Download PET CT Scan

PET CT Scan
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Purchaser’s Specifications
PET CT Scan
Manufacturer
Brand
Type/Model
Country of Origin
Description of Functions
Positron Emission Tomography Scanner with multi-detector (32 slice or more) Spiral CT
scanner.
A latest technology high resolution whole body Positron Emission Tomography system with
integrated 32 slice Spiral CT scanner (PET-CT) designed for providing volume measurements
of metabolic and physiological processes using positron emitters, as well as for producing
accurate structural and anatomical fusion images and making attenuation maps for attenuation
correction.
The CT must also be completely able to function as a full diagnostic CT machine.
Operational Requirements
Advanced Positron Emission Tomography with Integrated multi-slice CT Studies for
comprehensive Oncology, Cardiac, Respiratory, Abdominal, Neuro studies including brain
perfusion, general vascular and whole body imaging application with optimal radiation dose
efficiency.
The system must be state of the art with fast acquisition speeds for imaging with good temporal
resolution.
Bidder shall indicate the year of manufacturing.
It shall be DICOM ready.
It shall integrate and interface with PACS and RIS.
System Configurations
PET-CT complete with Patient Table, control and evaluation Unit, Computer system, latest
user software and network module.
Dry film printer, 1 unit.
Laser colour printer, 1 unit.
CT pressure injector
UPS for the entire system, 1 unit.
Bidder shall indicate brand and model information here and provide technical data document
for major components specified above.
Technical Specifications
PET-CT Gantry:
Gantry shall have integrated PET & CT hardware.
Aperture size 70 cm or more patient port and uniform for both PET and CT.
Entire range of rotation times for full 360 degree with a minimum time less than 0.4 seconds.
Ring diameter more than 75cm. PET/CT scan range: 170 cm or more.
The Scanner must have low power laser lines orthogonally mounted on the gantry for patient
alignment and auto contouring. The laser shall be mounted in such a way that the patient can be
positioned form either side of the gantry and the patient bed.
The geometric axial field of view (FOV) as measured from the outer edges of the crystals in
the axial direction must be minimum 15 cm.
The transverse field of view shall be 65 cm or more.
The separation (centre to centre) between slices acquired simultaneously without any axial
motion shall be less than or equal to 5 mm.
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Purchaser’s Specifications
Efficient gantry cooling system for continuous operation of the equipment.
PET Performance Specifications:
All specifications must comply with NEMA Standards Publication (NU2-2007/2012/latest).
Performance Measurements, without altering instrument parameters. The scanner must have a
detector configuration of a continuous ring around the patient bore.
LSO/LYSO based detector (Isotropic crystal) with high light yield and high energy resolution.
Axial spatial resolution at 1 cm from the central axis of the gantry shall be less than or equal to
6 mm.
Transverse and axial resolution must be better than 6.5 mm FWHM at 1 cm & 10 cm from the
Central axis of the gantry.
System efficiency / Sensitivity must exceed 5 cps / kBq at 350 KeV.
System NECR specifications at clinical dose of 10 mCi must exceed 50 kcps at 350 Kev
3-D scatter fraction shall be less than 39%.
Uniformity shall be < 5 % and inter slice uniformity <15%.
System shall have dynamic PET acquisition capability to acquire PET image independent of
CT.
It must be capable of acquiring 45 or more transverse cross- sectional slices, simultaneously
without undergoing any axial motion.
System shall use Time of Flight information for better lesion detectability and software’s to
enhance the spatial resolution and sensitivity and shall be quoted as a standard feature.
Detector: Crystal (Preferably Isotropic); material: LSO, LYSO or better >20 mm thickness for
detecting 511 KeV gamma photons in coincidence. The scanner performance shall follow
specifications as per NEMA NU2-2007 or later recommendation.
Resolution (In mm): PET component of system shall be able to provide 5.0 mm or less uniform
resolution at one centimetre and High resolution algorithm shall also be quoted as standard.
Attenuation correction shall be CT based. Protocol/Algorithm for attenuation correction shall
be independent of metal/mA/IV contrast related artefacts.
Shall have ECG gating and respiratory Gating with supporting hardware and software.
Imaging Table Features:
Precision bed with low attenuation carbon fibre pallet and minimum sag of the patient table
top. It shall be able to bear 180 kg or more patient weight.
