Additional Usage Information - Shockwave Medical 825D Manuel D'utilisation

Step 11 – Lithoplasty Catheter End of Life
The Generator is designed to sense the end of the useful life of the
Lithoplasty Catheter. Should this occur the 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 Lithoplasty Catheter
with a new one is required before the Generator may be used again.
Refer to the applicable Lithoplasty Catheter IFU for useful life
specifications.
Step
Step 12 – Lithoplasty Catheter Replacement
Detach the Lithoplasty Catheter by first sliding the sterile sleeve out of
the way moving it proximally along the Connector Cable.
Next, gently pull the CATHETER CONNECTOR and Connector Cable
apart to separate the Lithoplasty Catheter from the Connector Cable
connector (see illustration).
Take care not to contaminate the connectors with fluids or other
foreign matter during this procedure. Position Connector Cable to help
ensure the connector remains free of contamination until the
Lithoplasty Catheter can be replaced.
CAUTION: Discard the used Lithoplasty Catheter per standard hospital
procedures. Used Lithoplasty Catheters cannot be re-sterilized and are
designed for single use only. Re-use of Lithoplasty Catheters can lead
to patient injury.
Connect a new Lithoplasty Catheter and resume patient treatment
following the steps outlined above, beginning at step #5.
CAUTION
EQUIPMENT DAMAGE
The Generator delivers low-energy, short-duration, high-voltage pulses to the Lithoplasty Catheter through the Connector Cable.
The system is designed not to deliver pulses unless a Lithoplasty Catheter connector is mated with the Connector Cable and
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 Generator in treatment
scenarios that may differ from the basic sequence of events defined in Section 4.0 above.
TOPIC
Tones
LBL 60780 rev. B
ADDITIONAL INFORMATION
The Generator is designed to supplement its visual indicators with tones. The 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 Generator. Also occurs at the end of the pre-programmed therapy pause
period.
Three beeps – Negative prompt. Occurs when attempting to activate the Generator but when one or
Picture or additional info if applicable
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