 selected lead | |
| BATTERY | Provision of Battery | Yes |
| Battery Type | Built in Rechargeable Battery | |
| Battery capacity of continuous rhythm recording on single charge (minutes) | 30 | |
| Battery capacity | 30 ECG or 30 minutes of continous rhythm recording on single charge | |
| Connectivity to ECG Machine | LAN | |
| The individual patient lead should be change without replacing the whole patient cable assembly | Yes | |
| ENVIRONNMENTS PARAMETERS | Operating temperature and humidity | Temperature of 10 to 40 degree Celsius and Relative Humidity of 15 to 90% |
| POWER SUPPLY | Power input | 220-240 V AC, 50 Hz fitted with Indian plug |
| ACCESSORIES | ECG Machine 12 leads with interpretation | 1 |
| Patient Cable | 2 | |
| Chest Electrodes Adult (set of Six) | 1 | |
| Chest Electrodes Paediatric (set of Six) | 2 | |
| Limb Electrodes | 2 for adults and 2 for paediatric | |
| Power cable for charging | Yes | |
| Supplied with Clip electrode | Yes | |
| Compatible trolley provided | No | |
| CERTIFICATION & REPORTS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes | |
| Manufacturing unit certification | ISO:13485 (Latest) | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date | Yes | |
| Compliance to Safety Standards | IS 13450:Part 2:Sec 25 / IEC 60601-2-25 | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement | Yes | |
| WARRANTY | Warranty (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 2, 3, 4, 5 Or higher |
| Miscellaneous Parameters | User/Technical/Maintenance manuals to be supplied in English in hard and soft copy | Yes |
| The Principal Manufacturer must have direct Presence/approved service center In India | Yes | |
| Installation and demonstration of equipment and training to be provided after completing supplies before acceptance | Yes | |
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