OEC Fluorostar Operator Manual May 2015

© May 2015 GE OEC Medical Systems, Incorporated 384 Wright Brothers Dr. Salt Lake City, Utah 84116 Phone (801) 328 9300 Fax (801) 328 4300

Table of Contents

Table of Contents 1

Introduction and Safety... 16 1.1

Intended Use... 16

1.2

Intended Operator... 16

1.3 1.3.1

Equipment Training... 17 Training Frequency Recommendation... 18

1.4

Scope... 18

1.5 1.5.1

An Overview... 19 Construction and Function... 19

1.6

Safety Requirements and System Functions... 20

1.7 1.7.1 1.7.2 1.7.3 1.7.4

General Details... 22 Legal Manufacturer... 22 Place of Manufacture of the GE OEC Fluorostar... 22 Representative in the European Union... 22 Messages... 22

1.8 1.8.1

Service Numbers... 23 Service Worldwide... 23

1.9

Consent... 23

1.10

Hazards... 23

1.11 1.11.1

Electrical Safety... 24 Directive for the User... 25

1.12 1.12.1

Burns... 25 Draping... 25

1.13 1.13.1 1.13.2 1.13.3

EMERGENCY STOP... 26 EMERGENCY STOP Function Test... 27 Restart... 27 Recovery Management... 27

1.14 1.14.1

Components with Dangerous Electrical Voltage... 28 Hazards... 28

5477468_2

GE OEC Fluorostar

3

Table of Contents 1.15

System Error... 41

1.16

Non-Approved Modifications... 41

1.17

Compatibility of Components... 42

1.18

External Devices... 42

1.19

Patient Environment... 43

1.20

Electromagnetic Standard Compliance and Documentation IEC60601-1-2:2007... 44 Electromagnetic Emission... 45 Electromagnetic Immunity... 45 Use Limitation... 52

1.20.1 1.20.2 1.20.3

2

Safety and Regulatory Information... 55 2.1

System Classification... 55

2.2

Compliance with Standards... 55

2.3 2.3.1 2.3.2

Environmental Protection... 56 Disposal... 56 Lithium Battery... 56

2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7

Quality Control... 56 Checks Prior to Each Use... 57 Image Intensifier... 57 Cleaning and Disinfection... 58 Cleaning the LCD Monitor... 58 Daily or Weekly Checks... 58 Monthly Inspection... 62 Image Quality Control... 62

2.5

Imaging Chain... 65

3

4

Radiation Safety... 67 3.1

Deterministic Effects of Ionizing Radiation on Humans... 67

3.2 3.2.1

Dose to Patient... 68 Standard Fluoroscopy Mode... 68 GE OEC Fluorostar

5477468_2

Table of Contents 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8

Low Dose Fluoroscopy Mode... 69 Hand Surgery Fluoroscopy Mode... 70 Thorax Fluoroscopy Mode... 70 Hip Fluoroscopy Mode... 71 Snapshot Mode... 71 Radiography Mode... 72 High Performance Pulsed Fluoroscopy Mode... 72

3.3

Dosimetric Indications... 74

3.4

Dose Reduction Measures for the Patient... 75

3.5

Dose to Operator... 77

3.6

Dose Reduction Measures for the Operator... 80

3.7

Filtration in the Beam... 81

3.8 3.8.1 3.8.2

Dose-Area Product (DAP)... 81 Measured DAP... 81 Calculated DAP... 81

3.9

Protective Devices and Accessories... 82

3.10

Termination of Radiation... 82

3.11

Key Switch to Protect Against Unauthorized Use of X-Rays... 83

4

Summary of Functions... 85 4.1

Hardkey Function Description... 86

4.2 4.2.1

Softkey Function Description... 88 Text Entry Control Panel (for Patient or Physician Management)... 88 Operating Modes Control Panel... 89 X-Ray Control Panel for Radiography and Fluoroscopy... 92 Post-Processing Control Panel... 96 DICOM Control Panel... 99

4.2.2 4.2.3 4.2.4 4.2.5

5477468_2

GE OEC Fluorostar

5

Table of Contents

5

6

System Controls and Operation... 101 5.1 5.1.1 5.1.2 5.1.3 5.1.4

Start-Up...101 Connection to the Power Supply...101 Connecting Hand and Foot Switches...102 Double Foot Switch...103 System Input Power...104

