Abiomed Impella 5.5 Manuel Utilisateur page 19

ALARMS OVERVIEW
The Automated Impella Controller monitors various functions to determine
whether specific operational parameters are within expected limits. When a
parameter goes outside of its specified limits, the controller sounds an alarm
tone and displays an alarm message that can be viewed on the display screen
on the front of the controller. The alarm tone indicates the severity of the
alarm. The alarm message on the display screen is color-coded for severity
and provides details on the cause of the alarm and how to resolve the alarm.
For a full list of all Impella alarms, refer to the Automated Impella Controller
Instructions for Use document.
ALARM LEVELS
Alarms are divided into three levels of severity:
• Advisory (white)
• Serious (yellow)
• Critical (red)
Category Description Audible Indicator*
Advisory Notification 1 beep every 5 minutes
Abnormal
situation. 3 beeps every
Serious
Prompt action 15 seconds
needed.
High priority.
10 beeps every
Critical Immediate
6.7 seconds
action needed.
* Sound pressure of audible alarm indicators is >80 dBA
MUTE ALARM FUNCTION
Pressing the MUTE ALARM button on the upper right of the Automated
Impella Controller display screen will silence the audible alarm indicator for
2 minutes (for red or yellow alarms) or 5 minutes (for white advisory alarms).
When an alarm is silenced, the words "MUTE ALARM" next to the button are
replaced by the mute alarm indicator, a crossed-out bell icon.
The audible indicator will shut off if an alarm condition is resolved before
you press MUTE ALARM. The visual message, however, will continue to
be displayed, with the alarm header on a gray background, for 20 minutes
or until you press MUTE ALARM. This allows you to identify the alarm that
occurred.
Impella 5.5 ® with SmartAssist
Visual Indicator
Alarm header on
white background
Alarm header on
yellow background
Alarm header on red
background
® Circulatory Support System
SYMBOLS
2023-11-30
123456
123456
2023-11-30
Glucose
Do Not Flush
Do Not Clean with Alcohol
Caution; follow instructions for use
Defibrillator-proof type CF equipment
Keep dry
Storage temperature
(e.g. 10°C to 25°C)
Declares conformity with Directive
93/42/EEC for medical devices or with
Regulation (EU) 2017/745 on medical
devices, and with Directive 2011/65/EU
on the restriction of the use of certain
hazardous substances in electrical and
electronic equipment
Date of manufacture (eg, 2023-11-30)
Protect from sunlight
Symbol for lot designation; the
manufacturer's lot designation must be
stated after the LOT symbol
Abiomed part number
(eg, part number 123456)
Manufacturer's serial number
(eg, serial number 123456)
Use-by date
(eg, use before 2023-11-30)
Do not reuse
Sterilized using ethylene oxide
Medical Device
Federal (USA) law restricts this device
to sale by or on order of a physician:
Prescription only.
Do not use if package is damaged
Single sterile barrier system with
protective packaging inside
Use glucose in the purge fluid
Do Not Flush with syringe
Do not use alcohol or alcohol-based
products for cleaning.
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