1. Remote Device Monitoring: Understanding What’s Right For You
4/1/2017
Remote Device Monitoring: Understanding What’s Right For You
This presentation discusses remote monitoring systems, including trans-telephonic, scheduled remote follow-up and daily/weekly checks with an example of the LATITUDE system from Boston Scientific
Information adapted from LifeBeat, Fall 2008, “Device Monitoring: Understanding what is right for you” (C9-099).

2. Disclaimer
This presentation is provided with the understanding that the slide content must not be altered in any manner as the content is subject to FDA regulation. If portions of the slide presentation are used, the appropriate indications, contraindications, warnings, precautions, and adverse events must be included.
Remote Device Monitoring

3. Imagine the possibilities
Remote Device Monitoring
Imagine the possibilities
4/1/2017
Your doctor may be getting important information from your device while you are relaxing at home.
Imagine relaxing in the comfort of your home. At the same time, your doctor is getting important information (data) from your cardiac device—such as whether your device delivered high-energy therapy or how much energy is left in the battery.
Imagine also measuring your weight and blood pressure from home and having the measurements automatically sent to your doctor.
Does this scene sound like science fiction? It's not. Remote patient management systems offer a new way to check data stored in implanted cardiac devices. It gives us a look at how doctors and nurses may check cardiac device patients in the future.
Remote Device Monitoring

4. Remote Device Monitoring Overview
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Remote Device Monitoring
Factors that determine the type of monitoring you may have
Types of remote device monitoring systems
Trans-telephonic monitoring
Scheduled remote follow-up
Daily/weekly checks
Remote device monitoring systems
The LATITUDE® Patient Management System
An example of a remote device monitoring system
This presentation has two sections.
First, we will talk about remote device monitoring. We will review what type of monitoring may be appropriate for your device and show examples of available systems. The systems are very similar, but have unique characteristics on how patients use may use them.
The second part will explain one type of remote device monitoring system, the LATITUDE Patient Management system from Boston Scientific.
Remote Device Monitoring

5. What is remote device monitoring?
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“Remote" because you don't need to be at your doctor's office to have your device checked.
"Monitoring" because the remote system can check your device for specific information per your doctor’s orders (for example, if the battery status and event information) and as scheduled by your doctor.
How often your device is monitored is determined by your doctor.
Remote device monitoring allows your doctor to check your device between follow-ups.
Remote monitoring can support more timely comprehensive care for your heart health.
Remote Device Monitoring

6. What is remote device monitoring?
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All patients should have regular monitoring of their device and health.
Three factors determine what type of monitoring system your doctor will prescribe for you:
The type of device you have.
The manufacturer of your device.
What you and your doctor decide is the best approach for you.
Why are there so many types of monitoring systems?
Why do I use one monitoring system for my device, while someone else I know uses a different system?
Everyone with an implantable heart device should have regular monitoring to make sure their device is working properly with their condition.
The technology behind implantable heart devices has changed greatly since the first pacemaker was implanted in Similarly, technology has also greatly changed the way health care professionals monitor devices.
There are three main factors that determine what type of monitoring system your doctor will prescribe for you:
The type of device you have
The manufacturer of your device
What you and your doctor decide is the best approach for you
[Common questions are shown in the screen]
Remote Device Monitoring

7. Remote Device Monitoring
1. Type of Device You Have
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If you have a pacemaker (Pacemaker or CRT-P):
Trans-telephonic monitoring (TTM) offers real-time transmission of heart rate sent over phone line.
In-home remote monitoring as scheduled (manufacturer dependent) offers real-time device and heart data sent over phone line to web-based system.
If you have an implanted cardioverter defibrillator (ICD, CRT-D):
In-home remote monitoring as scheduled by physician with data sent over a secure phone line to web-based system.
Implantable heart rhythm devices include pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) pacemakers and defibrillators. The devices all use similar digital technology. However, each is designed to treat a specific heart condition. The devices have different features and use a variety of monitoring systems.
Patients with pacemakers from certain manufacturers may use in-home (remote) monitoring. Trans-telephonic monitoring (TTM) is also common for pacemakers and CRT pacemakers.
If you have certain models of ICD or CRT defibrillators, you may be able to use in-home remote monitoring.
Special in-home equipment attached to a standard phone line would be used during a remote monitoring session.
Remote Device Monitoring

