St. Jude Medical Confirm Rx DM3500 User manual

Conrm Rx™
Model DM3500
Insertable Cardiac Monitor
User's Manual

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical
or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service
marks of St. Jude Medical, LLC and its related companies.
‡ Indicates a third-party trademark, which is property of its respecve owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
Pat. hp://www.abbo.com/patents
© 2022 St. Jude Medical, LLC. All Rights Reserved.

Descripon
This manual describes the following St. Jude Medical™ device:
Table 1. Conrm Rx insertable cardiac monitor
Name Model Number Descripon MRI Status
Conrm Rx DM3500 Insertable cardiac
monitor
MR Condional
The St. Jude Medical™ Conrm Rx™ insertable cardiac monitor (ICM) is designed to monitor and store
electrogram (EGM) data and to communicate with the programmer and paent applicaon.
The ICM constutes the inserted poron of the system. The Merlin™ Paent Care System (PCS) with
soware version 23.0 (or greater), myMerlin™ mobile applicaon (app), and Merlin.net PCN, and the
external magnet constute the external poron of the system.
The myMerlin™ mobile applicaon will provide internet connecvity to enable the clinician to access a
paent’s device data through a clinician portal.
Intended Purpose
The Conrm Rx™ ICM is intended to help physicians and clinicians monitor, diagnose and document the
heart rhythm in paents who are suscepble to cardiac arrhythmias and unexplained symptoms by
detecng arrhythmias and transming data for review.
1

Indicaons
The Conrm Rx™ ICM is indicated for the monitoring and diagnosc evaluaon of paents who experience
unexplained symptoms that may be associated with cardiac arrhythmias, such as: dizziness, palpitaons,
chest pain, syncope, and shortness of breath, as well as paents who are at risk for abnormal cardiac
rhythms such as bradycardia, tachycardia, and sinus pauses. The Conrm Rx ICM is also indicated for
paents who have been previously diagnosed with atrial brillaon (AF) or who are suscepble to
developing AF. The Conrm Rx ICM is intended to be inserted subcutaneously in the le pectoral region,
also described as the le anterior chest wall.
Intended Use
The Conrm Rx™ ICM is intended to help physicians and clinicians monitor, diagnose and document the
rhythm in paents who are suscepble to cardiac arrhythmias and unexplained symptoms, as indicated.
Table 2. Accessories and their intended uses
Accessory Model Number Intended use
Incision tool DM3520 The Conrm Rx ICM Incision Tool is intended to
puncture the skin, as a rst step during the inseron
procedure of the Conrm Rx ICM.
Inseron tool DM3510 The Conrm Rx ICM Inseron Tool is intended to
create a subcutaneous pocket and deliver the
2

Table 2. Accessories and their intended uses
Accessory Model Number Intended use
Conrm Rx ICM through the skin incision into the
subcutaneous pocket.
Accessory kit DM3500A The Conrm Rx ICM Accessory Kit, which includes
the incision and inseron tool, is intended to
implant the Conrm Rx ICM device.
Intended Paent Populaon
The intended paent populaon for the Conrm Rx™ ICMs includes adults who meet the indicaons for use.
The Conrm Rx has not been tested in pediatric paents.
Intended User
The Conrm Rx™ ICM device should be used by or under the supervision of physicians or allied health
professionals trained in the implantaon and management of implantable cardiac monitors.
3

Intended Clinical Benets
The intended clinical benet of Conrm Rx™ ICM is to help physicians and clinicians monitor, diagnose and
document the heart rhythm in paents who are at risk for cardiac arrhythmias by detecng arrhythmias and
unexplained symptoms and transming data for review.
The expected clinical performance of the Conrm Rx ICM is an R-wave amplitude of comparable to or higher
than 0.2 mV, an AF detecon sensivity that is comparable to or greater than 78 percent and an AF
detecon posive predicve value that is comparable to or greater than 64 percent.
MRI Safety Informaon
Tesng has demonstrated that the Conrm Rx™ ICM is condionally safe for use in the MRI environment
when used according to instrucons in the MRI Ready Monitor Systems manual.
CAUTION: Advise paents that they should not bring a mobile device into the scanner magnet room.
Mobile devices are considered MR Unsafe.
Contraindicaons
There are no known contraindicaons for the inseron of the Conrm Rx™ ICM. However, the paent’s
parcular medical condion may dictate whether or not a subcutaneous, chronically inserted device can be
tolerated.
4

