Low Alarms - HeartWare Ventricular Assist System Instructions For Use Manual

Suction
The ventricular suction detection alarm is triggered if the suction algorithm has identified a ventricular suction condition. This may self-clear if the suction is transient.
Controller Fault
The controller contains two microprocessors - one which controls pump function (PMC) and a second which controls user interface functions (UIC) such as Controller Display and buttons.
The controller fault alarm indicates a possible controller malfunction may have occurred, but during this fault the UIC processor still receives a heartbeat message from the PMC indicating
the PMC is still functioning and controlling the pump. The controller fault alarm will result in the word "Call" in the controller display, notifying the patient to call the Clinician. The Clinician
should query the patient about the frequency and duration of alarm as well as any additional alarms and changes in pump flow, speed or power. The patient should also be asked about
any clinical symptoms/changes including dizziness, shortness of breath, angina and/or palpitations. Based on the patient's responses, the following course of action should be taken:
If there was a single, isolated controller fault alarm with no change in pump or clinical parameters, instruct the patient to report any additional alarms that may occur. Download
◗ ◗
the controller log files at the patient's next clinic visit and send to HeartWare for analysis.
Instruct the patient to return to the center as soon as reasonable (not emergently) so the controller log file can be downloaded and sent to HeartWare for analysis if one of the
◗ ◗
following situations occurs:
If a controller fault alarm has occurred and been resolved multiple times over a 24-hour period, or
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If a controller fault alarm has occurred in conjunction with other alarms even though it has not affected pump flow, power or speed and there are no concurrent clinical
◗ ◗
symptoms.
The decision to change the controller or what other action is needed will be based on the log file analysis and the patient's clinical condition.
The patient should be instructed to change the controller and return to the implanting center as soon as is reasonable (within 12-16 hours) if one of the following occurs:
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The controller fault alarm is occurring frequently (more than 1 time per hour), with increasing frequency,
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If the controller fault alarm has occurred and not resolved,
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If the controller fault alarm has occurred in conjunction with other alarms, and is associated with a change in pump flow, speed or power or any adverse clinical symptom such
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as lightheadedness or shortness of breath.
Download the log files from the original controller and the current controller and send them to HeartWare for analysis.
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When a medium alarm resolves, there is no audible alarm or light displayed in the Alarm Indicator located on the controller. However, the message on the Controller Display will
remain until the message is cleared by pressing the Scroll Button. A new alarm will also clear a resolved medium alarm from the controller display. For instructions on how to
silence (mute) an alarm, see Section 13.5.
The Controller Display and Alarm Indicator will continue to display all active alarms. Any new alarm condition will inactivate the 60-minute mute. The controller fault alarm audio can be
permanently silenced but this cannot be done by the patient (requires the monitor, Section 8.6.3 "Alarm Settings Tab").

13.3 Low Alarms

A low alarm is indicated by a solid YELLOW Alarm Indicator. The message indicates whether to replace a low battery or reconnect a power source (battery, AC adapter or DC adapter).
The alarm gets louder after 5 minutes and even louder after 10 minutes, if the alarm is not muted.
Message on Controller Message on Controller
(line 1)
Low Battery 1 Replace Battery 1
Low Battery 2 Replace Battery 2
Power Disconnect Reconnect Power 1
Power Disconnect Reconnect Power 2
The following are Low-Priority Alarms:
Low Battery
This alarm is triggered if any batteries have a remaining capacity between 10% and 25%.
Power Disconnect
This alarm is triggered if a power source to the controller is disconnected or defective. The power supply should be replaced immediately because the patient will be without a
backup power source.
WARNING: Disconnecting both power sources (batteries and AC or DC adapter) at the same time will stop the pump. At least one power source must be connected at all times.
Meaning
(line 2)
Battery 1 is low
Battery 2 is low
Power source 1 is disconnected or defective
Power source 2 is disconnected or defective
Ventricular Assist System
Low Alarms
Alarm Indicator
YELLOW
Alarm Sound
Alarm gets louder after 5 minutes and even
louder after 10 minutes, if alarm not muted.
Able to mute alarm for 5 minutes. Press Alarm
Mute Button.
Instructions For Use
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