Conexus Wireless Telemetry

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Conexus Wireless Telemetry
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MICS Background

• In the United States, the Federal Communications
  Commission (FCC) regulates use of the radio
  frequency spectrum, and regulatory rules make a
  number of frequency bands potential candidates
  for use by medical devices.
• However, ONE frequency band is designated
  specifically for implanted medical devices the
  Medical Implant Communications Service (MICS)
• The FCC established MICS in 1999 to provide an
  ultra-low power, mobile radio service for
  transmitting data in support of diagnostic or
  therapeutic functions associated with implanted
  medical devices.
• The MICS frequency band operates from 402 MHz to
  405 MHz. The use of the 402-405 MHz band is
  compatible with international frequency
  allocations, and these frequencies are conducive
  to transmitting radio signals in the human body.

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Conexus Wireless Telemetry

• Medtronics Conexus Wireless Telemetry operates
  on the MICS band
• Medtronic strategically chose MICS for optimum
  operation in clinics and operating rooms
• Conexus Wireless Telemetry employs several
  unique mechanisms used to avoid radio
  interference, when present including Smart Radio.

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Smart Radio

• Selects one of 10 channels within the MICS
  frequency band to establish a telemetry session
  based on the MICS standard Listen Before Talk
  (LBT) frequency-access protocol.
• Scans all channels in the MICS band for other
  users, or noise, prior to establishing a
  telemetry session. Conexus Telemetry will open a
  session on the least interfered channel.
• This protocol allows multiple simultaneous
  programming sessions to be collocated without
  interference.

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Conexus Performance Testing

• Conexus has been in development / testing for
  nearly 10 years.
• Medtronic has initiated variety of testing in
  both bench and real world settings.
• Users can have confidence in the ability to
  conduct all aspects of device interrogation and
  programming within labeled range (2-5M)

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Potential Clinical Applications

• Implant
• Remove programming head from sterile field

• Follow-up
• Perform wandless programming / interrogation
• Potentially eliminate surface electrodes with
  Leadless ECG

• Remote Monitoring
• Wirelessly / Automatically transmit device data
  to peripheral monitors

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• Brief Statement Medtronic ICDs and CRT-ICDs
• Indications
• Medtronic Implantable Cardioverter
  Defibrillators (ICDs) are indicated for
  ventricular antitachycardia pacing and
  ventricular defibrillation for automated
  treatment of life-threatening ventricular
  arrhythmias.
• Medtronic Cardiac Resynchronization Therapy
  (CRT) ICDs are indicated for ventricular
  antitachycardia pacing and ventricular
  defibrillation for automated treatment of
  life-threatening ventricular arrhythmias and for
  the reduction of the symptoms of moderate to
  severe heart failure (NYHA Functional Class III
  or IV) in those patients who remain symptomatic
  despite stable, optimal medical therapy and have
  a left ventricular ejection fraction less than or
  equal to 35 and a QRS duration of 130 ms.
• Contraindications
• Medtronic ICDs and CRT-ICDs are contraindicated
  in patients whose ventricular tachyarrhythmias
  may have transient or reversible causes, patients
  with incessant VT or VF, patients who have a
  unipolar pacemaker. Medtronic ICDs are also
  contraindicated for patients whose primary
  disorder is bradyarrhythmia.
• Warnings and Precautions
• Changes in a patients disease and/or
  medications may alter the efficacy of the
  devices programmed parameters. Patients should
  avoid sources of magnetic and electromagnetic
  radiation to avoid possible underdetection,
  inappropriate sensing and/or therapy delivery,
  tissue damage, induction of an arrhythmia, device
  electrical reset or device damage. Do not place
  transthoracic defibrillation paddles directly
  over the device. Additionally, for CRT-ICDs,
  certain programming and device operations may not
  provide cardiac resynchronization.
• Potential Complications
• Potential complications include, but are not
  limited to, rejection phenomena, erosion through
  the skin, muscle or nerve stimulation,
  oversensing, failure to detect and/or terminate
  tachyarrhythmia episodes, acceleration of
  ventricular tachycardia, and surgical
  complications such as hematoma, infection,
  inflammation, and thrombosis.
• See the device manual for detailed information
  regarding the implant procedure, indications,
  contraindications, warnings, precautions, and
  potential complications/adverse events. For
  further information, please call Medtronic at
  1-800-328-2518 and/or consult Medtronics website
  at www.medtronic.com.
• Caution Federal law (USA) restricts these
  devices to sale by or on the order of a
  physician.

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• Brief Statement 2090 Programmer
• The Medtronic/Vitatron CareLink programmer
  system is comprised of prescription devices
  indicated for use in the interrogation and
  programming of implantable medical devices.
  Prior to use, refer to the Programmer Reference
  Guide as well as the appropriate programmer
  software and implantable device technical manuals
  for more information related to specific
  implantable device models. Programming should be
  attempted only by appropriately trained personnel
  after careful study of the technical manual for
  the implantable device and after careful
  determination of appropriate parameter values
  based on the patient's condition and pacing
  system used. The Medtronic/Vitatron CareLink
  programmer must be used only for programming
  implantable devices manufactured by Medtronic or
  Vitatron.
• See the device manual for detailed information
  regarding the instructions for use, indications,
  contraindications, warnings, precautions, and
  potential adverse events. For further
  information, please call Medtronic at
  1-800-328-2518 and/or consult Medtronics website
  at www.medtronic.com.
• Caution Federal law (USA) restricts this
  device to sale by or on the order of a physician.

www.medtronic.com Medtronic USA, Inc. Toll-free
1 [phone] (24-hour technical support
for physicians and medical professionals) April
2006