REVEAL LINQ™
Medical procedure and EMI precautions
Manual for Health Care Professionals
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.
CareLink, Medtronic, Medtronic CareLink, Reveal, Reveal LINQ, TUNA
1 Medical procedure and EMI precautions
1.1 Introduction
This manual is intended for physicians and other health care professionals who treat patients who have a
Medtronic Reveal LINQ insertable cardiac monitor. To view this manual online or to download it, refer to the
Medtronic Manual Library at www.medtronic.com/manuals.
The "Warnings, precautions, and guidance for clinicians performing medical procedures" section of this document
is useful to health care professionals who perform medical procedures on patients with Medtronic insertable
cardiac monitor systems and who consult with the patients’ cardiologists. This section provides warnings,
precautions, and guidance related to medical therapies and diagnostic procedures that may cause serious injury
to a Reveal LINQ patient, interfere with a Reveal LINQ insertable cardiac monitor (device), or permanently
damage the device.
The "Warnings, precautions, and guidance related to electromagnetic interference (EMI)" section of this
document provides precautions and other information related to electromagnetic interference (EMI) that is helpful
to patients in their daily living. Health care professionals can review the information with their patients and use it
as a reference for post-procedure consultations.
For guidance on unusual or new medical procedures or potential EMI scenarios you are concerned about when
treating Reveal LINQ patients that are not addressed in this manual, contact Medtronic as follows:
●
In the United States, contact a Medtronic representative, Medtronic Technical Services at
tshelp@Medtronic.com or at 1 800 505 4636, or Medtronic Patient Services at 1 800 551 5544.
●
Outside the United States, contact a Medtronic representative.
Caution regarding concomitant device implants: – If the Reveal LINQ patient has an implanted pacemaker or
defibrillator, the automatic detection of arrhythmia episodes in the Reveal LINQ device may be affected by the
paced heart rhythm. To minimize the possibility of the Medtronic CareLink Programmer programming head and
telemetry interfering with a pacemaker or defibrillator, do not hold the Patient Assistant activator or the
programming head directly above an implanted device not manufactured by Medtronic while the Reveal LINQ
programmer application is active.
1.2 Warnings, precautions, and guidance for clinicians performing medical procedures on Reveal LINQ patients
The influence of medical equipment on Reveal LINQ device performance varies considerably according to the
type of unit and energy levels employed. In situations where risks are known, the patient’s Reveal LINQ device
health care provider should interrogate the device and save the device data before performing a medical
procedure that may impact device data. After the medical procedure and at the patient’s and clinician’s earliest
convenience, the patient’s Reveal LINQ device health care provider should check device function.
The following subsections provide warnings, precautions, and guidance for health care providers that perform the
specified medical procedures on Reveal LINQ patients.
1.2.1 Ablation (RF ablation or microwave ablation)
Ablation is a surgical technique in which radio frequency (RF) or microwave energy is used to destroy cells by
creating heat. Ablation may temporarily affect Reveal LINQ device data collection, cause device electrical reset,
or damage the device. To avoid such effects, observe the following precautions:
●
The ablation equipment should not directly contact the Reveal LINQ device.
●
Use short, intermittent, and irregular bursts at the lowest clinically appropriate energy levels.
If an electrical reset occurs, the patient’s Reveal LINQ device health care provider should reprogram device
parameters, as needed.
3
1.2.2 Diagnostic radiology (x-rays, mammograms, CT scans, and fluoroscopy)
Normally, the accumulated dose from diagnostic radiology, such as from chest x-rays, is not sufficient to damage
the Reveal LINQ device. If the device is not directly exposed to the radiation beam, no risk of interference with
device function occurs. However, the following precautions apply to mammograms, CT scans (if the device is
directly in a CT scan beam), and some forms of high-intensity fluoroscopy.
