Xera medical system & Technology

ISO13485 Quality management system

Identification code: D-20-1173

Technical specification

Product name: Diagnostic X-ray SYSEM

Model name: GR10X-40K & 50K

Controlled copy □ Date: 2021/12/28

Non-Controlled copy □ Revision: 02
Document retention period(10years) 2021/12/28 ~ 2031/12/27

XERA Medical System & Technology Co., Ltd.

Gulden Sokak 13/2 Kavaklidere Ankara Turkey Telephone: +90-312-467-6550 Fax: +90-312-467-7532

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APPROVAL INFORMATION

Creator:
Yasemin 28/12/2021
Signature & Date

Approver:
Huyngtai KiM
28/12/2021
Signature & Date

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Table of contents
TABLE OF CONTENTS ................................................................................................................................................. 3
1. OVERVIEW .......................................................................................................................................................... 4

1.1 Overview of device ..................................................................................................................................................................... 4

1.2 Name and address of the manufacturer ............................................................................................................................. 4

2. DEVICE DESCRIPTION AND SPECIFICATION .............................................................................................. 4

2.1 Device Name................................................................................................................................................................................. 4

2.2 Device classification ................................................................................................................................................................... 4

2.3 Intended use ................................................................................................................................................................................. 4

2.4 Contra-Indication ...................................................................................................................................................................... 4

2.5 Principle ........................................................................................................................................................................................ 4

2.6 Product Lifetime ........................................................................................................................................................................... 5

3. SPECIFICATION OF THE DEVICE ................................................................................................................... 5

3.1 General specifications ................................................................................................................................................................. 5

3.2 Software Information ............................................................................................................................................................... 8

3.3 Model differences ....................................................................................................................................................................... 8

3.4 Appearance .................................................................................................................................................................................. 8

4. BLOCK DIAGRAM ............................................................................................................................................ 11

4.1 Block Diagram ......................................................................................................................................................................... 11

4.2 Description .................................................................................................................................................................................. 12

5. ENVIRONMENTAL SPECIFICATIONS ........................................................................................................... 13
6. APPENDIX Ⅰ. FPD SPECIFICATION ............................................................................................................... 14
7. APPENDIX II. REVISION HISTORY ............................................................................................................... 15

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1. Overview
1.1 Overview of device
This device consists of X-ray control, high-voltage generator, X-ray tube, X-ray tube support, irradiation equipment,
detector (detector), patient table, patient photography stand, digital imaging device, etc.
A high frequency inverter (Inverter) X-sensor voltage device designed to generate X-rays by combination of tube voltage,
tube current, irradiation time, etc. so that it can be filmed at various angles for diagnosis of the patient's skeletal, respiratory,
and urinary systems.
The digital imaging system is used to obtain the images taken by the X-ray unit as radiation from the X-ray unit passes
through the human body and is transmitted by the detector.

1.2 Name and address of the manufacturer

Manufacturer Xera Medical System & Technology Ltd
Gulden Sokak 13/2 Kavaklidere Ankara Turkey

2. Device description and specification

2.1 Device Name
Diagnostic X-ray SYSEM
Model Name GR10X-50K GR10X-40K
Generator DMG-50KAX B DMG-40KAX A(3p) DMG-40KAX B(1p)
Collimator M38 & Crux 104i
X-ray tube E7252X E7239X
Bucky Stand XEBS-W1
Bucky Table XEBT-W4
Tube Stand XETS-W1
FPD 14inches by 17 inches, 17inches by 17 inches
Acquisition S/W VXvue

2.2 Device classification

Rule: According to the Rule 10 of Classification Criteria, Annex IX, MDD 93/42/EEC as amended by 2007/47/EC.
GMDN Code: 17904 (General-Purpose Radiography digital imaging system)
Class: Class IIb:

2.3 Intended use

GR10X-50K and GR10X-40K is intended for use by a qualified/trained doctor or technician on both adult subjects for
taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

2.4 Contra-Indication
The GR10X-50K and GR10X-40K are not to be used for pediatric patients and not intended to be used for mammography.

2.5 Principle
When the external rated power is transferred to the X-ray control unit, set the tube current and time required for each
shooting and issue an X-ray inspection order, conduct the primary measurement of the high voltage generator.
When the set voltage is applied, a high pressure is generated to make X-rays on the secondary side.

When this high pressure is applied to the X-ray tube, an X-ray occurs when the electrons are released and hit the target
at high speed.

This X-ray is passed to the body part where you want to diagnose it.

X-rays passing through the subject form interactions through the selenium layer of the detector and convert them into
electrical signals, and the charges are collected through electrodes located in each pixel and output to the signal

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processing unit via a thin film transistor (TFT) array.

