clarifications no:1 to tender dossier · 2020. 11. 20. · installation, commissioning,...

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CLARIFICATIONS No:1 to TENDER DOSSIER

Contract Title: Supply of Medical Equipment for the Secondary Healthcare Premises - Relaunch

Publication Reference: SIHHAT/2018/SUP/INT/10-BIS

CN: Contract Notice

TD: Tender Dossier

DOC: Document

ART: Article

ITT: c4b_itt_en [Instructions to Tenderers]*

DC: Draft Contract

TS: c4f_annexiitechspeciiitechoffer_en [Annex II + III: Technical Specifications + Technical Offer]*

GC: General Conditions

SC: c4d_specialconditions_en [Special Conditions]*

PG: c4h_perfguarantee_en [Performance Guarantee]

TG: c4n_tenderguarantee_en [Tender Guarantee]

App B: Appendix B to Annex II - Training Proposal [Appendix B to Annex II+III Training Proposal]*

Ann V: Annex V - Warranty Proposal [Annex V - Warranty Obligations Form]*

* In-parenthesis parts show the title inside the documents.

Further to the requests received from the tenderers, the following clarifications are provided.

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CLAUSE QUESTION ANSWER

1 CN 8

Participation is open to all natural persons who are

nationals of and legal persons (participating either

individually or in a grouping – consortium – of

tenderers) which are effectively established in a Member

State of the European Union or in an eligible country or

According to the requirements on the

left, we would like to clarify that; if we

offer a product, which is originating

from the United Kingdom for the

relevant tender on 29.03.2019 and if

Please be informed that the goods originating

from the United Kingdom will be threatened

as goods originating from third countries

provided that;

- The United Kingdom withdraws

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territory as defined under the Regulation (EU) No

236/2014 establishing common rules and procedures for

the implementation of the Union's instruments for

external action (CIR) for the applicable instrument under

which the contract is financed (see also heading 22

below). Participation is also open to international

organisations.

All supplies under this contract must originate in one or

more of these countries.

Please be aware that after the United Kingdom's

withdrawal from the EU, the rules of access to EU

procurement procedures of economic operators

established in third countries and of goods originating

from third countries will apply to candidates or tenderers

from the United Kingdom and to all candidates or

tenderers proposing goods originating from the United

Kingdom depending on the outcome of negotiations. In

case such access is not provided by legal provisions in

force at the time of the contract award, candidates or

tenderers from the United Kingdom, and candidates or

tenderers proposing goods originating from the United

Kingdom could be rejected from the procurement

procedure.

the United Kingdom will not

withdrawal from the European Union

until the date of signing the contract by

us, will our contract be valid? After

the signing the contract; We will give

medical device order from the United

Kingdom. So that please clarify; If

United Kingdom will withdrawal from

the European Union after the signing

the contract, will our contract be valid?

from the European Union prior to the

award decision (contract signature

accordingly),

- No rules/regulations developed

covering the United Kingdom

originated goods within the scope of

the rules of access to EU

procurement procedures (depending

on the outcome of negotiations).

Please be aware that the statements cover the

procurement procedure (please see on the lef

: “will apply to candidates or tenderers”

and “candidates or tenderers from the United

Kingdom, and candidates or tenderers

proposing goods originating from the United

Kingdom could be rejected from the

procurement procedure” and “at the time of

the contract award”).

Please also be aware that following the

contract signature, the contract remains valid

regardless of the origin of the goods and the

outcomes of the withdrawal of the United

Kingdom from the European Union.

2 CN 16(1)

……

The average annual turnover of the tenderer in

the last three years must be equal or exceed the

50% tenderer’s financial offer.

……

We kindly request to revise the

requirement as “The average annual

turnover of the tenderer in the last

three years must be equal or exceed the

10% tenderer’s financial offer.”

Considering the volume of the tender and the

risk assessment of the Contracting Authority,

the existing requirement assessed to be

sufficient.

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3 CN 16(3)

…..

The tenderer has delivered supplies under at

most three contracts with a budget of at least

one-fourth (¼) of the financial offer of the lot

being tendered in supply of medical

equipment(s).

…..

We kindly request to revise the

requirement as “The tenderer has

delivered supplies under at most three

contracts with a budget of at least one-

fifth (1/5) of the financial proposal of

the lot being tendered in supply of

medical equipment(s).”.

Considering the volume of the tender and the

risk assessment of the Contracting Authority,

the existing requirement assessed to be

sufficient.

4 ITT 1.1

The subject of the contract is the supply, delivery,

installation, commissioning, maintenance, after-sales

service by the contractor of the following goods:

Lot 1 High Level Ventilator - Neonatal 227

Lot 2 Transport Ventilator 106

Lot 3 C-Arm Digital X-Ray Device 70

Lot 4 Haemodialysis Device 145

in 4 lots to the points at the provinces of Turkey (please

refer to the Appendix-A, delivery points list), within 120

(one hundred and twenty) calendar days for Lot-1 and

Lot-2; 150 (one hundred and fifty) calendar days for Lot-

3; 90 (ninety) calendar days for Lot-4 as also stated in

Special Conditions, DDP , in accordance with point 15

of the Contract Notice. Please be aware that the

Contracting Authority reserves the right to update the

quantities per delivery point at any time based on the

possible fluctuations on the number of migrants.

Taking into consideration that the

production, delivery, installation and

commissioning of 70 systems for 49

different distribution sites, we kindly

request to extend the implementation

period for Lot-3 to 210 calendar days.

Considering the current official deadline of

the project under which this tender is being

funded (SIHHAT), there is no possibility to

extend the period as requested.

5 ITT 1.3

None of the supplies must be accompanied by an

additional ‘lot’ consisting of spare parts and/or

consumables.

We request a clarification on what is

exactly demanded in the sentence.

The item has been revised as:

The supplies described under all lots must be

accompanied by an additional ‘lot’ consisting

of spare parts and/or consumables. Neither

the unit price, nor the overall price of spare

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parts will influence the evaluation of the

tenders, except where they vary substantially

between the tenders received. Lists of spare

parts must be drawn up by tenderers on the

basis of their professional experience and the

expected places of use; they must show the

unit prices of the parts, calculated as

specified in Article 11 (below). The

contracting authority reserves the right to

alter the list of spare parts; any changes will

appear in the contract.

Please also refer to Changes No:2 to TD.

6 ITT 3.1

Participation is open to all natural persons who are

nationals of and legal persons (participating either

individually or in a grouping – consortium – of

tenderers) which are effectively established in a Member

State of the European Union or in an eligible country or

territory as defined under the Regulation (EU) No

236/2014 establishing common rules and procedures for

the implementation of the Union's instruments for

external action (CIR) for the applicable instrument under

which the contract is financed (see also heading 22 of the

contract notice). Participation is also open to

international organisations. All supplies under this

contract must originate in one or more of these countries.

However, they may originate from any country when the

amount of the supplies to be purchased (as a whole or, if

divided into lots, per lot) is below EUR 100 000.

Should we understand the total Lot

price or the unit price from the

definition of “below EUR 100.000”

that is mentioned in the article in

question as follows: “However, they

may originate from any country when

the amount of the supplies to be

purchased (as a whole or, if divided

into lots, per lot) is below EUR

100.000?

As clearly stated in the existing item in

bracelet “(as a whole or, if divided into lots,

per lot)”; the item refers to the total value of

each Lot.

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7 ITT 28

The tenderers and, if they are legal entities, persons who

have powers of representation, decision-making or

control over them, are informed that, should they be in

one of the situations of early detection or exclusion, their

personal details (name, given name if natural person,

address, legal form and name and given name of the

persons with powers of representation, decision-making

or control, if legal person) may be registered in the early

detection and exclusion system, and communicated to

the persons and entities listed in the above-mentioned

decision, in relation to the award or the execution of a

procurement contract.

We request a clarification on what is

exactly demanded or what is

emphasized in the sentence on the left.

The contracting authority shall take all

necessary measures to ensure full compliance

with the principles of PRAG and also by

facilitating the detection of unreliable

economic operators and the protection of

the European Union's financial interests. To

this aim, an Early Detection and Exclusion

System (EDES) is established by the

Financial Regulation to reinforce the

protection of the Union's financial interests

and to ensure sound financial management.

This item empowers the Contracting

Authority to communicate the data of

Tenderer to the EDES if necessary.

8 DC 1.1

The subject of the contract shall be the supply, delivery,

installation, commissioning, testing, inspection, training

and warranty services of the following supplies:

Lot 1: High Level Ventilator – Neonatal

Lot 2: Transport Ventilator

Lot 3: C-Arm Digital X-Ray Device

Lot 4: Haemodialysis Device

The place of acceptance of the supplies shall be indicated

in the Appendix A of the Annex II+III technical

specifications and technical offer, the time limits for

delivery shall be 120 (one hundred and twenty) calendar

days for Lot-1 and Lot-2; 150 (one hundred and fifty)

calendar days for Lot-3; 90 (ninety) calendar days for

Lot-4 and the Incoterm applicable shall be DDP. The

implementation period of tasks shall run from the date of

commencement of the contract to the date for provisional

acceptance.







Please see the answer to clarification number

4 above.

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9 DC 1.3

The supplies described under all lots must be

accompanied by an additional ‘lot’ consisting of spare

parts and/or consumables. Neither the unit price, nor the

overall price of spare parts will influence the evaluation

of the tenders, except where they vary substantially

between the tenders received. Lists of spare parts must

be drawn up by tenderers on the basis of their

professional experience and the expected places of use;

they must show the unit prices of the parts, calculated as

specified in Article 11 (below). The contracting authority

reserves the right to alter the list of spare parts; any

changes will appear in the contract.

Could you consider removing the

following part “The contracting

authority reserves the right to alter the

list of spare parts; any changes will

appear in the contract." For the sake of

the principle of efficient use of public

resources?


The supplies which form the subject of the

contract for all lots must be accompanied by

the spare parts described by the contractor in

its tender and by the accessories and other

items necessary for using the goods over a

period of 10 years, as specified in the

instructions to tenderers.

Please also refer to Changes No:2 to TD.

10 SC 19.1

The supply, delivery, installation, commissioning,

testing, inspection and training of goods will be

completed in 120 calendar days for Lot-1 and Lot-2; 150

calendar days for Lot-3 and 90 calendar days for Lot-4

starting from the date of commencement of the contract.








4 above.

11 SC 25.2

Inspection and testing shall take place upon delivery, and

in accordance with Article 25 of the General Conditions

and Technical Specifications Annex II + III at the

delivery points in Appendix A to Special Conditions.

