Tenders Are Invited For Medical Equipments – Supply, Installation And Maintenance Of Air And Oxygen Gas Mixers With Monitoring And Associated Consumables

Medical Equipments – Supply, Installation And Maintenance Of Air And Oxygen Gas Mixers With Monitoring And Associated Consumables. Context Oxygen Therapy Constitutes An Essential Treatment Modality In Intensive Care, Emergency, Intensive Care And Neonatology, In Particular To Prevent Intubation, Optimize Extubation Conditions And Improve The Prognosis Of Patients With Acute Respiratory Distress Syndrome (Ards). In These Settings, The Accuracy And Stability Of The Inspired Fraction Of Oxygen (Fio₂) Delivered To The Patient Are Critical Requirements. Any Drift In The Gas Mixture Can Lead To Serious Consequences, Such As Hypoxemia Or Iatrogenic Hyperoxia, The Latter Being Particularly Harmful In The Neonatal Population (E.G. Retinopathy Of Prematurity). Consequently, In Accordance With The Recommendations Of Learned Societies And Applicable International Standards (In Particular Iso 80601-2-55), Any Air/Oxygen Mixing Device Intended For Use In Critical Care Must Allow: Continuous Measurement Of The Fio₂ Actually Delivered, A Real-Time Display, A Visual And Audible Alarm System (High And Low Thresholds). Thus, Only Mixers Integrating An Oxygen Analyzer (O₂ Cell) With Alarm System And Screen Will Be Considered To Comply With Clinical Safety Requirements. Principle Of Dissociation Of The Mixer And The Monitoring System In Order To Guarantee Optimal Control Of Operating And Maintenance Costs, The Market Must Allow The Functional And Commercial Dissociation Of The Mechanical Mixing System And The Fio₂ Monitoring System. The Mechanical Mixer, Including In Particular The Device For Adjusting The Oxygen Concentration, As Well As The Internal Mechanical Components Ensuring The Mixing Of The Gases, Must Be Able To Be Supplied For Clinical Use Independently Of The Fio₂ Monitoring System. The Monitoring System, Including The Oxygen Analyzer, The O₂ Cell, The Digital Display And The Alarm Devices, Must Be Able To Be Preserved And Reused When It Remains Functional And Compliant. This Modularity Is Intended To Allow The Replacement Of The Mechanical Part Of The Mixer In The Event Of Wear Or Failure, Without Requiring The Systematic Replacement Of The Monitoring System When It Remains Operational. Consequently, The Bidder Must Propose A Solution Allowing: • The Use Of The Mechanical Mixer With A Fio₂ Monitoring System; • Replacement Of The Mechanical Mixer Independently Of The Monitoring System; • Replacement, If Necessary, Of The O₂ Cell Or The Monitoring System Independently Of The Mechanical Mixer; • The Separate Ordering Of These Different Elements; • The Distinct And Transparent Identification Of Their Unit Price In The Offer; • Maintenance And Replacement Of The Components Concerned Without Systematic Replacement Of The Entire Device. The Tenderer Must Specify In His Offer The Technical Modalities Allowing