Environment Conditioning; Generator Inspection And Test - Shockwave Medical 825D Manuel D'utilisation

5.4 Environment Conditioning

The Generator is designed to be used indoors in a controlled environment. Refer to Appendix C for specified
operating conditions.
Allow the 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 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 Generator or its accessories. Such condensation could result in a possible malfunction
or equipment damage if operated.
WARNING
USE ENVIRONMENT
Allow the Generator and its accessories (including Lithoplasty Catheters and 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 Generator following installation per the steps below is recommended prior to
placing the 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
Step 1 – Physical Condition Inspection
Inspect all surfaces of the 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 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 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 Generator
CHARGER CONNECTOR per Sections 5.2 - 5.3.
Confirm the BATTERY CHARGING indicator is displayed.
Step 3 – Turn the 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.
Step 4 – Confirm Battery Capacity
If the battery has been charging for at least twelve hours, as indicated in
Section 5.3, the battery capacity shown in the BATTERY CAPACITY display
should be full as shown.
LBL 60780 rev. B
Picture or additional info if applicable
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