|
Item |
Technical requirements |
Quantity, pcs |
|||
|
Infant ventilator with HFOV |
Product Description Device designed to provide temporary ventilation for premature born, infant and pediatric patients who require assistance maintaining adequate ventilation. Equipment to be used in critical care areas, stationary. |
24 |
|||
|
|
Electrical Requirements:
|
|
|||
|
|
Technical specifications:
|
|
Goods should be provided on DAP (Kyiv, Ukraine) basis.
If you are interested in submitting a bid for these items/services, kindly fill in the attached submission form and send to the secure email address indicated below/ not later than June 26, 2024 at 10:00 AM (Kyiv time).
Please ensure to mark your email with the ITB reference number and the words “Sealed bid. Do not open before June 26, 2024 at 10:00 AM (Kyiv time).”.
Secure email address for bid submission ua-procurement@unfpa.org
Note: Do not submit your bid/proposal to the contact person’s email address!
Please submit your quotation in USD currency. Conversion of currency into the UNFPA preferred currency, if the offer is quoted differently from what is required, shall be based only on UN Operational Exchange Rate prevailing at the time of competition deadline.
Bidding shall be conducted through ONE envelope. The technical bid containing the technical specifications and the financial bid containing the price information shall be submitted together.
Annex - 1
Bid Submission Form
Name of Bidder:
Contact Person:
Title:
Email Address:
Telephone Number:
Date of Bid: ________________________
Bid No: UNFPA/UKR/ITB/24/03
Currency of Bid price:
Delivery time (days from receipt of order till dispatch):
Expiration of Validity of Bid/Proposal (The bid shall be
valid for a period of at least 3 months after the Closing date.):
|
I hereby certify that this company, which I am duly authorized to sign for, accepts the General Terms and Conditions of UNFPA http://www.unfpa.org/resources/unfpa-general-conditions-contract and we will abide by this bid/proposal until it expires.
We undertake, if our bid/proposal is accepted, to commence and complete delivery of all items in the contract within the time frame stipulated.
We understand that you are not bound to accept any bid you may receive and that a bidding contract would result only after final negotiations are concluded on the basis of the technical and price bids proposed.
Name and title Date and Place
Annex – 2
Bidders Identification Form
Bid No. UNFPA/UKR/ITB/24/03
- Organization
|
Company/Institution Name |
|
|
Address, City, Country |
|
|
Telephone/FAX |
|
|
Website |
|
|
Date of establishment |
|
|
Legal Representative: Name/Surname/Position |
|
|
Legal structure: natural person/Co. Ltd, NGO/institution/other (please specify)
|
|
|
Organizational Type: Manufacturer, Wholesaler, Trader, Service provider, etc. |
|
|
Areas of expertise of the organization |
|
|
Current Licenses, if any, and permits (with dates, numbers and expiration dates) |
|
|
Years supplying to UN organizations |
|
|
Years supplying to UNFPA |
|
|
Production Capacity |
|
|
Subsidiaries in the region (please indicate names of subsidiaries and addresses, if relevant to the bid) |
|
|
Commercial Representatives in the country: Name/Address/Phone (for international companies only) |
|
- Quality Assurance Certification
|
International Quality Management System (QMS) |
|
|
List of other ISO certificates or equivalent certificates |
|
|
Presence and characteristics of in-house quality control laboratory (if relevant to bid) |
|
- Expertise of Staff
|
Total number of staff |
|
|
Number of staff involved in similar supply contracts |
|
- Client Reference List
Please provide references of main client details.
|
Name of company |
Contact person |
Telephone |
|
|
1. |
|
|
|
|
2. |
|
|
|
|
3. |
|
|
|
- Contact details of persons that UNFPA may contact for requests for clarification during bid evaluation
|
Name/Surname |
|
|
|
Telephone Number (direct) |
|
|
|
Email address (direct) |
|
|
P.S.: This person must be available during the next two weeks following receipt of bid.
Annex – 3
Product Item Overview Form
|
Description and minimum /mandatory specifications
|
Description of items offered and Bidder’s statements on deviations (To be completed by the bidder) |
(To be completed by UNFPA during evaluation) |
|
|
Device designed to provide temporary ventilation for premature born, infant and pediatric patients who require assistance maintaining adequate ventilation. Equipment to be used in critical care areas, stationary.
