LBL 61876 rev. E, March 2018
EN
5
4.
Product Use and Therapy Delivery
Before use read all sections of this operator’s manual and familiarize yourself with all controls, displays and connector features. Charge the IVL Generator before use (see
Sections 5.2, 5.3). Also refer to the IFU provided with the IVL Catheter for additional information before use. Not all clinical procedures will follow the sequence below. The
following steps serve as a guide for use of the IVL Generator in clinical applications.
Step
Picture or additional info if applicable
Step 1 – Turn the Generator On
Momentarily depress the POWER ON/OFF button. All indicators on the IVL Generator will come on briefly as a test. The THERAPY STATUS
indicator will come on yellow and green during this test. The POWER STATUS indictor will continue to be on green.
Step 2 – Confirm Battery Capacity
With the Generator powered on, the BATTERY CAPACITY will be shown in the right side of the display. The battery symbol should be at least
partially filled as shown.
If the battery symbol is empty, additional charging of the battery is recommended before use because there may not be an adequate charge to
complete a patient treatment.
Step 3 – Check Diagnostics
Confirm that the display is as pictured with no error messages displayed. If an error message is displayed, refer to Troubleshooting, Section
7.0.
Normal display with no errors shown to the right.
If a yellow light is displayed, refer to Troubleshooting, Section 7.0.
If any error messages come on during use, refer to Troubleshooting, Section 7.0.
Error Condition – Catheter error shown to the right.
Step 4 – Connect IVL Connector Cable
Disconnect the Charger Module from the CHARGER CONNECTOR if it is connected.
Slide the CONNECTOR DOOR fully to the left, revealing the THERAPY CONNECTOR as shown.
Connect the GENERATOR CONNECTOR end of the Connector Cable to the THERAPY CONNECTOR. Orient the connector and gently push in.
The connector is magnetic and will engage as the magnet gets close. Push gently to confirm connector is fully engaged.
Slide CONNECTOR DOOR to left to reveal the
THERAPY CONNECTOR
THERAPY CONNECTOR:
Step 5 – Prepare IVL Catheter for Use
Prepare the catheter for use following the instructions in the IVL Catheter IFU. Use a sterile sleeve to cover the distal end of the IVL Connector
Cable. Protect the connector from contamination by fluids.
N/A
Step 6 – Connect IVL Catheter
Take care not to contaminate either connector end with fluids or other foreign matter during this procedure prior to mating.
Connect the IVL Catheter to the CATHETER CONNECTOR end of the IVL Connector Cable using the same method outlined in step 4.
NOTE: Ensure that the sterile sleeve also covers the CATHETER CONNECTOR.
The THERAPY STATUS indicator on the IVL Generator front panel and the CATHETER CONNECTOR will be yellow, indicating that the IVL
Generator is ready to activate.
The IVL Catheter balloon dimensions will appear in the BALLOON SIZE display. The total number of available pulses for the selected IVL
catheter will appear in the PULSE COUNT field.
Step 7 – Position the IVL Catheter
Following conventional angioplasty catheter technique, introduce and position the IVL Catheter as desired. Use caution to prevent unintentional
movement of the IVL Connector Cable and IVL Catheter during treatment.
(Refer to the IVL Catheter IFU)
Step 8 – Activate the IVL Generator
Inflate the IVL Catheter and verify pressure per the instructions indicated in the IVL Catheter IFU. Press the THERAPY ON/OFF button once.
The THERAPY STATUS indicator on the IVL Generator front panel and on the CATHETER CONNECTOR will now be green, indicating that the IVL
Generator is now ready to deliver therapy. To deactivate the IVL Generator at any time, simply press the IVL Generator THERAPY ON/OFF
button again and verify that the THERAPY STATUS indicator light is yellow.
