GM85 User Manual Ver 2.0 March 2017

GM85 Model

Detector S4335-W

GM85

S4343-W S3025-W

Generator

Tube

SMG-40

LUC-13L

(32kW/40kW)

XRR-3332X

• For detailed information about different components and features of the system, refer to the respective sections in this user manual. • Please note that some components, options, and features may not be available in some countries due to pending regulatory approval.

State of California Proposition 65 Warning (US only) WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.

This product bears a CE marking in accordance with the provisions of the 93/42/EEC MDD.

Revision History Version

Date

History

1.0

August 19, 2016

Initial Release

1.1

September 6, 2016

Contents Revision and Configuration Update

1.2

October 12, 2016

The 3rd RM Check List (KO) and FDA Additional Information Request Update

1.3

October 20, 2016

Handle Instruction Label Update

1.4

October 25, 2016

Content Related to the Wireless Hand Switch Update

1.5

November 11, 2016

Current Expression of Safety Instructions Rewritten in Line with Our DR's

2.0

March 28, 2017

Contents Revision and Configuration Update

Table of Contents About this Manual Symbols Used in this Manual...i-i User Requirements ...i-ii User Contact Surface Area...i-ii Service Centers...i-iii Manufacturer Information...i-iii Contact Information...i-iii

1. Safety Instructions Safety Symbols... 1-1 General Safety...1-5 Mechanical Safety...1-6 Electrical Safety... 1-7 Fire Safety... 1-7 Safety from Explosion...1-8 EMC (Electromagnetic Compatibility)...1-8 Radiation Safety...1-9

2. System Overview System Purposes... 2-1 General Features...2-2 Classification...2-3

3. Operating the System Hardware System Components... 3-1 Starting the System...3-2 Main Connections and Line Circuit Breaker...3-2 Control Panel...3-5 Main Display...3-10

GM85 | Table of Contents

Moving the System... 3-11 Drive Unlock...3-11 S-Station Login Request Screen... 3-12 System Moving Grip Bar... 3-13

Emergency Brake Release Button... 3-15 Bumper Sensor...3-16 Tube Head Unit... 3-17 Operating the Collimator... 3-17 Operating Tube Head Unit... 3-18 Sub Display... 3-20 SID Guide... 3-20 Quick Positioning Button... 3-21

Collimator... 3-23 Structure...3-23 Collimator Control Panel...3-25

Arm and Column Parking...3-29 How to set the parking position...3-29 How to release the parking position... 3-30

Arm and Column Operation...3-31 Arm/Column Brake Release Button... 3-31 Movement Controls of the Column and Telescopic Arm...3-32

System Status Indicator ... 3-34 Peripheral Connections...3-35 Apron Hanger... 3-36 Wired Exposure Switch (Button 2/Button 3, Option)...3-37 Wired Exposure Switch (Button 2)...3-37 Wired Exposure Switch (Button 3, Option)... 3-38 Preparation... 3-40 Exposure... 3-40 Collimator Lamp... 3-40

TOC-2

GM85 | Table of Contents

Wireless Exposure Switch (Option)...3-41 Infrared Type... 3-41 Bluetooth Type... 3-44

Storage... 3-48 Detector Lock... 3-53 Wireless Detector... 3-55 Precautions... 3-56 Configuration... 3-61 Installing the Battery in the Detector... 3-63 Battery Charger... 3-71

X-ray Tube Warm-Up Procedure...3-73 Radiographic Operation...3-75 X-ray Beam Alignment with Respect to Patient...3-75

4. S-Station Overview...4-1 System Self-Test and Login...4-2 System Self-Test Items...4-2 System Self-Test...4-3 System Login...4-3

Entering and Managing Patient Information... 4-4 Worklist...4-4 Creating Patient Information...4-9 Editing Patient Information ... 4-11 Deleting the Patient Information... 4-12

Capturing and Acquiring an Image...4-13 Acquisition... 4-13 Setting the Capturing Conditions... 4-16 Exam Lists... 4-19 Acquiring an Image... 4-23 Preview...4-24 TOC-3

GM85 | Table of Contents

Managing an Image...4-31 Capturing Additional Images... 4-36 Transferring and Deleting an Image...4-37 Changing the Exam Information... 4-40

Editing an Image... 4-46 Image Editing Tools...4-47 Post-Processing an Image ... 4-58 How to Adjust the Post-Processing Parameters... 4-60 Printing an Image... 4-68

