CT Scan 128 Slice Simulator Wide Bore Flat Bed

Ref: Tender No:

TATA MEMORIAL CENTRE

CENTRAL PURCHASE UNIT

TECHNICAL SPECIFICATION OF :- - " CT SCAN 128 SLICE SIMULATOR WIDE BORE FLAT BED”, Qty: 01 "

Intended Use: 128 Slice - or more CT Scan for imaging, image guided procedure & Radiotherapy simulation

Please quote the model which is including the latest state of art equipment and meets the basic minimum specifications. The quoted model should be latest introduced with end of life not before 10 years from the date of installation at TMC.

Name of the Vendor :

Sr. No. Technical Specifications / Scope of supply COMPLIANCE 1) Mention "Complied /Not Complied" 2) Highlight any deviations. 3) Mention part number/Catalogue number of the relevant item quoted. REMARK

i Name of the Manufacturer :

ii Country of Origin:

iii Model Name / Model No. of the Equipment (If the equipment is a combination of more than one equipment then list down the model no. pertaining to each)

iv Year of Introduction Internationally

v Year of Introduction in India

vii Technical Specifications/Scope of supply

viii "MULTI-DETECTOR CT SCAN system" , complete as per below mentioned configuration and specifications:

xi Features and specifications required:

x Multi-slice Multi detector CT scanner should be of latest generation capable of 128 slices or more acquisition/generation per 360 degree rotation. The machine should have latest Iterative reconstruction method to reduce dose. The machine should be capable of Dual energy Applications.

xi The tenderer should offer their Top of the line latest generation scanner which meets the specification

1 The CT Scan Should have low voltage slip rings incorporated in the gantry.

2 The minimum scan time for a 360 degree rotation should be 0.35 sec or less. There should be choice to select Different scan times.

3 The gantry has a tilt of +/- 20 degrees on either side and remote tilt should be available.

4 The gantry should be provided with user control panels on either side for easy positioning.

5 The gantry should have 3D laser positioning lights.

6 The scan field of view in acquisition mode is from 200mm to 500 mm intermediate steps for scanning different anatomies.

7 Aperture is 70 cm in diameter or more.

8 Please mention the parameters that are displayed on the front side of gantry.

B X- Ray Generator:-

1 The X-ray generator should be High Frequency type.

2 The generator should be compact and in built in the gantry.

3 The system x-ray power should be 70 kW or more.

4 The X-ray cooler is built in the gantry.

5 It should have a pediatric protocol. Mention details of this protocol.

1 Anode Heat Storage capacity of at least 7 MHU or more.

2 Mention cooling rate in KHU / minute

3 Specify the focal spot size as per lEC standard.

4 Tube current should be 600 mA or more

5 Tube voltage should be between 80 to 140kV/p. It should have a pediatric protocol.

D Detectors ( Data Aquisition System ) (Stellar /Clarity/Nanopanel Elite/Pure Vision Optics)

1 The detector offered should be solid state array.

2 In one rotation it should be capable of performing 128 slice scan or more.

3 Mention no. of Reconstruction or projections

4 Minimum number of rows of detectors should be 64 or more

5 Mention details of Axial Acquisition mode

6 Mention details of Spiral Acquisition mode

E Patient Table

1 The patient table offered should have a minimum load bearing capacity of atlest 200kg.

2 Mention Horizontal travel and speed of table.

3 Mention Vertical travel and speed of table.

4 Metal free scanable range should be 150cm or more.

F Spiral Acquisition

1 Spiral acquisition should be minimum 0.35 sec or less.

2 Mention minimum slice thickness in Spiral acquisition mode. Specify entire range.

3 The system offered should have continuous spiral capacity of at least 60 sec and above.

4 The range of spiral facility in axial direction should be more than 100 cms.

5 The reconstruction time in spiral scan should not be more than 0.1 sec.

6 The system should have the smart mA or equivalent facility or ability to track contrast medium to trigger scan should be included in the scope of the supply.

