External Accessories; Patient Pack; Heartware Shower Bag; Recommended Equipment For Use At Home - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare
Understand the meaning of alarms and demonstrate appropriate responses to alarm conditions
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Successfully switch from one controller to another controller
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Understand the importance of not pulling, twisting or kinking the driveline or power cables, especially while sitting, getting out of bed, adjusting controller or power sources,
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or when using the shower bag.
Patients should be educated in the importance of having a backup controller readily available at all times including when changing power sources. Clinicians should emphasize this
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education in patients who may be at risk of catastrophic cardiovascular collapse if a pump shutdown occurrs. Patients at risk include those with a fused aortic valve, an aortic valve
that has been sewn shut due to aortic valve regurgitation, or patients with very poor ventricular function.
Following hospital discharge, the patient's understanding of the HeartWare
include reinforcement of the procedure for switching to a backup controller in the case of an emergency.

16.11 External Accessories

16.11.1 Patient Pack

The patient pack is used to safely secure, store and carry the controller and batteries. It can be used in or out of the hospital, when resting, sleeping or ambulating. One controller
and two batteries fit into the patient pack.
16.11.2 HeartWare Shower Bag
®
A shower bag is available for use in conjunction with the HeartWare
on shower bag operation prior to use.
Patients may shower when they have received permission from their clinician to do so. Patients who shower must use the HeartWare
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The controller should be connected to two batteries during showers; it should never be plugged into an AC wall outlet.
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DO NOT kink or twist the driveline or the power cables.
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DO NOT allow water or other fluids to enter the controller, power adapters, batteries, battery charger or connectors. If this happens, contact HeartWare.
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DO NOT submerge HeartWare
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DO NOT allow patients to take a bath or swim.
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Hearing-impaired patients should not shower unless their caregiver is close by to hear alarms.
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16.12 Recommended Equipment for Use at Home

The minimum recommended amount of HeartWare-supplied equipment needed for use
at home after discharge from the hospital is:
2 Controllers with AC power adapters
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1 Battery charger with battery charger AC power adapter
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4 Batteries
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1 Patient Pack
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1 Driveline cover
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1 DC adapter
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2 Alarm adapters
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1 Shower bag
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NOTE: The monitor is not recommended for use at home.
Device recipients should avoid areas with high magnetic forces such as theft detection devices or airport security systems.
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Keep cell phones a minimum of 0.5 meters (20 inches) away from the controller.
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16.13 Electrostatic Discharge (ESD)

Static electricity is widely present and more so in certain conditions such as in drier environments and in the vicinity of certain materials and fabrics such as silk clothing and carpeting.
Discharge of static electricity, commonly referred to as electrostatic discharge (ESD), may interfere with electronic equipment. The HeartWare® Controller, as a piece of electronic
equipment, is susceptible to ESD.
The controller may alarm in certain situations as a result of ESD. These alarms include a "Controller Failed" or a high priority audible alarm without accompanying alarm text on the
controller screen. If either of these alarms occurs, the controller should be switched to the backup controller.
In the event of a "Controller Fault" alarm, it should be treated as directed in the IFU ("Medium Alarms, Controller Fault" section), since there are a number of potential causes for this
alarm. In the case of a "Controller Fault" alarm and the alarm will not clear, a controller exchange should be performed.
Be aware of Electrostatic Discharge (ESD) and its potential to cause disruptive and possibly fatal faults in susceptible patients.
Avoid devices and conditions that may induce strong static discharges (e.g., television or computer monitor screens) as electrostatic discharges can damage the electrical
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parts of the system and cause the LVAD to perform improperly or stop.
Always have a backup controller handy when changing power sources. Be watchful for unusual changes in power or flow alarms for a period of time following equipment
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changes.
I
30 HeartWare Ventricular Assist System
®
® System's operation and alarms should be re-evaluated during routine follow-up visits. This training should
System. To ensure safe and appropriate use of the shower bag, all patients and caregivers should be trained
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System components in water or other fluid.
®
WARNING
Whenever patients with the HVAD
excursion they must always have the following equipment with them:
2 Controllers
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4 Charged batteries
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1 Patient Pack
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1 Shower bag
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1 AC power adapter
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1 Driveline cover
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Emergency contact information
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WARNING
WARNING
Shower Bag.
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Pump leave the hospital or their house on an
®