Catalogue values for ICU Ventilators (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | ICU Ventilator |
| PRODUCT INFORMATION | Patient Type | Adult, Pediatric and Neonatal |
| Type of technology | Compressor | |
| Tidal volume in ml | (2 ml or less) to (1500 ml or more) | |
| Respiration rate, breaths/min | up to 80 or more | |
| Trigger mechanism | Both pressure and flow | |
| FiO2% | 21 to 100 | |
| Inspiratory flow rate, L/min | upto 120 or more | |
| Inspiratory pressure, cm H2O | upto 80 or more | |
| IE ratio | 1:10 to 4:1 | |
| Sigh breath function | Yes | |
| PEEP/CPAP, cm H2O | upto 40 or more | |
| Pressure support, cm H2O | 0 to 40 or more | |
| Leak compensation | Yes | |
| Auto 100%/Increase O2 button | Yes | |
| Control panel lock | Yes | |
| Facility for double lung ventilation | Yes | |
| PATIENT ASSESSMENT TOOLS | Maximum wave forms displayed | 3 (Pressure and time, volume and time , flow and time) |
| Number of loops | 2 loops (P-V, F-V) with facility of saving of 1 Loops for reference | |
| Maximum trending time in hrs | ≥24 hr | |
| Lung recruitment tools (PV loops) / OLT (Open lung tools) | Yes | |
| Lung mechanics visualization tool | Yes | |
| Capnography/CO2 monitoring | Yes, No | |
| Esophageal / transpulmonary pressure monitoring | Yes, No | |
| Modes of ventilation | Volume controlled, Pressure Controlled, Pressure Support, SIMV with Pressure support, SIMV with volume control with pressure support, CPAP/PEEP, Inverse Ratio Ventilation, Non invasisve ventilation, Apnea /back up ventilation, SIMV (VC) with Pressure support, SIMV (PC) with Pressure Support, SIMV (PRVC) with Pressure Support | |
| APRV(Airway Pressure Release Ventilation) /Bivent/Bi level | Yes | |
| MMV(Mandatory Minute Ventilation) + PSV (Pressure Support Ventilation) /ASV( Adaptive Support Ventilation ) or ALPV(Adaptive Lung Protection Ventilation) or Automode | Yes | |
| PRVC(Pressure-Regulated Volume Control ventilation)/Auto flow | Yes | |
| High flow oxygen therapy | Yes | |
| Automatic weaning system provided | Yes | |
| Volume Support | Yes | |
| Ventilation monitoring facility | The Ventillator is a Microprocessor Controlled ventilator with integrated facility for Ventilation monitoring | |
| Monitored / Displayed parameters | Peak inspiratory pressure, Mean airway pressure, PEEP pressure, Tidal volume, Minute volume, Spontaneous minute volume, FiO2 (analyzed %), Respiratory rate, Inspiratory time, Expiratory time, IE ratio, Plateau Pressure | |
| Availability of Status indicator on display | Ventilator mode, Battery life, patient data, alarm settings, clock | |
| Patient alarms | Low/high FiO2, Low/high minute volume, Low inspiratory pressure, High pressure, Low PEEP, High PEEP, Apnea, Continuous high pressure/occlusion, Inverse IE, High respiratory rate, Breathing circuit disconnect | |
| Equipment alarms | Gas-supply failure, Power failure, Vent inoperative, Low battery, Self-diagnostic | |
| RSBI (Rapid Shallow Breathing Index) | Yes | |
| Expiratory Time constant ( Tcexp) | Yes | |
| Compliance static and/or dynamic | Yes | |
| Inspired and/or expired resistance | Yes | |
| Occlusion pressure | Yes | |
| Inspiratory and expiratory hold | Yes | |
| Spontaneous frequency | Yes | |
| Total peep, intrinsic peep, extrinsic peep | Yes | |
| Expiratory block is autoclavable and no routine calibration required | Yes | |
| Auto compensation for ET Tube | Yes | |
| Facility for automatic compliance & Leakage compensation for circuit available | Yes | |
| RS 232 out put port | Yes | |
| USB/Memory card | Yes, No | |
| Availability of Remote alarm/display port | Yes, No | |
| Facility to Report (vent alarms and patient status) | Yes | |
| HL/7 Compliant out put | Yes, No | |
| Type of coloured display | LED/LCD/TFT | |
| Display should be touch screen | Yes | |
| NIV (Non Invasive Ventilation) to be possible in all modes of ventilation available | Yes | |
| Minimum Size of display (±2%) | 15.0 | |
| Graphic display have automatic scaling facility for waves | Yes | |
| HARDWARE AND ELECTRICAL REQUIREMENTS | Power supply | 220-240 V , 50 Hz AC |
| Provision of UPS | Yes, No | |
| Backup time in hrs | 2 | |
| Internal backup battery | Yes | |
| Backup time of internal battery in mins | 30 mins or more | |
| Built in air source | Air compressor (external) | |
| Availability of stand alone compressor | Yes | |
| Compressor shall provide an oil free Medical air, with Peak output flow should be minimum 150 LPM and Air quality complying with ISO compressed air purity class | 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, to have washable air filter | Yes | |
| Seller shall ensure compatibility of compressor with ventilator | Yes | |
| Nebulizer with particle size less than 3 micron | Yes | |
| ADDITIONAL ACCESSORIES | Number of reusable silicon breathing circuits | 2 |
| NV mask(Re usable)-Small,medium and large | 2 Each | |
| Length of Power cord in m | ≥ 3 m | |
| Flow sensor Placement | Distal | |
| Number of flow sensor | 2 Reusable | |
| Humidifier: Servo controlled with digital monitoring of inspired gas temperature with heating wire | 1 | |
| Trolley for ventilator with circuit holding arm | Yes | |
| CERTIFICATIONS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid Medical Device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes | |
| Certification for manufacturing unit | ISO:13485 (Latest) | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes | |
| Electrical Safety Standard | IEC 60601-1-2 or Equivalent BIS | |
| Safety and Essential Performance | IS 13450 Part 2 Section 12 | |
| MISCELLANEOUS PARAMETERS | 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 | |
| User/Technical/Maintenance 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, with their part numbers and price lists to be supplied to the buyer at the time of supplying the equipment | 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 | |
| WARRANTY | Warranty (years) | 5 Or higher |
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