Clinical Specialty CARDIOLOGY

Generic Name SINGLE –PLANE ANGIOGRAPHY

Clinical Purpose Simple-plane angiography machine is intended to
perform diagnostic and therapeutic procedure at
adult and pediatric institutes.

A fully digital flat signal plane cardiac angiography / cardiac catherization system dedicated for
Pediatric and Adult diagnostic as well as interventional cardiac procedures. Capable of head to toe
coverage without repositioning of patient. Companies shall offer their latest systems and applications
with best resolution and minimum possible radiation dose.

POSITIONING ARM
The system should be ceiling/floor mounted with maximum head side free space.
GEOMETRY:
 C-Arm or G-Arm geometry.
 Motorized digital flat panel system with smart colision detector.
 Rotation range(degree) ROA/LAO+-/105 or more Cranial / Caudal: Minimum +/-45.
 Rotation Speed : 40/ sec or more in LAO / RAO for rotaional angiography.
 SID Range 95-105 cm or wider range (PA/Laterial)
 Iso-centric height: Variable / fixed
 Auto positioning: Programmable auto positioning of selected angulations, (50 or more)
programmable positions.
 All rotational angles should be digitally displayed on the monitor.
 Motorized / manual packing & rotation of the positioning arm, capable of head-to-toe coverage
without patient repositioning.
 DIGITAL FLAT PANEL DETECTOR

Detector must be latest version or model from the manufacturer. Bidder must mention detector model
in technical offer.
 Detector size: ( Procuring agency shall select one of the following detector sizes according to
clinical requirement)

30*30 cm or Larger
FURTHER DETECTOR SPECIFICATIONS

 Asi/Csl/aSe type
 Image matrix of 1024*1024 pixels at minimum 14 bits depth for detector.
 Standard cardiology size with three formats.
 Built in temperature stabilizer.
 Integrated Colloision protection / Collision detection technology.

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All other standard accessories according to this digital fiat panel.
Dose management with Fluoro filters range of 0.1/0.2mm to 0.6/1.0 mm Cu/Real time automatic filter
selection based on patient body weight.
Minimum spatial resolution 2.51p/mm.
Minimum Pixel size of 200 pm.
Removable grid for pediatric applications.
Minimum DOE at >75% or better.
PATIENT SUPPORT TABLE:

A) ADULT SETUP: Floor mounted, 8-ways horizontal floating top catheterization table with
up/down vertical, longitudinal and transverse movements with pivoting.

(Procuring institute shall select one of the above table configurations)

FURTHER TABLE SPECIFICATIONS:

 Minimum table length 280 cm with unobstructed image coverage.

 Longitudinal travel up to 1200 mm with table top movement.
 Lateral Travel: 280 mm.
 Vertical Travel: 90-100 cm from the floor
 CPR should be possible in any table position.
 All table mounted controls.
 Table top should be able to accept patents' weight of up to 200kg plus 100 kg for resuscitation.
 Table top should be metal free (X-ray density < 2mm Al equivalent or better)
 Complete accessories including arm holders, hand grips, arm supports, arm rests and positioning
aids.
X-RAYS GENERATOR:

 Microprocessor based high frequency using fiber optics for data communication between each
imaging system. (Mention model in Technical offer)
 Dedicated X-Rays generator of 100KW
 Radiographic mA up to 1000
 Radiographic kV 41/50-125kVp
 Serial filming exposures with shortest exposure of 1 mS, with automatic KV and mA control for
optimum Image quality.
 Capability of digital radiography and fluoroscopy.
 Capability of doing multiple rate digital pulsed fluoroscopy and cine at range of 3.75 to 30 fps.
 Capability to change frame rate during the same study.

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X-RAYS TUBE (Mention Models in technical offer)

 Tube (liquid /metal bearing technology)

 Tube must be latest version model from the manufacturer.
 Minimum of five years unconditional warranty on the x-rays tubes by the original manufacture.
 (To be confirmed by the manufacturer)
 Housing heat storage capacity, HU 3MHU or more.
 Dual/ Triple focus with Anode heat storage capacity 3MHU or more.
 Capacity to enable maximum continuous heat dissipation within system type during serial
exposure.(Vendors must specify system type and maximum heat dissipation capability)
 Rotating anode with focal spot size of minimum 0.3-0.5 to 0.8-1.0 mm .
 State of art cooling system (As per manufacturers design / Recommendations)

RADIATION REDUCTION AND MONITORING SYSTEMS:

