Medtronic SDNSW03623 Reference Guide

CareLink RemoteView with RemoteControl
Reference Manual
CareLink RemoteView with RemoteControl
Reference Manual
This manual describes how to set up and use the RemoteView application and RemoteControl feature to establish a remote connection to a CareLink 2090 programmer. For full CareLink 2090 programmer information, see the CareLink 2090 Programmer Reference Manual.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
CareLink™, RemoteControl™, RemoteView™, Vitatron™
Medtronic
CareLink RemoteView with RemoteControl
Contents
1 System overview ....................................................... 6
1.1 System description ................................................. 6
1.2 System access controls ............................................. 7
1.3 Data privacy ...................................................... 7
2 Using the RemoteView application ....................................... 8
2.1 RemoteView icon .................................................. 8
2.2 To use the RemoteView application ................................... 9
3 Using the RemoteControl feature ....................................... 12
3.1 RemoteControl safety ............................................. 12
3.2 Instructions for programmer specialists .............................. 12
3.3 Instructions for patient care providers ................................ 15
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CareLink RemoteView with RemoteControl

1 System overview

1.1 System description

The RemoteView application is designed to enable an authorized remote operator to view a CareLink 2090 programmer screen. During a RemoteView session, a remote operator (programmer specialist) provides guidance on a Medtronic or Vitatron cardiac implantable device check without having control of the Model 2090 programmer.
The RemoteControl feature is designed to enable an authorized programmer specialist to control a CareLink 2090 programmer. A RemoteControl session takes place in a clinical setting to provide assistance during an implant procedure or to conduct a device follow-up session. The local operator is a patient care provider who must remain in the room with the patient and the CareLink 2090 programmer at all times during a RemoteControl session.
The RemoteView application and RemoteControl feature share a basic hardware platform, programming language, data security features, and session initiation processes. See Figure 1 for a high-level depiction of the system.

Figure 1. System overview

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1 Secure Medtronic server. 2 Patient care provider is in the same room as patient and CareLink 2090 programmer. 3 Programmer specialist uses RemoteView application or RemoteControl feature to conduct a
session from their remote system.
4 The Medtronic server relays images of the CareLink 2090 programmer screen. If using the
RemoteControl feature, the programmer screen receives remote commands from the
programmer specialist’s system. 5 Patient care provider and programmer specialist communicate by telephone during the session. 6 Programmer specialist views images of the CareLink 2090 programmer screen via the Medtronic
server. If using the RemoteControl feature, the programming specialist controls the programmer
via the Medtronic server.
CareLink RemoteView with RemoteControl

1.2 System access controls

User access to the RemoteView application or RemoteControl feature is based on the role assigned to a specific username. Usernames and roles are assigned, granted, and controlled by Medtronic prior to use. Separate usernames are required to use the RemoteView application and RemoteControl feature.
User capabilities are determined at the time of login and authentication. When the user enters their username and password, this user only has the capabilities for either the RemoteView application or RemoteControl feature.

1.3 Data privacy

Patient data may be viewed on the remote system during a RemoteView or RemoteControl session. Medtronic provides the software on the Model 2090 programmer as well as the connectivity via a Medtronic server, which enables this to occur. Medtronic does not, however, collect, use, or retain any patient’s personal or health data via the RemoteView application or RemoteControl feature.
The patient care provider is responsible for complying with all applicable data privacy and data protection laws and regulations when choosing to allow the programmer specialist to view the patient’s data via the RemoteView application or RemoteControl feature, including obtaining consents and other agreements that may be required. Allowing the viewing of patient data by the programmer specialist in another country could constitute a data transfer under the laws where the patient care provider is located. For this purpose, please see Section 2.2.1 for the RemoteView server locations.
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Medtronic CareLink RemoteView with RemoteControl

2 Using the RemoteView application

2.1 RemoteView icon

The RemoteView icon on the programmer provides information about the connection between the programmer and the remote system. The icon changes to indicate the connection status between the programmer and the remote system.

Table 1. RemoteView icon states

RemoteView
icon state
Color What the icon indicates
Grayed out (not selecta­ble)
Gray RemoteView application is available but not con-
Gray with flashing green RemoteView connection in progress. A connection
RemoteView application disabled. This icon is not selectable. If you click the icon, the programmer beeps. This grayed out icon indicates either the RemoteView application is not available/suppor­ted or the programmer does not meet hardware system requirements. If your programmer does not meet hardware system requirements, contact Medtronic Technical Support.
nected. There is no connection between the pro­grammer and a remote system.
between the programmer and a remote system has been initiated, but a connection is not yet estab­lished.
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Table 1. RemoteView icon states (continued)
RemoteView
icon state
Color What the icon indicates
Green RemoteView connection established. A success-
Gray with red X RemoteView connection attempt failed. You can
CareLink RemoteView with RemoteControl
ful connection has been established between the programmer and a remote system.
attempt to reconnect by clicking the icon again. Any of the following conditions may cause a connection attempt to fail:
• Network card error. Check with clinic network support staff.
• Network cable connection error. Check to see if the network cable is connected.
• No internet access. Check with clinic network support staff to ensure HTTPS on port 443 is enabled and assigned a static IP address to provide secure Internet connections to the pro­grammer.
• Incorrect server configuration. The program­mer and the remote system must be configured to use the same Medtronic server. See Sec- tion 2.2.1 for more specific information related to the Medtronic servers.
• Invalid session key entered. Try to re-enter the session key.