Mammography – Mammography involves compressing the breast between two plates in order to take various
x-ray views. During the mammography procedure, manipulation or angular stress of the Reveal LINQ device
between the plates could cause tissue trauma, vascular trauma, or pain, or affect device sensing. Before
scheduling a mammogram, the cardiologist and mammography clinician should weigh the potential risks against
the benefits and evaluate other diagnostic options. To minimize device manipulation or angular stress that a
mammography procedure can cause, allow sufficient time for the Reveal LINQ device pocket and incision to heal
before performing a mammography procedure.
CT Scan – A CT scan is a computerized process in which two-dimensional x-ray images are used to create a
three-dimensional x-ray image. If the patient undergoes a CT scan procedure and the Reveal LINQ device is
exposed to the CT scan beam, oversensing may occur for the duration of time that the device is in the beam.
Fluoroscopy – Fluoroscopy is an x-ray procedure that makes it possible to see internal organs in motion by
producing a video image. Similar interference as described for CT scan may be observed for some forms of
high-intensity fluoroscopy.
1.2.3 Diagnostic ultrasound
Diagnostic ultrasound is an imaging technique that is used to visualize muscles and internal organs, their size,
structures, and motion as well as any pathological lesions. It also is used for fetal monitoring and to detect and
measure blood flow. Diagnostic ultrasound, such as echocardiogram, poses no risk of electromagnetic
interference.
1.2.4 Diathermy treatment (including therapeutic ultrasound)
Diathermy is a treatment that involves the therapeutic heating of body tissues. Diathermy treatments include high
frequency, short wave, microwave, and therapeutic ultrasound. Except for therapeutic ultrasound, do not use
diathermy treatments on Reveal LINQ patients. Diathermy treatments may result in serious injury or damage to the
Reveal LINQ device. Therapeutic ultrasound is the use of ultrasound at higher energies than diagnostic ultrasound
to bring heat or agitation into the body. Therapeutic ultrasound is acceptable if treatment is performed with a
minimum separation distance of 15 cm (6 in) between the applicator and the Reveal LINQ device. If you have
specific concerns about particular patient conditions and the use of diathermy, contact Medtronic.
1.2.5 Electrosurgery
Electrosurgery (including electrocautery, electrosurgical cautery, and Medtronic Advanced Energy surgical
incision technology) is a process in which an electric probe is used to control bleeding, to cut tissue, or to remove
unwanted tissue. Electrosurgery may temporarily affect Reveal LINQ device data collection, cause device
electrical reset, or damage the device. To avoid such effects, observe the following precautions:
●
The electrosurgery equipment should not directly contact the Reveal LINQ device.
●
Use short, intermittent, and irregular bursts at the lowest clinically appropriate energy levels.
If an electrical reset occurs, the patient’s Reveal LINQ device health care provider should reprogram device
parameters, as needed.
4
1.2.6 External defibrillation and cardioversion
External defibrillation and cardioversion are therapies that deliver an electrical shock to the heart to convert an
abnormal heart rhythm to a normal rhythm. Medtronic cardiac devices are designed to withstand exposure to
external defibrillation and cardioversion. While damage to a cardiac device from an external shock is rare, the
probability increases with increased energy levels. Use the lowest clinically appropriate energy. Do not place
defibrillation paddles directly over the Reveal LINQ device, and try to avoid having the device between the paddles
when defibrillating. Defibrillation may lead to tissue damage, device reset, or loss of stored data. After defibrillation
and at the patient’s and clinician’s earliest convenience, the Reveal LINQ device health care provider should
check device function. If an electrical reset occurs during external defibrillation or cardioversion, the Reveal LINQ
device health care provider also needs to reprogram device parameters.
1.2.7 Hyperbaric therapy (including hyperbaric oxygen therapy, or HBOT)
Hyperbaric therapy is the medical use of air or 100% oxygen at a higher pressure than atmospheric pressure.
Hyperbaric therapies with pressures exceeding 4 ATA (approximately 30 m or 100 ft of seawater) may affect
Reveal LINQ device function or cause device damage. To avoid or mitigate risks, do not expose Reveal LINQ
patients to pressures exceeding 4 ATA.
