Emergency Procurement: Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast

New amendment added #2: Dear Bidders,Please be advised that the below amendments are made to the RFQ requirements:RFQ_Section_III_RFQ/2025/58443_Returnable Bidding Forms_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast rev.1The Form E: Technical Bid Form was added with the section:List of subcontractors RFQ_Section_II_RFQ/2025/58443_Schedule of R-ts_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast was revised with:Item1 X RAY radiology diagnostic workstation with digital flat panel detector  Clause 3.9 of Section II Schedule of R-ts amended to be read as follows:Response Time-≤ 25 msClause 3.13 of Section II Schedule of R-ts amended to be read as follows:Certifications- CE MDD/MDR Class I, RoHS, IEC 60601 compliantItem 2 C-arm digital X-Ray Clause 2.1 of Section II Schedule of R-ts amended to be read as follows:Motorized vertical movement – not less than 40cmClause 6.8 of Section II Schedule of R-ts amended to be read as follows:Mosaic display – no less than 6 imagesItem 3 C-arm digital X-Ray Clause 2.1 of Section II Schedule of R-ts amended to be read as follows:Motorized vertical movement – not less than 40 cmClause 3.5 of Section II Schedule of R-ts  amended to be read as follows:Pulse Width in pulsed fluoroscopy mode – not less than 20 msClause 4.4 of Section II Schedule of R-ts amended to be read as follows: Pixel size – not more than 155 microns”Clause 4.5 of Section IISchedule of R-ts amended to be read as follows: DQE at 0 pairs of lines/cm – not less than 70%Clause 6.5 of  the Section II Schedule of R-ts amended to be read as follows: Road-mapping RSAClause 6.12 of  the Section II Schedule of R-ts amended to be read as follows:Mosaic display – no less than 6 imagesItem 4 Digital X-Ray System with 3 working places Clause 1.1 of Section II Schedule of R-ts  amended to be read as follows:System based on a remote-control tilting table, vertical stand, and overhead or column-mounted X-ray tube, providing a full range of radiological examinations, including radiography and fluoroscopyClause 2.10 of Section Schedule of R-ts amended to be read as follows:Control of all system functions: table movements and generator exposure parameters using a single touchscreen console or single consoleClause 3.4 of Section II Schedule of R-ts amended to be read as follows: Coverage of the patient without repositioning not less than 180 cmClause 4.2 of Section II Schedule of R-ts amended to be read as follows:Adjustment of tomographic layer height – not worse than from 0 to 330 mm, with a step of 1 mmClause 7.14 of Section II Schedule of R-ts amended to be read as follows:Control of generator functions via a touchscreen console (≥12”) or standard consoleClause 11.8 of Section II Schedule of R-ts  amended to be read as follows:Availability of Ukrainian and/or English-language program interfaceClause 13.3 of Section II Schedule of R-ts amended to be read as follows:Built-in sensors: Ambient light sensor and color front sensorClause 14.7 of Section II Schedule of R-ts amended to be read as follows:Throughput – not less than 45 films/hour (14×17 size)Clause 14.9 of Section II Schedule of R-ts amended to be read as follows:Interface Ethernet (RJ-45) for DICOMClause 14.11of Section IISchedule of R-ts amended to be read as follows: mage quality control – Manual or automatic image adjustment (brightness, contrast, gamma, sharpnessClause 14.13  of Section II Schedule of R-ts amended to be read as follows:Dimensions ≤ 80 x 80 x 60 cm (W x D x H)Clause 14.14 of Section II Schedule of R-ts amended to be read as follows:Weight – not more than 90 kgClause 14.15 of Section II Schedule of R-ts  amended to be read as follows:Certifications CE (Medical Device), ISO 13485, FDA , RoHClause 14.16 of Section II Schedule of R-ts amended to be read as follows:Included Software – All dedicated software and tools required for DICOM configuration, printing, and operation must be provided by the manufacturer with the device.ProItem 5 Mobile X-Ray Device Clause 3.6 of Section II Schedule of R-ts amended to be read as follows: Monobloc rotation around transversal axis not less than from Monobloc rotation around transversal axis – not less than from (–40)° to (+90)°Clause 4 of Section II Schedule of R-ts amended to be read as follows:Technical characteristics of generatorClause 6 of Section II Schedule of R-ts amended to be read as follows:Technical characteristics of electrical mainsClause 8.7  of Section II Schedule of R-ts amended to be read as follows:Limiting resolution – not less than 3.5 line pairs per mm (lp/mm)Item 6 Ultrasound diagnostic systemClause 2.6  of Section II Schedule of R-ts amended to be read as follows:Dynamic receive focusing or equivalent technology that ensures optimal focus across the entire image depth – availabilityClause 2.13 of Section II Schedule of R-ts amended to be read as follows:B mode max frames per second (fps), at least: 850Clause 2.15 of Section II Schedule of R-ts amended to be read as follows:Maximum power consumption: 1000 VAClause 3.7 of Section II Schedule of R-ts  amended to be read as follows:PWD PRF range, at least: 500-40000 HzClause 3.9 of Section II Schedule of R-ts amended to be read as follows:CWD PRF range, Hz, at least: 1500-40000 HzClause 3.12  of  Section II Schedule of R-ts amended to be read as follows:Color Doppler max frames per second (fps), at least: 850Clause 3.14 of  Section II Schedule of R-ts amended to be read as follows:Power Doppler max frames per second (fps), at least: 850Clause 3.17 of  Section II Schedule of R-ts amended to be read as follows:Tissue Doppler max frames per second (fps), at least: 850Clause 3.40 of  Section II Schedule of R-ts amended to be read as follows:International Ovarian Tumor Analysis or integrated tumor classification software that performs a similar function to IOTA, including classification of ovarian masses into benign, malignant, or indeterminate categories based on ultrasound features and/or clinical parametersClause 6 of Section II Schedule of R-ts amended to be read as follows:Technical characteristics of printer and auxiliary equipmentClause 7of Section II Schedule of R-ts mended to be read as follows:Technical characteristics: connectivity and memory Clause 9.1.4 of Section II Schedule of R-ts amended to be read as follows:Curvature, not more than: 46 mmClause 9.3.2 of Section II Schedule of R-ts amended to be read as follows:Field of view/angle, at least: 179°Other requirements Clause 2.5 of Section II Schedule of R-ts amended to be read as follows:Commissioning works on putting equipment into operation must be done within 7 calendar days after delivery of the equipmentClause 2.6 of Section II Schedule of R-ts amended to be read as follows:Manufacturer’s standards. All offered equipment has to be manufactured by ISO 9001:2015 or ISO 13485:2016 certified manufacturers. Copies of the original certifications,issued by authorized notified bodies,shall be included in the bidPlease check the amended documents RFQ_Section_III_RFQ/2025/58443_Returnable Bidding Forms_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast rev. 2And  RFQ_Section_II_RFQ/2025/58443_Schedule of requirements_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast rev.1 in the Documents section.The deadline for the submission is 28.07.2025The deadline for clarifications is 23.07.2025Thank you.

New clarification added: please, clarify, what language of training proposal preferable, ukrainian or english? (2.12TRAINING: The Bidder has to organize appropriate user training in Ukrainian  language for effective and problem-free use of the equipment included in this tender at the location of delivery. A training proposal for the operation of the equipment must be submitted by the Bidder in the tender. This proposal shall include at least: •Schedule and duration •Description of training materials)/Dear Bidder,Please find below the clarification on your question.As stated in Section 2.12 TRAINING, the user training must be conducted in the Ukrainian language to ensure effective and problem-free use of the equipment by end users.However, the training proposal submitted as part of the tender may be provided in either Ukrainian or English, as long as it clearly describes the scope, schedule, duration, and materials to be used.To summarize:Training must be delivered in Ukrainian.Training proposal (documentation) may be submitted in Ukrainian or English.This ensures clarity for the evaluation team while meeting end-user operational needs.Thank you.Procurement team.

New clarification added: Dear UNOPS,According to Ukrainian legislation, each X-ray must be supplied with a dosimeter. The requirements for Item 5 Mobile X-Ray Device do not specify such a device. Should a dosimeter be included in the Mobile X-Ray Device?/Dear Bidder,Please find below the clarification on your question.Please note that the technical requirements for Item 5 – Mobile X-Ray Device do not specifically request the inclusion of a dosimeter in the scope of supply.However, in accordance with national regulatory requirements, a dosimeter may be included either as a built-in (integrated) component or as a separate (auxiliary) certified device, depending on the system design and the manufacturer's implementation.Therefore:Bidders are not required to include a dosimeter in their offer, as it is not specified in the tender documentation.Nonetheless, if a dosimeter is included—either integrated within the X-ray system or supplied separately—it must be clearly indicated and fully compliant with Ukrainian health and radiation safety regulations.Thank you.Procurement team.This approach ensures that systems delivered under the tender remain compliant with local legislation, while maintaining flexibility in sourcing and design.

