St Jude Medical SJMRFICMDM3 Implantable Cardiac Monitor User Manual ICM OUS v1
St. Jude Medical Implantable Cardiac Monitor ICM OUS v1
User Manual
Confirm 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,
Inc. and its related companies.
Pat.
http://patents.sjm.com
©
2016 St. Jude Medical, Inc. All Rights Reserved.
Description
This manual describes the following St. Jude Medical™ device:
Table 1. Confirm Rx insertable cardiac monitor
Name
Model Number
Description
MRI Status
Confirm Rx DM3500 Insertable cardiac
monitor
MR Conditional
The St. Jude Medical™ Confirm Rx™ insertable cardiac monitor (ICM) is designed to detect
arrhythmias and wirelessly transmit data to the Merlin.net™ Patient Care Network (PCN).
The ICM constitutes the inserted portion of the system. The Merlin™ Patient Care System (PCS) with
software version 23.0 (or greater), magnet, myMerlin mobile application (app), and Merlin.net PCN
constitute the external portion of the system.
The Merlin PCS and magnet are used to interrogate and program the device in the clinic. Remote
transmissions are performed using the app. The app also allows patients to record and send EGMs of
symptomatic events to the clinic. All remotely transmitted data is made available on Merlin.net where
clinicians can log in, review data, and make a diagnosis.
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Indications for Use
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 other cardiac arrhythmias. It is also indicated for
patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing
atrial fibrillation.
Magnetic Resonance Imaging (MRI)
The Confirm Rx™ ICM is conditionally safe for use in the MRI environment when used according to
instructions in the MRI Ready Monitor Systems manual.
Contraindications
There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient’s
particular medical condition may dictate whether or not a subcutaneous, chronically inserted device
can be tolerated.
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Warnings and Precautions
Sterilization
The device and the incision and insertion tools have been sterilized with ethylene oxide prior to
shipment. They are intended for single use only and should not be resterilized.
If the sterile package has been compromised, contact St. Jude Medical.
Do not insert the device if the dot on the ethylene oxide label is purple. Purple indicates that the
package has not been sterilized. Return the device to St. Jude Medical.
Package Inspection
Check the "use-before" date on the package label. Do not insert the device if its "use-before" date
has expired.
Do not use the device 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.
Storage
Store the device in a clean area. Store the device between -20° and 60°C because temperatures
outside this range may damage the device.
After cold storage, allow the device to reach room temperature before programming or inserting
the device because cold temperature may affect initial device function.
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Insertion
Insert the device no deeper than 2 cm to ensure reliable data transmission.
Device Replacement
Replace the device within one month of receiving a low battery alert, if necessary or desired.
Replace the device immediately upon receiving a low battery alert if frequent EGMs are being
stored and remotely transmitted.
Explant and Disposal
Interrogate the device and turn monitoring off before explanting, cleaning or shipping the device to
prevent unwanted EGM and episode storage.
Explant the device upon receiving an EOS alert.
Return all explanted devices to St. Jude Medical.
Never incinerate the device because of the potential for explosion. Explant the device before
cremation.
Environmental and Medical Therapy Hazards
Instruct patients to avoid devices that generate a strong electric or magnetic interference (EMI).
EMI could cause device malfunction or damage, resulting in inappropriate episode storage or
inhibition of episode storage. Moving away from the source or turning it off will usually allow the
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device to return to its normal mode of operation.
Hospital and Medical Environments
Electrosurgical cautery may cause device malfunction or damage. If electrocautery is necessary,
keep the current path and groundplate as far away from the device as possible.
External defibrillation may damage the device. Minimize current flowing through the device by
following these precautions when using external defibrillation on a patient with a device:
- Position defibrillation paddles as far from the device as possible (minimum of 13 cm)
- Use the lowest clinically appropriate energy output
- Confirm the device function following any external defibrillation
Do not direct high radiation sources such as cobalt 60 or gamma radiation at the device. If a
patient requires radiation therapy in the vicinity of the device, place lead shielding over the device
to prevent radiation damage and confirm its function after treatment.
Lithotripsy may permanently damage the device. Avoid it unless the therapy site is not near the
device.
Avoid diathermy, even if the device is programmed off, as it may damage tissue around the device
or may permanently damage the device.
Diagnostic and therapeutic ultrasound treatment is not known to affect the function of the device.
Transcutaneous Electrical Nerve Stimulation (TENS) may interfere with device function. To reduce
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interference, place the TENS electrodes close to one another and as far from the device as
possible. Monitor cardiac activity during TENS use.
