Request for Quotation – Platelet Incubator and Agitator System

Dear Sales Team, We are interested in purchasing a Platelet Incubator and Agitator System for a blood bank facility in Mozambique. Please provide your technical and commercial quotation for a complete system consisting of a platelet incubator and a compatible horizontal platelet agitator, designed for the storage of platelet concentrates under continuous agitation and controlled temperature. 1. Incubator – Minimum Technical Requirements - Adjustable temperature range covering at least +20°C to +24°C, with a set point of +22°C. - Thermoelectric solid-state heating/cooling technology, or equivalent. - Forced-air circulation. - Temperature uniformity of ≤ ±1°C and resolution of 0.1°C, or equivalent. - Continuous electronic temperature recording, with exportable historical data. - Audible and visual alarms for high/low temperature, power failure, open door and agitation failure. - Agitator movement monitoring with interruption alarm, or equivalent. - Digital/touchscreen interface with password protection, or equivalent. - Glass door for visual inspection without opening the incubator, or equivalent. 2. Platelet Agitator – Minimum Technical Requirements - Horizontal flatbed agitator with continuous, gentle linear motion, or equivalent. - Capacity for at least 48 whole-blood-derived platelet units or at least 16 apheresis platelet units, or equivalent. - At least 6 ventilated drawers, or equivalent. 3. Required Accessories and Services The supply must include: - Additional drawers compatible with the proposed agitator. - Compatible remote temperature monitoring system. - Installation and IQ/OQ qualification, including the corresponding documentation. 4. Regulatory and Quality Requirements The proposed equipment must comply with the following requirements: - Brand-new equipment, unused and supplied in the manufacturer's original packaging. - Electrical supply: 220–230 V ±10%, 50 Hz, with a plug compatible with the electrical network in Mozambique, or an adapter supplied. - CE marking under the applicable MDR/IVDR requirements, FDA approval, or equivalent approval from a regulatory authority that is an IMDRF member. - Manufacturer certified to ISO 13485 or equivalent. - Electrical safety compliance with IEC 60601-1 or IEC 61010-1, as applicable, or equivalent. - Registration/import authorization with Mozambique's ANARME, or a formal commitment to obtain it before delivery. - User manual and quick-start guide in Portuguese; service manual in Portuguese or English. - Guaranteed availability of spare parts and consumables for at least 5 years. - Technical support in Mozambique or a formal commitment to provide it. - All supplied accessories and consumables must be manufactured by, or validated by, the equipment manufacturer. - Manufacturer's authorization letter if the quotation is submitted by an authorized distributor or reseller. 5. Model Status and Manufacturer Declaration The proposed model must be the manufacturer's latest generation for this application, currently marketed in the European Union or the United States, or in its country of origin if that country is an IMDRF member. Please provide a manufacturer declaration confirming: - Model launch year. - Current commercial availability in the relevant reference market. - That the model is not discontinued or replaced by a newer version. - Commitment to technical support and spare parts availability for the required period. 6. Documents and Commercial Quotation Please provide: - Original manufacturer's catalogue and technical datasheets. - Product photographs and model references. - Regulatory certificates and applicable electrical safety certificates. - ISO 13485 certificate. - Technical description confirming compliance with each requirement. - Manufacturer's declaration and authorization letter, where applicable. - Unit price and total price, including accessories, additional drawers, remote monitoring system and IQ/OQ qualification. - Warranty period, delivery time, installation costs and payment terms. - Estimated shipping costs to Maputo, Mozambique. Please clearly identify any requirement that is not met, is optional, or requires an additional cost. We would appreciate receiving your complete technical and commercial proposal. Best regards, Allbino Mozambique