New clarification added: Dear UNOPS,Please, clarufy about B. Technical specifications for Goods Item 1-6– Comparative Data Tables - Item 5 Mobile X-ray Device, p 3.3. Handle height no more than 100 cm - which parameter is meant? Please provide a more detailed explanation./Dear Bidder,Please find below the clarifications on your questions. Item 5: Mobile X-ray Device – Section 3.3Requirement:Handle height – not more than 100 cmThis parameter refers to the maximum vertical height from the floor to the top edge of the primary push/pull handle of the mobile X-ray device when in the standard transport position (i.e., device not elevated or in use mode).Thank you.Procurement team.

New clarification added: Item number 9.3.1: “ Frequency range , at at least : 4.0 - 11.0 MHz " .Please change to – “ Frequency” range , at least : 4.0 – 10.0 MHz »The established upper limit of the frequency range at 11.0 MHz exceeds clinical needs for intracavitary studies and does not affect the quality of diagnosis in most cases.The frequency range of 4.0–10.0 MHz is standard for modern intracavitary sensors and fully complies with international standards, providing high-quality images for gynecological, urological and other intracavitary examinations.Many leading manufacturers produce sensors with an upper limit of 10.0 MHz , and these systems are widely used in medical practice, demonstrating high efficiency and reliability.MHz upper limit requirement significantly narrows the pool of potential bidders, limits competition, and may lead to an increase in procurement costs without objective necessity.Changing this requirement to a more realistic one will attract more participants, increase competition, and ensure efficient use of funds without reducing the quality of diagnostics.Item number 9.3.2: “ Field of view / angle , at least : 180° ” .Please change to – “ Field” of view / angle , at least : 179°»The established requirement for a minimum viewing angle of 180° is excessive and unjustified from a clinical point of view, since a difference of 1° has no significant impact on the quality of the obtained image and diagnosis.The 179° viewing angle also meets international standards for intracavitary examinations, provides a complete overview of anatomical structures and a high level of diagnostic information.Many modern ultrasound systems from leading manufacturers use sensors with a viewing angle of 179°, which confirms the practical sufficiency of such a characteristic.The 180° requirement unreasonably narrows the circle of potential bidders, limits competition, and may lead to an increase in the cost of procurement without improving diagnostic quality.Changing this requirement to a more realistic and widespread one among manufacturers will attract more participants, increase competition, and ensure efficient use of funds.Establishing such requirements will make the tender more accessible to a larger number of suppliers, which, in turn, will contribute to budget optimization and increased procurement efficiency.We hope that our proposal will be positively considered and that the above arguments will be taken into account when forming the final requirements for the tender documentation./Dear Bidder,Please find below the clarifications on your questions.Clarification on Items 9.3.1 and 9.3.2The upper limit of 11.0 MHz in the frequency range for intracavitary probes is specified to ensure high-resolution imaging, particularly for:Detailed assessment of endometrial and ovarian structuresEarly-stage oncological changes in gynecologyPediatric or slender-patient intracavitary applicationsWhile a range up to 10.0 MHz is common, 11.0 MHz is supported by several leading systems and offers a clear advantage in axial resolution—especially for superficial or fine-structure visualization. This is not excessive but rather reflects an enhanced performance expectation aligned with modern diagnostic standards.Therefore, the 11.0 MHz requirement remains as a minimum technical threshold to ensure diagnostic versatility. The request to reduce it to 10.0 MHz is not accepted.Item 9.3.2 – Field of View / Angle: at least 180°Request: Change to 179° AcceptedWe acknowledge that the difference between 179° and 180° has no meaningful clinical impact, and many high-end intracavitary probes from reputable manufacturers specify a 179° field of view, which remains sufficient for comprehensive anatomical visualization.Therefore, the requirement will be revised as follows:Field of view / angle: at least 179°Thank you.Procurement team.

New clarification added: Dear Bidder,Please find below the clarifications on your questions.Item 3.25 – Trapezoid (Wide View) Scanning using Convex Transducers: Availability Not AcceptedTrapezoidal or “Wide View” scanning with convex transducers is not exclusive to one manufacturer and is available under different names across many brands (e.g., "Extended Field of View," "Virtual Convex," or "Wide Sector Imaging").This feature is clinically important because it allows an expanded field of view without compromising spatial resolution—especially useful in abdominal and obstetric applications when imaging large organs (e.g., liver, uterus) from limited acoustic windows.The requirement ensures diagnostic completeness, especially in tight scanning conditions, and cannot be removed without reducing system functionality.Vendors may offer functionally equivalent implementations with different naming—these will be considered compliant if supported by manufacturer documentation.Item 8.1 – Single Crystal Technology Transducers: Availability Not AcceptedSingle crystal (or “monocrystal”) transducer technology offers superior sensitivity, broader bandwidth, and higher signal-to-noise ratio compared to conventional piezoelectric (composite) transducers. These improvements translate into:Deeper penetration in obese or technically difficult patientsImproved axial and contrast resolutionWider frequency coverage, enabling better multi-depth imagingAlthough not required in the standard probe set, having at least one transducer using this advanced technology allows facilities to address complex diagnostic scenarios more effectively.Thus, retaining this requirement supports higher diagnostic quality in demanding cases without mandating it for all transducers.Item 8.9 – Transesophageal Probe Compatibility: Availability Not Accepted The tender specifies this as an optional capability, not as a required delivered item. This means that the ultrasound platform must be capable of connecting a transesophageal probe in the future, should clinical needs expand (e.g., cardiology, intraoperative use).It does not increase current cost or complexity but ensures investment protection and system flexibility. Therefore, this requirement is retained.Item 8.10 – Laparoscopic Probe Compatibility: Availability Not Accepted Justification:This is defined as a potential future option, not as a mandatory component of the delivered set. Laparoscopic probes are essential in some surgical or intra-abdominal applications and require special port compatibility.Retaining this requirement ensures that the system is technically scalable and compatible with future minimally invasive imaging workflows, supporting surgical integration or guided biopsy.Systems that offer compatibility—though not including the probe in this delivery—will be considered compliant. The requirement is therefore justified.   Item 9.2.1 – Frequency range, at least: 3.0 – 12.0 MHz Not AcceptedThe upper limit of 12.0 MHz was established to ensure high-resolution superficial imaging capability, which is critical in clinical scenarios such as:Vascular studies (e.g., carotid artery stenosis, superficial veins)Small parts imaging (e.g., thyroid, breast, scrotum)Musculoskeletal and dermatological diagnosticsPediatric and neonatal imagingWhile many transducers do offer a range up to 11.0 MHz, higher-end linear probes capable of reaching 12.0 MHz or more provide improved axial resolution and better tissue contrast differentiation—especially in superficial tissues.Additionally, numerous global manufacturers (not limited to Canon) supply probes with bandwidths extending up to or beyond 12.0 MHz, including GE, Philips, Siemens, and Mindray.Therefore, the specification of 3.0–12.0 MHz reflects the minimum expected diagnostic performance standard and supports comprehensive clinical use without being discriminatory.The request to reduce the upper limit to 11.0 MHz is thus not accepted as it may reduce the diagnostic capability for surface-level imaging.Thank you.Prucurement team.

