Multiple Alarms; How To Silence (Mute) Alarms; Status Message Display; Surgical Implant Procedure - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare

13.4 Multiple Alarms

It is possible to have concurrent alarm conditions. For multiple alarms, the Alarm Indicator "
alarm. An arrow is displayed on the right side of the alarm for multiple alarms (Figure 65). Use the Scroll Button to see all active alarms.
Alarm Indicator and Alarm Sound for Multiple Alarms
Multiple Alarm Condition
More than 2 High Alarms Flashing RED
High and Medium Alarms Flashing RED
High and Low Alarms Flashing RED
More than 2 Medium Alarms Flashing YELLOW
Medium and Low Alarms Flashing YELLOW
More than 2 Low Alarms YELLOW
nOTE: If an arrow is displayed on the right side of the alarm message, there are multiple active alarms. Use the
Scroll Button to see all alarm conditions. Press the Scroll Button to advance to the next alarm or to the pump
parameters (flow, speed and power). If the Scroll Button is not touched for 1 minute the controller automatically
displays the most severe alarm on the controller display. If a new alarm occurs, the controller display will show the
new alarm.

13.5 How to Silence (Mute) Alarms

High alarms CANNOT be silenced. However, medium and low alarms may be silenced for 5 minutes by pressing the Alarm Mute Button. Clinicians can also mute medium alarms for one
hour by pressing and holding the Alarm Mute Button, then pressing and holding the Scroll Button, followed by releasing the Alarm Mute Button, and finally releasing the Scroll Button.
The alarm will sound again if a new alarm condition occurs during the mute interval. The medium priority "Electrical Fault" alarm and "Controller Fault" alarm can be permanently
disabled by accessing the Alarm Settings in the monitor's System Screen (see Section 8.6.3 "Alarm Settings Tab").
WARNING: Silencing an alarm does not resolve the alarm condition. ALWAYS investigate, and if possible, correct
the cause of any alarm.

13.6 Status Message Display

The monitor may display a status message where alarms are typically displayed. The following are potential status messages:
Message
VAD Off Driveline connected to controller and HVAD
Data @ Limit Patient data cannot be stored due to maximum number of patients or lack of storage space
NOTE: The monitor will overwrite files at its data limit, which is based on the amount of hard disk space used. The
USB flash drive can be used to transfer log files.

14.0 SURGICAL IMPLANT PROCEDURE

nOTE: In order to optimize patient outcomes HeartWare suggests that the following techniques be considered at the time of HVAD
TEE
◗ ◗
—
Inspect LA and LV for thrombus - thoroughly remove any thrombus present.
— Check for PFO - PFO should be surgically repaired prior to HVAD
Coring
◗ ◗
— After coring, make sure margins of the core are clean and smooth.
— Perform visual inspection of cored area and remove any loose tissue and/or clots.
De-Airing
◗ ◗
— After placement of HVAD Pump in the LV, passively fill the LV and pump.
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— Elevate the apex of the heart and shake gently to remove any entrapped air in the heart/HVAD
—
Clamp the distal outflow graft. After anastomosis of the outflow graft to the ascending aorta, complete the de-airing process using standard technique.
Pump Speed (RPM)
◗ ◗
— Prior to starting the HVAD Pump, the LV should be full. The pump must always start at 1800 RPM.
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—
Speed should be increased by no more than 100 RPM at a time.
— Increase the HVAD Pump speed slowly to avoid suction events. Suction events can lead to the ingestion of tissue/clot from inside the LV, and may also lead to
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episodes of ectopy.
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22 HeartWare Ventricular Assist System
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Alarm Indicator
Loud, continuous, unable to mute
Loud, continuous, unable to mute
Loud, continuous, unable to mute
Gradual increase in volume if alarm NOT muted
Gradual increase in volume if alarm NOT muted
Gradual increase in volume if alarm NOT muted
Potential Causes
Pump manually stopped
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Pump implant.
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" will display the color of the most severe alarm and the alarm will sound the most severe
Alarm Sound
Pump.
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Figure 65: Arrow on right side of the alarm on
controller display indicates two or more alarms. Use
scroll button to see all alarms.
Pump implant:
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