7 System should perform Tilt Spiral Scan as standard at any of the chosen angles in 128 slices /rotation acquisition/generation.

8 High resolution scan package of 0.63 mm or less should be offered as standard.

9 Latest iterative reconstruction technique launched by company used for low dose scanning should be offered as standard.

10 Pitch factor 0.2 to 1.5

G Computer section:

1 Computer offered should be the latest multitasking processors and a menu driven platform with a RAM size of at least 64 GB.

2 The display matrix should be at least 1024 x 1024 or better.

3 The reconstruction time for a axial scan should be more than 0.1 sec.

4 Standard amount of computer RAM should be at least 64 GB.

5 Please specify the hard disk capacity for the console for both images and raw data.

6 It should have facility to store a least 400000 (512 x 512) images.

7 External media option: DVD, CD, USB-HBB, and Memory stick.

8 DICOM facility to send, store, print receive etc should be standard.

9 PC based connectivity should be standard for easy transfer of images and report.

10 Additional OEM based work station with archival as well as DICOM print should be included in the scope of supply.

11 The system should have standard software like isotropic 3D volume rendering, MIP, CT angio display, virtual endoscopy, colonoscopy, Brain perfusion,Dental, should be available. as standard on the main console as well as work station.

12 The following software should be offered as standard (MIP, MPR, SSD, ROI, VOLUME, CALCULATION, CT NUMBER DISPLAY, WINDOW WIDTH, WINDOW LEVEL, TOPOGRAM DISPLAY, CINE DISPLAY, HRCT LUNG, DYNAMIC SCAN, ONCOLOGY SPECIAL PROTOCOL)

13 Stenosis measurement, wall motion analysis, etc should be possible on the main console or workstation.

14 Automatic display of MPR images after scan is required.

15 4DCT :- Software: -4DCT data acquisition software, Retrospective and Prospective acquisition -Retrospective and Prospective acquisition -Phased and amplitude based acquisition -Binning of various phases -Export to existing/any: network, Treatment planning system, treatment unit Hardware: -Interface for existing motion management: network, treatment planning system, treatment unit.

H Image Reconstruction section:-

1 Real time display of 512 x 512 matrix

2 Slice thickness 0.625 to 10mm.

3 Reconstruction field of 5 to 50 cm

4 Reconstruction time of 23 images / second or better.

5 Direct generation of Axial, Sagital and coronal images from standard scan protocols

1 The system should have a resolution of at least 16 Line Pair / cm and +/- 10% at standard parameters and using CAT phantom in X-Y direction for entire width of detector.

2 The low contrast resolution should be atleast 5 mm or better at 3 HU with 10mm slice on 20cm Catphan phantom. Please mention the dose at which the resolution is achieved.

3 Artifact suppression protocols to maintain LCR at low dose should be standard.

4 Specify the CT dose index.

J DOSE REDUCTION TECHNIQUES

1 There should be pre-patient collimation to reduce unnecessary dose to the patient.

2 Advanced Iterative Reconstruction with dose reduction capability should be offered as standard.

3 Advanced dose limiting technology for critical organs should be offered as standard.

4 Pediatric & infant Imaging protocols for Low dose scanning must be provided.

K Clinical Application:

1 Automatic Bone removal software.

2 Cerebral angiography package with Automated 3D assessments of infarcted tissue and tissue at risk, Automatic Table and Bone Removal, Best Plane, fast toggling, lesion picking, recalculation mode, follow-up workflow.

3 Virtual endoscopy (Colonoscopy and bronchoscopy flythrough).

4 Volume rendered technique.

5 Neuro Perfusion of brain.

6 Perfusion of Body

7 CT Angiography

8 Bolus Tracking software

10 Lung Nodule analysis

11 Metal Artifact Reduction

12 Calcium scoring.

13 Automatic calculation of vessel stenosis.

14 Triple rule out study.

L Image transfer / Networking:

1 Interface for transfer of medical images and information using the DICOM standard. Facilitates communication the devices from different manufacturers.

