EOI FOR TOMO MAMMOGRAPHY

Tomo- Mammography System consisting of exposure stand with attached swivel system, separate console with radiation shield, automatic exposure control and mammography X-Ray Tube.

Equipment should be upgradable to Contrast Enhanced Mammogram, stereotactic biopsy and latest AI solutions.

An integrated Full Field - Digital Flat Panel Detector .

The workstation should be able to send, receive and print according to DICOM standards.

The workstation should also be able to obtain DICOM modality, work list from connected information system and send information about performed procedure to the connected information system.

Read and Write in CD/DVD for data Storage and review.

Mammography System

The system should consist of a tube head and detector assembly that has isocentric rotation for every positioning.

The isocentric movements should be motorized.

The maximum compression force and all standard compression paddles (please specify)

The patient table should have motorized grid movement.

Magnification devices of ratio 1.5 or 1.8 should be offered. Please specifiy and also Focal spot sizes to be mentioned

Digital display of compression force and compression thickness should be available.

kV range: please specify.

mAS range: please specify.

Exposure time: please specify.

Maximum mA: please specify.

Rotating anode tube with the following parameters:

Focal spot size: please specify

Anode heat storage: please specify

Tube heat Storage: please specify

Anode material: please specify

Please mention the filter material used in the tube

Tube Auto angulation facility to avoid physical strain for radiographer during MLO positioning.

Type of Detector, Please specify.

Detector size: 24cmx29cm or more. Control button, for adjustment of height & angles should be operable from gantry as well as from foot paddles

SID of 65cm or more

Grid ratio and lines-pair per cm to be mentioned: Please specify.

Pixel size:Please specify. Scanning resolution should remain same, it is specified for 2D, 3D and Stereotaxy.

Scan angle and Mode of acquisition- Continuous or step & shoot (to be specified)

Fully integrated approved Tomosynthesis Mammography system to be supplied as the standard component.

It should be possible to perform 3D exam in both CC and MLO views.

It should be possible to obtain both standard 2D and 3D view without repositioning of the patient or any change in the attachments.

Specify time taken for tomosynthesis acquisition.

Capable of reproducing tomo images based on iterative / FPB reconstruction algorithm for low dose examination and to minimize lag and ghost effect from the images

Facility of generating 2D projected image reconstructed from Tomosynthesis images

Should have the display of all parameters after exposure.

Should display the dose delivered after each exposure.

Should be possible to control KV, MAS & fitter parameters from AWS control panel

Image matrix in pixels and image size in Mega Pixels: please specify

5 Megapixel Grayscale Medical Grade LCD Display ( HDD storage capacity to be specified)

Workflow configurable per technologist.

X-ray generation and detector control functions integrated in a single operator console and controlled through the Graphical User Interface (GUI)

Please specify availability of control device capable of tracking actual number of exposures by display of icon versions of acquired images.

Special processing for implants

Ability to perform repeat/reject analysis

The following imaging processing should be possible on the workstation:

Following DICOM services should be provided standard with offered acquisition workstation for both 2D and tomosynthesis dataset (valid the same with acquisition workstation datasheet or DICOM compliance statement):

Retrieval of images from CD, DVD, Pendrive or PACS.

The Image processing as well as reviewing software should be from same OEM of Mammography.

Local image storage capacity: minimum 10,000 mammography studies (HDD storage capacity to be specified) (Quantity- 2 Nos)

The workstation should enable immediate image display for general survey for patient positioning. It should be able to store 10,000 or more images.

Standard hanging protocols

Dedicated key pad for commonly used image display and functions.

The following image processing should be possible on the workstation :

Image display:

Image evaluation:

Lead barrier for console with built in lead glass window and a narrow stable base. Two additional lead barrier size -0.5 mm

Dehumidifier of 110 Litre - 2 Nos.

Phantoms for system callibration

Standard accessories (Which comes along with the machine, pricing of which is part of the equipment).

Performance certificates of IQ,OQ,PQ tests to be submitted at the time of installation/commissioning.

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

CDSCO :Provide the certificate, in case, it is mandatory for this equipment.

Vendor to submit the technical data sheet, brochure etc as a tender document with reference to the quoted make & model. Please mention the reference page no., etc in these documents against each technical specifications in the compliance.

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.

Please submit pre installation requirements [electrical, HVAC, Compressed air along with air pressure mentioned), water requirement (RO/DI/Distilled water with its pressure, flow rate per hour) ; if any of the above is essential].

Vendor to provide UPS with adequate capacity, if required for the quoted equipment. If not required, vendor to mention the same.

Vendor to submit details of the footprint size of the quoted model.

Vendor shall provide details of the input power requirements.

Item/Equipment quoted should not be a second hand/refurbished/on verge of obsolescence/outdated model.

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 MMR region. If there are no installations of the quoted model in MMR region, then the quoted model may have to be brought in at ACTREC for demo purpose 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)

User's/Installation list: A list of installations of the quoted model with the address and contact numbers to be provided.

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

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, ICTREC Campus". If needed, Bidder has to arrange for the labourers at no charge to ICTREC. (Before submitting the quotation, bidders may visit ICTREC to know unloading site and installation site).

Installation,Commissioning and Training is included in the scope of supply. Bidder, Manufacturer and/or its authorized representative should undertake installation and commissioning of the equipment.

Safety requirement: It should follow safety requirement. Please specify certification with certifying agency & country with copies of certificate.

Training:

Operational/Application training to be provided onsite to all departmental staff for at least 6 weeks and primary level maintenance training to be provided to inhouse Biomedical Engineers.

Local Service Support: Should have local office and service support/service engineer for attending the breakdown calls. Details to be submitted.

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

Warranty- 2 Years

Warranty 2 Years : Comprehensive-on site- factory warranty for the entire equipment system. All third party and bought out items, accessories, attachment, software etc. integrated with the system should also be covered by 2 years factory warranty from respective manufacturers. The vendor should perform at least 2 nos. of preventive maintenance services/ year, all breakdown visits and QA/QC as per prescribed protocol during the warranty period. Vendor to submit SOPs for PMS at the time of installation/ commissioning. This is mandatory requirement.

Warranty and CMC Should include at least 2 preventive maintenance service/ year and unlimited breakdown calls along with spares.b) All bought out items quoted along with the main system (local/non-local) and UPS should be covered. c) Yearly calibration, Validation, Testing and measuring equipment used should be traceable to SI units through National/ International standards (as per NABL/NABH norms). d) PM kit if any. e) All upgrades/update, no seperate licence fees will be payable.

CMC- cost per annum will be considered for all bidders for 8 years after warranty (Should include QA QC annually as per AERB noms.)

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

1. Complete operational manuals of quoted model should be provided. 2. Company should provide technical support for hardware and software, spares and consumables.

Penalty Clause: