Abiomed Impella Manuel D'utilisation page 20

WHITE CONNECTOR CABLE
Length
Service life
SLAVE MONITOR CONNECTION
If equipped with a VGA connector, the Automated Impella Controller can
be connected to a monitor to display information from the controller, at a
resolution of 800 x 600 pixels. The connection between the controller and
the monitor can be made using a cable up to 20 feet in length.
CLEANING
• Clean the Automated Impella Controller keypad and display with
either 70% isopropyl alcohol or soap and water. (NOTE: Be aware
that soft buttons may be activated when you spray or wipe the
display)
• Clean the Automated Impella Controller housing with mild detergent
• Sani-Cloth HB wipes may be used to clean the AIC.
• Do NOT clean with or expose any part of the clear sidearm of the
Impella Catheter (e.g., infusion filter, pressure reservoir) to alcohol.
Alcohol has been shown to cause cracks and leaks in these
components.
Carefully read labels on common skin preps and lotions to avoid
using any alcohol-containing products in the area of the infusion
filter or pressure reservoir.
• Do NOT allow any fluids to enter the connector sockets.
• Clean the connector cable with 70% isopropyl alcohol.
Alcohol Warning
Do NOT clean the Impella Catheter infusion filter or pressure
reservoir with alcohol and AVOID exposing these components to
products containing alcohol.
STORING THE AUTOMATED IMPELLA
CONTROLLER
The Li-Ion batteries must be charged for 5 hours prior to
system operation in order to meet the runtime requirement
of 1 hour. Failure to do so will yield a shorter runtime. After
being unplugged, the Automated Impella Controller will
operate for at least 60 minutes after the batteries have
been fully charged.
Place the AIC on a horizontal surface to prevent falling.
• Connect the AC power cord to an AC outlet.
• The battery may be destroyed if the Automated Impella Controller is
stored with a depleted battery.
• To keep the Automated Impella Controller battery charged, the
controller should be plugged into an AC outlet. When plugged
into an AC outlet, the controller battery will charge whether the
controller is on or off.
Battery Power Note
If the Automated Impella Controller is allowed to discharge completely
and the system shuts down due to low battery, the controller will need to
charge for an extended period of time before it will turn on again.
IMPELLA SYSTEM LIMITED SERVICE WARRANTY
Impella System Limited Service Warranty (Europe)
Please contact your EU representative for warranty information.
20
INSPECTIONS, MAINTENANCE AND REPAIR
2.5 m
The Automated Impella Controller (AIC) is subject to service in accordance
Single use only
with §7 MPBetrV (German regulation). Service includes in particular
maintenance and repair. Maintenance activities include the yearly
inspections and maintenance required to ensure the continued safe and
correct operation of the AIC. The corresponding work may only be carried
out by technicians authorized by Abiomed.
A sticker on the device indicates the date for the next required inspection. This
example shows a sticker indicating that inspection is required in June 2020.
The following inspections are required for the Automated Impella
Controller:
• Inspection of labeling and instructions for use
• Visual inspection of the device and its accessories for any signs of
damage
• Testing for electrical safety as per DIN VDE 751 or DIN EN 60 601
• Leakage current test
• Dielectric strength test
• Functional testing of all switches, keys, rotary knobs, sockets, and
control lights on the device
• Checking battery operation
If defects become apparent during the technical safety inspections that
could endanger patients, employees, or third parties, then the device must
not be operated until the defects have been remedied by proper technical
servicing.
PATIENT ENVIRONMENT
The Automated Impella Controller and the components of the Impella
System are approved for use within the patient environment, as defined in
IEC 60601-1-1 / IEC 60601-1: 3 rd edition, and in the following figure.
CONTROLLER
1.5 m
CONTROLLER
1.5 m
2.5 m
User Manual