2 DICOM Storage (Send/Receive)

3 DICOM Query/Retrieve

4 DICOM Basic print .

5 DICOM Get Worklist (HIS/RIS)

7 DICOM Storage Commitment

8 DICOM Viewer on CD .

9 Interfacing with the existing PACS and Hospital information system will be vendors responsibility

M Regulatory Requirment : please enclose copies:

1 Please specify whether equipment is US FDA approved. Please attach 510K certificate.

2 Please specify whether the System fulfills European CE /ICMED/BIS criteria. Please attach certification document.

3 AERB approval for the quoted model is mandatory. Please attach certificate.

4 The vendor should assist and facilitate site approval , registration , licensing and certification of the facility by AERB.

5 Vendor should not be blacklisted from any govt institution or Judicial or semi judicial authority. An affidavit to this effect should be submitted.

N Standard accessories:

The following essential accessories to be provided with the unit:-

1 Bidder to provide OEM workstation Qty -01 with desktop computer qty-01 in addition to console for reporting puprpose

2 Complete hemodynamic Monitor 12 " Display with IBP , NIBP , ECG ,EtCO2 , SpO2 , Temperature ,Invasive Pressure transducers ,Slave Monitoring option enabled ( Softaware and hardware as standard ) , with battery backup

a) Invasive Pressure transducers :4 no.s

b) SPO2 Probe : 01 Adult , 01 Pediatric

c) Temperature Probe - 2no.s,

d) Slave display on the main monitor

e) 5 lead ECG cable : 2no.s

f) EtCO2 Module :-01 nos

g) NIBP cuff :- Adult 02 nos , pediatric 02 nos

h) NIBP cable :- 01 nos

i) Monitor stand / mount ( Monitor will be mounted on anesthesia machine )

j) Slave monitoring should provided with slave display at the CT console area .

3 Anesthesia Workstation -01 Qty

a) Durable with a sturdy kit.

b) Antistatic wheels with brakes

c) Shelves for monitors

d) The anesthesia workstation should have in built ventilator with min. 6'' TFT display.

e) Gas delivery system:

i Gas specific high pressure blocks.

ii Non interchangable gas supply inlet for cylinders with step down regulators

iii Pressure reducing valves.

iv Color coded indexed gas supply hoses.

v Provision of additional O2 port for powering a ventury device.

vi Provision for manual as well as mechanical ventilation.

vii Provision for both open as well as closed circuit.

viii Provision for attachement of 2 cylinders one each of O2 and N2O cylinders.

ix Provision to monitor the expired gas volume, O2 monitor sensor probe along with all the tubings and connections with alarms.

x Ability to monitor the expired TV/minute volume,respiratoy rate and FiO2

xi Quick and easy change over form open circuit to closed cicuit and vice versa.

xii Ability to bypass the soda lime canister and convert to an open circuit.

xiii Provision for emergency flow of 100% O2 under high pressure through both circuits.

xiv Audible and visual alarms for airway pressure, disconnection, oxygen failure.

f) Flow meters:

i For oxygen, nitrous oxide and air with safety feature

ii Oxygen failure alarm, audible and visible

iii Anti-hypoxia safety mechanism to ensure that O2 concentration doesn’t fall below minimum 23% at any time.

g) Vaporisers: 2Nos with each Unit

i Should have provision to connect two vaporisers.

ii Vaporiser safety lock.

iii Vendor Should provide Vaporisers-2Nos (isoflurane-1No,sevoflurane-1No)

h) Ventilators:

i Ventilators for controlled ventilation of adults as well as children

ii Volume contorlled/pressure controlled/Pressure Support.

iii Inbuilt PEEP administration.

iv Provision for manual and mechanical ventilation

v Monitoring for airway prsesure- Peak and PEEP, plateau

vi Provision to monitor expired gas volume, O2 monitor sensor probe along with all the tubings and connections with alarms.

