Medical Procedure and EMI Warnings, Precautions, and
Guidance
for implanted pacemakers and defibrillators
Manual for Health Care Professionals
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to
their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or
in other countries.
This manual is for physicians and other health care professionals who treat patients who have the following
Medtronic implanted cardiac devices:
• Pacemakers, including cardiac resynchronization therapy pacemakers (CRT-P)
• Cardioverter defibrillators (ICD), including cardiac resynchronization therapy defibrillators (CRT-D)
Note: The warnings, precautions, and guidance in this manual do not apply to patients who have leadless
transcatheter cardiac devices or implantable cardiac monitors.
To view or download this manual online, see the Medtronic eManuals website at www.medtronic.com/manuals.
Chapter 2 provides a short overview of electromagnetic interference (EMI).
3
Chapter 3 describes the most common device responses to electromagnetic interference (EMI).
Chapter 4 provides EMI guidelines for clinicians to discuss with their patients.
Chapter 5 provides guidance for the perioperative care of patients with implanted devices for medical procedures.
Chapter 6 provides information related to EMI for health care professionals who perform medical procedures on
patients with Medtronic implanted cardiac device systems, in consultation with patient cardiologists. This section
provides warnings, precautions, and guidance for medical therapies and diagnostic procedures that present
potential risk to the patient or to the operation or physical integrity of the Medtronic system. Some common medical
procedures that pose no risk for EMI are also listed. This chapter also includes technical and procedural
information for the application of a Medtronic Model 9466 patient magnet. The patient magnet can mitigate the
effects of EMI on an implanted device. Use of the patient magnet is suggested for a number of the medical
therapies and diagnostic procedures described in this chapter.
Chapter 7 provides precautions and other information related to 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-implant
consultations.
For guidance on medical procedures or potential EMI scenarios that are not documented in this manual,
customers can contact the following Medtronic resources:
• Customers in the USA can contact Medtronic Technical Services at +1 800 505 4636 for pacemakers and
CRT-Ps or +1 800 723 6243 for ICDs and CRT-Ds. You can also submit questions to tshelp@medtronic.com
or to your Medtronic representative.
• Customers outside of the USA can contact a Medtronic representative.
2 Overview of electromagnetic interference (EMI)
This chapter details the types of EMI and lists the electromagnetic field intensity limits for Medtronic implanted
pacemakers and ICDs.
2.1 Types of EMI
Medtronic pacemakers and ICDs comply with standards for testing of implanted cardiac devices in the presence
of EMI. These devices operate properly when a patient is exposed to the electromagnetic fields commonly
encountered at work, at home, or in other environments. Medtronic advises patients, their clinicians, and their
employers to consult with each other to consider EMI safety before the patient returns to work after receiving a
pacemaker or an ICD.
Note: See Section 2.2, Applicable standards for safety and electromagnetic compatibility, page 5 for more
information.
There are 3 principal types of EMI:
• Conducted interference occurs when the patient is in direct contact with the electrical source. The greatest
risk occurs from poorly maintained or ungrounded electrical equipment or items. Patients with an implanted
pacemaker or ICD must avoid conducted current.
• Radiated fields are signals propagated through the air. They can induce current that is detectable by an
implanted pacemaker or ICD. Common sources of these fields include high-voltage power lines, radio
transmission towers, or two-way wireless communication equipment.
• Static magnetic fields are produced by permanent magnets or direct current (DC) electro-magnets.
Permanent magnets are the most common type of magnet in consumer products.
See Chapter 3, Device responses to EMI, page 5 for details on how EMI affects implanted pacemakers and
ICDs.
4
2.2 Applicable standards for safety and electromagnetic compatibility
Medtronic pacemakers and ICDs conform to the following industry standards for active implantable medical
devices for safety and electromagnetic compatibility:
• ANSI/AAMI/ISO 14117
• EN 45502-1
• EN 45502-2-1
• EN 45502-2-2
• ISO 14708-1
• ISO 14708-2
• ISO 14708-6
3 Device responses to EMI
This chapter describes the most common device responses to electromagnetic interference (EMI).
Potential EMI impact on implanted pacemakers and ICDs – Table 1 describes the potential impact of EMI on
implanted pacemakers and ICDs.
Note: If you remove the source of EMI or if the patient moves away from or turns off the source of EMI, the implanted
cardiac device resumes normal operation.