8. 2. The Device Manufacturer
Remote Device Monitoring
2. The Device Manufacturer
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Each device manufacturer or company uses its own proprietary technology.
One company’s system will not monitor a device from another company.
Some systems allow you to use additional in-home equipment (such as weight scales and blood pressure measurement devices).
Each manufacturer's devices and monitoring systems must meet very stringent requirements and earn the approval of the U.S. Food and Drug Administration (FDA). A manufacturer's monitoring system is designed to work only with their devices. For example, if you have a Boston Scientific device, your device cannot use a remote monitoring system from another manufacturer.
While each manufacturer's monitoring systems are similar, differences do exist. Talk to your doctor about which system is right for you.
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9. Remote Device Monitoring
3. Best Approach for You
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You and your doctor will decide what monitoring system is the best for you.
The most important factor that determines the monitoring system you will use for your device is what you and your doctor decide.
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10. Trans-telephonic Monitoring Overview
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Trans-telephonic Monitoring Overview
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Trans-telephonic Monitoring (TTM)
Transmits through a standard phone line.
Use of TTM is arranged by your doctor.
Services not typically provided by pacemaker manufacturer.
TTM is a more traditional type of monitoring system that also uses a landline phone. TTM converts signals from a pacemaker into sound waves and sends them over the phone. The monitoring station at the other end of the phone receives the sound wave signals and converts them back into the original signals in the form of an electrocardiogram (ECG) or heart rhythm recording.
Remote Device Monitoring

11. Remote Device Monitoring Overview
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Common features of remote device monitoring systems include the following:
Scheduled Remote Follow-Up
Daily and Weekly Device Checks
May replace some in-clinic follow-ups
Implanted device interrogation at a predetermined time set by your doctor
Checks specific device and heart health information
Interrogations between follow-ups
Daily and/or weekly device interrogations set by your doctor
Checks specific device information
Remote device monitoring is an over-arching umbrella term for device monitoring at home. Remote monitoring can be scheduled, which may replace a clinic visit. Remote monitoring can also be done daily or weekly, depending on your doctor’s settings, which are done between quarterly device follow-up times.
Scheduled remote follow-up is communicated less often than daily or weekly device checks.
Some systems enable your doctor to collect the same type of information remotely that is normally collect during a routine office visit.
For example, the system can check your heart rate and rhythm and the treatment your device delivered since your last visit. At an office visit, this process is typically done by holding a wand over the device.
Remote Device Monitoring

12. What is a scheduled remote follow-up?
Remote Device Monitoring
What is a scheduled remote follow-up?
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Routine scheduled follow-up:
Gathers data from your implanted device:
Real-time picture of your heart rate (EGM)
Specific information about your device and heart health (manufacturer specific)
Appears on a secure website for review
You may get a note from your clinic before or after your in-home follow-up appointment.
You may get a bill for the in-home follow-up.
If you have a wireless system:
The monitor will perform the follow-up automatically.
If you have a wanded system:
You will participate in the follow-up at the scheduled time.
Remote device follow-up establishes a recurring follow-up schedule according to patient needs and practice protocol, while maintaining scheduling flexibility to accommodate changes in patient needs or schedule.
If your system is wireless, you may not realize that this follow-up takes place. If your system is wanded, you will be participate in the follow-up at home.
Your clinic may send you a note to remind you of your in-home follow-up appointment and/or to confirm the interrogation took place and everything is okay with your device.
You may also get a bill from your insurance company since a remote follow-up does serve as a medical procedure, even if it is from your home.
Remote Device Monitoring