Data Security
St. Jude Medical takes a broad and deep approach to ensuring the safety, security and privacy of the paent
informaon and data on our devices and systems connecng paents to healthcare providers and clinics.
Paents, clinical sta, and hospital IT sta do not need to congure the device or take any special acon, for
example rewall use, to safeguard paent informaon and device data. The following safeguards are
provided:
▪To prevent unauthorized data access, the device encrypts wireless communicaon.▪
▪Over BLE, the device checks the authorizaon of any external enty before granng it access. ▪
All safeguards for the devices will be provided throughout the stated warranty period or unl a replacement
product is available. The cybersecurity bill of materials (CBOM) is available upon request.
Bluetooth Communicaon
The device uses BLE with authencaon methods to enable use with only applicable St. Jude Medical™
authorized products.
In the event of excessive BLE usage, which is an indicator of a possible aack on the device baery, BLE
communicaon is turned o. The programmer will read the BLE shut-o during a clinic visit. You may choose
to alert the paent of this occurrence.
5

Summary of Safety and Clinical Performance
A summary of the safety and clinical performance for this device is available at hps://ec.europa.eu/tools/
eudamed. Search for the device using the UDI-DI provided on the outer packaging of the device. This is the
SSCP locaon aer the launch of the European Database on Medical Devices/Eudamed.
Warnings
Device Replacement
▪Replace the device within one month of receiving a low baery alert, if necessary or desired. Replace
▪
the device immediately upon receiving a low baery alert if frequent EGMs are being stored and
remotely transmied.
Precauons
Sterilizaon and Reuse
▪The package contents have been sterilized with ethylene oxide before shipment. This device is FOR▪
SINGLE USE ONLY and is not intended to be resterilized.
6

▪Do not reuse or resterilize. The eects of reprocessing are unknown and these devices have not been▪
tested for reuse.
▪Do not use the device or accessories if the packaging is wet, punctured, opened or damaged because ▪
the integrity of the sterile packaging may be compromised. Return the device to St. Jude Medical.
▪Do not implant the device when the sterility indicator within the inner package is purple, because it▪
might not have been sterilized, or when the storage package has been pierced or altered, because this
could have rendered it non-sterile.
Inspecng and Handling the Device
Inspect the packaging before removing the device. Do not implant the device if the Use Before Date on the
outer box and the tray has been exceeded. Prior to implant, interrogate the device to verify baery status.
Storage and Handling
▪Store the device at room temperature of 22°C (72°F). Excursions are permied between 15°C and 30°C ▪
(59°F and 86°F).
▪During transportaon and handling, the device can be exposed to temperature excursions between ▪
-20°C and 60°C (-4°F and 140°F).
▪Exposure to temperatures outside this range may result in damage to the device or device malfuncon. ▪
7

▪Do not implant a device that has been dropped on a hard surface while outside of its intact shelf▪
package, or from a height of more than 24 inches (61 cm) while within its intact shelf package. Sterility,
integrity, or funcon cannot be guaranteed under these condions, and the device should be returned
to St. Jude Medical for inspecon.
Temperature Equilibrium
▪Aer cold storage, allow the device to reach room temperature before programming or inserng the
▪
device because cold temperature may aect inial device funcon.
Inseron
▪Ensure that the paent’s skin or ssue condion is conducive to ICM implant. Implanng device on frail/ ▪
thin paents, paents with a large amount of subcutaneous fat, droopy skin, or non-elasc skin may
lead to skin erosions.
▪Insert the device in the subcutaneous space, just under the skin. Place the device no deeper than 2 cm ▪
to ensure reliable data transmission.
▪Ensure the correct orientaon of the ICM device in the Inseron Tool by making sure the labelling is ▪
facing outward (visible) and aligned right-side-up with the labelling on the inseron tool.
8

