FGXR System

FGXR System Specifications

 Line powered X-ray Generators

System Model FGXR-32S FGXR-40S FGXR-52S FGXR-68S FGXR-82S

Generator Model FGXR-32 FGXR-40 FGXR-52 FGXR-68 FGXR-82

Output Rating 32kW 40kW 52kW 68kW 82kW

Line Nominal, 230VAC, 1Ф

400/480VAC, 3Ф
Phase 400/480VAC, 3Ф

Line Voltage
±10% (Frequency: 50/60Hz)
Range

40~125kV (optional 150kV)

kV Range 40~150kV, 1kV step
, 1kV step

mA Range 10 to 400mA 10 to 500mA 10 to 640mA 10 to 800mA 10 to 1,000mA

Timer Range 0.001 to 10 sec, 38 steps

mAs Range 0.1 to 500mAs (Optional higher mAs)

640mA@81kV 800mA@85kV 1,000mA@82kV
400mA@80kV 500mA@80kV
Max. 500mA@104kV 640mA@106kV 800mA@102kV
320mA@100kV 400mA@100kV
Power Output 250mA@125kV 320mA@125kV
400mA@130kV 500mA@136kV 640mA@128kV
320mA@150kV 400mA@150kV 500mA@150kV

Power
Minimum 125% of output rating
Requirement
75A(230Vac,1Ф) 100A(230Vac,1Ф)
Minimum Breaker 75A(400Vac,3Ф) 90A(400Vac,3Ф) 100A(400Vac,3Ф)
50A(400Vac,3Ф) 65A(400Vac,3Ф)
Rating 40A(480Vac,3Ф) 50A(480Vac,3Ф)
65A(480Vac,3Ф) 75A(480Vac,3Ф) 90A(480Vac,3Ф)

Low Speed
Rotor Supply Dual Speed (Option for FGXR-52)
Dual Speed (Option for 3Ф)

Reproducibility Coefficient of Variation: kV < 0.005, Time < 0.005, mAs < 0.01

kV < ±(1%+1kV), mA < ±(3%+1mA), Time < ±(1%+0.5ms), mAs < ±(3%
Accuracy
+0.1mAs)

Linearity Coefficient of Linearity < 0.01 : CL = (X1-X2)/(X1+X2), where X is mR/mAs

Anatomical
User programmable max. 1,280 programs with APR utility software
Programs

Technique
4 point display(kV, mA, Time, mAs)
Selection

Image Receptors 2 Bucky + 1 Non-Bucky

Leakage
Less than 2mR/hr
Radiation

Dimension / Control Console 336(W) x 47(H) x 232(D) mm / 1.7kg(3.8lbs)

Weight Main Cabinet 650(W) x 655(H) x 455(D) mm / 100kg(220lbs)

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 Capacitor assisted X-ray Generators

System Model FGXR-C32S FGXR-C40S

Generator model FGXR-C32 FGXR-C40

Power Rating 32kW 40kW

Line Nominal, Phase 110/120/230VAC, Single phase

Line Voltage Range ±10% (Frequency: 50/60Hz)

kV Range 40~125kV(optional 150kV), 1kV step

mA Range 10 to 400mA 10 to 500mA

Timer Range 0.001 to 10 sec, 38 steps

0.1 to 500mAs
mAs Range
Requires mA Sliding-down at 500mAs

400mA@80kV 500mA@80kV
Max. 320mA@100kV 400mA@100kV
Power Output 250mA@125kV 320mA@125kV
Optional 200mA@150kV Optional 250mA@150kV

Rotor Supply Low Speed (Optional LSS Brake)

Reproducibility Coefficient of Variation: kV < 0.005, Time < 0.005, mAs < 0.01

kV < ±(1%+1kV), mA < ±(3%+1mA), Time < ±(1%+0.5ms), mAs < ±(3%
Accuracy
+0.1mAs)

