RequiredOEM Authorization Certificate Bid to RA enabled No Portable Ventilator ( 2 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Standards UMDNS Code 18-098 * Certifications for the product Both US FDA & EU CE Both US FDA & EU CE Certification number and date - * Confirmity to quality management standards ISO 9001 & ISO 13485 ISO 9001 & ISO 13485 Confirmity to electrical safety standards IEC 60601-1 or ISO 80601-2-12 or BIS equivalent * 1/6 Vibration resistance certification EN 794-3 EN 794-3 Aviation Standards: Should have airworthiness as per RTCA DO-160D aviation standards Should have airworthiness as per RTCA DO-160D aviation standards Performance Parameters Scope of item Portable transport ventilators are defined as mechanical ventilators that are specifically designed to facilitate intrahospital and/or interfacility transport of ventilated patients. These devices are relatively small and lightweight
Requiredand can be hand-carried if necessary during transport. Transport ventilators may provide basic or advanced modes of ventilation for neonatal
Requiredpediatric
Requiredand/or adult patients * Clinical application Portable transport ventilators are designed to take the place of manual ventilation or "bagging" during emergency or transport situations * Patient type Pediatric and neonatal Pediatric and neonatal Tidal volume in ml 20 ml or less- 300 ml or more 20 ml or less- 300 ml or more Respiration rate
Requiredbreaths/min Upto 80 * Trigger mechanism Pressure or flow * FiO2 % 21-100 * Inspiratory flow rate
RequiredL/min Upto 120 * Inspiratory pressure
Requiredcm H2O Upto 50 * IE ratio Adjustable or infinitely variable Adjustable or infinitely variable PEEP/CPAP
Requiredcm H2O 0-20 * Pressure support
Requiredcm H2O Upto 35 or more * Panel lock Yes * 2/6 Operating modes Assist/control modes A/C volume breaths and A/C pressure breaths * SIMV modes SIMV volume breaths
RequiredSIMV pressure breaths
RequiredSpontaneous/CPAP mode
RequiredCPAP pressure support
RequiredNon-invasive ventilation
RequiredApnea- backup vent mode * Monitored/Displayed Parameters Peak inspiratory pressure
RequiredMean airway pressure
RequiredPEEP pressure
RequiredTidal volume
RequiredMinute volume
RequiredFiO2
RequiredRespiratory rate
RequiredInspiratory time
RequiredExpiratory time
RequiredIE ratio * 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 * Type of display LED LED Size of display in inches 4 * Patient Transport Capability Mounting of the equipment Rail mounted Rail mounted Rail mount or trolley mount should be of the same OEM Yes * Hand carrying during transport Yes * MRI compatibility of equipment Yes Yes Magnetic field strength
RequiredT 3 T 3 T Guass line restriction in G (in case of non MRI compatible put NA) - * 3/6 Built in air source Air compressor Air compressor Should work with External high pressure source/cylinders and low flow Oxygen supply * Power source Mains and battery operated Mains and battery operated Battery type Li-ion * Should be able to work with car ambulance battery Yes Yes Power supply NA for battery operated NA for battery operated Operating time in hrs More than 5 hrs More than 5 hrs Weight (including battery) in kgs 3.75 * Warranty in years 5 5 Additional Accessories Reusable silicon breathing circuits 2 adult
Required2 pediatric
Required2 neonatal 2 adult
Required2 pediatric
Required2 neonatal NV mask 2 adult
Required2 pediatric
Required2 neonatal 2 adult
Required2 pediatric
Required2 neonatal Length of Power cord in m 3 m * Charging adapter to be supplied Yes * Reports Number of supplies in Central/State/PSU Govt Hospitals ( Hint: Seller should supply a performace certificate of the device to the buyer incase demaneded after placement of order) >3 <3
Required>3 OEM/Reseller ( if supplied by reseller shall ensure uninterputed availabilty of all spares for 10 years) Yes * Availability of toll free facility for technical support maintened by OEM or authorized agencies Yes * User/Technical/Mainten ance manuals to be supplied in English in hard and soft copy Yes * 4/6 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.
