Belgium – Medical equipments – Fourniture, installation et maintenance de mélangeurs de gaz air et oxygène avec monitorage et les consommables associés

Context

Oxygen therapy is an essential modality for managing patients in intensive care, emergency departments, intensive care units, and neonatal care, particularly to prevent intubation, optimize extubation conditions, and improve the prognosis of patients with acute respiratory distress syndrome (ARDS). In these contexts, the precision and stability of the fraction of inspired oxygen (FiO₂) delivered to the patient are critical requirements. Any deviation 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). Therefore, in accordance with the recommendations of learned societies and applicable international standards (notably ISO 80601-2-55), any air/oxygen mixing device intended for use in critical care must allow for: continuous measurement of the actual FiO₂ delivered, real-time display, and a visual and audible alarm system (high and low thresholds). Thus, only mixers integrating an oxygen analyzer (O₂ cell) with an alarm system and screen will be considered compliant with clinical safety requirements.

PRINCIPLE OF SEPARATION OF THE MIXER AND THE MONITORING SYSTEM

To ensure optimal control of operating and maintenance costs, the market must allow for the functional and commercial separation of the mechanical mixing system and the FiO₂ monitoring system. The mechanical mixer, including the device for adjusting the oxygen concentration and the internal mechanical components that ensure the mixing of 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 retained and reused when it remains functional and compliant. This modularity is intended to allow the mechanical part of the mixer to be replaced in case of wear or failure, without requiring the systematic replacement of the monitoring system when it remains operational. Consequently, the tenderer must necessarily propose a solution allowing for: • The use of the mechanical mixer with an FiO₂ monitoring system; • The replacement of the mechanical mixer independently of the monitoring system; • The 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; • The maintenance and replacement of the components concerned without the systematic replacement of the entire device. The tenderer must specify in their offer the technical modalities allowing this separation as well as the compatibility between the different elements.

ADAPTATION TO NEONATAL, PEDIATRIC, AND ADULT POPULATIONS

The market concerns equipment intended for use with populations with very different needs in terms of gas flow, particularly in neonatal care and pediatric applications requiring high flows, particularly in large patients. The proposed equipment must therefore allow the use of flow meters adapted to the different populations and clinical uses, while ensuring sufficient precision of the flow delivered over the entire range considered. The market must in particular allow the ordering of the mixer with flow meters adapted to: • Neonatal applications with very low flow, particularly around 3 L/min and 5 L/min; • Pediatric and intermediate applications; • Applications requiring higher flows, potentially reaching approximately 20 L/min; The availability of several flow meter ranges or calibers must allow the device to be ordered according to the clinical indication and the population concerned, without compromising the precision of the flow delivered. The tenderer must specify, for each flow meter proposed: • The nominal flow range; • The precision or maximum measurement/delivery error; • The minimum measurable and/or deliverable flow; • The maximum flow; • The conditions under which the announced performances are guaranteed; • The compatibility with the proposed mixer; • Any differences in performance between the different calibers. Flow meters intended for low flows must in particular have performances adapted to the needs of neonatal care. The sole ability to reach a high maximum flow cannot be considered sufficient: the precision of the flow over the entire range of use is an essential requirement of the market. The different flow meters and configurations must be able to be ordered separately, in order to avoid the acquisition of an oversized equipment relative to the clinical need.

Scope

The subject of the present market includes, in particular, at the expense of the contractor: • The supply and delivery of medical gas mixers air/O₂; • The supply of mixers in a configuration adapted to the intended clinical use, particularly with regard to the population cared for and the required flow range; • The supply of flow meters suitable for each mixer configuration; • The installation and commissioning of the equipment; • The supply of FiO₂ monitoring systems, including in particular the display, the oxygen analyzer, and the alarm devices; • The guarantee of supplies and services; • Preventive and corrective maintenance; • The...