Configuration...4-75 General Settings...4-75 DICOM... 4-84 Viewer... 4-94 THU Configuration... 4-106 Admin... 4-109 Reject and Usage Analysis Tool... 4-122

Secondary Display for Tube Head (THU)...4-126 System Standby... 4-126 Worklist... 4-127 Acquisition...4-128 Image Preview... 4-137

S-Align...4-139 Display Angles of S-Align Detector and Tube...4-139 S-Align Operating Conditions... 4-140 Steps for Running S-Align... 4-140

TOC-4

GM85 | Table of Contents

5. Advanced Applications S-Share (Option)... 5-1 Detector Registration... 5-1

Tube & Line Enhancement...5-4 Creating Tube & Line Enhancement View...5-5 Managing the Tube & Line Enhancement Image...5-6 Transferring Tube & Line Enhancement Images ... 5-7 Deleting Tube & Line Enhancement Images... 5-7

SimGrid (Option)... 5-8 SimGrid Operating Conditions...5-9 Applying SimGrid During Image Capturing...5-10

Pediatric Exposure Management... 5-12 Overview... 5-12

Quality Assurance Program (QAP, Option)...5-16 Preparation of QAP... 5-16 Procedure to Run QAP... 5-17 Procedure to Use QAP... 5-18 Displaying QAP Results...5-22

Bone Suppression...5-23

6. Accessories Tether (Option)... 6-1 Overview... 6-1 Directions for Use...6-2

Portable Grid (Option)... 6-4 Overview...6-4 Directions for Use...6-5

Weight Distribution Cap (Option)...6-7 Overview... 6-7 How to Use the Weight Distribution Cap... 6-7

TOC-5

GM85 | Table of Contents

Detector Holder (Option)... 6-8 Overview...6-8 How to Fix the Detector Holder...6-9 CAUTION...6-11

Barcode Scanner (Option)...6-13 Overview... 6-13 Connecting... 6-13 Configuration... 6-14

Portable ODD (Option)...6-15 Directions for Use... 6-16

7. Maintenance and Regular Inspection System Inspection... 7-1 Battery Maintenance...7-1 Daily Inspection... 7-2 Periodic Inspection... 7-5 Inspection for System Message and Error Message...7-7 Periodic Replacement of Part...7-7

Cleaning...7-8 Disposal... 7-10 Maintenance Information and Format...7-11 Maintenance... 7-11 Filing Complaints... 7-11 Report Format...7-12

Disclaimer... 7-18

TOC-6

GM85 | Table of Contents

8. Specifications System... 8-1 Electrical Characteristics...8-2 X-ray Generator...8-3 X-ray Tube... 8-4 Collimator...8-5 Total Filtration...8-5 Detector... 8-6 Detector Battery and Battery Charger... 8-8 Mechanical Specifications... 8-9 Label...8-10 List of Parts...8-13

9. Appendices Applied Standards... 9-1 FCC Statement of Conformance... 9-4 EMC Compliance Declaration...9-5 Technical Exposure Reference Table and Skin Entrance Measure Value... 9-11 Exposure Index... 9-14

Abbreviations...9-22 Required Public Statement for Open Source Licensed Software Used in this Product... 9-24

TOC-7

GM85 | About this Manual

About this Manual Symbols Used in this Manual The specifications and details of this manual may be changed in order to improve the product or to enhance its performance. The following symbols are used throughout this manual to alert the user to the relevant safety instructions or to provide any useful information when using the GM85. Symbol

Name

Description

DANGER

Advice about conditions or situations that if not heeded or avoided will cause serious personal injury or death.

WARNING

Advice about conditions or situations that if not heeded or avoided could cause serious personal injury or catastrophic damage of equipment or data.

CAUTION

Advice about conditions or situations that if not heeded or avoided could cause personal injury or damage to equipment or data.

NOTE

Alerts readers to pertinent facts and conditions. Notes inform readers of information that is important, but is not necessarily related to possible personal injury or damage to equipment.

• Please note that orders are based on the individually agreed specifications and may not contain all features listed in this manual. • Please note that some components, options, and features may not be available in some countries due to pending regulatory approval. • The screenshots and illustrations in this manual are for illustrative purposes only and may be different from what you see on the screen.

