RequiredExperience with Government Bid to RA enabled No Cardiac Monitor With Defibrillator ( 1 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Standards Conformity to Certification European CE US FDA
RequiredEuropean CE
RequiredBoth US FDA and European CE
RequiredBIS Certification number and date - * Confirmity to Manufactures Certification ISO 9001 & ISO 13485 ISO 9001 & ISO 13485
RequiredICMED 9001 & 13485 1/7 Conformity to Safety Standards IEC 60601-2-4 or Equivalent BIS * Performance Parameters Capability parameter of defibrillator ECG Monitoring
Requireddefibrillation ECG monitoring
Requiredexternal defibrillation
Requiredexternal pacing (transcutaneous)
Requiredinternal defibrillation and recording
RequiredECG Monitoring
Requireddefibrillation Technology of defibrillator Biphasic technology * Modes in defibrillator Manual Automated external defibrillation
RequiredManual
RequiredAutomated external defibrillation and manual Maximum energy selection in joules 360 * Capability of ECG Monitoring ECG leads
Requiredmulti function electrodes
Requiredpaddles * Number of wave- forms 2 2
Required3
Required4 Patient compatibility to defibrillate Adult
Requiredpediatric patients Adult
Requiredpediatric patients
RequiredPediatric Type of display TFT TFT
RequiredLCD Size of display screen in inch 6 * Provision to display ECG waveform on bright high resolution display Yes * Facility to have synchronized cardio version Yes Yes
RequiredNo Ability to display CPR index on screen real time No Yes
RequiredNo Ability to filter out CPR artefacts to see organised rhythms without interrupting chest compression No Yes
RequiredNo Provision of within built rechargeable battery Yes * Battery backup to deliver number of 50 * 2/7 shocks at maximum energy Weight of defibrillator with battery and paddles in Kg 4 * Provision of in built recorder Yes Yes
RequiredNo Provision of printing ECG trace & stored information Yes Yes
RequiredNo Facility of External non-invasive pacing No Yes
RequiredNo Type of external transcutaneous pacing modes Demand mode Demand mode
RequiredFixed mode (asynchronous)
RequiredBoth Demand mode and fixed mode Pulse width of External non- invasive pacing in milli seconds NA 40
RequiredNA Ability to measure chest compression rate and depth in real time with visual feedback on screen with rate and depth indicator Not Provided Integrated with defibrillator
RequiredDefibrillator with external sensors
RequiredNot Provided Facility to monitor EtCO2 No Yes
RequiredNo Facility to monitor NIBP No Yes
RequiredNo Facility to monitor SPO2 No Yes
RequiredNo Upgradability to monitor EtCO2 Yes Yes
RequiredNo Upgradability to monitor NIBP Yes Yes
RequiredNo Upgradability to monitor SPO2 Yes Yes
RequiredNo ECG monitoring Using 3 lead Using 12 leads
RequiredUsing 3 lead
RequiredUsing 5/6 lead
RequiredNot available Provision of user selectable alarm settings Yes * The machine should work on mains as well as on rechargeable battery Yes * 3/7 Ability to select energy from paddles Yes * Ability to charge and discharge through paddles as well as from main unit Yes * Facility for internal defibrillation No Yes
RequiredNo Charging time for maximum energy in seconds 7 * Mechanism of self test of unit Automatic and manual * Unit should do self test with facility to give printout of defibrillator testing report and also have code ready indicator on unit Yes * Provision of stainless steel trolley with lockable castors No Yes
RequiredNo Suitability of defibrillator for transport on ground (ambulance) Yes Yes
RequiredNo Defibrillator suitable to use at high altitudes and in air craft Yes Yes
RequiredNo Defibrillator should display selected energy Yes Yes
RequiredNo Defibrillator should display delivered energy Yes Yes
RequiredNo Suitability of defibrillator for transportation in air (aircraft) No Yes
RequiredNo Availaibility of suitable protection for dust and water Yes Yes
RequiredNo Accessories Li-ion Battery 1 1
RequiredNot provided ECG cable 1 1
Required2
RequiredNot provided NIBP pediatric cuff with hose 1 1
Required2
RequiredNot provided 4/7 NIBP adult cuff with hose 1 1
Required2
RequiredNot provided Reusable airway adaptor to be used with ETCO2 main stream/side stream sensor and cable 1 1
Required2
RequiredDisposable airway adpater - 2 each for intubated and non intubated patient with EtCO2 mainstream sensor and cable
RequiredNot provided Disposable airway adpater with EtCO2 mainstream sensor and cable Not provided One each for incubated and non intubated patient
Required2 each for incubated and non incubated patient
RequiredNot provided External defibrillator paddles (pediatric in built in adult) 1 1
Required2
RequiredNot provided Multi Function Defibrillator & Monitoring pads/gel sheets 12 10
Required12
RequiredNot provided
Required5 Recorder paper roll 10 10
RequiredNot provided Reusable CPR feedback sensor/or similar product reused 1 1
Required2
RequiredNot provided Miscellaneous Parameters Warranty in years 2 1
Required2
Required3
Required4
Required5 Original User Technical manuals to be supplied in English in hard and soft copy Yes * Original copy of operating and service manuals to be supplied in English in hard and soft copy Yes * Calibration and preventive maintenance certificate has to be provided as per requirement Yes * Installation
RequiredDemonstration and training to be provided at consignee end at any part of country Yes * The Principal Manufacturer Must Have Direct Presence/approved Yes * 5/7 service center In India Advanced maintenance task required shall be documented and procedures required for local calibration and routine maintenence and list of imp spare parts with accessories along with part numbers to be furnished Yes * Availabilty of toll free facility for technical support maintened by OEM or authorized agencies Yes * Provide Certificate from the principal that spare parts will be available from next 10 years at the time of supplies to the buyer Yes * Copies of all certifications to be provided to buyer on demand at time of supplies Yes * * 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.
