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CT Simulator Unit

FDA technical specification for CT simulator unit

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

Civic Drive, Filinvest City
Alabang 1781 Muntinlupa City

TECHNICAL SPECIFICATIONS FOR
CT SIMULATOR UNIT (at least 16 MULTISLICE)
Scope
This includes the supply, delivery, installation and commissioning of CT Simulator.
Application/Use
Radiotherapy patient simulation and treatment planning.
Standard Composition
• Scanner Gantry
• X-ray Generator and Tube
• Detection System
• Couch
• Operator Console
• Image Display Device
• Scan Parameters
• Image Collection and Processing
• Data/Image Storage, Management and Connectivity
• Accessories
• External positioning lasers
• CT Simulation software
• Power Requirements
• Other Requirements
• Other Terms and Conditions
Technical Specifications

Scanner Gantry

X-ray generator
and tube

Scanner aperture
Tilt
Laser positioning
lights – planes
Controls
Digital read-out
Generator type
Anode heat capacity
Maximum tube
voltage

80 cm or bigger
-30° to +30° or greater
Transaxial, sagittal, coronal with position accuracy of ± 1mm
or better
Located on either or both sides of the gantry
Couch and gantry positions/settings
High frequency
2 MHU or higher
If higher, please specify _________ MHU
130 kV or higher

Focal spot

 200 mA
 If higher, please specify _____ mA
With AEC system
Dual (high speed rotating anode)

Detector type

Solid state array

Material
Dimension
Couch top movement
System

Carbon fiber
Minimum of 235 cm by 40 cm
Motor driven and manual

Maximum tube
current
Detection
system

Couch

Horizontal travel

Range: 170 cm or longer
Speed: Variable with maximum speed of at least 10 mm/s
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Vertical travel

Operator
Console

Maximum weight
allowed on couch
Table top
Location of table top
controls
Input devices

Operating panel /
Control desk

Image display
device

Scan
parameters

Recorded instruction
system options
Operator-patient
communication
system
Acquisition
workstation
Review workstation
(Optional)
Image reconstruction
time
Scan region
Scan fields of view
Extended field of
view
Scan modes

Image
Collection and
Processing

Minimum rotation
time in spiral/helical
mode
Slice thickness
Reconstruction matrix
Image display

Image processing

Scannable range: At least 150 cm or more
Reproducibility of movement: Better than ±0.25 mm
Range: 55-95 cm when outside the gantry
Moving range within the gantry: 20 cm
Minimum height outside the gantry: 52 cm ±1cm
180 kg or heavier
Flat with patient positioning index
Table side, control console and hand pendant
Keyboard with integrated function keys and mouse
- Remote control of couch movement and gantry tilt
- Displays all scan parameters and CTDI and DLP values
for each procedure
- With programmable adult and pediatric scan protocols
- Allows selection of scan parameters
- Allows window width and window level adjustments
- With image processing/evaluation functions
User customizable recording
Two-way communication system
- Microphone and speakers
At least 1 unit medical grade LCD/LED-type monitors
Diagonal dimension of image screen, 21” or bigger
At least 3 megapixel LCD/LED-type monitors
Diagonal dimension of image screen, 21” or bigger
Less than 1.5 s for any mode
Whole body, including head
At least 50 cm or more
Minimum of 70 cm
Axial, spiral/helical, dynamic, volumetric, and other scanning
modes (please specify) ____________
≤ 0.5 s
User selectable, starting with 1mm or less
≥ 512 x 512
Display matrix: 1024 x 1024
Window width: continuously variable
Window level: continuously variable
Multiple image display
Three-dimensional (3D) display of images
Image retrieval: Display images can be
changed from patient to patient or from one image
to another image for the same patient using the
keyboard or on-screen menus
Scanned projection radiography processing:
 Anatomical scale
 Slice position setting
 Slice position display
 Zoom out / zoom in
CT image analysis:
 ROI setting and processing
 Measurement of distance and angle between two
positions
 Histogram
 CT number display
 Volume calculation
 Profile

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Data/Image
Storage,
Management
and
Connectivity