Table 1. Potential EMI impact on implanted pacemakers and ICDs
EMI sourcePotential impact on a pacemakerPotential impact on an ICD
Conducted interference; radiated electric / magnetic fields
Static magnetic fields (direct
current)
a
EMI oversensing can cause both pacemakers and ICDs to provide insufficient pacing support. If pacing therapy
is inhibited, pacemaker-dependent patients can be deprived of adequate cardiac output.
b
See Section 3.3, Reversion, page 6 for more information.
c
Application of pacing therapy at an excessive rate such that it causes symptoms or compromised cardiac
hemodynamics.
d
Inadequate tachyarrhythmia therapy (failure to provide anti-tachyarrhythmia pacing, cardioversion, or
defibrillation therapy).
e
Pacemakers will switch their operating mode and rate in the presence of a strong magnet. For pacemakers that
have not reached recommended replacement time (RRT) or elective replacement indication (ERI), the device
will operate in an asynchronous mode at 85 min–1. For pacemakers that have reached RRT or ERI, the
pacemaker will operate in an asynchronous mode at 65 min–1. Asynchronous pacing can induce an arrhythmia.
f
Tachyarrhythmia detection and anti-tachyarrhythmia pacing therapy are available in some models of
pacemakers. Exposure to static magnetic fields can result in inadequate tachyarrhythmia therapy.
g
Static magnetic fields do not affect pacing in ICDs.
Inhibition of pacing therapya; noise
reversionb; high-rate pacing
c
Asynchronous pacinge; suspension of
tachyarrhythmia detection, and suspension of anti-tachyarrhythmia pacing
therapy
f
Inhibition of pacing therapya; suspension of tachyarrhythmia detection, and
suspension of therapyd; high-rate pacingc; delivery of inappropriate highvoltage therapy
Suspension of tachyarrhythmia detection which will prevent tachyarrhythmia
therapy delivery
d,g
5
3.1 Oversensing
Oversensing is the most common consequence of device overexposure to EMI. Oversensing occurs when a
device detects EMI in addition to intrinsic cardiac signals. Several factors can trigger oversensing, such as the
duration of EMI exposure or the path of the electrical or magnetic current.
Inappropriate sensing of tachyarrhythmias – Some medical procedures use equipment that can create EMI
that an implanted pacemaker or ICD does not filter out but interprets as a rapid heart rate. If this interference
persists, it can meet the criteria for tachyarrhythmia detection for which the device can deliver inappropriate
tachyarrhythmia therapy.
Inhibition of pacing and cardiac resynchronization therapy – Oversensing can inhibit pacing or cardiac
resynchronization therapy in pacemakers and ICDs. If a patient is pacemaker-dependent, prolonged pacing
inhibition can cause hemodynamic instability.
3.2 Device reset
Device reset, also known as a power on reset (POR) or an electrical reset, is a recovery response to an unexpected
device event. Device reset is a rare response to EMI or to ambient radiation. A device reset can also occur in
response to the direct exposure to some types of therapeutic ionizing radiation.
Device reset settings are safe for most patients, but they can be therapeutically suboptimal. Perform the following
steps if an implanted device reports a device reset:
1. Schedule an immediate clinic appointment with your patient.
2. Restore the patient’s parameter values for pacing, arrhythmia detection, and arrhythmia therapy with a
Medtronic programmer or a Medtronic device manager.
3. Download the saved device data file according to the procedure provided in the instructions for use for your
Medtronic programmer or Medtronic device manager. This file includes the device memory image that
Medtronic uses to analyze the device.
4. Contact Medtronic Technical Services for further guidance.
3.3 Reversion
Reversion, also known as noise reversion, initiates asynchronous pacing in the presence of strong EMI. It
minimizes the effect of EMI that can inhibit pacing. During reversion, a pacemaker responds as follows:
• Pacing occurs at the sensor-indicated rate for all rate responsive modes (excludes VVIR and VDIR).
• Pacing occurs at the programmed lower rate for all non-rate responsive modes (includes VVIR and VDIR).
The device resumes normal operation when the EMI source is removed.
4 General guidelines for patients in the presence of EMI
Advise patients to observe the following general guidelines in the presence of EMI:
• Area restrictions – consult with your clinician before entering an area where signs are posted that warn persons
with an implanted pacemaker or ICD.
