Supply of Complex Medical Devices for Operation Theaters of Primary Health Centres in Madagascar // Fourniture de Dispositifs Médicaux Complexes pour les salles d'opération chirurgicale des centres de santé de base à Madagascar

New amendment added #4: Esteemed Potential BiddersPlease find that the deadline has been extended.Additionally, the following document have been amended:6. OTM-01 - Anesthesia equipment- V.04.docx6. OTM-10 - Benchtop autoclave - V.03.docxThe inserted or modified text can be identified in color blue.Kind regards

New clarification added: Esteemed Potential BiddersPlease review the followig clarifications :35. To ensure a smooth and efficient installation process, could you please provide a detailed breakdown of the specific alterations needed at each installation site? This information would be invaluable in allowing us to accurately assess the scope of work and allocate the necessary resources.Specifically, we would like to understand:The current state of the electrical infrastructure at each site.Any structural modifications that may be required.Any other specific provisions or requirements that need to be addressed.A comprehensive understanding of these "provision alterations" will enable us to develop a more accurate project timeline and cost estimate.Answer: - The list is not available at the moment but will be available at the purchase order. So please manage the worst case.Kind regards

New clarification added: Esteemed Potential BiddersPlease review the followig clarifications :30. OTM-01 - Anesthesia equipment Accessories included in the offered price. 12.“5 (five) adapters compatible with the anesthetic agent loading system for each Vaporizer provided.” Anesthesia with a pour fill dosing method vaporizer don't need adapters. As for this item, our equipment adopts vaporizer with a pour fill dosing method, so the vaporizers do not need any adapters. As a result, can we just respond "Not Applicable" for this point? OR please kindly change this point into:"Anesthesia with key fill dosing method vaporizer should have 5 (five) adapters compatible with the anesthetic agent loading system for each Vaporizer provided.-This requirement applies only to vaporizers that need adapters for the anesthetic agent filling system. Therefore, 'Not applicable' is acceptable if the vaporizers offered do not require an adapter for filling.31. OT-10 - Benchtop Autoclave. Please kindly change it into:"Loading capacity of at least, Separately: one (1) sterilization container DIN 3/4, one (1) sterilization container DIN 1/2 and one (1) sterilization container DIN 1/1.- Accepted. Amended document to be uploaded shorlty.32. Regarding your clarification on September 04th, 2024 for OTM-04 - Ceiling operating light, could you share us what is the ceiling material?The ceiling materials are different in the different installation sites.- The list is not available at the moment but will be available at the purchase order. So please manage the worst case.33.  Anesthesia equipment. 6.Valves group: open, semi-closed, closed, heated, with soda lime absorber., Please kindly change this requirement into:"Valves group: open(if applicable), semi-closed, closed, heated, with soda lime absorber.- Accepted. Amended document to be uploaded shorlty.34. For OTM-02 -Surgical Suction Machine, Please we need to know the desired suction machine body/cabinet material ie made of ABS(Plastic) or Stainless Steel.- The body material is no-specified so that both ABS and Stainless Steel are aceptable.Kind regards

