Operator Manual IGS 520 530 540

InnovaTM IGS 520, InnovaTM IGS 530,
InnovaTM IGS 540

Operator Manual
WARNING: BEFORE USING THIS SYSTEM

THIS SYSTEM SHOULD BE USED ONLY BY EMPLOYEES ADEQUATELY TRAINED IN THE USE OF THIS EQUIPMENT. BEFORE USING
THIS SYSTEM, THE OPERATOR SHOULD BE THOROUGHLY ACQUAINTED WITH THE INSTRUCTIONS FOR USE AND SAFETY
RECOMMENDATIONS PROVIDED IN THIS MANUAL.
FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE AND SAFETY RECOMMENDATIONS PROVIDED IN THIS MANUAL CAN CAUSE
SERIOUS INJURY TO THE PATIENT, TO THE OPERATOR OR TO OTHER PERSONS.
5499294-1-1EN
Revision 2
InnovaTM IGS 520, InnovaTM IGS 530, InnovaTM IGS 540
Direction 5499294-1-1EN , Revision 2

!

2
Table of contents
Chapter 1 - Foreword 31
1 Using This Module 31

2 Printing this Module 31
3 Electronic Operator Manual 32
4 Quebec 33
Chapter 2 - Introduction 35
Chapter 3 - Safety and Regulatory 36
1 Regulatory Requirements 36
1-1 Electromagnetic Compatibility (EMC) 36
1-1-1 Electromagnetic Compatibility of the vascular system 36
1-1-2 Detailed Electromagnetic Compatibility of the vascular system 36
1-1-3 Electromagnetic Compatibility of the vascular system with Fluoro UPS (Innova option) 37
1-1-4 Detailed IEC60601–1–2 Electromagnetic Standard Compliance conditions 37
1-1-4-1 Electromagnetic Emission 38
1-1-4-2 Electromagnetic Immunity IEC 60601-1-2 39
1-1-4-3 Recommended Separation Distances for Portable and Mobile RF Communications 41
Equipment IEC 60601-1-2
1-1-4-4 Limitations Management 41
1-1-4-5 Use Limitation 42
1-1-4-6 Installations Requirements and Environment Control 42
1-2 Additional Regulatory Requirements 43
1-3 Specific Requirements for product with Open Monitor suspension (Option) 44
1-4 Recycling 44
1-5 Control of Pollution caused by Electronic Information Products (EIP's) 45
1-5-1 Explanation of Pollution Control Label 45
1-5-2 Name and Concentration of Hazardous Substances 45
1-6 Vermont labeling regulations (US) on Mercury 46
1-7 Patient Confidentiality 47
2 General Safety 47
2-1 Equipment Application Specification 48
3
2-1-1 Patient Population 48

2-1-2 Intended Operator 48
2-1-3 Application Environment 49
2-1-4 Operator Position 50
2-1-5 Contrast Agents 50
2-2 Be Sure the Equipment is Functioning Before each Use 50
2-2-1 Emergency power off 51
2-2-2 Collision Sensors and the routine for clearing collisions. 51
2-2-3 Large Display Monitor suspension. 51
2-2-4 Innova Central touch screen. 51
2-3 Always Be Alert to Patient Safety Concerns 51
2-4 Radiation Safety 51
2-5 Establish Emergency Procedures 52
2-6 Equipment Installed in Patient Vicinity 52
2-7 Accessories 54
2-8 Periodic maintenance and inspection 56
2-9 Storage media 57
2-10 Extra Iodine Injection 57
2-11 Image Presentation 57
3 Protection against radiation 57
3-1 Biological Deterministic Effects of Dose 57
3-2 Dose Monitoring 57
3-3 Concept of Interventional Reference Point (Patient Entrance Reference Point) 58
3-4 Significant Zone of Occupancy 58
3-5 Skin Spacer Use 59
3-6 How to Reduce Radiation Exposure Dose 59
3-6-1 Radiation Time 59
3-6-2 Protection 59
3-6-3 Other Methods to decrease Exposure Dose 60
3-7 Avoid Unnecessary Exposure to Radiation 60
3-7-1 X-ray Without Image 60
3-8 Protective devices and Accessories 61
3-9 Retake - Improper Use 61
4
3-10 Dose and Dose Rate Measuring Procedure 61

3-10-1 Test Equipment 61
3-10-1-1 Phantom 61
3-10-1-2 Dosimeter 61
3-10-2 Measurement Procedure 61
3-10-2-1 Relevant parameters 61
3-10-2-2 Positioning of phantom and measuring chamber 62
3-10-2-3 Checking the test conditions 62
3-10-2-4 Basic measurements 62
3-10-2-5 Operator selectable parameters 62
3-10-3 Compliance Criteria 62
4 Protection against electrical hazards 63
4-1 Covers 63
4-2 Cabinet Air Flow 63
4-3 Uninterruptible Power Supply UPS 63
4-4 Laser 63
5 Protection against mechanical hazards 63
5-1 Patient Positioning on Tabletop 63
5-2 Use Extreme Care when Positioning the Equipment 64
5-3 Movement of Patient on the Table 65
5-4 System Collision 65
5-5 Split or Punctured Table 65
5-6 Driving the Table 65
5-7 Cardiac Pulmonary Resuscitation (CPR) 66
IQ
5-7-1 CPR with Innova Table 66
5-7-2 CPR with Omega Table 67
5-8 Patient Loading/Unloading 67
5-9 Clearance of the Patient in case of Emergency (Power Loss, Equipment Failures) 69
5-10 Check Equipment after collision 69
5-11 Table Brakes failure 69
5-12 3rd Party Imaging/Data Medical Device 70
6 Protection against contamination / infection / allergy / toxicity hazards / 70
biological hazards
5
6-1 General Information 70

6-2 Equipment Cleaning Instructions 70
6-3 Suspensions Cleaning 71
6-4 Disinfection 71
6-5 High Level Disinfection 71
6-6 Recommended Cleaning Agents 72
6-7 Recommended Disinfecting Agents 72
6-8 Guidance for the Use of the Cleaning and Disinfecting Agents Listed 72
6-9 Flammable Gasses 72
6-10 Latex 72
7 Protection against effect of incorrect output data sent to network (Dicom) 72
7-1 Stenosis Analysis on networked devices 72
Chapter 4 - Safety and Regulatory Instructions for Use 73
1 Indications for Use 73

2 Safety 73
2-1 Environmental Conditions 73
2-2 Equipment Classifications 73
3 Electrical Hazards 76
3-1 Power-off the System 76
3-2 Emergency Power OFF/STOP Procedure 76
3-3 Emergency STOP Recovery 77
4 Protection regarding Ionizing Radiations Hazards for Innova IGS 520 78
4-1 Mode of Operation 79
4-1-1 Innova Digital 79
4-1-2 Reference Display 80
4-1-3 Live Display 80
4-1-4 Table Side Status Control (TSSC) 81
4-1-5 Innova Central touch screen 81
4-2 Dose to Patient 83
4-2-1 Skin Dose Levels 84
4-2-2 Available Settings 84
4-2-3 Radiation Data 85
6
4-2-4 IQ Standard 86
4-2-5 Receptor Dose Limited Standard 92
4-2-6 Receptor Dose Limited Standard: Countries limited to 5 R/min in Fluoroscopy 98
4-2-7 IQ Plus 99
4-2-8 Receptor Dose Limited Plus 104
4-3 Dose to Patient in Japan 109
4-3-1 Fluoroscopy/Roadmap/Blended Roadmap/Subtracted Fluoroscopy Air Kerma Levels 110
4-4 Dose to Patient in Australia/WA and Australia/ACT 110
4-5 Dose to patient in Canada/Ontario 110
4-6 Dose to Operator (Isodoses) 110
4-6-1 Gantry in Vertical position - Dose at 1 meter from ground 110
4-6-2 Gantry in Vertical position - Dose at 1.5 meter from ground 111
4-6-3 Gantry in Lateral position - Dose at 1 meter from ground 112
4-6-4 Gantry in Lateral position - Dose at 1.5 meter from ground 113
4-7 Technical Factors Range for Innova IGS 520 114
4-8 Contribution of Filtration with 20 cm Detector 114
4-8-1 Contribution of Filtration along the Beam 114
4-8-2 Total filtration 115
4-9 Disable X-ray Whenever X-ray Are Not Necessary 115
4-10 Dosimetric Calibration 115
4-11 Application Mode and Service Mode are not exclusive 115
4-12 Leakage Radiation 116
4-13 Spectral Filtration 116
4-14 Dose Management 116
7

5-2-7 IQ Plus 140
8

6-2-7 IQ Plus 179
7 Protection regarding Functional Hazards 196
7-1 3rd Party Software 196
7-2 Loss of Imaging 196
7-3 Loss of Power 196
9
7-4 System Recovery after a power Cut 197

7-5 Emergency Procedure for Image Recovery or System Lock Up with 19" monitors 197
7-6 Emergency Procedure for Image Recovery or System Lock Up with Large Display 198
monitor
7-7 Latency (Image Display Delay), Polymerization Time and Acquisition mode use 200
7-8 Control of transfer of data to an archiving system 201
7-9 SID Failure - Degraded mode 201
7-10 Prevent Unnecessary Interruption of a Procedure Arising from a Collision 202
7-11 Automatic Exposure Control 202
7-12 Lead Shield Positioning 202
7-13 Risk of confusion between live Fluoro images and automatic replay of stored Fluoro 202
images
7-14 InnovaIQ Table 203
7-15 Degraded Fluoro image quality 203
7-16 Comfort accessories 203
7-17 Open Suspension Positioning 203
8 Protection regarding Mechanical Hazards 203
8-1 Table Motion User Interfaces 204
IQ
8-2 Innova Table 206
8-2-1 Table Side User Interface Positioning 206
8-2-2 Tableside Cart (Option) 207
8-2-3 Mattress 207
8-3 Precaution regarding Detector Anti-Collision Device 209
9 Protection against Contamination / Infection Hazards / Biological Hazards 209
9-1 Attachment of Protective (Sterile) Drapes 209
9-1-1 Equipment (image receptor, X-ray tube-collimator assembly, Smart Handle, Smart Box, 209
Table Side Status Control, Innova Central touch screen)
9-1-2 Large Display Monitor handle 211
9-1-3 Accessories 212
10 Symbols 213
10-1 Audio/Visual Indications 214
10-2 Special Notices 216
10-3 X-ray Tube 217
10-4 Power ON and OFF 218
10
10-5 Type B applied part 218

10-6 Electrical Class 219
10-7 Electrical Current 219
10-8 Ground 219
10-9 Collimator 220
10-10 Cardiac Pulmonary Resuscitation (CPR) 220
10-11 Maximum Patient Weight 221
10-12 Maximum permissible table load 221
10-13 Table end rail maximum load 221
10-14 Footswitch and Table Panning Device (TPD) 221
10-15 Smart Handle/Smart Box/Table Side Status Control 222
10-16 Innova Console 222
10-17 Application 222
10-18 Grid Out 224
10-19 Acquisition 224
10-20 InnovaIQ Table 224
10-21 Status Icons 225
10-22 Remote Stand (Option) 226
10-23 Tableside Cart (Option) 227
10-24 Head Extender 228
10-25 Patient Browser Network Status Icons 229
10-26 Electronic Operator Manual 229
10-27 Surgical and Patient Comfort Accessories 230
10-28 Bolus Handle 230
10-29 X-ray LED 230
10-30 Filtration 231
10-31 Product identification 231
Chapter 5 - Radiation Safety 232
1 How X-ray Radiation is created and the "Dose" concept 232

2 Doses parameters 232
2-1 Incident dose 232
2-2 Surface dose 233
11
2-3 Exit dose 233

2-4 Image receptor dose 234
2-5 Dose rate at image receptor 234
2-6 Dose-area product 234
2-7 Body dose and effective dose 235
2-8 Maximum Symmetrical Radation Field 236
3 Effect of Ionizing Radiation on Humans 236
3-1 Concept of Intervention Reference Point 236
4 General Dose Reduction Measures for The Patient 237
4-1 Distance between the X-ray tube and the patient 237
4-1-1 Inverse square law 237
4-2 Distance between the patient and the detector 237
4-3 Collimation 237
4-4 Compression 237
4-5 Anti scatter grid 238
4-6 Record and Fluoro mode selections 239
4-7 Frame rates 239
4-8 Field of View 239
4-9 Radiation filtration / hardening 239
5 General Dose Reduction Measures for the Staff 239
5-1 Protection from X-ray Radiation 239
5-1-1 Distance 239
5-1-2 Shielding 240
5-2 General Precautions 240
6 Dose Reduction Measures on the Innova System 241
7 Smart Fluoro 241
7-1 Benefits of LIH 241
7-3 Tabletop 241
8 Special Case 242
8-1 Pediatrics 242
9 Legal Provisions 242
10 Dose Reduction: 7 easy steps to remember 242
12
Chapter 6 - Revolution Digital Detector 244
1 Imaging Chain 244

2 Digital Image Quality 245
3 Detective Quantum Efficiency 246
4 The Impact of Noise 246
5 The Role of Contrast 246
6 The Role of Spatial Resolution 247
6-1 Definition and settings 247
6-2 Detector spatial resolution vs. Modulation Transfer Function (MTF) 248
6-3 Detector spatial resolution performances 248
6-4 System spatial resolution performances 249
7 Radiation Dose 249
Chapter 7 - Innova System 250
1 General Description 250

2 System Components 250
2-1 Basic Components 250
2-2 Option 251
2-3 Option Connection 253
3 Innova Console 255
4 General Specifications 255
4-1 Generator 255
4-2 Gantry 256
4-3 Table 257
4-3-1 Omega Tables 257
IQ
4-3-2 Innova Table 258
4-4 Innova Digital 258
4-5 Innova Imaging 259
4-5-1 Innova IGS 520 259
4-5-2 Innova IGS 530 259
4-5-3 Innova IGS 540 259
5 How to Perform System Power-Up 259
6 How to Perform System Power-Down 262
13
7 Vascular Control Interface Module 262

Chapter 8 - Innova Digital 264
1 Guidelines for the best usage of the system 264

2 Innova Digital Screen 264
2-1 Monitoring Bar 265
2-1-1 ECG Status 265
2-1-2 Disk Space Status 266
2-1-3 Heat Units Status 266
2-1-4 X-ray Timer 267
2-1-5 Fluoro / Record Ready 268
2-1-6 X-ray Disable Button 268
2-2 Utilities Key 268
2-3 Exam / Utilities Charring 269
3 How to prepare for a New Patient Acquisition 270
4 How to modify Patient Information 273
5 How to select an Acquisition Protocol 274
5-1 List of Categories 275
5-2 List of Protocols 275
5-2-1 Dose limited protocols 278
6 Fluoroscopy and Acquisition 278
6-1 Fluoro UPS (Option) 280
7 No Sub Fluoroscopy Acquisition 281
7-1 Field of View (FOV) 282
7-2 Fluoro Detail 283
7-3 Fluoro Frame Rate 284
7-4 Fluorostore (Option) 284
7-5 X-ray Timer 286
7-6 Cumulated Time 286
7-7 Image Rotation 287
7-8 Patient Orientation 288
7-9 Image Flip 296
8 How to perform a Roadmap Fluoroscopy Acquisition 298
14
9 How to perform a Blended Roadmap Fluoroscopy Acquisition (Option) 300

9-1 Create the Vessel Image 300
9-2 Enter / Exit Blended Roadmap 300
9-3 Reposition Gantry/Table 303
9-3-1 Systems equipped with an Omega table 303
9-3-2 Systems equipped with an InnovaIQ table 304
9-4 Mask Acquisition and Registration 305
9-5 Blended Roadmap Acquisition 306
9-6 Landscape and Vessels Adjustment 306
9-7 FOV Management in Blended Roadmap 306
10 How to perform a Subtracted Fluoroscopy Acquisition 308
11 Simultaneous Fluoro Sub / NoSub Display (Option) 310
12 How to select an Acquisition Mode 311
13 How to perform a Record Acquisition 311
13-1 DSA Mode (Option depending on system configuration) 312
13-2 Dynamic Mode (Option depending on system configuration) 316
TM
13-3 InnovaChase Mode (Option) 318
TM
13-4 InnovaBreeze Mode (Option) 319
13-4-1 Application Description 319
13-4-2 Before You Start 319
13-4-2-1 On the Positioner 319
13-4-2-2 Patient Positioning 320
13-4-2-3 Anticollision Precaution 320
13-4-2-4 On the Innova Console 320
13-4-2-5 On the Control Panel 320
13-4-3 Making an Acquisition in Bolus Mode 321
13-4-3-1 On the Innova Console 321
13-4-3-2 In the Examination Room 321
13-4-3-3 At the Console 321
13-5 Innova 3D, Innova Subtracted 3D and Innova CT Modes (Options) 323
13-5-1 Application Description 323
13-5-2 3D Spin Acquisition 324
13-5-2-1 3D Spin Images Acquisition 324
15
13-5-2-2 Patient Positioning 324

13-5-2-3 On the Innova Digital Screen 325
13-5-2-4 Making an acquisition in 3D Spin 326
13-5-3 Image Network 327
13-5-4 3D Image Reconstruction 327
13-5-5 3D Model Display 328
13-5-6 3D Image Archiving 328
13-5-7 3D Quick Guide 328
13-5-7-1 3D Acquisition 328
13-5-7-2 3D reconstruction 329
13-5-7-3 3D display 330
13-5-7-4 Subtracted 3D Reconstruction and Display 333
14 How to review a Sequence/Photo 334
14-1 Sequence/Photo Viewer 334
15 How to End an Exam 337
16 How to Abort an Exam 337
17 Stenosis Analysis (Option) 337
17-1 Analysis Limitations 338
17-2 Stenosis Analysis at a Glance 338
17-3 Performing Stenosis Analysis 339
17-4 Reference Description for Stenosis Analysis Toolbar 340
17-5 Calibrating on a Catheter Diameter 341
17-6 How to achieve an accurate catheter calibration 342
17-7 Stenosis Quantification (available for Dynamic, subtracted DSA, Bolus and 344
subtracted 3D Modes only)
17-7-1 In case of Auto-calibration 345
17-7-2 In case of Catheter Calibration 346
17-8 Stenosis Quantification Results (available for Dynamic, subtracted DSA, Bolus and 346
17-9 Measure Distance 348
17-10 Multi Segments 349
17-11 Innova OneTouch QA (option available on the optional Innova Central touch screen) 349
18 Ventricular Analysis (Option) 356
16
18-1 Ventricular Analysis at a glance 357

18-2 Performing Ventricular Analysis 357
18-3 Reference description for Ventricular Analysis Tool Menu 358
18-4 Draw Diastolic Contour 359
18-5 Draw Systolic Contour 360
18-6 Global Ejection Fraction Analysis 361
18-7 Wall Motion Analysis 366
18-8 Multi Segments 370
19 StentViz (Option) 371
19-1 Automatic StentViz Workflow 372
19-2 Manual StentViz Workflow 375
19-3 StentViz Best Practice 377
19-4 StentViz User Messages 377
20 StentVesselViz (Option) 378
20-1 Output Description 378
20-1-1 StentViz Images 378
20-1-2 StentVesselViz Sequence 379
20-2 Automatic StentVesselViz Workflow 379
20-3 Manual StentVesselViz Workflow 382
20-4 StentVesselViz Best Practice 385
20-5 StentVesselViz User Messages 386
21 Dose Map 386
21-1 Dose Map integrated workflow 386
21-2 How to set Dose Map? 388
21-2-1 Dose Map preferences 388
21-2-2 Dose Map dedicated entries in Patient info tabs 390
21-3 Dose Map limitations and recommendations 391
21-4 Information provided by Dose Map 392
21-4-1 Dose Map representation - On Reference Display 392
21-4-2 Dose Map representation - Store on photo 395
21-4-3 Dose Map user messages 397
21-5 Dose Map accuracy 397
22 Remote Control 398
17
22-1 Collage / In-room Browser (Option) 399

23 DL Keypad 401
23-1 Edge Enhancement Filter Selection 402
24 Dose Information Record 403
25 How to Check or Reset the ECG signal (Option) 403
25-1 ECG icon indication on the DL by color and on the live display 404
25-2 ECG icon indication on the live display 406
25-2-1 Status "Online" 406
25-2-2 Status "Stabilizing" 407
25-2-3 Status "No Trigger" 407
25-2-4 Status "Offline" 408
26 How to Check the Disk Space 409
27 How to Check the Heat Unit Informations 409
28 How to Delete 410
28-1 How to delete a Patient 410
28-2 How to delete an Exam 412
28-3 How to delete a Sequence 412
28-4 How to delete a Photo 413
29 How to Network Images to a Workstation, Archive Stations 413
29-1 Auto Archive 413
29-2 How to configure and select a Host 414
29-3 How to Network Patient 418
29-4 How to Network Exam 419
29-5 How to Network Sequence / Photos 419
29-6 How to check the status of Network Image operations 420
29-7 Network Queue Management 423
29-7-1 SENDING/ARCHIVING Queues 423
29-7-2 SENDING/ARCHIVING Queues Functions 424
30 How to use Worklist 424
30-1 How to configure and select a Worklist host 425
30-2 Retrieving the worklist 427
30-3 Worklist settings configuration 428
30-4 Creating Innova patients from worklist 429
18
31 Modality Performed Procedure Step (MPPS) 432

31-1 How to configure and select a MPPS host 432
31-2 How to send MPPS 434
31-3 How to check status of MPPS transfers 434
31-4 How to integrate MPPS with Mac-Lab/CardioLab and Carddas system 435
31-4-1 Known limitations with Mac-Lab/CardioLab system 436
32 How to Network DICOM Dose Structured Report (Dose SR) to Dose SR 436
Receiving stations
32-1 How to configure and select a Dose SR host 436
32-2 How to Network DICOM Dose Structured Reports 439
32-3 How to check the status of Dose SR transfers 439
32-4 How to integrate Dose SR with AW system 440
32-4-1 Known limitations with AW Reporting Tool display 441
33 Innova Screens Image Display 441
33-1 Geometry Display 442
IQ
33-1-1 Innova Table 442
33-1-2 Omega Table 443
33-2 Status and Image Review 443
33-3 Technique factors display accuracy 446
33-4 Dose Estimation 446
33-5 Monitor Pattern 448
33-5-1 Monitor Contrast Adjustment Check 449
33-6 Stopwatch 449
33-7 Electronic Shutter 450
Chapter 9 - InnovaSpinTM (Option) 453
1 Application Description 453

2 Safety Recommendations 453
3 Acquisition Procedure and Timing 453
4 Trajectories Settings 454
5 User Messages 454
Chapter 10 - Innova Positioner 456
1 How to move the Table/Gantry 456
19
1-1 Omega Smart Box 456

1-2 InnovaIQ Table Smart Box 458
1-3 Table Panning Assist Joystick (item 1) 460
1-4 Table Control Up/Down and Tilt (item 3) 461
1-5 Emergency Stop (item 11) 461
1-6 Omega Smart Handle (Not available with InnovaIQ Table) 462
1-7 Manual L-Arm Positioning 464
1-8 Additional Table Panning Handle 465
1-9 Omega Table Side Status Control (TSSC) 466
IQ
1-10 Innova Table Side Status Control (TSSC) 468
1-11 Table brakes button management 470
1-12 Tableside Cart (Option) 470
1-12-1 General Description 470
1-12-2 Environmental working conditions 471
1-12-3 How to move the Tableside Cart 471
1-12-4 Table Side User Interfaces on the Tableside Cart 472
1-12-5 Cable Routing 473
1-12-6 Safety mechanism 474
1-13 Error Management (available with Omega table only) 475
1-14 Remote Stand (Option) 475
1-15 InnovaIQ Cable Holder 476
1-15-1 How to Swap TSUIs 477
1-15-2 How to Add/Remove Cables - For Moving Specific TSUIs 477
1-15-3 How to Use with TableSide Cart 477
1-15-4 How to Remove and Install the Sheath 477
1-15-4-1 Detaching 478
1-15-4-2 Attaching 478
1-15-5 How to Place Cables In and Out of the Sheath 478
1-15-6 How to Release the Cable Loops 479
1-15-7 How to Loop the Extra Cable Length 479
1-16 Omega Cable Holder 479
1-16-1 How to swap TSUIs 480
1-16-2 How to Rotate the Table beyond 90 deg. when Cable Holder is in use 481
20
1-16-3 How to Use with TableSide Cart 482

1-16-4 How to Remove and Install the Sheath 482
1-16-4-1 Detaching the Sheath 482
1-16-4-2 Attaching the Sheath 483
1-16-5 How to Loop the Extra Cable Length 484
2 Collimator Control 484
2-1 Contour Filter Control 485
3 Omega Table Auto Positioning 486
3-1 Auto Positioning Control 486
3-2 Auto Positioner Selector 487
3-3 2D Send Angles 487
4 InnovaIQ Table Auto Positioning 489
4-1 Auto Positioning Control 489
4-2 Auto Positioner Selector 489
4-3 2D Send Angles (Gantry, Table, Gantry+Table) 490
5 Digital Detector Housing Controls 492
5-1 Up/Down Control 493
5-2 Emergency Back-Out 493
TM
5-3 InnovaTrace (on Innova IGS 520 and Innova IGS 530 only) 493
5-4 InnovaSense patient contouring (option on Innova IGS 520 and Innova IGS 530 494
only)
6 Collision Sensors 496
6-1 Level 1 497
6-2 Level 2 (Digital Detector only) 498
7 Skin Spacer 499
8 Innova Central touch screen (Option) 499
8-1 Innova Central touch screen Installation 500
8-2 Innova Central touch screen menus 500
8-3 Innova Central touch screen customization 511
8-3-1 Location of the customized pages (Favorites tab) 512
8-3-2 Creation and renaming of Favorites sub-tabs 512
8-3-3 How to populate Favorite sub-tabs 514
8-3-4 Button arrangement on a favorite sub-tab or between tabs 515
21
8-3-4-1 Move a button inside the current tab 516

8-3-4-2 Arrange buttons between tabs 517
8-3-4-3 Delete a button from the current tab 518
8-3-5 Advanced features to manage Favorites sub-tabs 519
8-3-5-1 How to change the tab order 520
8-3-5-2 How to delete the content of a favorite sub-tab 521
8-3-5-3 How to delete a Favorites sub-tab 522
8-4 Dose Reduction on Innova Central touch screen 522
8-5 Smart Nav 523
8-5-1 Functions and application accessible through Smart Nav 524
8-5-2 Navigation and function selection through Smart Nav 524
8-5-3 Smart Nav sub menu and functions descriptions 525
9 Table accessories 528
9-1 Shoulder Rests 528
9-2 Footrest 531
9-3 Table Head Extender 534
9-4 IV pole 535
Chapter 11 - Alarm Systems 536
1 Alarm management 536

2 Alarm Message Format 536
3 Alarm System Performances 536
4 Degraded Mode of the Alarm Management 537
5 List of Alarm Messages 537
Chapter 12 - Large Display Monitor Option 541

2 System Components 541
2-1 Basic Components 541
2-2 Option 541
3 Safety recommendations 541
4 Connection of external devices 541
5 How to control the Large Display Monitor 542
5-1 How to Manage Groups 542
22
5-1-1 How to Create a New Group 543

5-1-1-1 Group naming 543
5-1-1-2 Composing a group 544
5-1-2 How to Modify a selected Group 545
5-1-3 How to Modify the name of the selected group 546
5-1-4 How to Delete a selected Group 547
5-2 How to change the Large Display Monitor layout 548
5-3 How to Identify Innova monitors 548
5-4 How to Identify the presence/absence of signal 549
5-5 How to recognize availability of the Large Display Monitor 550
6 Second Large Display Monitor (Replica) (Option) 550
Chapter 13 - Monitor Suspension 552
1 LCD Monitor Suspensions 552

1-1 3, 4 or 6 LCD Monitors Suspension 552
1-2 Large Display Monitor Suspension 552
1-2-1 Standard use 552
1-2-2 Degraded Mode 552
1-3 Precautions 554
1-4 Operation 554
1-5 Periodic Maintenance 555
2 Open Monitor Suspension 555
Chapter 14 - Cathlab Frontiers Solutions (Option) 556
1 General Application Description 556

TM
2 Integrated Innova - s5i system option - applicable for s5i 556
2-1 s5i System components 556
2-2 Entering Patient Information on s5i 557
2-3 Running an IVUS Case with the Innova Central Touch Screen 557
2-4 Running an FFR Case with the Innova Central Touch Screen 557
2-5 Display of the s5i screen on the GE angiographic X-ray system monitor solution 557
2-6 Use of the s5i system in OR configuration 558
3 Integrated Vivid E9 solution (Option) 558
3-1 System Setup 559
23
3-2 Safety recommendations 560

3-3 Procedure specific layouts 560
Chapter 15 - OR Configuration (Option) 561

2 Interruption of Power Supply 562
3 Attachment of Protective (Sterile) Drapes 562
Chapter 16 - Surgical and Patient Comfort Accessories 570
1 Equipment Installed in Patient Vicinity 570

2 Accessory rail load consideration 570
3 Instructions for Use 570
3-1 Removable Table Rails 571
3-1-1 Installation 571
3-1-2 Removal 572
3-1-3 Equipment care 572
3-2 Other accessories 572
3-2-1 Armboard with thick pad (armrest) 572
3-2-2 Rail Extender 573
3-2-3 Adaptor rail 573
3-2-4 Head Widener 573
3-2-5 Table Width Extender 574
3-2-6 Round Post Clamp 574
3-2-7 Universal Clamp 574
3-2-8 Anesthesia Screen Holder 575
3-2-9 Patient Restraint Strap 575
3-2-10 Accessory Cart 575
Chapter 17 - Quality Assurance Program (QAP) 577
1 Introduction 577
1-1 What is QAP? 577
1-2 How to launch QAP? 577
1-3 Web Pages 577
1-4 Status 578
24
1-4-1 Other System Measurements 578

1-4-2 Recommendation #1 578
1-4-3 Recommendation #2 578
1-4-4 Use of metallic phantoms 578
2 Parameter monitoring 579
2-1 The parameters that are monitored are 579
2-2 Frequency 579
3 Quality criteria 579
4 Material 579
Chapter 18 - ILinq User Guide 581
1 Introduction 581
2 Starting ILinq 581
3 ILinq Features 582
3-1 Contact GE 582
3-2 Settings 582
3-3 Messages 582
3-4 TiP Virtual Assist 582
3-5 iLinq Help 583
3-6 About iLinq 583
3-7 Close 583
4 iLinq Notifications 583
4-1 Message Notification 584
4-2 Chat Notification 584
Chapter 19 - Workstation Configuration 585
1 Advantage Workstation (AW) Configuration (Option) 585

1-1 Introduction 585
1-1-1 Helpful Information 585
1-1-2 Compliance to Standards 585
1-2 Patient List Browser 585
1-2-1 Tools 585
1-2-2 Patient List preference 585
1-2-3 Network manager 586
25
1-2-4 Printer manager 586

1-2-5 AW administration 586
1-2-6 CD Composer 586
1-3 Viewer 588
1-3-1 Display Tools 589
1-3-2 Display 589
1-3-3 Modality 590
1-3-4 Mouse mode 591
1-3-5 Edit 592
1-3-6 Annotation 593
1-3-7 Measure 594
1-3-8 Preferences 595
1-3-9 Layout Manager 596
1-3-10 In-room Monitor Display 597
1-4 In-room 3D (Option) 597
1-4-1 Configuration 597
1-4-2 Main "In-room 3D" Control Panel 598
1-4-3 Operation 599
1-4-4 User Interface 599
1-4-5 In-room 3D Interface Launch at Table-Side 601
1-4-5-1 In-room 3D Main Panel 601
1-4-5-2 In-room 3D Mouse Joystick 603
1-4-5-3 In-room 3D Mouse Cursor Mode 604
1-4-5-4 In-room 3D Mouse Interface Description 604
1-4-5-5 In-room 3D Preferences 607
1-4-5-6 Volume Rendering Settings 607
1-4-5-7 In-room 3D Mouse Preferences Settings 608
2 CA 1000 Workstation Configuration (Option) 609
2-1 Stenosis Analysis and Auto Calibration 609
2-2 Ventricular Analysis and Auto Calibration 609
Chapter 20 - Diamentor M4 KDK (Option) 610
1 Introduction 610
26
1-1 General description of the Diamentor M4 KDK 610

1-2 Dose Measurement at Interventional Reference Point 611
2 Operating Controls and Indicators 611
2-1 Diamentor M4 KDK, front view 611
2-2 Diamentor M4 KDK, top view 612
3 Performing a Measurement 613
3-1 Constancy Check 613
3-2 Measurement 614
3-2-1 Note on warm-up time 614
3-2-2 Chamber-Patient Distance 615
4 System Configuration (Setup Menu) 616
4-1 Some Basic Facts 616
4-2 Factory Settings 617
4-3 Displaying the Setup Menu 618
4-4 Selecting the Language 618
4-5 Selecting the Display Format (Display Submenu) 618
4-6 Bar Graph Limits (Display Submenu) 620
4-7 Filter Depth (Display Submenu) 620
4-8 Time (Option) 621
4-9 Sensitivity (Display Submenu) 621
4-10 Display Test (Display Submenu) 621
4-11 Date & Time (Date & Time Menu) 621
4-12 Zero Adjustment (Corrections Menu) 622
4-13 Chamber Temperature, Air Pressure and Correction Factors (Corrections Menu) 622
4-14 Source-Chamber Distance 623
4-15 Printer Control (Printer Menu) 623
4-16 Entering the Label Headline 624
4-17 Dose Area Product Unit 624
4-18 RS232 Interface (SERIAL port 9) 624
4-19 Print Mode 624
5 Maintenance 625
6 Restrictions 625
27
Chapter 21 - Maintenance Schedule 626
Chapter 22 - Appendix - Technical Publications 633
1 System Line Voltage without Fluoro UPS 633

2 System Line Voltage with Fluoro UPS UL 633
3 System Line Voltage with Fluoro UPS CE 633
4 System Line Voltage - Options 634
5 System Line Current Specifications 634
6 Generator Rating and Duty Cycle 634
6-1 High Voltage Generator Classification for Japan 634
6-2 Generator rating in primary contacted mode 634
6-3 Generator rating in gridded mode 634
6-4 Generator duty-cycle 635
6-5 Minimum mAs 635
7 System: Maximum deviation of kVp and mA actual parameters from the 635
displayed parameters (during exposure)
8 System: Nominal Tube Current at Maximum kVp 635
9 System: Nominal Tube Voltage Range when mA is Maximum 635
10 System: Maximum Power 635
11 System: Maximum mA at nominal tube voltage 636
Chapter 23 - Appendix - Radiation Safety Tutorial 637
1 Warning 637
2 Learning objective 637
3 Teaching points 637
4 Radiation dose is a natural consequence of x-ray imaging 637
5 Displayed Dose Parameters 637
5-1 Cumulated Air Kerma 638
5-2 Cumulated Dose Area Product (DAP) 638
6 Effects of ionizing radiation on humans 639
6-1 Deterministic effects 639
6-2 Stochastic effects 640
7 Dose reduction measures for the patient 640
7-1 List 640
28
7-2 Appropriate protocols 640

7-3 Equipment distances and angulations 641
7-4 Sequence duration, Last Image Hold 641
7-5 Virtual collimation 642
7-6 FOV selection 642
7-7 AutoExposure preferences, Normal/Low setting 643
7-8 Frame Rate 644
7-9 Fluoro limit 644
7-10 Threshold 645
7-11 Dose Reduction (Innova Central touch screen) 646
8 Dose reduction measures for the staff 646
9 Pediatrics Case 647
9-1 Dose-related Parameters Default Values 647
9-2 List of Pediatric Protocols 648
10 Dose settings for pediatrics in Innova systems 649
11 Electrophysiology (EP) Exam Case 650
12 Legal Provisions 650
Chapter 24 - Appendix - Dose Map accuracy procedure 651
1 Overview 651
2 Procedure for Single Model 651
2-1 PA measurement 651
2-1-1 Set up geometrical measurements 651
2-1-2 Set up feature configuration 653
2-1-3 Run the measurements 653
2-1-4 Analyse the results 654
2-2 Lateral Measurement 655
2-2-4 Analyze the results 657
3 Procedure for Dual Model 658
3-1 PA measurement 658
29

3-2 Lateral Measurement 660
Chapter 25 - Glossary 664
1 Acronyms in use 664

Chapter 26 - Importer Offices of GE Healthcare 670
Chapter 27 - Revision History 671
30
Chapter 1 - Foreword
1 Using This Module
Throughout the text in this manual, certain type styles and symbols differentiate between one tool or graphic and
another. The conventions are as follows:
• Menu titles and window names appear in boldface: Application menu.
• Menu options appear in boldface: Done.
• Graphical mouse-selected or key-selected buttons (on-screen "soft keys") or field names (filled in by the user)
appear in boldface, within brackets: [View].
• Graphical touchkey buttons (Innova console on-screen buttons) appear in boldface, within braces: {TUBE
WARMUP}.
• On-screen prompts and messages appear in boldface typewriter font: Login:.
• User typed-in responses appear in regular typewriter font: root.
• Keyboard hardkeys, mouse buttons and Table Side User Interfaces (TSUI) hardkeys/buttons with text inside,
are within <> : <Enter>, <left>, <M>, <Fr>, <Low>, <Med>, <High>, <Pref>, <STOP>, <+>, <->.
• Icon with drawing/symbol inside (on-screen "soft keys") or TSUI buttons with drawing/symbol inside : the symbol
of the button appears in the text. Symbol examples: Stopwatch, Room Light, Rotation Brakes, Lat/Long Brakes.
Symbols may also be represented as the name of the symbol in boldface white on a gray background:
Stopwatch
• Functions for the TSUI joystick and panning handle are in boldface: Table Panning handle, Collimator joystick.
To continue this module, select item from menu list in panel on the left.
2 Printing this Module

Note: The print feature is not available from the DL. To print, you must first load the OM DVD on an external
PC. The print feature will run using the Acrobat Reader software.
Acrobat Reader software installation:
If Acrobat Reader software is not already installed on your PC, follow the steps described further to install it:
• Open Windows Explorer
• Click on the DVD drive
• Click on Acrobat
• Click on Acroread5
• Double click on rp500enu.exe to launch the installation.
How to print
Clicking on the PRINT button hereafter will launch Acrobat Reader and display this OM in PDF file format in the
current language.
Use the standard Acrobat Reader Print icon and define your print range "All", "Current page", "Page from ... to ..."
After print completion, close Acrobat Reader application.
You are now back to Online Operator Manual.
Note: If you need to print in another language, you must return to the Title Page and select the language prior to
clicking on the PRINT button.
Printing
Foreword 31
Click on PRINT button:
3 Electronic Operator Manual

This device is delivered with an electronic Operator Manual.
This section explains how to access the electronic Operator Manual that contains the instructions necessary to use
the system.
Note: Some operator manual addendums are delivered in paper only. Some options or accessories are delivered
with a paper operator manual.
Symbol indicating that the Instruction For Use (Operator

Manual) is supplied in electronic format.
The operator manual is available on the system itself (see section Innova Digital / Innova Digital Screen / Utilities
Key)
The Operator Manual is also available on the Internet at:
http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library
• On the home page enter the part number of the Operator Manual in the search window and click on [Search] to
launch the search.
The part number is indicated in the table below. Choose the one matching your language.
OM part-no Language
5499294-1-1BG Bulgarian
5499294-1-1CS Czech
5499294-1-1DA Danish
5499294-1-1DE German
5499294-1-1EL Greek
5499294-1-1EN English
5499294-1-1ES Spanish
5499294-1-1ET Estonian
5499294-1-1FI Finnish
5499294-1-1FR French
5499294-1-1HR Croatian
5499294-1-1HU Hungarian
5499294-1-1ID Indonesian
5499294-1-1IT Italian
5499294-1-1JA Japanese
5499294-1-1KO Korean
32 Foreword
5499294-1-1LT Lithuanian
5499294-1-1LV Latvian
5499294-1-1NL Dutch
5499294-1-1NO Norwegian
5499294-1-1PL Polish
5499294-1-1PT-BR Portuguese (Brazil)
5499294-1-1PT-PT Portuguese (Portugal)
5499294-1-1RO Romanian
5499294-1-1RU Russian
5499294-1-1SK Slovakian
5499294-1-1SR Serbian
5499294-1-1SV Swedish
5499294-1-1TR Turkish
5499294-1-1ZH-CN Simplified Chinese
1 - Search window
This screen capture is given as an example and is not legally binding.
The result of the search will be the Operator Manual in pdf format in one language.
• Click on the underlined Filename.
• In the next window, click on [ACCEPT] to download the file.
A paper copy of Operator Manual can be ordered at no additional cost. Please, send a request to your Sales or
Service representative. They will transfer your request to CEMEURDIST@med.ge.com. In application of the EU
Commission Regulation on electronic instructions for use of medical devices, in European Union, your request
should be treated within 7 days.
4 Quebec
Foreword 33
GE Healthcare= "GE Santé" in Province of Quebec - Canada.
34 Foreword
Chapter 2 - Introduction
Product Name: Medical X-ray angiography equipment.
The Innova IGS 520, Innova IGS 530, Innova IGS 540 is a fully integrated single plane angiographic x-ray imaging
system that meets a wide range of clinical needs for interventional and diagnostic imaging with excellent image
quality, extensive real-time processing, innovative dose management, ease of positioning, improved workflow and
image management for excellent clinical versatility without compromise.
Innova IGS 520 is an angiographic X-ray system equipped with a 21 cm Digital Detector.
The interventional configuration allows to perform diagnostic and interventional procedures. Additionally the OR
configuration (OR table) allows to perform surgery and x-ray guided surgical procedures (refer to OR Configuration
(Option) and Application Environment.)
Product Software Version: IGS5_2.0
Introduction 35
Chapter 3 - Safety and Regulatory

US federal law restricts this device to sale by or on the order of a physician.
This symbol stands for the prescription legend statement “Caution: US federal law restricts this
device to sale by or on the order of a physician."
The following symbols are used in this document to highlight safety information:
Caution advises of an avoidable condition that

could cause minor physical injury, or damage to
equipment or data.
WARNING ADVISES OF AN AVOIDABLE CONDI-

TION THAT MAY ALLOW OR CAUSE A PERSONAL
INJURY OR THE CATASTROPHIC DESTRUCTION
OF EQUIPMENT OR DATA.
DANGER ADVISES OF AN AVOIDABLE CONDI-

TION THAT WILL CAUSE SERIOUS OR FATAL IN-
JURY.
1 Regulatory Requirements
1-1 Electromagnetic Compatibility (EMC)
The Innova IGS 520, Innova IGS 530 and Innova IGS 540 need special precautions regarding EMC. The Innova
IGS 520, Innova IGS 530 and Innova IGS 540 have to be installed and put into service according to the EMC
requirements joined in the Operator Manual and in the Pre-Installation Manual.
1-1-1 Electromagnetic Compatibility of the vascular system
This equipment complies with IEC60601-1-2 Edition 2.1 and Edition 3 EMC standard for medical devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio
frequency interference to other medical and non-medical devices and radio communications nearby.
In order to provide a reasonable interference protection against radio communication services, this product
complies with the IEC60601-1-2 standard requirements at the premises of a typical user, and the CISPR11
standard emission limits (CISPR11 Group1 Class A).
This product is not likely to introduce significant disturbance in its vicinity, in the CISPR11 standard Group1
bandwidth (150 KHz - 1 GHz), assuming a separation distance can be set up and maintained versus sensitive
products.
The Innova system has no significant intentional radio emitter, which radiates electromagnetic energy and
electromagnetic fields (EMF) susceptible to induce known adverse health effects.
The level of these non-ionizing radiation was assessed under the required and recommended limits, addressing the
workers and general public located nearby the Innova system.
Compliance with these limits will ensure that workers and the general public exposed to the electromagnetic fields
are protected against all known adverse health effects in the 0 Hz to 300 GHz bandwidth.
1-1-2 Detailed Electromagnetic Compatibility of the vascular system
Detailed requirements and recommendations about the power supply distribution and installation are listed in the
next paragraph called "Detailed IEC60601-1-2 Electromagnetic Standard Compliance conditions", and in the PIM
36 Safety and Regulatory

document (Pre-Installation Manual).

However, there is no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment on and off),
the user (or qualified service personnel) should attempt to correct the problem by one or more of the following
measure(s):
• Reorient or relocate the affected device(s),
• Increase the separation between the equipment and the affected device,
• Power the equipment from a source different from that of the affected device,
• Consult the point of purchase or service representative for further suggestions.
The manufacturer is not responsible for any interference caused by using other than recommended interconnect
cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications
could void the users' authority to operate the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded, except when technologically
prohibited. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency
interference.
Do not use devices, which intentionally transmit RF signals (cellular phones, transceivers, or radio-controlled
products) in the vicinity of this equipment, as it may cause performance outside the published specifications.
Recommended separation distances are detailed in the next paragraph called "Detailed IEC60601-1-2
Electromagnetic Standard Compliance conditions", and in the PIM document (Pre-Installation Manual).
Keep the power to these type devices turned off when near this equipment.
The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who
may be around this equipment to fully comply with the above requirement.
In order to achieve the Electromagnetic Compatibility for a typical installation, and this medical system, further
detailed data & requirements are described in the next paragraph called "Detailed IEC60601-1-2 Electromagnetic
Standard Compliance conditions", and in the PIM document (Pre-Installation Manual).
The magnetic field environment from an MRI device located nearby is a risk of interference. The recommended
maximum magnetic field amplitude is specified in the next paragraph called "Detailed IEC60601-1-2
Electromagnetic Standard Compliance conditions", and in the PIM document.
1-1-3 Electromagnetic Compatibility of the vascular system with Fluoro UPS (Innova option)
In addition, in case of using the Fluoro UPS option (Uninterruptible Power Supply), the installation requirements
shall be applied for the Electromagnetic Compatibility of the full vascular system with the Fluoro UPS option.
The PDB (Power Distribution Panel) associated with the Fluoro UPS option, requires the correct cable sizing and
routing, and component installation, as per defined in the next paragraph called "Detailed IEC60601-1-2
Electromagnetic Standard Compliance conditions", and in the associated PIM document (Pre-Installation Manual).
1-1-4 Detailed IEC60601–1–2 Electromagnetic Standard Compliance conditions
This equipment complies with IEC60601–1–2 Edition 2.1 and Edition 3 EMC standard for medical devices.
The Innova system is suitable to be used in the electromagnetic environment, as per the limits & recommendations
described in the tables here after:
• Emission Compliance level & limits (see Table 1).
• Immunity Compliance level & recommendations to maintain equipment clinical utility (see Table 2, Table 3 and
Table 4).
Note: This system complies with above–mentioned EMC standard when used with supplied cables up to maximum
lengths referenced in the MIS MAPS or system cables interconnect diagrams.
Essential Performance List
Essential Performance IEC Standard Reference Comments
Safety and Regulatory 37

Access to CPR position in less than IEC 60601-1 Clause 4.3 - From Risk CPR position is defined as:
15s (+1s in tilted conditions) Management tilt angle =0° and table top fully moved
towards feet along the longitudinal ax-
is.
Ability to position patient support for IEC 60601-1 Clause 4.3 - From Risk
imaging the zone of interest Management
Ability to position and orient the X-ray IEC 60601-1 Clause 4.3 - From Risk Includes the ability to position gantry
beam vs. patient Management isocenter vs. patient
Ability to distinguish anatomic struc- IEC 60601-2-54: Imaging perfor- Ability to distinguish images noise or
tures and interventional devices in mances artifacts from anatomic structures
images IEC 60601-2-54: Automatic Control and interventional devices.
System The automatic control system regu-
lates the acquisition parameters to
make visible anatomic structures of
interest and interventional devices.
Ability to guide interventional gesture IEC 60601-2-54: Imaging perfor-
with X-Ray imaging mances
Ability to export DICOM Radiation IEC60601-2-43: Radiation dose docu- Capability to export DICOM Radiation
Dose Structured Report mentation Dose Structured Report through the
network
System reset in less than 3 minutes IEC60601-2-43: Recovery manage-
ment
No unwanted movement of the table IEC60601-2-46 Clause 201.4.3 Applicable only to surgical configura-
in any SINGLE FAULT CONDITION tion and Tilting table
and combined fault condition with dor-
For EMC testing, the SINGLE FAULT
mant failure
CONDITION requirements of the gen-
eral standard do not apply. See §4.2
of IEC60601-1-2 Ed3
1-1-4-1 Electromagnetic Emission

Table 1
The Innova system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Innova system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment
Radio–Frequency Group1 The Innova system uses Radio Fre-
quency energy only for its internal
Emissions Class A
function. Therefore, its Radio Fre-
CISPR11 Limits quency emissions are very low and
are not likely to cause any interfer-
ence in nearby electronic equipment.
The Innova system is suitable for use
in all establishments other than do-
mestic and those directly connected
to the public low-voltage power supply
network that supplies buildings used
for domestic purposes.

Harmonic emissions Not Applicable The Innova system is suitable for use
IEC 61000-3-2
Voltage fluctuations / flicker emissions Not Applicable The Innova system is suitable for use
IEC 61000-3-3
1-1-4-2 Electromagnetic Immunity IEC 60601-1-2

Table 2
IMMUNITY Test IEC 60601–1–2 Compliance Level Electromagnetic Environment
Test Level
Electrostatic +/- 6 kV contact +/- 6 kV contact Floors are wood, concrete or
discharge (ESD) ceramic tile or floors are covered with
+/- 8 kV air +/- 8 kV air
synthetic material and the relative humidity is at
IEC 61000-4-2
least 30 %.
Electrical fast +/- 2 kV for power +/- 2 kV for power Mains power quality is that of a typical commer-
transient/burst supply lines supply lines cial or hospital environment.
IEC 61000-4-4 +/- 1 kV for input/ +/- 1 kV for input/
output lines output lines
Surge +/- 1 kV line(s) to +/- 1 kV line(s) to Mains power quality is that of a typical commer-
line(s) line(s) cial or hospital environment.
IEC 61000-4-5
+/- 2 kV line(s) to +/- 2 kV line(s) to
earth earth
Voltage dips, short 0% Un for 5 sec 0% Un for 5 sec Mains power quality is that of a typical commer-
interruptions and cial or hospital environment. If the user of the
voltage variations Innova system requires continued operation
on power supply during power mains interruptions, it is recom-
input lines mended that the Innova system be powered
from an uninterruptible power supply.
IEC 61000-4-11
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) is at levels characteristic of a typical location in
magnetic field a typical commercial or hospital environment.
IEC 61000-4-8
Note: Un is the a.c. mains voltage prior to application of the test level.
Table 3

IMMUNITY Test IEC 60601-1-2 Test Compliance Level Electromagnetic Environment
Level
Conducted Radio Fre- 3 Vrms V1=3v Portable and mobile RF communications equip-
quency ment is used no closer to any part of the Innova
150 kHz to 80 MHz
IEC 61000-4-6 system, including cables, than the recommended
separation distance calculated from the equation
Radiated Radio Fre- 3 V/m E1=3v/m
applicable to the frequency of the transmitter.
quency
80 MHz to 2.5 GHz Recommended separation distance:
IEC 61000-4-3
where P is the maximum output power rating of

the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in metres (m).
Field strengths from fixed RF transmitters, as de-
termined by an electromagnetic site survey*, are
less than the compliance level in each frequency
range.**
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
Note: * Field strengths from fixed transmitters, such as base stations for cellular telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be performed. If the measured field strength exceeds the RF compliance level above, observe the
Innova system to verify normal operation in each use location. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Innova system.
** Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.
THE INNOVA IGS SYSTEM IS A LARGE, PERMANENTLY INSTALLED MEDICAL EQUIPMENT

FOR WHICH THE SIMULATED OPERATION IN AN ANECHOIC CHAMBER IS NOT FEASIBLE
AND CONSEQUENTLY IS EXEMPT FROM THE TESTING REQUIREMENT SPECIFIED BY IEC
61000-4-3.
THE INNOVA IGS SYSTEM HAS NOT BEEN TESTED FOR RADIATED RF IMMUNITY OVER THE ENTIRE
FREQUENCY RANGE 80 MHz TO 2.5 GHz.

THE INNOVA IGS SYSTEM HAD BEEN TESTED IN SITU FOR RADIATED RF IMMUNITY ONLY AT
SELECTED FREQUENCIES IN THE RANGE 80 MHz TO 2.5 GHz.
ISM Frequencies (MHz) Field level Modulation
433.920 (ISM)* 3V/m 80 % AM at 1 kHz rate

915 (ISM)*
1440
1750
1920
2450 (ISM)*
* Industrial, scientific and medical (ISM) radio bands

Equipment used for tests:
• RF signal generator.
• RF power amplifier.
• Transmitting antenna.
• Field sensor.
• Field meter.
The Recommended Separation Distances are listed in section "Recommended Separation Distances for Portable
and Mobile RF Communications Equipment IEC 60601–1–2" Table 4.
These are guidelines. Actual conditions may vary.
1-1-4-3 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC
60601-1-2
Table 4
Frequency of Transmit- 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
ter
Equation
Rated Power of Trans- Distance (meters) Distance (meters) Distance (meters)

mitter (watts)
10 mW 0.11 0.11 0.22
100 mW 0.37 0.37 0.74
1 1.1 1.1 2.3(*)
10 3.7 3.7 7.4
100 12 12 23
For transmitters rated at a power not listed above, the DISTANCE can be estimated using the equation in the
corresponding column, where P is the power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note: These are guidelines. Actual conditions may vary.
1-1-4-4 Limitations Management

Adhering to the distance separation recommended in section "Recommended Separation Distances for Portable
and Mobile RF Communications Equipment IEC 60601-1-2" Table 4, between 150 KHz & 2.5 GHz, will reduce
disturbances recorded at the image level, but may not eliminate all disturbances. However, when installed and
operated as specified herein, the system will maintain its essential performance by continuing to acquire, display,
and store diagnostic quality images safely.
For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put 2.3 meters (see (*) in section
"Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2"
Table 4) apart from the Innova system (in order to avoid images interferences risks).
1-1-4-5 Use Limitation
THE USE OF ACCESSORIES, TRANSDUCERS, AND CABLES OTHER THAN THOSE

SPECIFIED MAY RESULT IN DEGRADED ELECTROMAGNETIC COMPATIBILITY OF THE
INNOVA SYSTEM.
1-1-4-6 Installations Requirements and Environment Control
In order to minimize interference risks, the following requirements shall apply:
• Cables shielding & grounding:

All interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not
properly shielded and grounded may result in the equipment causing radio frequency interference.
• Separated Power supply distribution panel & separated power line:
– This product complies with the radiated emission limits as per the CISPR11 Group1 ClassA standard.
– The Innova system is predominantly intended for use (e.g. in hospitals) with a dedicated supply system, and
with an X–ray shielded room.
– In case of using in a domestic environment (e.g. doctors’ offices), in order to avoid interferences, it is
recommended to use a separated AC power distribution panel & separated power line, and an X–ray
shielded room.
• Subsystem & accessories Power supply distribution:
All components, accessories subsystems, systems which are electrically connected to the Innova system, have
to be all AC power supplied by the same power distribution panel & line.
Note: In order to avoid interferences, the same AC power distribution panel should supply all components,
accessories, the Innova system (& subsystems as the Advantage Workstation). The separated AC power line
should supply the whole AC power distribution panel sockets.
• Stacked components & equipment:
The Innova system should not be used adjacent to or stacked with other equipment; if adjacent or stacked use
is necessary, the Innova system should be observed to verify normal operation in the configuration in which it
will be used.
• Low frequency magnetic field:
– In case of an Innova system, the Gantry (digital detector) shall be apart 1 meter from the generator cabinet,
and 1 meter apart from the analog (CRT) monitors. These distances specifications shall minimize the low
frequency magnetic field interference risk.
– Other electrical equipment may disturb and interfere with these Innova components. The control of the
clearing distances from the noise sources is recommended from the HF electrosurgery generator, power
supplies converters from nearby monitors or from other close electrical equipment). Refer to respective
device manufacturers instructions & recommendations in such cases.
• Static magnetic field limits:
– In order to avoid interference on the Innova system, static field limits from the surrounding environment are
specified.

– Static field is specified less than <1 Gauss in Examination room, and in the Control Area.
– Static field is specified less than <3 Gauss in the Technical Room.
• Electrostatic discharges environment & recommendations:
– In order to reduce electrostatic discharge interference, install a charge dissipative floor material to avoid
electrostatic charge buildup.
– The relative humidity shall be at least 30 percent.
– The dissipative material shall be connected to the system ground reference, if applicable.
• EMI Filter Box for the Fluoro UPS (CE) Option: The Fluoro UPS (CE) option requires an EMI filter box placed
upstream the PDB (Power Distribution Panel). The EMI filter box will be delivered as a single product by GE
Consumer & Industrial.
The maximum cable length between the entrance EMI filter and the PDB is 3 m. (Implying the separation
distance between the EMI filter box and the PDB is less than 3 m).
Route separately EMI filter incoming power lines and outgoing power lines (refer to
Electrical Connections).
1-2 Additional Regulatory Requirements

This product complies with the regulatory requirements of the following:
• Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:
Manufacturer's name and address, address of the manufacturing site and European registered
place of business (the two addresses correspond to the same entity):
GE MEDICAL SYSTEMS SCS GE Medical Systems SCS

283 RUE DE LA MINIERE 283 rue de la Minière
78530 BUC - FRANCE BP 34 78533 Buc Cedex
Tel: +33 1 30 70 40 40 France
Tel: +33 1 30 70 40 40
FOR CONTINUOUS COMPLIANCE WITH THE MEDICAL DEVICE DIRECTIVE 93/42/CEE (CE
MARKING), CONSULT YOUR GE REPRESENTATIVE BEFORE ADDING OPTIONS OR
ACCESSORIES OTHER THAN THOSE INDICATED IN THIS MANUAL. THE CE LABEL FOR
THE SYSTEM IS LOCATED ON THE C-ARC.
• Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration,
Department of Health, USA).
• Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
• Canadian Standards Association (CSA).
• International Electro technical Commission, international standards organization, when applicable.
• EMC IEC-60601-1-2: Edition 2.1 (2004) and Edition 3 (2007).
• Innova IGS system has been designed, manufactured and tested to meet the applicable requirements of 21
CFR 1020.30, 1020.32. When the Innova IGS system is installed and tested according to the manufacturer
instructions, the system meets the applicable requirements. Each components falling under the performances
regulated in 21 CFR 1020.30 bears a certification label mentioning the following text:
"COMPLIES WITH DHHS RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J".
• CDRH certification label of the C1 cabinet and C2 cabinet can be found on the door of the cabinet.

• CDRH certification label of the Jedi generator can be found on the part into the C1 Cabinet.
• CDRH certification label for the Collimator, Tube and Detector (CDRH label = model number) are located on the
parts.
• CDRH certification label of VCIM (Vascular Control Interface Module) and the TSSC (Table Side Status Control)
are located on the parts.
• CDRH certification label of Tabletop can be found on the backside of the tabletop.
– A copy of the labels of the certified CDRH components that are not accessible to view is provided on the
L-Arm for collimator and X-ray tube; and on the Gear cover for X-ray flat panel detector.
• Regulatory markings for a specific country are only in the concerned local language. In general, these markings
are designated by the related country code as per ISO 3166-1.
• Eurasian Conformity (EAC)
This product passed all conformity assessment (approval) procedures that correspond to the requirements of
applicable technical regulations of the Customs Union.
This product complies with the regulatory requirements set in the regulation CU TR 020 / 2011 ‘electromagnetic
compatibility of technical products'.
1-3 Specific Requirements for product with Open Monitor suspension (Option)
For Innova IGS Systems with Open Monitor Suspension option, the overhead monitor suspension shall be installed
by strictly following the GEMS installation instructions. The manufacturer specifically disclaims any and all liability
arising out of or relating to the use or performance of the monitor suspension (including cables), including, without
limitation, any liability or claims relating to patient injury, death, or the reliability of such monitors suspension(s).
This option consists in the delivery of a Innova IGS System without the standard fully integrated Mavig overhead
suspension, its associated suspension rails and cables, to allow the customer (purchaser) to choose his (their) own
monitors suspension(s). Only GE monitors are permitted as primary image display.
The Innova IGS system with Open Monitor Suspension option is delivered with up to 6 exam-room 19” monitors,
and the display features are then the same as a Innova IGS System delivered with a standard Mavig monitors
suspension.
Note: This option does not modify the Control room monitor configuration delivered with the Innova IGS system.
Where an overhead monitor suspension(s) is supplied by the Purchaser of the Innova IGS System, the overhead
monitors suspension(s) shall comply with the applicable Regulation enforced in the country (e.g., when installed in
an European Community country, the associated monitors suspension(s) shall be CE marked under Directive
93/42/EEC).
The association of Innova IGS product delivered with Open Monitor Suspension option and the purchaser’s
(customer) monitors suspension(s), is not covered by Innova IGS product certification.
1-4 Recycling
• Instruments or accessories at end of life span:
Disposal of equipment and accessories must meet the applicable national regulations for waste treatment.
Equipment and accessories at the end of their life span must have all materials or components removed that
can be hazardous to the environment (such as accumulators, batteries, transformer oil, etc). Please consult
your local GEHC contact before disposing of these products.
• Packaging:
The materials used for our equipment packaging are recyclable. These materials must be collected and
processed according to the regulations applicable in the countries in which equipment or accessories are
unpacked.

• Waste Electric, Electronic Equipment (WEEE - 2002/96/EC):
This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted
municipal waste and must be collected separately. Please contact an authorized representative of the
manufacturer for information concerning the decommissioning of your equipment.
• Battery recycling (Battery 2006/66/EC):
The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be
recycled or disposed of in accordance with local or country laws. The letters below the separate collection
symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery.
To minimize potential effects on the environment and human health, it is important that all marked batteries that
you remove from the product are properly recycled or disposed.
For information on how the battery may be safely removed from the device, please consult the service manual
or equipment instructions. Information on the potential effects on the environment and human health of the
substances used in batteries is available at this url:
http://www.gehealthcare.com/euen/weee-recycling/index.html.
1-5 Control of Pollution caused by Electronic Information Products (EIP's)
The purpose of this chapter is to answer the position that GEHC has taken regarding the People's Republic of
China Electronic Industry Standard SJ/T11364-2006 "Marking for the Control of Pollution Caused by Electronic
Information Products" (EIP's).
1-5-1 Explanation of Pollution Control Label
This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese
standard SJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic
Information Products. The number in the symbol is the Environment-Friendly Use Period (EFUP), which indicates
the period during which the toxic or hazardous substances or elements contained in electronic information products
will not leak or mutate under normal operating conditions so that the use of such electronic information products will
not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is
"Year"
In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and
environmental conditions as defined in the product manual.
Consumables or certain parts may have their own label with an EFUP value less than the product.
This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled
properly after decommissioning.
1-5-2 Name and Concentration of Hazardous Substances
Innova Single Plane - Hazardous substances' name and concentration
Component Hazardous substances' name

Name
Pb Hg Cd Cr (VI) PBB PBDE
Patient Table X O O X X X

X-ray Tube As- X O O X O O

sembly
C1 Cabinet X O X O X X
C2 Cabinet O O O O O O
Large Display O O O O O O
Cabinet
Large Display X O X O X X
UPS
Tube Chiller O O O O O O
Tube Chiller Au- O O O O O O
totransformer
Detector Chiller X O O O O O
Control Panel X O O O O O
User Interfaces O O O O O O
(except Innova
Central touch
screen)
Innova Central X X O O O O
touch screen
AW LCD Moni- X X O O O O
tor
19" Monitor X O O O O O
Innova Digital X X O O O O
Color LCD Mon-
itor
Large Display X X O O O O
Monitor
X-ray Tube Col- X O O O O O
limator
Digital Detector X O O O O O
LC Gantry X O O X X X
PDB CE X O O O X X
Fluoro UPS CE X O O O O O
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is
below the limit requirement in SJ/T11363-2006.
X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used
for this part is above the limit requirement in SJ/T11363-2006
• Data listed in the table represents best information available at the time of publication.
• Applications of hazardous substances in this medical device are required to achieve its intended clinical uses,
and/or to provide better protection to human beings and/or to environment, due to lack of reasonably
(economically or technically) available substitutes.
1-6 Vermont labeling regulations (US) on Mercury

This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance
with local, state, or country laws. (Within this system, except 19" Monitor, the backlight lamps in some monitor
display contain mercury.)
Devices containing Mercury bear the following label:
Lamp contains mercury, dispose according to state/local law.
1-7 Patient Confidentiality

For some maintenance operations related to image quality, it may be necessary for the Service organization to
send some images back to the manufacturer for analysis. The images may be sent through CDs or via Insite
connection. The images may contain personally identifiable information (for example, a patient’s name or Social
Security number) in the Patient Identification field. Some countries have laws related to the confidentiality of
personally identifiable information.
To comply with these laws, the customer shall send anonymized data to GE. The customer shall follow its internal
anonymization procedures or the following procedure to suppress the Patient Identification field before archiving
the images for non-medical purposes (such as image quality investigation):
1. If the images are still on hard disk, suppress the patient identification as follows:
a. Enter the patient information screen,
b. Click on the Patient Identification field,
c. Suppress manually the Patient Identification,
d. Click on [Apply] to confirm. Then, archive this exam.
2. If the images were already networked, first restore the images on the AW or CA1000 workstation, and then use
the [Anonymous Maker] to remove the Patient Identification field prior to burning images on CD/DVD.
2 General Safety
In case of a discrepancy between a generic and a specific instruction for use, the specific instruction will always
prevail.
This system contains operating safeguards to provide maximum safety. Before calling for service, be certain proper
operating procedures are being used.
Satisfactory equipment performance requires the use of service personnel specially trained on X-ray apparatus. GE
Healthcare is responsible for the effects on safety, reliability and performance only if the following conditions are
met:
• The electrical wiring of the relevant rooms complies with all national and local codes as well as the Regulations
for the electrical equipment of buildings published by the Institution of Electrical Engineers.
• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by GE Healthcare's
authorized service representatives.
• The equipment is used in accordance with the instructions for use.
ALWAYS BE ALERT TO SAFETY WHEN YOU OPERATE THIS EQUIPMENT. YOU MUST BE
FAMILIAR ENOUGH WITH THE EQUIPMENT TO RECOGNIZE ANY MALFUNCTIONS THAT
CAN BE A HAZARD. IF A MALFUNCTION OCCURS OR A SAFETY PROBLEM IS KNOWN TO
EXIST, DO NOT USE THIS EQUIPMENT UNTIL QUALIFIED PERSONNEL CORRECT THE
PROBLEM.
NO EQUIPMENT SHALL BE CONNECTED TO THE POWER STRIP OF THE CONTROL ROOM

EXCEPT THOSE EXPLICITLY SPECIFIED IN THE SERVICE MANUAL. ANY SUCH
MODIFICATION OR ADDITION LEADS TO A MODIFIED MEDICAL SYSTEM THAT IS NOT
COVERED BY MEDICAL STANDARD IEC 60601-1 AND CAN RESULT IN REDUCED LEVEL

OF SAFETY.
2-1 Equipment Application Specification
2-1-1 Patient Population
• Age: newborn to geriatric.
• Weight: 204 kg maximum.
2-1-2 Intended Operator
• Knowledge: The usage of the system described in this Operator Manual requires specific technical and medical
knowledge and skills regarding, at a minimum, radiation protection, safety procedures and patient safety.
People using, moving, working with the system must have acquired such knowledge and skills during their
education curriculum.
• Language Understanding:
Operator Manual and System Screens are translated* in the following languages. Users must understand one of
these languages before using the system.
Code Operator Manual System Screens (GUI)

BG Bulgarian English
HR Croatian English
CS Czech English
DA Danish Danish
NL Dutch Dutch
EN English English
ET Estonian English
FI Finnish Finnish
FR French French
DE German German
EL Greek English
HU Hungarian English
ID Indonesian English
IT Italian Italian
JA Japanese English
KO Korean English
LV Latvian English
LT Lithuanian English
NO Norwegian Norwegian
PL Polish English
PT-BR Portuguese (Brazil) English
PT-PT Portuguese (Portugal) Portuguese (Portugal)
RO Romanian English

RU Russian English
SR Serbian English
ZH-CN Simplified Chinese English
SK Slovakian English
ES Spanish Spanish
SV Swedish Swedish
TR Turkish English
Note: * Depending on the region of sale, some translations may not be available.
• Equipment Training: Training is available from GE Healthcare. Some country regulations require that equipment
training be followed before any use of the system. 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.
Contact GE Healthcare representative for training options.
• Training Options: From in person application training to self-training with the Online Operator Manual delivered
with the Innova IGS System and the safety instructions of the paper booklet, Operator Manual DVD. The
Operator Manual DVD shall be placed in a location easily accessible to the operator in case of emergency.
• 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 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.
2-1-3 Application Environment
• General
– Indoor use only.
– The Innova is suitable for Interventional X-ray procedures (angiograms, device placement, non vascular or
minimally invasive surgery) and can be used:
• either in an Interventional Room.
• or in a dedicated lab within an Operating Room Environment which is outside a location designated for
marked "AP" or "APG" Equipment. Category AP Equipment is an Equipment or Equipment part complying
with specified IEC60601-1 requirements on construction, marking and documentation in order to avoid
sources of ignition in a flammable anaesthetic mixture with Air. Category APG Equipment is an
Equipment or Equipment part complying with specified IEC60601-1 requirements on construction,
marking and documentation in order to avoid sources of ignition in a flammable anaesthetic mixture with
Oxygen or Nitrous Oxide.
– The Operating Room Environment is an environment which has environmental characteristics equivalent to
an Operating Room for infection control. Special attention is required to clean suspended equipment as per
device recommendation and Preventive Maintenance.
– The device is not to be used to do open surgical procedures except when equipped with the OR table and if
installed in a dedicated Operating Room.

• Conditions of Visibility
– Ambiant luminance: 150 lux maximum.
• Physical
– Temperature range: 15°C to 32°C.
– Relative humidity range: 30% to 70%, non condensing.
– Altitude range: sea level to 2000 m (15-32°C) .
Note: The chiller is able to dissipate maximum continuously power at 3000 meters in an ambient
temperature up to 20°C, for this altitude the technical room temperature shall not exceed 20°C.
– Atmospheric pressure range: 794 hPa to 1060 hPa.
Read and understand all the instructions in the Operator Manual before attempting to use the system and request
additional training from GE Healthcare if needed.
Periodically open the Operator Manual to review the procedures and safety precautions.
FAILURE TO FOLLOW THE OPERATING INSTRUCTIONS AND SAFETY PRECAUTIONS

COULD RESULT IN SERIOUS INJURY TO THE PATIENT, OTHERS OR YOURSELF.
FAILURE TO FOLLOW THE OPERATING INSTRUCTIONS AND SAFETY PRECAUTIONS

PROVIDED IN MANUFACTURER’S INSTRUCTIONS OF HIGH FREQUENCY SURGICAL TOOL,
CARDIAC DEFIBRILLATORS AND CARDIAC DEFIBRILLATOR-MONITOR COULD RESULT IN
SERIOUS INJURY TO THE PATIENT, OTHERS OR YOURSELF. ATTENTION IS DRAWN TO
THE FACT THAT THE INNOVA IGS SYSTEM IS NOT PROTECTED AGAINST
DEFIBRILLATION SHOCKS.
2-1-4 Operator Position
Operator should position in exam room around the table or near the Tableside Cart in close proximity to the Table
Side User Interface (TSUI) and two meters maximum from the monitors or in control room behind the Innova
Console.
2-1-5 Contrast Agents
When an imaging procedure requires a contrast medium, the compatible contrast agent types to be used with the
angiographic X-ray system are:
• Iodine-containing compounds that in part are specifically designed to absorb X-rays.
• Carbon dioxide (CO2).
2-2 Be Sure the Equipment is Functioning Before each Use
Visually inspect the equipment for damage and missing parts. Do not turn on electrical power if any of the cover
panels are not in place or broken; hazardous electrical or mechanical parts could be exposed. Damaged parts may
lose their degree of protection against harmful ingress of liquids or may fall. Replace the damaged or missing parts.
Verify that the following controls are operating correctly:
• Motion Controls, Motion Enables and Table Top Brakes
• Emergency power-off
• Motion emergency stop
• Collision Sensors and the routine for clearing collisions
• Audible signal and error messages display.
• Verify no alarm message is displayed on the console or on the monitor (refer to Alarm Systems / List of Alarm
Messages).
Damaged controls could result in unintended motion. Do not operate the equipment if the controls are not

operating properly.
When covering the equipment with sterile drapes or other protective covering, be sure th e covering does not
interfere with the Motion Controls or Motion Enables.
Note: As per local regulations, record of these functional checks have to be kept with the equipment.
Motion Controls, Motion Enables and Table Top Brakes.
– Perform a daily check of the gantry pivot axis (RAO/LAO rotation) position by moving it to PA position by
using the Auto Positioner command.
Check that the gantry C arm is in vertical position and that "RAO/LAO 0 deg" +/- 1 deg is displayed on the
Geometry area, left on the live display.
Note: When using the InnovaIQ Table, position the table horizontally prior to moving the gantry to a PA
position.
Move the gantry pivot axis and check that the displayed angle is updated.
In case of mismatch detected, call your local Service Representative.
– For system using an Omega IV, Omega V or InnovaIQ Table, perform a daily check of the table Up/Down axis
by moving the table to its lowest position.
Check that " " is displayed on the Geometry area, left on the live display.
Move the table Up and check that the displayed value is updated.
In case of mismatch detected, call your local Service Representative.
2-2-1 Emergency power off
ACTIVATE THE WALL AND CONTROL PANEL EMERGENCY STOPS MONTHLY.
2-2-2 Collision Sensors and the routine for clearing collisions.
CHECK THE COLLISION SENSORS DAILY BY DEPRESSING DIGITAL DETECTOR SENSOR.
2-2-3 Large Display Monitor suspension.
CHECK DAILY THE PRESENCE OF THE LIVE IMAGE AND THE REFERENCE DISPLAY ON
THE 2 BACKUP MONITORS THAT ARE LOCATED EITHER AT THE BACK OF THE
SUSPENSION OR ON AN ADDITIONAL SUSPENSION.
2-2-4 Innova Central touch screen.
• Check functionally the Innova Central touch screen mechanical fixing on the rail.
• Inspect visually the Innova Central touch screen housing and cable integrity.
• Inspect visually the Innova Central touch screen for chemical residuals or blinded spots.
• Check the operation of the touch-button selection, the joystick motion and pushbutton functions .
ASK FOR EXCHANGE IF ANY OF THE ABOVE FUNCTIONS SHOW DETERIORATION.
2-3 Always Be Alert to Patient Safety Concerns

Provide assistance for getting the patient on and off the table. Be sure all patient health lines (IV, oxygen, etc.) are
positioned so they will not be caught when moving the equipment. Never leave the patient unattended while in the
system room. An unattended patient could fall from the table, activate a motion control, or encounter other
problems which could be hazardous.

2-4 Radiation Safety

Always use proper Technique factors for each procedure to minimize X-ray exposure and to produce the best
diagnostic results. In particular, you must be thoroughly familiar with safety precautions before operating this
System.
2-5 Establish Emergency Procedures
It is not always possible to determine when some components, such as X-ray tubes, are nearing the end of their
operating lives. These components could stop operating during a patient examination.
ESTABLISH PROCEDURES FOR HANDLING THE PATIENT IN CASE OF THE LOSS OF

FLUOROSCOPIC IMAGING OR OTHER SYSTEM FUNCTIONS. FAILURE OF FLUOROSCOPIC
IMAGING MAY HOWEVER BE RECOVERED BY FOLLOWING THE PROCEDURE SPECIFIC
FOR EACH VASCULAR SYSTEM.
2-6 Equipment Installed in Patient Vicinity
Note: Patient vicinity is defined as a space within the room 1.83 m beyond the perimeter of the examination table
and extending vertically 2.29 m above the floor.
The components that may be installed within patient vicinity are:
• Omega Table
• InnovaIQ Table
• C-Arm
• Monitors
– Monitors installed in the patient vicinity may not be medical equipment (i.e.: compliant with medical
equipment standard - IEC 60601-1). If this is the case, an additional ground protection wire is connected to
the monitor to meet medical system safety requirement.
• Injector
• Rad-shield
• Volcano s5i system controls and Patient Interface Modules (PIMs):
– s5i Trackball Controller (Control Console II).
– s5i Joystick.
– s5i Intra Vascular Ultrasound (IVUS) PIM.
– s5i Rotational PIM (only in a sterile bag).
– s5i Fractional Flow Reserve (FFR) PIM.
• Table Side User Interfaces (TSUI)
– Smart Box
– Smart Handle
– Table Side Status Control
– Table Panning Handle
• Innova Central touch screen
– Cable which connects the Innova Central touch screen to the Innova system through a dedicated connector
on the Patient table.
• In-room 3D Mouse
• Accessories:

– Table Head Extender

THE TABLE HEAD EXTENDER SHALL NOT BE USED WHILE THE TABLE IS TILTED.
FAILURE TO DO SO MAY RESULT IN SEVERE PATIENT INJURY.
THE TABLE HEAD EXTENDER IS NOT COMPATIBLE WITH THE INNOVAIQ WIDE
TABLE TOP.
X-ray exposure must not be performed with the X-ray tube above the table with the table extender between
the patient and the image receptor.
– IV pole
– Mattress and mattress slicker
– Shoulder Rests
– Footrest
– Digital Head holder: Attach Head Positioning device onto the head end of the table with the head cradle
pointing to the end of the table. The clamp angle pressure bar should be resting on top of the table and the
blue stabilizing feet under the table.
Tighten the clamping systems with the four- pronged knob.
Test to check that head holder is securely attached to the table.
Adjust the height and angle of the head cradle by loosening the long handled knob.
Once cradle is set at desired position tighten the long handled top.
Place the patient’s head in the head cradle. Use the two velcro© straps to hold the forehead and chin in
place.
Additional adjustment maybe made to the position of the head cradle by loosening and tightening the long
handled knob if desired.
THE DIGITAL HEAD HOLDER MUST NOT BE USED TO RESTRAIN THE PATIENT'S HEAD
WHEN THE TABLE IS TILTED, ONLY WHEN IT IS HORIZONTAL. IT IS NOT DESIGNED
FOR THAT USAGE AND MAY CAUSE INJURY TO THE PATIENT.
– Horizontal Armboard (HB-1)
The horizontal armboard (HB-1) with a flat plate sliding under the mattress enables to support patient’s arm.
Its radiolucency allows imaging the arms.

– Quick Strap
Disposable Velcro-like strap helps immobilize patient.
Quick strap is not to be used when the table is tilted. The strap might exert mechanical
force which may harm the patient.
– Clear-Vu Arm Support
The Clear-Vu Arm Support provides comfortable means of supporting the patient’s arms in a prone or supine
position during an interventional procedure.
– Surgical and Patient Comfort Accessories

All these components are medical components.
2-7 Accessories
Surgical and Patient Comfort Accessories
All accessories are removable.
To avoid improper operation of accessories, always verify proper connection by checking

the label above the connector when attaching an accessory to the table.
Attach only GE approved accessories to the table. Be sure to connect each accessory to the
proper connector, as labeled on the table. In particular, be sure to connect the grounding
cables.

Table accessory rail load consideration:
1 - On the table accessory rails:

The maximum load a table-side accessory rail can handle is 40 kg.
In case of heavy injector (i.e. MEDRAD Avanta - 33.5 kg - ...) installed on the table accessory rail, only light
extra load not exceeding 5 kg at 100 mm from the rail (i.e.: IV pole with its accessories: saline bag, etc. Use
IV Pole to hang only IV Fluids. The max load on the IV pole shall be 1 kg max per hook.) is allowed to be
installed on the same rail as the injector.
Typical installation on the front table accessory rail is Smart Handle or Smart Box, Table Side Status
Control (TSSC), Innova Central touch screen, Table panning device and cables support.
Here are some GEHC accessories and their weight:
Devices on table rails Weight (kg)

Smart Box (for Omega table) with cables 5.8
Smart Box (for InnovaIQ table) with cables 5.5
IPX4 Smart Box (for OR table) with cables 6.0
Smart Handle with cables 4.3
TSSC (for Omega table) with cables 5.7
IQ
TSSC (for Innova table) with cables 5.4
IPX4 TSSC (for OR table) with cables 6.0
Volcano s5i Trackball Controller (Control Console II) 3.5 (~5 with its
holder)
Volcano s5i Joystick 0.5
Volcano s5i Intra Vascular Ultrasound (IVUS) PIM 0.7 (~2 with its
holder)
Volcano s5i Fractional Flow Reserve (FFR) PIM 1.0
Innova Central touch screen 4.1
In-room 3D Mouse 2.9
Cable support 0.5
Table Panning Device (TPD) 1.0
Rad-shield 13.6
On each screw of the table accessory rail, the maximum allowed torque is 64 N.m. All GEHC accessories
listed above are compliant with this specification. In case of non-GEHC accessory installation on the table
accessory rail, make sure the torque remains below 64 N.m.
2 - If needed, an optional rail can be installed at table foot end of the Omega V table for other accessories
installation. The total weight of all devices installed on this rail shall remain below 20 kg.
In any case, always make sure the weight of devices on the table side-rail remains below 40 kg, and below
20 kg on the optional table foot end rail. Also, make sure the torque on each screw is below 64 N.m,
according to the following formula:
Torque = 10 x weight (kg) x distance to the rail (m).
For example, a 5 kg load, located 10 cm away from the rail, has a torque of : 10 x 5 (kg) x 0.1 (m) = 5 N.m.
To avoid damage to an accessory or the table covers, no accessory, such as an IV Pole or

Innova IVUS, should be placed too low or in the vicinity to come into contact with the table
covers during vertical or tilt motions.

Check that each accessory is properly mounted and clamped if provided with clamps before
any use.
2-8 Periodic maintenance and inspection
Periodic maintenance is required for continued SAFE operation. Qualified personnel should
perform periodic maintenance as specified in the maintenance schedule of the Service
Manual and Operator Manual.
• Descriptions and scheduled frequency of the required periodic maintenance are provided in the Service
documentation supplied with the equipment. It is the owner's responsibility to supply or arrange for this service.
Refer to Maintenance Schedule Chapter for the list of the periodic maintenance requirements.
• Inspection intervals are based on average daily use of one eight-hour shift. More frequent inspection is
appropriate where equipment use is above average. Refer to Section Safety and Regulatory / General Safety /
Be Sure the Equipment is Functioning Before each Use in this chapter or refer to the table below for details.
Daily Checks
Actions Refer to
-
Shutdown at least once per day
Gantry pivot axis check Safety and Regulatory / General Safety / Be Sure the Equipment is
Functioning Before each Use
Table up/down check Safety and Regulatory / General Safety / Be Sure the Equipment is
Collision sensors check Safety and Regulatory / General Safety / Be Sure the Equipment is
Diamentor constancy check Diamentor M4 KDK (Option) / Performing a Measurement / Constan-
cy Check
Innova Central touch screen Safety and Regulatory / General Safety / Be Sure the Equipment is
Monthly checks
Actions Refer to
Wall and control panel emergency stop Safety and Regulatory / General Safety / Be Sure the Equipment is
Suspensions cleaning Safety and Regulatory / Protection against contamination / infection /
allergy / toxicity hazards / biological hazards / Suspensions Cleaning
QAP check Quality Assurance Program (QAP) / Parameter monitoring / Fre-
quency
Check Once every 3 months

Action Refer to
UPS battery recharge if not used Innova Digital / Fluoroscopy and Acquisition / Fluoro UPS (Option)
FAILURE TO PERFORM THE PERIODIC INSPECTION AND MAINTENANCE COULD ALLOW

DETERIORATING CONDITIONS TO DEVELOP WITHOUT BEING DETECTED. THIS
DETERIORATION COULD RESULT IN EQUIPMENT FAILURES WHICH COULD CAUSE

SERIOUS INJURY OR EQUIPMENT DAMAGE.

2-9 Storage media
Put storage media (tapes, CDs) in safe conditions: temperature (see the instructions on CD
packages).
2-10 Extra Iodine Injection
When used in automatic mode, the injector can be triggered by the system before or after X-ray (X-ray delay or
Inject delay).
When the injector is fired before X-ray, there is always an unpredictable residual risk that X-ray will not start, so, the
injection could be lost (our internal data give a very low occurance rate).
Always use the X-ray delay mode (injection first then X-ray) only when clinically appropriate.
2-11 Image Presentation
The image presentation does not automatically follow the patient position over the table top
(Prone, Supine, Head to Toes reversed…). It is the responsibility of the Operator to control
the patient orientation on the image. Failure to control may lead to misinterpretation of the
image displayed for diagnostic purposes.
3 Protection against radiation

3-1 Biological Deterministic Effects of Dose
Biological effects of any dose should be divided into low and high levels. During most procedures, the effects of
patient irradiation are low. Cardiac or neurology procedures could give the patient high doses of radiation, and this
can be the cause of injuries to the patient (e.g.: skin injuries, alopecias). In order to minimize this risk without
adversely affecting the clinical objectives of the procedure, it is currently admitted that precautions should be taken
when skin dose in a single location can exceed 1 Gy.
Due to the duration of total fluoroscopic time and the number of acquisition sequences in a single location, the risk
is particularly important in cardiac and neurology procedures.
GE Healthcare equipment includes dose limitations mechanisms; in particular, the conventional entrance skin Air
Kerma rate is maintained below 88 mGy/min (10 R/min), or at a lower level depending of local regulation, in a plane
representative of patient skin dose, and positioned 30 cm from the entrance of the Image Receptor. Therefore, in
this plane, the value of 1 Gy may be reached in 10 to 12 minutes of fluoroscopy for thick body parts, or for body
parts of average patients viewed with a large angulation, or for obese patients; usual levels of fluoroscopy of the
head or for average patients without large angulation are 2 to 5 times lower.
In particular configurations required for an examination, patient skin could be significantly closer to the X-ray
source, with dose rate increased as the inverse square of the distance.
In case of long procedures and/or when X-ray is focused on a single location. Use low
fluoro and record detail in order to reduce risk of patient injury due to ionizing radiation and
other recommendation listed in Safety and Regulatory / Protection against radiation / How
to Reduce Radiation Exposure Dose.
3-2 Dose Monitoring
• "Dose monitoring" is a feature of the Innova system, displaying air kerma rate, cumulated air kerma and DAP.
• Output parameters are displayed in the DL console and on the live & reference displays.
• The dose levels are determined with a measurement method based on the measured Generator X-ray
Technique parameters (kVp, mAs), on the Spectral Filtration position reported by the collimator, on measured
mR/mAs calibration values obtained with a radiation dosemeter, and on a transfer function (computation).