Radiofrequency (RF) ablation in a patient with a device may cause device malfunction or damage.
Minimize RF ablation risks by:
- Disabling monitoring
- Avoiding direct contact between the ablation catheter and the inserted device
- Positioning the groundplate so that the current pathway does not pass near the inserted
device, i.e., place the groundplate under the patient’s buttocks or legs
Home and Occupational Environments
High-voltage power transmission lines may generate enough EMI to interfere with device operation
if approached too closely.
Communication equipment such as microwave transmitters or high-power amateur transmitters
may generate enough EMI to interfere with device operation if approached too closely.
Home appliances in good working order and properly grounded do not usually produce enough
EMI to interfere with device operation. There are reports of device disturbances caused by electric
hand tools or electric razors used directly over the device insertion site.
Wireless communication devices such as computers that operate on a wireless network, cellular
phones, smart phones, tablets, and even cordless telephones may generate enough EMI to
interfere with device operation.
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A variety of industrial equipment produce EMI of sufficient field strength and modulation
characteristics to interfere with proper operation of the device. These include, but are not limited
to: arc welders; induction furnaces; very large or defective electric motors; and internal
combustion engines with poorly shielded ignition systems.
Electronic Article Surveillance (EAS)
Advise patients that the Electronic Article Surveillance/Anti-theft (EAS) systems such as those at
the point of sale and entrances/exits of stores, libraries, banks, etc., emit signals that may interact
with the device. It is very unlikely that these systems will interact with their device significantly.
However, to minimize the possibility of interaction, advise patients to simply walk through these
areas at a normal pace and avoid lingering near or leaning on these systems.
Metal Detectors
Advise patients 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 significantly. To minimize the possibility of interaction, advise
patients to simply walk through these areas at a normal pace and avoid lingering. Even so, the
device contains metal that may set off the airport security system alarm. If the alarm does sound,
the patient should present security personnel with their patient identification card. If security
personnel perform a search with a handheld wand, the patient should ask that they perform the
search quickly, stressing that they should avoid holding the wand over the device for a prolonged
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period.
Mobile Devices
The device has been tested for compatibility with handheld wireless transmitters in accordance
with the requirements of ISO 14117:2012. This testing covered the operating frequencies (450
MHz - 3 GHz) and pulsed modulation techniques of all of the digital cellular phone technologies in
worldwide use today. Based on the results of this testing, the device should not be affected by the
normal operation of cellular phones when used more than 15 cm from the device.
To minimize the possibility of interaction, advise patients not to carry a cellular phone in a breast
pocket or on a belt within 15 cm of the device, and to use a cellular phone on the side of their
body opposite from the device.
Potential Adverse Events
Possible adverse events (in alphabetical order) associated with the device, include, but are not limited
to the following:
Allergic reaction
Bleeding
Chronic nerve damage
Erosion
Excessive fibrotic tissue growth
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Extrusion
Formation of hematomas or cysts
Infection
Keloid formation
Clinician Use Information
Physician Training
Physicians should be familiar with sterile device insertion procedures and with follow-up evaluation and
management of patients with an insertable cardiac monitor (or should refer the patient to such a
physician).
Package Contents
The device is supplied in a sterile tray for introduction into the operating field. The tray contains:
One monitor
One incision tool
One insertion tool
The outer box contains:
Literature
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Opening the Sterile Package
To open the package:
1. Peel back the outer tray cover, starting with the corner labeled with an arrow.
2. Observing sterile technique, lift up the end of the inner tray that rests in the recess in the outer tray
or flip over the outer tray so that the inner tray falls onto the table.
3. Peel off the inner tray cover, starting with the corner labeled with an arrow.
4. Use the recessed areas to facilitate removing the tools from the tray.
Choosing the Insertion Location
The Confirm Rx™ ICM is inserted under the skin in the left pectoral region. Common insertion locations
are listed in the table below.
Table 2. Insertion locations
Insertion location
Mapping recommended
4th intercostal space, 45° relative to the sternum,
along axis of the heart
No
4th intercostal space, parallel to the sternum No
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Insertion location
Mapping recommended
Anterolateral, inframammary between the 5th and
6th ribs
Yes
Inserting the Device
To insert the device:
1. Pull back the skin and make an angled cut with the incision tool.
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Figure 1. Pull back the skin and make incision
2. Hold the insertion tool as shown in the figure below. Completely insert the introducer under the
skin through the incision site.
