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Mobile Radiographic X-ray Machine
FDA technical specification for mobile radiographic x - ray machine
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
MOBILE RADIOGRAPHIC X-RAY MACHINE
Scope
This includes the supply, delivery, installation and commissioning of mobile x-ray machine.
Application/Use
General radiography
Standard Composition
• General Specifications
• High Tension Generator
• X-ray Tube Assembly
• Control Unit
• Accessories
• Other Requirements
• Other Terms and Conditions
Technical Specifications
General
Specifications
of the Unit
High Tension
Generator
X-ray Tube
Assembly
Maneuverable
Complete with handrails and positive foot or hand operated breaks
Electrically grounded
□ Motorized and manually driven
□ Manually driven
Maximum height of 2 meters at transport position
Ground to focus
At least 2 meters
distance
Generator
High frequency
Kilovoltage Setting:
Minimum Setting: 40 kV
Maximum Setting: ≥ 125 kV
Generator settings
Maximum tube current:
□ 100 mA
□ If higher please specify: ______ mA
Anode
Rotating
Nominal focal spot
Small focus: ≤ 0.8 mm
size
Large focus: > 0.8 but ≤ 1.5 mm
Total filtration
≥ 2.5 mm Al equivalent
Multi-leaf
Collimation system
Manually controlled
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Tube head rotation
Tube arm movement
Locking mechanism
Overload protection
indicator
Technique selector
Display
Control Unit
Exposure switch
Ready and x-ray
exposure indicator
Indicators for motor
driven units
Shielded storage
compartment
Radiation Protection
Device
Accessories
Others
Power
Requirements
Visual/audible
□ Kilovoltage (kV)
□ Milliamperage (mA)
□ Time (sec or msec and/or pulse) / milliampere
second (mAs)
□ Kilovoltage (kV)
□ Milliamperage (mA)
□ Time (sec or msec and/or pulse) / milliampere
second (mAs)
Dead-man type hand switch with cable (at least 2 m) and
push button
Audible and/or visible
Unit is fully charged
Unit is being charged
Unit needs to be charged
At least five (5) 14” x 17” cassettes with exposed and
unexposed films divider
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
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
1 pc measuring caliper, sliding, double sided, scaled in cm,
with blunt edges and parallel arm
Hanger/s for lead apron/s
1 phase , 220 VAC, 60Hz as applicable to the power supply of the end-user
Grounding system
Other
Requirements
With field lamp and cross-hair centering
Rotation: minimum of ±45°
Lateral axis:
□ 0 - 90°
□ Not applicable (for units with swiveling out tube
support assembly)
Longitudinal axis: minimum of ±90°
□ Lateral
□ Horizontal
□ Vertical
Electromagnetic/manual
Documents
dedicated grounding system for the machine shall be
provided by the bidder
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
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-
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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 mobile x-ray machine.
This constitutes revisions done by CDRRHR technical working group which was approved on June 16, 2014.
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