LBL 61876 rev. E, March 2018
EN
4
3.2
Control and Indicator Functions
CONTROL
DESCRIPTION
MORE INFO
POWER ON/OFF
Turns IVL Generator on or off.
Refer to 3.1 IVL Generator Front View
THERAPY ON/OFF
Press to activate the IVL Generator.
IVL Connector Cable and a valid IVL Catheter must be
connected to activate.
INDICATOR
DESCRIPTION
MORE INFO
POWER STATUS Indicator
On green when IVL Generator is on.
Refer to 3.1 IVL Generator Front View
On yellow when user action is required regarding the IVL Catheter (CATH).
See Section 4 step 6.
On red when internal diagnostics have detected a problem (SYS).
See Section 7.
BATTERY CAPACITY
Display/ Charging Status
Indicates battery charge remaining.
See Section 4 step 2.
BATTERY CHARGING
Indicator
Lightning bolt symbol appears when the Charger Module is connected and is charging
the battery from mains power.
Charge IVL Generator before use. See Sections 5.2 and 5.3.
BALLOON SIZE Display
IVL Catheter Balloon Diameter and Length
When IVL Connector Cable and valid IVL Catheter
connected.
PULSE COUNT Display
Number of Pulses available.
Counts down from available Pulse Count Per Catheter during
treatment as each pulse is delivered. Refer to applicable IVL
Catheter IFU for the Max Pulse Count.
THERAPY STATUS
Indicator
On green when the device is ready to deliver therapy. Flashes to indicate therapy is
in process. On yellow when therapy is paused or deactivated.
See Section 4, Steps 5 – 9.
3.3
Front Panel Connectors
FEATURE
DESCRIPTION
MORE INFO
CONNECTOR DOOR
Slide right to connect charger.
Slide left to connect IVL Connector Cable.
See Section 4,
Step 4.
CHARGER CONNECTOR
Used to connect to charger module.
See Section 5.3
THERAPY CONNECTOR
Used to connect to IVL Connector Cable (the Connector Cable connects the IVL
Generator to the IVL Catheter).
See Section 4
Step 4.
3.4
IVL Connector Cable
Pressing and holding the THERAPY CONTROL on the IVL Connector Cable initiates therapy delivery. The IVL Generator must first be activated (THERAPY STATUS indicators on
IVL Generator front panel and CATHETER CONNECTOR will be green). Refer to Section 4.0, Step 8 for more information.
3.5
IVL Generator – Rear View
There are no controls or indicators on the rear of the IVL Generator. Refer to Appendix B for more information regarding the symbols used.
Catheter Connector
Therapy Control
Therapy Status