• The air kerma (referred as "Exposure Dose" / "Rate") and exam dose (referred as "Exposure Dose" /
"Cumulated") parameters are computed for the Interventional Reference Point.
• The DAP (Dose Area Product) is computed based on collimator opening (FOV and collimation).
• The accuracy of the displayed dose rate and cumulated dose is ±35% down to 100 mGy for dose and 6
mGy/min for dose rate. The accuracy of the DAP is ±30% down to 2.5 Gy.cm2 for DAP.
3-3 Concept of Interventional Reference Point (Patient Entrance Reference Point)
The INTERVENTIONAL REFERENCE POINT (IRP) or PATIENT ENTRANCE REFERENCE POINT, is intended to
be representative of the point of intersection of the X-ray beam axis with the patient. For the GE Healthcare
systems including an isocenter, the IRP is the point on the reference axis 15 cm from the isocenter towards the
focal spot.
This distance is assumed to represent a good approximation of the value of the actual focal spot to skin distance
during interventional procedures. If one considers currently available methods to estimate absorbed doses to
selected tissues for radioscopic and cine-angiographic examinations of the coronary arteries of adults, these
methods rely on the use of distinct operating conditions commonly used in radiological examinations of the heart.
These operating conditions are associated with a view, an arterial projection, and technique factors on the X-ray
equipment such as the X-ray tube voltage (kV), the half value layer (HVL), and the focal spot to skin distance, the
focal spot to image receptor distance and the entrance field size.
A review of the operating conditions derived from analyses of practice indicates that the defined interventional
reference point is, in fact, a fair approximation of the focal spot to skin distance for each field. Unfortunately, similar
data are not available for non-cardiac diagnostic and interventional procedures.
Isocenter
The Isocenter is the point at which the rotational axes of the L-Arm and the rotational axis of the C-Arm intersect.
Focal Spot to Interventional Reference Point Distance
For Frontal plane X-ray Tube: 57 cm (22.4").
3-4 Significant Zone of Occupancy

There is a significant zone surrounding the table that identifies proximity to the radiation source. Included in the
significant area is the table side area where the Physician stands to perform the procedure.
3-5 Skin Spacer Use
EXPOSURE RATE IS APPROXIMATELY 1.5 TIMES GREATER AT 305 mm FROM THE FOCAL
SPOT THAN AT 380 mm. USE THE SKIN SPACER TO ENSURE A MINIMUM DISTANCE OF
380 mm.
3-6 How to Reduce Radiation Exposure Dose
3-6-1 Radiation Time
In Fluoro: check and control the elapsed fluoroscopy time. When possible change the entry point of the beam in
order to reduce local dose.
In Record: try to keep the frame rate at the lowest value compatible with medical requirements; minimize the total
sequence.
3-6-2 Protection

When the tube is positioned under the table the patient helps protect the staff.
Additional lead aprons and protective devices such as lead gloves, glasses and thyroid shields are also effective in
limiting occupational exposure dose.
IN ORDER TO REDUCE RISKS ASSOCIATED WITH IONIZING RADIATION AND FACILITATE

COMPLIANCE WITH LOCAL REGULATION CONCERNING RADIATION PROTECTION,
ALWAYS USE RADIATION SHIELDING DEVICES (CEILING MOUNTED AND TABLE-SIDE
RAD-SHIELDS). THEY WILL PROTECT THE OPERATOR AGAINST STRAY RADIATION
(RADIATION LEAKAGE PLUS RADIATION SCATTERED BY THE PATIENT); THIS
PROTECTION SHOULD BE CONSIDERED AS PARTICULARLY CRITICAL WHEN
PERFORMING INTERVENTIONAL OR LONG PROCEDURES.
3-6-3 Other Methods to decrease Exposure Dose
• Select a protocol with RDL auto exposure preference whenever possible.
• Select a protocol with "Max Dose Reduction" setting instead of "Balanced IQ/Dose" setting for Fluoro 15 fps, 7.5
fps and 3.75 fps (only for no sub fluoroscopy).
• Use Low fluoro detail whenever possible.
• Use lowest fluoro available frame rate whenever possible.
• Maximize the distance between the patient and the X-ray tube.
• Minimize the distance between the patient and the Image Receptor.
• Collimate.
• Remove grid only for infants up to 1 year old at Field of View smaller than 20 cm.
Note: Overall imaging efficiency, in terms of image quality achieved for a given Air Kerma, is equal or better using
grid and minimal air gap compared to no grid with air gap except for the smallest patient anatomies (e.g.: infants) at
Field of View smaller than 20 cm.
For all anatomies, except for infants (patients up to 1 year old) at Field of View smaller than 20 cm, it is preferable
to use the grid with minimum air gap.
3-7 Avoid Unnecessary Exposure to Radiation
When possible stay behind the lead glass radiation shield or lead screen.
When in unshielded areas wear protective apparel such as goggles, lead aprons, and gloves.
3-7-1 X-ray Without Image

In case of obvious X-ray emission (audible signal and/or red light signal on) without image on the live display,
perform the following actions:
1. Release the footswitch.
2. If X-ray are still emitted, depress the "RESET" button on the system console until the system resets.
3. If X-ray are still emitted, switch off the Power Distribution Box (PDB) by turning to OFF the RED PDB switcher
on the system cabinet, in the technical area.
3-8 Protective devices and Accessories
Refer to the accessories catalog for a complete list of available radio-protection devices. (Rad shield, gloves,
apron, glasses, etc.)
3-9 Retake - Improper Use
Improper use of the system could lead to retakes of diagnostic images, thus requiring
additional patient and operator exposure to radiation. Therefore, observe operating
instructions.
3-10 Dose and Dose Rate Measuring Procedure
This procedure is intended to provide the details to be able to conduct measurement of radiation data consistently
with radiation data documented in the user instructions specific to each vascular system.
3-10-1 Test Equipment
3-10-1-1 Phantom
Material - Polymethyl-methacrylate (PMMA)
Rectangular blocks with sides equal to or exceeding 25 cm.
Nominal thickness: 20 cm. (the phantom may be fabricated from layers of material) area density of the nominal 20
cm.
Phantom: 23.5 gcm-2 +/- 5 %.
3-10-1-2 Dosimeter
The measuring probe must be small enough to cover not more than 80 % of the area of the X-ray beam in the
plane of measurement and the area of its surface perpendicular to the source-detector axis must not exceed 30
cm².
3-10-2 Measurement Procedure
3-10-2-1 Relevant parameters
The following are the factors that need to be referenced, when relevant to the equipment settings concerned:
• Equipment configuration:
1. Orientation of the X-ray BEAM (vertical unless otherwise specified);
2. PATIENT SUPPORT in or out;
3. ANTI-SCATTER GRID in or out;
4. Appropriate ENTRANCE FIELD SIZE selected (FOV).
• Operating settings (representative of normal use):
1. Technical details of parameters included in each mode of operation;
2. Frame rate;
3. Selectable added filters automatically applied;
4. Selectable added filters manually applied.

• Test geometry:
1. Focal spot to image receptor distance (SID);
2. Focal spot to detector distance;
3. X-ray field size at the measuring detector;
4. Positioning of phantom;
5. Positioning of measuring detector.
For each of these factors, a value is assigned and is indicated prior the radiation data stated (see hereafter in the
user instructions specific to each vascular system) they must absolutely be used in case of measurement of
radiation data.
3-10-2-2 Positioning of phantom and measuring chamber
The phantom is placed near the image receptor, leaving as much of the available distance as possible between the
X-ray tube assembly and the entrance surface of the phantom. (This is to minimize the effect of scattered radiation
on the measurements). Refer to radiation data in the user instructions specific to each vascular system.
Recommendation:
Position the measuring detector at a point that is either at the interventional reference point (see Safety and
Regulatory / Protection against radiation / Concept of Interventional Reference Point (Patient Entrance Reference
Point) (only if there is at least 20 cm distance between the measuring detector and the phantom) or half-way
between the focal spot and the entrance surface of the phantom. In that case, the readings are to be corrected to
the appropriate distance. Any other position that would minimize stray radiation may be used.
The surface of the phantom must be aligned perpendicular to the X-ray beam axis within ±2 degrees in all
directions.
3-10-2-3 Checking the test conditions
Before any dosimetric measurements are done, verify that the equipment settings under test and the associated
measuring arrangements are in compliance with Configurations of the equipment and test geometries defined
in radiation data in the user instructions specific to each vascular system.
Dosimetry is not to proceed, and therefore compliance with dosimetric statements cannot be determined, unless
the associated information is in itself compliant.
3-10-2-4 Basic measurements
Measure the dose rate (air kerma rate) for each of the radioscopic settings.
Measure the air kerma per image for each radiographic settings.
Measurements are made using the 20 cm phantom.
3-10-2-5 Operator selectable parameters
For settings in normal mode measured in previous paragraph "Basic measurements", measure the dose rate (air
kerma rate) using the nominal 20 cm PMMA phantom:
• for each operator selectable entrance field size (FOV); (as defined in radiation data).
• for each operator selectable added filter; (if applicable as defined in radiation data).
• for each operator selectable pulse repetition frequency; (if applicable).
3-10-3 Compliance Criteria
From the measured values obtained in the tests, calculate the corresponding values of reference air kerma (rate) at
Interventional Reference Point by using the inverse square law if necessary.
Compliance is verified if:
• no value stated in the instructions for use (hereafter in paragraph "radiation data") differs from the

corresponding calculated value by more than 50 % of the stated value;

• in respect with the two radioscopic modes of operation, the ratio of the "normal" value to the "low" value is not
less than 2*.
The values are only valid for the factory settings. When settings are changed they may deviate.
* In some isolated specific cases, a normal to low ratio down to 1.8 could be seen. Compliance is maintained since
these are isolated cases, with a ratio difference comparable to the typical measurement gage and since other
means are available to the operator to reduce the reference air kerma rate (FOV change, fps change, Autoexp
selection change), and therefore an equivalent safety can be maintained.
4 Protection against electrical hazards

4-1 Covers
DO NOT REMOVE COVERS OR PANELS. OPERATOR CONSOLE AND CABINETS CONTAIN

HIGH VOLTAGE CIRCUITS FOR GENERATING AND CONTROLLING X-RAYS. PREVENT
POSSIBLE ELECTRIC SHOCK BY LEAVING COVERS OR PANELS ON THE EQUIPMENT.
THERE ARE NO OPERATOR SERVICEABLE PARTS OR ADJUSTMENTS INSIDE THE
CABINETS. ONLY TRAINED AND QUALIFIED PERSONNEL SHOULD BE PERMITTED
ACCESS TO THE INTERNAL PARTS OF THIS EQUIPMENT.
4-2 Cabinet Air Flow
Do not lay any object on the cabinets that would restrict airflow from the top of the cabinet.
4-3 Uninterruptible Power Supply UPS
AFTER POWERING OFF THE SYSTEM BY THE GENERAL BREAKER OR THE CONSOLE
ON/OFF, SOME PARTS CONTINUE TO BE ENERGIZED THROUGH A BATTERY FOR A
COUPLE OF MINUTES IN ORDER TO PROPERLY SHUTDOWN THE COMPUTERIZED
COMPONENTS. BEFORE INSPECTING OR SERVICING THE SYSTEM, ENSURE THAT ALL
PARTS ARE CORRECTLY DE-ENERGIZED. (REFER TO THE SAFETY PROCEDURE DEFINED
IN THE SERVICE MANUAL).
4-4 Laser
A laser product is used to connect external modalities to the Large Display Monitor.
This product implements an optical module used for data transmission, manufactured by OPTICIS CO., LTD., and
classified as laser Class 1.
Center wavelength minimum = 1300 nm and maximum = 1550 nm.
Invisible LED radiation not in excess of class 1 safety limits (CDRH and EN 60825).
If applicable:
Switch off the laser product before moving optical fibers.
Do not put your eye in front of the laser diode aperture.
Class 1 Laser Product
5 Protection against mechanical hazards

5-1 Patient Positioning on Tabletop

The system anti collision device is based on a virtual volume representing the patient loaded on the tabletop in
"standard position".
This "standard position" is defined as head of the patient located at head end (gantry side) of the tabletop.
1 Patient Head
For any other position of the patient over the table top (use of table head extender, patient positioned lower on the
table top, patient head to toes reversed...), a special attention is required from users to watch any gantry motion
when approaching the patient, the virtual patient volume being in this case not in the same location than the patient
on the table top.
5-2 Use Extreme Care when Positioning the Equipment
The safety of everyone near the moving equipment depends on the operator at the controls. Although collision
sensors are provided on the image receptor and collimator, they are not intended to be a substitute for careful
operation. Be sure the equipment path is clear before starting a motion. When positioning the equipment, carefully
observe the moving parts, and stop the motion before making contact. The sensors are provided for added
protection in case of inadvertent contact, and are not to be relied on as a normal means for stopping the motion.
Improper equipment positioning could result in serious injury or equipment damage.
THE OPERATOR'S ATTENTION IS DRAWN TO THE PRESSURE THAT MAY BE APPLIED ON

THE PATIENT BODY IN CASE OF ACTIVATION OF SYSTEM ANTI-COLLISION DEVICES
(BUMPERS, SWITCH PLATE). EVEN IF THE PRESSURE APPLIED IS FAR FROM 200 N (20
kg) WHICH IS THE MAXIMUM PRESSURE RECOMMENDED BY SAFETY STANDARD FOR
INTENTIONAL APPLICATION OF AN ACCESSORY ON THE PATIENT BODY FOR CLINICAL
PURPOSE, THE PRESSURE MAY SOMETIMES BE IMPORTANT FOR PATIENTS HAVING
UNDERGONE RECENT SURGERY (ON THE THORAX/ABDOMEN FOR INSTANCE).
SPECIAL ATTENTION MUST BE TAKEN REGARDING THE POSITIONING OF THE IN-ROOM

MONITOR SUSPENSION. BEFORE RAISING OR TILTING (IF APPLICABLE) THE TABLE,
ALWAYS POSITION THE MONITOR SUSPENSION TO AVOID COLISION WITH THE PATIENT
AND THE EQUIPMENT. FAILURE TO THIS RECOMMENDATION MAY CREATE PATIENT
INJURY AND/OR EQUIPMENT DAMAGE.
IN THE "FOLLOW THE GANTRY" MODE, USER’S ATTENTION IS MORE FOCUSED ON THE
AW IN-ROOM MONITOR THAN ON THE MOVING GANTRY. DURING SUCH OPERATION,
ALSO KEEP CONSTANT ATTENTION TO THE GANTRY TO AVOID COLLISION WITH THE
PATIENT AND PEOPLE WORKING CLOSE TO THE GANTRY. FAILURE TO FOLLOW THIS
RECOMMENDATION COULD RESULT IN SEVERE INJURIES TO THE PATIENT OR STAFF
WORKING IN THE ROOM.
SPECIAL ATTENTION MUST BE TAKEN WHEN MOVING THE SUSPENSION OR IF THE

GANTRY PUSHES THE SUSPENSION IN ORDER TO AVOID COLLISIONS WITH THE
PATIENT OR THE USERS.

Always use proper accessories to hold the patient and prevent risk of injury during the
motion of the equipment.
5-3 Movement of Patient on the Table
Never leave the patient unattended. An unattended patient could fall from the table, activate
a motion control, or encounter other problem, which could be hazardous. In addition, it is
recommended to use restraints, such as Velcro straps. The restraints limit, but do not
eliminate the risk for the Patient to fall; in no way they can be used to support the Patient
weight.
With a InnovaIQ Table, Velcro straps are not appropriate to immobilize the patient when the table is tilted,
patient could slightly slide over the mattress and be hurt by the Velcro straps. To prevent the risk for the
patient to fall, never leave the patient unattended while the table is tilted.
The Omega tabletop mattress is provided with three Velcro strips on each side. The InnovaIQ Table Top
mattress is provided with a set of Velcro strips on bottom side. While loading or unloading the patient, it is
recommended to grip the Velcro strips to avoid the mattress shifting.
Ensure the Velcro strips are well stuck on the tabletop prior to loading or unloading the patient.
5-4 System Collision

Anti-collision software and sensors are provided for patient safety. The sensor pads, which surround the X-ray tube
and the Image Receptor, contain pressure sensitive collision sensors. There is one level of collision sensing for
X-ray tube sensor and there are two levels for Image Receptor sensor.
DEPENDING ON SYSTEM CONFIGURATION: THE REAR OF THE IMAGE RECEPTOR LIFT IS

NOT PROTECTED BY COLLISION SENSOR. WHEN THE GANTRY L-ARM IS ROTATED BY
AT LEAST +45°, A COLLISION BETWEEN THE REAR OF THE IMAGE RECEPTOR LIFT AND
THE PATIENT COULD OCCUR DURING A GANTRY MOTION. SPECIAL ATTENTION TO THE
PATIENT IS REQUIRED WHEN WORKING WITH THE GANTRY L-ARM ROTATED BY AT
LEAST +45°.
5-5 Split or Punctured Table
A SPLIT OR PUNCTURED TABLETOP MAY INJURE PATIENT AND OPERATOR HAND.

REPLACE TABLETOP IMMEDIATELY.
SIGNIFICANT TABLETOP DAMAGE WILL REDUCE STRUCTURAL INTEGRITY AND REQUIRE IMMEDIATE
REPLACEMENT OF TABLETOP. MINOR DAMAGE, SPLINTERS, AND CHIPS, WILL NOT REDUCE
INTEGRITY BUT REQUIRE CARE IN USE AND PATIENT POSITIONING TO AVOID INJURY.

5-6 Driving the Table
DRIVING THE TABLE TOP INTO FIXED OBJECTS MAY SEVERELY INJURE PATIENT. BE
SURE TO CHECK FOR OBSTRUCTIONS ABOVE AND BELOW THE TABLE BEFORE
RAISING OR LOWERING THE TABLE TOP.
5-7 Cardiac Pulmonary Resuscitation (CPR)
IF CARDIAC PULMONARY RESUSCITATION (CPR) IS REQUIRED WHILE THE PATIENT IS

ON THE TABLE, IT IS MANDATORY TO MOVE THE TABLE TOP TOWARD THE FOOT END,
POSITIONING IT OVER THE BASE OF THE TABLE AS DEMONSTRATED BY THE TWO
LABELS LOCATED ON THE SIDE OF THE TABLE BASE. CPR CAN THEN BE PERFORMED.
AT NO TIME SHOULD AN ADDITIONAL PERSON OR HEAVY EQUIPMENT BE PLACED ON
THE TABLE TOP WHILE PERFORMING CPR. ALWAYS MAINTAIN SUFFICIENT CLEARANCE
AROUND THE PATIENT SO AS TO BE ABLE TO CONDUCT CPR.
5-7-1 CPR with InnovaIQ Table

CPR position can be reached by manually moving all needed axes.
In addition, InnovaIQ Table allows positioning of CPR by using the TSSC Auto Positioner.
Using the operator selector, toggle the left arrow from operator "1" or the right arrow from operator "9" (or "F"
depending on your configuration), to select operator "C"
When the "C" operator is selected, a message appears on the monitors until the CPR position is reached or "C"
operator is deselected. Pressing down while simultaneously tilting UP or DOWN on the Auto Positioner joystick will
automatically move all table and gantry axis in such a way that:
• Table tilt is moved back to horizontal position.
• Table top is moved toward the foot end.
• Table height is moved at least at 15 cm below the gantry isocenter.
CPR can be performed when the system is in the above position.
In addition to reaching the CPR position as described above, the Auto Positioning also reaches the following
positions:
• Gantry pivot and gantry C-arm are moved to PA position (0°).
• Detector is moved to its highest position.
• Table height is lowered to 20 or 25 cm below the gantry isocenter (depending on your configuration).
Note: If the table is tilted, it is recommended to move to a CPR position using the Auto Positioner on the TSSC.
A CPR COMMAND CANNOT BE COMPLETED AFTER THE POSITIONER ENABLE/DISABLE

BUTTON IS ACTIVATED ON THE INNOVAIQ TABLE SMART BOX (BUTTON 7). IN CASE A
CPR COMMAND IS REQUIRED, ENABLE FIRST THE POSITIONER (BUTTON LIGHT OFF)
PRIOR TO PERFORMING A CPR COMMAND.

THE CPR AUTO POSITIONING CAN NOT BE COMPLETED IN CASE OF COLLISION OR IF

ONE OF THE TABLE OR GANTRY AXIS IS NOT FUNCTIONAL (I.E. TABLE OR GANTRY
WORKING IN DEGRADED MODE). IN SUCH CASE, USE MANUAL COMMANDS TO MOVE
THE PATIENT TO CPR POSITION.
THE GANTRY AND TABLE MOTIONS MAY BE SLOWED DOWN BECAUSE OF A NEAR
COLLISION RISK. IN THIS CASE, IT MAY BE FASTER TO USE MANUAL COMMANDS TO
MOVE THE PATIENT TO A CPR POSITION.
5-7-2 CPR with Omega Table
CPR position can be reached by manually moving all needed axes.
To reach CPR position, move the table top toward the foot end. CPR can be performed when the system is in this
position.
In addition to reaching the CPR position as described above, the table height may be lowered and Detector may be
moved to its highest position.
In the event of power loss the table may be manually pushed longitudinally to the foot end
and rotated. This operation may require more than one person.
5-8 Patient Loading/Unloading
BEFORE LOADING OR UNLOADING THE PATIENT ONTO OR OFF THE TABLE:
1 - CHECK / BRING BACK THE TABLE TOP TO HORIZONTAL POSITION.

2 - ADJUST THE TABLE HEIGHT AND MOVE THE TABLE TOP TOWARD THE FOOT END FOR THE BEST
PATIENT ACCESS.
3 - ACTIVATE THE POSITIONER DISABLE BUTTON TO ENSURE THAT NONE OF THE TABLE AND GANTRY
WILL MOVE.
4 - DISABLE X-RAY.
5 - REMOVE ALL ACCESSORIES AND CONTROLS.
6 - HOLD THE TABLETOP.
ALSO, THE PATIENT SHOULD BE SECURELY SUPPORTED BY HOSPITAL STAFF AS THE TRANSFER IS
MADE FROM BED/GURNEY TO TABLE AND VICE VERSA.
With the Omega Table, the Positioner Enable/Desable button only enables/disables
commands from the Smart Box/Handle and Table Side Status Control. It does not
enable/disable table top brakes command from the Fluoro/Record footswitch or the Table
Panning handle. This caution is not applicable on InnovaIQ Table.
In case of table hang when tilted which cannot recover after a system reset, a tilting
bed/gurney should be used to securely transfer the patient from the tilted table to the tilted
bed/gurney. Also, hold the tabletop and securely support the patient as the transfer is made
from table to bed/gurney. It is mandatory to comply with these instructions in order to
minimize the risk of patient falling from table during unloading process.
System User Interface

Omega Smart Box
InnovaIQ Table (IR configuration) Smart Box
InnovaIQ Table (OR configuration) Smart Box

Omega Smart Handle
7 Positioner Enable/Disable: activate this button to disable all table/gantry axis commands (button light ON).
Press again on this button to reactivate all table/gantry axis commands (button light OFF)
5-9 Clearance of the Patient in case of Emergency (Power Loss, Equipment Failures)
In the event of power loss with the patient positioned between the image receptor and table,
the patient may be released by manually moving the table longitudinally to the foot end and
then rotating it. In case of InnovaIQ Table, the table rotation only can be manually performed.
This operation may require more than one person.
5-10 Check Equipment after collision

In case of collision between two parts of the system (e.g. gantry against a monitor) have the parts carefully
inspected before resuming the procedure.
5-11 Table Brakes failure
IN CASE OF FAILURE OF THE TABLE BRAKES, IT IS STILL POSSIBLE TO OVERCOME THE

TABLE BRAKES LOCK BY PUSHING MANUALLY ON THE TABLE TOP WITH SUFFICIENT
STRENGTH SO AS TO CLEAR THE PATIENT AS NEEDED IN CASE OF EMERGENCY
SITUATION.

IN CASE OF INNOVAIQ TABLE, THE TABLE ROTATION ONLY CAN BE MANUALLY PERFORMED. THIS
OPERATION MAY REQUIRE MORE THAN ONE PERSON.
5-12 3rd Party Imaging/Data Medical Device
For 3rd party imaging/data medical devices, refer to the safety recommendations in sections: Cathlab Frontiers
Solutions (Option) and Workstation Configuration / CA 1000 Workstation Configuration (Option).
6 Protection against contamination / infection / allergy / toxicity hazards /

biological hazards
THE MATTRESS DELIVERED WITH THE OMEGA TABLE IS NOT FULLY WATERPROOF. TO
AVOID MATTRESS CONTAMINATION DUE TO FLUID ABSORPTION AND BIOLOGICAL
HAZARDS, ALWAYS USE A SLICKER (COVER THE MATTRESS WITH A FULLY
WATERPROOF SHEET OR COVER) BEFORE INSTALLING THE PATIENT ON THE
MATTRESS.
THE MATTRESS DELIVERED WITH THE INNOVAIQ TABLE IS WATERPROOF IN NORMAL

CONDITIONS. DO NOT USE A SLICKER WITH THIS MATTRESS TO AVOID MATTRESS OR
PATIENT SLIPPAGE DURING TILT PROCEDURES. IN CASE OF CONTAMINATION INSIDE
THE MATTRESS COVER DUE TO FLUID ABSORPTION, IT IS MANDATORY TO REPLACE
THE MATTRESS WITH THE SAME MODEL.
ALWAYS COVER THE TABLETOP WITH A SHEET OR A MATTRESS BEFORE INSTALLING

THE PATIENT ON THE TABLE TO PREVENT THE DIRECT CONTACT OF THE PATIENT WITH
THE TABLETOP.
Mattress should be used with Omega tables. Mattress, slickers or sheets in direct contact with the patient must be
ISO 10993 certified.
6-1 General Information
In order to prevent any patient contamination and according to the local regulation, after
each procedure, thoroughly clean and disinfect any parts likely to become soiled during
use. This includes parts which were in patient vicinity or in contact with the patient and any
parts that could be contaminated by operators, in particular the waterproof mattress.
Improper cleaning methods or the use of certain cleaning and disinfecting agents can
damage the equipment, cause poor imaging performance or increase the risk of electric
shock.
To avoid possible injury or equipment damage:
• Do not use harsh detergents, abrasive cleaners, high alcohol concentration or Methanol at any concentration.
• Do not expose equipment parts to steam or high temperature sterilization.
• Never allow liquids to enter the internal parts of the equipment. Do not apply cleaning sprays or liquids directly
to the equipment; always use a clean cloth dampened with the spray or liquid. If you become aware of liquid
entry, disconnect the electrical supply and have the equipment checked by qualified service personnel before
returning it to use.
6-2 Equipment Cleaning Instructions
The entire system surfaces should be scrubbed as needed using a soft, damp gauze or cloth to remove all visible
residue. Scrubbing with a soft bristle brush (such as a toothbrush) may be necessary to reach corners or to remove
material that has dried onto the surface.
Subsequent disinfection may not be effective if the surfaces are not thoroughly clean.
Rinse all surfaces with clean water to remove visible soap residue, taking care to avoid liquid entry to internal

equipment parts. Dry surfaces with a soft cloth to remove any visible residue.
Due to the relationship between length and multiple widths of the mattress, it is absolutely recommended not to
remove the cover from the mattress for laundry. Otherwise, it would then be extremely difficult to reposition the
mattress in its cover.
Although the footswitches are compliant with the applicable standards, it is recommended
to avoid liquid (bodily fluids, contrast agents, cleaning agents...) ingress into the footswitch.
In case of liquid ingress, ensure the footswitch is thoroughly rinsed and dried. In addition
we recommend to put a drape over the footswitch to avoid any bodily fluids, contrast
agents, cleaning agents ingress.
6-3 Suspensions Cleaning

At least once a month, external metallic surfaces and exposed tracks, should be wiped to remove any foreign
material that may have accumulated.
If the tracks are wiped with a cloth slightly moistened with oil, sufficient lubrication will be provided to insure smooth
operations and to protect again rust. Enameled surfaces should be cleaned using a clean cloth moistened slightly
with a good mild cleaner and polish acceptable for such use.
6-4 Disinfection
Exam room equipment including system, monitors, suspensions and accessories, can be disinfected with suitable
liquid chemical germicide, bactericide and antiviral. Surfaces must first be cleaned of all visible contamination (see
above). The disinfecting liquid must have a minimum contact time with the surface to be effective. Equipment parts
should be wiped with a wet cloth as directed by the instructions for use provided with the disinfecting liquid. Further
rinsing or wiping with clear water and drying with a soft cloth should be done to remove any disinfecting liquid
residue that may remain. Take care to avoid liquid entry to internal equipment parts.
Note: Only handles from the Large Display Monitor suspension can be disinfected.
For non GE equipment refer to respective device manufacturers instructions and

recommendations for cleaning and disinfection.
6-5 High Level Disinfection

In the event that you feel a high level disinfection is necessary due to equipment contact with broken skin, or being
used with infected or immune compromised patients, the same patient contact surfaces may be high level

disinfected with a liquid chemical germicide rated for high-level disinfections. The same process used as that for
intermediate level disinfections is generally followed; however, the time of contact is usually much longer for
high-level disinfections.
6-6 Recommended Cleaning Agents
• Soap with lukewarm water.
6-7 Recommended Disinfecting Agents
The following legally marked products have been used on GE equipment without causing equipment damage.
• SURFANIOS (Supplier: ANIOS)
• CLEANSINALD (Supplier: TASKI) replacing the TASKI DS 5001 no more available
• MORNING MIST (Supplier: BUTCHERS)
6-8 Guidance for the Use of the Cleaning and Disinfecting Agents Listed
Note: For the Large Display Monitor, only Surfanios, Cleansinald and Morning Mist products have been tested.
Always follow the cleaning and disinfecting agents manufacturer's instructions and
precautions for mixing, storage, method of application, contact time, rinsing requirements,
protective clothing, shelf life and disposal to help assure effective and safe use of the
product.
6-9 Flammable Gasses
Do not use equipment in the presence of flammable gasses.
6-10 Latex
There is no presence of latex in the system and no part in contact with the patient contains latex.
7 Protection against effect of incorrect output data sent to network (Dicom)

Attention of users is drawn on the fact that data sent through Dicom network are not fail-safe.
FOR EVERY EQUIPMENT CONNECTED ON THE NETWORK AND USING DICOM, USERS
MUST VERIFY THE COMPATIBILITY THROUGH DICOM CONFORMANCE STATEMENT
7-1 Stenosis Analysis on networked devices

Stenosis Analysis used on networked devices and using data acquired on the angiography equipment must be
used with the equivalent precautions as those described for the equipment (See the specific Stenosis Analysis
chapter of this manual).

Chapter 4 - Safety and Regulatory Instructions for Use

X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR. UNLESS
MEASURES OF PROTECTION ARE STRICTLY OBSERVED. THOUGH THIS EQUIPMENT IS

BUILT TO THE HIGHEST STANDARDS OF ELECTRICAL AND MECHANICAL SAFETY, THE
USEFUL X-RAY BEAM BECOMES A SOURCE OF DANGER IN THE HANDS OF THE
UNAUTHORIZED OR UNQUALIFIED OPERATOR. EXCESSIVE EXPOSURE TO X-RAY
RADIATION CAUSES DAMAGE TO HUMAN TISSUE. THEREFORE, ADEQUATE
PRECAUTIONS MUST BE TAKEN TO PREVENT UNAUTHORIZED OR UNQUALIFIED
PERSONS FROM OPERATING THIS EQUIPMENT OR EXPOSING THEMSELVES OR OTHERS
TO ITS RADIATION. BEFORE OPERATION, PERSONS QUALIFIED AND AUTHORIZED TO
OPERATE THIS EQUIPMENT SHOULD BE FAMILIAR WITH THE RECOMMENDATIONS OF
THE INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, CONTAINED IN
ANNALS NUMBER 26 OF THE ICRP, AND WITH APPLICABLE NATIONAL STANDARDS.
1 Indications for Use

The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating
fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic
and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and
rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
2 Safety
2-1 Environmental Conditions
The conformity with the standard IEC 60601-1 series has been established for an ambient temperature up to 32°
Celsius.
2-2 Equipment Classifications
The following equipment classifications are applicable to the product:
Classification category Equipment classification

Protection against electric shock Class I*.
TO AVOID THE RISK OF ELECTRIC
SHOCK, THIS EQUIPMENT MUST ONLY BE CON-

NECTED TO A SUPPLY MAINS WITH PROTECTIVE
EARTH.
Safety and Regulatory Instructions for Use 73

Degree of protection against electric shock Type B applied parts
Applied parts complying with the specified requirements

of the IEC 60601-1 standard to provide protection against
electric shock, particularly regarding allowable patient
leakage current and patient auxiliary current include:
- Mattress of the InnovaIQ table, Patient support of
Omega table
- Table accessories: shoulder rest, foot rest, table head
extender, head widener with pad/cushion, width extender
with pad/cushion, armboard with thick pad/cushion, rail
extender and patient restraint strap with cushion.
Degree of protection against harmful ingress of water Ordinary equipment (enclosed equipment without protec-
tion against ingress of water); except footswitch which is
a IPX8 device (protected against the effects of submer-
sion).
Systems with OR table: Table, TSSC, Smart Box, Table
Panning Device, and Innova Central touch screen are
IPX4 devices (protected against the effects of splashing).
Method(s) of sterilization or disinfection recommendedby Sterilization: not applicable.
the manufacturer Disinfection: refer to operator manual (Chapter Safety
and Regulatory section Disinfection), recommended dis-
infecting agents.
Degree of safety of application in the presence of a flam- Equipment not suitable for use in the presence of a flam-
mable anesthetic mixture with air or with oxygen or ni- mable anesthetic mixture with air or with oxygen or ni-
trous oxide trous oxide.
Mode of operation Continuous operation with intermittent loading.
Laser Class 1
The OR table mattress has antistatic properties. As it is connected to the ground and placed on a conductive
tabletop, this provides an antistatic leakage path for the surgical configuration: it is mandatory to use the OR table
mattress provided with the equipment.
* Classification Exemption:
The following accessible conductible parts are grounded.
74 Safety and Regulatory Instructions for Use

Omega Smart Box: Item 1
InnovaIQ Table (IR configuration) Smart Box: Item 1
InnovaIQ Table (OR configuration) Smart Box: Item 1

The Innova systems are compliant to electromagnetic compatibility IEC 60601-1-2 Edition 2.1 (2004) and Edition 3
(2007) standards for medical devices.
For further information, see the pre-installation manual.
3 Electrical Hazards
3-1 Power-off the System
AFTER THE SYTEM IS POWERED-OFF BY THE INNOVA CONSOLE OR THE PDB (POWER
DISTRIBUTION BOX), THE FOLLOWING COMPONENTS ARE STILL ACTIVATED BY THE
UPS (UN-INTERRUPTIBLE POWER SUPPLY) BATTERY FOR ABOUT 5 MINUTES. IT
ALLOWS THE COMPUTERIZED COMPONENTS OF THE SYSTEM TO BE PROPERLY
SHUTDOWN:
• C1 CABINET
• INNOVA DIGITAL SCREEN AND REMOTE KVM POWER SUPPLY (MOUSE AND KEYBOARD POWER
SUPPLY BOX)
• THE LARGE DISPLAY CABINET IN THE TECHNICAL ROOM AND THE LARGE DISPLAY MONITOR IN
THE EXAM ROOM
IN CASE OF UNSAFE SITUATION, PRESS THE GENERAL EMERGENCY STOP BUTTON

LOCATED AT 1.5 METERS ABOVE THE FLOOR NEAR THE ACCESS DOOR. THIS BUTTON
WILL SHUT DOWN ALL THE SYSTEM COMPONENTS STILL ACTIVATED BY THE UPS
BATTERY.
3-2 Emergency Power OFF/STOP Procedure
Your system has a large Emergency Power OFF/STOP Button installed at an accessible location.

Emergency Power Off/Stop button
An Emergency Power OFF/STOP Button is also located on the Power Distribution Box (PDB).
PRESS THE EMERGENCY POWER OFF/STOP BUTTON ANYTIME THERE IS AN

EMERGENCY CONDITION. THIS WILL REMOVE ALL POWER FROM THE SYSTEM.
• The emergency button should be used for emergencies only.
3-3 Emergency STOP Recovery
After an emergency, if you have used the Emergency STOP button, the system can be returned to normal
operation by using few basic start up steps:
1. Unlock the Emergency STOP Button.
2. On the Power Distribution Box (PDB), reset the main circuit breaker in case it was switched OFF.
3. On the Power Distribution Box (PDB), press on the ON Button.
PDB EU PDB UL
1 - ON 1 - ON
2 - OFF 2 - OFF
4. If available, check that the Fluoro UPS is ON.

5. If the Large Display Monitor option is installed:
– Push the Large Display Cabinet UPS ON push button during 3 s (Item 1).

– Wait for 30 s that the UPS "Power On Indicator" stays ON (no more blinking) (Item 2).
6. Press the ON button on the Innova console for 0.5 seconds.
4 Protection regarding Ionizing Radiations Hazards for Innova IGS 520

Innova product is provided with a choice of 4 AutoExposure Preferences: "IQ Plus", "IQ Standard", "RDL Plus
(Receptor Dose Limited Plus)" and "RDL Standard (Receptor Dose Limited Standard)". Doses ratio are measured
as per IEC 60601-2-43 conditions.
• IQ Plus - High Contrast, 100% Dose
lQ Plus produces images of arteries and guidewires optimized for high object contrast at a nominal dose of
100%.
• IQ Standard - Low Noise, 70% Dose
Using approximately 70% of the dose of IQ Plus, lQ Standard is optimized to produce images with low
fluoroscopic scintillation noise.
• Receptor Dose Limited Plus - High Contrast, 55% Dose
Using approximately 55% of the dose of IQ Plus, Receptor Dose Limited Plus (RDL Plus) is optimized to
produce images with high contrast.
• Receptor Dose Limited Standard - Low Noise, 35% Dose
Working with a low dose - approximately 35% of that of IQ Plus - Receptor Dose Limited Standard (RDLS) is
optimized to produce images with low fluoroscopic scintillation noise and recommended for long time
procedures.
Dose Reduction Strategy allows two modes selection for the Fluoro low Frame Rates, 15 fps and 7.5 fps: either the
"Balanced IQ/Dose" mode allowing up to 25% (with Fluoro 15 fps) and up to 44% (with Fluoro 7.5 fps) dose
reduction versus Fluoro 30 fps or the "Max Dose Reduction" mode allowing up to 50% (with Fluoro 15 fps) and up
to 75% (with Fluoro 7.5 fps) dose reduction versus Fluoro 30 fps.
For both dose reduction strategies, Fluoro 3.75 fps offers 50% dose reduction compared to Fluoro 7.5 fps.

AutoExposure preferences and dose reduction strategy is set by Service via the Service User Interface (SUIF).
Dose for Low Detail mode is about 50% of Normal Detail mode for Fluoroscopy, Dynamic Record and
InnovaChaseTM (except for Fluoroscopy around high reference dose (87 mGy, 43 mGy, 21 mGy)), and < 60% of
Normal Detail dose for DSA, Bolus and 3DCT.
Depending on system configuration and available options, the Normal detail for unsubtracted Fluoroscopy is further
optimized for dynamic situations to visualize fast moving objects: High Contrast Fluoroscopy (HCF) option, for
Normal (HCF) detail.
Depending on system configuration and available options, several acquisition modes can be available.
• DSA mode: primary use for general angiography procedures.
• Innova 3D (3D) mode / Innova CT (3DCT) mode: primary use for 3D reconstruction and display of any region of
interest.
• Dynamic Record mode: primary use for general cardiac procedures.
• InnovaChaseTM mode: primary use for angiography procedures not requiring subtraction.
4-1 Mode of Operation
4-1-1 Innova Digital
1 Field of View selection depending on the detector size

2 Record mode selection: DSA, 3D, 3DCT, Chase, Dynamic
Fluoro mode selection: No Sub, Sub, Roadmap
3 Fluoro parameters selection: frame rate, detail level
Fluoro technique parameters display: kV, mA and spectral filtration

4 Record parameters selection: frame rate, detail level

Record technique parameters display: kV, mA, ms and spectral filtration
5 Record AutoExposure: IQ Standard, Receptor Dose Limited, IQ Plus, Receptor Dose Limited Plus,
Fluoro AutoExposure: IQ Standard, Receptor Dose Limited, IQ Plus, Receptor Dose Limited Plus,
Fluoro Dose Reduction Strategy: Balanced IQ, Max Dose Reduction
4-1-2 Reference Display
1 Record parameters display: record mode, detail level, frame rate, acquisition duration and X-ray/inject delay
Record technique parameters display: kV, mA (peak for DSA and Chase, otherwise: average), ms
2 Fluoro parameters display: fluoro mode, detail level and frame rate
Fluoro technique parameters display: kV, mA
4-1-3 Live Display

1 Selected FOV display
4-1-4 Table Side Status Control (TSSC)
4 FOV/2 switches + 1 digital display

13 Fluoro Detail Level
11 Fluoro NoSub/Sub, NoSub/Roadmap or NoSub/Blended Roadmap

4-1-5 Innova Central touch screen
Record Screen
1 Record mode selection: DSA, 3D, 3DCT, Chase, Dynamic


Fluoro Screen
1 Protocols from Anatomical List

2 Image Flip for patient orientation
3 Fluoro mode selection: NoSub, Sub, Roadmap, Blended Roadmap
4 Simultaneous Display of live display 1 and live display 2 of Subtracted and NoSub Fluoro when in a subtract-
ed fluoro mode
6 Landscape percentage change of any subtracted fluoro image. If in Blended Roadmap, the label changes to
Landscape/Vessels
4-2 Dose to Patient

Note 1: Fluoroscopy, Subtracted Fluoroscopy, Roadmap and Blended Roadmap acquisition modes belong to the
Fluoroscopy category, while all the other modes belong to Radiography.
Note 2: Roadmap, Blended Roadmap and Subtracted Fluoroscopy specific settings are the same, thus tables are
only provided for Roadmap, the Roadmap radiation data are directly applicable for Blended Roadmap and
Subtracted Fluoroscopy as well.
Note 3: InnovaSpinTM acquisitions use the same settings as as standard Cardiac or InnovaChaseTM acquisitions.
Note 4: Fluoroscopy doses in Adult and Pediatric modes are the same at identical frame rate and detail level, thus
no separate dose tables are provided for these modes. Primary dose reduction in case of pediatrics exams is
achieved by setting the default detail and frame rate to low in Pediatric protocols. For more detail on pediatric dose
reduction please refer to Appendix - Radiation Safety Tutorial / Dose settings for pediatrics in Innova systems.

Note 5: 3D acquisition can be used in unsubtracted and subtracted modes. In these cases the same loading
factors are used, that results in identical dose/ frame values. For this reason detailed data are provided only for
unsubtracted 3D. Since subtracted 3D requires 2 consecutive spins, thus the integrated dose in sub 3D is the
double of unsubtracted 3D acquisition.
Note 6: Unsubtracted fluoroscopy in 3.75 fps uses the same settings per frame as in 7.5 fps. This results in
identical kVp, pulse width, and spectral filters, while the time averaged mA and dose rate in 3.75 fps fluoroscopy
are half of the corresponding 7.5 fps values. Because of this direct relationship separate tables for 3.75 fps are not
provided.
Note 7: Loading factors and dose rate tables for High Contrast Fluoroscopy (HCF) option are provided for Normal
detail only, since this option is active in Normal fluoro detail only.
4-2-1 Skin Dose Levels
The skin dose levels in normal use may be high enough to cause deterministic effects. The availability of the
different settings (table below) has a considerable effect on the radiation quality, the delivered dose rate and the
image quality.
4-2-2 Available Settings
Available Fluoroscopy Roadmap / DSA Dynamic InnovaChaseTM 3D 3DCT

settings Blended Record
Roadmap /
Subtracted
Fluoroscopy
Available configurations
Orientation of 0 deg. (vertical) to horizontal (- 117 / + 105 degrees)
the X-ray
beam
Patient sup- In
port
Anti-scatter In or Out
grid
Field Of View 20 cm (nominal), 17 cm, 15 cm, 12 cm
Operating settings
Technical de- Selected kV: Selected kV: Selected Selected Selected kV: Selected Selected kV:
tails of para- 60-120 kV 60-120 kV kV: kV: 60-120 kV kV: 60-120 kV
meters in- 50-125 kV 60-120 kV 60-120 kV
cluded in
mA: 33.6 mA mA: 31.2 mA mA: 41.7 - mA: 1 - 866 mA: 100 - 866 mA: 1 - 786 mA: 100 -
each mode of
Average Max Average Max 1000 866
operation
@ 30 fps - 8 @ 30 fps - 8
ms pw ms pw
Focal spot: 0.6Focal spot: 0.6 Focal spot: Focal spot: Focal spot: 1.0 Focal spot: Focal spot:
0.3, 0.6 or 0.6 or 1.0 0.6 or 1.0 1.0
1.0
Frame rate 30 fps, 15 fps, 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 5 fps 30 fps 30 fps
7.5 fps, 3.75 7.5 fps fps, 1.875 fps
fps fps, 1.0 fps,
0.5 fps

Selectable Without or Without or Without or Without or Without or with one Without or Without or
added filters with one of the with one of the with one of with one of of the below Cu with one of with one of
automatically below Cu below Cu the below the below thicknesses: the below the below Cu
applied thicknesses: thicknesses: Cu thick- Cu thick- 0.1 mm Cu, Cu thick- thicknesses:
0.1 mm Cu, 0.1 mm Cu, nesses: nesses: 0.2 mm Cu, nesses: 0.1 mm Cu,
0.2 mm Cu, 0.2 mm Cu, 0.1 mm Cu, 0.1 mm Cu, 0.3 mm Cu 0.1 mm Cu, 0.2 mm Cu,
0.3 mm Cu, 0.3 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.3 mm Cu
0.6 mm Cu, 0.6 mm Cu, 0.3 mm Cu, 0.3 mm Cu, 0.3 mm Cu,
0.9 mm Cu 0.9 mm Cu 0.6 mm Cu, 0.6 mm Cu, 0.6 mm Cu,
0.9 mm Cu 0.9 mm Cu 0.9 mm Cu
Geometry
Source to im- 85 to 119 cm +/- 1 cm
age distance
(SID)
Modes of op- Low, Normal Low, Normal Low, Nor- Low, Nor- Low, Normal Low, Nor- Low, Normal
eration mal mal mal
Default detail Normal/Low Normal/Low Normal/Low Normal/Low Normal/Low Normal/Low Normal/Low
in Adult/
Pediatric
mode
Loading fac- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Normal: Low or Nor- Low or Nor-
tors range af- mal: mal: mal: mal: 60 - 120 kV mal: mal:
ter selection 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV 60 - 120 kV 60 - 120 kV
of the mode
mA: mA: Normal mA: Normal mA: mA: 100 - 866 Normal mA: Normal mA:
Min: 0.0075 Min: 0.015 mA 41.7 - 1000 1 - 866 1 - 786 100 - 866
mA Average Average @
Low mA: Low mA: Low mA: Low mA:
@ 3.75 fps, 2 7.5 fps, 2 ms
41.7 - 500 1 - 681 1 - 786 100 - 786
ms pw pw
Max: 33.6 mA Max: 31.2 mA
Average @ 30 Average @ 30
fps, 8 ms pw fps, 8 ms pw
Highest refer- See tables at See tables at No dose No dose No dose limits ap- No dose No dose lim-
ence dose each Auto Ex- each Auto Ex- limits ap- limits applied: limits ap- its applied:
(IRP = Inter- posure Prefer- posure Prefer- plied: plied: plied:
Normal setting Normal set-
ventional ence ence
Normal set- Normal set- gives approx. 2 Normal setting gives ap-
Reference
ting gives ting gives times more dose ting gives prox. 2 times
Point)
approx. 2 approx. 2 than Low setting approx. 2 more dose
times more times more times more than Low set-
dose than dose than dose than ting
Low setting Low setting Low setting
Typical set of values in cardiac procedures
Diagnostic Normal Normal Normal Normal Normal Normal Normal
Interventional Normal Normal Normal Normal Normal Normal Normal
Note: For 5 R receptor dose limited countries, refer to Safety and Regulatory Instructions for Use / Protection
regarding Ionizing Radiations Hazards for Innova IGS 520 / Dose to Patient / Receptor Dose Limited Standard:
Countries limited to 5 R/min in Fluoroscopy.
4-2-3 Radiation Data
Procedure for measuring dose rate.

Refer to the section: Generic Safety and Regulatory instructions for use for vascular systems.
WHEN MEASURING DOSE, ALWAYS DO A FLUORO RUN PRIOR TO THE RUN IN STEP1
(ACQUIRING TECHNIQUE FACTORS), OTHERWISE SPECTRAL FILTER SELECTION, AND
THUS THE MEASURED DOSE MAY NOT BE REPRODUCIBLE.
4-2-4 IQ Standard
Dose rate with 20 cm PMMA Configuration and Operating Settings
Available config- Fluoroscopy Roadmap / DSA Dynamic InnovaChaseTM 3D 3DCT

urations Blended Record
Roadmap /
Subtracted
Fluoroscopy
Orientation of the Vertical Spin
X-ray beam
Patient support In (Out for dosemeter measurement)
Anti-scatter grid In
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 30 fps, 15 fps, 7.5 fps, 30 fps, 15 5 fps 30 fps 30 fps
7.5 fps, 3.75 7.5 fps 3.75 fps, fps
fps 1.875 fps,
1.0 fps,
0.5 fps
Selectable added In Low 30 fps: n Low 30 fps: In Low: In Low: 0.3 In Low: 0.2 mm Cu In Low: In Low: 0.3
filters automati- 0.9 mm Cu 0.9 mm Cu 0.1 mm mm Cu 0 mm mm Cu
In Normal: 0.1 mm
cally applied In Normal 30 In Normal 30 Cu Cu
In Normal: Cu In Normal: 0.3
fps: fps:
In 0.2 mm Cu In Nor- mm Cu
0.6 mm Cu 0.6 mm Cu
Normal: mal: 0
In Normal
In Low 15 fps: 0.1 mm mm Cu
(HCF)30 fps:
0.6 mm Cu Cu
0.6 mm Cu
In Normal 15
In Low 15 fps: fps:
0.9 mm Cu 0.3 mm Cu
In Normal 15
In Low 7.5 fps:
fps:
0.6 mm Cu
0.6 mm Cu
In Normal 7.5
In Normal
fps:
(HCF)15 fps:
0.3 mm Cu
0.6 mm Cu
In Low 7.5 fps:
0.9 mm Cu
In Normal 7.5
fps:
0.6 mm Cu
In Normal
(HCF) 7.5 fps:
0.6 mm Cu
Geometry

Source to image 102.5 cm Max SID

distance (SID)
Distance of focal 67.5 cm 72 cm
spot to measuring
detector
X-ray field size at Square of: 174 cm² Square Square of: 178
the measuring de- of: 145 cm²
tector cm²
Positioning of Distance between top of phantom and anticollision plate (airgap): 17 cm Phantom centered in
phantom isocenter
Note 1: For all data in this section, measurements are done in 2-steps: 1st step (technique factors acquisition) in
automatic mode with PMMA and table in; 2nd step - Dose measurement in manual mode, repeating the technique
factors without PMMA and table.
Note 2: In 3D/3DCT the 2nd step of the measurement method is different form other (2D) modes. The 1st step
(technique factors acquisition) is done at maximum SID (or 108 cm SID), during a 3D/3DCT spin, when the gantry
is in PA position. 2nd step (dose measurement) is done with the dosemeter probe in isocenter on the table.
Note 3: IEC 60601-1 conditions for all dose rate data are derived by applying a geometrical correction factor using
the inverse square law. For all acquisition modes except 3D/3DCT, the dose values without the correction factor of
1.4 correspond to the dose rates at US regulation conditions (21 Code Of Federal Regulation).
Note 4:The dose rate in normal detail is the same with or without the High Contrast Fluoroscopy (HCF) option,
although loading factors can be different.
Dose rate in fluoroscopy (radioscopy) and roadmap/blended roadmap/subtracted fluoroscopy
(radioscopy) with 20 cm PMMA
For "Dose to Patient" and "Variation of factors" data with country settings Luxembourg, New Zealand, please refer
to the corresponding data in section Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 520 / Dose to Patient / Receptor Dose Limited Standard: countries limited to 5
R/min in Fluoroscopy.
For "Dose to Patient" and "Variation of factors" data with country settings Austria, Denmark, Germany,
Switzerland, please refer to the corresponding data in section Safety and Regulatory Instructions for Use /
Protection regarding Ionizing Radiations Hazards for Innova IGS 520 / Dose to Patient / Receptor Dose Limited
Standard.
Dose rate in fluoroscopy (radioscopy) at 30 fps with 20 cm PMMA
Mode of Operation Low Normal Normal (HCF)
Loading factors auto- 74.5 kVp, 25.0 mA avg 80.7 kVp, 25.0 mA avg 80.3 kVp, 25.5 mA avg
matically selected
Dose rate at Interna- 7.4 x 1.4 mGy/min 19.5 x 1.4 mGy/min

tional Standardization
conditions (IEC
60601-1)
Dose rate in roadmap/blended roadmap/subtracted fluoroscopy (radioscopy) at 30 fps with 20 cm PMMA
Mode of Operation Low Normal
Loading factors automatically selected 80.0 kVp, 15.4 mA avg 80.0 kVp, 23.5 mA avg

Dose rate at International Standardization 6.8 x 1.4 mGy/min 17.4 x 1.4 mGy/min
conditions (IEC 60601-1)
Loading factors automat- 76.5 kVp, 15.6 mA avg 80.3 kVp, 18.7 mA avg 82.2 kVp, 17.9 mA avg
ically selected
Dose rate at Internation- 5.5 x 1.4 mGy/min 15.2 x 1.4 mGy/min

al Standardization condi-
tions (IEC 60601-1)
Note: The dose data above correspond to the default Fluoro Low Frame-Rate Dose Reduction Strategy selection
(Balanced IQ/Dose). If Max Dose Reduction is used, the dose rates in 15 fps are the 50% of the 30 fps measured
values.
Dose rate in fluoroscopy (radioscopy) at 7.5 fps with 20 cm PMMA
Loading factors auto- 77.8 kVp, 9.4 mA avg 85.3 kVp, 9.3 mA avg 84.3 kVp, 10.0 mA avg
matically selected
Dose rate at Interna- 3.0 x 1.4 mGy/min 9.5 x 1.4 mGy/min

tional Standardization
conditions (IEC
60601-1)
Dose rate in roadmap/blended roadmap/subtracted fluoroscopy (radioscopy) at 7.5 fps with 20 cm PMMA
(Balanced IQ/Dose). If Max Dose Reduction is used, the dose rates in 7.5 fps are the 25% of the 30 fps measured

values.
Highest reference doses in fluoroscopy (radioscopy) and roadmap/blended roadmap/subtracted
fluoroscopy (radioscopy)
Highest reference dose Low Frame-rate Dose Reduction Strategy

(IRP = Interventional Reference
Balanced IQ/Dose Max Dose Reduction
Point)
at 30 cm from im- at IRP and maxi- at 30 cm from im- at IRP and maxi-
age receptor mum SID age receptor mum SID
Frame- 30 fps Normal < 87.6 mGy/min < 194.7 mGy/min < 87.6 mGy/min < 194.7 mGy/min
Rate (10 R/min) (10 R/min)
Low < 43.8 mGy/min < 97.4 mGy/min < 43.8 mGy/min < 97.4 mGy/min
(5 R/min) (5 R/min)
15 fps Normal < 87.6 mGy/min < 194.7 mGy/min < 43.8 mGy/min < 97.4 mGy/min
(10 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
7.5 fps Normal < 43.8 mGy/min < 97.4 mGy/min < 21.9 mGy/min < 48.7 mGy/min
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Dose in Dynamic Record (radiography) with 20 cm PMMA

For "Dose to Patient" and "Variation of factors" data with country settings Austria, Germany, New Zealand,
Standard.
Loading factors automatically select- 71.9 kVp, 72.9 mA avg (30 fps), 70.8 kVp, 130.7 mA avg (30 fps), 7.0
ed 5.0 ms ms
Dose rate at International Standard- 38.6 x 1.4 µGy/frame 96.3 x 1.4 µGy/frame
ization conditions (IEC 60601-1)
Note: Data applicable to all frame rates.

Dose in DSA (radiography) with 20 cm PMMA
Standard.
Dose in DSA <7.5 fps (radiography) with 20 cm PMMA

Loading factors automatically selected 85.5 kVp, 313.5 mA peak, 50.2 94.5 kVp, 327.4 mA peak, 61.7 ms
ms PW PW
Dose rate at International Standardiza- 0.95 x 1.4 mGy/frame 1.54 x 1.4 mGy/frame
tion conditions (IEC 60601-1)
Note: Data applicable to all frame rates lower than 7.5 fps.
Dose in DSA 7.5 fps (radiography) with 20 cm PMMA
ms PW PW
Dose in InnovaChaseTM (radiography) with 20 cm PMMA
Loading factors automatically selected 74.8 kVp, 25.3 mA avg, 7.0 ms PW 79.9 kVp, 28.5 mA avg, 7.0 ms
PW
Dose rate at International Standardization 136 x 1.4 µGy/frame 288 x 1.4 µGy/frame
Dose in 3D (radiography) with 20 cm PMMA (Max SID)
Loading factors automatically 74.0 kVp, 56.9 mA avg, 3.5 ms PW 73.0 kVp, 112.1 mA avg, 7.0 ms PW
selected
Dose rate at actual 3D mea- 123 µGy/frame 239 µGy/frame

surement conditions
Dose rate at US regulation con- 123 x 0.73 µGy/frame 239 x 0.73 µGy/frame
ditions (21 Code Of Federal
Regulation)
Dose rate at International Stan- 123 x 1.6 µGy/frame 239 x 1.6 µGy/frame
dardization conditions (IEC
60601-1)
Dose in 3DCT (radiography) with 20 cm PMMA (Max SID)
selected

Dose rate at actual 3DCT mea- 55.0 µGy/frame 110 µGy/frame

surement conditions
Dose rate at US regulation con- 55.0 x 0.73 µGy/frame 110 x 0.73 µGy/frame
Regulation)
Dose rate at International Stan- 55.0 x 1.6 µGy/frame 110 x 1.6 µGy/frame
60601-1)
Field of view dependence of Dose rate in fluoroscopy/roadmap/blended roadmap/subtracted

fluoroscopy and dose in Dynamic Record/DSA/InnovaChaseTM/3D/3DCT with 20 cm PMMA
Field Of View 20 cm 17 cm 15 cm 12 cm
(nominal)
Mode of operation Fluoroscopy (Radioscopy) @ 30 fps (mGy/min)
Low 7.4 mGy/min 8.6 mGy/min 9.8 mGy/min 12.4 mGy/min
Normal 19.5 mGy/min 22.7 mGy/min 26.3 mGy/min 31.7 mGy/min
Mode of operation Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)
Mode of operation Roadmap/Blended Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 30 fps

(mGy/min)

(mGy/min)
Mode of operation Roadmap/Blended Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 7.5 fps

(mGy/min)

Mode of operation Dynamic Record (Radiography) (µGy/frame)
Low 38.6 µGy/frame 58.8 µGy/frame 86.2 µGy/frame 101.2 µGy/frame
Normal 96.3 µGy/frame 134.0 µGy/frame 154.8 µGy/frame 178.6 µGy/frame
Mode of operation DSA 7.5 fps (Radiography) (mGy/frame)
Low 0.90 mGy/frame 0.92 mGy/frame 0.92 mGy/frame 0.86 mGy/frame
Normal 1.40 mGy/frame 1.42 mGy/frame 1.42 mGy/frame 1.38 mGy/frame
Mode of operation DSA <7.5 fps (Radiography) (mGy/frame)
Mode of operation InnovaChaseTM (Radiography) @ 5 fps (µGy/frame)
Low 136 µGy/frame 176 µGy/frame 204 µGy/frame 269 µGy/frame
Normal 288 µGy/frame 342 µGy/frame 410 µGy/frame 450 µGy/frame
Mode of operation 3D (Radiography) @ 30 fps (µGy/frame) (Max SID)
Mode of operation 3DCT (Radiography) @ 30 fps (µGy/frame) (Max SID)
4-2-5 Receptor Dose Limited Standard

For InnovaChaseTM Normal/Low, 5 fps, please refer to measurements in Dose to Patient for IQ Standard.
Available con- Fluoroscopy Roadmap / DSA Dynamic 3D 3DCT

figurations Blended Record
Roadmap /
Subtracted
Fluoroscopy
Orientation of Vertical
the X-ray beam

Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 fps 30 fps 30 fps
7.5 fps, 3.75 fps 7.5 fps fps, 1.875 fps,
1.0 fps, 0.5 fps
Selectable In Low 30 fps: In Low: 0.1 mm In Low: 0.3 mm In Low: 0 mm In Low: 0.3 mm
In Low 30 fps:
added filters 0.9 mm Cu Cu Cu Cu Cu
0.9 mm Cu
automatically In Normal 30
In Normal 30 In Normal: 0.1 In Normal: 0.3 In Normal: 0 mm In Normal: 0.3
applied fps:
fps: mm Cu mm Cu Cu mm Cu
0.6 mm Cu
0.6 mm Cu
In Normal
(HCF)30 fps: In Low 15 fps:
0.6 mm Cu 0.6 mm Cu
In Normal 15
In Low 15 fps:
fps:
0.9 mm Cu
0.3 mm Cu
In Normal 15
fps: In Low 7.5 fps:
0.6 mm Cu 0.6 mm Cu
In Normal In Normal 7.5
(HCF)15 fps: fps:
0.6 mm Cu 0.3 mm Cu
In Low 7.5 fps:
0.9 mm Cu
In Normal 7.5
fps:
0.6 mm Cu
In Normal
(HCF)7.5 fps:
0.6 mm Cu
Geometry
Source to im- 102.5 cm Max SID
age distance
(SID)
Distance of fo- 67.5 cm 72 cm
cal spot to mea-
suring detector
X-ray field size Square of: 174 cm² Square of: 145 Square of: 178
at the measur- cm² cm²
ing detector
Positioning of Distance between top of phantom and anticollision plate (airgap): Phantom centered in isocenter
phantom 17 cm

Note 4: The dose rate in normal detail is the same with or without the High Contrast Fluoroscopy (HCF) option,
Loading factors automatically 73.0 kVp, 12.6 mA avg 71.5 kVp, 19.3 mA avg 71.5 kVp, 19.2 mA avg
selected
Dose rate at International 3.4 x 1.4 mGy/min 8.6 x 1.4 mGy/min

Standardization conditions
(IEC 60601-1)
selected

(IEC 60601-1)

values.
selected

(IEC 60601-1)
values.

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Loading factors automatically selected 67.1 kVp, 62.8 mA avg (30 fps), 67.8 kVp, 125.1 mA avg (30 fps),
5.0 ms 7.0 ms
Dose rate at International Standardization 25.4 x 1.4 µGy/frame 53.8 x 1.4 µGy/frame

ms PW PW
ms PW PW
selected

surement conditions

Regulation)

60601-1)

selected
Dose rate at actual 3DCT mea- 31 µGy/frame 55 µGy/frame

surement conditions

Regulation)

60601-1)

fluoroscopy and dose in Dynamic Record/DSA/3D/3DCT with 20 cm PMMA
(nominal)

(mGy/min)

(mGy/min)


(mGy/min)
Low 0.50 mGy/frame 0.55 mGy/fram 0.55 mGy/frame 0.53 mGy/frame
4-2-6 Receptor Dose Limited Standard: Countries limited to 5 R/min in Fluoroscopy

The countries limited to 5 R/min detector dose in Fluoroscopy are the following: Luxembourg, New Zealand.
For Fluoroscopy, Roadmap / Blended Raodmap / Subtracted Fluoroscopy, Dynamic Record, DSA, 3D and 3DCT
Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor Dose Limited Standard.

Point)
at 30 cm from im- at IRP and maxi- at 30 cm from image at IRP and maxi-
age receptor mum SID receptor mum SID

Fluoro 30 fps Normal < 43.8 mGy/min < 97.4 mG/min < 43.8 mGy/min < 97.4 mGy/min
Frame- (5 R/min) (5 R/min)
Rate
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Low < 21.9 mGy/min < 48.7 mGy/min < 21.9 mGy/min < 48.7 mG/min
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Low < 21.9 mGy/min < 48.7.mGy/min < 21.9 mGy/min < 48.7 mGy/min
(2.5 R/min) (2.5 R/min)
4-2-7 IQ Plus
For DSA, InnovaChaseTM and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient
for IQ Standard.
Available Fluoroscopy Roadmap / Blended Dynamic Record 3D

configurations Roadmap / Subtract-
ed Fluoroscopy
X-ray beam
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 30 fps, 15 fps, 7.5 fps 30 fps, 15 fps 30 fps
3.75 fps

Selectable added Low 30 fps: 0.6 mm Cu Low 30 fps: 0.6 mm Cu In Low: 0.1 mm Cu In Low: 0 mm Cu
filters automati- Normal 30 fps: 0.3 mm Normal 30 fps: 0.6 mm In Normal: 0.1 mm Cu In Normal: 0 mm Cu
cally applied Cu Cu
Normal (HCF) 30 fps: Low 15 fps: 0.6 mm Cu
0.3 mm Cu Normal 15 fps: 0.3 mm
Cu
Low 15 fps: 0.6 mm Cu
Low 7.5 fps: 0.6 mm Cu
Normal 15 fps: 0.3 mm
Normal 7.5 fps: 0.3 mm
Cu
Cu
Normal (HCF) 15 fps:
0.2 mm Cu
Cu
Normal (HCF) 7.5 fps:
0.2 mm Cu
Geometry
distance (SID)
spot to measur-
ing detector
X-ray field size at Square of: 174 cm² Square of: 145 cm²
the measuring
detector
phantom isocenter
the inverse square law. The values without the correction factor of 1.4 correspond to the dose rates at US
regulation conditions (21 Code Of Federal Regulation).
Radiations Hazards for Innova IGS 520 / Dose to Patient / Receptor Dose Limited Standard, countries limited to 5
Standard.
For "Dose to Patient" and "Variation of factors" data with country settings Japan, for the Low Dose preference,

please refer to the corresponding data in section Safety and Regulatory Instructions for Use / Protection regarding
Ionizing Radiations Hazards for Innova IGS 520 / Dose to Patient / IQ Standard. The only exception is Max Dose
Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when using "IQ Plus".
For "Dose to Patient" and "Variation of factors" data with country settings Australia/WA, Australia/ACT, please
refer to the corresponding data in section Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 520 / Dose to Patient / IQ Standard.
selected

(IEC 60601-1)
selected

(IEC 60601-1)
values.

selected

(IEC 60601-1)
values.

Point)
at 30 cm from im- at IRP and maxi- at 30 cm from im- at IRP and maximum
age receptor mum SID age receptor SID
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)


Standard.
For "Dose to Patient" and "Variation of factors" data with country settings Italy, Spain, Portugal and Belgium,
Ionizing Radiations Hazards for Innova IGS 520 / Dose to Patient / IQ Standard.
5.0 ms 7.0 ms

selected

surement conditions
Regulation)
60601-1)

fluoroscopy and dose in Dynamic Record/3D with 20 cm PMMA
(nominal)
Mode of opera- Fluoroscopy (Radioscopy) @ 30 fps (mGy/min)

tion

tion

Mode of opera- Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)

tion
Mode of opera- Roadmap/Blended Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 30 fps

tion (mGy/min)
Mode of opera- Roadmap/Blended Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 15 fps

tion (mGy/min)
Mode of opera- Roadmap/Blended Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 7.5 fps

tion (mGy/min)
Mode of opera- Dynamic Record (Radiography) (µGy/frame)

tion
Mode of opera- 3D (Radiography) @ 30 fps (µGy/frame) (Max SID)

tion
4-2-8 Receptor Dose Limited Plus

For DSA and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor
Dose Limited Standard.
For InnovaChaseTM Normal/Low, please refer to measurements in Dose to Patient for IQ Standard.

configurations Roadmap / Subtract-
ed Fluoroscopy


X-ray beam
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 30 fps, 15 fps, 7.5 fps 30 fps, 15 fps 30 fps
3.75 fps
Selectable added Low 30 fps: 0.6 mm Cu Low 30 fps: 0.6 mm Cu In Low: 0.2 mm Cu In Low: 0 mm Cu
filters automati- Normal 30 fps: 0.3 mm Normal 30 fps: 0.6 mm In Normal: 0.2 mm Cu In Normal: 0 mm Cu
cally applied Cu Cu
Normal (HCF) 30 fps: Low 15 fps: 0.6 mm Cu
0.3 mm Cu Normal 15 fps: 0.3 mm
Cu
Normal 15 fps: 0.6 mm
Cu
Cu
0.6 mm Cu
Cu
Normal (HCF) 7.5 fps:
0.3 mm Cu
Geometry
distance (SID)
spot to measur-
ing detector
the measuring
detector
phantom isocenter
Note 4:The dose rate in normal detail is the same with or without the High Contrast Fluoroscopy (HCF) option,


Radiations Hazards for Innova IGS 520 / Dose to Patient / Receptor Dose Limited Standard, countries limited to 5
Ionizing Radiations Hazards for Innova IGS 520 / Dose to Patient / Receptor Dose Limited Standard. The only
exception is Max Dose Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when
using "Receptor Dose Limited Plus".
selected

(IEC 60601-1)
selected

(IEC 60601-1)

values.
selected

(IEC 60601-1)
values.

Point)

(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
5.0 ms 7.0 ms

selected

surement conditions

Regulation)

60601-1)


(nominal)

(mGy/min)

(mGy/min)

(mGy/min)

4-3 Dose to Patient in Japan

4-3-1 Fluoroscopy/Roadmap/Blended Roadmap/Subtracted Fluoroscopy Air Kerma Levels
Japan dose regulation enforced April 1st, 2001 requires that standard exams be carried out at a patient
fluoroscopic dose not exceeding 50 mGy/min and permits for exams requiring high level of fluoroscopic dose that
the dose exceeds this value without exceeding however 125 mGy/min.
On Innova IGS 520, standard exams will have to be performed using the Fluoroscopy/Roadmap/Blended
Roadmap/Subtracted Fluoroscopy "Low" detail button located on the Innova Digital screen or on the Innova Central
touch screen.
Exams requiring high level of Fluoroscopy dose shall be performed using the Fluoroscopy "Normal" detail button
located on the Innova Digital screen or on the Innova Central touch screen. The usage of this special mode, in the
case the patient dose is not limited at 50 mGy/min, will be indicated permanently on the in-room reference display
by the annotation "Normal" and by a permanent audible signal.
4-4 Dose to Patient in Australia/WA and Australia/ACT
In Australia/WA and Australia/ACT the highest reference dose rates in fluoroscopy (radioscopy) at 30 cm from
image receptor are limited to 43.8 mGy/min. (43.8 x 1.4 mGy/min at IEC 60601-1 International Standardization
conditions).
The data given in the OM tables are directly applicable to Australia/WA and Australia/ACT, whenever the provided
dose rate is lower than the limit of 43.8 x 1.4 mGy/min (IEC 60601-1 conditions), while in other cases the dose rate
is reduced by the system to this limiting level (in Fluoro, Roadmap, Blended Roadmap and Subtracted Fluoroscopy
modes only.)
4-5 Dose to patient in Canada/Ontario
To ensure local regulatory compliance for Canada/Ontario regarding patient entrance exposure, it is recommended
to avoid IQ+ Auto Exposure Preference.
4-6 Dose to Operator (Isodoses)
You will find hereafter the Isokerma Maps representing the dose values in the vicinity of the equipment.
The purpose is to provide information on the distribution of the stray radiation for guidance in the radiological
protection of staff. These maps do not provide information for determining radiation shielding for a specific
procedure room.
The measurements have been conducted in accordance with the protocol given in IEC 60601-2-43: 120kVp, SID =
SID Max, 25x25x25 cm PPMA Phantom, placed at isocenter with 100 cm² (10x10) beam aperture at phantom
entrance plane (FOV = 20 cm).
4-6-1 Gantry in Vertical position - Dose at 1 meter from ground
Units: Relative Air Kerma: µGy / Gycm2
Distances: Radius at 1, 2 and 3 meter
(Vertical X-ray beam and IRP* at the center of the Map)

Vertical 1 meter
(*) Interventional Reference Point

4-6-2 Gantry in Vertical position - Dose at 1.5 meter from ground

Vertical 1.5 meter

4-6-3 Gantry in Lateral position - Dose at 1 meter from ground
(IRP* at the center of the map)

Lateral 1 meter

4-6-4 Gantry in Lateral position - Dose at 1.5 meter from ground

Lateral 1.5 meter

4-7 Technical Factors Range for Innova IGS 520
• kVp range: 40-125 kVp +/- 10%;
• mA range: 1 - 1000 mA peak +/- 20% +/- 1 mA.
4-8 Contribution of Filtration with 20 cm Detector
4-8-1 Contribution of Filtration along the Beam

4-8-2 Total filtration

IPEM publication(*) with the minimum Half Value Layers (HVL) specifications has been used to determine the total
filtration.
At the X-ray tube voltage of 70 kV minimum total equivalent filtration of : 3.5 mm Al equivalent.
Tube Head Filter of 3.3 mm AL equivalent at 70 kV.
Luxembourg only: range of total filtration: 2.5 mm to 3.5 mm Al equivalent at 70 kV.
(*) IPEM: Institute of Physics and Engineering in Medicine, Fairmount House, 230 Tadcaster Road, York, Y024
1ES, UK. Report 78 Catalog of Diagnostic X-ray Spectra and Other Data K Cranley, B.J. Gilmore, G.W.A Fogarty
and L. Desponds (Electronic Version prepared by D. Sutton) http://www.ipem.org.uk
4-9 Disable X-ray Whenever X-ray Are Not Necessary
X-ray should be disabled whenever they are not necessary to prevent the possibility of
irradiation being emitted through the inadvertent actuation of an irradiation switch.
Press on the X-ray disable button on the touchscreen or the digital screen (monitoring bar) to disable/re-enable
X-ray.
The button is lit when X-ray are disabled (refer to Innova Digital / Innova Digital Screen / Monitoring Bar / X-ray
Disable Button).
In case of obvious X-ray emission (audible signal and/or red light signal on) without image on the live display, the
user shall perform the following actions:
• First, to release the footswitch.
• Second, if X-ray are still emitted, to depress the "RESET" button on the Innova console until the system resets.
• Third, if X-ray are still emitted, to switch off the Power Distribution Box (PDB) by turning to OFF the RED PDB
switcher on the system cabinet, in the technical area.
4-10 Dosimetric Calibration
To maintain the calibrations of all dosimetric indications, the "mR/mAs" calibration procedure shall be strictly made
following the Periodic Maintenance (PM) interval for that calibration (6 months). (Refer to the Logbook).
4-11 Application Mode and Service Mode are not exclusive

NEVER ACQUIRE IMAGES WITH A PATIENT ON THE TABLE, IF THE REFERENCE DISPLAY
LISTS THE FOLLOWING:
"CALIBRATION" IN PLACE OF "PROTOCOL NAME"
"SERVICE" IN PLACE OF "EXAM TYPE"
THAT MEANS THAT THE SYSTEM IS NOT PROPERLY SET FOR APPLICATION AND THOSE ACQUISITION
PARAMETERS MIGHT BE INADEQUATE.
4-12 Leakage Radiation
The maximum operating factors (leakage technique factors) of the Innova IGS 520 are: Fluoro, 120 kV, 16 mA, SID
max.
In these conditions, the leakage radiation of the radiation source assembly measured is: 0.45 mGy (52
milliroentgens) in 1 hour (worst case 0.65mGy (75 milliroentgens)) at one meter in any direction from the diagnostic
source assembly composed of:
• X-ray Tube Performix 160A.
• Beam Limiting Device (Card Collimator AMP).
4-13 Spectral Filtration
Spectral filtration is added filtration that is inserted between the X-ray tube source and the patient in order to
harden the beam and reduce the soft radiation. The harder the beam, the better the penetration of the anatomy
allowing the X-ray photons to exit the patient and reach the digital detector. The spectral filters also absorb the
softer radiation so that it never reaches the patient and keeps the Air Kerma radiation and absorbed dose to a
minimum.
In addition, the beam limiting device features additional filters of: 0.1, 0.2, 0.3, 0.6 and 0.9 mm Cu which
corresponds to 6.5, 9.6, 12.6, 22 and 30 mm Alu equivalent at 70 kV.
The value of the additional spectral filtration is permanently displayed in the Fluoro and Record window located at
the bottom of the Innova Digital Screen.
The additional spectral filtration value is part of the Fluoro and Record techniques.
FOR PEDIATRIC PROCEDURE AND IF DEMANDED BY LOCAL REGULATION, THE

PRESENCE OF THE MINIMUM REQUESTED ADDITIONAL SPECTRAL FILTRATION MUST BE
CHECKED BEFORE PERFORMING ANY RECORD OR FLUORO ACQUISITION. IF THE
MINIMUM REQUESTED ADDITIONAL SPECTRAL FILTRATION IS NOT IN PLACE, SELECT
THE APPROPRIATE PEDIATRIC PROTOCOL.
4-14 Dose Management
• Spectral filter: 0.1 mm Cu, 0.2 mm Cu, 0.3 mm Cu, 0.6 mm Cu and 0.9 mm Cu.
• Selection of a low level of dose (half of the normal dose available at the working position), as per IEC
60601-2-43 conditions.
• Removable Anti scatter grid for infants up to 1 year old at Field of View smaller than 20 cm.
• Display of cumulated Dose Area Product, Air Kerma rate and cumulated Air Kerma at the working position,
along the exam.
The estimation of the total dose (cumulated Air Kerma)(mGy) delivered to the patient is permanently displayed
and updated on the live and reference displays. After the predefined Dose Treshold value is reached, values are
displayed in reverse video.
In that occurrence, apply the section Safety and Regulatory / Protection against radiation / How to reduce
Radiation Exposure Dose.
Display prior the predefined Dose Threshold value is reached
Live display Reference display

Display after the predefined Dose Threshold value is reached


100%.
procedures.

interest.
• Bolus mode: primary use for bolus chasing procedures.


2 Record mode selection: DSA, 3D, 3DCT, Chase, Bolus, Dynamic

Record technique parameters display: kV, mA (peak for DSA, Chase and Bolus, otherwise: average), ms
5-1-3 Live Display



Record Screen


Fluoro Screen

ed fluoro mode
Landscape/Vessels
5-2 Dose to Patient

Note 3: InnovaSpinTM acquisitions use the same settings as standard Cardiac or InnovaChaseTM acquisitions.

provided.
image quality.
Available Fluo- Roadmap / DSA Dynamic Inno- Bolus 3D 3DCT

settings roscopy Blended Record vaChaseTM
Roadmap /
Subtracted
Fluo-
roscopy
Orientation 0 deg. (vertical) to horizontal (-117 / + 105 degrees)
of the X-ray
beam
Patient sup- In
port
grid
Field Of 30 cm (nominal), 20 cm, 16 cm, 12 cm 30 cm 30 cm (nominal), 20 cm,
View (nominal) 16 cm, 12 cm
Operating settings
Technical Selected Selected Selected Selected Selected kV: Selected kV: Selected kV: Selected kV:
details of kV: kV: kV: kV: 60-120 kV 50-125 kV 60-120 kV 60-120 kV
parameters 60-120 kV 60-120 kV 50-125 kV 60-120 kV
included in
mA: 33.6 mA: 25 mA mA: 41.7 - mA: 1 - 866 mA: 100 - mA: 41.7 - mA: 1 - 786 mA: 100 -
each mode
mA Aver- Average 1000 866 866 866
of operation
age Max @ Max @ 30
30 fps - 8 fps - 8 ms
ms pw pw
Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot:
0.6 0.6 0.3, 0.6 or 0.6 or 1.0 1.0 0.6 or 1.0 0.6 or 1.0 1.0
1.0

Frame rate 30 fps, 15 30 fps, 15 7.5 fps, 30 fps, 15 5 fps 1 fps, 2 fps 30 fps 30 fps
fps, 7.5 fps, fps, 7.5 fps 3.75 fps, fps
3.75 fps 1.875 fps,
1.0 fps, 0.5
fps
Selectable Without or Without or Without or Without or Without or 0.1 mm Cu Without or Without or
added fil- 0.1 mm Cu, 0.1 mm Cu,
ters auto- 0.2 mm Cu, 0.2 mm Cu,
matically or 0.3 mm or 0.3 mm
or 0.3 mm or 0.3 mm or 0.3 mm or 0.3 mm or 0.3 mm
applied Cu Cu
Cu Cu Cu Cu Cu
Selectable Not applicable
added fil-
ters manu-
ally applied
Geometry
Source to 89 to 119 cm +/- 1 cm
image dis-
tance (SID)
Modes of Low, Nor- Low, Nor- Low, Nor- Low, Nor- Low, Normal Low, Normal Low, Normal Low, Normal
operation mal mal mal mal
Default de- Normal/LowNormal/LowNormal/LowNormal/Low Normal/Low Normal/Low Normal/Low Normal/Low
tail in Adult/
Pediatric
mode
Loading Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor-
factors mal: mal: mal: mal: mal: mal: mal: mal:
range after 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV 60 - 120 kV
selection of
mA: mA: Normal mA: Normal mA: mA: 100 - Normal mA: Normal mA: Normal mA:
the mode
Min: 0.0075 Min: 0.015 41.7 - 1000 1 - 866 866 41.7 - 866 1 - 786 100 - 866
mA Aver- mA Aver-
Low mA: Low mA: Low mA: Low mA: Low mA:
age @ 3.75 age @ 7.5
41.7 - 500 1 - 786 41.7 - 500 1 - 786 100 - 786
fps, fps, 2 ms
2 ms pw pw
Max: 33.6 Max: 25 mA
mA Aver- Average @
age @ 30 30 fps, 8
fps, 8 ms ms pw
pw
Highest ref- See tables See tables No dose No dose No dose lim- No dose lim- No dose lim- No dose lim-
erence at each Au- at each Au- limits ap- limits ap- its applied: its applied: its applied: its applied:
dose (IRP = to Exposure to Exposure plied: plied:
Normal set- Normal set- Normal set- Normal set-
Interven- Preference Preference
Normal set- Normal setting gives ting gives ting gives ting gives
tional Ref-
ting gives ting gives approx. 2 approx. 2 approx. 2 approx. 2
erence
approx. 2 approx. 2 times dose times dose times dose times dose
Point)
times dose times dose than Low than Low than Low than Low
than Low than Low setting setting setting setting
setting setting
Diagnostic Normal Normal Normal Normal Normal Normal Normal Normal

Interven- Normal Normal Normal Normal Normal Normal Normal Normal

tional
5-2-4 IQ Standard

configura- roscopy Blended Record vaChaseTM
tions Roadmap /
Subtracted
Fluo-
roscopy
Orientation Vertical Spin
of the X-ray
beam
Patient sup- In (Out for dosemeter measurement)
port
Anti-scatter In
grid
Field Of 20 cm 30 cm 20 cm
View
Operating settings
3.75 fps 1.875 fps,
1.0 fps, 0.5
fps

Selectable In Low: In Low: In Low: 0.1 In Low: 0.2 In Low: 0.1 In Low: 0.1 In Low: 0 In Low: 0.3
added filters 0.3 mm Cu 0.3 mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu
automatical- @ 30 fps @ 30 fps
In Normal: In Normal: In Normal: In Normal: In Normal: 0 In Normal:
ly applied 0.3 mm Cu 0.3 mm Cu
0.1 mm Cu 0.2 mm Cu 0.1 mm Cu 0.1 mm Cu mm Cu 0.3 mm Cu
@ 15 fps @ 15 fps
0.3 mm Cu 0.3 mm Cu
@ 7.5 fps @ 7.5 fps
In Normal: In Normal:
0.3 mm Cu 0.3 mm Cu
@ 30 fps @ 30 fps
0.3 mm Cu 0.3 mm Cu
@ 15 fps @ 15 fps
0.3 mm Cu 0.3 mm Cu
@ 7.5 fps @ 7.5 fps
In Normal
(HCF):
0.3 mm Cu
@ 30 fps
0.3 mm Cu
@ 15 fps
0.3 mm Cu
@ 7.5 fps
Geometry
Source to 102.5 cm Max SID 108 cm, Max
image dis- SID
tance (SID)
Distance of 67.5 cm 72 cm
focal spot to
measuring
detector
X-ray field Square of: 174 cm² Square of: Square of: Square of:
size at the 390 cm² 145 cm² 178 cm²
measuring
detector
Positioning Distance between top of phantom and anticollision plate (airgap): 17 cm Phantom centered in
of phantom isocenter
(technique factors acquisition) is done at maximum SID (or at 108 cm SID), during a 3D/3DCT spin, when the
gantry is in PA position. 2nd step (dose measurement) is done with the dosemeter probe in isocenter on the table.

Standard.
selected
Dose rate at International Stan- 10.3 x 1.4 mGy/min 24.4 x 1.4 mGy/min
60601-1)
Loading factors automatically se- 87.0 kVp, 2.9 mA avg 80.0 kVp, 9.4 mA avg 80.0 kVp, 9.9 mA avg
lected
60601-1)
Note: The dose data above correspond to the default Fluoro/Roadmap/Blended Roadmap/Subtracted Fluoroscopy
Low Frame-Rate Dose Reduction Strategy selection (Balanced IQ/Dose). If Max Dose Reduction is used, the dose

rates in 15 fps are the 50% of the 30 fps measured values.

selected
60601-1)
rates in 7.5 fps are the 25% of the 30 fps measured values.

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)


Standard.
5.0 ms 7.0 ms
Dose rate at International Standardiza- 53.3 x 1.4 µGy/frame 102.2 x 1.4 µGy/frame

Standard.
ms PW PW
ms PW PW
Loading factors automatically selected 76.9 kVp, 14.7 mA avg, 7.0 ms 76.7 kVp, 29.7 mA avg, 7.0 ms PW
PW

Dose in Bolus (radiography) with 20 cm PMMA
Focal Spot FS 0.6 FS 1.0
Mode of Operation Low Normal Low Normal
Loading factors auto- 110.1 kVp, 161.3 mA 112.8 kVp, 296.6 mA 95.5 kVp, 473.4 mA 98.0 kVp, 686.6 mA
matically selected peak, 16.9 ms PW peak, 17.2 ms PW peak, 10.4 ms PW peak, 12.7 ms PW
Dose rate at Interna- 0.35 x 1.4 mGy/ 0.600 x 1.4 mGy/ 0.34 x 1.4 mGy/ 0.71 x 1.4 mGy/
tional Standardiza- frame frame frame frame
tion conditions (IEC
60601-1)
selected

surement conditions

Regulation)

60601-1)
selected

surement conditions

Regulation)

60601-1)
Dose in 3DCT (radiography) with 20 cm PMMA (108 cm SID)

selected

surement conditions

Regulation)

60601-1)

fluoroscopy and dose in Dynamic Record/DSA/InnovaChaseTM/Bolus/3D/3DCT with 20 cm PMMA
(nominal)

(mGy/min)

(mGy/min)

(mGy/min)

Mode of operation Bolus FS 0.6 (Radiography) (mGy/frame)
Low 0.35 mGy/frame N/A N/A N/A
Normal 0.67 mGy/frame N/A N/A N/A
Mode of operation 3DCT (Radiography) @ 30 fps (µGy/frame) (108 cm SID)


Available config- Fluoroscopy Roadmap / DSA Dynamic Bolus 3D 3DCT

Roadmap /
Subtracted
Fluoroscopy
X-ray beam
Field Of View 20 cm 30 cm 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 30 fps, 15 fps, 7.5 fps, 30 fps, 15 1 fps, 2 fps 30 fps 30 fps
7.5 fps, 3.75 7.5 fps 3.75 fps, fps
fps 1.875 fps,
1.0 fps, 0.5
fps
Selectable added In Low 30 fps: In Low 30 fps: In Low: 0.1 In Low: 0.3 In Low: 0.1 In Low: 0.3 In Low: 0.3
filters automati- 0.3 mm Cu 0.3 mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu
cally applied In Normal 30 In Normal 30
In Normal: In Normal: In Normal: In Normal: 0.2 In Normal:
fps: fps:
0.1 mm Cu 0.3 mm Cu 0.1 mm Cu mm Cu 0.3 mm Cu
0.3 mm Cu 0.3 mm Cu
In Normal
In Low 15 fps:
(HCF) 30 fps:
0.3 mm Cu
0.3 mm Cu
In Normal 15
In Low 15 fps: fps:
0.3 mm Cu 0.3 mm Cu
In Normal 15
In Low 7.5 fps:
fps:
0.3 mm Cu
0.3 mm Cu
In Normal 7.5
In Normal
fps:
(HCF) 15 fps:
0.3 mm Cu
0.3 mm Cu
In Low 7.5 fps:
0.3 mm Cu
In Normal 7.5
fps:
0.3 mm Cu
In Normal
(HCF)7.5 fps:
0.3 mm Cu
Geometry

Source to image 102.5 cm Max SID 108 cm,

distance (SID) Max SID
spot to measuring
detector
X-ray field size at Square of: 174 cm² Square of: Square of: 145 Square of:
the measuring de- 390 cm² cm² 178 cm²
tector
Positioning of Distance between top of phantom and anticollision plate (airgap): 17 Phantom centered in
phantom cm isocenter
Loading factors automatical- 88.7 kVp, 1.7 mA avg 80.6 kVp, 6.3 mA avg 80.7 kVp, 6.2 mA avg
ly selected

(IEC 60601-1)
Dose rate at International Standardiza- 5.2 x 1.4 mGy/min 12.2 x 1.4 mGy/min

ly selected

(IEC 60601-1)
Loading factors automati- 83.0 kVp, 1.1 mA avg 77.0 kVp, 3.5 mA avg 77.6 kVp, 3.6 mA avg
cally selected

(IEC 60601-1)


Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
ed 5.0 ms ms

ms PW PW

ms PW PW
60601-1)
selected

surement conditions

Regulation)

60601-1)
selected

surement conditions

Regulation)


60601-1)
Dose in 3DCT (radiography) with 20 cm PMMA (108 cm SID)
selected

surement conditions

Regulation)

60601-1)

fluoroscopy and dose in Dynamic Record/DSA/Bolus/3D/3DCT with 20 cm PMMA
(nominal)

(mGy/min)


(mGy/min)

(mGy/min)

Mode of operation 3DCT (Radiography) @ 30 fps (µGy/frame) (108 cm SID)

For Fluoroscopy, Roadmap / Blended Roadmap / Subtracted Fluoroscopy, Dynamic Record, DSA, Bolus, 3D and
3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor Dose Limited
Standard.

