Tender For Eoi For Hdr Co-60 Brachy Unit With Treatment Planning System And Brachy Accessories; A Treatment Unit 1 A high dose rate brachytherapy unit capable of intracavity, interstitial, intraluminal and surface mould radiation therapy. 2 Unit should be on wheels for easy mobility 3 Motorized head movement for various heights/Fixed 4 Check cable that ensures the treatment path is clear and free from obstruction 5 Separate stepper motors to control the check cable and source cable 6 Built- in radiation detector 7 Treatment channels ≥ 20 8 Manual source retraction option/mechanism in the event of power failure or emergency. 9 In case of emergency, Inbuilt battery backup should be available 10 Last Man Out switch should be provided including installation and electrical commissioning 11 In-built source container with adequate shielding should be provided 12 Should be supplied with Transport container 13 Emergency container with forceps. 14 A single operated quick lock system shall be provided to secure the unit in position when parked or during treatment. 15 Should be supplied with OT Table meeting the following specifications: a Table should be battery and electrically operated. b Remote control should be available to control movements. c Up/Down movement d Trendlenburg/reverse trendelenburg e Horizontal slide (forward/backward) function f Lateral slide function g Lateral tilt for both sides h Hand rest i Lithotomic stand (leg rest) should be available. High lithotomy stirrups for Prostate Brachytherapy j Brake system should be available to lock the movement of the table. 16 Trolley - MR compatible patient trolley (Qty: 1) should be provided. 17 Patient treatment couch (Semi motorized) with Applicator Fixation Device (Qty:1) should be provided 18 Operator chair (For Gynae brachytherapist while introducing the applicators) should be provided (Qty: 1) B Control Console 1 High resolution ≥ 18 inch flat monitor with CPU, keyboard, mouse, compact colour Laser printer (for Console) with reverse printing and connectivity to server. 2 Network facility to treatment planning system (Seamless integration with imaging machines including ultrasound) 3 Access to authorized user with password protection 4 Automatic decay correction 5 Keeping track of patient’s fractionated treatment 6 Variable treatment length with minimum 1 mm step size should be provided 7 Dwell position display 8 Dwell time display 9 Display of indexer length, activity and dose 10 In built protection circuit to prevent treatment without proper applicator connection and proper indexer locking 11 Online display of status code with an indication of the action required 12 Built in log book 13 Safe, secure and archival and retrieval of patient data to an external storage device 14 If communication between control console and afterloader is lost, whether by software or hardware failure, the source shall immediately and automatically be retracted. 15 There shall be a means of programming & editing the dwell positions and dwell times into the control console. 16 Dwell times at each dwell position shall be programmable from 0.4 - 999 seconds or more with a resolution/accuracy of 0.1 seconds C Radiation source 1 Co-60 source. 1.1 Activity: 2 Ci (±10%) 1.2 Active length: ≤ 3.5 mm 1.3 Active diameter: ≤ 0.5 mm 1.4 Capsule length: ≤ 4.6 mm 1.5 Capsule diameter: ≤ 1 mm 2 Treatment path curvature: ≤ 20 mm 3 Reproducibility of source position: ± 1 mm 4 Maximum numbers of cycles allowed/guaranteed with single Co-60 source: 100000 or more 5 Maximum lenth of treatment: 40 cm or more 6 Supply of sources : 2 sources within 10 years as standard D Applicators: standard accessories 1 Fletcher Suit Type Intracavitary Applicators (Intrauterine tube and ovoid)(Qty: 6) a Intrauterine Tube angles (degree) : 15,30, 40/45 b Ovoid size (Diameter in mm): 15/16,20,25,30 2 Cervix intracavitary CT/MR Intrauterine tube and ovoid applicator (Qty: 4) a Intrauterine Tube angles (degree) : 15,30, 40/45 b Ovoid size (Diameter in mm): 15,20,25,30 c Should be compatible with 1.5 and 3 Tesla MRI 3 Cervix intracavitary CT/MR ring or equivalent applicator (Qty: 1 each) a Set 1 i Ring size diameter (in mm): 25/26 ii Ring angle (degree): 30,45,60 iii Intrauterine length (in mm): 20,40,60 iv Intrauterine angle (degree): 30,45,60 v Rectal retractor- one for each set vi Sterilising caps b Set 2 i Ring size diameter (in mm): 30 ii Ring angle (degree): 30,45,60 iii IU length (in mm): 20,40,60 iv IU angle (degree): 30,45,60 v Rectal retractor- one for each set vi Sterilising caps c Should be compatible with 1.5 and 3 Tesla MRI 4 Standard Vaginal Vault Brachytherapy Cylindrical Applicator with Intrauterine Tube (Qty: 2). a Cylinder size diameter (mm): 20,25,30, 35 b Please quote all available angles and lengths for intrauterine tubes. 