Emergency Procurement: Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast

New clarification added: Dear partners,Section II: Schedule of requirementsE-Sourcing reference no: RFQ/2026/61448Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblastSummary of Requirements for the Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblastLot 3 Expert-Class ICU Ventilator with Integrated Humidifier and Dedicated Compressor -1 item 3.2.1.4 Requirement: “Inspiratory Flow: Up to ~210 L/min (turbine max).”We kindly ask you to provide clarification on the need to deliver a flow rate of 180 L/min during inhalation.From a practical standpoint, the maximum sufficient flow rate for daily clinical use is 100 L/min during inhalation.Sean M. Hickey; Abdulghani Sankari; Al O. Giwa in Hickey SM, Sankari A, Giwa AO. Mechanical Ventilation. 2024 Mar 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. PMID: 30969564 report:"Setting Mechanical Ventilation:Inspiratory flow rate (IFR): The inspiratory flow rate is usually set between 40 and 60 L/min to achieve an inspiratory and expiratory ratio of 1:2 or 1:3. A higher inspiratory flow rate (up to 90 L/min) is often recommended in cases of severe distal airway obstruction, such as acute COPD exacerbation or severe asthma exacerbation. This higher rate allows for longer expiratory time to empty the lungs, targeting an inspiratory-to-expiratory ratio (I:E) greater than 1:3."The International Organization for Standardization (ISO) requirements for inspiratory flow rates in mechanical ventilators are primarily defined in ISO 80601-2-12:2023 (Particular requirements for basic safety and essential performance of critical care ventilators). The key requirement related to inspiratory flow:Inspiratory Flow Capability: Critical care ventilators are generally expected to provide an inspiratory flow rate of up to 150 liters/min or more.In light of the above, we respectfully propose revising the requirement to:“Inspiratory Flow: no less than ~150 L/min.”We believe this adjustment maintains the clinical objective of high-performance ventilation while ensuring technological neutrality and fair participation of qualified manufacturers.Thank you in advance for your attention and cooperation./Dear Bidder,Thank you for the interest in the tender.Please find below the clarification on your question.The requirement:“Inspiratory Flow: Up to ~210 L/min (turbine max)” is intended to ensure that the ventilator is capable of delivering high peak inspiratory flow when clinically required, particularly in complex ICU settings, including but not limited to:Severe obstructive lung disease (e.g., acute COPD/asthma exacerbation)High spontaneous inspiratory demand (flow starvation prevention)ARDS patients requiring protective ventilation with high peak flow and short inspiratory timePatients with high minute ventilation demand (sepsis, metabolic acidosis)Non-invasive ventilation (NIV) with high leak compensation requirementsWhile it is acknowledged that routine inspiratory flow settings are commonly within 40–60 L/min, and in many cases below 100 L/min, the specification refers to the maximum flow capability of the turbine system, not to the routinely applied clinical setting.In high-acuity ICU environments, elevated peak flow capacity:Improves patient–ventilator synchronyReduces inspiratory effort and flow starvationSupports high inspiratory flow waveforms (square/descending ramp)Enhances performance during NIV and leak compensationProvides reserve capacity for extreme clinical scenariosRegarding ISO 80601-2-12:2023, this standard defines minimum safety and performance requirements. A capability of 150 L/min may meet the minimum expectation under ISO; however, the present procurement aims to secure an expert-class ICU ventilator with advanced performance margins, suitable for tertiary and critical care environments.Therefore:The requirement specifies maximum turbine capacity, not mandatory routine operating flow.The ~210 L/min value reflects market availability among high-end ICU ventilators and ensures performance headroom.This requirement does not mandate continuous delivery at that level but ensures availability when clinically indicated.At this stage, the requirement remains unchanged.We confirm that the specification is aligned with the intended clinical use and level of care foreseen for the receiving institution.Thank you.Procurement team. 

New amendment added #1: Dear Bidders,Please be advised that the below amendments are made to the RFQ requirements:The deadline for submission is extended by 04.03.2026.The deadline for the clarifications is extended by 25.02.2026.RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblastLot 3 Expert-Class ICU Ventilator with Integrated Humidifier and Dedicated Compressor  -1 itemClause 3.1.2  of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “The system shall include a humidification system supplied as part of the ventilator solution and an internal air-generation system (turbine or compressor) to ensure full functionality in facilities without central compressed air supply”.Clause 3.2.1.4  of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “Inspiratory Flow: not less than 180 L/min”.Clause 3.2.1.6  of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “PEEP adjustable range: minimum 0–45 cmH₂O, with an allowable tolerance of ±5 cmH₂O”.Clause 3.2.1.8   of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “FiO₂ adjustable range: 21–100%”.Clause 3.2.3.3   of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “Alarm status, trend monitoring”.                          4. RFQ_Section_II_RFQ_2026_61448_Schedule of requirements Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast_Lot 3Lot 3 Expert-Class ICU Ventilator with Integrated Humidifier and Dedicated Compressor  -1 itemClause 3.1.2  of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “The system shall include a humidification system supplied as part of the ventilator solution and an internal air-generation system (turbine or compressor) to ensure full functionality in facilities without central compressed air supply”.Clause 3.2.1.4  of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “Inspiratory Flow: not less than 180 L/min”.Clause 3.2.1.6  of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “PEEP adjustable range: minimum 0–45 cmH₂O, with an allowable tolerance of ±5 cmH₂O”.Clause 3.2.1.8   of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “FiO₂ adjustable range: 21–100%”.Clause 3.2.3.3   of the RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast has been amended to be read as follows: “Alarm status, trend monitoring”.Please check the amendment documents:RFQ_Section_II_RFQ_2026_61448_Schedule of requirement Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast.rev.1RFQ_Section_II_RFQ_2026_61448_Schedule of requirements Provision of Thromboelastograph, ENT Treatment Cabinet, Intensive Care Ventilator to Mykolaiiv oblast_Lot 3 rev.1in the Documents section.

