Volcano CORE Mobile - Catheter and Wire Use Cautions and Warnings

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300004969171/B Page 13 of 148

Catheter and Wire Use Cautions and Warnings

NOTE: See the package insert for a complete description of product usage, warnings, and

precautions.

Main Page

default chapter3
- Table of Contents3
- Patents8
- Patents and Trademarks8
- Trademarks8
- For Use Only by Trained Medical Personnel9
- Read and Review Manual before Operation9
- System Use Cautions and Warnings9
- Warnings and Precautions9
- Pim Use Cautions and Warnings12
- Catheter and Wire Use Cautions and Warnings13
Chapter 1: Overview14
- Introduction14
- Indications for Use17
- Clinical Applications18
- Contraindications18
- Possible Adverse Reactions18
Chapter 2: System Description20
- System Overview20
- Monitor21
- Control Console22
- Joystick Controller Option25
- Workstation (Central Processing Unit)27
- Printer27
- Connector Panel27
- Patient Interface Module30
- Catheters30
- Available Options31
Chapter 3: System Setup32
- Overview32
- Installation32
- Turning System on33
- Ivus Software Settings33
Chapter 4: Preparing for a Case44
- Overview44
- Ensure System Power Is on44
- Connect the Pim45
- Enter Patient Information46
Chapter 5: Acquiring Ivus Images48
- Overview48
- Insert the Catheter48
- Adjust the Image (if Desired)49
Chapter 6: Recording Ivus Images54
- Overview54
- Recording a Video Loop54
- Saving a Frame56
Chapter 7: Reviewing Ivus Images57
- Overview57
- Reviewing Saved Frames58
- Reviewing Video Loops58
- Display Mode64
- Printing64
Chapter 8: Making Measurements and Annotations67
- Making Measurements67
Chapter 9: Using Vh Ivus76
- Overview76
- Activating Vh Display77
- Using the Vh Screen78
- Using Target Assist81
Chapter 10: Using the Chromaflo Feature82
- Overview82
- Activating the Chromaflo Feature82
- Controlling the Sensitivity83
- Setting the Region of Interest83
- Deactivating the Chromaflo Feature84
Chapter 11: Ending an Ivus Case86
- Overview86
- Ending a Case86
- Deleting a Case87
Chapter 12: Archiving an Ivus Case88
- Overview88
- Archiving Options88
- Archiving Using Dicom90
- Printing Images90
Chapter 13: Switching Modes92
- Overview92
- Entering Patient Information92
- Switching Modes92
Chapter 14: Retrieving and Deleting an Ivus Case94
- Overview94
- Retrieving a Case94
- Deleting a Case95
- Removing Power from System96
Chapter 15: Image Export Option97
Chapter 16: Troubleshooting99
- Message Alerts99
- Potential Imaging Artifacts104
- EU Battery Directive, 2006/66/EC Requirements109
Chapter 17: Maintenance111
- Service111
- Maintenance Frequency111
- User-Performed Maintenance112
- Volcano-Certified Maintenance115
Chapter 18: Technical Specifications117
- Imaging Catheters117
- Video117
- Core Mobile Dimensions and Weights119
- Power119
- Recording Devices121
- Classifications121
- Emc Statement121
- Electrical Safety122
- Environmental Conditions122
- Dicom Image Storage122
- Essential Performance, Catheter Operating Temperatures123
- Essential Performance, System123
- Catheter Acoustic Outputs124
- Measurement Accuracy127
- Accessories and Replacement Parts128
- Standards and Regulations129
- Symbols135
- Glossary137
Appendix A: Vh Measurements138
- Frame Results138
- Segment Results138
Appendix B: Technology Summary140
- Methods140
- Accuracy Analysis141
- Results142
Appendix C: Configuring Dicom143
- Worklist Servers Configuration147

Volcano CORE Mobile - Catheter and Wire Use Cautions and Warnings

Table of Contents