Abbott HeartMate Touch Quick Start Manual
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Abbott HeartMate Touch Quick Start Manual

Left ventricular assist system communication system
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Abbott
™
H
M
L
V
A
S
EART
ATE
EFT
ENTRICULAR
SSIST
YSTEM
HeartMate Touch
™
Communication
System

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Summary of Contents for Abbott HeartMate Touch

  • Page 1 Abbott ™ EART ENTRICULAR SSIST YSTEM HeartMate Touch ™ Communication System Quick Start Guide...
  • Page 4 ™ 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.
  • Page 5 HeartMate Touch™ Communication System Overview ..... . 1 How to Use the HeartMate Touch™ Communication System ....6 Quick Start .
  • Page 6 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 ®...
  • Page 7 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...
  • Page 8 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.
  • Page 9 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.
  • Page 10 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.
  • Page 11 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.
  • Page 12 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.
  • Page 13 6. Tap YES. The HeartMate Touch App closes. 7. Tap to launch the HeartMate Touch™ App. Press and hold the button on the HeartMate Touch Wireless Adapter for 3 seconds. A blinking blue light appears. Figure 5 Turn on Bluetooth ®...
  • Page 14 Figure 6 Select Adapter ID Number Note: If the HeartMate Touch Wireless Adapter that you intend to connect to is not listed, check that the HeartMate Touch Wireless Adapter is ready to connect (e.g., displays a blinking blue light) and tap Refresh ( 2.
  • Page 15 Note: The passcode is for first time pairing between HeartMate Wireless Adapter and Tablet only. Note: If the HeartMate Touch Wireless Adapter is not paired within 30 seconds, the connection process (pair) will be canceled. Connect the System Controller 1. Connect the System Controller to the Power Module and then wait for CONTINUE to become active.
  • Page 16 Name the Session 1. Create a name for this session and tap Done. IMPORTANT! Only create names that identify the session. Do not enter any protected health information or individually identifiable health information. Follow your organization's policies, procedures, and employee training that correspond to HIPAA regulatory standards. IMPORTANT! You should restrict the characters to a through z, 0 through 9, underscores (_), and periods (.).
  • Page 17 Start and Use See the Instructions for Use that came with your HeartMate II or HeartMate 3 Left Ventricular Assist System for detailed instructions on using the HeartMate Touch Communication System. Monitor View. The Monitor view is the default view displayed upon connection. It displays primary operating parameters (Speed, Flow, Power, and Pulsatility Index (PI)) with trendlines.
  • Page 18 2 Communication Icon. The flashing communication icon ( ) indicates active communication between the System Controller and HeartMate Touch App. If the icon is not flashing or has disappeared, restart the connection. 3 Connected Device Information. Displays the System Controller serial number (HeartMate 3 only) and the current session name.
  • Page 19 8 View All Alarms. Tap View All Alarms to view a full list of active and inactive alarms. Disconnect Wireless Communication There may be instances when you need to disconnect the HeartMate Touch App from the HeartMate Touch Wireless Adapter. (e.g., You need to replace the HeartMate Touch Wireless Adapter.) 1.
  • Page 20 HeartMate Touch Wireless Adapter Status When the HeartMate Touch Wireless Adapter is connected to the Power Module, the HeartMate Touch Wireless Adapter light indicates its operating status. The HeartMate Touch Wireless Adapter status conditions are shown below. Powered On. The HeartMate Touch Wireless Adapter will illuminate a solid white light for 1 second upon connection to the Power Module.
  • Page 21 Export Data To send data such as HeartMate Log Reports to Abbott for diagnostic purposes, you will need to export the data and save it to a Flash Drive. 1. Tap Menu ( ) > Historical. You will be prompted to confirm loading the data.
  • Page 22 After the data loads the Historical view appears. Figure 13 Historical View 3. Tap Export. The message below appears before you proceed. Figure 14 Exporting Data Message 4. Tap YES. A box appears with a prompt asking you to provide a name for the export. IMPORTANT! Only create export names that identify the export file.