The Contractor shall be liable for any damage that might

be given to public or private property, or the general

public, during the installation or throughout the operation

period of the project in line with its purposes within the

warranty period. The Contractor shall be liable for

compensation of losses arising from such damages.

We request the article to be modified

as covering the direct losses only, as it

is not possible to find out the direct

and indirect losses when it is specified

as all losses.

The item remains unchanged considering the

needs of the Contracting Authority and the

public interest.

12 SC 26.3

By derogation, the final payment to the contractor of the

amounts due shall be made within 90 days after receipt

by the contracting authority of an invoice and of the

application for the certificate of provisional acceptance.

Could you consider revising the item

as “By derogation, the final payment to

the contractor of the amounts due shall

be made within 60 days after receipt

by the contracting authority of an

invoice and of the application for the

There is no contradiction between the

documents. Please be aware that the

particular items in the Special Conditions

serves for the purpose to derogate from

General Conditions. The term “by

derogation” at the very beginning of the item

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certificate of provisional acceptance.”

in order to eliminate conflict between

documents as the document 'ANNEX

I:GENERAL CONDITIONS" Article

26.3 states that the payment would be

done within 60 days.

clearly states that the Contractşng Authority

here derogates from article 26.3 of the

General conditions with this particular item

in Special Conditions.

13 SC 32.6

- Repair time: Within 30 calendar days from the receipt

of the malfunctioning goods. If during 30 calendar days,

it is foreseen that the goods cannot be repaired and the

malfunction is not fault of the operator, corresponding

functional item should be provided until malfunctioning

goods is repaired.

Could the item considered to be

revised as “Repair time:Within 30

calendar days from the receipt of the

malfunctioning goods. If during 30

calendar days, It Is foreseen that the

goods cannot be repaired and the

malfunction is not fault of the operator,

In case, the warranty period wlll be

added free of charge for 2 days per

day.” considering various conditions

such as production, logistics,

installation, calibration of imaging

systems consisting of numerous units

having high technologic value, it is not

possible to leave a substitution device

within repair period?

The article has already been revised by

Changes No:1 to Tender Dossier, please refer

the public document.

14 GC 12.1(a)

Without prejudice to Article 32 (warranty obligations)

and Article 38 (force majeure), the contractor shall

assume (i) full responsibility for maintaining the

integrity of the supplies and (ii) the risk of loss and

damage, whatever their cause, until the final acceptance

as foreseen in Article 34.


as “Without prejudice to Article 32

(warranty obligations) and Article 38

(force majeure), the contractor shall

assume (i) full responsibility for

maintaining the integrity of the

supplies and (ii) the risk of loss and

damage, whatever their cause, until

The partial provisional acceptance as

foreseen in Article 34.” considering

the fact that in the current form of the

article, the risks and damages in the

Please be aware that “General Conditions” is

not a dynamic document subject to the

modification but a stable template document

itself.

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systems delivered to the end users will

be delivered to the relevant hospitals

after 5 years following the provisional

acceptance. In its current form, the

amount of the Insurance to be made for

each system affects the unit price of

the system?

15 GC 17.2

Such license shall carry the right to grant sub-licenses

and shall be transferable by the contracting authority to

third parties without the consent of the contractor being

required.

Please clarify that grant of the

sublicense will be limited to the end

users which are the hospitals not any

other 3rd party.


14 above.

16 GC 26.7

For supplies not covered by a warranty period, the

payments listed above shall be aggregated. The

conditions to which the payments of pre-financing and

final payments are subject, shall be as stated in the

special conditions.

We request information about what is

exactly intended to express with the

sentence of "For supplies not covered

by a warranty period, the payments

listed above shall be aggregated.".

If the goods under the contract are not subject

to the warranty period, the payments shall be

aggregated; which is not a case for none of

the lots under the subject tender as all the

goods required to be covered by warranty

period.

17 GC 26.8

The payment obligations of the European Commission

under this contract shall cease at most 18 months after

the end of the period of implementation of the tasks,

unless the contract is terminated in accordance with these

general conditions.


same as with the warranty period as

“The payment obligations of the

European Commission under this

contract shall cease at most 120

months after the end of the period of

implementation of the tasks, unless the

contract is terminated in accordance

with these general conditions.” as the

judgment proceedings for any dispute

that might arise between the parties

within the scope of the tender and

similar proceedings are likely to

exceed 18 months?


14 above.

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18 GC 32.2

The contractor shall be responsible for making good any

defect in, or damage to, any part of the supplies which

may appear or occur during the warranty period and

which:

a) results from the use of defective materials, faulty

workmanship or design of the contractor; and/or

b) results from any act or omission of the contractor

during the warranty period; and/or appears in the

course of an inspection made by, or on behalf of, the

contracting authority.

We kindly request to change the clause

as follows: “The contractor shall be

responsible for making good any

defect in, or damage to, any part of the

supplies which may appear or occur

during the warranty period and which:

a) results from the use of

defective materials by Contractor's

technical services, faulty workmanship

or design of the contractor; and/or

b) results from any act or

omission of the contractor during the

warranty period; and/or

c) appears in the course of an

inspection made by, or on behalf of,

the contracting authority.


14 above.

19 GC 32.3

The contractor shall at its own cost make good the defect

or damage as soon as practicable. The warranty period

for all items replaced or repaired shall recommence from

the date when the replacement or repair was made to the

satisfaction of the project manager. If the contract

provides for partial acceptance, the warranty period shall

be extended only for the part of the supplies affected by

the replacement or repair.

We kindly request the removal of the

item.


14 above.

20 GC 32.4

If any such defect appears or such damage occurs during

the warranty period, the contracting authority or the

project manager shall notify the contractor. If the

contractor fails to remedy a defect or damage within the

time limit stipulated in the notification, the contracting

authority may:

a) remedy the defect or the damage itself, or employ

someone else to carry out the tasks at the contractor's risk

and cost, in which case the costs incurred by the

contracting authority shall be deducted from monies due

to or from guarantees held against the contractor or from

both; or


as follows: “If any such defect appears

or such damage occurs during the

warranty period, the contracting

authority or the project manager shall

notify the contractor.”.


14 above.

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b) terminate the contract.

21 GC 32.5

In case of emergency, where the contractor cannot be

reached immediately or, having been reached, is unable

to take the measures required, the contracting authority

or the project manager may have the tasks carried out at

the expense of the contractor. The contracting authority

or the project manager shall as soon as practicable

inform the contractor of the action taken.

We kindly request the removal of the

item.


14 above.

22 GC 34.1

Upon expiry of the warranty period, or where there is

more than one such period, upon expiry of the latest

period, and when all defects or damage have been

rectified, the project manager shall issue the contractor a

final acceptance certificate and a copy thereof to the

contracting authority, stating the date on which the

contractor completed its obligations under the contract to

the project manager's satisfaction . The final acceptance

certificate shall be issued by the project manager within

30 days after the expiration of the warranty period or as

soon as any repairs ordered under Article 32 have been

completed to the satisfaction of the project manager .

Upon expiry of the warranty period, or

where there is more than one such

period, upon expiry of the latest

period, and when all defects or damage

have been rectified, the project

manager shall issue the contractor a

final acceptance certificate and a copy

thereof to the contracting authority,

stating the date on which the

contractor completed its obligations

under the contract to the project

manager's satisfaction. The final

acceptance certificate shall be issued

by the project manager by the end of

the warranty period or as soon as any

repairs ordered under Article 32 have

been completed to the satisfaction of

the project manager.


14 above.

23 PG NA

(....)We note that the guarantee will be released within 60

days of the issue of the final acceptance certificate

(except for such part as may be specified in the special

conditions in respect of after sales service). [and in any

case at the latest on (at the expiry of 18 months after the


as follows: “(....) We note that the

guarantee will be released within 30

days of the issue of the provisional

acceptance certificate (except for such

Please be aware that the relevant part of the

document is not subject to the revision as it is

a standard template contained in the PRAG.

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period of implementation of the tasks)] 1.(...) part as may be specified in the special

conditions in respect of after sales

service) . (...)”.

24 TG NA

(....)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

[and in any case at the latest on (1 year after the deadline

for submission of tenders)]2 .(....)


as follows: “(... .) We note that the

guarantee will be released at the latest

within 30 days at the latest after the

provisional acceptance,, including any

extensions, in accordance with Article

8 of the Instructions to tenderers. (...)”.

Please be aware that the relevant part of the

document is not subject to the revision as it is

a standard template contained in the PRAG.

25

TS –

General

Require

ments

3.9

Unless otherwise stated (please see technical

specifications for each Lot for the specific

requirements of each Lot), the contractor at least 2

(two) days free training of at least 2 (two) staff to

determine the use, maintenance, calibration, care

and possible defects of the device with their trained

staff. These trainings will be repeated up to 3 times

for each device if requested during the warranty

period. This requirement will be certified by the

contractor in the tender file. The date and place

which will be determined by the center. Documents

and equipment’s required for training shall be met

by the Contractor.


as follows: “Unless otherwise stated

(please see technical specifications for

each Lot for the specific requirements

of each Lot), the contractor at least 2

(two) days free training of at least 2

(two) staff to determine the use, daily

maintenance, calibration, first level

intervention in case of malfunctions

/care and possible defects of the device

with their trained staff. These trainings

will be repeated once more free of

charge for each device if requested

during the warranty period. This

requirement will be certified by the

contractor in the tender file.

Documents and equipment's required

for training shall be met by the

Contractor.”.

The requirement remains unchanged

considering the needs of the Ministry and

sustainability of the health services.

26 TS 1.3

The device should be in fully compact structure. All

parameter adjustments and values of measurements shall

be made and tracked on at least 12’’ internal monitor of

In order to increase the number of

qualified competitors we kindly

request to change the clause as

The specification remains unchanged

considering the needs of the Ministry.

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the ventilator. The internal screen of the device should be

separated from the main unit and put on pendant if

wanted in the future.

follows: “The device should be in fully

compact structure. All parameter

adjustments and values of

measurements shall be made and

tracked on at least 12'' internal monitor

of the ventilator. The internal screen of

the device should be separated from

the main unit or ventilator should be

separated from the transport cart and

put on pendant if wanted in the

future.”

27


as follows: “The device should be in

fully compact structure . All parameter

adjustments and values of

measurements shall be made and

tracked on at least 12" internal monitor

of the ventilator or on the ventilator

with 10" screen and having the

same brand integrated humidifier

device. The internal screen of the

device should be separated from the

main unit and put on pendant if wanted

in the future or should be in fully

compact structure.”.