5 CT/MRI compatible Vaginal Vault Brachytherapy Cylindrical Applicator with Intrauterine Tube (Qty: 1). a Cylinder size diameter (mm): 20,25,30,35 b IU tube angle (degree): 0, 15,30 c IU length (In mm): 0,40,60,80 d Should be compatible with 1.5 and 3 Tesla MRI 6 CT/MRI compatible Vaginal Vault multichannel Brachytherapy Cylindrical Applicator with Intrauterine Tube (Qty: 1) a Cylinder size diameter (mm): 25,30,35 b Intrauterine tube: Please quote all available angles and lengths c Should be compatible with 1.5 and 3 Tesla MRI d Plastic tubes compatible with applicator (Qty: 40 plastic tubes), if applicable 7 Combined Interstitial and Intracavitary Cervical Brachytherapy Ring Applicator with straight/angulated and divergent needles or equivalent prototype a Set 1 (Qty: 3 ) i Ring Size (Diameter in mm): please quote smallest. ii Intrauterine Tandem angle and length: Please quote all available angles and length between 0 to 8 cm iii Add-on Accessories Qty-10 per set to be supplied, if applicable. iv Should be compatible with 1.5 and 3 Tesla MRI v Intravaginal ring extension for the smallest ring for patients with vaginal disease or equivalent b Set 2 (Qty: 1) i Ring Size (Diameter): 26 mm ii Intrauterine Tandem angle and length: Please quote all available angles and length between 0 to 8 cm iii Add-on Accessories Qty-10 per set to be supplied, if applicable. iv Should be compatible with 1.5 and 3 Tesla MRI c Guidining tubes: Qty-20 nos/needle holding templates-Qty-1 nos as applicable or equivalent d Obturators for needles: Qty:20 (including stilletes for intravaginal template) 8 Ovoid type Intracavitary Interstitial Cervical BrachytherapyApplicator with straight needles and option for central needles or equivalent (Qty: 1 ) a Ovoid sizes (in mm) : 15,20,25,30 b Intrauterine tube angles (in degrees) : 15, 30,40/45 c Intrauterine tube length (in mm): 0,30,40,50,60 (Qty- 1 each) or single IU with cervical stopper (total Qty- 6) as applicable c Add-on Accessories Qty-10 to be supplied, if applicable. d Should be compatible with 1.5 and 3 Tesla MRI 9 Universal Pelvic Interstitial Brachytherapy Template with straight/divergent needles for cervical, endometrial, prostatic and urethral brachytherapy (Qty:1) 10 Endometrial applicator complete set, Please Specify (Qty:2) 11 Oesophagus applicator set with mask (Qty:1) 12 Bronchus applicator with set mask (Qty:1) 13 Breast implant template set (Qty:1) 14 Prostate implant template set (Qty:1) 15 Nasophrynx Applicator set (Qty:1) 16 Interstitial Implant needles (20 cm length): Qty- 50 17 Interstitial implant needle: 10 cm (Qty-20 ), 15/16 cm length (Qty: 30 ) 18 Nylon tubes Sharp:for intracavitary/interstitial - Qty:200, specify needle length (desirable > 29 cm) 19 Obturator for nylon tubes (Qty- 30 nos) compatible with supplied needles) 20 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. 21 Transfer tubes for flexible needles (Qty-30) , rigid needles (Qty-30) and all other quoted applicators. 22 Radio-opaque dummies: a For all quoted applicators (Qty-1 set each) b Intertitial needles (Qty-25) 23 MR dummy markers for MR applicators : (Qty- 3 set each) 24 Should be provided with standlone stepper stabiliser system to hold the ultrasound transrectal probe. E TPS for HDR brachytherapy a) Technical Specification of Workstation and Server for Database and Backup Software - Qty. 1 No. 1 Processor Description : Intel i7, 13th Gen, 12 Cores, 30MB Cache and up to 4.90 GHz Clock or Higher 2 Memory: 32GB RAM or higher 3 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. 4 Total Capacity for Data Storage/Backup: Min 6TB capacity with SSD/NL-SAS/SATA Hard disk for Data Storage and backup of TPS database. 5 Operating System : Windows 11 Professional or higher, 64 bit, licensed copy. 6 Microsoft Office: Microsoft Office 2024 Standard Edition or higher 7 Graphics: NVIDIA T1000 4 GB or AMD Radeon™ RX 6300, 4GB GDDR6,Half Height, Min 2xDP-DP Adapter or better 8 Input devices: Wired Keyboard & Mouse, Optical Drive (R/W) 9 Ports: USB 2.0, 3.2 or better, Port: DP or HDMI, 1G Ethernet port 10 Display: 24 Inch (1920 x 1080), TN/IPS Panel or higher 11 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. b) Technical Specification for TPS Reviewing Workstation - Qty. 3 Nos. 1 Processor Description: Intel i7, 13th Gen, 12 Cores, 30MB Cache and up to 4.90 GHz Clock or Higher 2 Memory: 32GB RAM or higher 3 Capacity for OS: 1TB PCIe® NVMe SSD or higher for OS and Application 4 Operating System : Windows 11 Professional or higher, 64 bit, licensed copy. 5 Microsoft Office: Microsoft Office 2024 Standard Edition or higher 6 Graphics: NVIDIA T1000 4 GB or AMD Radeon™ RX 6300, 4GB GDDR6,Half Height, Min 2xDP-DP Adapter or better 7 Input devices: Wired Keyboard & Mouse, Optical Drive (R/W) 8 Ports: USB 2.0, 3.2 or better, Port: DP or HDMI, 1G Ethernet port 9 Display: 24 Inch (1920 x 1080), TN/IPS Panel or higher c) Technical Specification for NAS Storage - Qty 1 No. 1 Form Factor: Floor Mount/rack mount 2 Storage Details: Network Attached Storage with 16TB usable storage capacity after RAID configuration. 