5.2

Running in the X-Ray Generator...105

5.3

Powering On Unit...106

5.4

Restarting the System after Power Supply Failure...106

5.5 5.5.1 5.5.2 5.5.3

Powering OFF the System...107 Powering OFF Normally...107 Complete Separation From the Power Supply...107 Procedure when Powering OFF...107

5.6 5.6.1

Operating the GE OEC Fluorostar...109 Reset/Alarm off...110

5.7

Start Menu...111

5.8 5.8.1 5.8.2 5.8.3 5.8.4

The Display Monitor...112 Status of displayed images...114 Dual Monitor...114 Cross Hair on and off...116 External Monitor Connection to Video out...116

5.9 5.9.1

Steering and Braking...117 Transporting the System...118

5.10 5.10.1

Precautionary Measures during System Transport . . .119 Precautions during Monitor Cart Transport...122

5.11 5.11.1

Motorized Height Adjustment...123 Cardiac Pulmonary Resuscitation (CPR)...124

5.12 5.12.1 5.12.2 5.12.3 5.12.4

Moving and Braking the C-Arm...124 Support Arm and C-Arm Rotation...124 C-Arm Orbital Motion...126 C-Arm Swivel Motion...128 C-Arm Horizontal Motion...129 GE OEC Fluorostar

5477468_2

Table of Contents 5.12.5

Danger of Tripping... 130

5.13

Error Messages... 131

5.14 5.14.1 5.14.2 5.14.3 5.14.4

Alarm Systems in GE OEC Fluorostar... 132 Alarm inputs... 132 Alarm outputs... 132 Alarm delay... 133 Meaning of alarm outputs... 133

5.15

Warnings... 135

6

Fluoroscopy... 137 6.1

Fluoroscopy Operating Modes... 137

6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.2.8

Selecting the Fluoroscopy Operating Mode... 138 Standard Fluoroscopy... 139 Hand Surgery Fluoroscopy... 139 Thorax Fluoroscopy... 139 Hip Fluoroscopy... 140 Fluoroscopy with Reduced Dose Rate... 140 Snapshot... 140 Pulse Mode... 141 High Performance Fluoroscopy Pulse Mode... 142

6.3

Incident Messages displayed in the Operating Modes Control Panel... 142

6.4

Manual kV Adjustment... 144

6.5

Metal artifact correction... 144

6.6 6.6.1 6.6.2 6.6.3

Display in Fluoroscopy Mode... 145 kV and mA Display... 145 Radiation Time Display... 145 Dose (AK) and Dose Area Product (DAP) Display... 145

6.7

Fluoro Time Control, Acoustic Alarms, LED... 146 Acoustic Alarms and LED... 146 Safety Termination after 10 Minutes... 147 Radiation Time Reset... 148

6.7.1 6.7.2 6.7.3 5477468_2

GE OEC Fluorostar

7

Table of Contents 6.7.4 6.8

Autowindow...149

6.9 6.9.1 6.9.2 6.9.3 6.9.4 6.9.5

Collimator Control...150 Collimator Preview...150 Iris Collimator...150 Slit Collimator / Half Collimator 1 and 2...150 Position Half Slit Collimator asynchronously to the left/to the right...151 Move all Collimators to Home Position...152

6.10 6.10.1 6.10.2 6.10.3 6.10.4 6.10.5 6.10.6 6.10.7 6.10.8

Image processing...152 Magnification 1...152 Magnification 2...152 Image Reversal horizontal...152 Image Reversal vertical...153 Image Rotation counter-clockwise...153 Image Rotation clockwise...153 Quick Rotation...153 Return to Home Position...154

6.11 6.11.1 6.11.2

Saving Images...154 Manual...154 Automatic...154

6.12 6.12.1 6.12.2

Other Storage Media...154 USB Stick...154 CD/DVD Burner...155

6.13 6.13.1 6.13.2

Documentation...155 Video Printer (Option)...155 i-Print...155

7

8

More Acoustic Alarms...149

Radiography... 157 7.1

Radiography Control Panel...157

7.2 7.2.1

Overview...158 Acoustic Alarm (Alarm-4)...158

7.3

Exposure Time Adjustment and Display...159 GE OEC Fluorostar

5477468_2

Table of Contents 7.4

kV Adjustment... 159

7.5

Film Cassette Holder (option)... 160

8

Digital Image Processing, Storage and Documentation... 161 8.1

Post-Processing Control Panel... 161

8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6 8.2.7 8.2.8 8.2.9

Digital Image Processing... 162 Image Annotation... 162 Autowindow... 163 Averaging... 163 Digital Zoom / Magnification... 164 Edge Enhancement... 165 Editing Brightness and Contrast... 166 Image Negate... 166 Horizontal and Vertical Image Reversal... 166 Image Swap... 168