Linearity Coefficient of Linearity < 0.01 : CL = (X1-X2)/(X1+X2), where X is mR/mAs

Anatomical Programs Programmable 1280 programs with Software

Technique Selection 4 point display(kV, mA, Time, mAs): kV/mAs, kV/mA/Time, kV/AEC option

Image Receptors 2 Bucky + 1 Non-Bucky

Dimension Main Cabinet 628(W) x 978(H) x 435(D) mm

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 Stand-alone X-ray Generators

System Model FGXR-U32S FGXR-U40S

Generator model FGXR-U32 FGXR-U40

Power Rating 32kW 40kW

Line Nominal, Phase 100-240VAC, Single phase

Line Voltage Range ±10% (Frequency: 50-60Hz)

kV Range 40~125Kv(optional 150kV), 1kV step

mA Range 10 to 400mA 10 to 500mA

Timer Range 0.001 to 10 sec, 38 steps

mAs Range 0.1 to 500mAs

400mA@80kV 500mA@80kV
Max. 320mA@100kV 400mA@100kV
Power Output 250mA@125kV 320mA@125kV
Optional 200mA@150kV Optional 250mA@150kV

Rotor Supply Low Speed (Optional LSS Brake)

Reproducibility Coefficient of Variation: kV < 0.005, Time < 0.005, mAs < 0.01

kV < ±(1%+1kV), mA < ±(3%+1mA), Time < ±(1%+0.5ms), mAs < ±(3%
Accuracy
+0.1mAs)

Linearity Coefficient of Linearity < 0.01 : CL = (X1-X2)/(X1+X2), where X is mR/mAs

Anatomical Programs Programmable 1280 programs with Software

Technique Selection 4 point display(kV, mA, Time, mAs): kV/mAs, kV/mA/Time, kV/AEC option

Image Receptors 2 Bucky + 1 Non-Bucky

Dimension Main Cabinet 628(W) x 978(H) x 435(D) mm

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 Patient Table

1) 4-way Floating tabletop table

Model FPBT-4

Longitudinal 1,000(±500)mm
Tabletop
Movement Transverse(Lateral) 250(±125)mm

Bucky Longitudinal 350mm

Inherent Filtration Less than 1.2mmAl at 100kV

Tabletop Max. Patient Weight 300kg (660lbs)

Size 2,200(W) x 750(D) x 70(H) mm

Bucky Type Oscillating Fixed

FD 100cm, 200lpi, ratio 10:1

Grid FD 34~44inch, 103 lpi, ratio 10:1
Optional removable grid

Lock(Brake) EM Lock, beam sensor on/off

Center indication Buzzer sound and LED

Electrical Rating 100–240Vac, 200VA, 50/60Hz

Dimension / Weight 2,200(W) x 750(D) x 660 or 720(H) mm / 150kg(330lbs) or

155kg(342lbs)

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2) Elevating table

Model FPBT-6

Longitudinal 1,000(±500)mm
Tabletop
Transverse(Lateral) 250(±125)mm

Travel 285(565~850)mm,
Movement Speed 21mm/sec
Vertical
Motorized movement by Foot Switch
Operating
DC-motor (Linear Actuator)

Bucky Longitudinal 350mm

Inherent Filtration Less than 1.2mmAl at 100kV

Tabletop Max. Patient Weight 300kg(660lbs)

Size 2,200(W) x 810(D) x 45(H) mm

Bucky Type Oscillating Fixed

FD 34~44inch, 103 lpi, ratio FD 100cm, 200lpi, ratio 10:1

Grid
10:1 Optional removable grid

Lock(Brake) EM Lock, Foot Switch on/off

Center indication Transverse center, height center

Side Cover 2-story telescopic Cover

Electrical Rating 100–240Vac, 400VA, 50/60Hz

Dimension / Weight Max. 2200(W) x 810(D) x 850(H) mm / 260kg(573lbs)

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 Vertical Wall Stand

Model FWBS

Cassette stroke Vertical 1,640mm (420~2,060mm from floor to Bucky center)

