PET-CT Scanner

TATA MEMORIAL HOSPITAL

CENTRAL PURCHASE UNIT

Department: Nuclear Medicine, MPMMCC Varanasi

Technical Specification of PET-CT Scanner for MPMMCC, Varanasi, Total Qty. 1 No.

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

Sr. No Specifications Compliance Remarks

Country of Origin:

Year of Introduction:

Probable end of support:

I) Integrated PET and multi-slice spiral CT scanner of at least 16 slices: designed to provide accurate registration and fusion of high-resolution PET and CT images.

II) Should be capable of functioning as a CT scanner or PET scanner alone as required.

III) The CT component should comprise a whole body Multi slice CT scanner, capable of obtaining 16 slices or more per rotation.

IV) The PET component should be capable of imaging all applicable PET radio-pharmaceutical agents and have sensitivity of atleast 11 cps /kbq NEMA. The axial FOV must be of atleast 22cms or better.Higher axial FOV & Higher sensitivity is preferred.

V) All reconstruction algorithms and for image reconstruction must be made available, that are available for that product.

VI) Must contain advanced quantitation software with maximum value recovery possible.

A DETECTOR ASSEMBLY

1 Type: specify (LSO/ LYSO/ BGO)

2 Gantry aperture >=70 cm

3 Crystal Thickness 20 mm or greater.

4 Size of crystal 4mmX4mmX20mm or greater

B SYSTEM PERFORMANCE

1 Axial FOV should be 22 cm or more.

2 Transaxial FOV (cm) should be 69cm or more

3 No of image Planes should be >=79

4 Transverse resolution (mm) should be 3.5mm or better

5 Axial resolution (mm) should be 4.5 mm or better

6 Sensitivity (cps/KBq) NEMA 11 cps /kbq or better

7 Peak NECR should be 120 kcps or more

8 Coincidence window (nsec) should be 10 nsec or less

9 Scatter fraction should be 40% or less

The system should be capable of

1 Volume acquisition

2 Combined PET/CT operation protocols

3 Automated multi-bed acquisitions

4 Automatic PET initialization following CT

D Combined PET/CT whole body protocols

1 Store function for multiple user-defined combinations of CT and PET protocols.

2 Capability for arbitrary combination of Multiple CT and PET Protocols

E PET Exam planning

1 PET bed planning based on Spiral CT acquisitions

2 Selection and positioning of PET examination ranges on CT topogram should be possible

F Data Corrections and Reconstruction

The system should be capable of

1 CT based attenuation correction

2 Scatter correction

3 Decay correction

4 Deadtime correction

5 Detector efficiency normalization

6 FORE/OSEM reconstruction

G Image Display

Following features should be offered as standard

1 Whole body viewer with standing MIP views

2 Number of orthogonal views should be possible

3 PET-CT image fusion of co–registered data

H Maintenance and Quality control

1 Automated calibration of PET and CT detectors and electronics after placement of Ge 68 Phantom.

2 Automated daily quality assurance of PET acquisition system.

3 Acquisition of normalization and well counter calibration data.

1 Aperture: 70cms or more

2 Rotation Mechanism-Spiral/Axial/Helical

3 Scan Field should be 50cm or more

4 Rotation Time 360 degree should be 0.7 sec or less

5 Bi-way Patient Communication System - between console and Machine room should be possible

6 System should be having single integrated gapless gantry with least tunnel length.

7 Integrated cooling system with heat dissipation outside the Gantry Room

1 Maximum Power 50kW or more

1 MA range should be lower atleast 20mA or less and higher 340mA or high

2 Tube Voltage kV range should be 80-130/140

3 Anode heat storage capacity atleast 6.0MHU

4 Anode heat dissipation rate should be >800 KHU/Min

5 Computer Control anode temperature monitoring

D DETECTOR SYSTEM

1 Number of elements should be >17000

2 Detector coverage should be >19mm

3 Number of Detector Rows should be 16 or more

iii) PATIENT TABLE

1 Table should be made up of Low attenuating material

2 Scanable length (Metal free) with or without extender should be 190cm or more.

3 Weight bearing capacity of table should be 200kg or more.

iv) IMAGE ACQUISITION AND RECONSTRUCTION

1 Different type of acquisition mode for PET/CT : static, Dynamic and Whole body scan & ECG Gated.

2 Volume acquisition: 16 slices per rotation or more

3 Real time reconstruction should be >20 images / sec)

4 Slice thickness (mm) should be 0.75mm or less

5 Scan field of view should be 50cm for diagnostic

6 Extended Reconstructed field of view should be provided

7 Reconstruction matrix 512 X 512 or better

8 Real time dose modulated acquisition (modulation of X-ray beam according to patient anatomy) should be provided.

9 Metal Artifact Reduction software should be offered as standard

v) IMAGE DISPLAY

1 Dual Monitor 18 inch or more should be provided

2 Monitor type should be LCD/LED/TFT or better quality

3 CINE display facility should be provided

4 Filming (Interactive and automatic) facility should be provided

5 Monitor shall be of resolution 1280 x 1024

vi) PERFORMANCE OF SYSTEM (IMAGE QUALITY)