8.3 8.3.1

Image Save... 169 Other Storage Media... 169

8.4

Recalling Saved Images... 171

8.5

Delete Current Image... 172

8.6 8.6.1 8.6.2 8.6.3 8.6.4

Documentation... 172 Video Printer (Option)... 172 i-Print... 172 Thumbnail display... 173 Printing Directly from Printer... 173

9

Patient Management... 175 9.1

New Patient... 175

9.2

New Examination... 177

9.3

Loading Patient Data... 178

9.4

Changing Patient Data... 181

9.5

Deleting Patient Data... 182

5477468_2

GE OEC Fluorostar

9

Table of Contents

10

9.6 9.6.1 9.6.2 9.6.3

Physician Management...184 Delete Physician...184 Add New Physician...185 Change Physician...186

9.7

Save Data...186

9.8

Data Backup...187

9.9

Check Disk Space...187

10

Setup Menu... 189

10.1

Overview...189

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5 10.2.6

User Setup 1...191 Change Language...191 Assigning a Password...193 System Configuration 1...195 Preview Setup...197 Lamps/Sound/Tests...198 System Configuration 2...201

10.3 10.3.1 10.3.2 10.3.3 10.3.4

User Setup 2...203 HDD Statistics...204 Software Version...205 Save Log File...206 Slideshow...207

10.4 10.4.1 10.4.2 10.4.3 10.4.4 10.4.5 10.4.6 10.4.7 10.4.8 10.4.9 10.4.10

Service Menu (Technician Use only)...209 Set Date / Time...210 System Information...212 Delete all Patient Data...213 Delete all Physician Data...214 Cross Hair Setup...215 Lateral Setup...216 System Configuration...217 DICOM Setup...219 kV / mA Accuracy...221 License Management...222 GE OEC Fluorostar

5477468_2

Table of Contents

11

Labels and Symbols... 223

11.1 11.1.1 11.1.2 11.1.3 11.1.4

Overview... 223 System label... 225 MC System Label... 226 Generator label... 227 Other labels... 227

11.2

Locations of Labels and Symbols... 231

12

Technical Reference... 233

12.1

Technical Specifications... 233

12.2

System Classification... 233

12.3

Electromagnetic Compatibility... 234

12.4

Installation... 234

12.5

Installation Environment... 234

12.6

Network fuses... 234

12.7

Electrical Grounding... 235

12.8

Input Power... 235

12.9

Main Fuses... 235

12.10 12.10.1

Electrical Ratings... 235 Maximum energy input... 236

12.11

Imaging Performance... 236

12.12 12.12.1 12.12.2 12.12.3 12.12.4 12.12.5 12.12.6

Fluoroscopy Operating Mode... 237 Anode Current During Fluoroscopy... 238 Standard Fluoroscopy... 239 High Performance Fluoroscopy Pulse Mode... 240 Snapshot... 240 Hip Fluoroscopy... 241 Thorax Fluoroscopy (Live Image without Integration)... 242 Hand Surgery Fluoroscopy... 242 Fluoroscopy with Reduced Dose... 243

12.12.7 12.12.8 5477468_2

GE OEC Fluorostar

11

Table of Contents 12.13

Radiography...244

12.14

Accuracy...245

12.15 12.15.1

X-Ray Generator Information...245 Temperature Management of the Maxiplus 3000 Generator...246 Temperature Display...247

12.15.2

12

12.16

X-ray Tube Assembly...248

12.17 12.17.1 12.17.2 12.17.3

Tube Data...248 Heating and Cooling Curves DF-151R...248 Focal Spot: 0.5 DF-151R...249 Focal Spot: 1.5 DF-151R...249

