Whale MultiScan G-Arm System XGB6-12-1026 User manual

XGB6-12-1026
B6
1.04
ENG This user manual includes detailed usage instructions for the G-
Arm system. Please read this manual before using equipment. You can
always use to open or close this manual (PDF format).

Release Date
Rev Date
1.04 August 2018
The text of this manual was originally written, approved and published by the manufacturer in En-
glish.
This manual may not be reproduced, in whole or in part, without the written permission of Beijing
East Whale Imaging Technology Co., Ltd.
The contents of this document are accurate at the time of publication. However, changes in design
and additional features can, at any time, be incorporated in the hardware and software and may
not be reflected in this version of the document. Contact technical service for clarification, if dis-
crepancies arise.

XGB6-12-1026, Rev 1.04 3
Contents
Contents
Contents .......................................................................................... 3
Chapter 1 - Overview and Safety .................................................... 9
1.1 Overview ...............................................................................................................11
1.2 System Intended Use..........................................................................................11
1.3 Safety Classification...........................................................................................12
1.4 Safety Hazard Alerts...........................................................................................12
1.5 Safety Hazard Overview....................................................................................12
1.6 Safety - Operation...............................................................................................14
1.7 Safety - Power Supply ........................................................................................14
1.8 Required Work Space.........................................................................................16
1.9 Radiation Protection..........................................................................................16
1.9.1 General Protection.......................................................................................17
1.9.2 Keeping Distance .........................................................................................17
1.9.3 Reducing Dosage .........................................................................................17
1.9.4 Exposure Alert ...............................................................................................17
1.9.5 Source-to-skin Distance .............................................................................17
1.9.6 Penetration of Fluids ...................................................................................19
1.9.7 Stray Radiation.............................................................................................19
1.9.8 Zone of Extra-focal Radiation...................................................................22
1.9.9 Representative Values of Reference AKR ................................................22
1.10 Acronyms and Abbreviations ..........................................................................24
1.11 Symbols and Nameplates.................................................................................25
1.12 Equipment Malfunction....................................................................................25
1.13 Responsibility.......................................................................................................25
Chapter 2 - Start-up....................................................................... 27
2.1 Connecting Cables..............................................................................................29
2.2 Turning the System On......................................................................................32
2.3 Turning the System Off......................................................................................33
2.4 Power-off Protection..........................................................................................33
Chapter 3 - System Components................................................... 35
3.1 Control Unit Components.................................................................................37

Contents
4B6 User Manual
3.2 G-Arm Components ...........................................................................................38
3.3 Component Configuration...............................................................................38
3.4 Laser Light Indicator ..........................................................................................39
3.5 Skin Spacer (Optional).......................................................................................40
3.6 Exposure Lamps and Audible Signals............................................................41
3.7 USB & Network Ports ..........................................................................................41
Chapter 4 - Mechanical Positioning.............................................. 43
4.1 Dimensions & Weights.......................................................................................45
4.1.1 G-Arm Dimensions.......................................................................................45
4.1.2 Control Unit Dimensions............................................................................45
4.1.3 Equipment Weights .....................................................................................46
4.1.4 Operation Table Dimensions ....................................................................46
4.2 Movement Controls............................................................................................46
4.3 G-Arm Orbital Rotation.....................................................................................48
4.4 G-Arm Radial Rotation ......................................................................................49
4.5 Image Intensifier Adjustment ..........................................................................49
4.6 G-Arm Height Adjustment ................................................................................50
4.7 G-Arm Attitude Restoration..............................................................................50
4.8 Maneuvering the G-Arm ...................................................................................51
4.9 Moving the Control Unit....................................................................................53
4.10 Moving the G-Arm ..............................................................................................54
4.11 Locking the Equipment in Position.................................................................55
4.12 Positioning the Monitors...................................................................................56
Chapter 5 - Operating Controls .................................................... 59
5.1 Viewing & Control Monitors .............................................................................61
5.2 Control Panel .......................................................................................................62
5.2.1 Adjust the voltage/current values............................................................64
5.2.2 Adjust the FoV ...............................................................................................64
5.3 Touch-screen Controls.......................................................................................65
5.4 Collimator.............................................................................................................65
5.5 Footswitch............................................................................................................66
5.6 Emergency Stop Switches.................................................................................68
Chapter 6 - X-ray Imaging Process................................................ 69
6.1 Fluoroscopy Imaging Work-flow ....................................................................71
6.2 Fluoroscopy Imaging Process..........................................................................72
Chapter 7 - Fluoro Imaging Modes ............................................... 73
7.1 Overview ...............................................................................................................75
7.1.1 Bi-plane real-time fluoroscopy .................................................................77
7.1.2 Default mode after startup........................................................................77
7.1.3 Recommended mode for different clinical applications ....................77
7.2 Automatic Continuous Fluoroscopy ..............................................................78
7.3 Manual Continuous Fluoroscopy ...................................................................78