1.2.8 Lithotripsy
Lithotripsy is a medical procedure that uses mechanical shock waves to break up kidney or gallbladder stones.
Lithotripsy can permanently damage the Reveal LINQ device if it is at the focal point of the lithotripsy beam. If
lithotripsy is required, keep the focal point of the lithotripsy beam at least 5 cm (2 in) from the device. If lithotripsy
is performed closer than 5 cm (2 in) from the device, the Reveal LINQ device health care provider should check
device function at the patient’s and clinician’s earliest convenience.
1.2.9 Magnetic resonance imaging (MRI)
An MRI is a type of medical imaging that uses magnetic fields to create an internal view of the body. Reveal LINQ
is an MR Conditional device. If certain criteria are met and the warnings and precautions provided by Medtronic
are followed, patients with an MR Conditional device are able to undergo an MRI scan. For details on performing
MRI scans on a Reveal LINQ device patient, contact the patient’s cardiologist or Medtronic to obtain the
Reveal LINQ MRI Technical Manual or to get answers to your questions.
1.2.10 Radiation therapy
Exposing the Reveal LINQ device to therapeutic levels of ionizing radiation (such as that produced by cobalt
machines or linear accelerators used for cancer treatment) may trigger inappropriate episode detection or corrupt
the data stored in memory. After radiation therapy and at the patient’s and clinician’s earliest convenience, the
Reveal LINQ device health care provider should check device function. Cumulative radiation levels above 5 Gy
may permanently damage the device.
1.2.11 Radiotherapy
Radiotherapy is a cancer treatment that uses radiation to control cell growth. Exposing the Reveal LINQ device to
direct or scattered neutrons may cause electrical reset of the device, errors in device function, errors in diagnostic
data, or loss of diagnostic data. To help reduce the chance of electrical reset due to neutron exposure, deliver
radiotherapy treatment using photon beam energies less than or equal to 10 MV. The use of conventional x-ray
shielding during radiotherapy does not protect the device from the effects of the neutrons. If photon beam energies
exceed 10 MV, Medtronic recommends that the Reveal LINQ device health care provider interrogate the device
immediately after radiotherapy treatment. If an electrical reset occurs, the patient’s Reveal LINQ device health
care provider should reprogram device parameters, as needed. Electron beam treatments that do not result in
neutron production will not cause electrical reset of the device.
5
1.2.12 Transcutaneous electrical nerve stimulators (TENS)
TENS therapy (including neuro muscular electrical stimulation or NMES) is a pain control technique that uses
electrical impulses passed through the skin to stimulate nerves. Using TENS equipment can affect the data stored
in the cardiac device.
1.2.13 Transurethral Needle Ablation (Medtronic TUNA® therapy)
Transurethral needle ablation is a surgical procedure used for benign prostatic hyperplasia (BPH) in which
precisely focused, conducted radiofrequency energy is used to ablate prostate tissue. Reveal LINQ patients may
conditionally undergo procedures that use the Medtronic TUNA system. To avoid affecting Reveal LINQ device
function when performing the TUNA procedure, position the return electrode on the lower back or lower extremity
at least 15 cm (6 in) away from the Reveal LINQ device.
1.3 Warnings, precautions, and guidance related to electromagnetic interference (EMI) for Reveal LINQ patients
The Reveal LINQ cardiac monitor is not affected by most household electrical items. However, the
electromagnetic energy fields of certain electrical items may temporarily affect the cardiac monitor’s ability to
collect information about the patient’s heart and can reduce the amount of data available for the clinic to analyze.
By following simple guidelines included in this section, the patient may avoid data collection problems related to
electrical interference. Any effects of electromagnetic energy fields on the heart monitor data will stop when the
patient moves away from the source of the electromagnetic energy field.
