LBL 61876 rev. E, March 2018
EN
11
A treatment case, for the purposes of interpreting the BATTERY CAPACITY display, is conservatively defined as 900 therapy pulses delivered over one hour. Actual battery
performance will vary based on actual therapy delivered.
If the battery does not indicate full charge following twelve (12) hours of charging, remove the IVL Generator from service and contact your Shockwave Medical
representative.
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.
WARNING – POSSIBLE DEVICE SHUTDOWN
This device operates only from an internal battery source. Charge the IVL Generator battery when not in use. Always operate the IVL Generator when the battery
symbol is at least ¼ Full. IVL Generator may shut down without warning when the battery symbol is Empty. Remove the IVL Generator from use and contact your
Shockwave Medical representative in the event the battery symbol frequently appears Empty or if the battery symbol does not appear full after twelve hours of charging.
6.1.2
Testing the IVL Generator
The IVL Generator will automatically perform an array of built in tests designed to detect certain malfunctions each time it is turned on. In addition, the IVL
Generator features an automated test of the lithotripsy output system which may be initiated by the user. Confirmation of satisfactory test results is
recommended daily, before cases are initiated, or as directed by your Biomedical Department. These tests may be done as follows:
Step
Picture or additional info if applicable
Step 1 – Turn the IVL Generator On
Momentarily depress the POWER ON/OFF button. All indicators on the IVL Generator will come on briefly as a test. The THERAPY STATUS
indicator will come on green and yellow during this test. The POWER STATUS indictor will continue to be on green.
Step 2 – Check Diagnostics
When powered on, the IVL Generator will perform an array of built in tests designed to detect certain malfunctions. If an error is detected,
an error message will be displayed. If no error is displayed, these tests passed successfully.
If an error message is displayed, refer to Troubleshooting, Section 7.0.
Step 3 – Initiate the Output Test
The Charger Module must be connected to AC Mains and to the IVL Generator CHARGER CONNECTOR to run this test.
This test is initiated manually by depressing and holding the THERAPY ON/OFF button and releasing this button when the THERAPY STATUS
indicator comes on green. Pressing this button for three seconds is required.
Step 4 – Confirm Output Test Result
The output test requires approximately 15 seconds to complete. During this time the THERAPY STATUS indicator will remain on green.
Upon successful completion of this test, the IVL Generator will sound four beeps. If no error message appears on the display then this test
has passed successfully.
6.1.3
Inspecting the IVL Generator
Physical inspection of the IVL Generator on a daily basis is also recommended to help ensure that all components required for reliable operation are in good condition.
Physical Condition Inspection
Inspect all surfaces of the IVL Generator exterior including the Charger Module. Confirm there is no visible damage such as cracks or chips
in any component.
Disconnect the Charger Module from the IVL Generator and slide the CONNECTOR DOOR left and right. Verify it is not damaged, also
verify it is retained in its track and it slides easily left to right. Reconnect the Charger Module to the Generator.
Inspect the IVL Connector Cable and AC Mains Cable. Confirm there are not any damaged, split or cracked materials and electrical
contacts are free of extraneous matter.
6.1.4
Cleaning the IVL Generator
Dirt and extraneous matter may be removed from the IVL Generator and IVL Connector Cable using a soft cotton cloth or a lint free wipe. If needed, use only isopropyl
alcohol sparingly as a cleaning agent.
Do not allow any fluids to penetrate the exterior surfaces of the device. Allow equipment to dry thoroughly before testing or use.
Clean connector areas carefully. Do not attempt to clean interior surfaces of connectors or connector contacts. In the event that an IVL Connector Cable has become
contaminated or malfunctions, remove this cable from use and contact your Shockwave Medical representative.
WARNING – SHOCK OR FIRE HAZARD
Do not immerse any portion of the IVL Generator in water or other fluids. Do not immerse IVL Connector Cables in water or other fluids. Avoid spilling any fluids on the
IVL Generator. Spilled liquids may cause the IVL Generator to perform inaccurately or malfunction.
Do not clean with solvents or flammable agents as this may cause damage to the IVL Generator and possibly cause harm to the user
Do not autoclave or sterilize the IVL Generator or IVL Connector Cables as this may cause the IVL Generator to malfunction.
6.2
Monthly Maintenance
There is no specific test or inspection which is recommended to be conducted on a monthly basis in addition to the tests and inspections included in Section 6.1. However, it
is recommended that the shift supervisor or Biomedical Department review staff practices on a monthly basis to help ensure this recommended maintenance is being
completed on a daily basis or as directed by the Biomedical Department.
