Specifications include, but are not limited to: Bids must be direct from the manufacturer. Any bid response not from a manufacture will be rejected. Units must come ready to plug in and start operating. Must be FDA approved and have the following certifications: IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2014, ANSI/AAMI ES60601-1:2005/(R)2012, ISO 80601-2-12:2011, CAN/CSA-C22.2 NO. 60601-1:14, EN ISO 5356-1:2015, ISO 80601-2-55:2011 Units must include at a minimum the following: Power Cord Language Kit Demo Lung Assembly, Adult Bacteria Filter, Mainflow (Neo,Peds,Adult) Oxygen Cell Li-Ion Battery- Rechargeable Dust Filter for Hepa & Cooling Fan Battery Calibrator w/cord Communication Board with C02, Nurse Call & Com 1 Option DuoPap / APRV Option NIV / NIV-ST CAPNOSTAT-5 CO2 Sensor Pelican Case Power Cord Pelican Transport Case (Hard Side) Clinical Training Service Training Tuition Training must include: Theory of operation of the ventilator Theory of operation of components within the ventilator Instruction on use of diagnostics software for problem identification and resolution Instruction on use of diagnostic software for ventilators calibration requirements Instruction documentation Preventative maintenance schedules and components required for preventative maintenance. Validation of comprehension of materials will require the participant to successfully complete a written posttest and successful performance of problem identification and resolution utilizing diagnostic software and calibrations. Instruction on cleaning procedures of the ventilator and reusable components for the ventilator circuit. Instruction on functional/preoperational validation of ventilator prior to patient applications.