The signal processing department performs the amplification and digital data conversion process, and the data (imaging
device) delivered to the workstation via cable is stored as a DICOM file, a medical imaging standard, through an
operational program.

The stored images are sent by the operating program to the Picture Archiving & Communication System (PACS) server
for use in image reading.

2.6 Product Lifetime

The lifecycle of the GR10X-50K 40K is 20,000 hours of average time (MTBF) between failures, and the average life
span is 5.4 years guaranteed by 10 hours per day.

3. Specification of the device

3.1 General specifications
This X-ray system was designed for diagnosis’s human beings and could get good regulations by controlled digital
value by microprocessor.

Component Model Specifications

 230VAC ±10%, 50/60Hz
 Output :40kW, 1-Phase
 kV Range: 40 – 150 kV
Generator DMG-40KAX A  mA Range: 10 – 500 mA
 ms Range: 1 – 10000 ms
 mAs Range: 0.1 – 630 mAs
 CE Mark: CE0197

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Component Model Specifications

 230/400-277/480VAC ±10%, 50/60Hz
 Output :40kW, 3-Phase
 kV Range: 40 – 150 kV
DMG-40KAX B  mA Range: 10 – 500 mA
 ms Range: 1 – 10000 ms
 mAs Range: 0.1 – 630 mAs
 CE Mark: CE0197
 400 - 480VAC, 50/60Hz
 Output: 50KW, 3-Phase
 kV Range: 40 – 150 kV
DMG-50KAX B  mA Range: 10 – 630 mA
 ms Range: 1 – 10000 ms
 mAs Range: 0.1 – 630 mAs
 CE Mark: CE0197
 40-150kV, 50/60Hz, 150/180Hz
 Rotating 12° at high speed
E7252X
 Dual focal spots
 Small focus: 0.6 ㎜ / Large focus: 1.2 ㎜
Tube
 40-125kV, 50/60Hz
 Rotating 16° at high speed
E7239X
 Dual focal spots
 Small focus: 1.0 ㎜ / Large focus: 2.0 ㎜
 24VAC, 50/60 Hz
 Form of X-ray Beam Field (Rectangular)
 Image Receptor Alignment (Single Laser)
 Max Tube Voltage 150 kV

M-38
 Light source (LED lamp 24 VAC 1A/24VDC 1A)
 Inherent filtration 1.2 mmAl
Added filteration 0.5 mmAl (TBD)
 Weight 5 kg
 Max field size (less than 48cm x 48cm at SID 100 cm)
Collimator
 Min field size (less than 1 cm x 1 cm at SID 100 cm)
 24VAC, 50/60 Hz
 Form of X-ray Beam Field (Rectangular)
 Max Tube Voltage 150 kV
 Light source (LED lamp 24 VAC 4A/24VDC 4A)
Crux 104i
 Inherent filtration 1.0 mmAl
 Weight 8 kg
 Max field size (less than 43cm x 43cm at SID 100 cm)
 Min field size (less than 2 cm x 2 cm at SID 100 cm)
 Power input (220VAC, 50/60 Hz)
Tube Stand XETS-W1  Column Top LED display according to the detector
 Automatic display of SID and tube rotation angle

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Component Model Specifications

 Vertical travel: 1470 mm (413 mm to 1883 mm)
 Longitudinal travel: Approx. 1700 mm (Rail 2210 mm)
 Lateral travel distance: Approx. 180 mm
 Column rotation: ± 180° with mechanical detent at each 90°
 Horizontal rotation of X-ray beam: ± 180° with manual lock
 Added filtration: 0.8 mmAl
 Power input (24VDC)
 Size: 2,200L x 750W x 657H (mm)
 Table movable distance (longitudinal): ± 400 mm
 Table movable distance (Transverse): ± 125 mm
Bucky Table XEBT-W4
 The maximum allowable mass of patient: 300kg
 Locking system: Electromagnetic lock
 Inherent filtration 0.8 mmAl
 Weight: 165 kg
 Power input (24VDC)
 Column Top LED display according to the detector
Bucky Stand XEBS-W1
 Vertical movement: Approx. 1400 mm (340 to 1740 mm)
 Inherent filtration 0.5 mm Al
 Scroll wheel for user convenience
Generator XECO-W1
 7" LCD display with GUI
Console
XEMC-W1  Power & Exposure SW On/Off

Detector  Refer to Appendix Ⅰ

 DAP – Digital Resolution: 0.01 μGy·m2

 DAP – Measuring range: 0.1 – 99,999,999 μGy·m2
 DAP rate – Digital Resolution: 0.6 μGy·m2/min
 DAP rate – Measuring range: 0.1 – 99,999,999 μGy·m2
 Exposure time range: 1 ms – 10 sec
DAP meter VacuDAP-2004
 Sensitivity difference between sensor fields: < 5%
 Attenuation factor: < 1.04
 Supply voltage (positive and negative): ± (11.5 – 16) VDC
 Digital output: Differential signal (RS 422), pulse width 2 μs
 Ramp output (with ramp module): 0 – 10 V