The horizontal motion of the patient bed must be electrically motorized and computer
controlled with an independent operator control option as well. Operator controls accessible
from both sides of the patient must be provided for both horizontal and vertical movements.
A digital readout of the horizontal and vertical position of the bed must exist and must be
located near the aperture controls for the bed to provide ease in positioning.
Paediatric pallet, Head support, Arm support, Knee-leg and all others support are to be
provided.
Attachable Flat table top on the PET-CT gantry with external LASER system, required
software and complete sets of immobilization devices for PET/CT based treatment planning in
Radiotherapy department.
The horizontal travel of the bed shall enable the full length scanning of a patient in one scan
acquisition. Full body horizontal scan range must be equal to or more than 180 cm and vertical
travel from 60-90 cm.
Image Reconstruction :
Reconstructed slice width: <1mm to 10mm.
Iterative reconstruction methods with OSEM or others options.
FBP reconstruction methods.
Pitch-preferably freely selectable.
Display matrix 1024x1024 or more.
The system shall have a data editing facility for data acquired due to irregular heartbeat.
Computer System : Acquisition / Processing Workstation
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Purchaser’s Specifications
One sets of acquisition workstation shall have independent of processing workstation. Three
Processing workstations are independent of each other with all concurrent licensed software
and one workstation are for review purpose with all required software, shall have DICOM
Radiotherapy Export (RT).
Acquisition as well as all workstation console shall have latest technology with latest hardware,
operating system and software with minimum 2.5 GHz processor, 6 GB RAM, 500 GB or more
HDD, Optical Mouse, Key-board, High resolution flat panel LCD based 21 inch (diagonal)
colour monitor with minimum resolution of 1024 x 1024, CD-DVD combo drive with writing
facility and 1000 CD & two 32 GB Flash drive with each processing workstation.
The computer workstation shall be of latest specifications at the time of shipment.
Latest windows based DICOM ready software to be provided for fast acquisition and
processing. Latest and upgradeable software and hardware with all licenses, (and upgrades for
ten year) for all Quantitative Oncology, Quantitative Cardiology including bolus tracking,
CTA coronary tree, plaque analysis, calcium scoring, bone mineral densitometry, myocardial
perfusion quantification and Quantitative Neurology including perfusion application shall be
provided with Stereotactic software for localizing lesions .Connectivity with other DICOM
enabled imaging modalities shall be possible. Computer Aided Detection (CAD) for lung
nodule identification and growth rate calculation. CT Fluoroscopy with monitor near gantry.
Image and Radiotherapy structure transfer through network in DICOM ready format to
treatment planning system in Radiotherapy department.
Quality Control software for scanner calibration (for all scanner performance parameters
including CT parameters as per NEMA latest recommendations).
Provision to make DICOM ready /PDF/AVI/MPEG digital output. Software for CT/PET/MRI
fusion and provision for multiple phases in 3D demonstration and treatment planning system.
PET DICOM higher version (latest release) must be implemented. It shall have the ability to
import MR/CT DICOM Data by networking with CT scan and MRI Facility of this Institute.
Specialized Software’s (Latest Version only): All processing workstation must have
specialized quantification software’s for Brain (Scenium or equivalent for Quantification of
Cerebral perfusion/cerebral blood flow and flow reserve, Quantification of metabolic
parameters) & for Cardiac studies (4DM or equivalent quantification and fusion software for
PET, SPECT, CT and MRI based myocardial perfusion evaluation and flow reserve).
Myocardial perfusion study software with ECG Gated studies, wall motion and wall thickening
abnormality analysis/quantification with bulls eye map display. Separate Fusion software for
registration of PET-CT images with imported MR Images and networking / cabling with
satisfactory demonstration.
One additional computer (laptop) having core i7 or latest version processor, 4GB RAM, 500
GB or more HDD, High resolution 15 inch display and CD-DVD RW facility must be
equipped with latest generation pharmacokinetic software and internal dose assessment
software (OLINDA and MIRDOSE).
Data Acquisition:
Acquisition modes: Acquisition in 3D modes must include Static, Whole Body, Dynamic and
Gated Acquisition provisions. 3D whole body acquisition protocols with prospective 3-D
reconstruction algorithm. Iterative reconstruction technique shall also be available.