The following information is also provided to the patient in the Reveal LINQ patient manual. The cardiology nurse
or doctor may want to review this information with the Reveal LINQ patient. If you have any questions or concerns
about EMI, contact a Medtronic representative.
1.3.1 General guidelines for patients
Area restrictions – Before entering an area where signs are posted prohibiting persons with an implanted cardiac
device, such as a pacemaker, ICD, or cardiac monitor, consult with your doctor.
Proper grounding of electrical items – To avoid interference from electrical current that may leak from
improperly grounded electrical items and pass through the body, observe the following precautions:
●
Make sure that all electrical items are properly wired and grounded.
●
Make sure that electrical supply lines for swimming pools and hot tubs are properly installed and grounded
according to local and national electrical code requirements.
1.3.2 Wireless communication devices
Wireless communication devices include transmitters that can affect cardiac devices. When you use wireless
communication devices, keep them at least 15 cm (6 in) away from your cardiac device. The following items are
examples of such devices:
●
Handheld cellular, mobile, or cordless telephones (wireless telephones); two-way pagers; personal digital
assistants (PDAs); smartphones; and mobile email devices
●
Wireless-enabled devices such as laptop, notebook, or tablet computers; network routers; MP3 players;
e-readers; gaming consoles; televisions; DVD players; and headsets
●
Remote keyless entry and remote car starter devices
Using wireless telephones – Cardiac devices have been tested with many types of wireless telephone
technologies to ensure that they operate correctly while a wireless phone is in use. Keep a cardiac device at least
15 cm (6 in) away from the antenna of a handheld wireless telephone (for example, by holding the telephone to the
ear farthest away from the cardiac device). Do not carry the telephone in a pocket over the device or in a shoulder
bag near the device.
6
1.3.3 Household and hobby items with motors and other items that cause EMI
Household and hobby items that have motors or that generate electromagnetic energy fields could interfere with
a cardiac device. Keep a cardiac device at least 15 cm (6 in) away from the following items:
●
Handheld kitchen appliances, such as electric mixers
●
Sewing machines and sergers
●
Personal care items, such as corded handheld hair dryers, corded electric shavers, electric or ultrasonic
toothbrushes (base charger), or back massagers
●
Remote controller of radio-controlled toys
●
Two-way walkie-talkies (less than 3 W)
The following sections describe some household and hobby items that require special precautions:
Induction cook tops – An induction cook top uses an alternating magnetic field to generate heat. Keep a cardiac
device at least 60 cm (24 in) away from the heating zone when the induction cook top is turned on.
Electronic body fat scale – Using this type of scale can affect the data stored in the cardiac device.
UPS (uninterruptable power source) up to 200 amperes – Keep a cardiac device at least 30 cm (12 in) away
from a UPS. If the UPS is operating by battery source, keep a cardiac device at least 45 cm (18 in) away.
Electronic pet fences or invisible fences – Keep a cardiac device at least 30 cm (12 in) away from the buried
wire and the indoor antenna of electronic pet fences or invisible fences.
Home-use electric kilns – Keep a cardiac device at least 60 cm (24 in) away from home-use electric kilns.
Handheld metal detectors – Keep a cardiac device at least 60 cm (24 in) away from the detector end.
Boat motors – Keep a cardiac device at least 30 cm (12 in) away from electric trolling motors or gasoline-powered
boat motors.
Portable electric generators up to 20 kW – Keep a cardiac device at least 30 cm (12 in) away from portable
electric generators.
1.3.4 Home power tools
Most home power tools should not affect cardiac devices. Consider the following common-sense guidelines:
●
Keep all equipment in good working order to avoid electrical shock.
●
Be certain that plug-in tools are properly grounded (or double insulated). Using a ground fault interrupter outlet
is a good safety measure (this inexpensive device prevents a sustained electrical shock).
Some home power tools could affect cardiac device operation. Consider the following guidelines to reduce the
possibility of interference:
Electric yard and hand-held power tools (plug-in and cordless) – Keep a cardiac device at least 15 cm (6 in)
away from such tools.
