Abiomed Impella LD Gebrauchsanweisung Seite 22

Severity Alarm Header
AC Power Disconnected
Audio Off
Impella Position Unknown
Purge Cassette Incompatible
Purge Flow Decreased
Purge Flow Increased
Purge Volume Low
Surgical Mode Enabled
Unexpected Controller Shutdown
20
Action
Controller is running on battery power.
The audio for the following alarm has been
disabled. <Alarm will be listed here>
Impella position unknown due to low pulsatility,
assess cardiac function.
Contact Abiomed Service to update Impella
Controller.
The purge flow has decreased by 2.5 mL/hr or
more.
This is a notification only; no action is required.
The purge flow has increased by 2.5 mL/hr or
more.
This is a notification only; no action is required.
1. Open PURGE SYSTEM menu and select
Change Purge Fluid.
2. Follow the instructions to change the purge
fluid.
Impella pump stopped. Purge system running.
'Impella Stopped' alarm disabled. To exit this
mode, start Impella pump.
Switch to back-up Controller if condition
persists.
SYMBOLS
YYYY-MM-DD
REF 123456
SN 123456
Non Sterile!
Cause
AC power was disconnected.
User has disabled audio for Placement Signal
Not Reliable, Purge Pressure High, Purge
System Blocked, Suction alarm.
Impella Catheter position unknown due to
low pulsatility; or catheter position unknown
detected by algorithm.
Incompatible purge cassette RFID version.
Purge flow has decreased by ≥2.5 mL/hr.
Purge flow has increased by ≥2.5 mL/hr.
There are 30 mL (in addition to 5% of the
starting bag volume) or fewer remaining in
the purge fluid bag.
Surgical Mode has been enabled to silence
'Impella Stopped' alarm at P-0.
Unexpected restart of controller due to
software of hardware failures.
Caution; consult instructions for use
Defibrillator-proof type CF equipment
Keep dry
Storage temperature (eg, 10°C to 30°C)
Declares conformity with Directive 93/42/EEC for medical devices, and
Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
Date of manufacture (eg, YYYY-MM-DD)
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)
The product is not sterile
User Manual