 Grid pulsed / physical radiation reduction system / flat emitter technology/ similar technology
tubes with radiation dose management and with auto adjusting Fluoro filters.
 Dedicated X-Rays radiation dose monitoring and dose reduction software features. (Clarity /
Dose Rite/ Blue Print / Care + Clear). Firms will be bound to quote their latest available
certified versions. Automatic copper filtration - Fluoro filters range of 0.1/0.2mm to 0.6/1.0 mm
Cu.
 Angulation dependent automatic exposure control including KV, mA, pulse width & focal spot
adjustments.
 Automatic calculation and optimization of exposure data based on fluoroscopic data.
 Radiation free patient positioning without active Fluoro.
 Active patient skin radiation dose monitoring based on actual C-arm angulations, table positions.
 Radiation free collimation.
 Real-time displays on main examination room monitor as well as control room monitor including
cumulative Air Kerma display; cumulative Dose Area Product and Fluoro time.
 DICOM structured report containing patient, procedure and dose data.

HIGH RESOLUTION DIGITAL IMAGING AND ACQUISITION/ FLUOROSCOPY SYSTEM WITH REAL TIME
IMAGE PROCESSING:

 High resolution digital imaging system with outstanding image quality.

 Acquisition, storage and display all at minimum 12 bits.
 Parallel processing capability / multitasking facility.
 Real time filtering and roadmap function.
 Magnetic disk capacity for storage of minimum 50,000 images in 1024 x 1024 x 12 bit on the
magnetic disk of main console.
 Minimum scene length 10 seconds in 1024 matrix @ minimum 30fps.
 Images storage and retrieval from archive disk for possible manipulation and quantification
using available software packages (compatible format / bits).

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MONITORING SYSTEM:

 Medical grade large display monitor in examination room minimum 55" in size along with TWO
19" or larger medical grade monitors for backup if built-in backup is not available in the large
monitor. Monitors should be ceiling mounted with original ceiling suspension system.
 Two LCD/LED medical grade monitors for live images and road mapping in the control room,
minimum 18" inch or larger size.
 All monitors should be Medical Grade,complied with international standards for medical
monitors as recommended by manufacturer and all with the same brand.

CONTROLS:

 Integrated table side single touch screen console to adjust system parameters, display setting of
55” monitor, frame rates, hernodynamio system controls and quantitative analysis.
 All controls of digital imaging system, Measurements,post processing & quantifications analysis
shall be in the control room as well as the examination room with replay / display in auditorium
room. Quantification and processing should be possible.
 The control panel can be mounted at any side of the patent table

RECORDING / ARCHIVING & COMMUNICATION SYSTEM:

 Recording/ archiving system should be DICOM-3 compatible.

 Digital images should be stored as backup on CDs / DVDs with incorporated original DICOM
handling software / DICOM player from original manufacturer.
 DICOM (Send/store, commitment, retrieve/query)
 PACS compatibility/ integration.
 Compatibility to display Intra-Vascular Ultrasound, OCT, and FFR system images on main screen.
Compatibility to display of ultrasound /echocardiography system Images.
 Ethernet connection to connect with other terminals.
 Integrated bi-directional intercom system.

SOFTWARE PACKAGES:

The bidders should quote their licensed software with part number in their principal offer.

Complete analysis package for following cardiac applications should be included:

 Dynamic pre and post PTCA / Valvotomy comparison with one image live and other reference.
 Automatic loop replay after acquisition or fluoroscopy.
 Dynamic real time pan /zoom.
 Dynamic real time digital imaging processing like edge enhancement or gamma correction, noise
reduction (spatial filtration).
 Online image density (gray scale) correction.
 Simultaneous display of fluoroscopy and reference images.
 Standard quantification packages for Left Ventricular Analysis.
 Facility to review previous studies in the examination room from the patients' old CD.
 Automatic positioning of the c-arm corresponding to reference image.

Store Fluoro facility to store last fluoroscopy run.

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DEDICATED ADULT FEATURES :

 Digital subtraction angiography package with manual / real time pixel shift for compensation of
patient movement during acquisition.
 Real time / live stent visualization/ enhancement software with integrated table side control
with touch panel (latest version by the manufacturer).
 Rotational angiography software.
 Quantitative coronary analysis software.

