QUESTIONS AND ANSWERS€¦ · Is the CE – certificate and the manufacturer declaration enough to confirm the product origin? Instructions to Tender Article 4, Special Conditions

REPUBLIC OF BULGARIA MINISTRY OF REGIONAL DEVELOPMENT AND PUBLIC WORKS

ISPA IMPLEMENTING AGENCY – DIRECTORATE “EUROPEAN INFRASTRUCTURE PROJECTS”

17-19, “St.St. Kiril and Metodiy” Str., 1202 Sofia, Bulgaria; Tel.: (+ 359 2) 9405 200; Fax: (+ 359 2) 988 15 41; e-mail: [email protected]

November 2008 ISPA IA, MRDPW Page 1/15

PROJECT: Supply of medical equipment, furnishing and vehicles for 3 hospitals in the towns of Kurdzhali, Smolyan and Vratsa

Ref. No. HiPERB/05/D/SUP/BG

QUESTIONS AND ANSWERS

pursuant to Clause 13 “Additional information before the deadline for submission of tenders” from the INSTRUCTIONS TO TENDER

No. Question / Group of questions TD reference Answer

GENERAL QUESTIONS and Questions referring to

PART A – INSTRUCTIONS TO TENDERERS (ItT) / PART B – SPECIAL CONDITIONS (SC) / ANNEX I: GENERAL CONDITIONS (GC)

1. In case that the submitted technical offer exceeds considerably the required technical parameters in the tender specification will it be evaluated higher by the evaluation committee?

The only selection criterion is the offered price. See Item 17 of the Procurement Notice published on the web-site: http://www.mrrb.government.bg/index.php?lang=en&do=notice&id=447

2. The subject of the contract

There is a discrepancy in the quantity of Item 19 “Gynecological chair”, Lot 1, Part II in the Article 1.1 of the Instructions to Tender and Article 1.1 of the Draft Contract and Special Conditions (Lot 1). Please clarify.

Instructions to Tender

Art.1.1

Draft Contract Art.1.1

The correct number for Item 19 “Gynecological chair” is 1 (one).

HiPERB/05/D/SUP/BG Supply of medical equipment, furnishing and vehicles for 3 hospitals in the towns of Kurdzhali, Smolyan and Vratsa, Republic of Bulgaria




3. ORIGIN

In case there is an item from the tender list that cannot meet the Origin clause. That means that there may be no manufacturer from the EU member countries or the other countries involved in this tender that produces one item. Will there be an exception for such items, that may not be produced in the countries stated by the article ORIGIN?

Instructions to Tender

Art. 4,

Special Conditions

Art. 10

No exception from the Rules of Origin.

See also point 2.3.1. in the Practical Guide to Contract procedures for EC external actions:

http://ec.europa.eu/europeaid/work/procedures/implementation/practical_guide/documents/new_prag_final_en.pdf

4. ORIGIN

Is the CE – certificate and the manufacturer declaration enough to confirm the product origin?

Instructions to Tender Article 4,

Special Conditions

Art. 10

The confirmation of the product origin will be required only from the successful tenderer. CE – certificate and the manufacturer declaration are not enough and a specific Certificate of Origin will be required for each one of the items.

On this stage of tendering a Declaration of Origin from the Tenderer is sufficient.

See also the Answer No 3 above.

5. QUALITY

In case that the bidder quotes goods manufactured in Bulgaria for Lot 2, could you please specify precisely what quality certificate do you require.

General Conditions

Art. 24

There are two types of quality certificates required by the Contracting Authority:

The first one is required for the Tenderer/Manufacturer. See point 16.2.b. in the Procurement Notice published on the web-site: http://www.mrrb.government.bg/index.php?lang=en&do=notice&id=447

and the text in the Instructions to Tenderers, Article 11, Part 3; and the Administrative Compliance Grid.

The second one is for the products to be supplied

See Art.24 and Art.32 in the General Conditions; See also the specific requirements for each item.

Materials not definitely specified shall be of the best quality employed for the purpose in commercial practice. Materials shall be free from all defects and imperfections that might affect the serviceability and appearance of the finished product.





6. ASSESMENT

Will the successful candidates be assessed lot by lot or the final contract will be signed for each item in the Lot?