1 High Contrast Spatial Resolution >=15lp/cm at 0% MTF

2 Low contrast resolution should be 5mm or better (CATPHAN 20cm )

Vii) COMPUTER AND ARCHIVING CAPCACITY

1 Capacity of system disc (TB) >1 TB

2 Raw data (GB) storage should be > 800GB

3 Long Term storage (Preferably on CD-R) option should be made available

viii) SPIRAL SCANNING FACILITY

1 Longest continuous spiral scan time (at least 100 sec).

2 Fastest rotational speed should be 0.6 sec or less.

3 Minimum slice width (less than 1.0mm).

4 Length of continuous spiral scan with or without extender should be >190cm.

5 Image quality (should be constant for the complete length of the spiral scan).

6 Pitch range between 0.6 or less and 1.7 or more

ix) CLINICAL APPLICATION – SOFTWARE

(These functions should be possible from Main console 1024x1024matrix).

1 3D Reconstruction and Display.

2 Shaded surface display.

3 Maximum intensity projection.

4 Minimum intensity projection.

5 Volume rendering technique.

6 Cine Display.

7 CARE Bolus / Smart prep./ Any other equivalent facility.

8 Real time Multiplanar Reconstruction and display.

9 Volume measurements of tissues and organs.

10 Quantitative lung evaluation either in console or in workstation (at least one workstation should have it).

11 Pre and post processing filter functions.

12 CT angiography with rotation facility.

13 CT perfusion multi organ.

14 Advanced vessel analysis for vessel and lesion quantification either in console or in workstation.

15 Fly-through image software for airways, bowel (colonography) and vessels.

16 Multi-modality image fusion (CT/MR, CT/PET), PET/MR

17 Pediatric protocols.

18 Any other clinical application including those under development and on offer.

19 Application software for followup PET CT Scans using PERCIST/RECIST criteria.

20 Brain 3D SSP software with FDG normal data base with Z-score Images.

21 Processing software for dynamic PET

x) DICOM CONNECTIVITY

1 Dicom Ready for integration with PACS Systems

2 The System should be compatible with HIS/RIS

xi) WORK STATIONS

1 Total no. of workstations should be 3 excluding console.

2 Should have display matrix of 1024x1024, with colour monitor with RAM that should be compatible or supportive for 4D scan.

3 Software for Multiplanar and 3D image reconstruction in Gray scale and colour, CT angiography.

4 Having maximum and minimum intensity projection, volume rendering, multi-modality image fusion, and fly-through image software.

xii) PERIPHERALS

1 Lead Lined Foot Operated Waste bins for PET Qty:- 2 Nos.

2 Lead POT compatible for F18- FDG Vial.

3 Automatic pressure injector for contrast injection- Dual head:- 1 Nos. with 100 syringes

4 UPS at least 30 min back-up for 3 Workstation .

5 Desktop PC with latest specifications, Qty:- 3 Nos. (i7,16GB ram, 24" display, SSD 512 GB, windows 11).

6 Lead shield for Daily QA phantom or pin source, Qty:- 1 Nos.

7 Lead Apron, Qty:-1 Nos.

8 Long Forceps and Tongs, Qty:-2 Nos. each.

9 Lead Syringe Carrier for F-18 FDG, Qty:-2 Nos.

10 Pocket Dosimeter, Qty:-1 Nos.

11 Survey cum contamination monitor, Qty:- 1 Nos.

12 Survey Meter Ionisation Based, Qty:- 1 Nos.

13 Radiation Stickers set, Qty:- 1 Nos.

14 Lead Single Syringe Holder for PET, Qty:- 3 Nos.

xiii) OTHER REQUIREMENTS

1 Various positioning aids

2 Infant immobilizers

3 Quality Assurance phantoms & Tools for CT & PET: PET- CT Registration Phantom 1 Qty & Daily QA PET Phantom 1 Qty Should be Provided. Phantoms required for AERB Acceptance tests has to be taken care by Company during the test by the OEM.DQA Phantom for scanner to be provided included in CMC including return of phantom after useful life for 10 years during warranty and CMC

4 Multiple number of users definable scanning protocols

5 Extended patient scheduling facility

6 Manuals & other charts

7 All the software related to the system should be handed over to USER.

8 Service toolkit should be provided to Biomedical Engineering department.

9 Service training to be provided to Biomedical Engineers.

10 The bidding company should ensure OEM/direct Affiliate service support based in the country & OEM application support based in the country to ensure better quality from experienced team & shorterd own time considering the patient flow in the hospital.

