Heartware ® Ventricular Assist System Setup - HeartWare Ventricular Assist System Instructions For Use Manual

14.1 HeartWare ® Ventricular Assist System Setup
Battery Charger
1) Connect the battery charger AC adapter to the battery charger and then plug its power cord into an electrical outlet. Verify the power indicator is lit next to "HeartWare."
Verify availability of four fully charged batteries. If batteries are not fully charged, start charging depleted batteries at least 4 hours before the HVAD
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Monitor
Connect the monitor AC adapter to the monitor and then plug its power cord into an electrical outlet.
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2) Turn the monitor on. The monitor program will appear in a few minutes.
3) Connect the monitor data cable to the serial port on the monitor and to the blue connector on the controller.
Press the HVAD Pump Icon to access the System Screen and enter the password (see Section 8.6 "System Screen" for more detail).
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5) Press Setup tab to display Patient, VAD, Controller and Monitor tabs (see Section 8.6.2 "Setup Tab").
Press the Monitor tab and enter monitor date and time.
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7) The monitor battery should be charged a minimum of 4 hours before starting the implant procedure.
Backup Controller
Press the Controller tab on the Setup Screen, and then press the 'Disable "VAD Stop" Alarm' button.
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2) Connect the monitor data cable to the blue data port on the controller.
Plug the AC adapter into an electrical outlet.
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Connect the controller to the AC Adapter.
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5) Connect a fully charged battery to the controller.
NOTE: Once powered, the controller performs a self-test and will display a temporary message regarding the status of the self-test. If the controller fails the self-test, a controller
fault alarm message will appear. In that case replace the controller with the second controller.
6) Press Speed/Control tab and reduce the set speed to 1800 RPM.
Press Setup tab to display Patient, VAD, Controller and Monitor tabs (see Section 8.6.2 "Setup Tab").
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8) Press the Patient tab and enter the Patient ID and Implant Date.
9) Ensure the Hematocrit setting is 30%.
Press VAD tab and enter HVAD Pump serial number and verify that Lavare Cycle and Suction Response are "Off".
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11) Press Controller tab and enter controller date and time.
Press the Alarm Settings tab to set the Low Flow Alarm limit and High Power Alarm limits. Default settings are 1 L/min for low flow and 16 watts for high power.
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Remove data cable.
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14) 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 controller.
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If no alarm adapter is available: Press and hold the Alarm Mute and Scroll Buttons on the controller until a "beep" is heard, or for at least 5 seconds.
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15) Disconnect both power sources from controller.
Set the backup controller aside for use during the Pre-Implant Test.
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NOTE: A backup controller should always be available and programmed identical to the primary controller.
Programming Initial Settings for the Primary Controller
Press the Controller tab on the Monitor Setup Screen, and then press the 'Disable "VAD Stop" Alarm' button.
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2) Connect the monitor data cable to the blue data port on the controller.
Plug the AC adapter into an electrical outlet.
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Connect the primary Controller to the AC Adapter.
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5) Connect a fully charged battery to the controller.
Press Speed/Control tab and reduce the set speed to 1800 RPM.
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Press Setup tab to display Patient, VAD, Controller and Monitor tabs (see Section 8.6.2 "Setup Tab").
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8) Press the Patient tab and enter the patient's ID and Implant Date.
Ensure the Hematocrit setting is 30%.
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10) Press VAD tab and enter HVAD ® Pump serial number and verify that Lavare Cycle and Suction Response are "Off".
11) Press Controller tab and enter controller date and time.
Press the Alarm Settings tab to set the Low Flow Alarm limit and High Power Alarm limits. Default settings are 1 L/min for low flow and 16 watts for high power.
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13) Press the Logout button and return to the Clinical (Home) Screen.
After setting up the primary controller, keep both power supplies connected to the controller so that the pump does not stop, then restart automatically when power is restored. During
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implant the HVAD should be started only by pushing the password protected "Start" button.
15) Place the controller in the Patient Pack (carry bag) and position the bag close to the head of the OR table so the driveline can be connected to the controller after tunneling.
WARNING: In order to minimize the risk of air embolus during implant, keep both power supplies connected to the controller after setting up the primary controller.
Disconnecting and then reconnecting both power supplies will result in the controller starting the pump as soon as the driveline is connected.
NOTE: Any changes to the primary controller should also be made to the backup controller.
Ventricular Assist System
Pump implant procedure.
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Instructions For Use 23