Medium Alarms - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare
The following are High-Priority Alarms:
*No Power (no message): If both power sources are disconnected from the controller, a loud, continuous alarm will sound and there will be NO message on the Controller Display. The
Pump is NOT pumping and power sources should be connected immediately. If this action does not resolve the alarm condition replace the controller.
HVAD ®
VAD Stopped: The HVAD Pump will stop if the driveline is disconnected or if the controller fails. The text message indicates whether to connect the driveline or change the controller.
®
Controller Failed: Indicates a potential controller failure and the controller should be exchanged for a new controller. The HVAD
WARNING: If there is a "Controller Failed" alarm, switch to the backup controller.
Critical Battery: Displayed when there are a few minutes of battery time remaining to power the HVAD
charged battery or use the AC adapter or DC adapter.
If the controller has lost communication with a battery and the other power port is connected to either a battery with a remaining capacity of 25% or greater, or a valid power adapter,
the controller shall generate a Power Disconnect alarm associated with the non-communicating battery. This alarm condition will clear or activate a different alarm if any of the
following conditions occur:
Communication with battery is re-established.
1)
2) The remaining capacity of other battery drops below 25% - in this case a critical battery alarm will be triggered.
When the controller has lost communication with a battery and the other power connector is NOT connected to a valid power supply or is connected to a battery with a remaining capacity
of less than 25% the controller will generate a Critical Battery alarm. This alarm condition will clear when any of the following occur:
Communication with battery is re-established.
1)
2) The non-communicating battery is disconnected.
3) The other power source is switched to a valid power adapter or to a battery having a remaining capacity of 25% or greater.

13.2 Medium Alarms

A medium alarm starts at a low volume and gets louder over the next minute, unless the Alarm Mute button is pressed. Pressing the Alarm Mute button will silence medium and low level
alarms for 5 minutes or until an additional alarm occurs. If the Alarm Mute button is not pressed, after 5 minutes the alarm volume is elevated to the level used in high alarms. A medium
alarm is indicated by a flashing YELLOW Alarm Indicator, and the text message tells the patient to call medical personnel for instructions to resolve the alarm condition.
Message on Controller Message on Controller
(line 1)
High Watts Call
Electrical Fault
Low Flow
Suction
Controller Fault Call
Controller Fault Call ALARMS OFF
The following are Medium-Priority Alarms:
High Watts
This alarm warns of a high power condition in running the HVAD
Tab"). This could be an indication of thrombus forming within the pump.
Electrical Fault
A fault in the continuity of the pump to controller electrical connection triggers this alarm. The fault could be in the HVAD
The audio portion of this alarm can be permanently disabled via the monitor (see Section 8.6.3 "Alarm Settings Tab"). When this alarm condition occurs, the HVAD
on a single stator and will consume slightly more power.
Low Flow
The low flow alarm is triggered if average flow drops below the Low Flow Alarm threshold (see Section 8.6.3 "Alarm Settings Tab").
I
20 HeartWare Ventricular Assist System
®
(line 2)
A change in the status of the HeartWare
detected
Controller malfunction
Controller malfunction
◗ ◗
Suction detection, low flow alarms disabled
◗ ◗
High power and VAD disconnected alarms may be
◗ ◗
disabled
® Pump. The alarm is triggered when the Watts exceed the High Power Alarm threshold (see Section 8.6.3 "Alarm Settings
® Pump or the battery has malfunctioned. Replace battery 1 or 2 with a fully
Medium Alarms
Meaning Alarm Indicator
® System is Flashing YELLOW
Pump may not be pumping.
®
Alarm Sound
Gradual increase in volume over
◗ ◗
the first minute if alarm not muted
Alarm gets louder after 5 minutes
◗ ◗
if alarm not muted
Able to mute alarm for 5 minutes
◗ ◗
or 1 hour
Electrical Fault (audio) can be
◗ ◗
permanently disabled
Controller Fault (audio) can be
◗ ◗
permanently disabled
Pump motor, driveline and connector or within the controller.
®
Pump will be running
®