Acquisition protocols: The acquisition program shall support pre-programmed scan protocols
with acquisition and reconstruction parameters and patient information with simple dynamic
editing of parameters. These parameters would include all information necessary to acquire
data on the PET scanner (e.g. scan duration, patient information, frame/list mode, bed motion),
as well as information necessary for reconstruction.
Whole Body Acquisition: Latest multi bed shall advance the bed from one position to the next
automatically or continuous acquisitions (e.g. for the purpose of whole body oncology studies).
Dynamic Frame / List Mode Acquisition: The acquisition set-up software must support
multi-frame acquisitions of different (arbitrary) frame duration’s with no loss of data between
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Purchaser’s Specifications
frames.
Reconstruction start image reconstruction shall simultaneously start for the acquired images,
while acquisition is still in process.
Pixel Size: The user shall have the capability to specify the pixel size for reconstruction. The
reconstruction program shall support reconstruction in image sizes of at least 128x128 or
higher.
Scatter Correction: A scatter correction technique that in space variant and adjusts for patient
geometry must be included. Scatter correction must be provided based on scan of the actual
patient, whose scan is being corrected and processed automatically.
ECG Gating and Respiratory Gating shall be part or the offer and area to be provided with
necessary software. Acquisition matrix: 1K x 1K.
Dual Isotope input is also required.
Image Quality : Parameters for the following must be specified at 20 cm FOV and
CATPHAN phantom:
 Low contrast delectability – 5 mm at 3 HU least.
 High contrast resolution – 12 LP/cm at least.
Image Hard Copy Device
Laser imager Dry chemistry DICOM with flexible formatting and software controlled
operational capabilities with networking – latest model at the time of supply. Printing of films
of 14”x17”, 10”x12”&10”x8” size in a resolution of 600 or more dpi- 01 no.
Two in nos. network Laser Colour printers with compatible high capacity ink cartridges, with
at least 16 million colours and 1200 dpi spatial resolution with accessories including
workstation, digital DICOM compatible.
Lamination machine with 100 nos. of lamination roll for laminating paper images/reports- 01
no.
CT Scanner:
X-ray Generator, microprocessor controlled high frequency 60 KW or more, automatic selftesting system, KV range minimum 70 KV or more and minimum 120 KV or more.
X-ray Tube :
 Shall be capable of meeting the exceptional demands of multi-slice imaging
 Maximum tube current range at least 600 mA or more.
 Rotating anode type with high heat storage capacity of 6.0 MHU or above.
Spiral CT:
 Freely selectable Slice Thickness for prospective or retrospective reconstruction.
 Gapless Single Spiral time shall be 90 seconds or more.
 Metal free Scan length minimum shall be 150 cm.
 Rotation time shall be 0.4 second or less.
 All these parameters shall meet international standard with verifiable tube parameters.
 Multiple Pitch factor settings shall be available.
 Slice thickness shall be 0.625mm or less for isotropic resolution.
 Low contrast detectability - at least 5 mm /3HU /20 mGy.
 High contrast resolution shall be better than 0.35 mm.
Data Acquisition System:
 Display of radiation dose per examination is essential.
 Mechanism for adaptability of the tube current during one scans rotation for
dose regulation.
Image storage server and processor:
Bidder to state the details of high end server specification which will be supplied.
Image Evaluation Tools:
 Parallel evaluation of multiple regions of interest in circle, irregular and
polygonal form
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Complete statistical evaluation software for axial and 3D images. Blood flow
quantification packages for perfusion studies please give details.
 Profile cuts, horizontal, vertical, oblique.
 Annotation, labelling, online, measurements, ROI etc.
 Dynamic evaluation of contrast enhancement in organs and tissue, calculation
of time density curves, peak enhancement images, time to peak images, image
subtraction etc.
 2D image zoom, pan, manipulate, averaging reversal of grey scale values,
mirroring, image filter functions, advanced image algorithms and advanced
bone correction.
Image transfer/network:
 System shall be fully DICOM 3 compatible for DICOM send and receive.
 System shall able to export the image files in JPEG/AVI, MPEG or other digital
output.
Accessories:
Automatic Pressure injector – 01 (One) in nos.
