Standard Medical Device Specification V1.2 Device CODE ITEM Name Specs HTM-029 ECG Device Items Included Quantity 12 Leads ECG: • Trolley • ECG patient lead set (two per device). • PDF report file export via Wi-Fi, LAN, & USB. • Wireless acquisition module • Report Interpretation software algorithm. • Noise filter (Software) • Keyboard /Barcode reader. • POWER REQUIREMENTS: 220-240 V. • IEC Plug Type-G • CE Market • FDA • Ability to connect the device through network in different V-LAN (The workstation will be connected in different V-LAN from the ECG device) so we can transfer the ECG PDF easily. • Rechargeable Battery. • All Equipment provided shall be of current production, new, and of first-rate quality. • Reconditioned or previously used equipment shall be unacceptable. • Connectivity: HL7, DICOM: C-Store, Patient Query • Data Transfer: USB, Wi-Fi, LAN, • OS Support by OEM shall be guaranteed at least 5 years (MUST BE CE 7 or Latest). • Disposable Electrodes (1 Box) 4 Thermal Software & firmware patches (free for lifetime) • paper (1 Box) • Vendor should supply two (2) copies of all Operator’s, Maintenance and Repair Manuals, Such Manuals shall include all technical service documentation that is provided to the Vendor's own service personnel at no additional charges or fees. Each technical documentation set shall include, but not be limited to detailed troubleshooting guides, schematic diagrams with function descriptions, installation instructions, calibration and setting instructions, illustrated parts lists, and preventive maintenance procedures. Standard Medical Device Specification V1.2 • • • • • • - The vendor should supply without any additional charges or fees, all updates to service manuals, schematics, and diagnostics that are provided to the Vendor's service engineers for as long as the Dhaman own the equipment. Software "update kits,” “improvements,” and “fixes” which are normally released by the Vendor as operational modifications should be provided at no cost for as long as Dhaman owns the Equipment. A software “upgrade” which is released by the Vendor to provide discrete operational enhancements and/or new features and applications should be provided for 5 years after acceptance of Equipment. Management system Warranty will begin after formal acceptance of the Equipment or upon a mutually agreed date. The Vendor shall make available adequate Applications Training to all shifts of designated Department employees. The vendor shall make available to Dhaman a limited number of training opportunities. The training shall be the same as offered to 2 the Vendor's own service personnel and should be scheduled in agreement with Biomedical Engineering Team within the first quarter of equipment acceptance. All costs of such training shall be paid by the Vendor for Online Training. Three years’ service contract (Unlimited Visits) - 10.1" or more high-res color touchscreen presents all 12 leads of data simultaneously. - Captures best 10 seconds of ECG data from memory, reducing need for repeat ECGs. - VERITAS™ algorithm uses gender-specific, adult/ped criteria for interpretation. - Wide screen improves navigation, data entry & electrode connection verification. - Wireless data acquisition increases workspace flexibility - Supports pacemaker spike detection with 40,000 sps/channel data capture. - Includes hook-up confirmation by detection and display of lead reversals. - 1k sps/channel capture for signal assessment during analysis, display & printing