  • Page 23 5. Enter a name for the export (e.g., ABC_123) and then tap Done. An exporting data message appears briefly. An export was successful message appears. Figure 16 Export Data Message 6. Tap OK. The Historical view appears.
  • Page 24 Save Files to the Flash Drive (SanDisk iXpand‡ Drive App) You may need to accept the license agreement prior to using the iXpand Drive App. 1. Gently lift up on the Flash Drive flexible Lightning‡ connector and firmly connect it to the Tablet Lightning‡...
  • Page 25 5. Tap On My iPad. You will see the HeartMate Touch (HeartMate Touch™ App) folder. On My iPad‡ Select Figure 19 HeartMate Touch Folder 6. Tap HeartMate Touch. You may see a few folders here. Search for the name prefix for the folder you just created e.g., ABC123_20180524_122311 (name_YYYYMMDD_HHMMSS)
  • Page 26 7. Tap the folder you just created e.g., ABC123..The folder opens. You should see 5 files for the HeartMate 3 and 2 files for the HeartMate II. Figure 20 HeartMate 3 (5 files) / HeartMate II (2 files) 8. Tap Select. From here, you can select the file by tapping the button that appears next to the file icon.
  • Page 27 Note: If the iXpand Drive App does not show, tap More > Select the App. The iXpand Drive App will appear in the share menu. Figure 21 Window with Options to Tag, Copy, or Save...
  • Page 28 11. Tap . The SanDisk iXpand Drive App appears. Figure 22 SanDisk iXpand‡ Drive App IMPORTANT! Only create names that identify the folder. Do not enter any protected health information or individually identifiable health information. Follow your organization's policies, procedures, and employee training that correspond to HIPAA regulatory standards. IMPORTANT! You should restrict the characters to a through z, 0 through 9, underscores (_), and periods (.).
  • Page 29 Adapter Status HeartMate Touch App notification: Connection lost to a Behavior and appearance: Wireless Device. No audible alarms. The Tablet for use with the HeartMate Touch App is no Notification means: longer wirelessly communicating with the HeartMate Touch Wireless Adapter.
  • Page 30 The HeartMate Touch App message: Solid blue light. HeartMate Touch Wireless Adapter Status HeartMate Touch App notification: Connection lost to a Behavior and appearance: System Controller. No audible alarms. The HeartMate Touch Communication System is no longer Notification means: communicating with the System Controller.
  • Page 31 Power Module. Re-insert the HeartMate Touch Wireless Adapter into the Power Module. To resolve notification: Press and hold the button on the HeartMate Touch Wireless Adapter for 3 seconds to turn on Bluetooth® wireless technology. A blinking blue light appears.
  • Page 32 HeartMate Touch App notification: Communication lost to Behavior and appearance: “Adapter ID: 123456”..Reconnecting. No audible alarms. The HeartMate Touch App is attempting to reconnect to the HeartMate Touch Wireless Adapter. Notification means: Note: During the reconnection process, the LVAD will continue to operate at its current settings.
  • Page 33 2. Gently pull the HeartMate Touch Wireless Adapter from the Power Module socket. 3. Insert the HeartMate Touch Wireless Adapter back in to the Power Module socket. 4. Restart the App and connect the HeartMate Touch Wireless Adapter to the Tablet for use with the HeartMate Touch App.
  • Page 34 2. Gently pull the HeartMate Touch Wireless Adapter from the Power Module socket. 3. Insert the HeartMate Touch Wireless Adapter back in to the Power Module socket. 4. Restart the App and connect the HeartMate Touch Wireless Adapter to the Tablet for use with the HeartMate Touch App.
  • Page 35 Issue The HeartMate Touch App does not detect the HeartMate Touch Wireless Adapter ID number - even when the HeartMate Touch Wireless Adapter is ready to connect. (HeartMate Touch Wireless Adapter is illuminating a blinking blue light.) Resolution 1. Tap Refresh ( 2.
  • Page 36 3. Ensure that the HeartMate Touch Wireless Adapter is fully connected to the Power Module socket. 4. Press and hold the button on the HeartMate Touch Wireless Adapter for more than 3 seconds. 5. If the issue persists, replace the HeartMate Touch Wireless Adapter.
  • Page 38 Back Cover United States & Canada Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 Telephone: +1-925-847-8600 Fax: +1-925-847-8574 HeartLine™: +1-800-456-1477 Note: Thoratec is now part of Abbott. Document: 100167125.B Publication Date: 07/2020 *100167125.B*...

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