vii Ability to monitor the expired TV/minute volume, tidal volume, respiratoy rate and FiO2

viii Tidal volume delivery should be in the range from atleast 20ml-1400ml

ix Respiration rate: 4-60 bpm (or more)

x PEEP setting: upto 20 cmH20

xi Peak pressure setting upto 50cmH20

i) Breathing system:

i Should have integrated CO2 absorber with easy removal and refitting during the operation.

ii Should be autoclavable at 134 deg C.

iii Should have APL valve, inspiratory valve, expiratory valve.

iv should have mechanism to prevent moisture condensation (eg. Heating circuit or equivalent )

v Should work on mains Power and with battery backup of 45 minutes minimum with fully charged batteries

j) International standards : The unit should comply with international standards and should have markings of European CE/USFDA/BIS/ICMED and the bidder should submit a copy of certificates.

k) Gas monitoring: It should have inbuilt gas monitoring for CO2, N2O, O2 and Anesthesia agent for inspiratory and expiratory values. It should be to monitor and display MAC value on the screen.

l) The financial bid should include all the essential accessories

m) Open and closed circuit for both adult and pediatric

n) Venturi system need to be provided

0) Essential consumables:

i AGM Water trap, Sample line-10 nos

ii Mask No. 3 & 4 - 1+1 each

iii Sodalime Box -1 box

4 For Radiation Protection:-

a) Wrap around lead Aprons of -06 nos (Zero lead or equivalent)

b) Coat Apron of -10 nos (Zero lead or equivalent)

c) Thyroid Collars of -10 nos.(Zero lead or equivalent)

d) Lead Glass window for console room 150 x 200 cm - 2 number.

e) Lead Goggles - 05 No

f) Gonadal Shield - 2 nos

g) Paediatric Gonadal Protection- 02 No

h) Head Shield - 05 No (Zero lead or equivalent)

i) Mobile Apron Hangers (for 10 aprons) - 02 Nos

j) Should comply to US FDA/ European CE/ BIS/ ICMED certification. Please attach copy of the certificate(s).

5 Bi Phasic Defibrillator with ECG , AED mode AND inbuilt pacing mode .

6 Dehumidifier of 110 Litre - 2 Nos.

7 Patient Support System (Indexed Couch) :- -Carbon fiber flat table top -Vertical limits & accuracy(≤ ± 1 mm) -Total longitudinal travel (Please specify the range) -Horizontal limits & accuracy(≤ ± 1 mm) -Speed -Controls -Compatibility with Radiotherapy Machine(LINAC available) -AAPM TG 66 compliance

8 CT Accessories (Positioning and QA devices) :- One Set of 3 external Static LASER System

9 Water Bath/ Oven (with adjustable temperature settings):- 01 QTY Dimensions suitable for 6 clamp Abdomino-Pelvic thermoplastic mould. (provide make and specifications).

10 "DUAL HEAD INJECTOR " , complete as per below mentioned configuration and specifications:

Features and specifications required:

1 Flow Rate should be 0.1-10.0 mL/sec

2 Maximum Pressure should be 300 psi

3 Contrast Heat Maintainer should be 37°C ± 4°C, 5 W

4 Maximum Volume should be 190ml

5 Manual fill rate should be Up to 10 ml/s

6 Auto fill Rate should be Up to 10 ml/s

7 Number of Phases should be 6

8 It should be integrated with Wireless communication (WiFi) between console room & Scan room modules.

9 It should Colour touch screen on injector head at least 7" or better as well as on console room display .

10 It should have facility to inject contrast & saline simultaneously.

11 It should have built In eGFR calculator.

12 It should have facility to upgrade with 'Weight based dosing' protocol.

13 It should have facility to store injection history upto 100 records.

14 Injector Should be operable on mains as well as rechargable Battery.

15 Quantity of consumables is given below . Price should be quoted in the finacial bid and the rate should be appilicable for 2 years.

:- The vendor should supply the 200 set of consumables( syringes + connector tubings ).

