Low Energy Linear Accelerator System

TATA MEMORIAL HOSPITAL

CENTRAL PURCHASE UNIT

DEPARMENT : RADIATION ONCOLOGY

Technical specifications- " Low Energy Linear Accelerator System" Qty 01 for Radiation Oncology Dr. BBCI, Guwahati.

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 12 years from the date of installation at BBCI-TMC.

Sr. No. Specifications Detailed Specifications Compliance Remarks

Country of Origin

Year of Introduction Internationally

Year of Introduction in India

Probable end of support :

A ESSENTIAL PARAMETERS

Parameters Specifications

1 Photon Energy 6MV FF and/or 6MV FFF

2 RF Source Magnetron / Klystron.

3 Waveguide Type Standing / Travelling wave .

4 Electron Gun Sealed / Unsealed

5 Treatment Modes Normal - TSD / TAD

Rotation - CW / CCW

Service mode/non clinical mode must be ENABLED

6 Dose-Rate FF: 100 - 500 MU/min in steps or higher dose rates.

FFF: Minimum 800 MU/min or higher, specify for individual photon energy

7 Field Size at isocentre Maximum static field size: 25 x 25 cm2 (or more)

Minimum: 0.5 x 0.5 cm2 .

Penumbra : < 10 mm for 10 x 10 cm² field at Dmax and TSD 100 cm.

8 Beam Flatness for FF beam Photon FF beam : As per IEC 60976/AERB For Field Size 5 x 5 cm2 to 30 x 30 cm² : ≤ 106 % . For Field Size > 30 x 30 cm2 : ≤ 110 %

9 Beam Symmetry Photon FF beam : As per IEC 60976/AERB For Field Size 5 x 5 cm² and above: ≤ 103%.

10 Gantry Gantry type: Ring gantry/ C type

Gantry speed ≥ 1 RPM for C type , Gantry speed ≥ 2 RPM for Ring type

Rotation ±180° (360° total)

Read out - Digital

Accuracy dig-readout 0.5°

Control - Hand pendent and control-console (as applicable)

Target - Axis Distance ≥: 85 cm

ODI Range : 75 cm to 150 cm, 0.5 cm resolution (as applicable)

ODI Accuracy ± 0.1 cm at TSD 100 cm (as applicable)

Gantry Rotation Isocentre ≤ 2 mm dia. Sphere.

11 Collimator Rotation: ± 175°

Control: Hand pendent and control- console (as applicable)

Readout accuracy : ± 0.5°

Collimator Rotation Isocentre ≤ 2 mm dia. Sphere

Virtual/ Dynamic/ Motorised Wedge (as applicable)

12 Asymmetric Collimators Upper Jaw/MLC: Asymmetrical, Lower jaw/MLC : Asymmetrical

Treatment Delivery with Dynamic Jaw Tracking. .

Rotational (Arc based) IMRT

13 Multi-leaf collimator (MLC) Minimum no. of Leafs: 114 leaves.The physical/effective leaf width at isocenter: Central 20 x 40 cm² : 5 mm or less, outer 20 x 40 cm²: 10mm or less.

MLC should be capable of performing: 3DCRT, IMRT,Rotational IMRT, SRT, SBRT

Interface between MLC & latest R&V System should be provided.

Photon leakage radiation through MLC when either pair of jaws is replaced with MLC : Maximum : ≤ 2%, Average: ≤ 0.75%.Photon leakage radiation (Maximum) through MLC when MLC is used as tertiary jaws: ≤ 5%.

Max. leaf retracting position ≥ 20 cm

Over center travel of MLC leafs (≥14 cm) for IMRT treatments.

Maximum field length 40 cm.

Penumbra at Dmax ≤ 6 mm for field size 10 x 10 cm².

Leaf position accuracy : ±1 mm .

Max. leaf speed: 2.5 cm/sec or more .

Inter-digitation of leafs should be available .

