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.

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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.

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