28 TS 1.5

VG (Volume Guarantee) property should be present as

standard. Tidal volume limiting properties other than this

mode shall not be accepted.

(VG (Volume Guarantee) property and

VTV (Volume Targeted Ventilation)

properties are the same properties and

only the names of the properties differ.

Therefore, in order to increase the

number of qualified competitors we

kindly request to change the clause as

follows: VG (Volume Guarantee) or

VTV (Volume Targeted Ventilation)



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property should be present as standard.

Tidal volume limiting properties other

than these modes shall not be

accepted.”

29 TS 1.6

There should be freeze or save button on the device and

wave forms or loops should be frozen or saved as instant

images.


as follows: “Freeze or save buttons

should be present on the device, wave

forms and loops should be frozen or

saved as instant images.”.

The specification remains unchanged. Please

also see the Changes No.1 to Tender Dossier

for the updated version of the item.

30 TS 1.7

HFOT (High Flow O2 Therapy) feature should be added

to the devices optionally. The price of this feature

shouldn’t exceed %15 of tender unit price.


as follows: “HFOT (High Flow 02

Therapy) feature should be added to

the devices optionally or in ncpap

mode flow can be ad justed

manually from 6-20 lpm . The price

of this feature shouldn't exceed %15

of tender unit price.”.



31 TS 1.14.8 Tidal volume: 2-200 ml


as follows: “Tidal Volume : 2-150

ml.”.

The specification has been revised as:

Tidal Volume : 2-150 ml.

Please also refer to Changes No.2 to Tender

Dossier.

32

TS 1.15

The device must have an integrated back lighted LCD

graphic display at least 12 inches.

- Airway pressures,

- Flow, Volume, Pressure Curves,

-Trend curves of measurements or numerical values

should be monitored on this screen.


as follows: “The device must have an

integrated back lighted LCD graphic

display at least 10 inches.”.


The device must have an integrated back

lighted LCD or LED graphic display at least

12 inches.

- Airway pressures,

- Flow, Volume, Pressure Curves,

- Trend curves of measurements or numerical

values should be monitored on this screen.

33


as follows: “The device must have an

integrated back lighted LCD

or LED backlight monitor graphic

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display at least 12 inches.

- Airway pressures,

-Flow, Volume, Pressure Curves,

Trend curves of measurements or

numerical values should be monitored

on this screen.”


Dossier.

34

TS 1.16

3 (three) waveforms and 2 breathing cycles or 4

waveforms should be monitored at the same time on the

internal screen of the device. In addition, respiratory

cycles (P / F, P / V, V / F) should be monitored.


as follows: “3 (three) waveforms and 2

breathing cycles or 3 waveforms

should be monitored at the same time

in the internal screen of the device . In

addition, respiratory cycles (P / F, P /

V, V / F) should be monitored.”.

The specification remains unchanged.

35


as follows: “3 (three) waveforms and 2

breathing cycles or 4 waveforms or

1(one) waveforms and 2 (two)

breathing cycles should be monitored

at the same time on the internal screen

of the device. In addition, respiratory

cycles (P I F,P I V, V I F) should be

monitored.”.

36 TS 1.17

The humidifier supplied with the device must have the

following features.


as follows: “The ventilator should

have an integrated humidifier which

can be controlled from the ventilator

screen and functions according to

the parameters set by the user. The

companies which cannot fulfill this

feature must supply external

humidifier which is clearly defined

in items 1.17.1, 1.17.2, 1.17.3,

1.17.4.”.


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37 TS 1.19

The device must contain the following alarms:

- Air and oxygen shutdown alarm or gas pressures low alarm

-System failure alarm

-High airway pressure alarm

- Low airway pressure alarm or PEEP alarm

- High and low oxygen concentration alarm or oxygen

value deviation alarm

- Flow sensor failure alarm

- Oxygen sensor failure alarm

- Flow sensor clogged (dirty) alarm or flow sensor

failure

-Disconnection or cycle fail alarm (leakage or

connection error in the patient circuit)

- High minute volume alarm

- Low minute volume alarm

- Low tidal volume alarm or low minute volume alarm

- Apnea alarm

- Endotracheal tube clogged alarm or high pressure in the

inspiratory tube alarm or high airway pressure alarm or P

Op high alarm

- Clogging in the patient circuit or high airway pressure

or resistance height alarm or inspiration-expiratory tube

alarm (Against the increase in resistance due to clogging

or curling in the patient circuit)

As the requested version also fully

satisfies the requirements, we kindly

request to change the clause as

follows: “The device must contain the

following alarms:

- Air and oxygen shutdown alarm or

gas pressures low alarm or no gas

alarm -System failure alarm

-High airway pressure alarm or high

pressure threshold exceeded alarm

- Low airway pressure alarm or PEEP

alarm

- High and low oxygen concentration

alarm or oxygen value deviation

alarm

- Flow sensor failure alarm or floor

sensor defective alarm

- Oxygen sensor failure alarm or 02

calibration fail alarm

- Flow sensor clogged (dirty) alarm or

flow sensor failure or flow sensor

contaminated alarm

- Disconnection or cycle fail alarm

(leakage or connection error in the

patient circuit)



- Low tidal volume alarm or low

minute volume alarm

- Apnea alarm

- Endotracheal tube clogged alarm or

high pressure in the inspiratory tube

alarm or high airway pressure alarm


The device must contain the following

alarms:

- Air and oxygen shutdown alarm or gas

pressures low alarm

- System failure alarm

- High airway pressure alarm or high

pressure threshold exceeded alarm

- Low airway pressure alarm or PEEP alarm

- High and low oxygen concentration alarm

or oxygen value deviation alarm

- Flow sensor failure alarm or floor sensor

defective alarm

- Oxygen sensor failure alarm

- Flow sensor clogged (dirty) alarm or flow

sensor failure alarm

- Disconnection or cycle fail alarm (leakage

or connection error in the patient circuit)



- Low tidal volume alarm or low minute

volume alarm

- Apnea alarm

- Endotracheal tube clogged alarm or high

pressure in the inspiratory tube alarm or high

airway pressure alarm or P Op high alarm

- Clogging in the patient circuit or high

airway pressure or resistance height alarm or

inspiration-expiratory tube alarm (Against

the increase in resistance due to clogging or

curling in the patient circuit).


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or P Op high alarm or blocked fresh

gas alarm

- Clogging in the patient circuit or high

airway pressure or resistance height

alarm or blocked fresh gas alarm or

inspiration-expiratory tube alarm

(Against the increase in resistance

due to clogging or curling in the

patient circuit).”.

Dossier.

38 TS 1.23 The device must have RS 232 and USB output.


as follows: “The device must have RS

232 or USB output.”.


39 TS 1.26

There should be a led indicator on the device or on the

uninterruptible power supply indicating the electrical

connection. In the absence of the mains supply, the

battery indicator of the device or uninterruptible power

supply indicator must warn the user.


as follows: “There should be a led

indicator or halo indicator on the

device or on the uninterruptible

power supply indicating the electrical

connection. In the absence of the

mains supply, the battery indicator of

the device or uninterruptible power

supply indicator must warn the user.”.


There should be a led indicator or halo

indicator on the device or on the

uninterruptible power supply indicating the

electrical connection. In the absence of the

mains supply, the battery indicator of the

device or uninterruptible power supply

indicator must warn the user.


Dossier.

40 TS 1.29

HFO + VG feature and n-HFO feature or proportional

pressure support (SPN-PPS) can be added to devices to

which HFO feature can be added in the future.


as follows: “HFO + VG feature or n-

HFO feature or proportional pressure

support (SPN- PPS) can be added to

device to which HFO feature can be

added in the future.”.


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41


as follows: “HFO + VG feature and n-

HFO feature or HFO+VTV (Volume

Target Ventilation) feature and

nHFOV (Nasal High-Frequency

Oscillation Ventilation) feature or proportional pressure support (SPN-

PPS) can be added to devices to which

HFO feature can be added in the

future.”.

42 TS 1.30

Materials To Be Supplied With The Ventilator

The following accessories will be provided for the

operation of the device and their suitability for the

current system will be indicated.

1- Oxygen central system connection hose: 1 pc

2- Central system air connection hose: 1 pc

3- Dual line heated disposable air circuit (Inspiration and

expirium line heater assembly)should be provided. The

disposable Chamber with automatic filling must be

double floated. In addition, there must be a pressure flow

limiter for the mechanical ventilators with pressure

control in the set package. Devices of the companies that

offer mechanical ventilator with this feature should be

fully compatible. All parts (chamber, patient set, flow

limiter and other accessories) must be original and the

same brand with moisturizing device.. Disposable sets of

materials from different manufacturers shall not be

accepted. :20 pcs

4- Disposable nasal CPAP set: 10 sets

(Each nasal set will contain prong, mask, bone, and if

any, interconnection devices. Prong, mask and bone

should have different size options.)

5- Sling arm for patient circuit: 1 pc

6- For systems working with hot wire principle, reusable

flow sensor: 5 pcs

7- Test lung: 1 piece

8- Humidifier unit and accessories: 1 pc


as follows: “3 Dual line heated

disposable air circuit (Inspiration and

expirium line heater assembly) should

be present. For the systems having

disposable Chamber, the disposable

chamber with automatic filling must

be double float. In addition, there must

be a pressure flow limiter for the

pressure controlled mechanical

ventilators in the set package. Devices

of the companies that offer mechanical

ventilator with this feature should be

fully compatible. All parts (chamber,

patient set, flow limiter and other

accessories) must be the same brand

with moisturizing device and original.

Disposable sets of materials from

different manufacturers shall not be

accepted : 20 pcs

4- Disposable nasal CPAP set: 10 sets

(Each nasal set will contain prong,

mask, bone, and if any,

interconnection devices. Prong, mask


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9- Expiration or exhalation set (full set): 1 pc

and bone should have different size

options.)

