LBL 61876 rev. E, March 2018
EN
12
6.3
Other Maintenance
Shockwave Medical recommends that you contact your Shockwave Medical representative if you have any questions or concerns about maintenance.
Shockwave Medical recommends replacement of IVL Connector Cables every three years to reduce the possibility of failure during patient use. In the event IVL Connector
Cable connectors have become contaminated or the IVL Connector Cable malfunctions, remove this cable from use and contact your Shockwave Medical representative for a
replacement. Additional IVL Connector Cables can be ordered separately.
NOTE:
The IVL Connector Cable should not be disposed of in the normal waste stream; it should be sent to a separate collection facility for recovery and recycling.
6.4
Product Useful Life
The IVL Generator has been designed to provide a useful life of three years or more. Life expectancy is based on actual usage. Periodic inspection per the maintenance
schedule above is recommended by Shockwave Medical to assess continued use.
7.
Troubleshooting
If a problem is detected with the IVL System during use or testing, refer to the troubleshooting tips below. If the problem cannot be corrected, remove the equipment from
service and contact your Shockwave Medical representative and or email [email protected].
Technical Support:
For Shockwave Medical Technical Support, contact your local Shockwave Medical representative or
www.shockwavemedical
.com.
WARNING – SHOCK HAZARD
Do not attempt to service the system. It contains no operator serviceable components and dangerous high voltages may be present. No user modification or servicing of this
equipment is allowed. If any part of this product appears damaged, remove from use and contact your Shockwave Medical representative for repair or replacement.
Observation
Possible Cause
Corrective Action
Unit will not turn on
Battery requires charge
Connect Charger Module to the IVL Generator and to AC
Mains.
Allow the IVL Generator to charge at least twelve (12) hours
prior to use
Battery will not charge
(BATTERY CHARGING indicator is off)
Disconnected cable
Connect Charger Module to the IVL Generator and also to
AC Mains.
NOTE: two cable connections are required.
Low BATTERY CAPACITY indicated when the
battery symbol is Empty
Battery requires charge
Connect Charger Module to the IVL Generator and to AC
Mains.
Allow the IVL Generator to charge at least twelve hours
prior to use
System Error displayed and red light around
POWER ON/OFF button.
Built in tests have detected a malfunction within the IVL
Generator
Turn IVL Generator off, wait one second and turn the IVL
Generator on again.
NOTE: If SYS fault cannot be resolved, remove IVL
Generator from service and contact your Shockwave Medical
representative.
Catheter Error Displayed
Catheter connection has not been made properly or has
become disconnected.
Make sure IVL Connector Cable is connected to IVL
Generator
Make sure valid IVL Catheter is connected to IVL Connector
Cable
IVL Catheter has reached its useful life or is defective
Replace IVL Catheter
IVL Connector Cable has reached its useful life
Replace Connector Cable
THERAPY STATUS indicator on IVL Generator front
panel or on the IVL Connector Cable does not turn
on
Valid IVL Catheter is not connected
Make sure IVL Connector Cable is connected to IVL
Generator
Make sure IVL Catheter is connected to IVL Connector Cable
Replace IVL Catheter
IVL Generator will not activate
(THERAPY STATUS is off)
Valid IVL Catheter is not connected
See THERAPY STATUS indicator troubleshooting step above
IVL Generator will not activate
(THERAPY STATUS is yellow)
THERAPY ON/OFF button is pressed
Release THERAPY ON/OFF button, try again
THERAPY STATUS changed from green to yellow
IVL System has automatically paused therapy (see Section
4.0 Step 10
THERAPY STATUS should indicate green again, within the
pause period specified in the IVL Catheter IFU
THERAPY ON/OFF button on the IVL Connector
Cable is pressed, but IVL Generator does not
deliver pulses
IVL Generator cannot be activated
(THERAPY STATUS indicator is off)
If error message(s) appear, see troubleshooting guide
above
IVL Generator has not yet been activated (THERAPY STATUS
indicator is yellow)
Press THERAPY ON/OFF button once (THERAPY STATUS
should turn green)
IVL System has automatically paused therapy (THERAPY
STATUS indicator is yellow, see Section 4.0 Step 9)
THERAPY STATUS should indicate green again, within the
pause period specified in the IVL Catheter IFU
IVL Catheter or IVL Connector Cable is faulty
(THERAPY STATUS indicator is green)
Replace IVL Catheter
Replace IVL Connector Cable