XGB6-12-1014, Rev 1.04 5
Contents
7.4 Automatic Pulse Fluoroscopy ..........................................................................79
7.5 Manual Pulse Fluoroscopy ...............................................................................80
7.6 DR Fluoroscopy ...................................................................................................80
7.7 Half Dose Fluoroscopy.......................................................................................81
7.8 Resolution & Penetration Features.................................................................82
7.9 Tissue & Bone Features ......................................................................................83
7.10 Automatic Exposure Control............................................................................84
Chapter 8 - Workstation Software................................................ 87
8.1 Viewing Screens ..................................................................................................89
8.1.1 Last-image hold (LIH)..................................................................................90
8.1.2 Fluoroscopy time summary.......................................................................90
8.1.3 First letter combination for fluoroscopy modes ...................................91
8.2 Control Screen .....................................................................................................91
8.3 Selecting Exposure Modes ................................................................................92
8.4 Registering Patients ...........................................................................................94
8.4.1 Manually register a new patient ..............................................................94
8.4.2 Register a patient from the worklist ........................................................95
8.4.3 Register a patient from local database...................................................97
8.5 Retrieving Patient/Study Info...........................................................................98
8.5.1 Select and open a study..............................................................................98
8.5.2 Search for a patient study..........................................................................99
8.5.3 Delete a study................................................................................................99
8.6 Cine-loop (Optional) ........................................................................................100
8.7 Panoramic Imaging .........................................................................................101
8.8 Processing Images............................................................................................102
8.8.1 Sharpening ..................................................................................................102
8.8.2 Noise reduction...........................................................................................103
8.8.3 Brightness and contrast ...........................................................................103
8.8.4 Rotation........................................................................................................104
8.8.5 Magnification .............................................................................................105
8.8.6 Annotation ..................................................................................................106
8.8.7 Mirror ............................................................................................................108
8.8.8 Inversion.......................................................................................................109
8.9 Comparing Images...........................................................................................109
8.10 Operation Guidelines (Optional)...................................................................110
8.11 Generating Dose Reports................................................................................111
8.12 Printing Images.................................................................................................113
8.12.1 Print through a DICOM printer ...............................................................116
8.13 Managing Images and Studies......................................................................116
8.13.1 Edit patient information...........................................................................116
8.13.2 Save an image ............................................................................................117
8.13.3 Save a study.................................................................................................118
8.13.4 Export an image.........................................................................................118
8.13.5 Transfer an image to the PACS server...................................................119
8.13.6 Delete an image .........................................................................................120
8.14 Changing Password.........................................................................................121