Digitally controlled CT contrast injection system (latest model – Dual Head) with Pedestal
head mount, syringe heater with minimum 500 nos. of compatible syringe (200 ml) and
connector for dual injection system.
State of the art General Anaesthesia Induction System with Crash Cart and Resuscitation
Unit:
 Anaesthesia gas delivery system for delivery of oxygen, nitrous oxide and medical air
with pressure gauges.
 Circle absorber system.
 Precision maintenance free vaporiser for halothane, Isoflurane/ Sevoflurane.
 Anaesthesia ventilator: Must be able to set tidal volume, respiratory rate and I:E ratio.
 Ventilator must have audible alarms for ventilator failure, low oxygen supply pressure,
inadequate volume delivery, disconnection alarm, and power supply failure.
 Monitoring system to monitor Anaesthetic gases, ECG, EtCO2, Pulse Oxymeter and
airway pressure, NIBP, 2IBP , rectal/&skin temperature.
Non Invasive Monitor:
 Portable and Light weight preferably <10kg
 Modular with 12 inch multi-colour TFT display.
 Monitoring parameters: ECG, respiration, NIBP, SpO2 and temperature.
 Digital and 6 waves / traces display.
 Trends up to 24 hours.
 60 minutes or more battery back-up.
 Convenient handle for carrying the same.
 Able to fix with bed/trolley.
Monitor cum Defibrillator with Recorder:
 Biphasic, latest model, with auto and manual mode. Manual selection up to 200 J.
 Must be mains and battery operated, with charging indicator.
 Must be able to deliver 30 shocks with fully charged battery.
 Must have true 1-2-3 Color-coded operations.
 Must have inbuilt thermal recorder.
 Must have automatic lead switching to see patient ECG through paddles or leads.
 Shall measure chest impedance and must be able to compensate.
 Must be provided with Adult and Paediatric external paddles.
 Must have both Synchronous and Asynchronous mode.
 The charging time to highest energy level must be less than 5 seconds.
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Purchaser’s Specifications
 Disposable defibrillator pads – 10 nos. with each machine
 Must have external pacemaker facility.
12 channel ECG machine (standard make) with all accessories: 01 no.
Crash Cart: 01 no.
Resuscitation unit: 01 no.
Infant Cradles: (Branded / Standard make): 01no.
(Minimum 600 mm long and one 800 mm long cradle with stabilizing straps).
Phantoms and other accessories: For Quality control sets:
Complete sets of Phantoms and other accessories for CT & PET-CT quality assurance and
calibration sources including pin source.
 For Spatial resolution: One no. of Hamilton syringe (100 micro litre capacity), one
packet of capillary tube (1mm diameter).
 For Sensitivity: A complete set of Sensitivity Phantom,
 For Scatter fraction, count-rate losses and random measurements : NEMA scatter
fraction phantom
 For Image Quality and PET-CT image registration: Image Quality Phantom
(IEC/NEMA 2001/2007 body phantom or equivalent).
 For Coincidence timing resolution for TOF positron emission tomography (If
required): As per requirement of scanner.
 For 2-D–3-D Radioactivity concentration calibration: A Cylindrical Phantom (
fillable F-18 Phantom)
 For CT QC: CT Phantom (to test display profile with width, high contrast modulation
and low contrast resolution, slice, image noise and image uniformity etc.
 For the KVp value and the half-value layer test (CT QC): Type 1100 aluminium HVL
filter set capable of adding 1–10 mm aluminium filtration to the beam.
 For Computed tomography number (CT QC): A phantom with areas of different
densities, with, at a minimum, water, polyethylene, acrylic polymers, Teflon and air.
One set sources for calibration likes phantom (Germanium-68) Calibration Sources and other
Sources, (calibrated for the date of installation) to last for least10 year-to be replaced as
required.
Radiation detecting Alarms meter (standard imported make like Ludlum, Biodex, Capintec or
better etc.: 03 nos.
Radiation Sign: (Biodex, Capintec or better etc.): Each 07 nos.
(Radiation Area, Radioactive Materials and other relevant messages caring).
Automatic Dosimetry (TLD) Reader along with annealing unit with 500 TLD Discs and 50
Discs Holder , TLD powder ( Lithium Fluoride / Calcium Fluoride Dysprosium / Calcium
Fluoride Manganese ) with standard accessories (Standard make) : 01sets.
