Emergency Procurement: Re-tender Provision of the monitors to Kharkiv oblast

New amendment added #1: Dear Bidders,Please be advised that RFQ/2026/612617 has been revised and amended.Kindly refer to the document RFQ_2026_612617_RFQ Amendment 01_Summary of Revisions.pdf  for a summary of the changes made to the initial RFQ documents package.Thank you. 

New clarification added: Dear Bidder,Please find below the clarification on your questions.Item 2.6 – CertificationsThe requirement is clarified as follows:Bidders shall provide complete and verifiable certification details for each applicable component (including monitors, CMS software, and related equipment), including:type of certificate (e.g., CE marking, ISO 13485, ISO 9001, EMC/LVD compliance);name of the legal manufacturer;issuing / notified / accredited body;certificate number/reference;issue and expiry dates;scope of certification (including products and manufacturing sites);applicable regulation/standard (e.g., MDR 2017/745, EMC Directive, etc.);copy of certificate or EU Declaration of Conformity (DoC).Regarding CMS software and PC hardware:If classified as a medical device, relevant CE MDR (or EU DoC) is required.If not classified as a medical device, MDR CE is not mandatory; however, compliance with applicable EU directives (e.g., EMC, LVD) or equivalent is required.A CE marking from the supplier alone is not sufficient, unless supported by an EU DoC identifying the manufacturer and applicable directives/standards.Detailed certification data is required. CMS/PC components may follow non-medical CE frameworks where applicable, but must be supported by valid DoC and compliance evidence.           Export Documentation (Commercial Invoice / Packing List)The requirement is clarified as follows:The Commercial Invoice and Packing List may be issued by the Bidder (Supplier) and do not need to be issued directly by the manufacturer, provided that:the documents are accurate, complete, and consistent with the contract and delivered goods;they clearly identify the manufacturer(s), country of origin, and product details;they comply with international trade and customs requirements, including language (English) and required formatting.This approach is aligned with standard international trade practices.Commercial Invoice and Packing List issued by the Bidder are acceptable, provided they meet all contractual and customs requirements.                                                               Item 1.4.4.2 (User-friendly software):  The requirement is clarified as follows:“User-friendly software” refers to the overall usability and intuitive operation of the system rather than a single specific feature. It is understood as the ability of clinical staff to operate the monitor efficiently, safely, and with minimal training.Compliance with this requirement may be demonstrated through the following characteristics (not exhaustive):Intuitive user interface, including logical menu structure and clear navigation;Touchscreen operation and/or dedicated keys/controls enabling quick access to core functions;Clear and readable display of parameters, waveforms, and alarms;Efficient workflow, including minimal steps for common actions (e.g., patient admission, alarm setting, parameter adjustment);Multilingual interface support (including English, and where applicable local language);Contextual help or guidance features, where available.No specific requirement is set regarding a fixed number of hotkeys or a particular interface type, provided that the system achieves effective and safe clinical usability.Bidders are requested to support compliance through manufacturer documentation, screenshots, or user manual excerpts.“User-friendly” refers to intuitive, efficient, and clinically safe operation, not to a single predefined technical feature.                                                                                                                    Item 1.4.4.16 (Software tools):                                                                                                                      The requirement is clarified as follows:“Statistical analysis and interpretation” tools within the CMS refer to software functionalities that support clinical assessment of patient data over time, beyond simple real-time display.Examples of acceptable tools include (not exhaustive):Trend analysis of vital parameters (e.g., HR, SpO₂, NIBP, EtCO₂), including graphical and tabular views over selectable time periods;Summary statistics, such as minimum, maximum, and average values over defined intervals;Event and alarm review, including logging, filtering, and correlation with parameter changes;Arrhythmia/event analysis, where applicable (e.g., frequency or distribution of detected events);Tabular data review and export for clinical documentation;Basic interpretation aids, such as highlighting of abnormal values, threshold exceedances, or parameter deviations.These tools are intended to support clinical decision-making and retrospective review, not to replace advanced diagnostic or standalone analytical systems.Bidders shall demonstrate availability of such functionalities through manufacturer documentation (e.g., CMS software manuals, screenshots, or feature descriptions).“Statistical analysis and interpretation” refers to trend analysis, summary statistics, and event/alarm review tools supporting clinical assessment, not advanced standalone analytics.    Items 1.1.9-1.1.10.5 (Accessories):                                                                                                            The requested approach is accepted with conditions.It is acknowledged that accessories are not always fully detailed in the main User Manual/IFU. Therefore, confirmation of compliance through a Technical Specification/Data Sheet is acceptable, provided that:The document is issued or officially endorsed by the Manufacturer (e.g., signed, stamped, or on official letterhead);It clearly identifies the model, part number, and compatibility with the offered system;It specifies the relevant technical characteristics demonstrating compliance with the requirement;It is consistent with other submitted documentation (e.g., brochures, catalogues, IFU where applicable).Where available, submission of catalogue excerpts or official accessory lists is also encouraged to strengthen verification.The Purchaser reserves the right to request additional supporting documentation if needed during evaluation.A Manufacturer-issued or endorsed Technical Specification/Data Sheet is acceptable for confirming accessory compliance, subject to the above conditions.            Thank you.

