LBL 61876 rev. E, March 2018
EN
9
STEP 5 – Mount the battery Charger Module in the same fashion as the IVL Generator.
CAUTION – IV POLE TIP HAZARD
Observe the recommendations noted herein for mounting the IVL Generator to an IV pole. Failure to comply with recommendations could result in an injury to the user or
patient.
5.2
Connecting to Line Power
The IVL Generator normally operates from an internal, rechargeable battery system. However, in order to charge the battery system, the Charger Module must first be
connected to line power. Locate the AC Mains Cable shipped with the IVL Generator and connect it to the AC Mains input as indicated in the figure on the next page. Choose
a safe location where connection of this power cable to AC Mains will not create a trip hazard and connect it to the AC Mains outlet.
The Charger Module is designed to operate from power supplies world-wide. See Appendix C for more information.
WARNING – SHOCK HAZARD
To avoid the risk of electrical shock, this equipment must only be connected to a grounded electrical outlet (electrical supply mains with protective earth.) Use with a
hospital grade receptacle. Grounding reliability can only be achieved when connected to an equivalent receptacle marked “hospital use” or “hospital grade”. Only use the
Charger Module provided with the IVL Generator to avoid shock.
5.3
Charging the Internal Battery
Charging the battery requires the Charger Module be connected to AC Mains, and the Charger Module must also be connected to the CHARGER CONNECTOR located on the
front panel of the IVL Generator (see Section 3.1).
It will be necessary to disconnect the IVL Connector Cable from IVL Generator, if one is attached. To do so, gently pull the IVL Connector Cable connector straight from the
IVL Generator. Move the CONNECTOR DOOR fully to the right to cover the THERAPY CONNECTOR and expose the CHARGER CONNECTOR.
Connect the cable coming from the front of the Charger Module to the CHARGER CONNECTOR on the front of the IVL Generator (see Section 3.1). Ensure that the CHARGER
MODULE cable is fully seated into the CHARGER CONNECTOR. The BATTERY CHARGING indicator will be displayed with a lightning bolt inside the battery symbol to indicate
the battery is now charging (see Step 2 of Section 5.5 for illustration).
Charge the battery for at least twelve hours prior to use. After twelve hours, BATTERY CAPACITY should show a completely filled in battery symbol (see Step 4 of Section 5.5
for illustration).
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.
5.4
Environment Conditioning
The IVL Generator is designed to be used indoors in a controlled environment. Refer to Appendix C for specified operating conditions.
Allow the IVL Generator to be stored in the ambient conditions of the usage environment for at least 24 hours before turning it on. This must be done with the IVL Generator
unpacked and removed from its shipment materials. This is important because shipping, storage and use environments may vary widely and could cause condensation within
the IVL Generator or its accessories. Such condensation could result in a possible malfunction or equipment damage if operated.
WARNING – USE ENVIRONMENT
Allow the IVL Generator and its accessories (including IVL Catheters and IVL Connector Cables) to adjust to room temperature and humidity conditions for at least twenty
four hours before use. See Appendix C for specified operating conditions. Operating the equipment outside of these environmental conditions may cause equipment
malfunction or damage.
5.5
Generator Inspection and Test
Inspection and test of the IVL Generator following installation per the steps below is recommended prior to placing the IVL Generator into clinical service. Also confirm that
the inspection and test requirements of your Biomedical Department have been satisfied prior to placing this equipment into clinical service.
Step
Picture or additional info if
applicable
Step 1 – 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 IVL 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.
Step 2 – Confirm Battery Charging
The Charger Module must be connected to AC Mains and to the IVL Generator CHARGER CONNECTOR per Sections 5.2 - 5.3.
Confirm the BATTERY CHARGING indicator is displayed.
Step 3 – Turn the IVL Generator On
Momentarily depress the POWER ON/OFF button. The POWER STATUS and THERAPY STATUS indicators will turn on briefly as a test. The
indicators will come on green and then yellow during this test. The POWER STATUS indicator will remain green if no internal fault is
detected. The THERAPY STATUS indicator will turn off.
IVL Generator
IV Pole Mounting Bracket
Charger Module
IV Pole