Electrical Requirements: ● Power requirements according to Ukraine standards: 220 VAC ± 10%, 50 Hz. ● Power cord with “F” type plug for medical devices. ● Built-in rechargeable battery, allowing at least 2.5 hours of continuous operation.
Technical specifications: ● Premature born, infant and pediatric patients up to 30 Kg. ● Mounted on a trolley with four (4) antistatic castors, at least two of the castors with brakes. Structure made at least of steel tube with anticorrosive finish in epoxy/electrostatic paint or higher quality. ● Gas inlet connections for supply from wall outlets: O₂ and Air. Connections compliant with DIN (according to the requirements of the destination country). With security systems to avoid errors in the gas connection. ● Display LCD, at least 12”. ● Hot-wire flow sensor, proximal to patient. ● Flow sensor removable and autoclavable, included. Cable for flow sensor included. ● Automatic compliance and leakage compensation. ● Expiratory valve or expiratory block autoclavable ● Self-test ● Leak test. ● Preoxygenation function. 23% – 100% O2, up to 2 min ● PEEP/CPAP range at least: 0 – 30 cmH₂O ● Ventilation rate 2-200 bpm ● Tidal volume 2–300 ml ● Adjustable I/E ratio or adjustable inspiration time. ● Peak inspiratory pressure: at least 4 to 60 cm H2O. ● Inspiration rise time adjustable. ● Inspiratory flow: at least 1 - 32 l/min ● Expiratory flow: at least 2 - 10 l/min ● Constant / Bias Flow adjustable at least: 5 to 20 Lpm ● Manual breath in all modes. Maximum time manual breath adjustable: at least 2 – 30s ● Inspiration time in the range of at least 0.1 -2 seconds ● FiO₂ adjustable: 21 - 100%. Oxygen cell included. ● High-frequency oscillation ventilation. Pressure amplitude range: 5 - 90 mbar. Frequency range: at least between 5 and 20 Hz Mean airway pressure: at least 5 - 40 mbar VTG in HFOV at least 0,2 ml - 30 ml I:E HFO: 1:1, 1:2, 1:3 Recruitment Maneuver: Frequency, inspiratory Time, and Pmean, adjustable. ● Volume, flow, and pressure adjustable trigger ● Termination criteria for PSV must be modifiable by the user. ● Ventilation modes, at least: o Intermittent Positive Pressure Ventilation (IPPV), with Volume-limited ventilation. o Volume guarantee ventilation o Volume-limited o Positive Pressure Ventilation (IPPV) o Positive Pressure Ventilation (IPPV) with Volume-limited ventilation and Volume guaranteed. o Synchronized Intermittent Positive Pressure Ventilation (S-IPPV), with Volume-limited ventilation and Volume guaranteed. o Synchronized Intermittent Mandatory Ventilation (SIMV) o Synchronized Intermittent Mandatory Ventilation (SIMV), with pressure support (PSV), Volume-guarantee and Volume-limited. o Continuous Positive Airway Pressure mode (CPAP), with Backup Frequency o Pressure supports ventilation with Synchronized Intermittent Positive Pressure Ventilation (PSV + S-IPPV), with Volume guaranteed and Volume-limited. o Pressure support ventilation with Synchronized Intermittent Positive Pressure Ventilation (PSV + SIMV), with Volume guaranteed and Volume-limited. o Biphasic positive airway pressure mode (BiLevel Airway Pressure Ventilation, BiPAP, DuoPAP, PDUO or similar) o Backup ventilation o High frequency oscillatory ventilation (HFOV) with volume guarantee o Non-invasive ventilation: o Nasal intermittent positive pressure ventilation (nIPPV) o Nasal continuous positive airway pressure (nCPAP) o Biphasic positive airway pressure mode o O2 Therapy High and Low Flow Oxygen Therapy (Optional) o nHFO ● Monitored and Displayed parameters, at least: o Capnography (sensor included) o Respiratory rate o Inspired and expired tidal volume o Minute volume. o I:E ratio o Inspiratory and expiratory times. o Airway pressure, peak and mean. o FiO2 o PEEP o Peak pressure o Waves vs time: pressure, volume, and flow o Pressure-Volume, Flow-Volume and Pressure-Flow loops. o Battery status. o Alarm settings. o Resistance, compliance C20/C o Ventilation gas leak ● Audio and visual alarms for at least: o High and low airway pressure. o Tidal volume o Minute Volume o FiO₂ o Apnea o Respiratory rate o Patient disconnection o Gas supply failure o Power failure o Low battery o System failures ● All materials resistant to disinfection with hospital-grade products. ● Indications and messages on the equipment must be in English language as mandatory, and preferably also in Ukrainian language.