New clarification added: Dear Bidder,Please find below the clarifications on your questions. Item 6: Ultrasound Diagnostic SystemItem 2.6: “Full Focus: Availability”We acknowledge that the terminology “Full Focus”refers to continuous dynamic receive focusing along the entire image depth. While this functionality is advantageous for ensuring consistent image sharpness without manual adjustment, we agree that equivalent technologies under different names exist across other leading ultrasound manufacturers.In the interest of encouraging broader participation and avoiding brand-specific language, we will revise the requirement to reflect a more general, performance-based description.Revised requirement:2.6: Dynamic receive focusing or equivalent technology that ensures optimal focus across the entire image depth – availability.This allows for equivalent features provided by other manufacturers—such as Siemens' "Dynamic Focusing," GE’s “Advanced Dynamic Receive Focusing,” or Mindray’s “iClear/iBeam”—to be considered compliant, provided they achieve comparable clinical performance. This adjustment preserves the clinical intention of the original requirement while promoting fair competition.Item 2.15: “Maximum power consumption: 800 VA”We accept this revision. The proposed increase to 900 VA is reasonable and reflects the typical power requirements of modern high-performance ultrasound systems, especially when configured with integrated or connected peripherals (e.g., B/W digital printers, additional probes, or gel warmers).This adjustment does not compromise energy efficiency goals or clinical performance standards and allows broader participation by manufacturers offering technically compliant solutions.Revised requirement:2.15: Maximum power consumption: not more than1000 VA. Item number 3.7: “ PWD PRF range , at least : 500-52000 Hz ” We partially accept the request and confirm that the requirement will be revised to a minimum PWD PRF range of 500 to 40,000 Hz.This revision reflects the following clinical and technical considerations:A PRF ceiling of 40,000 Hz is consistent with capabilities of many high-end general-purpose ultrasound systems and covers the vast majority of vascular and high-flow Doppler applications.While PRF values above 40,000 Hz are used in select high-velocity or deep vessel assessments, these are specialized scenarios not considered routine for this procurement context.This adjustment strikes a balance between ensuring broad vendor participation and preserving clinical utility for end users. Revised Requirement:Item 7 – PWD PRF Range: at least 500 to 40,000 HzClarification on Items 3.12 and 3.14 (Color & Power Doppler fps)Item 3.12 – Color Doppler max frames per second (fps), at least: 1100Item 3.14 – Power Doppler max frames per second (fps), at least: 1000The original fps thresholds of 1100 and 1000 were intended to reflect the maximum technical capacity of premium ultrasound systems in high-performance imaging modes (e.g., ultrafast Doppler, plane-wave acquisition).After further review, we recognize that many advanced diagnostic systems currently available on the market demonstrate maximum achievable frame rates in the range of 850–900 fps, particularly in Color and Power Doppler modes with narrow sector or shallow depth settings.While 640 fps may be sufficient for routine clinical imaging, the higher threshold is maintained to ensure the procured systems are equipped with modern high-speed imaging capabilities, which support more demanding diagnostic applications and future-proof clinical performance.This adjustment expands eligibility while preserving the clinical and technical ambitions of the specification. It also aligns with other revised performance indicators across the tender.Revised Specifications:Item 3.12: Color Doppler max frames per second (fps): at least 850Item 3.14: Power Doppler max frames per second (fps): at least 850Systems meeting or exceeding these values, as documented by the manufacturer, will be considered fully compliant.Thank you.Procurement team.

New clarification added: Tender ParticularsAccording to the Tender Particulars section: «Partial quotations shall not be allowed. Bidders must quote prices for the total goods and/or services for the total requirement requested. Evaluation will be done for the total requirement.»However, this tender includes six different types of medical equipment, including diagnostic and surgical X-ray systems and ultrasound systems, which usually come from different manufacturers. High-quality manufacturers often specialise in one or two product categories and may not cover the entire range. Prohibiting partial quotations would significantly limit competition and potentially exclude qualified suppliers who could offer superior technology for selected items.We request that participation be allowed with selected items, rather than solely for full-lot offers. This would promote fair competition, ensure wider participation and increase the chances of obtaining the highest-quality equipment in each category.Section II: Schedule of requirementsItem 4 – Digital X-Ray System with 3 working placesSection 1.1: «C-arm Mobile Stand, Compliance»We would be grateful if you could provide clarification as to whether this refers to an RF tilting table system.The current wording is ambiguous and may lead to misinterpretation.Section 9: «Technical specifications of the X-ray image intensifier with TV system and image processing system»Request: Please remove this requirement.Image intensifier technology is now obsolete. Modern systems use a dynamic flat panel detector (FPD) to provide superior image quality, supporting both fluoroscopy and radiography in a one unit. The requirement for outdated image intensifier systems contradicts the current global standard and could unintentionally disqualify manufacturers offering cutting-edge equipment.Section 11.8: «Ukrainian-language program interface availability»Request: Please change to «Availability of Ukrainian and/or English language program interface.»In accordance with the provisions outlined in Item 1, Section 4.3, which permit the utilisation of both Ukrainian and English-language interfaces, it is reasonable to conclude that end users can operate English-language software. It is imperative that consistency is maintained across all items. English is the international standard in medical software, and most international manufacturers provide certified software only in English. As this is an international tender, requiring only a Ukrainian interface may unintentionally restrict the participation of global suppliers.Item 5 – Mobile X-Ray DeviceSection 4: «Technical characteristics of tomography»Request: Please change to «Technical characteristics of the X-ray generator»Please note that mobile X-ray systems do not include tomography functionality. This appears to be a technical mistake, as subsequent sections describe requirements for the generator. Amending the section title would eliminate any confusion. /Dear Bidder,Please find below the clarifications on your questions.Tender Particulars – Partial QuotationsAs stated in the Tender Particulars, partial quotations are not permitted. Bidders must quote for the total requirement. This ensures implementation consistency, unified support, and reliable service coverage. Suppliers are encouraged to collaborate with partners  if necessary.Item 4 – Digital X-Ray System with 3 Working Places1.1 “C-arm Mobile Stand, Compliance”This was a typographical error. The system must be based on a remote-controlled tilting table with vertical stand, not a C-arm.Corrected specification: System based on a remote-controlled tilting table with vertical stand.Section 9: X-ray Image Intensifier with TV System and Image Processing SystemThe term “X-ray image intensifier with TV system” refers to the general functional imaging component of the system. However, we confirm that systems utilizing dynamic flat panel detectors (FPDs) for fluoroscopy and radiography are fully acceptable and considered advanced.11.8 Ukrainian-language Program InterfaceAccepted.To promote wider participation and align with Item 1, Section 4.3, English and/or Ukrainian interfaces will be accepted.Revised requirement: Availability of Ukrainian and/or English-language program interface.Item 5 – Mobile X-Ray DeviceSection 4: “Technical Characteristics of Tomography”This was a section labeling error. The title has been corrected to reflect the actual technical content.Revised section title: Technical characteristics of the X-ray generator.Thank you. Procurement team. 

New clarification added: Dear Procurement team,Will the company's offer be considered in this tender if the company is not the official representative of the manufacturer of the proposed equipment in Ukraine, but has an Manufacturer`s Authorization Form in form G? /Dear Bidder,Thank you fpor the interest in the tender. Please find below the clarifications on your questions.Yes, the company’s offer will be considered in the tender if it holds a valid Manufacturer’s Authorization Form (Form G), even if it is not the official representative of the manufacturer in Ukraine.According to standard UNOPS procurement rules: Manufacturer’s Authorization Form is intended to confirm that the bidder is duly authorized by the manufacturer to supply, install, and provide warranty service for the proposed equipment.Thank you.Procurement team. 

New clarification added: Dear Bidder,Please find below the clarifications on your questions:We thank you for your detailed comments and proposed adjustments. Each request has been evaluated based on clinical relevance, image quality standards, and system interoperability. Please find our final decisions below: Item 2: C-arm Digital X-RayWe thank you for your detailed comments and proposed adjustments. Each request has been evaluated based on clinical relevance, image quality standards, and system interoperability. Please find our final decisions below:3.6 Max. Pulse Rate in Pulsed Fluoroscopy Mode – not less than 25 pulses/sWe do not accept this change. A pulse rate of 25 pulses/s is important in procedures requiring high temporal resolution, such as trauma, orthopedic manipulation, or pediatric interventions. It allows smoother real-time imaging and better visualization of fast movements. The dose can still be managed through operator settings and dose optimization protocols. Rejected Requirement remains unchanged: Max. pulse rate – not less than 25 pulses/s3.11 Iris CollimatorWe accept this revision. The essential requirement is the presence of a reliable, integrated collimation system. Whether implemented via an iris collimator or an equivalent solution (e.g., motorized shutter-type or rectangular multi-leaf collimators), it must ensure accurate and safe X-ray beam limitation. Accepted Revised requirement: Collimator (iris or equivalent) must be available4.3 Image Matrix in Overview Format – not less than 1300 × 1300We do not accept this change. A higher image matrix (≥1300×1300) provides better spatial resolution, especially critical for high-detail fluoroscopic imaging in musculoskeletal or interventional procedures. Lower matrix values may reduce diagnostic clarity. Rejected Requirement remains unchanged: Image matrix – not less than 1300 × 13004.4 Pixel Size – not more than 155 micronsWe do not accept this change. Pixel size directly affects spatial resolution and diagnostic precision. A pixel size of ≤155 µm ensures clearer visualization of fine structures, foreign bodies, or fractures. Increasing pixel size would reduce detail and potentially impair image quality in key clinical applications. Rejected Requirement remains unchanged: Pixel size – not more than 155 microns Item 4: Digital X-Ray System with 3 Working Places2.10 Control of All System Functions via Single Touchscreen Console AcceptedWhile touchscreen consoles provide modern usability, a well-integrated single console—whether touchscreen or traditional—can fulfill operational requirements.Revised requirement: Control of all system functions: table movements and generator exposure parameters using a single touchscreen console or single console.3.1 Adjustable SID (Source-to-Image Distance) Range – not less than 110 to 180 cm Not Accepted. The current minimum of 110 cm is required for imaging flexibility, especially for small anatomical regions and pediatric cases. A higher lower limit would reduce system versatility.Requirement remains unchanged: Adjustable SID range – not less than 110 to 180 cm.4.2 Adjustment of Tomographic Layer Height – not worse than 0 to 350 mmAccepted  A tomographic layer range of 330 mm is sufficient for standard clinical applications and matches typical vendor capabilities.Revised requirement: Adjustment of tomographic layer height – not worse than from 0 to 330 mm, with a step of 1 mm.7.14 Generator Control via Touchscreen Console ≥12” Diagonal AcceptedThough a ≥12” touchscreen interface is preferred, a standard console ensuring complete generator control is also acceptable. Revised requirement: Control of generator functions via a touchscreen console (≥12”) or standard console.13.3 Built-in Sensors: Ambient Light, Color Front, Human PresenceAcceptedThe human presence sensor is not essential for diagnostic performance. Revised requirement: Built-in sensors: Ambient light sensor and color front sensor.Thank you.Procurement team.