Instructions to Tender Article 7

The assessment will be made and the contracts will be awarded lot by lot. See Article 7 of the Instructions to Tender .

7. TRANSLATION

A lot of certificates requested (client’s reference, balance sheets etc.) are not in English language. Which is the form of translation into English language, i.e. translation in English, certified by a lawyer is accepted? Or else?


All translations must be made by a sworn translator, which certificate must be attached also. A translation certified by a lawyer is also acceptable.

8. TENDER GUARANTEE

Due to our bank’s request, can the expiration date of the tender guarantee be written on the Tender Guarantee form from Annex V? If yes, which would be that date? That means that following paragraph from the tender guarantee will be altered as following in bold:

We note that the guarantee will be released at the latest within 45 days of the expiry of the tender validity period, including any extensions, in accordance with Article 8 of the Instructions to Tenderers, that means the tender guarantee’s expiration date is xx day xx month 2009.


Tender Guarantee

Form

The period of validity of the Tender Guarantee is 45 days beyond the period of validity of the tender which is 90 days after the deadline for Submission of Tender.

Taking into consideration the provisions of Art. 8 of the Instructions to Tenderers, the Contracting Authority prefers that the text in the template of the Tender Guarantee remains without alteration.

In case that the Bank insists a date to be mentioned, please indicate the minimum possible period as mentioned above and add the following text:

“Pursuant to Article 8 of the Instructions to Tenderers this guarantee will be extended accordingly.”





ANNEX II: TECHNICAL SPECIFICATIONS

Annex II – 1: (LOT 1)

Supply of medical devices and apparatuses for “One-Day-Surgery” Unit in the Multi-Profile Hospital for Active Treatment “Dr. Atanas Dafovski” – Kurdzhali, Cancer Medical Centre – Smolyan and Interregional Cancer Hospital – Vratsa

I. Medical devices and apparatuses for “One-Day-Surgery” Unit in the Multi-Profile Hospital for Active Treatment “Dr. Atanas Dafovski”, KURDZHALI

9. 1. Anaesthesia equipment

2.1. Respirator ... with tidal volume adults: 0 – 1500 ml

Since every tidal volume over 1400 ml has not a direct medical application, we and other producers do not offer such characteristics. Would it be acceptable to offer an anesthesia device with a tidal volume 0 to 1400 ml?

Annex II-1, Part I,

Item 1-2.1

The tidal volume of the Respirator is specified in the range from 0 till 1500 ml because the calculation of this volume is made on the basis of body weight (10ml/kg) to be able to cover patients with higher weight.

However the range from 0 till 1400 ml is acceptable.

10. 2.2.3. Sensitive trigger (for children): 0.2 – 2 mbar

By our devices and by the devices produced by other leading companies the trigger is controlled by the flow, accordingly its dimension is l/min. Could we offer a device with such characteristics as an alternative?

Annex II-1, Part I,

Item 1-2.2.3

Most of the manufacturers of anaesthesia equipment offer the trigger sensitivity in mbar. A offer could be accepted in l/min if the offered equipment shows the same range pointed in the technical specification.

11. 3. 2 pcs of absorbers for СО2

The number of absorbers is not important, but their total volume. What does this requirement mean: two absorbers working simultaneously or two absorbers and one of them is reserve?

Annex II-1, Part I,

Item 1-3

The requirement of two absorbers working in series is motivated by practical and economical efficiency in exchange of CO2 absorbent.





12. 4.1. 2 pcs of flowmeters for О2 with ranges of 0.2-2 l/min and 2-12 l/min

4.2. 2 pcs. of flowmeters for N2O with ranges of 0.1-1 l/min and 1-10 l/min

4.3. 1 pc. Flowmeter for air with a range of 0.2 -12 l/min

This is an old technology. Is it possible to be replaced with an electronic flowmeters, which are more exact due to their possibility to display a flow from 0.1 to 20 L with accuracy of 0.01?

Annex II-1, Part I, Items 1-4.1,4.2,4.3

If the proposal exceeds the requirements it should be considered as acceptable. Most of the anaesthesiologists in Bulgaria are habituated to use flowmeters considering it as more reliable and chipper for technical maintenance.