Accessories: ● Support arm for patient-circuit, adjustable. ● One (1) Air pressure regulator, compatible with the medical gas system of the health unit if it is necessary. ● One (1) O2 pressure regulator, compatible with the medical gas system of the health unit if it is necessary. ● Hoses for Air and O2, length: at least 2 meters (2-3 meters preferably), with their respective connections compatible with the gas inlet of the equipment and the supplied pressure regulators. ● One (1) expiratory valve or expiratory block autoclavable, in addition to that included in the device. ● One (1) test lung, neonatal size. ● Sixty (60) Neonatal disposable patient circuits for invasive ventilation, complete, including pressure line if applicable. ● Two hundred (200) complete disposable neonatal high-frequency ventilation circuits (including adapters, filters, pressure lines and any element necessary for their correct functioning). Only applies if they are different from conventional ventilation circuits. ● Nine (9) neonatal nasal masks, in three different sizes, for nCPAP and nIPPV, reusables. ● Nine (9) neonatal nasal prongs, in three different sizes, for nCPAP and nIPPV, reusables. ● Twenty (20) Neonatal disposable patient circuits for non-invasive ventilation, complete, including all necessary adapters. ● One (1) Oxygen cell, if applicable, in addition to that included in the device. ● One (1) cable for proximal flow sensor, in addition to that included with the device. ● Two (2) distal flow sensors, reusable, if applicable, in addition to that included in the device. ● Three (3) Neonatal (proximal) flow sensors, reusable, in addition to that included in the device. ● One (1) capnography sensor, in addition to that provided with the device, and ten (10) reusable adapters for patient circuit (pediatric size).
NOTE: If applicable, all other necessary accessories and consumables for the correct operation of the product during the first 12 months, including all standard tools, cleaning, and lubrication materials, even if they are not included in these required technical specifications must be included and listed in the offer.
Documentation required: Bidder shall furnish the following documents: ● Manufacturer brochure or data sheet including at least all technical specifications required. ● User manual must be provided including installation requirements, operation instructions, maintenance and procedures for decontamination, storage conditions, safe disposal. ● Service manuals must be provided including preventive maintenance and calibration procedures, equipment necessary for preventive maintenance and repair, diagrams, and circuits. ● List of all common spare parts and accessories with part numbers. ● Manufacturer authorization Letter. ● Commitment manufacturer letter including: o installation and commissioning on site would be performed by the manufacturer or his representative in the country (according to the general requirements in the bid document under the clause “Installation and commissioning on site"). o at least two (2) years of full onsite warranty. o at least five (5) years of Spare Parts availability. o training on use, cleaning, and disinfecting for the healthcare staff, and basic maintenance for the technical staff, in Ukrainian and English language.
NOTE: All the documents must be submitted in English and Ukrainian language as mandatory. The Russian language could be accepted as an exception to the Ukrainian language.
Regulatory approvals required: Bidder shall furnish documentary evidence to demonstrate that the good offered is approved according: ● Valid certificate or approval letter from national Ukrainian regulatory body, which confirms local registration of the product and permission to use it in medical practice. ● Valid manufacturing licenses. ● And at least one of the following regulatory approvals and certificates: o European Certificate of Conformity (CE) with Regulation 2017/745 or Directive 93/42 EC and Agreement Letter signed with the NB demonstrating the on-going MDR application, for Class IIb devices, or o FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States, or o Other regulatory bodies of an IMDRF founding member country such as Australia, Canada, or Japan.
