Abbott HeartMate Touch User manual

Abbott
HEARTMATE™LEFT VENTRICULAR ASSIST SYSTEM
HeartMate Touch™
Communication
System
Quick Start Guide

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™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2020 Abbott. All Rights Reserved.
Bluetooth and Bluetooth Logo are registered trademarks of Bluetooth SIG, Inc.

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HeartMate Touch™ Communication System Overview . . . . . . . . . . . . . . . . . . . . . . 1
How to Use the HeartMate Touch™ Communication System . . . . . . . . . . . . . . . . . 6
Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

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HeartMate Touch™ Communication System Overview
The HeartMate Touch™ Communication System is intended for use by clinicians in the hospital to
provide a detailed, large-scale display of system performance. The HeartMate Touch Communication
System can be used with the HeartMate II™ or HeartMate 3™ Left Ventricular Assist System. Using
the HeartMate Touch Communication System, clinicians can also enter and change operating
parameters and system settings. The HeartMate Touch Communication System is required during
implant procedures and any time close monitoring of system operation is needed. The Tablet should
be placed on a stable surface. The HeartMate Touch Communication System is shown on top of the
Power Module (Figure 2)
The Tablet for use with the HeartMate Touch App must be connected to the Power Module through a
Bluetooth®pairing to the HeartMate Touch™ Wireless Adapter. In addition, the Power Module must
be connected to the System Controller. These connections allow the transfer of System Controller
data through the Power Module for display on the Tablet display screen. The wireless communication
range with the HeartMate Touch Wireless Adapter is up to 5 meters (16.40 feet). The HeartMate
Touch Communication System should only be used when in direct view of the patient.
Figure 1 HeartMate Touch™ Communication System

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IMPORTANT! For complete information on using the HeartMate Touch Communication System see
the Instructions for Use that came with your HeartMate II or HeartMate 3 Left Ventricular Assist System.
Figure 2 HeartMate Touch™ Communication System on top of the Power Module

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HeartMate Touch™ App. The HeartMate Touch App provides clinicians
with the ability to wirelessly monitor a patient’s HeartMate II™ Left Ventricular
Assist System or HeartMate 3™ Left Ventricular Assist System.
The HeartMate Touch App also provides clinicians with the ability to program
system parameters such as pump speed, assess and track alarm conditions,
and view and save performance data. Its use during HeartMate II Left
Ventricular Assist System implantation or the HeartMate 3 Left Ventricular
Assist Device implantation is required.
Tablet for use with the HeartMate Touch App. The Tablet deployed
with HeartMate Touch App serves as the display screen and is installed with a
protective case.
HeartMate Touch™Wireless Adapter. The HeartMate Touch Wireless
Adapter facilitates Bluetooth pairing, when it is connected to the Power
Module. The wireless communication range with the HeartMate Touch
Wireless Adapter is up to 5 meters (16.40 feet). Every HeartMate Touch
Wireless Adapter has its unique ID number, to ensure correct pairing.
Power Adapter and USB cable. The Power Adapter and
2-meter (6.56 feet) USB cable with Lightning‡connector are used to charge
the Tablet from a power outlet.
Flash Drive. The Flash Drive has a Lightning connector and USB connector.
The Flash Drive is used for exporting and transferring data generated from the
HeartMate Touch App. The Flash Drive is also used to store data that is
exported from the HeartMate Touch App.

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Please contact Abbott if you have questions or concerns. For Abbott contact information, see the
Back Cover of this manual.
WARNING !
• Do not disconnect the Power Module patient cable from the Power Module when
troubleshooting for a "Connection lost to HeartMate 3 Controller" notification or a
"Connection lost to HeartMate II Controller" notification on the HeartMate Touch App.
• Do not disconnect the System Controller power cable connectors from the Power Module
when troubleshooting a "Connection lost to HeartMate 3 Controller" notification or a
"Connection lost to HeartMate II Controller" notification on the HeartMate Touch App.
• To prevent system component damage and personal injury, refer any servicing of HeartMate
Left Ventricular Assist System equipment to Abbott-trained service personnel only.
• The HeartMate Touch System may be interfered with by other equipment, even if that other
equipment complies with CISPR EMISSION requirements.

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CAUTION !
• Use of equipment and supplies, other than those specified in this manual or sold by Abbott for
replacement parts, may affect the electromagnetic compatibility of the Left Ventricular Assist
System with other devices, resulting in potential interference between the Left Ventricular
Assist System and other devices.
• If the Tablet for use with the HeartMate Touch App is mounted on top of the Power Module,
do not attempt to lift or carry the two components. Doing so may damage the Power Module
and/or Tablet for use with the HeartMate Touch App.
• Pump flow is estimated from pump power. Under abnormal conditions this may result in an
overestimation of pump flow or an undisplayed pump flow reading. See the Pump Flow
section (4 HeartMate Touch Communication System chapter) in the Instructions for Use that
came with your HeartMate II or HeartMate 3 Left Ventricular Assist System for more
information.
• No single parameter is a surrogate for monitoring the clinical status of the patient, and the
changes in all parameters should be considered when assessing any clinical situation.
• Position the Power Module and HeartMate Touch Communication System away from sources
of lint, dust, and pests, and away from heat and/or humidity sources such as a fireplace,
radiant heater, nebulizer, and steam kettle.
• Pump flow readings will vary with changes in blood viscosity for the HeartMate II Left
Ventricular Assist System.
• Before using the HeartMate Touch Communication System, be sure you read and understand
all warnings, cautions, and instructions.
• For complete information on using the HeartMate Touch Communication System, refer to the
manual that accompanied the device.
• Use the HeartMate Touch Communication System only when in the direct view of the patient.