Shockwave Medical Lithoplasty 825D Manual Del Operador página 13

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Step
Picture or additional info if applicable
Step 8 – Activate the Generator
Inflate the catheter and verify pressure per the instructions indicated in
the Lithoplasty Catheter IFU.
Press the THERAPY ON/OFF button once. The THERAPY STATUS
indicator on the Generator front panel and on the CATHETER
CONNECTOR will now be green, indicating that the Generator is now
ready to deliver Lithoplasty therapy.
To deactivate the Generator at any time, simply press the Generator
THERAPY ON/OFF button again and verify that the THERAPY STATUS
indicator light is yellow.
Step 9 – Deliver Therapy
While observing balloon positioning and lesion characteristics under
fluoroscopy, press and hold the THERAPY CONTROL on the Connector
Cable.
The Generator will deliver Lithoplasty pulses via the catheter balloon
while the THERAPY CONTROL is depressed unless the 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 increment by one, and the
Generator will sound one click.
Confirm therapy delivery by continuously monitoring under
fluoroscopy (see Lithoplasty Catheter IFU for additional information).
To stop therapy, simply release the THERAPY CONTROL.
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 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 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 Lithoplasty Catheter IFU for specifics on the
maximum number of continuous pulses allowed and the duration of
the pre-programmed pause period.
LBL 60780 rev. B 13 | P a g e