13. 7. gas feed with medical gases from an autonomous feeding module –compressed air concentrator, oxygen and vacuum, compatible with the design of the anaesthetic apparatus, securing its normal function

What does this requirement (this module) mean? Should it be build-in or detached?

Annex II-1, Part I,

Item 1-7

The requirement of an autonomous gas supply module (concentrator generating compressed air and oxygen) as well as independent vacuum assures a working independence of the whole equipment on the central gas supplying. The compatibility of the anaesthesia machine allows free mobility use in all the operating halls without central gas supply. The beneficiary doesn’t have a central gas supply system for compressed air.

14. 7.2. pressure О2: 1.5 bar 7.3. compressed air pressure: 1.5 bar

By the above-mentioned requirements for tidal volume and breathing frequency, pressure 1.5 bar would be extremely insufficient for the normal work of the device.

Annex II-1, Part I, Items

1-7.2,7.3

According to the explanations in the previous point about the independent gas supply and the mobility of the machine, the requirement of the pressure of compressed air and oxygen is appropriated with the dimensions and the weight of the concentrator and the entire system mobility.

15. 9. built-in volume monitor with LCD

The TFT technology is more contemporary. Would you accept it as alternative?

Annex II-1, Part I,

Item 1-9

TFT technology is acceptable too.





16. 10. built-in oxygen monitor for measuring the volumetric inspiratory concentration of oxygen from 0 to 100 % О2

Inspiratory O2 concentration lower then 16% is lethal and the presence of protection against such low O2 inspiratory concentration is mandatory for every device.

Annex II-1, Part I,

Item 1-10 The requirement for availability of sound and visual alarm with adjustment of the limits from 18% to 99% excludes the oxygen concentration to drop under 16% without an activation of the alarm.

17. 11. patient monitor … with built-in printer …

Not many producers of a medical equipment have patient monitors with a built-in printer. Could we offer a detached small printer?

Annex II-1, Part I,

Item 1-11

The requirement of built-in printer in the monitor defines less area used.

18. 4. Infusion pump

Please, specify if you need a syringe or volumetric pump?

What do you mean, by saying “two channel” pump, please describe in other words in more details.

Annex II-1, Part I, Item 4

It’s about volumetric pump.

Up to six channel infusion pumps could be seen on the market. Two channel pumps could make two independent infusions with separated measurement. As this is not common accepted in Bulgaria one channel pump offers will be accepted as well.

19. 9. Echograph with colour Doppler

Please, specify the number and type of transducers.

Please advise us, what is the reel need of this item.


As in the technical specification doesn’t contains the range and the number of the transducers you could offer any but if the offer contains more transducers which cover examination of abdomen, heart, small parts and vessels it will be also accepted.

20. 11. (Laparoscopic system) Endoscope surgery apparatuses

1.1.5. Water-proof camera head, with a video-adapter with variable focal distance, from 16 mm to 34 –

this parameter is for one company only

Is it possible laparoscopic operation and 2x optical zoom?

Annex II-1, Part I, Item

11-1.1.5

The variable focal distance issue has different solutions as parameters in different companies. Suggested 2x optical zoom limits the parameters too. According to these arguments the words “from 16mm to 34 mm” in Item 1.1.5 have to be considered as excluded from the specification.





21. 1.2. Endoscopic integrated camera – video console for video-laparoscope and video-laparoscope PAL – please explain

Annex II-1, Part I,

Item 11-1.2

The details refer to video part of the system – camera and processing console. The PAL system is European accepted video standard. As a final description has to be considered as follows:

1.2. “Endoscopic integrated camera with video console for laparoscope, PAL

22. 1.4. Xenon light source 180W …

Is this power 180W obligatory? Is it possible to be approx 180W?

Annex II-1, Part I,

Item 11-1.4

Lower than 180W light source power is not acceptable because in laparoscopy the light source is of basic importance for the approach and the quality of the operations. As a final description has to be considered as follows:

1.4. “Xenon light source 180W or more ...”

23. 1.5. Insufflator CO2 – min. 40 L/min

Is this Flow 40 L/min correct as minimal? We suggest as correct from 0 – max Flow 20 L/min.