Soldering guns and demagnetizers – Keep a cardiac device at least 30 cm (12 in) away from these tools.
Gasoline-powered tools and gasoline-powered yard equipment – Keep a cardiac device at least 30 cm
(12 in) away from components of the ignition system. Turn off the motor before making adjustments.
Car engine repair – Turn off car engines before making any adjustments. When the engine is running, keep a
cardiac device at least 30 cm (12 in) away from components of the ignition system.
7
1.3.5 Industrial equipment
After recovering from the Reveal LINQ insertion procedure, you likely will be able to return to work, to school, or
to your daily routine. However, if you will be using or working near high-voltage equipment, sources of high
electrical current, magnetic fields, or other EMI sources that may affect device operation, consult with your doctor.
You may need to avoid using, or working near, the following types of industrial equipment:
●
Electric furnaces used in the manufacturing of steel
●
Induction heating equipment and induction furnaces, such as kilns
●
Industrial magnets or large magnets, such as those used in surface grinding and electromagnetic cranes
●
Dielectric heaters used in industry to heat plastic and dry glue in furniture manufacturing
●
Electric arc and resistance welding equipment
●
Broadcasting antennas of AM, FM, shortwave radio, and TV stations
●
Microwave transmitters. Note that microwave ovens are unlikely to affect cardiac devices
●
Power plants, large generators, and transmission lines. Note that lower voltage distribution lines for homes
and businesses are unlikely to affect cardiac devices.
1.3.6 Radio transmitters
Determining a safe distance between the antenna of a radio transmitter and a cardiac device depends on many
factors such as transmitter power, frequency, and the antenna type. If the transmitter power is high or if the antenna
cannot be directed away from a cardiac device, you may need to stay farther away from the antenna. Refer to the
following guidelines for different types of radio transmitters:
Two-way radio transmitter (less than 3 W) – Keep a cardiac device at least 15 cm (6 in) away from the antenna.
Portable transmitter (3 to 15 W) – Keep a cardiac device at least 30 cm (12 in) away from the antenna.
Commercial and government vehicle-mounted transmitters (15 to 30 W) – Keep a cardiac device at least
60 cm (24 in) away from the antenna.
Other transmitters (125 to 250 W) – Keep a cardiac device at least 2.75 m (9 ft) away from the antenna. For
transmission power levels higher than 250 W, contact a Medtronic representative for more information.
1.3.7 Security systems
When passing through security systems, follow these precautions:
Electronic antitheft systems, such as in a store or a library, and point-of-entry control systems, such as
gates or readers that include radio frequency identification equipment – These systems should not affect
a cardiac device, but, as a precaution, do not linger near or lean against such systems. Simply walk through these
systems at a normal pace.
Airport, courthouse, and jail security systems – Given the short duration of security screening, it is unlikely
that metal detectors (walk-through archways and handheld wands) and full body imaging scanners (also called
millimeter wave scanners and three-dimensional imaging scanners) in airports, courthouses, and jails will affect
a cardiac device. When encountering these security systems, follow these guidelines:
●
Always carry your cardiac device ID card. If a cardiac device sets off a metal detector or security system, show
your ID card to the security operator.
●
Minimize the risk of temporary interference with your cardiac device while going through the security
screening process by not touching metal surfaces around any screening equipment.
●
Do not stop or linger in a walk-through archway; simply walk through the archway at a normal pace.
●
If a handheld wand is used, ask the security operator not to hold it over or wave it back and forth over your
cardiac device.
●
If you have concerns about security screening methods, show your cardiac device ID card to the security
operator, request alternative screening, and then follow the security operator’s instructions.
8
Medtronic, Inc.
*M955776A001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636
Europe/Africa/Middle East
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41 21 802 7000
Technical manuals
www.medtronic.com/manuals
© Medtronic, Inc. 2013
M955776A001A
2013-07-22
Loading...