LBL 61876 rev. E, March 2018
EN
1
OPERATOR’S MANUAL
Intravascular Lithotripsy (IVL)
Generator and Connector Cable
LBL 61876 Rev E / Revision Date: March 2018
Contents
1.
Introduction ............................................................................................................................................................ 2
1.1
The IVL Generator - How Supplied .................................................................................................................................................................. 2
1.2
Required Devices and Procedure Supplies for Use with the IVL Generator .............................................................................................................. 2
1.3
Device Description ....................................................................................................................................................................................... 2
1.4
Intended Use/Indication for Use ..................................................................................................................................................................... 2
2.
Safety Information .................................................................................................................................................. 2
2.1
Terms ........................................................................................................................................................................................................ 2
2.2
Contraindications ......................................................................................................................................................................................... 2
2.3
Dangers ..................................................................................................................................................................................................... 2
2.4
Warnings .................................................................................................................................................................................................... 2
2.5
Cautions ..................................................................................................................................................................................................... 3
3.
Product Orientation ................................................................................................................................................. 3
3.1
IVL Generator - Front View ............................................................................................................................................................................ 3
3.2
Control and Indicator Functions ...................................................................................................................................................................... 4
3.3
Front Panel Connectors ................................................................................................................................................................................. 4
3.4
IVL Connector Cable ..................................................................................................................................................................................... 4
3.5
IVL Generator – Rear View ............................................................................................................................................................................ 4
4.
Product Use and Therapy Delivery .......................................................................................................................... 5
4.1
Additional Usage Information ......................................................................................................................................................................... 6
5.
Installation ............................................................................................................................................................. 7
5.1
IV Pole Mounting .......................................................................................................................................................................................... 7
5.2
Connecting to Line Power .............................................................................................................................................................................. 9
5.3
Charging the Internal Battery ......................................................................................................................................................................... 9
5.4
Environment Conditioning.............................................................................................................................................................................. 9
5.5
Generator Inspection and Test ....................................................................................................................................................................... 9
6.
Maintenance .......................................................................................................................................................... 10
6.1
Daily Maintenance .......................................................................................................................................................................................10
6.1.1
Charging and Testing the Internal Battery .............................................................................................................................................. 10
6.1.2
Testing the IVL Generator .................................................................................................................................................................... 11
6.1.3
Inspecting the IVL Generator ............................................................................................................................................................... 11
6.1.4
Cleaning the IVL Generator .................................................................................................................................................................. 11
6.2
Monthly Maintenance ...................................................................................................................................................................................11
6.3
Other Maintenance ......................................................................................................................................................................................12
6.4
Product Useful Life ......................................................................................................................................................................................12
7.
Troubleshooting .................................................................................................................................................... 12
8.
Appendix A: Electromagnetic Compatibility Guidance ........................................................................................... 13
9.
Appendix B: Symbols ............................................................................................................................................. 14
10.
Appendix C: Specifications .................................................................................................................................... 15
10.1
Appendix C1: General Specifications ..............................................................................................................................................................15
10.2
Appendix C2: Performance Specifications ........................................................................................................................................................15
NOTE: This Operator’s Manual provides information required for proper operation of the IVL Generator and IVL Connector Cable. Replacement IVL Connector Cables are
available from Shockwave Medical, Inc. Refer to the applicable IVL Catheter Instructions for Use (IFU) for patient treatment information.
To Be Used Exclusively with the Shockwave Medical IVL System.
TEXT CONVENTIONS: Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as ON, CATH, SYS) are used to indicate
controls, connectors and lighted annunciators.