■■ Indication for Use The GM85 Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

i-i

GM85 | About this Manual

User Requirements CAUTION: • This equipment may only be operated by users who have received professional medical education and training, such as physicians, radiologists, cardiologists, and other medical specialists. • Please read the user manual and the safety information carefully before using this equipment. • Operating the equipment without reading the safety information may result in personal injury to the patient or to yourself. • Federal law restricts this device to sale by or on the order of a physician.

User Contact Surface Area

Patient Contact Surface Area (Detector)

i-ii

GM85 | About this Manual

Service Centers ■■ Korea Service Center: 1644-0550

■■ Oversea Please contact the local distributor.

Manufacturer Information SAMSUNG ELECTRONICS Co., LTD. 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea

Contact Information SAMSUNG ELECTRONICS Co., LTD. 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea SAMSUNG ELECTRONICS (UK) LTD. Blackbushe Business Park Saxony Way, Yateley, Hampshire GU46 6GG, UK U.S. Agent NEUROLOGICA CORPORATION, a Subsidiary of SAMSUNG ELECTRONICS Co., LTD. 14 Electronics Avenue, Danvers, MA 01923 USA

i-iii

Safety Instructions

1

Safety Symbols... 1-1 General Safety... 1-5 Mechanical Safety... 1-6 Electrical Safety... 1-7 Fire Safety... 1-7 Safety from Explosion...1-8 EMC (Electromagnetic Compatibility)...1-8 Radiation Safety... 1-9

GM85 | Safety Instructions

Safety Instructions This chapter provides safety information and instructions that users and physicians must be fully familiar with before using the system. Since they are provided to ensure personal safety and to prevent damage to the system, it is important that you read and understand them thoroughly in order to operate the system correctly. If you need additional training, please contact the designated service personnel authorized by the manufacturer. The GM85 Mobile DR System complies with FDA Radiation Performance Standards under Title 21 CFR, Subchapter J, Parts 1020.30 and 1020.31. WARNING: Before using the GM85, make sure that you read through and fully understand the safety instructions presented in this manual. The manufacturer assumes no liability for any accidents which may occur due to operations performed without following the relevant safety instructions.

Safety Symbols The table below shows the symbols related to maintaining the safety of the patient and the user. Symbol

Description Indicates any probable hazards arising from dangerous voltages including high voltage.

Indicates danger of pinching or clamping of feet.

Indicates danger of pinching or clamping of fingers.

Indicates that only authorized personnel can access the area due to radiation. Indicates content which, if you fail to follow the accompanying instructions, may cause personal injury or damage to the product.

1-1

GM85 | Safety Instructions

Symbol

Description Indicates that the accompanying operating instructions in the user manual must be followed to safely operate the equipment.

Fragile/Fragile contents; handle with care.

Indicates the presence of devices such as a radio frequency transmitter.

Indicates that leaning or sitting may be dangerous.

Indicates that pushing the object may be dangerous.

Indicates that leaning against the object may be dangerous.

No stepping on the surface.

Indicates that the equipment can withstand up to 25 kg in weight.

<150kg

Indicates that the wireless detector can support a front weight of up to 150 kg when placed on a flat surface.

<100kg

Indicates that the wireless detector can support a localized weight of up to 100 kg when placed on a flat surface. Indicates that the user should be careful to avoid impact and handle with care.

Indicates that there is a built-in antenna at the relevant spot.

1-2

GM85 | Safety Instructions

Symbol

Description Indicates that the system has been powered off by the emergency stop button pressed.

Identifies a Type B applied part that is in compliance with IEC 60601-1. Protection against harmful ingress of water or particulate matter. Indicates that the equipment is only suitable for an alternating current. Indicates that the equipment is only suitable for a direct current. Identifies a grounding terminal. Identifies a terminal to be connected to an external conductor for protection against electric shock. Identifies the frame or chassis terminal.

Indicates the exposure or the imminent exposure of X-rays.

Indicates a reference to an X-ray source assembly.

Indicates a reference to the X-ray tube. For example, if this symbol is attached to the surface of a component, such as the focused anti-scatter grid, it has to be oriented towards the X-ray tube. Indicates the selection of a small focal spot or the connections for the corresponding filament. Indicates the selection of a large focal spot or the connections for the corresponding filament. Denotes the collimator control that uses light to demarcate the X-ray radiation area.