New clarification added: Dear Sir/Madam,Is it acceptable, in order to comply with the requirement for a registration certificate for the equipment to be used in the territory of Ukraine in accordance with the applicable legislation, including the State Registration Certificate, to provide a letter of guarantee with an explanation regarding the subsequent submission of the certificate of conformity and the declaration of conformity with the requirements of the Resolution of the Cabinet of Ministers of Ukraine dated October 2, 2013, at the time of delivery of the medical device?Will the requirement be considered fulfilled if we provide a declaration and a certificate of conformity to confirm the following requirement:"The equipment must have a registration certificate for the use of the goods in the territory of Ukraine in accordance with the current legislation of Ukraine, including the State Registration Certificate"?/Dear Bidder,Please find below the clarifications on your questions.1. No, this is not acceptable. The required documentation (declaration and/or certificate of conformity) must be provided at the time of bid submission. A letter of guarantee promising future delivery does not fulfill the stated requirement and will render the offer non-compliant.2. Yes, this will be considered acceptable provided that the declaration and certificate of conformity clearly confirm that the medical device is authorized for use in Ukraine and compliant with the Resolution of the Cabinet of Ministers No. 753 dated October 2, 2013. The documents must be properly issued and valid under Ukrainian law.Thank you.Procurement team.

New clarification added: Dear Bidder,Please find below the clarifications on your questions.Item 4: Digital X-Ray System with 3 Working Places2.10 Control of All System Functions via Single Touchscreen ConsoleWe accept this revision. While touchscreen consoles offer enhanced usability, a well-designed single-console system—whether touchscreen or not—can meet operational requirements and ensure centralized control.Revised requirement: Control of all system functions: table movements and generator exposure parameters using a single touchscreen console or single console3.1 Adjustable SID (Source-to-Image Distance) Range – not less than 110 to 180 cmWe do not accept this change. The existing lower limit of 110 cm is necessary to support certain small field and pediatric imaging projections. A higher minimum would reduce flexibility.Requirement remains unchanged: Adjustable SID range – not less than 110 to 180 cm4.2 Adjustment of Tomographic Layer Height – not worse than 0 to 350 mmWe accept this revision. A tomographic layer height of 330 mm is clinically sufficient for nearly all standard tomographic examinations and aligns with most manufacturer designs. Revised requirement: Adjustment of tomographic layer height – not worse than from 0 to 330 mm, with a step of 1 mm7.14 Generator Control via Touchscreen Console ≥12” DiagonalWe accept this change. While a ≥12” touchscreen is preferred, a standard console providing full control of generator functions is also acceptable if it ensures operational reliability and ease of use. Revised requirement: Control of generator functions via a touchscreen console (≥12”) or standard console13.3 Built-in Sensors: Ambient Light, Color Front, Human PresenceWe agree that human presence detection does not directly impact display performance or diagnostic image quality.Revised requirement: Built-in sensors: Ambient light sensor and color front sensor14.13 Dimensions ≤ 80 × 60 × 60 cm14.14 Weight ≤ 80 kgWe accept this revision. These adjusted limits still comply with workspace and ergonomic standards while allowing inclusion of higher-performance models.Revised requirements:14.13 dimensions – not more than 80 × 80 × 60 cm (W × D × H)14.14 Weight – not more than 90 kg   Item 5: Mobile X-Ray Device3.6 Monobloc Rotation Around Transversal Axis – not less than from (–40)° to (+100)°We accept this revision. A monobloc rotation up to +90° fully supports all standard vertical stand imaging positions. Additional rotation beyond 90° is not clinically required for typical mobile X-ray use and may limit compatibility with otherwise compliant systems. Revised requirement: Monobloc rotation around transversal axis – not less than from (–40)° to (+90)°8.7 Limiting Resolution – not less than 3.57 lp/mmhis revision. A limiting resolution of 3.5 lp/mm is consistent with modern digital detectors using CsI conversion layers and ensures high diagnostic image quality. It also harmonizes requirements across similar equipment categories in the tender. Revised requirement: Limiting resolution – not less than 3.5 line pairs per mm (lp/mm)Thank you.Procurement team.

New clarification added: Dear Bidder,Please find below the clarifications on your questions:Item 1 – X-Ray Radiology Diagnostic Workstation with Digital Flat Panel Detector3.9 Response Time – not more than 20 msWe agree that for diagnostic review of static X-ray images, a response time of 25 ms does not compromise clinical usability or image integrity. Therefore, the requirement is revised as follows:Response Time – not more than 25 msItem 2 – C-arm Digital X-Ray2.1 Motorized Vertical Movement – not less than 42 cmWe accept this change, as the 2 cm reduction does not compromise clinical positioning or image access and allows broader market inclusion.Requirement will be revised to: Motorized vertical movement – not less than 40 cm3.5 Pulse Width in Pulsed Fluoroscopy – not less than 20–34 ms3.6 Max. Pulse Rate – not less than 25 pulses/sWe do not accept these changes. Higher pulse rates (≥25 pulses/s) and the flexibility of variable pulse widths up to 34 ms are critical for obtaining smoother, more continuous imaging in dynamic and interventional procedures—such as cardiac, pediatric, or vascular interventions. Lowering the pulse rate to 18 pulses/s may result in reduced temporal resolution, motion artifacts, and compromised real-time visualization.Both requirements remain unchanged:3.5 Pulse Width in pulsed fluoroscopy – not less than 20–34 ms3.6 Max. Pulse Rate – not less than 25 pulses/s3.10 X-ray Tube Heating Capacity – not less than 1,100,000 HUWe acknowledge that 650,000 HU may be adequate for standard procedures; however, the original requirement ensures better heat dissipation and stability during prolonged or repeated imaging, particularly in interventional or bariatric cases. To maintain equipment reliability and prevent overheating during long cases:The original requirement remains unchanged.4.3 Image Matrix in Overview Format – not less than 1300 × 13004.4 Pixel Size – not more than 155 micronsWe appreciate the proposal; however, the specified minimum resolution and pixel size are required to ensure high image clarity and diagnostic precision, especially in interventional and orthopedic imaging. Lowering these values could compromise spatial resolution and limit the ability to detect small structures or subtle contrast variations.Therefore, both requirements remain unchanged:4.3 Image matrix in overview format – not less than 1300 × 13004.4 Pixel size – not more than 155 microns6.2 Touchscreen on Monitor Cart6.2.1 Icons for ease of use6.2.2 Visualization of live fluoro imageThese touchscreen features are important for enhancing workflow, usability, and procedural safety. Icons facilitate intuitive control, while live fluoro visualization—though at reduced quality—provides essential real-time feedback during procedures and positioning.Such features are standard in modern systems and contribute to operational efficiency.Therefore, both sub-requirements remain unchanged6.8 Mosaic Display – not less than 16 imagesWe acknowledge the concern and agree that a 6-image mosaic view provides sufficient capability for comparative review in routine procedures, while still supporting practical diagnostic needs without overburdening the interface.The requirement is revised as follows:6.8 Mosaic display – not less than 6 images                                                                                                                                                                                                 Item 3: C-arm Digital X-Ray2.1 Motorized Vertical Movement – not less than 42 cmWe accept this revision. A minimum vertical movement of 40 cm remains clinically functional for standard positioning and allows wider compatibility across C-arm models.Revised requirement: Motorized vertical movement – not less than 40 cm3.5 Pulse Width in Pulsed Fluoroscopy Mode – not less than 19–34 msWe accept this revision. A minimum pulse width of 20 ms provides adequate image quality and dose control across typical surgical and interventional use cases.Revised requirement: Pulse Width in pulsed fluoroscopy mode – not less than 20 ms3.11 X-ray Tube Heating Capacity – not less than 1,600,000 thermal unitsWe do not accept this change. A heating capacity of 1,600,000 HU is critical for high-throughput environments and extended procedures, ensuring thermal stability and protecting system longevity.Requirement remains unchanged: X-ray tube system heating capacity – not less than 1,600,000 HU4.5 DQE at 0 lp/cm – not less than 72%We accept this adjustment. A DQE of 70% or more at zero spatial frequency is consistent with high-quality imaging systems and ensures diagnostic confidence at reduced dose levels.Revised requirement: DQE at 0 lp/cm – not less than 70%6.2 Touchscreen on Monitor Cart6.2.1 Icons for ease of use6.2.2 Visualization of live fluoro imageWe do not accept this change. Touchscreen icons enhance usability, and even limited-resolution live fluoro previews provide essential visual confirmation for positioning and safety during procedures. These are standard features in modern C-arm systems and important for workflow efficiency. Both sub-requirements remain unchanged.Thank you.Procurement team.