Environmental and Medical Therapy Hazards
▪Advise paents to avoid devices that generate a strong electric or magnec interference (EMI). EMI▪
could cause malfuncon of or damage to the device, resulng in inappropriate episode storage or
inhibion of episode storage. Moving away from the source or turning it o will usually allow the device
to return to its normal mode of operaon.
Hospital and Medical Environments
Electrosurgical Cautery
▪Electrosurgical cautery may cause device malfuncon or damage. If electrocautery is necessary, keep ▪
the current path and ground plate as far away from the device as possible.
External Debrillators
▪External debrillaon may damage the device. Minimize current owing through the device by▪
following these precauons when using external debrillaon on a paent with a device:
–Posion debrillator paddles as far from the device as possible (a minimum of 13 cm). –
–Use the lowest clinically appropriate energy output. –
–Conrm the device is funconing following any external debrillaon. –
9
–
–
–

High Radiaon Sources
▪Do not direct high radiaon sources such as cobalt 60 or gamma radiaon at the device. If a paent▪
requires radiaon therapy in the vicinity of the device, place lead shielding over the device to prevent
radiaon damage, and conrm the device is funconing aer treatment.
Medical Lithotripsy
▪Lithotripsy may permanently damage the device. Avoid it unless the therapy site is not near the device. ▪
Diathermy
▪Avoid diathermy, even if the device is programmed o, as it may damage ssue around the device or
▪
permanently damage the device.
Ultrasound Therapy
▪The device should not be exposed to therapeuc levels of ultrasound energy, as the device can ▪
inadvertently concentrate the ultrasound eld and cause harm that might not be immediately
detectable. Diagnosc ultrasound treatment is not known to aect the funcon of the device.
Transcutaneous Electrical Nerve Smulaon
▪Transcutaneous Electrical Nerve Smulaon (TENS) may interfere with device funcon. To reduce ▪
interference, place the TENS electrodes close to one another and as far from the device as possible.
Monitor cardiac acvity during TENS use.
10

Radiofrequency Ablaon
Radiofrequency ablaon in a paent with a device may cause malfuncon or damage. Minimize RF ablaon
risks by:
▪Disabling monitoring▪
▪Avoiding direct contact between the ablaon catheter and the inserted device▪
▪Posioning the groundplate so that the current pathway does not pass near the inserted device. For ▪
example, place the groundplate under the paent's buocks or legs.
Home and Industrial Environments
▪A variety of devices produce electromagnec interference (EMI) of sucient eld strength and
▪
modulaon characteriscs to interfere with proper operaon of the device. These include: high-
powered radio, television, and radar transmiers/antennas; high-voltage transmission lines; home
appliances; arc or resistance welders; equipment with large motors; inducon furnaces; very large or
defecve electric motors; and internal combuson engines with poorly shielded ignion systems.
▪Advise paents to not play sports or engage in acvies where there is a risk of repeve blows to the ▪
implanted device area.
11

Electronic Arcle Surveillance (EAS)
▪Advise paents that the Electronic Arcle Surveillance/An-the (EAS) systems such as those at the▪
point of sale and entrances/exits of stores, libraries, banks, or tag readers that include radio frequency
idencaon (RFID) equipment emit signals that may interact with the device. To minimize the
possibility of interacon, advise paents to simply walk through these areas at a normal pace and avoid
lingering near or leaning on these systems.
Metal Detectors
▪Advise paents that metal detector security systems such as those found in airports and government▪
buildings emit signals that may interact with their device. It is very unlikely that these systems will
interact with their device signicantly. To minimize the possibility of interacon, advise paents to
simply walk through these areas at a normal pace and avoid lingering. Even so, the device contains
metal that may set o the airport security system alarm. If the alarm does sound, the paent should
present security personnel with their paent idencaon card. If security personnel perform a search
with a handheld wand, the paent should ask that they perform the search quickly, stressing that they
should avoid holding the wand over the device for a prolonged period.
Wireless Communicaons Devices
▪To minimize the possibility of interacon, advise paents not to carry a cellular / mobile phone in a ▪
breast pocket or on a belt within 15 cm of the device, and to use a cellular / mobile phone on the side
of their body opposite from the device.
12