5- Sling arm for patient circuit: 1 pc

6- For systems working with hot wire

principle, reusable flow sensor: 5 pcs

7- Test lung: 1 piece

8- Humidifier unit and accessories: 1

pc

9- Expiration or exhalation set (full

set) : 1 pc (when available)

43 TS 2.5

In the ventilator, the parameters defined below should be

adjusted at least in defined intervals.

a) Tidal volume: 50-2000 ml

b) Respiration frequency: 5-60 breathes/minute

c) Inspiration time: 0.3-3.0 seconds or I:E ratio is

at least 1:4-3:1

d) PEEP/CPAP: 0/off-20 cmH2O

e) Pressure Control Ventilation Mode Pressure

(PCV pressure/Pinsp): 5-55 cmH2O

f) Spontaneous Respiration Pressure Support

(PSV Pressure): 2-35 cmH2O

g) FiO2: Should be adjusted at least between %40-

%100

h) Flow value should go up to 100 liters/minute at

least.

i) Pressure Triggering: Between (-9) and (-0.1)

cmH2O or flow trigger should be between 1 and

9 liter/minute at least.


as follows: “In the ventilator, the

parameters defined below should be

adjusted at least in

defined intervals.

a) Tidal volume: 5-2500 ml

b) Respiration frequency: 5-60

breathes/minute

c) Inspiration time: 0.3-3.0 seconds or

I:E ratio is at least 1:4-3:1

d) PEEP/CPAP: 0/off-20 cmH2O

e) Pressure Control Ventilation Mode

Pressure(PCV pressure/Pinsp): 5-55

cmH2O

f) Spontaneous Respiration Pressure

Support (PSV Pressure): 2-35 cmH2O

g) FiO2: Should be adjusted at least

between %40-%100

h) Flow value should go up to 100

liters/minute at least.

i) Pressure Triggering: Between (-9)

and (-0.1) cmH2O or flow trigger

should be between 1 and

9 liter/minute at least.”.


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44 TS 2.6

The device should have respiration modes with the

parameters written below.

a) Assisted/ Volume-controlled Mandatory

Respiration (A/CMV-V.AC)

b) Pressure Controlled Synchronized Interval

Mandatory Respiration (P-SIMV-PC-

BIPAP/PS)

c) Volume Controlled Synchronized Interval

Mandatory Respiration ( /V-SIMV-VC-SIMV)

d) Pressure Supported Ventilation (PSV) or

Spontaneous Respiration (SPONT-

SpnCPAP/PS)

e) Continuous Positive Airway Pressure (CPAP-

SpnCPAP)

f) Back-up ventilation or apnea back-up

ventilation

The device should have respiration

modes with the parameters written

below.

a) Assisted/Volume-controlled

Mandatory Respiration (A/CMV-

V.AC) or VCNAC

b) Pressure Controlled

Synchronized Interval Mandatory

Respiration (P-SIMV-PC-

BIPAP/PS) or P SIMV+PS -APCV

(BILEVEL ST) c) Volume Controlled Synchronized

Interval Mandatory Respiration ( N -

SIMV-VC-SIMV)

d) Pressure Supported

Ventilation (PSV) or Spontaneous

Respiration (SPONT-SpnCPAP/PS)

e) Continuous Positive Airway

Pressure (CPAP-SpnCPAP)

f) Back-up ventilation or apnea back-

up ventilation


The device should have ventilation modes

with the parameters written below.

a) Assisted/Volume-controlled

Mandatory Ventilation (A/CMV-

V.AC) or equivalent mode

b) Pressure Controlled Synchronized

Interval Mandatory Ventilation (P-

SIMV-PC-BIPAP/PS) or equivalent

mode c) Volume Controlled Synchronized

Intermittent Mandatory Ventilation

( /V-SIMV-VC-SIMV)

d) Pressure Supported Ventilation

(PSV) or Spontaneous Ventilation

(SPONT-SpnCPAP/PS)

e) Continuous Positive Airway Pressure

(CPAP-SpnCPAP)

f) Back-up ventilation or apnea back-

up ventilation


Dossier.

45 TS 2.8

The device should have an internal gas mixer. Oxygen

concentration in the inspiration air should be adjusted

between %40-%100. Oxygen concentration should be

adjusted through the device and the change in the

amount of oxygen flow shouldn’t be required for

concentration change.

Could you consider revising the

specification as: “The device should

have an internal or external gas

mixer. Oxygen concentration in the

inspiration air should be adjusted

between %40 -%100. Oxygen

concentration should be adjusted

through the device or with original

external mixer for concentration

change.” ?


The device should have an internal or

integrated gas mixer. Oxygen concentration

in the inspiration air should be adjusted

between %40 -%100. Oxygen concentration

should be adjusted through the device or

with original integrated mixer for

concentration change. The change in the

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amount of oxygen flow shouldn’t be required

for concentration change.


Dossier.

46 TS 2.15

The structure of the ventilator should have an at least 4,5

inch internal TFT or LCD and Electro-Luminescence

(EL) screen from which the monitorized parameters and

alarm status can be monitored in writing.


as follows: “There should be an

internal TFT or LCD or

ElectroLuminescence (EL) screen at

least 8 inch in dimension, through

which monitorized parameters

and alarm statuses can be monitored in

writing, in the structure of the

ventilator.”.


47 TS 2.20

The followings shall be provided with each device:

d) 3 adult type, 3 pediatric type reusable respiration

circuits and current sensors and/or 3 expiratory valve

systems or cassettes.

e) One original carrier bag and stand, 3.5 lt oxygen tube

and regulator clock, assembly apparatus for patient’s bed

or stretcher.

f) At least 2 meters long oxygen hose and required lock

clip, sleeves, connectors etc.


as follows: “…..

a) 3 adult type reusable, 3 pediatric

type reusable or disposable

respiration circuit and current sensors

and/or 3 expiratory valve systems or

cassettes.

b) One original carrier bag and stand,

oxygen tube of 2 or 3,5 It and

regulator clock, assembly apparatus for

patient 's bed or carrier.


The followings shall be provided with each

device:

a) 3 adult type, 3 pediatric type reusable

respiration circuits and current sensors and/or

3 expiratory valve systems or cassettes.

b) One original carrier bag and stand, 3.5 lt

oxygen tube and regulator clock, assembly

apparatus for patient’s bed or stretcher.

c) At least 2 meters long oxygen hose and

required lock clip, sleeves, connectors etc.


Dossier.

48 TS 2.23

During the warranty period, the contractor shall realize

the periodical maintenances of the device (not being less

than 4 times a year) in place, all expendables being its

own.

Could you consider revising the

specification as: “During the warranty

period, the contractor shall realize the

periodical maintenances of the device

(not being less than 2 times a year) in


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place, all expendables being its own.”?

49 TS

2.38

(New) -

The device must be suitable for use in

ambulances, aircraft and on the

ground.

The insertion of such requirement has been

regarded unnecessary considering the

intended purpose of the device.

50

TS 3.1

The system will include an image amplifier, an x-ray

tube, 2 (two) monitors mounted on a C-armed stative,

and an integrated monitor on the stative or wheeled table.



request you to change the clause as

follows “In the system, the image

intensifier and X-ray tube shall be

mounted on a C-arm stative. 2 (two)

monitors shall be on an C arm stative

or separate cart stand.”.


The System will include an image amplifier

and an x-ray tube which mounted on a C-

armed stative. There should be 2 (two)

monitors or 1 (one) integrated monitor on the

stative of wheeled table.


Dossier. 51




follows “In the system, the Flat

detector, X-ray tube shall be mounted

on a C-arm stative. 2 (two) monitors

shall be on separate cart stand.”.

52 TS 3.3

There will be continuous and pulsed fluoroscopy in the

system and there will be digital radiography or single

image mode. All of these features will be shown in the

current product catalog obtained from the Product

Tracking System.

We kindly request you to change the

clause as follows “There will be

continuous and pulsed fluoroscopy in

the system and there will be digital

radiography or single image mode. All

of these features will be shown in the

current product catalog.”.

The catalogues are welcomed to be registered

to the Product Tracking System. The item

will remain unchanged.

53 TS 3.4

At least 12.5 pulse / second pulsed fluoroscopy will be

done in the system.






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follows “At least 10 pulse/second

pulsed fluoroscopy will be done in the

system.”.

54




follows “At least 25 pulse/second

pulsed fluoroscopy will be done in the

system.”

55 TS 3.8

If required, DSA option must be added to the system

including pixel shift or remask or masking, landmark,

peak opacification, roadmark or roadmap or subtraction

modes.




follows “If required, DSA option must

be added to the system including pixel

shift or remask or masking, landmark

or peak opacification, roadmark or

roadmap or subtraction modes.”.



56 TS 3.9

The system should have anatomic programs such as

general, orthopedic, spine, vascular, or the imaging

technique that is automatically activated in the system to

achieve optimum image quality. Companies will explain

these features.




follows “The system should have

anatomic programs such as general,

orthopedic, spine or the imaging

technique that is automatically

activated In the system to achieve

optimum Image quality. Companies

will explain these features.”.


The system should have anatomic programs

such as general, orthopedic, spine or the

imaging technique that is automatically

activated In the system to achieve optimum

Image quality. Companies will explain these

features.


Dossier.

57 TS 3.10.1 C-Arm opening should be at least 75 cm.




follows “C-Arm opening should be at

least 83 cm.”.



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58 TS 3.10.3 SID in C-Arm shall be at least 94 cm.




follows “SID in C-Arm shall be at

least 103 cm.”.



59 TS 3.10.9

For ease of use in the system, different color codes

should be used for each brake and movement.




follows “For ease of use in the system,

different color codes should be used

for each brake and movement or the

system should be equipped with a

warning sign indicating whether the

device is in the brake position or not.


For ease of use in the system, different color

codes should be used for each brake and

movement or the system should be

equipped with a warning sign indicating

whether the device is in the brake position

or not.


Dossier.

60

TS 3.11.1 The x-ray generator must have at least 15 kW and at

least 40 kHz high frequency.




follows “The x-ray generator must

have at least 2,3 kW and at least 30

kHz high frequency.”. The item has been revised as:

The x-ray generator must have at least 12

kW and at least 40 kHz high frequency.


Dossier. 61





have at least 12 kW and at least 40

kHz high frequency.”.





have at least 2,2 kW and at least 20

kHz high frequency.”.

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62 TS 3.11.2

The fluoroscopic tension shall be at least 40 kV to 120

Kv.




follows “The fluoroscopic tension

shall be at least 40 kV to 110 kV.”.


The fluoroscopic tension shall be at least 40

kV to 110 kV.


Dossier.

63

TS 3.11.3 At continuous fluoroscopy, the current value shall be at

least 15 mA.

In the specifications item 3.12.4,

Anode cooling capacity required is at

least 73000HU/min. with 15mA

continuous fluoroscopy by definition,

15mA x 120KV=1800W at least

required value. 1800W x (4/3) x

60=144 000 HU/min which is double

the required cooling capacity.

Therefore, there is a contradiction in

the required specifications. To

overcome the contradiction, the item

requested to be revised as “At

continuous fluoroscopy, the current

value shall be at least 7.5 mA or

maximum current value shall be at

least 15mA”.


At continuous fluoroscopy, the current value

shall be at least 13 mA.


Dossier.