New clarification added: Dear Bidder,Please find below the clarifications on your questions.Item 1 – X-Ray Radiology Diagnostic Workstation with Digital Flat Panel Detector3.9 Response Time – not more than 20 msWe agree that for diagnostic review of static X-ray images, a response time of 25 ms does not compromise clinical usability or image integrity. Therefore, the requirement is revised as follows:Response Time – not more than 25 msItem 2 – C-arm Digital X-Ray2.1 Motorized Vertical Movement – not less than 42 cmWe accept this change, as the 2 cm reduction does not compromise clinical positioning or image access and allows broader market inclusion.Requirement will be revised to: Motorized vertical movement – not less than 40 cm3.5 Pulse Width in Pulsed Fluoroscopy – not less than 20–34 ms3.6 Max. Pulse Rate – not less than 25 pulses/sWe do not accept these changes. Higher pulse rates (≥25 pulses/s) and the flexibility of variable pulse widths up to 34 ms are critical for obtaining smoother, more continuous imaging in dynamic and interventional procedures—such as cardiac, pediatric, or vascular interventions. Lowering the pulse rate to 18 pulses/s may result in reduced temporal resolution, motion artifacts, and compromised real-time visualization.Both requirements remain unchanged:3.5 Pulse Width in pulsed fluoroscopy – not less than 20–34 ms3.6 Max. Pulse Rate – not less than 25 pulses/s3.10 X-ray Tube Heating Capacity – not less than 1,100,000 HUWe acknowledge that 650,000 HU may be adequate for standard procedures; however, the original requirement ensures better heat dissipation and stability during prolonged or repeated imaging, particularly in interventional or bariatric cases. To maintain equipment reliability and prevent overheating during long cases:The original requirement remains unchanged.4.3 Image Matrix in Overview Format – not less than 1300 × 13004.4 Pixel Size – not more than 155 micronsWe appreciate the proposal; however, the specified minimum resolution and pixel size are required to ensure high image clarity and diagnostic precision, especially in interventional and orthopedic imaging. Lowering these values could compromise spatial resolution and limit the ability to detect small structures or subtle contrast variations.Therefore, both requirements remain unchanged:4.3 Image matrix in overview format – not less than 1300 × 13004.4 Pixel size – not more than 155 microns6.2 Touchscreen on Monitor Cart6.2.1 Icons for ease of use6.2.2 Visualization of live fluoro imageThese touchscreen features are important for enhancing workflow, usability, and procedural safety. Icons facilitate intuitive control, while live fluoro visualization—though at reduced quality—provides essential real-time feedback during procedures and positioning.Such features are standard in modern systems and contribute to operational efficiency.Therefore, both sub-requirements remain unchanged6.8 Mosaic Display – not less than 16 imagesWe acknowledge the concern and agree that a 6-image mosaic view provides sufficient capability for comparative review in routine procedures, while still supporting practical diagnostic needs without overburdening the interface.The requirement is revised as follows:6.8 Mosaic display – not less than 6 images                                                                                                                                                                                                 Item 3: C-arm Digital X-Ray2.1 Motorized Vertical Movement – not less than 42 cmWe accept this revision. A minimum vertical movement of 40 cm remains clinically functional for standard positioning and allows wider compatibility across C-arm models.Revised requirement: Motorized vertical movement – not less than 40 cm3.5 Pulse Width in Pulsed Fluoroscopy Mode – not less than 19–34 msWe accept this revision. A minimum pulse width of 20 ms provides adequate image quality and dose control across typical surgical and interventional use cases.Revised requirement: Pulse Width in pulsed fluoroscopy mode – not less than 20 ms3.11 X-ray Tube Heating Capacity – not less than 1,600,000 thermal unitsWe do not accept this change. A heating capacity of 1,600,000 HU is critical for high-throughput environments and extended procedures, ensuring thermal stability and protecting system longevity.Requirement remains unchanged: X-ray tube system heating capacity – not less than 1,600,000 HU4.5 DQE at 0 lp/cm – not less than 72%We accept this adjustment. A DQE of 70% or more at zero spatial frequency is consistent with high-quality imaging systems and ensures diagnostic confidence at reduced dose levels.Revised requirement: DQE at 0 lp/cm – not less than 70%6.2 Touchscreen on Monitor Cart6.2.1 Icons for ease of use6.2.2 Visualization of live fluoro imageWe do not accept this change. Touchscreen icons enhance usability, and even limited-resolution live fluoro previews provide essential visual confirmation for positioning and safety during procedures. These are standard features in modern C-arm systems and important for workflow efficiency. Both sub-requirements remain unchanged.Thank you.Procurement team.

New clarification added: Dear Bidder,Please find below the clarifications on your questions:Item 2.5 – Commissioning Works TimelineWe acknowledge that installation and commissioning of complex systems such as the Digital X-Ray System with 3 working places may require more time, especially if the installation space must be prepared in advance. Therefore, we accept the proposed revision. The requirement is updated as follows:2.5 Commissioning works on putting equipment into operation must be done within 3 calendar days after delivery of the equipment, except for Item 4 (Digital X-Ray System with 3 working places), for which commissioning must be completed within 7 working days, provided that the recipient prepares the room for installation.Item 2.6 – Manufacturer’s StandardsWe agree that both ISO 9001:2015 and ISO 13485:2016 are internationally recognized standards for quality management systems. ISO 13485 is specifically designed for medical devices and is sufficient for our purposes. Therefore, the requirement is revised as follows:2.6 All offered equipment must be manufactured by ISO 9001:2015 or ISO 13485:2016 certified manufacturers. Copies of the original certifications, issued by authorized notified bodies, shall be included in the bid.Item 2.10 – Technical Documentation for Maintenance and RepairWe acknowledge the legal framework in Ukraine that restricts equipment maintenance and repair to authorized service providers licensed by the State Nuclear Regulatory Inspectorate and relevant bodies. Accordingly, we accept the comment and revise the requirement as follows:2.10 The Bidder shall provide technical documentation (e.g., user manuals and service guidelines) necessary for the safe use and basic user-level maintenance of the equipment. Documents used to confirm technical compliance—such as datasheets, technical specifications, and certificates—must be submitted in English . The requirement for the User Manual and Operating Instructions in Ukrainian (Item 2.11) remains mandatory to ensure usability by end-users.Thank you,Procurement team.

New clarification added: Dear Bidder,Please find below clarifications on your questions:Response to Comment – Item 1.1: C-arm Mobile Stand, Compliance  Reference    to a “C-arm Mobile Stand” in Item 1.1 is a typing error. This terminology does not apply to a Digital X-Ray System with 3 working places, which is based on a remote-controlled tilting table configuration.The correct description should read:1.1 System based on a remote-control tilting table, vertical stand, and overhead or column-mounted X-ray tube, providing a full range of radiological examinations, including radiography and fluoroscopy.This correction will be made accordingly. Thank you for bringing it to our attention.Response to Requests – Item 14: Dry Laser Printer14.7 Throughput ≥ 60 films/hour (14×17 size):We acknowledge that high-throughput printers typically come in larger sizes. However, the current throughput requirement reflects the operational needs of busy diagnostic departments. To ensure sufficient productivity while allowing broader participation, we agree to revise the requirement as follows:14.7 Throughput – not less than 45 films/hour (14×17 size)14.9 Interface Ethernet (RJ-45) for DICOM; optional USB for maintenance:We agree that Ethernet (RJ-45) is sufficient for DICOM operation, and that maintenance interfaces vary by manufacturer. Therefore, we revise the requirement as follows:14.9 Interface – Ethernet (RJ-45) for DICOM14.11 Image Adjustments – Brightness, contrast, gamma, sharpness adjustable; test pattern support:We acknowledge that most modern printers from leading manufacturers feature automatic image quality control, which minimizes the need for manual adjustment of brightness, contrast, gamma, or sharpness.Therefore, we accept solutions with automatic image optimization as a fully compliant and advantageous feature. The requirement will be updated as follows:14.11 Image quality control – Manual or automatic image adjustment (brightness, contrast, gamma, sharpness)14.13 Dimensions ≤ 80×60×60 cm & 14.14 Weight ≤ 80 kg:We recognize that certain high-functionality models (e.g., with dual film trays) may slightly exceed these limits without impacting usability. To allow flexibility while preserving space and handling considerations, we accept the proposed tolerances. The requirements are revised as follows:14.13 Dimensions – not more than 80×75×60 cm14.14 Weight – not more than 90 kg                                                                                                                                                                                        14.15 Certifications – CE (Medical Device), ISO 13485, FDA (for US market), RoHS:We acknowledge that mandatory certifications are already covered in Section 2: Other Requirements, Subsections 2.6 and 2.7. Additionally, FDA certification is only relevant for the U.S. market and is not required in Ukraine.Therefore, to avoid duplication and maintain relevance, this requirement will be removed.                                                                                                       14.16 Included Software – DICOM configuration and print tools provided by manufacturer:We agree that printer configuration and operation are typically performed via the control panel or IP interface, and that methods vary by manufacturer.However, we clarify that any dedicated software or tools required for full functionality, DICOM integration, or configuration—as provided by the manufacturer—must be supplied with the device. This ensures proper installation, setup, and use in accordance with the manufacturer's intended operation.The requirement will be updated as follows:14.16 Included Software – All dedicated software and tools required for DICOM configuration, printing, and operation must be provided by the manufacturer with the device.                                                                                                                                                                                                                  Response to clariffication comments – Item 5: Mobile X-Ray Device                                                                                                                                                  Thank you for your careful review. We confirm that the following are typographical errors and will be corrected accordingly:Section 4: Technical characteristics of tomographyCorrected to: Technical characteristics of generatorSection 6: Technical characteristics of the compression deviceCorrected to: Technical characteristics of electrical mainsSection 7: Technical characteristics of the X-ray generatorCorrected to: Characteristics of the image processing stationThese corrections will be reflected in the updated documentation. We appreciate your attention to detail.Thank you,Procurement team.