Safety & product Standards: Bidder shall furnish the following documents: ● Valid ISO 13485 certificate. ● Signed and dated Declaration of Conformity (DoC) according to ISO 17050 to demonstrate that, the good offered, meet at least the follow international safety & regulatory standards: o IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance o IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests o ISO 80601-2-12: This standard outlines the basic safety and essential performance requirements for a ventilator in critical care environments, ensuring compliance with ventilation accuracy, alarms, monitoring capabilities, electrical safety, mechanical
|
|
|
Annex - 4
Price Schedule Form
Name of Bidder:
Date of Bid:
Bid No: UNFPA/UKR/ITB/24/03
Currency of Bid price: USD
Delivery time (days from receipt of order till dispatch):
(Note: maximum number of days is: 90 days)
Expiration of Validity of Bid/Proposal (The bid shall be
valid for a period of at least (3) months after the Closing date.):
|
Item name and model |
Manufacturer/ Country of Origin |
Unit price (USD) |
Quantity |
Total Price (USD), DAP Kyiv |
Delivery schedule (days upon order) |
|
|
|
|
|
|
|
|
PROVIDED THAT A PURCHASE ORDER IS ISSUED BY UNFPA WITHIN THE REQUIRED BID VALIDITY PERIOD, THE UNDERSIGNED HEREBY COMMITS, SUBJECT TO THE TERMS OF SUCH PURCHASE ORDER, TO FURNISH ANY OR ALL ITEMS AT THE PRICES OFFERED AND TO DELIVER SAME TO THE DESIGNATED POINT(S) WITHIN THE DELIVERY TIME STATED ABOVE.
Name and title Date and Place
Annex - 5
Fast Track Procurement Questionnaire
for Medical Devices
PART I. Manufacturer information
Bidder (if not manufacturer): Click here to enter text.
Manufacturer: Name of manufacturer: Click here to enter text.
Country: Click here to enter text.
Address (office): Click here to enter text.
Address (manufacturing site(s)): Click here to enter text.
Contact person’s name: Click here to enter text.
Email: Click here to enter text.
Phone: Click here to enter text.
PART II. Product information
Product Identification (Trade name, Type, Model, Package size, Intended use, etc.):
Click here to enter text.
Product Code, Reference number(s): Click here to enter text.
Product details (materials, dimensions, size, volume, features, etc. For electrical devices specify voltage, frequency and plug supplied.): (E.g. If a stainless steel product, identify AISI type or composition. If a plastic product, identify type or composition.)
Click here to enter text.
PART III. Regulatory Status
|
3.1 Is the product CE marked? Certification body and number: |
□ Yes |
Start Date: Click here to enter text. |
|
□ No |
||
|
3.2 Is the product FDA approved? 510k clearance #: Click here to enter text. |
□ Yes |
Start Date: Click here to enter text. |
|
□ No |
||
|
3.3 Is the product approved by National Regulatory Agency or Department? Name of agency and type of approval: Click here to enter text. |
□ Yes |
Start Date: Click here to enter text. |
|
□ No |
||
|
3.4 Provide details of any other current regulatory approvals for this product. Name of jurisdiction and type of approval: Click here to enter text. |
□ Yes |
Start Date: Click here to enter text. |
|
□ No |
||
3.5 Manufacturer QMS ISO 13485 Yes ☐ No ☐
QMS ISO 9001 Yes ☐ No ☐
-
- Certification body and number: Click here to enter text.
- Expiration date: Click here to enter text.
3.6 FOR STERILE PRODUCTS - If the manufacturing process is subcontracted:
|
Name and address of the subcontractor |
QMS certification of the subcontractor - Identify Regulatory body and/or number and expiry date |
|
Click here to enter text. |
Click here to enter text. |
3.7 FOR ELECTRICAL or BATTERY-OPERATED PRODUCTS
|
If the device contains Lithium metal and Lithium ion batteries, does it comply with clause 38.3 of the recommendations on “Transport Of Dangerous Goods” from the United Nations? |
Yes ☐ No ☐ |
|
Does it comply with the latest IATA Dangerous Goods Regulations (DGR)? |
Yes ☐ No ☐ |
|
Testing laboratory, Test Report reference, specify standard |
Click here to enter text. |
PART IV. Checklist of required documentation
|
Product class |
Minimum documentation required |
|
class I |
☐ Copy of ISO 13485* (or ISO 9001*) QMS certificate. |
|
class I measuring |
☐ Copy of EC certificate (referencing the name/number of the notifying body), and/or 510k FDA clearance, and/or approval letter or certificate from a National Regulatory Body. |
|
class IIb |
☐ Copy of EC certificate (referencing the name/number of the notifying body) with an additional copy EC Design Examination certificate, and/or 510k/PMA FDA clearance, and/or approval letter or certificate from a National Regulatory Body. |
*) UNFPA accepts the versions of currently active standards, which are recognized by the International Organization for Standardization at the time of document submission.