1-3

GM85 | Safety Instructions

Symbol

Description Denotes the control for opening the collimator both vertically and horizontally to increase the X-ray radiation area. Denotes the control for closing the collimator both vertically and horizontally to decrease the X-ray radiation area. Denotes the control for closing the collimator either vertically or horizontally to decrease the X-ray radiation area. Denotes the control for opening the collimator either vertically or horizontally to increase the X-ray radiation area.

Indicates laser radiation from the equipment. This symbol indicates that the European Directive on Waste of Electrical and Electronic Equipment (WEEE) must be adhered to and the device must not be disposed of as unsorted municipal waste, but must be collected separately. Please contact an authorized representative of the manufacturer or an authorized waste management company for information concerning the decommissioning of your equipment. This separate collection symbol is affixed to a battery or its packing, to advise that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the symbol indicate whether the battery contains certain elements (Li=Lithium, Pb=Lead, Cd=Cadmium, Hg=Mercury). All batteries removed from the equipment must be properly recycled or disposed of. Please contact an authorized representative of the manufacturer or an authorized waste management company for information concerning the decommissioning of your equipment. Pollution Control (Only applicable to People’s Republic of China (PRC)). This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese Standards. It must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer or an authorized waste management company for information concerning the decommissioning of your equipment. Table 1–1. Special Symbols 1-4

GM85 | Safety Instructions

General Safety ■■ Before using the equipment, the user should check that: • All components are connected correctly. • All components are operational when the system is powered on. WARNING: • Since this system generates X-rays, it must be installed and used in compliance with the relevant international laws and regulations. For more information on the safety instructions for installing the equipment, refer to the installation manual. • Only authorized users are permitted to use this system. If it is used by anyone who is not fully familiar with the safety precautions, operating instructions and maintenance schedule, it may be hazardous to both the patient and the user.

■■ If any electrical or mechanical fault occurs, stop using the system immediately. You can identify faults from the display or warnings. ■■ Please consult the manufacturer before connecting a component from any other systems to this system. Any auxiliary device connected to the system must be IEC certified (data processing equipment: IEC 60950, medical electrical equipment: IEC 60601-1). Also, if the auxiliary device is connected to a signal I/O port, it should comply with IEC 60601-1-1. ■■ Medical equipment requires periodic maintenance and management. For more information, refer to Maintenance and Regular Inspection. ■■ If an error message appears while the system is in use, it may stop operating. When an error message appears, contact the service center. ■■ The manufacturer will not accept liability for: • Fault, damage or personal injury incurred as a result of the user incorrectly performing maintenance on the system. • Personal injury incurred as a result of the user’s negligence. • Fault, damage or personal injury incurred due to use of an auxiliary device which is not provided by the manufacturer.

1-5

GM85 | Safety Instructions

Mechanical Safety WARNING: • When moving the arm unit or system, the operator must pay close attention to ensure that the limbs of both operator and patient are not caught between the system and any peripheral units. • Avoid collisions and overturning. Collisions and overturning can not only damage the system, but can also cause serious injury. • When on a slope, in an entrance, or encountering obstacles, move the system as slowly as possible. Be especially careful when descending/ascending a steep slope. • Do NOT unpark or move the tube head on a slope steeper than 5°. When stopping the system, always park the system on a level floor or surface, avoiding slopes, since there is a danger of the system rolling down the slope and overturning. • If the system is parked on a slope steeper than 7°, it will not be able to move. Do NOT stop the system on a slope. • Do NOT move the system over steps higher than 1 cm. When encountering obstacles, move the system as slowly as possible to avoid obstacles. • When moving the system, look out for any obstacles in front of it. • The system is designed for indoor use only. Moving the system along surfaces that cause strong vibrations, such as on outdoor roads, over large steps, or down steep slopes, is dangerous and should be avoided.

1-6

GM85 | Safety Instructions

Electrical Safety ■■ This medical equipment complies with electrical safety class I type B in accordance with IEC 60601-1. ■■ This system must be used in an operating environment compliant with IEC requirements. WARNING: • For safety reasons and for proper functioning, make sure that the Unit is connected to a standard outlet with grounding. • The operation of the Air-Conditioning System or Heating may produce condensation in the equipment. Wait until the condensation evaporates before performing an exposure. As a general rule, raise or lower the room temperature gradually to avoid condensation. • During exposure, do not use the detector near devices generating a strong magnetic field as this may cause the detector to malfunction. DANGER: Do not remove any cover or disassemble or manipulate internal components in the unit. These actions could cause serious personal injuries and/or equipment damage.