13. How are daily and/or weekly checks done?
Remote Device Monitoring
How are daily and/or weekly checks done?
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Your doctor sets a schedule determining when your device will be checked.
Depending on the device you have:
A wireless communicator will automatically receive information, or
You will hold “wand” over your device to allow your monitor to receive your device information.
Information from your device is collected by your monitor then sent by a phone line to your doctor’s secure web site.
Your doctor/nurse then checks your information which they have received.
The devices information is downloaded and may be sent over a regular phone line to a secure web site. From this web site, the doctor can look at the downloaded information and check the device.
The technology in current in-home remote monitoring systems allows your doctor to get data from your device whether you are at home or in your doctor's office.
Remote Device Monitoring

14. How is information sent?
Remote Device Monitoring
How is information sent?
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Most in-home monitoring systems use standard land lines to connect to the internet.
If you have DSL (digital phone lines), you may need an adapter for your phone system.
Some systems use cellular technology.
Keep the monitor connected to a power outlet and a phone line at all times, unless otherwise directed by the manufacturer.
The in-home monitor sends the device data to your doctor through your phone line.
Some systems allow you to stay on the phone even if the monitor is scheduled to send data.
If you have a digital phone system, you may need to work with the monitor manufacturer to identify connection possibilities.
Remote Device Monitoring

15. What information is checked?
Remote Device Monitoring
What information is checked?
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Your doctor will set the monitoring system to check:
Battery status
Leads
Certain device settings
Certain device conditions that need immediate attention
Your doctor will program your system to collect the data as often as needed to manage your care.
Remote Device Monitoring

16. What can’t remote monitoring do?
Remote Device Monitoring
What can’t remote monitoring do?
4/1/2017
Does not eliminate contact with your doctor.
Always contact your doctor about symptoms you are experiencing.
Does not replace emergency response (911).
Always call 911 or activate EMS for medical emergencies or a change in your health status.
Cannot change device settings.
Does not replace all visits with your doctor.
Does not eliminate contact with your doctor. Always contact your doctor about symptoms you are experiencing
Does not replace emergency response (911). Always call 911 or activate EMS for medical emergencies or a change in your health status.
Cannot change device settings.
Does not replace all visits with your doctor.
Remote Device Monitoring

17. Benefits of remote monitoring
Remote Device Monitoring
Benefits of remote monitoring
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Doctor has access to specific device information.
Doctor can manage your care and respond more efficiently to any health changes communicated by your monitoring system.
System will alert doctor of certain device conditions needing attention.
System is portable if you travel.
Patient support representatives available to assist you in your communications.
Because device checks can take place in the clinic or at your home, the frequency of your clinic visits may decrease – with remote monitoring between office follow-ups, the level of connection to your doctor increases.
The remote monitor transmits specific device and health information through your regular phone line to a secure web site that only your health care support team can access.
Using this information, your doctor can take action sooner and make changes when needed.
You have access to helpful company representatives from the privacy of your own home.
Remote Device Monitoring

18. Remote Device Monitoring
In an emergency…
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Remote monitoring does not replace physician contact!
Always call 911 in an emergency.
Always call your doctor if your health changes suddenly or dramatically.
Remote monitoring does not replace standard emergency services.
Remote Device Monitoring

19. Remote Device Monitoring Systems
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Systems commonly available in the US:
Medtronic Carelink®
St. Jude and HouseCall Plus™
Biotronik CardioMessenger®
Boston Scientific LATITUDE® system
Four device manufacturers offer remote device monitoring systems.
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20. Remote Monitoring Systems
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Remote Monitoring Systems
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Medtronic CareLink Network
The patient monitor enables you to “connect” your implanted device to your clinic via a standard phone line.
Available for Medtronic ICDs, CRT, pacemakers and implantable cardiac monitors in the United States.
The system from Medtronic is called Carelink.
Remote Device Monitoring