New clarification added: Esteemed Potential BiddersPlease review the followig clarifications :24. Marketing authorization or local health registration: of the brands and models offered in force at the time of the offer in the country of manufacture, issued by the national regulatory authority in accordance with its local procedures. Please clarify which documents are you exactly expecting-   We require a certification that the offered goods can be freely sold in the Country of Origin according to local regulation. I.E. FDA certification for US or CE certification for EU.25. On the clarification issued on 08-27, one question regarding, is supplier responsible for installing both the ceiling load-bearing steel structure and the operating light, or only for installing the operating light on the pre-installed steel structure? Your reply was the supplier will be responsible for installing both the ceiling load-bearing steel structure and the operating light. Can you explain further on what you mean by installing the ceiling load-bearing steel structure? Because the wording can lead to different explainations and it will affact supplier's budget. Thank you!-- The supplier will be responsible for fixing to the slab the supporting structure from which the lamp will hang. See picture. (https://drive.google.com/file/d/1yLtvgPxd2FUliqjJOMAY-2amtWJNl4qK/view?usp=sharing)26. Pneumatic Specification Flowmeters: AIR: 0-1L/min; 1-15L/min, O2: 0-1L/min; 1-10l/min, N2O: 0-1L/min; 1-12L/min. From a clinical perspective, the actual use will not reach this parameter. The conventional flow rate is a few liters. Currently, the trend of anesthesia machines is to use low flow rates, which are generally less than two liters or one liter of total flow rate. If the flow rate is too high and exceeds the metabolic capacity required by the human body, the remaining anesthetic gas will be discharged as waste gas, resulting in increased loss of anesthetic. If there is no exhaust gas collection system, it will discharge waste that damages the surgeon's body. Q: Please consider change AIR: 0-1L/min; 1-15L/min into AIR: 0-1L/min; 1-12L/min.- Modification accepted. See amendment.27. Regarding the Anesthesia equipment acccessories, Item No.12 requirement: 5 (five) adapters compatible with the anesthetic agent loading system for each Vaporizer provided. Diflurane is used relatively infrequently and the vaporizer to hold Diflurane is also expensive. The drug price is more expensive than other anesthetics and the boiling point is low. Therefore, it is recommended to use the other four（Sevoflurane. Isoflurane, Enflurane, Halothane） anesthetics.   with 4 adapters.- The anesthetic agents, including the possibility of desflurane, will be confirmed at the time of the award, depending on clinical needs. In the event of a price difference, quotations may be provided for options both with and without a desflurane vaporizer.Kindly note that the technical requirements include at least two (2) empty vaporizers with agent level indicators and five (5) adapters compatible with the anesthetic agent loading system for each vaporizer"28. Please send clarifications on the below:- OTM-01 - Anesthesia equipment: The following technical requirement is mentioned 'Inspiratory flow: at least from 1 to 80 L/min.'. Please inform if this should be 'Inspiratory flow: at least from 10 to 80 L/min.'. Could you please also consider an extension of the deadline by one week?- 1. Yes. See amendment.29. Please extend the DAP delivery 90 calendar days to at least 120 days,- Please review amended documentKind regards

New amendment added #3: Esteemed Potential BiddersPlease find that the deadline has been extended.Additionally, the following document have been amended:6. OTM-01 - Anesthesia equipment- V.033 ITB_Section_III_Schedule of Requirements - V.02FR 3 ITB_Section_III_ListedesBesoins - V.02The inserted text can be identified in color blue and the removed text can be identified in color red and strucked out.Kind regards