Contents
6B6 User Manual
8.15 Quitting Workstation Software .................................................................... 121
8.16 System Settings ................................................................................................ 121
8.16.1 About............................................................................................................ 123
8.17 DICOM Setup..................................................................................................... 124
8.17.1 Add a DICOM service................................................................................ 125
8.17.2 Combine with a DICOM service ............................................................. 126
8.17.3 Set up local host ........................................................................................ 127
Chapter 9 - Maintenance ............................................................ 131
9.1 Maintenance Period Overview ..................................................................... 133
9.2 Inspecting Cables............................................................................................. 133
9.3 Checking the I.I. Movements ......................................................................... 134
9.4 Checking Locking Wheel Movements......................................................... 135
9.5 Checking Laser Indicator................................................................................ 135
9.6 Checking Monitor Rotation Movements.................................................... 136
9.7 Checking Exposure Indication ...................................................................... 136
9.8 Measuring Dosimetric Indication Values................................................... 136
9.9 Measuring Automatic Exposure Control.................................................... 137
9.10 Measuring Accuracy of Tube Voltage ......................................................... 138
9.11 Cleaning and Disinfection ............................................................................. 139
Chapter 10 - Technical Specifications......................................... 141
10.1 System ................................................................................................................ 143
10.2 Output Electric Power ..................................................................................... 143
10.3 X-ray Tube Assembly....................................................................................... 143
10.4 Generator........................................................................................................... 144
10.5 Image Intensifier .............................................................................................. 144
10.6 Deviations.......................................................................................................... 144
10.7 TV-Chain ............................................................................................................ 144
10.8 Printer ................................................................................................................. 144
10.9 Grid...................................................................................................................... 144
10.10 G-Arm.................................................................................................................. 145
10.11 Weights............................................................................................................... 145
10.12 Computer........................................................................................................... 145
10.13 Operation Table Dimensions ........................................................................ 145
10.14 Operation Environment ................................................................................. 145
10.15 Transport and Storage Environment .......................................................... 145
10.16 Diagnostics Table ............................................................................................ 146
10.17 Quality Standards............................................................................................ 146
Chapter 11 - Trouble-shooting ................................................... 147
11.1 Trouble-shooting ............................................................................................. 149
Chapter 12 - Transport and Storage........................................... 151
12.1 Transport and Storage Environment .......................................................... 153
12.2 Related Symbols............................................................................................... 153

XGB6-12-1014, Rev 1.04 7
Contents
Chapter 13 - Electromagnetic Compatibility Statement............ 157
13.1 Information on Electromagnetic Compatibility........................................159
13.2 Emitted Electromagnetic Interference.........................................................159
13.3 Electromagnetic Immunity.............................................................................160
13.4 Recommended Safe Distance........................................................................161
Appendix I - Symbols & Nameplates............................................163
A(I)-1 Symbols...........................................................................................................165
A(I)-2 Rulers ...............................................................................................................167
A(I)-2-1 SID Ruler ..................................................................................................167
A(I)-2-2 G-Arm Orbital Rotation Ruler .............................................................167
A(I)-2-3 G-Arm Radial Rotation Ruler ..............................................................167
A(I)-2-4 G-Arm Vertical Movement Ruler ........................................................168
A(I)-3 Labels...............................................................................................................168
A(I)-4 Nameplates....................................................................................................169
A(I)-4-1 Symbols on nameplates ......................................................................169
A(I)-4-2 Product Nameplate ..............................................................................170
A(I)-4-3 G-Arm Nameplate .................................................................................171
A(I)-4-4 Control Unit Nameplate ......................................................................171
Appendix II - Components and Accessories................................. 173
A(II)-1 Components and Accessories....................................................................175
Appendix III - Related Documents ............................................... 177
A(III)-1 Related Documents......................................................................................179
Appendix IV - QC Test Log Form ..................................................181
A(IV)-1 Dosimetric Indication Value Test ..............................................................183
A(IV)-2 Automatic Exposure Control Test .............................................................183
A(IV)-3 Accuracy Test of kV Values .........................................................................184

Chapter 1 - Over view and S afety
CHAPTER 1
OVERVIEW AND
SAFETY

XGB6-12-1014, Rev 1.04 11
Overview Chapter 1 - Overview and Safety
1.1 Overview
This manual can also be used as a general guide for planning the pre-instal-
lation, installation and daily service of the G-Arm system.
This manual includes functional descriptions as well as operational instruc-
tions exclusively for the specific model of B6 (hereafter in this manual re-
ferred to as the G-Arm system). It is intended for qualified medical personnel
who have been trained for operating the G-Arm system. It is not designed to
be used as a substitute for certified training in the radiological or medical
field.
1.2 System Intended Use
The G-Arm system is a mobile digital X-ray diagnostic system, which is in-
tended to generate X-ray fluoroscopic image of a patient. The application in-
cludes: real-time positioning and monitoring operations in trauma surgery,
orthopedics, spine surgery, chest surgery, etc. It is not intended to be used
in interventional procedures.
The G-Arm system permits a qualified doctor or technologist to take a range
of diagnostic exposures of spinal column, chest, abdomen, extremities, and
other body parts on the patients.
CAUTION
Potential hazards exist in the use of medical electronic devices and X-
ray systems. X-ray equipment may cause injury if improperly used.
Carefully read this manual and follow the instructions prior to operat-
ing this equipment.
CAUTION
The G-Arm system is prohibited for dental, mammography, and
tomography.
CAUTION
The G-Arm system will not be in physical contact with patients and is
supposed to be operated only in the operation room. It shall not be
used in the environment with rich oxygen.
WARNING
This unit is designed to rotate around the patient, minimizing any
direct contact.

