Vad Tab; Controller Tab - HeartWare Ventricular Assist System Instructions For Use Manual

Figure 33: Setup: VAD tab
Figure 35: Lavare Cycle
Figure 34: VAD ID dialog
box
Figure 36: Dialog box for pump speed changes
Figure 37: Controller tab ("Set Defaults" does not
appear on monitor REF 1521)
Figure 38: Controller Language Selection

8.6.2.2 VAD Tab

The VAD tab (Figure 33) is used to enable or disable the Lavare Cycle and Suction Response and to enter the HVAD
number. "Fixed" mode (manual entry of pump speed) is the only mode currently available, therefore this button is disabled.
Press the VAD ID button to enter the HVAD
ID button, a dialog box is displayed (Figure 34) and the serial number is entered by using the keypad to enter letters
and numbers. The first two letters of the VAD ID are fixed with the letters "HW". After the information is entered, press
the change button. If an incorrect number is entered press cancel and start again.
The "Lavare Cycle", when enabled, periodically slows and increases the RPM for a short period and returns the RPM
to baseline. This algorithm is designed to provide a brief fluid pulse approximately once per minute through the VAD.
See Section 7.3.3 "Lavare Cycle" for more information.
To turn the Lavare Cycle on, press the "Lavare Cycle" button. A dialog box displays, "Turn Lavare Cycle ON?" Press
"Yes" (Figure 35).
To turn the Lavare Cycle off, care must be taken not to do so during the cycle or certain alarms may become disabled:
From the VAD tab, observe the speed display
1)
2) Note when the Lavare cycle commences (a decrease in speed of approximately 200 RPM)
3) Wait 15 to 30 seconds and then press the "Lavare Cycle" button. A dialog box displays, "Turn Lavare Cycle OFF?"
Press "Yes" to turn the Lavare Cycle off.
4)
Do not turn the Lavare Cycle off while the cycle is occurring or certain alarms may become disabled.
warning:
Button
To verify that alarms are enabled:
Press the "Alarm Settings" tab
5)
6) Note the current "Low Flow Alarm Limit" setting and then raise the setting to a value 1.0 L/min above the current
reported flow value
Verify that a Low Flow Alarm occurs
7)
8) Return the Low Flow Alarm Limit to the previous setting
The Suction Response button includes two options for suction detection:
Suction Response "Off." This is the default setting.
◗ ◗
Suction Response on with "Alarm." An alarm will sound if a suction event is detected.
◗ ◗
See Section 7.3.2 "Ventricular Suction Detection Alarm" for more information on suction detection.
When the pump speed is changed by accessing the Speed/Control tab, the dialog box reminds users that this will disable
the suction detection alarm (Figure 36).

8.6.2.3 Controller Tab

The Controller tab (Figure 37) allows the user to enter the controller date and time, select the controller language and
activate the 'Disable "VAD Stop" Alarm' feature. Monitor REF 1511 (no longer being placed on the market) also allows the
user to set controller default values.
Press the Controller Date and Controller Time buttons to enter the controller date and time, respectively.
Press the Controller Language button to select the language desired on the controller. After pressing, a pop up screen will
appear as shown in Figure 38.
Ventricular Assist System
Pump serial number from the Implant Kit package. After pressing the VAD
®
Pump serial
®
I
Instructions For Use 11