HDR Co-60 Brachy Unit with Treatment Planning System and Brachy Accessories

Treatment Unit

A high dose rate brachytherapy unit capable of intracavity, interstitial, intraluminal and surface mould radiation therapy.

Unit should be on wheels for easy mobility

Motorized head movement for various heights/Fixed

Check cable that ensures the treatment path is clear and free from obstruction

Separate stepper motors to control the check cable and source cable

Built- in radiation detector

Treatment channels ≥ 20

Manual source retraction option/mechanism in the event of power failure or emergency.

In case of emergency, Inbuilt battery backup should be available

Last Man Out switch should be provided including installation and electrical commissioning

In-built source container with adequate shielding should be provided

Should be supplied with Transport container

Emergency container with forceps.

A single operated quick lock system shall be provided to secure the unit in position when parked or during treatment.

Should be supplied with OT Table meeting the following specifications:

Table should be battery and electrically operated.

Remote control should be available to control movements.

Up/Down movement

Trendlenburg/reverse trendelenburg

Horizontal slide (forward/backward) function

Lateral slide function

Lateral tilt for both sides

Hand rest

Lithotomic stand (leg rest) should be available. High lithotomy stirrups for Prostate Brachytherapy

Brake system should be available to lock the movement of the table.

Trolley - MR compatible patient trolley (Qty: 1) should be provided.

Patient treatment couch (Semi motorized) with Applicator Fixation Device (Qty:1) should be provided

Operator chair (For Gynae brachytherapist while introducing the applicators) should be provided (Qty: 1)

Control Console

High resolution ≥ 18 inch flat monitor with CPU, keyboard, mouse, compact colour Laser printer (for Console) with reverse printing and connectivity to server.

Network facility to treatment planning system (Seamless integration with imaging machines including ultrasound)

Access to authorized user with password protection

Automatic decay correction

Keeping track of patient’s fractionated treatment

Variable treatment length with minimum 1 mm step size should be provided

Dwell position display

Dwell time display

Display of indexer length, activity and dose

In built protection circuit to prevent treatment without proper applicator connection and proper indexer locking

Online display of status code with an indication of the action required

Built in log book

Safe, secure and archival and retrieval of patient data to an external storage device

If communication between control console and afterloader is lost, whether by software or hardware failure, the source shall immediately and automatically be retracted.

There shall be a means of programming & editing the dwell positions and dwell times into the control console.

Dwell times at each dwell position shall be programmable from 0.4 - 999 seconds or more with a resolution/accuracy of 0.1 seconds

Radiation source

Co-60 source.

Activity: 2 Ci (±10%)

Active length: ≤ 3.5 mm

Active diameter: ≤ 0.5 mm

Capsule length: ≤ 4.6 mm

Capsule diameter: ≤ 1 mm

Treatment path curvature: ≤ 20 mm

Accuracy of source position: ± 2 mm

Maximum numbers of cycles allowed/guaranteed with single Co-60 source: 100000 or more

Maximum lenth of treatment: 40 cm or more

Supply of sources : 2 sources within 10 years as standard

Applicators: standard accessories

Fletcher Suit Type Intracavitary Applicators (Intrauterine tube and ovoid) (Qty: 6)

Intrauterine Tube angles (degree) : 15,30, 40/45

Ovoid size (Diameter in mm): 15/16,20,25,30

Cervix intracavitary CT/MR Intrauterine tube and ovoid applicator (Qty: 4)

Intrauterine Tube angles (degree) : 15,30, 40/45

Ovoid size (Diameter in mm): 15,20,25,30

Should be compatible with 1.5 and 3 Tesla MRI

Please quote total 6 numbers of Intrauterine Tubes for each set of applicator.

Cervix intracavitary CT/MR ring or equivalent applicator (Qty: 1 each)

Ring size diameter (in mm): 25/26

Ring angle (degree): 30,45,60

Intrauterine length (in mm): 20,40,60

Intrauterine angle (degree): 30,45,60

Rectal retractor- one for each set

Sterilising caps

Ring size diameter (in mm): 30/32

Ring angle (degree): 30,45,60

IU length (in mm): 20,40,60

IU angle (degree): 30,45,60

Rectal retractor- one for each set

Sterilising caps

Should be compatible with 1.5 and 3 Tesla MRI

Standard Vaginal Vault Brachytherapy Cylindrical Applicator with Intrauterine Tube (Qty: 2).

Cylinder size diameter (mm): 20,25,30, 35

Please quote all available angles and lengths for intrauterine tubes.