64

We kindly request the item to be

revised as “At continuous fluoroscopy,

the current value shall be at least 13

mA.”

65 We kindly request the item to be

revised as “At fluoroscopy , the current

value shall be at least 75 mA.”.

66 We kindly request the item to be

revised as “At continuous fluoroscopy,

the current value shall be at least 5,4

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mA.”.

67

TS 3.11.4 In pulsed fluoroscopy, the current value shall be at least

12 mA.

60 mA or more current will add more

powerful working conditions.

Therefore we kindly request the item

to be revised as “In pulsed

fluoroscopy, the current value shall be

at least 60 mA.”


considering the needs of the Ministry. 68


revised as “In pulsed fluoroscopy , the

current value shall be at least 60 mA or

fluoroscopy; the current value shall

be at least 110 mA.”.

69


revised as “In pulsed fluoroscopy, the

current value shall be at least 7,2

mA.”.

70

TS 3.11.5

The system will include digital boost or digital spot or

digital radiography or digital exposures or single image

mode. In this mode which operates separately from

fluoroscopy, the current value will be at least 75 mA.


revised as “The system will include

digital boost or digital spot or digital

radiography or digital exposures or

single image mode. In this mode which

operates separately from fluoroscopy,

the current value will be at least 13

mA.”. The specification remains unchanged


71


revised as “The system will include

digital boost or digital spot or digital

radiography or digital exposures or

single Image mode. In this mode

which operates separately from

fluoroscopy, the current value will be

at least 8 mA.”

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72

TS 3.11.7 X-Ray generator must be single tank or monoblock or

split block structure.

Monoblock system helps acquiring

images with sharp pulses and without

radiating patient unnecessarily. Non-

monoblock system means extra dose to

the patient. The requested statement is

defined same as the technical

specification of Boarders & Coast

Office Type-2 C-arm system bulk

tender in 2015 (Tender No: 2015-

56699). To define an advanced C-arm

system it is kindly requested to revise

the item as follows “X-Ray generator

must be monoblock structure.”.


73

The C-Arms which have separate tube

and generator blocks cause artefacts in

sensitive medical devices (especially

ultrasound etc.) due to high voltage

between them. Therefore, we kindly

request the item to be revised as “X-

Ray generator must be single tank

or monoblock structure.”.

74

TS 3.12.2

X-ray tube should be double focused. The small focus

dimensions shall be 0.3 mm at most and the large focus

dimension shall be at least 0.6 mm.


revised as “The X-ray tube should be

single or double-focused. In the

systems with X-ray tube double

focus, small focus dimensions should

not be more than 0.3 mm, the largest

focus dimension should be no more

than 1.0 mm. For single-focus systems,

the size of the focus shall be 0.6 mm.”.


75


revised as “The X-ray tube should be

double-focused. Small focus size

should not be more than 0.6 mm, the

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largest focus size should be no more

than 1.5 mm.

76

TS 3.12.3 The anode heat capacity of the device shall be at least

311.000 HU.

Systems with rotating anode and high

anode heat capacity allows working on

much more patients quickly without

causing any hesitance during

procedures. In addition to that, X-ray

tubes with rotating anode have much

more lifetime because of erosion will

be less in rotating anodes comparing to

fixed anodes. The requested statement

is defined same as the technical

specification of Boarders & Coast

Office Type-2 C-arm system bulk

tender in 2015 (Tender No: 2015-

56699). To define an advanced C-arm

system in the technical specification, it

is kindly requested to revise the item

as “The anode heat capacity of the X-

Ray tube with rotating anode shall

be at least 311.000 HU.”.


The anode heat capacity of the device shall

be at least 300.000 HU.


Dossier.

77




follows “The anode heat capacity of

the device shall be at least 300.000

HU”.

78






HU.”.

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79






HU.”.

80

TS 3.12.4 Anode cooling capacity shall be at least 73.000 HU

/ min.




follows “Anode cooling heat capacity

shall be at least 60.000 HU/min”.


Anode cooling capacity shall be at least

72.000 HU / min.


Dossier.

81





shall be at least 72.000 HU/min”.

82




follows “Anode cooling capacity shall

be at least 18.000 HU/ min.”.

83





shall be at least 48.000 HU/min.”.

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84

TS 3.12.5

The heat capacity of the x-ray haube should be at least

1900 kHu or the system's heat capacity should be 10000

kHU.




follows “The heat capacity of the x-ray

haube should be at least 1890 kHu or

the system's heat capacity should be

10000 kHU.”.


The heat capacity of the x-ray haube should

be at least 1800 kHu or the system's heat

capacity should be 10000 kHU.


Dossier.

85







10000 kHU.”.

86







10000 kHU.”.

87







10000 kHU.”.

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88 TS 3.12.6

There will be 0.1 mm copper (Cu) and 3 mm aluminum

(Al) filter at the tube outlet to filter the harmful emission

rays.




follows “There will be 0.1 mm copper

(Cu) or 3 mm aluminum (Al)

equivalent filter to filter out the

harmful emission rays at the tube

outlet.”.


89

TS 3.12.7

The system must have at least one of the following

special software that improves the image quality.

Companies will show this feature in their original

catalogues:

- EASY (Enhanced Acquisition System) with automatic

dose adjustment

- ODDC (Object Detected Dose Control) that can make

automatic dose adjustment by detecting object and

motion

- Anatomically Programmed Fluoroscopy (APF) control

system

- A feature that automatically adjusts contrast and

brightness and ensure the production of sharp, low-dose

images (IDEAL: Intelligent Dose Efficiency Algorithm)



request you to remove this item from

the Technical Specifications.


The system must have at least one of the

following special software that improves the

image quality. Companies will show this

feature in their original catalogues:

- EASY (Enhanced Acquisition System) with

automatic dose adjustment

- ODDC (Object Detected Dose Control) that

can make automatic dose adjustment by

detecting object and motion

- Anatomically Programmed Fluoroscopy

(APF) control system

- A feature that automatically adjusts contrast

and brightness and ensure the production of

sharp, low-dose images (IDEAL: Intelligent

Dose Efficiency Algorithm)

- the filter which reduces motion blur by

detecting dynamic motion by means of

motion adaptation and double leaf collimator

which can function asymmetrically

- DDC (Dynamic Density Compensation)

which provides the optimum images to be

obtained by automatic dose adjustment

according to the anatomical features of

each different patient.

90



request you to add the following to the

item “DDC (Dynamic Density

Compensation) which provides the

optimum images to be obtained by


according to the anatomical features

of each different patient.”.

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Dossier.

91 TS 3.13.2

The image amplifier section will have a laser or lighted

centering device.




follows “The Flat Detector section

will have a laser or lighted centering

device.”.


92

TS 3.13.3 There will be both an iris and a parallel layer collimator

in the system.




follows “There will be both an iris and

a parallel layer or slot diaphragm

collimator in the system.”.


There will be both an iris and a parallel layer

collimator or equivalent technology in the

system.


Dossier. 93




follows “There will be both an iris and

a parallel layer or symmetric and

asymmetric collimator in the system.

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94

TS 3.13.5 Collimator DQE rate should be at least %65.

The terminology of DQE means

“Detective Quantum Efficiency” and,

it is an Image Intensifier related

terminology. Therefore, the

amendment request is for clarifying the

specification wording and the

meaning. Please also note that our

Image Intensifier has 65% DQE rate

so, we will comply with the technical

specifications, if the wording and the

meaning can be clarified. The item is

requested to be revised as follows

“Image Intensifier DQE rate should

be at least %65.”. The specification has been removed from the

Technical Specifications.


Dossier.

95

Detective quantum efficiency (DQE) is

one of the fundamental physical

variables related to image quality in

radiography and refers to the

efficiency of a detector in converting

incident x-ray energy into an image

signal.

The words "quantum efficiency" have

a precise meaning, because the DQE

measures the quantum efficiency of an

equivalent virtual detector, which

produces at its output the same signal-

to-noise ratio (SNR) of the real

detector even when the input signal is

the same.

The DQE is generally defined by the

ratio of the squared output signal-to-

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noise ratio (SNRo)2 to the squared

input signal-to-noise ratio (SNRi)2 of

the imaging detector.

DQE is dependent on radiation

exposure, spatial frequency, MTF, and

detector material. The quality (voltage

and current) of the radiation applied is

also an important influence on DQE.

DQE is therefore directly proportional

to the MTF of a detector; as an

imaging system, however, adds noise

to the output information, the DQE is

also in relation to SNR, with inverse

proportionality. Thus, the DQE

measures the SNR and MTF at various

spatial frequencies.

Therefore, we request this

specification to cover the “image

intensifier” not the collimator or to be

removed from the specifications.

96 We kindly request you to change the

clause as follows “Image intensifier

DOE rate should be at least %60.”.

97 We kindly request you to change the

clause as follows “Flat Detector DOE

rate should be at least %65.”.

98 TS 3.14 Image Amplifier


revised as “Flat Detector”.



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99

TS 3.14.1 The diameter of image amplifier must be at least 12

inches.


clause as follows “The diameter of

image amplifier must be at least 9

inches.”. The specification remains unchanged


100


clause as follows “The size of Flat

Detector must be at least 29 cm x 29

cm.”.

101

TS 3.14.2 Images should be processed in at least 32 bits.

32 bit image processing is available on

PC used for post processing. On the

other hand, this requirement is located

in Image Amplifier section. However,

Image Intensifiers have 16 bit image

processing in general. To comply with

the technical specifications and

participation in the tender, it is kindly

requested to revise the item as follows

“Images should be processed in at least

16 bits.”.


Images should be processed in at least 16

bits.


Dossier.

102




follows “Images should be processed

in at least 16 bits for each monitor.”.

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103

With the state of the art technology in

medical field, grayscale images

represented by max 16bit which leads

to 65536 different grayscales, which is

beyond human perception. So

maximum available bit size is 16bit,

therefore maximum possible image

processing for grayscale images 16bit.

But because of the attainable DQE

(detective quantum efficiency ) with

the current technology, meaningful

processed bit should be at least 12bit-

which is 4096 grayscale which is still

not detectable difference by the most

human. Therefore, we kindly request

you to change the clause as follows

“Images should be processed in at

least 12 bits.”.

104



request you to revise the item as

“Images should be processed in at least

14 bits.”.

105 TS 3.14.3

There will be at least 1K X 1K CCD high resolution

camera in the device.

We kindly request you to revise the

item as “There will be at least 1,5K X

1,5K Flat Detector in the device.”.


There will be at least 1K X 1K CCD or

CMOS high resolution camera in the device.