Bucky Type Oscillating Fixed

FD 150cm, 200lpi, ratio 10:1

Grid FD 40~72inch, 103 lpi, ratio 10:1
Optional removable grid

Lock(Brake) EM Lock, Switch on/off

Balance Counter Weight

Electrical Rating 24VDC, 1A

Dimension / Weight Max. 1,920(H) x 740(W) x 410(D) mm / 120kg(264lbs)

 Floor Mounted Tube Stand

Model FTS-FM6

Tube Rotation Angle ±135°

Longitudinal Max. 2,100mm

Lateral 220mm
Tube stroke
1,580mm
Vertical
(430~2,010mm from floor to focus)

Lock(Brake) EM Lock, Switch on/off

Balance Counter Weight

Column Rotation 90° step, Foot Lock

Electrical Rating 24VDC, 3A

Dimension / Weight 2,060(H) x 1,140(D) mm / 240kg(529lbs)

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 X-ray Tube

Tube E7239X / E7242X / E7252X / RAD-14 / RTM782HS /

Model/Maker Toshiba Toshiba Toshiba Varian IAE

Focal Spot
1.0/2.0mm 0.6/1.5mm 0.6/1.2mm 0.6/1.2mm 0.6/1.2mm
Size

Rating(0.1s) 22.5/47kW 18/50kW 27/75kW 32/77kW 32/78kW

Max. Anode
140kHU(100kJ) 200kHU(142kJ) 300kHU(210kJ) 300kHU(210kJ) 300kHU(210kJ)
HU

Target Angle 16° 14° 12° 12° 12.5°

Max. kV 125kV 125kV 150kV 150kV 150kV

Weight 16kg(35.3lbs) 16kg(35.3lbs) 18kg(39.7lbs) 16.4kg(36.2lbs) 20kg(44.1lbs)

Inherent
0.9mmAl/75kV, IEC60522 0.6mmAl/75kV 1.2mmAl/75kV
Filtration

Additional
1.0mmAl
Filtration

Half Value
More than 2.9mmAl eq. at 80kVp
Layer

Leakage Less than 100mR/hr

Radiation

Tube RAD-21 /
E7254X / Toshiba E7255X / Toshiba
Model/Maker Varian

Focal Spot Size 0.6/1.2mm 0.6/1.2mm 0.6/1.2mm

Rating(0.1s) 40/102kW 40/102kW 36/100kW

Max. Anode HU 400kHU(285kJ) 300kHU(210kJ) 300kHU(210kJ)

Target Angle 12° 12° 12°

Max. kV 150kV 150kV 150kV

Weight 25kg(55.1lbs) 20kg(44.1lbs) 18.9kg(41.7lbs)

0.7mmAl/75kV,
Inherent Filtration 0.8mmAl/75kV, IEC60522
IEC60522

Additional
1.0mmAl
Filtration

Half Value Layer More than 2.9mmAl eq. at 80kVp

Leakage Less than 100mR/hr

Radiation

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 Collimator

Model / Maker R108F / RALCO

Control Manual with 30sec. lamp timer

Field Shape Rectangular

Max. Field Size More than 43x43cm(17x17inch) at 100cm SID

Leakage Radiation Less than 100mR/hr

Max. kVp shield 125kV (Optional 150kV)

Inherent Filtration Min. 2.0mmAl eq.

Luminosity Over 160LUX at 100cm SID (Typ. 250LUX)

Light source Single LED

Standard Tape measure, Rotating flange

Option Laser line, Near port moving shutters, Manual rotating filters
Electrical Rating 20–30Vac, 30VA, 50/60Hz

Dimension / Weight 223(W) x 246(D) x 140(H) mm / 6.6kg(14.6lb)

 AEC Ion Chamber (Option)

Field 3 Fields

X-ray Energy Range 40~150kV

Dose Rate Range 0.2mV/mR~8V/mR

Exposure Dose Range 0.4~600mAs

Inherent Filtration 0.4 mm Al eq.