New clarification added: Dear Bidder,Please find clarifications on your questions.Answer on Item 1 :   We acknowledge that FDA 510(k) certification is primarily applicable to the U.S. market and is not mandatory for Ukraine. However, the inclusion of FDA 510(k) in this section does not imply it is required for compliance, but rather serves as an optional indicator of international regulatory recognition for equivalent products.That said, the core requirements for market access and regulatory compliance in Ukraine are already covered under:CE Marking (MDD/MDR Class I) – for European market conformity,RoHS – for environmental compliance,IEC 60601 – for electrical safety and medical equipment standards.We also confirm that the mandatory certifications are specified in Section 2: Other Requirements, particularly Subsections 2.6 and 2.7, which are binding for qualification purposes.Therefore, to avoid redundancy and ensure clarity, we agree to remove the FDA 510(k) mention from Item  Response to Request for Change – Item 2.4: Angulation – not less than ±180°The currently specified minimum angulation of ±180° ensures sufficient rotational flexibility of the C-arm for a wide range of diagnostic and interventional procedures, including lateral, oblique, and posterior-anterior imaging positions. This level of angulation already meets the clinical needs of the end user.While we recognize that some high-end systems offer ±270° rotation for improved access and workflow efficiency in order to maintain a balance between clinical functionality and broad market availability, the original requirement of: Angulation – not less than ±180°”remains unchanged. Response to Request for Change – Item 2.5: Vertical Free Space of C-arm – not less than 77 cmWe acknowledge that increasing the vertical free space of the C-arm may enhance flexibility during imaging of bariatric patients and improve access in certain procedural setups. However, the currently specified minimum of 77 cm already meets the essential clinical requirements for general diagnostic and interventional procedures, including coverage for a broad range of patient body types.While systems offering ≥80 cm vertical clearance may provide added ergonomic advantages, this is typically a feature of larger or more specialized C-arm models and could unnecessarily limit the pool of technically compliant offers, thus reducing competition.Therefore, in the interest of maintaining technical sufficiency while ensuring wide market participation, the requirement:“Vertical free space of C-arm – not less than 77 cm” remains unchanged.Response to Request for Change – Item 2.6: Depth of C-arm – not less than 67 cmWe understand that a greater C-arm depth (source-to-detector distance) can enhance imaging coverage, especially for larger anatomical regions and bariatric patients. However, the currently defined minimum depth of 67 cm has been set to ensure:Sufficient field coverage for general radiographic and fluoroscopic applications,Compatibility with a broad range of mobile C-arm systems used in routine diagnostics and interventions,While a depth of 70 cm or more may be advantageous in certain specialized cases, it is not a mandatory functional requirement for the clinical needs outlined in this procurement.Therefore, the requirement: “Depth of C-arm – not less than 67 cm”remains unchanged.Response to Request for Change – Item 2.7: Distance between Source and Image Receptor (SID) – not less than 99 cmWe acknowledge that increasing the Source-to-Image Distance (SID) to 105 cm or more can offer benefits in imaging larger patients (including bariatric cases) by reducing magnification and improving image quality. Such extended SID capabilities are typical of more advanced C-arm systems.However, the currently specified minimum SID of 99 cm is sufficient to meet the core diagnostic needs and ensures compatibility with a wide range of C-arm models suitable for general use.We confirm that:Solutions offering a greater SID than the minimum specified (e.g., ≥105 cm) are fully acceptable and welcome,provided that all other mandatory technical and regulatory requirements are met.Therefore, while the requirement:“Distance between source and image receptor (SID) – not less than 99 cm”remains unchanged, solutions with improved specifications beyond the minimum are encouraged and will be considered positively during evaluation.Response to Request for Change – Item 6.8: Mosaic Display – no less than 16 imagesIn line with this practical usage and to ensure optimal workflow and readability during procedures, we accept the proposed change.The requirement is revised as follows:6.8 Mosaic Display – no less than 6 imagesThis adjustment remains aligned with clinical needs while allowing flexibility for systems offering higher mosaic capabilities.  Response to Requests – Item 3: C-arm Digital X-Ray2.4 Angulation – not less than ±180°:The specified range of ±180° meets clinical needs for standard diagnostic procedures. While wider angulation is acceptable, the minimum requirement remains unchanged to ensure broader competition.2.6 Depth of C-arm – not less than 67 cm:The current specification ensures sufficient diagnostic coverage while maintaining compatibility with a wide range of systems. Advanced solutions with greater depth are welcome, but the minimum remains unchanged.       3.1 Maximum Generator Power – not less than 15 kW:The specified 15 kW generator power ensures sufficient performance for general diagnostic and interventional use. While higher power systems (e.g., ≥20 kW) offer enhanced performance for bariatric patients and extended procedures, the current requirement remains unchanged. However, more powerful systems are welcome3.11 X-ray Tube System Heating Capacity – not less than 1,600,000 HU:The current heating capacity ensures reliable performance for typical procedure durations. Systems offering higher tube heat capacity (e.g., ≥2,600,000 HU) are acceptable, but the minimum requirement remains unchanged.4.3 Image Matrix in Overview Format – not less than 1536×1536:The specified matrix provides adequate image quality for diagnostic accuracy. Higher-resolution detectors are encouraged and welcome, but the minimum remains unchanged to allow broader competition. 4.4 Pixel Size – not more than 150 microns:Thank you for your observation. Based on the specified field size (30×30 cm) and image matrix (≥1536×1536), we acknowledge the inconsistency. Your proposed correction is accepted. The requirement is revised to:4.4 Pixel size – not more than 155 microns6.5 Road-mapping RSA (single frame and multi-frame):We agree that the terminology “single frame Road-mapping” may be unclear and non-standard. To align with commonly used clinical terminology, the requirement is revised to:6.5 Road-mapping (RSA)6.12 Mosaic Display – no less than 16 images:Your comment is accepted. To reflect typical clinical practice and maintain usability, the requirement is revised to:6.12 Mosaic display – no less than 6 imagesThank you.Procurement team.

New clarification added: Dear Bidder,Please find below clarifications on your questions.7.    IOTA classification system is a well-known and widely used clinical decision support tool that helps in the evaluation of ovarian masses, similar in principle to other standardized risk stratification systems such as TIRADS for thyroid and BI-RADS for breast.In order to maintain clinical intent while ensuring open competition, we clarify the following: The requirement will be adjusted to accept any integrated tumor classification software that performs a similar function to IOTA, including classification of ovarian masses into benign, malignant, or indeterminate categories based on ultrasound features and/or clinical parameters. Systems offering alternative integrated tools that support ovarian mass risk stratification or tumor classification—whether proprietary or equivalent to IOTA—will be considered fully compliant, provided that the functionality is clearly documented in the manufacturer’s official literature.This clarification ensures that the clinical objective of supporting tumor risk assessment is preserved, while allowing a broader range of technically advanced systems to participate.       8.  We confirm that the requirement will be modified to: “Curvature, not more than 46 mm” in order to ensure fair competition and accommodate commonly used probes.9. Your proposed probe with 46 mm curvature will be considered compliant.                                                                                                                                            10.We acknowledge that standard 2D linear probes often have 128, 192, or 256 elements, depending on the manufacturer and system class. However, the specified minimum of 240 elements  is based on clinical imaging requirements, particularly for high-resolution 3D and 4D ultrasound applications, where improved spatial resolution, more precise beam steering, and enhanced image quality are critical.Probes with at least 240 elements allow for:Finer lateral resolution and better tissue differentiation,Superior image rendering in 3D/4D volumetric studies,Improved beamforming accuracy, especially in dynamic imaging (e.g., fetal echocardiography or cardiac valve assessments).This requirement is not based on a preference for a specific brand but reflects the minimum technical performance necessary to achieve the diagnostic capabilities expected by the end user.Therefore, the requirement “Number of elements, at least: 240” remains unchange.Thank you.Procurement team.Best regards.

