ECG Machine

Description

Certificates

Confirmity to standardsEuropean CE
Certification number and dateCE-12351 2018-04-20
Confirmity to safety of electromagnetic compatibilityIEC-60601-1-2:2001 (or equivalent BIS)
Confirmity to safety standardIS – 13450 / IEC60601-1-2005

Performance Parameters

PurposeECG 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 MachineAutomatic, Manual and Rhythm
ECG machine should have ECG lead annotation facilityYes
Leads which is in ECG machine should be able to acquire simultaneously and interpret them12
Number of channels12
ECG machine should acquire lead ECG for both adult and paediatric patientsYes
The ECG machine should have facility to show lead fail indicationYes
The ECG machine should have facility to show lead reversal indicationYes
The ECG machine should have facility to show the impedance to quality check of connectionYes
Acquisition time for ECG Machine in sec10 sec
Digital sampling rate for Pacemaker spike detection40000 s/sec/channel
Recording of digital sampling for pacemaker1000 s/sec/channel
ECG machine should have real time colour backlit display of ECG waveforms with signal qualify indication for each leadYes
ECG machine should have frequency filtersArtifact, AC and low and high pass frequency filters
Number of ECGs which can be store in ECG Machine151-200
ECG machine should have full screen preview of ECG report for quality assessment checks prior to printYes
Type of inbuilt screenLCD
Size of screen in inches7
Display resolution of ECG machine in pixels640 x 480
ECG machine should have interpretation facility of the amplitudes, duration and morphologies of ECG waveforms and associated rhythm for adult and pediatric patientYes
ECG machine should have alphanumeric keyboard for patient data entryHard keys
Size of printing paperA4
Resolution of digital array printer using thermal sensitive paper in ECG Machine in dpi200 dpi x 500 dpi on 25 mm/sec speed
ECG machine report formatReport 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 batteryYes
Battery capacity50 ECG or 1 hour of continous rhythm recording on single charge
Connectivity to ECG MachineWireless LAN
Storage on external portable memoriesUSB support
The individual patient lead should be change without replacing the whole patient cable assemblyYes
Noise level in dba5
Weight of ECG Machine in Kg4.5
Frequency in Hz300
Availability of latest interpretation softwareYes
Wireless acquisition module with RF technologyNo
System should have the dedicated software to download the ECG form machine in PDF formatNo
Warranty in years3
User and service manual of ECG MachineYes

Environmental Parameters

Operating temperature and humiditytemperature of 10-40 degree C and relative humidity of 15-90%

Trolley

Provision of trolleyNo
Material of Frame of trolleyNo Trolley Provided
Material of Top of trolleyNo Trolley Provided
Number of castorsNo Trolley Provided
Number of brakes for castorsNo Trolley Provided
Height of trolley in inchNo Trolley Provided
Provision of railing for top shelfNo Trolley Provided
Availability of suitable cable arm having holder for ECG cables when not in useNo Trolley Provided

Power Supply

Power input220-240 V AC, 50 Hz fitted with Indian plug
Length of power cable in meter3
Resettable over current breaker shall be fitted for protectionYes

Accessories

ECG Machine 12 leads with interpretation1
Patient Cable2
Chest Electrodes Adult (set of Six)1
Chest Electrodes Paediatric (set of Six)Not provided
Limb Electrodes2 for adults and 2 for paediatric
Thermal paper for 500 patients1 SET
Power cable for chargingYes
Supplied with Clip electrodeYes

Reports

Manufacturer shall be ISO certifiedISO 13485
ISO cetification deatils such as date and numberAPRIL 07 2019 NUMBER:04716Q10124R3M
Availability of test report from govt/ NABL/ILAC accredited lab covering all parametersNo
Test report number , Incase test reports not availabble , put NANA
Test report date, Incase test reports not availabble , put NANA
Name of test lab , Incase test reports not availabble , put NANA
Address of test lab , Incase test reports not availabble , put NANA
Copies of all test reports to be provided to buyer on demand at time of supplies ,Yes

Reviews

There are no reviews yet.

Be the first to review “ECG Machine”