 Energy range / tube voltage: 40 – 150 kV

 Dose rate range: 0.5 – 1000 μGy
 Exposure dose rate (70-80 kV, 25 mmAl): 1 – 100 μGy
 Digital resolution (selectable): 0.025 μGy
 Exposure time range: 1 ms – 10 sec
AEC Chamber
 Sensitivity difference between sensor fields: < 5%
 Attenuation factor: < 1.04
 Supply voltage (positive and negative): ± (11.5 – 16) VDC
 Digital output: Differential signal (RS 422), pulse width 2 μs
 Ramp output (with ramp module): 0 – 10 V

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Component Model Specifications

 18-7/8 X 17-1/4,103L/Inch,10:1, 34-44”
 18-7/8 X 17-1/4,103L/Inch,10:1, 40-72”
GRID
 18-7/8 X 17-1/4,215L/Inch,10:1, 34-44”
 18-7/8 X 17-1/4,215L/Inch,10:1, 40-72”

3.2 Software Information

1) Image Acquisition software
Manufacture: VIEWORKS Co., Ltd
Software name: Vxvue Version: V1.0.0.86b6

2) Generator software
Manufacture : Delta ELECTRONICS, INC.
Project name: DMP-100R (Model: DMG-40KAX A, DMG-50KAX B)
Software name: Firmware Version: S00E25_Add40kVComp3kV_9A5E
GUI version: GUI Ver5.2.8d

3.3 Model differences

The product model GR10X-50K features high tube voltage and consists of DMG-50KAX B (50 kW) generator and the
E7252X X-ray tube. On the other hand, the GR10X-40K-Single Phase employs a lower tube voltage generator, DMG-
40KAX A (40 kW), than the GR10X-50K, and E7239X X-ray tube. , GR10X-40K-Three Phase employs a lower tube
voltage generator, DMG-40KAX A (40 kW), and E7239X X-ray tube. Both models meet the intended use.

3.4 Appearance
1) Tube Stand

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2) Bucky Table

3) Bucky Stand

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4) Console
Basic Console

Mini Console

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4. Block diagram
4.1 Block Diagram

Bucky Stand
Bucky Stand
Board
Main Power
Tube Stand
Bucky
Line HV, Rotor
Tube
Base
DAP
Indicator
Tube Stand SYS CON
Power Board
Generator
AEC Chamber
Collimator
Trigger
Signal Detector
Handle Bar

ARM Bucky Table

Bucky Table
Hand SW Console
SYS CON Base Board

Bucky
Indicator

Data Foot SW
Workstation

AEC Chamber

Detector

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4.2 Description
Item Description
Adjusts the X-ray irradiation condition and controls the
Console
display device.
X-ray
Generator
Generator Generates a high voltage applied to the apparatus.

Connected with the X-ray generator with high-voltage

X-ray Tube
cables to generate X-ray radiation.
Collimator Limits the range of X-ray radiation for the intended target.
High Voltage Cable Connected between the generator and X-ray tube.
Supports X-ray tube and helps the operator to move for
Tube Stand
each examination.
Supports bucky and helps the operator to move for each
Bucky Stand
examination.
Supports patient on the table top and helps the operator to
Bucky Table
move for each examination.
Detector Image acquisition

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5. Environmental Specifications
Item Environmental Condition
Temperature 10°C ~ 40C°
Relative Humidity Range 30%RH ~ 65%RH
Atmospheric Pressure Range 700hPa ~ 1060hPa
Storage temperature -10°C ~ 55C°

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6. APPENDIX Ⅰ. FPD Specification

Origin Model XERA’s Model

FXRD-2530VAW FPD-2530VAW
1
FXRD-2530VAW PLUS FPD-2530VAW PLUS

FXRD-3643VAW FPD-3643VAW
2
FXRD-3643VAW PLUS FPD-3643VAW PLUS

FXRD-4343VAW FPD-4343VAW
3
FXRD-4343VAW PLUS FPD-4343VAW PLUS

FXRD-1717VA FPD-4343VA
4
FXRD-1717VB FPD-4343VB

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7. Appendix II. Revision History

REV. Date ITEMS Revision content

R00 2019/9/3 Firstly

R01 2021/02/25 Specification modification
R02 2021/12/28 Changes of the Technical Specification
 Size: 2200L x 750W x 657H (mm)
 Table movable distance(longitudinal) : ± 400 mm
 Collimator added (Crux 104i)

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