• Symptoms of EMI – if you become dizzy or feel rapid or irregular heartbeats while using an electrical item,
release whatever you are touching or move away from the item. The implanted cardiac device should
immediately return to normal operation. If symptoms do not improve when you move away from the item, notify
your clinician. If you have an ICD and you receive a therapy shock while using an electrical item, release the
item or move away from it, then notify your clinician.
• Proper grounding of electrical items – To avoid interference from electrical current that can leak from
improperly grounded electrical items and pass through the body, observe the following precautions:
– Confirm that all electrical items are properly wired and grounded.
6
– Confirm that electrical supply lines for swimming pools and hot tubs are properly installed and grounded
according to local and national electrical code requirements.
5 Perioperative management of patients with implanted pacemakers or ICDs
Perioperative care of a patient with an implanted pacemaker or an implanted ICD requires thorough
communication between the procedure team and the device team. The procedure team includes the clinicians
who perform the medical procedure. The device team includes the clinicians who monitor the device function. The
device team leader is an electrophysiologist, a cardiologist, an anesthesiologist, or a surgeon with expertise in
device management. If the patient’s device team is not available, a resident device team can evaluate the patient
and provide recommendations to the procedure team.
Observe these general precautions:
• The perioperative management of devices must consider the health of the patient, the type of device, and the
procedure.
• The procedure team informs the device team of the type of procedure and any sources for EMI.
• The device team gives the procedure team a prescription for the perioperative management of the patient in
consideration of the potential to the device for EMI. For most patients, the prescription can be made from a
review of records maintained by the device clinic. Consult with device specialists if clinic records are not
available.
6 Warnings and precautions for medical procedures and equipment
This chapter describes the potential for EMI from medical procedures and equipment to patients with a Medtronic
implanted pacemaker or a Medtronic implanted ICD.
Table 2. Acceptability of medical equipment and procedures for patients with an implanted pacemaker or an
implanted ICD
AcceptabilityAcceptability criteria
AcceptableThe equipment and procedure have a low potential for EMI with an
implanted device, and they are safe if the equipment is in proper working
condition and used as intended.
Acceptable with precautionsThe equipment and procedure have some potential for EMI with an
implanted device. You can mitigate the effects of the EMI if the equipment
is in proper working condition and used as intended, and if you follow the
precautions in this document.
Not recommendedThe equipment and procedure have a high potential for EMI with an
implanted device, and they are not safe. You cannot mitigate the effects of
the EMI.
Note: The off-label use of any medical equipment or procedure described in this document voids these
acceptability criteria.
6.1 Medical procedures and equipment that require warnings, precautions, and guidance for
health care professionals
This section describes medical procedures and equipment that require precautions for patients with a Medtronic
implanted pacemaker or ICD:
• A pacemaker can be a single-chamber pacemaker, a dual-chamber pacemaker, or a CRT-P.
• An ICD can be a single-chamber ICD, a dual-chamber ICD, or a CRT-D.
7
For a list of commonly performed medical procedures that are acceptable without precautions for patients with
implanted cardiac devices, see Section 6.2, Medical procedures and devices that are acceptable for patients withimplanted pacemakers and ICDs, page 19.
Ablation
Cryogenic ablation – Acceptable. Cryogenic ablation is indicated for the treatment of atrial fibrillation. This
procedure creates lesions in the cardiac tissue near the pulmonary veins with cryothermal energy (pressurized
liquid nitrous oxide).
Radiofrequency (RF) or microwave ablation – Acceptable with precautions. RF or microwave ablation is
a surgical technique in which energy creates heat to destroy cells. Common types of ablation include, but are not
limited to, intracardiac ablation and endometrial ablation.
RF or microwave ablation used for cardiac device patients can result in, but is not limited to, ventricular tachyarrhythmias, oversensing, unintended tissue damage, or unintended device function.
Observe the following precautions when you administer RF or microwave ablation to a patient with an implanted
pacemaker or ICD:
• Make sure that temporary pacing and defibrillation equipment is available.
• Avoid direct contact between the ablation catheter and the implanted system.
• Consider using at least 2 methods to monitor the patient during ablation. These methods can include arterial
pressure display, ECG, manual monitoring of patient rhythm (taking pulse), ear or finger pulse oximetry, or
Doppler pulse detection.