New clarification added: Dear Bidder,Thank you for the interest in the tender. Please find the clarification on your question.•    Items 1.3.1.11, 1.3.7-1.3.7.4 (Redundant CO2):The requested change is accepted.The requirement will be revised to avoid duplication of functionality. Where a Multi-gas (AG) module is provided and includes CO₂ measurement, a separate dedicated CO₂ module is not required.The intent of the specification is to ensure availability of CO₂ monitoring; however, this can be fully achieved through the Multi-gas module without the need for redundant equipment.Bidders shall ensure that the Multi-gas module supports clinically appropriate CO₂ monitoring (e.g., EtCO₂ measurement) and provide supporting manufacturer documentation.A separate CO₂ module is not required if CO₂ measurement is included within the Multi-gas module.•    Item 1.3.2.5 (QTc analysis):The requested change cannot be accepted.The requirement for QTc analysis is retained as it represents an important clinical monitoring parameter, particularly in settings where patients are at risk of arrhythmias, electrolyte imbalance, or are receiving medications known to prolong the QT interval.QTc monitoring provides valuable real-time information for early detection of cardiac risk, supporting timely clinical decision-making in ICU, emergency, and perioperative environments. Many modern patient monitors include QT/QTc analysis as a standard or widely available feature.Furthermore, the requirement does not impose a disproportionate restriction on competition, as compliant devices are available from multiple manufacturers.The requirement for QTc analysis remains unchanged.•    Items 1.3.9.3 & 1.2.9.1, 1.3.10.1, 1.4.4.15 (EEG sensitivity & Full Disclosure):The requested change is partially accepted.The requirement for configurable EEG sensitivity is retained. This functionality is considered essential to ensure proper signal visualization and interpretation across different clinical conditions and patient variability, and it is commonly supported in EEG/BIS-capable monitoring systems.The requirement for “minimum 24 h full disclosure waveforms” will be relaxed. Continuous long-duration raw waveform storage may be dependent on system architecture, memory capacity, or optional software packages and is not always included in standard configurations. Instead, the requirement will be interpreted as the ability to review EEG trends and/or waveform data over a clinically relevant period, without mandating a strict 24-hour full disclosure storage.Bidders shall provide details of the available trend storage and waveform review capabilities in the offered configuration.Configurable EEG sensitivity remains required; the 24 h full disclosure waveform storage is relaxed to clinically relevant trend/waveform review capability.•    Items 1.4.4.7, 1.4.4.8, 1.4.4.14 (CMS Features):The requested changes are partially accepted.The requirement for displaying date/time on the patient information bar will be relaxed. It is acceptable for date/time to be displayed elsewhere on the screen (e.g., header or corner of the CMS interface), provided it is clearly visible and continuously accessible to the user.The requirement for audible alarms at the CMS station is retained. Audible alarms are a critical safety feature for centralized monitoring, ensuring timely awareness of patient status changes, especially in multi-bed environments. While alarm fatigue is a recognized concern, it is typically addressed through configurable alarm management (e.g., prioritization, volume adjustment, delay settings), rather than removal of audible alerts.The requirement for split screen mode will be relaxed. Alternative display configurations (e.g., single-bed detailed view, multi-bed overview, or other manufacturer-specific layouts) are considered acceptable, provided they support effective clinical monitoring and navigation.Date/time display location is flexible; audible alarms at CMS remain mandatory; split screen requirement is relaxed in favor of equivalent display configurations.•    Item 1.4.5.2 (UPS):The requested change is partially accepted.The requirement for a UPS with voltage regulation for the patient monitor is removed, provided that the offered monitor includes an integrated internal battery with sufficient autonomy (e.g., minimum 2 hours or as otherwise specified) to ensure safe operation during power interruptions.However, for the CMS/CPU (central station), the requirement for a UPS with voltage regulation is retained. Central monitoring systems are critical infrastructure components, and uninterrupted operation—including data integrity, alarm continuity, and system stability—must be ensured beyond the autonomy typically provided by internal device batteries.UPS requirement is removed for the monitor (with adequate internal battery) but remains mandatory for CMS/CPU systems.•    Item 1.4.1.2 (Hardware Brand):The request is accepted with conditions.It is acknowledged that, for Central Monitoring Station (CMS) solutions, the software is typically provided by the medical device manufacturer, while the PC hardware may be sourced locally by the distributor or integrator in accordance with the software requirements.In this context, submission of a Guarantee Letter is acceptable in lieu of a manufacturer manual for the PC, provided that the following conditions are met:The bidder clearly specifies the proposed PC configuration (CPU, RAM, storage, graphics capability, network interfaces, operating system, etc.);The configuration is fully aligned with the CMS software manufacturer’s minimum/recommended requirements;The Guarantee Letter confirms that the supplied PC will be fully compatible, properly configured, and validated for operation with the offered CMS software;Where available, official system requirements or compatibility statements from the CMS manufacturer shall be provided to support compliance.The bidder remains fully responsible for ensuring system performance, stability, and interoperability of the complete CMS solution.A Guarantee Letter is acceptable, provided it is supported by a detailed PC specification and confirmation of compliance with CMS software requirements.                                                 Thank you.