Point)
Frame- 30 fps Normal < 43.8 mGy/min < 97.4 mG/min < 43.8 mGy/min < 97.4 mGy/min
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
5-2-7 IQ Plus
For DSA, Bolus, InnovaChaseTM and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to
Patient for IQ Standard.

configurations Roadmap / Subtracted
Fluoroscopy


X-ray beam
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 30 fps, 15 fps, 7.5 fps 30 fps, 15 fps 30 fps
fps, 3.75 fps
Selectable Low 30 fps: 0.3 mm Low 30 fps: 0.3 mm Cu Low: 0.2 mm Cu Low: 0.2 mm Cu
added filters au- Cu Normal 30 fps: 0.3 mm Normal: 0.2 mm Cu Normal: 0 mm Cu
tomatically ap- Normal 30 fps: 0.3 Cu
plied mm Cu Low 15 fps: 0.3 mm Cu
Normal (HCF) 30 fps: Normal 15 fps: 0.3 mm
0.2 mm Cu Cu
Low 15 fps: 0.3 mm
Cu
Cu
Normal 15 fps: 0.3
mm Cu
0.2 mm Cu
Low 7.5 fps: 0.3 mm
Cu
Normal 7.5 fps: 0.2
mm Cu
Normal (HCF) 7.5
fps: 0.1 mm Cu
Geometry
distance (SID)
spot to measur-
ing detector
the measuring
detector
phantom isocenter


Standard.
cally selected

(IEC 60601-1)
cally selected

(IEC 60601-1)

ly selected

(IEC 60601-1)

Point)

Low < 87.6 mGy/min < 194.7 mGy/min < 87.6mGy/min < 194.7 mGy/min
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Standard.
Loading factors automatically se- 73.5 kVp, 77.1 mA avg (30 fps), 5.0 72.1 kVp, 151.9 mA avg (30 fps), 7.0
lected ms ms
Dose rate at International Stan- 75.2 x 1.4 µGy/frame 140.7 x 1.4 µGy/frame
60601-1)

selected

surement conditions

Regulation)


60601-1)

(nominal)

tion

tion

tion
Mode of opera- Roadmap/Blended Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 30 fps (mGy/min)

tion

tion

tion (mGy/min)

tion


tion

For DSA, Bolus, 3D and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for
Receptor Dose Limited Standard.
Available Fluoroscopy Roadmap / Blended Dynamic Record

configurations Roadmap / Subtracted Fluo-
roscopy
Orientation of the X- Vertical
ray beam
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 fps, 7.5 fps 30 fps, 15 fps
fps
Selectable added fil- Low 30 fps: 0.3 mm Cu Low 30 fps: 0.3 mm Cu Low: 0.3 mm Cu
ters automatically ap- Normal 30 fps: 0.3 mm Cu Normal 30 fps: 0.3 mm Cu Normal: 0.3 mm Cu
plied Normal (HCF) 30 fps: 0.2 mm
Cu
Normal 15 fps: 0.3 mm Cu
Normal 7.5 fps: 0.3 mm Cu
Normal (HCF) 15 fps: 0.2 mm
Cu
Normal (HCF) 7.5 fps: 0.2 mm
Cu
Geometry
Source to image dis- 102.5 cm
tance (SID)
Distance of focal spot 67.5 cm
to measuring detector

X-ray field size at the Square of: 174 cm²

measuring detector
Positioning of phantom Distance between top of phantom and anticollision plate (airgap): 17 cm
Standard.
ly selected

(IEC 60601-1)

ly selected

(IEC 60601-1)
ly selected

(IEC 60601-1)


Point)
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
lected ms ms
Dose rate at International Stan- 36.2 x 1.4 µGy/frame 72.4 µGy/frame

60601-1)

fluoroscopy and dose in Dynamic Record with 20 cm PMMA
(nominal)

tion

tion


tion

tion

tion

tion (mGy/min)

tion

touch screen.


conditions).
modes only.)
procedure room.
Vertical 1 meter



Vertical 1.5 meter


Lateral 1 meter


Lateral 1.5 meter

• kVp range: 40-125 kVp +/- 10%;


filtration.
X-ray.
Disable Button).

max.
milliroentgens) in 1 hour at one meter in any direction from the diagnostic source assembly composed of:
• Beam Limiting Device (Collimator) AF DSA 01.
minimum.
In addition, the beam limiting device features three additional filters of: 0.1, 0.2 and 0.3 mm Cu which corresponds
to 6.5, 9.6, 12.6 mm Alu equivalent at 70 kV.

• Spectral filter: 0.1 mm Cu, 0.2 mm Cu and 0.3 mm Cu.
along the exam.



100%.
procedures.

interest.
• Bolus mode: primary use for bolus chasing procedures.



Record technique parameters display: kV, mA (peak for DSA, Chase and Bolus, otherwise: average), ms
6-1-3 Live Display



Record Screen


Fluoro Screen

ed fluoro mode
Landscape/Vessels
6-2 Dose to Patient

Note 3: InnovaSpinTM acquisitions use the same settings as standard Cardiac or InnovaChaseTM acquisitions.

provided.
image quality.

settings roscopy Blended Record vaChaseTM
Roadmap /
Subtracted
Fluo-
roscopy
Orientation 0 deg. (vertical) to horizontal (-117 / + 105 degrees)
of the X-ray
beam
Patient sup- In
port
grid
Field Of 40 cm (nominal), 32 cm, 20 cm, 16 cm 40 cm 40 cm (nominal), 32 cm,
View (nominal), 32 20 cm, 16 cm
cm
Operating settings
Technical Selected Selected Selected Selected Selected kV: Selected kV: Selected kV: Selected kV:
details of kV: kV: kV: kV: 60-120 kV 50-125 kV 60-120 kV 60-120 kV
parameters 60-120 kV 60-120 kV 50-125 kV 60-120 kV
included in
mA: 33.6 mA: 25 mA mA: 41.7 - mA: 1 - 866 mA: 100 - mA: 41.7 - mA: 1 - 786 mA: 100 -
each mode
mA Aver- Average 1000 866 866 866
of operation
age Max @ Max @ 30
30 fps - 8 fps - 8 ms
ms pw pw
Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot:
0.6 0.6 0.3, 0.6 or 0.6 or 1.0 1.0 0.6 or 1.0 0.6 or 1.0 1.0
1.0

3.75 fps 1.875 fps,
1.0 fps, 0.5
fps
Selectable Without or Without or Without or Without or Without or 0.1 mm Cu Without or Without or
added fil- 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu,
ters auto- 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu,
matically or 0.3 mm or 0.3 mm or 0.3 mm or 0.3 mm or 0.3 mm or 0.3 mm or 0.3 mm
applied Cu Cu Cu Cu Cu Cu Cu
Selectable Not applicable
added fil-
ters manu-
ally applied
Geometry
Source to 95 to 119 cm +/- 1 cm
image dis-
tance (SID)
Modes of Low, Nor- Low, Nor- Low, Nor- Low, Nor- Low, Normal Low, Normal Low, Normal Low, Normal
operation mal mal mal mal
Default de- Normal/LowNormal/LowNormal/LowNormal/Low Normal/Low Normal/Low Normal/Low Normal/Low
tail in Adult/
Pediatric
mode
Loading Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor- Low or Nor-
factors mal: mal: mal: mal: mal: mal: mal: mal:
range after 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV 60 - 120 kV
selection of
mA: mA: Normal mA: Normal mA: mA: 100 - Normal mA: Normal mA: Normal mA:
the mode
Min: Min: 41.7 - 1000 1 - 866 866 41.7 - 866 1 - 786 100 - 866
0.0075 mA 0.015 mA
Low mA: Low mA: Low mA: Low mA: Low mA:
Average @ Average @
41.7 - 500 1 - 786 41.7 - 500 1 - 786 100 - 786
3.75 fps, 7.5 fps, 2
2 ms pw ms pw
Max: Max:
33.6 mA 25 mA Av-
Average @ erage @ 30
30 fps, 8 fps, 8 ms
ms pw pw
Highest ref- See tables See tables No dose No dose No dose lim- No dose lim- No dose lim- No dose lim-
erence at each Au- at each Au- limits ap- limits ap- its applied: its applied: its applied: its applied:
dose (IRP = to Exposure to Exposure plied: plied:
Normal set- Normal set- Normal set- Normal set-
Interven- Preference Preference
Normal set- Normal setting gives ting gives ting gives ting gives
tional Ref-
ting gives ting gives approx. 2 approx. 2 approx. 2 approx. 2
erence
approx. 2 approx. 2 times dose times dose times dose times dose
Point)
times dose times dose than Low than Low than Low than Low
than Low than Low setting setting setting setting
setting setting
Diagnostic Normal Normal Normal Normal Normal Normal Normal Normal

Interven- Normal Normal Normal Normal Normal Normal Normal Normal

tional
6-2-4 IQ Standard

configura- roscopy Blended Record vaChaseTM
tions Roadmap /
Subtracted
Fluo-
roscopy
Orientation Vertical Spin
of the X-ray
beam
Patient sup- In (Out for dosemeter measurement)
port
Anti-scatter In
grid
Field Of 20 cm 40 cm 20 cm
View
Operating settings
3.75 fps 1.875 fps,
1.0 fps, 0.5
fps

Selectable In Low: In Low: In Low: 0.1 In Low: 0.2 In Low: 0.1 In Low: 0.1 In Low: 0 In Low: 0.3
added filters 0.3 mm Cu 0.3 mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu
automatical- @ 30 fps @ 30 fps
In Normal: In Normal: In Normal: In Normal: In Normal: 0 In Normal:
ly applied 0.3 mm Cu 0.3 mm Cu
0.1 mm Cu 0.2 mm Cu 0.1 mm Cu 0.1 mm Cu mm Cu 0.3 mm Cu
@ 15 fps @ 15 fps
0.3 mm Cu 0.3 mm Cu
@ 7.5 fps @ 7.5 fps
In Normal: In Normal:
0.3 mm Cu 0.3 mm Cu
@ 30 fps @ 30 fps
0.3 mm Cu 0.3 mm Cu
@ 15 fps @ 15 fps
0.3 mm Cu 0.3 mm Cu
@ 7.5 fps @ 7.5 fps
In Normal
(HCF):
0.3 mm Cu
@ 30 fps
0.3 mm Cu
@ 15 fps
0.3 mm Cu
@ 7.5 fps
Geometry
Source to 102.5 cm Max SID
image dis-
tance (SID)
Distance of 67.5 cm 72 cm
focal spot to
measuring
detector
X-ray field Square of: 174 cm² Square of: Square of: Square of:
size at the 694 cm² 145 cm² 178 cm²
measuring
detector
Positioning Distance between top of phantom and anticollision plate (airgap): 17 cm Phantom centered in
of phantom isocenter
(technique factors acquisition) is done at maximum SID, during a 3D/3DCT spin, when the gantry is in PA position.
2nd step (dose measurement) is done with the dosemeter probe in isocenter on the table.

Standard.
lected
60601-1)
lected
60601-1)


lected
60601-1)

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)


Standard.
5.0 ms 7.0 ms
Dose rate at International Standardiza- 51.9 µGy/frame 97.3 x 1.4 µGy/frame


Standard.
ms PW PW
ms PW PW
Loading factors automatically selected 80.0 kVp, 13.8 mA avg, 7.0 ms 80.0 kVp, 27.2 mA avg, 7.0 ms PW
PW

60601-1)
selected

surement conditions

Regulation)

60601-1)
selected

surement conditions

Regulation)

60601-1)

fluoroscopy and dose in Dynamic Record/DSA/InnovaChaseTM/Bolus/3D/3DCT with 20 cm PMMA

(nominal)

(mGy/min)

(mGy/min)

(mGy/min)

Low 0.22 mGy/frame 0.32 mGy/frame N/A N/A
Normal 0.44 mGy/frame 0.63 mGy/frame N/A N/A

Available config- Fluoroscopy Roadmap / DSA Dynamic Bolus 3D 3DCT

Roadmap /
Subtracted
Fluoroscopy
X-ray beam
Field Of View 20 cm 40 cm 20 cm
Operating settings

Frame rate 30 fps, 15 fps, 30 fps, 15 fps, 7.5 fps, 30 fps, 15 1 fps, 2 fps 30 fps 30 fps
7.5 fps, 3.75 7.5 fps 3.75 fps, fps
fps 1.875 fps,
1.0 fps, 0.5
fps
Selectable added In Low 30 fps: In Low 30 fps: In Low: 0.1 In Low: 0.3 In Low: 0.1 In Low: 0.3 In Low: 0.3
filters automati- 0.3 mm Cu 0.3 mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu
cally applied In Normal 30 In Normal 30
In Normal: In Normal: In Normal: In Normal: 0.1 In Normal:
fps: fps:
0.1 mm Cu 0.3 mm Cu 0.1 mm Cu mm Cu 0.3 mm Cu
0.3 mm Cu 0.3 mm Cu
In Normal
In Low 15 fps:
(HCF) 30 fps:
0.3 mm Cu
0.3 mm Cu
In Normal 15
In Low 15 fps: fps:
0.3 mm Cu 0.3 mm Cu
In Normal 15
In Low 7.5 fps:
fps:
0.3 mm Cu
0.3 mm Cu
In Normal 7.5
In Normal
fps:
(HCF) 15 fps:
0.3 mm Cu
0.3 mm Cu
In Low 7.5 fps:
0.3 mm Cu
In Normal 7.5
fps:
0.3 mm Cu
In Normal 7.5
fps:
0.3 mm Cu
Geometry
distance (SID)
spot to measuring
detector
X-ray field size at Square of: 174 cm² Square of: Square of: 145 Square of:
the measuring de- 694 cm² cm² 178 cm²
tector
Positioning of Distance between top of phantom and anticollision plate (airgap): 17 Phantom centered in
phantom cm isocenter


ly selected

(IEC 60601-1)
ly selected

(IEC 60601-1)

cally selected

(IEC 60601-1)

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

ed 5.0 ms ms

ms PW PW
ms PW PW
60601-1)

selected

surement conditions

Regulation)

60601-1)
selected

surement conditions

Regulation)

60601-1)

fluoroscopy and dose in Dynamic Record/DSA/Bolus/3D/3DCT with 20 cm PMMA
(nominal)


(mGy/min)

(mGy/min)

(mGy/min)


For Fluoroscopy, Roadmap / Blended Roadmap / Subtracted Fluoroscopy, Dynamic Record, DSA, Bolus, 3D and
3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor Dose Limited
Standard.

Point)
Frame- 30 fps Normal < 43.8 mGy/min < 97.4 mG/min < 43.8 mGy/min < 97.4 mGy/min
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
6-2-7 IQ Plus
For DSA, Bolus, InnovaChaseTM and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to
Patient for IQ Standard.


configurations Roadmap / Subtracted
Fluoroscopy
X-ray beam
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 30 fps, 15 fps, 7.5 fps 30 fps, 15 fps 30 fps
fps, 3.75 fps
Selectable Low 30 fps: 0.3 mm Low 30 fps: 0.3 mm Cu Low: 0.2 mm Cu Low: 0.1 mm Cu
added filters au- Cu Normal 30 fps: 0.3 mm Normal: 0.2 mm Cu Normal: 0 mm Cu
tomatically ap- Normal 30 fps: 0.2 Cu
plied mm Cu Low 15 fps: 0.3 mm Cu
Normal (HCF) 30 fps: Normal 15 fps: 0.3 mm
0.2 mm Cu Cu
Low 15 fps: 0.3 mm
Cu
Cu
Normal 15 fps: 0.2
mm Cu
0.1 mm Cu
Low 7.5 fps: 0.3 mm
Cu
Normal 7.5 fps: 0.1
mm Cu
Normal (HCF) 7.5
fps: 0.1 mm Cu
Geometry
distance (SID)
spot to measur-
ing detector
the measuring
detector
phantom isocenter

Standard.
ly selected

(IEC 60601-1)
ly selected


(IEC 60601-1)
ly selected

(IEC 60601-1)

Point)

(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Standard.
lected ms ms
60601-1)

selected

surement conditions

Regulation)


60601-1)

(nominal)

tion

tion

tion

tion

tion

tion (mGy/min)

tion


tion

For DSA, Bolus, 3D and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for
Receptor Dose Limited Standard.
Available Fluoroscopy Roadmap / Blended Dynamic Record

configurations Roadmap / Subtracted Fluo-
roscopy
Orientation of the X- Vertical
ray beam
Field Of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 fps, 7.5 fps 30 fps, 15 fps
fps
Selectable added fil- Low 30 fps: 0.3 mm Cu Low 30 fps: 0.3 mm Cu Low: 0.3 mm Cu
ters automatically ap- Normal 30 fps: 0.3 mm Cu Normal 30 fps: 0.3 mm Cu Normal: 0.3 mm Cu
plied Normal (HCF) 30 fps: 0.2 mm Low 15 fps: 0.3 mm Cu
Cu Normal 15 fps: 0.3 mm Cu
Normal (HCF) 15 fps: 0.2 mm
Cu
Normal (HCF) 7.5 fps: 0.2 mm
Cu
Geometry
Source to image dis- 102.5 cm
tance (SID)
Distance of focal spot 67.5 cm
to measuring detector

X-ray field size at the Square of: 174 cm²

measuring detector
Positioning of phantom Distance between top of phantom and anticollision plate (airgap): 17 cm
Standard.
ly selected

(IEC 60601-1)

ly selected

(IEC 60601-1)
cally selected

(IEC 60601-1)


Point)
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Loading factors automatically se- 68.4 kVp, 67.1 mA avg (30 fps), 5 ms 68.0 kVp, 134.5 mA avg (30 fps), 7
lected ms
60601-1)

fluoroscopy and dose in Dynamic Record with 20 cm PMMA
(nominal)

tion

tion


tion

tion

tion

tion (mGy/min)

tion

touch screen.


conditions).
modes only.)
procedure room.
Vertical 1 meter



Vertical 1.5 meter


Lateral 1 meter


Lateral 1.5 meter

• kVp range: 40-125 kVp +/- 10%;


filtration.
X-ray.
Disable Button).

max.
milliroentgens) in 1 hour at one meter in any direction from the diagnostic source assembly composed of:
• Beam Limiting Device (Collimator) AF DSA 01.
minimum.
In addition, the beam limiting device features three additional filters of: 0.1, 0.2 and 0.3 mm Cu which corresponds
to 6.5, 9.6, 12.6 mm Alu equivalent at 70 kV.

• Spectral filter: 0.1 mm Cu, 0.2 mm Cu and 0.3 mm Cu.
along the exam.


7 Protection regarding Functional Hazards

7-1 3rd Party Software
INSTALLING AND USING UNVALIDATED SOFTWARE MAY CAUSE SYSTEM TO FAIL OR

NOT WORK AS INTENDED. SOFTWARE INSTALLATION TO BE DONE ONLY BY QUALIFIED
GE PERSONNEL.
7-2 Loss of Imaging
ESTABLISH PROCEDURES FOR HANDLING THE PATIENT IN CASE OF THE LOSS OF

FLUOROSCOPIC IMAGING OR OTHER SYSTEM FUNCTIONS DURING AN EXAM. FAILURE
OF IMAGING MAY HOWEVER BE RECOVERED IN FOLLOWING PROCEDURE SET BELOW.
7-3 Loss of Power
THE INTERRUPTION OF THE MAIN POWER SUPPLY TO THE EQUIPMENT DURING ITS USE
COULD LEAD TO A HAZARDOUS SITUATION. THE EQUIPMENT MAIN POWER SUPPLY
MUST BE PROVIDED THROUGH AN UNINTERRUPTIBLE POWER SUPPLY (UPS) AT
FACILITY LEVEL OR USING THE FLUORO UPS OPTION, OR THROUGH A STAND-BY
GENERATOR. REFER TO SECTION APPENDIX - TECHNICAL PUBLICATIONS / SYSTEM
LINE VOLTAGE WITHOUT FLUORO UPS FOR THE CHARACTERISTICS OF THE INPUT LINE.
Functions maintained in Equip- Equipment with Fluo- Equipment with institu- Equipment with institu-
case of power supply ment ro UPS option tional stand-by genera- tional uninterruptible
main failure tor3 power supply3
Preservation of stored im- Yes Yes Yes Yes
ages
Availability of fluoroscopy No Yes1* After boot2 Yes
2
Availability of record No No After boot Yes
Availability of equipment No Yes1 After boot2 Yes
motion
Availability of equipment No Yes1 After boot2 Yes
motion for CPR

1
: Functions remain available until batteries are unloaded. At least 5 minutes of fluoroscopy are available if the
batteries are fully loaded.
2
: When the power supply is restored by the generator, the system needs to be powered-on following the procedure
available in the instruction for use.
3
: Refer to section Appendix - Technical Publications / System Line Voltage without Fluoro UPS for the
characteristics of the input line.
*
: On configurations with Large Display Monitor Option, the images display is guaranteed on the backup monitors
only.
7-4 System Recovery after a power Cut
• Overview
The Innova System provides an automatic shutdown for the power cut of more than 500 ms. An UPS
(Un-interruptible Power Supply) delivers power to the DL and the RTAC to make this shutdown clean.
• System restart
Refer to section System - How to Perform System Power-Up for the description of the procedure to restart the
system after a power cut.
7-5 Emergency Procedure for Image Recovery or System Lock Up with 19" monitors
There may still be a residual risk of:
• One system lock up every 1 000 patients.
• One X-ray exposure sequence interrupted every 10 000 records.
Handle Emergency or at risk procedures with precaution.

7-6 Emergency Procedure for Image Recovery or System Lock Up with Large Display

monitor
There may still be a residual risk of:
• One system lock up every 1 000 patients.
• One X-ray exposure sequence interrupted every 10 000 records.
• The Large Display option may experience power cut separately from the Interventional system.
Handle Emergency or at risk procedures with precaution.
THE LARGE DISPLAY MONITOR IS POWERED SEPARATELY FROM THE INTERVENTIONAL

SYSTEM AND DOES NOT INCLUDE A UPS (UN-INTERRUPTIBLE POWER SUPPLY).
DEPENDING ON THE CONNECTION TO THE POWER SUPPLY NETWORK OF THE
HOSPITAL AND THE PRESENCE OF A UPS FOR THE INTERVENTIONAL SYSTEM, IT MAY
EXPERIENCE A POWER CUT WHILE THE INTERVENTIONAL SYSTEM IS STILL
OPERATIONAL. THE OPTION INCLUDES 2 BACKUP MONITORS BEHIND THE SUSPENSION
THAT ARE POWERED BY THE INTERVENTIONAL SYSTEM TO PROVIDE THE LIVE IMAGE
AND REGULATORY INFORMATION TO OPERATE THE INTERVENTIONAL SYSTEM.


7-7 Latency (Image Display Delay), Polymerization Time and Acquisition mode use
LATENCY OR IMAGE DISPLAY DELAY IS DEFINED AS THE TIME LAG BETWEEN THE
OPERATOR ACTION AND THE DISPLAY OF THAT ACTION ON THE MONITOR. THIS LAG
VARIES DEPENDING ON THE ACQUISITION FRAME RATE.
• ABOUT 200 MS FOR FRAME RATES OVER 15 FPS.
• ABOUT 850 MS FOR FRAME RATE OF 1.9 FPS.
THE OPERATOR SHOULD HAVE THIS LATENCY IN MIND WHEN MAKING A CHOICE OF EMBOLIC AGENTS
USED DURING INTERVENTIONS IN RELATIONSHIP TO POLYMERIZATION TIME.
There is a residual risk of a frozen Image being displayed on the live display if a failure occurs, this has never been
observed though. If X-ray has been interrupted during Fluoro or Record, a Frozen image may remain displayed on
the live display. The X-ray on indicator is active, "X-ray acquisition in progress message" is displayed, and the
X-ray on light remains on. Special precautions should then be taken for all interventional procedures and
manipulation.
7-8 Control of transfer of data to an archiving system
Innova System does not feature archiving but provides capability to connect an archiving system. So, not being an
archiving system, Innova ensures the control of transfer of the data to the archiving system.
The control of transfer is ensured by:
• the double confirmation before deletion of an item if this one is not successfully transferred,
• the network queue.
In the network queue items selected for archive are flagged using the following statuses:
• ACTIVE: The data transfer is in progress; only one item is flagged as "ACTIVE" in the queue.
• PENDING: The data transfer is waiting to be performed; multiple items can be flagged as "PENDING".
• FAILED: The data transfer was not completed due to an error ("FAILED"). The user shall re-transfer the item.
An item may be a patient, an exam, a sequence or a photo.
If the data was successfully transferred, the item is removed from the network queue. An empty queue means that
all items were successfully transferred.
In case of successful transfer, the DL guarantees that the transfer occurred with no data loss, but the DL does not
give any guarantee that the data has been successfully archived on the receiving system, it is recommended that
the user checks that the data is correct on the receiving system before deleting it from DL.
7-9 SID Failure - Degraded mode
In case of SID failure, the following message is displayed on the in-room monitor:
SID failure. Collimation activated. To raise detector, use pink button
If this message appears on the in-room monitor, user has to move the detector towards its highest position in using
the emergency back-out button (1) placed on the detector as shown above. X-ray are available even if the error

message is shown, applied x-ray parameters ensures minimal dose to the user and the patient.
7-10 Prevent Unnecessary Interruption of a Procedure Arising from a Collision
Note: Different measures have been implemented to prevent unnecessary interruption of a procedure arising from
a collision. At obstacle approach:
• the gantry slows down (half speed).
• warning icons are displayed on live display.
• an optional audible signal warns the operator of an imminent close collision.
7-11 Automatic Exposure Control
The procedure to verify the Automatic Exposure Control is available in the DVD SM "InnovaTM IGS 520, InnovaTM
IGS 530, InnovaTM IGS 540" (Functional Checks Tabs/CHK0024 - ABC Stabilization Point Checks). Apply this Job
Card.
7-12 Lead Shield Positioning
SPECIAL ATTENTION MUST BE TAKEN WHEN MOVING THE LEAD SHIELD CLOSE TO THE
PATIENT DURING A PROCEDURE. ALWAYS VERIFY FIRST THAT THE CATHETER CANNOT
BE ACCIDENTALY WITHDRAWN FROM THE PATIENT BEFORE MOVING THE LEAD SHIELD.
7-13 Risk of confusion between live Fluoro images and automatic replay of stored
Fluoro images
THE OPERATOR'S ATTENTION IS DRAWN TO A POTENTIAL MISINTERPRETATION

BETWEEN LIVE FLUORO IMAGES AND REPLAY OF FLUOROSTORE IMAGES. WHEN THE
OPERATOR WHO DEPRESSES THE FLUORO PEDAL (EXPOSURE) IS DIFFERENT FROM
THE OPERATOR PERFORMING THE INTERVENTION, THERE IS A RISK THIS OPERATOR
UNDERTAKES AN INTERVENTIONAL GESTURE ON THE MISTAKEN ASSUMPTION THAT A
CURRENTLY DISPLAYED IMAGE IS LIVE WHILE IT IS A FLUORO REVIEW IMAGE. ALWAYS
ENSURE THE REVIEW PICTOGRAMS (as shown with arrows on illustration below) ARE NOT
DISPLAYED, PRIOR TO UNDERTAKE INTERVENTIONAL GESTURE.

7-14 InnovaIQ Table
Secure all devices or equipment located on the table top prior to tilting the table to avoid
injury to patients and staff.
7-15 Degraded Fluoro image quality
THE LARGE SIZE OF THE 40 CM DETECTOR MAKES IT VERY SENSITIVE TO

ELECTROMAGNETIC WAVES AND RADIO FREQUENCY. WITH SUCH DETECTOR SIZE, IN
CASE A NAVIGATION SYSTEM USING ELECTROMAGNETIC WAVES OR A RADIO
FREQUENCY ABLATOR IS REQUIRED, ALL FLUORO PERFORMED DURING THE USE OF
SUCH EQUIPMENT MIGHT BE BADLY DEGRADED SUCH AS SOME ANATOMY AREAS
COULD NOT BE VISIBLE ANYMORE. DO NOT PERFORM PROCEDURE REQUIRING
FLUORO IMAGES WHILE USING AN ELECTROMAGNETIC NAVIGATION SYSTEM OR A
RADIO FREQUENCY ABLATOR ON THE INNOVA IGS 540.
7-16 Comfort accessories
Some parts of the comfort accessories are not radiolucent and may cause image quality
artifacts that require distinguishing them from anatomical structures.
7-17 Open Suspension Positioning
SPECIAL ATTENTION MUST BE GIVEN WHEN MOVING THE OPEN MONITOR SUSPENSION
CLOSE TO THE PATIENT DURING A PROCEDURE. BEFORE MOVING IT ALWAYS VERIFY
THAT THE CATHETER CANNOT BE ACCIDENTALY WITHDRAWN FROM THE PATIENT.
8 Protection regarding Mechanical Hazards

8-1 Table Motion User Interfaces
Omega Table Smart Box
Omega Table Smart Handle
InnovaIQ Table (IR configuration) Smart Box

InnovaIQ Table (OR configuration) Smart Box
Involuntary mechanical shocks on the Smart Box joysticks may produce unwanted
positioner motion and cause injuries. In case the Smart Box needs to be removed from the
table, always leave it in an area where its joysticks are protected from shocks.
WHILE CLAMPING TSUI ON RAIL (ON THE TABLE SIDE, ON THE CART OR ON THE
REMOTE STAND), IT IS IMPORTANT TO DOUBLE CHECK THAT TSUI IS CORRECTLY
CLAMPED ON BOTH ITS LATERAL SIDES. THERE IS A RISK OF TSUI FALL, UNWANTED
TABLE AND GANTRY MOTION AND INJURY WHEN THE TSUI IS NOT CORRECTLY
CLAMPED.

Upper side
Lower side
TSUI is correctly clamped TSUI is not correctly clamped
8-2 InnovaIQ Table
ALWAYS SECURE PATIENT WITH APPROPRIATE RESTRAINTS BEFORE TILTING THE

TABLE IN ANY DIRECTION.
8-2-1 Table Side User Interface Positioning
In case of table tilt required during a procedure, always position the InnovaIQ Smart Box in such a way that it stays
reachable in any table tilt angulation.
For systems using the Smart Box and Table Side Status Control (TSSC) installed at the foot end of the table, it is
recommended to always install the Smart Box left of the TSSC as shown in the picture below:
Recommended Position
Position to avoid

Note: When a Smart Box or TSSC is installed near the foot end of the rail, it may be difficult to access and view the
controls when the table is tilted Trendelenburg. Move the tableside controls closer to the head end of the rail.
8-2-2 Tableside Cart (Option)
The Tableside Cart is provided to the customer fully installed and ready to use. Any mechanical configuration
modification must be performed by qualified and trained engineers only.
This product must be serviced with Manufacturer approved original replacement parts only. Failure to follow this
recommendation will void the Manufacturer’s warranty and will release the Manufacturer from liability and warranty
claims.
The Manufacturer cannot be held liable for unauthorized modifications made to the system or use of the system for
unintended purposes. Since improper modifications may impair proper operation, safety, or reliability of the system,
all modifications need to be authorized by the Manufacturer.
NEVER POSITION THE TABLESIDE CART IN A LOCATION WHERE IT COULD ENTER IN

COLLISION WHILE THE TABLE IS TILTED OR MOVED UP OR DOWN.
When positioning or moving the Tableside Cart, avoid collision with other equipment.
Failure to do so may lead to severe damage on both the Tableside Cart and other
equipment. In case of severe collision or equipment damage, immediately stop operation of
the system. Keep the area around the Tableside Cart clear of any equipment.
The Tableside Cart is not designed to hold other accessories than those installed at tableside of GE Healthcare
Cardiovascular Imaging systems.
Compatible Table Side User Interface (TSUI) allowed to be installed on the Tableside Cart:
• Smart Box
• Table Side Status Control (TSSC)
• Central Touch Screen
• Volcano Touch Pad Controller
The Tableside Cart is not designed to hold the injector head or injector control panel.
The maximum weight a rail can hold is limited to 13 kg, which is always more than any combination of 2 of the
above TSUI.
The maximum weight the Tableside Cart can hold is limited to 50 kg. Do not stand on wheels or Tableside Cart
base.
To prevent the Tableside Cart from falling over, never move or use it on a slope greater than
10°.
Do not open covers.
8-2-3 Mattress
THE MATTRESS CONTRIBUTES TO PATIENT SAFETY WHEN THE TABLE IS TILTED. IN

CASE OF MATTRESS DAMAGE WHICH REQUIRES ITS REPLACEMENT, IT IS MANDATORY
TO REPLACE IT WITH THE SAME MODEL. THERE IS A RISK OF PATIENT FALL WHEN THE
TABLE IS TILTED IN CASE ANOTHER MATTRESS MODEL IS USED.

To prevent any patient fall risk during a table tilt, the mattress is secured to the table top using a set of Velcro
strips.
DO NOT USE THE MATTRESS UPSIDE DOWN. THERE IS A RISK OF PATIENT FALL WHEN
THE TABLE IS TILTED BECAUSE VELCRO STRIPS ARE LOCATED UNDER THE MATTRESS
ONLY.
A set of Velcro strips is installed on the table top and under the mattress at mid length and at foot end.
In case the mattress needs to be removed from the table top, pull up the mattress at foot end, then at the mid
section to release the Velcro strips.
To install the mattress, start from head end.

1. Align the mattress head end to the table top head end.
2. Roll out the mattress aligned to the table top longitudinal axis.
3. Check that the Velcro strips are facing each other and press on the mattress to engage the strips at mid section
and foot end.
8-3 Precaution regarding Detector Anti-Collision Device
THE OPERATOR'S ATTENTION IS DRAWN TO THE PRESSURE THAT MAY BE APPLIED ON

THE PATIENT BODY IN CASE OF ACTIVATION OF DETECTOR ANTI-COLLISION DEVICES
(BUMPERS, SWITCH PLATE). YOUNG PATIENT (i.e. BABIES), NARROW AND SMALL
HUMAN OBJECTS (i.e. NOSE), SENSITIVE AREAS (i.e. AFTER SURGERY) ARE MORE
SENSITIVE TO PRESSURE. THEREFORE ATTENTION OF OPERATOR IS DRAWN TO AVOID
ANY POTENTIAL COLLISION. IN ADDITION, IT IS RECOMMENDED TO TURN PATIENT'S
HEAD TO THE RIGHT/LEFT AND TO REDUCE GANTRY SPEED WHEN IN THE VICINITY OF
THE PATIENT'S HEAD.
9 Protection against Contamination / Infection Hazards / Biological Hazards

9-1 Attachment of Protective (Sterile) Drapes
TO PROTECT AGAINST POSSIBLE BIOLOGICAL HAZARDS, ISO 10993 CERTIFIED DRAPES

SHALL BE USED ON THE DETECTOR, IN DIAGNOSTIC AND INTERVENTIONAL CONTEXTS.
Bodily fluids may damage internal components if they are allowed inside the equipment.
Use drapes, if necessary, to protect equipment when performing procedures.
If you are performing a procedure where draping is necessary, you can choose among the following solutions. You
can contact your local GE representative for more information on how to order these solutions.
ALL THE DRAPES USED ON ACCESSORIES, ON MATTRESS AND ON DETECTOR SHALL

BE ISO 10993 CERTIFIED.
9-1-1 Equipment (image receptor, X-ray tube-collimator assembly, Smart Handle, Smart Box, Table Side Status
Control, Innova Central touch screen)
Image Receptor

X-ray tube - Collimator assembly
Smart Handle
Smart Box

Table Side Status Control (TSSC)
Innova Central touch screen
9-1-2 Large Display Monitor handle

The Large Display Monitor suspension can receive cover sheets in order to preserve the sterility of the
environment.
Tool clips may be added on the cover sheets to avoid slippage during usage.
Please refer to the picture below for mounting:
These tool clips can be purchased at the following manufacturers:
Manufacturer Link Manufacturer reference

Farnell www.farnell.com 708-1558
Farnell www.farnell.com 155-25-22

Springmasters www.springmasters.com 80112BP, 80112WP, 80112

Toolclip www.toolclip.com 108, 108V, 2-B, 2-BV, FB-FXL
Terry tool - 80-28-3
Buckandhickman www.buckandhickman.com/find/keyw 8165009028
ord-is-tool+clips/product-is-103026
9-1-3 Accessories
Injector Control Console
In-room 3D Mouse

InnovaIQ Table Shoulder Rest
10 Symbols
Symbols used on the vascular systems and in its accompanying documents are shown and explained in this
section.
• Audio/Visual Indications
• Special Notices
• X-ray Tube
• Power ON and OFF
• Type B Applied Part
• Electrical Class
• Electrical Current
• Ground
• Collimator
• Cardiac Pulmonary Resuscitation (CPR)
• Maximum Patient Weight
• Maximum permissible table load
• Table end rail maximum load
• Footswitch and Table Panning Device (TPD)
• Smart Handle - Smart Box - Table Side Status Control
• Innova Console
• Application
• Grid Out
• Acquisition
• InnovaIQ Table
• Status Icons
• Remote Stand (Option)

• Tableside Cart (Option)

• Head Extender
• Patient Browser Network Status Icons
• Electronic Operator Manual
• Surgical and Patient Comfort Accessories
• Bolus Handle
• X-ray LED
• Filtration
• Product identification
10-1 Audio/Visual Indications
This table provides a summary of the major audio/visual indications provided by the console.
INDICATIONS CAUSE COMMENT

VISUAL AUDIO * OTHER
None. Normal procedure dur- Normal operation.
ing all modes of X-ray
exposure except for
Medium, low-pitched, con- fluoroscopy (in this
tinuous tone. case, there is only a
visual indicator but no
tone).
Note: For Japan, Nor-
mal procedure during
all modes of X-ray ex-
posure including fluo-
roscopy (in all this
case, there is a visual
indicator and a tone).
Brief flash on VCIM Normal procedure dur- Normal fluoroscopy op-
at the initiation of ing fluoroscopy X-ray eration.
fluoro. exposure (Fluoro):
Brief tone. brief audible signal at
the initiation of irradia-
tion.
None. X-ray Timer reaches Press the X-ray Timer
5.0 minutes. Reset button to silence
the audible signal and
FLASHING Pulsed tone. reset timer to 0 minute.
In Italy, X-rays are dis-
abled after 10 minutes
without reset.
None. HUA (Heat Unit Avail- Wait for X-ray tube to
able) value is below or cool (HUA greater than
equal to 20%. 20%).
High, continuous tone.

None. None. Shows status of ECG Green means signal is

signal detected and online, yel-
low means system is sta-
bilizing, orange may
need reset and white
means system is offline
Note: * The behavior may change depending on country selection. Refer to Safety and Regulatory Instructions for
Use / Protection regarding Ionizing Radiations Hazards for Innova IGS 520 / Dose to Patient in Japan or Safety and
Regulatory Instructions for Use / Protection regarding Ionizing Radiations Hazards for Innova IGS 530 / Dose to
Patient in Japan or Safety and Regulatory Instructions for Use / Protection regarding Ionizing Radiations Hazards
for Innova IGS 540 / Dose to Patient in Japan for more detail.
Buzzer Kit: Allows to propagate all audio indications in the exam room.
• The loudness of the loudspeaker was adjusted at installation. Contact your GE Service Representative for any
further modification.
• For cleaning, unplug the power source before cleaning. Do not use liquid cleaners or aerosol cleaners. Use a
damp cloth for cleaning.
• Do not attempt to service any part of the speaker yourself as opening or removing covers may expose.
Fluoroscopy and Radioscopy audible signals may be configured. Push Fluoro icon or Record icon in monitoring bar
to open the sound configuration window:
The following settings are available for Fluoroscopy and Radioscopy. By default at installation, the system is
configured with a short beep for Fluoroscopy and a continuous tone for Radioscopy.
NONE BEEP CONTINUOUS

FLUOROSCOPY No audible signal Short tone at the initiation of -
irradiation
RADIOSCOPY No audible signal Short tone at the initiation of Continuous tone during irra-
irradiation diation
Note for Japan: As described in Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 520 / Dose to Patient in Japan or Safety and Regulatory Instructions for Use /
Protection regarding Ionizing Radiations Hazards for Innova IGS 530 / Dose to Patient in Japan or Safety and
Regulatory Instructions for Use / Protection regarding Ionizing Radiations Hazards for Innova IGS 540 / Dose to
Patient in Japan, the usage of special high level Fluoroscopy mode is indicated permanently on the Reference in
room monitor by the annotation "Normal" and by a permanent audible signal. Therefore, Fluoro and Record beep
settings do not apply in this special mode.
Note: With the continuous tone setting, slower frame rates will sound like a beep signal.
Fluoroscopy and Radioscopy sound can be selected from the respective drop-down menu:

Extra caution should be taken if the Fluoro or Record sound is set to "None". Inadvertent
x-ray activation and unknowingly activating the footswitch will not be detectable by an
audible signal because the sound will be deactivated.
10-2 Special Notices
Dangerous voltage. Indicates an avoidable dangerous

high voltage hazard.
Warning label for dangerous voltage.
General Caution.
This symbol is used to highlight the fact that there are
specific warnings or precautions associated with the
device, which are not otherwise found on the label.
This symbol on the equipment means that the operat-

ing instructions should be consulted to assure safe op-
eration.
Identifies an emergency stop control device

General warning sign.
General mandatory action sign.
Consult instructions for use.
Follow operating instructions.
General prohibition sign.
10-3 X-ray Tube
X-ray emission. X-ray tube head is emitting X-rays.

Take adequate precautions to prevent the possibility of
any persons carelessly, unwisely, or unknowingly ex-
posing themselves or others to radiation.
X-ray source assembly. Indicated a reference to an X-

ray source assembly.

X-ray tube. Indicates a reference to the X-ray tube, i.e.

to mark the surface of a grid that is to be oriented to-
wards the X-ray tube.
Identifies controls or indicators associated with normal

rotational speed of the X-ray anode.
Identifies the plane where is located the X-ray tube fo-

cal spot into the system.
10-4 Power ON and OFF
Switch or switch position that applies and removes

power to part of the equipment. This does not apply
main voltage.
A white <SYSTEM RESET> button. Use this button to

reset the Innova System.
Switch or switch position that applies mains voltage.

Indicated connection to the main voltage for all main
switches or their positions. This symbol is used in all
cases where safety is involved.
Switch or switch position that removes the main volt-

age. Indicated disconnection from the mains for all
main switches or their positions. This symbol is used in
all cases where safety is involved.
10-5 Type B applied part

Applied part complying with the specified requirements

of the IEC 60601-1 standard to provide protection
against electric shock, particularly regarding allowable
patient leakage current and patient auxiliary current.
10-6 Electrical Class
Class II Equipment. Protection against electrical shock does not rely on basic insulation
only, but in which additional safety precautions such as double or reinforced insulation
are provided. There is no provision for protective earthing or reliance upon insulation
conditions.
10-7 Electrical Current
Alternating Current. Indicates equipment that is suit-

able for alternating current only.
Direct Current. Indicates equipment that is suitable for

direct current only.
Both direct and alternating current. Indicates equip-

ment that is suitable for both direct and alternating cur-
rent.
10-8 Ground
Functional Earth (ground) Terminal. Terminal directly

connected to a point of a measuring supply or control
circuit or to a screening part which is intended to be
earthed for functional purposes.
Noiseless (clean) earth (ground). Identifies any termi-

nal of a specially designed earthing system where
noise from earth of leads will not cause a malfunction
of the equipment.
Protective earth (ground). Identifies any terminal which

is intended for connection of an external protective
conductor to protect against electrical shock in case of
a fault.
Frame or chassis. Identifies the frame or chassis termi-

nal.

Equipotentiality. Identifies terminals that bring the vari-

ous parts of equipment or systems to the same poten-
tial when connected together. These terminals are not
necessarily at earth (ground) potential. The value of
the potential may be indicated next to the symbol.
10-9 Collimator
Identifies controls for opening the collimator blades, or

indicates partially or fully open state.
Identifies controls for closing the collimator blades, or

indicates closed state.
Collimator blades closed. The controlled blades are

shown in thicker lines.
Collimator Blades open. The controlled blades are

shown in thicker lines.
10-10 Cardiac Pulmonary Resuscitation (CPR)
Move the table top toward the foot end before

performing a CPR procedure. These labels
could be in the reverse direction.

Do not perform a CPR procedure if the table

is not centered over the table base. These la-
bels could be in the reverse direction.
10-11 Maximum Patient Weight
The maximum patient weight the InnovaIQ Table can

accept is 204 kg
The maximum patient weight the Omega Table can ac-

cept is 204 kg
10-12 Maximum permissible table load
The maximum permissible load including accessories

the InnovaIQ Table can accept is 320 kg.
The maximum permissible load including accessories

the Omega Table can accept is 304 kg.
10-13 Table end rail maximum load
20 kg maximum load allowed

10-14 Footswitch and Table Panning Device (TPD)
Do not use the footswitch cover as a footrest or stand on it
Table Top Longitudinal and Lateral Brakes Release (on footswitch and TPD)
10-15 Smart Handle/Smart Box/Table Side Status Control
This sticker is located on the back side of each Table Side User Interface
(TSUI). Do not place TSUI on the floor. Unwanted table or gantry motion
could be activated.
10-16 Innova Console
Radiation Hazard Symbol.

This sticker is located on VCIM. Caution X-rays.
10-17 Application
Displayed on left side of the live display to show that the displayed image is a
live fluoroscopic image.
Displayed on left side of the live display during a Fluoro performed in Auto Flu-
orostore mode.

Displayed on left side of the live display to show that the displayed image is a
recorded image.
Displayed on left side of the live display to show that the displayed image is the
frozen last fluoroscopic image.
Displayed on left side of the live display to show that the displayed image, pre-
viously recorded, is reviewed.
Displayed on left side of the live display to show that a mask is available for the
Roadmap fluoro.
Displayed on the left side of the live display to show the system is in Blended
Roadmap and the selected percentage of vessel visibility
30% Displayed on left side of the live display to show the selected level of landscape
for Subtracted or Roadmap fluoro.
Displayed at the bottom right of the live display to show that the displayed im-
age is a previously recorded image reviewed in Play mode Forward nominal
speed (review in loop)
age is a previously recorded image reviewed in Play mode Forward half speed
(review in loop)
age is a previously recorded image reviewed in Play mode Forward high speed
(review in loop)
age is a previously recorded image reviewed in Play mode Backward nominal
age is a previously recorded image reviewed in Play mode Backward half
age is a previously recorded image reviewed in Play mode Backward high
age is a previously recorded image reviewed in Pause mode (frozen image)
age is a previously stored fluoroscopic image reviewed in Play mode Forward
nominal speed (review in loop)
half speed (review in loop)
high speed (review in loop)

age is a previously stored fluoroscopic image reviewed in Play mode Backward
age is a previously stored fluoroscopic image reviewed in Pause mode (frozen
image)
Displayed on left side of the live display to show that an ECG signal is being
detected
10-18 Grid Out
Displayed on left side on the live display, in the Geometry area, to show that
the anti-scatter grid has been removed and is not in the X-ray beam.
10-19 Acquisition
Displayed at the bottom of the control room console to show that a fluoroscopic
or record acquisition is in progress
10-20 InnovaIQ Table
This sticker is located on the top right and top left of the
bellows surrounding the table base.
Do not leave hand/fingers on the bellows
There is a potential risk of hand/fingers pinch when the
table is moving down.

Located on each side of the table base.

Do not stand or leave any material under the table top
while tilted; potential risk of crush. These labels could be
in the reverse direction.
Do not stand between the table top head end and the
gantry pivot when the positioner is not disabled using the
Positioner Enable/Disable button located on the Smart
Box.
Risk of severe injury when the table top is moving to-
wards the gantry pivot.
Located on top of each shoulder rest and on the footrest

facing each shoulder rest pole.
Do not remove one shoulder rest with patient heavier
than 125 kg and table is tilted or needs to be tilted.
Do not use the footrest with patient heavier than 125 kg
in case the weight will be applied on one point only when
the table will be tilted.
10-21 Status Icons
Displayed on the right side of the right side of the reference display to show
that disk space is still available.
Displayed on the right side of the right side of the reference display to show
that disk starts to be full.
Blinking icon displayed on the right side of the reference display to show that
disk is near to be full.

Displayed on the right side of the reference display to show that disk is full.
Displayed on the right side of the reference display to show that at least 50% of
heat units are still available in the X-ray tube.
Displayed on the right side of the reference display to show that available heat
units in the X-ray tube are between 30% and 50%.
Blinking icon displayed on the right side of the reference display to show that
available heat units in the X-ray tube are below 30%.
Displayed on the right side of the reference display to show that the maximum
heat units are reached in the X-ray tube.
Displayed on the right side of the reference display to show that the Fluoro is
ready (enabled).
Displayed on the right side of the reference display to show that the Fluoro is
not available (disabled).
Displayed on the right side of the reference display to show that the Record is
ready (enabled).
Displayed on the right side of the reference display to show that the Record is
not available (disabled).
10-22 Remote Stand (Option)

Label for Locking Direction Note:

The direction label also posted on the backside to take care of both RH and LH
Installations.
Label for Maximum Load Warning Note:

The warning labels are also posted on the bottom side of the arms to reference
both the right handed or left handed installations.
10-23 Tableside Cart (Option)

This sticker is located close to the middle of each rail.

No more than 13 kg on each rail.
This sticker is located at the base of the Tableside Cart.

No more than 50 kg for overall weight on the base of the Tableside Cart.
This sticker is located on each front wheel.

Do not stand on the Tableside Cart base or wheels.
10-24 Head Extender

Label for maximum patient weight on head extender.
10-25 Patient Browser Network Status Icons

The below icons appear in the Network Status column of the Patient, Exam, Sequence and Photo Browser.
Network Status refers to the consolidated transfer status of all the network activities in the DICOM network.
Network activity in Innova includes:
(a) DICOM Worklist (optional)
(b) DICOM MPPS
(c) DICOM Image Push
(d) DICOM Image Storage commitment (optional)
(e) DICOM Dose Structured Report Push
(f) DICOM Dose Structured Report Storage commitment (optional)
Indications Cause Comment

Empty No network activity available Can either be deleted (if not used) or perform some ac-
tions.
Sending Some network activity is in-progress Recommended not to perform a delete operation.
If deletion is still required, the system will provide warn-
ings and perform the deletion operation after user’s con-
firmation.
Archiving Archival is in-progress (Image or Dose This activity can take some time. Depends on the
Structured Report) Archiving station setup.
Recommended not to perform a delete operation.
If deletion is still required, the system will provide warn-
ings and perform the deletion operation after user’s con-
firmation.
Information Some network activity did not take Recommended to place the mouse over the icon to read
place (or) all the network activities and perform the action required.
completed but the patient exam is still
Recommended not to perform a delete operation.
active.
Completed All network activities completed. Can be safely deleted.
Failed Some network activity failed. Recommended to place the mouse over the icon to read
and perform the action required.
Recommended not to perform delete operation.
10-26 Electronic Operator Manual

Symbol indicating that the Instruction For Use (Operator Manual) is sup-
plied in electronic format. It is located on the L-arm.
10-27 Surgical and Patient Comfort Accessories
Label for maximum load for surgical and patient comfort accessories.
Note: Refer to the table in Surgical and Patient Comfort Accessories /
Accessory rail load consideration for the weight values.
Lock/Unlock symbol.
Side Up symbol.
10-28 Bolus Handle
Bolus button
Table Speed
10-29 X-ray LED

X-ray ready
10-30 Filtration
To indicate a reference to a radiation filter or a value of filtration.
10-31 Product identification
Indicates the medical device manufacturer.
Indicates the date when the medical device was manufactured.
Indicates the manufacturer's catalogue number so that the medical device can be
identified.
Indicates the manufacturer's serial number so that a specific medical device can be
identified.

Chapter 5 - Radiation Safety

Radiation safety and the amount of dose the patient and staff receive during a procedure being a concern, this
section aims at increasing your knowledge and helping you develop safe work habits. It will give you a quick
overview of the topic of X-ray radiation and dose through a simple explanation of the equipment, technology and
discusses the different techniques available to reduce dose.
• How X-ray radiation is created and the "Dose" Concept
• Dose Parameters
• Effects of ionizing radiation on humans
• General Dose reduction measures for the patient
• General Dose reduction measures for the staff
• Special Dose reduction measures
• Dose reduction measures on the Innova System
• Special Case
• Legal Provisions
1 How X-ray Radiation is created and the "Dose" concept

X-ray radiation is produced by an X-ray tube that directs a beam of energetic high speed electrons at a target. The
force with which the electrons strike the target depends upon the accelerating voltage measured in kilovolt peak
(kVp). Higher voltage produces greater force and increases the quality (energy) of the X-rays by increasing their
penetrating power. Increasing the electron current measured in milliamperes (mA) without changing the kVp will
increase the quantity of radiation without improving the quality.
As the X-ray beam leaves the tube, lower energy X-rays what have little diagnostic value due to their poor
penetrating power, are filtered out by the tube wall and the exit portal. Filtration of the primary beam can be
increased by adding aluminum or other filtering material to the exit portal of the tube. This is referred to as the
inherent filtration. The lower energy X-rays that are filtered out are less penetrating and therefore, do not supply
any diagnostic value as the more penetrating higher energy X-rays do. As radiation penetrates objects and human
bodies, it passes through them and is weakened in the process. This weakening is equivalent to a reduction in the
number of individual radioactive particles. The measurement of the amount of radiation is what we call "dose". It
could be dose to the patient or dose to the detector.
In a fluoroscopic and a radiographic exposure, it is advised to use the highest kVp possible that will produce good
diagnostic image quality while penetrating the patient and at the same time using the greatest filtration to minimize
the patient's exposure. In other words, not all the radiation particles generated during an X-ray are used to produce
the resulting images, and because radiation can cause damage to the human body, we try to achieve the greatest
possible effect; the best image with the smallest amount of radiation dose.
2 Doses parameters
There are different types of dose depending on where and how the measurement is taken and if the measurement
is for the patient or the detector dose.
2-1 Incident dose
The incident dose is the dose measured in the middle of a radiation field on the surface of a body or a phantom.
However, it is only measured at this point if there is no body in the path of the X-ray beam. Thus, there is no scatter
radiation from the body during this measurement. When radiation strikes a substance, there is always a certain
scattering of radioactive particles. This is comparable to light striking a glass surface; a certain portion of the light is
always reflected.
The unit used to measure the incident dose is joules per kilogram, and is known as "Gray" where 1 Gray (Gy) = 1
J/kg. The former unit used to measure the incident dose was the "Rad", and using this unit, 1 Rad (rd) = 0.01 Gy,
or 1 Gy = 100 rd. But because today's doses are generally very small, they are usually described using the unit
232 Radiation Safety

"mGy", that is, 0.001 Gy.

Incident dose = the dose measured on the intended surface of the patient, but without the presence of the
patient
The System International unit (SI unit) used to measure the incident dose is the Gray, where 1 Gy = 1 J/kg
2-2 Surface dose

The surface dose is measured with the body in the path of the beam. Because of the scattered radiation that
results on the surface and in the depths of the body, the surface dose differs from the incident dose by including
the amount of scattered radiation.
Thus we can say:
Surface dose = incident dose + scattered radiation from the body
The SI unit used to measure the surface dose is the Gray (Gy)
2-3 Exit dose

The exit dose serves in the evaluation of the X-ray image. It is measured in the radiation field in immediate
proximity to the surface of the body where the beams exit from the body. On the basis of the exit dose and the
surface dose, we can calculate how much radiation must have remained in the patient's body.
Radiation in the body = surface dose - exit dose
The SI unit used to measure the exit dose is the Gray (Gy)
Radiation Safety 233

2-4 Image receptor dose

The image Receptor dose is measured at Revolution Digital Detector. The image receptor dose is generally smaller
than the exit dose, because the radiation weakens before it reaches the image receptor, for example by
encountering objects after the patient's body such as the anti-scatter grid.
Image receptor dose <= exit dose
The SI unit used to measure the image receptor dose is the Gray (Gy)
2-5 Dose rate at image receptor

In order to measure a dose, the beam must operate for a certain period of time. The dose rate therefore represents
the measured dose for the amount of time required to complete the dose measurement. If the image receptor dose
is measured in the process, then the dose rate is the image receptor dose rate. If the dose is measured at a
different site, then the dose rate is determined using one of the previously mentioned dose parameters.
measured dose
Dose rate = ----------------------
required time
The SI unit used to measure the dose rate is Gray per second: (Gy/s) or in usual unit (mGy/min)
2-6 Dose-area product
The dose-area product is a measurement of the amount of radiation that the patient absorbs. The dose-area
product is independent of the distance between the X-ray tube and the measuring device because the further away
from the X-ray tube this measurement is taken, the more the size of the device increases, and the dose itself
decreases (see diagram). The dose to the patient can be calculated from the dose-area product, the size of the
measuring device, and the distance to the X-ray tube and the patient.
Dose-area product = dose * surface area of the measuring device

The SI unit used to measure the dose-area product is the Gray * meter² (Gy*m²) or in usual unit cGy*cm² or
Gy*cm².
Dose-area product
The dose-area product at 50 cm from X-ray tube is just as great as dose-area for 100 cm or 200 cm, because the
size of the measuring device increases with greater distance to the X-ray tube. But the dose itself decreases with
greater distance to the tube. Thus the dose-area product is the same at each position if the size of the measuring
device enables it to detect all of the radiation.
2-7 Body dose and effective dose
The body dose is the comprehensive concept for the organ or partial-body dose equivalent and the effective dose.
In the practical application of radiation protection, however, local and individual doses are monitored, because body
doses cannot be measured directly. The Radiation Protection Regulations therefore use the concept of effective
dose, in which all the individual doses to the irradiated organs or parts of the body are multiplied by a factor and
then added together. The resulting value may not exceed the dose limit for the effective dose that a patient is
allowed to receive.
Body dose = sum of all organ or partial-body doses
Effective dose <= patient dose limit
The SI unit used to measure the body dose and the effective dose is the sievert, where 1 sievert = 1 Sv = 1
Joule/kilogram = 1 Gray

2-8 Maximum Symmetrical Radation Field

Maximum Symmetrical radiation: 370 mm x 400 mm at 1 m according to IEC 60806.
3 Effect of Ionizing Radiation on Humans

Biological effects of any dose should be divided into low and high levels. During most procedures, the effects of
patient irradiation are low. Cardiac or neurology procedures could give the patient high doses of radiation, and this
can be the cause of injuries to the patient (e.g.: skin injuries, alopecias). In order to minimize this risk without
adversely affecting the clinical objectives of the procedure, it is currently admitted that precautions should be taken
when skin dose in a single location can exceed 1 Gy.
The danger of radiation exposure is increased as the area of the body that receives the exposure is increased.
Certain tissues such as bone marrow are more sensitive to radiation than others. Genetic effects of radiation are
considered as a special hazard when the gonads are exposed to radiation. Lens of the Eyes, the Thyroid, blood
forming organs or a developing embryo is the most radiation sensitive.
Radiation damage to the body is generally greater when the dose is given in a one shot exposure than if the dose
is spread over a greater period of time. The effects of large doses or radiation usually show up in a short period of
time. However, delayed effects of radiation may show up after many years in a form such as cancer or leukemia.
Due to the duration of total fluoroscopic time and the number of acquisition sequences in a single location, the risk
is particularly important in cardiac and neurology procedures.
GE Healthcare equipment includes dose limitations mechanisms; in particular, the conventional entrance skin Air
Kerma rate is maintained below 87 mGy/min (10 R/min), or at a lower level depending of local regulation, in a plane
representative of patient skin dose, and positioned 30 cm from the entrance of the Image Receptor. Therefore, in
this plane, the value of 1 Gy may be reached in 10 to 12 minutes of fluoroscopy for thick body parts, or for body
parts of average patients viewed with a large angulation, or for obese patients; usual levels of fluoroscopy of the
head or for average patients without large angulation are 2 to 5 times lower.
In particular configurations required for an examination, patient skin could be significantly closer to the X-ray
source, with dose rate increased as the inverse square of the distance.
3-1 Concept of Intervention Reference Point
The Interventional Reference Point is intended to be representative of the point of intersection of the X-ray beam
axis with the patient. For the Innova systems including an isocenter, the Interventional Reference Point is the point
on the reference axis 15 cm from the isocenter towards the focal spot.
This distance is assumed to represent a good approximation of the value of the actual focal spot to skin distance
during interventional procedures. If one considers currently available methods to estimate absorbed doses to
selected tissues for radioscopic and cine-angiographic examinations of the coronary arteries of adults, these
methods rely on the use of distinct operating conditions commonly used in radiological examinations of the heart.
These operation conditions are associated with a view, an arterial projection, and technique factors on the X-ray
equipment such as the X-ray tube voltage (kV), the half value layer (HVL), the focal spot to skin distance, the focal
spot to image receptor distance and the entrance field size.
A review of the operating conditions derived from analyses of practice indicates that the defined interventional

reference point is, in fact, a fair approximation of the focal spot to skin distance for each field.
4 General Dose Reduction Measures for The Patient

4-1 Distance between the X-ray tube and the patient
4-1-1 Inverse square law
A bundle of X-rays corresponds to the shape of a cone, with the tube at its tip. The intensity or dose of the radiation
emitted from the source of the X-ray beam diminishes with the square of its distance from the source. If you double
the distance x, the dose changes by a factor of 1/(2²), and if you triple it, the dose changes by a factor of 1/(3²).
Inverse square law
In general, the dose amounts to 1/x². Therefore, if you double the detector-to-target distance, you will need four
times as much radiation to achieve the same image blackening.
A Skin Spacer may be used to assure a minimum distance of 380 mm to the patient's skin. If you positioned the
patient too close, this would lead to excessive skin dose radiation to the patient; thus, increasing the distance
between the X-ray tube and patient helps to reduce the amount of skin dose radiation to the patient. For example,
the exposure rate is approximately 1.5 times greater at 305 mm from the focal spot to the patient than 380 mm.
4-2 Distance between the patient and the detector
The detector should be kept as close to the patient as possible for all exposures. This helps the Innova system to
select the lowest optimal technique factors to visualize the anatomy properly. When the distance between the
patient and the detector is excessive, not only is the magnification increased but so are the technique parameters
which could lead to a poor image that is too gray and flat losing small vessel detail.
4-3 Collimation
Collimation brings about a genuine dose reduction and also produces better image quality. Collimation is performed
using collimators (multi-leaf collimators or iris diaphragms) that are attached directly in front of the X-ray tube.
Collimation at the target is the most effective radiation protection for the patient and personnel, because it narrows
the area that the radiation can strike.
4-4 Compression
Because radiation scatters in a body exposed to X-rays, compression of the body is another way to reduce the

radiation dose. Scattered radiation also produces an undesirable reduction in contrast in the X-ray image. With
compression, the thickness of the body is reduced, and so a lower dose is absorbed by the body. Additionally,
compression ensures that less scattered radiation occurs.
4-5 Anti scatter grid
The grid ratio is 13:1
Before mounting, check if the reference is the same on the anti-scatter grid and the following illustration:
Anti-scatter grid
Anti-scatter grid
Supplier Reference:
Anti-scatter grid 21 cm: 9896 010 67911
Cross section of an anti scatter grid
The anti-scatter grid is located between the patient and the Revolution Digital Detector. It is the most effective
method of reducing scattered radiation. The grid absorbs a portion of the scattered radiation in its lead plates.
This absorbed dose therefore does not reach the Revolution Digital Detector, even though it has already passed
through the patient. Thus, the use of an anti-scatter grid leads to an increase in the dose, because the amount of
radiation that reaches the Revolution Digital Detector, is not reduced until it has passed through the patient: if the

anti-scatter grid is used, the patient must be exposed to a higher dose of radiation in order for the minimum dose to
reach the Revolution Digital Detector. But, we are not talking about excessive amounts of increased dose and one
needs to understand the benefits as well as the trade offs of using a grid. In cardiac procedures, the chest area of
the patient , where the X-ray beam has to penetrate, is the largest portion of the patient as well as some patients
are over weight and present a challenge to imaging to begin with. Then add steep angles for the views of the heart,
and you have fairly high techniques as compared with the rest of the body. If there was no grid used, all the
secondary scatter exiting the patient would reach the detector as well as the primary beam. The scatter has no
usefulness for creating a good image so the grid helps to eliminate it before it can affect the overall image quality.
We can differentiate between individual anti-scatter grids using their grid ratios. This is the relationship between the
height of the plates to the distance from each other.
The greater the grid ratio, the greater the grid's effect. Thus, the required dose increases with the grid ratio. The
typical grid ratio is 13:1 for the Innova Systems.
4-6 Record and Fluoro mode selections
The Innova System provides the user with two Record modes and two Fluoroscopy modes. The Low selection for
each will use lower dose to the receptor while providing lower patient skin dose. The image quality of the Low mode
may be compromised because of the patient's size or the steepness of the angle. In that case, the Normal mode
should be used. Neither mode will increase the skin dose to the patient beyond the allowed limit of the country.
When possible, change the entry point of the beam in order to reduce the local dose to the patient. For long
interventional procedures, this will help to reduce any potential of skin burns to the patient.
4-7 Frame rates
In Record mode, try to keep the frame rate at the lowest value compatible with the medical requirement. Frame
rates are set depending on the blood flow of the vessel and or the movement of the anatomy. In addition, the
shorter the length of the sequence and the fewer sequences acquired will help to reduce the total exam dose to the
patient.
4-8 Field of View
There are four Field of Views available on the Innova Systems. Even though the detector doesn't need additional
dose to create an optimal image, there is a slight increase of dose to the receptor to minimize the noise seen in the
image. Even though this dose increase is minimal, using the largest Field of View with the least amount of
magnification will assure the least amount of dose used.
4-9 Radiation filtration / hardening
The quality of the X-ray also plays a great role in the size of the administered dose. X-ray radiation normally has
so-called "hard" and "soft" particles, that is, particles with a lot of energy and particles with little energy. Hard
particles are better for the patient, because they pass through the body. Soft particles, by contrast, get caught
inside the body because they are too weak to pass through and out of it. Therefore, it is primarily soft radiation that
creates unnecessary exposure to the patient. For this reason, copper and aluminum are used as filters in front of
the X-ray tube. The soft radiation is caught in the filter plates, and the remaining radiation emerging from the filter is
"harder". This additional filtration can also reduce the dose to the patient without diminishing image quality,
because in any case only the "hard" rays reach the Revolution Digital Detector.
5 General Dose Reduction Measures for the Staff

Following the dose reduction measures for the patient will indirectly effect the dose to the staff. Personnel in the
Cardiac Cath lab are exposed to X-ray radiation at all times and need to follow additional recommendations to
reduce the amount of radiation they receive in the work place.
5-1 Protection from X-ray Radiation
5-1-1 Distance
Distance is a very effective, and in many cases, is the most easily applied method of radiation protection.
The inverse square law applies to most sources of X-ray. Each time you double your distance from the source of

radiation, the intensity of the radiation per unit mass is reduced by a factor of four.
For the greatest safety, stay as far from the source of radiation as possible. When the tube is positioned under the
table the patient helps to protect the staff. Radiation travels in a straight line. Don't stand where the tube is pointing
towards you, but behind the X-ray tube if possible. Also, any distance six feet (1.83 m) or more away from the X-ray
source and patient is considered safe.
Significant Zone of Occupancy
There is a significant zone surrounding the table that identifies proximity to the radiation source. Included in the
significant area is the tableside area where the Physician stands to perform the procedure. All equipment within this
zone 1.5 m around the patient are medical components (table, positioner, monitors, injector, radiation protection
shield, etc.) that must be in compliance with medical device regulation.
5-1-2 Shielding
Any material placed between you and the source of X-ray radiation will absorb some of the radiation, thus reducing
its intensity. The more material with the greatest density will absorb more radiation. High atomic number materials
such as lead, are the most useful for absorbing X-rays. Depending on the energy of the X-rays, only 1 or 2 mm of
lead will reduce the radiation dose by a factor of more than 100.
Shielding can come in many forms. Lead aprons and protective devices such as lead gloves, glasses, thyroid
shields are also effective in limiting occupational exposure dose. When working near the X-ray equipment other
objects can be placed in between you and the radiation. An eye and thyroid lead window shield, a lead radiation
shield mounted on the table or equipment, or a mobile stand shield. Of course, the best shielding is standing
behind lead window panels and lead walls outside the angiographic room.
Proper shielding cannot eliminate X-ray, but it can reduce the quantity to an acceptable level.
5-2 General Precautions
1. Stay as far away as possible from the source of radiation. Know the path of the primary beam and work as far
from it as possible.

2. Minimize your time near radiation sources.

3. Always wear your dosimeter and be aware of all radiation levels in your environment.
4. Employ appropriate thickness and quantities of shielding. Use all available protective barriers like lead aprons,
thyroid shields, lead glasses, lead drapes, and lead screens.
5. Use lead masks, collimators and other devices to limit the primary beam to the minimum opening consistent
with the information needed.
6 Dose Reduction Measures on the Innova System

With the development of the all digital Innova system and the Revolution Digital Detector, one of the main
objectives was to provide superior image quality with the least amount of dose. To accomplish this, several features
are used in conjunction with each other. More information about the system as a whole is found in the Instructions
for Use section.
7 Smart Fluoro
Fluoroscopy is performed at low dose compared to record and inherently shows more noise. Quantum noise is a
direct function of the quantity of X-rays. At a given level of clinically acceptable noise, dose reduction can be
achieved either by at least two methods: Slowing the pulsing rate or advanced digital processing of successive
frames acquired with low dose pulsed fluoroscopy.
Fast (30 fps) pulsed fluoroscopy uses short, high intensity pulses to better freeze motion in the image. It is also
possible to skip pulses, filling the "gap" with previous image. This reduces the quantity of X-rays used and results in
less dose per image. When you reduce the pulse rate, the inherent temporal averaging performed by the human
visual system is less effective and images may look a bit noisier at lower frame rate. This can be compensated by
increasing dose per frame appropriately, yet achieving dose saving in reduced frame rate mode to the extent
possible. The images may appear slightly jerky at lower frame rates. Innova systems offer reduced pulse rate
option during fluoroscopy.
An alternative method of lowering dose is to digitally process images, by averaging several successive images into
one, or by performing averaging within a given frame. Temporal averaging allows the use of the same X-rays more
than once. This is equivalent to more photons to the image, for the same patient dose. Using image processing, the
temporal averaging effect of the eye is thus further enhanced. During digital processing, moving objects have to be
treated differently to avoid blurring. GE has a patented technique called Smart Fluoro for effective temporal
averaging of frames. The algorithm effectively discriminates moving object edges from the background to ensure
that noise is reduced while moving objects are preserved. In addition GE offers an advanced spatial denoising
algorithm that combines wavelet-based multi-resolution decomposition with edge-preserving spatial filters. This
algorithm reduces noise level without degrading the clarity of edges and fine details.
7-1 Benefits of LIH
Last Image Hold (LIH) provides an image in between the live fluoro images to use as a reference image and
eliminates the need for extended fluoro exposures
minimum. The Innova Systems have automatic spectral filtration that appropriately inserts either 0.1 mm, 0.2 mm,
0.3 mm, 0.6 mm or 0.9 mm of copper (depending on system) into the fluoroscopy or record exposure if needed.
7-3 Tabletop
The material from which the tabletop is constructed is also significant for the required dose, because the tabletop is
penetrated by the radiation and weakens it before it reaches the image intensifier. Therefore, if at all possible the
tabletop should not contain any material that strongly weakens the radiation or absorbs it well, such as lead or
metals in general. Carbon fiber has proven to be the best material for X-ray system tabletops because its radiation
absorption is minimal and the tabletop can take a great amount of stress; today a tabletop is expected to be able to

support a patient weighing up to 204 kg or 450 pounds.
8 Special Case
8-1 Pediatrics
Because children have a greater sensitivity to radiation than adults, special conditions apply to pediatric radiology.
When possible, an attempt should be made to avoid X-ray examinations altogether and to use alternative
procedures. But when X-rays can not be avoided, there are a few basic practices that can be used to minimize the
dose to a child.
For infants up to 1 year old the anti scatter grid can be removed from acquisitions performed at Field Of View
smaller than 20 cm.
Collimation to the specific area of interest is still the first choice of reducing dose to a child.
And when possible, it is especially important to use a gonad shield.
For access to specific dose settings for pediatrics in Innova Systems, select a protocol on the DL console where
the name contains ‘peds’ or ‘pediatrics’ (see Innova Digital / How to select an Acquisition Protocol).
For details about how the system optimizes the exposure techniques and how it complies with regulation about
dose settings for pediatrics, (SV-Richtlinie, point about Tabelle I 1, Kinder KB25 < 0.2 µGy/s and the alternative
application note E21), please refer to Appendix “Dose settings for pediatrics in Innova systems” or the following
article:
Barry Belanger, John Boudry: Management of pediatric radiation dose using GE fluoroscopic equipment. Pediatr
Radiol (2006) 36 (Suppl 2): 204–211.
9 Legal Provisions
In many countries or states, by means of rules, guidelines or regulations, lawmakers have contributed to improving
radiation protection for patients and medical personnel; after all, medical exposure to radiation is the single largest
source of radiation exposure among the general population. On an international level, guidelines are laid down by
the International Commission on Radiological Protection (ICRP). Many of the rules, guidelines or regulations are
governed by the ALARA concept (As Low As Reasonably Achievable), meaning the production of a diagnostically
relevant image at minimum possible dose.
10 Dose Reduction: 7 easy steps to remember

1 Use LOW vs. NORMAL Details • Will reduce the dose by around 50%.
• Use LOW vs. NORMAL Details only if Image Quality is adequate.
• LOW can be set up by default in Protocols (ask Applications Spe-
cialist).
2 Use the lowest acceptable frame rates • Lower frame rate can further reduce the dose by around 50%.
(example 15 fps vs. 30 fps)
• Different default fps between Record and Fluoro can be stored in
protocols.
3 Minimize duration of X-ray • Don’t image longer than necessary in fluoro and record.
• Avoid using one anatomical view for long periods of time/many
runs.
• Consider using InnovaSpin in lieu of prolonged imaging in one in-
cidence.
4 Detector close to patient • Bring the Detector as close as possible to the patient.
• Can further reduce the dose by around 15%.
• Use Innova Sense if available.

5 Highest table working height • Use the highest table working height acceptable.
• Maximize X-ray tube to patient distance.
6 Collimate • Always collimate to the anatomical area of interest.
• Use the largest acceptable image detector Field of View, with col-
limation, in lieu of image magnification.
• If image magnification is required, use the lowest acceptable
dose rate.
7 Monitor cumulative patient dose • Set thresholds of cumulative patient dose (Yellow/Orange/Red
levels).
• Keep track of cumulative dose display on monitor relative to these
thresholds during the case.
Image Quality Trajectories • Options are available to reduce dose up to 75%.
• Review with GEHC Applications or Service the available IQ Tra-
jectories.
• Ask them to customize the IQ protocols (IQ+, IQ Standard, RDL+,
RDL).
• Dose strategy need to be adjusted according to the user and clini-
cal procedure needs.
As Low As Reasonably Achievable.

Chapter 6 - Revolution Digital Detector

Cardiovascular Angiography has been using the Image Intensifier (II) and the associated imaging chain since
the1950's. The II technology has been developed and improved for many years but is now at the end of it's life.
There are few if any improvements that haven't been tried and tested to increase the image quality for the type of
diagnostic and interventional procedures that are now being performed in the Cath lab. Businesses had to look at
today's technology and see what was being developed that could eventually be applied to the medical industry's
needs. Computers and digital technology were developing together and made a perfect fit.
GE Healthcare (GEHC) started their development of the digital flat panel in the early 1980's. In 2000, GEHC
introduced the first Revolution Digital Flat-Panel detector (DFP) the Innova 2000.
The DFP replaces the analog image intensifier (II), camera optics, pickup tube or CCD camera, and analog to
digital converters. It therefore provides the first full digital imaging chain. Because it replaces the components that
degrade image quality with a DFP detector, it can capture information with minimal loss. The result is improved
image quality.
1 Imaging Chain
Conventional Cardiac Imaging Chain with Image Intensifier
The components of the image intensifier:

• The image intensifier receives X-rays transmitted through the patient
• The Image Intensifier transforms X-ray into light.
• An aperture located between the output phosphor and video camera controls the amount of light delivered to the
camera.
• The video camera converts the light into an analog electronic signal.
• The analog signal is routed through the analog to digital converter.
• The digital signal is displayed as a binary set of numbers and displayed on an image monitor
Now consider what happens when we add a digital detector to the equation.
Digital Cardiac Imaging Chain with Flat-panel Detector
244 Revolution Digital Detector

• The digital detector receives the X-rays transmitted through the patient
The Revolutionary Digital Detector replaces everything but the X-ray tube and patient.
As you can see, there is a reduction of the total number of parts that make up the digital versus the analog imaging
chain. Image quality can be affected by each component in the chain. Not only are there fewer parts that can fail,
but fewer to optimize. An image chain is only as good as it's weakest link. Note that at each stage in this process,
the X-ray signal is degraded to some extent, even if the individual components are optimized for the application. As
a result, typically less than 40% of the original image information is available for use in image production.
Because of its high Detective Quantum Efficiency (DQE), it has the potential to capture over 80% of the original
image information. And it equips the user with a wide range of post-processing tools to further improve that signal -
including many that can be applied automatically.
2 Digital Image Quality

Let's look at what makes up the digital flat-panel and other factors that contribute to the improved image quality.
The flat-panel detector consists of a two dimensional array of amorphous silicon thin-film transistors (TFTs) and
photodiodes, with cesium iodide scintillator, all deposited on a single substrate. Using technology similar to that
used in the fabrication of integrated circuits, layers of amorphous silicon and various metals and insulators are
deposited on glass substrate to form TFTs, diodes, interconnects, and contacts. The scintillator, which converts
X-rays to light, is evaporated on top of these materials. Electronics for scanning out the detector and for sensing
and digitizing the signals are attached to the contact fingers at the sides of the detector. The TFT switches are
activated by scan electronics connected to one edge (or two opposite edges) of the detector to read out the stored
charge. Data collection electronics connected to the other two edges of the detector convert the charge to digital
values.
The operation:
Revolution Digital Detector 245

• A cesium iodide scintillator absorbs X-ray photons, converting them to light

• Light is converted into an electronic charge by an array of low noise photodiodes, each representing a pixel or
picture element.
• The electronic charge at each pixel is read out by low noise electronics and turned into digital data sent to an
image processor.
New Standard for Digital Imaging Quality

Earlier we mentioned the image quality improvement as a result of Detective Quantum Efficiency (DQE). But what
is DQE and why is it so important with this new technology?
3 Detective Quantum Efficiency

DQE is the measurement of the combined effect of detector noise and contrast performance. DQE is widely
recognized in the scientific imaging community as the most accurate gauge of image quality - a gauge that
incorporates most traditional image-quality measurements, including signal-to-noise ratios and spatial frequency.
Digital systems that focus on DQE, rather than limiting spatial resolution, provide benefits in object detectability.
Higher DQE, especially at the low-to-mid spatial frequencies where most clinically relevant information is found,
means detectability even for low contrast objects.
4 The Impact of Noise

Quantum and electronic noise are unavoidable in a digital imaging chain. The effect, often expressed as
signal-to-noise ratio (SNR), can vary widely from system to system.
High SNR, or low system noise, is key to capturing the greatest proportion of useful image information in a digital
image. Often the only way to compensate for poor SNR is to increase radiation dose, which is often an
unacceptable trade-off.
5 The Role of Contrast

Contrast performance describes a system's ability to capture and display an object's actual contrast - especially
critical when imaging such inherently low-contrast objects as balloons and stents under fluoroscopy that has a
limited amount of X-ray dose that can be used.
Most digital X-ray detectors have a wide dynamic range to permit capture of a wide range of low-to-high signal

intensities, as well as very high contrast resolution to permit the display of thousands of shades of gray. In fact,
that's one of the digital X-ray's great advantages over conventional imaging systems. Digital X-ray detectors can
successfully image areas that might be under or over exposed.
6 The Role of Spatial Resolution

6-1 Definition and settings
Spatial resolution is the ability to visualize individual spatial or 2D frequencies on an image. It is generally assessed
using targets made of high image contrast line pairs at known frequencies in line pair per millimeter (lp/mm). Spatial
resolution, measured in the plane of the detector, is bound by pixel pitch on digital images.
The Innova IGS 540 system has a detector size of 41 cm x 41 cm comprising a 2048 x 2048 array of imaging
elements or pixels on a 200 micron pitch.
The detector spatial resolution, as defined in IEC 61223-3-1 1999, is the highest spatial frequency of the specified
line-pair target that can be resolved on a digital image, measured with the line-pair tool as close as possible to the
detector entry, collimated to the edge of the phantom, no attenuating layer, anti-scatter grid in, at maximum SID,
line-pair tool oriented at 45°. The lines of a group shall be detectable over the major part of the total length meaning
that more than half of the length of the line pair group should be visible in order for the group to be resolved.
The detector spatial resolution defined in the French standard uses the same setup as the IEC 61223-3-1 1999, but
resolution is assessed differently. The detector spatial resolution is, starting from the lowest frequencies, the
frequency just before the first spatial frequency of the specified line-pair target that cannot be resolved on a digital
image.
The system spatial resolution is a measure of the system capability to resolve small objects in the plane of the
patient through the thickness of the patient body modelled by 20cm of PMMA or water equivalent.
The resolution test phantoms used for detector and system resolution measurements in IEC 61223-3-1 1999 is:
phantom 07-535 CN 15400 of thickness 0.05 mm Pb, and groups 0.6 to 5.0 lp/mm.
When testing very low dose acquisition modes, it is recommended to use 0.1mm Pb thick phantoms such as:
phantom 07-541 (type 41) of thickness 0.1 mm Pb, and groups 0.6 to 3.4 lp/mm.

6-2 Detector spatial resolution vs. Modulation Transfer Function (MTF)

An imaging system's ability to render the contrast of an object as a function of object detail is traditionally
expressed as its Modulation Transfer Function (MTF). But MTF is normally measured under ideal laboratory
conditions, using high contrast objects and high dose while minimizing scatter radiation and noise. Therefore, it is
not a reliable indicator of performance in real clinical situations. MTF can be useful for film-based systems that
have no post processing, but doesn't apply with digital systems that can achieve any desired MTF through the use
of post processing features.
On the other hand, spatial resolution can be tested in clinical conditions using a representative level of dose, of
patient absorption and level of noise on the image.
Spatial resolution is the preferred way to measure how well individual objects can be rendered by an imaging
system.
6-3 Detector spatial resolution performances
Acceptance criteria in DSA mode (IQ Standard)
FOV (cm) < 20 > 20

Detector spatial resolution (lp/mm) 2.00 1.00
The detector spatial resolution performances of the Innova IGS Systems also answer to country regulations.
Detector spatial resolution acceptance criteria per modes for Germany
Acquisition type Fluoro No Sub DSA Dynamic Record InnovaChaseTM

Detector spatial reso- 1.0 1.2 1.0 1.2
lution (lp/mm) in max
FOV
Detector spatial resolution acceptance criteria in fluoroscopy for France
FOV range (cm) 11 to 13 15 to 18 20 to 25 28 to 33 35 to 42

Detector spatial 2.00 1.80 1.40 1.25 0.90
resolution (lp/mm)
Detector spatial resolution acceptance criteria in fluoroscopy for Italy and Spain

FOV range (cm) 15 to 18 23 to 25 30 to 35

Detector spatial resolution 1.4 1.0 0.8
(lp/mm)
Detector spatial resolution acceptance criteria for Australia VIC and QLD
FOV range(cm) <14 14 to < 23 >23

Detector spatial resolution 1.6 1.2 0.8
(lp/mm)
6-4 System spatial resolution performances

All measurements are done with 20 cm PMMA.
System spatial resolution acceptance criteria in fluoroscopy for Australia NSW
FOV range (cm) 11 to <18 18 to <26 26 to <30 30 to 36 >36

System spatial 1.8 1.6 1.4 1.2 1.0
resolution (lp/mm)
System spatial resolution acceptance criteria for France
Acquisition type Dynamic Record DSA InnovaChaseTM

FOV (cm) Closest to 20 Closest to 20 Closest to 20
System spatial resolution (lp/mm) 1.6 1.6 1.6
7 Radiation Dose
Reducing radiation dose is another potential advantage of digital detectors. A detector with high DQE has the
potential to deliver significant object detectability improvement at the equivalent dose, or to permit object
detectability comparable to film's at a reduced dose. Or to say it another way, high DQE allows acquisition of the
same image quality at a lower dose, or better image quality at the same dose. Now the cardiologist can choose
between superior image quality or dose savings to the patient or staff. For example, the doctor may not need the
same image quality for a diagnostic study and can choose a setting that will allow for lower dose. But if the
procedure develops into an interventional procedure, the doctor can then select a different setting allowing for
superior image quality for placing the balloon or stent.
In addition, with the development of AutoEx, the optimal exposure technique for the patient size and the level of
contrast and sharpness desired can be selected. This allows for the entire procedure to be viewed with the same
image quality, no matter the angle or field of view (magnification). In addition, GE uses adaptive spatial and
temporal denoising algorithms with dynamically adjusted parameters depending on the size of the patient and the
level of noise seen in the image. On small to average size patients, the system is rarely pushed to the maximum
technique or dose limit. But for large patients and steep angles, that is a different story. In the US, the skin Air
Kerma radiation that the patient can receive during fluoroscopy is 10R/min. But many countries are reducing that
limit to 5R/min. As we have already discussed, the less Signal (dose) you have the more noise in the image you
have. To counteract that, the dynamic Image Processing will adjust to provide for a smoother more contrasty
fluoroscopy image when the dose is limited or at the maximum amount allowed.

Chapter 7 - Innova System

1 General Description
The Innova Cardiovascular Imaging System incorporates GE's exclusive Revolution Solid-state Digital Detector to
reliably provide consistently high imaging performance through the full range of angiography procedures. The
Innova is a fully integrated imaging system that meets all clinical needs for interventional and diagnostic
angiography procedures with advanced image quality, innovative dose management and ease of positioning.
1 Gantry
2 Table
3 Smart Box
4 Table Side Status Control (TSSC)
5 X-ray Tube
6 Digital Detector
2 System Components
Availability of configurations may vary according to the country regulatory registration
2-1 Basic Components
• C-arm unit (including C-arm, control cabinet and table-side control boxes)
• Angio Table: Omega V or InnovaIQ Table; Cardiac table: Omega IV (all with mattress included)
• Table Side User Interface (TSUI): Smart Box or Smart Handle (not available with InnovaIQ Table), Table Side
Status Control (TSSC)
• X-ray high-frequency and high-voltage generator: JEDI 100
250 Innova System

• X-ray tube: Performix 160A

• Collimator
• Image detection unit
• In-room and control monitors
• Chiller
• Accessories (table panning device, dual footswitch with table unlock, IV pole & Mount, footrest/shoulder rests...)
• Ceiling and table mounted radiation protection.
Reference of table mounted radshield validated with Innova Systems:
– E30591 JA
– E11181 EA
– E30591 J
– E30581 LA
2-2 Option
Availability of options may vary according to configuration and to the country regulatory registration.
• Injector Interface (*)
Reference of injector validated with Innova Systems:
– ACIST CVi (Pedestal and table mount version) (*)
ACIST CVI TABLE MOUNT VERSION IS NOT COMPATIBLE WITH INNOVAIQ TABLE
AND OR TABLE.
– MEDRAD Mark 7 Arterion (Integrated pedestal or table mount versions) (*)
DO NOT USE CEILING MOUNT AND FREESTAND PEDESTAL VERSIONS.
MEDRAD MARK 7 ARTERION TABLE MOUNT VERSION IS NOT COMPATIBLE WITH

INNOVAIQ AND OR TABLE.
– MEDRAD Avanta (Pedestal or table mount versions) (*)
MEDRAD AVANTA TABLE MOUNT VERSION IS NOT COMPATIBLE WITH INNOVAIQ
AND OR TABLE.
• Table head extender
• Digital Head holder
• Horizontal Armboard (HB-1)
• Quick Strap
• Clear-Vu Arm Support
• Diamentor Dose Monitoring
• Integrated Innova - s5i system option (IVUS) (*)
• InnovaIQ Table
• OR Table (OR Configuration)
• UPS
• Wall-mount suspension
• In-room 3D
Innova System 251

• CRT Monitor Suspension

• Large Display Monitor
• TSUI options : Smart Handle; Smart Box; second Smart Box; second Smart Handle; second TSSC; Remote
TSSC; Remote Smart Handle; Remote Smart Box.
• OMEGA Table Foot end rail
• Second Footswitch with cover
• Workstation (including power supply, image processing system, TV display system) (*)
• Software:
– InnovaBreezeTM
– InnovaChaseTM
– InnovaSpinTM
– Innova 3D
– Innova Subtracted 3D
– Innova CT
– DSA
– Dynamic
– InnovaSense patient contouring
– Fluorostore
– High Contrast Fluoroscopy (HCF)
– In-room Browser
– Stenosis Analysis Application
– Ventricular Analysis Application
– Administration package
– Blended Roadmap
– ECG Acquisition Package
– InnovaTM Vision (*)
– InnovaTM TrackVision (*)
– InnovaTM EPVision (*)
– InnovaTM HeartVision (*)
– StentViz
– StentVesselViz
– Innova OneTouch QA
– Simultaneous Fluoro Sub / NoSub Display
• Remote Stand (*)
• Tableside Cart
• Open monitor suspension (*)
(*) These options are delivered with their own instructions for use. Refer to them before any use.
Note: Refer to Innova IGS 520, Innova IGS 530, Innova IGS 540 Operator Manual (This manual) for the
information related to the use of the Tableside Cart on how to configure the Table Side User Interfaces (TSUIs)
252 Innova System

when using the Tableside Cart.

