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Patient Care and Management
6
HeartMate III Left Ventricular Assist System Instructions for Use
6-3
Postoperative Patient Care
Proper care of a patient who is supported by the HeartMate III Left Ventricular Assist System
requires a thorough understanding of the system operation and patient condition.
WARNING !
• There is risk of embolism at Pump explant or reoperation if manipulation of the Pump or
conduit is performed prior to the initiation of cardiopulmonary bypass and stoppage of Left
Ventricular Assist Device pumping.
• If the Left Ventricular Assist Device stops operating and blood is stagnant in the Pump and
conduits for more than a few minutes (depending on the anticoagulation status of the
patient), there is a risk of stroke or thromboembolism should the Pump be restarted.
• If the Left Ventricular Assist Device stops operating, counsel the patient to seek immediate
medical attention to treat retrograde flow within the Pump. Treatment measures may include
heparinization, standard interventions for acutely decompensated congestive heart failure,
and surgical exploration.
• Before using any HeartMate power accessories (Power Module, Mobile Power Unit,
Battery Charger, or HeartMate 14 Volt Lithium-Ion batteries), all users (including clinicians,
patients, and caregivers) must be trained on their use.
• Certain parts of the HeartMate III Left Ventricular Assist System are not compatible with
other HeartMate systems (such as the HeartMate II Left Ventricular Assist System). Only use
HeartMate III parts with the HeartMate III system.
• If the Pump loses external power, it may stop. If the Pump stops, connect to external power
immediately. The HeartMate III Pump will not re-start unless external power is applied to the
System Controller.
• Do not allow patients to swim or take tub baths while implanted with the Left Ventricular
Assist Device. Patient immersion in water or liquid may cause the Pump to stop.
• Do not allow HeartMate III patients to shower without a doctor's permission. Patients may
be allowed to shower, but only after sufficient postoperative healing and only with a
doctor's permission. If a patient is approved for showering, he or she must always use the
Shower Bag for every shower. The Shower Bag protects external system components from
water and moisture. If external system components have contact with water or moisture, the
patient may receive a serious electrical shock or the Pump may stop.
• Keep the Power Module and the Mobile Power Unit dry and away from water or liquid. If
the Power Module or the Mobile Power Unit comes into contact with water or liquid, either
may fail to operate properly or cause a serious electrical shock.
Summary of Contents for HeartMate III
Page 1: ...Instructions for Use ...
Page 2: ......
Page 3: ...Thoratec Corporation HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM Instructions for Use ...
Page 4: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ii ...
Page 6: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE iv ...
Page 10: ...Contents viii HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ...
Page 12: ...1 Introduction 1 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 28: ...1 Introduction 1 18 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 30: ...2 System Operations 2 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 88: ...3 Powering the System 3 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 112: ...3 Powering the System 3 26 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 166: ...4 System Monitor 4 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 208: ...4 System Monitor 4 44 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 210: ...5 Surgical Procedures 5 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 378: ...A A 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 390: ...B B 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 420: ...C C 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 426: ...C C 8 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 428: ...D D 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 448: ...E E 10 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 457: ......