Remote Device Monitoring: Understanding What

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Remote Device Monitoring Understanding Whats
Right For You

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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.

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Imagine the possibilities

• Your doctor may be getting important information
  from your device while you are relaxing at home.

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Remote Device Monitoring Overview

• 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

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What is remote device monitoring?

• 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
  doctors 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.

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What is remote device monitoring?

• 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?
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1. Type of Device You Have

• 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.

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2. The Device Manufacturer

• Each device manufacturer or company uses its own
  proprietary technology.
• One companys 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).

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3. Best Approach for You

• You and your doctor will decide what monitoring
  system is the best for you.

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Trans-telephonic Monitoring Overview

• 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.

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Remote Device Monitoring Overview

• 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

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What is a scheduled remote follow-up?

• 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.

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How are daily and/or weekly checks done?

• 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
  doctors secure web site.
• Your doctor/nurse then checks your information
  which they have received.

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How is information sent?

• 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.

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What information is checked?

• Your doctor will set the monitoring system to
  check
• Battery status
• Leads
• Certain device settings
• Certain device conditions that need immediate
  attention

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What cant remote monitoring do?

• 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.

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Benefits of remote monitoring

• 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.

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In an emergency

• Remote monitoring does not replace physician
  contact!
• Always call 911 in an emergency.
• Always call your doctor if your health changes
  suddenly or dramatically.

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Remote Device Monitoring Systems

• Systems commonly available in the US
• Medtronic Carelink
• St. Jude Merlin_at_Home and HouseCall Plus
• Biotronik CardioMessenger
• Boston Scientific LATITUDE system

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Remote Monitoring Systems

• 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.

www.carelinknetwork.com/
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Remote Monitoring Systems

• St. Jude Merlin_at_Home
• 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
• The patient monitor enables you to connect your
  implanted device to your clinic via a standard
  phone line.
• For use with AtlasTM and EpicTM ICDs and Atlas HF
  and Epic HF CRT devices.

www.sjm.com/
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Remote Monitoring Systems

• 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.

www.biotronik.com/en/us/
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Remote Monitoring Systems

• 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.

www.aboutlatitude.com
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LATITUDE Patient Management System
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LATITUDE Patient Management System

• 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 manufacturers instructions.
• After set-up, your doctor can begin monitoring
  your device.

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LATITUDE Patient Management System

• 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.

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.
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LATITUDE Patient Management System

• 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.

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LATITUDE Wanded Communicator
Interrogate Button
Communicator Wand
Action Button
Menu Selection Buttons
Volume Control
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LATITUDE Patient Management System

• 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 Communicatorcan 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.

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LATITUDE Wireless Communicator
Wireless antenna
Interrogate Button
Action Button
Menu Selection Buttons
Volume Control
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Other in-home monitoring tools

• 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
Wireless blood pressure cuff
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How does this equipment work?

• 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.

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LATITUDE Patient Management System
Think of daily or weekly remote monitoring like a
smoke detector. It will only notify you if there
is an alert.
Would you put the batteries in your smoke
detector only once or twice a month?
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LATITUDE Patient Management System

• 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.

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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Questions?

• What questions do you have about remote device
  monitoring?

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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 Scientifics 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 Scientifics CRM product performance
  report on www.bostonscientific.com 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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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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Thank you!

• This presentation was sponsored byBoston
  ScientificCardiac Rhythm Management
• We work to improve the quality of life for
  cardiac patients and those who care for them.