Weight 2kg (4.4lb)

 Options
- Pedestal console stand
- Patient compression belt
- Patient hand grips (Tabletop, Wall stand – Overhead, Chest)
- Cassette holders (Lateral, External Wall Bucky)
- Full-spine imaging apparatus
- DC brake for low speed starter of x-ray generator
- Radiation protection
 Wearing(apron, neck guide, glove), movable x-ray protection wall

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OPERATING
Ambient temperature range 10 C to 40 C (50 F to 104 F)
Relative humidity range 30% to 75%, non-condensing
Atmospheric pressure range 700 hPa to 1060 hPa

TRANSPORT AND STORAGE

Ambient temperature range -10 C to 70 C (14 F to 158 F)..
Relative humidity range 5% to 95%, non-condensing.
Atmospheric pressure range 500 hPa to 1100 hPa

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 APPLICABLE STANDARDS

The main components of FGXR-SD System comply with the regulatory requirements and design
standards in this section as follows:

SAFETY

☞ IEC/EN 60601-1 2nd Edition

■ EN 60601-1(1990)
Medical electrical equipment - Part 1: General requirements for safety
■ EN 60601-1-1:2001
Medical electrical equipment
Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical
electrical systems
■ EN 60601-2-7:1998 (2nd Edition)
Medical electrical equipment -
Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray
generators
■ EN60601-1-3:1994
Medical electrical equipment –
Part 1-3: General requirements for safety. Collateral standard:
General requirements for radiation protection in diagnostic X-ray equipment
■ EN60601-2-28:1993
Medical electrical equipment –
Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube
assemblies for medical diagnosis
■ EN60601-2-32:1994
Medical electrical equipment -
Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment
■ UL60601-1:1st Edition, 2006-04-26

☞IEC/EN 60601-1 3rd Edition

■ EN 60601-1:2006
Medical electrical equipment -- Part 1: General requirements for basic safety and essential
performance
IEC 60601-1:2005
■ EN 60601-1-3:2008
Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential
performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-3:2008
■ EN 60601-1-6:2010
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 60601-1-6:2010
■ EN 60601-2-54:2009
Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-54:2009
■ EN 60601-2-28:2010
Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-28:2010

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2) EMC

■ EN60601-1-2(2007)
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests
■ CISPR 11:2009/A1:2010
■ EN61000-3-2:2000 + A2:2005
■ EN61000-4-2:1995 /A1:1998/A2:2000
■ EN61000-4-3:2006/A1:2007
■ EN61000-4-4:2004
■ EN61000-4-5:2005
■ EN61000-4-6:2003/A1:2004/A2:2006
■ EN61000-4-8:1993/A1:2000
■ EN61000-4-11:2004

3) Clinical Evaluation

■ MEDDEV. 2.7.1
EVALUATION OF CLINICAL DATA:
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

4) OTHERS

■ EN 980 (2008)
Graphical symbols for use in the labeling of medical devices
■ IEC TR60878 (2003)
Graphical Symbols for electrical equipment in medical practice
■ IEC60417-1(2000)
Graphical Symbols for use on equipment-part1: overview and application
■ ENISO 14971: 2012
Medical devices - Application of risk management to medical devices (ISO 14971:2012)
■ ENISO13485: 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
■ ISO9001: 2008
Quality management systems-Requirements
■ 93/42/EEC as amended by 2007/47/EC
Council Directive concerning medical devices
■ EN 1041:2008
Information supplied by the manufacturer with medical devices
■ EN 62220-1:2004
Medical electrical equipment — Characteristics of digital X-ray imaging devices
—Part 1: Determination of the detective quantum efficiency
■ EN 62304:2006 Medical device software — Software lifecycle processes
■ EN 62366:2008
Medical devices - Application of usability engineering to medical devices
IEC 62366:2007

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