21. Remote Monitoring Systems
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Remote Monitoring Systems
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St. Jude
The patient monitor enables you to “connect” your implanted device to your clinic via a standard phone line.
For use with CurrentTM RF ICD and PromoteTM RF CRT-D devices.
St. Jude Housecall Plus
For use with AtlasTM and EpicTM ICDs and Atlas HF and Epic HF CRT devices.
St. Jude has had two systems, Housecall Plus and
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22. Remote Monitoring Systems
Remote Device Monitoring
Remote Monitoring Systems
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Biotronik CardioMessenger
A portable unit that receives data from the implanted device. It is the link that connects you to the Biotronik service center.
Available for Biotronik ICDs, CRT and pacemakers in the continental United States and in over 50 countries.
The Biotronik systemsis called CardioMessenger.
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23. Remote Monitoring Systems
Remote Device Monitoring
Remote Monitoring Systems
4/1/2017
Boston Scientific LATITUDE System
The patient monitor enables you to “connect” your implanted device to your clinic via a standard phone line.
Available for Boston Scientific ICDs and CRT devices in the United States, Puerto Rico and the Virgin Islands.
The Boston Scientific system is the LATITUDE® Patient Management system.
Using the LATITUDE Patient Management Communicator, some of your in-clinic follow-ups can now be conducted in your home.
The LATITUDE Patient Management system can also monitor your heart health and specific device information in between scheduled follow-ups.
We will explore this example of a remote patient management system.
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24. LATITUDE Patient Management System
Remote Device Monitoring
LATITUDE Patient Management System
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You are implanted with a cardiac device 1
The clinic enters your name into the remote patient management system 3
You set up the equipment at home. 5
Clinic receives implant form 2
Boston Scientific ships equipment to your home 4
Clinic begins managing patients 6
This is an example of the how the LATITUDE Patient Management System becomes available to patients.
[Slide builds 1-6]
After your device is implanted, your clinic will enroll you into the LATITUDE remote management system. This will allow them to set up the schedule for your remote visits and coordinate those sessions with office visits.
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25. LATITUDE Patient Management System
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LATITUDE Patient Management System
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When the in-home equipment arrives at your home:
Information to help you set up your equipment:
A video setup guide (in both VHS and DVD formats)
A detailed patient manual
A one-page sheet with instructions and illustrations
LATITUDE Patient Support number
Set up your equipment as soon as you receive it based on manufacturer’s instructions.
After set-up, your doctor can begin monitoring your device.
When your in-home equipment arrives, it may be in a plain brown box that says ‘Medical devices.’ You can accept the shipment as it is part of your doctor’s prescription for your implanted device. Inside, you will find instructions to setting up your in-home equipment.
Remote Device Monitoring

26. LATITUDE Patient Management System
Remote Device Monitoring
LATITUDE Patient Management System
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To set up your equipment:
Place your equipment where your sessions will take place, such as by the bedside.
The Communicator plugs into your regular phone line and electrical outlet.
Instructions are provided to guide you through the set-up process.
Setting up the in-home device is much like setting up an answering machine.
Determine where your sessions are likely to take place – such as near your bedside. That way an automatic in-home system can collect the data from your device while you sleep. It is also a comfortable place for you to do remote sessions if your monitor has a wand attached.
If you have a phone jack in your bedroom, you may want to put the in-home monitor on the nightstand next to your bed.
Your doctor decides how often to collect the data, and the remote monitoring system does the rest.
Remote Device Monitoring

27. LATITUDE Patient Management System
Remote Device Monitoring
LATITUDE Patient Management System
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If your in-home equipment is the LATITUDE Wanded Communicator:
A blinking white action button reminds you when it is time to send your information.
Simply hold the wand over your device.
Press the blue interrogation button to send information from your device.
Remote monitoring, on average, takes 10 to 15 seconds to complete but may take more time if additional information needs to be collected.
The Communicator screen will indicate when the session is over.
The wanded in-home monitor can stay near your bedside to send data from your device through your phone to a secure website where only your healthcare support team can view your information. You will hold that wand over your device during the session. The monitor will tell you when you can replace the wand on the monitor.
Remote Device Monitoring