Lead Shielded Waste Containers (12mm Lead) for PET Radiopharmaceutical waste (Biodex,
Capintec, Ludlum, or equivalent): 03 nos.
Shielded L Bench – high energy type (PET compatible with lead glass (Biodex, Capintec,
Ludlum or equivalent): 01 no.
Shielded Decay drum for long half-life radioactive materials having energy 400 KeV or above
(Biodex, Capintec, Ludlum or equivalent): 01 no.
Digital Pocket dosimeter-Gamma & Beta (Ludlum, Rotem, Biodex, Canberra or equivalent):
06 nos.
Digital Portable radiation survey meter (Ludlum, Rotem,Victoreen, or equivalent): 02 nos.
Digital Handheld Contamination monitor (Ludlum, Rotem, Victoreen or equivalent): 01 no.
Lead bricks with bottom, corner and top: 1 set (54 or more nos.)
Shielded syringe holders (Tungsten made) (Biodex, Capintec, Rotem or equivalent): 02 each
for 2ml, 5 ml, 10ml.
Shielding transport containers for FDG (Biodex, Capintec, Rotem or equivalent): 01 each for
multi and single dose
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Purchaser’s Specifications
Transport trolley for transport of shielding container (Biodex, Capintec, Rotem or equivalent):
01 each for Multidose and Single Vials.
Light weight Radiation Protection Aprons with stand (Branded / Foreign made): 05 each.
Area Zone Monitor (Ludlum, Rotem, Biodex or equivalent): 02 nos.
Gonadal Shield, Thyroid Shield (of different sizes): 04 nos. (each)
PET Eye goggles with lead tinted glass (Biodex/Capintec/ Rotem or equivalent): 02 nos.
Digital temperature and humidity control reader (Branded/Standard made): 03 nos.
PET Dose Calibrator (CRC 55tR or equivalent) with one set of all three calibration sources
(Ba-133, Co-57 and Cs-133): 03 nos.
Lead lined glove (for PET Radiopharmaceutical Handling): 02 sets.
Lead glass minimum 100 X 80 cm or more with frame lead equivalence 2mm.
Gun Monitor: 01 no.
PET Dose Cabinet: Heavy duty metal top table (SS or better) with provision of Dose Calibrator
and L-Bench (Biodex, Capintec or Imported) installation with considering radiation safety
requirements like lead bricks (Biodex, Capintec or Imported): 01 set.
Long Tool (72 inch or larger with lock and unlock option) (Biodex, Capintec or Imported): 01
no.
Decontamination Kit (Biodex, Capintec or Imported): 01 no.
Various size forceps (12 and 18 inch) (Fisher or Branded): Each 5 nos.
Glucometer (Imported): 04 nos.
Digital Infusion Pump (Imported): 02 nos.
Automatic Blood pressure measuring apparatuses (Imported): 02 nos.
Tools (hardware and software) for PET/CT guided biopsy (Latest available model): 01 sets
PET sharps container: 1 no.
Syringe Needle destroyer, electric: 02 nos.
Electronic (fully Digital) weighing machine with Minimum range of 0-200kgs with SS top
plate: 02 nos.
Stainless steel side trolley in the PET/CT room: 01 no.
Collapsible wheel chair with rubberized swivel wheels: 01 no.
X-ray LCD illuminators for minimum 5 films view: 02 nos.
Dehumidifier with minimum 35 litres /day capacity: 01 no.
Core i7 PC for patient reports with laser printer: 01 no.
Core i7 based laptop for teaching purposes: 01 no.
High End Scanner (A3 size scanner with full optical resolution: (Optical Resolution of 9600
dpi by 9600 dpi across full A3 bed, and scan method single pass ) (HP, Canon or equivalent):
01 no.
PET Radioisotopes FUME HOOD with movable protective shield for 511 KeV or
above:01 no.
The fume hood shall comply with the German International standard and safety
requirements, the DIN 12924 NEU. Shall be sliding window type with built-in double wall
socket 220V,and water fitting with drainage basin, Size approx. 1200mm (W) x 820mm
(D) x 2620 mm (H), Materials: The fume hood shall be constructed of stainless steel(Type
304) .Inner chamber finished in chemical -resistant Epoxy paint and work surface covered
with thick non glossy stainless steel sheet. Filter (Charcoal filters) and Exhaust to be lead
suitable distance as per safety standards.