Accessories

Power
Requirements

Other
Requirements

CT image processing:
 Continuously selectable image
magnification
 Multi-frame display
 Addition/Subtraction of images
 Comment and annotation insertion
 Top/bottom, right/left, black/white reversal of image
 Image reconstruction algorithms/filtering
 Multiplanar reconstruction/reformatting
 Image stacking
 Image annotation and labeling
 Images are DICOM format ready for storage, retrieval,
and compatible for teleradiology and networking
system
□ Film
Storage media
□ CD/DVD
□ Others, please specify: _________
Back-up storage
□ CD/DVD
media
□ Hard drive with storage capacity of 3 TB
 QC phantom(s) to test low contrast, high contrast, CT number calibration,
Uniformity, Slice thickness, and Scan localization accuracy
 Electron density phantom
 Couch and laser alignment test tool
 Immobilization and positioning devices
- Headrests
- Positioning pads and cushions
- Straps (head, body, shoulders, knees, and legs)
- Support (head, shoulders, knees, and legs)
- Boards (Belly, Wing, Breast, etc.) (Optional)
 Couch top extension/Cradle extender (Optional)
 Automatic injector for contrast media (Optional)
 2 lead rubber apron of at least 0.25 mm Pb equivalence
 at least 100 cm x 60 cm (39” x 24”) lead glass of 1.5 mm Pb equivalence
 Hard copy imaging device (for film and paper storage media) (Optional)
 External laser (advantageous if supplied/installed with the CT scan unit to
ensure compatibility)
 Simulation software (advantageous if supplied and installed by the authorized
CT scan and TPS unit supplier to ensure compatibility)
3 phase, 220 VAC/380-460 VAC, 60 Hz as applicable to the power supply of the enduser
Supplier to provide appropriate transformer when applicable
At least 2 units split type, 2 hp, 220 VAC, 60 Hz for the
Air-conditioning units
CT scan room and 1 unit split type, 1 hp, 220 VAC, 60
Hz for the control room
Automatic voltage
1 unit, appropriate with the power rating of the CT
regulator
scanner and with a voltage regulation range of 150300 V
dedicated grounding system for the machine shall be
Grounding system
provided by the bidder
Dehumidifier
1 unit, 60 Hz, 220 VAC
1 unit for electrical ancillary equipment, with a battery
UPS
run-time of ≥ 20 min
Emergency light
2 units for CT room and 1 unit for the control room
Two sets of the following:
 operation and instruction manuals
 service and installation manuals
Documents
 wiring and schematic diagrams
 x-ray tube data specifications
 parts list

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Additional specification/requirement for upgrading diagnostic CT scanner to CT simulator:
CT simulator external laser
Table top
CT Simulation software

1 set
-Flat with patient positioning index
- Material: carbon fiber
- Dimension: Minimum of 235 cm by 40 cm
Must be compatible with the CT Scan and
Treatment Planning System

Immobilization and positioning
device

-Boards (Belly, Wing, Breast, etc.)

QC phantom(s)

- to test low contrast, high contrast, CT
number calibration, Uniformity, Slice
thickness, and Scan localization accuracy
(If not yet available)

Electron density phantom
Other Terms and Conditions
-

-

-

Three (3) years warranty for parts and service after passing the acceptance testing of the Center for
Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration
(FDA) – Department of Health (DOH) as provided in the DOH AO No. 21, s. 1996 dated 4 June 1996.
Must comply with the applicable requirements under the DOH Administrative Order (A.O.) No. 35, s.
1994.
The transportation expenses and per diem of the CDRRHR-FDA Medical Physics Team shall be
shouldered by the bidder.
Bid offer is in Philippine peso to include taxes and duties; transportation to site, delivery, installation and
testing expenses on site (hospital) by the bidder.
Certification from the manufacturer
 that the bidder has the capability for corrective and preventive maintenance of the unit.
 that the bidder/supplier has the engineer/s trained and capable for corrective and preventive
maintenance for the model bidded. Service engineer should be presently employed by the
bidder/supplier or authorized by the manufacturer.
 guaranteeing delivery of equipment and all accessories within the time period set by the Bids
and Awards Committee (BAC).
 guaranteeing the availability of all spare parts for the next ten (10) years duly authenticated by
the Philippine Embassy in the country of origin.
 that the equipment is a brand new unit and not a discontinued model.
 that the terms and conditions stated in the contract shall be honored by the manufacturer in the
event that a change of exclusive distributorship will occur during the duration of the said
contract.
Supplier’s engineer shall perform preventive maintenance on the machine during the warranty period
of at least quarterly.
The bidder must provide certification type of training on the applications/operations, and basic
maintenance for users and maintenance personnel of the hospital.
Certificate of exclusive distributorship from the unit manufacturer mentioning the name of the Philippine
representative.
Certification from the bidder of 95% uptime guarantee for the equipment offered within the warranty
period. Accumulated downtime in excess of 5% shall be added to the warranty period.
The bidder must submit the original brochure with technical specifications in English language.
The machine should conform to the International Electrotechnical Commission (IEC) standard or its
equivalent national standard. The bidder must provide Certificate of Declaration of Conformity.
Inventory of spare parts for the unit/model offered duly signed by the manufacturer.
Certification from the Foreign Ministry of Health that the company can sell the product/model in that
country of origin.
The bidder shall specify post warranty comprehensive preventive maintenance costs including list and
price of major spare parts for the next three years after warranty.

Note: This technical specifications replaces the previous technical specifications for CT Simulator unit. This
constitutes revisions done by CDRRHR technical working group which was approved on September 29, 2014.

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