2-3 Option Connection
Some options need to connect a ground cable for equalizing potiental on Omega or InnovaIQ tables (Injectors...),
refer to items 1 and 2.
Omega and InnovaIQ tables provide a specific connector to synchronize injectors, refer to items 3 and 4.
Peripheral Device connections for Omega Table Peripheral Device connections for InnovaIQ Table
1 - Equalization socket connector 2 - Equalization socket connector

3 - Injector connector 4 - Injector connector
In addition, the Omega Table allows the connection of the following devices:
Innova System 253

1 Gantry
2 Status control
3 Debug screen
4 Footswitch
5 TPD
6 Gantry
7 Status control
8 Injector
9 3D mouse
10 Central Touch Screen
In addition, the InnovaIQ Table allows the connection of the following devices:
254 Innova System

1 Central Touch Screen

2 TSUI (1 to 4)
3 TPD 1 and TPD 2
4 3D mouse
5 Equalization connection
6 Protective Earth (x 2)
More information can be found in the service manual provided with the system.
When the cover is opened, do not touch the accessible contacts of connectors and the patient simultaneously.
3 Innova Console
1 Innova Digital Color LCD Monitor

2 Exposure Hand Switch
3 Innova Console
4 Console Keyboard and Mouse
4 General Specifications
Specifications may be subject to change without modification in the behavior of the system.
4-1 Generator
Specifications apply to generator independently from tube association and system applications.
Nominal output power: 100 kW
Max kW of generator's output when loading time is 0.1s, 100kW.
• Peak power
Maximum peak power: 100 kW (may be limited, depending on the mode or application)
• Average power
Average power is intended to be the average power computed in a wide time frame, greater than one hour.
Innova System 255

Maximum average power: 3.2 kW (may be limited, depending on the mode or application)
• Range of high frequency used by the high-voltage generator: 20 kHz - 60 kHz
• kV-mA range
kV from 40 kV to 125 kV
Maximum mA: 1000 mA
• Large focus
Maximum mA: 1000 mA
Maximum power: 100 kW
• Small focus
Maximum mA: 400 mA
• Compressed focus
Maximum mA: 200 mA
4-2 Gantry
• L-arm rotates on its vertical axis +/- 100° (+/- 95° motorized limit set).
• Offset C-arm (pivot) permits -117°/+105° RAO/LAO rotation.
• The C-arm permits 50° cranial and 45° caudal angulation of the imaging system.
• The combination of movements of the C-arm and L-arm permits +/- 55° cranial and caudal angulations.
• The offset arm throat depth of 107 cm (42") with L-arm at 0° provides femoral coverage on most patients.
• Rotation speed of Offset-C-arm (Pivot) and C-arm; 0-15° per second (0-20° per second for Innova IGS 520 and
Innova IGS 530 with the InnovaSense option).
• Rotation speed of L-arm: 10° per second.
• SID Fully motorized (8.9 cm/s - 3.5 in/s).
• SID range of 85 cm to 119 cm (33.5" to 46.8") for Innova IGS 520. Travel distance of 34 cm (13.4").
• SID range of 89 cm to 119 cm (35" to 46.8") for Innova IGS 530. Travel distance of 30 cm (11.8").
• SID range of 95 cm to 119 cm (37.4" to 46.8") for Innova IGS 540. Travel distance of 24 cm (9.5").
• X-ray tube Focal Spot to Isocenter 72 cm (28.3") .
• Isocenter to the floor of 107 cm (42").
• X-ray tube reference axis is tilted by 3° versus the X-ray beam axis in the anode direction on the Innova IGS
520.
• X-ray tube reference axis is tilted by 1° versus the X-ray beam axis in the cathode direction on the Innova IGS
540.
• A green LED is located on Pivot inner cover to indicate the X-ray status. This LED is on when the system is
ready to perform X-rays, otherwise the LED is off.
256 Innova System

4-3 Table
4-3-1 Omega Tables
The Omega table can operate while engaging the motor drive, table height up and down while fully extended,
supporting a maximum table weight of 304 kg: maximum of 204 kg for patient weight, maximum weight of 40 kg of
accessories can be installed on each table accessory rail and maximum of 20 kg on the table end rail.
Omega IV (with Innova IGS 520 only) Omega V

Table Top filtration Less than 0.85 mm aluminium equivalent
Mattress 2.5 cm (1") Mattress + Slicker: less than 0.70 mm aluminium equivalent
Maximum Patient Weigth 204 kg (450 lb)
Maximum Table Load 304 kg (670 lb)
Tabletop Length 300 cm (118") 333 cm (131")
Tabletop Width 46 cm (18") in Patient Trunk Area - 67 cm (26.4") max
Horizontal Float Movement 8-way
Horizontal Motorized Movement NA 2-way
Longitudinal Speed NA 0 to 15 cm/s
Longitudinal Travel 110 cm (43.3") 170 cm (67")
Equivalent Fluoroscopic Coverage 126 cm (49.6") 186 cm (73")
Transverse Travel Manual +/-14 cm (+/-5.5")
Vertical Travel 30 cm (12")
Vertical Travel above Floor From 78 cm (30.7") to 108 cm (42.5")
Vertical Speed 2 cm/s (0.8"/s) at 50 Hz
2.5 cm/s (1"/s) at 60 Hz
Table Base 61 cm x 52 cm (24" by 20.5")
Innova System 257

Table Rotation +/- 180°
4-3-2 InnovaIQ Table

The InnovaIQ Table can operate while engaging the motor drive, table height up and down while fully extended,
supporting a maximum patient weight of 204 kg.
Note: In addition to the above patient weight, the table can also support a maximum weight of 116 kg of
accessories (not exceeding 40 kg of accessories on each side rail, 20 kg for an end rail, or 16kg for miscellaneous
components on top of the table such as mattress, shoulder rest, etc.).
InnovaIQ Table
Table Top filtration Less than 0.85 mm aluminium equivalent
Mattress 5 cm (2") Mattress : less than 1.20 mm aluminium equivalent
Maximum Patient Weigth 204 kg (450 lb)
Maximum Table Load 320 kg (705 lb) including accessories
Maximum Tabletop Load 251 Kg (553 lb) including surgical and patient comfort acces-
sories
Tabletop Length 333 cm (131")
Tabletop Width 46 cm (18") in Patient Trunk Area - 67 cm (26.4") max
Tabletop Width 53 cm (21") in Patient Trunk Area (for Wide Table Top only)
Horizontal Float Movement 8-way
Horizontal Motorized Movement 8-way
Longitudinal Speed 0 to 25 cm/s
Longitudinal Travel 170 cm (67")
Equivalent Fluoroscopic Coverage Innova IGS 520: 186 cm (73")
Innova IGS 530: 194 cm (76")
Innova IGS 540: 198 cm (78")
Transverse Travel Motorized +/-13 cm (+/-5.1")
Transverse Speed 0 to 10 cm/s
Vertical Travel 57 cm (22.4”)
Vertical Travel above Floor From 80 cm (31.5") to 137 cm (53.9")
Vertical Speed 0 to 2.5 cm/s
Table Base 73 cm x 55 cm (29" by 21.7")
Tilt Travel From 20° Head Down to 12° Head Up
Tilt Speed 0 to 2°/s
Table Rotation +/- 180°
Patient Support Type Cantilevered
4-4 Innova Digital

DICOM V3.0 implementation in the Innova Digital is described in its Conformance Statement. It can be used to
verify compatibility with other DICOM devices.
258 Innova System

On the DL image disk, it is possible to store up to 4000 sequences and photos altogether as long as disk space is
still available.
4-5 Innova Imaging
4-5-1 Innova IGS 520
0 Mag 1 Mag 2 Mag 3 Mag
Available input screen size of detector (cm) 20 17 15 12
Horizontal sampling frequency; (lp/mm) 2.5 2.5 2.5 2.5
• Hi-resolution 1280 line analog video output.

• Hi-resolution 1280 line monitor, 60 Hz.
• Visibility range: 4 cm - 13 cm (using 20 cm PMMA and 16 cm PMMA step wedge).
5 How to Perform System Power-Up

To turn on power to the Innova system:
• Press the [On/Off] button on the Innova Console for 0.5 seconds.
Innova System 259

1 X-ray Indicator
2 Audible Signals
3 System Reset
4 ON/OFF
5 X-ray Timer Reset
6 Auto inject ON/OFF
Note: In case a system power-Up is required right after a system power-Down, wait until the control room console
is fully blackened prior to initiate the system power-Up. The control room console then stays blackened for about 1
minute before the new display appears, but the power-Up action is taken into account. There is no need to initiate
additional power-Up during this 1 minute of blackened screen.
Whenever the Innova System Main power has been removed with the wall main circuit breaker, turning ON the
Innova will require additional steps.
• Verify the wall emergency button is unlocked.
• Switch ON the wall main circuit breaker if needed.
• Go to the technical room where the Power Distribution Box (PDB) and the UPS stand.
• Verify the PDB emergency button is unlocked.
• Verify the UPS test switch is on "normal" position.
For PDB (CE):
• Close the disconnecting switch DM1 (item 1) on EMI filter ( if EMI filter is present) and switch S1 (item 2) on
PDB, if needed:
260 Innova System

• Ensure the pilot lamp (24V-OK) (item 3) is lit on.

• Wait for 20 seconds then ensure the pilot lamps H2 (Ph1-2 OK) (item 4) and H3 (Ph2-3 OK) (item 5) are lit on.
• Push the green PDB START button (S2) (item 6) on the PDB front panel.
For PDB (UL):
• Close the breakers CB1 (item 1), CB2 (item 2), CB3 (item 3), CB4 (item 4), CB5 (item 5) and CB6 (item 6) if
needed.
• Wait for 20 seconds then ensure the pilot lamps PL1 (item 7) and PL2 (item 8) are lit on.
• Push the green PDB START button (item 9) on the PDB front panel.
If the Large Display Monitor option is installed:
Innova System 261

• Ensure that UPS front panel (item 1) is activated.

• Push the Large Display Cabinet UPS ON button (Item 2). Hold it on for 5 seconds.
• A message "UPS is starting..." is displaying on UPS front panel. Then ensure that UPS power on indicator (Item
3) is lit on.
If 20KVA UPS is present, switch on the ‘Invertor on button on UPS’ (green button), if needed.
Now the system is ready to start. Go back to the control room and push the ON/OFF button on the Innova Console.
6 How to Perform System Power-Down

• Select [End Exam] on the Digital console.
• Press the [On/Off] button on the Innova console for 2 seconds.
The system will take approximatively 3 minutes to shutdown.
7 Vascular Control Interface Module
262 Innova System

1 X-ray ON Indicator
2 Audible Signals
- X-ray timer
- X-ray on
3 System RESET
4 System ON-OFF
5 X-ray Timer Reset
6 Auto Inject ON/OFF
The Innova Console controls are:

• ON/OFF Turn system power off and on.
To switch ON press for at least 0.5 s.
To switch OFF press for at least 2 s.
When the operator uses the on/off button of the Innova console, by default the system starts with the patient
management screen when boot is complete.
• SYSTEM RESET Press the Reset button for 2 s to reset the system.
Note: The reset button is inhibited for 90 s after a system boot is started.
The system will take approximatively 3 minutes to reset.
• INDICATOR LAMP for X-ray (Fluoroscopy and Record).
• X-ray ON appears in the right side of the console, and the console beeps when X-ray are being produced. X-ray
are produced when the X-ray prep/exposure switch on the hand control or foot pedal is pressed.
• Auto Inject ON/OFF
Press on the button (button lit) to synchronize the injection with the acquisition.
• X-ray Timer Reset

Depending on local regulation, press the button to reset the X-ray timer after the elapsed duration.
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Chapter 8 - Innova Digital

1 Guidelines for the best usage of the system
• Boot the system one hour before the first acquisition (Fluoro or Record) to work at stable temperature and so
get the best image quality.
• To avoid saturation in the image, always collimate and use appropriate contour filters.
• While performing Fluoro, do not close collimator blades more than 50 % of the current nominal FOV setting.
• Always perform a Fluoro between two Record acquisitions.
• Always check the number of available exposures before starting a Record acquisition.
• For optimal performance, shutdown the system once daily.
2 Innova Digital Screen
1 Exam Management Screen

2 Utilities Menu
3 Patient Browser
4 Monitoring Bar
5 Acquisition Protocol Window
6 Worklist Browser
7 Application Selection Window
264 Innova Digital

8 Record Information Window

9 Fluoroscopy Information Window
10 X-ray Timer and Dose (Air kerma) Information Window
No selection is allowed during Record or Fluoro acquisition. Only Monitoring Bar can be opened by clicking on one
of the monitoring icons.
2-1 Monitoring Bar
The monitoring bar consists of the seven icons, which provide information about the state and availability of the
following functions: ECG Signal, Disk Space, Heat Units, X-ray Timer, Fluoro, Record, X-ray disable button.
ECG Signal Disk Space Heat Units Sta- X-ray Timer Fluoro Ready Record Ready X-ray Disable
Status Button Status Button tus Button Status Button Icon Icon Button
A color code with five levels is used:

• (0) White: function is disabled.
• (1) Green: function is OK / Ready or ECG is Online.
• (2) Yellow: function is above a first threshold. ECG is Stabilizing the signal.
• (3) Yellow flashing: function is above a second threshold.
• (4) Orange: function is not available. User action may be needed (reset X-ray timer, free disk space, reset
R-peak detection, etc). ECG is not detecting a trigger.
Clicking on one of the first four icons will open a pop up window containing more detailed info.
The X-ray disable button does not obey to this color code (refer to Innova Digital / Innova Digital Screen /
Monitoring Bar / X-ray Disable Button).
2-1-1 ECG Status
Click on the ECG button to display:

• The heart beats being detected
• To reset the R-peak detection
• The different thresholds for each warning level shall be as defined:
– Warning level is WHITE. No ECG signal is received at all. It is Offline
– Warning level is YELLOW. The signal is being received and the system is “learning” or stabilizing
– Warning level is GREEN. A signal is being received and the system is delivering triggers. It is Online
– Warning level is ORANGE. A signal is received but the system is not capable of delivering triggers. It is not
triggering.
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2-1-2 Disk Space Status
Click on the Disk Space button to display:

• The estimated exposures available.
• The run time available.
• The Disk Space allocated.
• The different thresholds for each warning level shall be as defined:
– Strictly below 1 sequence, warning level is ORANGE. X-ray are not allowed anymore.
– Between 1 and 3 sequences, warning level is blinking YELLOW.
– Between 3 and 10 sequences, warning level is YELLOW.
– Higher than 10 sequences is GREEN.
Note: Always check that enough disk space is available before starting a procedure.
2-1-3 Heat Units Status
Click on the Heat Units Status button to display Heat Units Information.
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The value indicates the current system availability.

There are 3 thresholds defining 4 states:
• Equal 0%, warning level is ORANGE. X-ray are not allowed anymore.
• Between [0, 30]% , warning level is blinking YELLOW.
• Between [30, 50]%, warning level is YELLOW.
• Higher or equal to 50%, warning level is GREEN.
In addition to the different colors of the Heat Units Status button, the message "Heat Unit Remaining is equal or
under 20%" is displayed at the bottom of the live display when the remaining heat units reaches 20%.
A continuous audible signal is also activated as long as the remaining heat units become higher than 20%.
If X-ray are ON when the 20% threshold is reached, the audible signal is activated only after the X-ray switch is
released.
2-1-4 X-ray Timer
Click on the X-ray Timer Status button to display the elapsed X-ray time since last timer reset.
There are 2 thresholds defining 3 states (depending on country local regulation):

• From 0 to 5 minutes, warning level is GREEN.
• After 5 minutes, warning level is blinking YELLOW.
• After 10 minutes of cumulated X-rays, warning level is ORANGE and X-rays are disabled until the X-ray timer is
reset. This threshold is enabled only in Italy.
Maximum continuous acquisition: if a fluoro acquisition is maintained continuously without interruption, it will be
Innova Digital 267

terminated automatically after 10 min.

Note: The icon is still yellow after the 10 min continuous X-rays in all countries but Italy.
This timer counts the cumulated Fluoro time since last timer reset.
Note: For US only (Compliance to 21 CFR 10.20.32), this timer counts the total cumulated Fluoro and Record time,
since last timer reset.
2-1-5 Fluoro / Record Ready
The Fluoro and Record monitoring icons have 2 states:

• Green: READY (enabled) for X-ray - Fluoro / Record.
• Orange: NOT AVAILABLE (disabled), e.g. due to End Exam, disk full, Over limit Heat Units...
2-1-6 X-ray Disable Button
The X-ray button allows disabling or enabling X-rays, outside an acquisition, by pressing the button.
The X-ray button has three states:
• INACTIVE state: during an acquisition, the button is inactive:
• DISABLED state: outside an acquisition, when X-rays are disabled:
• ENABLED state: outside an acquisition, when X-rays are enabled:
2-2 Utilities Key
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iLinq: Access to direct interactive communication with GEHC via In Site Connection.
Service: Access to a panel of menus such as Quality Assurance Program (QAP), InnovaSpin Parameters,
configuration and Service...
When selecting Service, a pop up window opens:
Click OK after the Warning was read and understood

Help: Access to the Operator Manual.
Alarm messages: Access to the list of translated Alarm messages.
Snapshots: Allows to capture all screens including images (image must be paused first) and the last Error Log.
Product Software Version: Access to the Software Version information of the product.
2-3 Exam / Utilities Charring
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3 How to prepare for a New Patient Acquisition

Note: Always check the disk space available before performing a new Patient acquisition.
Note: Before patient creation, we recommend to delete patients whose data has been pushed/archived.
270 Innova Digital

To enter information for a new patient:

• Click on the "PATIENT" tab at the upper left of DL Screen.
• Select from the PATIENT BROWSER. The Patient and Exam Info window appears:
Fill in the patient information. Patient Name and Identification are required fields. If they are left
blank, an error message appears.
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• Last -First Names.

• Identification number.
• Date of birth.
• Sex.
• Height/weight.
• Head to end distance.
• Other Patient ID.
• Physician Name (this is a list box).
• Select the Exam Type (this is a list box).
• Click on the "Other Exam Info" tab – Fill in the available information:
• Select [Apply] to create patient and return to Patient Browser.

• Select [Cancel] to cancel patient entry.
• Select [Start Exam] to begin a procedure.
Note: If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting system, the Start Exam
information is also sent to that system using the DICOM "MPPS in progress" message.
In case of test acquisitions needed, select the "Test Patient" on top right of the menu. Patient Last Name and
Patient Identification fields will be automatically filled with "Test GE" information.
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4 How to modify Patient Information

The button allows the user to review the patient’s name and identification as well as the exam
information that has been entered for a procedure. Also, it allows the modification of this information.
To modify the information for an existing patient:

• Click on the “PATIENT” tab at the upper left of the DL screen.
• Select from the PATIENT BROWSER. The Patient/Exam Info window appears:
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• Click on the lock icon to modify patient information.
• New and editable fields will appear and can be modified while the original patient information is still shown on
the left side.
Note: If the patient information was retrieved from a worklist, it cannot be modified and the patient and identification
fields will remain grayed out. Only information manually typed in can be modified.
• Click on [Apply] to accept the changes.
• Click on [Cancel] to exit with no changes.
• Click on [Start Exam] to begin the procedure.
5 How to select an Acquisition Protocol
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Innova Digital screen
The protocols are classified inside categories. The list of protocols is organized in a 2 levels hierarchy.
A folder list displays and selects protocols.
5-1 List of Categories
Find below the protocols available:
Abdomen
Cardiac & Combo
Chest
EP DoseSense
Head
Lower Limbs
Pediatrics
Surgery (only with the surgical system configuration)
Upper Limbs
Vascular
X-ray Quality Test
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5-2 List of Protocols

Find below the list of default protocols available:
Category Protocol Name

Abdomen 1 Abdomen dose limited
Aorta
Body Soft Tissues
Needle Placement
Pelvis
Record Dose Limited Needle
Single Shot
Cardiac & Combo 1 Cardiac dose limited
Cardiac 1
Cardiac 2
Combo 1
Combo 2
Coronaries
Needle Placement
Ventriculogram
Chest 1 Chest dose limited
Aorta-Arch
Pulmonary
EP DoseSense DoseSense EXTRA LOW
DoseSense LOW
DoseSense MEDIUM
DoseSense NORMAL
DoseSense MAPPING
Head 1 Head dose limited
Carotids
Cerebral
Cerebral Sharp
Single Shot
Soft Tissues
Lower Limbs 1 Lower Limbs dose limited
Femoral
Foot
Lower Leg
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Pelvis
Popliteal
Pediatrics Pedia Abdomen
Pedia Cardiac
Pedia Cardiac Neonate
Pedia Cerebral
Pedia Chest
Pedia Lower Limbs
Pedia Upper Limbs
Surgery 1 Surgey dose limited
2 Single shot
Abdomen
Chest
Extremities
Head/Neck
Upper Limbs 1 Upper Limbs dose limited
Elbow-Forearm
Hand
Shoulder-Humerus
Vascular DSA 0.3 Focal Spot
REC 0.6 Focal Spot
REC 1.0 Focal Spot
REC 2 fps-20 s, Fl 15 fps
X-ray Quality Test Quality Assessment Cardiac
Quality Assessment DSA
USE THE "NEEDLE PLACEMENT" PROTOCOL LOCATED EITHER IN THE ABDOMEN OR

CARDIAC ANATOMY WHICH AUTOMATICALLY DISABLES THE INNOVASENSE PATIENT
CONTOURING FUNCTION IN CASE OF PROCEDURE THAT INVOLVES THE USE OF SMALL
INVASIVE OBJECTS/DEVICES (I.E. BIOPSY OR OTHER NEEDLES) OR OBJECTS MADE OF
NON-CONDUCTIVE MATERIALS (PLASTIC... I.E. OXYGEN MASK) WHICH PROJECT OUT
FROM THE PATIENT SKIN SURFACE, THESE OBJECTS/DEVICES BEING TOO SMALL
AND/OR NOT DETECTED BY THE CAPACITIVE SENSORS. FAILURE TO THIS MAY CAUSE
SEVERE PATIENT INJURY IN CASE THE DETECTOR HITS THE INVASIVE OBJECT/DEVICE.
DURING SURGERY, SELECTION OF ANY OF THE PROTOCOLS UNDER "SURGERY"

CATEGORY, WILL AUTOMATICALLY DISABLE THE INNOVASENSE PATIENT CONTOURING
FUNCTION. CAPACITIVE SENSORS DOES NOT DETECT THE SURGICAL DEVICES THAT
WOULD PROJECT OUT FROM THE PATIENT. OPERATORS HAVE TO PAY ATTENTION AND
FAILURE TO THIS MAY CAUSE SEVERE PATIENT INJURY IN CASE THE DETECTOR HITS
THE INVASIVE OBJECT/DEVICE.
From the Protocols:
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• Using the mouse, select a protocol by clicking on the protocol name.

The selected protocol is then displayed in reverse video.
Note:
• The "X-ray Quality Test" anatomy is for Service usage only. It is recommended not to select the "Quality
Assessment Cardiac" or "Quality Assessment DSA" protocol.
• In case a navigation system using electromagnetic waves is required during a cardiac procedure, it is
recommended to select/use the "DoseSense MAPPING" protocol which is set to reduce/optimize the image
artefacts created by the navigation system.
Use this protocol only in case a navigation system using electromagnetic waves is required
during a cardiac procedure. Otherwise Fluoro image quality might not be optimum.
Due to the large size of the 40cm detector, we recommend to avoid performing cardiac
procedure requiring the use of a navigation system using electromagnetic waves on the
Innova IGS 540. In such case, the artifacts created by the navigation system are not
compensated which can significantly lower the Fluoro image quality.
• On the Innova IGS 530, to optimize the visibility of soft tissues in the brain during intra cranial procedures, it is
recommended to select/use the "Soft Tissues" protocol located in the "Head" anatomy when a 3DCT acquisition
at 10°/s is required using the 30 cm field of view. The SID being reduced for such 3DCT acquisition, particular
attention must be brought to well center the patient's head in lateral to avoid risk of collision between gantry and
table top.
• To adjust the edge enhancement filter level used by default in a protocol, refer to section "Edge Enhancement
Filter Selection".
All acquisition protocols are preloaded with parameters to deliver a standard image quality. It is always possible to
modify the preloaded protocol parameters in order to customize/optimize the image processing parameters in
Record, Fluoro NoSub, Fluoro Sub, Fluoro Roadmap and Blended Roadmap. The strength of temporal and spatial
denoising, the brightness, contrast and sharpness of the images can be fine-tuned according to individual
preferences. Blended Roadmap also allows modifying the wire contrast over the vessel and the default vessel
density. If needed, contact your GE Healthcare Representative for any acquisition protocol
modification/optimization.
Any parameters, protocols and/or application changes to GEHC Equipment shall be Customer's sole responsibility
as well as any decision having regard to such clinical responsibilities and duty of care owed to patients.
Accordingly, the Customer will be solely liable for the decision to modify the protocol and the consequences
thereof. GEHC shall in no event be held liable for any damages resulting directly or indirectly from such
modification by the Customer of the protocol, as such modification will be made on Customer's instructions only.
5-2-1 Dose limited protocols
The system is delivered with one dose limited protocol for each of the following protocol categories: abdomen,
cardiac, chest, head, low limbs, surgery and upper limbs.
A dose limited protocol is set with following parameters:
• Fluoro: Receptor Dose Limited Plus autoexposure; 15 fps; Low detail.
• Dynamic record: Receptor Dose Limited Plus autoexposure; 15 fps; Low detail.
• DSA record : Receptor Dose Limited Plus autoexposure.
The predefined dose limited protocol is at the top of the list in each protocol category and have "dose limited" in its
name. It is selected by default upon system boot or reset, but this function can be changed.
It is recommended not to rename or modify these protocols.
If a dose limited protocol is modified, there is a risk of delivering higher dose than how the protocol is to be used.
6 Fluoroscopy and Acquisition

Fluoroscopy and Record Foot Pedal
278 Innova Digital

Depending on local regulation, the large footswitch cover may be mandatory. It is recommended to install the large
cover on the footswitch located in remote position.
1 Fluoro
2 Record
3 Table Top Longitudinal and Lateral Brakes Release.
Note: With the InnovaIQ Table, the activation of the switch will only release the lateral table top brake when the
table is tilted.
Do not use the footswitch cover as a footrest or stand on it. The cover may break and lead
to uncontrolled X-ray.
A green led located on the gantry (ready for X-ray LED below) indicates when X-rays are available.
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6-1 Fluoro UPS (Option)

Note: Fluoro UPS usage requires the system to be powered-on: Fluoro UPS is not available for system boot.
In case of main power failure, the Innova system is suddenly unavailable.
With the use of the Fluoro UPS, all functionalities of the Innova system, except Record acquisition, are still
available and secured for 5 minutes.
THE AUTONOMY TIME IS GUARANTEED IF BOTH:
- THE BATTERY IS FULLY CHARGED. THE BATTERY CHARGE DURATION TIME IS ABOUT 8 HOURS.
- A REGULAR MAINTENANCE CHECK IS ENSURED BY PERIODIC PREVENTIVE MAINTENANCE (REFER
TO YOUR SERVICE CONTRACT)
In case of main power failure, the Innova system will automatically switch to UPS mode within 2 s maximum.
The message "Powered with UPS" displayed at bottom of the live display will inform users that the Innova system
is working under UPS.
Note: In case of main power failure during a Record acquisition, the acquisition will be aborted but already acquired
images will be saved on the image disk.
While Innova system is running under UPS mode:
• When less than 3 minutes of UPS power are available, the message "!!! 3 min before X-ray inhibit. UPS low.
Secure patient (1.9)" is displayed on the live display for 1 min.
• When less than 2 minutes of UPS power are available, the message "!!! 2 min before X-ray inhibit. UPS low.
Secure patient (1.9)" is displayed on the live display for 1 min.
• When less than 1 minute of UPS power are available, the new message "!!! 1 min before X-ray inhibit. UPS low.
Secure patient (1.9)" is displayed on the live display for 40 s.
PATIENT MUST BE SECURED IMMEDIATELY. INNOVA SYSTEM IS GOING TO SHUTDOWN

VERY SOON.
• When less than 20 seconds of UPS power are available, the permanent message "System near to be shutdown.
Exit exam" is displayed on the live display.
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INNOVA SYSTEM IS READY TO SHUTDOWN.
If the main power is back before the UPS battery is discharged, the Innova system automatically switches off from
UPS mode within 2 s maximum.
In case of main power recovery during a Fluoro acquisition, the message "Power restored. Release fluoro for full
functionality" is displayed. The Innova system will switch off from UPS mode only after the end of the Fluoro in
progress.
Notes:
Regular Preventive maintenances are required to ensure the availability of the fluoro UPS option. In addition, the
UPS device has the ability to detect cases of undercharged batteries and some failure conditions of the UPS. In
both cases, the message "!! Exam interruption risk if power is lost. UPS failure. Call Service (2.15)" will be
displayed.
This message will be cleared if the batteries are recharged, or if the UPS failure condition disappears. Note that if
the operator presses the Mute button on the UPS, this message will also disappear while the error condition
remains and will remain unnoticed until the next UPS automatic test. It is therefore important to contact GE service
when pressing the Mute button on the fluoro UPS.
• If the Innova system does not recover full acquisition functionality after the main power is restored, reselect the
protocol in use and resume.
• All Maintenance and Service of the UPS must be performed by qualified personnel only.
• In case of UPS storage for more than 3 months, recharge UPS battery every 3 months to prevent any battery
damage.
7 No Sub Fluoroscopy Acquisition
No Sub Fluoro can be activated from:

• The Innova Digital screen by selecting the No Sub tab in the Fluoro window.
• The Table Side Status Control (TSSC) using the Sub/NoSub toggle button.
• The Innova Central touch screen using the Fluoro Mode button.
The Fluoro icon is displayed on the left side of the live display during Fluoro to show that the displayed
image is a live fluoroscopic image.
Innova Digital 281

is displayed at the bottom of the control room console to show that a fluoroscopic acquisition is in
progress.
After each Fluoro exposure, a Last Image Hold (LIH) is displayed on the live display.
7-1 Field of View (FOV)
There are four available FOV settings:
• 20 cm, 17 cm, 15 cm and 12 cm for Innova IGS 520.
• 30 cm, 20 cm, 16 cm and 12 cm for Innova IGS 530.
• 40 cm, 32 cm, 20 cm, and 16 cm for Innova IGS 540.
The FOV can be changed on the Innova Digital screen (see Illustration FOV - Innova Digital Screen) or on the
tableside control (TSSC).
For Innova IGS 520: 20 cm = 0 Mag, 17 cm = 1 Mag, 15 cm = 2 Mag and 12 cm = 3 Mag.
There are + and - symbols to allow for ease of up/down selection on the tableside control (see Illustration FOV -
TSSC, Item 4).
FOV - Innova Digital Screen
FOV - TSSC
282 Innova Digital

The FOV can be changed dynamically during fluoroscopy without releasing the pedal. This provides the clinician
improved flexibility and workflow on the Innova IGS 520, Innova IGS 530, Innova IGS 540. The default FOV is 20
cm on Innova IGS 520, 30 cm on Innova IGS 530 and 40 cm on Innova IGS 540.
7-2 Fluoro Detail
There are two settings Low and Normal that are selected at tableside on the TSSC. See Illustration Fluoro Details -
TSSC (Item 13) or on the Innova Digital screen see Illustration Fluoro Detail - Innova Digital Screen.
Note: The level of fluoro detail selected is always displayed with the Fluoro parameters on the reference display
while in Exam.
Fluoro Detail - Innova Digital Screen
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Fluoro Detail - TSSC
7-3 Fluoro Frame Rate

Fluoro can be performed at different frame rates: 30 fps, 15 fps, 7.5 fps or 3.75 fps.
Note: Use low fluoro frame rate as often as possible to reduce patient skin dose.
Fluoro Frame Rate - Innova Digital Screen
7-4 Fluorostore (Option)

Use the [Store] button located on the TSSC (see Illustration Fluorostore - TSSC - Item 15) to enable storage and
looping display of the last 450 frames of the Fluoro just performed.
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Fluorostore - TSSC
Depending on the Fluoro frame rate used, the Fluorostore function allows to store up to:
• 15 s of Fluoro when performed at 30 fps.
• 30 s of Fluoro when performed at 15 fps.
• 60 s of Fluoro when performed at 7.5 fps.
• 120 s of Fluoro when performed at 3.75 fps.
The stored images are added into the DL database as a new Fluoro sequence.
The looping display starts automatically after the sequence is stored and enables better visualization of low
contrast objects thanks to repeated display without repeated exposures to the patient.
The stored Fluoro sequence has the same basic review capabilities (autoreview, Play/Pause...) as typically used
for Record sequence.
The Fluoro sequence is shown in the sequence browser with a specific icon (see Illustration - Fluoro Sequence
icon) and has limited processing capabilities (measurements and quantifications are not allowed on such fluoro
images).
Fluoro Sequence icon
Innova Digital 285

is displayed at the bottom right of the live display.
There are two ways to use the [Store] button:

On request Fluorostore:
• After each Fluoro, the [Store] button blinks during 30 s. While the [Store] button is blinking, press the [Store]
button to manually store and play in loop the last 450 images of Fluoro acquisition which was just performed.
Note: The [Store] button will stop blinking in case:
- A new acquisition, Fluoro or Record is started.
- End Exam is selected.
Auto Fluorostore:
• At any time but right after a fluoro, press on the [Store] button to activate the Fluoro autostorage and loop
feature. The [Store] button will be permanently lit. Each following Fluoro performed will be automatically stored
and displayed in loop until the [Store] button is manually switched Off.
Note:
– A specific icon is displayed on the left side of the live display during a Fluoro performed in Auto
Fluorostore mode.
– The autostorage selection will automatically be deactivated at End Exam.
7-5 X-ray Timer
The X-ray TIME RESET button (Item 17 lower left corner) will blink and reset the X-ray timer.
This timer counts the cumulated time while the Fluoro foot switch is depressed.
Note: For US only (Compliance to 21 CFR 10.20.32), this timer counts the total cumulated Fluoro and Record time
since last timer reset.
When the timer reaches 5 minutes, a warning tone is audible during Fluoro.
Press the button to reset the X-ray timer after the elapsed duration, or at any time, depending on local regulation.
The timer can be reset either at the tableside control or at the Innova Console.
In case of continuous fluoro without interruption, X-ray will be terminated after 10 min and the error message
"Fluoro interrupted: reset Fluoro timer to continue" will be displayed.
Note: In Italy, after 10 min of cumulated X-rays, X-rays are disabled until the X-ray timer is manually reset.
7-6 Cumulated Time
It is reset to zero at end Exam. If the exam is resumed from an existing exam, the value is set to the total X-ray time
(Fluoro and Record) recorded in this exam.
286 Innova Digital

1 Total X-ray time (Fluoro and Record)

2 Total fluoro time
7-7 Image Rotation

The image displayed on each live display can rotate according to the angulation of the 3 gantry axis (L, C and
offset arms). In order to keep the "head up" display when the L arm is positioned at 0° or 90°, a 90° image rotation
is performed when the image rotates more than +/- 45°. The 90° image rotation is not performed in real time. Fluoro
or Record hand/foot switches must be released first to activate the rotation.
IN CASE OF SYSTEM FAILURE, THE ROTATION OF THE IMAGE DISPLAYED ON THE LIVE
DISPLAY MIGHT NOT BE AUTOMATICALLY CORRECTED TO KEEP THE "HEAD UP"
DISPLAY WHEN THE L ARM IS OUT OF 0° OR 90°. IN CASE SUCH CONDITION OCCURS,
AVOID TO START PROCEDURE WHICH REQUIRES A PERMANENT PATIENT "HEAD UP"
DISPLAY.
By default the [Image Rotation] key is active. Deselect the [Image Rotation] to prevent the image to automatically
rotate 90° when the L-Arm is moved more than +/- 45°. In such case, the image will be displayed "head up" only
when the L-Arm will be at 0°.
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7-8 Patient Orientation

Patient Position on the DL
The Patient Position is the position of the patient on the table regardless of the imaging system. It is the
responsibility of the operator to select the correct patient position prior to any acquisition.
From the Patient Position pull down list, select the correct patient icon to match the current patient position on the
table.
This information is used by the system to correctly label patient orientation markers to avoid
misinterpretation of the image displayed for diagnostic purposes. It is also used by the 3D reconstruction
software to reconstruct the image in the correct orientation.
288 Innova Digital

Patient Position will automatically default to Head First Supine when End Exam is selected.
Patient Position in the exam room
The current selected Patient Position is displayed in the exam room on the live monitor.
Innova Digital 289

Patient is in Head First Supine Patient is in Head First Prone
If the displayed patient position on the live monitor does not match the actual patient position in the exam room,
correct the patient position on the DL screen.
If the table is 180° rotated, an icon “180°” indicating the table rotation state will appear on the live monitor.
290 Innova Digital

The patient position relative to the table top does not change when the table is rotated so there is no need to
reselect a patient position on the DL screen.
However, the patient position relative to the imaging system is the opposite of the display (patient position display
shows his head under detector, while his feet are actually under the detector).
Note: the patient orientation markers (L, I, R) are described in the "Patient Orientation markers" section below.
Patient Position at start exam
When clicking on Start Exam, a display of the current selected patient position on the DL screen will alternate with
a question mark reminding the user to verify the correct patient position has been selected. This effect will stop
upon selecting a patient position from the list or after 30 seconds.
Patient Orientation markers

Patient orientation is the orientation of the patient in the XR image.
The patient orientation is indicated by 1 to 3 direction letters located on the top, left and right edges of an x-ray
image in review or LIH: Right/Left, Superior/Inferior, Anterior/Posterior (R/L, S/I, A/P). It is not indicated on live
images.
The patient orientation markers correspond to the patient orientation in the image. It includes gantry and table
angulations, patient position on the table, and image transformations such as flips and rotations.
Patient orientation markers are part of the DICOM information and are transferred to a workstation which may have
the ability to display them.
The following example is of a patient placed on the table supine, head first, gantry in the PA position and table
position centered and not tilted.
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1 - Patient's right (R) is located on the left of the image

2 - Patient's head (Superior) is located on the top of the image
3 - Patient's left (L) is located on the right of the image
Additional patient directions appear when there are LAO/RAO and CRA/CAU angulations. The main direction of the
patient is indicated by the first letter. The potential secondary direction is indicated by the second letter and the
potential third direction, which is the least important, is indicated by the third letter.
292 Innova Digital

1 - Patient's anterior (A) is the dominant direction and the patient's right side (R) is also viewed.
2 - Patient's superior (S) is the dominant direction
3 - Patient's left side (L) is the second dominant direction
4 - Patient's anterior (A) direction is also viewed but it is the least important.
Superior/Inferior or Head/Feet display
By default, the Superior/Inferior patient direction is indicated by letters “S” and “I”. However, there is a configuration
to display this direction with the letters “H” (Head) and “F” (Feet) instead. Contact your GE representative to change
this setting.
Innova Digital 293

Patient Orientation display/transfer option
In the Preferences Tab on the DL screen, “Patient Orientation Preferences” allows the display or not of the patient
orientation markers. This configuration is accessible at any time except during an acquisition.
When the configuration is set to “Yes”, the patient orientation markers on acquired sequences or photos will be
displayed and transferred to workstations.
When the configuration is set to “No”, the patient orientation markers will not be displayed or transferred. If the
configuration is “No” and you need to retrieve the patient orientation of your acquired sequences, click on “Yes” and
re-launch the sequence or photo review. The markers will appear. If the sequence or photo without patient
orientation was already transferred to a workstation, they will need to be re-pushed.
Note: the change of display preference will not affect the images that are in the queue for transfer.
Modification of Patient Orientation
If the patient position on the table was not selected properly, the patient orientation markers will be incorrect. In this
case, it is possible to manually annotate the images through the Modify Patient Orientation interface.
Select the sequence or photo to modify. To select multiple sequences or photos, press and hold the shift key while
selecting.
Right click on your selection then left click on the “Modify Patient Orientation” dialog box.
294 Innova Digital

Right-click on multiple selection
The Modify Patient Orientation interface appears:
Innova Digital 295

Click on the box that matches the correct patient orientation for the selected images or the Clear Orientation box.
Click on Apply. The change will apply to all frames in a sequence or photo, even if the patient orientation changes
during the acquisition.
Any sequence or photo that is in the queue for transfer cannot be modified.
If the sequence or photo containing incorrect patient orientation markers was already transferred, they will need to
be re-pushed.
7-9 Image Flip
It is the responsibility of the Operator to correctly verify the patient orientation by

confirming that it matches the information displayed on the live display.
In case of image inversion selected, the and/or keys will be automatically highlighted and a specific
icon will be displayed below the and keys on the digital screen.
296 Innova Digital

Image Flip - Innova Digital Screen
Three choices are possible:

: flip the image horizontally: icon displayed.
: flip the image vertically: icon displayed.
+ : flip the image horizontally and vertically: icon displayed.
Image Flip will be automatically removed at each Start Exam (default image flip settings at start exam = no or
flip selected).
The icon will be also displayed in the Geometry area (Item 1) of each live display and over any image
reviewed on each live or reference display (Item 1).
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8 How to perform a Roadmap Fluoroscopy Acquisition

Roadmap Fluoro can be activated from:
• The Innova Digital Screen by selecting the Roadmap tab in the Fluoro window.
• The Table Side Status Control (TSSC) by pressing the Sub button (Item 11).
• The Innova Central touch screen by selecting the Fluoro Mode button.
Note: The Sub button (Item 11) located on the TSSC toggles between Fluoro No Sub mode and the last used
Subtracted Fluoro mode (FluoroSub or Fluoro Roadmap).
When Fluoro Roadmap is selected, the label Fl. Roadmap is displayed on the reference display.
298 Innova Digital

Roadmap Fluoro - Innova Digital Screen
Subtracted Fluoro - TSSC
- Perform a fluoroscopy depressing the fluoro footswitch; this is the mask acquisition phase.
The Fluoro icon is displayed on the left side of the live display during Fluoro to show that
the displayed image is a live fluoroscopic image.

After a short time, "Inject" flashes on the live display.
- Inject manually the contrast media to perform a roadmap run.
Note: In case the 7.5 fps fluoro is used, inject for at least 2 s to acquire enough frames. Doing so
will optimize the peak opacification phase of the mask acquisition.
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- Release the fluoro footswitch.

A "Mask" icon is displayed on the left side of the live display to show that the Fluoro mask was
acquired.
- Depress again the fluoro footswitch. The displayed fluoro images are subtracted. The vessel roadmap should
be visible in white color.
- The subtraction level can be adjusted using the LANDSCAPE function. Select an appropriate "Landscape"
level in the Fluoro window or use the "LANDSCAPE" button on the Table Side Status Control (TSSC).
THE FLUORO LANDSCAPE FEATURE AFFECTS ONLY THE BACKGROUND VISIBILITY OF

THE IMAGE. WHEN USING SUB FLUORO WITH LANDSCAPE, NEVER MOVE THE TABLE. IF
SO, INJECTED VESSELS WILL NOT MATCH ANYMORE WITH THE ANATOMY.
The predefined LANDSCAPE values are: 0, 30, 50, 70 and 100%.
A "Landscape" icon and the level value are displayed on the left side of the live display to
show the selected level of landscape.

- At 100% landscape the fluoro images are not subtracted, vessel roadmap is not visible.
- 0% landscape = full subtraction imaging.
Note: Modification of Landscape level is available at any time during the Roadmap time from the TSSC only.
DURING THE ROADMAP FLUOROSCOPY, DO NOT MOVE THE TABLETOP AND / OR THE
GANTRY NOR CHANGE THE FIELD OF VIEW, THE FLUORO DETAIL, THE IMAGE FLIP
SETTINGS, INSERT OR REMOVE CONTOUR FILTERS. IF DONE THE IMAGE QUALITY WILL
BE SERIOUSLY DEGRADED.
Note: The mask is aborted when Roadmap mode is exited, or when "END EXAM" is activated or when another
protocol is selected.
Note: When the roadmap fluoro is deselected, the landscape function is disabled.
9 How to perform a Blended Roadmap Fluoroscopy Acquisition (Option)

Blended Roadmap overlays a vessel structure over the live subtracted fluoroscopy.
9-1 Create the Vessel Image
The vessel image used for Blended Roadmap must be a photo displayed on the reference display. It can come
from a DSA, a bolus, or a subtracted 3D sequence. It is identified on the In-room Browser and on the DL console
Photo Browser by the mask icon next to the photo number.
Note: The quality of the vessel information displayed in blended roadmap depends on the quality of the created
vessel image.
In-room Browser Photo Browser
9-2 Enter / Exit Blended Roadmap

Blended Roadmap can be activated by selecting:
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• Blended Roadmap tab on the Innova Digital console.

• Blended Roadmap Fluoro mode on the Innova Central touch screen.
Also, Blended Roadmap Fluoro can be activated from the NoSub Fluoro mode by pressing the Sub button on the
Table Side Status Control (TSSC).
Note: The Sub button located on the TSSC toggles between NoSub Fluoro mode and the latest used Subtracted
Fluoro mode (Roadmap, Blended Roadmap or Subtracted). Blended roadmap must be the last used subtracted
fluoro mode or the default Roadmap may be selected.
DL Console - Roadmap
DL Console - Blended Roadmap
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Innova Central touch screen
TSSC
When Blended Roadmap is selected, the label Blended Rdmp is displayed on the reference display.
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Reference display
Note: When trying to enter Blended Roadmap, an error message may pop up in the following cases:
Condition Error Message

Reference display is black, or displays the IRB Selection Failed; select a subtracted record photo.
Photo displayed is not a sub DSA, sub Bolus, or sub 3D
photo
Photo was stored from a zoomed sequence
Sequence where photo comes from is no more on the Selection Failed; original sequence deleted.
disk
Current and photo patient positions are different Selection Failed; patient position mismatched.
Current and photo flips are different Selection Failed; image flip mismatched.
Current and photo image rotations are different Selection Failed; image rotation mismatched.
In this case, first select a good vessel image / change the settings, then re-enter Blended Roadmap.
9-3 Reposition Gantry/Table
The vessel information blended with the live fluoro is relevant only if the live fluoro is taken from the same
angulations as the vessel photo. After activating Blended Roadmap, the vessel image position and the current
system positions are compared and if needed, tools are provided to help repositioning of the gantry and the table
back to where the vessel image was acquired.
9-3-1 Systems equipped with an Omega table
• If the gantry position has changed, the system automatically triggers the Send Angle function. Activate the Auto
Positioner joystick (top or bottom) to drive the gantry back to where the vessel mask was acquired.
• If the table position has changed, the system automatically displays the table repositioning tool. Manually adjust
the axis of the table until a check mark is displayed next to all axis.
Note: A check mark is displayed when within a range of 5 mm for longitudinal, lateral and vertical movement
and 0.3 degrees for rotation.
• If neither the gantry nor the table was moved, no specific action is required. Perform a fluoro acquisition (see
next step).
See illustrations below.
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Need to reposition the Gantry Need to reposition the Table No repositioning needed
9-3-2 Systems equipped with an InnovaIQ table

• If the gantry and/or the table position has changed, the system automatically triggers the Send Angle function.
Activate the Auto Positioner joystick (top or bottom) to drive either the gantry or the table or both back to where
the vessel mask was acquired.
• If the table rotation has changed, the system automatically displays the table repositioning tool. Manually adjust
the rotation until a check mark is displayed next to it.
Note: A check mark is displayed when within a range of 0.3 degrees
• If neither the gantry nor the table was moved, no specific action is required. Perform a fluoro acquisition (see
next step).
See illustrations below.
Need to reposition the System Need to reposition the Rotation No repositioning needed
Note: Blended Roadmap Send Angles may fail or be cancelled, and an error message may pop up in the following
cases:
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Condition Error Message

30 s time-out Send Angles stopped / not allowed. Restart Blended
Rdmp to continue.
3D spin test started / Bolus start position selection
PA / LAT motion while system position is being moni-
tored
Patient Position Change
In this case, exit and re-enter Blended Roadmap.

9-4 Mask Acquisition and Registration
Blended roadmap uses a fluoro mask to remove unnecessary anatomy and to check repositioning accuracy. The
next step after repositioning is to acquire this fluoro mask.
Perform a fluoroscopy by pressing the fluoro footswitch; this is the mask acquisition phase. The Fluoro icon
is displayed on the left side of the live display during Fluoro to show that the displayed image is a live
fluoroscopic image.
AFTER ENOUGH FRAMES HAVE BEEN ACQUIRED FOR 1 OR 2 SECONDS, THE SYSTEM
AUTOMATICALLY STOPS THE ACQUISITION.
Release the fluoro footswitch. A "Vessel" icon is displayed on the left hand side of the live display, in
order to show that the system is ready for a Blended Roadmap acquisition, and the percent of vessel density.
LIH shows the subtraction between the fluoro mask and the vessel photo to verify the registration of the subtracted
roadmap.
See illustration below:
Sample image showing correct registration Sample image showing 5 mm misregistration
If neither gantry or table was repositioned, and the patient did not move, registration should not be necessary.
IT IS THE USER’S RESPONSIBILITY TO ENSURE THAT THE REGISTRATION BETWEEN THE

FLUORO MASK AND THE VESSEL PHOTO IS SATISFACTORY FOR CLINICAL PURPOSES.
MISREGISTRATION COULD LEAD TO THE VESSEL MAP BEING DISPLAYED INCORRECTLY
AND COULD CAUSE POSSIBLE INJURY TO THE PATIENT.
Pixel shift is provided to improve the registration if it is needed. Pixel Shift is available from the:
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• Innova Central touch screen joystick

• DL Keypad
• Remote Control
Horizontal, vertical and diagonal pixel shift is provided. If the pixel shift is held active during the registration, the size
of the shift will increase with time.
Note: It is not advised to try to modify the Landscape, Vessel or any other function while in the Pixel Shift phase as
these changes will not be apparent until fluoro is reinitiated and Pixel Shift may be aborted.
Note: During the registration phase, pressing the store photo button creates a photo of the LIH without subtraction
and deactivates pixel shift.
Note: If fluoro is activated too quickly without visually checking the registration, a message will be displayed to
remind the user to check the registration. It is recommended to restart Blended Roadmap and verify the registration
or this message will continue to warn the user at every fluoro.
9-5 Blended Roadmap Acquisition
Press the fluoro footswitch again to perform a Blended Roadmap acquisition. The fluoro mask is subtracted from
the displayed fluoro images to remove anatomy, and the selected vessels from the photo image are overlaid.
Note: During subtracted fluoroscopy, it is recommended not to move the tabletop, the gantry, change the field of
view, the fluoro detail, the image flip settings, or insert or remove contour filters to avoid serious image quality
degradation.
9-6 Landscape and Vessels Adjustment
The subtraction level can be adjusted using the LANDSCAPE function. Select an appropriate "Landscape" level in
the Fluoro tab of the DL console, or use the Table Side Status Control (TSSC) or the Innova Central touch screen
joystick.
The predefined LANDSCAPE values are: 0 (full subtraction), 30, 50, 70 and 100 (no subtraction)%.
Modification of Landscape evel is available at any time during the Blended Roadmap only from the TSSC and
Innova Central touch screen joystick.
Note: In order to activate Landscape adjustment by the Innova Central touch screen joystick, press
Landscape/Vessels button on the Fluoro tab of the Innova Central touch screen. Move the joystick up or down to
adjust landscape.
The vessel density can be adjusted using the VESSELS function. Select an appropriate "Vessels" level in the
Fluoro tab of the DL console, or use the Innova Central touch screen joystick.
The predefined VESSELS values are: 0 (no vessels), 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100%.
Note: At 100% landscape the fluoro images are not subtracted. In this case vessel roadmap is not shown.
Modification of Vessels level is available at any time during the Blended Roadmap from only the Innova Central
touch screen joystick.
Note: In order to activate Vessels level adjustment by the Innova Central touch screen joystick, press
Landscape/Vessels button on the Fluoro tab of the Innova Central touch screen. Move the joystick left or right to
adjust vessel level.
Landscape and vessel density can be changed without fluoro. The display of percentages will update but not the
image until fluoro is reinitiated.
9-7 FOV Management in Blended Roadmap
The vessel image FOV is automatically adjusted to the Blended Roadmap settings.
If a vessel photo is taken with a larger FOV than live fluoro, then the center part of the vessel image is used for
roadmapping.
Note: Do not change FOV after the fluoro mask acquisition or between subsequent blended roadmap runs,
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because misregistration artifacts may occur (subtraction of images of different sizes). If FOV change is needed, exit
Blended Roadmap, change FOV, re-enter Blended Roadmap and acquire fluoro mask in the new FOV.
See the illustration below.
Vessel image Blended Roadmap image
If a vessel photo is taken with a smaller FOV than live fluoro, then the available vessel information does not extend
to the whole fluoro image.
See illustrations below
Vessel image Blended Roadmap image
Note: In that case, the registration image looks like the following; the borders of the fluoro image appear
unsubtracted.
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Sample image showing correct registration
10 How to perform a Subtracted Fluoroscopy Acquisition

Subtracted Fluoro can be activated from:
• The Innova Digital Screen by selecting the Sub tab in the Fluoro window.
• The Table Side Status Control (TSSC) by pressing the Sub button (Item 11).
Note: The Sub button (Item 11) located on the TSSC toggles between Fluoro No Sub mode and the last used
Subtracted Fluoro mode (FluoroSub or Fluoro Roadmap).
• If Sub fluoro was used prior to No Sub fluoro, the TSSC button toggle between No Sub and Sub fluoro.
• If Roadmap fluoro was used prior to No Sub fluoro, the TSSC button toggle between No Sub and Roadmap
fluoro.
When Fluoro Sub is selected, the label Fluoro Sub is displayed on the reference display.
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Subtracted Fluoro - Innova Digital Screen
Subtracted Fluoro - TSSC
- Perform a fluoroscopy depressing the fluoro footswitch.

The Fluoro icon is displayed on the left side of the live display during Fluoro to show that
the displayed image is a live fluoroscopic image.

After a short time (1 s when using 30 or 15 fps; 2 s when using 7.5 fps), the image displayed on the
live display switches automatically from No Sub to Sub.
- The subtraction level can be adjusted using the LANDSCAPE function. Select an appropriate "Landscape"
level in the Fluoro window or use the "LANDSCAPE" button on the Table Side Status Control (TSSC).
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THE FLUORO LANDSCAPE FEATURE AFFECTS ONLY THE BACKGROUND VISIBILITY OF

THE IMAGE. WHEN USING SUB FLUORO WITH LANDSCAPE, NEVER MOVE THE TABLE. IF
SO, INJECTED VESSELS WILL NOT MATCH ANYMORE WITH THE ANATOMY.
The predefined LANDSCAPE values are: 0, 30, 50, 70 and 100%.
A "Landscape" icon and the level value are displayed on the left side of the live display to
show the selected level of landscape.

- At 100% landscape the fluoro images are not subtracted, vessel roadmap is not visible.
- 0% landscape = full subtraction imaging.
Note: Landscape level can be modified at any time during Fluoro Roadmap from the TSSC only.
DURING THE SUBTRACTED FLUOROSCOPY, IT IS HIGHLY RECOMMENDED NOT TO MOVE

THE TABLETOP AND / OR THE GANTRY NOR CHANGE THE FIELD OF VIEW, THE FLUORO
DETAIL, THE IMAGE FLIP SETTINGS, INSERT OR REMOVE CONTOUR FILTERS. IF DONE
THE IMAGE QUALITY WILL BE SERIOUSLY DEGRADED.
Note: The mask is aborted each time the fluoro footswitch is released.
Note: When the Subtracted fluoro is deselected, the landscape function is disabled.
11 Simultaneous Fluoro Sub / NoSub Display (Option)

Depending on system configuration, it is possible to display simultaneously the subtracted and non subtracted
fluoro images.
The simultaneous Fluoro Sub / NoSub display can be activated from the Innova Digital Screen by activating the
Sub NoSub button located below the Landscape level selection in the Sub or Roadmap tab of the Fluoro window.
310 Innova Digital

Simultaneous Fluoro Sub / NoSub Display - Innova Digital Screen
12 How to select an Acquisition Mode

Depending on system configuration, several Record acquisition modes can be available for each protocol listed in
the Protocols.
As previously explained, a Record acquisition can be performed using either the DSA, Dynamic, Chase, Bolus, 3D
or 3DCT mode.
After a protocol was selected in the Protocols, look at the Acquisition Mode tabs located at the top of the Record
Parameter window of the Innova Digital Screen to see which Record acquisition modes are available,
and, using the mouse, click on the Record acquisition mode needed to perform the next acquisition.
All Record parameters are automatically set and the Innova system is ready to acquire using the selected mode.
13 How to perform a Record Acquisition

Depending on system configuration and available options, all acquisition modes are displayed in most of the
protocols. (Some Cardiac protocols have only Dynamic and Chase acquisition modes available). Those modes are:
• Dynamic mode: primary use for general cardiac procedures.
• InnovaChaseTM (Chase) mode: primary use for non subtracted dynamic acquisition over any region of interest.
• InnovaBreezeTM (Bolus) mode: primary use for subtracted lower limbs arteriogram.
Innova Digital 311

interest.
The Record icon is displayed on the left side of the live display during Record acquisition to show that the
displayed image is a live image.
The radiation icon is displayed at the bottom of the control room console to show that a record
acquisition is in progress.
13-1 DSA Mode (Option depending on system configuration)
• Select among "Abdomen, Chest, EP DoseSense, Head, Lower Limbs, Upper Limbs, Vascular" from the
"Protocols". Double click on the anatomy name to open it.
Then click on one procedure among the proposed choice.
In the "Vascular" anatomy, specific procedures are available such as:

"REC 2 fps-20 s, Fl 15 fps" to perform angio procedures using 15 fps fluoro.
"DSA 0.3 Focal Spot" to perform angio procedures using a fixed 0.3 focal spot.
Note: Because of the low available power on such small focal spot, use this procedure over
thin/low density areas.
"REC 0.6 Focal Spot" to perform angio procedures using a fixed 0.6 focal spot.
"REC 1.0 Focal Spot" to perform angio procedures using a fixed 1.0 focal spot.
Automatically the Application tab confirms the selected acquisition mode.
The DSA acquisition is divided into 3 segments. A different frame rate and duration can be set for each of the 3
segments.
During acquisition, a dedicated button located on the side of the Record hand switch allows to commute from the
current segment to the next one before the total duration of the current segment.
• In the Record window DSA tab, select the frame rate needed for each of the three segments using the frame
rate pull down list between 0.5; 1; 2; 4 or 7.5 fps.
• Select the duration of each segment using the duration pull down list between:
– 1; 3; 5; 10; 15; 20; 30 s for the first segment.
– 0; 1; 3; 5; 10; 15; 20; 30 s for the second segment.
For the third segment, the duration list is dynamic and the maximum allowed duration is
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automatically computed to comply with two limitations:

– Maximum number of frame acquired: 450 frames.
– Maximum total duration of the acquisition: 600 s (10 mn).
If the maximum allowed duration is equal to 100 s (1 mn 40 s), then the available pull down list will
be: 0; 1; 3; 5; 10; 15; 20; 30; 100 s.
If the maximum allowed duration is inferior to 100 s (28 s for example), then the available pull down
list will be: 0; 1; 3; 5; 10; 15; 20; 28 s.
If the maximum allowed duration is superior to 100 s (328 s for example), then the available pull
down list will be: 0; 1; 3; 5; 10; 15; 20; 30; 100; 328 s.
Note: Any modification of the frame rate in the 3 segments or duration of segment 1 and/or 2 will affect the
maximum duration allowed for segment 3.
Note: In case only one segment is needed, set the duration of segment 2 and 3 to 0. In case only two segments
are needed, set the duration of segment 3 to 0.
Note: If 7.5 fps is selected, do not select longer acquisition duration than 30 s in case the acquisition needs to be
burnt on a CD in order not to exceed the maximum storage capacity of the CD. A single run cannot be burnt on
more than one CD.
• Select the needed Record Detail Level.
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• Select injection parameters

Acquisition can be performed using either Manual or Automatic injection.
When Auto Inject is selected (injector automatically triggered by the Innova system), the
X-ray or Injection Delay must be set (or kept) at Zero on the injector unit. In order to prevent
any conflict between the injector unit and the Innova system, X-ray or Injection Delay must
only be selected from the Control Room Innova Console. Setting (or keeping) some X-ray or
Injection Delay on the injector unit itself could create some acquisition abort.
In case of Automatic injection selection, the injector is automatically triggered by the system.
When Auto Injection is selected, it is possible to preset an injection delay (X-ray then Injection start) or X-ray delay
(Injection then X-ray start) by opening the selected pull down list.
Click on the +/- field to open the Injection/X-ray delay edit window and add/remove new/existing values.
To add a new value in the list, type the value and click on .
To delete an existing value, open the pull down list, select the value to remove and click on .
From this window, it is also possible to enter a new delay to use for the next acquisition. Just enter the value and
click OK to close the edit window and apply the new value. In this case, this new value will not be saved and added
314 Innova Digital

to the list.
Note: New Injection or X-ray delay must be entered by step of 0.5 s only (i.e. 1 s, 1.5 s, 2 s...).
• Perform DSA acquisition
Depress and hold the hand/foot switch to initiate the acquisition.
Acquisition parameters are computed from the previous fluoro. In case of table/gantry motion, FOV change,
geometry modification... since the previous fluoro, the Record acquisition could be inhibited and a new Fluoro
required.
If such situation occurs, perform a short fluoro (2 s minimum) then depress the acquisition switch again.
Note: Always check the image quality at the beginning of the run before launching the injection (images shall not
be dark nor contain excessive saturation).
Note: If the expose trigger of the hand/foot switch is released during acquisition, X-ray and injection will stop.
In case of Manual injection, "Inject" will be displayed on the left side of the live display to inform when injection can
start.
The acquisition starts using parameters set for segment 1, then those set for segment 2, then those set for
segment 3.
In case it is required to commute from one segment to the next one before the complete duration set for that
segment, pressing on the Skip Segment button located on the side of the record hand switch will make the
acquisition switch to parameters set for the next segment.
Record Hand Switch
- The Heat Units Information displayed are only estimations made by the system depending
on acquisition parameters computation. - The Heat Units Information are available from the
control room Innova Digital screen Heat Units window and from the reference display. At the
beginning of a DSA sequence, the system will automatically check the possibility of the
requested run. If the entire run duration is not possible because of thermal limitation (tube
too hot), then a 5-seconds long popup is displayed on the frontal live display, informing the
user of the maximum possible run duration. If the user does not release the pedal, the run
starts and will end when reaching that duration. Before a Record acquisition is performed, it
is the responsibility of the user to check the Heat Units informations. Depending on the
information displayed, the next Record acquisition may or may not be completed as
requested by the user.
Innova Digital 315

Depending on acquisition parameters computation and available heat units, the system will display a Warning pop
up on the frontal live display in case the requested run cannot be completed.
In this pop up, the computed available run time is displayed and a 5 seconds count down starts to let the user take
the decision to perform or not the acquisition, knowing that the run will be aborted before its completion.
Keep the hand/foot switch pressed to allow the run to start.
Release the hand/foot switch within 5 seconds (before count down reaches zero) to abort the acquisition.
Change acquisition parameters or wait for the X-ray tube to cool down to succeed in acquisition completion.
Note: Reaching X-ray tube thermal limit will interrupt the acquisition and require to wait for X-ray tube to cool down
or to modify acquisition parameters. Fluoro is always available. After reaching the thermal limits, the subsequent
DSA acquisition will have a 10 seconds access time.
13-2 Dynamic Mode (Option depending on system configuration)
Note: Before performing the first cardiac procedure after an angio procedure, check the Heat Units Status window
for heat units availability. It should be at least 50% for a diagnostic cardiac case or 70% for an interventional
cardiac case. The subsequent cardiac procedures can be performed without any thermal limitation. Fluoroscopy is
always fully available.
• Select "Cardiac & Combo" from the "Protocols". Double click on the anatomy name to open it.
Then click on one procedure among the proposed choice.
In addition to specific protocols such as Coronaries, EP, Needle Placement, Pedia Cardiac, Pedia Cardiac Neonate
and Ventriculogram, two protocols labeled Cardiac 1 and Cardiac 2 can be modified at installation to better fit local
needs during cardiac procedures. Two other protocols labeled Combo 1 and Combo 2 can also be modified at
installation to access other angio acquisition modes needed for angiography and peripheral procedures.
Automatically the Acquisition tab confirms the selected acquisition mode.
316 Innova Digital

• In the Record window Dynamic tab, select the Frame Rate needed using the Frame rate pull down list between
30 or 15 fps.
• Select the needed Record Detail level.
• Select injection parameters.
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Select Auto injection to automatically trigger the injector from the Innova system (for more detail, see Innova Digital
/ How to perform a Record Acquisition / DSA Mode).
• Perform Cardiac acquisition
13-3 InnovaChaseTM Mode (Option)
• After selection of an angio protocol, select the Chase acquisition mode from the Current Application window
located on the left side of the Innova Digital screen. If the selected protocol does not offer this choice, select
another protocol from the "Protocols".
• In the Record window, select the level of detail and injection parameters.
For more detail about injection parameters, refer to Innova Digital / How to perform a Record Acquisition / DSA
Mode).
• Perform InnovaChaseTM acquisition
InnovaChaseTM Acquisition is available using only:
5 fps acquisition frame rate.
1.0 large focal spot.
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Table top manual panning (non subtracted images).

The maximum record duration is limited to 90 s.
13-4 InnovaBreezeTM Mode (Option)
The Bolus chase acquisition mode is available on:
• Innova IGS 540 on the 40 cm and 32 cm Field of View.
• Innova IGS 530 on the 30 cm Field of View.
• Omega V table.
• InnovaIQ Table in horizontal or tilted position.
13-4-1 Application Description
The InnovaBreeze option is intended to perform subtracted angiography in real time of the lower limbs for
diagnostic purpose.
13-4-2 Before You Start
13-4-2-1 On the Positioner
• The L must be at +/- 90° (+/- 3°).

• The table-top must be centered (rotation is not allowed).
• The gantry must be in PA relative to the table (+/- 2° CRA-CAU, +/- 15° RAO-LAO). If the table is tilted and the
system is being used in mechanical mode, toggle to anatomical mode and back to check this.
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13-4-2-2 Patient Positioning

• To get the maximum patient coverage, position the patient so that the head is located at head end of the table
top.
• Using Fluoro, check that the patient is perfectly aligned with the table top/Digital Detector between Start and
End positions.
• Use proper accessories (Velcro straps...) to immobilize the legs/feet of the patient.
During the bolus acquisition, the table top will move between the Start and End positions at
high speed. Always check that all tubings (injector, pressure...) connected to the Patient will
be long enough and will have an extra length of at least 15 cm when the table will reach the
Start or End position. Failure to this recommendation could cause severe injury to the
Patient at punction location.
13-4-2-3 Anticollision Precaution
Make sure to clear the area before launching the procedure to avoid any activation of the
anticollision system that would abort the X-ray acquisition and injection.
13-4-2-4 On the Innova Console
• After selection of an angio protocol, select the Bolus acquisition mode from the Current Application window
located on the left side of the Innova Digital screen. If the selected protocol does not offer this choice, select
another protocol from the "Protocols".
• If the table top is in the allowed range, the S/E button of the Table Control Panel lits.
Any protocol selection performed after the Start/End positions were memorized will lose
these positions.
• Select the acquisition parameters:
- Available frame rates at rest (when the table top does not move) are: 1 fps and 2 fps.
- Step length is fixed to 5 cm.
- Auto/Manual injection with X-ray/Injection Delay.
- Normal or Low Record Detail.
13-4-2-5 On the Control Panel

The Bolus Chasing mode must have been selected before the Start/End button can be used.
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12 Start / End / Reset
Note: Press once on the S/E button to store the Start position.
Press a second time on the S/E button to store the End position (there must be at least 30 cm between Start and
End positions).
Press a third time on the S/E button to reset (clear) the Start and End positions.
Note: A 15 minutes time out is allowed between:
- Memorization of Start and memorization of End position.
- Memorization of End position and beginning of bolus acquisition.
13-4-3 Making an Acquisition in Bolus Mode
13-4-3-1 On the Innova Console
• Select the Bolus Chase protocol and the appropriate acquisition parameters (refer to Innova Digital / How to
perform a Record Acquisition / InnovaBreezeTM Mode (Option) / Before You Start / On the Innova Console).
13-4-3-2 In the Examination Room
• In order to always get the maximum field coverage on the patient even using a small field of view, move the
table top up to the end and keep the Digital Detector close to the patient.
• Move the table top to center the patient over the abdomen. The S/E button of the Control Panel must be ON to
allow to store the table position. Press the S/E button to memorize the table Start position. The S/E button goes
OFF.
• Correct centering is checked using fluoroscopy, from the abdomen to the feet.
Longitudinal movement is the only movement available. When the table top is moved more than 30 cm from the
Start position and is in the allowed range, the S/E button blinks.
• After centering over the feet, press the S/E button to memorize the table End position. The S/E button goes
OFF.
Note: From the time the Start position is memorized to the time the exposure switch is pressed all gantry axis are
locked except:
- Table Up/Down.
- Digital Detector Up/Down.
- Longitudinal table top.
Collimation, Contour Filters and Field of View selection are available until the exposure switch is pressed.
Fluoro is always available until the acquisition starts.
13-4-3-3 At the Console
Prep/Expose Handswitch Bolus Chasing Handswitch
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1 Table Speed
2 Bolus Button
• Press and hold the prep/expose Innova handswitch button.

Note: Except in case of emergency, this button must NOT be released during the entire Bolus acquisition.
• The table is automatically positioned at the Start position (Abdomen).
Note: In order to optimize the acquisition, the table will always stop 5 cm further than the memorized Start position.
Special attention is required regarding the length of cables, pipes, catheter... connected to the patient. These
devices must be long enough to follow the total table motion safely.
• The Mask sequence is performed at a fixed frame rate, from the Abdomen to the feet. Two trial shots are
performed at low dose (about 25% of nominal dose) prior to each mask acquisition. The table then returns to the
Start position and "Depress Bolus button" is displayed in the Status area.
• On the Bolus Chasing handswitch: depress and release the Bolus button (See Illustration above).
• The X-ray Run begins.
The injection begins after the programmed delay.
• Use the Table Speed button of the Bolus Chasing handswitch to follow the contrast media.
Note: In case of image pasting needed after the Bolus acquisition, adapt the table movement to ensure that the
central horizontal strip of the acquired images is always well opacified. Ideally, the contrast agent should be visible
on at least 75% of the image. If necessary, proceed to separate acquisition for each leg.
• Increase or decrease the speed of the table by pressing more or less firmly on the button.
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1 Table stopped (button released) 2 Maximum speed (button fully pressed)
• When the table speed button is released, the table stops on the next Mask position. Images are then acquired at
the frame rate at rest.
• To optimize the last acquisition, the table will stop at 4 cm maximum further than the memorized End position.
• To stop the X-ray Run:
- Release the prep/expose Innova handswitch button at any time or,
- Press then release the Bolus button on the Bolus Chasing handswitch after the table has reached its stop
position.
Note: Until the Bolus Chase protocol is exited or the S/E button is depressed to clear the Start and End memorized
positions, the system is still ready to perform another identical bolus acquisition.
A 15 minutes time out will automatically clear both memorized table positions if no action is perform on the system
after the completion of the bolus.
13-5 Innova 3D, Innova Subtracted 3D and Innova CT Modes (Options)
13-5-1 Application Description
Depending on system configuration, three 3D Spin modes can be available.
Innova CT is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide
images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the
physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
Innova Subtracted 3D reconstructs 3D volumes from 2 consecutive rotational acquisitions to provide images that
help clinicians to quickly visualize vessels without the need to remove surrounding bone, tissue and implanted
devices during procedures using angiography for aneurysm coiling, stent insertion, vessel embolization, etc.
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Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.
Innova 3D / Innova Subtracted 3D / Innova CT images should not be used on their own for
diagnosis or treatment but always in complement of 2D images (live or recent recorded
images).
The Innova 3D and Innova CT reconstruction is carried out on the Advantage Workstation and allows
reconstructions from a single 200° (approximate) spin acquired at a frame rate of 30 fps.
The Subtracted 3D reconstruction is carried out on the Advantage Workstation VS4 release or above, and allows
reconstructions from two consecutive 200° (approximate) spins of approximately 150 images each acquired at a
frame rate of 30 fps and a rotation speed of 40° per second.
All reconstructed 3D models can have 5123 resolution. A 2563 resolution mode is also available when faster
reconstructions are needed.
3D models produced can be visualized on the Advantage Workstation using the Volume Viewer Plus software.
The Volume Viewer software offers the ability to:
• Manipulate the 3D model around all three axes.
• Perform distance, and volume measurements.
• Navigate inside vessels (with Navigator option).
• Display MPVR (Multi Planar Volume Reconstruction) cross-sections: axial, sagittal, coronal and oblique
cross-sections.
• Detect vessels and remove un-wanted structures from the image.
13-5-2 3D Spin Acquisition
The 3D Spin Acquisition procedure is performed in two steps:
• 3D calibration acquisition using the helix phantom for definition of volume reference points (to be performed
once every six months).
Two levels of information message are displayed:
– 6 months-15 days: "3D Calibration near to expire. Call Service to perform 3D Calibration".
– After 6 months: "3D Calibration out of date. Call Service to perform 3D Calibration".
3D acquisition and reconstruction are still allowed.
A small "*" will be displayed left to the reconstruction date of the 3D model on the Advantage Workstation.
• Acquisition of patient images using a specific 200° (approximate) rotation protocol around the patient.
13-5-2-1 3D Spin Images Acquisition
• In Innova 3D mode, the rotation is performed at 40°/s, at a frame rate of 30 fps, providing approximately 150
images in a 5 seconds acquisition.
• In Innova Subtracted 3D mode, two rotations, "Mask" and "Contrast" are performed at 40°/s, at a frame rate of
30 fps, and provide approximately 300 images in approximately 20 seconds.
• In Innova CT mode, 3 rotation speeds are available: 40°/s, 20°/s and 10°/s, also at a frame rate of 30 fps,
providing approximately 150 images, 300 images or 600 images respectively. Using more views allows to
improve the visualization of bones and soft-tissues.
Note: As the source images are acquired during the 3D spin, several detector and processing corrections are
applied and tuned to optimize resulting 3D image consistency during reconstruction. This process may result in
the presence of certain anomalies visible while reviewing the source images. The potential anomalies may
include a horizontal line or contrast change across the middle of an image and/or image-to-image contrast
oscillations. In general these anomalies are generated by rapid corrections taking place to account for the
presence of raw radiation within the field of view during the spin. The degree of visibility of these anomalies will
depend on several factors related to the patient, system and geometry of the spin. These anomalies appear
solely in the 2D spin image and allow for an improved display of the 3D model.
13-5-2-2 Patient Positioning
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Using Fluoro in PA and Lateral projections, properly center the region of interest (ROI) at isocenter.
Special attention must be paid to the patient immobilization during the 3D Spin acquisition
sequence. Any patient motion during the fast rotation of the gantry could injure the patient.
It is advised, particularly if the patient is not anaesthetized, to use appropriate restraining
devices to completely immobilize the patient (head, arms, legs) in order to keep the patient,
and so the region of interest, perfectly still throughout the acquisition sequence. Any
patient motion will also reduce the quality of the images and the 3D reconstruction. Explain
the procedure to the patient and ask him not to move prior to performing a 3D spin images
acquisition.
Use appropriate collimation to limit patient radiation and cut raw radiation.
Note: Because contour filter blades can create artifacts on 3D models, blades are automatically parked as soon as
a 3D acquisition mode is selected.
13-5-2-3 On the Innova Digital Screen
For an Innova 3D acquisition, select the 3D acquisition mode in the Acquisition Mode tabs area. If the selected
protocol does not offer this choice, select another angio protocol from the Protocols.
For an Innova Subtracted 3D acquisition, select the 3D acquisition mode in the Acquisition Mode tabs area. If the
selected protocol does not offer this choice, select another angio protocol from the Protocols.
Select the acquisition parameters:

• Activate the "Subtraction" button.
• Auto/Manual injection with X-ray Delay.
• Normal/Low Record detail.
For an Innova CT acquisition, select the 3DCT acquisition mode in the Acquisition Mode tabs area.
Select the acquisition parameters:

• Rotation speed (selection available only in Innova CT from the Innova Console or the optional Innova Central
touch screen).
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• Auto/Manual injection with X-ray Delay.

• Normal/Low Record detail.
Use appropriate injection parameters (volume, rate, delay) in order that vessels are properly
opacified during the entire image acquisition phase.
13-5-2-4 Making an acquisition in 3D Spin

As soon as the 3D or 3DCT mode is selected, the Test button starts to blink on the right side of the TSSC and the
message "Ready for Spin Test" is displayed at bottom left of the live display.
Press and hold the Test button (14):

• The detector moves to maximum SID (119 cm/46.8").
• The gantry moves from its current position to the End of rotation position.
• All gantry axes are reinitialized.
• The gantry performs its test rotation at 15°/s from End to Start position.
On the Innova IGS 530, when using the "Soft Tissues" protocol, the SID is reduced to 108
cm (42.5") for 3DCT acquisition performed at 10°/s to optimize the visibility of soft tissues in
the brain. - Make sure that the table top is centered in lateral to avoid collision during the
gantry test rotation. - Use such protocols with reduced SID for intra cranial 3DCT
acquisition at 10°/s only.
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Make sure to clear the area before launching the procedure to avoid any activation of the
anticollision system that would abort the X-ray acquisition and injection.
Special attention must be paid to select the appropriate 3D spin mode for the current exam
(Innova 3D mode versus Innova Subtracted 3D mode) to avoid: - Unnecessary retake,
causing extra X-ray dose and injection to patient (when Innova 3D mode is selected instead
of Innova Subtracted 3D), - Or mechanical hazard to clinical staff arising from unexpected
gantry movement (when Innova Subtracted 3D mode is selected instead of Innova 3D).
At the end of the test rotation, the Test button goes Off and the message "Ready. Clear rotation area" is displayed
on the live display.
Note: From the beginning of the Test Rotation, all table and gantry axes are locked. Pressing on the Test button
after the completion of the Test Rotation will abort the 3D Spin set up and free all table and gantry axes. If needed,
the patient can be repositioned. A new Test Rotation is then required.
Press and hold the prep/expose Innova handswitch button:
Note: Except in case of emergency, this button must NOT be released during the entire 3D Spin
acquisition
• The first X-ray run, or Mask, starts at a speed of 40 degree/second. A message "Spin Acquisition in Progress" is
displayed in the bottom left corner of the live display.
• The gantry automatically goes back to the start position at a speed of 30 degree/second. A message "Returning
to Start Position" is displayed.
• The injection starts.
• The second X-ray run, Contrast, starts after the programmed x-ray delay. A message "Spin Acquisition in
Progress" is displayed in the bottom left corner of the live display.
• The review automatically starts subtracted at 30 fps. Mask, Contrast and Subtracted spins can be reviewed
separately.
Note: Stenosis Analysis is available on the subtracted images.
Note: The 2 spin of approximate 150 images ("Mask" and "Contrast") are concatenated into a single approximate
300 images sequence.
Note: Typical duration from the press of the exposure handswitch to the end of X-ray, is approximate 20 seconds
for an X-ray delay of 0 seconds.
When the gantry reaches the End position, X-ray are stopped and the Test button starts to blink again; the system
is ready for a new 3D Spin acquisition (new Test Rotation must be performed first).
All calibration data needed for the 3D reconstruction are saved with the images in the same sequence.
This will allow to reconstruct the 3D Spin acquisition anytime.
13-5-3 Image Network
After the 3D Spin acquisition is completed, acquired images are automatically transferred to the Advantage
Workstation.
Note: 3D images will always be sent to a predefined specific remote host (AW workstation).
Non 3D images will be sent to the remote host selected in the Host Selection screen.
3D images can be sent to 2 different hosts: the specific 3D host (AW workstation) and the host selected in the Host
Selection screen. In such case, the status of the 3D sequence in the DL Sequence Browser will change to sent
only after successful completion of the 3D sequence data transfer to both hosts.
13-5-4 3D Image Reconstruction
As soon as all acquired images are received at the Advantage Workstation, the 3D reconstruction is started
automatically.
Note: For detailed information on the use of the reconstruction software, refer to the Innova 3D XR Operator
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Manual.
13-5-5 3D Model Display
The 3D model of vessels and/or interventional devices can be analyzed using a range of 3D analysis tools
including:
• MIP (maximum intensity projection).
• Volume Rendering.
• MPVR (multi-planar volume reconstruction).
• Axial, sagittal, coronal and oblique cross-sections.
• Electronic scalpel and 3D shutter.
• Distance and volume measurements.
• Navigator (endovascular-like).
• Customized screen layouts for Innova 3D and Innova CT.
13-5-6 3D Image Archiving
The 3D model is saved as a DICOM object, and as such can be archived on a CD-ROM. This model can later be
reviewed on any Advantage Workstation with the Volume Viewer Plus software.
Additionally, the user can archive the spin acquisition on PACS, then at any time later retrieve and reconstruct a 3D
model from it.
Archiving of "screen capture" images that are created from the 3D model is also possible on a PACS.
13-5-7 3D Quick Guide
13-5-7-1 3D Acquisition
• Isocenter the region to be imaged using lateral and frontal fluoro.
• When using the 30/32 cm or 40 cm FOV, use appropriate collimation to avoid raw radiation, which can degrade
the 3D image.
• Use collimator blades as required, but as the 3D image might be slightly smaller than 2D image, make sure to
keep an appropriate margin by NOT collimating too tightly.
• For optimum vessel contrast, injection should be as selective as possible.
• Vessels should be completely opacified from the beginning of the injected spin until the end.
– X-ray delay: If a DSA series is available, use the "scale" button on the DL keypad to display the time line and
measure the delay between injection start and vessel completely filled. Enter this delay as X-ray delay.
– Injection parameters: select volume and flow rate such that the injection duration is equal to the
above-computed X-Ray delay plus 5 seconds rotation duration.
– As a guideline, injection parameters should be equal or inferior to the one used for an unsubtracted 3D.
Subtracted 3D enables automatic bone removal, one can expect same vessel segmentation and visibility
with volume of contrast product inferior to the one used for a no sub 3D.
• Any patient motion during either gantry rotations (mask and / or contrast spin) or in between those two rotations,
will degrade the 3D image quality causing artifacts such as streaks or blurring. Informing the patient about the
gantry rotation and instructing the patient not to move, and if possible not to breathe (approximately 20
seconds), during the entire 3D acquisition will help. In case of cerebral procedures, ask the patient to close
his/her eyes during the spin/s. If possible with general anesthesia, stop the respirator.
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"Non-Sub 3D" "Sub 3D"

Bone removal with subtracted 3D
• For intracranial vascular studies, it is recommended to use the 20 cm FOV to avoid the presence of skull in the
3D image. This simplifies the 3D processing on the AW and may require the skull to be manually removed.
13-5-7-2 3D reconstruction
• 3 modes are available to reconstruct 3D Spin images:
– To get optimum spatial resolution, reconstruct the 3D Spin using the "512" 3D volume size.
– To speed up the reconstruction keeping a very good spatial resolution, use the "Fast 512" 3D volume size to
reconstruct the 3D Spin. Reconstruction time is about 50% compared to "512" with a spatial resolution
slightly lower.
512 Fast 512
– In case of large amount of images to reconstruct or to get the shortest reconstruction time, reconstrut the 3D
Spin using the "256" 3D volume size. Reconstruction time is about 12% (8 time less) compared to "512" with
the lowest spatial resolution.
• Reconstruction filters
– Vascular: primary choice is None, Bone filter enhances 3D vessel sharpness but increases noise in
cross-section.
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– Bones: primary choice is Bone kernel.

– Low, Medium or High smoothing filter is to be used only in 256 to average the noise and increase contrast
visibility in soft tissues.
• For 512 reconstruction in the abdomen, do not use "Bone" if your main interest is to look at Volume Rendering
images (and not to look at cross-sections).
• For the abdomen, 256 reconstruction might be a good option if your main interest is to look at Volume
Rendering images:
– Faster reconstruction time.
– Less noise in the Volume Rendering images.
• For Volume Rendering purposes, 512 Low Smooth and 256 Bone seem almost equivalent, so 256 Bone is
recommended (because much faster than 512 Low Smooth).
• How to control the "noise" in a 3D Volume Rendering image:
13-5-7-3 3D display
• When looking at a 3D image, keep in mind that it is a reconstructed image which may also contain
reconstruction artifacts. Always compare a 3D image with other patient data in case unexpected structures are
discovered.
• When using scalpel, select only the 3D images you are working on, otherwise black areas will be created in
cross-sections.
• A fast way to isolate and display a ROI is to use the Sphere Shutter (adjust shutter diameter as required) or the
Box Shutter.
• On cross-section images, a large slice thickness (between approximately 5 mm and a few centimeters)
improves vessel visibility.
• Influence of "VR Opacity" on the 3D image.
512 Bone, Opacity 30% 512 Low Smooth, Opacity 60%
A Higher VR Opacity will provide smoother vessels, but will also increase the visibility of undesired structures
(bone, etc).
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512 None, Opacity 60% 256 Bone, Opacity 60%
512 None, Opacity 30% 256 None, Opacity 30%
256 High Smooth, Opacity 60%
• When performing measurements, it is better to drop points on a cross-section of minimal thickness than on a 3D
view. For measuring vessel diameter, the cross-section must be orthogonal to the vessel.
• How to create a cross-section orthogonal to a vessel:
– The wrong way to do it:
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Oblique cross-section
which is not necessarily
orthogonal to the vessel
axis (because in 3D the
vessel is not necessarily
parallel to the plane of
the screen).
MIP or VR image
– A right way to do it:
MIP or VR image
1st Oblique cross- 2nd Oblique cross- Oblique cross-
section parallel to section perpendicu- section orthogonal
the vessel axis lar to the vessel ax- to the vessel axis
is
• Reminder: How to measure a distance in V V

– When in Volume Viewer, there are two ways to measure a distance:
– When "projection (2D)" is selected, points are dropped in a plane and result refers to the distance between
these points in the same plane.
– When "from volume (3D)" is selected, points are dropped in the space along a virtual line. Points are
dropped at the intersection of these virtual lines with any anatomy found. Result refers to the distance
between these 2 points which can be located in different planes.
– The same visual distance between both points can display two completely different results.
- "2D" displays the length of the segment visualized on the image
- "3D" displays the length of the segment drawn in the space. In fact, the 3D segment is going from the small
vessel located on the front of the image to the large vessel located in the background of the image. This
oblique segment is much longer than it seems.
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Recommendation is to use a cross section view to measure a distance.