Explant and Disposal
▪Interrogate the device to acquire stored EGMs and episode data and turn monitoring o before▪
explanng, cleaning or shipping the device to prevent unwanted EGM and episode storage.
▪Explant the device with standard surgical tools upon receiving an End-of-Service (EOS) alert. ▪
▪Locate the device by palpang it or by using uoroscopy and mark its locaon (directly above the ▪
implanted device or the header side of the device). Following asepc techniques, make an incision
either on the implant scar or at the header end of the ICM wide enough to accommodate the ICM.
Ensure that the device is freed from suture before removing the device.
▪Return all explanted devices to St. Jude Medical.
▪
▪Never incinerate the device because of the potenal for explosion. Explant the device before cremaon.▪
Potenal Adverse Events
Possible adverse events (in alphabecal order) associated with the device, include the following:
▪Allergic reacon▪
▪Bleeding ▪
▪Chronic nerve damage▪
▪Erosion ▪
▪Excessive broc ssue growth ▪
13

▪Extrusion▪
▪Formaon of hematomas or cysts ▪
▪Infecon▪
▪Keloid formaon▪
▪Migraon▪
Clinician Use Informaon
Physician Training
Physicians should be familiar with sterile device inseron procedures and with follow-up evaluaon and
management of paents with an insertable cardiac monitor (or should refer the paent to such a physician).
See the Monitoring Devices Help manual for instrucons on programming the insertable cardiac monitor.
Paent Follow-Up
The frequency of paent remote monitoring and follow-up visits depends on the paent's condion and
should be determined by the healthcare praconer. See the Monitoring Devices Help manual for more
informaon.
A follow-up visit should include (at a minimum):
14

▪Review of the FastPath™ Summary screen▪
▪Review of stored episodes and real-me EGMs ▪
▪Conrmaon that the nal parameter sengs are correct.▪
See also:
▪Baery Status (page 30)▪
Package Contents
The device is supplied in a sterile tray for introducon into the operang eld. The tray contains:
▪One monitor
▪
▪One incision tool▪
▪One inseron tool
▪
The outer box contains:
▪Literature ▪
Pre-Inseron Device Setup
Prior to opening the sterile package, apply a magnet to the Conrm Rx device for at least three seconds and
then remove. Interrogate the device with the Merlin™ PCS and follow the on-screen prompts. The user
15

interface will provide a prompt to insert the device once the required informaon is entered. See the
Monitoring Devices Help manual for instrucons on programming the insertable cardiac monitor.
Opening the Sterile Package
To open the package:
1. Peel back the outer tray cover, starng with the corner labeled with an arrow.1.
2. Observing sterile technique, li up the end of the inner tray that rests in the recess in the outer tray or2.
ip over the outer tray so that the inner tray falls onto the table.
3. Peel o the inner tray cover, starng with the corner labeled with an arrow.3.
4. Use the recessed areas to facilitate removing the tools from the tray.4.
Choosing the Inseron Locaon
The Conrm Rx™ ICM is inserted under the skin in the le pectoral region. Common inseron locaons are
listed in the table below. Mapping may be benecial as part of the pre-inseron process, especially for the
Anterolateral, inframammary posion between the 5th and 6th ribs.
Table 3. Inseron locaons
4th intercostal space, 45° relave to the sternum, along axis of the heart
16

Table 3. Inseron locaons
4th intercostal space, parallel to the sternum
Anterolateral, inframammary between the 5th and 6th ribs
NOTE:
▪ An implant site parallel to the midline, closer to the sternum and away from the lower half of the pectoral▪
region and breast area may help minimize device movement.
▪ Consider paent comfort when selecng an inseron locaon.▪
General Site Mapping
Either clinical ECG equipment or the Merlin™ PCS may be used to perform surface mapping. See the
Monitoring Devices Help manual for a descripon of how to perform mapping using the Merlin PCS.
When performing pre-inseron surface mapping, use conducve ECG patches spaced approximately 4 cm
apart. This distance approximates the Conrm Rx ICM inter-electrode spacing.
Evaluate potenal inseron locaons to opmize the following signal characteriscs:
▪High amplitude R-wave that demonstrates minimal variaon in dierent paent posions, such as ▪
sing versus lying down.
▪High R-wave to T-wave rao ▪
17

Inserng the Device
To insert the device:
1. Prepare the inseron site using convenonal ansepc and local anesthec procedures.1.
2. Pull back the skin and make an angled cut with the incision tool.2.
NOTE: Create the incision above the nal insertable cardiac monitor posion to reduce the force of
gravity acng on the incision site during healing.
Figure 1. Pull back the skin and make incision
18