CT/MRI compatible Vaginal Vault Brachytherapy Cylindrical Applicator with Intrauterine Tube (Qty: 1).

Cylinder size diameter (mm): 20,25,30,35

IU tube angle (degree): 0, 15,30

IU length (In mm): 0,40,60,80

Should be compatible with 1.5 and 3 Tesla MRI

CT/MRI compatible Vaginal Vault multichannel Brachytherapy Cylindrical Applicator with Intrauterine Tube (Qty: 1)

Cylinder size diameter (mm): 25,30,35

Intrauterine tube: Please quote all available angles and lengths

Should be compatible with 1.5 and 3 Tesla MRI

Plastic tubes compatible with applicator (Qty: 40 plastic tubes), if applicable

Combined Interstitial and Intracavitary Cervical Brachytherapy Ring Applicator with straight/angulated and divergent needles or equivalent prototype

Set 1 (Qty: 3 )

Ring Size (Diameter in mm): please quote smallest.

Intrauterine Tandem angle and length: Please quote two qtys of available angles with Intrauterine length of 0/20, 40 and 60 mm for each angles (total 6 Qty for each set of applicators) .

Add-on Accessories (Interstitial add on kit) Qty - 2 per applicator to be supplied, if applicable.

Should be compatible with 1.5 and 3 Tesla MRI

Intravaginal ring extension for the smallest ring for patients with vaginal disease or equivalent

Set 2 (Qty: 1)

Ring Size (Diameter): 26 mm

Intrauterine Tandem angle and length: Please quote two qtys of available angles with Intrauterine length of 0/20, 40 and 60 mm for each angles (total 6 Qty for each set of applicators).

Add-on Accessories (Interstitial add on kit) Qty- 2per applicator to be supplied, if applicable.

Should be compatible with 1.5 and 3 Tesla MRI

Guidining tubes: Qty-20 nos/needle holding templates-Qty-1 nos if applicable or equivalent

Obturators for needles: Qty:20 (including stilletes for intravaginal template)

Ovoid type Intracavitary Interstitial Cervical BrachytherapyApplicator with straight needles and option for central needles or equivalent (Qty: 1 )

Ovoid sizes (in mm) : 15,20,25,30

Intrauterine tube angles (in degrees) : 15, 30, 40/45

Intrauterine tube length (in mm): Quote any two length of Intrauterine tubes for each Intrauterine angles and also quote 0 mm/straight IU tube as applicable. (Total Qty:7)

Add-on Accessories (Interstitial add on kit) Qty- 2 per applicator to be supplied, if applicable.

Should be compatible with 1.5 and 3 Tesla MRI

Universal Pelvic Interstitial Brachytherapy Template with straight/divergent needles for cervical, endometrial, prostatic and urethral brachytherapy (Qty:1)

Endometrial applicator complete set, Please Specify (Qty:2)

Oesophagus applicator set with mask (Qty:1)

Bronchus applicator with set mask (Qty:1)

Breast implant template set (Qty:1)

Prostate implant template set (Qty:1)

Nasophrynx Applicator set (Qty:1)

Interstitial Implant needles (20 cm length): Qty- 50

Interstitial implant needle: 10 cm (Qty-20 ), 15/16 cm length (Qty: 30 )

Nylon tubes Sharp:for intracavitary/interstitial - Qty:200, specify needle length (desirable > 29 cm)

Obturator for nylon tubes (Qty- 30 nos) compatible with supplied needles)

Flexible nylon implant tube set single leader and double leader (Qty: 100 each), all necessary accessories needs to be included. Please provide all necesaary accessories for full functionality of the applicator.

Transfer tubes for flexible needles (Qty-30) , rigid needles (Qty-30) and all other quoted applicators.

Radio-opaque dummies:

For all quoted applicators (Qty-1 set each)

For intertitial needles (Qty-25)

MR dummy markers for MR applicators : (Qty- 3 set each)

TPS for HDR brachytherapy

Technical Specification of Workstation and Server for Database and Backup Software - Qty. 1 No.

Processor Description : Intel i7, 13th Gen, 12 Cores, 30MB Cache and up to 4.90 GHz Clock or Higher

Memory: 32GB RAM or higher

Capacity for OS: 1TB PCIe® NVMe SSD or higher for OS and Database Application in RAID Configuration. Bidder should mention the RAID config required for the proposed TPS application in the bid.

Total Capacity for Data Storage/Backup: Min 6TB capacity with SSD/NL-SAS/SATA Hard disk for Data Storage and backup of TPS database.