In case the measurement is performed on a 3D view, using "projection (2D)" will give the exact
length of the segment visualized.
13-5-7-4 Subtracted 3D Reconstruction and Display
Single or multiple volume reconstruction and display can be selected.
The "Mask" volume will be useful to see any implanted device such as a stent, coils, or clips.
The "Subtracted" volume will enable injected vessels while removing both background anatomy and implanted
devices. Depending on clinical purpose, the comparison or merge of the information brought by both volumes can
bring added value as illustrated on the three cases below:
Angio: analysis of stent deployment
"3D Mask" "Plaque and Stent"
"Non-Sub 3D" "Sub 3D" "Sub 3D Merge" with Plaque and

Stent
Oncology: Quality control after PVE
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"Non-Sub 3D" after PVE Glue only (from mask) Vessels only (from "Sub 3D")
"Sub 3D merge"
"Drag & Drop" merge showing glue
and vessels
Neuro: analysis of coiled aneurysm
"Non Sub 3D" "Sub 3D" "Sub 3D Merge"

Drag and Drop merge showing coils
14 How to review a Sequence/Photo

14-1 Sequence/Photo Viewer
Note: If you have an active patient's exam started (seen by the "Ready" displayed at top right corner of Digital
screen), you can only review the sequences that have been acquired on the current patient.
• Click on the [Patients] tab. This brings the PATIENT BROWSER.
• Select the patient you want to review by clicking on it once.
• Click on the [Exams] tab. This brings the EXAM BROWSER of the patient you have selected.
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Exam Browser
If there is more than one Exam available for the patient, both of them can be reviewed from the Sequence Browser.
To activate this function, highlight the desired exams to review by holding down the Control key and clicking on
them with the mouse.
• Select the exam you want to review and double click on it. This brings up the SEQUENCE BROWSER window
and automatically launches the review of first sequence.
Sequence Browser
• In the SEQUENCE/PHOTO BROWSER window, double click on any sequence/photo that you wish to review.
A Sequence name is displayed on the image in the upper right corner during review.
The Review icon is displayed on the left side of the live display as soon as the review is launched to
show that the displayed image in review was previously recorded.
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, , , are also displayed at the bottom right of the Live display to show that the displayed
image is either a previously recorded or stored fluoroscopic image reviewed in Play or Paused mode (review in
loop or frozen image).
If there are no Sequences acquired at this time, the Browser will be blank. As each Record Sequence is stored to
the digital disk, a new icon will appear with the number of the sequence.
A single click on a Sequence icon only activates it for other processing. The icon will be highlighted to indicate that
it has been selected. Selection can be for the following:
1. Name - Each Sequence can be named up to 8 characters. A menu window will open displaying a predefined
list. Adding or deleting from this list is allowed.
Sequence naming can be performed during Fluoro or Record acquisition.
2. Delete - this will delete the Sequence from the digital disk. It can not be retrieve after the OK for deletion has
been accepted. Multiple sequences can be deleted at a time by holding down the Control key and clicking on
each icon with the mouse. If a Sequence is deleted from a list, the numbering of the other ones is not changed.
3. Network - this will start the transfer of the Sequence to the Network. Multiple sequences can be networked at a
time by holding down the Control key and clicking on each icon with the mouse.
Sequence network can be initiated during Fluoro or Record acquisition.
If the Sequence icon has a Yellow box around it, this indicates that this is the Sequence that is presently being
reviewed.
Review of the Sequence can be accomplished by using the Keypad, Remote control or the Digital console and
mouse. None of these are active during an exposure.
Note: Reviewing images at frame rates higher than acquisition frame rates will cause some frames been skipped
during display.
Photo Browser
• In the PHOTO BROWSER window, double click on any photo that you wish to review.
A Photo name is displayed on the image in the upper right corner during review.
If there are no Photos stored at this time, the Browser will be blank. As each Photo is stored to the digital disk, a
new icon will appear with the number of the sequence. During an exposure, a message will appear "Acquisition in
Progress" on the Digital console. A single click on a Photo icon only activates it for other processing. The icon will
be highlighted to indicate that it has been selected. Selection can be for the following:
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1. Name - Each Photo can be named up to 8 characters. A menu window will open displaying a predefined list.
Adding or deleting from this list is allowed.
Photo naming can be performed during Fluoro or Record acquisition.
2. Delete - this will delete the Photo from the digital disk. It can not be retrieve after the OK for deletion has been
accepted. Multiple Photos can be deleted at a time by holding down the Control key and clicking on each icon
with the mouse. If a Photo is deleted from a list, the numbering of the other ones is not changed.
3. Network - this will start the transfer of the Photo to the Network. Multiple photos can be networked at a time by
holding down the Control key and clicking on each icon with the mouse.
Photo network can be initiated during Fluoro or Record acquisition.
If the Photo icon has a Yellow box around it, this indicates that this is the Photo that is presently being reviewed.
Review of the Photo can be accomplished by using the Keypad, Remote control or the Digital console and mouse.
None of these are active during an exposure.
15 How to End an Exam

When all Fluoro and Record acquisitions are no longer required, select END EXAM in the upper right corner of the
SEQUENCE BROWSER screen or on the Innova Central Touch Screen. After this:
1. No exposures can be made.
2. The READY message will disappear.
3. The image graphics on the live and reference display are erased.
4. The image monitor will be blank.
At this time, any patient's images can be viewed on the Digital.
If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting system and DICOM MPPS is
enabled, the End Exam notification is sent to that system using "MPPS Completed" message.
If the Innova system is connected to a DICOM Dose Structured Report Receiving system and some exposures is
taken, the Dose Information will be exported to that system at End Exam.
16 How to Abort an Exam

If DICOM MPPS is enabled in Innova, when a wrong exam is started and need to be aborted, select ABORT EXAM
in the upper right corner of the SEQUENCE BROWSER screen.
After this:
1. No exposures can be made.
2. The READY message will disappear.
3. The image graphics on the live and reference display are erased.
4. The image monitor will be blank.
At this time, any patient's images can be viewed on the Digital.
If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting system, the Abort Exam notification
is also sent to that system using "MPPS Discontinued" message.
If the Innova system is connected to a DICOM Dose Structured Report Receiving system and some exposures is
taken, the Dose Information will be exported to that system at Abort Exam.
17 Stenosis Analysis (Option)

Stenosis Analysis (SA) application allows for an estimation of distances (for instance vessel size at the Stenosis
position) and a Stenosis ratio by a trained user. It can be used to help an experienced physician assess lesion
lengths.
Innova Digital 337

THE STENOSIS ANALYSIS FUNCTION IS A REFERENCE TOOL ONLY AND IS NOT

INTENDED AS A MEANS OF MAKING A DIAGNOSIS.
While the SA calculations take into account all available information, it should be kept in mind that these results are
provided only as estimates to help the diagnosis, not as reliable measurements. In particular, the results are not
robust to a number of factors including (but not restricted to) the followings:
• Mistake on the effective distance between the object to measure and the table top leading in the entry of an
inaccurate value for the automatic calibration.
• Use of autocalibration on images acquired in full lateral view.
• Mistake on the effective size of the catheter (error in the entry, error on the catheter labeling) or other user
inputs (points clicked).
• Significant error (more than +/- 4 cm) on the location of the artery above the table (in case of autocalibration on
some systems).
• Catheter and vessel not in a same plane parallel to the detector plane.
• Measurement of objects in an axis not parallel to the detector plane.
• Bad positioning of catheter contours when using catheter calibration.
• Bad positioning of vessel edges.
• Conic deformation of X-ray beam when calibrating on or measuring objects not centered in the image.
• Exceptional failures in the positioner geometry measurement system.
• Patient motion during the sequence or between sequences.
• Vessel geometry affected by temporary changes (spasm, over-sizing due to medication…).
Therefore, special care should be taken when using the application in a diagnostic or interventional context -
displayed results should be confronted to other sources of information - including (but not restricted to) personal
assessment of practitioner and visual check - before taking a decision based on the data.
To get analysis results expressed in mm, Stenosis Analysis can be performed using either the autocalibration or
the catheter calibration. In case of use of catheter calibration, the empty catheter and the vessel to analyse must be
present in the same sequence.
The empty catheter must be in the vessel to analyse and at the same level as the lesion to
quantify, else the measurement results displayed will be wrong. See Innova Digital /
Stenosis Analysis (Option) / Calibrating on a Catheter Diameter.
Note: Before starting acquisition, exit the Stenosis Analysis (SA) application to have access to the display of the
X-ray technique factors on the INNOVA Digital Screen.
17-1 Analysis Limitations
The software will not allow analysis under the following conditions:
• Image type is not the original acquired image (i.e. photos cannot be used to perform an analysis).
• Some functionalities only work in the following conditions:
– Stenosis quantification can be used on Dynamic, subtracted DSA, subtracted Bolus and subtracted 3D
images only (not available on InnovaChaseTM, 3D/3DCT images and Cardiac images acquired using a Field
of View larger than 20 cm).
Multi-segments and Distance Measurement functionalities are always available.
Note: Stenosis quantification and Distance measurement cannot be performed on Fluoro image: Fluoro LIH and
Fluoro sequence created using the Fluorostore function. In such case, a pop up will be displayed and the
application will fail.
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17-2 Stenosis Analysis at a Glance

Using the Stenosis Analysis application to calculate stenosis size involves the activities summarized below.
• Select Study Image.
• In case of catheter calibration:
Review patient loops and select two image-frame:
– The one that most clearly shows the empty catheter
– The one that most clearly shows the stenosis of interest.
Calibrate System to Catheter Diameter.
Here you tell the system what size of catheter you are using, and then place 2 points within the
catheter to define the section for diameter detection.
The system uses the known catheter diameter to calculate screen pixels per millimeter.
This metric is used later in calculating stenosis size.
• Stenosis Quantification; available for Dynamic, subtracted DSA, subtracted Bolus and subtracted 3D images
only (not available on InnovaChaseTM, 3D/3DCT images and Cardiac images acquired using a Field of View
larger than 20 cm).
Place 2 points or more within the vessel from the proximal to the distal part of the stenosis to define the section
for automatic detection. The system determines the narrowest lesion width compared to the reference diameter,
and then calculates stenosis percentages.
• In case of automatic calibration:
Enter object to table top distance as requested or use default proposed value (15 cm for Cardiac image; 8 cm
for Angio image).
• System calculates stenosis and displays report; available for Dynamic, DSA, Bolus and subtracted 3D modes
only.
You'll be given the option of saving the results electronically. When the report is saved electronically, it's added
in the Photo Browser as a normal photo.
17-3 Performing Stenosis Analysis
• Once need for analysis has been established, select the desired sequence from the SEQUENCE BROWSER
and begin playback.
• Review the images that most clearly show the stenosis of interest (and the catheter if needed).
• Click the Stenosis Analysis button on the SEQUENCE BROWSER to start the analysis.
The Stenosis Analysis button can be selected while in a review or paused mode.
If selected during a review, it will stop and then:
• The Stenosis Analysis icon will appear on the left side of the live display indicating that Stenosis Analysis is
active.
• The selected image and the Stenosis Analysis toolbar will appear on the flat panel.
Note: Any X-ray acquisition will exit the Stenosis Analysis application.
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Stenosis Analysis Button
Stenosis Analysis Window
17-4 Reference Description for Stenosis Analysis Toolbar
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The functions provided by the Stenosis Analysis Toolbar are:
1 Autocalibration
2 Catheter Calibration
3 Stenosis Quantification
4 Show/Hide Results
5 Hide Contours
6 Show Real Contours
7 Show Real and Ideal Contours
8 Multi Segments
9 Measure Distance
10 Zoom Image
11 Store Photo
12 Exit
17-5 Calibrating on a Catheter Diameter

Calibration measures the pixel size at the vessel plane perpendicular to the X-ray beam by using a catheter as a
calibration device.
The user gives the external diameter of the catheter, which is supplied by the manufacturer (usually in French), and
then indicates a portion of the catheter visible on the image.
The system automatically detects the external diameter of the catheter and computes the calibration factor for this
acquisition and its associated accuracy. The calibration factor is reliable for all objects located at the same plane
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(+/- 1.5 cm) as the catheter and for all the images acquired with the same geometric parameters of the X-ray
system.
The catheter calibration can be performed on cardiac images or non-subtracted digital angiographic images. If in
subtracted mode, the application will switch automatically to non-subtracted mode when clicking on the catheter
calibration button. Automatic catheter detection may not work on subtracted frames.
The imprecision displayed below the calibration factor is the estimated confidence interval around the result
returned by the application (in %).
For example, if you get a calibration factor of 0.1 mm/pixel with an imprecision of 10%, it means that the real factor
is between 0.09 mm/pixel and 0.11 mm/pixel.
17-6 How to achieve an accurate catheter calibration
• Select a frame where the catheter is completely empty: no contrast media and no guide-wire or any kind of tool.
Guide Line:
Always calibrate on a completely empty catheter
Watch the imprecision percentage displayed in the calibration result box: if higher than 20%, select another
frame and redo the calibration in order to get the lowest imprecision as possible.
• Enter the exact size of the catheter used.
The catheter must be at the same distance from the detector than the vessel to be measured.
A difference in distance of 5 cm may cause a 5% error in the vessel dimension. The catheter
must be as close as possible to the vessel to be measured in the image.
Reject those, which do not fit the external edges of the catheter.
• Select a catheter segment long enough (at least 2 cm on the screen) in the straight section of the catheter.
• Examine carefully the traced contours.
• Steps to calibrate a catheter
• Click on the icon for Catheter Calibration (2) on the Stenosis Analysis Toolbar.
The Input the Catheter Size dialog box appears.
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A preloaded 10 lines catheter list is available from the Catheter list.

Default catheter names are between "Standard 3 French and Standard 9 French".
In the Input the Catheter Size dialog box, select one of the existing catheters from the catheter list, and click on the
OK dialog button. To quit the dialog box without any change, click Cancel.
• If you do not find a catheter in the list with the appropriate size, define your own catheter and add it to the
catheter list. Just enter the name of the new catheter in the Catheter Name field, specify the catheter size in
either one of the two Catheter Size fields, and click on the Save Catheter dialog button. The minimum and the
maximum value that can be saved for a catheter is 3 F (1 mm) and 9F (3 mm), respectively. Both size fields are
synchronized.
• It is also possible to use a catheter size without saving it. Enter the catheter size into the Catheter Size box and
click OK.
• To delete a catheter from the list, select the intended catheter in the Catheter list and click on the Delete
Catheter dialog button.
• To sort the catheter list by catheter name or catheter size in ascending or descending order, click on one of the
dialog box located on top of the list, either Catheter Name or Size.
Note: To get the mm measurement of a catheter, divide the catheter French size by 3. Example: a 6 F catheter
divided by 3 = 2 mm.
Note: The catheter list is sorted by catheter size from the smallest (3 F) to the largest (9 F).
In all cases, you should ensure that the calibration was performed using the appropriate catheter size by checking
the Object Size displayed in the calibration result box at anytime a sequence is calibrated
Stenosis Analysis application shall only be used with catheter between 3 and 9 French (1-3
mm). Also, depending of the manufacturer, the given product catheter size may not be
accurate, else the measurement results displayed will be wrong. In such case, you may
possibly want to customize your catheter sizes. In all cases, it is recommended to check the
displayed catheter size before accepting the calibration results.
• Place two points within the catheter, as close as possible to the end but not on a curve, to define the section for
diameter detection.
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• The system automatically finds and displays the catheter edges. The "Confirm the catheter detection" message
appears.
BEFORE ACCEPTING ANY CALIBRATION BY CLICKING ON OK, IN THE "CALIBRATION

RESULTS" POP-UP WINDOW, ALWAYS DOUBLE-CHECK CATHETER SIZE DISPLAYED IN
THE "CALIBRATION RESULT" GREY BOX, ON THE DL SCREEN.
THE AUTOMATIC EDGE DETECTION PROGRAM WILL SHOW THE DETECTED BORDER OF
THE CATHETER. YOU SHALL CHECK THAT THE EDGES BEING DISPLAYED ARE
MATCHING THE CATHETER BORDER BEFORE ACCEPTING THE CALIBRATION RESULTS.
IF THE MATCHING IS NOT ACCURATE, PLEASE CANCEL AND RESTART A NEW
CALIBRATION.
17-7 Stenosis Quantification (available for Dynamic, subtracted DSA, Bolus and
The basic principles of this functionality are the automatic detection of the vessel edges in a selected portion of the
artery, then the quantitative measurement of the vessel length and diameters along the selected segment.
The application is able to quantify vessels up to 5 mm on Cardiac images acquired on Dynamic mode with FOV
less than or equal to 20 cm and vessels up to 50 mm on subtracted DSA, Bolus and subtracted 3D images.
The contrast media used to differentiate the vessels from the patient background must be radio-opaque (iodine) so
that vessels appear as dark structures with respect to the background. Quantification is not applicable on
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radio-transparent opacification (CO2).

The user has the option of placing only two points to start the automatic detection. For a tortuous vessel or one that
is very close to another one, more points will increase the precision on the stenosis vessel path.
• Pick the image that best shows the area of interest.
The user shall select the frame containing the vessel to be quantified before clicking on the Stenosis Analysis
button in the SA toolbar.
• From the Stenosis Analysis Toolbar, click on the Stenosis Quantification button (3).
Guidelines appear in the dialog area, left of the screen:
• Place two or more points within the vessel from the proximal to the distal part of the stenosis to define the
section for automatic detection. Double click the last point to start the calculation and get the results. To move a
point, drag it with left mouse button. To delete a selected point, press the Delete key.
Note: The ability to accurately measure a vessel can be hindered by:
• The presence of a stent or guiding catheter in the vessel.
• A calibration or quantification performed on edge or corner of the image (conic deformation of X-ray) can
degrade the accuracy by up to 7.5%.
17-7-1 In case of Auto-calibration
• If the image is not calibrated, the Auto-calibration dialog box opens asking you to enter the "object to table top
distance".
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The goal of auto-calibration is to allow the software to compute the pixel size in a given image without using any
kind of reference object. Auto-calibration is entirely based on the known geometry of the imaging system. The
only parameter that the user has to specify is the Object to Tabletop distance defined as being the shortest
distance between the center of the object to be measured and the top of the table.
As opposed to catheter calibration, auto-calibration is available only after a region of interest has been defined
in the image. It means that auto-calibration can be launched only after vessel contours or segments are drawn
in the image.
Calibration results are automatically saved at the sequence level. If you launch the application on a previously
calibrated sequence, the calibration information will also be loaded as well as the sequence itself.
Enter the object (vessel) to table top distance or use the default value (15 cm for Cardiac image; 8 cm for Angio
image), then click OK to get results in metric units.
THE OBJECT (VESSEL) TO TABLE TOP DISTANCE IS DEFINED FROM THE TOP OF THE
TABLE TOP AND NOT FROM THE TOP OF THE MATTRESS. IF THE DISTANCE ENTERED
DIFFERS FROM THE ACTUAL DISTANCE, THE RESULTING MEASUREMENTS WILL BE
INACCURATE OF ABOUT 1% PER CENTIMETER OF DIFFERENCE.
In case a new auto-calibration is needed, after points were dropped, it is always possible to launch it manually
pressing on the Auto-calibration icon (1) on the Stenosis Analysis toolbar.
Upon completion of auto-calibration, Stenosis Analysis report is displayed with the computed results.
Notes: To accurately measure a vessel, note the followings:
• Input the correct distance the anatomy is from the table top.
• The greater the gantry angulation towards a lateral position, the higher the imprecision result will be. Avoid
using Auto-calibration for lateral images; use catheter calibration instead.
• Always take into account the imprecision displayed with each measurement.
17-7-2 In case of Catheter Calibration
IN CASE OF USE OF CATHETER CALIBRATION, THE QUANTIFICATION MEASUREMENTS

SHALL ONLY BE TAKEN INTO ACCOUNT WHEN THE CATHETER USED FOR CALIBRATION
AND THE QUANTIFIED VESSEL ARE IN THE SAME PLANE, PLANE THAT SHALL BE
PARALLEL TO THE FLAT PANEL DETECTOR. ANY OTHER CASES WILL LEAD TO
UNDERESTIMATED IMPRECISION.
Note: The ability to accurately measure a vessel can be hindered by a table panning between frame used for
catheter calibration and frame used for quantification (increase the risk of catheter and vessel not in the same
plane).
Situations such as described above will result in additional inaccuracy that will not be taken into account by the
algorithm. So, the percentage of imprecision linked to results will be underestimated and will not reflect reality.
17-8 Stenosis Quantification Results (available for Dynamic, subtracted DSA, Bolus and
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Stenosis Quantification Results Box
Vessel Profile Box
The Results Box displays results of stenosis quantification and their imprecision.
The imprecision displayed after each measurement is the estimated confidence interval around the result returned
by the application (in mm).
For example, if you get a Reference Diameter of 2 mm ± 0.2 mm, it means that the real reference diameter is
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between 1.8 mm and 2.2 mm.

The Vessel Profile Box shows the detected vessel diameters in mm versus the distance in mm along the vessel
path from the beginning of the vessel portion. The profile corresponds to the vessel portion between the first and
the last point entered by the user.
Once the calculation is finished and the results are displayed, you have several options on how to modify the
results. In the Profile box, click and drag on any line to modify the placement. The edge detection of the vessel will
be drawn in yellow. It will fill in where the vessel is over or under sized.
STENOSIS ANALYSIS SHALL NEVER BE TAKEN AS LITERAL PROOF, BUT SHALL BE

DOUBLE CHECKED BY THE PHYSICIAN. STENOSIS ANALYSIS IS A REFERENCE TOOL
ONLY AND IS NOT INTENDED AS A MEANS OF MAKING A DIAGNOSIS.
• Decide if the Reference segment is placed in the best area to represent the normal vessel size. If not, from the
vessel profile, grabbing the black dot, move the segment to the desired area. Do the same with the stenosed
segment representing the tightest lesion narrowing.
• Move the same way the lesion length segments (proximal and distal) to best represent the area of interest.
• Other modifications can be done to the drawing using the Stenosis Analysis Toolbar.
• Show/Hide Results (4) will remove and redisplay the Result and Profile windows.
• Hide Contours (5) will remove the vessel drawing temporarily. By clicking on icon (6) or (7), the drawing will be
returned.
• Show Real Contours (6) displays only the stenosis contours and will redisplay the vessel drawing if removed
with Hide Contours.
• Show Real and Ideal Contours (7) displays the stenosis contours and the plaque area and will redisplay the
vessel drawing if removed with Hide Contours.
Note: Hide and show the contours to visually verify the adequation between the edges detected and the actual
vessel shape.
• To edit stenosis contour, right-click on any part of the contour. A line of seven crosses will appear on the edited
contour area. Grab and move any points within this area to modify the contour. Double click with left button to
confirm your modification. Each side of the stenosis can be edited separately.
• Zoom Image (10) will enlarge the image to double size in both directions. Click on it again to go back to the
normal display.
• Store Photo (11) will save the SA results as a photo image in the Photo Browser. You will be asked to select
whether this is a Pre- or Post- Interventional frame, and you might indicate the concerned region of interest,
which will be displayed at the bottom of the taken photo.
• Exit (12) will close the Stenosis Analysis window. No Stenosis Quantification results will be saved except by
using the Store Photo function.
17-9 Measure Distance
Distance Measurement is used to obtain up to 7 length only between two points and their ratio.
Click on the Measure Distance button (9) to activate the function.
Measuring a length:
• Position the cursor at the beginning for the first point and click. Move the mouse and draw the line to the second
point and click. A length will be displayed.
• A maximum of 7 lengths can be displayed with their ratio relative to the first length measured taken as
reference.
Note: The objects to measure may not be in a plane perpendicular to the X-ray beam. Then, foreshortening in the
length measurement may happen. The software is not able to detect or correct foreshortening. It is the user
responsibility to interpret the results of the Distance Measurement function.
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WHEN DRAWING A SEGMENT ON AN UNZOOMED FRAME, THE USER SHALL ENSURE HE

DOESN'T MAKE AN ERROR OF MORE THAN 1 PIXEL FOR EACH POINT DEFINED.
The imprecision being displayed for each segment take into account a 1 pixel error for each click, no more. Also,
when the distance is displayed in pixels, it is always displayed based on the non-zoomed image, even if zoomed.
Note: The Ratio between the segments is computed without taking into account the imprecision link to calibration
or user error when clicking points. If the user error is at max 1 pixel for each segment, Ratio imprecision is less than
10.5% starting with 20 pixels segments. User shall be very careful with Ratio results taking into account smaller
segments.
17-10 Multi Segments
Clicking on the Multi Segments Icon (8) will allow to drop more than 2 points and to display the total length between
the first and last point.
ENSURE THAT THE MEASURED OBJECT IS IN THE SAME PLANE AS THE CATHETER,
PARALLEL TO THE DETECTOR AND TAKE INTO ACCOUNT THE IMPRECISION FOUND
AROUND THE CALIBRATION FACTOR.
Note: Only one Multi-segments can be displayed at a time.
17-11 Innova OneTouch QA (option available on the optional Innova Central touch
screen)
Using the Review Tab of the Innova Central touch screen located at table side, it is also possible to launch the
Stenosis Analysis application.
From the Review tab, select Stenosis Analysis (SA) to enter the application.
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The most useful functions are available to quantify a vessel or measure a distance.
Note: Only Autocalibration is available at table side. In case of catheter calibration required, perform the calibration
from the control room console.
Launch the transfer of the image displayed on the live display in the Innova Central touch screen.
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After the completion of the transfer, the central part of the image appears on the Innova Central touch screen.
And the displayed Region Of Interest (ROI) is visualized on the live display.
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Use the Innova Central touch screen joystick to roam the image:
• Tilt the joystick left/right to see further left/right (the viewport moves left/right, the image moves toward right/left).
• Tilt the joystick up/down to see further up/down (the viewport moves up/down, the image moves down/up).
The location of the ROI visualized on the live display always matches the image displayed on the Innova Central
touch screen.
Use the Zoom/Roam functions to better visualize and center the part of vessel to quantify.
The Zoom button on the Innova Central touch screen switches zoom state on both images, Innova Central touch
screen and live display.
Drop points apart of the stenosis to quantify from proximal to distal by just touching the vessel (at least 2 points
must be dropped).
All dropped points can be deleted by using the Delete All Points button.
One single point can be selected by just touching it, moved by just dragging it or deleted by pressing on the Delete
Selected Point button.
After all points are dropped, press on the OK button to launch the quantification.
After completion of the quantification, results are displayed on the live display.
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The image can be zoomed using the Zoom button and roamed using the Innova Central touch screen joystick.
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The Calibration Result window can be hidden by pressing on the Show/Hide Calibration button.
Note: The Stenosis Analysis Results and Vessel Profile windows cannot be hidden.
Vessel diameters along the vessel can be moved by using the Move Diameter button.
Select the diameter which needs to be moved by selecting either "Reference", "At Stenosis", "Lesion Start" or
"Lesion End".
The selected diameter is highlighted on the live display. Tilt the Innova Central touch screen joystick right/left to
move the selected diameter. When the optimum position is found, select another diameter or press the Move
Diameter button again to end diameter movement.
As for Stenosis Quantification, launch the transfer of the image displayed on the live display in the
Innova Central touch screen.

After the completion of the transfer, the central part of the image appears on the Innova Central touch screen.
If needed, zoom and roam the same way as for Stenosis Quantification by using the Innova Central touch screen
joystick.
Drop points (at least two) by touching the image displayed on the Innova Central touch screen. All points or
selected point can always be deleted.
Select a point by touching it and drag it in the image to move it.
Press the OK button to end the drawing.
If needed, select one of the preloaded Object to table top distance from the pull down list.
Select the Contours key and then one of the predefined displays from the pull down list. This function
is only available after a Stenosis Quantification has been performed.
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When possible, allows to toggle between Sub and NoSub image display.
When available, allows to display or not the calibration result window.
During a vessel quantification, allows to move the "Reference" or "At Stenosis" or "Lesion Start" or
"Lesion End" vessel diameter.

Allows to zoom/unzoom images displayed on the Innova Central touch screen and live display. During
stenosis quantification, the image displayed on the Touch Screen can be roamed by using the Innova Central touch
screen joystick.
Allows to exit from the in-room Stenosis Analysis application (in-room SA).
After In-room Stenosis Analysis is launched, it is always possible to launch the review of the selected sequence or
of another one from the control room console. In such case, the pop up below is displayed:
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Click on "Cancel" to continue the in-room Stenosis Analysis application.

Click on "Exit" to exit from the in-room Stenosis Analysis application.
Double click again on the sequence to review in the Sequence Browser to launch the review.
While In-room Stenosis Analysis is on going, it is also possible to continue the analysis from the control room. Click
the "Stenosis Analysis" button on the Control room. The pop up below is displayed:
Click on "Cancel" to continue the in-room Stenosis Analysis application.

Click on "Exit" to exit from the in-room Stenosis Analysis application.
Click on "Switch" to switch the Stenosis Analysis application on the Control room console to continue the analysis.
18 Ventricular Analysis (Option)

Ventricular Analysis (VA) is an application designed for analyzing and quantifying the left ventricle (LV). The user
can perform two types of quantification: Global Ejection Fraction (GEF) analysis and Wall Motion (WM) analysis.
The output of the Global Ejection Fraction quantification provides the user with information on left ventricle volumes
and the ejection fraction. This set of information gives the user a good idea about how well the entire left ventricle is
functioning.
From the results of Wall Motion analysis, the user can estimate the adequacy of blood supply to each distinct
region of the left ventricle.
In addition to these two major functions, a "Multi-segments" feature allows to draw a multi-segment line to estimate
segments lengths.
VENTRICULAR ANALYSIS IS ONLY AN ESTIMATION TOOL, AND IS NOT INTENDED AS A

MEANS OF MAKING A DIAGNOSIS.
Note: Ventricular quantification and Distance measurement cannot be performed on a fluoro image such as Fluoro
LIH or a fluoro sequence created using the Fluorostore function. A message will be displayed and the application
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will fail.
Note: Before starting acquisition, exit the Ventricular Analysis (VA) application to have access to the display of the
X-ray technique factors on the INNOVA Digital Screen.
Contrast media
For ventricular analysis to be successful, the contrast media injected in the left ventricle should have enough
volume to fill the entire ventricle during multiple cardiac cycles and to visualize the end diastolic and end systolic
phases of the cycles.
Quantification
Based on the end-diastolic and end-systolic contour of the left ventricle defined manually by the user, Ventricular
Analysis provides a means to perform Wall Motion (WM) and Global Ejection Fraction (GEF) calculations. Wall
Motion analysis is built upon the Sheehan's centerline method. Global Ejection Fraction analysis provides results
calculated with both the Simpson's rule method and the Dodge-Sandler Area-Length method.
18-1 Ventricular Analysis at a glance
Using the Ventricular Analysis application involves the five activities summarized below.
1. Select study image.
Review patient LV-gram.
2. Launch Ventricular Analysis application.
The VA application can be launched while in review or paused.
3. Select two frames and manually draw LV contour:
The one that most clearly shows the end of Diastolic contour.
The one that most clearly shows the end of Systolic contour.
4. Generate the Global Ejection Fraction and Wall Motion report.
On application request, enter the object to tabletop distance (or use default value) to perform the automatic
calibration. The distance entered shall be determined from the center of the measured object to the top plane of
the table without mattress.
5. Save the GEF and WM report.
When the report is saved, it is added in the Photo Browser as a standard photo.
18-2 Performing Ventricular Analysis
1. Once need for analysis has been established, select the desired sequence from the SEQUENCE BROWSER
and begin playback.
2. Review the images that most clearly show the end of Diastolic and end of Systolic contours.
3. Click the Ventricular Analysis button on the SEQUENCE BROWSER to start the analysis.
The Ventricular Analysis button can be selected while in a review or paused mode.
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If selected during a review, it will stop and then:

• The Ventricular Analysis icon will appear on the left side of the live display indicating that Ventricular Analysis is
active.
• The selected image and the Ventricular Analysis toolbar will appear on the flat panel.
Note: Any X-ray acquisition will exit the Ventricular Analysis application.
18-3 Reference description for Ventricular Analysis Tool Menu
The functions provided by the Ventricular Analysis tool menu are:
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1 Auto-calibration select to manually launch a new autocalibration

2 Draw Diastole select to start to draw End-Diastolic Contour
3 Delete Diastole select to delete the Diastolic contour
4 Draw Systole select to start to draw End-Systolic Contour
5 Delete Systole select to delete the Systolic contour
6 Show/Hide contours select to show/hide graphics/reports already performed on the image
7 Generate GEF report select to launch the Global Ejection Fraction report
8 Generate WM report select to launch the Wall Motion report
9 Multi-segments select to draw a multi-segment line and get length measurements
10 Store photo select to save the image/graphic/report as a standard photo
11 Exit select to exit from the Ventricular Analysis application
18-4 Draw Diastolic Contour

Using the Play/Pause and/or Next/Previous Frame keys, select the frame which most clearly shows the end of
Diastolic contour.
Click on the icon Draw Diastole (2) on the Ventricular Analysis tool menu.
Following the instructions in the hint window, enter the points of the diastolic contour by clicking with the left mouse
button. The LV diastolic contour shall contain at least 3 points.
Each point entered is represented by a yellow cross.
The application builds up the LV diastolic contour by connecting the user-specified LV edge points using a bicubic
spline interpolation. The diastolic contour is represented by a red curve.
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To edit a point already entered, move over the point, click on it, and drag it to the correct position with the left
mouse button kept pressed.
To insert a new point in the contour, click on the contour with the left mouse button.
To delete a selected point, press the Delete key on the keyboard.
If you do not get an acceptable curve using the editing functions, the Delete Diastole (3) allows you to
easily delete and redraw the curve.

During the modifications, the contour is updated real-time in the screen.
To end the drawing, double-click the last point or any point of the contour, or click on the Draw Diastole button. The
contour becomes thinner (Draw Diastole button OFF).
To insert a new point to the contour, click on it with the left mouse button. The contour becomes active again (Draw
Diastole button ON).
To modify the location of any point after finishing the curve, click on the point with the left mouse button, and drag it
to the right place. The contour becomes active again (Draw Diastole ON).
When you finish with the modifications, press Draw Diastole again (OFF).
The LV contour is automatically saved at the sequence level. It means that if you already drew a contour in the
past, then launching Ventricular Analysis again later on that same sequence will display the frame selected in the
viewer with the LV contour drawn on it.
It is possible to change the frame during the diastolic contour edition. The diastolic frame will be the one on which
the contour edition is finished.
18-5 Draw Systolic Contour
As for the Diastolic contour, using the Play/Pause and/or Next/Previous Frame keys, select the frame which most
clearly shows the end of Systolic contour.
Note: The Systolic frame must be selected in the same heart cycle as the Diastolic frame to preserve the best
result accuracy.
Click on the icon Draw Systole (4) on the Ventricular Analysis tool menu.
Follow the same process to draw/edit/delete the Systolic contour.

The Systolic contour is represented by a blue curve.
After the Systolic contour is ended by double clicking on it or clicking again on the Draw Systole button, both
Diastolic and Systolic contours connected with the 100 equidistant chords are displayed.
Click on Show/Hide contours (6) to display or not the Diastolic and/or Systolic contour.
It is possible to change the frame during the systolic contour edition. The systolic frame will be the one on which the
contour edition is finished.
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18-6 Global Ejection Fraction Analysis

The GEF analysis uses two different methods for estimating Left Ventricular (LV) volumes: the Simpson's Rule and
the Dodge-Sandler Area-Length Method. Both methods aim at modeling the left ventricle in 3D, based on the
accurate determination of the LV border on the diastolic and the systolic frame. Both methods also require the
determination of the long axis of the LV.
Ventricular Analysis uses linear correction formulas with coefficients varying between X-ray systems so as to
counterweight the errors exhibited by the mathematical models during the 3D modeling process.
Note: These two methods are validated for LV acquired in RAO 30° angulation. So, if the sequence was not
acquired in RAO 30° +/- 10°, or with a CRA or CAU angulation greater than 10°, or with more than 5° difference
between the end of Diastolic and end of Systolic frame, a warning message about the loss of result accuracy will be
displayed.
Simpson's Rule Method
Simpson's Rule is based on the idea that the volume of an object can be determined by "cutting" the object into thin
"slices", measuring the volume of each slice and summing the volumes of all slices. Simpson's Rule is applied to
the left ventricle by slicing it into "discs" along the long axis, as shown in the illustration below. The area of each
disc is calculated and multiplied by the disc's thickness to determine its volume.
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Dodge's method
The left ventricle is approximated by a prolate ellipsoid with its long axis in the 30° RAO projection. The calculation
of the volume of a prolate ellipsoid only requires knowledge of the length of the longest axis and the area of the
ellipse. The axis of revolution length is the long axis of the LV. The computation of the ellipse area is based on the
mechanical tracing of the LV projection border.
After both end of Diastolic and Systolic contours are drawn, click on Generate GEF report (7) on the
Ventricular Analysis tool menu.

If needed, the Auto-calibration dialog box opens asking you to enter the "object to table top distance".
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The goal of auto-calibration is to allow the software to compute the pixel size in a given image without using any
kind of reference object. Auto-calibration is entirely based on the known geometry of the imaging system. The only
parameter that the user has to specify is the Object to Tabletop distance defined as being the shortest distance
between the center of the object to be measured and the top of the table.
As opposed to catheter calibration, auto-calibration is available only after a region of interest has been defined in
the image. It means that auto-calibration can be launched only after LV contours or segments are drawn in the
image.
Calibration results are automatically saved at the sequence level. If you launch the application on a previously
calibrated sequence, the calibration information will also be loaded as well as the sequence itself.
Enter the object (heart) to table top distance or use the 15 cm default value, then click OK to get results in metric
units.
THE OBJECT (HEART) TO TABLE TOP DISTANCE IS DEFINED FROM THE TOP OF THE
TABLE TOP AND NOT FROM THE TOP OF THE MATTRESS. IF THE DISTANCE ENTERED
DIFFERS FROM THE ACTUAL DISTANCE, THE RESULTING VOLUMES WILL BE
INACCURATE OF ABOUT 3% PER CENTIMETER OF DIFFERENCE.
In case a new auto-calibration is needed, it is always possible to launch it manually pressing on the Auto-calibration
icon (1) on the Ventricular Analysis toolbar.
Upon completion of auto-calibration, centerline computation and GEF quantification, the GEF report is displayed
with the computed results.
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The GEF analysis results report includes the report header, patient and exam information, the Diastolic and
Systolic image, and the results table.
The results table provides the end diastolic, end systolic and stroke volumes of the left ventricle computed in two
ways (Dodge's method and Simpson's method). These volumes are provided in both ml and ml/m² (normalized by
the body surface area. Patient weight and height must be entered). Also, the table contains the Global Ejection
Fraction value expressed in %.
If the sequence has not been calibrated for Ventricular Analysis, then the resulting units of ml or ml/ m² are not
displayed. In this case, only percentage values appear.
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The volumes displayed are calculated from the following equation:

Vcorrected = A * Vmeasured + B
The Vmeasured is the volume in ml resulting directly from the Dodge's and Simpson's methods. Because these
methods overestimate the actual left ventricle volumes, the coefficients A (slope) and B (intercept) are applied to
obtain the actual volume Vcorrected in ml, which is the volume displayed in the Results table.
The Global Ejection Fraction (GEF) is calculated as the ratio of the End diastolic and End systolic volumes.
IF THE SEQUENCE HAS NOT BEEN CALIBRATED FOR VENTRICULAR ANALYSIS, THIS
CORRECTION IS NOT APPLIED, WHICH LEADS TO A LESS ACCURATE VALUE OF THE
GEF.
If you hide the GEF report by pressing again the Generate GEF report button, you will see both Systolic and
Diastolic contours in the image connected with the 100 equidistant chords.
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In case you are not satisfied by results delivered in the GEF report:
1. Hide the current GEF report by pressing again the Generate GEF report button.
2. Modify the position of the existing points on the Diastolic or Systolic contour, add new points, or delete the
contours and draw new ones.
3. Press the Generate GEF Report button. (If requested, perform auto-calibration.)
The new GEF report appears in the screen.
Before exiting the GEF report, click on Store Photo (10) to save the report in the Photo Browser as a
standard photo.
18-7 Wall Motion Analysis
Wall Motion Analysis analyzes the wall motion dynamics of the left ventricle using the Sheehan's centerline
method. This method computes the lengths and locations of 100 chords equally spaced between the user-defined
heart contours.
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According to the Sheehan's centerline method, each chord is drawn perpendicular to the centerline which is
constructed midway between the End- Diastolic (ED) and the End-Systolic (ES) contour. The length of the chord
represents the wall motion at a given location of the ventricle contour. The value will be negative if, at a given point
of the contour, the ES contour is located outside the ED contour.
Since the heart size varies from patient to patient, the absolute extent of motion will vary even in normal hearts of
different size. To normalize for heart size, each chord length is divided by the length of the ED perimeter. The
normalized chord data can then be standardized.
This is done by subtracting from each chord the average of a group of normal patients (called the normal mean),
and dividing the result by the standard deviation from the normal mean for that chord.
Note: This method is validated for LV acquired in RAO 30° or LAO 60° angulations. So, if the sequence was not
acquired in RAO 30° +/- 10° or LAO 60° +/- 10°, or with a CRA or CAU angulation greater than 10°, or with more
than 5° difference between the end of Diastolic and end of Systolic frame, a warning message about the loss of
result accuracy will be displayed.
After both end of Diastolic and Systolic contours are drawn, click on Generate Wall Motion report (8) on
the Ventricular Analysis tool menu.

If needed, the Auto-calibration dialog box opens asking you to enter the "object to table top distance" (refer to GEF
analysis for Auto-calibration procedure).
Upon completion of auto-calibration, centerline computation and Wall Motion quantification, the Wall Motion report
is displayed with the computed results.
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The Wall Motion analysis report includes a report header, patient and exam information, a heart graph, a standard
deviation graph, and a results table.
The Heart graph field (top right of the WM report) contains the Systolic and Diastolic contours previously drawn by
the user, together with the corresponding RAO/LAO values. Also, the 100 chords representing the current wall
motion of the left ventricle are displayed (current patient chords).
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To gather precise and relevant information on hypokinesia and hyperkinesia in different ROIs, study the Standard
deviation graph and the Results table.
The standard deviation graph (bottom left of the WM report) shows the normalized wall motion as a function of
chord number, based on Wall Motion computation.
In the case of hypokinesia, the normalized wall motion is a negative value. For hyperkinesia, the normalized wall
motion is positive.
Left ventricle with normalized motion between -2 and +2 can be considered as normal.
The Results table field (bottom right of the WM report) contains a table with the results of Wall Motion Regional
analysis.
The results provide information about the impact on the wall motion of the three main coronary arteries (LAD, RCA,
and CFX) affected with single or multiple diseases. Also, the chord interval is specified for each vessel ROI in the
'Chord #' column. The chord interval associated with a main coronary territory is different in the case of RAO 30°
+/- 10° and LAO 60° +/- 10° acquisition. The table below shows the chord intervals for each ROI in both cases.
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CHORD INTERVALS ASSOCIATED WITH DIFFERENT CORONARY TERRITORIES
Region of Interest (ROI) Chord interval for RAO 30° Chord interval for LAO 60°
CFX single 10 - 80 19 - 67
CFX multiple 10 - 80 19 - 67
LAD single 10 - 66 50 - 67
LAD multiple 10 - 58 50 - 67
RCA single 51 - 80 38 - 74
RCA multiple 59 - 80 38 - 74
The 'Hypokin. SD' column displays the average of hypokinesia severity in standard deviation unit in a certain ROI. If
the average of the hypokinesia value is lower than -2, then it is displayed in bold. Negative values in this column
refer to hypokinesia. Wall motion is considered normal, if it is between -2 and +2.
For each ROI, the '% Total LV contour' column displays what percentage of the entire length of the left ventricle
contour can be characterized with hypokinesia outside the [-2;+2] range.
For each ROI, the 'Hyperkin. op. ROI SD' column displays the possible hyperkinesia compensation in the opposite
ROI. It corresponds to a significant hyperkinesia if it is positive and outside the range [-2; +2].
If you hide the WM report by pressing again on the Generate WM report button, you will see both Systolic and
Diastolic contours in the image connected with the 100 equidistant chords.
In case you are not satisfied by results delivered in the WM report:
1. Hide the current WM report by pressing again the Generate WM report button.
2. Modify the position of the existing points on the Diastolic or Systolic contour, add new points, or delete the
contours and draw new ones.
3. Press the Generate WM Report button. (If requested, perform auto-calibration.)
The new WM report appears in the screen.
Before exiting the WM report, click on Store Photo (10) to save the report in the Photo Browser as a
standard photo.
18-8 Multi Segments
Click on the icon Multi-segments (9) on the Ventricular Analysis tool menu to draw a link made of multiple
segments (multi-segments) on a single frame of a sequence, and to estimate the length of the segments.
Note: Only one Multi-segments can be displayed at a time.
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Following the instructions in the Hint window, enter the points of the multi-segment by clicking with the left mouse
button.
Before you place the first point, you can perform frame navigation using the Play/Pause or Next/Previous frame
functions.
The adjacent points of the multi-segments can be as close as you want from each other. However, remember that
the smaller the distance between the points is, the higher the imprecision will be.
While creating the multi-segments, you can edit any of the points already entered. Move over a point, the pointer
will change to a crosshair cursor, and then click and drag with the left mouse button to the intended position.
Also, you can insert points between two points already entered. Move over the intended position on the segment
line (the pointer will change to a crosshair cursor), and click with the left mouse button.
Double-click the last or any existing point to indicate that the multi-segment is finished.
To draw a new multi-segment on the selected frame, repeat the above procedure.
Before exiting, click on Store Photo (10) to save the image with measurements in the Photo Browser as a
standard photo.
After all analysis are performed and all images/graphics/reports saved, click on the Exit icon
(11) to exit the Ventricular Analysis application.
19 StentViz (Option)
The StentViz application is designed to enhance the visibility of a stent placed during an interventional Cardiac
procedure. Additionally, StentViz may help the cardiologist assess the correct deployment of the stent in the vessel.
If a stent was already placed, it may also be used to verify the positioning of a new balloon before the deployment
of the second adjacent stent, or before re-dilatation of the stent.
The result is shown on the static image below detailing the enhanced image image quality and contrast of the stent.
There are two StentViz images displayed on the reference display. One where the full guidewire is displayed and a
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second where the portion of the guidewire between the balloon marker-balls has been subtracted. The subtracted
guidewire is intended to ease the visualization of the stent.
There are four different displays the image will be divided depending on the original direction the vessel was
imaged.
Note: This application is restricted to heart anatomy only and can be launched only on images acquired using the
automatic StentViz workflow described below.
The success of the StentViz application might be altered by the poor quality of the images (high noise level…), the
type of balloon used (low marker radio-opacity), the radio-opacity of the guidewire, and or high radio-opacity
structures in the vicinity of the markers.
Note: The StentViz resulting photo is a recomputed image. Always associate it with the original recorded sequence
for interpretation.
19-1 Automatic StentViz Workflow
To launch the StentViz application acquisition to image a deployed stent the following is required:
1. Deflate the balloon and leave it in position inside the stent. StentViz will detect and focus on both markers of the
balloon and on the guidewire to perform the image processing.
2. A cardiac related protocol needs to be selected. On DL console or on the Innova Central touch screen (option),
select Dynamic and then StentViz to launch the application. An icon will be displayed on Live monitor to indicate
the StentViz acquisition mode is set for the next single dynamic acquisition.
The message “READY FOR STENT VIZ” is displayed at the bottom left of the Live monitor in the Status area.
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DL record acquisition console
Innova Central touch screen Record Tab
StentViz acquisition mode icon
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3. Perform a short Record acquisition centered on the display stent and deflated balloon. A "Stop X-Ray" blinking
message will be displayed on the Live monitor when enough frames are acquired. You can release the pedal at
this stage.
The acquired sequence is stored in the DL Sequence browser with a specific default "Pre-StentViz" label.
"Pre-StentViz" sequence displayed on Live monitor
4. At the end of acquisition, StentViz processing is automatically launched. The message "STENT VIZ IN
PROGRESS" is displayed at the bottom left of the Live monitor in the Status area. The typical processing time is
less than 10 seconds. Because image processing is performed in the background, fluoro, record, review and
image processing are always available.
5. At the end of StentViz processing time, the message "STENT VIZ IN PROGRESS" is replaced by "STENT VIZ
PHOTO READY" at the bottom left of the Live monitor and the resulting image is automatically displayed on the
reference display as a photo showing the stent with enhanced image quality and contrast. As for other photos,
this photo is stored in the DL Photo browser with a specific default "StentViz" label.
StentViz photo displayed on Reference monitor
Note: In case of fluoro or record acquisition, or image review in progress at the completion of the StentViz
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processing, the resulting photo is displayed only at the end of the fluoro or when the review switches to Pause
mode.
Note: The next Dynamic acquisition will be performed without StentViz processing. In case a new StentViz
acquisition is required, reselect the StentViz button on the DL Console or Innova Central touch screen (option).
19-2 Manual StentViz Workflow
If the StentViz processing is not successful, StentViz can be manually launched on previously acquired StentViz
sequence:
1. Select the StentViz native sequence (labeled “Pre-StentViz”) and launch the review. Zoom the image and center
it on the stent. This will increase the sucess rate and decrease the processing time.
2. Launch StentViz through the “StentRefine” button from the DL sequence browser on the control room console,
the DL remote control using the Menu key, or from the Innova Central touch screen (Option) using Review
menu or the SmartNav menu.
Note: StentRefine is used indifferently for StentViz or StentVesselViz post-processing. The selection of StentViz
or StentVesselViz post-processing is automatically done by the system depending of the acquisition setting of
the native sequence.
DL sequence browser
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Innova Central touch screen Review Tab
DL remote control - Menu
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SmartNav menu
3. Refer to steps 4 and 5 of Automatic StentViz Workflow.

19-3 StentViz Best Practice
• Before performing the StentViz short record acquisition, perform fluoroscopy to:
– Verify that the balloon has only 2 markerballs. StentViz will fail if the balloon shows 1 or 3 markers.
– Verify that there is only one pair of markers in the image. StentViz will fail if 2 balloons are in the same
image.
– Management of stent positioning to insure overlap: in case 2 adjacent stents are required and the first one is
already deployed, position the balloon with the second non deployed stent next to the first one.
– Verify that the pair of markers and the stent are in the same vessel and/or as close as possible to each
other. The closer the stent is to the markers, the sharper the stent will be displayed on the StentViz resulting
image.
– Verify that the markers are not super-imposed to highly radio-opaque objects (like metallic staples, guidewire
tip or injected catheter).
– Verify that the stent is radio-opaque. The more radio opaque the stent is the higher the StentViz image
quality will be.
• During the StentViz short record acquisition:
– Make sure that the markers are visible in every frame.
– Do not move the balloon during the StentViz acquisition.The only allowable motion is from anatomy.
– Do not move the table or gantry during the StentViz acquisition.
19-4 StentViz User Messages
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Location Message Description
Live and Refer- StentViz already running. Restart it The previous StentRefine or StentViz post-processing is
ence monitor manually later still running
This is not an eligible sequence for The sequence selected for the StentRefine post-
StentRefine processing has not been acquired using a StentViz
workflow
StentViz not available. Not enough The acquire sequence or selected sequence does not
frames in sequence have enough frames for StentViz post-processing.
Redo and wait until "X-Ray Stop" is displayed.
StentViz failure, apply zoom and StentViz processing has failed.

launch StentRefine Select the StentViz native sequence (labeled "Pre-
StentViz") and launch the review.
Zoom on the sequence and center it on the stent.
Launch StentViz through the "StentRefine" button.
20 StentVesselViz (Option)
The StentVesselViz application is designed to enhance the visibility of a stent placed during an interventional
Cardiac procedure. Additionally, StentVesselViz may help the cardiologist assess the correct deployment of the
stent in relation with the lumen of the artery.
If a stent was already placed, it may also be used to verify the positioning of a new balloon before the deployment
of the second adjacent stent
The result is shown on:
1. The static image below detailing the enhanced image quality and contrast of the stent (StentViz).
2. A dynamic zoomed image sequence which displays a progressive fading between the enhanced stent image
and an injected vessel image.
Note: The StentVesselViz application includes the StentViz processing.
20-1 Output Description
20-1-1 StentViz Images
There are two StentViz images displayed on the reference display. One where the full guidewire is displayed and a
second where the portion of the guidewire between the balloon marker-balls has been subtracted. The subtracted
guidewire is intended to ease the visualization of the stent.
There are four different displays the image will be divided depending on the original orientation the vessel was
imaged.
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Note:The StentViz resulting photo is a recomputed image. Always associate it with the original recorded sequence
for interpretation.
20-1-2 StentVesselViz Sequence
The StentVesselViz outputs a sequence of images that displays a video fading between a stent enhanced image
(StentViz image) and the lumen of the vessel it is deployed in. The sequence starts by displaying the injected
vessel. Then the stent enhanced image (with subtracted guidewire) progressively appears over the vessel. The
stent enhanced image is registered so that the balloon marker-balls are at the same location as in the vessel
image. In a third phase, the vessel disappears to leave the full stent enhanced image. Finally the guidewire is
displayed over the stent image.
Note: This application is restricted to heart anatomy and can be launched only on images acquired using the
Automatic StentVesselViz workflow described below.
The success of the StentVesselViz application might be altered by poor quality of the images (high noise level…),
the type of balloon used (low marker radio-opacity), the radio-opacity of the guidewire, and or high radio-opacity
structures in the vicinity of the markers.
20-2 Automatic StentVesselViz Workflow
To launch the StentVesselViz application acquisition to image a deployed stent the following is required:
1. Deflate the balloon and leave it in position. StentVesselViz will detect and focus on both markers of the balloon
and on the guidewire to perfom the image processing.
2. A cardiac related protocol needs to be selected. On DL console or on the Innova Central touch screen (option),
select Dynamic and then StentVesselViz to launch the application. An icon will be displayed on Live monitor to
indicate the StentVesselViz acquisition mode is set for the next single Dynamic acquisition.
The message “READY FOR STENT VESSEL VIZ” is displayed at the bottom left of the Live monitor in the
Status area.
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DL record acquisition console
Innova Central Touch Screen Record Tab
StentVesselViz acquisition mode icon
3. Perform a single and continuous Record acquisition centered over the deployed stent and delated balloon, first
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part without injection of contrast media, second part with injection of contrast media:
– Non-injected frames: an "inject" blinking message will be displayed on the Live monitor when enough non
injected frames are acquired.
– Injected frames: proceed as usual for an injected acquisition - standard injection-.
The acquired sequence is stored in the DL Sequence browser with a specific default "Pre-StentVesselViz" label.
"Pre-StentVesselViz" sequence displayed on Live monitor

Note: For a better post-processing efficiency and a better image quality, usage of 15fps is recommended.
4. At the end of acquisition, StentVesselViz processing is automatically launched. The message "STENT VESSEL
VIZ IN PROGRESS" is displayed at the bottom left of the Live monitor in the Status area. Because image
processing is performed in the background, fluoro, record, review and image processing are always available.
5. After an estimated typical processing time less than 10 seconds, the StentViz resulting image is automatically
displayed on the Reference monitor as a photo showing the stent with enhanced image quality and contrast. As
for other photos; this photo is stored in the DL Photo browser with a specific default "StentViz" label.
Note: In case of fluoro or record acquisition, or image review in progress at the completion of the StentViz
processing, the resulting photo is displayed only at the end of the fluoro or when the review switches to Pause
mode.
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StentViz photo displayed on Reference monitor
6. At the end of StentVesselViz processing time, the message "STENT VESSEL VIZ IN PROGRESS" is replaced
by "STENT VESSEL VIZ READY" at the bottom left of the Live monitor. The typical processing time is less than
30 seconds. The resulting sequence is automatically displayed on the Live monitor as a sequence showing the
stent with enhanced image quality and contrast and the vessel filled with contrast media.
"Post-StentVesselViz" sequence displayed on Live monitor
The sequence will be stored in the DL sequence browser with a specific default "Post-StentVesselViz" label.
Note: If the "Pre-StentVesselViz" sequence (or native sequence) is not in review or paused at the end of the
StentVesselViz processing, the review of the StentVesselViz post-sequence is to be launched manually. Launch
"Post- StentVesselViz" review through the "Play/Pause" or "Next/Prev" button from the DL remote control or from
the DL keypad, or through the "Recall sequence" button on the Innova Central touch screen (Option).
Note: The next Dynamic acquisition will be performed without StentVesselViz processing. In case a new
StentVesselViz acquisition is required, reselect StentVesselViz button on DL Console or Innova Central touch
screen (option).
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20-3 Manual StentVesselViz Workflow

If the StentVesselViz processing is not successful, StentVesselViz can be manually launched on previously
acquired StentVesselViz sequence:
1. Select the StentVesselViz native sequence (labeled “Pre- StentVesselViz”) and launch the review. Zoom on the
sequence and center it on the stent. It will increase the sucess rate and decrease the processing time.
2. Launch StentVesselViz through the “StentRefine” button from the DL sequence browser on the control room
console, the DL remote control using the Menu key, or from the Innova Central touch screen (Option) using
Review menu or the SmartNav menu.
Note: StentRefine is used indifferently for StentViz or StentVesselViz post-processing. The selection of StentViz
or StentVesselViz post-processing is automatically done by the system depending of the acquisition setting of
the native sequence.
DL sequence browser
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Innova central touch screen
DL remote control
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SmartNav menu
3. Refer to steps 3 to 6 of Automatic StentVesselViz Workflow.

20-4 StentVesselViz Best Practice
• Before performing the StentVesselViz record acquisition, perform fluoroscopy to:
– Verify that the balloon has only 2 markerballs. StentVesselViz will fail if the balloon shows 1 or 3 markers.
– Verify that there is only one pair of markers in the image. StentVesselViz will fail if 2 balloons are in the same
image.
– Management of stent positioning to insure overlap: in case 2 adjacent stents are required and the first one is
already deployed, position the balloon with the second non deployed stent next to the first one.
– Verify that the pair of markers and the stent are in the same vessel and/or as close as possible to each
other. The closer the stent is from the markers, the sharper the stent will be displayed on the StentVesselViz
resulting image and sequence.
– Verify that the markers are not super-imposed to highly radio-opaque objects (like metallic staples, guidewire
tip or injected catheter).
– Verify that the stent is radio opaque. The more radio opaque the stent is the higher the StentVesselViz
success will be.
• During the StentVesselViz record acquisition:
– Make sure that the markers are visible in every non-injected frame and in most injected frames.
– Do not move the balloon during the StentVesselViz acquisition. The only allowable motion is from anatomy.
– Do not move the table or gantry during the StentVesselViz acquisition.
– Avoid superimposition of other coronary arteries onto the stent as much as possible.
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– Avoid large breathing motion during the injected phase of the sequence as much as possible.
20-5 StentVesselViz User Messages
Live and Refer- StentVesselViz already running. The previous StentRefine or StentVesselViz post-
ence monitor Restart it manually later processing is still running
This is not an eligible sequence for The sequence selected for the StentRefine post-
StentRefine processing has not been acquired using a StentVes-
selViz workflow
StentVesselViz not available. Not The acquire sequence or selected sequence does not
enough frames in sequence have enough frames for StentVesselViz post-
processing. Redo and wait until "Inject" in displayed be-
fore injecting.
StentVesselViz failure, apply zoom StentVesselViz processing has failed.Select the

and launch StentRefine StentVesselViz native sequence (labeled "Pre-
StentVesselViz") and launch the review. Zoom on the
sequence and center it on the stent. Launch StentVes-
selViz through the "StentRefine" button.
21 Dose Map
THE CUMULATED AIR KERMA (CAK) REMAINS THE REFERENCE FOR DOSE
MANAGEMENT.
21-1 Dose Map integrated workflow

Dose Map is a feature used to calculate, display and record the estimated local cumulated dose during the
procedures done on the GE X-Ray angiographic system. It is designed to provide to the user a visualization of the
distribution of the local cumulated dose all along the exam as well as the current projection of the beam.
The local dose is calculated depending on the estimated air kerma, the gantry position, the table position, the table
estimated attenuation, the estimated backscatter correction and the system settings.
Calculation and cumulated local dose is updated for each acquisition and displayed upon user request or upon
configured threshold.
The Dose Map display is only available during an active exam. It uses the following patient data to calculate the
dose:
• Patient height
• Patient weight
• Patient date of birth
• Head to end distance when the exam is performed in the head area (see dual patient model below). It is the
distance between the top of the patient's head and the end of the table top.
Note: Head to end distance is not a parameter that can be set using Worklist. It has to be entered on the Patient
information screen prior to the start of the exam.
Depending on the protocol selected, a patient model is set:
• Dual model, where the head and neck are defined and used for the following Anatomy protocols:
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– Cardiac and Combo:

• Combo1
• Combo2
– Head:
• Head
• Carotid
• Cerebral
• Peds Cerebral
• Soft tissue
– Surgery:
• Head-Neck
• Single model is used for all protocols except the one previously described.
Single model Dual model
Deployed single model Deployed dual model
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Single model icon Dual model icon
During the exam, the Dose Map will be displayed on the Reference display:
• Automatically, if the amount of dose received locally has exceeded a pre-defined threshold
• On request, using one of the following ways:
– [Dose Map] button on the DL Sequence Browser
– {Dose Map} button on the “Dose” tab on the Innova Central touch screen
– <Dose Map> menu button on the remote control or {Dose Map} button on Smart Nav
Note: The same buttons can be used to close the Dose Map on Innova Central touch screen and Browser.
Additionally, the next pedal press for fluoroscopy or record will automatically close the Dose Map. Any photo that
was hidden by the Dose map will be redisplayed on the Reference display.
Note: Dose Map cannot be displayed during an acquisition.
For systems equipped with the Innova Central touch screen, the "Dose" tab will be automatically displayed when
the system determines that a threshold of local dose is reached and lower dose settings would be beneficial.
If predefined, the final Dose Map will be automatically saved as a photo at the end of the exam.
Note: Dose Map cannot be saved using the [Store Photo] command.
21-2 How to set Dose Map?
21-2-1 Dose Map preferences
Dose Map predefined preferences must be set before the start of an exam in the Preferences tab on the DL
screen.
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The Preferences tab contains the following patient information:

• Pediatrics limit age threshold: used to set the maximum patient age defined for pediatrics. The range is from
0-21 years of age.
• Pediatrics local dose threshold: local dose threshold applied to a patient younger or equal to the age defined
in the Pediatrics limit age threshold. It can be a selection of 0.5 Gy, 1 Gy, 2 Gy or 2.5 Gy.
• Adult local dose threshold: local dose threshold applied to a patient older than the age defined in the
Pediatrics limit age threshold. Can be a selection of 1 Gy, 2 Gy, 3 Gy, 4 Gy or 5 Gy.
For example, if the Pediatrics limit age threshold is defined as 15 years of age, the Pediatrics local
dose threshold will be applied to a patient younger or equal to 15 years of age. The Adult local
dose threshold will be applied for a patient age at starting 16 years of age. The patient’s age is
calculated from his date of birth or his age if it has been modified in the Patient exam information
screen.
Note: In the case where no difference is selected between pediatrics and adults, the Pediatrics
limit age threshold will be set to 0 and the local dose threshold will be set by the Adult local dose
threshold.
• Notification below local dose threshold: defines the local dose level from which the Dose Map will be
automatically displayed when the local dose has been exceeded. It can be:
– (50%, 100%)
– (50%, 75%, 100%)
– (33%, 66%, 100%)
For example, if the predefined local dose threshold is 2 Gy and (50%, 100%) is selected, the Dose
Map will be displayed when the maximum local dose threshold exceeds 1 Gy and then again when
the maximum local dose threshold exceeds 2 Gy.
• Notification above local dose threshold: the local dose threshold (pediatric or adult) has been fixed and
should not be exceeded in normal conditions. If for any reason the exam needs to be continued, an additional
Dose Map display can be set to:
– None
– One or more of 150%, 200%, 300%, 400%, or 500%
• Default head to end distance: head to end distance is the distance between the top of the patient’s head and
the nearest end of the table top. In the case where the norm is to place the head of the patient always at the
same distance from the end of the table top, perform the measurement and enter the value in the Default head
Innova Digital 389

to end distance field; which allows the system to use this automatically for each patient.
Note: Head to end distance or Default head to end distance are used by the system to set dual
model used for exams done in the head area. There is no need to enter a value for Head to end
distance or Default head to end distance if the exam is done outside the head area (thorax, pelvis,
etc…).
• Dose Map automatically stored as photo:
– If [Yes] is selected, Dose Map will be automatically saved as photo at the end of the exam. It will then be
managed as any other exam photo taken during the same exam.
– If [No] is selected, no Dose Map will be saved and no photo will not be accessible at a later time.
• Mattress type: Dose Map internal computation uses the mattress type to have a better precision. It can be:
– 1" / 2.5 cm Omega standard mattress with slicker
– 1" / 2.5 cm Omega anti sore mattress
– 2" / 5 cm Omega anti sore mattress
– 2" / 5 cm InnovaIQ anti sore mattress
Note: This list only includes mattresses delivered with GE IGS systems. The GE service engineer
or applications specialist can help select the appropriate mattress.
In case you don't find the used mattress in the previous list, you have two possibilities:
1. Select the 1" / 2.5 cm Omega anti sore mattress
2. If the Al equivalent filtration of the mattress is known at 100kV, select the GE mattress with the
closest lower equivalency of Al filtration.
GE Mattress Al equivalent for GE mat-

tress
1" / 2.5 cm Omega standard mattress with slicker < 0.7 mm Al equivalent
1" / 2.5 cm Omega anti sore mattress < 0.64 mm Al equivalent
2" / 5 cm Omega anti sore mattress < 1.3 mm Al equivalent
IQ
2" / 5 cm Innova anti sore mattress < 1.3 mm Al equivalent
When preferences are set:

• Click on [Apply] to accept the changes
• Click on [Cancel] to exit with no changes
21-2-2 Dose Map dedicated entries in Patient info tabs
The current exam's Head to end distance can be entered in three different ways:
• Patients / Patient and Exam Info: Head to end distance
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• Patient/Exam Info window: Head to end distance
• Preferences tab: Default head to end distance (refer to Dose Map Preferences above)
Note: Head to end distance is not a parameter filled using Worklist. It had to be manually entered prior to the
exams.
21-3 Dose Map limitations and recommendations
Dose Map models (single or dual) are only based on thorax estimation, not including the arms.
No Dose Map is provided when the decubitus patient position is used.
Each time the following parameters are changed during an exam, the current Dose Map is closed and a new map
is set:
• Patient data change: birth date, age, weight, height, head to end distance
• Protocol change driven by an anatomical change: from all except head area to head area
• Patient position change
• [End exam] followed by a Resume Exam
The following are recommendations:
• Enter patient data before starting the exam, including head to end distance. Avoid changing data during the
exam.
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• Place patients at the same Head to end distance which allows the use of the Default head to end distance to be
set on the system. If not, then the Head to end distance will have to be measured prior to each exam.
• If it is anticipated to perform an exam on the head or neck region, select a dedicated protocol at the beginning of
the exam.
• Avoid changing patient position during an exam.
• If there is an interruption in the exam, it is recommended to activate X-ray lock versus [End Exam] then [Start
Exam]. This will avoid the system from creating a new dose map.
Additional recommendations:
• When using the Large Display Monitor, the Reference display must be included in the selected layout.
• In case of multiple dose maps created during the same exam, the total estimated local dose amount is the sum
of the estimated local dose in each map.
21-4 Information provided by Dose Map
21-4-1 Dose Map representation - On Reference Display
Local cumulated dose is represented as a 2D view of a 3D model.
The length of the model is the length of the table, with a pixel resolution of 1 cm2. Cumulated local dose levels are
represented using a grey scale. The grey scale is directly linked to the local dose threshold chosen in the
Preferences tab. The least amount of radiation is represented from black to white, the highest amount of radiation.
The Dose Map is displayed on the Reference display’s image area. The Dose Map is composed of three areas:
1. Full view of the cumulated local dose on the model
2. Zoomed view of the cumulated local dose on the model
3. Information area
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Full view of the cumulated local dose on the model

The following information can be found in full view area:
• Cumulated local doses on the deployed model
• Table silhouette to localize the cumulated local dose versus patient lying on the table
• Active radiated area is projected on the model as a dotted box
Zoomed view of the cumulated local dose on the model
The following information can be found in the zoomed view area:
• x6 zoom of the cumulated local doses centered on the projected radiated area
• Table silhouette displayed to localize the cumulated local dose versus patient lying on the table
• Active radiated area is projected on the model as a dotted box
Information area
The following information can be found in the information area:
• Gauge to indicate the maximum value of the cumulated local dose in the beam:
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– Dose indication is given from 0% to 100% of the local dose threshold

– Local dose threshold is indicated. Example: 1 Gy
– Vertical bars indicate the notification levels below the local dose threshold defined in the Preferences tab
• Icon bar to display icons giving indications on the Dose Map. The following icons can be displayed depending of
context:
Icons related to a normal behavior

Icons Meaning
Patient position to indicate how the patient is lying on the table. This icon is
similar to the one selectable on the DL Console
Head to end distance with value indicated in centimeters
Only displayed in the case dual model is selected:
• Cardiac and Combo:
– Combo1
– Combo2
• Head:
– Head
– Carotid
– Cerebral
– Peds Cerebral
– Soft tissue
• Surgery:
– Head-Neck
Icons indicating a less accurate Dose Map
Icons Reason for inaccuracy
Displayed when the following patient information has not been filled in: age,
height, weight, or head to end distance. In this case, the system uses default
parameters that can be over or under estimated compared to the patient laying
on the table.
A change of patient data during the exam will cause the current map to store as
a photo and the creation of a new blank map.
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Estimation done on patient younger than 18 years old.

Accuracy for patients younger than 18 years old is lower than for other patients.
Indicates the usage of multiple Dose Map after a second map was created dur-
ing the same procedure.
Estimation of local cumulated dose has to be done adding the local value on
the two maps.
Displayed when more than 1 Gy of the sum of Air Kerma on the map is missing
dose data during the Dose Map calculation.
21-4-2 Dose Map representation - Store on photo

If predefined, the final Dose Map is automatically saved as a photo at the end of the exam. Dose Map stored as
photo is composed of three areas:
1. Full view of cumulated local dose on the model
2. Data area (instead of Zoomed view)
3. Information area
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Full view of cumulated local dose on the model

The following information can be found in full view area:
• Cumulated local doses on deployed model
• Table silhouette to help to localize the cumulated local dose versus patient lying on the table
• Non deployed model contouring to help understand if cumulated local dose is on model sides or on model back
Data area
The following information can be found in data area:
• Dose Map creation date and time (time of map creation)
• Dose Map end date and time (time of map end: end exam, or following a map reset)
• CAK dose dispatched on Dose Map
Information area
The following information can be found in the information area:
• Gauge to indicate the maximum value of the cumulated local dose on the full map:
396 Innova Digital

– Dose indication is given from 0% to 100% of the local dose threshold

– Local dose threshold is indicated. Example: 1 Gy
– Vertical bars indicate the notification levels defined in the Preferences tab
• Icon bar to display icons giving indications on the Dose Map. The icons are identical to the icons on Reference
display, except:
Icons related to a normal behavior

Icons Meaning
In case of multiple Dose Maps created during the same procedure, this icon will be includ-
ed on all photos except the last one.
In case of multiple Dose Maps created during the same procedure, this icon will be includ-
ed on the last photo.
In this case, two maps have been created and stored during the procedure.
21-4-3 Dose Map user messages

Patients / Patient and Exam Info BMI out of range. Verify patient height In case patient's BMI is outside
and weight. [16,45]
Exams / Patient info
Live display (Notification value) When Dose Map is automatically dis-
played
Live and Reference display Dose Map reinitialized due to a change In case of map reset
to the model
Dose map unavailable for decubitus pa- In case decubitus patient position is
tient position selected, to advice Dose Map is not
available for this patient position
Dose map unavailable until system reset In case Dose Map is not working
is performed
Dose Map is not available until after the In case Dose Map display is request-
first X-ray is performed ed before first X-Ray has been per-
formed
21-5 Dose Map accuracy
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Note: If the mattress used has no GE part number or the GE part number doesn’t figure in the mattress list defined
in Dose Map / How to set Dose Map? / Dose Map preferences, or in case of accessory usage in the beam: Dose
Map accuracy is not guarantee.
Refer to Appendix - Dose Map Accuracy procedure.
22 Remote Control
1 Cancel 13 Previous Sequence

2 Menu 14 Exam Loop (Collage / In-room Browser)
3 Brightness/Contrast Selection 15 Next Sequence
4 2D Send Angles 16 SUB/No Sub Selection / Pixel Shift UpLeft / Roam / IRB
5 Pixel Shift Selection 17 Faster Review / Contrast + / Pixel Shift Up / Roam / IRB
6 Not used 18 Mask Selection to select another mask if needed / Pixel Shift Up-
Right / Roam / IRB
7 Zoom 19 Backward Review / Brightness - / Pixel Shift Left / Roam / IRB
8 Store Photo 20 Enter Key
9 Recall Photo 21 Forward Review / Brightness + / Pixel Shift Right / Roam / IRB
10 Previous Image 22 Previous Sequence / Pixel Shift DownLeft / Roam / IRB
11 Play / Pause 23 Next Sequence / Pixel Shift DownRight / Roam / IRB
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12 Next Image 24 Slower Review / Contrast - / Pixel Shift Down / Roam / IRB
22-1 Collage / In-room Browser (Option)

From the Remote Control, press on the Exam Loop key (key 14 on Remote Control Illustration) to activate and
display the In-room Browser (IRB) on the reference display.
Note: An image review must be started first to allow the IRB activation and display.
The IRB can also be activated from the Exam Loop key of the Sequence Browser or the Exam Mode key of the
DL keypad.
Sequence thumbnails are displayed first with their original sequence number; photo thumbnails are then displayed
with a dedicated photo icon and their original photo number.
A thick horizontal white line separates sequences and photos.
Note: In case of multiple exams performed on a Patient, sequences of each exam are displayed first (a thin
horizontal white line separates each exam), then, after the thick white line, photos of each exam are displayed (a
thin white line also separates each exam).
Once the IRB is displayed on the reference display, use the Exam Loop key to switch focus either on the IRB or on
the live display. Refer to the highlighted label in side panel of both IRB or live displays to visualize where the focus
is located.
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Focus on live display
Focus on IRB
Note: The IRB will stay displayed on the reference display even when the focus is on the live display.
The IRB will be removed only in case of Start/End Exam or Store/Recall photo.
It will not be possible to activate or take focus on the IRB during a Stenosis quantification of acquisition.
When the focus is on the IRB, use one of the eight Remote Control arrows to select the sequence or photo to
review.
A dedicated icon shows the selected thumbnail:
After selection, press on the Remote Control Enter key to launch the review.
A dedicated icon shows the sequence in review:
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Note: The thumbnail selection can also be performed using the DL keypad joystick. Press also on the DL keypad
Enter key to launch the review.
A small arrow is displayed in the bottom right corner of the IRB to indicate that more than 16 thumbnails are
available (see 1).
Use the Remote arrow keys to scroll and see the other available thumbnails.
While focus is on the IRB, the 6 blue keys of the Remote Control (or equivalent functions on the DL keypad) can be
used without exiting focus from the IRB.
Any other processing function activation (Zoom, Pixel Shift...) will automatically switch focus on the live display.
In case of photo thumbnail selection and Enter key pressed, the selected photo will replace the IRB on the
reference display and the system will react as if a Recall photo was activated.
Press on Exam Loop again to re-display the IRB when the photo is not needed anymore.
23 DL Keypad
Innova Digital 401

1 Reset Brightness and Contrast to Default Values 13 Pixel Shift Selection

2 Contrast Adjustment 14 Edge Enhancement / Pixel Shift / Roam Adjustment
3 Brightness Adjustment 15 Zoom
4 Start and Stop Review within a Sequence 16 Edge Enhancement Filter Selection
5 Review Next Image 17 Auto Archive Mode Selection
6 Review Next Sequence 18 Shuttle Knob for Image Review
7 Store Photo 19 Monitor Pattern
8 Recall Photo 20 Exam Mode (Collage / In-room Browser)
9 Review Previous Image 21 Time Scale ON/OFF Control
10 Review Previous Sequence 22 Show/Hide Image Infos
11 SUB/No Sub Selection 23 Show/Hide the electronic shutter in review
12 Mask Selection to select another mask if needed
Note: The monitor pattern is not available while in review or under Ready for exam status (exam in progress).
• To display the pattern on both live and reference displays, press the blank (19) button.
• To remove the pattern:
1. Creating a new patient and starting the exam will blacken both screens.
2. Starting a review on any sequence will remove the pattern from the live display.
3. Recalling a photo will remove the pattern from the reference display.
23-1 Edge Enhancement Filter Selection
402 Innova Digital

Edge Enhancement can be used to sharpen or smooth the image content. A range of filter values is available and
permits to obtain different image looks. By default, the edge filter used during acquisition is applied during DL
review. This default edge enhancement value can be changed.
The following procedure should be followed to adjust the desired level of edge enhancement for Cardiac/DSA no
Sub/Bolus/Chase/DSA/Innova 3D/Innova 3DCT acquisitions:
• Load the sequence to be reviewed.
• Press the "Edge Enhancement Filter Selection" and select the preferred filter setting for the type of acquisition
reviewed.
• Apply the same number as the filter selected to the "Customer Sharpness Sensitivity" parameter in the
acquisition protocol (ask Applications Specialist).
24 Dose Information Record

The following dose information are recorded at exam level:
1 Fluoro time (h:min:s)

2 Dose (mGy)
3 DAP (Gy.cm2) - Total / Record / Fluoro
When starting a new exam these fields are empty.

During exam the dose information are displayed on reference display (Dose, TotalDAP and Total Fluoro time).
During exam these dose information are not updated in the exam browser.
Dose information related to the current procedure is stored into the database after each record acquisition and at
the end of the exam.
In case of system failure requiring a reset during a procedure, dose related to fluoro
acquisitions performed after the last record acquisition is lost.
If a reset is needed during a procedure requiring fluoro only, all patient dose information are entirely lost. A way to
estimate the cumulated patient skin dose (worst case) in Gy is obtained by multiplying the estimated performed
fluoro time in minutes by 0.1.
e.g. for a performed fluoro time of 60 min, the estimated cumulated patient Air Kerma is: 60 x 0.1 = 6 Gy.
A way to estimate the cumulated DAP (Dose Area Product) in Gray.cm² (worst case) is by multiplying the estimated
performed fluoro time in minutes by 0.1 and further multiplied by 100.
e.g. for a performed fluoro time of 60 min, the estimated DAP is: 60 x 0.1 x 100 = 600 Gy x cm²
Always end any exam by using the "End Exam" key located on the top of the DL flat panel in
order to save all dose information related to the exam.
At "End exam", the actual dose information are recorded and displayed on the appropriate fields in the exam
browser.
Doing a start exam on an already performed exam will update the dose information on the reference display with
the values previously recorded at exam level.
25 How to Check or Reset the ECG signal (Option)
Innova Digital 403

The icon is used as a visual update of the status of the ECG signal. Waveform & detected peaks are sent in real
time during all kinds of acquisition modes to the AW. When the ECG is enabled and well received (i.e. status is
Online), the ECG data will be automatically stored in the DICOM header of the corresponding sequence for the
following record modes: DSA, Dynamic mode, unsubtracted Innova 3D and Innova CT.
Click on the ECG icon on top of the Innova DL screen to display the beats per minute and to reset the R-wave peak
to peak detection
There are 4 possible ECG status modes, which will be displayed on the DL and the live display (Offline, Stabilizing,
Online and No Trigger).
25-1 ECG icon indication on the DL by color and on the live display
Offline (White and grayed out):

No ECG signal is received or there is no active exam.
404 Innova Digital

Stabilizing (yellow):
A signal is received, and the system is "learning" the ECG.
The algorithm detecting the peaks needs a period of 10 seconds to analyze the waveform (polarity, amplitude, etc.)
before being able to trigger.
An hour glass will be displayed during the stabilization phase.
Online (green):
A signal is received and the system is delivering triggers.
Innova Digital 405

No Trigger (orange):
A signal is received but the system is not capable of delivering a trigger.
25-2 ECG icon indication on the live display

25-2-1 Status "Online"
406 Innova Digital

The system is receiving the signal, the current BPM are displayed.
25-2-2 Status "Stabilizing"
The hourglass will be displayed during the stabilization phase.

25-2-3 Status "No Trigger"
Innova Digital 407

The "- -" will be displayed if there is no R – Peak detection or there is noise in the signal.
Note: Always refer to the hemodynamic or electrophysiology system as the prime reference for the status of the
patient’s ECG, not the Innova system.
25-2-4 Status "Offline"
No ECG signal is received, the ECG line is black, there is no ECG indication
If the ECG signal is lost:
In most situations, check the hemodynamic monitor verifying there is no electrode failure. Once that is confirmed,
perform a reset of the R-peak detection to try to recover the signal.
408 Innova Digital

There are some situations that the ECG waveform analyzer will be 'lost'.
Examples:
• Noise cannot be differentiated from a regular signal and will try to detect peaks.
• When peaks are detected at a frequency greater than 300 BPM, the display of the BPM value will be
">300BPM" until the frequency is less.
• If the polarity of the signal is changing, it is probable that no peak will be detected.
• If the signal is too noisy: false peaks may be detected.
• If the signal amplitude is increasing: false peaks may be detected.
• If the signal amplitude is decreasing: no peak may be detected.
26 How to Check the Disk Space

Click on the Disk Space icon on top of the Innova Digital screen to display the available Disk Space.
Innova Digital 409

27 How to Check the Heat Unit Informations

Click on the Heat Units icon on top of the Innova Digital screen to display the estimated exposures and run time
available.
28 How to Delete
Note: Before to delete any data from the Innova Digital, always check that all data was successfully pushed and
available on the AW Workstation.
28-1 How to delete a Patient
410 Innova Digital

Patient Browser
Delete Patient
• Click on the [Patients] tab at top left of DL screen to select the PATIENT BROWSER. By a simple click; select
the patient(s) you want to delete.
Note: You can select multiple patients:
Innova Digital 411

• Using <Shift> + left mouse button for contiguous patients.

• Using <Control> + left mouse button for non-contiguous patients.
• While holding the [Control] key, click on the [Delete] key.
• The pop-up "Confirm Delete Patient" will appear.
• Select [Cancel] key to cancel deletion.
• Select [OK] or press the <Enter> key to confirm deletion.
If not all of the sequences of a patient have been pushed/archived, another pop-up "Patient
'Last Name' was not sent to network/archived yet. Confirm delete patient?" will appear. If the
Innova system is connected to a Patient Monitoring/Scheduling/Reporting system and at
least one MPPS message was not sent yet, a similar pop-up will be displayed indicating
“MPPS data is not yet sent” and asking to confirm the deletion. If DICOM Dose Structured
Report is configured and atleast one DICOM Dose Structured Report message was not sent
yet, a confirmation popup shall be displayed to user indicating “Dose Report is not yet
sent” and asking to confirm the deletion.
• After a delete is done, the PATIENT BROWSER will be updated and redisplayed.
28-2 How to delete an Exam
• Click on the [Patients] tab at top left of DL screen to select the PATIENT BROWSER. Select a single patient by
a simple click.
– Click on the [Exams] tab to select the EXAM BROWSER. The Exam Browser window appears.
– Select on the exam(s) to be deleted.
Note: You can select multiple exams:
• Using <Shift> + left mouse button for contiguous exams.
• Using <Control> + left mouse button for non-contiguous exams.
• While holding the [Control] key, click on the [Delete] key.
• The pop-up "Confirm Delete Exam" will appear.
If not all of the sequences of an exam have been pushed/archived, another pop-up "Exam
from date 'DD-MMM-YYYY' was not sent to network/archived yet. Confirm delete exam?" will
appear. If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting
system and at least one MPPS message was not sent yet, a similar pop-up will be displayed
asking to confirm the deletion. If DICOM Dose Structured Report is configured and atleast
one DICOM Dose Structured Report message was not sent yet, a confirmation popup shall
be displayed to user indicating “Dose Report is not yet sent” and asking to confirm the
deletion.
• After a delete is done, the EXAM BROWSER will be updated and redisplayed.
28-3 How to delete a Sequence

a simple click.
• Click on the [Exams] tab to select the EXAM BROWSER Select a single exam by a simple click.
• Click on the [Sequences] tab. The SEQUENCE BROWSER window appears.
• Click on the sequence to be deleted.
412 Innova Digital

Note: You can select multiple sequences:

• Using <Shift> + left mouse button for contiguous icons.
• Using <Control> + left mouse button for non-contiguous icons.
• While holding the [Control] key, click on [Delete] key. The message "Confirm Delete Selected Sequence(s)"
appears.
If one of the sequences has not been pushed/archived, another pop-up "Sequence was not
sent to network/archived yet. Confirm delete sequence?" will appear.
• After selection has been done, the SEQUENCE BROWSER will be updated and redisplayed.
28-4 How to delete a Photo
a simple click.
• Click on the [Exams] tab to select the EXAM BROWSER Select a single exam by a simple click.
• Click on the [Photos] tab. The PHOTO BROWSER window appears.
• Click on the photo to be deleted.
Note: In case of a biplane photo, both Frontal and Lateral photo will be deleted at the same time.
Note: You can select multiple photos:
• Using <Shift> + left mouse button for contiguous icons.
• Using <Control> + left mouse button for non-contiguous icons.
• While holding the [Control] key, click on [Delete] key. The message "Confirm Delete Selected Photo(s)"
appears.
If one of the photos has not been pushed/archived, another pop-up "Photo was not sent to
network/archived yet. Confirm delete photo?" will appear. Select [OK] (or press the <Enter>
key) to confirm deletion. Select [Cancel] key to cancel deletion.
• After a selection is made, the PHOTO BROWSER will be updated and redisplayed.
29 How to Network Images to a Workstation, Archive Stations

You can manually or automatically transfer, exams, sequences or photos to one or several hosts (workstation,
PACS...).
Note: In order to optimize data security, it is strongly recommended to always work in Auto Archive mode.
29-1 Auto Archive
The Auto Archive button on the Digital keypad activates the auto transfer of sequences or photos as they are
acquired.
Auto Archive is active when the button is illuminated. If a manual transfer is desired, a single push of the illuminated
Auto Archive button will deactivate the Auto Archive transfer.
Innova Digital 413

Alternatively, it is possible to preset the Auto Archive to ON or OFF by default in the Browser. By default, the Auto
Archive is set to ON. The update will require a system restart.
Note: Transfer will pause when there is a fluoro, record or review in progress.
29-2 How to configure and select a Host
• Click on the [Net] button at the top of the DL screen. The NETWORK QUEUE appears:
414 Innova Digital

• Click on the [Select Host] button. This opens the host configuration screen. The Worklist and MPPS tabs are
displayed if Worklist option and MPPS are enabled.
• Select the Image tab to create or modify Image hosts.

If user clicks on the [Add] button, empty host parameter fields will be displayed for the new host.
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All fields will have to be filled in to create a new host.

The Host Label field is limited to 20 characters.
The Network Address field is limited to 15 characters and the user will only be able to enter numbers (0-9) and dots
(.).
The Port Number field is limited to 5 characters and the user can only enter numbers (0-9).
The AE Title field is limited to 16 characters.
If Storage Commitment option not enabled, the ‘Archive Station’ radio buttons will be disabled.
If Storage Commitment option is enabled, the ‘Archive Station’ radio buttons will be enabled.
Initial state of radio buttons:
• For Archive Station "No" is selected by default
• For 512 transfer of images there will be no default selection.
If the user checks ‘yes’ for the ‘Archive Station’ option, the ‘Storage Commitment’ edit fields will be enabled and, if
they are empty, they will be filled in automatically with the same values as the storage host.
[Verify] button allows checking if the network connection is alive between the Innova system and the remote host.
416 Innova Digital

By pressing [Save] button and if all fields are filled in, the new host will be added to the list in the left window.
User can select the 3D reconstruction host (if 3D option is selected).
User can set the auto push option. 'Yes' is selected by default. If automatic push behavior is not required, this
parameter is to be selected as ‘No’. It requires a system restart to update changes made to this setting.
From the available host(s) list in the left window, the user can select one or several hosts by clicking on its/their
name with the left mouse button.
In case of several hosts selected, use the Up and Down buttons to prioritize the transfer. The hosts may also be
dragged up or down to change their priority. Transfer is performed to the host from first line of the list to last bottom
line of the list.
At the bottom of each Patients/Exams/Sequences/Photos Browser, the selected host(s) is (are) displayed in priority
order from left to right.
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Host set in the system for 3D acquisition network is labeled with "3D" written after the host name).
Note: Whatever be the priority of the 3D host in the host list, a 3D acquisition is always networked first. Host set as
archive station is labeled "host name*" (small star written after the host name).
• Click [Exit] to return to the Network Queue.

