Instructions for BIOTRONIK models including: Electromagnetic Compatibility EMC of Active Cardiac Devices, Compatibility EMC of Active Cardiac Devices, EMC of Active Cardiac Devices, Active Cardiac Devices, Cardiac Devices, Devices
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Electromagnetic Compatibility (EMC) of Active Cardiac Devices: Pacemakers, ICDs, CRT Devices, and Cardiac Monitors Electrical devices and processes generate
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DocumentDocumentElectromagnetic Compatibility (EMC) of Active Cardiac Devices: Pacemakers, ICDs, CRT Devices, and Cardiac Monitors 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 electrial 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. · 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. 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. Your implanted device may be showing the following signs of electromagnetic interference: · The pacemaker/CRT-P device cannot emit a pacing pulse or unnecessarily speeds up the heart rhythm 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 Interference with the implanted unlikely at the specified distance 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 Interference with the implanted device unlikely Interference with the implanted device Interference with the implanted unlikely at the specified distance device is possible Contraindication Bluetooth CD, DVD, VCR players, radio Computer Copy machine dLAN, PLC, PowerLAN (Powerline Communication) e-reader Electronic ankle tag Fax machine Inductive hearing loop, induction loop system Inductive smartphone charging station Navigation system/GPS NFC (near-field communication) Printer Video games VR headset Wireless headphones, headset Wireless remote control WLAN router (2.4 GHz) Telecommunications/Office/Multimedia Ham radio1 15 cm CB radio handset (max. 3 W) Cordless landline telephone Game console, Wii, PlayStation Hearing aid streamer Mobile phone/smartphone Modem Multimedia player, mp3 player, iPod Router Stereo speaker Tablet, iPad Walkie-talkie Wireless remote control (model-making) WLAN router (5.1-5.7 GHz) 40 cm CB radio mobile car station (max. 10 W) 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 Interference with the implanted device unlikely Interference with the implanted device Interference with the implanted unlikely at the specified distance device is possible Contraindication Fitness wristband Full-body scanner Heart rate monitor, smartwatch Infrared heating cabin Sauna, tanning bed Stationary metal detector Tattooing V-pay Hobby/Sport/Travel PowerPlate* 15 cm IPL1 hair removal system 30 cm Anti-theft devices Electric bicycle (motor) Segway (motor) Ski pass scanner Go-Kart Mobile metal detector 60 cm Ergometer (magnetic brake) Golf caddy (motor) Treadmill (motor) Battery-operated, cordless power tools Electric car (driving) Keyless entry system (car) Low-voltage power line (220 V) Phase tester, double-pole 5 m Maritime radar Tools / Motors /Electronics 15 cm Arc welding Corded power tools Electric fence Fan heater High-voltage test station Phase tester, single-pole 30 cm Gasoline-powered tools (chain saw, 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) 1 IPL - Intense Pulsed Light * Physician's approval needed because of physical stress and possible rate adaptation of the implanted device Interference with the implanted device unlikely Interference with the implanted device Interference with the implanted unlikely at the specified distance device is possible Contraindication Bone density measurement Capsule endoscopy Diagnostic ultrasound Diagnostic X-ray, e.g.: · CT (computed tomography) · Mammography · PET (positron emission tomography) ECG/EMG (electromyography) Hearing aid/cochlear implant Heart rate monitor Laser treatment (eyes/skin) Magnetic mat Massage mat, massage chair Medical Procedures2 MRI (magnetic resonance imaging)3 15 cm Cardioversion/external defibrillation CPAP mask (sleep apnea therapy) Dental treatment Glucose monitor Hearing aid streamer Insulin pump Ultrasonic dental cleaning Bioresonance therapy 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/Microneedling · Neurostimulation · Transcutaneous electrical nerve stimulation (TENS) 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 ProMRI 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 Status: July 2023 © 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