Hvad ® Pump Pre-Implant Test - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare
14.2 HVAD ® Pump Pre-implant Test
Examine the HVAD Pump implant kit package and other component packaging. They must be unopened and without
1) ®
any visible damage including abrasion, delamination or punctures.
WARNING: Sterile components are intended for single use only. DO NOT use if package is damaged or opened.
DO NOT re-sterilize or re-use.
2) Set up a sterile back table to prepare and test the HVAD
Open the driveline extension cable first. Pass it onto the sterile field, wipe it off with a damp sponge and set on sterile
3)
back table. Dispose of sponge and change gloves.
NOTE: The driveline extension cable should only be used during the pre-implant test. It should not be connected
when the VAD is running.
Grasp the Tyvek lid of the HVAD
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contaminate the inner sterile tray.
5) Pass the HVAD ® Pump tray and other components aseptically onto the sterile field. Examine all components, including
the surgical tools, for damage, corrosion or any abnormalities that might affect the safety or functionality of the tools. If
any abnormalities are noted please use the appropriate backup supplies.
6) Cover the HVAD ® Pump with a sterile towel. With the driveline extended on the back table, remove the Tyvek sleeve
(peel off by hand) covering the polyester covered portion of the driveline (see Figure 66). Wipe the driveline with a lap
sponge moistened with antibiotic irrigation and discard the sponge.
7) On the sterile field, fill a basin with 2 liters of 5% dextrose.
Attach the sterile driveline extension cable to the HVAD
8)
"Controller") to the non-sterile assistant.
WARNING:
An audible click should be heard when connecting the driveline to the controller or driveline
extension. Failure to ensure a secure connection may cause an electrical fault.
Clamp the sterile portion of the extension cable to the sterile field on the table to prevent cable movement.
9)
10) The non-sterile assistant should have the backup controller and a charged battery ready for use. Completely submerge
the HVAD Pump in the dextrose solution. Fill the pump with dextrose and gently rotate it with the inflow cannula facing
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up in the dextrose to allow any trapped air to escape.
11) At least 4 inches (10.2cm) of dextrose solution must be above the VAD inflow and outflow conduits.
When the HVAD Pump is completely submerged in the sterile basin and is de-aired, point the inflow cannula towards
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the wall of the basin and position your hand over the VAD outflow.
13) The non-sterile assistant should connect the driveline extension cable to the silver connection of the backup controller
and then connect the battery to the controller. Ensure that the driveline cover on the driveline extension cable is pushed
fully forward to cover the exposed metal driveline connector and the mating connector on the controller.
14) The pump will start at 1800 RPM.
WARNING: During the Pre-Implant Test and prior to implantation: The HVAD
submerged in fluid before being turned on. Never turn on the HVAD
that was turned on without total submersion in fluid.
NOTE: During the HVAD
® Pump Pre-Implant Test, a low priority alarm will sound since one of the controller power
ports is empty.
15) Run the pump for 30-60 seconds. If, at any time during this test, the power exceeds 3 Watts, do not use the
pump - set it aside and repeat this process using the backup HVAD
16) After the test is complete, disable the "no power" alarm. If a red alarm adapter is available, insert it into the blue
connector on the backup controller. If no alarm adapter is available, press and hold the Alarm Mute and Scroll Buttons
until a "beep" is heard, or for at least 5 seconds. Remove the battery from the controller. This will power down the
controller and will stop the pump.
Wearing clean, dry, gloves, disconnect the driveline extension cable from the controller and the pump.
17)
Connect the driveline cap to the driveline by pushing both connectors together until you feel a "click" (Figure 67).
18)
Protect the connector from exposure to fluids.
Cover the inflow cannula of the HVAD
19)
I
24 HeartWare Ventricular Assist System
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® Pump.
Pump implant kit package at the point indicated and peel back, taking care not to
Pump and pass the distal portion of the cable (labeled
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Pump in air. DO NOT use an HVAD
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Pump with the yellow inflow cap.
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Pump must be completely
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Pump
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Pump.
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Figure 66: Tyvek sleeve covering polyester on driveline
Figure 67: Driveline cap connection