Dossier.


item as “There will be at least 1K X

1K CCD or CMOS high resolution

camera in the device.”.

106 TS 3.14.4 The image amplifier must have at least 3 areas.



request you to revise the item as “The



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image amplifier must have at least 2

areas”.

107 We kindly request you to revise the

item as “The Flat Detector must have

at least 3 areas.”.

108 TS 3.15.2

The memory capacity of the device must be at least

30.000 images.


item as “The memory capacity of the

device must be at least 15.000

images.”.



109 TS 3.15.4

There should be special software in the device which

improves the image quality. There should be ODDC

(Object Detected Dose Control) or EASY (Enhanced

Acquisition System) which can make automatic dose

adjustment by detecting object and motion or the filter

which reduces motion blur by detecting dynamic motion

by means of motion adaptation and double leaf

collimator which can function asymmetrically or the

property (IDEAL= Intelligent Dose Efficiency

Algorithm) which enables the formation sharp images

with low dose by automatically setting the contrast and

brightness in the device. The companies shall indicate

this property in original catalogues.






The system must have at least one of the

following special software that improves the

image quality. Companies will show this

feature in their original catalogues:

- EASY (Enhanced Acquisition System) with


- ODDC (Object Detected Dose Control) that

can make automatic dose adjustment by

detecting object and motion

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110



request you to revise the item as

“There should be special software in

the device which improves the image

quality. There should be ODDC

(Object Detected Dose Control) or

EASY (Enhanced Acquisition System)

which can make automatic dose

adjustment by detecting object and

motion or the filter which reduces

motion blur by detecting dynamic

motion by means of motion adaptation

and double leaf collimator which can

function asymmetrically or the

property (IDEAL= Intelligent Dose

Efficiency Algorithm) which enables

the formation sharp images with low

dose by automatically setting the

contrast and brightness in the device

or DDC (Dynamic Density

Compensation or companies specify

their own similar software and / or

hardware features. The companies

shall indicate this property in original

catalogues.”.

- A feature that automatically adjusts contrast

and brightness and ensure the production of

sharp, low-dose images (IDEAL: Intelligent

Dose Efficiency Algorithm)

- the filter which reduces motion blur by

detecting dynamic motion by means of

motion adaptation and double leaf collimator

which can function asymmetrically

- DDC (Dynamic Density Compensation)

which provides the optimum images to be

obtained by automatic dose adjustment

according to the anatomical features of each

different patient.


Dossier.

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111


item as “There must be special

software in the system that Improves

the Image quality. There should be

ODDC (Object Detected Dose

Control) which can adjust dose

automatically by perceiving object and

motion,EASY (Enhanced Acquisition

System) or the property which

generates sharp and low dose images

by automatically adjusting the contrast

and brightness (IDEAL: Intelligent

Dose Efficiency Algorithm) or the

filter which reduces the motion blur by

perceiving the dynamic motion due to

motion adaptation and asymmetrical

double-leaf collimator. Companies will

show these features in their original

catalogs.”.

112 TS 3.15.8 The image should be converted to negative and can be

enlarged.




image should be able to be

enlarged.”.



113 TS 3.15.16 Optical Magnification


item as “Optical Magnification or

Detector Zoom”.



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114

TS 3.15.18 The UPS will be given to supply the system's

workstation for at least 10 minutes.

The C-Arm systems have to be used in

operating room where is totally

covered by a central UPS system

specifically. Using an additional

standalone UPS system will cause

contamination in the hospital which is

totally against the International

regulations. Besides, some devices

have “Linux” based operating systems

and because of that unique feature,

there is no loss of image in case of loss

of electricity. Therefore, we kindly

request the item to be revised as “The

UPS will be given to supply the

system's workstation for at least 10

minutes or captured images can be

saved automatically without the need

of UPS.”.


There should be an external UPS or an

integrated UPS to supply the system's

workstation for at least 10 minutes.


Dossier.

115




UPS will be given to supply the

system's workstation for at least 10

minutes or there should have an

integrated UPS that can feed the

workstation of the system.”.

116 TS 3.15.20

Multi-modality surgical workstation imaging or pulsed

fluoroscopy should be able to reach at least 175 mA to

reach high level modality in the system.

Multi-modality surgical workstation is

available with the system. However,

mA is measured only for X-ray tube

and not for the multi-modality

workstation. In addition to that, max.

mA values of continuous fluoroscopy,

pulsed fluoroscopy and digital

Based on the needs of the Ministry, the

specification remains unchanged.

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exposure mode are defined and

requested at the specification items of

3.11.3., 3.11.4 and 3.11.5. To comply

with the technical specifications and


requested to revise the item as “Multi-

modality surgical workstation should

be available with the system.”.

117





118

To comply with the technical

specifications and participation in the

tender, it is kindly requested to revise

the item as “Multi-modality surgical

workstation imaging or pulsed

fluoroscopy should be able to reach at

least 24 mA to reach high level

modality in the system.

119


revised as “Multi-modality surgical

workstation imaging or pulsed

fluoroscopy should be able to reach at

least 8 mA to reach high level

modality In the system.”.

120 TS 3.15.21

The workstation unit in the device must have at least 1.5

processors, at least 4 GB of RAM, and at least 2 USB 3.0

compatible drives.

Our system has 4 USB 2.0 ports with

the system. To comply with the

technical specifications and


requested to revise the item as “The

workstation unit in the device must

have at least 1.5 processors, at least 4

GB of RAM, and at least 2 USB 2.0



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compatible drives.”.

121

Comparing the “Windows” based

systems, “Linux” systems are

specifically optimized for medical

devices according to the needs of the

device and they work with higher

performance without needing more

RAM or processors. Therefore, we

kindly request the item to be revised as

“The workstation unit in the device

must have at least 1.5 processors, at

least 4 GB of RAM, and at least 2

USB 3.0 compatible drives Tech or

unit should have Linux operating

system.”

122


revised as “The workstation unit in the

device must have at least 1.5

processors, at least 4 GB of RAM, and

at least 2 USB drives.”.

123


revised as “The workstation unit in the

device must have at least 1.5

processors, at least 4 GB of RAM,and

at least 1 USB 3.0 compatible drives.

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124 TS 3.16.2

There should be at least two 18 '' diagonal sized LCD or

TFT monitors in the system.

The brightness of the LCD monitor is

an important feature. Therefore, we

kindly request the item to be revised as

“There should be at least two 18 ''

diagonal sized LCD monitors in the

system and the brightness should be

at least 500 cd/m2”.



125

TS 3.16.3

Monitors should be on a separate transport stand, if

needed only the monitors should be rotated at 180°

without moving the tripod or the live image should be

rotated up to 180° in total with the touch control panel

displayed and they should be able to tilt.


revised as “Monitors should be on a

separate transport stand or the

monitors of the device must be able

close on each other.”.


Monitors should be on a separate transport

stand, if needed only the monitors should be

rotated at 180° without moving the tripod or

the live image should be rotated up to 180° in

total with the control panel displayed and

they should be able to tilt.


Dossier.

126



separate transport stand if needed only

the monitors should be able to rotate

up to 180 degree in total and the

height of the monitors should be

adjustable .”.

127



separate transport stand, only the

monitors should be rotated 180 degrees

without moving the tripod and should

be able to tilt or the live image should

be rotated up to 180 degrees in total

with the touch control paneldisplayed

and the monitors shall have a viewing

angle of 160 degrees (vertical and

horizontal).”.

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128

TS 3.16.5

Patient information, cumulative dose, kV and mA values

should be monitored on the test monitor at the touch

mobile imaging station during the procedure.


revised as “Patient information,

cumulative dose, kV and mA values

should be monitored from the

monitor on the mobile imaging

station during the procedure.”.


Patient information, cumulative dose, kV and

mA values should be monitored on the test

monitor at the mobile imaging station during

the procedure.


Dossier.

129


revised as “Patient

Information,cumulative dose,kV and

mA values should be monitored on the

display monitor mounted on a stand-

alone stand or on a stand-up bracket

separate from the C-arm system during

the procedure.”.

130 TS 3.17.1

2 foot pedal and 2 hand buttons will be delivered with

the device.

Foot pedal is integrated with the

system so, another second foot pedal

will not have any function for the

system. In addition to that, one foot

pedal and one hand button are already

requested at the specification item of

3.11.6. On the other hand, the system

configuration includes one foot pedal

only. Optionally, companies can also

provide remote control which also

helps user reviewing acquired images

and parking them on reference, also

magnification can be changed without

touching the system. Therefore, it

helps standard workflow very

efficiently. Please see what other

functions it has: Run loop, Overview

run/exam, Retrieve previous

image/run, Retrieve next image/run,

Park image on Reference monitor,



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Retrieve image from Reference

monitor, Protect image/release image,

SmartMask, Fluoroscopy mode

selection, II-format selection,

Subtraction on/off, Image grab. To use

public interest properly, it is kindly

requested to revise the item as “1 foot

pedal and 1 hand buttons and 1

wireless remote control will be

delivered with the device.”.

131 It is kindly requested to revise the item

as “1 foot pedal and 1 hand buttons

will be delivered with the device.”.

132


revised as “1 foot pedal and 2 hand

buttons will be delivered with the

device.” given such revision does not

make any clinical and functional

restriction.

133 TS 3.17.2

Radiation shielding with the following features and

amounts shall be delivered.

- 4 skirt-vest lead aprons which are easy to wear

(with touch fasteners on the shoulder) in sizes

of 1 large, 1 small and 2 medium sizes, which

don’t contain lead, the weight of which will be

at most 10 kg in 0.5 mm Pb equivalent or at

most 4 kg in 0,5 mm Pb equivalent.

- 1 adult male, 1 adult female and 1 pediatric

gonad protectors which do not contain lead in

0,5 Pb equivalent or equal to 0,5 mm Pb

- 2 adult, 1 pediatric thyroid protectors which do

not contain lead in in 0,5 Pb equivalent or equal

to 0,5 mm Pb equivalent.

To comply with the technical

specifications via our authorized

supplier, it is kindly requested to revise

the first bullet of the item as

“- 4 skirt-vest lead aprons which are

easy to wear (side adhesive instead

of shoulder), 1 large, 1 small and 2

medium sizes, which don’t contain

lead, the weight of these aprons

will be at most 8 kg in 0.5 mm Pb

equivalent.”.


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134 TS 3.18

Vertical radiation scattering for patient and user safety

when the system is in the upright position (image

amplifier at the top, bottom of tube) with a standard 20-

25 cm water conjugated acrylic phantom at 70-80 kV

voltage, at 2-4 mA current or at maximum power

according to IEC standard 30 cm from image amplifier

should not exceed 2.0 mGy/hour within the range 0 cm

to 50 cm or 1 mGy / h within 50 cm-100 cm range.

