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Stationary Radiographic X-ray System
FDA technical specification for stationary radiographic x-ray system
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
STATIONARY RADIOGRAPHIC X-RAY SYSTEM
Scope
This includes the supply, delivery, installation and commissioning of general radiography
x-ray system.
Application/Use
Radiographic procedures
Standard Composition
• X-ray Generator and Tube
• X-ray Tube Support Assembly
• X-ray Table
• Vertical Image Receptor Stand
• Control Console
• Automatic Exposure Control (AEC) Device (Optional)
• Image Receptor
• Image Display Device
• Accessories
• Power Requirements
• Other Requirements
• Other Terms and Conditions
Technical Specifications
Generator
Generator settings
X-ray Generator
and Tube
Anode
Nominal focal spot
size
Total filtration
Permanent filtration
Collimation system
High frequency inverter system
Kilovoltage:
Minimum Setting: 40 kV
Maximum Setting: ≥ 125 kV
Maximum tube current:
□ 100 mA
□ If higher please specify: ______ mA
Rotating
Small focus: ≤ 0.8 mm
Large focus: > 0.8 but ≤ 1.5 mm
≥ 2.5 mm Al equivalent
≥ 1.5 mm Al equivalent
□ Automatically controlled collimator
□ Manually controlled collimator
With field lamp and automatic shut-off timer
With crosshair centering and pre-indication of field
sizes at certain source to image distance
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Mounting
X-ray Tube
Support
Assembly
Locking mechanism
Tube arm movement
Swiveling out tube
assembly (Optional)
Tube angulations
Stationary
Grid
X-ray Table
Accessories
(Optional)
Vertical Image
Receptor Stand
Grid
Movement
Overload protection
indicator
Technique selector
Control
Console
Display
Exposure switch
□ Floor
□ Ceiling
□ X-ray table
□ Floor to Ceiling
□ Floor to Wall
Electromagnetic/manual
□ Lateral
□ Horizontal
□ Vertical
At least ± 90°
At least ± 90°
□ Basic
□ 4 or 6-way floating
Reciprocating
Ratio:
□ 12:1
□ 10:1
□ 8:1
Grid frequency: At least 70 lines/inch (27 lines/cm)
Focal distance: At least 35 inches (90 cm)
□ Image receptor holder for cross-table exposure
Immobilizing devices:
□ Head clamp
□ Abdominal/head straps
Reciprocating
□ Parallel
□ Focused
Focal distance: At least 40 inches (100 cm)
Ratio:
□ 12:1
□ 10:1
□ 8:1
Grid frequency: At least 70 lines/inch (27 lines/cm)
□ Vertical
□ Tilting
Visual/audible
□ Kilovoltage (kV)
□ Milliamperage (mA)
□ Time (sec or msec and/or pulse) / milliampere
second (mAs)
□ Anatomical programming function
□ Kilovoltage (kV)
□ Milliamperage (mA)
□ Time (sec or msec and/or pulse) / milliampere
second (mAs)
□ Anatomical programming function
Dead-man type hand switch with cable (at least 2 m)
and/or console push button
Ready and x-ray
exposure indicator
Automatic
Exposure
Audible and/or visible
Location
□ Table
□ Vertical Image Receptor Stand
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Control (AEC)
Device
(Optional)
Image Receptor
Image Display
Device
Accessories
Power
Requirements
Other
Requirements
Exposure steps
At least 5 exposure steps
□ Film- Screen
□ Photostimulable Phosphor (for Computed
Radiography System)
Type
□ Direct Digital Radiography
□ Flat panel detector
□ Charge-coupled device (CCD)
□ Film viewer
Type
□ Monitor
Number of banks: ______
Size: 14” x 17” each bank
Film viewer
Luminance: 1500 cd/m2
With film clips
Monitor
At least 1 unit medical grade LCD/LED type monitors
1 lead rubber apron of at least 0.25 mm Pb
equivalence
1 lead rubber thyroid shield of at least 0.25 mm Pb
equivalence
1 pair of lead rubber gloves of at least 0.25 mm Pb
equivalence
Radiation protection
device
1 set of lead rubber gonadal shields with minimum of
0.5 mm Pb equivalence
contact shields for male adult, female adult, infant
male and infant female
upright gonadal shield for chest x-ray
examinations
At least 21 cm x 26 cm (8” x 10”) with 1.5 mm Pb
Viewing window
equivalence
1 pc measuring caliper, sliding, double sided, scaled
in cm, with blunt edges and parallel arm
Others
Hanger/s for lead apron/s
1 phase/3 phase, 220-240VAC, 60Hz as applicable to the power supply of the
end-user
Supplier to provide appropriate transformer when applicable
Air-conditioning units
At least 2.0 hp, 220 VAC, 60 Hz
Automatic voltage
1 unit, appropriate with the power rating of the x-ray
regulator
machine and with a voltage regulation range of 150300 V
dedicated grounding system for the machine shall be
Grounding system
provided by the bidder
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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Other Terms and Conditions
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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 stationary radiographic
x-ray system. This constitutes revisions done by CDRRHR technical working group which was approved on
June 16, 2014.
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