Chapter 1 - Overview and Safety Safety Classification
12 B6 User Manual
1.3 Safety Classification
1.4 Safety Hazard Alerts
Pay attention to all areas of this manual marked with this symbol . Four
types of safety hazard alert words are included in this manual: Danger, Warn-
ing, Caution and Note.
1.5 Safety Hazard Overview
Potential hazards exist in the use of medical electronic devices and X-ray sys-
tems. Operators using the equipment need to understand the safety issues,
WARNING
This equipment cannot be used for pregnant women, unless it is used
as directed by physicians.
Electric Shock Protection Type: Class I
Operation Mode: Continuous Operation
Liquid Ingress Protection Degree:IPX0
Applied Part:NONE
Quasi Applied Part: G-Arm, Image intensifier assembly, X-ray
tube assembly (type B applied)
MOP (Means of Protection): Control Unit: MOOP (Means of Operator
Protection)
G-Arm: MOPP (Means of Patient Protec-
tion)
Table 1-1: Safety Hazard Alerts
Alert Circumstances for Use
Indicates an imminently hazardous situation that, if not
avoided, could result in serious injury or death.
Indicates a potentially hazardous situation that, if not avoided,
could result in serious injury or death.
Indicates a potentially hazardous situation that, if not avoided,
may result in minor or moderate injury, equipment damage or
loss of data.
Indicates important information necessary for users to under-
stand.
DANGER
WARNING
CAUTION
Notes

XGB6-12-1014, Rev 1.04 13
Safety Hazard Overview Chapter 1 - Overview and Safety
emergency procedures, and the operating instructions provided in this
manual.
Protection against electric shock
Be sure the protective earth cable is properly connected to the control unit
prior to use.
Do not use the G-Arm system if the power cable is damaged.
Do not remove or open the casing or covers of the equipment. The internal
circuits of the G-Arm system generate high voltages and can cause serious
injury or death. To minimize the shock hazard, the power cable must be con-
nected to a UL-approved power receptacle.
Radiation protection
The G-Arm system is designed and manufactured with the highest safety
standards. However, no design can guarantee absolute safety or complete
protection. See "RadiationProtection" (s1.9, p16) for more information on this
topic.
Explosion protection
Do not operate the equipment in the presence of flammable or explosive
liquids, vapors or gases.
If flammable substances are detected after the system has been turned on,
do not attempt to turn the system off. Evacuate and ventilate the area before
turning the system off.
Implosion protection
Jarring or striking the system could lead to serious mechanical shocks, lead-
ing to explosion. This may result in injury from flying debris.
Electrical fire protection
This equipment is not suitable for use in the presence of flammable gases.
Conductive fluids that drain into the active circuit components of the system
may cause short circuits that may result in electrical fire. Therefore, do not
place fluids or food on any part of the system.
Make sure that the fire extinguisher at the site has been approved for use on
electrical fires, to prevent electrical shock or burn.
WARNING
Do NOT use this unit in the presence of potentially flammable anes-
thetic gas or equivalent.
WARNING
This unit shall NOT be operated at an altitude above 3000 meters
(9842 feet).

