Speed/Control Tab; Setup Tab; Patient Tab; Downloading Controller Log Files - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare

8.6.1 Speed/Control Tab

Upon entering the System Screen, waveforms are available for displaying real-time flow (L/min) or real-time power (Watts).
The preferred waveform is selected by pressing the Flow or Power tab (Figure 28).
The Speed/Control tab is used to adjust RPM and to turn the VAD on or off. The Set RPM button is used to adjust the pump
speed (RPM) from 1800 to 4000, and the VAD button is used to turn the pump on and off. When the Set RPM button is
pressed, a dialog box will appear with an up arrow and a down arrow. Pressing the up or down arrow will change the pump
speed in increments of 20 RPM.
nOTE: Recommended minimum pump speed during patient support is 2400 RPM.
Confirm the speed adjustment by pressing the change button. The HVAD
to the running state of the HVAD Pump:
®
VAD: ON means the HVAD Pump is pumping; the button is RED and labeled STOP. To stop VAD, press STOP.
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VAD: OFF means the HVAD ® Pump is NOT pumping; the button is BLUE and labeled START. To start VAD, press START
◗ ◗
(Figure 29).
A dialogue box will appear prompting the user to confirm each action.
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8.6.2 Setup Tab

When the Setup tab is pressed, four tabs are displayed and include: Patient, VAD, Controller and Monitor (Figure 30). The
function of each is described below.

8.6.2.1 Patient Tab

The Patient tab is used to enter Patient ID, Implant Date and Hematocrit. Press the Patient ID to enter patient identification.
The patient ID is entered by using the keypad (Figure 31). The A to Z and 0 to 9 tabs allow entry of numbers or letters.
nOTE: Patient ID must be entered for patient's alarms to be displayed in the monitor's alarm log.
Press the Implant Date button and enter the HVAD
entry or the Cancel button to cancel entry (Figure 32).
The hematocrit can be changed using the Hematocrit (%) button. This method allows the clinician to manually input the
patient's hematocrit using a measurement obtained from a blood sample. The default hematocrit value is 30%.

8.6.2.1.1 Downloading Controller Log Files

All logs are maintained in the controller in non-volatile flash memory. The Log Files button allows the clinician to obtain
alarm and trend data from the controller and to transfer it from the patient's controller to a USB flash drive.
The process for downloading log files from the controller is as follows:
Using the monitor data cable, connect the blue data port on the controller to the monitor.
◗ ◗
Check that the data download icon in the lower left hand corner of the monitor is flashing grey. The data download
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icon will become black when the download is complete. It may take up 10 minutes for all the data to transfer from
the controller to the monitor.
Press the Pump Icon to access the System Screen and enter the password.
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Press Setup tab.
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Press Patient tab.
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Wait until the data download icon stops flashing and turns black then disconnect the monitor data cable from the
◗ ◗
controller.
nOTE: DO NOT disconnect the controller from the monitor when the data transfer icon is flashing, as data
is being transferred. If the message, "Log Transfer Not Complete!" appears, re-connect the monitor and
controller to complete the data transfer.
5 seconds after disconnecting the data cable, the Log Files button will appear. Press this button and a list of the
◗ ◗
patient logs will be displayed.
Place a HeartWare ® Monitor compatible USB memory stick into the USB port on the left side of the monitor.
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Select the logs to be saved. Press the Save to USB button.
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A confirmation screen will appear to affirm selection. If correct, press YES button.
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A download complete message will appear when data download is complete. Press OK.
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Remove the USB stick and email the three files: data, alarm and events (3 separate files) to
◗ ◗
hvadlogsintl@heartware.com.
nOTE: The maximum storage for each controller is 3000 entries, which equates to approximately 31 patient
days. A USB flash drive can be used intermittently to download data.
I
10 HeartWare Ventricular Assist System
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® Pump button is colored and labeled according
Pump implant date using the keypad. Use the Enter button to confirm
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Figure 28: System screen
Figure 29: System Screen – VAD start
Figure 30: Setup patient tab
Figure 31: Patient ID
dialog box
Figure 32: Implant Date screen