29-3 How to Network Patient
• Click on the [Patients] tab on the top of the DL flat panel to go to the PATIENT BROWSER.
• Click on the patient(s) to be transferred.
Note: You can select multiple patients:
– Using <Shift> + left mouse button for contiguous selection of patients.
– Using <Control> + left mouse button for non-contiguous selection of patients.
• Click on the [Network] button on the right of the DL screen.
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• Wait for the images to arrive on the remote host.
29-4 How to Network Exam

• Select a patient and click on the [Exams] tab. The EXAM BROWSER appears.
• Click on the exam(s) to be transferred.
Note: You can select multiple exams:
– Using <Shift> + left mouse button for contiguous selection of exams.
– Using <Control> + left mouse button for non-contiguous selection of exams.
• Click on the [Network] button on the right of the DL screen.
• Wait for the images to arrive on the remote host.
29-5 How to Network Sequence / Photos

• Select a patient and click on the [Exams] tab on the top of the DL screen to go to the EXAM BROWSER.
• Select an exam and click on the [Sequences/Photos] tab on the top of the DL flat panel to go to the
SEQUENCE/PHOTOS BROWSER.
• Click on the sequence(s)/photo(s) to be transferred.
Note: You can select multiple sequences/photos:
– Using <Shift> + left mouse button for contiguous selection of sequences/photos.
– Using <Control> + left mouse button for non-contiguous selection of sequences/photos.
• Click on the [Network] button on the right of the flat panel.
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29-6 How to check the status of Network Image operations

CASE 1: If the Network status at Patient Browser is FAILED, then place the mouse over the FAILED status.
If the tool-tip displays: "Failure occurred during image transferring. See Exam tab for more details."
Go to the EXAM Browser of that Patient.

If any Exam displays Network status as "FAILED", place the mouse over the FAILED status.
If the tool-tip displays "Failure occurred during image transferring. See Sequences/Photos tab for more details."
Go to the SEQUENCE and PHOTO Browser of that Patient - Exam.

If any Sequence or Photo displays Network Status as "FAILED", place the mouse over the FAILED status.
Follow the tool-tip instructions to recover the error.
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CASE 2: If the Network status at Patient Browser is INFORMATION, then place the mouse over the
INFORMATION status.
CASE 2.1: If the tooltip indicates "There is no image host configured" then, configure and select an Image push
host. Refer How to configure and select a Host
CASE 2.2: If the tooltip indicates "There are images that have not been transfered. A manual push is required"
then, go to Exams tab.
In the Exams tab, click on the network status for the exam with "Information" status.
If the tooltip indicates “There are unsent images” then, go to Sequences and Photos tab.
Manually push the unsent Images.
CASE 2.3: If Tooltip indicates "This patient is under exam", it implies that the exam is ongoing.
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CASE 3: If the Network status at Patient Browser is SENDING, then place the mouse over the SENDING status.
If the tool-tip indicates: "Sending Image(s) is in progress" then, image push is underway. Need to wait for the
network operation to end.
CASE 4: If the Network status at Patient Browser is ARCHIVING, then place the mouse over the ARCHIVING
status.
If the tool-tip indicates: "Archiving of Image(s) is in progress" then, image archival is underway. Need to wait for the
network operation to end.
CASE 5: If the Network status at Patient Browser is COMPLETED, then place the mouse over the COMPLETED
status.
If the tooltip indicates "Images have been transferred successfully" then, it implies successful transfer of all images
for the selected patient.
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29-7 Network Queue Management

• Click on the [Net] tab of the DL screen to open the SENDING or (if any) ARCHIVING queue.
29-7-1 SENDING/ARCHIVING Queues
The Network queue contains the following columns:

• Patient Name.
• Item type (patient, exam, sequence or photo).
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• Item number will show its number according to its type.

• Host Label will show the name of the destination host.
• Status will contain the transfer status (Pending, Active or Failed):
– PENDING: waiting to be processed.
– ACTIVE: the item is currently being transferred.
– FAILED: when transfer of item failed to the host or one of the hosts. In this case the item remains in the
queue. It is removed from the queue only by use of the Delete Selected button. It can also return in the
queue with PENDING status by use of the Retry Failed Button.
Note: Successfully transferred items are removed from the Network Queue.
29-7-2 SENDING/ARCHIVING Queues Functions
• Delete Selected: Remove the selected item from the queue. This function is available only on items with
PENDING or FAILED status.
• Clear Pending: Remove all PENDING items from the queue, after completion of the ACTIVE item transfer.
• Retry Failed: Return all items with FAILED status to the active part of the queue; their status is changed to
PENDING.
• Retry Selected: Allow to resend selected items with PENDING status (neither successfully pushed nor failed) in
case of communication problem.
• Abort: Immediately abort the current ACTIVE task.
• Select Host: Give access to configuring different host(s).
30 How to use Worklist

The worklist option allows to retrieve the patient demographic information from a worklist provider.
The worklist option can be enabled by GE Service personnel only.
If the worklist option is enabled, the patient browser will look as follows:
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30-1 How to configure and select a Worklist host
• Click on the [Net] tab of DL Screen. The NETWORK QUEUE appears.

• Click on the [Select Host] button.
This opens the window with different tabs to configure the hosts.
Note: The tab MPPS is displayed, only if MPPS is enabled.

Selecting the Worklist tab of Host Configuration screen, the user can configure the Worklist host.
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Only one Worklist host can be configured.

By pressing [Save] button if all fields are filled in, the new host will be saved.
User can modify the host configuration details of the existing host.
User can DELETE the host by clicking the [Clear] and [Save] button in the given order.
User can set the automatic retrieve of Worklist at boot. 'Yes' is selected by default. Changing this parameter would
require a system restart.
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30-2 Retrieving the worklist

Go to Patient Browser.
If Worklist option is enabled, the patient Browser will be split horizontally and displays Worklist Browser in the
bottom.
If the worklist option is not present, the patient list will be full screen and none of the worklist buttons is seen.
The three worklist specific buttons are:

• [Refresh]: retrieves the worklist from the worklist provider.
• [Settings/Search]: opens the settings definition window.
• [Add to database]: allows creating patients/exams in the Innova database from the items selected in the
worklist.
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Pressing the [Refresh] button on the patient Browser retrieves the worklist.
While the query is in progress, the system remains fully available for other operations.
During the query, the [Refresh] button toggles to [Cancel Query], allowing canceling the query in progress.
If the query fails, the last successful query result remains displayed.
The worklist can be sorted by patient name or by scheduled start date and time by clicking on the header row.
30-3 Worklist settings configuration

The worklist settings is configured from the [Settings/Search] button.
Three matching criteria are available:

• Modality worklist,
• Scheduled exam date,
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• Patient information (optional).
The system will retrieve items that satisfy the criteria defined in all three boxes. In the "Date" area, only one item
can be selected.
The "Modality Worklist" criteria and the "Date" criteria are stored persistently on the system. The patient criterion is
stored as long as the system is not re-booted.
MODALITY WORKLIST
One or both or none of the checkboxes may be selected
• This room: The scheduled system's DICOM AE-Title matches the local dicom AE-Title.
• This modality: The modality of the scheduled procedure step is "XA", X-ray angiography.
• Leaving both checkboxes unchecked: Selecting this will have the effect of bypassing the scheduled system
selection criteria, since it will always match.
• Both checkboxes checked: The scheduled system's DICOM AE-Title and the modality of the scheduled
procedure step will be used for filtering.
Note: This selection must be used when a GE Mac-Lab is used to retrieve the worklist.
Note: To see the local system's AE-Title, select Service from the Browser. In Service User Interface, choose
configuration application, then DICOM.
DATE
Any date: Selecting this will have the effect of bypassing the date selection criteria, since it will always match.
From ... to: Enter the selected dates in the following format: 01-Jan-2001.
PATIENT SEARCH
Multiple matching criteria can be defined in this area.
For the last name and first name, the query will match if the name in the worklist provider contains the given name.
E.g.: querying for "John" will return "John", "Johnson" ...
The tab key navigates between the fields.
[Refresh now] button
This has the same effect as [Apply] + [Refresh].
[Apply] button
The window is closed. The settings definition is saved.
[Cancel] button
All edits are discarded. The window is closed.
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30-4 Creating Innova patients from worklist

Creating Innova patients from the worklist can be done by:
• Clicking on the [Add to database] button.
• Double clicking a line from the worklist Browser.
• Dragging a line from the worklist Browser into the patient Browser.
IN CASE SOME PATIENT/EXAM INFORMATION OF THE PATIENT TO BE IMPORTED

ALREADY EXISTS IN THE INNOVA DATABASE, BUT BELONGS TO ANOTHER
PATIENT/EXAM, A POP UP WINDOW WILL BE DISPLAYED TO WARN USERS ABOUT THE
“RISK OF PATIENT/EXAM DATA/IMAGES MIX”.
Three scenarios can occur:
1 – Same patient information but different exam information.
2 – Different patient information but same exam information.

3 – Same patient information with study information belonging to another patient.
Case 1: The patient has only one scheduled procedure step:

• Selecting the patient line or the scheduled procedure step line has the same effect. If creates the patient with
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one exam in the database.
Case 2: The patient has more than one scheduled procedure step:
• To create one exam from each procedure step, select and import each procedure step individually.
• Selecting and importing the patient line or a group of scheduled procedure steps will import the first procedure
step.
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Importing items from the worklist will open the patient and exam info screen, pre-filled with the information from the
worklist provider.
To ease the patient identification in Review Stations and Archive Stations, the patient demographic information is
not editable if it was created from the worklist (patient last and first name, patient ID, date of birth, other patient
identification and sex). If editing is required, it should be done on the worklist provider, then the worklist should be
refreshed and the patient re-imported.
31 Modality Performed Procedure Step (MPPS)

Innova System MPPS, together with the Innova System Worklist functionality, provides customers with a
bi-directional interface between the Patient Monitoring/Scheduling/Reporting System and the Innova system.
Demographic information is retrieved seamlessly from the Patient Monitoring/Scheduling/Reporting System to the
Innova system previous to the examination, while X-ray acquisition information is sent to the Patient
Monitoring/Scheduling/Reporting System once the examination is completed.
31-1 How to configure and select a MPPS host
• Click on the [Net] button at the top of the DL screen.
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This opens the window to configure the hosts. The tabs MPPS and Worklist is displayed if MPPS and Worklist
option is enabled.
Selecting the MPPS tab of Host Configuration screen, the user can configure the MPPS host.
Only one MPPS host can be configured.
By pressing [Save] button if all fields are filled in, the new host will be saved.
A [Verify] button allows checking if the network connection is alive between the Innova system and the remote
host.
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User can modify the host configuration details of the existing host.
User can DELETE the host by clicking the [Clear] and [Save] buttons in the given order.
31-2 How to send MPPS

MPPS will be sent automatically by the system.
At Start Exam, the initial MPPS message is sent over the network. At End Exam or Abort Exam, the final MPPS
message is sent over the network.
This message contains all patient demographic, dose related and exam related information.
31-3 How to check status of MPPS transfers
In the Patient and Exam Browser, the Network status will also consolidate the MPPS transfer status.
If the tool-tip displays: "Failure occurred during MPPS transferring. See Exam tab for more details."
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Steps to Resend MPPS:

Only Failed MPPS can be resent.
For resending failed MPPS, right-click on the selected Patient or Exam and click "Resend Failed MPPS".
Resend Failed MPPS from Patient Browser:
Resend Failed MPPS from Exam Browser:
status.
If the tooltip indicates "MPPS data has been transferred successfully" then, it implies successful transfer of all
MPPS for the selected patient.
31-4 How to integrate MPPS with Mac-Lab/CardioLab and Carddas system

In case the Innova system is connected to a Mac-Lab/CardioLab patient monitoring/scheduling/reporting or
Carddas patient scheduling/reporting system, the benefit is the automatic and complete X-ray documentation within
the Patient Monitoring/Scheduling/Reporting System. X-ray exam information is saved as part of the patient record
and report of the Patient Monitoring/Scheduling/Reporting System.
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THE EXAM STARTED ON INNOVA SYSTEM MUST ALWAYS BE THE EXAM THAT IS ACTIVE
ON THE PATIENT MONITORING/SCHEDULING/REPORTING SYSTEM. STARTING ANOTHER
EXAM ON INNOVA SYSTEM WILL LEAD TO FAILING THE EXPORT OF THE EXAM DOSE
AND DATA.
MAKE SURE THAT THE EXAM IS PROPERLY CLOSED BY PRESSING THE [END EXAM or
ABORT EXAM] BUTTON ON THE INNOVA SYSTEM BROWSER SCREEN. PRESSING THE
[END EXAM or ABORT EXAM] BUTTON WILL ACTIVATE THE AUTOMATIC TRANSFER OF
THE EXAM DATA. IF THE INNOVA SYSTEM IS RE-STARTED WITHOUT PROPERLY
CLOSING THE EXAM, THE EXAM DATA WILL NOT BE AUTOMATICALLY TRANSFERRED.
Each time an exam is ended on Innova System, the X-Ray information of the recently performed exam is sent to
the patient monitoring/scheduling/reporting system.
If the patient information is not populated on the Patient Monitoring/Scheduling/Reporting system, or the study is
not activated on the Patient Monitoring/Scheduling/Reporting system, it will be impossible to retrieve on Innova the
patient demographics via the Worklist. Therefore, a new patient and exam must be created manually on Innova.
At the end of this unscheduled exam, the X-ray exam information will be integrated in the patient record of
Mac-Lab/CardioLab and Carddas.
31-4-1 Known limitations with Mac-Lab/CardioLab system
The 'Cine Dose', 'Fluoro Dose', 'Total Dose' and 'Cine Frames' fields is not displayed in the Dose Report of
Mac-Lab/CardioLab. The user may get these values from the information displayed on the Innova screens. The
user can also find these values in the DICOM Dose Structured Report document that will be available in the Dose
Report Receiving station.
32 How to Network DICOM Dose Structured Report (Dose SR) to Dose SR

Receiving stations
DICOM Dose Structured Report (abbreviation: Dose SR) is a standard medium defined by DICOM to convey dose
information. It is structured document [a tree of information] containing X-ray and dose information. It is driven by
Safety and Regulatory guidelines [IEC Edition3].
Transfer of Dose SR is mandatory in the system.
Automatically Dose SR transfers, happens to one or several hosts (workstation, PACS...) configured.
32-1 How to configure and select a Dose SR host
• Click on the [Net] button at the top of the DL screen. The NETWORK QUEUE appears.
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This opens the window to configure different hosts. The tabs MPPS and Worklist is displayed if MPPS and Worklist
option is enabled.
Select the Dose SR tab of Host Configuration screen to create or modify Dose SR hosts.
If the user clicks on the 'Add' button, empty host parameter fields will be displayed for the new host.
Innova Digital 437

If Storage Commitment workflow is not enabled, the ‘Archive Station’ radio buttons will be disabled.
If Storage Commitment workflow is enabled, the ‘Archive Station’ radio buttons will be enabled.
Initial state of radio buttons: For Archive Station "No" is selected by default.
If the user checks ‘yes’ for ‘Archive Station’ option, the ‘Storage Commitment’ edit fields will be enabled and, if they
are empty, they will be filled in automatically with the same values as the storage host.
By pressing [Save] button and if all fields are filled in, the new host will be added to the list in the left window.
From the available host(s) list in the left window, user can select one or several host by clicking on its/their name
with the left mouse button.
In case of several hosts selected, use the Up and Down buttons to prioritize the transfer. The hosts may also be
dragged up or down to change their priority. Transfer is performed to host from first line of the list to last bottom line
of the list.
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• Click [Exit] to return to the Network Queue.

32-2 How to Network DICOM Dose Structured Reports
Optionally if storage commitment option is enabled, upon successful Dose SR transfer the system will request for
archival of the Dose SR's sent to the selected Dose Archive Stations.
In the Browser, when END or ABORT EXAM is clicked, Dose SR is automatically sent to all the configured Dose
SR SCP(s), if any acquisition [fluoro or record] was taken during the study, irrespective of the acquisition being
stored or pushed or deleted.
Note: ABORT EXAM will be enabled only if MPPS is enabled.
Dose SR has the dosage information of the exam performed, cumulated at every Performed Procedure Step level.
Run information (consolidated and not per frame) is provided for all fluoros, fluorostores and record acquisitions
[i.e, for every irradiation event] acquired for a Performed Procedure Step in Dose SR object
The reference to all images (record or fluoro acquisitions) that is acquired during the exam [in-between START and
END EXAM] is also included in the Dose SR object.
For the fluoro acquisitions, though the pixel data is not stored in system, Dose SR includes the available dose
values and irradiation event UID s associated with the fluoro image.
32-3 How to check the status of Dose SR transfers
In the Patient and Exam Browser, the Network status will also consolidate the Dose SR transfer status.
If the tool-tip displays: "Failure occurred during Dose Report transferring. See Exam tab for more details."

Innova Digital 439

Steps to Resend Dose SR:

Successful and Failed Dose SR’s can be resent.
For resending Dose SR’s, right-click on the selected Patient or Exam and click "Resend Dose Report".
Resend Dose Report from Patient Browser:
Resend Dose Report from Exam Browser:
status.
If the tooltip indicates "Dose Report has been transferred successfully" then, it implies successful transfer of all
Dose Reports for the selected patient.
32-4 How to integrate Dose SR with AW system

In case the Innova system is connected to a AW system in which Reporting Tool is installed, Innova can be
configured to transfer Dose SR automatically to AW system. The report can be viewed using the Reporting Tool in
AW.
1. Add AW as a new Data Transfer host in Dose SR tab.
2. Select AW as a destination host in Dose SR tab.
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3. Test the connection to AW system. In DL Browser, go to the NET tab, click the [Select Host] button.
Click on Dose SR tab.
a. Highlight the remote host in the left side window.
b. Click on the [Verify] button. A message box is displayed indicating the successful Echo to AW host.
32-4-1 Known limitations with AW Reporting Tool display
1. It could be possible that for DAP value’s <10-3 or >107, values displayed in the report are inconsistent with
Innova value displayed with AW Reporting Tool 2.8 and before. Reporting Tool 2.9 to be installed to overcome
the problem.
2. In the Reporting Tool, click on [Options] button In Display options window, set Decimal places to "4".
3. Restart AW.
33 Innova Screens Image Display
Innova Digital 441

Live Display
1 Patient data area

2 Display state
3 Live dose
4 Geometry area
33-1 Geometry Display

33-1-1 InnovaIQ Table
A specific "Tilted Table" icon followed by the tilt angulation in degrees is displayed on the left side of the live
display, in the Geometry area.
Example:
• in case of 8 degree Trendelenburg (head down) tilt, the tilt icon and 8 degrees will be dis-
played.
• in case of 8 degree Reverse Trendelenburg (head up) tilt, the tilt icon and 8 degrees will
be displayed.
• in case of table horizontal icon will be displayed.
When the geometry angles are displayed using anatomical labels (CRA/CAU, LAO/RAO), the displayed angles
take into account the position of the patient on the table, the rotation of the table and the tilt of the table.
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Examples:
• If the table is tilted 5 deg Trendelenburg and the gantry is 10 deg towards head, the display will show CRA 5.
• If the gantry is in the lateral position and the table is rotated 5 deg clockwise, the display will show LAO 90, CRA
5.
When the geometry angles are displayed with mechanical labels, plain gantry angles are used.
33-1-2 Omega Table
When the geometry angles are displayed using anatomical labels (CRA/CAU, LAO/RAO), the displayed angles
take into account the position of the patient on the table and the rotation of the table.
33-2 Status and Image Review
Displayed on left side of the live display to show that the displayed image
is a live fluoroscopic image.
is a recorded image.
Displayed on left side of the live display during a Fluoro performed in Au-
to Fluorostore mode.
is the frozen last fluoroscopic image.
Displayed on left side of the live display to show that the displayed image,
previously recorded, is reviewed.
Displayed on left side of the live display to show that a mask is available
for the Roadmap fluoro.
Displayed on the left side of the live display to show the system is in
Blended Roadmap and the selected percentage of vessel visibility
Displayed on left side of the live display to show the selected level of 30%
landscape for Subtracted or Roadmap fluoro.
Displayed at the bottom right of the live display to show that the displayed
image is a previously recorded image reviewed in Play mode Forward
image is a previously recorded image reviewed in Play mode Backward
Innova Digital 443

image is a previously recorded image reviewed in Pause mode (frozen
image)
image is a previously stored fluoroscopic image reviewed in Play mode
Forward nominal speed (review in loop)
Forward half speed (review in loop)
Forward high speed (review in loop)
Backward nominal speed (review in loop)
Backward half speed (review in loop)
Backward high speed (review in loop)
image is a previously stored fluoroscopic image reviewed in Pause mode
(frozen image)
Displayed on left side of the live display to show that an ECG signal is be-
ing detected
When reviewing a sequence or photo acquired when the table is tilted, a specific "Tilted Table" icon: or
is displayed on the bottom right side of the live or reference display.
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Reference display
Displayed on the right side of the right side of the reference display to
show that disk space is still available.
Displayed on the right side of the right side of the reference display to
show that disk starts to be full.
Blinking icon displayed on the right side of the reference display to show
that disk is near to be full.
Displayed on the right side of the reference display to show that disk is full.
Displayed on the right side of the reference display to show that at least
50% of heat units are still available in the X-ray tube.
Displayed on the right side of the reference display to show that available
heat units in the X-ray tube are between 30% and 50%.
Innova Digital 445

Blinking icon displayed on the right side of the reference display to show
that available heat units in the X-ray tube are below 30%.
Displayed on the right side of the reference display to show that the maxi-
mum heat units are reached in the X-ray tube.
Displayed on the right side of the reference display to show that the Fluoro
is ready (enabled).
Displayed on the right side of the reference display to show that the Fluoro
is not available (disabled).
Displayed on the right side of the reference display to show that the
Record is ready (enabled).
Displayed on the right side of the reference display to show that the
Record is not available (disabled).
Live and reference displays are managed independently, so, in some cases, it is possible to display images from
two different Exams of the same patient.
There is a delay between Photo storage and Photo display. In case of X-ray started before the Photo is displayed,
use Recall Photo to display the last stored Photo.
33-3 Technique factors display accuracy
The relative variation between actual and displayed high voltage (in kV unit) is within [0%; 0.07%].
The relative variation between actual and displayed tube current (in mA unit) is within [+/- 5%].
33-4 Dose Estimation
Error on dose estimation is within +/- 35 % interval in accordance with the international safety standard for Dose
Rate and Total Dose and which is valid down to 100 mGy for dose and 6 mGy/min for dose rate.
Error on Dose Area Product (DAP) estimation is within +/- 30 % interval in accordance with Switzerland legislation
which is valid down 2.5 Gy.cm² for DAP.
Compliance is tested with acquisition or duration longer than 3 seconds.
The estimation of the total dose (cumulated Air Kerma) (mGy) delivered to the patient is continuously displayed and
updated on the reference display. On the live display, the ratio (in percentage) of the actual Total Dose of the Dose
Threshold value is set within the protocol. The Dose Threshold value and a gauge icon visualizing the Dose
percentage of the Threshold are displayed during acquisition. After the Dose Threshold value is reached, the value
is displayed in reverse video. Once the Dose Threshold reaches twice the set Dose Threshold value, a warning
icon is displayed on the corresponding live display next to gauge icon.
Display prior to the predefined Dose Threshold value being reached:
Live Display Reference Display
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Display after the predefined Dose Threshold value is reached:
Display after the predefined Dose Threshold value has been exceeded (above 100%):
Display on live display after double of the predefined Dose Threshold value has been reached:
Live Display
Innova Digital 447

Possible states of the gauge icon depending on the actual Total Dose ratio to the Dose Threshold value.
0% of Threshold 101-125% of Threshold
1-25% of Threshold 126-150% of Threshold
76-99% of Threshold >200% of Threshold
100% of Threshold
Dose Threshold values are set in each protocol. The default Dose Threshold values are:
• 1 Gy Threshold for Pediatric protocols
• 2 Gy Threshold for protocols in head category
• 3 Gy Threshold for others
The Dose Threshold value of each protocol can be configured to any of the following values:
• 0.5 GY
• 1 GY
• 2 Gy
• 3 Gy
• 4 Gy
• 5 Gy
If you want to change Dose Threshold level for any of the protocols, contact your GE Healthcare Representative.
33-5 Monitor Pattern
On the DL keypad, a dedicated key (19) can be used to check the in-room/control room monitors.
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Note: The monitor pattern is not available while in review or under Ready for exam status (exam in progress).
• To display the pattern on both live and reference displays, press the blank (19) button.
• To remove the pattern:
1. Create a new patient and start the exam will blacken both screens.
2. Start a review of any sequence will remove the pattern from the live display.
3. Recall a photo will remove the pattern from the reference display.
33-5-1 Monitor Contrast Adjustment Check
The Contrast Adjustment Tool is used to set monitor brightness and contrast levels. They are correctly adjusted
when the 5% square inside of the black or white squares is visible. If this is not visible, brightness and contrast may
need to be readjusted. Monitor changes are to be performed only by service.
1 Contrast Adjustment Tool 1

2 Contrast Adjustment Tool 2
Innova Digital 449

33-6 Stopwatch
The Stopwatch when selected on the Innova Central touch screen has the capabilities of Start, Pause, Restart the
timer and Exit the function. Exit will abort the stopwatch and remove the display from the reference display's lower
left corner. Reclicking on Stopwatch button will close the window but leave the stopwatch displayed in the mode it
was last using.
After the Stopwatch button is pressed:

• Press on Start/Stop to start or stop the counting.
• Press on Reset to restart the counting from 0.
• Press on Stopwatch button again to hide/show the sub menu and keep counting.
• Press on Exit Stop Watch to close the sub menu and erase the display.
33-7 Electronic Shutter
When collimated, an electronic shutter can be automatically applied around the image area to optimize its esthetic
during Fluoro or Record acquisition, or during Review.
On the left side of the Innova Digital Screen, in the Image Display area, a Shutter button, activated by default,
allows to display or not the electronic shutter during acquisition (Fluoro or Record).
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The electronic shutter is always displayed few millimeters larger than the image area to keep the collimator blades
always visible during Fluoro or Record acquisition.
Note: In case collimator blades are moved during an acquisition, the electronic shutter displayed in review and
pushed will correspond to the largest position of the blades.
Using the Shutter button located on the DL Keypad it is possible to activate or not the electronic shutter in review.
In review, the electronic shutter is applied as close as possible to the image area to hide the collimator blades
completely.
Note: Only images acquired with electronic shutter can be reviewed with or without electronic shutter. For images
acquired without electronic shutter the Keypad’s Shutter button is inactive.
23 Show/Hide the electronic shutter in review
Innova Digital 451

THE OPERATOR'S ATTENTION IS DRAWN TO ALWAYS CHECK THE COLLIMATOR BLADE

EDGES ARE VISIBLE (NOT HIDDEN BY ELECTRONIC SHUTTER) BY CHECKING FOR A
SHARP TRANSITION BETWEEN THE ELECTRONIC SHUTTER EDGE AND THE COLIMATOR
BLADE EDGE. FAILURE TO CONTROL MAY LEAD TO NOT VISUALIZE EXPOSED
ANATOMY.
If a collimator blade edge is not visible, then the operator is recommended to:
For Record: Review the last acquired sequence with electronic shutter disabled to check for collimator blades
positions.
For Fluoro: Stop the ongoing Fluoro then disable the electronic shutter for the next acquisitions to check for
collimator blades positions.
For both cases: If the blades are not in their place, disable the electronic shutter using the Shutter button located
on the left side of the Innova Digital Screen, prior performing the next Fluoro or Record acquisition.
Note: When reviewing a stored Fluoro, it is not possible to remove the electronic shutter. In case of electronic
shutter failure during Fluoro, clinical data may be hidden by the electronic shutter and will be permanently lost.
Always refer to Recorded images on which electronic shutter can be disabled in review for diagnostic purpose.
452 Innova Digital

TM
Chapter 9 - InnovaSpin (Option)
The InnovaSpin option allows to perform an acquisition while the gantry rotates around its horizontal axis (pivot).
Rotation from RAO to LAO can be performed at up to 40°/s.
Rotation from LAO to RAO can be performed at up to 30°/s.
To prevent any collision during the rotation a test rotation at 10°/s must be performed first.
Time for gantry to speed up and slow down is included in the rotation trajectory.
1 Application Description
InnovaSpin is a software option that permits fast spin rotational angiography.
2 Safety Recommendations
1. Secure the patient on the table using appropriate restraints to prevent any motion during the gantry rotation.
2. Explain the procedure to the patient and ask him not to move during the gantry rotation
3. Clear the rotation area to prevent any collision during the rotation
4. In case of any problem during the rotation, releasing the exposure foot switch will activate the emergency break
of the gantry.
3 Acquisition Procedure and Timing

• Before selecting the InnovaSpin mode, select a protocol in Dynamic or InnovaChaseTM acquisition mode.
• Position the region of interest (ROI) at isocenter. The table top shall not be rotated.
• Using the Auto Positioner on the Table Side Status Control (TSSC), select Operator F then one of the 7
predefined rotation trajectories.
– Angles and speed of rotation can be checked on the lower left corner of the live display.
– "Spin" is displayed on the right side of the reference display.
– "Ready for Spin Test" is displayed in the status area of the live display.
– TEST button on the TSSC flashes.
• Press and hold the Test button. During Test rotation, perform short fluoros to check that the ROI is well
isocentered.
– "Spin Test in Progress" is displayed in the status area of the live display.
– Gantry first moves from current position to end of spin position. Manual motion of the table is allowed (except
table rotation).
– Then, gantry moves from end of spin to start of spin position (this phase is the safety test rotation). No
manual gantry or table motion is allowed.
– When the start position is reached, the Test button goes OFF and can be released. "Ready. Clear Rotation
Area" is displayed in the status area of the live display.
Note:
- The Test button must be pressed within 30 seconds after the trajectory was selected. In case of longer time,
reselect the trajectory to reactivate the Test button.
- The test rotation is valid for 5 minutes. After this time, the InnovaSpin mode will be aborted.
• Press on the exposure foot switch. X-ray starts and Test button goes ON. Perform injection as usual.
• When contrast media starts to appear on the image, press once on the Test button to start the gantry rotation.
– Test button goes OFF.
InnovaSpinTM (Option) 453

– At the end of the rotation, the gantry motion is stopped and X-ray can still be performed until the exposure
footswitch is released
• Releasing the exposure footswitch will exit from the InnovaSpin mode. "Dynamic" or "Chase" is displayed back
on the reference display.
Note: If you choose to keep shooting X-ray once the InnovaSpin is finished, some gantry vibrations might occur
and be visible on the image depending on the trajectory performed.
4 Trajectories Settings
Spin trajectories are preloaded in the Innova system.
However, gantry Start position, End position and rotation speed can be modified for each trajectory.
If needed, contact your GE Healthcare Representative for any trajectory modification.
5 User Messages
Information and error messages are displayed in the status and Error Message areas located at the bottom of the
live display.
Message What is happening?
"SELECTION NOT ALLOWED, ACQUISITION IS IN • You tried to enter spin mode with an X-ray switch-
PROGRESS" appears in error area. pressed. This in not allowed.
or
• You tried to reselect a trajectory with an X-ray switch
pressed. This is not allowed.
"SELECTION NOT ALLOWED, RELEASE TEST BUT- • You tried to enter spin mode with Test button-
TON" appears in error area. pressed. This is not allowed.
or
• You tried to reselect a trajectory with Test button-
pressed. This is not allowed.
"SELECTION NOT ALLOWED, TABLE IS ROTATED" You tried to enter spin mode with Table rotated. This is
appears in error area. not allowed.
"RECORD ACQUISITION NOT ALLOWED, SPIN TEST You tried to perform a record during test phase. This is
IS IN PROGRESS" appears in error area. not allowed.
"RELEASE FLUORO SWITCH FOR SPIN ACQUISI- You tried to select a new spin position during a Fluoro
TION" appears in error area. acquisition. This is not allowed.
"RELEASE TEST BUTTON FOR SPIN ACQUISITION" After test phase completed, you tried to start acquisition
appears in error area. with test button already pressed. This is not allowed.
454 InnovaSpinTM (Option)

"SPIN SETUP ABORTED, RESELECT TRAJECTORY" You got out of spin mode before performing spin acqui-
appears in error area. sition.
This can happen if:
• There was a user gantry or a table motion between
end and start position during test phase.
or
• There was a collision between end and start position
during test phase.
or
• You exited operator "F".
or
• You selected a new protocol.
or
• 5 minutes has been elapsed after a spin test.
"SPIN ACQUISITION ABORTED, RESELECT TRA- You stopped acquisition during Spin acquisition.
JECTORY" appears in error area. There is no error or status message and you cannot se-
lect the F operator: You tried to select InnovaSpin mode
but other than a Cardiac or the InnovaChaseTM protocol
is selected. This is not allowed.
"READY FOR SPIN TEST" appears in status field. You just entered Spin mode.
"SPIN TEST IN PROGRESS" appears in status field. Spin safe test is running.
"READY. CLEAR ROTATION AREA" appears in status You are ready to start acquisition then launch Spin.
field.
InnovaSpinTM (Option) 455

Chapter 10 - Innova Positioner
1 How to move the Table/Gantry

Depending on system configuration, a Smart Box or Smart Handle (not available with InnovaIQ Table) can be used
to activate all table and gantry axes.
These user interfaces are installed on the table accessory rails. If needed, they can be moved all along the rails on
both sides of the table or mounted on a tablesidecart (Option).
1-1 Omega Smart Box
456 Innova Positioner

# Symbol Name
1 Table Panning: press down first, then
pan.
2 Gantry Motion Control: press down

first, then tilt. Use the joystick to rotate
the C-arm around the patient.
3 Table Control Up/Down, Motorized
Longitudinal Tabletop: press down
first, then tilt.
4 Detector Elevator Control Up/Down:
press down first, then tilt Up/Down.
Move the joystick up or down to raise
or lower the detector.
5 Anatomic/Machine Mode Control.
Pressing this button allows to toggle
between Anatomical and Mechanical
modes. The selection affects the be-
havior of the positioning joysticks.
In Mechanical mode, each axis of the
gantry is controlled independently.
In Anatomical mode, the motion of the
axes is combined in order to allow
motion with respect to the patient.
6 L-Arm Control: squeeze first, then tilt
to position the L-Arm.
7 Positioner Enable/Disable: activate

this button to disable all table/gantry
axis commands (button highlighted).
Press this button again to reactivate
all table/gantry axis commands
(button light OFF).
8 InnovaSense patient contouring
(Option)
Innova Positioner 457

9 Not applicable A 3 positions black switch is located

under the Smart Box to adapt the
gantry and table directions to the lo-
cation of the Box.
Depending on the location of the
Smart Box, either on the right or left
side of the table, slide the black
switch toward the table head end to
be correctly oriented. Position the
black switch in intermediate position if
the Smart Box is installed at foot end
of the table. In this case, gantry C-
Arm and Pivot are reversed.
10 Not applicable Rail Fixation Release
The Positioner Enable/Disable button only enables/disables commands from the Smart
Box/Handle and Table Side Status Control. It does not enable/disable table top brakes
commands from the Fluoro/Record footswitch or the Table Panning handle.
Each joystick is equipped with a double activation (Enable and Command) system to avoid unintended activation of
the motion control commands. To activate a joystick, press down first to activate the Enable, and then apply the
desired Command.
Note: In case of collision between two mechanical parts or with the patient, with activation of a collision sensor (see
Innova Positioner / Collision Sensors), the anti-collision software stops the gantry. Release the enable trigger and
press it again. Gantry motion will automatically reverse to clear the collision. After the collision was cleared, call
Service in case the gantry moves permanently at low speed.
In case of collision between two mechanical parts or with the patient, without activation of a collision sensor, the
anti-collision software progressively slows down the gantry motion. An audible signal is activated and the visual
gantry display located at the bottom left of the live display is highlighted. The command of the gantry or table must
be released to prevent any collision.
Note:The Smart Box is equipped with protection barriers to prevent as much as possible the risk of unintended
motions. Do not remove the protection barrier.
1-2 InnovaIQ Table Smart Box
ALWAYS SECURE PATIENT WITH APPROPRIATE RESTRAINTS BEFORE TILTING THE

TABLE IN ANY DIRECTION.
InnovaIQ Table (IR configuration) InnovaIQ Table (OR configuration)

# Symbol Name
1 Table Panning Assist Joystick: press
down first, then pan.
2 Gantry Motion Control: press down

first, then tilt. Use the joystick to rotate
the C-arm around the patient.
3 Table Control Up/Down and tilt: press
down first, then:
-tilt Up/Down to move the table Up/
Down
-tilt Righ/Left to tilt table Head Up/
Down


gantry and table are controlled inde-
pendently.

(button light OFF).
(Option)

under the Smart Box to adapt the
cation of the Box.
Smart Box, either on the right or left
side of the table, slide the black
be correctly oriented.
11 Emergency Stop
Innova Positioner / Collision Sensor), the anti-collision software stops the gantry. Release the enable trigger and
1-3 Table Panning Assist Joystick (item 1)

The joystick is pressure sensitive.

As for other joysticks, press down first to activate the Enable, then apply more or less pressure in any direction to
activate the assisted panning.
After the Enable is activated, apply more or less pressure in any direction to speed up/slow down the table top
motion.
The assisted panning is also available when the table is tilted.
1-4 Table Control Up/Down and Tilt (item 3)
After the Enable has been activated by pressing down the joystick, move it Up or Down to raise or lower the table;
move it Right or Left to tilt the patient's head down or up.
The tilt range is from Trendelenburg 20 (head down) to Reverse Trendelenburg 12 (head up).
The tilt motion automatically stops for 1 second when the table reaches horizontal. Release the tilt command to
stop at horizontal ; maintain the tilt command to continue the tilt motion.
When the Anatomic mode is activated (button 5 light OFF), the region of interest (ROI) located at the center of the
image is kept centered whatever the tilt angulation is, and the gantry angulation related to the patient is preserved
while the table is tilting.
In such condition, the positioner works in the so called “Incidence keeping” mode in the tilt range from 12° Head up
to 20° Head down.
When the positioner works in Anatomical mode:
1 - The table automatically moves Up or Down and the longitudinal table top automatically moves toward
Head and Foot to keep the ROI centered when tilting the table.
2 - The gantry pivot and C-arm automatically move to keep the X-ray beam angulation related to the patient
constant when tilting the table.
3 - If the user pans and tilts the table while in the Anatomical mode, the Isocenter Tracking mode will
deselect and only keep the Incidence keeping mode active to allow the tilt of the gantry to follow the
panning and tilt of the table simultaneously.
Whenever tilting the table more than 5 degrees, explain to the patient that it is normal for
him/her to feel slight movement on the table. This will assure the patient and prevent any
unwanted movement during imaging.
When the Machine mode is activated (button 5 light ON), all table and gantry axes work separately.
In such mode, the ROI is not kept centered and the gantry angulation is not preserved when the table is tilted.
Moving the joystick Right/Left will only tilt the table.
1-5 Emergency Stop (item 11)
In case of emergency, press the Emergency Stop button.

All gantry and table motions will stop.

To reset from an emergency stop, press the Reset button at TSSC underside (See Section 1.7 - InnovaIQ Table
Side Status Control)
Note: This Emergency Reset button can be activated on the TSSC installed in the exam room only.
Note: When the Stop Button (11) is activated, the button is fully highlighted.
When the Stop Button (11) is not activated, the button light is dimmed and fluctuates to show that the button is alive
and in working condition.
THE STOP BUTTON (11) LIGHT PERMANENTLY OFF INDICATES A FAILURE IN THE
EMERGENCY STOP BUTTON MECHANISM. HANDLE THE SYSTEM WITH CARE AND
CONTACT YOUR GEHC SERVICE REPRESENTATIVE AS SOON AS POSSIBLE.
1-6 Omega Smart Handle (Not available with InnovaIQ Table)

# Symbol Name
1 Table Control Up/Dow, Motorized
Longitudinal Tabletop: press down
first, then tilt.
3 C-Arm Gantry Motion: Press Gantry
Enable first, then press button right or
left.
4 Table Panning/Pivot Gantry Motion:
press respective Enable first, then ro-
tate.
gantry and table are controlled inde-
pendently.

(button light OFF).


(Option)

under the Smart Handle to adapt the
cation of the Handle.
Smart Handle, either on the right or
left side of the table, slide the black
be correctly oriented.
11 Not applicable Table and Gantry Enable Release
(short or long button can be config-
ured at installation to enable either
the table or the gantry).
Innova Positioner / Collision Sensor), the anti-collision software stops the gantry. Release the enable trigger and
1-7 Manual L-Arm Positioning
Always use the L-Arm brake release button (1) to manually position the L-Arm. The brake release is located on a
handle at the upper end of the L-Arm. Press one or both side buttons on the handle to release the brakes and
manually position the L-Arm.
You can freely move the L-Arm to its limits in either direction. A built-in hard stop limits travel.
Note: In case of failure of the L-Arm brake, it is still possible to overcome the L-Arm brake by pushing with
sufficient strength so clear the patient as needed in emergency situations.
In normal situation avoid pushing the L-Arm without using the brake button, as it can create
a small drift of the "zero" position of the L-Arm, which can impact the Innova Vision
applications.

1-8 Additional Table Panning Handle

Press the switch located at the top of the handle to release the longitudinal and lateral tabletop brakes; the tabletop
can be moved manually.

1 Omega Table 2 Table Panning Handle
Note: With the InnovaIQ Table, the activation of the switch will only release the lateral table top brake when the
table is tilted.
1-9 Omega Table Side Status Control (TSSC)

1 Collimator Control 12 Bolus Start / End / Reset

2 Contour Filter Control 13 Fluoro Preference - Normal/Low
3 Auto Positioning 14 Spin Test Control
4 Field Of View Control 15 Fluorostore
5 Fluoro Landscape Control 16 Lateral / Longitudinal Brakes
6 Room Light Control 17 X-ray Timer Reset
7 Not Used 18 Table Rotation Brakes
8 Operator Selector (Auto Positioning) 19 Collimator Blades Parking Control
9 Record Detail Selection (DSA Option) 20 Contour Filter Blade Parking Control
Pref1 / Pref2 (Cardiac)
10 Emergency Stop 21 Auto Positioner Gantry Store Control
11 Subtracted, Roadmap or Blended Roadmap Se-
lection
Note: In case a second TSSC is used in control room, all commands driving any gantry motorized axis are disabled
(i.e.: gantry Test rotation).
In case of Emergency, press the Emergency Button (10). All Gantry and table motions will stop.
To reset, press the RESET Button at TSSC underside.

1-10 InnovaIQ Table Side Status Control (TSSC)
InnovaIQ Table (IR configuration)
InnovaIQ Table (OR configuration)

1 Collimator Control 12 Bolus Start/End/Reset

2 Contour Filter Control 13 Fluoro Preference - Normal/Low
3 Auto Positioning 14 Spin Test control
4 Field Of View Control 15 Fluorostore
5 Fluoro Landscape Control 16 Lateral / Longitudinal Brakes (lateral brake only
when table is tilted)
6 Room Light Control 17 X-ray Timer Reset
7 Not Used 18 Table Rotation Brakes
8 Operator Selector (Auto Positioning) 19 Collimator Blades Parking Control
9 Record Detail Selection (DSA Option) 20 Contour Filter Blade Parking Control
Pref1 / Pref2 (Cardiac)
10 Emergency Stop 21 Auto Positioner control for Gantry, Table and
Gantry/Table Store
11 Subtracted, Roadmap or Blended Roadmap Se-
lection
Note: When a second TSSC is used in the control room, the Lateral/Longitudinal brakes (button 16) and/or the
table Rotation brakes (button 18) are disabled.
Note: In case the Lateral/Longitudinal brakes (button 16) and or the table Rotation brakes (button 18) are activated
to release the brakes, these brakes will be automatically reengaged in case no motion is detected within the next 3
minutes.
In case of emergency, press the Emergency button (10). All Gantry and table motions will stop.
To reset, press the RESET button at TSSC underside.

Note: When the Stop button (10) is activated, the button is fully highlighted.
When the Stop button (10) is not activated, the button light is dimmed and fluctuates to show that the button is alive
and in working condition.
THE STOP BUTTON (10) LIGHT PERMANENTLY OFF INDICATES A FAILURE IN THE
EMERGENCY STOP BUTTON MECHANISM. HANDLE THE SYSTEM WITH CARE AND
CONTACT YOUR GEHC SERVICE REPRESENTATIVE AS SOON AS POSSIBLE.
1-11 Table brakes button management
Table brakes behavior versus button's state:
• Omega Table
If you press on the Table longitudinal/lateral button or Table rotation button, the table release brake function, will
be immediately activated: the user will be able to move the table manually.
• InnovaIQ Table
If you press on the Table Brake longitudinal/lateral button or Table rotation button, you will have to release the
button first to activate the selected function.
If you don't release it and continue to press, NO Table Release Brake function will be activated: the user will not
be able to move the table manually, the table will still be locked.
1-12 Tableside Cart (Option)
1-12-1 General Description
The Tableside Cart is delivered with two accessory rails, each designated to hold up to two GE Healthcare Table
Side User Interface (TSUI). Depending on the configuration, the Tableside Cart can be installed with one or two
accessory rails.

1 Tableside Cart configuration with one accessory rail

2 Tableside Cart configuration with two accessory rails
There are four configurations of the Tableside Cart with one accessory rail. The approximate height from the floor
to the rail for these four configurations is the following:
• 75.5 cm (29.7 in)
• 82 cm (32.3 in)
• 98 cm (38.6 in)
• 104.5 cm (41.2 in)
There are two configurations of the Tableside Cart with two accessory rails. The approximate height from the floor
to the rail for these two configurations is the following:
• Bottom rail: 75.5 cm (29.7 in) Top rail: 98 cm (38.6 in)
• Bottom rail: 82 cm (32.3 in) Top rail: 104.5 cm (41.2 in)
Contact your GE Service Representative for any mechanical modification.
Handles located on the front and on each side allow moving the Tableside Cart in any direction.
Two brakes located on the front side of both front wheels, can be used to immobilize the Tableside Cart when
needed.
1-12-2 Environmental working conditions
Because the TSUI’s cables are connected to the table, the Tableside Cart must remain near the InnovaIQ table at
a distance of 2 or 3 m around the table base, depending on the cable lengths.
If one of the TSUIs mounted on the Tableside Cart has a cable length of 3 m (118 in), the Tableside Cart must
remain at a maximum distance of 2 m around the table base.
If all the TSUIs mounted on the Tableside Cart have a cable length of 4 m (157.5 in), the Tableside Cart must
remain at a maximum distance of 3 m around the table base.
1-12-3 How to move the Tableside Cart
Release first both front wheel brakes by lifting up the brake command. Then use the frontal handle or handles on
each side of each accessory rail to move the Tableside Cart in any direction.
When the Tableside Cart is positioned at the proper location, push down the brake command located in front of

each of the frontal wheels to immobilize the Tableside Cart.
1 Brake released
2 Brake engaged
3 Handles used to move
1-12-4 Table Side User Interfaces on the Tableside Cart

The Tableside Cart is designed such that the TSUIs are clamped on its rails exactly the same manner as they are
clamped on the table accessory rails.

BEFORE USING THE TSUIs ON THE TABLESIDE CART, BE SURE THEY ARE WELL
CLAMPED ON THE RAILS. FAILURE TO DO SO MAY LEAD TO STAFF INJURY DUE TO
TSUIs FALLING.
ALWAYS ENSURE THE SWITCH SIDE CONFIGURATION OF THE SMART BOX IS

CONSISTENT WITH THE POSITION OF THE CART. FAILURE TO DO SO MAY RESULT IN
PATIENT OR STAFF INJURY DUE TO UNCONTROLLED MOTION.
When using the Smart Box on the Tableside Cart to move the gantry or the table, keep the
Tableside Cart accessory rails parallel to the table accessory rails or to the Tabletop end.
1-12-5 Cable Routing
The cable routing on the Tableside Cart is designed to avoid TSUIs cables hanging down from the rails or lying on
the floor.
Two cable strips are used for tying TSUI cables on the Tableside Cart and four cable winders are used for winding
the TSUI cables to minimize the cables lying on the floor.

1 Cable winder
2 Cable tie
ALWAYS ENSURE THE TSUI CABLES FROM THE TABLESIDE CART ARE NEVER IN A
LOCATION WHERE PATIENT OR STAFF COULD TRIP. USE THE FOUR CABLE WINDERS TO
REDUCE THE MINIMUM LENGTH OF THE TSUI CABLES LYING ON THE FLOOR.
1-12-6 Safety mechanism
The shape and size of the front and side handles is designed to avoid unexpected table and gantry motion due to
an unwanted activation of the TSUI in case of collision between the Tableside Cart and other equipment.
Wheels are designed to prevent any unexpected X-ray pedal activation and to roll over any TSUI cables.

1-13 Error Management (available with Omega table only)

In case of dysfunction detected either in the Control Panel, Smart Handle or Smart Box, the Field of View display
and the Auto Positioner Operator selection display windows located on the Control Panel will start flashing. (In
some cases, the flashing may start up to 5mn after the dysfunction started).
The two windows are used to display an error code in order to help your GE Service Representative solve the
problem.
Please, note this error code before calling GE Service.
The windows will display information as follows:
- for the first 5 seconds: error code flashes
- for the next 10 seconds: steady initial display, and so on.
THIS TYPE OF DYSFUNCTION MAY CAUSE UNEXPECTED GANTRY MOTION AND RESULT
IN SEVERE INJURY TO THE PATIENT OR PEOPLE AROUND THE GANTRY.
AS SOON AS THE ERROR CODE IS DISPLAYED ON THE CONTROL PANEL (TSSC), YOU MAY TERMINATE
YOUR EXAM WITH CAUTION AND MUST REPORT TO YOUR GE SERVICE REPRESENTATIVE
IMMEDIATELY.
1-14 Remote Stand (Option)
The Remote Stand is installed in the control room by your GE Service Engineer. It is used to mount the Smart Box
and TSSC in the control room allowing movement of the gantry and table remotely. The Remote Stand can be
configured to have the main column either to the left or right side of the rail arms. The direction will be selected
based on the position it is mounted on the counter to make the controls easily accessible to the user but not
extending beyond the counter surface. It is important that the stand and controls are always in a position that the
patient and equipment are clearly visible and the view unobstructed to the operator. Keep the surrounding area free
of objects that could fall on the controls and cause an uncontrolled motion.
DO NOT ATTEMPT TO MODIFY THE INSTALLATION OR CONFIGURATION OF THE REMOTE

STAND. TO DO SO, MAY RESULT IN SEVERE PATIENT OR STAFF INJURY DUE TO AN
UNCONTROLLED MOTION. CONTACT YOUR GE SERVICE REPRESENTATIVE FOR ANY
MODIFICATION.
The following user interfaces can be installed:
• Smart Box

The Remote Stand is equipped with a knob to lock or unlock the rotation of the two arms:
• Turning the knob counter clockwise will unlock the arms and allow rotation around the axis of the stand. Adjust
the position of the arms as needed.
• Turning the knob clockwise will lock the rotation of the arms and hold them in the desired position.
Note: Do not use the joysticks of the Smart Box or TSSC to move the stand.
ALWAYS ENSURE THAT THE ROTATION OF THE REMOTE STAND IS LOCKED BY PULLING
ON ITS ARM BEFORE USING THE EQUIPMENT. FAILURE TO DO SO MAY RESULT IN
SEVERE PATIENT OR STAFF INJURY DUE TO AN UNCONTROLLED MOTION.
1-15 InnovaIQ Cable Holder
The cable holder for the InnovaIQ Table encloses and guides the Table Side User Interface (TSUI) cables during
the table movements and thereby protects the cables from entangling and getting cut during table movements.
• The sheath can be moved from one side of the table to the other without opening it.
• It can be opened to selectively add or remove cables.
• It can be removed for cleaning.
THE CABLE HOLDER WILL BE EFFECTIVE ONLY WHEN THE SHEATH IS PROPERLY
INSTALLED AS PER THE OM INSTRUCTIONS.
DO NOT USE THE GUIDE ROD TO ATTACH DEVICES OTHER THAT THE CABLE SHEATH.
DO NOT USE THE GUIDE ROD TO ATTACH CABLES WITHOUT USING THE SHEATH.
MAKE SURE NO OBJECT LIES UNDER THE TABLE, WHICH THE CABLES COULD GET
CAUGHT INTO.
The following TSUI cables shall always be routed through the Cable Holder when installed on the table rail.
• Smart Box
• Table Panning Device (TPD)


• Ground wire from Innova IVUS (if it exists)
1-15-1 How to Swap TSUIs
• Position the table top towards head.
• Detach the sheaths on both sides.
• Remove the devices from the rail and keep them over the top of the table.
• Fix the devices onto the other side rail.
• Attach the sheaths on both sides.
1-15-2 How to Add/Remove Cables - For Moving Specific TSUIs
• Detach the sheath on both the sides.
• Open the sheath, remove the cables of the controls, which needs to be swapped and close the sheath.
• Remove the devices from the rail and move them to the other side.
• Open the other sheath and add the cables and close the sheath.
• Attach the sheaths on both sides.
1-15-3 How to Use with TableSide Cart
WHEN USING THE TABLESIDE CART, ALWAYS RELEASE THE CABLE LOOPS OF THOSE
CABLES ON THE TABLESIDE CARTOR THE CABLES WILL BE TOO SHORT TO LAY ON
THE FLOOR.
IF, AFTER USING THE TABLESIDE CART, THE DEVICES ARE BROUGHT BACK TO THE
TABLE RAIL, THE EXTRA CABLE LENGTH MUST BE LOOPED AGAIN TO AVOID CABLES
GETTING CAUGHT.
• If all the devices are moved to the TableSide Cart, the sheath can be left on the cables.
• If only some devices are moved to the cart, the cables of those devices should be taken out of the sheath.
1-15-4 How to Remove and Install the Sheath
Removing the Sheath
Note:

• The basic configuration has items 2, 3 and 4.

• Item 1, applicable only for with the adapter rail option and extension sheath.
1-15-4-1 Detaching
• Optionally when there is an extension sheath, unhook item 1.
• Detach the front portion of sheath from the turn button fastener (item 2).
• Detach the middle portion of sheath from the sliding ring (item 3).
• Detach the rear portion of the sheath from the behind the table foot (item 4).
1-15-4-2 Attaching
To install it attach it first to the shoulder screw at the back of the table (item 4), sliding ring (item 3), and finally the
turn button fastener on the other side (item 2). Optionally when there is an extension sheath, attach the hook joint
to the first spacer of accessory rail (item 1).
1-15-5 How to Place Cables In and Out of the Sheath
• Once the sheath is detached, open the zipper fully to release the sheath from the cables.
• To install the sheath, insert all the cables back into the sheath and close the zipper.
Note:
• Basic Configuration
While fixing the sheath zipper on each side, ensure all the cable markers (see illustration
Cable Markers, item 1) are aligned over the end of the zipper.
Cable Markers
• Optional configuration with extension sheath

There are two sheaths connected by two flap buttons (item 2).
Note: If in case the two sheaths are separated, connect them with the two flap buttons.

1-15-6 How to Release the Cable Loops

Release the TSUI cable loop by releasing the cable tie.
1-15-7 How to Loop the Extra Cable Length

Loop the excess cable length, which comes outside the sheath, individually, using the cable tie.
1-16 Omega Cable Holder
The cable holder for the Omega Table encloses and guides the Table Side User Interface (TSUI) cables during the
table movements and thereby protects the cables from entangling and getting cut during table movements.
• The cables in the center sheath divides to left and right sides rails accessories.
• It can be opened to selectively add or remove cables.
• It can be removed for cleaning.
THE CABLE HOLDER WILL BE EFFECTIVE ONLY WHEN THE SHEATH IS PROPERLY
INSTALLED AS PER THE OM INSTRUCTIONS.
DO NOT LEAVE ANY TSUI OR GROUNDING CABLES OUTSIDE THE SHEATH WHEN CMD IS
IN USE.
DO NOT TRY TO ROTATE TABLE BEYOND 90 DEG. WITHOUT FOLLOWING INSTRUCTIONS.
MAKE SURE NO OBJECT LIES UNDER THE TABLE, WHICH THE CABLES COULD GET
CAUGHT INTO.
The following TSUI cables shall always be routed through the Cable Holder when installed on the table rail.

• Smart Box
• Table Panning Device (TPD)
• Ground wire from table
• Injector (Mark V Table Mounted)
1-16-1 How to swap TSUIs
When side sheath option is used, follow below instructions to swap accessories:
• Unhook the accessory cable from rail hook.
• Remove the side sheath zipper; take only the desired cable out from the internal strap and button it back, then
close the zipper.
• Move the accessory to the other side.

• Route the cable in the other side sheath. Make sure it is going through the internal strap, and close the zipper.
• Hook the extra length cable in the rail hook to prevent sagging.
When Cable Holder mechanism is used, follow the below instructions:
• Unhook the accessory cable from rail hook.
• Remove the cable with ferrule from the Cable Holder mechanism, and move the accessory to the other side.

• Tag the ferrule in the other side Cable Holder mechanism.

• Open the flap in the middle sheath, and move the cable to the other side; button the flap back.
1-16-2 How to Rotate the Table beyond 90 deg. when Cable Holder is in use
DO NOT TRY TO ROTATE TABLE BEYOND 90 DEG. WITHOUT FOLLOWING INSTRUCTIONS.
Note: Table shall be rotated up to 90 deg. without any change in setup.
• Remove all ferrules from both side Cable Holder (with Cable Holder option); or unhook from the rails the two
hooks of the side sheath (with side sheath option).

• Remove central hook of middle sheath from cover plate.
• When the table is rotated back to its home position, make sure that all ferrules and hooks are placed back into
their original positions.
1-16-3 How to Use with TableSide Cart
WHEN USING THE TABLESIDE CART, ALWAYS RELEASE THE CABLE LOOPS OF THOSE
CABLES ON THE TABLESIDE CARTOR THE CABLES WILL BE TOO SHORT TO LAY ON
THE FLOOR.
IF, AFTER USING THE TABLESIDE CART, THE DEVICES ARE BROUGHT BACK TO THE
TABLE RAIL, THE EXTRA CABLE LENGTH MUST BE LOOPED AGAIN TO AVOID CABLES
GETTING CAUGHT.
• If all the devices are moved to the TableSide Cart, the sheath can be left on the cables.
• If only some devices are moved to the cart, the cables of those devices should be taken out of the sheath.
1-16-4 How to Remove and Install the Sheath
1-16-4-1 Detaching the Sheath
• Remove the side sheath zipper, unbutton the internal straps and take the cables out.
• Unhook the side sheath from the rail

• Remove the center sheath and middle sheath zippers to remove the center sheath.
• Unhook the sheath metal holder from the two supports.
1-16-4-2 Attaching the Sheath

• Collect all the cable self-laminated label marks together, and make sure cables are twist-free.
• Keep label marks at the start of the center sheath, and close sheath zipper.
• Button the center sheath flap at the top.

• Follow cable looping procedure in case extra length cables are found outside the center sheath.
Side Sheath Attaching:
• Attach the side sheath zipper with the center sheath.

• Put the cables inside the internal straps, and close the side sheath zipper.
• Mount the side sheath hooks on the channel block of rail.
1-16-5 How to Loop the Extra Cable Length
Once the center sheath is installed, the extra length of cables coming out of it has to be managed through cable tie
and holder.
• Use the cable tie to group cables on rest point bracket. Provide extra length of ~120mm from cable tie to the
center sheath end.
Note: In case of shortage of length of cables, adjust the cables in the center sheath to accommodate for extra
length requirement
• Use cable tie and holder to carry the loop of cables inside the rest point board.
• Confirm all TSUI connections are good; Close the rest point board with cover.

2 Collimator Control
The collimator is controlled automatically when operator selects a Field Of View on the TSSC.
The collimator may also be operated manually at the TSSC.
There is a permanent safety mechanism which ensures automatically for the operator that the X-ray beam will
never expose patient body areas which are not displayed on the monitor (SID and FOV tracking).
1 Not Used
2 Not Used
3 Lateral Blades Closed
4 Lateral Blades Open
5 Longitudinal Blades Open
6 Longitudinal Blades Closed
7 Auto-Collimation
Auto-Collimation: Provides the means to quickly open collimator blades to maximum exposure area for the
selected FOV. When in auto-collimation, LEDs on both iris blades control buttons are ON. As soon as the collimator
blades are manually entered in the FOV, LEDs go OFF.
There are two ways to visualize the location of the collimator blades:
• While performing Fluoro:
Move the collimator joystick to visualize and position real time the collimator blades over the selected anatomy.
• Out of Fluoro:
Move the collimator joystick to visualize and position virtual lines displayed over the Last Image Hold (LIH) or
over any image in review on the live display.
Note: Virtual lines displayed represent the current location of the collimator blades and may not match, in case
of gantry or table motion, with the anatomy of an image previously acquired.
These virtual lines are displayed just few seconds over the image each time the collimator blades are moved
either manually using the collimator joystick or either automatically when changing the gantry SID or detector
FOV.
Note: There is always a short delay between the time the collimator blades move and the time the position of
the virtual collimation lines is updated on the image. If X-ray is performed before the position of the virtual
collimation lines stabilizes, the X-ray beam might not perfectly match the area shown by the virtual collimation
lines.
Recommendation: wait for the virtual collimation lines to stabilize before performing fluoro or record
acquisition.
Gantry informations linked to the acquired image and displayed in the bottom right corner of the live display are
removed during the few seconds the virtual collimator lines are displayed.
Note: Collimator blades can be moved during DSA, Chase and Dynamic Record acquisitions. Collimator blades
controls are disabled during Bolus and 3D Record acquisitions to allow further successful image reconstruction.
2-1 Contour Filter Control

1 Left Contour Filter Blade Selection

2 Right Contour Filter Blade Selection
3 Central Contour Filter Blade Selection
4 Auto Parking Positioning
5 Moving Inside the Field
6 Moving Outside the Field
7 Rotation Control Clock Wise
8 Rotation Control Counter Clock Wise
Any combination in simultaneous blades selection is available.

Blade selection button lit when selected.
Note: Contour filter blades cannot be moved during any Record acquisition.
3 Omega Table Auto Positioning

The Auto Positioner stores gantry angulations only.
3-1 Auto Positioning Control
The Auto Positioning control allows storing and recalling gantry positions.
It gives access to 9 operators. 7 positions can be stored and recalled for each operator.
3 Auto Positioner Selector

8 Operator Selector
3-2 Auto Positioner Selector
1 Back to PA Position: press down first; then tilt left

2 Back to Lateral Position: press down first; then tilt right
3 7 memorized Gantry Positions
4 To reach a preselected position, press the number button first and enable the movement by pressing
the joystick down and then tilt upward
5 To reach a preselected position, press the number button first and enable the movement by pressing
the joystick down and then tilt downward
6 Press to store the position
To store a position:
• Move the gantry in the position to store.
• Using the Operator Selector (button 8), select an operator number.
• Using the Auto Positioner Selector (button 3), select a position number. The button light goes On.
• Press the store icon (button 6) to store the gantry position, the light of the position number goes Off then On
again to show that the storage is performed.
Note: If no storage action is performed within 30 seconds after the position number is selected, the light of the
position number will automatically go Off. In such case, reselect the position number again.
To recall a position:
• Using the Auto Positioner Selector (button 3), select a position number. The button light goes On and the gantry
position previously stored is displayed in reversed video on the live display.
• Using the Auto Positioner joystick, press down first then tilt the joystick Up or Down to move the gantry to the
previously stored position. At the end of the motion, the information "Position Reached" appears in the lower left
corner of the live display.
3-3 2D Send Angles
The 2D Send Angles function allows to position the gantry and the SID back to where an image was previously
acquired.
First, select the image of interest. The image you can send the angles from can be:
• A photo under review on the reference display.
• The image of a sequence under review on the live display.
• The image of a sequence or a photo under review on the In-room Browser.
Note: Particular photos, such as SMPTE photos, are not supported.

Note: Sequences under review need to be paused prior to sending the angles.
Note: When sending the angles from a sequence of the In-room Browser, the angles of the 1st frame of the
sequence are sent.
Then, send the angles of the selected image to the Auto Positioner, by:
• Pressing the Store Angle button on the Remote Control (see Remote Control illustration).
• Pressing the Send Angles button on the Review tab of the Innova Central touch screen (see Innova Central
touch screen illustration).
The Auto Positioner Selector displays the "0" Operator, and the Position lights turn On.
The angles sent are displayed and high-lighted on the live display. They are displayed in the same display mode
(anatomical / mechanical) as the current selection. See illustrations below.
Angles displayed in anatomical mode Angles displayed in mechanical mode
Note: The angles sent remain high-lighted until a gantry or table movement is initiated.
Note: The Send Angles may be cancelled in the following situations:
• 30 s time-out (no action during 30 s after the Send Angles request).
• Protocol or fluoro mode change.
• Patient position change.
• Auto Positioner Operator new selection.
In that case, a message “POSITION NOT REACHED” appears in the lower left corner of the live display, the angles
come back to normal display, and the Auto Positioner Selector comes back to the previous setting.
Note: The Send Angles request may fail in the following situations:
• System is configured in Bolus mode, and the start position has been selected.
• System is configured in 3D or Spin mode, and the test phase has started.
• Positioner is unable to reach the final position.
• Positioner is in degraded mode.
In that case, a message “POSITION NOT REACHED” appears in the lower left corner of the live display.
Finally, press the Auto Positioner joystick down and tilt it upward or downward to move the gantry to the
previously stored position. When the gantry reaches the final position, the message "POSITION REACHED"
appears in the lower left corner of the live display.

Note: In case of collision, the gantry motion is stopped, Send Angles is cancelled, and the message "POSITION
NOT REACHED" appears in the lower left corner of the live display.
Note: In order to avoid collision, gantry motion can be stopped by releasing the Auto Positioner joystick. Move the
table and re-start the motion by pressing the Auto Positioner joystick again.
4 InnovaIQ Table Auto Positioning

4-1 Auto Positioning Control
The Auto Positioning control allows storing and recalling gantry and/or table positions.
It gives access to 9 operators. 5 positions can be stored and recalled for each operator.
1 Auto Positioner Selector

2 Operator Selector
4-2 Auto Positioner Selector
1 Back to PA Position: press down first; then tilt left

2 Back to Lateral Position: press down first; then tilt right
3 5 memorized Gantry, or Table, or Gantry and Table Positions
4 To reach a preselected position (1 to 5), press the number button first and enable the movement by
pressing the joystick down and then tilt upward
5 To reach a preselected position (1 to 5), press the number button first and enable the movement by
pressing the joystick down and then tilt downward

6 Press to store a Gantry and Table Position

7 Press to store a Gantry Position
8 Press to store a Table Position
To store a position:
• Move the gantry and/or table in the position to store.
• Using the Auto Positioner Selector (button 3), select a position number. The button light goes On.
• Press the gantry icon (button 7) to only store a gantry position, the light of the position number goes Off then On
again to show that the storage is performed.
• Press the gantry + Table icon (button 6) to store gantry and table position, the light of the position number goes
Off then On again to show that the storage is performed.
• Press on the Table icon (button 8) to only store the table position, the light of the position number goes Off then
On again to show that the storage is performed.
Note: If no storage action is performed within 30 s after the position number was selected, the light of the position
number will automatically goes Off. In such case, reselect the position number will automatically go Off.
To recall a position:
• Using the Auto Positioner Selector (button 3), select a position number. The button light goes On and the
gantry, or table, or gantry + table position previously stored is displayed in reversed video on the live display.
• Using the Auto Positioner joystick, press down first then tilt the joystick Up or Down to move the gantry, or table,
or gantry + table to the previously stored position. At the end of the motion, the information "Position Reached"
appears in the lower left corner of the live display.
Note: The safety of everyone near the moving equipment depends on the operator at the controls. When
positioning the equipment using the Auto Positioning function, continuously observe all moving equipment, and
stop the motion before a collision can occur. The sensors are provided for added protection in case of an
inadvertent contact and are not to be relied on as a normal means for stopping the motion. Improper use of the
equipment while using the Auto Positioning function, could result in serious injury or equipment damage.
4-3 2D Send Angles (Gantry, Table, Gantry+Table)
The 2D Send Angles function allows to position the gantry (including SID), the table, or both the gantry and the
table back to where an image was previously acquired.
First, select the image of interest. The image you can send the angles from can be:
• A photo under review on the reference display.
• The image of a sequence under review on the live display.
• The image of a sequence or a photo under review on the In-room Browser.
Note: Particular photos, such as SMPTE photos, are not supported.
Note: Sequences under review need to be paused prior to sending the angles.
Note: When sending the angles from a sequence of the In-room Browser, the angles of the 1st frame of the
sequence are sent.
Then, send the angles of the selected image to the Auto Positioner, by:
• Pressing the Store Angle button on the Remote Control (see Remote Control illustration).
• Pressing the Send Angles button on the Review tab of the Innova Central touch screen (see Innova Central
touch screen illustration).

The Auto Positioner Selector displays the "0" Operator, and the Position lights turn On.
The angles sent are displayed and high-lighted on the live display. They are displayed in the same display mode
(anatomical / mechanical) as the current selection. See illustrations below.
Angles displayed in anatomical mode Angles displayed in mechanical mode
Note: The angles sent remain high-lighted until a gantry or table movement is initiated.
Note: The Send Angles may be cancelled in the following situations:
• 30 s time-out (no action during 30 s after the Send Angles request).
• Protocol or fluoro mode change.
• Patient position change or table tilt change.
• Auto Positioner Operator new selection.
In that case, a message “POSITION NOT REACHED” appears in the lower left corner of the live display, the angles
come back to normal display, and the Auto Positioner Selector comes back to the previous setting.
Note: The Send Angles request may fail in the following situations:
• System is configured in Bolus mode, and the start position has been selected.
• System is configured in 3D or Spin mode, and the test phase has started.
• Positioner is unable to reach the final position.
• Positioner is in degraded mode.
In that case, a message “POSITION NOT REACHED” appears in the lower left corner of the live display.
In order to reposition:
• The gantry, press the "Gantry" Store button of the Auto Positioner Selector (refer to button 7 of the Auto
Positioner Selector picture above). The "Gantry" Store button turns On, and the other Store buttons turn
blinking. The angles get high-lighted on the live display.
• The table, press the “Table” Store button of the Auto Positioner Selector (refer to button 8 of the Auto
Positioner Selector picture above). The "Table" Store button turns On, and the other Store buttons turn blinking.
The table information gets high-lighted on the live display.
• Both the gantry and the table, press the "Gantry+Table" Store button of the Auto Positioner Selector (refer to
button 6 of the Auto Positioner Selector picture above). The "Gantry+Table" Store button turns On, and the
other Store buttons turn blinking. Both the angles and table information get high-lighted on the live display.
By default, the Send Angles is configured as Gantry Send Angles.

See illustrations below:
"Gantry" Send Angles is active "Table" Send Angles is active "Gantry+Table" Send Angles is active
Note: Only table height and tilt axis are displayed high-lighted. Other axis are not shown.
Note: Gantry Send Angles repositions all axis of the Gantry, including the SID. It considers the current table tilt
position to reach the same incidence as the reviewed image.
Note: Table Send Angles repositions the Longitudinal, Lateral, Height and Tilt axis of the table. SID automatically
goes to max SID in order to avoid collision. In case patient contouring is active, SID is adjusted to the patient
position.
Note: Gantry+Table Send Angles repositions all axis of the Gantry, the SID and the Longitudinal, Lateral, Height
and Tilt axis of the table.
Finally, press the Auto Positioner joystick down and tilt it upward or downward to move the gantry, table, or
gantry+table respectively to the previously stored position. When the gantry, table, or gantry+table reach the final
position, the message "POSITION REACHED" appears in the lower left corner of the live display.
Note: In case of collision, the motion is stopped, Send Angles is cancelled, and the message "POSITION NOT
REACHED" appears in the lower left corner of the live display.
Note: In order to avoid collision, motion can be stopped by releasing the Auto Positioner joystick. Move the system
and re-start the motion by pressing the Auto Positioner joystick again.
5 Digital Detector Housing Controls

1 Up Detector Control 4 Digital Detector

2 Down Detector Control 5 Removable Grid
3 Emergency Back-out Button 6 Anti-Collision Belt
5-1 Up/Down Control

Lower or raise the Frontal Digital Detector by pressing either of the two Up/Down controls (See Illustration).
5-2 Emergency Back-Out
Raise (only) the Digital Detector by pressing one of the Emergency Back-Out buttons located on the Digital
Detector (See Illustration).
Note: This control must be used only:
1. To clear a collision Level 2 (see Innova Positioner / Collision Sensors) by allowing a 2.5 cm additional SID
course.
2. To move away the Digital Detector from the patient in case of gantry failure.
3. In case of SID failure. Use this button to bring the Digital Detector to its highest position to still allow X-ray.
5-3 InnovaTraceTM (on Innova IGS 520 and Innova IGS 530 only)
The Digital Detector housing is surrounded by a capacitive sensor ring (1) to prevent as much as possible collision
with the patient.
WITH SYSTEMS USING THE OMEGA TABLE, THE REAR OF THE DETECTOR LIFT IS NOT
PROTECTED AS WELL AS THE OTHER PARTS OF THE GANTRY. SPECIAL ATTENTION
MUST BE PAID TO THE PATIENT WHEN WORKING WITH THE L-ARM POSITIONED
AROUND 90° FROM THE TABLE AND A DEEP CAUDAL GANTRY ANGULATION IS USED. IN
SUCH POSITION, IT MAY HAPPEN THAT CAPACITIVE SENSORS WILL NOT DETECT SOON
ENOUGH PATIENT ANATOMY. ALWAYS WATCH PATIENT AND GANTRY WHEN L-ARM IS
AROUND 90° FROM THE TABLE AND GANTRY MOVED IN DEEP CAUDAL ANGULATION.

With these sensors, the gantry can rotate up to 20°/s.

These sensors are active as soon as a gantry enable trigger is depressed.
Depending on the positioner location around the patient, as soon as the distance between patient and detector
becomes too close, InnovaTrace sends the order to automatically raise the detector to prevent to touch the patient.
Manual control of the detector position is always available.
NARROW AND SMALL HUMAN OBJECTS (I.E. NOSE) ARE MORE DIFFICULT TO DETECT
BY THE SENSORS. SO IT IS RECOMMENDED TO TURN PATIENT'S HEAD TO THE LEFT OR
RIGHT AND TO REDUCE GANTRY SPEED WHEN IN THE VICINITY OF THE PATIENT'S
HEAD.
OBJECTS MADE OF NON-CONDUCTIVE MATERIALS (PLASTIC …I.E. OXYGEN MASK) OR

SMALL INVASIVE OBJECTS/DEVICES (I.E. BIOPSY OR OTHER NEEDLES) WHICH PROJECT
OUT FROM THE PATIENT SKIN SURFACE ARE NOT DETECTED BY THE SENSORS. SO IT IS
RECOMMENDED TO PAY PARTICULAR ATTENTION AND TO REDUCE GANTRY SPEED
DURING PROCEDURES THAT INVOLVE THE USE OF SUCH NEEDLE OR SMALL
NON-CONDUCTIVE OBJECTS (I.E. PROCEDURES PERFORMED UNDER TOTAL
ANESTHESIA, BIOPSIES, SPINE PROCEDURES …).
5-4 InnovaSense patient contouring (option on Innova IGS 520 and Innova IGS 530 only)
InnovaSense patient contouring incorporates implementation of advanced capacitive sensiting technology.
The system in this mode is aware of location of the patient and can dynamically adapt the receptor distance to
position receptor safely in proximity to the patient.
The Digital Detector housing is surrounded by a capacitive sensor ring (1) to prevent as much as possible collision
with the patient.

With these sensors, the gantry can rotate at up to 20°/s.

These sensors are active as soon as a gantry enable trigger is depressed.
NARROW AND SMALL HUMAN OBJECTS (I.E. NOSE) ARE MORE DIFFICULT TO DETECT
BY THE SENSORS. SO IT IS RECOMMENDED TO TURN PATIENT'S HEAD TO THE LEFT OR
RIGHT AND TO REDUCE GANTRY SPEED WHEN IN THE VICINITY OF THE PATIENT'S
HEAD.
When InnovaSense patient contouring is activated (Item 8 on Smart Box/Smart Handle), the Digital Detector
always stays at a constant safe distance from the patient while the gantry is moved in any direction. At the end of
the motion, keeping the gantry enable pressed, will move the detector down for even closer positioning (stops at
few cm from patient).
The Digital Detector will also move Up/Down in response to the table movement providing a smart system
response.
With InnovaSense patient contouring activated, bringing the detector at its highest position will prevent it to
automatically move down during a table Up/Down motion and /or longitudinal tabletop motorization.
When using the Auto Positioner, the Digital Detector will automatically move Up/Down during gantry motion to stay
at safe distance from the Patient. There is a button provided to activate or disable this function (Item 8).
IN CASE OF PROCEDURE THAT INVOLVES THE USE OF SMALL INVASIVE

OBJECTS/DEVICES (I.E. BIOPSY OR OTHER NEEDLES) OR OBJECTS MADE OF
NON-CONDUCTIVE MATERIALS (PLASTIC... I.E. OXYGEN MASK) WHICH PROJECT OUT
FROM THE PATIENT SKIN SURFACE, THE INNOVASENSE PATIENT CONTOURING MUST

BE DISABLED (ITEM 8) PRIOR MOVING THE GANTRY EITHER MANUALLY OR WITH THE
AUTO POSITIONER; THESE OBJECTS/DEVICES BEING TOO SMALL AND/OR NOT
DETECTED BY THE CAPACITIVE SENSORS. USE THE "NEEDLE PLACEMENT" PROTOCOL
LOCATED EITHER IN THE ABDOMEN OR CARDIAC & COMBO ANATOMY WHICH
AUTOMATICALLY DISABLES THE INNOVASENSE PATIENT CONTOURING FUNCTION.
FAILURE TO THIS MAY CAUSE SEVERE PATIENT INJURY IN CASE THE DETECTOR HITS
THE INVASIVE OBJECT/DEVICE.
A "Needle Placement" protocol, located in the "Cardiac & Combo" and "Abdomen" anatomy automatically disables
the InnovaSense patient contouring function and forbids its activation.
Such protocol must be selected prior to start any procedure that involve the use of small invasive objects/devices
which project out from the patient skin surface.
Note: When using an Angio protocol (located out of the "Cardiac & Combo" anatomy), the InovaSense patient
contouring function is automatically disabled at each new protocol selection or end of exam activation.
Note: Manual control of the Digital Detector is available at any time.
ALTHOUGH INNOVASENSE PATIENT CONTOURING FUNCTION DYNAMICALLY ADAPTS

THE RECEPTOR DISTANCE, THE USER IS ADVISED AT ALL TIMES TO VISUALLY GUIDE
AND CONTROL THE OPTIMAL RECEPTOR POSITIONING. THIS IS SPECIFICALLY
IMPORTANT WHILE POSITIONING THE RECEPTOR NEAR SMALL HUMAN ANATOMIES
SUCH AS NOSE, HEAD ETC.; NEAR OBJECTS MADE OF NONCONDUCTIVE MATERIAL
SUCH AS OXYGEN MASK AND NEAR AREA WHERE A PUNCTURE NEEDLE IS POSITIONED
IN THE PATIENT BODY.
THE RECEPTOR WILL NOT AUTOMATICALLY MOVE OUT OF THE WAY DURING MANUAL
PANNING UNLESS GANTRY ENABLE IS PRESSED.
6 Collision Sensors
The sensor pads surrounding the X-ray tube and Digital Detector contain pressure-sensitive collision sensors.
There is one level of collision detection for the X-ray tube sensor (see Innova Positioner / Collision Sensors / Level
1), and there are two levels for the Digital Detector sensor (see Innova Positioner / Collision Sensors / Level 1 and
Innova Positioner / Collision Sensors / Level 2).

1 Digital Detector Sensor

2 Collimator Sensor
With the InnovaIQ Table, additional sensors are located at the rear of the detector lift.
6-1 Level 1
During normal operation, Level 1 sensors activate immediately upon sensor detection of collision.
Note: Certain environmental pressure changes or operations such as cleaning may cause the system to detect a
Level 1 collision proactively under some circumstances. In most cases, the Level 1 indication would automatically
clear after a few minutes. If the Level 1 persists, the collision system can be reinitialized by pressing the detector
bumper with both hands for a few seconds and then releasing it. If both these methods fail, perform a system reset
to clear the Level 1 indication.
Activation:
When Level 1 collision sensors are activated, corresponding parts of the visual gantry display located on the left

side of the live display are highlighted and flashing. An audible signal is activated. Motions and drives for the
positioner and the table stop.
Clearing Procedure:
After a Level 1 collision sensor activates, remove the obstruction to allow the sensor to clear itself automatically. If
you are unable to remove the obstruction and the system must be driven to clear the sensor, perform the following
procedure:
1. Release the Smart Handle or Smart Box motion enable button. Press the button again, and the system
automatically backs out of the collision.
a. Collimator collision clearing. If you are clearing a collimator collision, then during collimator backout, the
system retraces the motion that preceded the collision.
b. Digital Detector collision clearing. If you are clearing a Digital Detector collision, the system first attempts to
raise the Digital Detector along its motion axis. If this is not successful, the system retraces the motion that
preceded the collision along the remaining axes.
2. If the collision remains after the backward motion, you can resume the positioner movement by releasing and
pressing the Motion Enable Trigger.
Note: In case the table top is under collision and the collision cannot be cleared as described above, such collision
can be cleared by moving manually the table top in longitudinal or lateral direction or by manually rotating it. With
the InnovaIQ Table, the table top can only be moved in lateral direction when the table is tilted (longitudinal direction
is locked).
Note: In case of collision sensor failure, messages such as "...Press Tube front plate to reinit" or "...Press Detector
front plate to reinit" will be permanently displayed on the Innova console at system boot. In such case, press once
on the specified sensor to reinitialize it.
Note: With the InnovaIQ Table, when the level 1 collision sensor is activated, all table axes are available in the
opposite way to better clear the collision.
Auto-Backout (not available with the InnovaIQ Table):
This feature is configured by your Service Engineer to either be ON or OFF. If the Auto-Backout feature is
configured ON, a collision with the Digital Detector while driving the major axes of the gantry (Pivot, C-Arm or
L-Arm) with the Smart Handle or Smart Box will cause the system to raise the Digital Detector along its motion axis,
without stopping the positioner movement. If the Digital Detector is at maximum SID, gantry movement will stop as
a normal Level 1 collision.
6-2 Level 2 (Digital Detector only)
Level 2 detection is a back-up for Level 1 detection. The Level 2 collision sensor on the Digital Detector is activated
if sensor detection continues beyond the normal and expected machine stopping distance.
Activation:
When the Level 2 collision sensor is activated, the Status Display indicator lits and an audible signal is activated. All
motions and drives for the gantry and the table are disabled.
Clearing Procedure:
1. Level 2 prohibits powered motions; therefore, you must clear the sensor manually or press the Digital Detector
emergency backout button (see Innova Positioner / Digital Detector Housing Controls).
Note: With the InnovaIQ Table, when the level 2 collision sensor is activated, all table axes are available in the
opposite way to better clear the collision.
2. Once you remove the obstruction or clear Level 2 using the backout button, all motions and drives are restored.
THE COLLISION SENSORS ARE NOT INTENDED TO BE A SUBSTITUTE FOR CAREFUL

EQUIPMENT OPERATION. WHEN POSITIONING THE EQUIPMENT, BE SURE THE
EQUIPMENT PATH IS CLEAR BEFORE STARTING A MOTION, CAREFULLY OBSERVE THE
MOVING PARTS, AND STOP THE MOTION BEFORE MAKING ANY CONTACT. THE
SENSORS ARE PROVIDED FOR ADDED PROTECTION IN CASE OF INADVERTENT
CONTACT, AND ARE NOT TO BE RELIED ON AS THE USUAL MEANS FOR STOPPING THE

MOTION. IMPROPER EQUIPMENT POSITIONING COULD RESULT IN SERIOUS INJURY OR

EQUIPMENT DAMAGE.
7 Skin Spacer
Depending on country regulation (e.g: as required in USA and New Zealand), the Skin Spacer must be installed
over the X-ray tube cover.
Innova IGS 520 with Skin Spacer Innova IGS 520 without Skin Spacer
Innova IGS 530 and Innova IGS 540 with Skin Spacer Innova IGS 530 and Innova IGS 540 without Skin
Spacer
When the Skin Spacer is installed over the X-ray tube cover, particular attention must be taken when moving the
table down, especially during patient loading/unloading phase.
With the Skin Spacer installed, do not stop the table too close to the spacer (keep about 5
cm in between) when loading the patient on the table.
Doing so will prevent the table top to collide with the Skin Spacer due to its flexibility.
8 Innova Central touch screen (Option)

Depending on the customer choice, the configured color theme of the Innova Central touch screen may be different
from the color themes used for the pictures of this manual.

The purpose of the Innova Central touch screen is to bring an easy and direct access from table side to most
commonly used functionalities related to the acquisition, image review, electrophysiology and Intra Vascular
Ultrasound.
A joystick is used to navigate in some of the functionalities.
A reset button located under the Innova Central touch screen (left side) allows to reinitialize it in case it hangs or
does not respond properly.
8-1 Innova Central touch screen Installation
The primary location of the Innova Central touch screen, connected at table base, is at table side. It can also be
installed on a cart, on an articulated arm or just placed on a table.
To install the Innova Central touch screen at table side, pull the handle located underside, position it over the table
accessories rail and release the handle.
Note: Before using the Innova Central touch screen, make sure it is well secured on the table accessories rail.
8-2 Innova Central touch screen menus
At the bottom of the Innova Central touch screen, permanent buttons are always available whatever menu is
selected.
Depending on configuration, on the top of the Innova Central touch screen, tabs give access to Innova fluoro,
record and image review, AW Vision, electrophysiology and intra vascular ultrasound dedicated screens.
When a small joystick is displayed on a button, it indicates that the Innova Central touch screen joystick needs to
be used to interact in the selected function. For example, when Recall Sequence is selected, move the joystick
right/left to visualize the next/previous sequence.
When a green frame is displayed around a button, it indicates that the given function is enabled.
For example:
When Auto Injection is switched on, it is displayed as follows:
When Auto Injection is switched off, it is displayed as follows:
Note: This status feedback is working only for the Innova and AW related functions. Do not expect visual feedback
on the Maclab and IVUS tabs.
• Innova Record screen:

This screen gives access to the most used Record acquisition parameters (frame rates, detail
levels, injection parameters...) as well as protocols and image flip selection..
Label Description
Protocols Allows to select an acquisition protocol within an anatomy.
Image Flip Allows to flip the image horizontally and / or vertically.
X-Ray Lock Interrupts the system from taking exposures when Fluoro or Record is no longer re-
quired.
End Exam Allows to close the current exam.
Record Mode Allows to select one of the available acquisition mode.
Detail Allows to select among Normal or Low Record detail.
3D Spin Speed Depending on system configuration, allows to select among three 3D gantry rotation
speed.
X-ray Delay Allows to set the delay between Injection and X-ray.
Subtraction Activates the Sub or NoSub display of the live image during the acquisition.
Frame Rate/Duration Allows to select a Record acquisition frame rate and duration.
Injection Delay Allows to set the delay between X-ray and injection.
Auto Injection (permanent Activates or deactivates the Auto Injection function.
area)
Stopwatch (permanent Allows to display/hide a stopwatch.
area)

• Innova Fluoro screen:
This screen gives access to the most used Fluoro acquisition parameters (frame rates, detail
levels,...) as well as protocols and image flip selection.
Label Description
Protocols Allows to select an acquisition protocol within an anatomy.
Image Flip Allows to flip the image horizontally and / or vertically.
X-Ray Lock Interrupts the system from taking exposures when Fluoro or Record is no longer re-
quired.
End Exam Allows to close the current exam.
Fluoro Mode Allows to select NoSub or Sub Fluoro, Roadmap or Blended Roadmap. When in Sub or
Roadmap Fluoro, allows to activate the Sub and NoSub simultaneous display.
Frame Rate Depending on the selected acquisition mode, allows to select among the available Flu-
oro frame rates.
Simultaneous Display When 2 live displays are configured, allows for the display of a subtracted fluoro image
simultaneously with the unsub fluoro image.
Detail Allows to select among two levels of Fluoro detail.