3 Supported protocols and OS: Linux, Microsoft Windows OS etc. FTP, SFTP and TFTP protocols, FTP over SSL/TLS 4 Connectivity: 10/100/1000 Gigabit Ethernet Port, USB 2.0/ USB 3.0 d) 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 e) Import of images from multimodality imaging devices ( Simulator/C-Arm/CT/MR/USG/PET CT etc). f) Rigid image registration (CT/MR/PET-CT etc.) g) Contouring tools with abillity to visualise atleast triplanar view. h) Calculation Algorithms TG 43. Should be upgradable to higher algorithm. i) Optimization algorithms should be available j) DVH calculation should be available k) USG based planning should be available l) Plan comparison tools should be available m) Applicator modelling & catheter reconstruction : Manual and Automated applicator reconstruction and catheter tracking should be available n) Transfer of treatment planning data to control console m) Input devices: DICOM-RT interface, import/export from any DICOM system. o) Interface for PACS/ other TPS (for image based plans) p) Comprehensive Antivirus for TPS and TCS should be provided as standard during warranty period F Quality Assurance Tools 1 Well type chamber (Qty- 1) 2 Reference class electrometer with integrated display (Qty-1) 3 Dosimetry cable provided should have length of 18 m or more (Qty-2). 4 Zone monitor ( Qty-2) 5 Survey meter cum contamination monitor (Qty- 2) 6 Source position check QA device/ Autoradiograph kit with 10 films 7 Indexer length measurement tool (Qty-1 ) G Accessories 1 Compact high speed Colour network LASER printer with reverse printing for TPS 2 External hard disc: 5 TBx3 3 Manuals (User manual and service manual) & Isodose charts 4 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. H Certification (please enclose copies) 1 AERB certification a 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) b 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) 2 FDA 510K certification/CE/ICMED/ISO 13485/BIS 3 It should follow all mandatory safety requirement for HDR after-loading unit, TPS (Software and Hardware), and all applicators quoted. I 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, TMH unit, 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. J Please submit the technical data sheet along with the brochure as a tender document with reference to the quoted make & model. K 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.). L Please specify pre installation requirements (electrical, HVAC ; if any of the above is essential) M Please specify footprint size & weight. N 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. O Predispatch inspection at factory will be required if desired by authorities. P Please visit the site to check whether quoted model can be accomodated in the available space. Q Please specify power consumption. R Local Service Support: Should have local office and service support/service engineer for attending the breakdown calls. S Response Time: Should not be more than 06 hrs from lodging a breakdown complaint on toll free or by email. T Warranty: 2 years U CMC: CMC for 8 years after warranty (Should include QA QC annually as per AERB noms.) i) 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. ii) Software service Agreement (SSA) : Comprehensive for ten years, including TPS , Server upgradation and upgrade of exixsting SW and HW for seamless integration iii) Antivirus package for 10 years V Penalty Clause: i) 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. ii) 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%. iii) The decision of the TMC management or its representative in determining the % of the downtime shall be final and binding. iv) 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. v) 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. Vi) 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. vii) 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. viii) 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. ix) 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. W UPS: Please Provide UPS with adequte capacity for the complete systems. With 30 min back up. X Back to back assurance to be taken by the supplier from OEM to supply spares for minimum 10 years and to be submitted. Y Training of staff: Training at globally renowned centre with experience of installation and use of the said equipment for two Radiation Oncologist,two Medical Physicist, two Radiotherapy Technologists and two Inhouse biomedical engineers. Z Buy Back: i Make: Elekta, Model: MicroSelectron, Sr No: 10299 ii Scope will include decommissioning, deinstallation and removal of the entire equipment and including its accessories, attachments and support equipment like UPS, positioning lasers etc from the campus with no cost to TMH.
