Abbott HeartMate Touch Quick start guide

Abbott

HEARTMATE

™

LEFT VENTRICULAR ASSIST SYSTEM

HeartMate Touch

™

Communication

System

Quick Start Guide

iii

™ 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

Bluetooth and Bluetooth Logo are registered trademarks of Bluetooth SIG, Inc.

iv

HeartMate Touch™ Communication System Overview . . . . . . . . . . . . . . . . . . . . . . 1

How to Use the HeartMate Touch™ Communication System . . . . . . . . . . . . . . . . . 6

Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

1

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

2

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

3

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.

4

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.

5

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.

6

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.

7

Quick Start

Set Up and Connect

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

2. Insert the

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

Module. The

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

connection.

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.

Figure 3 Header

4. Tap to launch the HeartMate Touch™ App.

CAUTION !

The Tablet for use with the HeartMate Touch

™ App should have its AC power adapter connected

to an AC electrical power outlet during the surgical procedure.

8

5. Tap the Language drop-down to select a language that matches the language selected for the

Tablet (in the Settings). A language change confirmation message appears.

Figure 4 Select a Language / Confirm

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

®

Wireless Technology

9

Pair

The HeartMate Touch App displays the available HeartMate Touch Wireless Adapters(s) in the order

in which they are detected (top to bottom).

1. Select the Adapter ID number and tap Connect.

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. A Bluetooth® Connections window appears. Enter the HeartMate Touch Wireless Adapter code

in the Bluetooth Pairing Request box.

Figure 7 Enter HeartMate Touch™ Wireless Adapter Code

3. Tap Pair.

CAUTION !

Select the Adapter ID number that matches the number on the HeartMate Touch Wireless

Adapter label.

HeartMate Touch Wireless

Adapter Code

10

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.

Note: It may take a few seconds after the System Controller is connected for CONTINUE to become

active.

Figure 8 Confirm the ID Number and System Controller Serial Number

2. Confirm the Adapter ID number and System Controller serial number.

Note: The System Controller serial number is not shown for the HeartMate II System Controller.

11

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 (.).

Figure 9 Create a Name for the Session

12

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. The Monitor view

also has a Reminders panel (right). The Reminders

panel provides reminders such as when to replace

the Backup Battery.

Clinical View. The Clinical view is intended to be

used during the implant procedure. It is the only view

with the ability to start, prime, and stop the pump. It

displays the primary operating parameters (Speed,

Flow, Power, PI) with trendline information for speed

and flow.

Historical View. The Historical view displays the

event and periodic records that are stored in the

System Controller and LVAD. Primary operating

parameters (Speed, Flow, Power, and PI) are shown

at the top of the window without trendlines.

13

Interface Overview

The regions discussed on this page are displayed in all views (Clinical, Monitor, Historical).

1 Menu. Tap Menu ( ). You can then choose from these views: Clinical, Monitor, Historical. You

can also disconnect the wireless communication.

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.

4 Locate. Tap Locate ( ) and the HeartMate Touch Wireless Adapter to which you are

connected will blink blue and white. This feature helps identify the device to which you are

connected.

5 Settings. Tap Settings ( ) to access the Pump, Controller, and Backup Battery settings and

information.

6 Alarm Silence. Displays the alarm silence status. You can also silence active alarms by tapping

Silence Alarms.

7 Alarm Status. Displays the top two priority active alarms.

5

4

3

2

1

6

7

8

14

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. Tap Menu ().

Figure 10 Disconnect HeartMate Device

2. Tap Disconnect HeartMate Device. A confirmation message appears asking you to confirm.

3. Tap YES to disconnect the HeartMate Touch App from the HeartMate Touch Wireless Adapter.

Disconnect

HeartMate Device

Menu

15

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.

Ready to Connect. After pressing and holding the round button,

the HeartMate Touch Wireless Adapter will illuminate a blinking

blue light. This light indicates the HeartMate Touch Wireless Adapter

is ready to accept a wireless connection to a HeartMate Touch App

for up to 60 seconds. If the HeartMate Touch Wireless Adapter is

not responding, change to a new HeartMate Touch Wireless

Adapter.

Connected. The HeartMate Touch Wireless Adapter will illuminate

a solid blue light when it is connected to and communicating with

the HeartMate Touch App.

Standby Mode. The HeartMate Touch Wireless Adapter light will

be off when it is in standby mode and not yet wirelessly connected to

the HeartMate Touch App.

Locate. The HeartMate Touch Wireless Adapter will illuminate a

blinking blue and white light when the HeartMate Touch App is

locating and identifying the HeartMate Touch Wireless Adapter. The

light will blink for up to 10 seconds.

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Abbott HeartMate Touch Quick start guide

Abbott HeartMate Touch Quick start guide

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