CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

HeartWare® System TrainingWritten Exam for Clinical Staff

1. Match the word on the right with the correct function:

a) This icon, located at the front of the controller, lights up when one or more alarms occurs.

____ AC Adapter

b) This button silences the low and medium audible alarms.

____ Alarm Indicator

c) This adapter/cable transfers power from an electric outlet to run the controller. ____ Alarm Mute Button

2. Label the cable connections to the controller:

a. Power Sourceb. Power Source

c. Driveline Connectord. Monitor Cable (Data)/ Alarm

Adapter Port

Page 1 of 6Rev02 9/12

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

HeartWare® System TrainingWritten Exam for Clinical Staff

Choose True or False3. The flashing red visual alarm on the

controller requires immediate attention. True False

4. It is ok to have moisture, cracks, tears or punctures in the driveline. True False

5. It is safe for a patient to take a tub bath or swim. True False

6. This button is used to see all active alarms and pump information on the controller display.

True False

7. The driveline cover must cover the controllers silver driveline connector to protect the controller from water. True False

8. A controller with a blank display and no audible alarm should be replaced. True False

9. The controller needs to be disconnected from driveline before defibrillating.

True False

10. The patient may not have a palpable pulse once they have been implanted with the HVAD® pump.

True False

11. The controller AC/DC indicator will be green if you are using the AC Adapter or DC Adapter (car adapter) to power the controller.

True False

12. The HeartWare® Monitor has an internal battery that can be used to power the monitor while transporting a patient.

True False

13. HVAD pump flow is preload dependent and afterload sensitive True False

Page 2 of 6Rev02 9/12

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

HeartWare® System TrainingWritten Exam for Clinical Staff

14. List 2 items the patient should take when he/she leaves the house:

_________________________________Answer: Charged Batteries, back up controller, emergency contact sheet, cell phone

15. How long does 1 fully charged battery usually provide power? ____________________________________________Answer: 4-6 hours

16. Why do LVAD patients take anticoagulation medicine?

_________________________________Answer: To reduce the risk of clots in blood and pump

17. When looking at the controller, how much power is remaining in a battery if there are:

4 green lights ______ % Answer: 75-100%

3 green lights ______ % Answer: 50-74%

2 yellow lights ______ % Answer: 25-49%

1 red light ______ % Answer: < 24%

18. Place a check beside activities that will cause the HVAD pump to stop:

___ Disconnecting the AC adapter while only one fully charged battery remains connected to the controller.

__ Disconnecting both batteries at the same time.

__ Disconnecting the driveline from the controller.

__ Unplugging the DC adapter without a back-up battery connected to the controller.

19. Two power sources should be connected to the controller at all times. What are the 3 different power options?

Battery and ____________________ Answer: BatteryBattery and ____________________ Answer: AC AdapterBattery and ____________________ Answer: DC Adapter

Page 3 of 6Rev02 9/12

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

HeartWare® System TrainingWritten Exam for Clinical Staff

20. Place a check beside activities that are not allowed while on the HVAD pump:

___ Chest x-ray

__ MRI Scan

___ CT Scan

___ Cardiac catheterization

__ Swimming

___ Walking

21. What is the recommended speed range for operation of the HVAD pump? ___________________________ RPMAnswer: 2400 to 3200

22. The ideal flow pulsatility, which is the difference between minimum and maximum of the flow waveform, should be how many L/min?___________________________L/minAnswer: 2-4 L/min

23. Please put the steps below in the correct order (1-9) to demonstrate the sequence for changing the controller:

4Pull back the white driveline cover from the original controller’s silver connector.

1 Have the patient sit or lie down.

5Disconnect the driveline from the original controller (this will stop the pump).

7Insert the red alarm adapter into the blue connector on the original controller.

2 Place the new controller within easy reach.

3 Connect back-up power sources to the new controller.

9 Slide the white driveline cover up to cover new controllers silver connector

6 Connect the driveline to the new controller (this will restart the pump)

8 Disconnect both power sources from the original controller.

Page 4 of 6Rev02 9/12

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

HeartWare® System TrainingWritten Exam for Clinical Staff

24. Put the following actions in the correct order to switch from battery operation to tethered AC power.

_3__ Connect AC power by lining up the solid white arrow on the cable connector with the white dot on the controller

_4__ Confirm that the power cable is properly locked to the controller by gently pulling on the cable near the connector

_1__ Plug the AC adapter into a grounded outlet_2__ Disconnect the battery with the least remaining charge

25. The battery charger has several status light indicators. Which status light will you see if the battery is charging but is not yet ready for use?

___ Blue___ Flashing Red___ Yellow___ No lights

26. What is the procedure to clear an old, inactive medium priority alarm? ___ Hold down the alarm mute button for 5 seconds to clear the alarm___ No action is needed, alarm clears itself___ Change out the controller___ Press the scroll to clear the alarm from the controller.

27. Match the battery charger light to the correct battery status:

No lights Battery ready.

Green Battery too cold or too hot, waiting to charge.

Yellow Battery resting after charge. Wait for green ready light.

Flashing Yellow Defective battery. Do not use.

Red Battery not charging. Check connections or switch battery to another slot. If persists do

not use.

Page 5 of 6Rev02 9/12

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

HeartWare® System TrainingWritten Exam for Clinical Staff

Flashing Red Battery being charged, not ready for use.

28. Which waveform represents a suction event?

________

_______

______

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