Landscape or • Not active in NoSub Fluoro

Landscape/Vessels
• Active and labelled "Landscape" in Sub/Roadmap Fluoro.
• Active and labelled "Landscape / Vessels" in Blended Roadmap Fluoro.
• Allows to increase / decrease the percentage of Fluoro landscape in Sub/Roadmap
Fluoro, provided the joystick is allocated to it
• Allows to increase / decrease the percentage of both Fluoro landscape and Fluoro
vessels in Blended Roadmap Fluoro, provided the joystick is allocated to it
Stopwatch (permanent Allows to display/hide a stopwatch.
area)
• Innova Review screen:
All basic review and display functions are directly available from this screen. When the In-room
Browser option is activated, all images acquired during the procedure can easily be reviewed using
the Innova Central touch screen joystick. For angio processing, Mask select and Pixel Shift are
directly accessible.
Label Description
Send Angles Activates the 2D send angles
Time Scale Displays/Hide a time line under the image in review on
the live display.
Stenosis Analysis Allows to launch the Stenosis Analysis application.
Stent Viz Activate the Stent visualization application

Zoom Activates/Desactivates the Zoom function:

• When active, move joystick up/down, right/left to roam
the image.
Brightness Contrast Enables the Brightness/Contrast adjustment:· When en-
abled, move joystick up/down to adjust Brightness and
right/left to adjust Contrast.
Filter Allows to set the edge enhancement filter level.
Cancel Cancels the last Pixel Shift, Brightness/Contrast, Filter...
selection.
Brings the image back to previous settings.
Subtraction Toggles between Sub and NoSub mode when in image
review.
Mask Select Activates/Desactivates the Mask Select function:
• When active, move joystick right/left to modify mask
selection.
Pixel Shift Activates/Desactivates the Pixel Shift function:
• When active, move joystick up/down and/or right/left
to pixel shift.
Menu (permanent area) Displays Smart Nav
Recall Sequence (permanent area) Brings focus back on live display:
• Press on top of joystick to Play/Pause the review.
• Move joystick right/left to review next/previous se-
quence when in Play; next/previous frame when in
Pause.
Recall Photo (permanent area) Displays on the reference display the last stored photo.
Store Photo (permanent area) Saves on disk the image displayed on live display and
displays this image on reference display.
• Innova Dose screen:

This Dose screen summarizes the parameters that can be adjusted to directly affect dose.
Label Description
Dose Map Displays or hides the local dose map
Dose reduction Selection of this button automatically reduces the dose
(refer to Innova Positioner / Innova Central touch screen
(option) / Dose Reduction on Innova Central touch
screen)
Protocol dose default Reselect the default dose settings of the currently select-
ed protocol
Fluoro Detail Allows to select between Normal or Low detail
Fluoro Frame Rate Depending on the selected acquisition mode, allows to
select among the available Fluoro frame rates
Record Detail Allows to select between Normal or Low detail
Record Frame Rate/ Duration Allows to select a Record acquisition frame rate and du-
ration
Note: a color code has been added to:

• Fluoro Detail
• Fluoro Frame Rate
• Record Detail
• Record Frame Rate/ Duration
A green color is displayed when the dose is at the minimum it can be set to.

A green/ yellow color is displayed when a dose reduction can be achieved by modifying that
parameter.
A yellow color is displayed when a parameter is not utilizing any dose reduction and any
modification will decrease the dose.
• AW screens: refer to Innova Vision applications User Guide - 5392954-x.
• Mac-Lab/CardiaoLab screens (Options):
Depending on system configuration, when a Mac-Lab and/or CardioLab system is/are connected to the Innova
system, the most commun physio functions such as probe selection, zero setting, scale selection,
measurements, gain selection... are directly accessible.
Refer to the Mac-Lab/CardioLab specific Operator Manual for detailed description of all these functions.
Label Description
Study > Emer- Begins a new study, bypassing the patient demographic input. The patient information is set as
gency follows:
• Last Name: Timestamp
• First Name: No Name
• MRN: Timestamp
Study > Close Closes the current Mac-Lab study in progress.
• Yes/No confirmation on the Innova Central touch screen.
• No confirmation from the Mac-Lab application.
Labels Labels a selected blood pressure channel ART, PA, VEN, PV, LA, RA, AO, RV, VC, SP, LV, or
PCW.
12 Lead Prints a Real-Time 12 lead. Also adds 12-Lead event to the log.

Scale Scales all pressures to 25, 50, 100, or 200 mmHg as selected.
P1 Selects blood pressure channel 1 in the Real-Time window.
P2 Selects blood pressure channel 2 in the Real-Time window.
Measure Measures the current active pressure. The pressure measurement is displayed in the Review and
Log windows.
Measure All Measures all displayed pressures. The pressure measurements are displayed in the Review and
Log windows.
Zero Sets the selected pressure to zero for calibration.
Zero All Sets all displayed pressures to zero for calibration.
Sweep Up Increases the scroll/sweep speed in the active window to the next scroll/sweep speed value up in
the list.
Sweep Down Decreases the scroll/sweep speed in the active window to the next scroll/sweep speed value
down in the list.
Update Saves about 10 seconds of signal data in the Review window (the actual time of data saved is de-
pendant on the number of channels displayed). A corresponding entry appears in the Log (green
time-stamp).
Switch Video Toggles the video signal sent to the monitor in the procedure room.
Stopwatch • Open: Opens a new stopwatch on the Real-Time window.
• Close: Closes the stopwatch opened above.
• Reset: Resets the time on the stopwatch to 0:00.
Start/Stop Stop- Starts or stops the stopwatch.
watch
Emergency Immediately starts saving signals in the Real-Time window to the optical disk. Also saves as
Save much data as possible from memory.
(permanent
area)
Stat Vitals Performs a Stat Vitals measurement. The current HR, SPO2, RR, temperature, Inspired CO2, and
(permanent Expired CO2 are recorded as-is from the Status area into the Log window.
area)

Label Description
Close Study Closes the current Mac-Lab study in progress.
• Yes/No confirmation on the Innova Central touch screen.
• No confirmation from the CardioLab application.
Mark Creates a new note at the current time with the Mark text in the Event Log.
12 Lead Prints a Real-Time 12 lead. Also adds 12-Lead event to the log.
Pace Switches the pacing settings to the highlighted channel poles.
Page Up Changes the display of the Real-Time window up one page.
Page Down Changes the display of the Real-Time window down one page.
Gain Up Increases the gain for the selected ECG, intracardiac, or high-level input channels.
Gain down Decreases the gain for the selected ECG, intracardiac, or high-level input channels.
Auto Save Enables/Disables the automatic saving option.
Manual Save Starts/Stops saving the signals in the Real-Time window.
Sweep Up Increments the scroll/sweep speed in the active window to the next scroll/sweep speed value up in
the list.
Sweep Down Decreases the scroll/sweep speed in the active window to the next scroll/sweep speed value down
in the list.
Update Saves about 10 seconds of signal data in the Review window (the actual time of data saved is de-
pendant on the number of channels displayed). A corresponding entry appears in the Log (green
time-stamp).

Switch Video Toggles the video signal sent to the monitor in the procedure room.
Image Freeze Freezes an image in the CardioImage window.
Emergency Immediately starts saving signals in the Real-Time window to the optical disk. Also saves as much
Save data as possible from memory.
(permanent
area)
Stat Vitals Performs a Stat Vitals measurement. The current HR, SPO2, RR, temperature, Inspired CO2, and
(permanent Expired CO2 are recorded as-is from the Status area into the Log window.
area)
• Volcano s5i tab:

• Integrated Innova - s5i system option - applicable for s5iTM:
Refer to the Volcano Operator Manual for more details about the specifics of functionality. A brief summary of
the buttons and its description is attached below for quick reference.
Label Description
Home / Live IVUS: If the system is not on the Home screen, go there.
If the system is on the Home screen and not in Live
mode, initiate Live mode, If the system is already on the
home screen and in Live mode, do nothing.
FFR: If an archived file is not loaded then go to the Home
screen and run.

Freeze/Live IVUS: If the system is not on the Home screen, go there

and initiate Live mode. If the system is on the Home
screen and not in Live mode, initiate Live mode. If the
system is on the Home screen and in Live mode, initiate
Freeze mode. If the system is on the Home screen and in
Freeze mode, initiate Live mode.
FFR: If the system is not on the Home screen, do noth-
ing. If the system is on the home screen and waveform
chart is frozen, start it running. If the system is on the
Home screen and waveform chart is running, stop run-
ning and stop recording if had been recording.
Ring Down IVUS: Toggle between Ringdown on and off states.
FFR: When running the waveform chart, Normalize.
ChromaFlo IVUS: Toggle between ChromaFlo on and off states.
FFR: Display message indicating that no action will be
taken.
Record IVUS: Begin recording a video loop.
FFR: If not on the Home screen, do nothing. If on the
Home screen and the waveform chart is running and
Normalize has been performed at least once for the cur-
rent patient, begin recording a run.
Bookmark IVUS: Place a bookmark in the video loop that is current-
ly being recorded or played.
FFR: If on the Home screen and the waveform chart is
running and data is being recorded, insert an event into
the recording.
Stop IVUS: If recording a video loop, stop the recording. If
playing or rapid-reviewing a video loop, stop the playback
or rapid review.
FFR: If on the Home screen, stop recording and stop run-
ning the waveform chart.
Save Frame IVUS: Save a frame from Live or the from the currently
playing grayscale video loop.
FFR: If a modal dialog is not present, perform a screen
capture.
Play IVUS: Begin playing the currently selected video loop.
FFR: Go to the Playback screen.
Scroll IVUS Toggle between Rapid Review on and off states.
taken.
Rapid Review IVUS Toggle between Rapid Review on and off states.
taken.
Stop IVUS: If recording a video loop, stop the recording. If
playing or rapid-reviewing a video loop, stop the playback
or rapid review.
FFR: If on the Home screen, stop recording and stop run-
ning the waveform chart.

Measure IVUS: Initiate autoborders.

taken.
VH IVUS: If the current catheter is boot mode 4, toggle be-
tween VH on and off states. If the current catheter is not
boot mode 4, do nothing.
taken.
Print IVUS and FFR: Send the current screen to the USB print-
er which is configured as the system printer.
Permanent Buttons:
Label Description
Auto Injection
In Room-Browser Activates/Desactivates the Collage/In-Room Browser
function:
• Move joystick up/down, right/left to select the se-
quence/photo to review.
• Press on top of joystick to launch the review of the se-
lected sequence/photo.
Recall Sequence Brings focus back on live display:
• Press on top of joystick to Play/Pause the review.
• Move joystick right/left to review next/previous se-
quence when in Play; next/previous frame when in
Pause.
Recall Photo Displays on the reference display the last stored photo.
Store Photo Saves on disk the image displayed on live display and
displays this image on reference display.
Emergency Save Immediately starts saving signals in the Real-Time win-
dow to the optical disk. Also saves as much data as pos-
sible from memory.
Stat Vitals Performs a Stat Vitals measurement. The current HR,
SPO2, RR, temperature, Inspired CO2, and Expired CO2
are recorded as-is from the Status area into the Log win-
dow.
Stopwatch
8-3 Innova Central touch screen customization

The Innova Central touch screen (Option) provides the possibility to control many applications of different
modalities, and many types of procedures performed by users with different preferences; but users need just a few
of these functionalities during a specific type of examination.

Innova Central touch screen customization enables to collect the frequently used functionalities to one single
surface based on the user preferences or the type of intervention. It means that you are able to copy the frequently
used Innova Central touch screen buttons to one single location, and use only this surface during the examination
without navigating through the different pages of the Innova Central touch screen.
The following section describes step by step how you can customize Innova Central touch screen. Please be aware
that the customization mode is available only out of exam, for safety reasons. During the examination you can use
the created favorite pages.
8-3-1 Location of the customized pages (Favorites tab)
Innova Central touch screen has a specific tab page called Favorites tab, which is indicated with a star icon. You
can collect your preferred functionalities under different favorite sub-tabs. After the system installation, Favorites
tab has one single sub-tab, which contains a short description about the usage of customization feature.
8-3-2 Creation and renaming of Favorites sub-tabs

You have the possibility to create a new favorite sub-tab with the help of the following steps:
1. Tap and hold your finger on the sub-tab area of the touch screen: entering to edit mode is indicated by the
animation. After animation has finished, a menu will be displayed.

2. Select the Add new tab item from the displayed list: a virtual keyboard is opened.
3. Enter the name of the new favorites sub-tabs, and press the [OK] button. The new favorites sub-tab with the
given name will be created.

8-3-3 How to populate Favorite sub-tabs

You can put any buttons from any configured modalities to a selected favorites sub-tab with the help of the
following actions.
1. Tap and hold your finger on the button which you would like to add to a favorite sub-tab. After the animation is
finished, a dialog is displayed where you can select the name of the favorite sub-tab from the available list.
2. Select the name of the Favorite sub-tab where you want to copy the button with the help of the pager arrows,
and press the [OK] button. The selected control functionality will be copied to the selected Favorite sub-tab.
3. Repeat the previous actions until you collect all functionalities you need for your examination.
Please be aware that a single functionality can be placed only once in a favorites sub-tab (functionalities cannot be
duplicated inside a single favorites sub-tab). The functionalities coming from different modalities can be simply
distinguished with the help of the colored stripe and caption of the buttons. Each modality has one specific color
that can also be found on the bottom left corner (colored squares) of the corresponding Tab:
• Purple: Innova / Record
• Green: Innova / Review
• Beige: Innova / Fluoro
• Yellow: AW
• Cyan: MLab
• Red: Volcano s5i

8-3-4 Button arrangement on a favorite sub-tab or between tabs

Innova Central touch screen customization provides some advanced features to create the best arrangement of the
sub-tabs on a comfortable way. When you tap and hold your finger on a button of a favorites sub-tab, a menu is
displayed after the animation is finished, which provides the following functionalities:
• Move within tab: Move the selected button inside the current sub-tab
• Copy to: Copy the selected button to another favorites sub-tab
• Move to: Move the selected button to another favorites sub-tab
• Delete button: Delete the selected button from the current sub-tab
• Cancel

8-3-4-1 Move a button inside the current tab

When you select the Move within tab item from the menu, a specific screen is displayed, where icons show the
positions where you can move the selected button.

By selecting an allowed location (displayed with green or blue arrows) you can put the button to an empty position
or you can swap two buttons. (Red icon means a position which is not allowed for the given button.)
8-3-4-2 Arrange buttons between tabs
You can arrange buttons between favorites sub-tabs by copying or moving them to another tab. To do this, you
have to select the Copy to or Move to item from the menu.
When you select Copy to or Move to item, a dialog window is displayed to enable selecting the new location of the
button.

Select the name of the sub-tab where you want to copy or move the button with the help of the pager arrows, and
press the [OK] button. The selected button will be copied or moved to the first free position of the selected tab.
8-3-4-3 Delete a button from the current tab
You can remove a button from the favorites sub-tab by selecting the Delete button item from menu. Before the
button is removed a confirmation dialog is displayed. Answer the question of the dialog according to your needs.

8-3-5 Advanced features to manage Favorites sub-tabs

If you populated more than one Favorites sub-tabs and tap and hold your finger on a sub-tab, an extended menu
list is displayed to allow sub-tab management.

The following additional functionalities are available in the extended sub-tab management menu:
• Move tab: change the order of tabs
• Delete all buttons: delete the content of the selected sub-tab
• Delete current tab: delete the selected sub-tab
8-3-5-1 How to change the tab order
Select the Move tab item of the menu: a dialog window will be displayed where you can chose where you want to
insert the selected sub-tab page (before another tab, or at the end of the tab page by selecting at the end).

8-3-5-2 How to delete the content of a favorite sub-tab

Select the Delete all buttons item of the menu. A confirmation dialog will be displayed, where you can approve the
content deletion of the selected sub-tab.

The approval of content deletion will result in an empty favorites sub-tab, which you can populate again according
to your preferences.
8-3-5-3 How to delete a Favorites sub-tab
Select the Delete current tab item of the menu. A confirmation dialog will be displayed where you can approve the
deletion of the selected sub-tab.
8-4 Dose Reduction on Innova Central touch screen
A {Dose Reduction} button is available on the Dose tab of the Central touch screen located at table side.
This button reduces the dose during the exam by modifying the following parameters (called dose optimization
settings) in one action:
• Fluoroscopy and Dynamic record modes: frame rate, detail, Autoexposure preference
• Angiographic record modes: Autoexposure preference
The {Dose Reduction} button applies the minimum between the current and the configured value of each dose
optimization setting. The current values are defined as the effective ones during the exam, whereas the configured
values are set in the Service User Interface (SUIF) and can be customized by a Service engineer or Application
specialist.
The default configured values are the same as in the Dose Limited protocols (refer to Innova Digital / How to select
an Acquisition Protocol / List of Protocols / Dose limited protocols).

The {Dose Reduction} button has 2 states:

• Available: means that at least one of the current values of dose optimization settings is higher than the
corresponding configured one.
• Not available: means that all current values of dose optimization settings are lower or equal to the
corresponding configured ones.
The {Protocol dose default} button sets the default values of the dose optimization settings from the current
protocol.
8-5 Smart Nav
“Smart Nav” is a graphical interface present on the system if the Innova Central touch screen option is available on
the system. Smart Nav provides an easy access to system functionalities (applications and actions to perform) from
a menu displayed on user request, on the Reference display in 2 monitors configuration or on the Live 2 display in
the 3 monitors configuration.
Smart Nav can be opened In Room by pressing the [Menu] button on either the Innova Central touch screen or the
DL remote control, or in the Control Room by pressing the [Menu] button on the DL keypad. The user can open
Smart Nav with a long press of the Innova Central touch screen joystick button.
If Smart Nav is displayed, the user can hide this menu by pressing the Innova Central touch screen [Menu] button,
using the remote control or DL keypad, or with a long press of the Innova Central touch screen joystick button.
Functions accessible through Smart Nav are organized in a contextual tree. If for example "Smart Nav” is

requested and the system focus is on a review, the menu will be displayed in “the review context” meaning the
review sub-menu will be pre-selected by the system on user display request.
8-5-1 Functions and application accessible through Smart Nav
The Smart Nav tree organization is presented below: sub menus are presented with a blue background and
applications or functions are presented with a white background.
Note that items related to optional applications or functionalities are present in the Smart Nav tree only if the option
is activated on the system:
• StentViz is available with the StentViz option
• InRoomBrowser is available with the In Room Browser option
• Pixel Shift, Mask Select and Substract are available with DSA, Bolus or Sub 3D options.
The context states recognized by the system are:
• Review: state in which the user requests the Menu display when reviewing fluoro or recorded sequences on the
Live 1 (Review has the focus).
• Photo: state in which the user requests the Menu display when reviewing photos on the Reference monitor
(Photo has the focus).
This logo indicates that the selected item is a sub menu.
This logo indicates that the selected item triggers an application or functionality.
8-5-2 Navigation and function selection through Smart Nav

In order to navigate, select an application or function, and control a functionality in Smart Nav, you can either use
the Innova touch screen joystick or the DL remote control arrows or the DL keypad joystick.
• On the Innova Central touch screen:
– Perform a Left, Up or Down movement of the joystick to navigated in the menu.
– Perform either a right movement of the joystick, or a short press on the joystick button to access a sub menu.
– Press the joystick button to select a function or application (a short press for IRB and Play/Pause).
• On the DL remote control:
– Use the Left, Up or Down arrows to navigated in the menu.
– Either use the right arrow or a press [Enter] to access a sub menu.
– Press [Enter] to select a function or application.
• On the DL keypad:
– Perform a Left, Up or Down movement of the joystick to navigated in the menu.
– Perform either a right movement of the joystick , or press [Enter] to access a sub menu.
– Press [Enter] to select a function or application.
8-5-3 Smart Nav sub menu and functions descriptions
The Review sub menu group functionalities are either useful in a review context or applicable on a fluoro or
recorded sequences.
• Select the Proc. Tools sub menu to reach processing functionalities.
• Select [Send Angles] to perform a smart angle on the last displayed recorded sequence.
• Select [IRB] to display the IRB (Smart Nav will be hidden).
• Select [Store Photo] to store a photo of the displayed frame of the sequence (Smart Nav will be hidden).
• Select [Review Photo] to display the last photo displayed (Smart Nav will be hidden).
• Select [Review Seq.] to play the last recorded sequence (Smart Nav will be hidden).
In Proc. Tools sub menu:
• Select the Display Tools sub menu to reach display functionalities.
• Select [Filter] in order to choose a filter to apply. Use the touch screen joystick, the remote control arrows or the
Dl keypad joystick to select the filter to apply on the sequence. Press on the touch screen joystick button or on
enter on either the remote control or the Dl keypad to exit the function.

The state of the Smart Nav will change. Select [Validate] to keep the performed modification.
Select [Reset] to reset the sequence to its initial state.
The number of the filter is displayed on the Live 1.

• Select [B/C] to apply brightness and contrast on the sequence; the following window is displayed in Smart Nav:

Use the touch screen joystick, the remote control arrows or the Dl keypad joystick to adjust the
brightness and contrast. Press on the touch screen joystick button or on enter on either the remote
control or the Dl keypad to exit the function. The state of Smart Nav will change.
Select [Validate] to keep the performed modification. Select [Reset] to reset the sequence to its
initial state.
• Select [Zoom] to apply a x2 zoom on the sequence. Use the touch screen joystick, the remote control arrows or
the Dl keypad joystick to adjust the roam the sequence. Press on the touch screen joystick button or on enter on
either the remote control or the Dl keypad to exit the function. The state of Smart Nav will change. Select
[Validate] to keep the performed modification. Select [Reset] to reset the sequence to its initial state.
• Select [Pixel Shift] to apply the pixels shift of a subtracted acquisition. Use the touch screen joystick, the
remote control arrows or the Dl keypad joystick to adjust the shift of the sequence. Press on the touch screen
joystick button or on enter on either the remote control or the Dl keypad to exit the function. The state of Smart
Nav will change. Select [Validate] to keep the performed modification. Select [Reset] to reset the sequence to
its initial state.
• Select [Mask Select] to select the mask of a DSA sequence or to switch between mask and sequence review
for bolus or subtracted 3D acquisitions. Use the touch screen joystick, the remote control arrows or the DL
keypad joystick. Press on the touch screen joystick button or on enter on either the remote control or the DL
keypad to exit the function. The state of Smart Nav will change. Select [Validate] to keep the performed
modification. Select [Reset] to reset the sequence to its initial state.
• Select [Subtract] to apply or remove subtraction on the sequence. If subtraction is applied, a check is displayed
on the subtraction icon.

In Display Tools sub menu:

• Select [Shutter] to apply or remove the shutter on the sequence. If the shutter is applied, a check is displayed
on the shutter icon.
• Select [Time Scale] to display or erase the time scale. If time scale is displayed, a check is displayed on the
time scale icon.
• Select [Annotations] to display or erase the annotations on the sequence. If the annotations are displayed, a
check is displayed on the annotations icon.
Select [StentViz] to enable the StentViz function (Smart Nav will be hidden).
Select [Dose Map] to display the active Dose Map (Smart Nav will be hidden).
The Stopwatch sub menu group functionalities are related to the timer. When entering the sub menu, if no timer is
playing, the timer is played automatically; select [Pause] to stop the counter. When entering the sub-menu, if a
timer is paused, select [Play] to start the count. Select [Stop] to erase the display (Stopwatch sub menu will
remain visible). Select [Reset] to reset the timer.
The Photo sub menu group functionalities are either useful in a photo context or applicable on a photo.
• Select [Review Seq.] to play the last recorded sequence (Smart Nav will be hidden).
• Select [IRB] to display the IRB (Smart Nav will be hidden).
• Select [Send Angles] to perform a smart angle on the last displayed photo.
• Select [Annotations] to display or erase the annotations on the photo. If the annotations are displayed, a check
is displayed on the annotations icon.
Note that for functionalities performed on the sequence or photo triggered through a different device (touch screen,
DL remote control, DL keypad), Smart Nav will be hidden.
9 Table accessories
9-1 Shoulder Rests
A set of shoulder rests is delivered with the InnovaIQ Table.
This set is made of three parts: one central module and two identical shoulder rests.

1 Shoulder Rests
2 Central Module
In the case of Trendelenburg tilt during a procedure, it is recommended to install the shoulder rests prior to starting
the procedure to increase the patient confidence and prevent movement while the table is tilting.
The shoulder rests must be installed as shown in the picture.
THE SHOULDER RESTS ARE NOT TRANSPARENT. FOR PROCEDURES REQUIRING

IMAGING OF THE NECK AND HEAD REGION, THE SHOULDER RESTS SHOULD NOT BE
USED. THE ADDITIONAL FILTRATION INTRODUCED BY THE SHOULDER RESTS MAY
RESULT IN IMAGE ARTIFACTS AND INCREASE THE DOSE TO THE PATIENT AND STAFF.
THE DISTANCE BETWEEN THE TWO SUPPORTING ARMS OF THE SHOULDER REST MAY
NOT SUPPORT SMALL CHILDREN AND ADDITIONAL SUPPORT WILL BE REQUIRED.
One shoulder rest pole can hold a 125 kg max patient weight. Do not use the shoulder rest
assembly with patients heavier than 125 kg in case one of the shoulder rest needs to be
removed during the procedure while the table is tilted or needs to be tilted afterward.

1- Clean and dry carefully the table top before installing the central module.
2- Install the central module from table top head end as shown on the picture and secure it to the table top by
rotating the knob clockwise (3) until the torq limitor is activated.
3- Insert the shoulder rest perpendicular to the central module, push UP (4) and rotate it (5) toward foot side until it
is locked.

ALWAYS VERIFY BY PULLING ON THE SHOULDER REST THAT IT IS COMPLETELY

LOCKED ON THE TABLE TOP.
To remove the shoulder rests assembly:
1. Push UP each shoulder rest and rotate it toward head side to bring it perpendicular to the central module.
2. Push DOWN the shoulder rest to remove it from the central module.
3. Rotate the central module knob counter clokway until the module can be easily removed from the table top.
Note: If the shoulder rest pad comes into direct contact with the patient, use an exchangeable protective cover to
avoid contamination between patients.
Note: Shoulder rest pad is just screwed on its pole and can be easily removed for cleaning or exchange if needed.
Note: The shoulder rest device cannot be mounted on the tabletop when the head extender is used.
9-2 Footrest
A footrest is delivered with the InnovaIQ Table.
This footrest is reusing the shoulder rest's central module.
With the patient reversed on the table and feet at head end, if a Trendelenburg tilt is used during the procedure, it
is recommended to install the foot rest prior to starting the procedure to increase the patient confidence and
prevent movement while the table is tilting.
The footrest must be installed as shown on the pictures.

One shoulder rest pole can hold a 125 kg max patient weight. Do not use the shoulder rest
assembly with patients heavier than 125 kg in case the weight will be applied on one point
only on the footrest when the table will be tilted.
1- Install the central module at the head end as shown in the picture and secure it to the table top by rotating the
knob clockwise (3) until the torq limitor is activated.
2- Insert the shoulder rest perpendicular to the central module, push UP (4) and rotate it (5) toward foot side until it
is locked.

ALWAYS VERIFY BY PULLING ON THE SHOULDER REST THAT IT IS COMPLETELY

LOCKED ON THE TABLE TOP.
3- Remove the shoulder rest pads by rotating them counter clockwise.
4- Slide the footrest onto the shoulder rest's poles and tighten each nut of the footrest onto the poles.

To remove the footrest:

1. Untight both footrest nuts rotating counter clockwise.
2. Lift the footrest off of the shoulder rest poles.
3. Follow the shoulder rests assembly removal procedure.
Note: Always remove first the footrest from the shoulder rest assembly, then remove the shoulder rest assembly
from the table top. To make these accessories easier to carry, always manipulate them separately.
9-3 Table Head Extender
X-ray exposure must not be performed with the X-ray tube above the table with the table extender between the
patient and the image receptor.

Table head extender is not compatible with digital headholder, head widener, shoulder rest
and foot rest.
9-4 IV pole
The IV pole provides support for any IV bag when intravenous therapy needs to be administered to the patient.
The IV pole clamps with through hole are also available for IV pole mounting. These clamps are mounted on the
removable rails (sleeve) or the rail extender.
The IV pole clamps are clamped either on the sleeve or the rail extender.

Chapter 11 - Alarm Systems

1 Alarm management
On Innova systems, an embedded alarm system informs operators that there is either a potential hazard or an
actual hazard.
The alarm system is fully functional and operational after system is ready for use.
The alarm system indicates technical alarm condition with the display of an error message containing the level of
priority.
The level of priority is indicated by the addition of "!" for Low priority, "!!" for Medium priority, "!!!" for High priority at
the beginning of the error message.
• ! Low priority indicates that operator awareness is required.
• !! Medium priority indicates that prompt operator response is required.
• !!! High priority indicates that immediate operator response is required.
The alarm error message is always displayed on live displays in exam room and in control room.
If more than one alarm is active at one time, the alarm error messages are displayed successively with a 10
seconds period.
2 Alarm Message Format

Each alarm message is formatted on the following pattern:
[ Priority ] [ Risk ] [ Impacted Functionality ] [ Instruction ] [ Index ]
Alarm priority Risk System impacted Recommended in- Alarm index

functionality struction
!! Patient fall risk. Gantry/Table lock Handle patient with (2.7)
failed. care.
The alarm index displayed at the end of the error message refers to the alarm description in this section of the
Operator Manual and in the Alarm Messages window available from the Utilities key located on top of the Innova
Digital screen.
3 Alarm System Performances

The alarm management in the Innova system is implemented among the different components of the system.
The following table gives the maximum latency between the time an alarm condition is detected by the system and
the time the alarm message is displayed on monitors.
Innova system functions Nominal display latency Maximum display latency

Gantry / Table motion 1s 5s
536 Alarm Systems

X-ray / Auto-injection 1s 3s
Alarm system not functional 3s 5s
4 Degraded Mode of the Alarm Management

In case of communication problem between internal components of the system, only the functions related to the
Gantry/Table motions remain available to the operator, Gantry/Table alarm are then not displayed.
When an internal communication problem is detected, the alarm message "!! Collision/patient fall risk. Alarm
system failure. Move with care. (2.1)" is displayed on monitors and console.
5 List of Alarm Messages

The following tables give the list of all alarm messages of the Innova systems along their detailed description
recommended corrective instructions.
If alarm persists contact your Field Service Representative.
In- Alarm message Corrective actions Description

dex
3.1 !!! Collision risk. Protocol Check InnovaSense patient contouring acti- Upon the selection of a pro-
change failed. Check patient vation state. tocol, InnovaSense patient
contouring Reselect protocol. contouring control error.
Reset system to recover. Risk of collision between the
detector and thin materials,
e.g. needles. InnovaTraceTM
sensors do not detect small
invasive object.
3.2 !!! Risk of resuscitation delay. Clear potential collision and reach CPR posi- A collision occurred during
Auto CPR failure. Move manually tion manually. automatic CPR motion. The
system can not reach the
CPR position by itself.
Unknown gantry or table po-
sition. Risk of uncontrolled
collision. Automatic CPR
motion is disabled.
A failure of one table axis
prevents the table to reach
the CPR position by itself.
2.1 !! Collision/patient fall risk. Move Gantry with caution. Communication problem de-
Alarm system failure. Move with Secure the Load/Unload patient procedure. tected inside Innova system.
care Reset the system. Gantry and Table alarms
cannot be displayed. Risk of
patient fall if patient load/
unload procedure is in
progress. Risk of collision
with the patient or by-
standers.
Alarm Systems 537

2.2 !! Collision risk. Detector lift Reset system to recover. Detector lift brake failure de-
brake failure. Reset system tected at system boot or re-
set. Risk of uncontrolled de-
tector lift down motion. De-
tector lift commands are dis-
abled after five consecutive
detections.
2.3 !! Collision risk. Table position Continue on going procedure with care. Unknown table position.
failure. Move with care Risk of uncontrolled colli-
sion. All gantry axes move
at half speed.
2.4 !! Extra dose risk. Acquisition Release exposure switch. The frame rate used during
frame rate error. Reselect proto- Reselect the protocol and restart the acqui- acquisition does not match
col sition. the requested frame rate.
Patient Air Kerma may be
higher than expected (up to
four time to nominal).
2.5 !! Extra dose risk. Spectral filtra- Stop acquisition and resume. Error detected in spectral fil-
tion failure. Restart acquisition If problem persists, terminate promptly on tration selection.
going procedure. Image quality may not be
optimal and patient skin
dose may be higher (up to
four times nominal).
2.7 !! Patient fall risk. Gantry/table Verify that Gantry and Table motion are dis- One of the Gantry or Table
lock failed. Handle patient care- abled. brake has not been activat-
fully Handle patient with care. ed after a Gantry/Table dis-
able command. One of the
gantry axis is not locked.
Table longitudinal or lateral
axis is not locked. Risk of
patient fall in case of acci-
dental table or gantry com-
mand during patient load /
unload.
2.8 !! Patient fall risk. Gantry/Table Stop Gantry/Table motion then resume. Gantry/Table disable com-
lock failed. Repeat lock command not available during
mand an ongoing motion, a 3D, a
Spin Cardiac or a Bolus ac-
quisition. Risk of patient fall
in case of accidental table or
gantry command during pa-
tient load / unload.
2.9 !! Patient fall risk. Tabletop Handle patient with care. Longitudinal/lateral brakes
brakes failure. Handle patient cannot be activated any-
carefully more. Risk of patient fall
during patient load / unload.
2.10 !! System lock up risk. Long time Reset system before the end of the day. System was not reset for 30
without reset. Reset system consecutive days. A reset of
the system is needed to
eliminate a growing risk of
system lock up.
538 Alarm Systems

2.11 !! Extra dose risk. Detector fail- Terminate promptly ongoing procedure to Error detected in detector
ure. Secure patient secure patient. X-rays will be inhibited after power supply. Image quality
the end of the current procedure. may not be optimal and pa-
tient Air Kerma may be high-
er (up to four times nomi-
nal).
2.12 !! Patient fall risk. Immediately Move back immedialety the table in horizon- One of the table brakes has
move table back to horizontal tal position. Handle the patient with care. been detected as defective.
Risk of patient fall due to a
table brake failure and un-
controlled motion of the ta-
ble top.
2.13 ! Hidden anatomy risk. Deselect Stop on going Fluoro or Record. Deselect The electronic shutter posi-
auto-shutter and resume electronic shutter using the Shutter button tion is not accurate and clini-
on the Innova Digital Screen and resume cal data may be hidden.
procedure.
2.14 !! Collision risk. Collision predic- Continue on going procedure with care. Unknown gantry or table po-
tion failure. Move with care sition. Risk of uncontrolled
collision. All gantry and table
axis move at reduced
speed. Auto-Positioning and
automatic CPR are dis-
abled.
2.15 !! Exam interruption risk if power Contact immediately GE service for repair of Undercharged UPS batter-
is lost. UPS failure. Call Service the UPS. ies or UPS failure. Risk that
the exam is interrupted and
the Innova system suddenly
unavailable in case of main
power failure.
1.1 !! Collision risk. Collision detec- Continue on going procedure with care. Gantry emergency stop fail-
tion failure. Move with care ure or bumper sensor fail-
ure. Risk of patient collision.
All gantry axes move at half
speed.
1.2 !! Collision risk. L-Arm clutch Continue on going procedure with care. Gantry clutch failure detect-
failure. Move with care ed. Risk of staff injury in
case of collision with L-arm
movement. All gantry axes
move at half speed.
1.3 ! Extra dose risk. Cumulated Cumulated dose displayed is not accurate; The cumulated dose dis-
Dose not accurate. Reset system do not use this information in patient played might be less than
records. the cumulated dose deliv-
Reset System. ered to the patient.
1.4 ! Extra dose risk. Spectral filtra- Stop acquisition and resume. Error in spectral filtration se-
tion failure. Restart acquisition If problem persists, terminate on going pro- lection. Image quality may
cedure. not be optimal and patient
Air Kerma may be higher
(up to twice nominal).
Alarm Systems 539

1.5 ! Over injection risk. Injection Reset Innova system and reinitialize injector. Automatic injection failure
stop failure. Reset system If problem persists, use manual injection. detected. Injector did not
stop the injection as expect-
ed.
1.6 !! Unintended motion risk. Mo- Continue with caution. Smart Handle / Smart Box /
tion command failure. Move Secure the Load/Unload patient procedure. TSSC not fully operational.
carefully Risk of unintended motion
due to loss of command pro-
tection.
1.7 ! Unintended motion risk. Check Verify on footswitch/console hand switch are Record foot / hand switch
exposure switches are released released. permanent activation is de-
Correct and reset system to recover. tected by the system con-
trol. Risk of unintended mo-
tion during 3D, Spin Cardiac
or Bolus acquisition.
1.8 ! Unused X-ray risk. Injector un- Stop acquisition if started. Automatic Injection failure
available. Use manual injection Reinitialize injector and resume or select detected. Injector got dis-
manual injection. armed before automatic in-
jection start.
1.9 !!! 3 min before X-Ray inhibit. Terminate promptly current operation to se- System will be shut downed
UPS low. Secure patient cure patient. 3 min after the first message
is displayed. Less than 20 s
!!! 2 min before X-Ray inhibit.
prior system shutdown after
UPS low. Secure patient
last message is displayed.
UPS low. Secure patient
!!! System near to be shut down.
UPS low. Exit exam
1.10 !!! 3 min before X-Ray inhibit. Terminate promptly current operation to se- The X-ray tube is not cooled
Tube cooling failure. Secure pa- cure patient. anymore. X-rays are
tient stopped 3 min after the first
message is displayed.
Tube cooling failure. Secure pa-
tient
Tube cooling failure. Secure pa-
tient
540 Alarm Systems

Chapter 12 - Large Display Monitor Option

The Large Display Monitor is a monitor with a resolution of 3840 x 2160 pixels for display of the Innova images and
external devices images in the exam room and provides the capability to arrange the images per preference
through the Innova Central touch screen.
2 System Components
2-1 Basic Components
• A large display cabinet in the technical room.
• A large display monitor in the exam room.
• A suspension in the exam room.
• A set of video source devices either in the exam or control room.
• A table side interface for controlling the display (Innova Central touch screen).
2-2 Option
• A large display monitor to replicate images from the exam room.
• A set of parts to have HD 2MP and HD 8MP output.
• A set of video source devices either in the exam or control room.
3 Safety recommendations
THE WORKING POSITION WITH THE LARGE DISPLAY MONITOR OPTION IS TWO METERS
MAXIMUM FROM THE MONITOR.
For Innova signals, the images can be reduced to 75% (960 x 768 pixels) of the native resolution (1280 x 1024
pixels). It is estimated that the image is still readable at 75% for a working distance of two meters or less.
DURING THE CRITICAL PHASES OF AN INTERVENTION, A LAYOUT THAT CONTAINS THE

INNOVA IMAGES AT 100% (1280 x 1024 PIXELS) SHOULD BE USED.
IMAGE RESIZING: THE LARGE DISPLAY MONITOR ALLOWS RESIZING OF THE IMAGES
(ZOOM, SHRINK). THE USER SHOULD PAY ATTENTION WHEN DOING A DIAGNOSTIC OR A
TREATMENT ON OVER ESTIMATED VESSELS/STENOSIS.
MAKE SURE THAT ALL THE IMAGES ON THE LARGE DISPLAY MONITOR OPTION DISPLAY
THE SAME PATIENT INFORMATION TO AVOID DATA MISMATCH.
4 Connection of external devices

For the following modalities, the Large Display Monitor provides a connection, ensures a frequency match and
equivalent image quality:
• Innova
• Mac-Lab / CardioLab / ComboLab / SpecialsLab
Note: Mac-Lab / CardioLab / ComboLab / SpecialsLab do not support the Real-Time Scrolling feature when
used with the Large Display Monitor. Use the standard sweeping waveform display mode.
• Volcano s5i
• AW
• CA1000
Large Display Monitor Option 541

• Vivid E9
FOR THE OTHER MODALITIES, THE LARGE DISPLAY MONITOR ONLY PROVIDES A
CONNECTION BUT DOES NOT ENSURE AN EQUIVALENT IMAGE QUALITY AND A
FREQUENCY MATCH.
If there is a degradation of the signal on the Large Display Monitor that prevents the use of the modality image, use
the original monitor of the modality.
If the frequency of the signal does not match the frequency of the allocated input port of the Large Display Monitor,
use the original monitor of the modality.
5 How to control the Large Display Monitor

The Innova Central touch screen provides an interface to control the Large Display Monitor.
Use this interface to select layouts and manage them into groups. A group is a set of layouts. Before using the
Large Display Monitor during exams or procedures, it is possible to create and store groups dedicated to each
specific type of examination.
Please be aware that the joystick of the Innova Central touch screen is not controlling the Large Display Monitor.
On the 'Large Display' tab, the function of the joystick remains to control the Innova functions.
5-1 How to Manage Groups

The Groups are managed from the Innova Central touch screen. Press the ‘Large Display’ tab on the Innova
Central touch screen in order to have access to the group management. Tap on the "Groups" button to display the
list of saved groups.
Select a group by tapping on it in the groups list.
Find the name of the selected group displayed in the upper left corner of the 'Large Display' tab.
542 Large Display Monitor Option

Note: Five groups can be displayed at the same time in the group list. The user may navigate using up and down
arrow in order to access to the whole group list.
5-1-1 How to Create a New Group
Press ‘Manage Groups’, then ‘Create new group’.
5-1-1-1 Group naming

Enter the name of the new group. The name of the group should contain between 1 and 16 characters.
Each group should have a unique name.
Once the name is entered, press ‘OK’ to go to the Starter group selection screen.

5-1-1-2 Composing a group

On this screen you may perform the following actions:
• Add a new layout to the group: tap on an empty layout box to add a new layout.
After tapping on the 'Assign new layout' box, a new page will appear with all the video inputs that are available.
Tap each video input to be displayed in the layout and the corresponding check mark will be displayed on the
layout button.

Selecting too many inputs at a time could cause the layout filter to return 0 matches. Reduce the number of
video inputs to widen the search.
Once the selection is done, press on "Apply Filter".
All layouts that respect the filtering criteria will be displayed.
Each window on the Innova Central touch screen shows 4 layouts..
Use the right and left arrow in order to navigate among pages of proposed layouts. An indicator shows the number
of pages and which one is currently displayed.
After creating a group, tap on the “Save Group” button and return to the main screen of the available groups.
5-1-2 How to Modify a selected Group
Press the ‘Groups’ button on the bottom of the Innova Central touch screen.
Press ‘Manage Groups’.
Select the group to modify.
Select ‘Edit selected group’ option.

The selected group's layouts will appear allowing the user to add, move or delete any layouts.
To move a layout in a group:

• Select the layout.
• Use the right and left arrow in order to move the layouts.
• Tap the red “X” to delete the layout.
• Tap “Save Group” to save the modifications.
5-1-3 How to Modify the name of the selected group
Select the group to rename.
Select ‘Edit selected group name’ option.

Type in the new name for that group with the soft keyboard.
Tap 'OK’.
5-1-4 How to Delete a selected Group
Select the group to delete.
Select ‘Delete selected group’ option.

Confirm the warning message to finalize the deletion process.
5-2 How to change the Large Display Monitor layout

Outside the acquisition, it is possible to select another layout by tapping the desired layout. To select a layout from
another group, press the ‘Groups’ button. Select the desired group. All the layouts from this group will appear.
Select the desired layout by tapping on it.
Use the paging buttons to navigate among layouts within the selected group.
The page indicator informs which page is currently displayed.
The background color of selected layout on the Central Touch Screen is white.
5-3 How to Identify Innova monitors
On the Large Display Monitor, the Innova images can be recognized by the specific labeling:
• The Frontal Live 1 image, and its possible duplicate, is defined by a medium blue horizontal line at the top of the
image.

• The Frontal Live 2 image, and its possible duplicate, is defined by a medium blue horizontal line at the top of the
image.
• The Frontal Reference image is defined by a light blue horizontal line on the top.
• The Frontal Reference duplicate image is defined by a light blue full border.
• The Lateral Live 1 image, and its possible duplicate, is defined by a medium orange horizontal line at the top of
the image.
• The Lateral Live 2 image, and its possible duplicate, is defined by a medium orange horizontal line at the top of
the image.
• The Lateral Reference image is defined by a light blue horizontal line on the top.
• The Lateral Reference duplicate image is defined by a light blue full border.
On the Innova Central touch screen, the rectangles representing the Innova inputs could be identified by the
specific labeling:
• The Frontal Live 1 image, and its possible duplicate, is represented by a medium blue rectangle.
• The Frontal Live 2 image, and its possible duplicate, is represented by a medium blue rectangle.
• The Frontal Reference image, and its possible duplicate, is represented by a light blue rectangle.
• The Lateral Live 1 image, and its possible duplicate, is represented by a medium orange rectangle.
• The Lateral Live 2 image, and its possible duplicate, is represented by a medium orange rectangle.
• The Lateral Reference image, and its possible duplicate, is represented by a light orange rectangle.
5-4 How to Identify the presence/absence of signal

When the device is not connected to the Large Display Monitor, an “unconnected” icon appears:

5-5 How to recognize availability of the Large Display Monitor

A notification message appears if the connection between the Large Display Monitor and the Innova Central touch
screen is not established or is being established. Until the connection is not properly set up, the Large Display
Monitor cannot be controlled.
6 Second Large Display Monitor (Replica) (Option)

When a second Large Display Monitor is installed on the wall, both Large Display Monitors display the same layout.
The image of the optional Large Display Monitor is a replica of the image of the Large Display Monitor located in
the exam room. This second monitor has similar performance as the Large Display Monitor of the exam room.


Chapter 13 - Monitor Suspension

1 LCD Monitor Suspensions
1-1 3, 4 or 6 LCD Monitors Suspension
The Innova IGS 520, Innova IGS 530, Innova IGS 540 can be delivered with 3, 4 or 6 LCD monitors suspension.
The LCD Monitor Suspension comes fully installed and pre-cabled, suspended by a Suspension Arm. For your
operational needs, no additional features need to be considered.
1-2 Large Display Monitor Suspension
1-2-1 Standard use
The Innova IGS 520, Innova IGS 530, Innova IGS 540 can be delivered with a Large Display Monitor suspension.
The Large Display Monitor suspension is delivered with one Large Display Monitor and two 19" monitors mounted
to the back of the suspension to use in case of a degraded mode of the Large Display Monitor.
The Large Display Monitor suspension comes fully installed and pre-cabled, suspended by a suspension Arm. For
your operational needs, no additional features need to be considered.
552 Monitor Suspension

1-2-2 Degraded Mode
IN CASE OF LARGE DISPLAY MONITOR FAILURE, ROTATE YOUR SUSPENSION TO

ACCESS THE BACKUP MONITORS FIXED ON THE BACK. CHECK DAILY THAT THE
BACKUP MONITORS ARE WORKING PROPERLY AND DISPLAYING ADEQUATE IMAGES.
For Innova IGS 520, Innova IGS 530, Innova IGS 540, the frontal live and reference displays will be fixed on the
back of the suspension.
If Simultaneous Fluoro Sub / NoSub Display option is installed on the Innova IGS 520, Innova IGS 530, Innova IGS
540, the Frontal Live and Simultaneous display monitors will be fixed on the back of the suspension.
Rotation in case of Large Display Monitor failure:
The rotation of the suspension in case of LCD failure can be done in one direction only depending on the room
configuration. The rotation angle is 180°, if it cannot be reached, rotate the suspension in the opposite direction.
Monitor Suspension 553

The label fixed on the handles indicates to the user the presence of backup monitors located at the back of the
suspension.
ENSURE MINIMUM CLEARANCE AROUND THE LARGE DISPLAY MONITOR IN ORDER TO

ALLOW THE ROTATION IN DEGRADED MODE.
IN A CASE WHERE THE LARGE DISPLAY MONITOR IS ACCIDENTALLY TURNED OFF, THE
BACK-UP MONITORS WILL STILL BE ON AND SHOULD BE USED.
1-3 Precautions
The installation, connection, removal and repair of all components must be performed by qualified, licensed
technicians only.
Ceiling mounted systems must be installed properly. Failure to follow the instructions
provided may lead to a potentially hazardous and unstable condition of the system.
These products must be serviced with manufacturer-approved, original replacement parts only. Failure to follow this
recommendation will void the manufacturer's warranty and will release the manufacturer from liability and warranty
claims!
When installing and adjusting the LCD Monitor Suspension System and/or associated components, or performing
any work on the system, be sure to remove all electrical power to the entire system. This is a hazardous
condition!
The suspension arm is under constant spring tension. When installing or removing components to or from the
system, always move the suspension arm slowly to its upper stop (upper maximum hub)! Otherwise, when
disconnecting components from the system, the suspension arm may jump upwards, causing damage or injury.
The Manufacturer can not be held liable for unauthorized modifications made to the system, or use of the system
for unintended purposes. Since improper modifications may impair proper operation, safety, or reliability of the
system, all modifications need to be authorized by the Manufacturer in writing.
Avoid all Collisions with other Equipment or Walls, Ceiling, etc. Severe Damage may occur!
In case of Collision or Damage, immediately stop Operation of System.
Disconnect the Power Supply immediately!!
Do not position anyone or walk underneath the system!
Inform Manufacturer immediately!
Do not use System in humid surroundings.
Do not open Covers, Cable Channels, etc.! Hazardous!
554 Monitor Suspension

1-4 Operation
Note: The suspension arm contains GAS SPRINGS. The gas inside of the springs reacts to temperature changes
by expanding or contracting, thus slightly changing their spring range.
Therefore, extensive temperature differences may affect the Suspension Arm performance. Please let the gas
springs adjust to your room climate, before you have the balance of your Suspension Arm adjusted. Even 10°
Celsius will have a (small) effect. Allow the suspension arm to acclimate to the room temperature for
approximately 12 hours.
Swing System in all desired directions. Avoid harsh movements. Do not turn more than 350° - System is blocked at
360° to avoid Cable torque.
Upward movement is easier if you swing System outwards (away from point of Suspension Arm fixation) before
you lift the System.
Downward movement is easier if you swing System inwards (towards point of Suspension Arm fixation) before you
lower the System.
1-5 Periodic Maintenance
On a regular basis (min. annually), have a technician check screws and cables of System for security.
Please refer to Service Manual for LCD Monitor Suspension for all necessary Measurements and Specification.
Note: System is designed for a life time of 10 (ten) years. After 10 years, exchange of the System is strongly
recommended.
2 Open Monitor Suspension

The Innova IGS system can be delivered with a monitor suspension purchased, provided and installed by the
customer or a third party supplier of his choice. Refer to the suspension manufacturer’s instructions for use before
any use.
In case of a Large Display Monitor mounted on an open monitor suspension, the two 19’’ backup monitors for the
Large Display Monitor degraded mode can be mounted at the back of the suspension or on an additional
suspension (refer to Monitor Suspension / LCD Monitor Suspensions / Large Display Monitor Suspension /
Degraded Mode and Safety and Regulatory / General Safety / Be Sure the Equipment is Functioning Before each
Use / Large Display Monitor suspension)
Monitor Suspension 555

Chapter 14 - Cathlab Frontiers Solutions (Option)

1 General Application Description
The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic
X-ray systems and imaging / data medical devices used in interventional and surgical cath lab environments and
cleared for commercial distribution.
The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that
simplify the end-to-end clinical workflow in the cath lab by implementing:
1. communication protocols for exchanging and automatically synchronizing patient, exam, system, and image
information between the angiographic X-ray systems and the imaging / data medical devices,
2. communication protocols for the control of imaging / data medical device functions from the angiographic X-ray
systems user interface,
3. interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE
angiographic X-ray systems.
EXCEPT FOR THE INTERCONNECTIONS THROUGH STANDARDIZED SW AND HW
INTERFACES (LIKE DICOM), ALL ASSOCIATIONS OF THE GE ANGIOGRAPHIC X-RAY SYSTEM WITH A 3RD
PARTY IMAGING/DATA MEDICAL DEVICE MUST BE APPROVED FOR USE BY THE MANUFACTURER
GEHC.
Cathlab Frontiers Solutions is the common name for the following system options:
• The Integrated Innova - s5i system option (Volcano s5iTM Imaging System: PN 400-0100.02, Software version
3.2.2)
• The Integrated Vivid E9 solution (Vivid E9 System: BT' 12 version).
2 Integrated Innova - s5i system option - applicable for s5iTM

The Integrated Innova - s5i system option simplifies the clinical workflow associated with the use of Volcano s5i
systems by:
1. automatically synchronizing the patient demographic and medical exam information (patient name, date of birth.
etc.) from angiographic X-ray systems with Volcano s5i systems.
2. providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray
systems user interface.
3. displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.
IN CASE OF CORRUPTED PATIENT DATA TRANSMISSION OR COMMUNICATION FAILURE

BETWEEN THE ANGIOGRAPHIC X-RAY SYSTEM AND S5I SYSTEM, THE S5I WILL DISPLAY
"INNOVA CONNECTIVITY OFF" AND THE ERROR MESSAGE "INNOVA CONNECTIVITY
ERROR (0). PATIENT DATA MUST BE MANUALLY ENTERED." THE INNOVA CENTRAL
TOUCH SCREEN BUTTONS OF THE S5I TAB WILL BE DISABLED AS WELL. IN SUCH CASE,
ALL PATIENT DATA MUST BE CHECKED ON THE S5I SYSTEM AND CORRECTED OR
ENTERED MANUALLY.
2-1 s5i System components
For the description of s5i System components, User interfaces, Patient Interface Modules and catheters, refer to
the following operator manuals delivered with your system:
• Volcano s5iTM Precision Guided Therapy System Operator’s Manual.
• Volcano FFR Option Operator’s Manual.
• Volcano Revo Option Operator’s Manual.
556 Cathlab Frontiers Solutions (Option)

2-2 Entering Patient Information on s5i

The patient data will be sent automatically to the s5i CPU for each case when the Patient Record is created or
modified on the GE angiographic X-ray system. When the user presses the IVUS/FFR tab on the Innova Central
Touch Screen, the system is ready for use. The s5i system checks for a match in the patient user ID and opens
with the data already in the appropriate fields. If there is an open case on the s5i CPU that does not match the
current user ID when the Patient Record is created, the case will be automatically saved to the s5i CPU hard drive.
If there is no available space on the CPU, user will be prompted on screen to archive the current case. The new
patient data will be imported into the CPU automatically when space is available.
2-3 Running an IVUS Case with the Innova Central Touch Screen
1. Select the IVUS/FFR tab on the Innova Central Touch Screen.
2. Plug the catheter into the PIM at the patient’s bedside.
3. Press Home (Live) button to go to Home screen and Live mode and press the Ringdown button to eliminate
ringdown artifact when used with an Eagle Eye catheter. Manual ringdown from the s5i Controller can be done
for peripheral catheters.
4. Place the catheter in the patient.
5. Press ChromaFlo if desired for imaging, or proceed with standard imaging.
6. You can save a snapshot of the live image at any time by pushing the Save Frame button.
7. Position the catheter distal to the lesion of interest and implement the pullback device if desired.
8. If the s5i Revo Option with its SpinVision (s5i Rotational PIM) is used, choose a pullback speed (1.0 mm/sec,
0.5 mm/sec or Manual).
9. Press the Record button on Innova Central Touch Screen to begin recording.
10.Press the Bookmark button to mark locations of interest during pullback if desired.
11.Press the Stop button on Innova Central Touch Screen to end Recording.
12.Press Play to review the current Recording, or select from the Playback list button.
13.Press Print to send the current s5i screen to the color printer.
14.The Measure button allows specific vessel and lumen measurements (when available).
15.On the remote Control Console select End Case and follow the standard archiving protocol. If the case is not
ended, the system will prompt the user to do so before the next IVUS case.
2-4 Running an FFR Case with the Innova Central Touch Screen
1. Select the IVUS/FFR tab on the Innova Central Touch Screen.
2. Plug the guide wire into the PIM-ffr at the patient’s bedside.
3. Position the pressure sensor on the guide wire immediately distal to the end of the guide catheter and press the
Ringdown button to normalize the Pd and Pa waveforms.
4. Place the guide wire in the patient.
5. Advance the guide wire to the location of interest. Induce hyperemia and press the Record button to begin
measurement.
6. After maximum hyperemia has been achieved, press Stop and the display will change to show the entire run for
review.
7. Press the Bookmark button to mark locations of interest during or within the run.
8. Press Print to send the current s5i screen to the color printer.
2-5 Display of the s5i screen on the GE angiographic X-ray system monitor solution
Cathlab Frontiers Solutions (Option) 557

The s5i screen can be displayed on GE angiographic system’s exam room display solution: either on a color
monitor from the LCD monitor suspension or on the Large Display Monitor.
In the LCD monitor suspension case a video switch may be used in the control room to share the s5i display and
the AW display on the same exam room color monitor.
In the Large Display Monitor case a dedicated "IVUS" linkset is used to route the s5i video signal to the Large
Display Monitor. Using the Innova Central touch screen, you can select from the predefined "IVUS" layouts.
However, it is possible to further optimize the layouts to fulfill all the needs of the clinical procedure (fully
customized input types, sizes, and positions). Contact the GE Service Office for your country to ask support for
further layout customization.
2-6 Use of the s5i system in OR configuration
To maintain the compliance with the operating table safety standard IEC 60601-2-46, not all s5i controls and
Patient Interface Modules (PIMs) are allowed to be mounted on the table rails or the table itself. Only the following
s5i controls and PIMs are allowed:
• s5i Trackball Controller (Control Console II
• Joystick
• s5i IVUS PIM
• s5i Rotational PIM (only in a sterile bag)
• FFR PIM
Note: The traditional s5i Control Console (Control Console I - IPX0 rating only) needs to be placed in the tableside
cart.
Note: The Volcano Touch Pad is applicable only to s5i GE Rev1, Rev2 and Rev2+ systems. It is not used any
more with the s5iTM Imaging System PN: 400-0100.02, Software Version 3.2.2.
To maintain the integrity of the sterile field the bedside mounted s5i system equipment should be located under a
sterile drape when configured for normal use. Refer to the Volcano operator manuals delivered with your system for
the use of sterile drapes/covers on the s5i system components.
3 Integrated Vivid E9 solution (Option)

TheIntegrated Vivid E9 solution (option) with the 6VT-D (4D TEE) probe, provide access to GE's cardiovascular
ultrasound system designed for cardiac 4D imaging. By displaying the Vivid E9 system output on Innova IGS Large
Display Monitor, the system simplifies the end-to-end clinical workflow for electrophysiology and structural heart
procedures like (but not limited too):
• TAVI/TAVR – Transcatheter Aortic Valve Implantation / Transcatheter Aortic Valve Repair
• ASD - Atrial Septum Defect closure
• MV - Mitral Valve repair / Mitral Valve clip
• LAA - Left Atrial Appendage closure.
The Large Display Monitor provides a connection for Vivid E9 system that ensures a frequency match and
equivalent image quality with Vivid E9 monitor.
The Vivid E9 system is depicted in the following picture:

For a complete description of the Vivid E9 systems and the 6VT-D (4D TEE) probe refer to the following User
Manuals:
• Vivid E9 User Manual - GA092907.
• TEE probes User Manual - KZ192871.
3-1 System Setup
During the clinical procedures the Vivid E9 system with the 6VT-D (4D TEE) probe will be positioned either on the
left or on the right side of the patient head area, at a distance which permits comfortable access of the TEE probe
towards the patient (transesophageal access). The Vivid E9 operator is standing between the equipment and the
patient head. The patient head area positions are shared with the anesthesiology equipment and operator, and the
interventional cardiologist and/or surgeons.
During the X-Ray procedure, the Innova IGS gantry movements are also limiting the Vivid E9 positions around the
head area, and a dedicated back out path has to be cleared for Vivid E9 park position.
The Vivid E9 has 3 types of connection cables:
• Power
• Network
• Large Display Monitor image link called Vivid E9 linkset cable
The power and the network connection cables belong to the Vivid E9. They shall be disconnected from the wall
access sockets and roll up to Vivid E9 cable hooks before moving the equipment out of the exam room.
The LDM image link cable should be disconnected from the back of the Vivid E9 and needs to be protected when
not in use.
The Vivid E9 linkset cable has the following end (including an EMC foam that needs to be used all the time):
Cathlab Frontiers Solutions (Option) 559

It is important to prevent any damage of the VividE9 linkset cable. To do so:

• Avoid stepping on or pulling out the cable when the Vivid E9 is operational and connected to the Large Display
Monitor.
• Roll up the Vivid E9 linkset cable and store it on the wall mounted cable hook when the Vivid E9 is not in use.
Make sure you insert the EMC foams in the VividE9 image linkset cable end.
3-2 Safety recommendations
The Vivid E9 system supports the use of a 4D Transesophageal Echocardiography (TEE) probe, the 6VT-D (4D
TEE) probe, that is used during all phases of the above mentioned clinical procedures.
ACCIDENTAL WITHDRAWAL OF A TEE PROBE MAY CAUSE DEEP SOFT TISSUE INJURY.
THE USER SHOULD MINIMIZE THE RISK OF THE INJURY BY: - LOCKING THE WHEELS OF
THE VIVID E9 SYSTEM WHILE IT IS IN USE - LOCKING THE INNOVA GANTRY AND TABLE
MOTIONS WHEN NO MOVEMENT IS NEEDED - TAKING SPECIFIC CARE WHEN MOVING
THE GANTRY AND/OR TABLE TO PREVENT THE ACCIDENTAL WITHDRAWAL OF THE
6VT-D (4D TEE) PROBE.
Since the Vivid E9 system is used in the vicinity of the patient, it may accidentally collide with Innova IGS Gantry
and/or Table.
ACCIDENTAL ENTRAPMENT, PINCH, OR CRUSH OF USERS BETWEEN THE VIVID E9 AND

THE INNOVA IGS SYSTEMS MAY CAUSE MUSCULOSKELETAL INJURIES. THE USER
SHOULD MINIMIZE THE RISK OF THE INJURY BY REMOVING THE VIVID E9 SYSTEM FROM
THE VICINITY OF THE INNOVA IGS WHEN PERFORMING QUICK GANTRY MOVEMENTS,
INNOVA SPIN OR 3D ROTATIONAL SPIN.
3-3 Procedure specific layouts
Using the Innova Central touch screen, you can select from the predefined Large Display Monitor layouts as
described in the previous sections of this Operator Manual. However, it is possible to further optimize the layouts to
fulfill all the needs of the clinical procedure (fully customized input types, sizes, and positions). Contact the GE
Service Office for your country to ask support for further layout customization.
Note: When selecting or configuring the needed layout, the Vivid E9 system is using the US #2 video input of the
Large Display Monitor.

Chapter 15 - OR Configuration (Option)

Note: OR configuration option may not be available in all countries, contact your respective GE Healthcare
representative for details.
The OR configuration of the product is designed in accordance with the operating table standard (IEC 60601-2-46),
it corresponds to the Innova IGS 520, Innova IGS 530 or Innova IGS 540 product equipped with:
• OR table (InnovaIQ table identified with an "OR" labeling on the Covers, refer to the picture below).
• IPX4 Table side user interface.
• Mandatory UPS.
• Removable table rails - Available in US (9.52 x 28.5 mm) and European (10 x 25 mm) standard sizes.
• Dedicated surgery protocols.
To maintain the compliance with the operating table safety standard, not all controls are allowed to be mounted on
the table rails. The following controls only are allowed:
• IPX4 Table Side Status Control (TSSC).
• IPX4 Smart Box (Smart Box).
• IPX4 Table Panning Device (TPD).
• IPX4 Innova Central touch screen.
• Innova IVUS PIM and TouchPad.
A tableside cart is provided to place any other control (3D mouse, Innova IVUS console and joystick).
Table mounted injectors are not allowed with the OR configuration.
PRODUCT DIFFERENTIATION:
The OR table corresponds to the OR configuration of the Innova x-ray angiographic system.The symbol on the
table with "OR" corresponds to OR Table and OR configuration of system.
OR Table
THE SYSTEM CAN BE USED FOR OPEN SURGERY OR IMAGE GUIDED SURGERY ONLY
WITH THE OR CONFIGURATION OPTION AND IF INSTALLED IN A DEDICATED OPERATING
ROOM.
THE TABLE DOES NOT HAVE BREAKABLE TABLE TOP (ARTICULATED JOINTS). IT IS NOT
RECOMMENDED TO PERFORM PROCEDURES REQUIRING INTRAOPERATIVE
ARTICULATIONS WITH THIS DEVICE.
OR Configuration (Option) 561

THE TABLE DOES NOT HAVE LATERAL TILT (CRADLING). IT IS NOT RECOMMENDED TO
PERFORM PROCEDURES REQUIRING INTRAOPERATIVE LATERAL TILT (CRADLING) WITH
THIS DEVICE.
TABLE MOUNTED INJECTORS ARE NOT ALLOWED TO MOUNT ON THE TABLE AS THEY
ARE NOT COMPATIBLE IN THE OR CONFIGURATION OF THE INNOVA SYSTEM.
3D MOUSE AND INNOVA IVUS (EXCEPT PIM & TOUCHPAD) SHALL BE MOUNTED ON THE
WHEELED STAND IN THE OR CONFIGURATION OF THE INNOVA SYSTEM AS THEY ARE
NOT COMPATIBLE WITH THE OPERATING TABLE.
2 Interruption of Power Supply

In the event of interruption of the power supply, OR Table remains powered by the UPS after power outage upto 5
minutes, movement into NORMAL and Trendelenburg POSITION remain possible.
Refer Innova Digital / Fluoro UPS.
3 Attachment of Protective (Sterile) Drapes

TO PROTECT AGAINST POSSIBLE PARTICLE REJECTION, A FULL DETECTOR AND LIFT
DRAPING MUST BE SET UP FOR ALL PROCEDURES COMBINING IMAGING AND
SURGERY.
Bodily fluids may damage internal components if they are allowed inside the equipment.
Use drapes, if necessary, to protect equipment when performing procedures.
You can choose among the following solutions, that must be ISO 10993 certified. You can contact your local GE
representative for more information on how to order these solutions.
Full drape kit:
1 - How to position the C-arc drape:
562 OR Configuration (Option)

For a safe and easy mounting of the drapes, 2 people are necessary.
• Remove the C-arc drape from the kit.

• Position the gantry in the PA position and rotate the table to provide proper clearance.
• Apply the C-arc drape by snapping the clips at the hose connection point:
• Break the “Tear Here” stickers (4 pieces) at the perforation lines and slide the drape to expand over the top and
bottom sections of the C-arc.
Note: Particular attention should be paid to avoid any contact between the sterile operator and the detector.

2 - How to position the Image detector drape:
For a safe and easy mounting of the drapes, 2 people are necessary.
In order to get proper clearance and access, you can position the gantry and the tabletop away from one another
by rotating the tabletop or by moving the gantry in backout or parking.
• Remove the image detector drape from the kit.
• Lower the detector to the lowest position. Lay the drape on a table, unfold the left and right and fan folds
keeping the label “this side up” exposed.
• Insert hands (left and right) at the bottom of the drape in the layer where hand labels are indicated.

• Lift drape up with hands inside (the inside of the drape will be exposed).
• Start positioning the drape over the detector.
Note: Particular attention should be paid to avoid any contact between non sterile body parts of the operator
(like head) and the drape.
At this stage of the draping procedure 2 people are necessary.
• Uncurl the drape completely.
• Match the drape’s trim sealed blue corners to the detector’s front corners.

• Raise the detector to its maximum height and fasten the first strap at its landing point area (if this strap is not
placed in the right spot, the drape will sag and not fit tightly to the detector.
• Lower the detector to the lowest position and fasten the 2nd strap. Fasten the strap such that no C-arc clip is
entrapped.
3 - How to position the Tube drape:

• Remove the x-ray tube drape from the kit.
• Rotate the gantry to LAO 90 or greater to decrease the opportunity of floor contact (If the drape needs to stay
sterile). This operation is possible when the gantry is in imaging position.

• Apply the drape. The drape should overlay the C-arc drape, but should not entrap any C-arc drape clip.
• Apply the 1st rubber band.
• Gather the excess material at the top of the C then place the 2nd rubber band around the drape.
• Using the adhesive bands at the drape’s corner, it is possible to improve the fitting of the drape.
4 - At the end of the draping, one should verify that:

• No side clips have been ripped out during mounting:
If yes, re-clip and try to be smoother when sliding the drape over the C-arc the next time. Be sure to break the
"Tear Here" stickers before sliding the drape.
• No C-arc clip have been entrapped in the Image detector drape or tube drape, as shown on the following
pictures. If so, there is a risk for the clips to be ripped out during extreme angulations of the C.

1 - Clip 1 - Clip
2 - Poly tie badly positioned, below the last clip 2 - Poly tie well positioned, above the last clip
Image detector drape is not correctly positioned, the Image detector drape is correctly positioned, the poly
poly tie is attached too low on the C-arc tie is attached above the last clip.
Tube drape not correctly positioned, last clip is inside Tube drape is correctly positioned, last clip is outside
the bag the bag
Clip should be outside the tube drape. Clip is outside the tube drape.
Half drape:
This drape is covering the entire Image receptor assembly, and the upper half of the C-arc. The mounting
instructions are identical to the Image detector drape above 2. There is an additional poly tie to attach around the
C-arc, at the end of the mounting.
This drape is to be used for procedures not requiring any C-arc movement. Pivot, swivel
and detector movements are allowed.
L Arm Access Plate & Access Holes:
This portion of L-arm need to be draped.

1 Access plate
2 Access holes

Chapter 16 - Surgical and Patient Comfort Accessories

1 Equipment Installed in Patient Vicinity
Patient vicinity is defined as a space within the room 1.83 m beyond the perimeter of the examination table and
extending vertically 2.29 m above the floor. The following accessories may be installed within patient vicinity:
• Removable table rails (called sleeve or surgical size rails)
• Rail extender
• Head widener (called head support widener)
• Adaptor rail for table side controls
• Table width extender
• Armboard with thick pad (armrest)
• Universal clamp (called universal socket)
• Round post clamp (called easy lock socket)
• Patient restraint strap
• Anesthesia screen holder (called flexible anesthesia screen holder or post)
Rails are available in US (9.52 x 28.5 mm) and European (10 x 25 mm) standard size.
2 Accessory rail load consideration

The maximum load of each rail of the removable table rails is 20 kg.
Below is the weight and load capacity of accessories that get mounted on removable table rails. This table
to be considered for loading of accessories to ensure not to exceed maximum permissible load limits:
Accessories Qty Weight/Unit (kg) Maximum load

Removable table rails 1 5 kg 20 kg on each side
(sleeve)
Rail extender 2 0.7 kg 15 kg
Adaptor rail for table side 1 1 kg 15 kg
controls
Head widener 1 1.5 kg 15 kg
Table width extender 2 1 kg 15 kg
Armboard with thick pad 2 1.8 kg 15 kg
(armrest)
Universal clamp 1 0.3 kg 15 kg
Round post clamp 2 0.6 kg 15 kg
Patient restraint strap 1 1 kg -
Anesthesia screen holder 1 1.6 kg 1.1 kg
(also called flexible anesthe-
sia screen holder or post)
Refer to System OM for the weight of the GEHC accessories.
570 Surgical and Patient Comfort Accessories

3 Instructions for Use

THESE ACCESSORIES SHALL NOT BE USED TO PAN/HANDLE THE TABLE.
OPERATORS SHALL NOT LEAN ON ACCESSORIES MOUNTED ON TABLE.
ACCESSORIES SHALL BE MOUNTED ON THEIR RESPECTIVE COMPATIBLE RAILS (E.G.:

NO SURGICAL ACCESSORIES SHALL BE MOUNTED ON THE FIXED TABLE ACCESSORY
RAILS).
SOME PARTS OF THESE ACCESSORIES ARE NOT RADIOLUCENT AND MAY CAUSE
IMAGE QUALITY ARTIFACTS, THAT MAY BE DIFFICULT TO DISTINGUISH FROM
ANATOMICAL STRUCTURES.
SOME ANTI COLLISION SYSTEMS ARE BASED ON A VIRTUAL VOLUME REPRESENTING A

STANDARD PATIENT LOADED ON THE TABLETOP IN "STANDARD POSITION". SURGICAL
AND PATIENT COMFORT ACCESSORIES ARE NOT INTEGRATED IN THIS VIRTUAL
VOLUME. SPECIAL ATTENTION IS REQUIRED FROM USER WHEN PERFORMING MOTIONS.
SOME OF THE ACCESSORIES MOUNTED ON THE REMOVABLE TABLE RAILS CAN

POTENTIALLY COLLIDE WITH TABLE DURING SOME TABLE MOTIONS. SPECIAL
ATTENTION MUST BE TAKEN REGARDING THE POSITIONING OF THE TABLE, TO AVOID
COLLISION WITH THE PATIENT AND THE EQUIPMENT. FAILURE TO THIS
RECOMMENDATION MAY LEAD TO PATIENT INJURY AND EQUIPMENT DAMAGE.
IN CASE OF CONTAMINATION INSIDE THE PADS OF HEAD WIDENER, ARMBOARD OR

WIDTH EXTENDER DUE TO FLUID ABSORPTION, IT IS MANDATORY TO REPLACE THE
DAMAGED PART.
To avoid damage to an accessory or the table covers, no accessory, such as an IV Pole or

Innova IVUS, should be placed too low or in the vicinity to come into contact with the table
covers during table motions.
Check that each accessory is properly mounted and clamped if provided with clamps before
any use. Failure to this recommendation may lead to patient injury and equipment damage
These accessories are delivered with their own instructions for use. Refer to them before any use.
3-1 Removable Table Rails
It is recommended that the table be rotated away from gantry during removable table rails insertion on/removal
from the table.
3-1-1 Installation
Before mounting the removable table rails, locate and secure all tubing, wires or catheters to avoid pinching, pulling
or otherwise interfering with safe and proper patient care.
1. Slide the removable table rails on to the tabletop until it hits the table Top.
Surgical and Patient Comfort Accessories 571

2. Rotate the knob upward into the locked position to secure it.
3. A potential equalization terminal is available on the rails to bring the various parts of equipment or systems to
the same potential when connected together.
3-1-2 Removal
1. Before removing the removable table rails, check that tubing, wires or catheters are not entangled.
2. Remove all accessories from it including any potential equalization plugs.
3. Unlock the removable table rails by rotating the lock knob downward.
4. Grip the removable table rails by the rails and pull it towards you.
3-1-3 Equipment care
Inspect the removable table rails and rails for damage, dents, or cracks before each use. If they seem damaged or
broken, contact your GE service representative for repair or replacement.
3-2 Other accessories
Once the removable table rails is mounted on the tabletop, it is used to mount other accessories like armboard, rail
extender, adaptor rail, universal clamp, round post clamp, patient restraint strap, anesthesia screen holder and
table width extender.
3-2-1 Armboard with thick pad (armrest)

The armboard with thick pad is a non-invasive medical device that can be attached to the removable table rails to
support patient’s arm(s) during imaging procedures or for administering anesthesia with improved patient comfort
(lateral, prone or supine).
3-2-2 Rail Extender
The rail extender is a non-invasive medical device designed to clip on the front end of the removable table rails
mouted on the table to extend the rails. Mounting of anesthesia screen holder and the addition of an IV Pole are
common applications.
3-2-3 Adaptor rail
The adaptor rail is a non-invasive medical device intended to mount table side control units on the trunk section of
the table top. This feature improves operator comfort for procedures requiring close work to the head of the table,
such as pediatric procedures.
3-2-4 Head Widener

The head widener is a non-invasive medical device that can be mounted at the head of the table in order to provide
additional support for the patient’s head.
3-2-5 Table Width Extender
The table width extender is a non-invasive medical device that can be mounted on the removable table rails to
increase the support surface for large or obese patients or to improve peri-operative comfort by supporting the
arms of any patient.
3-2-6 Round Post Clamp
The round post clamp is a non-invasive medical device designed to be clipped on the removable table rails in order
to hold other accessories with a round post connection. The clamp can hold the accessory, such as an anesthesia
screen holder, and rotate to offer a variety of alignment options.
3-2-7 Universal Clamp

The universal clamp is a non-invasive medical device designed to be clipped or slided on the removable table rails
in order to hold other accessories with a round post or blade connection. The clamp can hold the accessory, such
as an anesthesia screen holder, perpendicular to the rail.
3-2-8 Anesthesia Screen Holder
The flexible anesthesia screen holder is a non-invasive medical device designed to be mounted into two surgical
rail clamps (using a 5/8" OD round post) and support a typical screen between the sterile field and the patient’s
head. It can be flexed into most practical, clinical positions and securely hold the weight of the screen.
3-2-9 Patient Restraint Strap
The patient restraint strap is a non-invasive medical device designed to be attached to the removable table rails in
order to immobilize the patient.
3-2-10 Accessory Cart

The accessory cart is a non-medical device intended to store various medical accessories. It can be transported
between locations utilizing rolling casters and be secured in place.

Chapter 17 - Quality Assurance Program (QAP)

1 Introduction
1-1 What is QAP?
QAP stands for "Quality Assurance Program" which is the application that makes an assessment of the Innova
System image quality.
QAP is non-proprietary.
1-2 How to launch QAP?
QAP can be accessed via the Service User Interface (SUIF). To access SUIF, click on the Utilities button at the
top left of the Innova Digital screen.
Users must then click on Quality Assessment button in Navigation Area and follow QAP instructions on screen.
1-3 Web Pages

Once the QAP home page appeared, the user must press the [Start] button, follow the instructions and go through
the different pages until he gets the Image Quality status.
QAP procedure can be stopped at any time by clicking on the [Abort] button.
Start Page
Acquisition Page
Quality Assurance Program (QAP) 577

1-4 Status
When all images have been acquired and processing is finished, the application displays a status:
Quality Assurance Program has been completed successfully

Image quality is optimal.
Quality Assurance Program has failed
Image quality is not optimal
Please run the application again or call GE Service
Quality Assurance Program could not be done
Internal Error
Please run the application again or call GE Service
1-4-1 Other System Measurements

This section is intended to provide specific recommendations to physicists or persons in charge of testing the
system and its operation (e.g. for dose level measurement).
1-4-2 Recommendation #1
You need to open the SUIF Home Page and click on "System Parameters" button in the selection tree to be able to
display the Last Acquisition Parameter values. To access SUIF, click on the Utilities button at the top left of the
Innova Digital screen and select Service.
1-4-3 Recommendation #2
Refer to the "InnovaTM IGS 520, InnovaTM IGS 530, InnovaTM IGS 540" Service Manual to find HHS Procedures
recommended for dose measurement.
1-4-4 Use of metallic phantoms
In our systems the X-ray parameters are controlled by an automatic exposure control loop. At the beginning of
each acquisition and in case of positioning changes during acquisition this control loop ensures the optimal image
quality by modifying the tube voltage, current and exposure pulse width as needed for the given patient thickness.
The loop is designed to provide a fast and stable convergence for anatomical tissues. However, this optimal
response is not ensured when the field of view is covered by other materials, in particular, strange behavior may
occur when metallic phantoms are imaged.
578 Quality Assurance Program (QAP)

Some of the standard physics measurements are performed using metallic (copper and/or aluminum) phantoms for
simulating patient attenuation.
These are selected in such a way that the total X-ray absorption of the phantom is similar to an average patient.
However, since the atomic numbers of the metal phantoms are much higher than the ones of the elements in a real
patient, the response they give to tube voltage variations is very different. In practice it means that metallic
phantoms are more sensitive to voltage adjustments than the real anatomies. As a consequence, when the
exposure control loop tries to regulate for a metal phantom, it may overreact and produce oscillating techniques
(the displayed kV and mA values may periodically increase and decrease). Such oscillations are normal in the
presence of metal phantoms, and they do not occur when real anatomy is in the field. In order to avoid the
oscillations we suggest the usage of water, plexiglas or anatomical phantoms, which are much closer to real
tissues in X-ray absorption properties.
2 Parameter monitoring
2-1 The parameters that are monitored are
• Electronic Noise
• Row Correlated Noise
• Brightness Uniformity
• Signal to Noise Ratio uniformity
• Bad Pixels
• Noise Power Spectrum
• Conversion Factor
• Modulation Transfer Function
• Resolution uniformity
• Dynamic Range Linearity
• Dynamic Range Accuracy
• Contrast to noise ratio
• Contrast
2-2 Frequency
QAP shall be run on a periodic timeline going from every week to at least every month.
Logs will be automatically retrieved by OnLine-Center.
3 Quality criteria
Comparing the current values to typical values monitored with optimal image quality makes the Pass/Fail status.
This is made using the 6-sigma methodology.
4 Material
In order to perform QAP, you need the QAP Suitcase, which contains:
• The flat-field phantom (20 mm Al):
Quality Assurance Program (QAP) 579

• The QAP phantom holder + the QAP round insert:
580 Quality Assurance Program (QAP)

Chapter 18 - ILinq User Guide

1 Introduction
iLinq is a GE Service offering that is available on most diagnostic imaging equipment. iLinq brings direct,
interactive communications to GE Healthcare customers via an InSite connection directly on the diagnostic imaging
equipment itself.
The main focus of the iLinq release is the "Contact GE" feature. This functionality lets you request help from the
experts in GE's OnLine Center directly from the equipment's console. GE's technical experts in the OnLine Center
are informed of your request, and respond to your call.
The advantages of contacting GE in this manner are:
1. You stay in front of the console, and enter your request by simply pushing a few buttons.
2. You do not need to remember any specific instructions like telephone number, systemID reference, etc.
3. All your iLinq requests are treated as top priority calls. You will receive an electronic acknowledgement within a
few minutes, confirming the request. GE's OnLine center will call you shortly after to confirm job status.
4. The OnLine experts get your request for help directly via an electronic alert mechanism.
5. The OnLine experts can also communicate electronically, sending information back to you directly on the
equipment.
2 Starting ILinq
To access the iLinq features, click on the iLinq button on the DL Browser screen of your GE equipment. This is
located under the "Utilities" icon.
The iLinq main screen will appear.
If your GE equipment does not have the iLinq licenses installed, contact your local GE Service representative for
details on how to get it. iLinq is activated remotely, via the InSite connection, and does not require any manual step
or access to the equipment.
It is from this main screen that you select which iLinq feature to use.
1 Contact GE
2 Settings
ILinq User Guide 581

3 Messages
4 TiP Virtual Assist
5 iLinq Help
6 About iLinq
7 Close
8 GE Healthcare= 'GE Santé' in Province of Quebec - Canada
3 ILinq Features
3-1 Contact GE
Contact GE page is displayed as the homepage of the iLinq application.
Use this to ask questions to applications specialists or to send a problem report directly to the Online Center.
You can send requests for the same system or for some other system in the same facility using their System ID.
3-2 Settings
Clicking on the Settings link (2) opens a new page.
You can use this page to change the language settings for the iLinq application and to add the list of user names,
phone number and other System IDs which can be used later while submitting the Contact GE request.
3-3 Messages
Clicking on the Messages link (3) opens a new page.
A list of your sent and received messages appears, the most recent messages listed first. You may need to scroll
down to see all the messages.
582 ILinq User Guide

3-4 TiP Virtual Assist

Clicking on the TiP Virtual Assist link (4) opens a new page.
Allows a Customer to be remotely trained by an Application Specialist or the On Line Center. The Customer will
need to initiate a TVA session. Before starting the session, the Customer shall agree with the stated conditions that
appear in the page. To agree, the Customer will need to press the Accept button. The remote User connects to the
system by providing a Customer-defined password to watch and take control over the system standard inputs, that
is, the mouse and the keyboard.
The Customer may change the password that the remote User needs to enter by pressing the Change Session
Password button.
Once connected, the remote User will not be dependent on the Customer for any activity.
This feature does not impact regular clinical applications, and the Customer can disconnect the remote User at any
time from the console.
Notice: Depending on local regulation, patient consent might be required to autorize any GE Healthcare
support to access his/her demographic information prior the launch of the TVA program.
Note: The performances of the system may be degraded during a TVA session. The announced performances do
not apply in this mode.
3-5 iLinq Help
Clicking on iLinq Help link (5) opens a new page.
This page provides the user with a detailed tutorial on how to use the iLinq application and all its functionality.
3-6 About iLinq
Clicking on About iLinq link (6) opens a new page.
This page provides the version details of the iLinq application.
3-7 Close
Clicking on Close link (7) closes the iLinq application and returns you to the clinical browser.
4 iLinq Notifications
This feature allows the user to be notified when there is an incoming message or Chat request from the GE Online
ILinq User Guide 583

Center.
4-1 Message Notification
User shall be notified with the below image (toggling between them) on the clinical application User Interface (DL
Browser) if there is an incoming iLinq message from the GE Online Center.
This notification shall be stopped once the user opens the iLinq application and access the Messages page, or if
the system is reset.
4-2 Chat Notification
User shall be notified with the below image (toggling between them) on the clinical application User Interface (DL
Browser) if there is Chat initiated from the GE Online Center.
Once you open the iLinq application, you will see a small window (as shown below) on the right lower corner of the
iLinq page. You can accept to continue to chat with a GE Representative, or reject if you do not wish at that
moment.
This notification shall be stopped once the user opens the iLinq application and accept or decline the Chat
invitation, or if the system is reset.
584 ILinq User Guide

Chapter 19 - Workstation Configuration

1 Advantage Workstation (AW) Configuration (Option)
1-1 Introduction
- The Advantage Workstation (AW) delivered for the Innova system is loaded with a specific
software to allow Innova image review and processing. - Subtracted images acquired on the
Innova system can be visualized in Sub mode or reprocessed only on the AW delivered for
the Innova system. - Innova images networked to any other workstation/PACS... can be
reviewed only in No Sub mode.
1-1-1 Helpful Information
- To start AW:
Default login: sdc
Default Password: adw4.x, where 4.x is the AW core version number, as shown in table below:
AW core version Default password

4.6 adw4.6
4.5 adw4.5
4.4 adw4.4
4.3 adw4.3
4.2 adw4.2
Note: When a new AW is installed, it is loaded with the "sdc" default login and "adw4.x" default password. It is then
the responsability of users to ask their GE Service Representative for any login and password change. In case of
AW software upgrade, previous login and passwords are preserved. Also ask your GE Service Representative for
any change if needed.
- In AW you will be able to know the names of icons locating the mouse on the icon and waiting a green help
appears.
- The Browser of AW displays the patient structure like DICOM: One STUDY contains SERIES, one SERIES
contains images. The DL sequences are DICOM images, thus displayed in the IMAGE window. All the
sequences coming from Innova system are contained in one SERIES. All the photos coming from Innova
system are contained in a second SERIES.
1-1-2 Compliance to Standards
DICOM V3.0 implementation in AW is described in its Conformance Statement (2340652-100). It can be used to
verify compatibility with other DICOM devices.
1-2 Patient List Browser
Go into patient list browser using "Patient list" tab at left of the screen.
1-2-1 Tools
Click on "Tools" key.
1-2-2 Patient List preference
Select "Patient list Preference"
Set preference for:
• Layout
Workstation Configuration 585

– Display trash button -> yes

– Second trash -> yes
– Push -> yes
– CD writing -> yes
– Lock/unlock -> yes
– Window number -> patient, series, image
– Display exam box -> no
– Display exam & series boxes -> no
– Display exam, series & images boxes -> yes
• Filter
– No filter
• Split
– Split series -> yes
– Indicate initial series -> no
1-2-3 Network manager
Already configured to be connected to the DL screen.
1-2-4 Printer manager
Already configured to be connected with AW printer at install by GE service representative.
1-2-5 AW administration
Default values are auto-delete, auto-lock, screen saver are all OFF.
Change these values using administrator account if user's preference are different.
Login: Admin
Password: administrator
Choose 4 for configuration.
1-2-6 CD Composer
On the bottom of the screen, click on the CD icon to open the "CD Composer" window.
586 Workstation Configuration

Select the media to use to archive: either CD or DVD.

Note: Only DVD+R or DVD+RW are accepted.
Click on Prefs.

In "Select Profile":
• Set "General Purpose" to burn CDs non compressed.
• Set "Compress XA 512 cardiac" to burn CDs with 512 cardiac images compressed using the jpeg 14 lossless
compression ratio (1024 cardiac images must be downscanned first to 512 before being compressed).
• Do not set "Portable Disk" to keep the multi CD capability.
In "Embedded applications":
• Set "Add Centricity DICOM Viewer" to burn the DICOM Viewer with the images.
In "Other Options":
• Do not set "Downscan XA cardiac images to 512" to burn cardiac images in their original matrix size.
The purpose of downscan option is to convert a monochrome 1280 x 1024 @ 72 Hz video signal into a Low
Line Rate 625l @50Hz or 525l @60Hz video signal, to be connected to standard peripheral devices such as a
printer, a recorder or a monitor.
IMAGES CONVERTED THROUGH DOWNSCAN FEATURE ARE NOT VALIDATED FOR
DIAGNOSIS AND/OR INTERVENTIONNAL PURPOSES.
• Set "Check full media" to check all burnt data after CD is written.
Click on "Ok" before to exit.
1-3 Viewer

Go into patient list browser using "Viewer" tab at left of the screen.
1-3-1 Display Tools
Configure toolbox buttons as explained in paragraphs below.
1 Draw rectangular shutter 8 Subtraction

2 Display normal 9 Pixel shift
3 Peak opacification 10 Landscape
4 Zoom plus 11 Zoom minus
5 Save state 12 Replicate graphics
6 Draw user annotation 13 Erase graphic
7 Calibration 14 Draw distance
1-3-2 Display

1 Zoom minus 6 Zoom plus

2 Rotate left 7 Rotate right
3 Flip left right 8 Flip top bottom
4 Draw rectangular shutter 9 Draw circular shutter
5 Reverse Series 10 Display normal 11 Cine mode
Position the following items in toolbox:

• Zoom minus
• Zoom plus
• Draw rectangular shutter
• Display normal
Images from a system with the InnovaIQ Table, display the tilt degree of angulation in the Geometry area of the
viewer.
Note:The tilt angulation is only available on AW core version 4.4 and above. For earlier versions, this information is
not available in the viewer.
1-3-3 Modality

1 Subtraction 2 Landscape 3 Peak Opacification

4 Calibration 5 Pixel Shift 6 XR filter
7 Stenosis Analysis (Option) 8 LV Analysis (Option) 9 XA SCPT Split

• Subtraction
• Landscape
• Peak Opacification
• Calibration
• Pixel Shift
Set "XA SCPT Split" to Off to put all Secondary Capture (SCPT) in the same Series.
1-3-4 Mouse mode
-> Windowing mouse mode.