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Figure 2. Insert the introducer
3. Hold the insertion tool firmly at the incision site. Withdraw the plunger until the preloaded device
drops into the insertion channel.
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Figure 3. Withdraw the plunger
4. Continue to hold the insertion tool firmly at the incision site. Advance the plunger to insert the
device.
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Figure 4. Advance the plunger
5. Apply pressure to the incision site so that the device does not move, and then remove the insertion
tool.
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Figure 5. Remove the insertion tool
6. Program the device. Refer to the Merlin™ PCS on-screen help for details.
7. Close the incision site.
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Patient Education
St. Jude Medical™ provides a booklet for patients to explain the device and its operation. You can use
this to supplement your discussions with the patient and spouse or other interested persons.
Patient Identification Card
A patient identification (ID) card should be provided to all patients with a Confirm Rx™ ICM. The ID
card indicates that the patient has an inserted cardiac monitor.
Radiopaque Identification
Each device has an x-ray absorptive marker for non-invasive identification. The two-letter model code is
visible on a radiograph.
Table 3. X-ray ID code for Confirm Rx device
Device Model
X-ray ID Model Code
DM3500 CC
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Additional Information
For additional information on this device, see the Merlin™ PCS on-screen help.
FCC Statement
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses, and can radiate
radiofrequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Consult the dealer or an experienced radio/ TV technician for help.
Operation is subject to the following two conditions:
This device may not cause harmful interference.
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This device must accept any interference received, including interference that may cause
undesired operation.
Modifications not expressly approved by the manufacturer could void the user’s authority to operate the
equipment under FCC rules.
RTTE Declaration of Conformity
We, St. Jude Medical Implantable Electronic Systems Division, 15900 Valley View Court, Sylmar,
California 91342, declare under our sole responsibility that the product:
Confirm Rx™ Insertable Cardiac Monitor Model DM3500
to which this declaration relates is in conformity with the essential requirements and other relevant
requirements of the RTTE Directive (1999/5/EC). The product is in conformity with the following
standards and/or other normative documents:
Article 3.1a: Health and Safety Compliance with EN 45502-1/ISO 14708-1.
Limitation of exposure to EMF fields: compliant to
1999/519/EC and EN 62479:2010
Article 3.1b: EMC Compliance with EN 45502-1/ISO 14708-1.
Compliance with IEC 60601-1-2, 4th Edition
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Article 3.2: Spectrum
Compliance with EN 300 328 v1.9.1
Electromagnetic compatibility and Radio spectrum
Matters (ERM); Wideband transmission systems;
Data transmission equipment operating in the 2.4
GHz ISM band and using wide band modulation
techniques; Harmonized EN covering the essential
requirements of article 3.2 of the RTTE Directive
Authorized Representative in the European Union: St. Jude Medical Coordination Center BVBA, The
Corporate Village, Da Vincilaan 11 Box F1, 1935 Zaventem, Belguim
The conformity assessment procedures referred to in Article 10 and detailed in Annex IV of Directive
1999/5/EC has been followed with the involvement of TÜV SÜD BABT Notified body:
Statement of Compliance with License-Exempt RSS
Standard (Canada)
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the
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following two conditions: (1) this device may not cause interference, and (2) this device must accept
any interference, including interference that may cause undesired operation of the device.
Class B Instrument (South Korea)
This instrument is registered as an electromagnetically compatible instrument for home use and may be
used at home and all other locations.
Identification Information for Product Registration
This device has a label that contains, among other information, a product identifier in the following
format:
Table 4. Registration identification information
Identifier Type
Registration Identifier
FCC registration number RIASJMRFICMDM3500
Industry Canada (IC) registration number 8745A-DM3500123
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Wireless Technology Information
The following table summarizes the technical details of the Bluetooth®1 low energy (BLE) technology as
it is implemented in the device.
Table 5. Bluetooth low energy information
Parameter
Data
Antenna type Embedded antenna in header
Antenna dimensions
TBD
Modulation GFSK
Magnetic field strength (at 2 m distance) 34.69 uA/m
Electric field strength (at 2 m distance) 13.07 mV/m
Output power (EIRP*) 1 mW (0 dBm) typical, 10 mW (+10 dBm) maximum
Range 2 m typical
Center frequency 2.44 GHz
Channel 40 channels
Bandwidth 2 MHz per channel
Data flow Bi-directional
1 Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
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Parameter
Data
Protocol BLE
*EIRP = Equivalent isotropically radiated power
Radio Transmitter, Cables, Transducers
The device contains a radio transmitter/receiver with the following parameters.