New clarification added: Esteemed Potential BiddersPlease review the followig clarifications :12. Benchtop Autoclave Accessories 7.One (1) stainless steel or equivalent material stand to support the equipment. The stand shall bear the autoclave weight and shall be of the same manufacturer of the autoclave or recommended by the autoclave’s manufacturer. The stand shall be possible delivered un Q: 1.Please clarify the height of the stand. 2.And do you need wheels for the stand? 3. What's the meaning of delivered un? Please delete "un". Functionality and Performance / Fonctionnalité et performances 15.Built-in stainless steel water tank with automatic water fill. Q: Please clarify that whether you mean automatic water fill to the water tank? It's not neccesary, please change it into manual wanter fill or automatic water fill to the water tank.1. The requirement has been modified. See amendment.2. Wheels are not required.3. The requirement has been deleted. See amendment.4. Modification not accepted. The requirement holds.13. Is any local registration is required ?​- No local registration is required.14. Due to the complexity of the project and the site Madagascar located, the delivery time of DAP 90 days is imopossible. Please kindly consider change the delivery time into DAP 150 days.- No extension has been considered at the moment15. For Ceiling Oerating Light, Please confirm whether is requirement is acurate ''Light source color temperature greater than 8000 ºK.- The requirement has been modified. See amendment.16. OTM-01 - Anesthesia equipment About the Pneumatic Specification: 8."OUT gas sockets on gas supply group: one (1) socket for O2, one (1) socket O2 - AIR for scavenger feeding, 1 fresh gas connector for external use."Q:Please provide a more detailed explanation？ What is one (1) socket O2 - AIR for scavenger feeding and 1 fresh gas connector for external use? About the Lung ventilator: 12.Bronchomanometer: range at least -20 to - 80 cmH2O. Q:what does the Bronchomanometer mean? Alarm and displays  3.Flow sensor : Internal to the valves group, by magnetic perturbance, reusable: Q : Nowadays, differential pressure flow sensor is more common in the market. Moreover, magnetic perturbance & differential pressure flow sensor have the same effect. As a result, please kindly change this term into "3.Flow sensor : Internal to the valves group, by magnetic perturbance or by differential pressure, reusable,".Pneumatic specification:- The specification requires one oxygen out gas socket, one out gas socket to eliminate gases via the scavenging system and one auxiliary fresh gas outlet.Review amended documents.17. Due to the complexity and detailed nature of the bid preparation, we kindly request an extension of the submission deadline to September 6.- Please review latest amendment.18. The QTY is 33 in the file:"5 Form C1 Price Schedule - Annexe C1 Formulaire de bordereau des prix - Lot 7" , but in other files QTY of Lot 7 is 23.  Q: Please clarify this problem.- Please review revised document19. For the technical requirements of Lot1 Anesthesia equipment, we have below questions:  1. please clarify what is "adapter"? Does it mean the different vaporizers compatible with the anesthetic agent or the connection adapter bewteen Anesthesia machine and vaporizer? 2. Could you accept the anesthesia which is not equiped with the oximeter? 3. For the parameter of flowmeters, could you accept the slight deviation? for example AIR: 0.05 to 0.95 L/min 1.0 to 12.0 L/min; (Requirement: AIR: 0-1L/min; 1-15L/min) For the Lot 7 Neonatal incubator, please kindly confirm the total Qty is 23 or 33?1. The adapter is an element used to fill the vaporizer without spilling the anesthetic agent. It is placed on the spout of the anesthetic gas container and seals into the vaporizer's filling mouth. 2. The FiO2 sensor is important to confirm that the set oxygen concentration is the one delivered to the patient. Therefore, a device without FiO2 monitoring is not acceptable.3. For this parameter is it possible to accept a deviation below 10%.4. Please review amended documents.20. Hereby, we would like to highlight that we believe the requirement: "Light source color temperature greater than 8000 ºK," contained in the technical specification titled: “6. OTM-04 - Ceiling operating light - V.02”, a clerical error and, therefore, an unfeasible request. Surgical lights, primarily used in surgical environments, need to provide clear, precise, and shadow-free illumination to facilitate medical procedures. The color temperature of surgical lights is typically between 4000º and 6000º K, which represents a cool white light, ideal for the operating field.- Accepted. See amendment.21. Please clarify on who will do the customs clearance and if any importing tax will incur? We are asking because the final destinations are local hospitals.- As stated in the section Delivery place and Incoterms rules of the Section_III_Schedule of Requirements, UNOPS will handle custom clearance and the supplier will take over to complete the delivery.22. Reference is made to the Section II: Evaluation Criteria - Qualification criteria:  3. The Bidder shall demonstrate specific experience of at least five (5) contracts in the supply of products similar to those specified in Section III: Schedule of Requirements during the last three (3) years. At least two (2) must be for Countries in Sub-Saharan Africa. Given that this evaluation criteria could lead to the exclusion of some bidders with a multiyear experience in providing similar supplies in other geographical areas, we kindly ask you to provide us the possibility to take into consideration contracts concluded in the last five years and to extend the geographical area of reference. In order to assure a fair treatment of all the bidders or offers and the regularity of the competition, we kindly ask you to evaluate our request.- No modification of criteria is considered.23. We can see in the amendment that you have changed 5 Form C2 Delivery Schedule - Annexe C2 Formulaire de Calendrier de livraison - Lot 7 - V.02however, in the documents tab, we can see amendments in 5 Form C1 Price Schedule - Annexe C1 Formulaire de bordereau des prix - Lot 7 - V.02.xlsx and not delivery schedule. Kindly Clarify.-The updated document is the correct amendment.​Kind Regards

