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Spiral/Helical CT Scan unit

FDA technical specification for spiral/helical 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
SPIRAL/HELICAL (______ SLICE) CT SCAN UNIT
Scope
This includes the supply, delivery, installation and commissioning of CT scan.
Application/Use
Routine head/spine and body imaging procedures including contrast studies.
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
• Power Requirements
• Other Requirements
• Other Terms and Conditions
Technical Specifications
Scanner aperture
Tilt
Scanner
Gantry

Laser positioning lights – planes
Controls

X-ray
Generator
and Tube

Digital read-out
Generator type
Anode heat capacity
Maximum tube voltage

70 cm or bigger
-25° to +25° or greater or other means
suitable to the tilting movement of the
gantry in consideration.
Transaxial, sagittal, coronal
Located on either or both sides of the
gantry
Couch and gantry positions/settings
High frequency
□ 2 MHU
□ If higher please specify: ______ MHU
130 kV or higher
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Focal spot
Minimum slice thickness

□ 200 mA
□ If higher please specify: ______ mA
with AEC System
Single or dual
≤ 1.0 mm

Detection
System

Detector type

Solid state array

Couch

Scannable horizontal range
(Standard, without extension)
Vertical travel
Maximum weight allowed on
couch
Couch top movement
System

Maximum tube current

Input devices

Operator
Console

Operating panel/ Control desk

Recorded instruction system
options
Operator-patient communication
system
Acquisition workstation
Image Display
Device
Review workstation
(Optional)
Scan region
Maximum scan fields of view
Scan
Parameters

Image
Collection and
Processing

Scan modes
Minimum rotation time in
spiral/helical mode
Reconstruction matrix
Image display

120 cm or longer
54 cm or higher
180 kg or heavier
Motor driven and manual
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/LEDtype 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
Whole body, including head
≥ 50 cm
Axial, spiral/helical, dynamic, volumetric,
and other scanning modes (please specify)
____________
≤ 1 s (For cardiac application
recommended rotation time is ≤ 0.5 s)
≥ 512 x 512
Display matrix: ≥ 1024 x 1024
Window width: continuously variable
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Image processing

Data/Image
Storage,
Management
and
Connectivity

Storage media
Back-up storage media
Magnetic hard disk

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
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
□ CD/DVD
□ Others, please specify: __________
□ CD/DVD
□ Hard drive with storage capacity of 3 TB
Ability to burn images to disc

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Accessories

Power
Requirements

Set of QC phantoms with water phantoms for adult head and body and
pediatric head
 Adult and pediatric headrests and straps
 Coronal headrests
 Positioning pads and cushions
 Headrest support
 Wide and narrow body straps
 Knee support
 Elbow and shoulder level arm supports
 Leg support accessory
 Patient mat
 Couch top extension/Cradle extender
 Automatic injector for contrast media
□ single
□ dual (recommended for cardiac applications)
 2 lead rubber aprons 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)
3 phase, 220 VAC/380-460 VAC, 60 Hz as applicable to the power supply of
the end-user
Supplier to provide appropriate transformer when applicable

Air-conditioning units
Automatic voltage
regulator

Grounding system
Other
Requirements

Dehumidifier
UPS
Emergency light

Documents

At least 2 unit split type, 2 hp, 220 VAC, 60
Hz for the CT scan room and 1 unit split
type, 1 hp, 220 VAC, 60 Hz for the control
room
1 unit, appropriate with the power rating of
the CT scanner and with a voltage regulation
range of 150-300 V
dedicated grounding system for the machine
shall be provided by the bidder
Surge protection system shall be provided by
the bidder (optional)
1 unit, 60 Hz, 220 VAC
1 unit for electrical ancillary equipment,
with a battery run-time of ≥ 20 mins
1 unit for the CT scan equipment (Optional)
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
 wiring and schematic diagrams
 x-ray tube data specifications
 parts list

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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 computed tomography
x-ray machine. This constitutes revisions done by CDRRHR technical working group which was approved
on July 17, 2014.
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