14 Auto Field Sequencing AFS should be available

15 Portal Imaging & dosimetry feature (FF and FFF energies) Should fully integrate with Accelerator

Should be able to take images at any Gantry angles with variable X, Y or Z movements

Flat panel (aSi) Imaging area should be 40x40 cm2 with all available energies, with Pixel Matrix of minimum 1024 x 1024 or more. Should be able to acquire images at highest dose rate at iso centre.

Compatible with FFF energy mode.

Vendor shall mandatorily offer Integrated Portal dosimetry feature (for FF & FFF energies).

16 IGRT System Retractable arms/or integrated with gantry

Should have Cone beam CBCT (KV and MV both)

X- ray tube: radiography, fluoroscopy, CBCT, Triggered Imaging Utility. Extended CBCT, Short Arc CBCT

Flat panel detectors of min 40 X 30 cm or more, with Pixel Matrix of min 1024 X 1024 or more.

CBCT reconstruction, registration (MV-MV, KV-KV, KV-MV) should be available.

Fully integrated with latest R & V system and TPS.

3D image data should be reconstructed from series of 2D projection images acquired as the linear accelerator gantry is rotated.

Adaptive radiotherapy: pl specify latest modes of approaches towards acquisition, registration, review, dose reconstruction etc along with Deformable Image Registration software. Deformable Dose Accumulation, Dose calculation on deformed images and Adaptation should be available.

17 Treatment Couch 3D Robotic couch made of full carbon fibre top with Indexing capability.

Movements: Longitudinal, Lateral & Vertical (cm) :

Positioning Accuracy of couch movements:

Electrical / Mechanical Control; Control panel/pendent (Local and remote) : It should have the capability for remote controlled robotic positional correction facility. Plz specify.

Manual retraction of couch shall be available in case of power failure

Full Load capacity(wt.)≥ 180 kg.

Couch sag with full load capacity : As per AERB Tolerance.

Minimum height from floor ≥ 60 cm

Couch Collision detection system shall be available to protect against a collision between the detectors or radiation head with the patient on the table or any other object.

Scale convention (IEC or other):

18 Networking Record & Verify System (latest hardware and software)

Transfer of all parameters from existing Simulator, CT-simulators, MRI, PET-CT, USG etc & Treatment Planning System, and other TPS to the accelerator (existing and new) for automatic treatment setup & delivery should be provided.

Transfer of DRR/ Fluoroscopy images etc through R&V system for comparison with portal imaging

Transfer & Execution of Conformal & IMRT treatment plans from Existing and new Treatment Planning System should be provided.

Should be Networked with R & V and Existing Network System. All required interfaces should be provided. Provision for future networking options should be specified in detail.

Transfer and execution of MLC position parameter for normal and IMRT treatment including step & shoot and/or dynamic and/or rotational IMRT techniques from TPS.

Comprehensive Antivirus software for linac, TPS and networking will be provided by the site and supported by the vendor

19 Accessories Wedges – Dynamic/ Motorised /Equivalent

Mechanical Front pointer (SSD indicator) (as applicable)

Side Rails on both sides of Couch for Mounting Accessories. (as applicable)

CCTV Camera (Qty atleast 2). Remote controlled with remote zoom & focus facility.

In-room Colour flat Monitors LED 27” or higher (Qty : Two)

Laser Alignment System (3 cross & One Line laser system set), Total Qty : 1 set

Manual retraction tool (manual crank) for couch in case of power failure

20 Dosimetry System Built-in chambers. Two separate sealed chambers

Precision : ± 1% or 1 MU

Linearity : ± 1% or 1 MU

Reproducibility ± 2% or 1 MU

21 Safety System as per IEC / AERB standards X-ray absorbed dose due to leakage radiation (excluding neutrons) out side useful beams (As per AERB)

Emergency switches.

Door interlock & treatment (ON/OFF) /imaging warning lights etc.