Annex II-1, Part I,

Item 11-1.5

The CO2 flow is important for the approach and the quality of the operations too. If there is a limitation to 20 ml/min this will limit the variance of the operations and patients who will be operated. As a final description has to be considered as follows:

1.5. Insufflator CO2 – minimum 30 ml/min.

24. 1.6. Irrigation system

1.6.1. Irrigation with power of 800 mbar

Normally this power is (-) and suction for irrigation is between 0 – 400 mmHG.


11-1.6.1

As there are lots of technical decisions of this problem with variance of parameters Item 1.6.1 have to be considered as excluded.

25. 1.7. Medical archiving system

1.7.1. Recording on video CD

Only CD is a very old model. Is it possible a CD/DVD and USB model?


11-1.7.1

The suggestion about CD/DVD and USB is acceptable.





26. 1.9.3. Video laparoscope 10 mm, 30º

Not necessary in case combination with two telescopes.


11-1.9.3

The suggestion is acceptable. This change doesn’t exclude possibility for offering of combination with two telescopes apparatuses.

27. 1.9.18. Clip applicator 5 with clips

Normally is 10 mm only.

Annex II-1, Part I, Item 11-1.9.18

Item 1.9.18 has to be considered as excluded.

28. 12. Electric knife

1.1. At least 400 W in monopolar cutting, …

Normally max is up to 300 W in monopolar cutting. Please clarify.

Annex II-1, Part I,

Item 12-1.1

The power of the cutting is related to variance of tools which are being used and working area. Limitation of the power will limit variance and the quality of the operations. As a final description has to be considered as follows:

1.1. Up to 350 W or more in monopolar cutting …

29. 2. 2 modes of monopolar cutting ….. with FDFS technology.

Please explain FDFS technology? Are these parameter for only one company?

Annex II-1, Part I,

Item 12-2

FDFS cutting technology is lower tissue damage technology but it is not common used. Therefore this requirement is not necessary to be considered as an obligatory.

30. 13. Gastroscope (fiber)

Very old technology. Maybe no producer.

Annex II-1, Part I,

Item 13

Gastroscope (fiber) is not considered as an old technology because this kind of apparatuses is being used as a mobile apparatuses in emergency cases and in cases when the patient could not be moved to gastroscope room. It is produced by lots of manufacturers.

31. 14. Aspiration pump (Point from 1 to 11)

Parameter for one company only. Please make a correct.

Annex II-1, Part I,

Item 14

Technical parameters in points 1 and 3 are changed to:

1. Aspiration volume – 800 ml or more; 3. Power supply 220V +/-10% 50Hz.





II. Medical Еquipment/Apparatus for Cancer Medical Centre, SMOLYAN

32. 3. Echograph

Please, specify the number and type of transducers (Sub-item 5), and if there is a need of TEE (transesophageal) transducer, regarding the high price of this kind of transducers.

Please advise us, what is the reel need of this item.

Annex II-1, Part II, Item 3

Item 13.11 has to be considered as excluded from the specification.

Transducers will be for the following Clinical applications:

1. For Echocardiography: Sector broadband transducers (phased array probe) with approximate frequency range of 2 to 5 MHz and Doppler 2 to 4 MHz. To support 2D, color, powerful and tissue Doppler and harmonious image.

2. Abdominal convex transducer (convex probe) with frequency range of 2 to 5 MHz for B-mode and Doppler, PW option, color and powerful Doppler, harmonious and panoramic image and biopsy device.

3. Vascular broadband transducers with frequency range of 3 to 12 MHz. To support 2D, PW color, powerful Doppler and harmonious image. To maintain at least 10 degrees trapezium image and panoramic image of vascular, small parts, musculoskeletal, mamological surveys and surveys of the thyroid gland.

4. Pediatric abdominal and transfontanel convex transducer with frequency range of 5 to 8 MHz, PW option, color and powerful Doppler, harmonious and panoramic image and biopsy device.

33. 6. Negativoscope

Are the Indication dimensions external?

Would you accept quotation with dimensions close to indication?