DEDICATED PEDIATRIC FEATURES:

 Fusion software for 3D structure of CT/MRI image overlaying on 2D live Flouro without cone
beam CT.
 3D reconstruction software for pulmonary arteries, coarctation of aorta and right ventricular
outflow tract.
 Workstation for 3D reconstruction congenital heart defects including aorta, pulmonary artery
and RVOT supplied by the principal manufacturer.

PHYSIOLOGICAL HEMCDYNAMIC MONITORING SYSTEM: (Original from manufacturer of Angio system)

Integrated hemodynamic system full table side control having bi-directional communication the
machine for automatic acquisition, transfer of patient demographic data.

 Multichannel (16 channels or more) to record at least 4 channels IBP, Cardiac output with
thermo dilution method, Surface ECG in any configuration and simultaneous 12 lead ECG

OR

 Electrophysiology compatible Multichannel (64 channels or more) Hemodynamic system.

HEMODYNAMIC SYSTEM FEATURES:

 Complete software for all pediatric & adult. Right/left heart, AngioValvular hemodynamic
calculations such as gradients. valve areas, shunts including annotations and 12 channels ECG.
 Live Waveforms display on main 55" large monitor in the examination room.
 Digital display of all the parameters like IBP, Heart rale, cardiac output parameters.
 Possibility to print the waveforms simultaneously while acquiring the data in the background.
 Capability to store the waveforms on the hard disk of the physiological recording system.
 Two Monitors in the control room, one for live waveforms and the other for control and data
entry.
 Facility for freezing hemodynamic data and simultaneous recovery of recent data) compare
stored data with current waveform.

HEMODYNAMIC SYSTEM ACCESSORIES:

 Complete 12 lead ECG Cables (05).

 NIBP cuffs (Infant, Pediatnc, Adult) (10 each).
 Thermo dilution catheters SF 4 lumen (02).
 IBP pressure transducers (500).
 IBP transducer cables (10).
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  Holder for mounting the IBP transducer alongside patient table (10).
 DVD /CD writer for archiving of study data and waveform stored on hard disk independent of
live Fluoro.
 Portable pulse oximeter with pulse oximeter probes (Pediatric probes,adultprobes,infant
probes).
 Portable non-invasive hemodynamic / BP monitor with built-in batteries.
 Whole blood oximeter with cartridges.

DEDICATED BRANDED WORKSTATION: (Hardware should be as per manufacturer’s

recommendations & Software should be from original manufacturer of anglography system.

Online workstation to review studies directly and the facility to review studies with lossless compression
and original image quality as on console.

 DICOM-3 compatible.
 Capable of universal DICOM support.
 Original DICOM handling software from the manufacturer with permanent license.
 Edge enhancement, adjustable view speeds & post processing capabilities.
 High Definition Medical Grade LCD/LED monitor of minimum 19 inches size.
 CD / DVD writer and CD/DVD Rom Drive.
 Image storage capacity as per manufacturers approved hardware.
 SCSI or equivalent controller as per manufacturer’s approved hardware.
 Black & white laser printer.

REVIEW STATIONS FOR AUDITORIUM) CLASSROOM! DOCTOR OFFICE :

 Branded review station with connectivity to main angiogiaphy machine including all necessary
cabling / hardware for connectivity.
 Minimum 40" inch LED with live view of Fluoro imaging and capability of case review.

RADIATION PROTECTION EQUIQMENT / ACCESSORIES: (FDA CE approved)

 Ceiling suspended tilt table lead glass for radiation protection of operators head & neck regions
and upper body parts.
 Table mounted adjustable lower body radiation shields / flaps.
 Lead glass window size 4 x 1 meter or larger Pb equivalent 2.0 mm or better.
 Lead aprons (vest and skirt), double side with different sizes, light weight, Pd equivalent front
0.5mm and back 0.35 mm with belts. (FDA/ CE approved) (20).
 Lead aprons (single piece), double side with different sizes, light weight,Pd equivalent front
0.5mm and back 0.35 mm with belts. (FDA,' OF approved) (10).
 Wall mounted / Trolley mounted hangers for lead aprons (locally supplied).
 Thyroid shields with lead caps. (FDA / CE approved) (30).
 Lead Goggles, - light weight. (FDA / CE approved) (30).
 Patient protection lead sheet - light weight, 30 inches in size.
 Digital dosimeters (15).

