RequiredExperience with Government
RequiredAnnual Turnover
RequiredOEM Authorization Certificate Bid to RA enabled Yes ICU Ventilator ( 8 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Standards Certifications for the product EU CE EU CE
RequiredBoth USFDA and EU CE Certification number and date - * Confirmity to quality management standards ISO 9001 & ISO 13485 ISO 9001 & ISO 13485 1/10 Confirmity to electrical safety standards IEC 60601-1 or ISO 80601-2-12 or BIS equivalent * Performance Parameters UMDNS Code 17-429 * Scope of item Intensive care ventilators are defined as mechanical ventilators that can be configured to provide invasive ventilation (e.g.
Requiredwith an endotracheal tube or tracheostomy tube) or noninvasive ventilation (eg
Requiredwith a face mask) * Clinical application Mechanical ventilators are life support devices that move gas (e.g.
Requiredair and/or oxygen) to and from a patient's lungs. These devices may provide temporary or permanent respiration for patients who cannot breathe on their own
Requiredor who require assistance maintaining adequate ventilation * Patient Type Adult & pediatric Adult & pediatric Type of technology Compressor Compressor Tidal volume in ml 50 ml or less - 1500 ml or more 50 ml or less - 1500 ml or more Respiration rate
Requiredbreaths/min up to 80 or more up to 80 or more
Requiredup to 50 or more Trigger mechanism Pressure/flow Pressure/flow FiO2% 21-100 * Inspiratory flow rate
RequiredL/min upto 120 or more upto 120 or more Inspiratory pressure
Requiredcm H2O upto 80 or more upto 80 or more IE ratio 1:10 to 4:1 1:10 to 4:1 Sigh breath function Yes Yes PEEP/CPAP
Requiredcm H2O upto 40 or more * Pressure support
Requiredcm H2O 0-40 or more * Leak compensation Yes * Auto 100%/Increase O2 button Yes * 2/10 Control panel lock Yes Yes Facility for double lung ventilation Yes Yes Patient Assessment Tools Maximum wave forms displayed 3 (Pressure and time
Requiredvolume and time
Requiredflow and time) * Number of loops 2 loops (P-V
RequiredF-V) with facility of saving of 2 Loops for reference 2 loops (P-V
RequiredF-V) with facility of saving of 2 Loops for reference Maximum trending time in hrs ≥24 hr * Lung recruitment tools (PV loops) OLT (Open lung tools) Yes Yes Lung mechanics visualization tool No Yes
RequiredNo Capnography/CO2 monitoring No Yes
RequiredNo Esophageal transpulmonary pressure monitoring No Yes
RequiredNo Stress index No Yes
RequiredNo Modes of ventilation Volume controlled
RequiredPressure Controlled
RequiredPressure Support
RequiredSIMV with Pressure support
RequiredSIMV with volume control with pressure support
RequiredCPAP/PEEP
RequiredInverse Ratio Ventilation
RequiredNon invasisve ventilation
RequiredApnea/back up ventilation
RequiredSIMV (VC) with Pressure support; SIMV (PC) with Pressure Support; SIMV (PRVC) with Pressure Support * ASV(Adaptive support ventilation) or ALT No Yes
RequiredNo APRV/Bivent/Bi level Yes Yes MMV +PSV/ASV or ALPV or Automode No Yes
RequiredNo PRVC/Auto flow Yes Yes High flow oxygen therapy No Yes
RequiredNo 3/10 Automatic weaning system provided Yes Yes Volume Support Yes Yes Ventilation monitoring facility The Ventillator is a Microprocessor Controlled ventilator with integrated facility for Ventilation monitoring * Monitored/Displayed parameters Peak inspiratory pressure
RequiredMean airway pressure
RequiredPEEP pressure
RequiredTidal volume
RequiredMinute volume
RequiredSpontaneous minute volume
RequiredFiO2 (analyzed %)
RequiredRespiratory rate
RequiredInspiratory time
RequiredExpiratory time
RequiredIE ratio
RequiredPlateau Pressure * Availability of Status indicator for Ventilator mode
RequiredBattery life
Requiredpatient data
Requiredalarm settings
Requiredclock etc on display Yes * Patient alarms Low/high FiO2
RequiredLow/high minute volume
RequiredLow inspiratory pressure
RequiredHigh pressure
RequiredLow PEEP
RequiredHigh PEEP
RequiredApnea
RequiredContinuous high pressure/occlusion
RequiredInverse IE
RequiredHigh respiratory rate
RequiredBreathing circuit disconnect * Equipment alarms Gas-supply failure
RequiredPower failure
RequiredVent inoperative
RequiredLow battery
RequiredSelf-diagnostic * Non-forced Slow Vital Capacity No Yes