New clarification added: Esteemed Potential BiddersPlease review the followig clarifications :8. Question: OTM-02 - Surgical suction machine 7. Suction capacity at least 90 l/min. Suction capacity of 90 l/min is rarely seen in the market which limits other manufaturers and such capacity is not necessary in actual use. Please don't limit such tender within only one manufacturer which is unfair. PLease kindly consider change it into Suction capacity at least 85 l/min. OTM-04 - Ceiling operating light 10. Light source color temperature greater than 8000 ºK. This must be a mistake. As we all know, Light source color temperature are usually between 3500-6700K for human eyes, how can we use 8000 ºK during the surgical operation. Light source color temperature greater than 8000 ºK is blue color and harmful to our eyes. As a result, considering the normal characteristics of operating light, please change it into Light source color temperature between 4500-6500 ºK. OTM-05 - Operating table 2. Material: stainless steel 316/316L or other stainless steel with greater corrosion resistance. There is no need of using stainless steel 316/316L for such equipment as we can see the market around the world which is also with greater corrosion resistance . Steel 316/316L are usually used for surgical instruments which are touching with the body directly. As a result please change this into Material: stainless steel 304 or other stainless steel with greater corrosion resistance.    OTM-02 - Surgical suction machine: The requirement “Suction capacity at least 90 l/min.” is amended in “Suction capacity at least 85 l/min.”OTM-04 - Ceiling operating light: The requirement “Light source color temperature greater than 8000 ºK.” is amended in “Light source colour temperature available within the range of 4200 - 5000 ºK”OTM-05 - Operating table: The requirement “Material: stainless steel 316/316L or other stainless steel with greater corrosion resistance.” is amended in “Body material: stainless steel 304 or other stainless steel with greater corrosion resistance.”9. OTM-36 - Neonatal incubator  Electrical characteristics 3.Rechargeable batteries with at least the following characteristics: - automatic switch from electric-line mode to battery operating mode and vice-versa; - continuous working time in battery operating mode and standard external conditions not less than 1 hour; integrated batteries charger and low battery alarm. Q:The Neonatural incubator for this tender does not require a battery, which is a configuration required for Transporting Neonatural incubator. Please kindly delete this item.OTM-03 - Electrosurgical Unit 8、Work frequencies between 350-500Khz for cutting and 200-500Khz for coagulation. According to the feedbaks from many manufacturers in the market, the cutting and coagulation effect of the Electrosurgical Unit is better at 512KHZ and 500Khz is not enough. Q: As a result, it is recommended to expand the frequency range into 350-600Khz for cutting and 200-600Khz for coagulation. 16 Monitoring system of the electrode-patient connection of at least 1Khz measurement frequency. Q:What does it specifically refer to. 20 Minimum nominal high frequency output powers for cutting: Monopolar 300 W at 500 ohms -Bipolar 100W at 500 ohms21 Minimum nominal high frequency output powers for coagulation: -Bipolar 100 W at 125 ohms -Monopolar spray 100 W at 500 ohms -Monopolar forced 120 at 350 ohms According to the feedbaks from many manufacturers in the market, Bipolar 70W for surgery is sufficient, Bipolar 100W is restricted to certain manufaturers. Q: As a result, it is recommended to modify it into Bipolar ≥ 70W. OTM-04 - Ceiling operating light 9 Light field diameter: not less than 20 cm at 1 meter distance from the light source.According to the actual circumstances, Light field diameter ≥ 14CM is sufficient at 1 meter distance from the light source. Q:As a result, it is recommended to modify it into Light field diameter: not less than 14 cm at 1 meter distance from the light source.OTM-36 - Neonatal incubator Requirement "Rechargeable batteries with at least the following characteristics: automatic switch from electric-line mode to battery operating mode and vice-versa; continuous working time in battery operating mode and standard external conditions not less than 1 hour; integrated batteries charger and low battery alarm"Please be informed that the locations where the equipment will be used face challenges with a reliable power supply, making it necessary to have a device with an internal battery or external UPS. The technical specification is confirmed.OTM-03 - Electrosurgical Unit: The requirement “Work frequencies between 350-500Khz for cutting and 200-500Khz for coagulation.” is amended “Work frequencies between 350-600Khz for cutting and 200-600Khz for coagulation.”The requirement "Monitoring system of the electrode-patient connection of at least 1Khz measurement frequency" refers to the frequency of the test current used by electrosurgical devices to measure impedance for the purpose of assessing the contact between the return/neutral electrode and the patient's tissue.The requirement "Bipolar 100W at 500 ohms” is amended in “Bipolar 70W at 500 ohms” and “Bipolar 100 W at 125 ohms” is amended in “Bipolar 70 W at 125 ohms”OTM-04 - Ceiling operating light: The requirement "Light field diameter: not less than 20 cm at 1 meter distance from the light source" is confirmed.10. 1)Regarding Lot4, the ceiling operating light, we believe that the color temperature requirement of 8000K mentioned in the parameters is unreasonable. Typically, the color temperature range for such operating lights is between 3500K and 6000K. According to IEC60601 testing standards, the color temperature requirement should also not exceed 6000K. 2)Regarding the installation of the ceiling operating light, we need to clarify whether the supplier is responsible for installing both the ceiling load-bearing steel structure and the operating light, or only for installing the operating light on the pre-installed steel structure? 3)Regarding Lot5, we would like to confirm whether the product needs to be made of 316 stainless steel, as typically such products are made from 304 stainless steel. Additionally, given the significant price difference, the performance of 306 and 314 stainless steels is very similar.1. Accepted. See amendment.2. The supplier will be responsible for installing both the ceiling lead-bearing steel structure and the operating light.3. Accepted. See amendment.11. Benchtop Autoclave 11.Loading capacities for sterilization containers of dimensions: 470X274X135 mm size ¾, 300x274x247 mm size ½ and 500X200X120 mm.We have never seen such expression of dimensions:470X274X135 mm size ¾, 300x274x247 mm size ½ and 500X200X120 mm. And we don't know what dimensions you want Please clarify the dimensions you required.The requirement has been modified. See amendment.Kind regards 