■■ Be careful to ensure that no liquids enter the system. ■■ If the system malfunctions and there is an imminent danger to the patient or the user, please press the emergency stop button to stop the system. • The emergency stop buttons are located on the Control Panel. Both the moving system and the generator will be turned off when an emergency button is pressed. • If you turn off the system by pressing the emergency stop button, the patient information you are capturing may be lost. Be sure to use the emergency stop buttons only in an emergency. • If the system turned on while one of the emergency stop buttons was pressed, rotate the emergency stop button to release the lock before turning the system on again.

Fire Safety WARNING: • Do not operate the system in a location where there is a danger of fire. • In the event of a fire, stop the entire system immediately and disconnect the power cable. Make sure to extinguish the fire with a carbon dioxide fire extinguisher.

1-7

GM85 | Safety Instructions

Safety from Explosion WARNING: Do not operate the system in a location where there is a danger of explosion. This system is not designed to be used in a location where there is a danger of explosion and does not comply with the AP/AGP standard.

EMC (Electromagnetic Compatibility) ■■ This equipment needs special precautions regarding EMC and must be installed and put into service according to the EMC information provided in this user manual. ■■ Do not use any wireless devices, including cellular phones, near the system. All wireless devices, whether they comply with the EMC standard or not, may emit electromagnetic interferences and cause the system to malfunction when they are used nearby. ■■ All interconnecting cables to peripheral devices must be shielded and properly grounded, except when technologically prohibited to comply with EMC standards of Group 1 – Class A. CAUTION: This equipment should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the equipment must be tested and verified in order to ensure it operates normally in the configuration in which it will be used. WARNING: When using this system on a patient with an implantable pacemaker or an implantable cardioverter defibrillator, the patient must be informed that continuous X-ray exposure in pulse form may cause the pacemaker or cardioverter defibrillator to malfunction. When using this system, ensure that the patient’s implantable pacemaker or implantable cardioverter defibrillator is not directly exposed to the X-rays and that the exposure time is kept as short as possible.

1-8

GM85 | Safety Instructions

Radiation Safety ■■ This system complies with IEC 60601-1-3 (X-ray Radiation Protection). WARNING: • When examining a patient, the effective X-ray exposure area must be set as small as possible. If it is impossible to expose X-rays only onto the area to be examined, use lead protectors to protect the other parts of the patient’s body. • Expose radiation precisely to prevent the patient from being exposed to excessive radiation. • When examining a patient, observe the following in order to minimize the amount of X-ray radiation absorbed by the body: –– High tube voltage –– Short exposure time –– Enough distance between the patient and the X-ray tube

■■ When you have to expose X-rays, you must wear lead protectors. Also, wear a film badge or radiation dosimeter and always check the amount of radiation exposure when using them. CAUTION: Make sure to provide the means for audio and visual communication between the operator and patient during the examination.

1-9

System Overview

2

System Purposes... 2-1 General Features...2-2 Classification...2-3

GM85 | System Overview

System Overview System Purposes This system is equipment that captures images by transmitting X-ray radiation to a patient’s body. The X-ray radiation passing through a patient’s body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal processing device before being sent to the S-Station (Clinical Operation Software) and saved as a DICOM file, a standard format for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server and can be used for reading images. The GM85 is intended to be used for capturing digital X-ray images of various parts of the body including the head, chest, spine, abdomen, joints, hands, feet, and other organs. Note that its intended use does not include mammography. This manual contains all the information necessary to understand and operate the Mobile X-ray Units. It provides a general description, safety and regulatory information, and operating instructions and specifications concerning the system. It is not intended to teach radiology or to take any type of clinical diagnosis.