1 Windowing mouse mode 2 Cine mouse mode 3 Paging mouse mode

4 Mag glass mouse mode 5 Continuous zoom mouse 6 Scroll mouse mode
mode
7 Filming mouse mode
1-3-5 Edit

1 Erase graphic 2 Erase all graphics

3 Replicate graphics 4 Propag. all 5 Undo replicated graphics
6 Cut graphic 7 Copy graphic 8 Paste graphic
9 Save State 10 Reset State
11 Save Image Status: Read

• Erase graphic
• Replicate graphics
• Save state
1-3-6 Annotation

1 Draw arrow 2 Draw user annot

Text page
Side Marker

• Draw user annotation
1-3-7 Measure

1 Draw support cursor 5 Draw distance

2 Draw angle 6 Draw free hand
3 Draw spline 7 Draw rectangle
4 Draw ellipse 8 Draw segment

• Draw distance
1-3-8 Preferences

• Screen
– Screen annotation -> full
– Mag glass size -> normal
– Scale -> OFF
– Hospital, patient_name, patient_id, esi, system, date, geometry, acquisition_params, ras_coordinates,
frame_info, Windowing, graphic results -> all ON
• Film
– -> full
– Hospital, patient_name, patient_id, esi, system, date, geometry, acquisition_params, ras_coordinates,
frame_info, Windowing, graphic results -> all ON
• Autocine
– Select Autocine "On" to automatically launch the cine mode when opening the Viewer on a sequence. If "Off"
is selected, the cine mode will need to be manually started.
1-3-9 Layout Manager
Click on the Layout Manager key on top left of the Viewer to open the Layout Manager window.
At the bottom right of this window, click on the Protocol selection arrow to open the preloaded display protocol list.
In case the optional Adv Paste 2.0 application is loaded on the AW station, a set of 5 dedicated display protocols is
available (protocol names start with "Past..."). Use these display protocols on any "Pasted Series" for specific
display of a pasted image.
A specific protocol so called "Divided Screen" can also be used to divide the viewer/image in two parts and so allow

to apply a different processing on each part of the viewer/image.

One of the main benefit of this display protocol is to allow to apply different level of pixel shift on each part of the
screen/image.
When used over a Bolus series, this display protocol allow to pixel shift each leg separately.
1-3-10 In-room Monitor Display
The video of the in-room monitor can be switched ON or OFF from the remote button located in control room.
1 Video ON/OFF
1-4 In-room 3D (Option)

This section describes only In-room 3D application features associated with AW Volume Share 4 (AW4.5). For
detailed information, refer to Synchro3D & In-Room 3D - User Guide.
1-4-1 Configuration
The In-room 3D Mouse application requires:
• Installation of the Advantage Workstation (AW), Synchro3D and Volume Viewer products.
• Installation of an additional color LCD monitor mounted on the monitor suspension in the exam room.
• Installation of a device (In-room 3D Mouse user interface) installed at the tableside allowing images
manipulations and activation of gantry synchronization functions.
This new in-room monitor is a replication of the AW monitor located in control room and will be used to visualize the
3D image.

Configuration of the In-room 3D Application
Note: With the In-room 3D application, it is recommended to deactivate the screen saver time out on the AW
workstation.
1-4-2 Main "In-room 3D" Control Panel
Multimodality In-room 3D offers the capability to manipulate 3D images and to activate gantry synchronization
functions from the exam room.
Features are accessible through a dedicated software interface or from buttons located on the In-room 3D Mouse.
In-room 3D functions are applicable to CT, MR and XA images.

Main "In-room 3D" Control Panel
1-4-3 Operation
The user can visualize and control 3D models and their related reformatted views (Axial, Coronal, Sagittal, Oblique,
Curved, cross-section, and Lumen views) from the exam room. In-room 3D functions are applicable to CT, MR and
X-ray-Angiography 3D models. Typical controls are rotation of the 3D image rotation, adjustment of the volume
rendering, selection and rotation around a vessel of interest. The Gantry synchronization features, Send Angulation
and Follow the Gantry, can be controlled from the table-side. Features are accessible through a dedicated software
interface or from buttons located on the In-room 3D Mouse.
Exam room can take user interface control just by pressing any button on the In-room 3D Mouse (except for the
reset button).
Control room can take user interface control just by pressing any key on the AW control room keyboard.
1-4-4 User Interface
This section describes the In-room 3D features.
Refer to AW Operator Manuals for detailed explanations of "standard" 3D application and basic use of the AW.

In-room 3D Navigation Chart
Main path
1 Start Exam Room User interface from the Control Room
using the left control panel.
Open the In-room 3D tool located on the Display tools of
Volume Viewer and select In Room Control.
2 Start Exam Room User interface from the view contextual
menu.
In room interface can only be activated from views in left
screen monitor.
3 Select a 3D View and Activate the ‘Follow the Gantry’
mode
In-room 3D interface provides 2 ways of activating the
‘Follow the Gantry’ mode:
1 Click on the Follow the Gantry button on the interface
. by using the In-room 3D mouse cursor mode.
2 Push the toggle button "G/M" in the In-room 3D
. Mouse to toggle between Follow the Gantry and Man-
ual modes (cf. Workstation Configuration / Advantage
Workstation (AW) Configuration (Option) / In-room 3D
(Option) / In-room 3D Interface Launch at Table-Side /
In-room 3D Mouse Interface Description).

4 Send angulations to the interventional system.

The In-room 3D interface provides 2 ways to send angu-
lations:
1 Click on the Send Angulation button on the interface
. by using the In-room 3D mouse cursor mode.
2 Push the Send Angulation button in the In-room 3D
. Mouse (cf. Workstation Configuration / Advantage
Workstation (AW) Configuration (Option) / In-room 3D
(Option) / In-room 3D Interface Launch at Table-Side /
In-room 3D Mouse Interface Description).
5 Open VR preset preference panel.
6 Open In-room 3D Mouse Preferences.
1-4-5 In-room 3D Interface Launch at Table-Side

Once a 3D Spin is acquired on an Innova interventional system, the 3D model gets automatically reconstructed and
displayed on the In-room monitor. The user in the exam room can then take control of the 3D model without any
help from the control room by pressing any button on the In-room 3D Mouse (except the reset button).
Note: With the In-room 3D application, it is recommended to deactivate the screen saver time out on the AW
workstation.
Note: An information pop-up message appears during the initialization of the In-room 3D Mouse, do not touch the
3D joystick until the pop-up disappears. A total of 5 beeps can be heard during the In-room 3D Mouse initialization.
1-4-5-1 In-room 3D Main Panel
The following Illustration shows the functional areas and buttons of the In-room 3D main panel.

In-room 3D Main Panel
1 Patient Name 13 Set mode "Adjust shutter diameter" on the 3D joystick.

2 Exam Room 14 2D distance measurements
3 Switch between "Manual" or "Follow the gantry" 15 Switch between Surface, MIP or VR rendering mode
modes on 3D active view
4 Full screen display 16 Quit In-room 3D application
5 Multiple views layout 17 Send angulations to the gantry
6 Oblique view display (needs at least Oblique 18 Recall 3D image current orientation and 3D image pa-
view type and reformatted views display) rameters (VR preset, FOV)
7 Set up 3D view orientation to Anterior position 19 Set 3D image zooming and roaming modes
8 Store 3D image current orientation and 3D im- 20 Select oblique cut axis setting
age parameters (VR preset, FOV)

9 Set 3D image rotation to default orientation 21 Adjust window width and window level adjustment for
(Anterior-Posterior-Left-Right-Superior-Inferior) reformatted view and 3D MIP view
Adjust Volume Rendering threshold for 3D VR view
10 Set mode "Rotation/Paging" on the 3D joystick: 22 Save secondary capture of the selected view
• 3D Rotation on 3D view
• Image paging on Axial, Coronal, Sagittal,
Curved and Lumen views.
11 Set mode "Move Cursor position" on the 3D joy- 23 Select VR preset for 3D VR view
stick
12 Set mode "Adjust shutter diameter" on the 3D
joystick
1-4-5-2 In-room 3D Mouse Joystick

The 3D joystick provides four degrees of freedom for image manipulations as defined in the picture below:
In-room 3D Mouse Joystick
The 3D joystick controls are dependent on user interface mode and are also contextual to the current view type
(3D, Curved, Lumen….). See the table below for joystick control description.
Application Mode View Type Joystick Control

Roll Yaw Pitch Pull/Push
Free Hand Mode 3D MIP/VR, Image Image Image No
Oblique Rotation Rotation Rotation Action
Axial/Coro- Image No Slice Spacing No
nal/Sagittal Paging Action Action
Oblique
Curved (vessel Image No Vessel Rotation No
analysis mode) Paging Action Action
Lumen (vessel Image No Vessel Rotation No
analysis mode) Paging Action Action
Zoom/Roam 3D MIP/VR, Axial/ Roam Roam No Zoom In/Out
Coronal/Sagittal Up/down Left/Right Action
Oblique, Curved

Window Width/Lev-3D MIP, Axial/ Window Window No No

el Coronal/Sagittal Level Width Action Action
Oblique, Curved
3D VR VR Opacity No No No
Up/Down Action Action Action
Shuter 3D MIP/VR No No Diameter Adjust- No
Action Action ment Action
Oblique Mode 3D MIP/VR, Axial/ No No Axis No

Coronal/Sagittal Action Action Action
Oblique
3D Cursor 3D MIP/VR, Axial/ Cursor Cursor No No

Coronal/Sagittal Up/Down Left/Right Action Action
Oblique, Curved
2D Measurements 3D MIP/VR, Axial/ Cursor Cursor No No

Coronal/Sagittal Up/Down Left/Right Action Action
Oblique
1-4-5-3 In-room 3D Mouse Cursor Mode

From the In-room 3D Mouse, use either right or left mouse click to display a cursor that can be positioned using the
In-room 3D Mouse to select functions located the In-room 3D control panel.
Position your hand on the In-room 3D Mouse and move gently to position the cursor on the desired function.
1-4-5-4 In-room 3D Mouse Interface Description
Note: The 3D Mouse box is active only when the In-room 3D application is launched and the "Exam Room" is
displayed on top left of the main menu.

In-room 3D Mouse and Keyboard Table Side Box
Pressing this button allows to reset the In-room 3D Mouse device in case of abnormal motion of the image
without touching the mouse.
Note: Do not touch the In-room 3D Mouse during the reset (about 10 s). Wait until the initialization mes-
sage disappears. A total of 5 beeps can be heard during the In-room 3D Mouse reinitialization.
Pressing this button allows to toggle between the multiple views and the full screen view image display.m,
...).
Pressing this button allows to send the current 3D image angulations to the gantry.
Note:Make sure to select a 3D view on the Volume Viewer views layout.
Note: Make sure the proper patient position was selected on the Innova Digital Screen (prone, supine,
head to toes reversed…) prior to sending the current 3D image angulations to the gantry.
To reach the desired angulations, move the Auto Positioner joystick UP to move the frontal gantry to the
selected angles.
Pressing this button allows to move to the next view in the AW left screen view layout
Note: The function may be applied when the view is enlarged.

Pressing this button allows to store the current 3D Image angulations.

Up to 9 orientation slots can be stored.
In case the 9 orientation slots are already used, the angulations button map is displayed on screen:
Press one of the associated buttons to store the new orientation. The previous orientation already
mapped to this button will be replaced.
Note: If the "Save Store Angle as Secondary Capture" is selected in the In-room 3D Mouse Preferences
Orientation screen, each stored 3D image is automatically archived in the AW database and can be re-
viewed as Secondary Capture from the Image Browser.
Note: All stored 3D images are saved until Volume Viewer is exited from the current patient.
Pressing this button allows to recall previously stored 3D image angulations (if any).
In case of more than one angulations have been stored, the angulations button map picture is displayed
on screen to recall the selected orientation.

Pressing this button allows to switch between the "Follow the Gantry" and "Manual" modes.
Note: Make sure to select a 3D view on the Volume Viewer views layout.
When in "Manual" mode, 3D image can be manipulated at any time independently from the gantry posi-
tion.
When in "Follow the gantry" mode, 3D image orientation is linked to the frontal gantry position.
Moving the frontal gantry will make 3D image(s) rotate(s) in synchrony with the gantry.
Note: The Image rotation/flip and the table tilt/rotation are not taken into account in "Follow the Gantry"
mode.
Note: Make sure the proper patient position was selected on the Innova Digital Screen (prone, supine,
head to toes reversed…) prior to performing "Follow the Gantry".
The function of this button depends on the type of active view (the view contoured in red):
1 The active view is a 3D view. Pressing this button allows to successively display the 3D image in Su-
. perior, Inferior, Anterior, Posterior, Left or Right orientation.
Note: The sequence of orientations can be configured in the Preferences panel from the In-room 3D
assistant screen. (i.e. A-R-L-P can be preset).
2 The active view is any of the other views (Axial, Coronal, Curved, Lumen….). Pressing this button
. allows to page forward through a list of vessels of interest outlined in the QuickAVA or Advanced Ves-
sel analysis applications. If no vessels have been defined, this button is idle.
Caution: Make sure when paging through vessels of interest to visualize the correct vessel. This function
is not allowed in Full screen and Oblique view layouts.
Pressing this button allows to quickly switch between "Rotation" and "Roam and Zoom" modes.
The sensitivity of the mouse when used in Rotation or Translation can be customized using the Prefer-
ences panel of the In-room 3D assistant screen.
Note: When the ownership is in the Control room, pressing on any button (except Reset) allows to get
control to the Examination Room.
1-4-5-5 In-room 3D Preferences

From the Exam room panel, it is possible to select default VR settings, customize the In-room 3D Mouse sensitivity
and preset the sequence of default 3D image orientation.
1-4-5-6 Volume Rendering Settings

VR settings are modality dependant (CT/MR or X-ray).
The VR In-room 3D interface is limited to 6 presets.
When in the In-room 3D application, these 6 presets will be available using the VR rendering arrow located at the
bottom right of the In-room 3D main panel.

Note: Preset n°1 is always used as default VR preset when VR rendering mode is selected on the In-room 3D
Main Panel.
• Click on key to select up to 6 different VR display from the VR Presets library.
1-4-5-7 In-room 3D Mouse Preferences Settings

• Click on to customize the In-room 3D Mouse sensitivity and define the sequence of default 3D
image orientation.
• From the Rotations screen:

– Select "Like a mouse" to have the reference plane as the vertical plane of the monitor.
– Select "Like a 3D Object" to have the 3D image rotate like the In-room 3D Mouse.
If needed, adjust the sensitivity of the mouse for each axis.
• From the Roam & Zoom screen, adjust the sensitivity for both translations axis and zoom features.

• From the Orientation screen:

– Define the sequence of anatomical image orientation to use when pressing on the button on the In-room
3D Mouse box. By default SIAPLR are programmed but it is possible to create any other combination (i.e.
A-R-L-P) when using the 3D Mouse box SIAPLR button.
– Select "Save Store Angle as Secondary Capture" to automatically archive in the AW database each image
stored using the Store Angle button either on the In-Room 3 panel or In-room 3D Mouse box.
These images can be reviewed as any other Secondary Capture from the image browser.
2 CA 1000 Workstation Configuration (Option)

2-1 Stenosis Analysis and Auto Calibration
STENOSIS ANALYSIS SHOULD NOT BE USED ON SEQUENCES ACQUIRED WITH A TILTED

TABLE.
2-2 Ventricular Analysis and Auto Calibration
VENTRICULAR ANALYSIS SHOULD NOT BE USED ON SEQUENCES ACQUIRED WITH A

TILTED TABLE.

Chapter 20 - Diamentor M4 KDK (Option)

1 Introduction
1-1 General description of the Diamentor M4 KDK
The DIAMENTOR M4 KDK dosimeter assists Radiology personnel in giving additional informative values of a
patient's exposure during an examination. To meet regulatory requirements based on the international safety
standards IEC 60601-2-43 and/or 21 CFR 1020.32 (k), use as reference the exposure dose displayed on the DL
console, live or reference display.
4 parameters are available:
• The Cumulative Dose (while not in loading state).
• The Dose Area Product (while not in loading state).
• The Dose Rate (while in loading state).
• The Dose Area Product Rate (while in loading state).
In addition to these dosimetric indications, the irradiation time is also available on the Diamentor M4 KDK main and
secondary display.
Units available:
• Dose: mGy.
• DAP (Dose Area Product): cGy.cm², µGy.m², Gy.cm².
• Dose Rate: mGy/s.
• Dose Area Product Rate: cGy.cm²/s, µGy.m²/s, Gy.cm²/s.
Note: The ‘Cumulative dose’ and ‘Dose’ is the ‘Cumulative Air Kerma (CAK)’ and the ‘Dose rate’ is the ‘Air Kerma
Rate (AKR)’.
To record the Dose, DAP, Dose Rate, and DAP Rate, a double ionization chamber is fixed at the output of the
X-ray tube collimator. There is a cable connecting the chamber to the main unit.
One or two secondary displays connected to the main control unit and fixed on the monitor boom display the dose
information in the X-ray Room.
One ionization chamber can be connected to the main unit to record the Dose, DAP, Dose Rate, and DAP Rate of
one X-ray tubes.
610 Diamentor M4 KDK (Option)

An optional printer can be connected to the main unit to enable dose report printing on labels.
When the CAK reaches 10 Gy, the Diamentor M4 KDK displays OL (Overload). To avoid
information loss, before the CAK reaches 10 Gy (e.g. 5 Gy), write down (or print) the CAK
value and reset the Diamentor M4 KDK. Repeat this operation as many times as needed to
avoid the 10 Gy limit. At the end of the patient exam, add all written (or printed) values to
estimate the exam CAK value.
When an optional Diamentor M4 KDK is installed on the system, the values displayed on the DL console, live or
reference monitor may be different from the Diamentor M4 KDK values since they are based on the internal
dosimetric indications of the system.
1-2 Dose Measurement at Interventional Reference Point
A Diamentor is a device that displays dose values measured at a fixed distance of the focal point.
The interventional reference point is defined as the point on the reference axis, 15 cm from the isocenter, in the
direction of the focal point.
The following table presents the different possible Interventional Reference Point distances:
Chamber/Patient Distance (CPD) and Source/Chamber Distance (SCD) must be set at the following values
depending on the detector size :
System Flat Panel SOD (cm) Reference point dis- CPD SCD
(Source Object Dis- tance from source (in (in cm) (in mm)
tance) cm)
Innova IGS 520 20 x 20 72 57 (72-15) 30 270
Innova IGS 530 30 x 30 72 57 (72-15) 26 307
Innova IGS 540 40 x 40 72 57 (72-15) 26 307
2 Operating Controls and Indicators

2-1 Diamentor M4 KDK, front view
Diamentor M4 KDK (Option) 611

1. Digital display.
2. <Reset> key to reset to zero the dose area product and entrance dose readings as well as the time and to quit
the setup menu without saving the modified settings. Secondary displays connected are also reset.
Depending on the setup menu configuration, <Reset> will also initiate a printout; refer to Diamentor M4 KDK
(Option) / System Configuration (Setup Menu). In addition, the key is used to terminate entry of the
chamber-patient distance without saving the new value.
3. key: cursor control key used in the setup menu (up) and to enter the Chamber-Patient Distance.
4. <Enter> key to access submenus of the setup menu and to enable the Chamber-Patient Distance entry mode.
5. key: cursor control key used in the setup menu (down), to enter the Chamber-Patient Distance and to display
the calibration menu.
6. Contrast adjustment .
7. <Print> key to initiate a printout and to quit the setup menu, saving the modified settings. In addition, the key
is used to terminate entry of the Chamber-Patient Distance, saving the new value.
2-2 Diamentor M4 KDK, top view

1. Chamber connection B.
2. High-voltage fuse for ionization chamber (20 mA, slow-blow).
3. Chamber connection A.
4. Power switch.
5. Power input fuse.
6. Power input.
7. Nameplate (on rear panel).
8. <Test> button to perform a Diamentor M4 KDK (Option) / Performing a Measurement / Constancy Check of the
device.
9. Serial interface for connection of a printer or PC.
10.2 connectors for secondary displays.
Symbols as marked on the equipment
| power on
power off
contrast adjustment
brightness adjustment (secondary display)
up
down
AC voltage
3 Performing a Measurement
3-1 Constancy Check
Check the device performance every day, before putting the Diamentor M4 KDK into operation.
1. Turn on the device and wait for the display to illuminate.
2. Press the <Test> button 2.

Power switch 1 and <Test> button 2
The test screen will be displayed (Illustration Test screen). When no problem is found, the message "Test passed"
appears briefly afterwards. The test screen clears automatically after approx. 3 seconds.
Test screen
Note: This test is meant to check the stability of the electrical calibration. For this purpose a test charge is injected
to the amplifier input (deviation +/-1 %) and the resulting gain is compared with the factory calibration.
The percentage deviation is indicated for each channel. Deviations of +/-5 % are admissible (message: Test
passed). When the deviation exceeds +/ 5 %, the message "Test failed" appears (confirm message with <Print>).
In the second case, repeat the test. Should the "Test failed" message be displayed again, the Diamentor M4 KDK
must be repaired before it can be used again.
3-2 Measurement
When the device has passed the test, the measured values will be shown in the selected format as soon as
radiation is detected.
A filter or tubus placed between chamber and patient will reduce the dose area product and
entrance dose relevant for the patient. In this situation the Diamentor M4 KDK will display
dose area product and entrance dose values which are too high. According to national
regulations in Germany (1), however, it is sufficient to record the measuring value and the
filter or tubus in use for reconstruction of the radiation exposure level. Should the system
be permanently used with the filter or tubus, it is recommended to recalibrate the Diamentor
M4 KDK.
(1) Ask your competent authority about the regulatory situation.
3-2-1 Note on warm-up time
The device requires a minimum warm-up period of 15 minutes before a measurement can be performed, because
the leakage is very high during this time. As the leakage changes in the beginning, it would not make sense to
perform the zero adjustment within the first 15 minutes. The leakage has a strong effect only on measurements
with small measuring values and long measuring times. Therefore, measurements with high values and short times

can be taken earlier.

See Diamentor M4 KDK (Option) / System Configuration (Setup Menu) / Zero adjustment for further details.
1. Press the <Print> key to obtain a printout of the measured value, if you have not selected the AUTO PRINT
mode.
2. Then, before performing the next measurement, reset the display to zero with the <Reset> key.
3. If you are in the AUTO PRINT mode, the measurement will be automatically documented when you press
<Reset>.
Diamentor M4 KDK, <Print> and <Reset> keys
4. Having performed all measurements, turn off the Diamentor M4 KDK.

3-2-2 Chamber-Patient Distance
The Diamentor M4 KDK calculates the value of the entrance dose in the patient plane from the value measured in
the chamber plane.
The value is calculated according to the following formula:
DPat = Dose in patient plane

Dcha = Dose in chamber plane
SCD = Source-Chamber Distance
CPD = Chamber-Patient Distance
The Source-Chamber Distance depends on the X-ray unit and the installation of the measuring chamber. It must be
set once during installation of the Diamentor M4 KDK in the Corrections menu (See Diamentor M4 KDK (Option) /
System Configuration (Setup Menu) / Source-Chamber Distance). The Chamber-Patient Distance may vary
between measurements. Therefore, the value is set immediately before a measurement.
The Diamentor M4 KDK accepts Chamber-Patient Distances in the range of (0 ... 199) cm.
The entry mode for the Chamber-Patient Distance is enabled simply by pressing the <Enter> key.
When you are in this mode, a digit of the Chamber-Patient Distance will appear in reverse video, indicating that it
can be changed. You change the value with the / keys.
With the <Enter> key, you confirm the new value and activate the digit to the left which now appears in reverse
video. When you have entered the correct value, press <Enter> again to exit the entry mode and save the value.
Pressing the <Reset> key disables the entry mode for the Chamber-Patient Distance. Changes are not saved; the

previous Chamber-Patient Distance will be retained.

Pressing the <Print> key disables the entry mode for the Chamber-Patient Distance, but changes will be saved.
As the value of the Chamber-Patient Distance directly influences the measuring result of the entrance dose
according to the above formula, the accuracy of the measuring result depends strongly on the accuracy of the
Chamber-Patient Distance
Should the Chamber-Patient Distance vary considerably during a measurement, it is recommended to divide the
measurement into several single measurements if a very accurate measurement result is needed. For each of
these measurements you can set the correct Chamber-Patient Distance. Between measurements you must reset
the display to zero, and after the last measurement the results from the single measurements must be summed up
manually.
4 System Configuration (Setup Menu)

4-1 Some Basic Facts
The setup menu is used to perform some basic device adjustments. These settings are saved to the memory and
will not be lost when the device is switched off (See Diamentor M4 KDK (Option) / System Configuration (Setup
Menu) / Factory Settings). You can quit the setup menu at any time without saving the adjustments just made by
pressing the <Reset> key. If you wish to save the new settings, use the <Print> key to quit the menu. The setup
menu includes four submenus. The overview below shows the contents of each of the menus. The operating steps
are described on the following pages.
The device does not accept implausible entries.
Display (Submenu):
• Selection of the display format (independently for the Diamentor M4 KDK and the secondary display).
• Adjustment of the bar graph limits.
• Selection of the filter depth.
• Activation of the display test.
• Enabling/disabling the time display.
• Selection of the display resolution.
Date & Time (Submenu):
• Entry of date and time of day. Correction (Submenu):
• Initiating the zero adjustment.
• Entry of the chamber temperature.
• Entry of the chamber ambient pressure.
• Entry of the correction factor.
• Entry of the focus chamber distance.
Printer (Submenu):
• Entry of the printer control commands.
Language:
• English, German, Spanish, Italian, French.
Dose area product Unit:
• Selecting the unit for dose area product measurement: cGy.cm², µGy.m², Gy.cm².
RS232:
• Printer, PC or unassigned.

Print Mode:
• AUTO ON/OFF (initiate an automatic printout with <Reset>: yes/no).
4-2 Factory Settings
The device is delivered with the following factory settings:
Display format (1-4-5):
[D-d] [E-e] [D-d] [E-e] [D-d] [E-e]
Bar graph limits (1-4-6):
low = 0 and high = 3600 cGy.cm²/s
Filter depth (1-4-7):
3
Time (1-4-8):
ON
Display test (1-4-10):
N/A
Date & Time (1-4-11):
Is set to the date & time in Germany
Zero adjustment (1-4-12):
N/A
Chamber temperature (1-4-13):
20 °C
Air pressure (1-4-13):
1013 hPa
Correction factor (1-4-13):
1
Init code (1-4-15):
<000> <000> <000> <000>
Paper feed (1-4-15):
<009> <010> <000> <000>
Note: This is the printer setup for the STAR printer DP8340S (PTW ordering number L991096). This is also the
default setting even if the Diamentor M4 KDK is delivered without a printer.
Language (1-4-4):
English
Dose area product unit (1-4-17):
µGy.m²
RS232 (1-4-18):
Computer
Note: If the Diamentor M4 KDK is delivered with a printer, this option is set to "Printer".
Print mode (1-4-19):

AUTO OFF
4-3 Displaying the Setup Menu
• Press or and, keeping either key depressed, push <Enter> to display the setup menu. (If you press the
<Enter> key first, the Diamentor M4 KDK changes to the mode for entry of the Chamber-Patient Distance).
Setup menu
4-4 Selecting the Language

Before proceeding for further adjustments, you should first select the language.
• Using one of the cursor keys, move the cursor to "Language" and press <Enter>.
• Select English, German, Spanish, Italian or French and press <Enter>.
From now on the texts are displayed in the selected language and you can proceed to make further adjustments. In
order to save the language selection, however, you must exit the setup menu with <Print>.
4-5 Selecting the Display Format (Display Submenu)
On the Diamentor M4 KDK as well as on the secondary displays the measured values can be shown either on one
line or on two lines. When only a single line is used, the bar graph expands accordingly.
The following parameters can be selected independently for display on the left on each line of the Diamentor M4
KDK and the two secondary displays:
• [DFP] display of the dose area product.
• [EFD] display of the entrance dose.
• [dfp] display of the dose area product rate.
• [efd] display of the entrance dose rate.
• [D-d] automatic switching: display of the dose area product rate while radiation is detected
<--> display of the dose area product if no radiation is detected.
• [E-e] automatic switching: display of the entrance dose rate if radiation is detected
<--> display of the entrance dose if no radiation is detected.
• [ ] no measuring value.
In the first square brackets to the right of "Display" you choose the measuring value to appear in the first display
line of the Diamentor M4 KDK, in the second square brackets to choose the value for the second display line of the
Diamentor M4 KDK.
If you choose [ ] (= no measuring value) for the second display line, you get a full-size bar graph.
The measuring values selectable in the third up to the sixth square brackets are used for the configuration of the
secondary displays Diamentor SD.
For option [DFP], [dfp] and [D-d], the dose area product or the dose area product rate, respectively, is displayed in
the display area to the left. In the display area to the right you will see the measuring value for the fluoroscopy time.
The line is labeled with a "D:" in the left margin of the Diamentor M4 KDK but it is labeled with an "A:" on the
display of the Diamentor SD.

For option [EFD], [efd] and [E-e], the measuring value for the entrance dose rate, respectively, is displayed in the
display area to the left. In the display area to the right you will see the current chamber-patient distance. The line is
labeled with a "E:" in the left margin.
Using the cursor key , select "Display" and press <Enter>.
The Display submenu will be shown (Illustration Display menu).
Display menu
1 - Parameter for 1st line on Diamentor display

2 - Parameter for 2nd line on Diamentor display
3 - Parameter for 1st line on secondary display 1
4 - Parameter for 2nd line on secondary display 1
5 - Parameter for 1st line on secondary display 2
6 - Parameter for 2nd line on secondary display 2
The six pairs of brackets to the tight of "Display" represent the 6 lines to choose from Illustration Display Menu.
• Press <Enter> (the cursor starts flashing on the first bracket), then press one of the cursor keys repeatedly until
you reach the correct parameter.
– [DFP] display of the dose area product
– [EFD] display of the entrance dose
– [dfp] display of the dose area product rate
– [efd] display of the entrance dose rate
– [D-d] automatic switching: display of the dose area product rate while radiation is detected
<--> display of the dose area product if no radiation is detected.
– [E-e] automatic switching: display of the entrance dose rate if radiation is detected
<--> display of the entrance dose if no radiation is detected.
– [ ] no measuring value.
• Press <Enter> to move the next bracket.
• Proceed in the same manner for all other brackets.
• When finished, you can continue adjusting other device settings, or you can quit the submenu and the setup
menu with <Reset> (selections will be lost) or with <Print> (selections will be saved).

Example
1 - Measuring unit for the first line (display area to the left)
2 - Measuring unit for the second line (display area to the left)
3 - Measuring unit for the first line (display area to the right)
4 - Measuring unit for the second line (display area to the right)
5 - Fluoroscopy time
6 - Chamber-Patient Distance
7 - Bar graph for the dose area product rate
8 - Entrance dose
9 - Dose area product
4-6 Bar Graph Limits (Display Submenu)
The length of the bar graph corresponds to the dose area product rate. If the measured dose area product rate is
below the low limit, the bar graph will not deflect. If the measured value reaches the high limit, the bar graph
deflects to full scale. The bar graph starts flashing when the dose area product rate exceeds the high limit.
Note: The fact that the reading exceeds the high limit is indicated only by the bar graph flashing.
The bar graph scale is linear. Limits can be adjusted in the range between 0.000 cGycm²/s and 30,000 cGycm²/s.
The following limitations must be observed: (max. - min.) > 1 cGycm²/s; min. > 0.8 max.
• Call up the Display menu.
• Using the cursor keys, select "Bargraph limits" and press <Enter>.
• Using the cursor keys, adjust the first digit of the low limit, or press <Enter> to access the second digit.
4-7 Filter Depth (Display Submenu)
The Diamentor M4 KDK calculates the dose area product rate on the basis of the change of the dose area product
over a period of time T between approx. 0.6 and 6 seconds. The time T automatically adapts to the radiation pulse
frequency of the X-ray device, allowing the dose area product rate to be indicated even in the presence of pulsed
fluoroscopy.
The chain of dose area product rate values determined in this manner are sent through a digital filter with
adjustable filter depth for further smoothing before being displayed.
Major signal changes exceeding 12.5 % pass this filter undelayed. Minor changes build up in dependance of the
selected filter depth:
0 = filter off T = 60 ms (fixed)

1 = filter off residual noise for pulsed fluoroscopy approx. 9 %
5 = filter off residual noise for pulsed fluoroscopy approx. 9 % / 5 setting time to 90 %
approx. 5 x 2.3 x T
9 = filter off residual noise for pulsed fluoroscopy approx. 9 % / 9 setting time to 90 %
approx. 9 x 2.3 x T
4-8 Time (Option)

The fluoroscopy time determined by the Diamentor M4 KDK, both in continuous and pulsed mode, is equivalent to
the difference in time between beginning and end of the fluoroscopic sequence. In the pulsed mode, the time
includes the pauses, if these are shorter than 0.6 s.
If, in pulsed mode, pauses longer than 0.6 s occur, the fluoroscopy time determined by the Diamentor M4 KDK may
not be identical with the duration of the fluoroscopic sequence.
For this reason, the fluoroscopy time readout can be disabled in the Diamentor M4 KDK display Setup menu.
4-9 Sensitivity (Display Submenu)
You can choose between two sensitivity levels for the Diamentor M4 KDK display:
• Low sensitivity:
The display resolution for the dose area product is fixed at 0.1 cGycm².
The maximum DAP value that can be displayed is 99999.9 cGycm².
The display resolution for the dose area product rate is fixed at 0.1 cGycm²/s.
• High sensitivity:
The display resolution for the DAP begins at 0.01 cGycm².
If the sum of the DAP values measured in both channels reaches 9999.99 cGycm², the display resolution
changes to 1 cGycm².
With this resolution, the maximum DAP value that can be displayed is 999999 cGycm².
The display resolution for the dose area product rate is 0.01 cGycm²/s until the instantaneous value of the
added sum of the DAP rate values measured in both channels exceeds 9999.99 cGycm²/s.
If the instantaneous value of the added sum of the DAP rate measuring values exceeds 9999.99 cGycm²/s, the
display resolution changes to 1 cGycm²/s.
The same applies, when the display unit selected at the Diamentor M4 KDK is not cGycm².
The selected sensitivity is valid for the Diamentor M4 KDK display as well as for the secondary displays Diamentor
SD which can be connected.
The sensitivity does not affect the displayed entrance dose (rate).
4-10 Display Test (Display Submenu)
With the display test option you initiate a performance test of the digital display. The test ends automatically after
approx. 40 seconds.
• Call up the Display menu.
• Using the cursor keys, select "Display Test" and press <Enter>.
4-11 Date & Time (Date & Time Menu)
• In the Setup menu, move the cursor to "Date & Time" and press <Enter>.
The Date & Time menu appears.
• Move the cursor to Date or Time and press <Enter>.
• Using the cursor keys, adjust the first digit of the date or the time and press <Enter>.

• Adjust the other digits in the same manner. The internal clock does not stop while the menu is being displayed.
The Diamentor adopts the new time as soon as you quit the menu with <Print>.
Date & Time menu
4-12 Zero Adjustment (Corrections Menu)

High resolution of the charge is an important requirement in the measurement of the entrance dose. Consequently,
inevitable leakage currents of the chamber, chamber cable and amplifier have an influence on the measuring result
of the Diamentor M4 KDK. In order to obtain correct measurement results, the zero adjustment must be performed
with an unirradiated chamber and with great care.
Fluctuations in the leakage currents of the Diamentor M4 KDK are particularly strong in the first 15 minutes after
turning the device on. Therefore, you should allow for a warm-up period of at least 15 minutes before performing
the zero adjustment.
If you need measuring values with very little leakage during a long-term measurement, it is recommended to repeat
the zero adjustment after a warm-up period of four hours and then leave the Diamentor M4 KDK turned on (over
night).
The zero adjustment should be repeated if the ambient temperature or humidity changes.
• In the setup menu, move the cursor to "Corrections" and press <Enter>.
The Corrections menu appears and the cursor flashes on "Zero instrument".
• Press <Enter> to initiate the zero adjustment procedure.
If the system displays the message "Off-set current out of range. Confirm with PRINT" at the
end of the procedure, the system could not be zeroed.
Corrections menu
4-13 Chamber Temperature, Air Pressure and Correction Factors (Corrections Menu)
Before putting the Diamentor into operation, the chamber temperature and air pressure for air density correction
must be specified. If there are radiation absorbing parts between the patient and the chamber (such as the patient
couch), the corresponding correction factor must be entered as well.
• Display the Corrections menu.
• Using the cursor keys, select one of the menu items and press <Enter>.
• Using the cursor keys again, adjust the first digit and confirm it with <Enter>.
• Proceed in the same manner to adjust all other digits.

Adjustment ranges:
temperature (0 ... 70) °C
air pressure (500 ... 1500) hPa
correction factor 0.000 ... 9.999
The air density correction factor is calculated by the following formula:
PO = 1013 hPa
tO = 20 °C
t = actual temperature
P = actual air pressure
You can set only one correction factor for the Diamentor M4 KDK. As both measuring chambers form a unit, the
installation is the same for both chambers (under-table tube or over-table tube). Therefore, it would not make sense
to set different correction factors for the two chambers.
4-14 Source-Chamber Distance
The Diamentor M4 KDK calculates the value of the entrance dose in the patient plane from the value measured in
the chamber plane.
The values are calculated according to the following formula:
DPat = Dose in patient plane

Dcha = Dose in chamber plane
SCD = Source-Chamber Distance
CPD = Chamber-Patient Distance
The Source-Chamber Distance depends on the X-ray unit and the installation of the measuring chamber. It must be
set once during the installation of the Diamentor M4 KDK in the Corrections menu.
The Chamber-Patient Distance may vary between measurements. Therefore, the value is set immediately before a
measurement (See Diamentor M4 KDK (Option) / Performing a Measurement / Measurement / Chamber-Patient
Distance).
As the Source-Chamber Distance directly affects the measuring result, you should set the value as precise as
possible to avoid errors.
4-15 Printer Control (Printer Menu)
Via the printer menu you can make all adjustments required to control the printer.
The table below shows the adjustments for the recommended printers.
• In the setup menu, move the cursor to "Printer" and press <Enter>.
The Printer Setup menu appears.
Printer menu

Printer Left mar- Init code Paper feed

gin
STAR DP8340S <02> <000> <000> <000> <000> <009> <010> <000> <000>
COSYS LP2042 <06> <027> <081> <063> <000> <001> <012> <010> <000>
ELTRON COMPANION PLUS <06> <094> <080> <094> <080> <001> <094> <080> <000>
4-16 Entering the Label Headline

• Display the printer menu.
• Move the cursor to "H" and press <Enter>.
• Using the cursor keys, select the first character (numbers and letters) and press <Enter>.
• Proceed in the same manner to select the other characters.
You may enter a headline of up to 36 characters.
Setup menu (repeated)
4-17 Dose Area Product Unit

Different radiological units for dose area product reading can be selected: cGy.cm², mGy.m², Gy.cm².
• Display the Setup menu.
• Move the cursor to "Dose Area Product Unit" and press <Enter>.
• Using the cursor keys, select one of the units.
Note: The unit of the entrance dose is always mGy, irrespective of the unit set for the dose area product.
4-18 RS232 Interface (SERIAL port 9)
A printer or a PC can be connected to the serial port 9. In the RS232 menu, make the appropriate choice: "Printer",
"Computer", " " (port not assigned).
• Move the cursor to "RS232" and press <Enter>.
• Using the cursor keys, select one of the choices.
4-19 Print Mode
You can select an AUTO PRINT mode in which the Diamentor M4 KDK will automatically document the
measurement result when you delete it with <Reset> (AUTO ON).
• Move the cursor to "Print Mode" and press <Enter>.

• Using the cursor keys, select one of the options.
5 Maintenance
The measures provided by the M4 KDK are determined by Calibration factors.
A maintenance of the M4 KDK is necessary every two years to ensure calibration factors are valid (i.e. measures
are accurate).
If your equipment is maintained by GE Healthcare, this maintenance will be performed during a periodic
maintenance.
If your equipment is maintained by a service provider other than GE Healthcare, a request should be made to your
service provider to perform this maintenance or, alternatively, you may request a preventive maintenance from your
local GE Healthcare service provider.
6 Restrictions
The values recorded by the Diamentor M4 KDK are accurate as required by the International Standards in the
following working conditions:
• Temperature within 10 to 40 °C.
• Field of views not smaller than the smallest Field of view available with collimator blades wide opened.

Chapter 21 - Maintenance Schedule

In order to obtain continued safe performance of this X-ray equipment, a periodic maintenance program must be
established. It is the owner's responsibility to supply or arrange for this service.
Periodic Maintenance requirements detailed in the System Service Manual are listed in the following table.
In case of an open monitor suspension, refer to the manufacturer’s maintenance instructions and periodicity.
Sub- Check Job Card Periodicity

assembly
6M 1Y 2Y 3Y 5Y
LC Positioner Lock/Unlock CHK0085 x
check
Emergency CHK0087 x
Back Out
check
LC Anti- CHK0088 x
Collision
check
TSSC Emer- CHK0086 x
gency Stop
Button check
LC calibration CHK0090 x
check
Quick Appli- CHK0095 x
cation check
Grid detection PM0050 x
check
626 Maintenance Schedule

Table (For Tilting - x

Table) Check
the patient ta-
ble shoulder-
rest and mat-
tress to en-
sure no
cracks or cuts
are present.
(For Tilting - x
Table) Check
that there is
no detach-
ment initiation
of hook and
loop tapes
from mattress
cover and
from tabletop.
(For Tilting - x
Table) Check
that hook and
loop tapes in-
sure correct
fixation of
mattress to
the table top.
In case of fail-
ure, order
FRU 5309976
(standard
mattress) or
FRU 5398884
(mattress for
wide table
top) and in-
stall new mat-
tress.
Omega Table CHK0091 x
calibration
check
or Tilting Ta- CHK0062, x
ble calibration see section
check 4.2
Table Rota- PM0071 x
tion Brake
Plate cleaning
Table Lateral PM0094 x
Brake Plate
cleaning
(For Tilting - x
Table) Check
the sealant at
the base of
Maintenance Schedule 627

the Gantry
and table for
integrity, and
rework/redo
as necessary
Table Check the ta- CHK0196 x
ble moving
protective
earth cables
C1 Cabinet DL/RTAC fan PM0060 x
cleaning
DL battery re- PM0058 x
placement
(every 2
years)
RTAC battery PM0059 x
replacement
(every 2
years)
System back- SW0250, see x
up sections 3.1 &
3.2
PDU Battery PM0032 x
replacement
(for system
without Fluoro
UPS: every
year)
PDU Battery PM0032 x
Replacement
(for system
with Fluoro
UPS: every 2
years)
Jedi fan diag- PM0037 x
nostic
Jedi RAM KV PM0029 x
board re-
placement
(every 5
years)
KV accuracy PM0038 x
Filters Clean- PM0033 x
ing and Fan
Check
C2 Cabinet Filters Clean- PM0033 x
ing and Fan
Check

Console Quick monitor CHK0096 x

calibrations
check
Digital Detec- Flush, Fill, Air PM0051 x
tor Filter Clean-
ing
(Thermo-Con)
Quick Check PM0053 x
and Fill
(Thermo-Con)
X-Ray Tube Tube chiller PM0075 x
Chiller check
Collimator Collimator PM0036 x
Fan Check
X-Ray Tube 70°C Security CHK0037 x
- and C1-K1
relay Check
70°C Security PM0039 x
- Sensor
Check
Power Distrib- Emergency CHK0104 x
ution Box Power off
(EPO) check
Differential PM0070 x
Circuit Break-
ers Trigger
Check (CE
PDB ONLY)
Fluoro Unin- Fluoro UPS CHK0108 x
terruptible Functional
Power Supply Check
(UPS) Option (always after
service)
Fluoro UPS GEDE x
by GEDE
(every year)
Dosemeter Diamentor CAL0052 x
calibration -
Option

Integrated In- IVUS Rev 1 s5i GE Ser- x

nova - s5i Preventive vice Manual
system option Maintenance Chapter 6
IVUS Rev 2 s5i GE Ser- x
PC cooling vice Manual
maintenance (Model
807400-011)
Chapter 4
IVUS Rev 2+ s5i GE Ser- x
PC cooling vice Manual
maintenance (Model
807400-030)
Chapter 4
IVUS Rev 3 s5i Imaging x
PC cooling System Inte-
maintenance gration in IGS
Systems -
Service Man-
ual
Radiation Rad shield Rad- x
shield sus- Kenex sus- Shield_Kenex
pension pension _Install
check (for
Vendor
other supplier
see vendor
SM)

Large Display Large Display CAL0132 x

Monitor Monitor Cali-
bration (every
6 months)
Large Display CHK0191 x
Option func-
tional check
(every 6
months)
3kVA Large DR1070 x
Display Moni-
tor UPS Bat-
tery Replace-
ment
(For System
without Fluoro
UPS: every
18 months)
3kVA Large DR1070 x
Display Moni-
tor UPS Bat-
tery Replace-
ment
(For System
with Fluoro
UPS: every 3
years)
Suspension Mavig Sus- CHK0094 x
pension
check
Monitor Sus- PM0069 x
pension Rail
Cleaning
Image Quality ABC Stabi- CHK0024 x
lization point
check
Bad Pixel Service User x
Interface
(SUIF)
Pixel Gain SUIF x
Conversion SUIF x
Factor
mR mAs SUIF x
Fluoro Tapers SUIF x
IQST SUIF x
QA check SUIF x

3D Spin 3D Spin Cali- CAL0104 x

bration
Augmented CAL0129 x
Calibration
3D Spin CHK0051, x
Check see sections
4.2 and 4.5

Chapter 22 - Appendix - Technical Publications

1 System Line Voltage without Fluoro UPS
RMS Frequency Mains Volt- Peak Currents Standby Mains Added Transformer
Max (Hz) age (V) (A) Current / Wiring
Power Phase (A)
Input
(kVA)
(100ms)
110 50 380/400/415 243 per C1 19 3Ph + PG None
+/-10% 23 per Chiller
20 for C2
110 50 440 +/-10% 243 per C1 18 3Ph + PG A 150 kVA 440/400 V self
23 per Chiller transformer
20 for C2
110 60 480 +/-10% 192 per C1 16 3Ph + PG None
18 per Chiller
16 for C2
110 60 380/400/415 243 per C1 19 3Ph + PG A 14 kVA 400/480 V self
+/-10% 23 per Chiller transformer for chillers
20 for C2
2 System Line Voltage with Fluoro UPS UL

Power Phase (A)
Input
(kVA)
(100ms)
110 60 480 +/-10% 192 per C1 17 3Ph + N + None
18 per Chiller PG
16 for C2
3 System Line Voltage with Fluoro UPS CE

Power Phase (A)
Input
(kVA)
(100ms)
110 50 380/400/415 243 per C1 20 3Ph + N + None
+/-10% 23 per Chiller PG
20 for C2
110 60 380/400/415 243 per C1 20 3Ph + N + A 14 kVA 400/480 V self
+/-10% 23 per Chiller PG transformer for chillers
20 for C2
Appendix - Technical Publications 633

4 System Line Voltage - Options

Option Nominal Frequency Nominal Power Type of power input
Voltage consumption
LDM 100-120 V / 50 Hz or 60 Hz (+ 3 3 kVA Single phase
220-240 V Hz)
AW 100-127 V / 50 Hz or 60 Hz 11 A / 5.5 A Single phase
200-240 V
S5I GE 100-120 V / 50 Hz or 60 Hz 400 VA Single phase
230 V
5 System Line Current Specifications

Max Line Impedance for feeder line between Generator cabinet and Hospital
V 380 400 420 440 460 480
Ohms 0.09 0.096 0.102 0.108 0.114 0.12
Technique factors that constitute the maximum line current condition is 100 kV, 1000 mA.
Hospital feeder line protection:
• 480V 3~ or 3N 60Hz PDB configuration: circuit breaker, rating 150 A.
• 380/400/415V 3~ or 3N 50/60Hz PDB configuration: circuit breaker, rating 80 A.
6 Generator Rating and Duty Cycle

6-1 High Voltage Generator Classification for Japan
Standard model name

IRF-1000-150
6-2 Generator rating in primary contacted mode

Primary contacted mode is a discontinuous mode where X-ray pulses are obtained through kV pulses.
• Peak power: 100 kW.
• Average power: 3.2 kW avg.
• kV range: from 40 kV to 125 kV.
• mA range: from 10 mA up to 1000 mA.
6-3 Generator rating in gridded mode
Gridded mode is a discontinuous mode where X-ray pulses are obtained through tube current pulses with
permanent kV. Tube current pulses are obtained with the grid function which is responsible to cut tube mA on
cathode side.
• Peak power: 48 kW.
• kV range: from 60 kV to 120 kV.
• mA range: from 1 mA to 400 mA.
634 Appendix - Technical Publications

6-4 Generator duty-cycle

Generator can be used continuously as long as average power limitations described above are satisfied.
6-5 Minimum mAs
• 2 µAs in fluoro.
• 0.00325 mAs in record.
7 System: Maximum deviation of kVp and mA actual parameters from the

displayed parameters (during exposure)
• kVp = +/-10%.
• mA = +/-20%.
To measure kVp use an external HV-voltage divider in parallel with the tube (for example Machlett Dynalizer) and
measure the low-voltage output with a digital voltmeter (for example a Fluke 47).
To measure mA use the mid-point of the generator and correct by removing the generator bleeder current (contact
Service for more information).
8 System: Nominal Tube Current at Maximum kVp

• In fluoroscopy
– Maximum Tube current is 26.7 mA average (111.1 mA peak) for a tube voltage of 120 kV.
• In Dynamic record
– Maximum Tube current is 400 mA peak for a tube voltage of 120 kV in gridded mode.
– Maximum Tube current is 625 mA peak for a tube voltage of 120 kV in non gridded mode.
• In DSA record
– Maximum Tube current is 640 mA peak with a tube voltage of 125 kVp.
9 System: Nominal Tube Voltage Range when mA is Maximum

• In fluoroscopy
– Tube current is maximum at: 33.6 mA average, 140 mA peak in the tube voltage range of: 85 - 95 kV.
• In Dynamic record
– Tube current is maximum at: 866 mA peak with a tube voltage of 75 kV in non gridded mode.
– Tube current is maximum at: 400 mA peak in tube voltage range of 80 - 120 kV in gridded mode.
• In DSA record
– Tube current is maximum at: 1000 mA peak with a tube voltage of: 80 kVp.
10 System: Maximum Power

• In fluoroscopy, maximum power is 3.2 kW average (13.3 kW peak) with 120 kV, 26.7 mA average.
• In Dynamic record, in gridded mode, maximum power is 48 kW peak with 120 kV, 400 mA peak.
• In Dynamic record, in non gridded mode, maximum power is 65 kW peak with 100 kV, 650 mA peak.
• In DSA record, maximum power is 80 kW peak with 100 kV, 800 mA peak.
Appendix - Technical Publications 635

Note: 0.1s exposure time is in the range of DSA record exposure time.
11 System: Maximum mA at nominal tube voltage

French Quality Control: performance parameters for radiography in DSA mode with 100 ms pulse width:
kV mA max
Focal Spot 1 50 290
70 630
125 640
Focal Spot 0.6 50 169
70 313
125 267
Note: Measured on one pulse.
636 Appendix - Technical Publications

Chapter 23 - Appendix - Radiation Safety Tutorial

1 Warning
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR. UNLESS
MEASURES OF PROTECTION ARE STRICTLY OBSERVED. THOUGH THIS EQUIPMENT IS

BUILT TO THE HIGHEST STANDARDS OF ELECTRICAL AND MECHANICAL SAFETY, THE
USEFUL X-RAY BEAM BECOMES A SOURCE OF DANGER IN THE HANDS OF THE
UNAUTHORIZED OR UNQUALIFIED OPERATOR. EXCESSIVE EXPOSURE TO X-RAY
RADIATION CAUSES DAMAGE TO HUMAN TISSUE. THEREFORE, ADEQUATE
PRECAUTIONS MUST BE TAKEN TO PREVENT UNAUTHORIZED OR UNQUALIFIED
PERSONS FROM OPERATING THIS EQUIPMENT OR EXPOSING THEMSELVES OR OTHERS
TO ITS RADIATION. BEFORE OPERATION, PERSONS QUALIFIED AND AUTHORIZED TO
OPERATE THIS EQUIPMENT SHOULD BE FAMILIAR WITH THE RECOMMENDATIONS OF
THE INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, CONTAINED IN
ANNALS NUMBER 26 OF THE ICRP, AND WITH APPLICABLE NATIONAL STANDARDS.
2 Learning objective
Increase your knowledge and help you develop safe work habits. Quick overview of X-ray radiation and dose
through a simple explanation of the equipment, technology and to discuss the different techniques available to
reduce dose.
3 Teaching points
• Radiation dose is a natural consequence of x-ray imaging.
• Displayed Dose Parameters.
• Effects of ionizing radiation on humans.
• Dose reduction measures for the patient.
• Dose reduction measures for the staff.
• Pediatrics Case.
• Legal Provisions.
4 Radiation dose is a natural consequence of x-ray imaging

• Images are created by the interaction of x-rays with materials.
• During this interaction x-rays leave some energy in the patient.
– Energy at the Image Detector is about 100 to 1000 less than energy entering the pa-
tient.
• Absorbed dose = mean energy imparted by the x-ray beam per unit mass at a point in
the tissue.
• Air Kerma = mean energy imparted to air.
– Usual way of reporting radiation dose.
– Compared to actual Skin dose, the Air Kerma differs material absorption of dose (a
few % effect) and do not include backscatter from underlying tissue (a 10-40% effect).
Appendix - Radiation Safety Tutorial 637

5 Displayed Dose Parameters

5-1 Cumulated Air Kerma
• Air Kerma is cumulated over the

course of exam and displayed.
– By standard, it is determined for
a fixed distance to the x-ray
tube for isocentric C-arm
(Interventional Reference Point
or Patient Entrance Reference
Point).
• The cumulated Air Kerma is relat-
ed to the patient skin dose to some
extent:
– The reference point is only an
"average" representation of the
patient skin location.
– The accumulation is performed
over all gantry angulations and
Live display Reference display table positions.
1: Focal Spot
2: Reference Point
3: Isocenter
A: 57 cm on Innova monoplane units.
B: 15 cm
5-2 Cumulated Dose Area Product (DAP)

• DAP is the product of Air Kerma and exposed area and is cumulated over the course of exam and displayed.
– By nature, it is independent of distances to the focal spot.
• The cumulated DAP is related to the patient skin dose to some extent:
– DAP should be more representative of long-term risk (stochastic risk).
– The accumulation is performed over all gantry angulations and table positions.
– Several guidance levels based on DAP.
638 Appendix - Radiation Safety Tutorial

1: Focal Spot
S: Surface of Area
AK: Air Kerma
DAP: Dose (Air Kerma) Area Product
6 Effects of ionizing radiation on humans

6-1 Deterministic effects
• Table describes several possible effect to the patient skin/hair for different approximate range of Skin Dose
estimate.
• Skin Dose estimate is not equal to cumulated Air Kerma.
• Approximate 3/5 ratio between Skin Dose estimate and cumulated Air Kerma.
– Due to gantry/table movements and different distance.
– From SIR-CIRSE recommendation: Stecker MS, Balter S, Towbin RB, et al. Guidelines for patient radiation
dose management. J Vasc Interv Radiol 2009 20 (7 suppl) S263 – S273.
Summary of tissue reactions from single-delivery Radiation Dose to Skin

Approximate Range Reactions

(Gy)
0 to 2 • None Expected
2 to 5 • Transient erythema/epilation
Above 5 • Erythema/epilation transient or permanent

• Possible Moist desquamation, dermal athrophy above 10 Gy
For full table, refer to S. Balter et al. Fluoroscopically Guided Interventional Procedures: A
Review of Radiation Effects on Patients' Skin and Hair Radiology 254(2) 2010.
6-2 Stochastic effects

• Absorbed doses lower than deterministic threshold may increase natural risks of cancer or mutations.
• This risk is stochastic i.e. is a random effect. Within "linear non threshold hypothesis" the same collective dose
will generate the same number of pathologies regardless of the number of persons who receive it (100 mSv to
1000 persons each is equivalent to 10 mSv to 10 000 persons each, or to 1 mSv to 100 000 persons).
• Pediatrics patients are at greater risk with stochastic effects compared to adult, due to their longer potential life
and increased sensitivity to such effects.
7 Dose reduction measures for the patient

7-1 List
Several dose reduction means (non-exhaustive):
• Select the appropriate protocol.
• Appropriate use of Equipment distances (SID: Source to Image Distance, Table position).
• Change Gantry angulations during procedure.
• Minimize Sequence duration.
• Use of LIH (Last Image Hold).
• Adjust collimation without radiation.
• Select largest FOV with small exposed area with collimation.
• Select a lower dose rate:
– Use as low Frame rate as possible.
– Select Low detail vs Normal detail (~50% less dose).
– Have protocols preselected with lower dose setup (AutoEx preferences/fluoro dose strategy).
7-2 Appropriate protocols
• Select the appropriate protocol by target or anatomy:
– Use setup with the lowest value compatible with the medical requirement.
– Specific pediatric protocol available with Low detail setup.
– One ‘dose limited’ protocol by category, on top of list by default.

– EP protocols specifically set to further low-dose setup.

– Changes in default values, protocols names and order of appearance (by alphabetical order) can be made in
protocol by Service or Application specialist.
– Use Dose Reduction Button on Innova Central touchscreen (option) whenever available and possible.
7-3 Equipment distances and angulations

• Use of Equipment distances (SID: Source to Image Distance, Table position):
– Minimize distance between patient, Image detector.
– Maximize between Patient and X-ray tube.
– Use Skin Spacer.
– Keep distance between detector and patient at minimum, can be facilitated with auto contouring option
(Innova Sense , not available on Innova IGS 540).
• Use of Gantry angulations during procedure:

– Change angulations during the procedure, to avoid to cumulate dose on the same patient area.
7-4 Sequence duration, Last Image Hold

• Sequence duration:
– Minimize Radiation time, use the X-ray timer indications.
– The X-ray time flashes and emits an audible signal after 5 minutes of X-ray time.
• Use of LIH (Last Image Hold):
– LIH provides an image in between the live fluoro images to use as a reference image and eliminates the
need for extended fluoro exposures.
– Further reducing the need for additional fluoro exposure can be facilitated by storing the last frames (up to
450) of the fluoro sequence with the fluoro store option .
7-5 Virtual collimation

Adjust collimation without radiation (Virtual Collimation):
• Enables positioning of collimator blades without irradiation.
• Means to visualize the virtual position of collimator blades by lines displayed over the live display image
(regardless if there is an image, a LIH or nothing).
• Uses the regular joystick for positioning the collimator blades.
7-6 FOV selection

Select largest FOV with small exposed area with collimation:
• When compatible with medical requirements for anatomy and/or tool(s) visibility at the current viewing distance
to the display monitors.
• The dose rate is increased at smaller FOV to provide increased visibility from both magnification effect and
reduced noise content.
• Collimating within the FOV decreases the overall exposure.
Lower dose can be achieved by using less magnified view, using a larger FOV with some collimation inside as
appropriate.

FOV: Field of View
Example from the "Dose to patient" section, for Innova IGS 520, RDL+, Balanced Dose/IQ, 7.5 fps, Normal, at 20
cm patient size (PMMA cm). Refer to this Operator Manual section to find the data corresponding to your system
configuration.
7-7 AutoExposure preferences, Normal/Low setting

Lower dose rate:
• Select Low detail vs Normal detail (at tableside or console) when compatible with medical requirements for
anatomy and/or tool(s) visibility.
• Have protocols preselected with lower dose setup (AutoEx preferences).
– About 50% less Air Kerma rate in Low versus Normal, except at max Fluoro dose limits (limits explained in
next section).
Example from the "Dose to pa-

tient" section of the Operator Man-
ual, for Innova IGS 520, 15 fps,
Balanced IQ/Dose, 20cm FOV, at
20 cm patient size (PMMA cm).
Refer to this Operator Manual
section to find the data corre-
sponding to your system configu-
ration.
: Low
: Normal

Note: Depending on country regulations, some of the choice may not be available (e.g. only RDLx choices in
Germany)
Lower dose rate selectable within a large range.
Choice of AutoEx preference to be preset in protocol by Service or Application specialist.
7-8 Frame Rate
Lower dose rate:
• Use as low Frame rate as possible (at tableside or console) compatible with medical requirements for the image
refresh rate (versus anatomy and/or tool(s) movements or changes).
• Have protocols preselected with lower dose setup (fluoro dose strategy).
Pulsed fluoroscopy with a choice of frame rate: 30 fps, 15 fps, 7.5 fps, 3.75 fps**.
** Option
Two Dose Strategies (Max Dose Reduction and Balanced IQ/Dose) are provided on systems (to be preset within
protocols by Service or Application Specialist).
Example from the "Dose to pa-

tient" section, for Innova IGS 520,
RDL Plus, Normal, 20 cm FOV, at
20 cm patient size (PMMA cm).
FOV: Field of View

Max Dose Reduction: Dose rate drops directly with fluoro frame rate.
Balanced IQ/Dose: Maintains static object detectability, noise appearance. Based on perception experi-
ment (Case Western University, OH, from the D.L. Wilson group).
7-9 Fluoro limit

Selecting Fluoro limit "Low" and lower frame rates minimizes dose.
Highest reference dose (mGy/min) for For Autoexposure preference: IQ For Autoexposure preference: IQ
Fluoro settings Plus, RDL Plus Standard, RDL Standard
Balanced IQ/Dose Max Dose Reduc- Balanced IQ/Dose Max Dose Reduc-
tion tion
30 fps Normal < 87.6 < 87.6 < 87.6 < 87.6
15 fps Normal < 87.6 < 43.8 < 87.6 < 43.8
7.5 fps Normal < 43.8 < 21.9 < 43.8 < 21.9
3.75 fps Normal < 21.9 < 21.9 < 21.9 < 21.9

30 fps Low < 87.6 < 87.6 < 43.8 < 43.8
15 fps Low < 87.6 < 43.8 < 43.8 < 21.9
7.5 fps Low < 43.8 < 21.9 < 21.9 < 21.9
3.75 fps Low < 21.9 < 21.9 < 21.9 < 21.9
• Dose Limit in Fluoro can be lowered when reducing frame rate (up to 4x) and using a different fluoro frame rate
strategy (up to 2x).
• Two main different ways – main difference is on the Low detail management for the standard AutoEx
preferences which are set lower than the regular ones (up to 2x).
7-10 Threshold

Display prior to the predefined Dose Threshold value being reached: • Watch the dose display and apply
dose reduction means as appropri-
ate.
– The display changes above the
predefined threshold.
• Other recommendations exist for
procedural dose warning.
– eg Values above 5 Gy indicates
that the patient should have
clinical follow-up for determinis-
tic radiation-induced injury
(SIR-CIRSE recommenda-
tions).
Display after the predefined Dose Threshold value has been exceeded – eg. Use 500 Gy.cm2 as signifi-
(above 100%): cant radiation threshold
Live display Reference display (SIR-CIRSE).
– eg. Use 3000 mGy as first noti-
fication, then each further addi-
tional 1000 mGy (SIR-CIRSE).
– eg. Use first notification 3000
mGy, then second one at 6000
mGy (ACR).
SIR-CIRSE recommendation: Stecker
MS, Balter S, Towbin RB, et al.
Guidelines for patient radiation dose
management. J Vasc Interv Radiol
2009 20(7 supp) S263-S273.
Display on live display after double of the predefined Dose Threshold ACR recommendation: Mahdevappa,
value has been reached: M, Detorie, N. How to prepare for the
joint commission's sentinel event poli-
cy pertaining to prolonged fluo-
roscopy. American College of Radiol-
ogy. The Medical Physics Consultant
2008 601-603.
7-11 Dose Reduction (Innova Central touch screen)

When compatible with medical requirements for anatomy and/or tool(s) visibility, a lower dose rate can be obtained
by using the Dose Reduction button on the Dose tab of the Innova Central touch screen. This button can modify
simultaneously AutoExposure preferences, Normal/Low setting, and frame rate depending on the mode setup;
refer to section Innova Positioner / Innova Central touch screen (option) / Dose Reduction on Innova Central touch
screen for detailed description.
8 Dose reduction measures for the staff

• Minimize patient dose.

– Staff dose related to the patient dose scattered X-
rays mostly come from the patient dose entry
points.
• Be as far as possible.
– Radiation decreases as the inverse square of dis-
tance.
• Minimize your time near radiation sources when pos-
sible.
• Use radiation shield:
– Wear your personal ones.
– Position these between you and the patient dose
entry location, or locate yourself behind shields
whenever possible.
– Do not stay in the procedure room when your at-
tendance at tableside in not needed.
• Monitoring.
– Wear your personal dosimeter.
9 Pediatrics Case
The Innova IGS system is specifically designed to minimize radiation exposure while providing good image quality
for the intended pediatric and adult patients. Exposure to ionizing radiation is of particular concern in pediatric
patients as younger patients are more radiosensitive than adults and have a longer potential lifetime for the effects
of radiation exposure to manifest as cancer. Thus, the use of equipment and exposure settings designed for
pediatric patients are different from the ones used for adult patients.
• Children have a greater sensitivity to radiation than adults. When possible, avoid X-ray examinations and use
alternative procedures.
• Further to the presented means to minimize dose, also consider the application of:
– For infants up to 1 year old, remove the anti scatter grid from acquisitions performed at Field Of View smaller
than 20 cm.
– Use collimation to the specific area of interest.
– When possible, use a gonad shield.
• Use pediatrics protocols. Pediatrics protocols are set with lower dose setup than for adults.
– Select a protocol on the system console where the name contains "peds" or "pediatrics".
Note: Dose rate for pediatrics are automatically reduced as the system senses a small patient thickness from the
dose signal to the detector. See section Appendix - Radiation Safety Tutorial / Dose settings for pediatrics in
Innova systems for more details.
9-1 Dose-related Parameters Default Values
Dose-related parameters default values of adult vs. pediatric protocols

Dose-related para- Adult Pediatric car- Pediatric car- Pediatric an-

meters diac protocol diac protocol gio protocols
for neonates
Dose Threshold 2 or 3 Gy 1 Gy 1 Gy 1 Gy
Fluoro detail Normal* Low Low Low
Fluoro FPS 15 fps** 15 fps 30 fps 15 fps
Dynamic detail Normal* Low Low Low
Dynamic FPS 15 fps** 15 fps 30 fps 15 fps
DSA detail Normal N/A N/A Low
AutoExposure Mostly SUIF AutoExpo- RDL+ RDL+ RDL+

(Fluoro, record An- sure***
gio, record Cardiac)
* Few adult protocols have Fluoro or Dynamic detail default value at Low (a non-exhaustive example is Dose
Limited protocols).
** Few adult protocols have Fluoro or Dynamic FPS default value different from 15.
***Most adult protocols take the AutoExposure set in the Service User Interface (SUIF), but few adult protocols
have a defined AutoExposure (a non-exhaustive example is Dose Limited protocols defined at RDL+).
In addition to the dose-related default values, the system is able to optimize temporal resolution for pediatric
patients. The system also adapts a smaller ROI in dynamic fluoroscopy and in dynamic record, based on the exam
type (Angio or Cardiac) and the patient type (Adult or Pediatric). These correspond to attributes of a patient
protocol, and are set according to its usage. Further, there is a minimal spectral filtration of 0.1 mm for pediatric
protocols due to a higher radiosensitivity.
9-2 List of Pediatric Protocols
For pediatrics imaging, select a protocol on the system console under the “Pediatrics” category, or where the name
contains "Pedia".
Type of procedure Protocol name Category
Angio procedure Pedia Abdomen Pediatrics
Pedia Cerebral
Pedia Chest
Pedia Lower Limbs
Pedia Upper Limbs
Cardiac procedure Pedia Cardiac
Pedia Cardiac Neonate
In case of adult protocol selected while the patient’s age is below the “Pediatrics limit age threshold”, the following

events are trigged at start exam:

• An informative popup is displayed on the DL.
• A message is displayed on live monitors.
Both recommend using a pediatric protocol for young patients.
Note: The “Pediatrics limit age threshold” is editable before the start of an exam in the Preferences tab on the DL
screen. It is used to set the maximum patient age defined for pediatrics. The range is from 0-21 years of age.
Note: The patient's age is calculated from his date of birth or his age if it has been modified in the Patient exam
information screen.
10 Dose settings for pediatrics in Innova systems

Innova products are designed to automatically set the optimal X-ray technique parameters (kVp, mAs, focal spot
size, and spectral filtration) for a variety of operational modes, e.g. fluoroscopy, DSA, and digital cardiac record.
For this, an equivalent patient thickness (EPT) is determined based on the dose signal to the detector and the
technique values used for that exposure, and then the optimized technique parameters are set for the next
exposure using the patient thickness value and predetermined look-up tables (or “trajectories”) designed to give an
appropriate image quality for the lowest possible patient entrance dose.
For each available acquisition setting there are two trajectory tables: normal and low detail, giving two dose curves
versus EPT. The dose ratio of normal and low is 2 in case of fluoroscopy, at 20 cm PMMA. The "dose" is defined
here as the Air Kerma rate delivered by the X-ray equipment.
Predefined procedure protocols contain the default settings for clinical procedures, e.g. for pediatric protocols,
default detail and frame rate levels are low. Default low detail provides a dose reduction of a factor of 2 in case of
pediatrics compared to adult default; default low frame rates results in further dose reduction.
See an example of patient dose dependence on patient thickness in case of fluoroscopy with 30 pulses per second
on figure below (further values for other pulses per second settings and other settings are given in Operator
Manual for 20 cm PMMA thickness).
Air Kerma rates at IRP with RDL 30 fps fluoroscopy

Air Kerma rate
(mGy/min)
PMMA thickness (cm)

Low

Normal
Air Kerma rates at the interventional reference point (IRP) in case of fluoroscopy with 30 pulses per second, normal
and low detail Receptor Dose Limited (RDL) settings in FOV20, measured using phantoms with different thickness
on Innova IGS 530.
11 Electrophysiology (EP) Exam Case

Electrophysiology (EP) exams often require long fluoro times and are often less demanding in object visualization,
allowing in these cases to have radiation dose rate set to lower values compared to other exam types.
• Select an appropriate protocol when long fluoro times are expected for an EP exam. Use a protocol with the
lowest dose rate value compatible with the medical requirement. Several protocols are pre-set to lower radiation
dose rate, refer to the list of available protocols with "EP" in their name or category name.
• When compatible with medical requirement, apply the means presented in previous chapters to minimize dose:
– Monitor cumulative dose,
– Appropriate use of Equipment distances,
– Minimize Sequence duration,
– etc.
12 Legal Provisions
• In many countries or states, by means of rules, guidelines or regulations, lawmakers have contributed to
improving radiation protection for patients and medical personnel.
• On an international level, guidelines are laid down by the International Commission on Radiological Protection
(ICRP). Many of the rules, guidelines or regulations are governed by the ALARA concept (As Low As
Reasonably Achievable), meaning the production of a diagnostically relevant image at minimum possible dose.
• The material presented in this tutorial contains ways to improve radiation safety on Innova’s but is not deemed
to be exhaustive, read the Radiation Safety section for more details. Local legal provisions also prevails over the
ways presented in this document when applicable.

Chapter 24 - Appendix - Dose Map accuracy procedure

1 Overview
This procedure is to check the dose map feature accuracy. It takes over 2 hours to complete and requires the
following material:
• Dosimeter Model Radcal 2026 with -6cc ionization chamber
Note: Backscatter Correction Factor for other dosimeters
Presence of PMMA near the ionization chamber generates a large amount of backscatter
especially in large FOV. Generally Solid-state probes do not measure this backscatter. Apply the
following corrections to the dose measured by the dosimeter if your dosimeter does not measure
the backscatter:
• Dose measured with FOV 20cm: dosimeter readout value has to be multiplied by 1.20 (20%
correction factor).
correction factor).
correction factor).
• INSPEC-QAP Suitcase
• PMMA Slabs Elevator kit (in INSPEC-QAP Suitcase)
• 1m ruler
Before starting, check that all the covers and filters are in place, that the system is fully calibrated.
2 Procedure for Single Model

2-1 PA measurement
2-1-1 Set up geometrical measurements
Set the geometrical parameters as follow:
1. Move gantry in PA (with L=0)
2. Connect the ionization chamber to dosimeter controller.
3. Set the dosimeter controller in dose mode (cumulated dose).
4. Set the dosimeter on the mattress centered on the lateral axis of the table (Item 1), and at a distance of at least
70cm from the table top end (Item 2):
Appendix - Dose Map accuracy procedure 651

5. Set the PMMA elevator kit layers on the mattress on each side of the dosimeter ( or equivalent if not available).
6. Set the 15 cm of PMMA phantom above the dosimeter.
7. Set the table height as the function of the mattress:
Mattress 1'' Mattress 2''
Table height (as displayed 11 cm 13 cm
on Live display)
8. Use Fluoro to center the ionization chamber in the X-ray beam. Center the ionization chamber in the image as
shown in the Note. During this step do not move the table height.
Note: The ionization chamber position is very critical for the accuracy measurements. To
determine the center of the display area, plot on the monitor its two diagonals as shown on the
illustration below or use a ruler. The center of the display area and the center of the ionization
chamber must merge.
9. Set Maximum SID.

10.In the Preferences tab on the DL Browser: ensure that the mattress type configured is consistent with the
mattress on the table (refer to Innova Digital / Dose Map / How to set Dose Map? / Dose Map preferences).
At this point in the procedure, the Set up should be as follow:
652 Appendix - Dose Map accuracy procedure

1. Flat Panel Detector

2. Dosimeter
3. Mattress
4. Table
5. X-ray Tube
6. 15 cm PMMA
7. 5 cm of PMMA elevator kit
8. SID = Max
2-1-2 Set up feature configuration
On DL browser:
1. Create a new patient with the following information:
1. [Patient Height]: 194 cm
2. [Patient Weight]: 71 kg
3. [Date of Birth]: enter a date of birth so that the patient is older than 22 years old.
2. Start exam.
Note: The patient data entries have been defined in order to be consistent between the theoretical patient width
and PMMA width.
2-1-3 Run the measurements
1. On the DL console, set patient position: Head First Supine

2. On the DL console, select Aorta-Arch protocol.

3. On the DL console, select Max FOV.
4. Reset dosimeter to 0 dose cumulated.
5. On the DL console, select DSA normal detail and 7.5 fps for all segments.
6. Press for 3 seconds the Fluoro footswitch to get the right techniques.
7. Perform a DSA record mode.
8. Cumulate dose until you reach 750 mGy on the dosimeter. Note the exact value (in mGy) that you reached with
the dosimeter as "Dose1". Example: "Dose1 = 940 mGy".
Note: The value shall be close to 750 mGy.
Note: 1 R = 8.76 mGy.
9. Press [Dose Map] button on the DL sequence Browser and read the value of the gauge. Note the value as
"Dose2". Example: "Dose2 = 37.5%":
10.End exam.
2-1-4 Analyse the results
1. Compute "Dose3" in mGy by applying the following formula:
Dose3 (mGy) = Dose2 (%) x Adult local dose threshold (Gy) x 1000
Note: The Adult local dose threshold is set in the Preferences tab on the DL browser (refer to
Innova Digital / Dose Map / How to set Dose Map? / Dose Map preferences).
For example with Adult local dose threshold at 2 Gy and Dose2 at 37.5%:
Dose3 (mGy) = 37.5/100 x 2 x 1000 = 750 mGy
2. Compute the accuracy of Dose Map by applying the following formula:
Inaccuracy (%) = abs (Dose1 - Dose3) / Dose1 x 100

For example with Dose1 at 940 mGy and Dose3 at 750 mGy:
Inaccuracy (%) = abs (940 - 750) / 940 x 100 = 20%
2-2 Lateral Measurement
1. Center the table laterally:
1. Set an object on the mattress, centered on the lateral axis of the table.
2. Use Fluoro to center the object in the X-ray beam by moving the table laterally.
2. Move the Gantry into Lateral position.
3. Set the PMMA elevator kit layers on the mattress (or equivalent if not available):
4. Put the 15 cm PMMA phantom on the top of the elevator kit centered on the table.
5. Set the table height as the function of the mattress (do not move the table until the end of the measurement).
Table height (as displayed on Live 11 cm 13 cm
display)
Note: The table height is required in Lateral configuration in order to measure the dose at the right point
compared to the theoretical patient model computed by Dose Map. If the table height is disregarded, the dose
map accuracy is not guarantee.
8. Stick the dosimeter probe to the PMMA by using scotch tape (or any equivalent mean).
shown in the Note. During this step do not move the table height and the table lateral axis.

chamber must merge.
10.Set Maximum SID.

mattress on the table (refer to (refer to Innova Digital / Dose Map / How to set Dose Map? / Dose Map
preferences).

2. Dosimeter
3. Mattress
4. Table
5. X-ray Tube
6. 15 cm PMMA
7. 5 cm PMMA of elevator kit
8. SID = Max
On DL browser:


2. Start exam.
and PMMA width.
Note: 1 R = 8.76 mGy.
10.End exam.

2-2-4 Analyze the results

Dose3 (mGy) = 37.5/100 x 2 x 1000 = 750 mGy
Inaccuracy (%) = abs (940 - 750) / 940 x 100 = 20%
3 Procedure for Dual Model

3-1 PA measurement
1. Move gantry in PA (with L=0)
4. Set the dosimeter on the mattress, centered on the lateral axis of the table (Item 1).
5. Set the PMMA elevator kits (Items 2 - or equivalent if not available) on the mattress, on each side of the
dosimeter.
6. Set the 15 cm of PMMA phantom above the dosimeter.

7. Set the table height as the function of the mattress:
Table height (as displayed 13 cm 15 cm
on Live display)

shown in the Note. During this step do not move the table height.
chamber must merge.
9. Set Maximum SID.

On DL browser:
3. [Head to End distance]: 0 cm
2. Start exam.
and PMMA width.
2. On the DL console, in Head Anatomy, select Cerebral protocol.
Note: 1 R = 8.76 mGy.

"Dose2". Example: "Dose2 = 37.5%".

10.End exam.
Dose3 (mGy) = 37.5/100 x 2 x 1000 = 750 mGy
Inaccuracy (%) = abs (940 - 750) / 940 x 100 = 20%
3-2 Lateral Measurement
1. Remove the mattress from the Table.
2. Center the table laterally:
1. Set an object on the mattress, centered on the lateral axis of the table.
2. Use Fluoro to center the object in the X-ray beam by moving the table laterally.
3. Move the Gantry into Lateral position.
4. Put the 17 cm PMMA phantom on the table.
5. Set the table height as the function of the mattress (do not move the table until the end of the measurement).
Table height (as displayed on Live 13 cm 15 cm
display)
Note: The table height is required in Lateral configuration in order to measure the dose at the right point
compared to the theoretical patient model computed by Dose Map. If the table height is disregarded, the dose
map accuracy is not guarantee.
8. Stick the dosimeter probe to the PMMA by using scotch tape (or any equivalent mean).

shown in the Note. During this step do not move the table height and the table lateral axis.
chamber must merge.
10.Set Maximum SID.



2. Dosimeter
3. Table
4. X-ray Tube
5. 17 cm PMMA
6. SID = Max
On DL browser:
2. Start exam.
and PMMA width.
Note: 1 R = 8.76 mGy.

10.End exam.
Dose3 (mGy) = 37.5/100 x 2 x 1000 = 750 mGy
Inaccuracy (%) = abs (940 - 750) / 940 x 100 = 20%

Chapter 25 - Glossary
1 Acronyms in use
Acronym Defi- Comment Generic Standards Unit Medical appli- System com-
nition cation ponent
2D 2 Dimensional X
Application
3D 3 Dimensional X
Application
ABC Automatic X
Brightness Con-
trol
AE-Title Application Enti- X
ty Title
ALARA As Low As Rea- X
sonably Achiev-
able
AW Advantage X
Workstation
CAU Caudal X
CCD Coupled X
Charged Device
CDRH Center for De- X
vices and Radi-
ological Health
CFR Code of Federal X
Regulations
CFX Circumflex X
artery
CISPR Comité Interna- X
tional Special
des Perturba-
tions
Radioélectrique
s
cm centimeter X
CPD Chamber-Pa- X
tient Distance
CPR Cardiac Pul- X
monary Resus-
citation
CRA Cranial X
CSA Canadian Stan- X
dards Associa-
tion
664 Glossary
CT Computed To- X
mography (or
equivalent ap-
plication)
DAP Dose Area X
Product
DFP Digital Flat Pan- X
el
DICOM Digital Imaging X
and COmmuni-
cations in Medi-
cine
DL Digital Leader X
DQE Detective Quan- X
tum Efficiency
DSA Digital Subtract- X
ed Angiography
DVD+R DVD Record- X
able
DVD+RW DVD X
ReWritable
ECG ElectroCardioG- X
raphy
ED End-Diastolic X
EFUP Environment-Friend- X
ly Use Period
EIP Electronic Infor- X
mation Products
EMC Electro Magnet- X
ic Compatibility
EP Electro Physiol- X
ogy
ES End-Systolic X
F french X
FDA Food and Drug X
Administration
FNR Fluoro Noise X
Reduction
FOV Field of View X
fps Frame Per Sec- X
ond
GE General Electric X
GEF Global Ejection X
Fraction
Glossary 665
GEHC General Electric X

HealthCare
GEMS General Electric X
Medical Sys-
tems
Gy gray X
HHS Department of X
Health and Hu-
man Services
HRE High Radiation X
Exposures
HUA Heat Unit Avail- X
able
HVL Half Value Lay- X
er
ICRP International X
Commission on
Radiological
Protection
ID IDentifier X
IEC International X
Electrotechnical
Commission
II Image Intensifi- X
er
IPEM Institute of X
Physics and En-
gineering in
Medicine
IQ Image Quality X
IRB In-room Brows- X
er
IRP Interventional X
Reference Point
ISO Isocenter X
IVUS Intra Vascular X
Ultrasound Sys-
tem
J joule X
kg kilogram X
kVp kilovolt peak X
LAD Left Anterior X
Descending
artery
666 Glossary
LAO Left Anterio X

Oblique
LC L-C gantry X
LCD Liquid Crystal X
Display
LED Light Emitting X
Diodes
LIH Last Image X
Hold
LP L-P gantry X
LV Left Ventricle X
m meter X
mA milliAmpere X
mAs milliAmpere X
second
min minute X
MIP Maximum Inten- X
sity Projection
ml millilitre X
mm millimeter X
MPVR Multi Planar X
Volume Recon-
struction
MRI Magnetic X
Resonnance
Imagery
MTF Modulation X
Transfer Func-
tion
PA Posterio Anteri- X
or
PACS Picture Archiv- X
ing and Com-
munication Sys-
tems
PBB PolyBrominated X
Biphenyl
PBDE PolyBrominated X
Diphenyl Ether
PDB Power Distribu- X
tion Box
PIM Pre Installation X
Manual
Glossary 667
PM Periodic Mainte- X
nance
PMMA PolyMethyl- X
MethAcrylate
PMS Periodic Mainte- X
nance Schedule
QAP Quality Assur- X
ance Program
RAO Right Anterio X
Oblique
RCA Right Coronary X
Artery
RDL Receptor Dose X
Limited
REC Record X
RF Radio Frequen- X
cy
ROI Region Of Inter- X
est
RTAC Real Time Ac- X
quisition Con-
troller
s second X
SA Stenosis Analy- X
sis
SCD Source- X
Chamber Dis-
tance
SCPT Secondary Cap- X
ture
SID Source to Im- X
age Distance
SNR Signal to Noise X
Ratio
SUB Subtraction X
SUIF Service User In- X
terface
TFT Thin-Film Tran- X
sistors
TSSC Table Side Sta- X
tus Control
TSUI Table Side User X
Interface
668 Glossary
TVA Training Virtual X

Assist
UL Underwriter's X
Laboratories,
Inc.
UPS Uninterruptible X
Power Supply
US United State X
USA United States of X
America
VA Ventricular X
Analysis
VCIM Vascular Con- X
trol Interface
Module
VESA Video Electron- X
ics Standards
Association
VR Volume Ren- X
dering
WEEE Waste Electric, X
Electronic
Equipment
WM Wall Motion X
XA X-ray Angiogra- X
phy
Glossary 669
Chapter 26 - Importer Offices of GE Healthcare

AUSTRALIA
GE Healthcare Australia Pty Ltd
Building 4B, 21 South Street,
Rydalmere NSW 2116 Australia
1800 659 465
INDONESIA (ID)
PT GE Operations Indonesia
Gedung BRI II, Lantai 27
Jl. Jenderal Sudirman No. 44-46
Jakarta Pusat 10210
Indonesia
NEW ZEALAND
GE Healthcare Limited
8 Tangihua Street
Auckland, NEW ZEALAND
0800 659 465
TURKEY (TR)
Ithalatci : GE Medical Systems Türkiye Ltd. Sti
Esentepe Mah. Harman Sok. No: 8 Sisli – Istanbul / Turkiye
670 Importer Offices of GE Healthcare

Chapter 27 - Revision History
Part / Rev Date Reason for Change
5499294-1-1EN July 2015 Initial release of direction 5499294-1-1EN

rev 2
Revision History 671

© 2015 General Electric Company, All Rights Reserved.
GE Medical Systems SCS
283, rue de la Minière
78530, Buc
FRANCE
www.gehealthcare.com

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InnovaTM IGS 540

WARNING: BEFORE USING THIS SYSTEM

RECOMMENDATIONS PROVIDED IN THIS MANUAL.

SERIOUS INJURY TO THE PATIENT, TO THE OPERATOR OR TO OTHER PERSONS.

            

       

1 Using This Module 31

Chapter 3 - Safety and Regulatory 36

2-1-1 Patient Population 48

3-10 Dose and Dose Rate Measuring Procedure 61

6-1 General Information 70

1 Indications for Use 73

5-2-1 Skin Dose Levels 123

6-1-5 Innova Central touch screen 160

7-4 System Recovery after a power Cut 197

10-5 Type B applied part 218

1 How X-ray Radiation is created and the "Dose" concept 232

2-3 Exit dose 233

Chapter 6 - Revolution Digital Detector 244

1 Imaging Chain 244

1 General Description 250

7 Vascular Control Interface Module 262

1 Guidelines for the best usage of the system 264

9 How to perform a Blended Roadmap Fluoroscopy Acquisition (Option) 300

13-5-2-2 Patient Positioning 324

18-1 Ventricular Analysis at a glance 357

22-1 Collage / In-room Browser (Option) 399

31 Modality Performed Procedure Step (MPPS) 432

1 Application Description 453

1 How to move the Table/Gantry 456

1-1 Omega Smart Box 456

1-16-3 How to Use with TableSide Cart 482

8-3-4-1 Move a button inside the current tab 516

1 Alarm management 536

1 General Description 541

5-1-1 How to Create a New Group 543

1 LCD Monitor Suspensions 552

1 General Application Description 556

3-2 Safety recommendations 560

1 General Description 561

1 Equipment Installed in Patient Vicinity 570

1-4-1 Other System Measurements 578

1 Advantage Workstation (AW) Configuration (Option) 585

1-2-4 Printer manager 586

1-1 General description of the Diamentor M4 KDK 610

Chapter 21 - Maintenance Schedule 626

Chapter 22 - Appendix - Technical Publications 633

1 System Line Voltage without Fluoro UPS 633

7-2 Appropriate protocols 640

3-1-1 Set up geometrical measurements 658

1 Acronyms in use 664

Chapter 27 - Revision History 671

2 Printing this Module

Click on PRINT button:

3 Electronic Operator Manual

Symbol indicating that the Instruction For Use (Operator

GE Healthcare= "GE Santé" in Province of Quebec - Canada.

Chapter 3 - Safety and Regulatory

Caution advises of an avoidable condition that

WARNING ADVISES OF AN AVOIDABLE CONDI-

DANGER ADVISES OF AN AVOIDABLE CONDI-

36 Safety and Regulatory