To mitigate the effects of oversensing EMI during therapy, consider the following procedures if patient condition
allows:
PacemakersSee Section 6.3, How to initiate asynchronous pacing in a Medtronic pacemaker with a
Medtronic Model 9466 patient magnet, page 19.
ICDsSee Section 6.4, How to suspend tachyarrhythmia detection and therapies in a Medtronic
ICD with a Medtronic Model 9466 patient magnet, page 20.
Acupuncture, alternating current (AC)
Acceptable with precautions. AC acupuncture, also known as electroacupuncture, passes a small electrical
current between pairs of acupuncture needles.
AC acupuncture introduces electrical current into the body that can cause oversensing in a pacemaker or an ICD.
Patients should consult with their clinicians to determine if their cardiac condition allows them to undergo exposure to AC acupuncture.
To mitigate the effects of oversensing EMI during therapy, consider the following procedures if patient condition
allows:
PacemakersSee Section 6.3, How to initiate asynchronous pacing in a Medtronic pacemaker with a
Medtronic Model 9466 patient magnet, page 19.
ICDsSee Section 6.4, How to suspend tachyarrhythmia detection and therapies in a Medtronic
ICD with a Medtronic Model 9466 patient magnet, page 20.
Bone growth stimulators
A bone growth stimulator provides supplemental therapy to promote bone healing. There are 3 types of bone
growth stimulators:
Stimulator that introduces direct current (DC) into the body – Acceptable. A DC bone growth stimulator
generates insufficient EMI to affect an implanted pacemaker or an ICD.
Stimulator that introduces alternating current (AC) into the body – Acceptable with precautions. An AC
bone growth stimulator uses electrodes to introduce electrical current into the body. There is a potential for EMI
with an implanted pacemaker or ICD with the electrodes attached to the torso. When the electrodes are attached
to an extremity, the stimulator generates insufficient EMI to affect an implanted pacemaker or ICD.
8
Bone growth stimulators
To mitigate the effects of oversensing EMI during therapy, consider the following procedures if patient condition
allows:
PacemakersSee Section 6.3, How to initiate asynchronous pacing in a Medtronic pacemaker with a
Medtronic Model 9466 patient magnet, page 19.
ICDsSee Section 6.4, How to suspend tachyarrhythmia detection and therapies in a Medtronic
ICD with a Medtronic Model 9466 patient magnet, page 20.
Stimulator that produces an alternating magnetic field – Acceptable with precautions. This bone growth
stimulator delivers a short, high-intensity pulse to a coil in an insulated cuff to produce a therapeutic magnetic
field. This therapy does not introduce conducted current into the body. When the insulated cuff is on a patient’s
leg, the stimulator generates insufficient EMI to affect an implanted pacemaker or ICD. However, when the
insulated cuff is on a patient’s wrist or arm, maintain a 30 cm (12 in) distance between the cuff and the implanted
pacemaker or ICD.
Bone scan
Bone scans are used to diagnose and evaluate bone diseases and conditions. There are 3 types of bone scans.
X-ray bone scan (skeletal scintigraphy) – Acceptable. An x-ray bone scan uses small amounts of a radio-
pharmaceutical to show contrast between abnormal and healthy bone tissue. An x-ray bone scan generates
insufficient EMI to affect an implanted pacemaker or ICD.
Ultrasound bone scan (sonography or musculoskeletal ultrasound) – Acceptable. An ultrasound bone
scan uses a transducer to transmit high-frequency sound waves to create an image of bone tissue. An ultrasound
bone scan generates insufficient EMI to affect an implanted pacemaker or ICD.
Bone densitometry (dual-energy x-ray absorptiometry – DEXA) – Acceptable with precautions. Bone
densitometry is an enhanced form of x-ray technology used to measure bone density. It uses a small dose of
ionizing radiation to produce images used to diagnose osteoporosis and to assess patient risk for developing
fractures. These images are usually of the lower spine and the pelvis.
The accumulated dose of radiation from DEXA is insufficient to damage or interfere with the operation of an
implanted pacemaker or ICD. However, do not allow an implanted pacemaker or ICD to undergo direct exposure
to the radiation beam.
