ECG Machine

Description

Certificates

Confirmity to standards European CE
Certification number and date CE-12351 2018-04-20
Confirmity to safety of electromagnetic compatibility IEC-60601-1-2:2001 (or equivalent BIS)
Confirmity to safety standard IS – 13450 / IEC60601-1-2005

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.
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
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
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 151-200
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
Size of printing paper 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 3×4; 6×2, Rhythm for up to selected leads, 12 lead extended measurement, 1 minute of continuous waveform data for 1 selected lead
Provision of battery Yes
Battery capacity 50 ECG or 1 hour of continous rhythm recording on single charge
Connectivity to ECG Machine Wireless 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 5
Weight of ECG Machine in Kg 4.5
Frequency in Hz 300
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 No
Warranty in years 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
Material of Frame of trolley No Trolley Provided
Material of Top of trolley No Trolley Provided
Number of castors No Trolley Provided
Number of brakes for castors No Trolley Provided
Height of trolley in inch No Trolley Provided
Provision of railing for top shelf No Trolley Provided
Availability of suitable cable arm having holder for ECG cables when not in use No Trolley Provided

Power Supply

Power input 220-240 V AC, 50 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
Patient Cable 2
Chest Electrodes Adult (set of Six) 1
Chest Electrodes Paediatric (set of Six) Not provided
Limb Electrodes 2 for adults and 2 for paediatric
Thermal paper for 500 patients 1 SET
Power cable for charging Yes
Supplied with Clip electrode Yes

Reports

Manufacturer shall be ISO certified ISO 13485
ISO cetification deatils such as date and number APRIL 07 2019 NUMBER:04716Q10124R3M
Availability of test report from govt/ NABL/ILAC accredited lab covering all parameters No
Test report number , Incase test reports not availabble , put NA NA
Test report date, Incase test reports not availabble , put NA NA
Name of test lab , Incase test reports not availabble , put NA NA
Address of test lab , Incase test reports not availabble , put NA NA
Copies of all test reports to be provided to buyer on demand at time of supplies , Yes

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