Chapter 1 - Overview and Safety Safety - Operation
14 B6 User Manual
1.6 Safety - Operation
Notes
●No user-serviceable parts are provided within the unit.
●None of electronic objects or parts of the unit (fuses, circuit breaker, etc.)
shall be replaced or repaired by the hospital. Only service personnel autho-
rized by Beijing East Whale Imaging Technology Co., Ltd. are allowed to
perform these operations.
Only operate the control unit in a ventilated environment.
Do not operate the control unit near strong magnetic fields. Keep the G-Arm
system away from devices that generate strong magnetic fields. Such devic-
es include MRI unit, microwave oven, speaker, etc.
The additional equipment that is required to work with the G-Arm system
must conform to Standard EN 60601-1.
In the event of system failure, immediately cease the operation of the G-Arm
system and call the responsible service technician for help.
1.7 Safety - Power Supply
WARNING
The appropriate X-ray imaging exposure parameters should be consis-
tent with established Federal and Provincial/State radiation protection
practices and medical imaging standards in the local institution.
CAUTION
Do not use the system in unsafe conditions (smoke, fire, etc.), which
can lead to hardware failure.
CAUTION
To avoid damaging the unit, do not place anything, especially heavy
objects or liquid contents on top of the unit.
DANGER
The unit should be placed on stable and level ground.
Power Supply Requirement: 220/230 VAC, 50/60 Hz, 15 A
Power: 2500 VA (Momentary), 800 VA (Long-time)
Rated Line Voltage: 220/230 VAC
Line-voltage Regulation: 2% in bi-plane imaging (120 kV, 15 mA)

XGB6-12-1014, Rev 1.04 15
Safety - Power Supply Chapter 1 - Overview and Safety
Line-voltage regulation is based on measurements made at the input (pri-
mary winding) of the isolation transformer under standby conditions and at
maximum fluoroscopic exposure.
Percent Line Regulation = 100 (Vn - V1)/V1
Where
Vn stands for no-load line potential (standby), and V1 for load line po-
tential for maximum radiographic exposure.
Max. line current and technique
factors: 11 A, 120 kV, 15 mA (bi-plane imaging)
Highest electric power in high-
voltage circuit:1.8 kW (120 kV, 15 mA)(bi-plane imaging, peak), 1.2 kW (120 kV, 15 mA) (bi-plane imaging, maxi-
mum average)
Nominal electric power: 2.3 kW (100 kV, 15 mA, 1 s)
WARNING
To avoid the risk of electric shock, this equipment shall only be con-
nected to the power supply with protective earth.
When another device is used together with this unit, the combination
as a whole shall conform to the standard EN 60601-1.
WARNING
It is required to have the G-Arm connected to the Control Unit before
applying power to the G-Arm system.

Chapter 1 - Overview and Safety Required Work Space
16 B6 User Manual
1.8 Required Work Space
Figure 1-1 (p16) demonstrate the work space required for the operator to op-
erate the G-Arm system in any particular area.
1.9 Radiation Protection
X-ray radiation exposure can be harmful to the human body.The cumulative
effect it creates may last for months or years. Operators and service person-
nel should avoid direct exposure to the X-ray beam and take protective mea-
sures to avoid scattered radiation.
No design can guarantee absolute safety or complete protection for those
who fail to take adequate safety precautions. Only properly trained opera-
tors or authorized service personnel are allowed to operate this unit. Both
the operators and service personnel should be aware of the risk of X-ray ra-
diation during routine operation and the risk of high-voltage electric shock
during equipment maintenance.
Figure 1-1: Required work space (mm (inch))
CAUTION
Be sure to leave sufficient room to maneuver the G-Arm, and take the
required work space into consideration.

XGB6-12-1014, Rev 1.04 17
Radiation Protection Chapter 1 - Overview and Safety
1.9.1 General Protection
The owner of the G-Arm system must designate areas suitable for safe oper-
ations and maintenance of the equipment and ensure the G-Arm system are
only used in those areas. For example, allocate a room exclusively to the
equipment, where protective precautions like lead shields and lead screens
are provided to separate the X-ray radiation field from the human bodies ir-
relevant to the purpose of the clinical procedure.
While using the equipment, the owner must ensure that all personnel wear
radiation monitoring devices (operator dosimeter) and appropriate protec-
tive clothing, helmet, apron, goggles, shield, etc.
Remain alert for visual indicators and audible alarms that are activated when
ionizing radiation is being generated by the equipment in the work area.
Additionally, the G-Arm system uses grids to reduce the amount of scattered
radiation.
1.9.2 Keeping Distance
Maintaining a safe distance from the source is another effective protective
method. Locations more than 2 meters away from the X-ray focus is consid-
ered to be safe when equipped with protective devices and protective cloth-
ing.
1.9.3 Reducing Dosage
The collimator are carefully configured so that it regulates itself more pre-
cisely upon SID changes. Better precision in collimator movements boosts
the image quality and minimizes the dosage, and greatly reduces the
amount of scattered radiation.
1.9.4 Exposure Alert
The G-Arm system triggers a warning alarm when 5 minutes of fluoroscopic
imaging time is accumulated during a single study.
Related Topics
●"Fluoroscopy time summary" (s8.1.2, p90)
●"Exposure Lamps and Audible Signals" (s3.6, p41)
1.9.5 Source-to-skin Distance
The X-ray radiation value varies in proportion to the product of the kV value
and mA value.