2.2 To use the RemoteView application

To use the RemoteView application, the programmer needs to be connected to your clinic’s network. Before you begin, make sure your network is configured correctly.
Note: The RemoteView software installed on the remote system must support the geography of the programmer. There is a software version for each of the two geographic designations: “Europe” and “United States and World”.
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CareLink RemoteView with RemoteControl

2.2.1 Configure programmer to use the RemoteView Network

The geographic designation of the programmer needs to be configured in the RemoteView application before the programmer can establish remote connections over the RemoteView Network. One of the following geographic designations must be selected:
• United States and World–choose this designation if the programmer is physically located in the United States or anywhere else in the world except for Europe, as defined below.
• Europe–choose this designation if the programmer is physically located in Europe.
– “Europe” means: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, or the United Kingdom.
1. Press the Programmer icon, and then select [RemoteView Network Configuration…].
2. From the RemoteView Network Configuration screen, select the available field to display the geographic designation options.
3. Select either “United States and World” or “Europe”, depending on the programmer location.
4. Press [OK].
2.2.1.1 Medtronic server locations
The geographical designation corresponds to the location of the Medtronic server, which establishes the RemoteView connection between the programmer and the remote system. The Medtronic server corresponding to the “United States and World” designation is located in the United States. The Medtronic server corresponding to the “Europe” designation is located in a Western European country.
2.2.1.2 Install appropriate RemoteView software version
The RemoteView software version installed on the remote system must match the geographic designation configured in the programmer. For example, if the programmer is configured for the "Europe" geographic designation, the remote system needs the Europe software version to connect to that programmer, regardless of the location of the remote system. The remote system needs to have both software versions installed to connect to programmers in both geographic designations.
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CareLink RemoteView with RemoteControl

2.2.2 Enter RemoteView session key

A RemoteView session key is used by the Medtronic server to authenticate the connection between the remote system and the programmer. At the start of each session, the programmer specialist generates a session key using a secured Medtronic website, and then shares the session key with the patient care provider by telephone. Patient care providers perform the following steps:
1. Call the programmer specialist to start a consultation conversation and obtain the session key.
2. Press the RemoteView icon on the programmer task bar.
3. Enter the 7-digit session key provided by the programmer specialist into the Session Key field on the programmer using the number keys and press [Enter].

2.2.3 End RemoteView connection

A RemoteView connection can be ended by either the programmer specialist or the patient care provider using one of the following methods:
• The patient care provider ends a device application session and presses [End Session] on the programmer screen. An active RemoteView connection automatically terminates when the application software is exited.
• The patient care provider presses the RemoteView icon to terminate a RemoteView connection.
• The programmer specialist clicks the [X] in the upper-right corner of the connection window and clicks [End Session].
When the connection has ended, the RemoteView icon on the programmer task bar changes from a green, connected state back to the gray, not connected state. The programmer screen image becomes blank on the remote system screen.
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CareLink RemoteView with RemoteControl

3 Using the RemoteControl feature

3.1 RemoteControl safety

This section provides safety information for using the RemoteControl feature.
Caution: IMPORTANT SAFETY CONSIDERATIONS
The RemoteControl feature should not be used with patients in the following situations:
Underlying Rhythm test with pacer-dependent patients
Arrhythmia inductions and EP studies
Cardioversion
2290 pacing system analyzer
The programmer specialist cannot respond to emergency medical conditions that require use of equipment outside of the Model 2090 programmer, nor can the programmer specialist provide physical assistance with the programmer. The patient care provider must be qualified to respond to emergency medical conditions that may occur during routine use of the programmer. The patient care provider also must have the training and ability to perceive patient conditions and react accordingly. The patient care facility has the responsibility to provide appropriate personnel with the patient.

3.2 Instructions for programmer specialists

This section provides instructions for programmer specialists using the RemoteControl feature.