New clarification added: Dear Bidder,Thank you for your interest in the tender. Please find below the clarification on your question.  Item 1.2.8.3 (EtCO2 Accuracy):The requested change is accepted.The requirement for EtCO₂ accuracy will be revised to reflect a maximum permissible deviation, allowing devices with higher precision to be considered compliant. Accordingly, the wording will be updated to “± … or better” or “≤ ± …”, as applicable.This ensures that equipment offering improved accuracy (e.g., ±2 mmHg) is not excluded, while maintaining the intended minimum performance threshold and clinical reliability.The requirement is updated to allow equal or better EtCO₂ accuracy (≤ ± specified value).•    Items 1.1.2.5, 1.2.2.4, 1.2.2.5 (Pacemaker detection):The requirement refers to functional capabilities of the patient monitor and is clarified as follows:“Pacemaker detection” shall mean the ability of the monitor to identify pacemaker pulses and appropriately process/display ECG signals without misinterpretation, including correct heart rate calculation and waveform presentation for paced patients.“Lead-off detection” shall mean the ability of the monitor to automatically detect disconnected or improperly attached ECG leads and generate a corresponding notification.Both functions shall include clear visual indication on the screen (e.g., message, symbol, or waveform annotation) and, where applicable, audible alarm signals in accordance with standard monitoring practice.Bidders are requested to provide supporting manufacturer documentation (e.g., IFU, user manual excerpts) confirming the availability of these features.The requirement refers to functional detection capabilities with corresponding visual (and where applicable audible) alarms/indications, not merely textual labeling.•    Items 1.1.6.1, 1.3.5.2 (NIBP Modes):The requirement is clarified as follows:“STAT mode” refers to a dedicated rapid NIBP measurement function that performs repeated automatic measurements at short, predefined intervals over a limited period, typically used in emergency or unstable patient conditions.“Continuous mode” may be considered acceptable only if it provides equivalent functionality, namely:automatic repeated NIBP measurements at short intervals without manual re-triggering;operation within a defined short-duration cycle (not continuous indefinite measurement);safe operation in line with clinical standards (e.g., cuff inflation/deflation control, patient safety limits).Bidders shall clearly demonstrate in the manufacturer’s documentation (e.g., IFU/user manual) that the offered “continuous mode” meets the above criteria and is functionally equivalent to STAT mode.“Continuous mode” is acceptable only if proven functionally equivalent to STAT mode based on manufacturer documentation.•    Items 1.2.7.4, 1.3.6.4 (Invasive Pressure Labels):The requirement is clarified as follows:The abbreviations used in the specification refer to standard clinical parameters in patient monitoring:ABP – Arterial Blood PressureCVP – Central Venous PressurePAP – Pulmonary Artery PressureRA – Right Atrium (Right Atrial Pressure)LA – Left Atrium (Left Atrial Pressure)These terms are widely used in clinical practice and are considered standard across manufacturers and monitoring systems. The abbreviations correspond to standard hemodynamic parameters, and no change to the requirement is necessary.•    Item 1.3.8.2 (O2 Sensor):The requested change is partially accepted.The requirement for a paramagnetic O₂ measurement system remains unchanged, as it defines the intended measurement principle.However, the wording “fast-response” and “maintenance-free” will be treated as descriptive/non-mandatory characteristics, rather than strict compliance criteria. These terms reflect typical performance of paramagnetic sensors but may not be explicitly stated in all manufacturer documentation.Bidders are therefore not required to provide explicit confirmation of these exact terms, provided that the offered paramagnetic O₂ system meets standard clinical performance and functionality.The core requirement (paramagnetic O₂ system) is retained; “fast-response maintenance-free” is considered non-mandatory descriptive wording and will not be strictly evaluated.•    Item 1.3.9.2 (Impedance verification):The requirement is clarified as follows:“Manual and automatic impedance verification” refers to the capability of the system to check electrode impedance both on user demand (manual) and automatically without user intervention (automatic).Accordingly:Continuous impedance check is considered compliant as automatic verification, provided it performs ongoing or periodic impedance monitoring without manual triggering.Cyclic impedance check is also considered compliant as automatic verification, if it performs repeated checks at defined intervals.A manual impedance check function (user-initiated) must also be available.Bidders shall demonstrate through manufacturer documentation (e.g., IFU or user manual) that both manual and automatic (continuous or cyclic) impedance verification capabilities are supported.Continuous and cyclic impedance check are acceptable as automatic verification, provided a manual impedance check function is also available.•    Item 1.3.1.1 (Modularity):The requested change cannot be accepted.The requirement for a modular design is retained as it reflects a deliberate technical and operational need. Modular patient monitoring systems allow for scalability, flexibility, and future upgradeability, including the addition or replacement of measurement modules (e.g., IBP, EtCO₂, BIS, advanced hemodynamics) without replacing the entire unit.While integrated (pre-configured) monitors may provide similar functionality for a fixed configuration, they limit adaptability to evolving clinical requirements and may result in higher long-term costs due to full system replacement when additional parameters are needed or components fail.Furthermore, modular systems are standard in higher-acuity environments (e.g., ICU, operating theatre), where clinical flexibility and serviceability are essential.The requirement for modular design remains unchanged.Thank you.