New clarification added: Dear Bidder,Please find below clarifications.1.Please note that all technical specifications listed in the tender represent minimum mandatory requirements, based on the clinical needs and functionalities requested by the end users. The requirement for "at least 8 transmit focal zones" is included to ensure sufficient spatial resolution and image uniformity across the full imaging depth, particularly in applications where manual or selectable focal zones remain clinically important.We acknowledge that some modern ultrasound systems employ advanced dynamic transmit focus technologies, which automatically optimize focus across all depths without requiring manual focal zone selection. In such cases, if the system provides equal or superior image quality and resolution throughout the scanning depth compared to systems with fixed focal zones, this will be considered a compliant and acceptable alternative. To support such evaluation, we kindly request that you submit:A manufacturer-issued description of the dynamic focusing technology;Relevant technical documentation or user manual excerpts;A technical justification showing how this approach meets or exceeds the clinical performance expected from systems with ≥8 transmit focal zones.In summary, while the requirement for ≥8 focal zones represents the minimum standard, advanced solutions such as dynamic transmit focus will be accepted as compliant, provided their performance is clearly documented and validated. 2. This requirement is intended to ensure that the ultrasound system is capable of optimizing image quality by adjusting to the acoustic properties of different tissue types, which may include features such as adaptive sound speed correction, reception focus compensation, or other comparable methods.If your system performs Tissue Specific Optimization (TSO) by using automated sound speed adjustment to adapt to varying tissue types and compensate for acoustic discrepancies, and this functionality is clearly documented by the manufacturer, it will be considered compliant with the requirement.To avoid misinterpretation, we clarify that the core intent of this requirement is the availability of effective TSO functionality, regardless of the specific technical principle used (e.g., reception focus compensation vs. sound speed adjustment). Therefore, your proposed solution will be acceptable as long as it is supported by manufacturer-issued technical documentation demonstrating equivalent performance and functionality.There is no need to amend the specification, as the wording already allows for systems using alternative but functionally equivalent optimization methods. However, we emphasize that the claimed TSO functionality must be:Clearly described in the manufacturer’s official literature (e.g., brochure, technical manual),Demonstrated to perform tissue-specific image optimization, and Capable of adapting imaging parameters to improve diagnostic quality based on tissue characteristics.  3. We understand your concern regarding the specified high frame rates and agree that in typical clinical applications, real-time scanning operates at frame rates in the range of 25–75 fps, and occasionally higher in specialized modes or under optimized scanning conditions.The original values were intended to reflect the maximum technical capacity of the system under ideal imaging parameters (e.g., shallow depth, narrow sector, or high-frame-rate imaging modes such as ultrafast or plane-wave transmission). However, after reviewing available technologies and system capabilities, we acknowledge that high-end ultrasound platforms typically achieve maximum frame rates in the range of 800–1000 fps in such modes.Accordingly, we confirm that the frame rate requirements in the tender documents will be revised as follows:Item #2.13 – B-mode max fps: at least 850Item #3.12 – Color Doppler max fps: at least 850Item #3.14 – Power Doppler max fps: at least 850Item #3.17 – Tissue Doppler max fps: at least 850Systems offering a documented maximum frame rate of 882 fps or higher will be considered fully compliant, provided that this performance is clearly supported by official manufacturer documentation (e.g., product specifications, user manuals).   4.  Item #2.15 – Maximum power consumption: 800 VAWe acknowledge your observation that power consumption in this range does not directly impact clinical performance or operational feasibility in typical healthcare environments, and that higher-class systems with broader functionality may have slightly higher power requirements without presenting any practical limitations in clinical settings.After review, we agree that the original limit of 800 VA may unnecessarily restrict competition and exclude technically superior systems. Therefore, we confirm that:The requirement will be revised to:Maximum power consumption: not more than 1000 VAThis revised threshold will ensure inclusivity of advanced systems while maintaining reasonable power usage expectations in line with standard clinical infrastructure.   5.  Following a technical review, we confirm that the specified maximum value does not represent a clinically essential parameter and may limit the competitiveness of high-quality systems currently available on the market.Accordingly, to ensure fair competition while maintaining clinical relevance, we confirm that:The requirements will be adjusted as follows:Item 3.7 – PWD PRF range: at least 500–40,000 HzItem 3.9 – CWD PRF range: at least 1,500–40,000 HzSystems with a maximum PRF of 40,000 Hz, as verified in the official technical documentation issued by the manufacturer, will be accepted as fully compliant with the revised requirements.          7.    IOTA classification system is a well-known and widely used clinical decision support tool that helps in the evaluation of ovarian masses, similar in principle to other standardized risk stratification systems such as TIRADS for thyroid and BI-RADS for breast.In order to maintain clinical intent while ensuring open competition, we clarify the following: The requirement will be adjusted to accept any integrated tumor classification software that performs a similar function to IOTA, including classification of ovarian masses into benign, malignant, or indeterminate categories based on ultrasound features and/or clinical parameters. Systems offering alternative integrated tools that support ovarian mass risk stratification or tumor classification—whether proprietary or equivalent to IOTA—will be considered fully compliant, provided that the functionality is clearly documented in the manufacturer’s official literature.This clarification ensures that the clinical objective of supporting tumor risk assessment is preserved, while allowing a broader range of technically advanced systems to participate.Thank you,Procurement team.

New clarification added: In RFQ_Section_II_RFQ_2025_58443_Schedule of requirements_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast，2.4 : Bidder must have License for the right to work with ionizing radiation sources in Ukraine - issued by State Nuclear Regulatory Inspectorate of UkraineWe are the bidders. We don't have this certificate, but our local agent does. Can we proceed?/Dear Bidder,Thank you for the interest in the tender. Please find below the clarification on your question.The requirement stated in Section 2 of the RFQ – ""Bidder must have License for the right to work with ionizing radiation sources in Ukraine, issued by the State Nuclear Regulatory Inspectorate of Ukraine"" – is a regulatory condition set by national legislation for handling and working with ionizing radiation sources within Ukraine.However, it means that either the bidder or their officially designated local partner must hold a valid license issued by the State Nuclear Regulatory Inspectorate of Ukraine at the time of execution of relevant work involving ionizing radiation (such as installation, commissioning, calibration, maintenance, or service).Therefore, there are two acceptable ways to meet this requirement:If the international bidder has a local representative or aftersales partner in Ukraine who holds the required license, this can be considered compliant. In this case, it is necessary to provide:Documentation confirming the license issued to the local partner.An official agreement or letter of authorization confirming that this partner is responsible for the required licensed activities on behalf of the bidder."Thank you.Procurement team.

New clarification added: Dear Sirs,The "Bidder’s delivery data" table in the "Form B" contains the following cell: "FCA point(s) of delivery for offered products".Please let us know what should be indicated in this cell if the goods should be delivered using the "DDP" delivery terms to the respective locations. Should we indicate the respecttive city where the goods will be delivered: Mykolaiiv city, Domanivka village?Thanks. /Dear Bidder,Thank you for your interest in the tender. Please find below the clarification oin your question.1. Please insert in the section "Bidder’s delivery data for  Item (Form B),  FCA point(s) of delivery the loading point of the shipment for informotive purposes along with the Country of origin of offered products.  Thanbk you.Best regards.

New clarification added: seems a mistacen with numbers at pos 3.4Coverage of the patient without repositioning not less than 280 cm.  maybe it is 180 cm. cause at pos. 2.2.Tabletop dimensions not less than 225 x 74 cm length of tabletop just 225 cm as you can see. what mean pos.3.5Minimum distance between central X-ray beam and tabletop edges no more than 5 cm ? what mean pos.3.5Minimum distance between central X-ray beam and tabletop edges no more than 5 cm ?/Dear Bidder.Thank you for your interest in the tender. Please find below the clarifications on your questions.1. Section 3.4: "Coverage of the patient without repositioning – not less than 280 cm", we confirm that this appears to be a typographical error.Indeed, the stated value of 280 cm significantly exceeds the typical anatomical length of a human patient and the standard image coverage capabilities of mobile C-arm X-ray systems. After internal review and based on industry norms, we confirm that the correct value should be:"Coverage of the patient without repositioning – not less than 180 cm."This correction ensures alignment with practical diagnostic needs and standard device capabilities, such as whole-body coverage in supine position without repositioning.The amended specification will be reflected accordingly.   2. Minimum distance between central X-ray beam and tabletop edges – no more than 5 cm"refers to the positioning of the tabletop relative to the X-ray beam axis. Specifically, it defines how far the central axis of the X-ray beam can be from the edge of the tabletop when the C-arm is in its neutral (central) position.This requirement is important to ensure:Maximum anatomical coverage, especially during lateral or oblique imaging.Accessibility for imaging smaller anatomical regions or extremities near the edge of the patient table.Minimized repositioning of the patient for optimal beam centering.Thank you.Procurement team.

