Confirm Rx™ Model DM3500 Insertable Cardiac Monitor
CARDIOVASCULAR
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Confirm Rx™

Model DM3500
Insertable Cardiac Monitor

PRODUCT HIGHLIGHTS

Device

  • Small size (∼ 1.4 cc) with slim profile
  • Simple insertion procedure requiring minimal time and resources
  • Intuitive one-touch programming on the Merlin™ Patient Care System programmer based on ‘Reason for Monitoring'
  • Remote monitoring ready
  • Patient activated and auto activated triggers for EGM storage
  • Programmable data storage options to ensure capture of significant events while reducing the risk of missing unexpected events
  • Proven St. Jude Medical™ SenseAbility™ feature designed to allow accurate sensing over a wide range of signals
  • 1.5 T MR Conditional

Mobile App and Connectivity

  • Bluetooth® wireless technology between ICM and myMerlin™ app which patients can download onto their mobile device. No need for a separate bulky bedside transmitter or patient activator
  • ICM continuously monitors rhythm and myMerlin app proactively transmits data per schedule and alerts set by the clinic
  • App features integrated activator functionality, allowing patients to privately record and transmit EGMs during symptoms. No separate activator hardware required
  • Notifications inform patients of daily device checks and scheduled transmissions to promote remote monitoring adherence without burdening the clinic
  • App available in 35+ languages to engage patients and provide a personalized experience
  • Transmissions are sent to Merlin.net Patient Care Network providing clinicians with data review and reports
  • St. Jude Medical™ mobile transmitters may be purchased for patients without their own mobile device

Security Measures

  • The ICM encrypts its wireless communication using AES-128bit encryption and is designed to limit communications to only a single authenticated and paired myMerlin™ mobile app at any given time.
  • The ICM uses a proprietary pairing protocol as an added control measure in addition to the pairing procedure specified in Bluetooth® wireless technology low energy protocols. Pairing requests are authenticated using cloud-based public key cryptography authentication.
  • The ICM creates a unique 128-bit key for the paired mobile app and verifies it at the onset of every communication. If the unique key is not verified, the monitor denies access.
  • The ICM uses an authorization protocol, which limits a paired mobile app’s access based on clinician settings.
  • The myMerlin™ mobile apps encrypt wireless communication to Merlin.net™ PCN through a secure TLS connection using SHA256 cryptographic protection.
  • Merlin.net PCN is housed in a secured data center and is ISO27001:2013 certified. Access to patient data in Merlin.net PCN is restricted to authorized users as set by the clinic administrator. ICM data is encrypted using AES-128bit encryption.
  • Merlin.net PCN is successfully certified through the EU-US Privacy Shield program to transfer patient information from the EU to the US.

ORDERING INFORMATION



Rx Only


Indications
: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. Confirm Rx ICM Model DM3500 is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. 


Contraindications: There are no known contraindications for the implantation of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. 


Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. 


Limitations*: Patients may use their own Apple or Android mobile digital device to transmit information from their Confirm Rx ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology connection enabled and data coverage (cellular or WiFi

SJM-CFM-0716-0011a(1)

Last Updated: January 02, 2019

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