Installation - Shockwave Medical 825D Manuel D'utilisation

Use of Multiple
Lithoplasty Catheters
Automatic Off Feature
TOPIC
Following Usage

5.0 Installation

Important - Follow all steps in Sections 5.0 – 5.5 prior to use of this product.
The Generator is shipped as an assembled product, ready to install on an IV pole as outlined in Section 1.1. It is
designed to be mounted to an IV pole prior to use. Once mounted, it will appear as shown below.
LBL 60780 rev. B
more conditions are preventing activation. Examples include attempting to activate the generator
without a valid catheter attached or while holding down the THERAPY CONTROL. Also occurs when the
Generator is deactivated and in the event built in diagnostics detect a malfunction.
Multiple Lithoplasty Catheters may be used and re-used during the treatment of a single patient. The
Generator is designed to track the useful remaining life of each Lithoplasty Catheter; however, no more
than one of any given size Lithoplasty Catheter may be in use simultaneously. Discard used Lithoplasty
Catheters after patient treatment. Used Lithoplasty Catheters cannot be re-sterilized and are for single
use only. Re-use of Lithoplasty Catheters can lead to patient injury.
Connect and use Lithoplasty Catheters of varying sizes by following steps 5 – 9 above.
The Generator is designed to turn itself off and conserve battery power after periods of inactivity as
follows:
 No Lithoplasty Catheter is connected – Will turn off after five hours.
 Lithoplasty Catheter connected – Will turn off after one hour.
 If the Generator has turned itself off, simply press the POWER ON/OFF button to turn the
Generator back on. Patient treatment may resume by following steps outlined in Section 4.0.
ADDITIONAL INFORMATION
Follow these steps to prepare the Generator for future use:
1) Press POWER ON/OFF button once to turn the Generator off.
2) Remove and discard the Lithoplasty™ Catheter and sterile sleeve.
3) Coil and secure the Connector Cable
4) Slide the CONNECTOR DOOR to the right to protect the THERAPY CONNECTOR
5) 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 Generator CHARGER CONNECTOR per Sections 5.2 - 5.3.
Confirm the 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.
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