New amendment added #2: Esteemed Potential BiddersPlease find that the deadline has been extended.Additionally, the following document have been amended:6. OTM-10 - Benchtop autoclave - V.02.docx6. OTM-05 - Operating table - V.02.docx6. OTM-04 - Ceiling operating light - V.03.docx6. OTM-03 - Electrosurgical Unit - V.02.docx6. OTM-02 - Surgical suction machine - V.02.docx5 Form C2 Delivery Schedule - Annexe C2 Formulaire de Calendrier de livraison - Lot 7 - V.02The inserted text can be identified in color blue and the removed text can be identified in color red and strucked out.Kind regards

New amendment added #1: Esteemed Potential BiddersPlease find that the following documents have been updated: 6. OTM-04 - Ceiling operating light - V.02The inserted text can be identified in color blue.Kind regards 

New clarification added: Esteemed Potential BiddersPlease review the followig clarifications :4. Please cosider extend the bid submission date.- No further extension has been considered untill this moment.5. Question: 6. OTM-10 - Benchtop autoclave. 7. One (1) stainless steel or equivalent material stand to support the equipment. The stand shall bear the autoclave weight and shall be of the same manufacturer of the autoclave or recommended by the autoclave’s manufacturer. The stand shall be possible delivered un According to the product name, it's a Benchtop autoclave. Please confirm that you still want to add One (1) stainless steel or equivalent material stand ?- Yes we confirm the need of a stand, bench or table to support the autoclave according with the requirements.6 The tabs in mentioned in unops site which is mandatory as : 1) Marketing authorization or local health registration // Autorisation de mise sur le marché ou enregistrement sanitaire local : PLEASE CONFIRM WHICH DOCUMENTS IS REQIRED ON THIS ? 2) Marketing authorization or recognition from regulatory agencies / Autorisation de mise sur le marché ou reconnaissance des agences de réglementation: PLEASE CONFIRM WHICH DOCUMENTS IS REQUIRED ON THIS ? ALSO PLEASE CONFIRM IS ANY LOCAL REGISTRATION IS REQUIRED ?- The document required, between others are, for non medical devices are "Certificate of free sale: issued by National Regulatory Authorities of the country where they are manufactured". For medical devices the document required, between others are, "Marketing authorization or local health registration: of the brands and models offered in force at the time of the offer in the country of manufacture"; and for Medical Devices "Marketing authorization or recognition from regulatory agencies" for stringent regulatory agencincies of EU, USA, Canada, Japan or Australia.7. "I am writing to seek clarification regarding Lot 4. The specifications mention that the accessories include ""one spare bulb"" for the LED light. However, this does not seem feasible, as all the LEDs are integrated into a single circular light unit. Could you please clarify what is exactly meant by this requirement?"  - Please review amended documents to be uploadedKind regards