Patient and Caregiver Education and Skills Checklist Patient Initials Caregiver Initials Educator Initials Comments Received HVAD® System Patient Manual Reviewed life style recommendations, including travel procedures, emergency preparedness, activity limitations, etc. Reviewed what constitutes an emergency and emergency directions, including who and when to call HANDS-ON SKILLS CHECKLIST Review and Demonstration Trainee Trainer Initials Initials Successful Demonstration Certifier Initials and Date POWER SOURCE State the 3 combinations of power sources (2 batteries, 1 battery and AC adapter, 1 battery and DC adapter) Identify the amount of power remaining on a battery using the Test Button Identify the amount of power remaining on a battery using the battery indicator on the controller Successfully complete power source exchange from AC/DC adapter to battery Successfully complete power source exchange from battery to AC/DC adapters BATTERY CHARGER State the meaning of each status light on the battery charger Identify the power indicator light for the battery charger Successfully place and remove a battery in and out of a battery slot CONTROLLER Identify the four connectors to the controller (2 power supply, 1 driveline and 1 monitor connector) Identify the controller display, buttons and indicators (AC/DC indicator, alarm mute button, alarm indicator, battery indicator #1 & #2, scroll button and controller display) State purpose and care of driveline cover Successfully complete a controller exchange ALARMS Identify indicators (visual and audible) and actions of low priority alarms Identify indicators (visual and audible) and actions of medium priority alarms Identify indicators (visual and audible) and actions of high priority alarms Identify audible indicator and actions of “no power” alarm Identify silencing of alarms ACCESSORY PACKS Correctly place controller and batteries within the patient pack Successfully place controller and batteries in the shower bag DRIVELINE EXIT SITE CARE State the signs and symptoms of driveline exit site infection Successfully demonstrate driveline exit site care OTHER Page 1 of 2 GL1108 Rev01 11/14 Patient and Caregiver Education and Skills Checklist My signature below indicates that I have completed the above listed requirements for hands-on training certification of the HVAD® System and that all my questions have been answered to my satisfaction. _______________________________________ (Patient/Care Giver signature) _____________________ (Date) My signature below indicates that the patient/care giver has successfully completed the above listed requirements for hands-on training certification of the HVAD® System. _______________________________________ (Certifier signature) _____________________ (Date) WARNING: Serious and life-threatening adverse events, including stroke, have been associated with use of this device. A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation. For full prescribing information please see the Instructions for Use (IFU). The IFU can be found at www.heartware.com/clinicians/intructions-use. In the USA the HVAD system is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. 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. This Form has been provided by HeartWare for general informational purposes. The list of items on the Form is not intended to be an exhaustive list. The Form is not intended to constitute medical advice, nor should it be used as a replacement for the advice, treatment or diagnosis of a licensed physician. Only a licensed physician may make the decision to discharge a patient. Satisfactory completion of this Form does not qualify a patient for discharge, nor should such completion be used as a replacement for the evaluation or decision of a licensed physician. If you have questions related to the Form, you may contact your HeartWare representative. In addition, HeartWare Clinical Support is available via the Emergency Hotline (888.494.6365). This Hotline resource is available 24 hours a day, 7 days a week, 365 days a year. Page 2 of 2 GL1108 Rev01 11/14