Mobile DR Specs 2022

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Format of Philippine Heart Center (PHC) Technical Specification

Medical Devices Specification


(Including information on the following where relevant/appropriate, but not limited to)

NAME, CATEGORY AND CODING


1 Generic name Mobile C-Arm Machine FD 30
Specific type Mobile C-arm for digital imaging in
2 or variation
(optional)
PURPOSE OF USE
Clinical or Mobile C-arm
3
other purpose
Level of use (if The angiogram machine would be used at the of the Philippine Heart
4
relevant) Center.
Clinical The Mobile DDR will be used at the _____________ of the
department / (hospital/center).
5
ward
(if relevant)
A motorized direct digital imaging x-ray system for diagnostic and image
guided bedside procedures. Latest, most advanced technology and “
State of the Art” model, including version of the system and components.

a. Wireless Flat panel digital detector


Overview of
b. Mobile X-ray tube
6 functional
c. Mobile X-ray Generator
requirements
d. Digital Imaging software
e. Monitors/Display
f. Radiation protection

TECHNICAL SPECIFICATIONS
7 Detailed System specification
requirements Power output Min 32 to Max. 40 kW, min 300 to max. 500 mA
Footprint (l x w x h) 127.8 cm x 59.8 cm x 157 cm
Max. focal spot height 213.5 cm
Tube positioning: Max. horizon- 124.5 cm
tal extension
System weight (w/o optional ac- Approx. 300kg up to 400 kg
cessories)
DETECTOR High shock
Dimensions 35 cm x 43 cm
Scintillator Cesium iodide (Csl)
Weight 3.3 kg
Energy Range 40-150 kVp
Voltage/ current 12-18 V(dc)/ 2.1 t0 3 Ah capacity
Detector Battery Lithium-polymer technology (prevents overcharge)
Charge capability 300-340 maximum image per charge “dir
connect mode”
Expected life 500 charge/ discharge cycle in -80% full
charge energy
Detector Wireless system Network protocol TCP/IP, IPv4/IPv6
Network type – isolated private wireless LAN (WLAN) enter
prise wireless
IP Adressing static private IP addresses for detectors
and AP
System
System access Numeric keypad / PIN code or standard key switch
Standard battery pack Battery operation time 6-8 hrs/200 exposures at 70
kV/20 mAs
Standby time (On state) 8-12 hrs
High-power battery pack Battery operation time 8 h/270 exposures at 70 kV/20
mAs
Standby time (On state) 16-24 hrs
Image processing Automatic, dose-neutral image processing for enhanced org
specific contrast and high level of detail visibility
Accessories
Dose Area Product (DAP) mea- Integrated dose area product measurement system
surement chamber
wireless remote control Operating range 10 m, 180°
WLAN connectivity Industrial-strength WLAN module for increased reach and im
proved connectivity
Supported WLAN standards: 802.11 a/b/e/g/h/i/n
Supported frequency bands: 2.4 / 5 GHz
Display
8 parameters
(if relevant)
ACCESSORIES, CONSUMMABLES, SPARE PARTS, OTHER COMPONENTS
-Radiation protection accessories
-2 lead gowns (apron type) Pb 0.5mm
Accessories (if -2 radiation thyroid shields
9
relevant) -2 radiation lead glasses (2.0mm)
- 1 vertical shield
- 3 years of free comprehensive maintenance, parts of entire system.
TRAINING, INSTALLATION AND UTILIZATION
-Demolition works, including crating and storing of old angio equipment on
a predetermined designated area.
Pre-installation -Room preparation based on the approved plan, specification and GANTT
1
0
requirements chart to be submitted/ approved by Philippine Heart Service EMD.
(if relevant) -All civil mechanical electrical oxygen and compressed air requirements.
-Hauling of debris should be coordinates with PHC – EMD.
-Commissioning and testing.
Training of Training of users in operation and basic maintenance shall be provided.
1
1
user/s Comprehensive Technical Training of PHC-BIOMED, also to be specified
(if relevant) and provided.
1 User care (if Information to be provided by manufacturer / supplier, e.g. cleaning,
2 relevant) disinfection/sterilization method (for reusable devices).
WARRANTY AND MAINTENANCE
-The warranty period will start once the machine is declared operational
1
3
Warranty and would last for 3years.
-The warranty would include tube and parts of the entire system.
-Periodic maintenance would be every 3months during
1 Maintenance
4 tasks
-which maintenance parts needed to be replaced will still fall under
warranty period of 3years.
Type of -Comprehensive
1
5
service
contract
Spare parts 8 years after device acquisition.
1
6
availability
post-warranty
Equipment/ 5 years after device acquisition
1 Model
7 available in
the Market
Software / Capable for software upgrade.
1 hardware
8 upgrade
availability
DECOMMISSIONING
1 Estimated Life At least 10 years
9 Span
SAFETY AND STANDARDS
Regulatory FDA approval
2
0
approval /
certification
3 International ISO: 1348S
8 Standards
Regional / Philippines
3
9
Local
Standards
4 DOH-Philippines
0
Regulations

/njd
fn: tech-specs15

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