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Safety notes
Risks due to electromagnetic fields
This handpiece with cable complies with the reference values defined in EN 50527-2-1/2016 for active implantable medical
devices (AIMD) and cardiac pacemakers.
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD)
can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with
unipolar and bipolar pacemakers or ICD, if a safety distance between the control unit and the cardiac pacemaker or ICD of at
least 30 cm (11,8 inch) is maintained.
> Find out if patient or user have implanted systems before using the medical device and consider the application.
> Weigh the risks and benefits.
> Make appropriate emergency precautions and take immediate action on any signs of ill-health.
> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac
pacemaker or ICD.