Technical parameters are changed to:

Screen: (85100)х(4245) сm External Dimensions:(100110)x(4550)x(1015) сm with the possibility of mural Power supply: 220V / 50Hz ON / OFF button Minimum Luminance: 8000 cd/m²





34. 8. Rectoscope

4.1. Rectoscope set

Please give more information and specification.

Annex II-1, Part II,

Item 8-4.1

Technical parameters are changed to:

4.1. Rectoscope set biopsical clips set (including also clip type “spoon”) coagulation clip 4.2. Halogen light source > 100 W …… 4.5. Option for subsequent installation of video-monitoring system.

35. 9. Videofibrogastroscope

2. Patented cut-filter technology for 3D image

Specification for one company only.


Item 9-2

Item 2 has to be considered as excluded.

36. 4. Processor with memorizing function (up to 12 images during a procedure)

Specification for one company only.


Item 9-4

Item 4 is changed as follows:

4. Processor with memorizing function (min 10 images during a procedure)

37. 10. Fibrocolonoscope

Very old technology. Maybe no producer. Suggest: VIDEOCOLONOSCOPE


Videocolonoscope gives better opportunities in terms of quality, functional and statistics parameters, but this is a whole integrated system of optical, electronic and visualization part that makes the product considerably expensive.

The Fibrocolonoscope technology really is older but there are producers on the market and the point remains unchanged.





38. 12. Centrifuge

(Sub-item 6) As a dimensions you have specified quite precise and unique figures 216 x 231 x 292 mm (probably only one company in the world have them!!!), while there is indications about much more important issues like:

What kind of rotor is/are needed – swing-out or fixed angle?

What volumes will be operated in order to recognize what kind of rotors/adapters will be needed?


Item 6 has to be considered as excluded from specification.

A new item is added to the specification:

8. A fixed angle rotor with 6-10 nests for tubes.

39. 13. Thermostat

According to the description it is more like Dry Heat Sterilizer, since the thermostats are usually up to 70°C. However more of the available models on the market are powered by 220V / 50Hz. Please advise did power supply of 220V / 50Hz is allowed?

Please advise if it is allowed to have over temperature protection with an automatic cut-off instead of fire alarm?


The Thermostat will be used mostly as a Dry Heat Sterilizer.

Items 7 and 11 are changed as follows:

7. Minimum two-stage overheating protection

11. Power supply: 220V / 50Hz.

40. 13. Thermostat

Could you specify Thermostat or Sterilization Oven, because Temperature range and Volume indication in specification answered for Sterilization Oven?


See answer No 39 above.

41. (General question): It is requested for all items in the Lot 1 to be presented copy of the ISO 13485:2003. Items 12. Centrifuge and 13. Thermostat are Laboratory Equipment for General Use and they are not medical devices. Will you accept Quality Standard ISO 9001:2000 instead?


Items 12,13

Instructions to Tender,

Art. 20.2-2.b

For Items 12. Centrifuge and 13. Thermostat is acceptable ISO 9001:2000.





42. 14. Microtome for paraffin blocks

It is requested for the microtome to be “2. Additionally completed with semiconductor express freezer…”. According to the information we received from the manufacturer which we represent only company MICROM from Germany has such accessories. Please allow quotes without accessories!


Item 2 has to be considered as excluded from specification.

Item 3.4 is changed to:

3.4. Vertical movement amplitude – 40 mm

43. 15. Cytoscope

A flexible, compact or rigid cystoscope specified? Please publish a more detailed specification.


Cystoscope – refers to rigid one.

All Sub-items of the technical specification of the Cystoscope are replaced with the following:

Optics 3-5 мм., with a different angle – 0° / 12° Cystoscope thicknesses – 15 Fr, 17 Fr, 19 Fr, 21 Fr (allows

the taking of biopsies) Clip for foreign bodies Biopsy clip /Coldcup/ – size about 4Fr Optical light fiber, length 1.5 - 2 m Halogen light source – power >100 W External optics diameter: 8-10 mm Operating length: 200-210 mm Connecting bridge between the optics and the cystoscope Connecting bridge with working channel – 5Fr for taking of

biopsies Obturators corresponding to the size of the cystoscope.

44. 16. Uretrotome

3.3. A light guiding cable and light source for solid endoscopes included.

Request for more information and specification for a light source.