Neutron dose inside the treatment area and outside the treatment area, as per national / international standards

Last Man Out(LMO) Switch(Qty.2)

Various Beam off interlocks.

22 Leakage Radiation as per IEC / AERB standards Head leakage. As per AERB Safety Code.

Collimator transmission. As per AERB Safety Code.

Neutron Dose: As per AERB Safety Code

23 Treatment Planning System Four Advanced workstations which includes two dose calculation engines and two contouring systems(with Enterprise wide licences). Workstation Monitors should be with Minimum pixel Size : 1800Х1200. Total two dose calculation engines & two contouring systems.(Total Qty 4)

Latest HW/SW, upgradable for next 10 yrs

DICOM3 and full DICOM family

DICOM RT Import/export from all existing CT/MR/PET/PACS/C-ARM etc

Multi modality (CT, MR, PET etc) Image registration (rigid and deformable). Pl specify the solutions.

Manual and Atlas based / knowledge based/ templates based contouring both should be available

Fixed field and Rotational IMRT Optimization algorithms.

Graphics Processing Unit based system.

Specify fast dose calculation (CCC/AAA/Accuros XB, Monte carlo & equivalent) and optimization algorithm for 3DCRT/IMRT/Rotational IMRT/Electrons/MCO/ automated planning and other.

Adaptive dose calculation solutions with HW/SW.

Biological modelling and optimization solutions (EUD, TCP, NTCP etc) with HW/SW.

Import /export- Image/structure set/plan/ dose etc. to all machines and integration with network. (HW/SW)

24 Server Server 8 TB or higher storage capacity [Qty : 1].Migration of existing Data to the new Server will be sole responsibility of the vendor. The new server storage capacity should be scalable upto 10 years.

Latest Network Colour Printer Latest Network Colour Printer(Qty.1)

25 Software Service Agreement (SSA) Comprehensive SSA for all softwares availalbe including Linac, TPS, Networking for 10 years.

26 Manuals / Data book Operator, System and Schematic manuals.

27 Essential Spare Parts Provide the list of standard spare parts supplied with the machine.

28 Up-gradation Accessories

Hardware / Software upgrade for 10 years.

29 UPS (System) For complete system (for minimum of 30 minutes)

UPS (Work stations) Individual UPS for each TPS Workstation (including planning and contouring stations) with 30 minutes backup time.

B INSTALLATION REQUIREMENTS

1 Physical Dimensions and Weights Modulator

Auxiliary cabinet

Patient Treatment Couch

Control Console

2 Electrical Requirements Load - Standby

Input Voltage -Typical International:

3 Cooling Water/ Appropriate chiller( ) Temperature

Pressure difference (To specify)

4 Air Conditioning Temperature

Relative Humidity

Air changes (To specify no. per hour)

D Warranty from the date of commissioning 2 Years for complete System and 8 years CMC: includes 4 preventive maintenance and all breakdown visits. All bought out items used in system should also be included in the warranty.

E Delivery Schedule Please Specify

F Training of Staff Module based physical trainings for full competency and complete functionality.

Two Radiation Oncologists

Two Medical Physicists

Two Radiotherapy technologists

One Biomedical Engineer

G Equipment certification AERB type approval / NOC

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

If model quoted is introduced in year 2022 the above clearances shall be obtained by vendor before the installation of machine.

Enclose certification of calibration and inspection

Log book with instruction for daily, weekly, monthly, quarterly and yearly maintenance check list.

H Other Information No. of similar models: India / World (enclose list of institutions)

No. of certified engineers in India(enclose list of names)

Remote Diagnostics Facility (India / Abroad) availability

All consumables required for installation, standardization testing of system should be included in the cost

One digital camera for patient position photograph

A two-way Audio communication system

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.

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

Response Time: Should not be more than 6 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.

I 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 gurantee.

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

1 If 2 years warranty and CMC cost per annum will be considered for 8 years after warranty conditions are not adhered to, TMC reserves right to reject the offer.

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

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