XIII Other requirements:

1 Main Gantry system , UPS , Equipment room pannels should get occupied in given space as per layout shared . Please find attached layout plan .The vendors should inspect the site before quoting and ensure that the unit and all accessories can be installed in the available space without any functional compromise.

2 Live Demonstration of the equipment is required.

3 Please provide a list of installations of the quoted model.

4 Please submit the floor plan for installation and commission.

5 The Equipment/ System should comply to US FDA/ European CE/ BIS/ ICMED certification. Please attach copy of the certificate(s).

6 Should provide AERB NOC for quoted model.

7 Should provide AERB Type approval for quoted model.

8 The institute shall apply for AERB approval for layout and the tenderer shall facilitate in getting the same for institute.

9 Must provide online UPS with isolation transformer of adequte capacity for the complete systems. With minimum 15 minutes back up. SNMP card should be provided with the UPS as a standard. SNMP card should have a facility remotely examine/access the battery charge levels , input & output voltage , frequency, temperature ,alerts,alarms and other characteristics .

10 Training to be provided to Doctors , technicians and Biomedical Engineers.

11 Service tool kit hardware & software should be be kept on site to reduce down time.

12 All the software related licence, keys to the system should be handed over to USER.

13 Performance certificate from five govermrnt institutes is mandatory.

14 Please specify pre installation requirements (electrical, HVAC etc.)

15 Please specify footprint size & weight.

16 Please visit the site to check whether quoted model can be accomodated in the available space.

17 Please specify power consumption.

18 Vendor has to provide complete design for entire turnkey work related to the said equipment with concurrence of OEM .Vendor will also be responsible to vet the design and BOQ prepared by the turnkey agency / ACTREC.

19 All Necessary standards and norms. (As applicable).

20 Local Service Support: Should have local office and service support/service engineer for attending the breakdown calls, please provide the address along with list of engineers, their lacation and contact details in India.

21 Response Time: Should not be more than 06 hrs from lodging a breakdown complaint on toll free or by email.

22 Warranty: 2 years comprehensive-on site- Factory warranty for the entire equipment system. Warranty will cover the complete system inclding X-ray tube, Detector, Hardware, software and third party supplies. All bought out items used in system should also be included in the warranty. Warranty should include upgrades / update of sotwares and Hardware, No separate software licence fees will be payable should also cover 2 years factory warranty from respective manufacturers. The vendor should perform 4 nos. of preventive maintenance services/ year and QA/QC as per AERB prescribed protocol during the warranty period.

23 Comprehensive Maintanence Contract(CMC): Vendor to qoute for cmc for 8 years post 2 yeas warranty. CMC should include 4 preventive maintenances/ year and all breakdown visits. CMC will cover the complete system inclding X-ray tube, Detectors, Hardware, software and third party supplies allied equipment by the vendor. All bought out items used in system should also be included in the CMC. CMC should include upgrades / update cost sotwares and Hardware, No separate software licence fees will be payable. Should include QA QC annually as per AERB noms.Planned preventive maintenance and other planned maintenace activity should be done on Public Holdays and on Sundays.