Item 16-3.3

Item 3.3 is changed to:

3.3. Compatible light source with power min 100 W

Items 1.2, 1.3 and 1.4 has to be considered as excluded from specification.





III. Medical Еquipment/Apparatus for Interregular Cancer Hospital, VRATSA

45. 3. X-ray C-arm mobile device with monitoring system

As the clinical benefits for one or other medical application are not clearly defined in the listed tender technical specification, can we offer an X-ray C-arm mobile device with minimal technical deviations from the required technical parameters in the tender specification, but with much higher clinical benefit especially taking into account the beneficiary hospital?

Annex II-1, Part III, Item 3

Yes, it is possible.

46. 4. Rigid hysteroscope

No description for pump or insufflator CO2

Annex II-1, Part III, Item 4

In the Technical Specifications is not specified requirement for insufflation with CO2 as the apparatus can work without this option, i.e. it is not obligatory.





Annex II – 2: (LOT 2)

Medical furnishing/Hospital Equipment and miscellaneous goods for “One-Day-Surgery” Unit in the Multi-Profile Hospital for Active Treatment “Dr. Atanas Dafovski”, Kurdzhali and Cancer Medical Centre, Smolyan

I. Medical Furnishing and miscellaneous goods for “One-Day-Surgery” Unit in the Multi-Profile Hospital for Active Treatment “Dr. Atanas Dafovski”, KURDZHALI

47. 2. Operating lamp

Concerning operating lights, please confirm if there is no requirements of light intensity?

Would you please, clarify what is the purpose of double-walled corpus?


The requirements of the relevant legislation should be observed.

Double walled corpus is related to the material and the technology of the body structure as well as electrical safety and ecological requirements. If you offer apparatus with similar or better structure which cover the requirements it will be accepted.

48. 3. Hospital bed “intensive care” type

We can not offer any of our beds because we do not produce the beds made of stainless alloy structure.


It is important the beds to be made of stainless alloy because it is more functional and easy for maintenance.

That’s why the item 3 remains unchanged.

49. 4. Hospital bed “ordinary” type

What they mean by:

- four step movement - top flexible connections - tight mattress

Is it possible to produce bed with two lateral supports instead of four?


Four step movement means four types of movement of the hole bed and/or of the individual sections of the bed.

Tight mattress means water-tight mattress.

Top with flexible connections – the item has to be deleted

Item 3 is changed to:

3. Two or four lateral supports

50. 5. Bedside table

We should ask if it is possible to change the sizes for 51x40x86?


The proposed sizes seems to be a little small. That’s why the item 5 remains unchanged.





51. 6. Bandage trolley

It is a special production and will have a very high cost which will not be competitive to another companies.


The item 6 remains unchanged.

52. 9. Cabinet for storing the mobile apparatuses

Can you please, indicate the approximate dimensions and weight of apparatuses, who will be stored?


This could not be indicated. The number and the type of the apparatuses is specified but could not be predicted which apparatuses will be accepted. You could contact the companies which sell such apparatuses and take the dimensions.

53. 13. Lockers in the patients’ dressing-room

14. Lockers in the staff dressing-room

Indication sizes stated in “mm” or “cm”? (Sizes at least (mm) (H/W/D): 200 х 80 х 70), Please specify!

Annex II-2, Part I,

Items 13,14 The dimensions of the lockers in both dressing rooms have to be considered in centimeters.

II. Hospital equipment and miscellaneous goods for Cancer Medical Centre, Smolyan

54. 1. Hospital bed

What they mean by: - four step movement - top flexible connections - tight mattress

Is it possible to produce bed with two lateral supports instead of four?


See answer No 49.

55. 4. Couche for the consulting room and recovery room

5. Wardrobe

6. Table

Is it possible to be made of metal construction with epoxy cover, front-elements - wood or pressed wood?


Items 4,5,6

Usage of other materials is possible if not impair functional, aesthetic and design qualities of the goods.

Documents

QUESTIONS AND ANSWERS€¦ · Is the CE – certificate and the manufacturer declaration enough to confirm the product origin? Instructions to Tender Article 4, Special Conditions