28. LATITUDE Wanded Communicator
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LATITUDE Wanded Communicator
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Interrogate Button
Communicator Wand
Action Button
Menu Selection Buttons
Volume Control
This is an example of the LATITUDE Wanded Communicator. It has a removable wand attached to the back, an Action Button that blinks when a message is presented and a blue button for use during remote monitoring sessions.
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29. LATITUDE Patient Management System
Remote Device Monitoring
LATITUDE Patient Management System
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If your in-home equipment is the LATITUDE Wireless Communicator:
It is recommended that your LATITUDE Communicator stay near your bedside.
After it is set up, the Communicator can be configured by your doctor over the phone line.
Your doctor will determine when monitoring will occur.
You typically do not need initiate any action.
The LATITUDE Wireless Communicator can stay near your bedside to send data from your device through your phone to a secure website where only your healthcare support team can view your information. Once set up, you do not need to interact with the monitor. This will occur on a pre-set time scheduled by your doctor. For example, automatic wireless sessions may be scheduled to occur in the middle of the night.
Remote Device Monitoring

30. LATITUDE Wireless Communicator
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LATITUDE Wireless Communicator
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Wireless antenna
Interrogate Button
Action Button
Menu Selection Buttons
Volume Control
This is an example of the LATITUDE Wireless Communicator. It has an Action Button that blinks when a message is presented and a blue button for use during remote monitoring sessions. There are two different wireless communicators for LATITUDE, depending on the device you have implanted.
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31. Other in-home monitoring tools
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Other in-home monitoring tools
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Your doctor may prescribe additional in-home equipment, such as a weight scale and blood pressure cuff, to enhance your follow-up care.
These tools also make it easy for you to take an active role in managing your health.
LATITUDE Communicator
Wireless weight scale
If your doctor also wants to collect weight and blood pressure readings, you will receive a special blood pressure monitor and scale as part of your remote monitoring system.
Wireless blood pressure cuff
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32. How does this equipment work?
Remote Device Monitoring
How does this equipment work?
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Measure your weight and blood pressure as instructed by your doctor.
Your weight and blood pressure readings are automatically and wirelessly sent to the Communicator.
The Communicator sends this information to a secure computer system that your doctor can access.
This is how wireless equipment may work. Use it as prescribed by your doctor.
For your doctor to collect this information, you need to:
Step on the scale to weigh your self.
Put the blood pressure cuff on your upper arm and press the Start button.
The LATITUDE system does the rest. Your weight and blood pressure readings are automatically sent from the scale and cuff to the LATITUDE Communicator, and then on to your doctor.
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33. LATITUDE Patient Management System
Remote Device Monitoring
LATITUDE Patient Management System
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Think of daily or weekly remote monitoring like a smoke detector. It will only notify you if there is an alert.
You can keep your in-home monitoring system connected to a power outlet and a phone line so it is ready to use.
Would you put the batteries in your smoke detector only once or twice a month?
Remote Device Monitoring

34. LATITUDE Patient Management System
Remote Device Monitoring
LATITUDE Patient Management System
4/1/2017
Ask your doctor about remote monitoring while planning your trip. Some of the scheduled events may need to be temporarily changed.
The in-home monitor may be used while away from home for an extended period of time – just pack it up and take it with you.
The LATITUDE system may be used outside the 50 United States, Puerto Rico and the Virgin Islands.
The in-home monitor may be used while away from home for an extended period of time – just pack it up and take it with you. However, some monitors can only be used within the 50 United States, Puerto Rico and Virgin Islands. Check with the manufacturer about making appropriate travel arrangements.
Ask your doctor about remote monitoring while planning your trip. Some of the scheduled events may need to be temporarily changed.
We recommend packing the LATITUDE Communicator in your carry-on luggage. Other monitoring equipment – weight scale and blood pressure cuff – may be checked if well packed
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35. Remote Device Monitoring
Questions?
4/1/2017
What questions do you have about remote device monitoring?

