BIOTRONIK Electromagnetic Compatibility (EMC) of Active Cardiac Devices Instructions

BIOTRONIK Electromagnetic Compatibility (EMC) of Active Cardiac

Introduction

Electrical devices and processes generate electromagnetic fields. The varied use of modern technology makes them unavoidable in our working life, everyday life, and in medicine.

Electromagnetic fields can affect the functioning of active cardiac devices, which consists of sensing the heart rhythm and the associated heart stimulation.

BIOTRONIK’s active cardiac devices are tested and approved for electromagnetic compatibility in accordance with ISO 14117 and 14708-1/2/6. They are immune to interference from electrical devices, which in turn comply with international guidelines for limiting exposure to electromagnetic fields.

In the vicinity of electrical devices and depending on the strength of the electromagnetic field, a temporary effect on the implanted device cannot be ruled out.

However, there is no need to worry about permanent damage to the implanted device. It will be fully functional again as soon as the distance from the source of interference increases or the source is turned off.

Please discuss with your physician the procedures or devices that you should avoid or restrict owing to your condition, how to identify any effects on your implanted device, and what to do in such cases.

Signs of electromagnetic interference

• The pacemaker/CRT-P device cannot emit a pacing pulse or unnecessarily speeds up the heart rhythm
• Strong magnetic fields can prevent the ICD/CRT-D device from delivering therapy or generate unwanted defibrillation shocks due to interference signals
• The ICD/CRT-D device cannot emit a pacing pulse or unnecessarily speeds up the heart rhythm
• The cardiac monitor is affected when recording the data and might record external signals that may result in misinterpretation of the recorded data

Before any medical treatment, please inform your physician that you have an active cardiac device, so that appropriate precautions can be taken.

Please consult the warnings provided by electrical device manufacturers for any restrictions applying to users with active cardiac devices. Use only technically intact devices and only have them serviced and repaired by technicians.

This guide is designed to help you determine the electromagnetic compatibility (EMC), i.e., to assess electrical devices and procedures with regard to their potential to interfere with your implanted device.

The devices and procedures listed on the following pages have been classified into different categories with regard to their interference potential. This categorization is based on the interference resistance of active cardiac devices as specified in technical standards. The information provided is taken from standards and/or reflects empirical technical values for the electrical devices and implanted devices. Given the diversity of electrical devices and their interference potential, this list is only intended as a reference and does not claim to be complete.

Interference with the implanted
device unlikely| Interference with the implanted device unlikely at the specified distance| Interference with the implanted
device is possible – Contraindication
---|---|---

Household Appliances/Everyday Life

Battery charger (household battery)| 15 cm|
---|---|---
Can opener| Household magnet|
Coffee machine| Necklace with magnetic closure|
Dishwasher| Wireless heating base station|
Dryer|
Electric blanket, heating pad| 30 cm|
Electric kettle| Induction cooktop|
Electric shaver|
Electric toothbrush, ultrasonic toothbrush|
Emergency button, patient alarm|
Foot warmer|
Hairdryer|
Iron|
Magnetic mats/boards/foils (for table or wall)| |
|
Microwave|
Mixer|
Refrigerator|
Robotic lawn mower|
Smart meter (electricity, heating)|
Toaster|
Toothbrush charging unit|
Vacuum cleaner, robotic vacuum cleaner|
Washing machine|

Telecommunications/Office/Multimedia

Bluetooth| Ham radio1|
---|---|---
CD, DVD, VCR players, radio|
Computer| 15 cm|
Copy machine| CB radio handset (max. 3 W)|
dLAN, PLC, PowerLAN

(Powerline Communication)

| Cordless landline telephone|
Game console, Wii, PlayStation|
e-reader| Hearing aid streamer|
Electronic ankle tag| Mobile phone/smartphone|
Fax machine| Modem|
Inductive hearing loop,

induction loop system

| Multimedia player, mp3 player, iPod|
Router|
Inductive smartphone charging station| Stereo speaker|
Navigation system/GPS| Tablet, iPad|
NFC (near-field communication)| Walkie-talkie|
Printer| Wireless remote control (model-making)|
Video games| WLAN router (5.1-5.7 GHz)|
VR headset|
Wireless headphones, headset| 40 cm|
Wireless remote control| CB radio mobile car station (max. 10 W)|
WLAN router (2.4 GHz)| TETRA radio|
|
60 cm|
Satellite dish|

1.  According to approval standard, the following distances from transmitting antennas are recommended for ham radio:
   < 3 W = 15 cm
   3–15 W = 30 cm
   15–30 W = 60 cm
   30–50 W = 1 m
   50–125 W = 2 m
   125–250 W = 3 m
   250–500 W = 5 m
   500–1000 W = 6 m
   1000–2000 W = 9 m Hobby/Sport/Travel

   ---

Tools /Motors /Electronics****

leaf blower, snow blower, string trimmer)

|
|
Power wheelchair (motor)|
Running car motor|
|
60 cm|
| Car battery charger (incl. fast charging

station)

|
|
Forklift truck|
Generator|
Lawn mower|
Photovoltaic system transformer|
|
6 m|
| High-voltage power line

(110/220 kV)

|
|
|
10 m|
High-voltage power line (380 kV)|

Medical Procedures2
**** 1 IPL – Intense Pulsed Light

• Physician’s approval needed because of physical stress and possible rate adaptation of the implanted device
  Medical Procedures2

  ---

Bone density measurement| MRI (magnetic resonance imaging)3| Bio resonance therapy
---|---|---
Capsule endoscopy| Current-inducing procedures, e.g.:

  *  Andullation therapy
  * BIA (bioelectrical impedance analysis)
  * Body fat measurement
  * Diathermy, HF heat therapy
  * Electrocautery
  * Electrolysis
  * Electroshock therapy
  * HF/RF/Ultrasonic ablation
  * Interferential current therapy
  * Iontophoresis
  * Mesotherapy/Micro needling
  * Neuro stimulation
  * Transcutaneous electrical nerve
  * stimulation (TENS)  

Diagnostic ultrasound| 15 cm
Diagnostic X-ray, e.g.:

  * CT (computed tomography)
  *  Mammography
  *  PET (positron emission tomography)

| Cardioversion/external defibrillation
CPAP mask (sleep apnea therapy)
Dental treatment
Glucose monitor
ECG/EMG (electromyography)| Hearing aid streamer
Hearing aid/cochlear implant| Insulin pump
Heart rate monitor| Ultrasonic dental cleaning
Laser treatment (eyes/skin)
Magnetic mat
Massage mat, massage chair
| Lithotripsy/shock wave therapy
| Magnetic catheter navigation/Stereotaxis
| Magnetic field therapy (incl. pulsed magnetic field therapy mats)
| Radiation therapy
| Therapeutic ultrasound
2. In the case of contraindicated procedures that need to be performed on patients with an implanted device, a careful risk-benefit analysis must be done by the physicians involved. In order to avoid permanent damage to the implanted device, precautions must be taken. They need to be discussed with the responsible BIOTRONIK technical service department. 3. Patients with an implanted BIOTRONIK Pro MRI device system can undergo an MRI scan under certain conditions. To confirm that you can undergo an MRI scan under certain conditions, please contact your cardiologist or radiologist, or the clinic where you received your implanted device. These contact persons can answer your questions based on your complete medical history and the MRI scan requirements. Please note that the MRI scan requirements for patients with pacemakers or defibrillators depend on the combination of the implanted device and the lead(s): www.promricheck.com

Customer Support

© BIOTRONIK SE&Co. KG
All rights reserved. Specifications
are subject to modification, revision and improvement.
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
www.biotronik.com

References

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