New clarification added: Good day!- Please clarify the technical specifications for lot 3:in point 3.1.2 "The system shall include an integrated humidifier and a dedicated compressor to ensure full functionality in facilities with insufficient medical gas pressure or lack of central compressed air supply." we plan to offer a device that operates on a built-in turbine (this is a better option, since it does not depend on an external power supply, unlike a compressor). Does a device with a built-in turbine comply with clause 3.1.2?point 3.2.2.7 "High flow 02". By high flow is meant a mode with a flow of more than 30 liters/minute?point 3.2.3.3 "Alarm status, trend monitoring, and decision support" the part "decision support" is not clear. We suggest removing it. Leave the requirement as "Alarm status, trend monitoring"- Also, please clarify whether it is necessary to translate documents into English: similar contracts, certificates and declarations for goods in Ukrainian, company registration documents?Thank you!/Dear Bidder,Thank you for the interest in the tender. Please find below the clarifications on the questions.1. Answer  -Regarding Clause 3.1.2 – Humidifier and Air-Generation SystemThe requirement under Clause 3.1.2 is intended to ensure independent ventilator operation in facilities without reliable central compressed air supply.A ventilator equipped with an internal turbine-based air-generation system is considered compliant, provided that it ensures full functionality without reliance on central compressed air infrastructure. The requirement does not mandate a specific air-generation mechanism. Both turbine-based and compressor-based internal systems are acceptable.Additionally, the humidification system may be either built-in or a fully compatible external heated humidifier supplied as part of the ventilator solution, provided equivalent clinical performance is ensured.Following the first revision of the Tender Documentation, Clause 3.1.2 has been amended and now reads as follows:“The system shall include a humidification system supplied as part of the ventilator solution and an internal air-generation system (turbine or compressor) to ensure full functionality in facilities without central compressed air supply.”The Tender Documentation has been updated accordingly.                                                                                                                                                                                                       2. Answer   Regarding Clause 3.2.2.7 – High Flow O₂“High Flow O₂” refers to a high-flow oxygen therapy mode capable of delivering flows exceeding 30 L/min. Systems providing recognized high-flow therapy functionality meeting or exceeding this level will be considered compliant.                                                                                                                                                                                                                    3. Answer Regarding Clause 3.2.3.3 – Decision SupportThe term “decision support” refers to ventilator-integrated clinical assistance features such as advanced monitoring tools, trend analysis, or graphical guidance supporting clinical interpretation.However, to avoid ambiguity, the requirement is amended as follows:“Alarm status and trend monitoring.”The Tender Documentation will be updated accordingly.                                                                                                                                                                                                          4. Answer Regarding Translation of DocumentsDocuments issued in Ukrainian (including similar contracts, certificates, declarations of conformity, and company registration documents) do not require translation into English. Thank you.Procurement team.

New clarification added: Dear Sir/Madam,Greetings, we are interested in participating in this project and would like you to clarify the below mentioned points :1. Kindly let us know if product registration is required in this tender.2. Would it be possible to extend the bid submission deadline by 7–14 days due to the upcoming Chinese Spring Festival?Looking forward to your response.Regards,Export Dept./Dear Bidder,Thank you for your interest in the tender.Please find below the clarifications in response to your questions:1.  Yes, product registration is required. The offered medical device must be duly registered and permitted for circulation in Ukraine in accordance with the applicable legislation on technical regulation and conformity assessment.2. The submission deadline will be extended by 04.03.2026.Thank you.Kind regards,Procurement Team