● INSTALLATION REQUIREMENT

1 Physical Dimensions and Weights.

2 CT- PET Gantry.

3 Auxiliary cabinet.

4 Patient Couch.

5 Control Console & monitors.

● ELECTRICAL REQUIREMENTS

2 - Standby mode.

3 - Ready mode.

4 - Beam ON mode.

5 Power consumption.

6 Voltage line-to-line / 3 phase.

8 UPS details for CT & PET.

9 Voltage stabilizer.

● Performance parameters should as per latest NEMA NU2 2001

● Should provide AERB Type approval for quoted model.

● Please submit the floor plan for installation and commission.

● Should provide AERB NOC for quoted model.

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

● Should perform yearly calibration and preventive maintenance (2nos) during warranty & if entered into AMC (includes unlimited breakdown calls) /CMC (which will include spare replacement, breakdown calls) Testing & measuring equipment used should be traceable to SI units through National / international standards ( As per NABL norms). To submit SOPs for PMS at the time of installation/commissioning.

● Please specify footprint size & weight.

● Demo of the quoted model , will be required if so desired by the user, after the opening of the technical bid and prior to opening of financial bid. This is for technical evaluation.

● Predispatch inspection at factory will be required if desired by authorities.

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

● The unit should comply with CE /FDA/BIS/ICMED marking.

● Local Service Support: Should have local office and service support/service engineer for attending the breakdown calls.

● Response Time: Should not be more than 12 hrs from lodging a breakdown complaint on toll free or by email.

● Back to back assurance to be taken by the supplier from the OEM to supply spares for minimum 10 years and to be submitted.

● Installation, Commissioning, testing and Training

● Unpacking and Shifting the consignment to the installation site is to be included in the scope of supply. Bidder/manufacturer/authorized service provider should take responsibility to lift/shift the consignment from unloading site to the installation site . Unloading site shall be "Stores Department, MPMMCC Varanasi". If needed, Bidder has to arrange for the labourers at no charge to MPMMCC Varanasi. (Before submitting the quotation, bidders may visit MPMMCC Varanasi to know unloading site and installation site).

xiv) Warranty: 2 years

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 update of sotwares, 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.

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 update cost sotwares, 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. No extra cost will be payeble for service kit/PM Kit/Maintainanc kit, it should be covered under CMC.

xv) 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 HBCH & RC, Punjab 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.

Preventive maintenance on Saturdays/Sundays

xvi) TRAINING OF STAFF

1) Nuclear Medicine Physician: – 2 Weeks.

2) Scientific Officer:– 2 Weeks.

3) Scientific Assistant: – 2 Weeks.

xvii) Installation related Work and Site (Machine Room) Readiness

1 Installation related Work and Site (Machine Room) Readines work includes the provision of Electric Power Points, IT Points in Machine room and Console area which are required after installation for functioning of PET CT.

2 Beautification work of Machine room which inludes wooden smooth wall paneling with lights(Area of Machine room L xB xH 26'3'' X 16'11'' X 12' ) , false ceiling skylights with wallpaper.Skylight - ( Gantry Room ) - Providing and fixing of Skylight of translucent acrylic sheet of approved print design on exposed face ( 4' x 6' ), with box frame made with 18 mm ply covered with approved laminate on all exposed edges and shall be back lit with LED strips as per specifications and drawings, with all fitting, wiring & framing accessories necessary. skylight shall be flush to flase ceiling (The work shall include all material, fixing, wastages, labour, all lead and lifts at all levels, loading and unloading, transportation and other incidental charges, cleaning after completion, removal of excess material and debries from site to nearest waste collection etc.,complete as directed by the Engineer-in-charge.)

3 Internal Electrical wiring from UPS to machine room/console room and Electrical panels in UPS room/ Machine room which are required during installation of PET CT machine and electrical earthing for machine will be the responsibility of bidder.(room layout map attached for reference)

4 Any wear and tear to the building in the process of installation will be taken care by the bidder only.

5 Removal of installed tiles from the Machine room, Self leveling , preparation of base to install machine and vinyl flooring approved by the engineer incharge in the machine room and cable trench with proper finishing as required for installation is the responsibility of the bidder.

6 Any other pre requisite for the installation not mentioned here will be the responsibility of bidder.

7 Bidder are requested to visit the site before quoting in the tender.

xviii) Online UPS with isolation transformer/IGBT of adequate capacity for complete unit (with back to back full load of the unit) including 30 minutes back-up using maintenance free batteries.

1) If 2 years warranty, 8 years CMC and buyback conditions wherever applicable are not adhered to, TMC reserves right to reject offer.

2) Please mention whether UPS is required for the equipment. If so, should be included in the offer.

3) Only yes or no should be mentioned in the compliance report and additional info in remarks column.