How To Change The Controller - HeartWare Ventricular Assist System Instructions For Use Manual

The CONTROLLER DISPLAY provides pump information, including impeller speed
(RPM), power (Watts), and blood flow (L/min). When an alarm occurs, the pump
information is replaced by two lines of text that tell you what the alarm is and what to
do. Section 13.0 describes alarms in detail.
The ALARM INDICATOR lights when one or more alarms occur. The Alarm Indicator changes
color depending on the severity of the alarm and always displays the most severe alarm in the
case of multiple alarms. The display for each alarm priority includes:
High Alarm: Flashing Red
◗◗
The ALARM MUTE BUTTON will silence (mute) a low or medium alarm for 5 minutes or until a
new alarm occurs. A high priority alarm can only be silenced by resolving the alarm condition.
The SCROLL BUTTON on the right side of the controller is used to see all active alarms as well
as pump information (RPM, L/min, Watts) on the Controller Display. The Scroll Button will also
clear resolved medium alarms from the Controller Display and will brighten the Controller Display.
Simultaneously pressing and holding the ALARM MUTE BUTTON and the SCROLL BUTTON
for 5 seconds will prevent the "No Power" alarm from sounding when power is removed during
a controller exchange (see Section 9.3 "How to Change the Controller"). Use only on a controller
not connected to a pump.
The AC/DC INDICATOR will be green if the AC adapter or DC adapter is used to power the
controller.
Figure 51: Remove white driveline cover
Figure 52: Connect driveline to New
Controller (align the two red marks)
Figure 53: Replace driveline cover
Controller Display, Buttons, and Indicators
Medium Alarm: Flashing Yellow Low Alarm: Solid Yellow
◗◗ ◗◗

9.3 How to Change the Controller

A backup controller and fully charged batteries must be available at all times for controller failures or malfunctions. The backup controller
should be set with the same pump parameters and patient information as the primary controller.
NOTE: Patients with a fused aortic valve, an aortic valve that has been sewn shut due to aortic valve regurgitation, or patients with very
poor ventricular function should be educated in the importance of having a backup controller readily available at all times including when
changing power sources.
A controller failure or high priority controller malfunction will generate a high priority or RED alarm and the controller display will tell you
if you should "Change Controller."
To change the controller:
1) Have the patient sit or lie down.
2) Place the new controller within easy reach.
Connect backup power sources to the new controller.
3)
Confirm that the power cables are properly locked onto the controller by gently pulling on the cable near the connector.
◗ ◗
A "Power Disconnect" alarm will activate if a second power source is not connected to the new controller within 20 seconds
◗ ◗
of controller power up.
A "VAD Stopped" alarm will activate if the pump driveline is not connected to the new controller within 10 seconds. This
◗ ◗
alarm will resolve once the pump driveline is connected.
Pull back the white driveline cover from original controller's silver connector (Figure 51).
4)
5) Disconnect the driveline from the original controller by pulling the silver connector away from the controller. Do not disconnect
by pulling the driveline cable. A "VAD Stopped" alarm may activate.
Connect the driveline to the new controller (align the two red marks and push together) (Figure 52). If the "VAD Stopped" alarm was active
6)
on the new controller, it will now resolve.
The pump should restart. The RPM, L/min, and Watts numbers should show on the controller display.
◗ ◗
7) To prevent the controller alarm from sounding after the power is removed, follow these instructions:
If a red alarm adapter is available, insert it
◗ ◗
into the blue connector on the original controller.
Disconnect both power sources from the original controller. The controller will be turned off and all alarms silenced.
8)
Slide the white driveline cover up to cover new controller's silver connector (Figure 53).
9)
Contact HeartWare to obtain a new backup controller.
10)
Keep a spare controller and spare fully charged batteries available at all times in case of an emergency.
◗ ◗
Ventricular Assist System
If no alarm adapter is available:
◗ ◗
Press and hold the Alarm Mute and Scroll Buttons on
◗ ◗
the original controller until a "beep" is heard, or for at
least 5 seconds.
Release the Alarm Mute and Scroll buttons.
◗ ◗
WARNING
The two BATTERY INDICATORS located on the top of
the controller are labeled "1" and "2." Either the "1" or
"2" will be lit, depending upon which port is providing
primary power. If an AC or DC adapter is connected,
this will be the primary power source.
Battery capacity is displayed on the Battery Indicators
as follows:
75-100% battery capacity: 4 GREEN lights
◗ ◗
50-74% battery capacity: 3 GREEN lights
◗ ◗
25-49% battery capacity: 2 YELLOW lights
◗ ◗
<24% battery capacity: 1 RED light
◗ ◗
When the controller is attached to 2 batteries, it will
switch power sources when the primary battery reaches
25% capacity, provided the secondary battery has >30%
capacity.
NOTE: If the AC adapter or DC adapter is connected to
the controller, the corresponding Battery Indicator will
not display lights but the corresponding "1" or "2" will
be lit.
Instructions For Use
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