ALLIED ACCESSORIES:

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  Ceiling suspended shadow-less light.
 Crash cart (Country of origin: USA, EU & JAPAN) (02).
 Patient shifting trolley. (Country of origin: USA, EU& JAPAN) (06).
 Steel tray trolley for disposables, 5 x 3.5 feet 40 cm height (02).
 ACT machine (01).
 Single chamber override Pacing box capable of pacing up to @300BPM (02).
 Programmable portable contrast media injector (Medrad, Angiomat, Medtrone, Nemoto,
Guerbet) with disposable syringes (01).
 Writeable CDs/ DVDs (1000).
 Defibrillator (04).
 ECG Machine (04).
 Intra-Aortic Balloon pump machine (01).

QUALITY AND SAFETY STANDARDS: (For Angiography and Hemodynamics system) FDA 510K and
CE(MDD) as under:

A) Dedicated adult setup — FDA approval (adult angiography and hemodynamic system, and CE
approval.
B) Primarily adult setup along with pediatric procedures also being done — FDA approval (adult
angiography and hemodynamic system) end CE approval.
C) Dedicated pediatric setup - FDA approval (pediatric angiography and hemodynamic system) and CE
approval.
 Main operation: Equipment/Instrument/Applied parts shall conform to standards for electrical
safety IEC-60601-1 General requirements.
 System should meet IEC-60601-1-2 OR equivalent BIS General requirements of safety For
electromagnetic compatibility.
 Medical grade displays and power supplies.

POWER REQUIRMENTS:

 Three phase with line voltage of 440V. 50 Hz.

 Cabling for electrical power supply, generator & UPS connections.
 Cabling for proper earthing.
 250 KVA or more true online sine wave Double conversion UPS for whole system with a
minimum back up time of 10 minutes including room fights. microprocessor based IGBT
technology. Display and alarms of parameters. Three phase lirte voltage of 220 50Hz with all
necessary standard parts Including batteries. unconditional 5 years warranty for UPS and UPS
batteries.
 320 KVA (Stand by) Electric Power Generator with ATS penal power cables and sound proof
canopy (imported) set with automatic change over for complete load of Angiography Suite
including Air conditioners, lights and other load of Angiography suite. (Engine; Perkins/
Cummins/Caterpillar/ Volvo).

INSTALLATION:
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  Pre and Post Angiography Ward renovation include (Lighting Air Conditioning and Furnishing
Renovation of Patient waiting area for Angiography Includes (Comfortable Seating for 50 or
more person, LED T.V (02), Water Dispenser (02), Counter (01) and Air Condition (04).
 Complete Renovation of Cath Lab.
 Air conditioning and humidity control for control room, examination room. Machine and
technical rooms as per manufacturer’s recommendations.

WARRANTY:

 The warranty period shall be for FIVE YEARS unconditional for all essential components /
equipment to keep the machine functional including x-rays tube and flat panel detector,
monitors, machine cables and connecting leads, diesel generator. UPS with batteries,
hemodynamic system, non-proprietary items supplied with the machine with all specified
parameters that shall cover labor and parts for all equipment.
 During the period of machine functioning before formal signing of installation report,
rectification of errors or replacement of faulty parts shall be the responsibility of supplying firm
without any financial implications or liabilities at the institute or end users.
 The warranty shall start from the date of installation report signing.

OPTIONAL

OPTIONAL ITEMS:

 Mobile echocardiography system (4D) (01).

 Co-registration / Integration of Cardiac CT.

OPTIONAL FEATURES:

 Motorized longitudinal and lateral travel of patient support table I Stepping DSA feature.
 3D Rotational angiography system. Latest software version by the company.
 Integrated complete licensed Pediatric Catheterization Reporting Software with image illustrator
based on standard atlas tailored according to congenital heart defects, It should be Able import
data and images from main angiography system and overlay Sp02 and pressures over images
automatically. It should have a complete Hemodynamic calculation module.

GENERAL INSTRUCTIONS:

 OPTIONAL ITEMS I FEATURES" may be included in the tender specifications as per requirements
of procuring institute, Specifications of Items mentioned under headings "Optional Items' and
'Allied accessories' will be as per approved PVMS if available, whereas, certifications (FDA. CE &
MHLW) will be decided by procuring agency. Bidders may quote against respective items.
However, non-quoting or not meeting the required specifications for these items would not be
reasons to reject disqualify a bid. The procuring agency/Institute may procure optional items if
sufficient funds are available post financial bid.
 Bidder will be bound to provide undertaking from the manufacturer that in case the local
distributor gets changed during the mentioned warranty or service contract period, the new
authorized distributor shall own the warranty, backup services, replacement of parts and all
pending liabilities on behalf of the principal manufacturer.

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