LBL 61876 rev. E, March 2018
EN
6
Step
Picture or additional info if applicable
Step 9 – Deliver Therapy
While observing balloon positioning and lesion characteristics under fluoroscopy, press and hold the THERAPY button on the IVL Connector
Cable. The IVL Generator will deliver lithotripsy pulses via the IVL Catheter balloon while the THERAPY button is depressed unless the IVL
Generator determines that therapy is to be interrupted. As each therapy pulse is delivered, the THERAPY STATUS indicator will blink once, the
PULSE COUNT display will decrement by one, and the Generator will sound one click. Confirm therapy delivery by continuously monitoring under
fluoroscopy (see IVL Catheter IFU for additional information). To stop therapy, simply release the THERAPY button.
NOTE: There is no need to make any adjustments for dosage levels or pulse rates. All such settings are pre-programmed for given catheter
types.
Step 10 – Pause Period / Resume Therapy
The IVL Generator is designed to force a brief pause in therapy at designated intervals. If the user attempts to deliver a quantity of pulses
without pausing, the IVL Generator will automatically interrupt therapy for a pause period. The THERAPY STATUS indicator will be yellow during
this period. To resume therapy, wait for the THERAPY STATUS indicator to become green again (two beeps will sound). Simply release and
press the THERAPY CONTROL again to resume therapy. Refer to the applicable IVL Catheter IFU for specifics on the maximum number of
continuous pulses allowed and the duration of the pre-programmed pause period. Care must be taken not to exceed the recommended
maximum number of pulses in the same treatment segment.
Step 11 – IVL Catheter End of Life
The IVL Generator is designed to sense the end of the useful life of the IVL Catheter. Should this occur the PULSE COUNT will indicate “0”
pulses remaining and the IVL Generator will interrupt therapy. The display will indicate a catheter error and a yellow light will appear around the
POWER ON/OFF button. Replacing the IVL Catheter with a new one is required before the IVL Generator may be used again. Refer to the
applicable IVL Catheter IFU for maximum pulse count per catheter (useful life) specifications.
Step 12 – IVL Catheter Replacement
Detach the IVL Catheter by first sliding the sterile sleeve out of the way moving it proximally along the IVL Connector Cable. Next, gently pull
the CATHETER CONNECTOR and IVL Connector Cable apart to separate the IVL Catheter from the IVL Connector Cable connector (see
illustration). Take care not to contaminate the connectors with fluids or other foreign matter during this procedure. Position IVL Connector
Cable to help ensure the connector remains free of contamination until the IVL Catheter can be replaced.
CAUTION: Discard the used IVL Catheter per standard hospital procedures. Used IVL Catheters cannot be re-sterilized and are designed for
single use only. Re-use of IVL Catheters can lead to patient injury. Connect a new IVL Catheter and resume patient treatment following the
steps outlined above, beginning at step #5. Refer to the IVL Catheter IFU for information about recommended balloon overlap to prevent
geographic miss. However, care must be taken not to exceed the recommended maximum number of pulses in the same treatment segment as
indicated in the IVL Catheter IFU.
CAUTION
EQUIPMENT DAMAGE
The IVL Generator delivers low-energy, short-duration, high-voltage pulses to the IVL Catheter through the IVL Connector Cable. The system is designed not to deliver
pulses unless an IVL Catheter connector is mated with the IVL Connector Cable and IVL Generator. It is important not to allow the contacts or internal surfaces of
unmated connectors to be contaminated with fluids. Do not allow any connector to become contaminated by or immersed in fluids. Failure to observe these
precautions may damage the cables or catheters.
4.1
Additional Usage Information
The following topics and additional information may be useful in the use of the IVL Generator in treatment scenarios that may differ from the basic sequence of events defined
in Section 4.0 above.
TOPIC
ADDITIONAL INFORMATION
Tones
The IVL Generator is designed to supplement its visual indicators with tones. The IVL Generator will sound tones as follows:
•
Click – Sounds once per therapy pulse to confirm therapy delivery in process.
•
Two beeps – Positive confirmation of a user action. Occurs when connecting a valid catheter or when arming or disarming the IVL Generator. Also occurs at
the end of the pre-programmed therapy pause period.
•
Three beeps – Negative prompt. Occurs when attempting to activate the IVL Generator but when one or more conditions are preventing activation. Examples
include attempting to activate the IVL Generator without a valid IVL Catheter attached or while holding down the THERAPY button. Also occurs when the IVL
Generator is deactivated and in the event built in diagnostics detect a malfunction.
Use of
Multiple IVL
Catheters
•
Multiple IVL Catheters may be used and re-used during the treatment of a single patient. The IVL Generator is designed to track the useful remaining life of
each IVL Catheter; however, no more than one of any given size IVL Catheter may be in use simultaneously.
•
Connect and use IVL Catheters of varying sizes by following steps 5 – 9 above.
•
Discard used IVL Catheters after patient treatment. Used IVL Catheters cannot be re-sterilized and are for single use only. Re-use of IVL Catheters can lead to
patient injury.
Automatic
Off Feature
The IVL Generator is designed to turn itself off and conserve battery power after periods of inactivity as follows:
•
No IVL Catheter is connected – Will turn off after five hours.
•
IVL Catheter connected – Will turn off after one hour.
•
If the IVL Generator has turned itself off, simply press the POWER ON/OFF button to turn the IVL Generator back on. Patient treatment may resume by
following steps outlined in Section 4.0.
Following
Usage
Follow these steps to prepare the IVL Generator for future use:
•
Press POWER ON/OFF button once to turn the IVL Generator off.
•
Remove and discard the IVL Catheter and sterile sleeve.
•
Coil and secure the IVL Connector Cable
•
Slide the CONNECTOR DOOR to the right to protect the THERAPY CONNECTOR
•
If the last case of the day has been completed, or if the BATTERY CHARGING symbol is indicating empty, then place the battery on charge. The Charger Module
must be connected to AC Mains and to the IVL Generator CHARGER CONNECTOR per Sections 5.2 - 5.3.
•
Confirm the IVL Generator is charging; a lightning bolt symbol should appear inside the battery symbol.
NOTE: The battery is self-discharging and requires periodic recharges even during storage so that the battery will not discharge to an unacceptably low voltage level, which
could ultimately result in battery damage.