RequiredNo Physiologic Dead space Yes Yes RSBI Yes Yes Imposed work of Breathing ( WOBi) Yes Yes Expiratory Time constant ( Tcexp) Yes Yes 4/10 Compliance static and dynamic Yes Yes Inspired and expired resistance Yes Yes Occlusion pressure Yes Yes Inspiratory and expiratory hold Yes Yes Spontaneous frequency Yes Yes Total peep
Requiredintrinsic peep
Requiredextrinsic peep Yes Yes Expiratory block is autoclavable and no routine calibration required Yes Yes Auto compensation for ET Tube No Yes
RequiredNo Facility for automatic compliance & Leakage compensation for circuit available Yes Yes RS 232 out put port Yes Yes USB/Memory card No Yes
RequiredNo Availability of Remote alarm/display port Yes * Facility to Report (vent alarms and patient status) Yes * HLT Compliant out put Yes Yes Type of coloured display TFT TFT Display should be touch screen Yes Yes NIV (Non Invasive Ventilation) to be possible in all modes of ventilation available Yes Yes Size of display (in inches) 15 12
Required15
Required17
Required18 Graphic display have automatic scaling facility for waves Yes Yes
RequiredNo Power supply 220-240 V
Required50 Hz AC * 5/10 single phase Provision of UPS No Yes
RequiredNo Backup time in hrs 1 1
Required2
RequiredNA if not provided Internal backup battery Yes * Backup time for internal battery in mins 45 mins or more * Built in air source Air compressor (external) Air compressor (external) Availability of stand alone compressor No Yes
RequiredNo Compressor certification European CE US FDA
RequiredEuropean CE
RequiredBoth European CE and US FDA
RequiredBIS Compressor shall provide an oil free Medical air
Requiredwith Peak output flow should be minimum 150 LPM and Air quality complying with ISO compressed air purity class Yes Yes Medical Air Compressor should automatically activate in the event of wall air supply loss and replacement of internal filters should be performed without removing the compressor
Requiredhave washable air filter Yes * Seller shall ensure compatibility of compressor with ventilator Yes Yes Inbuilt nebulizer with particle size less than 3 micron Yes Yes Warranty in years 5 * Additional Accessories Reusable silicon breathing circuits for Adult
Requiredpediatric and Neonatal 2 each * NV mask(Re usable)-Small
Requiredmedium and large 2 Each * Length of Power cord in m >3 m * 6/10 Type of flow sensor Disposable Reusable
RequiredDisposable
RequiredNA No of reusable flow sensor NA * No of disposable flow sensor 50 50
Required100
RequiredNA Autoclavable exhalation valve/expiratory cassette/filter NA for flow Sensor * Humidifier: Servo controlled with digital monitoring of inspired gas temperature with heating wire 1 1 Trolley for ventilator with circuit holding arm Yes * Miscellaneous Parameters Number of installations in Central/State/PSU Govt Hospitals ( Hint: Seller should supply a performance certificate of the device to the buyer incase demanded after placement of order) >3 <3
Required>3 OEM/Reseller (if supplied by reseller shall ensure uninterrupted availability of all spares for 10 years) Yes * Availability of toll free facility for technical support maintened by OEM or authorized agencies Yes * During the warranty period it shall be ensured that all the break down calls are attended with in 24 hrs and the complete details of service agents/contact details should be furnished to buyer and consignee at time of supplies Yes * 7/10 User/Technical/Mainten ance manuals to be supplied in English in hard and soft copy Yes * Details of equipments and procedures required for local calibration and routine maintenance to be supplied and advanced maintenance task documentation also to be furnished Yes * List of important spares and accessories
Requiredwith their part numbers and price lists to be supplied to the buyer at the time of supplying the equipment Yes * Demonstration of equipment and training to be provided after completing supplies before acceptance Yes * The Principal Manufacturer must have direct Presence/approved service center In India Yes * Copies of reports and certifications to be furnished to buyer on demand at time of supplies Yes * * Bold specifications 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.