Operating System : Windows operating system 64 bit (Professional or higher) validated for the supplied TPS at the time of delivery. During the warranty and CAMC period of the system, vendor should provide security and feature updates and technical support of operating system with no cost to TMC.

Microsoft Office: Microsoft Office 2024 Standard Edition or higher

Graphics: NVIDIA T1000 4 GB or AMD Radeon™ RX 6300, 4GB GDDR6,Half Height, Min 2xDP-DP Adapter or better

Input devices: Wired Keyboard & Mouse, Optical Drive (R/W)

Ports: USB 2.0, 3.2 or better, Port: DP or HDMI, 1G Ethernet port

Display: 24 Inch (1920 x 1080), TN/IPS Panel or higher

Backup Software: 1.The proposed backup software license should be perpetual. If the license is subcription base bidder has to consider this for entire warranty and CMC period. 2. It should support scheduled backup scenarios, like daily, Weekly Monthly and yearly basis. 3. Software should perform the backup restoration. 4. Backup software application should able to configured with external Storage device over LAN.

Technical Specification for TPS Workstation - Qty. 3 Nos.

Processor Description: Intel i7, 13th Gen, 12 Cores, 30MB Cache and up to 4.90 GHz Clock or Higher

Memory: 32GB RAM or higher

Capacity for OS: 1TB PCIe® NVMe SSD or higher for OS and Application

Operating System : Windows operating system 64 bit (Professional or higher) validated for the supplied TPS at the time of delivery. During the warranty and CAMC period of the system, vendor should provide security and feature updates and technical support of operating system with no cost to TMC.

Microsoft Office: Microsoft Office 2024 Standard Edition or higher

Graphics: NVIDIA T1000 4 GB or AMD Radeon™ RX 6300, 4GB GDDR6,Half Height, Min 2xDP-DP Adapter or better

Input devices: Wired Keyboard & Mouse, Optical Drive (R/W)

Ports: USB 2.0, 3.2 or better, Port: DP or HDMI, 1G Ethernet port

Display: 24 Inch (1920 x 1080), TN/IPS Panel or higher

Technical Specification for NAS Storage - Qty 1 No.

Form Factor: Floor Mount/rack mount

Storage Details: Network Attached Storage with 16TB usable storage capacity after RAID configuration.

Supported protocols and OS: Linux, Microsoft Windows OS etc. FTP, SFTP and TFTP protocols, FTP over SSL/TLS

Connectivity: 10/100/1000 Gigabit Ethernet Port, USB 2.0/ USB 3.0

3-D Treatment planning system capable of carrying out the planning of HDR stepping source for all sites in a single plan irrespective of the number of catheters in an implant

Import of images from multimodality imaging devices ( Simulator/C-Arm/CT/MR/USG/PET CT etc).

Rigid image registration (CT/MR/PET-CT etc.)

Contouring tools with abillity to visualise atleast triplanar view.

Calculation Algorithms TG 43. Should be upgradable to higher algorithm.

Optimization algorithms should be available

DVH calculation should be available

USG based planning should be available

Plan comparison tools should be available

Applicator modelling & catheter reconstruction : Manual and Automated applicator reconstruction and catheter tracking should be available

Transfer of treatment planning data to control console

Input devices: DICOM-RT interface, import/export from any DICOM system.

Interface for PACS/ other TPS (for image based plans)

Comprehensive Antivirus for TPS and TCS should be provided as standard during warranty period

Quality Assurance Tools

Well type chamber (Qty- 1)

Reference class electrometer with integrated display (Qty-1)

Dosimetry cable provided should have length of 18 m or more (Qty-2).

Zone monitor ( Qty-2)

Survey meter cum contamination monitor (Qty- 2)

Source position check QA device/ Autoradiograph kit with 10 films

Indexer length measurement tool (Qty-1 )

Accessories

Compact high speed Colour network LASER printer with reverse printing for TPS

External hard disc: 5 TBx3

Manuals (User manual and service manual) & Isodose charts

CCTV with Flat Monitor, Dual view camera for patient and source position monitoring,two way communication system should be provided. Installation, electrical cabling and post installation maintenance should be under vendor scope.

Certification (please enclose copies)

AERB certification

Maximum leakage radiation level at 5 cm from the surface of the HDR unit in source 'OFF' Condition: ≤ 100 µSv/h (when unit is loaded with its maximum capacity)

Maximum leakage radiation level at 1 m from the source of the HDR unit in sourse 'OFF' Condition: ≤ 10 µSv/h (when unit is loaded with its maximum capacity)

FDA 510K certification/CE/ICMED/ISO 13485/BIS

It should follow all mandatory safety requirement for HDR after-loading unit, TPS (Software and Hardware), and all applicators quoted.