Figure 2-1. Mobile X-ray Unit

2-1

GM85 | System Overview

General Features The GM85 provides the best solutions for capturing digital X-ray images with the following advantages: ■■ Small footprint and lightweight with a collapsible column Collapsible column provides complete visibility and safety when moving, while being compact and lightweight making it easier to move through narrow spaces and in and out of elevators. ■■ Soft Driving – Silent and Maneuverable Movement Soft Driving technology gives safe, easy, maneuverable movement and 360-degree tight turn capability at crowded hospital facilities with a virtually silent working motor. ■■ Wide coverage with arm & tube head unit, S-Align The maximized tube reach and SID range allows easy positioning with S-Align which displays the detector’s angle. ■■ Quick Positioning Quick Positioning system enables easy forward/backward or CW/CCW rotation movement using the bedside drive controls. ■■ Long lasting battery with Quick Charging New battery and power saving technology enables uninterrupted work. ■■ Plug-in-Exposure Take X-ray exposures while the unit is charging. ■■ Large & Convenient Storage Space • Built-in storage for cleaning wipes, gloves, and cables. • Detector and detector battery charge automatically while the detector is in storage. • Safe and lockable detector storage is provided. ■■ Intuitive SID Guide with Auto-Collimator Intuitive laser guide helps to align SID and Auto-Collimator for easy positioning. ■■ Auto-Filter Additional filters can be automatically set according to the APR Manager on the S-Station. Auto filter applies the optimal filter settings, and helps reduce the required radiographic dosage when used in conjunction with the advanced S-Vue image processing technology. ■■ Wide dual-touch screens The display on the tube head unit allows for easy bedside controls.

2-2

GM85 | System Overview

■■ S-Station with intuitive touch interface S-Station with intuitive touch interface has fast booting and simple operation. ■■ Outstanding image quality S-Vue image processor provides outstanding image quality and advanced applications, while Tube & Line Enhancement, Pediatric Exposure Management, and SimGrid (Option) support diagnosis.

Classification ■■ Type of protection against electric shock: Class 1 equipment ■■ Degree of protection against electric shock: Type B applied part ■■ Degree of protection against ingress of water: Ordinary equipment ■■ Method(s) of sterilization or disinfection: Not Applicable ■■ Degree of safety of the application in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE: Not Applicable ■■ Mode of operation: Continuous operation with intermittent loading

2-3

Operating the System Hardware System Components...3-1 Starting the System... 3-2 Main Connections and Line Circuit Breaker... 3-2 Control Panel... 3-5 Main Display... 3-10

Moving the System... 3-11 Drive Unlock...3-11 S-Station Login Request Screen... 3-12 System Moving Grip Bar... 3-13

3

System Status Indicator ... 3-34 Peripheral Connections... 3-35 Apron Hanger... 3-36 Wired Exposure Switch (Button 2/Button 3, Option)... 3-37 Wired Exposure Switch (Button 2).. 3-37 Wired Exposure Switch (Button 3, Option)...3-38 Preparation... 3-40 Exposure... 3-40 Collimator Lamp... 3-40

Emergency Brake Release Button...3-15 Bumper Sensor...3-16 Tube Head Unit...3-17

Wireless Exposure Switch (Option)... 3-41

Operating the Collimator...3-17 Operating Tube Head Unit... 3-18 Sub Display...3-20 SID Guide...3-20 Quick Positioning Button... 3-21

Storage... 3-48 Detector Lock... 3-53 Wireless Detector... 3-55

Collimator... 3-23 Structure...3-23 Collimator Control Panel...3-25

Arm and Column Parking... 3-29 How to set the parking position...3-29 How to release the parking position...3-30

Arm and Column Operation.3-31 Arm/Column Brake Release Button... 3-31 Movement Controls of the Column and Telescopic Arm...3-32

Infrared Type... 3-41 Bluetooth Type...3-44

Precautions...3-56 Configuration... 3-61 Installing the Battery in the Detector...3-63 Battery Charger...3-71

X-ray Tube Warm-Up Procedure...3-73 Radiographic Operation...3-75 X-ray Beam Alignment with Respect to Patient...3-75

GM85 | Operating the System Hardware

Operating the System Hardware System Components ⑦

①

⑧

②

⑨ ⑩

③

⑪

④

⑫

⑤

⑬

⑥

⑭ ⑮

Figure 3-1. System Components

① Arm/Column Brake Release Button

⑨ Arm/Column Brake Release Button

② Parking Detent

⑩ Sub Display

③ Storage

⑪ Collimator Blade Control Knob

④ Battery Indicator

⑫ Emergency Stop Button

⑤ Main Display

⑬ System Power Button

⑥ Bumper Sensor

⑭ System Moving Grip Bar

⑦ System Status Indicator

⑮ Detector/Portable Grid Storage

⑧ Quick Positioning/SID Guide Button

3-1

GM85 | Operating the System Hardware

Starting the System The system can be operated in Stand-Alone mode using battery power only. Before switching the system power on, keep the unit connected to the mains to ensure that the system battery begins to charge. Before powering the system up, make sure that the line circuit breaker is in the ON position. If the line circuit breaker switches OFF or is in the OFF position, turn ON the line circuit breaker to start the system.