Radio transmitter parameters:
Frequency (range): 2.4000 to 2.4835 GHz
Bandwidth (-15dB): 2.398 to 2.4855 GHz
Channel: 40 channels using AFH
Modulation: GFSK
Radiated output power: 10 mW (+10 dBm) maximum
Magnetic field strength (at 2 m distance): 34.69 uA/m
Duty cycle: Variable, but low (<5%)
Semi-duplex capability
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The radio receiver in the device is using the same frequency and bandwidth as the transmitter.
Cables and transducers:
Cables and transducers are not used during normal use of the device nor while programming the
device.
Quality of Service for Wireless Technology
Bluetooth® low energy (BLE) wireless technology enables communication between the monitor and the
clinician programmer, smart phone, or tablet. The requirements for the quality of service (QoS) vary
depending on the use environment (operating room, recovery room, and home environment).
After the clinician programmer, smart phone, or tablet is paired with a monitor, the Bluetooth symbol is
visible on the clinician programmer, smart phone, or tablet. When the BLE connection is not active, the
symbol appears dimmed.
Other requirements include a semi-duplex transmission with a required acknowledge, a transmission
latency in each direction (2x), and a receive-to-transmit mode (RX-to-TX) time. Data is resent if not sent
successfully. Each key press may transmit up to 8 data packets, depending on the number of packets
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that need to be transmitted (i.e., if there is only one packet to transmit, only one packet will be
transmitted).
Wireless Security Measures
The wireless signals are secured through device design that includes the following:
The monitor encrypts its wireless communication.
The monitor only communicates with authenticated paired smart phones or tablets.
The monitor only pairs with one smart phone or tablet.
The monitor uses a proprietary pairing protocol in addition to the pairing procedure specified in
Bluetooth low energy protocols.
The monitor authenticates the pairing requests using an industry standard cloud-based
authentication and authorization protocol.
The monitor creates a unique key for the paired unit and verifies it at the onset of every
communication.
Technical Support
St. Jude Medical maintains 24-hour phone lines for technical questions and support:
1 818 362 6822
1 800 722 3774 (toll-free within North America)
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+ 46 8 474 4147 (Sweden)
For additional assistance, call your local St. Jude Medical representative.
Symbols
The following symbols may be found on the product or product label:
Symbol
Description
Sterilized using ethylene oxide
Consult instructions for use
Follow instructions for use on this website
Device has been demonstrated to pose no known hazards in a specified MRI
environment with specified conditions of use.
Date of Manufacture
Manufacturer
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Symbol
Description
Country of manufacture; BE- Belgium, MY- Malaysia, US- United States
Use by
Do not reuse
Serial number
Temperature limits
Humidity limitation
Denotes that the device contains a radio-frequency (RF) transmitter, which
may cause RF interference with other devices near this device.
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Symbol
Description
Authorized EC Representative in the European Community
The device contains a battery and the label is affixed to this device in
accordance with European Council Directives 2002/96/EC and 2006/66/EC.
These directives call for separate collection and disposal of electrical and
electronic equipment and batteries. Sorting such waste and removing it from
other forms of waste lessens the contribution of potentially toxic substances
into municipal disposal systems and into the larger ecosystem.
Return the device to St. Jude Medical at the end of its operating life.
Australian Communications and Media Authority (ACMA) and New Zealand
Radio Spectrum Management (RSM) Regulatory Compliance Mark (RCM)
This equipment is certified for type certification pursuant of Article 38-24 of
the Japan Radio Law
Korea Certification mark for electrical devices
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Symbol
Description
Reorder number
Do not use if package is damaged
Made in USA
Affixed in accordance with European Council Directive 90/385/EEC and
2014/53/EU. Hereby, St. Jude Medical declares that this device is in
compliance with the essential requirements and other relevant provisions of
these Directives.
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Cardiac Rhythm Management Division
Manufacturer:
St. Jude Medical
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
+1 818 362 6822
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
Manufacturing Site:
St. Jude Medical Puerto Rico LLC
Lot A Interior - #2 Rd Km. 67.5
Santana Industrial Park
Arecibo, PR 00612
USA
Manufacturing Site:
St. Jude Medical Operations (M) Sdn. Bhd.
Plot 102, Lebuhraya Kampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia
sjm.com
June 2016
ARTEN100151693 01