36. Important Safety Information
Cardiac Resynchronization Therapy Devices
Cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) are used to treat heart failure patients who have symptoms despite the best available drug therapy. These patients also have an electrical condition in which the lower chambers of the heart contract in an uncoordinated way and a mechanical condition in which the heart pumps less blood than normal. CRT-Ps and CRT-Ds are not for everyone including people with separate implantable cardioverter-defibrillators (CRT-P only) or certain steroid allergies. Procedure risks include infection, tissue damage, and kidney failure. In some cases, the device may be unable to respond to your heart rhythm (CRT-P only) or may be unable to respond to irregular heartbeats or may deliver inappropriate shocks (CRT-D only).
Implantable Cardioverter Defibrillators
An implantable cardioverter defibrillator (ICD) can protect you from the effects of sudden cardiac arrest by reviving your heart rhythm. An ICD is not for everyone, including people with certain steroid allergies. Procedure risks include infection and tissue damage. In some cases, the device may not respond to irregular heartbeats or may deliver inappropriate shocks.
Pacemakers
A pacemaker system can monitor and treat your heart rhythm by delivering electrical energy to pace your heart when it senses a slow rhythm. A pacemaker is not for everyone, including patients with certain steroid allergies. Patients who have additional medical conditions that may not allow the pacemaker to function appropriately should not receive a device. Procedure risks include infection, tissue damage and kidney failure. In some cases, the device may not respond to your heart rhythm.
For All Devices
In rare cases severe complications or device failures can occur. Electrical or magnetic fields can affect the device. Only your doctor knows what is right for you. These devices are available by prescription only. Individual results may vary.
Device Quality and Reliability
It is Boston Scientific’s intent to provide implantable devices of high quality and reliability. However, these devices may exhibit malfunctions that may result in lost or compromised ability to deliver therapy. Refer to Boston Scientific’s CRM product performance report on for more information about device performance, including the types and rates of malfunctions that these devices have experienced historically. While historical data may not be predictive of future device performance, such data can provide important context for understanding the overall reliability of these types of products. Also, it is important that you talk with your doctor about the risks and benefits associated with the implantation of a device.
(Rev. B)
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37. Important Safety Information
The LATITUDE Patient Management system is used to remotely communicate with a compatible pulse generator device from BSC CRM and send data to a central database. The LATITUDE system is contraindicated for use with any pulse generator other than a device from BSC CRM.
The LATITUDE system is designed to tell your doctor within 24 hours if alert conditions are detected by the Communicator. However, alert notification cannot occur if:
The Communicator is unplugged or is not able to connect to the LATITUDE system through an active phone line.
Your device and the Communicator cannot establish and complete a communication session. This session must be initiated by you if you have a device that uses inductive telemetry (Communicator that has a wand).
The Communicator becomes damaged or it malfunctions
Up to two weeks may go by before the LATITUDE system detects the events mentioned above, and additional time may be required for notification and resolution of the condition.
The wanded and wireless Communicator uses a radio frequency (RF) communication system to communicate with an optional weight scale and blood pressure monitor. This communication can be disrupted by electromagnetic interference. Avoid placing your Communicator next to or in the immediate vicinity of other wireless products and sources of electromagnetic energy. The wireless Communicator uses RF to also send and receive signals from the implanted device (RF enabled devices only). Using the blue Interrogate button more than as prompted by your Communicator or as instructed by your physician may lead to a decrease in the battery life of your implanted device. Your communicator is designed to be used in the continental US, Alaska, Hawaii, and Puerto Rico. These devices are available by prescription only.
(Rev. I)
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38. Thank you!
This presentation was sponsored by Boston Scientific Cardiac Rhythm Management
We work to improve the quality of life for cardiac patients and those who care for them.