The Quoted model should be have minimum 10 installation in INDIA unless it is a new equipment.

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 installtion site. Unloading site shall be Stores department, Main Building Basement,TMH. If needed ,bidder has to arrange for the laboures at no charge to TMH.(Before submitting the quotation,bidders may visit TMH to Know unloading and installtion site.

Please submit the technical data sheet along with the brochure as a tender document with reference to the quoted make & model.

Please specify list of consumables/consumable Spares ( i.e.spares need to be replaced at regular intervals, maybe quarterly/half yearly/yearly such as annual maintenance kit etc.).

Please specify pre installation requirements (electrical, HVAC ; if any of the above is essential)

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.

Please specify power consumption.

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

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

Warranty: 2 years

CMC: CMC for 8 years after warranty.

Include 4 preventive maintenance/ year and all breakdown visits. All bought out items used in system should also be included in the warranty.CMC should include upgrades / update cost, No separate software licence fees will be payable.This should also cover TPS , Server upgradation and upgrade of exixsting SW and HW for seamless integration.

Software service Agreement (SSA) : Comprehensive for ten years, including TPS , Server upgradation and upgrade of exixsting SW and HW for seamless integration

Antivirus package for 10 years

Penalty Clause:

The supplier and / or its Indian agent will be required to maintain the equipment and all its bought out items (including software updates and various licenses) used for the functionality of the system in good working condition during the warranty/ CMC period with 96% uptime guarantee.

Equipment shall be fully functional to be considered as the uptime. In case of partial functionality, the proportion of functionality shall be determined and downtime shall be adjusted by such proportion (i.e. if the equipment is 70% functional, 30% downtime shall be applicable). In cases where it is not possible to definitely determine the proportion of functionality, the downtime shall be considered as 100%.

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 equipment entirely or partially during warranty/CMC period shall also be included in the downtime while calculating the guaranteed uptime i.e. all features as per specifications in purchase order should be functional for uptime.

The penalty applicable for downtime shall be calculated on an hourly basis and will be at the rate of 0.004% per hour (0.1% per day) of the total cost of the equipment (excluding works), during and up to the period of warranty/ CMC. There shall be a permissible down time of 360 hours per year, beyond which the down time penalty will be applicable.

However, in case of the downtime exceeding seven days (i.e. 168 hrs) at a stretch, the downtime beyond these 168 hours will be considered for calculation of downtime penalty.

The levy of this penalty shall be at the discretion of director TMC irrespective of the overall up time of the equipment throughout the period of the warranty or CMC.

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.'

UPS: Please Provide UPS with adequte capacity for the complete systems. With 30 min back up.

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

Training of staff:

Decommissioning:

Scope will include decommissioning, deinstallation and removal of the entire equipment and including its accessories, attachments and support equipment like UPS. etc with no cost to TMH.

If 2 years warranty condition is not adhered to, TMC reserves right to reject the offer.

Please Provide make online UPS with isolation transformer of adequte capacity for the complete systems. With 30min back up.

Only Yes or No should be mentioned in compliance report and additional information should in remark columns.

Item Rate

Item Description

Cat (A) -Supply, Installation, Testing and Commissioning of HDR Co-60 Brachy Unit with Treatment Planning System and Brachy Accessories Qty 1 No. for Radiation Oncology Dept, TMH, with 2 year warranty

Supply, Installation, Testing and Commissioning of HDR Co-60 Brachy Unit with Treatment Planning System and Brachy Accessories Qty 1 No. for Radiation Oncology Dept, TMH, India as per tendered technical specifications

Cat (B) 8 Year CMC cost of HDR Co-60 Brachy Unit with Treatment Planning System and Brachy Accessories Qty 1 No. for Radiation Oncology Dept, TMH, post warranty period of 2 year

8 Year CMC cost of HDR Co-60 Brachy Unit with Treatment Planning System and Brachy Accessories Qty 1 No. for Radiation Oncology Dept, TMH, India, Qty. 1 No.

CMC cost for 1st year post warranty period of 2 year

CMC cost for 2nd year post warranty period of 2 year

CMC cost for 3rd year post warranty period of 2 year

CMC cost for 4th year post warranty period of 2 year

CMC cost for 5th year post warranty period of 2 year

CMC cost for 6th year post warranty period of 2 year

CMC cost for 7th year post warranty period of 2 year

CMC cost for 8th year post warranty period of 2 year