RequiredCertificate (Requested in ATC) Bid to RA enabled No ECG Machine ( 4 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Certificates Confirmity to standards European CE European CE Certification number and date - * Confirmity to safety of electromagnetic compatibility IEC-60601-1-2:2001 (or equivalent BIS) * Confirmity to safety standard IS - 13450 IEC60601-1-2005 * 1/7 Performance Parameters Purpose ECG machine is primary equipment to record ECG signal with interpretation which is required for recording and analyzing the waveforms with software. ECG machine is primary equipment to record ECG signal with interpretation which is required for recording and analyzing the waveforms with software. Operating modes of ECG Machine Automatic
RequiredManual 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 12 ECG machine should acquire lead ECG for both adult and paediatric 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 40000 s/sec/channel * Recording of digital sampling for pacemaker 1000 s/sec/channel * ECG machine should have real time colour backlit display of ECG waveforms with signal qualify indication for each lead Yes * 2/7 ECG machine should have frequency filters Artifact
RequiredAC and low and high pass frequency filters * Number of ECGs which can be store in ECG Machine 151-200 151-200 ECG machine should have full screen preview of ECG report for quality assessment checks prior to print Yes Yes Type of inbuilt screen LCD LCD
RequiredLED
RequiredTFT Size of screen in inches 5 5 Display resolution of ECG machine in pixels 640 x 480 * ECG machine should have interpretation facility of the amplitudes
Requiredduration 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 Hard keys Size of printing paper A4 A4 Resolution of digital array printer using thermal sensitive paper in ECG Machine in dpi 200 dpi x 500 dpi on 25 mm/sec speed * ECG machine report format Report formats of 3x4; 6x2
RequiredRhythm for up to selected leads
Required12 lead extended measurement
Required1 minute of continuous waveform data for 1 selected lead * Provision of battery Yes Yes Battery capacity 50 ECG or 1 hour of continous rhythm recording on single charge 50 ECG or 1 hour of continous rhythm recording on single charge 3/7 Connectivity to ECG Machine LAN LAN Storage on external portable memories USB support * The individual patient lead should be change without replacing the whole patient cable assembly Yes * Noise level in dba 12.5 * Weight of ECG Machine in Kg 5 * Frequency in Hz 300 * Availability of latest interpretation software Yes Yes Wireless acquisition module with RF technology Yes Yes System should have the dedicated software to download the ECG form machine in PDF format Yes Yes Warranty in years 3 3 User and service manual of ECG Machine Yes * Environmental Parameters Operating temperature and humidity temperature of 10-40 degree C and relative humidity of 15-90% * Trolley Provision of trolley No No Material of Frame of trolley No Trolley Provided No Trolley Provided Material of Top of trolley No Trolley Provided No Trolley Provided Number of castors No Trolley Provided No Trolley Provided Number of brakes for castors No Trolley Provided No Trolley Provided Height of trolley in inch No Trolley Provided No Trolley Provided Provision of railing for top shelf No Trolley Provided No Trolley Provided Availability of suitable cable arm having holder for ECG cables when not No Trolley Provided No Trolley Provided 4/7 in use Power Supply Power input 220-240 V AC
Required50 Hz fitted with Indian plug * Length of power cable in meter 3 * Resettable over current breaker shall be fitted for protection Yes * Accessories ECG Machine 12 leads with interpretation 1 1 Patient Cable 2 2 Chest Electrodes Adult (set of Six) 1 1 Chest Electrodes Paediatric (set of Six) Not provided 2
Required4
RequiredNot provided Limb Electrodes 2 for adults and 2 for paediatric 2 for adults and 2 for paediatric Thermal paper for 500 patients 1 SET 1 SET Power cable for charging Yes Yes Supplied with Clip electrode Yes Yes Reports Manufacturer shall be ISO certified ISO 13485 * ISO cetification deatils such as date and number - * Availability of test report from govt NABL/ILAC accredited lab covering all parameters No No Test report number
RequiredIncase test reports not availabble
Requiredput NA - * Test report date
RequiredIncase test reports not availabble
Requiredput NA - * Name of test lab
RequiredIncase test reports not availabble
Requiredput NA - * Address of test lab
RequiredIncase test reports not availabble
Requiredput NA - * 5/7 Copies of all test reports to be provided to buyer on demand at time of supplies
RequiredNA
RequiredIncase test reports not availabble NA
RequiredIncase test reports not availabble * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
