Jot Dx™ Insertable Cardiac Monitor

Model: DM4500

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Overview

The Jot Dx™ Insertable Cardiac Monitor (ICM) with SharpSense™ technology is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net™ Patient Care Network (PCN) for patients experiencing symptoms that may be cardiac-related, at risk for abnormal cardiac rhythms, or previously diagnosed with or susceptible to developing atrial fibrillation (AF).

The Jot Dx ICM utilizes the key episode feature on Merlin.net PCN to reduce monitoring burden, allowing the feature to be toggled on or off at facility or patient level.

Product Highlights

Device

The slim design allows a simple insertion procedure requiring minimal time and resources. Not noticeable after insertion in most patients.
SharpSense™ technology improves the detection of AF, Bradycardia and Pause, with high relative sensitivity.
Electrogram (EGM) scatterplots to easily identify relationships between variables.
Intuitive one-touch programming on the Merlin™ Patient Care System.
Remote monitoring ready.

Mobile App and Connectivity

Patient-activated and auto-activated triggers for EGM storage.
Proven SenseAbility™ sensing algorithm feature designed to allow accurate sensing over a wide range of signals.
Device is 1.5 Tesla (T) and 3T MR Conditional.
Bluetooth® wireless technology connects the ICM to the myMerlin™ mobile app, downloadable onto a smartphone. No separate bedside transmitter or patient activator is needed.
The ICM continuously monitors rhythm, and the myMerlin mobile 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 without requiring separate activator hardware.
App notifications inform patients of daily device checks and scheduled transmissions to promote remote monitoring adherence without burdening the clinic.
Over 35 languages are available on the myMerlin Mobile App for patient engagement and a personalized experience.
Transmissions are sent to the Merlin.net PCN, providing clinicians with data and reports.
Abbott mobile transmitters are available for patients without their own compatible mobile device.

Ordering Information

Contents: ICM device, insertion tool, and incision tool

MODEL NUMBER	DESCRIPTION	DIMENSIONS (H × W × T, MM)	WEIGHT (G)	VOLUME (CM³)	LONGEVITY
DM4500	Jot Dx ICM	49 x 9.4 x 3.1	3.0	1.4	2 years

Product Specifications

PHYSICAL SPECIFICATIONS

Model Number	DM4500
Device Coating	Parylene
X-Ray ID Model Code	CC
Telemetry	Bluetooth®

FEATURES

Parameter	Settings
Patient Trigger	Yes
Symptom Alert	Off / On (All Symptoms) / On (with Detection)
Remote Monitoring	myMerlin™ mobile app via Bluetooth® wireless technology
Patient Activator	myMerlin mobile app via Bluetooth® wireless technology
Tachycardia Trigger and Alert	Yes
Bradycardia Trigger and Alert	Yes
Pause Trigger and Alert	Yes
AF Trigger and Alert	Yes
Programmable AF Episode Duration	30 seconds, 1, 2, 6, 10, 20, 30, 60 min
AF Burden Alert	Off, 30 minutes, 1, 3, 6, 9, 12, 24 hrs
AF Continuous Episode Alert	Off, 10, 20, 30, 60, 180 min
Ventricular Rate during AF Alert	Off
AF Alert	Rate Threshold: 90, 100, 110, 120, 130, 140, 150, 175, 200 bpm Total Time: 1, 3, 6, 9, 12 hrs
Activity Inhibits Auto Detection	Programmable; On or Off
Noise Response Inhibits Auto Detection	Yes

DIAGNOSTICS

Parameter	Settings
Episodal Diagnostics	Yes
Total EGM Storage	60 min
Symptom EGM Duration	Pre-trigger – 4, 6, 8, 10, 12, 14 min Post-trigger – 30, 40, 50, 60 sec
Auto Detected EGM Duration	AF Pre- and Post-trigger – 10, 20, 30, 60, 90, 120 sec Other (Tachy, Brady, Pause) Pre- and Post-trigger – 10, 20, 30, 40, 50, 60 sec
Heart Rate Histogram	Yes
AF Diagnostics	Yes
AF Burden Trend	Yes

Longevity provided the following usage scenarios:

Average of one auto-detected episode per day
Average of one patient-activated symptom episode per month
Up to six-month shelf storage time

NOTE: At a maximum shelf storage time of 18 months, longevity is reduced by approximately five months.

Security Measures

The ICM encrypts its wireless communication and patient health information (PHI) data both at rest and in-transit from the ICM to the myMerlin™ Mobile App and Merlin.net™ PCN. All data is encrypted using Advanced Encryption Standard (AES).
AES 128-bit encryption is designed to limit communication to only a single authenticated and paired app transmitter at any given time.
The ICM uses the pairing procedure specified in Bluetooth® wireless technology low energy protocols and a proprietary pairing protocol as an added security measure. Pairing requests are authenticated using certificate-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.
Firmware upgrades for the ICM are cryptographically authenticated before installation.
The Merlin.net PCN is housed in a secured data center and is ISO27001:2013 certified. Access to patient data in the Merlin.net PCN is restricted to authorized users as set by the clinic administrator.

Rx Only

Brief Summary

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications for Use

Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. Jot Dx™ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. Jot Dx™ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. Jot Dx™ ICM has not been specifically tested for pediatric use.

Intended Use

Abbott ICMs are intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.

Contraindications

There are no known contraindications for the insertion of Jot Dx™ ICM. However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Potential 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 for use, contraindications, warnings, precautions and potential adverse events.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

	Jot Dx Insertable Cardiac Monitor User Manual User's manual for the Abbott Jot Dx Insertable Cardiac Monitor (Model DM4500), detailing its indications, contraindications, warnings, storage, insertion, explantation, and technical specifications.
	Abbott Insertable Cardiac Monitor System Patient Manual A comprehensive patient manual for the Abbott Medical Insertable Cardiac Monitor System, including Confirm Rx™ and Jot Dx™ models, and the myMerlin™ Mobile Application. This guide provides essential information on system operation, setup, and troubleshooting for patients.
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