New clarification added: Dear Bidder,Thank you for your interest int the tender.Please find the clarification on your question.Item 1.1.7                                                                                                                                                                                              The requirement under Item 1.1.7 (Resolution ≥1024×768) is retained as originally specified, as it reflects a minimum standard aligned with current clinical practice and market availability of modern patient monitoring systems. Contemporary patient monitors in the 10–12 inch category commonly support resolutions of at least 1024×768 or higher, enabling improved visualization of multiple waveforms, numeric parameters, alarm indicators, and trend data simultaneously.Reducing the requirement to ≥800×600 pixels would represent a downgrade in display capability, potentially limiting the clarity and usability of clinical information, particularly in multi-parameter monitoring scenarios (e.g., ICU, emergency care). Higher resolution contributes to better readability, more efficient clinical decision-making, and reduced risk of misinterpretation.Furthermore, the requirement does not impose a disproportionate restriction on competition, as compliant devices are widely available on the market from multiple manufacturers.The requirement remains unchanged.                                                                                                                                         Items 1.1.8, 1.3.11, 1.2.10, 1.4.5 (Power Supply):                                                                                                                       The requested change is partially accepted.The requirement under Items 1.2.10.1 and 1.4.5.1 is revised to allow power supply 100–240V~, 50/60Hz, as this reflects standard modern medical device design with universal switching power supplies and does not negatively impact performance or safety.However, the requirement for compatibility with the local electrical system is retained. While the explicit wording “single phase” may be removed as implicit for this type of equipment, the equipment must be fully suitable for operation within the national power infrastructure.Regarding the plug type, the requirement for a Type F (Schuko) plug or equivalent compatible with local sockets is retained. This is necessary to ensure safe and immediate usability of the equipment upon delivery without the need for adapters, in line with operational and safety considerations.The voltage/frequency range is updated to 100–240V~, 50/60Hz; “single phase” wording is removed; however, local plug compatibility (Type F or equivalent) remains mandatory.                                                                                               Items 1.1.2.7, 1.2.2.8, 1.1.5.4, 1.2.5.4, 1.3.4.10, 1.3.4.3 (Accuracy constraints):                                                                   The requested change is accepted.The requirements related to accuracy for HR, Pulse Rate, and Temperature will be revised to reflect maximum permissible deviation, ensuring that equipment offering equal or better performance is not excluded. Accordingly, the wording will be adjusted to “≤ ± …” or “± … or better”, as applicable.This clarification ensures that higher-precision devices (e.g., ±1 bpm or ±1%) are considered compliant, while maintaining the intended minimum performance threshold. It also aligns with standard procurement practice, where specifications define limits rather than fixed values.The requirement is updated to allow equal or better accuracy (≤ ± specified value).                                                            Item 1.2.8.1 (EtCO2 range):The requested change is accepted with clarification.The requirement for CO₂ measurement range will be updated to allow expression in either mmHg or %, provided that the offered range is clinically equivalent and covers the intended monitoring scope. Bidders may therefore specify the measurement range as 0–25% or equivalent in mmHg.However, it remains the bidder’s responsibility to ensure clear documentation of the conversion and confirm that the device supports standard clinical interpretation (including EtCO₂ monitoring), consistent with international practice.The requirement is revised to allow CO₂ measurement range expressed in % or mmHg, provided equivalence is demonstrated.Thank you.