12.18

Filtration in the Beam...250

12.19 12.19.1

DAC-8 Collimation System...251 Geometry of the X-Ray Beam...252

12.20

LCD Flat Panel Display Monitor...253

12.21 12.21.1 12.21.2 12.21.3 12.21.4 12.21.5 12.21.6 12.21.7

Connections...254 Directive for the User...254 Network connection...254 Video Output...254 USB...255 External Radiation Lamp...255 COM1 connector...255 Field Service Connections, Not for the User...256

12.22 12.22.1

Hand Switch Connectors...257 Foot Switch Connectors...258

12.23

Options and Upgrades...258

12.24 12.24.1

Accessories...259 Thermal Printer...259

12.25 12.25.1

Dimensions...260 Side View and C-Arm Dimensions GE OEC Fluorostar COMPACT and COMPACT2...261

GE OEC Fluorostar

5477468_2

Table of Contents 12.25.2 12.25.3 12.25.4 12.25.5 12.25.6

Front View and C-Arm Dimensions GE OEC Fluorostar COMPACT2 with Flat Monitor... 262 Front View and C-Arm Dimensions GE OEC Fluorostar COMPACT with Flat Monitor... 263 Side View and C-Arm Dimensions GE OEC Fluorostar SERIES... 264 Front View and C-Arm Dimensions GE OEC Fluorostar SERIES... 265 Dimensions Monitor Cart GE OEC Fluorostar MC... 266

12.26

Environmental and Transport Requirements... 267

12.27

System Storage... 268

12.28

Preparation for Long Term Storage or Shipment... 269

12.29

System Movement... 269

12.30 12.30.1

Maintenance... 269 Overview... 269

12.31 12.31.1

Periodic Maintenance... 270 Annual Maintenance... 270

13

Cine Mode and Vascular Imaging (option) 273

13.1

Toggle function of the double foot switch... 274

13.2

Activating the Cine Mode... 274

13.3 13.3.1 13.3.2

Vascular Imaging... 276 Subtraction Imaging... 276 Roadmapping Imaging... 278

13.4

Post-Processing... 280

14

DICOM (optional)... 283

14.1

Start DICOM... 283

14.2 14.2.1 14.2.2 14.2.3

Print... 284 DICOM Control Panel 2... 286 Compiling the Output... 291 Removing Selected Images... 292

5477468_2

GE OEC Fluorostar

13

Table of Contents 14.2.4

Print or Store Selected Images...292

14.3 14.3.1

Store...293 Data Flow Display...294

14.4

Dose Report...294

14.5

Media Export...297

14.6

Worklist View...301

14.7

Worklist Import...303

14.8

New Examination for a DICOM Patient...305

14.9

Close Examination for a DICOM Patient...308

14.10

DICOM Job List...311

14.11

Viewing DICOM CDs/DVDs...312

15

Options... 315

15.1 15.1.1 15.1.2 15.1.3 15.1.4

Laser Aiming Device Mounted on the Generator...315 Overview...315 Switching On...316 Safety Precautions...318 Reporting...318

15.2 15.2.1 15.2.2 15.2.3 15.2.4

Laser Aiming Device in Image Intensifier...319 Overview...319 Switching On...320 Safety Precautions...323 Reporting...323

15.3

Pediatric Option...324

15.4

Motorized Lateral Movement with Freewheel Coupling and Interface...326 Overview...326 Hand Controlled Motorized Lateral Movement...327 Hand Controlled...328

15.4.1 15.4.2 15.4.3

Index... 331 14

GE OEC Fluorostar

5477468_2

Revision History Manual Revision

Revision Date

Software Revision

Change Description

5477468_2

May 2015

03.00.XX

Corrected typos

5477468_1

June 2013

03.00.01

Initial release

5477468_2

GE OEC Fluorostar

15

Introduction and Safety

1

Introduction and Safety 1.1

Intended Use The GE OEC Fluorostar mobile radiology system is intended for use on human beings. Regulations on its use cover the areas of fluoroscopy and radiography in diagnostic and surgical applications. The range of applications includes urology, endoscopy, orthopedics, angiography, cardiological, vascular and neurological applications and applications in intensive care and A&E. It is suitable for daily use in a clinical environment by various users.