When the image amplifier is at the top and the tube is at

the bottom, 2.3 mGy/hour shouldn’t be exceeded when

the image amplifier 10 cm above the ground in 110 kV

voltage and 3 mA current. This measurement shall be

reported by the A-type inspection body of the Turkish

Accreditation Agency to the ISO 17020 standard

independent of the contractor following the installation

of the instrument.

The manufacturer companies have ISO

17025 standard for C-arm systems. To

comply with the technical

specifications and participation in the

tender, it is kindly requested to revise

the item as “Vertical radiation

scattering for patient and user safety

when the system is in the upright

position (image amplifier at the top,

bottom of tube) with a standard 20-25

cm water conjugated acrylic phantom

at 70-80 kV voltage, at 2-4 mA current

or at maximum power according to

IEC standard 30 cm from image

amplifier should not exceed 2.0

mGy/hour within the range 0 cm to 50

cm or 1 mGy / h within 50 cm-100 cm

range or at 120 kV voltage, at 2-4

mA current or at maximum power

according to IEC standard 25 cm

from image amplifier should not

exceed 10.0 mGy/hour within the

range 0 cm to 50 cm or 2 mGy / h

within 50 cm-100 cm range or when

the image amplifier is at the top and

the tube is at the bottom, 2.3 mGy/hour

shouldn’t be exceeded when the image

amplifier 10 cm above the ground in

110 kV voltage and 3 mA current. This

measurement shall be reported by the

A-type inspection body of the Turkish

Accreditation Agency to the ISO

17020 or ISO 17025 standard

independent of the contractor


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following the installation of the

instrument.”.

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135


revised as “When the system is in the

upright position (the image intensifier

is at the top and the tube is at the

bottom) the vertical radiation

scattering shall not exceed 2.0 mGy/h

at 0 cm - 50 cm or 1.0 mGy/h at 50 cm

- 100 cm at shooting at a distance of

30 cm away from the image intensifier

and at maximum power according to

the IEC standard or with standard 20-

25 cm water-conjugated phantom, 70-

80 kV voltage and 2-4 mA current or

when the image intensifier at the top,

tube is at the bottom, the image

intensifier shall not exceed 2.3 mGy/

hour at the 110 kV voltage , 3 mA

current, and at 10 cm height from the

flor or when the tube at the top, the

image intensifier is at the bottom or

when the tube at the bottom, the image

intensifier is at the top , the image

intensifier shall not exceed 2 mGy/

hour at the 110 kV voltage, 5,3 mA

current, and at 10 cm height from the

floor.”.

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136


revised as “Vertical radiation

scattering for patient and user safety

when the system is in the upright

position (Flat Detector at the top,

bottom of tube) with a standard 20-25

cm water conjugated acrylic phantom

at 70-80 kV voltage, at 2-4 mA current

or at maximum power according to

IEC standard 30 cm from Flat

Detector should not exceed 2.0

mGy/hour within the range 0 cm to 50

cm or 1 mGy/ h within 50 cm-100 cm

range or when the Flat Detector is at

the top and the tube is at the bottom,

2.3 mGy/hour shouldn't be exceeded

when the Flat Detector 10 cm above

the ground in 110 kV voltage and 3

mA current or when the system is in

the upright position (Flat detector at

the top, bottom of tube) fluoroscopy

shooting at a current of 20 mA at a

voltage of 125 kV, at a rate of 15 p/ s

(at 18x18cm) the tube have a height

of 10 cm should not exceed 2.5 Mg/

hour.

137 TS 3.19

The device and all external accessories must be

registered in the Product Tracking System.

The personal protective equipment is

regulated by 89/686 EEC Personal

Protective Equipment Regulations.

Therefore, there is no X-ray protective

apron, gonad protector, thyroid

protector etc. in the market which are

registered to Product Tracking System.

Therefore, we kindly request the item

Please be aware that the UPS’ are not

considered as accessories within the scope of

this article. Therefore, the item will remain

same.

Please be informed that all the medical

devices and accessories required to be

registered to Product Tracking System

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to be revised as “The device must be

registered in the Product Tracking

System.”.

according to the 93/42 EEC Medical Device

Regulations.

138 TS 3.20

The devices to be delivered by the contractor shall have

at least 5 (five) years of warrantee period after they are

accepted. The contractor is responsible for arranging the

warranty documents belonging to these devices in the

name of the administration and presenting their original

copies to the administration. In case it is not possible to

arrange warranty documents of the received devices in

the name of the administration, the Contractor is obliged

to present a document containing warranty undertakings

to the administration. The contractor shall undertake the

removal of the faults, defects and deficiencies

determined in the device under the scope of warranty

within the duration of the contract by the warranty

provider person or institution. In case this obligation is

not fulfilled by the contractor, the administration shall

deduct all cost for the provision of the warranty from the

receivables of the contractor or collect the costs by

forfeituring.

5 (five) years of warranty is demanded.

5 (five) year warranty can be given to

the devices. But after 2 (two) year

warranty period which is standard,

manufacturers is charging extra fee for

each year. In this case, we as

representatives have to add the price

difference arising from the extra

warranty period to our tender offer.

When the warranty period is 5 (five)

years, offered prices to the tender will

be higher than expected and market

price. After the standard 2 (two) year

warranty period of the devices, it will

be more advantageous for the user

institutions to make an annual

maintenance-repair agreement with the

authorized service of device.

In the item no 3.34 of the technical

specifications, the annual maintenance

and repair conditions (3% excluding

spare parts, 5% including spare parts)

is specified; the signing of a

maintenance-repair contract with these

conditions will be more effective and

in the interest of the institutions as the

service, authority brings the company

directly to the service provider.


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139 TS 3.21

During the warranty period, the seller shall remove the

defects of the manufacturing, assembly, material and

workmanship and the uncorrected defective parts shall

be replaced by a new one. During the warranty period,

there will be no charge for maintenance, repair and spare

parts.


revised as “During the warranty

period, the seller shall remove the

defects of the manufacturing,

assembly, material and workmanship

and the uncorrected defective parts

shall be replaced by a new one. During

the warranty period, there will be no

charge for maintenance, repair and

spare parts (excluding usage errors,

environmental conditions related

errors).


140 TS 3.22

During the warranty period, all software updates,

upgrades and re-installations will be made free of charge

by the contractor. The Contractor shall digitally deliver a

copy of all image processing, operating and service

software to be used in the system. The installation and

access limitation of these systems shall not be applied.

For the sake of terminological usage of

the terms, we kindly request the item

to be revised as “During the warranty

period, all software updates will be

made free of charge by the contractor.

The Contractor shall deliver together

with the system all image processing,

operating and service software to be

used in the system. The installation

and access limitation of these systems

shall not be applied.”.


141 TS 3.23

The Contractor shall carry out protective / preventive

maintenance and calibrations of the device and all

components (including accessories) at least four (4)

times a year for three (3) month periods in place.

Maintenance with remote connection will not be

accepted.

To ensure that the requirement is in

line with the period recommended by

the manufacturer, we kindly request

the item to be revised as “The

Contractor shall carry out

protective/preventive maintenance and

calibrations of the device and all

components (including accessories) at

least once (1) a year for in place.

Maintenance with remote connection

will not be accepted.


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142 TS 3.24

The Contractor shall perform periodic metrology

(testing, control, calibration, inspection, validation)

activities of the device and all components (including

accessories) during the warranty period, at least two (2)

times in six (6) month periods per year in accordance

with the Circular on Property and Service Purchase

Regarding Medical Devices and the Regulation on

Testing, Control and Calibration of Medical Devices and

Biomedical Metrology Activities Manual. The

Contractor shall not charge any additional fee for these

services during the warranty period.

The removal of this item is kindly

requested. The specification remains unchanged.

143 TS 3.25

Intervention time is at most 36 hours starting from the

date of fault notification. This duration starts when the

device malfunction is notified to the contractor or

authorized service by the related health facility or

affiliated institution. When a fault notification about the

device is made to the technical service, the device shall

be delivered in working condition within 3 working days

in case spare parts are not needed or within 5 working

days in case spare parts are needed. In case of spare part

change requires import permission, this duration shall

not exceed 20 working days after the intervention.


clause as follows “Intervention time is

at most 24 hours within official

working hours starting from the date of

fault notification . This duration starts

when the device malfunction is

notified to the contractor or authorized

service by the related health facility or

affiliated institution. When a fault

notification about the device is made

to the technical service, the device

shall be delivered in working condition

within 3 working days in case spare

parts are not needed or within 5

working days in case spare parts are

needed. In case of spare part change

requires import permission, this

duration shall not exceed 20 working

days after the intervention.”.


144 TS 3.26

If the device fault cannot be removed within 5 working

days after the intervention, the contractor provides

another device with similar properties to the

administration until the end of the repair process.


clause as follows “If the device fault

cannot be removed within 5 working

days after the intervention, warranty

period of the corresponding system


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should be extended by 1(one) calendar

day. The maximum extension is

limited to 45 days.”.

145 The article in question is requested to

be removed from the Technical

Specification.

146

TS 3.27

The device will be guaranteed a 95% uptime per year

during the warranty period. The device will be counted

down if the patient is not taken completely after the

initial intervention. If the 5% down time is exceeded, an

administrative fine shall be imposed in the amount of the

multiplication of the average of the total number of

transactions for the last 10 days of the device and the

maximum SUT transaction price for each working day.


clause as follows “The device will be

guaranteed a 95% uptime per year

during the warranty period. The device

will be counted down if the patient is

not taken completely after the initial

intervention . If the 5% down time is

exceeded, for each day of additional

down-warranty period of the

corresponding system should be

extended by 1(one) calendar day. The

maximum extension is limited to 45

days.”. The specification remains unchanged.

147


clause as follows “The device will be

guaranteed a 95% uptime per year

during the warranty period.The device

will be counted down if the patientIs

not taken completely after the initial

intervention. If the defective time

exceeds 5%,the warranty period will

be added free of charge for 2 days per

day.”.