New clarification added: Dear Bidder,Thank you for your interest in the tender. Please find below the clarifications on your questions.Answer 1. Answer (Regarding Requirement 3.1.2 – Humidification System and Air-Generation System)The intention of Requirement 3.1.2 is to ensure the availability of active heated humidification suitable for ICU ventilation, while maintaining independent operation in facilities without reliable central compressed air supply.The term “integrated humidifier” was not intended to mandate a built-in humidifier only. The clinical objective is to ensure that a humidification system is supplied as part of the ventilator solution and fully compatible with it, guaranteeing safe and uninterrupted ventilation. Both built-in humidifiers and fully compatible external heated humidifiers supplied as part of the offered system are acceptable, provided equivalent clinical performance is ensured.Furthermore, the requirement concerning air supply is intended to ensure independence from central compressed air infrastructure. The ventilator must therefore include an internal air-generation system, which may be based on turbine or compressor technology. No specific air-generation mechanism is mandated, provided that full ventilator functionality without reliance on central compressed air supply is ensured.In order to clarify this intent and ensure technological neutrality and fair competition, the technical specification has been amended accordingly.The Tender Documentation has been updated accordingly.   Answer 2. (Regarding Requirement 3.2.1.4 – Inspiratory Flow)The reference to “turbine max” does not mandate turbine-based technology. The requirement concerns overall inspiratory flow performance, regardless of the gas-generation mechanism (turbine, compressor, or equivalent). Ventilators providing a maximum inspiratory flow of not less than 180 L/min will be considered compliant, provided that adequate ICU ventilation performance is ensured.Accordingly, Requirement 3.2.1.4 is amended as follows:Inspiratory Flow: not less than 180 L/min.Answer 3. (Regarding Requirement 3.2.1.8 – FiO₂ Adjustable Range)In standard ICU practice, ventilators deliver FiO₂ from 21% (ambient air concentration) up to 100% when blending medical air and oxygen. This clarification ensures alignment with established clinical practice without limiting competition.Accordingly, the technical specification is amended as follows: FiO₂ adjustable range: 21–100%.Thank you.Procurement team. 

New clarification added: Dear UNOPS team,We kindly request you to clarify and amend several points in the Technical Specifications for Goods – Comparative Data Tables, specifically:Lot 3 Expert-Class ICU Ventilator with Integrated Humidifier and Dedicated Compressor  -1 item1.    Clarification of Section 3.2.3.3: "Decision Support"Section 3.2.3.3 mentions the requirement for "Alarm status, trend monitoring, and decision support". We kindly request a detailed clarification regarding the functional requirements for "decision support". Please specify which clinical decision support tools or automated protocols are expected to be integrated into the device.2.    Amendment to Section 3.2.1.6: PEEP RangeThe current requirement for the PEEP value is set at 0-45 смН2О. To foster broader competition and allow for a wider range of high-quality equipment to be proposed, we request amending this range 0-45 ±5 смН2О. This minor adjustment will ensure that more manufacturers can participate without compromising the clinical capabilities of the equipment required for critical care.3.    Amendment to Section 3.2.1.8: FiO2 RangeRegarding Section 3.2.1.8, we request to change the FiO2 range from 15-100% to 21-100%. Please note that atmospheric air contains approximately 21% oxygen; therefore, a range starting from 21% is the standard for the vast majority of modern medical ventilators and anesthesia machines. Adjusting this parameter to the industry standard of 21-100 % will significantly expand the pool of potential bidders and ensure the procurement of technologically up-to-date equipment.Lot 2 ENT Combine (ENT Treatment Unit / ENT Workstation) - 1 item1.    Amendment to Section 2.6: Anti-fog / Mirror WarmingRegarding Section 2.6, will it be considered compliant «Pre-heater device (nasoscope/laryngoscope etc warmer)»? Because it is also component of the ENT Workstation, which allows quickly heat the tool before inspection.We look forward to your response and the respective updates to the tender documentation./Dear Bidder,Thank you for your interest in the tender. Please find below the clarifications on your questions.1. Response to Question 1 – Decision SupportThe term “decision support” refers to integrated clinical support functionalities designed to assist clinicians in optimizing ventilation therapy. These functionalities may include, but are not limited to:Monitoring of lung mechanics (e.g. compliance, resistance, auto-PEEP)Trend monitoring with graphical displayWeaning support tools (e.g. assistance during spontaneous breathing trials)Guidance for parameter optimization (e.g. PEEP titration tools)Alerts based on respiratory mechanics or changes in patient conditionThis requirement does not prescribe any specific proprietary algorithm or manufacturer-exclusive automated protocol.Equivalent clinical support functionalities that support therapeutic decision-making will be considered compliant.2. Response to Question 2 – PEEP Adjustable RangeThe technical specification will be revised as follows:PEEP adjustable range: minimum 0–45 cmH₂O, with an allowable tolerance of ±5 cmH₂O3. Response to Question 3 – FiO₂ Adjustable Range  The request is accepted.The technical specification is amended as follows:FiO₂ adjustable range: 21–100%The Tender Documentation will be updated accordingly.4. Response to Question 4 – Anti-Fog DeviceYes.A pre-heater device intended for warming nasoscope or laryngoscope mirrors or instruments will be considered compliant, provided that it effectively performs the anti-fog function during examination. The specification remains unchanged.  Thank you.Procurement team.

New clarification added: Dear UNOPS Team,According to the documentation requirements. The bidder should download Evidence (contract, PO, etc.) of at least 2 contracts for the supply of the offered or equivalent goods realized in the previous 3 (three) years/These should be contracts for similar equipment or they could simply be for the supply of medical equipment?/Dear Bidder,Thank you for your interest in the tender.Please find below the clarification in response to your question:Contracts for the supply of the offered goods, or equivalent goods (including other medical products), completed within the previous three (3) years will be considered.Thank you.Kind regards,Procurement Team