PET Radio-pharmacy Supply:
Supply of 18F-FDG Isotope:
Bid shall include supply of calibrated F18 FDG dose to site basis for 10 patients
(10mCi/patient at door step) per consignment for 200 days per annum for 5 years. Delivery will
be as and when required in batches of 10 patient’s dose.
The purchaser has all the discretion powers to continue or discontinue the import of F-18 FDG
after 1 year during the 5 year contract.
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Purchaser’s Specifications
Supply of one 15 mCi (555 MBq) Semi-automated Gallium-68 PET generator and other
chemicals used for labelling of peptides (DOTATATE & Similar molecules) for 1st year after
installation of facility and annual supply of same for next 4 years is also quoted separately on
yearly basis. The contract for supply of Gallium-68 generator and other chemical necessary
accessory components for DOTATATE/DOTANOC labelling is reviewed and renewed every
year and the payment of which will be made on annual basis.
Consumables for 68Ga-peptide synthesis: For 6 months (4 elutions per month)
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Name of the chemical Quantity Requirement
Metal free water
1 litre
3 bottles
Acetone
500ml
6 bottles
Extra pure HCl
500ml
3 bottles
Ethanol
500ml
6 bottles
Ligand
1 mg
12-15 vials
Strata-XC
100/ pack 2 pks
RP C-18
10/pack
10pks
or as per requirement
8.
0.22 um filter
100/pack 1 box
Communication and Source security system:
Three sets of High Resolution CCTV for security of radioactive source and monitoring of
patients in post injection rooms with hard disk recording (at least one month storage capacity)
and multi-image display monitor (32 inch ) & one set of public address system (with DVD
player) along with 10 speakers placed in all rooms concealed in false ceiling.
Servo controlled stabilizer/CVT of suitable rating shall be provided.
UPS of at least 30 minutes operation with suitable rating shall be supplied for the complete
system including computer system, anaesthesia delivery system, monitor and defibrillator.
Accessories, Spare Parts and Consumables
All standard accessories/consumables/parts required for the proper operation of the above item
shall be included in the offer. Bidders shall specify, in a separate Excel worksheet, the quantity
and details of any items included in this offer which have not been specified in this Technical
Specifications Form.
All standard Maintenance tools and cleaning/ lubrication materials where applicable shall be
included. Bidders shall specify, in a separate Excel worksheet, the quantity and details of any
items included in this offer which have not been specified in this Technical Specifications
Form.
Operating Environment
Power supply: 380-415VAC 3 phase 50Hz fitted with appropriate plug for PET-CT and 220 –
240 VAC, Single phase 50 Hz, fitted with appropriate plug for other units. The power cable
must be at least 3 metres in length.
Standards & Safety Requirements
Must submit ISO 13485:2003/AC: 2007 AND
CE (93/42 EEC Directives) or USFDA approved product certificate.
Shall meet IEC-60601-1-2:2001General Requirements of Safety for Electromagnetic
Compatibility or must comply with 89/366/EEC; EMC directive
Shall meet IEC-60601-2-44 or EN-60601-2-445 Medical Electrical Equipment - PART 2-44:
Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography.
User Training
The Supplier shall conduct user training for this equipment to enable operators to use the
equipment properly. The training shall include the use of all operational functions of the
equipment, as well as routine checks and maintenance expected by users.
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Purchaser’s Specifications
One week on-site training by manufacturers' application specialist and service engineer for
training of medical and technical staffs to familiarize in proper operation and basic
maintenance and troubleshooting.
Warranty
Comprehensive warranty for 2 years after acceptance.
Maintenance Service During Warranty Period
During warranty period supplier must ensure preventive maintenance & corrective/breakdown
maintenance whenever required.
Manufacturer shall commit the availability of spare parts and consumables and accessories for
at least 10 years
Installation and Commissioning
The bidder must arrange for the equipment to be installed by certified or qualified personnel;
any prerequisites for installation to be communicated to the purchaser in advance, in detail.
Documentation
User (Operating) manual in English.
Service (Technical / Maintenance) manual in English.
List of important spare parts and accessories with their part numbers and costing.
Certificate of calibration and inspection from factory.