3.2.1 Starting a remote session

1. Establish a telephone connection with the patient care provider.
2. Confirm the patient’s identity.
3. Instruct the patient that it is important to communicate to the patient care provider and programmer specialist if the patient is not feeling well.
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4. Confirm the following items with the patient care provider:
• the patient is seated or lying down.
• the programmer head is not on the patient’s device.
• the Model 2090 programmer is set up and turned on.
5. Instruct the patient care provider to immediately notify the programmer specialist if the patient shows any symptoms or if the patient’s condition changes. Instruct the patient care provider of their responsibility to be prepared to deploy all appropriate local resources.
6. Instruct the patient care provider to remove the programmer head from the patient’s device at the end of the session.
7. Ensure the patient care provider understands the following items:
• the patient care provider should not touch the programmer unless instructed to do so.
• the patient care provider may need to tap the pen against the programmer screen to restore the programmer to a known state.
• at the bottom-left corner of the programmer screen is a red button labeled [VVI]. In rare cases, the patient care provider may be asked to press the button to deliver pacing therapy.
8. Open the RemoteView software on your system.
9. Log in with the username and password provided to you.
10. Instruct the patient care provider to place the programmer head over the patient’s device. The patient care provider should position the programmer head to get the maximum number of green bars showing. Then the patient care provider should press the gray [I] button on the programmer head. If appropriate, direct the patient care provider to attach ECG cables.
11. In a web browser, go to the following website: https://wwwp.medtronic.com/admsessionkey
12. Review the terms of use on the session key webpage before continuing.
13. Click [Generate Session Key].
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14. Read the following disclaimer to the patient care provider:
“You are about to enter a session key into the Medtronic programmer. Entering the session key allows me to control the programmer remotely. By entering the session key you are confirming that you will remain present during the session, you are able to identify and respond appropriately to emergency situations, and that you will follow any instructions I provide about operation of the Medtronic programmer during this session.”
15. Instruct the patient care provider to select the RemoteView icon with the touch pen.
16. Once the session key is generated, provide it to the patient care provider.
17. Ask the patient care provider to enter the session key using the touch pen.
18. The patient care provider may have to wait up to a minute for the RemoteView icon to change from gray with flashing green to green. See Table 1 for RemoteView icon states.
19. On the remote computer, go to the RemoteView software, select the session, and select [Accept].
20. On the remote system, click the green arrow to connect to the Model 2090 programmer. You can use your mouse to control the programmer as if you were there in person.
21. At the end of the session:
• Ensure all needed documentation has been printed or saved to a USB drive.
• Instruct the patient care provider to remove the programmer head from the patient’s device.
• See Section 2.2.3 for additional instructions on ending the remote session.
CareLink RemoteView with RemoteControl

3.2.2 Handling connection issues

• If the telephone connection is lost during the remote session, close the remote connection.
• If the network session is disconnected, generate a new session key and try to reconnect.
• If you cannot reconnect, instruct the patient care provider how to end the session. Ensure the programmer head is removed from the patient’s device.
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CareLink RemoteView with RemoteControl

3.3 Instructions for patient care providers

This section provides instructions for patient care providers using the RemoteControl feature.

3.3.1 Important safety considerations

• Ensure the patient is sitting in a chair or lying down for the duration of the device check.
• Monitor the patient for any signs of distress and report any change in the patient’s condition to the programmer specialist.
• In the event of an emergency, be prepared to deploy all appropriate resources.
• The programmer head has a powerful magnet. Do not place the programmer head over a patient’s device until instructed by the programmer specialist.
• Locate and identify the [VVI] button and be prepared to use it at the direction of the programmer specialist.
• Locate and identify the touch pen so you can use it as required at the direction of the programmer specialist.

3.3.2 Conducting a remote device check

1. Set up and turn on the Model 2090 programmer. Do not place the programmer head over the patient’s device until instructed to do so by the programmer specialist.
2. Establish a telephone connection with the programmer specialist.
3. Before starting the remote session, inform the programmer specialist of the patient’s name.
4. To start the session, use the touch pen to click the RemoteView icon on the programmer.
5. Use the touch pen to enter the session key provided by the programmer specialist.
6. The RemoteView icon provides the connection status.
7. When instructed to do so by the programmer specialist, perform a device interrogation:
a. Locate the patient’s device.
b. Place the programmer head over the device in a position to display the maximum
number of green bars.
c. Press the [I] button on the programmer head as required to begin the interrogation.
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8. During the device check, monitor the patient:
• Ensure the patient is sitting in a chair or lying down for the duration of the device check.
• Monitor the patient for any signs of distress and report any change in the patient’s condition to the programmer specialist.
• In the event of an emergency, be prepared to deploy all appropriate resources.
9. When the device follow-up is complete, work with the programmer specialist to ensure the session is ended properly. End the session by using the touch pen to tap the [End Session] button located near the bottom-right corner of the programmer screen.
10. When you end the session, remove the programmer head from the patient’s device.
11. After you end the phone call with the programmer specialist, you can safely power down the programmer.
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