Request for Quotation- Portable Radio Frequency (RF) Blood Tubing Sealer

Dear Sales Team, We are interested in purchasing a Portable Radio Frequency (RF) Blood Tubing Sealer for a blood bank and transfusion service facility in Mozambique. Please provide your technical and commercial quotation for a new, portable, battery-operated RF sealer designed for sterile sealing of PVC blood bag tubing, suitable for fixed and mobile blood collection operations. 1. Minimum Technical Requirements Please confirm compliance with each of the following specifications: 1. Sealing technology: Radio frequency sealing at 40.68 MHz or another equivalent ISM frequency. 2. Power supply: Rechargeable battery (Ni-MH, Li-ion or equivalent). 3. Battery autonomy: At least 500 sealing operations per full charge. 4. Tubing compatibility: Compatible with standard PVC blood bag tubing from different manufacturers. 5. Sealing time: Maximum 2 seconds per sealing operation. 6. Ergonomic design: Ergonomic sealing handpiece. 7. Weight: Maximum total weight of 3 kg, including the battery. 8. Tubing retention: Tubing retention system and protection against splashing. 9. Safety protection: Protection against electrical sparks and overheating. 10. Status indicators: Visual LED and audible signals indicating operating status, low battery, dirty electrodes and spark occurrence. 11. Separation mechanism: Sealing must produce a break line or notch allowing manual separation of the sealed tubing segments. 2. Required Accessories The quotation must include: - One additional rechargeable battery compatible with the proposed model. - One additional battery charger. - Replacement electrode set. - Dedicated transport case. All accessories must be manufactured by or validated by the equipment manufacturer for the proposed model. 3. Regulatory and General Requirements The proposed equipment must: - Be brand-new, unused and supplied in the manufacturer's original packaging. - Operate at 220–230 V ±10%, 50 Hz, with a plug compatible with Mozambique's electrical network or an adapter supplied. - Have CE marking under the applicable MDR requirements, FDA approval or equivalent approval from an IMDRF member regulatory authority, as applicable. - Be manufactured under an ISO 13485-certified quality management system or equivalent. - Comply with IEC 60601-1 or IEC 61010-1, as applicable, or equivalent electrical safety standards. - Have the required ANARME import authorization or a formal commitment to obtain it before delivery. - Include a user manual and quick-start guide in Portuguese, a service manual in Portuguese or English, and the original manufacturer's catalogue. - Guarantee spare parts and consumables availability for at least 5 years. - Include technical support in Mozambique or a formal commitment to provide it, with a maximum response time of 5 working days. - Ensure that all supplied accessories and consumables are manufactured by or validated by the equipment manufacturer. - Include manufacturer authorization if the bidder is not the original manufacturer. 4. Model Status and Manufacturer Declaration The proposed model must be the latest generation for this application and 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. - Confirmation that the model is not discontinued or replaced by a newer version. - Confirmation that the model is not manufactured exclusively for export markets. - Commitment to technical support and spare parts availability for at least 5 years. 5. Technical and Commercial Documentation Please provide: - Original manufacturer's catalogue and detailed technical datasheet. - Product photographs and exact model reference. - Technical documentation confirming the RF operating frequency. - Battery specifications and documented autonomy per full charge. - List of compatible PVC blood tubing types and manufacturers. - Documentation confirming sealing time and sealing performance. - Applicable CE/FDA or equivalent regulatory documentation. - ISO 13485 certificate or equivalent. - Applicable electrical safety certificates. - Manufacturer's declaration regarding model status and spare parts availability. - Manufacturer authorization letter, if applicable. - Unit price, including all required accessories. - Warranty period. - Delivery lead time and shipping costs to Maputo, Mozambique. - Payment terms and after-sales service conditions. Please clearly identify whether each requirement is fully compliant, partially compliant, optional or unavailable. Any deviations or additional costs must be explicitly stated. We look forward to receiving your complete technical and commercial proposal. Best regards, Procurement Department Mozambique