Main Connections and Line Circuit Breaker Outlet connected with this equipment should be compliant with local regulations and electrical requirements of equipment. Plug reel can be replaced only by our service engineers. Because the Plug is used as the means to isolate system from the outlet for the safety, be sure to place the system so that the Plug can be easily disconnected from the outlet. WARNING: Be sure to connect equipment to the standard outlet with Grounding for safety and proper operation.

Battery output will be disconnected from the system if the battery is fully discharged in order to protect the battery from over discharging. The system can not be powered on when the battery is disconnected from the system, even if the power button is pressed. Be sure to connect the unit to the mains and wait for few minutes to charge the battery before turning on system. When the system is not going to be used for a long period of time, fully charge the battery and ensure that the S-Station is properly shut down and then switch OFF the system power button. While the system is shut down, keep the line circuit breaker switched OFF. It is recommended that the battery be recharged once a month if the unit has been switched OFF for more than a month. Make sure that the battery is fully recharged at least once every 3 months when not using the system for extended periods of time.

Power Plug Line Circuit Breaker

Figure 3-2. Line Circuit Breaker 3-2

GM85 | Operating the System Hardware

WARNING: • If the battery is left uncharged for an extended period (3 months or longer), then the system will automatically disconnect the battery output to protect the battery from over discharging. If this is the case, then the system cannot be turned on again, even if it is connected to the mains. Contact our service engineer in order to reset the battery. • When the battery detects a malfunction, it will shut itself down and an alarm will sound for a certain period of time. If the alarm sounds while the charger is plugged into a power outlet, unplug it immediately. Do not restart the system and contact our service engineer. WARNING: • When not generating X-rays, keep the unit connected to the mains, even when the battery is fully charged. This ensures maximum storage of energy. • The line circuit breaker is designed to switch off when a system error occurs, such as overcurrent between internal circuits and the battery. It is not designed to power Off the system in normal use. If the system has to be powered off in normal use, use the system Power Off button on the main console. • Switch off the line circuit breaker only when system has a problem and the proper system shutdown is not available. If the system has to be switched off using the line circuit breaker, make sure that S-Station has been forced to terminate before switching off the line circuit breaker so that important data or system software is not damaged. • Any improper attempt to have a Lithium battery-powered device replaced by an inexperienced person may result in an unacceptable level of risk (e.g., excessive temperature, fire, or explosion). If a replacement is required, contact our service engineers. DANGER: • Do NOT connect other electrical equipment to the same power outlet by using a power strip or extension cords. Multiple connections to the same outlet can cause overcurrent of the wall outlet. • Charge the battery in a well-ventilated room and Do NOT cover the system during the charging of the battery. CAUTION: • When removing the plug from the electrical outlet, grasp the plug, not the cord. • Hold the plug when rewinding onto the cord reel. Do not allow the plug to whip about when rewinding.

3-3

GM85 | Operating the System Hardware

DANGER: • When pulling out the power cable, hold the plug portion and do NOT apply excessive force to the cable. Excessive force may damage the cable or internal cable reel. Do NOT apply excessive force to the cable after the whole cable has retracted. It can cause electric shock or fire by short circuit of power cable. • Place the system under 2.5 meter from cord reel to mains in a straight line to prevent applying excessive force to the cable as the figure below. Also, be careful not to pull out the power cable to the point when the yellow warning strap is visible on the cable. A red warning strap will appear on the cable if the power cable is continuously pulled after the yellow strap is visible. Do NOT pull out the power cable repeatedly to the point when the red warning strap appears. This can cause electric shock or fire by short circuit of power cable.

Warning Strap

3-4

GM85 | Operating the System Hardware

Control Panel To start the system, press the power button. The remaining battery charge is indicated on the battery indicator. If the battery indicator shows a low battery level, immediately charge the battery.

①

② ③

Figure 3-3. Control Panel

① Battery Indicator ② Outlet Connection Indicator ③ Battery Indicator for Detector Battery ④ System Power Button ⑤ Emergency Stop Button

3-5

④

⑤