24 PENALTY CLAUSE

The supplier and / or its Indian agent will be required to give the guarantee towards the performance of the equipment during the warranty period and in case of comprehensive annual maintenance contract period for maintaining the equipment in good working condition for a period of at least 300 days out of a period of 365 days a year (i.e. 95% uptime) 24 X 7. The ten hours non-functioning of the equipment or any part thereof will be considered as one day downtime. Total 3000 hours in a year will be considered as Uptime guarantee. Working time is 8.00a.m. To 6.00p.m. On week days and 8.00 a.m. To 4p.m. for Saturdays. The equipment shall be fully functional as part of the uptime and if it is partly functional it shall be considered as downtime and deduction shall be made on Pro-rata basis i.e. if the equipment is 70% functional & 30% downtime shall be applicable. The decision of the TMC management or its representative in determining the % of the downtime shall be final and binding. Essential period to shut down the installation entirely or partially shall also be included in the downtime while calculating the 95% guaranteed uptime i.e. all features as per specifications in purchase order should be functional for uptime. The supplier/agent shall be required to pay a penalty of 0.1% of total cost (Ex works) of equipment per day per machine excluding 150 hours permissible downtime. This rate shall increase commensurate with the rate increase of CMC. If the number of days downtime in each period of 365 days is more than the downtime permissible (which is to be calculated as defined above), the delay for not bringing the equipment in functioning order in any way, directly or even partially will be attributable to the firm. The bidder should provide the details of preventive maintenance to be undertaken through the year. Preventive maintenance to be done on public holidays & on sundays only. Preventive maintenance and breakdown will not be clubbed. The bill should be raised quarterly and will be paid at the end of every quarter only. If system is unserviceable for patients in its full capacity (full capacity : all features as demonstrated during commissioning) for more than 7 days at a stretch then these additional days exceeding 7 days will be considered as “downtime” and to levy penalty will be the discretion of Director TMC irrespective of 95% overall uptime in a year. This clause is to ensure maximum uninterrupted service to patients and hence Director, TMC’s decision in enforcing / invoking this clause will be final and binding for all. For CMC, W.O. issued by TMC shall be final as per D.A.E. Norms. TMC & its units shall not sign separate legal contract as per vendor’s format.

25 Important terms to be noted by the bidders:

a) Read the above scope of supply carefully and quote accordingly. Incomplete and /or partially complete offers are liable to be rejected.

b) Manufacturer/bidder should clearly indicate typical life span / Life expectancy of the quoted equipment.

c) Item/Equipment quoted should not be a second hand/refurbished/on verge of obsolescence/outdated model. Similarly, after award of contract, the item supplied should be a newly manufactured item .

d) After opening of the Technical bid (Part-1), Physical demonstration of the quoted model may have to be shown / arranged by the bidder, if requested by the Institute. Physical demonstration may be shown at one of the end user’s site/Principle company’s application lab/manufacturing site located in Mumbai/Navi Mumbai/Thane cities within 10 days from the date of request. Physical Demonstration may be requested to confirm the availability of any or all technical features as mentioned/stated in the technical bid. Physical Demonstration will also be a part of technical evaluation process. If the bidder does not comply, such bids are liable to be disqualified. (Demonstration of quoted model is to be shown and not the demonstration of similar models with different technical specifications and features)

e) Past experience of the bidders in terms of quality of supplied equipments, after sales service and application support will be taken into consideration while technical evaluation.. Bidders who has unsatisfactory past experience in any of the TMC/DAE unit in last 2-3 years, in terms of quality of supplied equipments, after sales service and application support, bids of such bidders may liable to be rejected.

f) Complete and detailed information should be provided in respect to each point specified in the specifications. Technical bids that are incomplete in any respect are liable to be rejected. Provide relevant supportive information, publications, catalogue, etc. Bidders providing misleading or wrong information are liable to be rejected. All technical claims should be printed in the technical brochure of the equipment.

g) If any contradictory statements /figures/information is observed in the compliance chart and in the technical bid, then the technical information mentioned in the product literature/brochure will be considered true and further evaluation will be done based on the information given in the product literature/brochure. Regarding the warranty and CMC terms, information quoted in the technical bid will only be taken as valid terms.

h) Compliance column may be filled with relevant data, figures, range etc. as applicable. Do not just mention "YES / NO / Complied ".

i) Declaration by the bidder

j) We have quoted for all the items meeting the description/scope of supply in the Financial bid as per prescribed format of the Tender documents and we agree that Partial/incomplete offers are liable for rejection.

27 L1 Calculation

L1 will be based on cost of the entire system and 8 years CMC cost including accessories and other support eqipment at landing cost at ACTREC ie. Equipment cost, applicable taxes and duties, transportation & insurance charges, installation charges along with 2 years warranty cost.