Capsule endoscopy
Contact Medtronic Technical Services. Capsule endoscopy, also known as video capsule endoscopy, uses
an ingestible digital camera that captures a video record of the patient’s digestive tract. The camera is in a
capsule with light-emitting diodes, a battery, and a transmitter. Transmission of the video data occurs in short
bursts of radiofrequency energy, approximately 2 per s, for an 8-hour diagnostic period.
Note: Contact Medtronic Technical Services to confirm that your capsule endoscopy system is safe for your
patient.
Central venous access catheter
Acceptable with precautions. Also known as a central line or a central venous line, a central venous access
catheter is placed into a large vein or into the heart. It administers medication or fluids that cannot be taken orally
or that can harm a smaller peripheral vein.
If transvenous leads are acute (within 30 days of implant), verify that they are actively fixed in the endocardium.
Confirm lead fixation with an x-ray or through a review of the stored device lead impedance and short interval
count data (if available). If a lead has dislodged, do not insert a central venous access catheter into the patient’s
heart.
Observe these precautions when you insert the guide wire of a central venous access catheter into the heart of
a patient who has an implanted pacemaker or ICD:
9
Central venous access catheter
• The presence of a guide wire can trigger an arrhythmia in the patient, independent of the implanted cardiac
device.
• Contact between a guide wire and sensing electrodes can cause inappropriate pacing or oversensing in an
implanted cardiac device.
• Contact between a guide wire and a coil can cause inappropriate shock or an electrical short in an implanted
ICD.
To mitigate the potential effects of a central venous access catheter, consider the following procedures if patient
condition allows:
PacemakersSee Section 6.3, How to initiate asynchronous pacing in a Medtronic pacemaker with a
Medtronic Model 9466 patient magnet, page 19.
ICDsSee Section 6.4, How to suspend tachyarrhythmia detection and therapies in a Medtronic
ICD with a Medtronic Model 9466 patient magnet, page 20.
Dental equipment
Acceptable with precautions. Dental procedures that use equipment such as apex locators, ultrasonic scal-
ers, drills, and pulp testers, pose no potential for EMI with an implanted pacemaker or ICD.
Accessories, such as office pillows or headrests, can contain magnets that can affect sensing or initiate asyn-
chronous pacing in an implanted pacemaker or ICD. Keep an implanted pacemaker or ICD at least 15 cm (6 in)
from these magnets.
Note: See “Electrosurgery” for guidance with electrosurgery used in periodontal surgery.
Diagnostic radiology includes the following procedures: computerized axial tomography (CT or CAT scan),
fluoroscopy, mammograms, and x-rays.
Normally, the accumulated dose of radiation from diagnostic radiology is insufficient to damage an implanted
pacemaker or ICD. If the implanted pacemaker or ICD is not directly in the radiation beam, there is no potential
for EMI, except where noted here.
CT scan – Acceptable with precautions. Oversensing can occur only when the implanted pacemaker or ICD
is directly in the CT scan beam.
PacemakersIf the device is in the CT scan beam for more than 4 s, see Section 6.3, How to initiate
asynchronous pacing in a Medtronic pacemaker with a Medtronic Model 9466 patient
magnet, page 19.
ICDsIf the device is in the CT scan beam for more than 4 s, see Section 6.4, How to suspend
tachyarrhythmia detection and therapies in a Medtronic ICD with a Medtronic Model 9466
patient magnet, page 20.
Fluoroscopy at < 1 cGy/min – Acceptable. Fluoroscopy at < 1 cGy/min generates insufficient EMI to affect an
implanted pacemaker or ICD.
Fluoroscopy at ≥ 1 cGy/min – Not recommended. EMI from fluoroscopy at ≥ 1 cGy/min can cause oversensing in an implanted pacemaker or ICD.
Mammography – Acceptable. Mammography generates insufficient EMI to affect an implanted pacemaker or
ICD.
X-ray – Acceptable. X-rays generate insufficient EMI to affect an implanted pacemaker or ICD.
Diagnostic ultrasound
Acceptable. Diagnostic ultrasound is an imaging technique that visualizes muscles and internal organs, their
size, structures, and motion, as well as any pathological lesions. It can also monitor a fetus, and it can detect and
measure blood flow. Diagnostic ultrasound generates insufficient EMI to affect an implanted pacemaker or ICD.
For precautions about therapeutic ultrasound, see “Diathermy (3 types)”.
10
Loading...
+ 22 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.