New clarification added: Dear UNOPS,In RFQ section 2 required "Bidder must have License for the right to work with ionizing radiation sources in Ukraine - issued by State Nuclear Regulatory Inspectorate of Ukraine"Could you please advise if it means as international bidder couldn't attend this tender? Or if our local aftersales partner have the license will meet this? or it is to apply this license for international bidder?Thank you!/Dear Bidder,Thank you for your interest in the tender. Please find below the ckarification on your question.The requirement stated in Section 2 of the RFQ – "Bidder must have License for the right to work with ionizing radiation sources in Ukraine, issued by the State Nuclear Regulatory Inspectorate of Ukraine" – is a regulatory condition set by national legislation for handling and working with ionizing radiation sources within Ukraine.This requirement does not automatically exclude international bidders from participating. However, it means that either the bidder or their officially designated local partner must hold a valid license issued by the State Nuclear Regulatory Inspectorate of Ukraine at the time of execution of relevant work involving ionizing radiation (such as installation, commissioning, calibration, maintenance, or service).Therefore, there are two acceptable ways to meet this requirement:If the international bidder has a local representative or aftersales partner in Ukraine who holds the required license, this can be considered compliant. In this case, it is necessary to provide:Documentation confirming the license issued to the local partner.An official agreement or letter of authorization confirming that this partner is responsible for the required licensed activities on behalf of the bidder.Thank you,Procurement team.

New clarification added: Dear UNOPS Team,Hope this message finds you well.We would like to request for a deadline extension for this tender. Please note that the manufacturer need more time considering the detailed documentation that is required for this tender and the complexity surrounding the end destination.The extension would allow us to make a comprehensive offer for this project.We look forward to hearing from your side.In additional to our deadline extension request, please also extend the clarification deadline./Dear Bidder,Thank you for the interest in the tender. Please find below the clarifications on your questions.We acknowledge your request for an extension of both the tender submission deadline and the clarification period. However, we regret to inform you that we are unable to accommodate these requests.This procurement is being carried out under a strict implementation schedule, driven by the operational needs and planning timelines of the end user. Any extension of the current deadlines would risk delaying the overall delivery, installation, and commissioning of the equipment, which is not feasible under the current framework.We appreciate your understanding and encourage you to submit your offer in accordance with the published timeline. Should you require any further clarification within the existing deadlines, please do not hesitate to contact usThank you.Procurement team.

New clarification added: Dear Procurement team,Our company is an official representative of one of the world’s largest manufacturers of medical equipment and intends to participate in this procurement.If the equipment partially does not meet the technical specifications or if some parameters are not specified in the manufacturer's technical documentation, how should we proceed in this case?Are we still allowed to participate in this procurement?Should we submit a request for the revision of certain technical specifications?/Dear Bidder,Thank you for the interest in the tender. Please find below the clarification on your question.Please note that all technical details outlined in the specifications represent the minimum technical requirements established based on the functional needs and quality standards necessary to ensure effective diagnostic performance. These requirements have been developed in close consultation with the end users to reflect the essential functionalities and operational conditions.Accordingly, all required technical parameters must be clearly documented in the official technical literature, user manuals, datasheets, or specifications issued by the original equipment manufacturer (OEM). The absence of such confirmation in the manufacturer’s documentation may render the offered equipment non-compliant.If your proposed equipment partially does not meet these minimum specifications or if certain parameters are not explicitly stated in the manufacturer's official documentation, you are welcome to submit a formal request for clarification of the technical requirements prior to the deadline for such requests.Thank you.Procurement team. 

New clarification added: please, clarify about B. Technical specifications for Goods Item 1-6– Comparative Data Tables - Item 2 C-arm digital X-Ray  - 1.6 Operation Table - there are no descriptions of this position.3.1 - Maximum generator power - not less than 5 kW - we have system which meet all other requirements but have 2.3 kW power. Is it critical?  Item  4 Digital X-Ray System with 3 working places -   9. Technical specifications of the X-ray image intensifier with TV system and image processing system - We do not have image intensifiers integrated onto the table, instead we have 43x43 cm Flat Detector for radiography and fluoroscopy. - is it critical if we offer FD instead I.I. from our side it is more technological but a little bit more expansive./Dear Bidder,Thank you for the interest in the tender. Please find below the clarifications on your questions:1.  B. Technical specifications for Goods Item 1-6– Comparative Data Tables - Item 2 C-arm digital X-Ray  - 1.6 Operation Table.Please be informed that the requirement is related to   Height adjustable, movable on castors,   radiolucent  X-ray table for use in the X-ray field of application. One of its main features must be the absence of a longitudinal brace at the front of the leg frame, allowing the free positioning of a C-arm. 2. The proposed configuration with a 2.3 kW generator cannot be accepted in place of the specified minimum 5 kW generator for the C-arm X-ray system.3. Usage of a 43x43 cm flat panel detector (FD) for radiography and fluoroscopy is acceptable. It will be considered under the evaluation with the requirement for an "X-ray image intensifier with TV system and image processing system." Thank you.Procurement team. 

New clarification added: Dear Sir or Madam,The tables of "Form B: Price Schedule Form" contains the "Unit price, without VAT (DDP)" and "Unit price, without VAT (DDP)" columns.However, according to the section "Duties and Taxes" of "Tender Particulars", prices should be given including VAT and all applicable taxes as well as customs duties and other expenses needed to meet the delivery requirement DDP Ukraine Incoterms.Does that mean that we can change the "Form B: Price Schedule Form" and put the "Unit price, including VAT (DDP)" and "Unit price, including VAT (DDP)" columns?/Dear Bidder,Thank you for your interest in the tender. Please find below the clarification on your request.1. Form B: Price Schedule Form was revised with the indication of the unit price as: Unit price DDP, USD incl. VAT and Total cost of the lot/item DDP, USD incl. VAT.2. Form B: Price Schedule Form was added with additional lines at the Form B as: Total cost of Goods, Cost of delivery  DDP, Mykolaiv region, Total cost of offer, DDP incl. VAT.Please check the amended documents RFQ_Section_III_RFQ/2025/58443_Returnable Bidding Forms_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast rev. 1 in the Documents section.Thank you,Procurement team. 

New amendment added #1:  Dear Bidders,Please be advised that the below amendments are made to the RFQ requirements:RFQ_Section_III_RFQ/2025/58443_Returnable Bidding Forms_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast:1. Form B: Price Schedule Form was revised with the indication of the unit price as: Unit price DDP, USD incl. VAT and Total cost of the lot/item DDP, USD incl. VAT.2. Form B: Price Schedule Form was added with additional lines at the Form B as: Total cost of Goods, Cost of delivery  DDP, Mykolaiv region, Total cost of offer, DDP incl. VAT.Please check the amended documents RFQ_Section_III_RFQ/2025/58443_Returnable Bidding Forms_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast rev. 1 in the Documents section.Thank you.

New clarification added: Dear Sirs/Madam, Thank you for invitation to participate in a tender posted by UNOPS. Tender details:Tender reference: RFQ/2025/58443Tender title: Emergency Procurement: Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast The technical specification includes six items. Is that acceptable if the Bidder submits the proposal for the several items, but for not all six? We would be grateful for a prompt response./Dear Bidder,Thank you for the interest in the tender.Please find below the clarification on your question.Under this RFQ ,partial quotations shall not be allowed, referring to the section Particulars: Partial quotations shall not be allowed. Bidders must quote prices for the total goods and/or services for the total requirement requested. Evaluation will be done for the total requirement.Thank you. Procurement team. 

New clarification added: Please tell, if the originals of the documents required for submission are in Ukrainian, do I need to provide a translation into English?/Dear bidder, thank you for your ineterst in the tender.Please find below the clarification on you request.All Returnable Bidding Forms under the document - RFQ_Section_III_RFQ/2025/58443_Returnable Bidding Forms_Provision of X-Ray equipment and Ultrasound to Mykolaiiv oblast must be submitted in English.Other documments related to the registration of the entity, certificates, previouse contracts, etc. could be provided in Ukranian language.Thank you.Procurement team.