Chapter 1 - Overview and Safety Radiation Protection
18 B6 User Manual
International regulations specify that a minimum source-skin distance (SSD)
of 300 mm shall be maintained. However, for specific surgical applications, a
minimum SSD of 200 mm is required.
The coverof the hole where the X-ray is emitted is the nearestposition to the
X-ray source that the patient body can reach during normal use, which me-
chanically preserves the minimum SSD.
The G-Arm system may come with an optional accessory - skin spacer - to
create additional space between the focal spot and the patient body. The
minimum SSDs that the G-Arm system can reach, with or without the skin
spacer installed, are illustrated as in the figure below:
In normal conditions, the SSD shall be far enough to keep the dosage as low
as possible.
Figure 1-2: Minimum Source-skin Distance (SSD)
1 SSD w/ Skin Spacer 2 SSD w/o Skin Spacer
3 Skin Spacer 4 Focal spot
DANGER
Exposing the eyes or the skin to the primary X-ray beam may result in
severe radiation burns in the event of repetitive or prolonged expo-
sures. The hazards are most often associated with exposure to X-ray
radiation including increased risks of cancer and genetic effects in
exposed populations.

XGB6-12-1014, Rev 1.04 19
Acronyms and Abbreviations Chapter 1 - Overview and Safety
1.9.6 Penetration of Fluids
Excessive amount of fluids such as antiseptics, cleaning solutions or body
fluids may damage the internal components if seeped through. Use drapes,
if necessary, to protect the equipment during clinical procedures. Do not ap-
ply excessive amounts of fluids when cleaning.
1.10 Acronyms and Abbreviations
The acronyms and abbreviations used in this manual are explained in the fol-
lowing table:
DANGER
The G-Arm system is not waterproof. If liquids drip into the equipment,
disconnect the power cord. Do NOT operate the system until it has
been cleaned and inspected by a qualified service engineer.
AE Title Application Entity Title
AEC Automatic Exposure Control
AKR Air Kerma Rate
AP Anteroposterior
Auto Automatic
Cont Continuous
C-Unit Control Unit
DICOM Digital Imaging and Communications in Medicine
DAP Dose Area Product
Fluo Fluoroscopy
DR Digital Radiation
I.I. Image Intensifier
LT Lateral
LIH Last Image Hold
Mfr. Manufacturer
SR Structured Report
PACS Picture Archiving and Communication Systems
PMMA Polymethyl-methacrylate
ROI Region of Interest
SID Source to Image Distance

Chapter 1 - Overview and Safety Symbols and Nameplates
20 B6 User Manual
1.11 Symbols and Nameplates
Various symbols, labels, and signs are fixed to or printed on the surface of
this product to provide you with additional information including warnings
and/or safety information.
For descriptions of these symbols, labels, signs and nameplates, see Appen-
dix I: "Symbols & Nameplates" (p163).
1.12 Equipment Malfunction
In the event that the system circuit breaker trips, which may indicate a sys-
tem malfunction, do not attempt to operate the equipment and contact the
manufacturer or the service engineer authorized by the manufacturer.
1.13 Responsibility
Regardless of the particular requirements set by the relevant liability stan-
dards, WHALE can be considered liable only when the following conditions
apply:
●Assembly, installation, adjustment, maintenance and modifications are
performed only by WHALE personnel or by persons authorized by Bei-
jing East Whale Imaging Technology Co., Ltd.
●Operations of this unit is in accordance with the instructions depicted
in the user manual with a proper version.
WHALE assumes no responsibility when the patient, the operating staff or
the third party are exposed to excessive X-ray radiation.
CAUTION
The terms of AP and LT used on the G-Arm system and in this manual
are only to indicate the X-ray plane on which the images are gener-
ated. They are not identical to the clinical terms of AP and LT.