1.2

Intended Operator Two user groups have been identifed as typical clinical users for the GE OEC Fluorostar system: Primary users - Operators and Practitioners The Operator group are those people responsible for operating the system functionality. Example operator tasks include: • System positioning • Selecting imaging modes and parameters • Entering and managing patient information • System setup • System cleanup Practitioners make use of the images displayed on the system to make clinical decisions. Example practitioner tasks include: • Planning procedures • Directing the Operator in placement of the C-arm • Viewing and interpreting the images

16

GE OEC Fluorostar

5477468_2

Introduction and Safety • Determining which images to archive • Determining when to terminate C-arm usage Depending on local laws and regulations, Practitioners may also be Operators. Primary users may be: • Radiologic Technologists • Nurses • Other Operating Room Support Staff • Practitioner Group • Medical Doctors • Other Clinicians Secondary users Secondary users provide support for the primary users in the intended use of the system, but are not directly responsible for either system operation or interpreting images generated by the system. Example secondary user tasks include: • System cleanup as part of room preparations • Helping the physician select sizes and placement of implants • Helping set up the system up for networking purposes • Checking the system for compliance with local regulations

1.3

Equipment Training Application specialists from GE Healthcare carry out training for users after the installation of the GE OEC Fluorostar.

5477468_2

GE OEC Fluorostar

17

Introduction and Safety

1.3.1

Training Frequency Recommendation The facility’s management should assess the initial and continuous training needs of qualified users, radiologists or other physicians responsible for the interpretation and / or acquisition parameters. The facility should identify the individuals that should take part in the training relative to dose reduction features, and dose related acquisition parameters. For safe and effective use of the system, GE Healthcare recommends that each user of the equipment reviews the procedures and safety precautions at least on annual basis and specially for dose management, GE Healthcare recommends a semestrial training. Contact a GE Healthcare representative for refresher training options as part of the Radiological Technologists continued education requirements for a licensure maintenance. It is highly recommend that physicians be provided adequate time to participate in training and image quality feedback.

1.4

Scope This manual contains information about system operation, components, control keys, switches and hazards of the GE OEC Fluorostar Digital Mobile C-Arm. It also contains Technical Reference information. This manual may not be reproduced in whole or in part without the written permission of GE OEC Medical Systems, Inc.

Caution

18

Federal law restricts this device to sale by, or on the order of, a physician.

GE OEC Fluorostar

5477468_2

Introduction and Safety

1.5

An Overview This manual contains operating instructions for radiological technicians, radiologists and other medical personnel who are trained to operate radiation equipment. These instructions are not suitable as a replacement for radiological or medical training. In conjunction with reading these instructions, the user should be qualified to operate such equipment. This radiology system was designed to be used by trained personnel in the fields of diagnostics, operative and postoperative applications.

1.5.1

Construction and Function The GE OEC Fluorostar system is constructed on a mobile support base. The housing of the mobile support base contains the power supply, the control electronics and the image processing system. It is operated by two consoles on the left and right sides. A horizontal arm holds the swivel mounted C-Arm, on the end of which the X-ray generator is attached, and opposite it, the image intensifier and camera. X-rays are triggered by means of a hand or foot switch. The X-ray beam passes through the patient, who is positioned between the X-ray generator and the image intensifier. The varying attenuation of the X-ray beam as it passes through the patient generates a visible image in the image intensifier and camera. This image is delivered to the image processing system, where it is displayed on the LCD flat screen with fluoroscopy parameters and patient data.

5477468_2

GE OEC Fluorostar

19

Introduction and Safety

1.6

Safety Requirements and System Functions These instructions provide guidelines to operate and use the system safely. The user should be trained in the use of equipment of this type, and should use this manual in combination with the corresponding training. It is the responsibility of the owner to ensure that the device or system is operated only by properly trained, qualified personnel who have obtained credentials from the appropriate authorities. The owner is responsible for verifying continued compliance with all applicable regulations and standards. Consult local, state, federal and/or international agencies regarding specific requirements and regulations applicable to the use of this type of medical electronic equipment. Potential hazards may occur when using electronic medical equipment and X-ray systems. All users must understand the safety and emergency instructions, as well as the operating instructions provided in this manual. Users must know how dangerous situations can be avoided. They must also know how they can protect themselves and other people from any possible harm. GE OEC Medical Systems confirms that each system is manufactured in accordance with the appropriate legal regulations. After-sale operating practices and safety are the responsibility of the owner/operator. GE OEC Medical Systems, Inc. assumes no responsibility or liability for after-sale operating and safety practices; nor can it be responsible for personal injury or damage resulting from misuse of its systems.

20

GE OEC Fluorostar

5477468_2