New clarification added: Dear Colleagues,We would like to kindly request clarification on several points related to the temperature monitoring requirements across the specified Lots.In section 1.1.9 (Lot 1), temperature monitoring (TEMP) is included among the required parameters (ECG, RESP, TEMP, SpO₂, NIBP). However, the number of temperature measurement channels is not specified. We would appreciate it if you could confirm the required number of TEMP channels.In sections 1.1.10 (Lot 1), 1.2.12.1 (Lot 2), and 1.3.13.1 (Lot 3), the procurement of two temperature sensors is specified. We kindly ask you to clarify the required type of sensors:Skin surface temperature probes, orEsophageal/rectal temperature probes.Additionally, please confirm whether both sensors should be of the same type or of different types.Thank you in advance for your time and clarification./Dear Bidder,Thank you for your interest in the tender. Please find below clarification on your question.1. Number of Temperature (TEMP) Channels (Lot 1, Section 1.1.9):The patient monitor shall support minimum one (1) temperature (TEMP) measurement channel.Systems supporting two (2) or more TEMP channels will be considered as equal or more advanced solutions, provided that full functionality of temperature monitoring is maintained. 2. Type of Temperature Sensors (Lots 1–3, Sections 1.1.10, 1.2.12.1, 1.3.13.1):The requirement for two (2) temperature sensors shall be interpreted as follows:The system shall be supplied with two (2) compatible temperature probes suitable for clinical use.Acceptable probe types include:Skin surface temperature probes;3. Configuration of Sensors:The two (2) sensors schould  be of the same type .Thank you.Procurement team. 

New clarification added: Dear Organizer,Limited Liability Company “Medical Company ‘EMPIRICA’” presents its compliments and kindly requests additional time to prepare clarifications in response to your inquiries in order to provide complete information and duly prepared documents./Dear Bidder,  Thank you for your interest in the tender. Unfortunately, we are unable to grant additional time due to the strict project implementation deadline. We kindly request you to submit the required documents within the originally specified timeframe.Thank you.Procurement team

New clarification added: Dear Sir/Madam,Greetings. Kindly confirm whether international bidders who are not registered in Ukraine are also eligible to participate.Additionally, we would like to inform you that we meet the required evaluation criteria, including ISO 9001 and ISO 13485 certifications.Thank you for your assistance.Best regards,Export dept./Dear Bidder,Thank you for your interest in this tender. Please find below the clarification on your question.No nationalities are excluded from submitting a bid, reffering to the Particularts Section:"Bidder eligibility."Thank you.Procurement Team

New clarification added: Dear UNOPS Team,Referring to Section C — Delivery Requirements, the Incoterms are stated as DPU 2020, Kharkiv Oblast, Ukraine, however the exact delivery facility address is not specified in the tender documents.As the supplier is responsible for all costs including unloading under DPU terms, could you please confirm:The exact facility name and address within Kharkiv Oblast?Whether delivery is to one or multiple locations?This is required for accurate freight cost estimation.Thank you./Dear Bidder,Thank you for your interest in this tender.Please find below the clarification on your question.1. The exact facility name and delivery address will be provided to the awarded bidder. 2. The city for delivery is  Kharkiv city (one location), Kharkiv oblast.Thank you.Procurement Team

New clarification added: Dear UNOPS Team,Hope this message finds you well.Could you please share the feedback on project and on our submission for the tender RFQ/2026/61493. We see the status of this project has changed to CANCELLED and our understanding is that this new tender (RFQ/2026/62617) is similar to the previous one.Your feedback will be helpful to better understand your requirements and you may share feeback on the contact information in the signature. This would be helpful to better understand your requirements and offer the right product/brand/model as needed.Many thanks and kind regards, /Dear Bidder,Thank you for your interest in this tender.Please be informed that the re-tender for the monitors  RFQ/2026/62617 has been launched following a revision of the procurement approach based on the mandatory compatibility of the items with each other, which now covers the full list of items. The evaluation will be conducted based on the total scope of the equipment.  The revision of the technical specification has been made accordingly.Kindly review the revised Schedule of Requirements.Please also note that the delivery terms have been revised to DPU Incoterms 2020.Thank you.Procurement Team