Abbott HeartMate Touch Quick Start Guide

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

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 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.

pairing to the HeartMate Touch™ Wireless Adapter. In addition, the Power Module must

Figure 1 HeartMate Touch™ Communication System

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

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 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.

‡ connector are used to charge

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.

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.

How to Use the HeartMate Touch™ Communication System

You will need to review the Quick Start section to learn how to set up your HeartMate Touch™ Communication System. See the Quick Start on page 7.

The Tablet for use with the HeartMate Touch App is compatible with a Flash Drive. You will use the drive to export the HeartMate Touch Communication System device data.

See the Export Data on page 16 for more information.

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.

Quick Start

Set Up and Connect

1. Verify the Power Module is set up and powered on.

2. Insert the Module. The connection.

CAUTION !

The Tablet for use with the HeartMate Touch to an AC electrical power outlet during the surgical procedure.

3. To turn on the Tablet, press and hold the top button until the logo appears.

IMPORTANT! Keep the Wi-Fi‡ and software automatic updates turned off in the Tablet for use with the HeartMate Touch app. Follow Abbott’s instructions regarding when to connect to Wi-Fi‡ and the process for maintaining approved software. Installing iOS‡ updates without Abbott notification may impact product use. If you have any questions, contact your local Abbott representative at any time.

Note: Before launching the HeartMate Touch App, setup the Tablet (in Settings) for the specific region, time zone, the language and time format that the Tablet is going to be used. Date and time display may vary and is dependent on your Settings and HeartMate Touch App language selected. Date and time displayed in the header (Figure 3) may also vary and is dependent on your Settings. Header format and content is subject to change.

HeartMate Touch™ Wireless Adapter into the socket located on the side of the Power

HeartMate Touch Wireless Adapter light displays a white light for 1 second upon

™ App should have its AC power adapter connected

4. Tap to launch the HeartMate Touch™ App.

Figure 3 Header

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