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148 TS 3.31

Before the contract is signed, the contractor is obliged to

present the price list of all spare parts, accessories and

expendables including lifed parts with no exceptions in

the tender offer file, which will not exceed %150 of the

unit device price. All parts, the types or amounts of

which are not included in the price list of all spare parts,

accessories and expendables including lifed parts with no

exceptions by the contractor shall be provided if the

administration demands free of any charges.


clause as follows “Before the contract

is signed, the contractor is obliged to

present the price list of all spare parts,

accessories and expendables including

lifed parts with no exceptions in the

tender offer file, which will not exceed

%200 of the unit device price. All

parts, the types or amounts of which

are not included in the price list of all

spare parts, accessories and

expendables including lifed parts with

no exceptions by the contractor shall

be provided if the administration

demands free of any charges. In the

period covered by the commitment

(during the warranty period and for 5

years thereafter) in case of

discontinued I changed I new spare

parts and the condition is documented

by the manufacturer; the price of the

parts offered with the new codes shall

not be included in the first list of spare

parts provided, but shall be considered

by the Administration.”.


149 TS 3.32

Being under the %150 amount determined, all parts need

for the function of the device which are not included in

the list of all spare parts, accessories and expendables

including lifed parts with no exceptions shall be met by

the companies free of charge. The contractor company

shall deliver a list of all spare parts, accessories and

expendables including lifed parts with no exceptions to

all health facilities to which the device is delivered

before the contract is signed. Within the 5 years after the

warranty, if the health facilities demand spare parts,


clause as follows “Being under the

%200 amount determined , all parts

need for the function of the device

which are not included in the list of all

spare parts, accessories and

expendables including lifed parts with

no exceptions shall be met by the

companies free of charge. The


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accessories and expendables including lifed parts with no

exceptions, the demands of the health facilities shall be

met on condition that the financial amount defined in this

list being the upper limit. Sales cannot be offered by the

contractor by demanding any price or additional price

under the name of exception or out of coverage.

contractor company shall deliver a list

of all spare parts including lifed parts

with no exceptions to all health

facilities to which the device is

delivered before the contract is signed.

Within the 5 years after the warranty ,

if the health facilities demand spare

parts, accessories and expendables

including lifed parts with no

exceptions, the demands of the health

facilities shall be met on condition that

the financial amount defined in this list

being the upper limit. Sales cannot be

offered by the contractor by

demanding any price or additional

price under the name of exception or

out of coverage. In the period covered

by the commitment (during the

warranty period and for 5 years

thereafter) in case of

discontinued/changed/new spare parts

and the condition is documented by the

manufacturer; the price of the parts

offered with the new codes shall not be

included in the first list of spare parts

provided, but shall be considered by

the Administration.”.

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150

TS 3.34

If the hospital administration wants to make a

maintenance and repair contract after the warranty, it can

demand a contract;

- At the rate of %3 of the annual unit device cost

excluding the spare parts at most,

- At the rate of %5 of the unit device cost

including all spare parts at most. The contractor

company meets this demand immediately.


clause as follows “If the hospital

administration wants to make a

maintenance and repair contract after

the warranty, it can demand a contract;

- At the rate of %4 of the annual

unit device cost excluding the

spare parts at most,

- At the rate of %8 (excluding

tubes & detector) of the unit

device cost including all spare

parts at most. The contractor

company meets this demand

immediately . The repair and

spare part requirements arising

from user errors shall be excluded

from the scope specified. The specification remains unchanged.

151

We request exclusion of the spare parts

in imaging systems that do not fail

frequently and the sales price of which

accounts to a major portion of the

system's sales price, as exemplified in

the specifications of public tenders

published before. We kindly request

you to change the clause as follows “If

the hospital administration wants to

make a maintenance and repair

contract after the warranty, It can

demand a contract;

- At the rate of %3 of the annual

unit device cost excluding the

spare parts at most,

- At the rate of %6 of the unit

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device cost including all spare

parts (excluding tube and

detector) at most. The contractor

company meets this demand

Immediately.

152

TS 3.38

The device must have a heat exchanger system to save

heat.

Could you consider moving the item

under the main title “A.

GENERAL DESCRIPTION OF

THE SYSTEM” as the requirement is

technical.

The specification has been moved to TS

3.15.22.

Please be informed that it is finely confirmed

by the Ministry that “heat exchanger” feature

does not necessarily addresses only one

brand.

153

The desired “heat exchanger” feature

is only available on one brand.

Therefore, the other specifications

requested in the technical

specifications become meaningless and

only one brand device can participate

in the tender with this exiting

specification. Therefore we kindly

request the removal of this

specification.

154




follows “The device must have a heat

exchanger system to save heat or

“ILX” (Integrated Liquid

CoolingSystem) or similar systems.”.

155 TS 3.39

The data on the display of the device should be in

Turkish or the buttons should be expressed as symbols.





technical.

The current place of the specification deemed

sufficient.

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156 TS 3.41

The device must be capable of self-test. The test program

should detect the current fault and calibration errors in

the system, alert the users, and cover all electronic,

electromechanical and hydromechanical sections.





technical.

The current place of the specification deemed

sufficient.

157 TS 3.45

The hospital administration shall provide the electrical

system up to the instrument panel, the panel of the

device and the next system shall be installed by the

contractor company.

We kindly request the removal of this

item. The specification remains unchanged.

158 TS 3.46

During the installation, necessary ceiling, cabling on the

floor walls, channel operations, lighting of the device

room and control room and other decoration works will

be done by the contractor.

C-arm x-ray devices are often used in

operating rooms. Since they are mobile

type devices and they need to be

moved to different operating rooms for

different operations, they do not need

cabling, channel operations, device

room, control room lighting and other

decoration works in ceiling and floor

walls. Therefore, we kindly request the

removal of this item from the technical

specifications.

The specification has been revised as:

During the installation, necessary ceiling,

lead coating of the room (in line with the

requirements of TAEK), cabling on the floor

walls, channel operations, lighting of the

device room and control room and other

decoration works will be done by the

contractor.

Please also refer to the Changes No.2 to TD.

159 TS 3.47

The appropriate table and 2 rotating type adjustable seats

will be provided for the X-ray control room where the

system will be installed.

These furnitures are used in mostly

Control Rooms of Imaging Systems.

However, C-arm systems are used in

Operating Rooms so, there is not any

Control Room. On the other hand, C-

arm systems are mobile systems and

not installed in any specific room. To

use public interest properly, it is kindly

requested the item to be removed from

the technical specifications.


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C-arm x-ray devices are generally used

in operating rooms and they are mobile

type devices so they do not need a

suitable table for the control room and

a swivel type adjustable seat.

Therefore, the removal of the item

from the technical specification is

kindly requested.

160

TS 3.48

24,000 BTU power split air conditioner will be supplied

by the contractor for cooling the place where the devices

will be installed and will be delivered in working

condition.

Split air conditioners are used in

mostly Control Rooms and Technical

Rooms of Imaging Systems. However,

C-arm systems are used in Operating

Rooms so, there is not any Control

Room and Technical Room. In

addition to that, Operating Rooms

have their own laminar flow system

for ventilation in a sterile way. So,

standard split air conditioners might

affect Operating Rooms sterility

negatively. To use public interest

properly, it is kindly requested the item

to be removed from the technical

specifications.


161

Today, in every hospital, there is a

modern air conditioning infrastructure

to keep the ambient temperature at the

desired level. So the second one is

unnecessary. At the same time, an

extra air conditioner will raise the offer

price. Therefore, we kindly request the

item to be removed from the technical

specification.

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TS 3.52

During the acceptance and inspection, when the

companies are asked for the tests regarding the technical

characteristics and performance of the device, the

necessary personnel and equipment will be provided free

of charge by the companies. The seller is responsible for

accidents and damages that may occur during the

acceptance and inspection.


clause as follows “During the

acceptance and inspection, when the

companies are asked for the tests

regarding the technical characteristics

and performance of the device, the

necessary personnel and equipment

will be provided free of charge by the

companies. The seller is responsible

for accidents and damages caused by

its own personnel that may occur

during the acceptance and inspection.”.

162 TS 3.53

The necessary trainings are provided by the Application

Specialists for at least three (3) days to use all the

functions of the system. These trainings will be given a

total of three times during the warranty period.

Application Experts should also be certified by TCESIS

Clinical Support Staff. These documents must be

notarized and presented in the tender dossier.


clause as follows “The necessary

trainings are provided by the

Application Specialists for at least

three (3) days to use all the functions

of the system. These trainings will be

repeated once more free of charge if

requested during the warranty period.

Application Experts should also be

certified by TCESIS Clinical Support

Staff. These documents must be

notarized and presented in the tender

dossier.”.

Considering the needs of the Ministry the

request has been found unacceptable.

163 TS 3.54

Training for at least three (3) days for basic maintenance,

first level malfunction detection and repair (fault codes

and interpretation, foot pedal and hand button repair,

software settings) shall be provided to carry out the tasks

and operations specified in the service manual for all

functions of the system. These trainings will be given a

total of three times during the warranty period. Technical

Service Specialists must have the training certificate

issued by the manufacturer. These documents must be


clause as follows “Training for at least

three (3) days for determining the use,

basic maintenance, first level

malfunction detection shall be

provided to carry out the tasks and

operations specified in the service

manual for all functions of the system.

These trainings will repeated once

Considering the needs of the Ministry the

requests have been found unacceptable.

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notarized and presented in the tender dossier. more free of charge if requested during

the warranty period. Application

Specialists must have the training

certificate issued by the manufacturer.

These documents must be notarized

and presented in the tender dossier.”.

164

It is very important to carry out

maintenance, repair and failure

interventions to the Imaging systems

consisting of numerous units having

high technological value, by

authorized engineers trained by the

manufacturer because of patient

health,safety and system performance.

Therefore, the article is requested to be

removed from the Technical

Specification.

165 TS New -

Touch sensitive panel or monitors are

easy use features. Therefore, we kindly

request the insertion of the additional

item to the technical specifications as

“At least one of the monitors on the

stand or the control panel of live image

on the C-arm will be touch sensitive.”.

The current state of the TS has been found

sufficient.

166 TS New -

We kindly request the insertion of the

additional item to the technical

specifications as “Monitors on the

stand must have up / down vertical

movement, or monitors should be able

to move at least +/- 10 degrees tilt.”.


sufficient.

167 TS New -



specifications as “With the wireless

remote control in the system, it shall


sufficient.

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be possible to easily switch between

images, select image amplifier, select

fluoroscopy mode or call up images on

the separate stand and watch the live

image displayed on the C-arm

.Additionally live image rotation can

be done on the touch control panel or

on the touch sensitive monitor by

tapping fingertip.”.

168 TS New -



specifications as “The device must

contain an energy storage unit (ESU)

or a Boost Caps energy storage unit to

maintain the continuity of power

supply. Devices that make power

increase with battery system will not

be accepted. The companies will

display the features mentioned above

by marking them on the catalog with

their full name.”.


sufficient.