Pacemakers, Implantable Cardioverter Defibrillators (ICD’s) and Heart Failure Devices
The following guidance is for the compatibility of Tynetec Telecare products with medical devices such as pacemakers and ICD’s.
The Tynetec range of Telecare products are designed to meet a specific level of electromagnetic radiation, and the approach taken with compatibility is to ensure that all Telecare products shall not emit more than the defined level of electromagnetic radiation, whilst a compatible secondary device should not be susceptible to electromagnetic radiation below specified levels.
Pacemakers and other medical devices should be manufactured such that they can withstand Electromagnetic Interferences (EMI) in accordance with their associated mandatory European directives and regulations.
These standards vary by product type, and users need to check details with the respective medical suppliers.
It is mandatory that social alarms and Telecare products conform to the European Electromagnetic Compatibility directive (89/336/EEC), which requires compliance with the following standards:
• Emissions EN55022 – this defines limits and methods of measurement of radio disturbance characteristics of information technology equipment
• Mains Harmonics EN61000-3-2 – EMC limits for harmonic current emissions
• Immunity – EN50130-4 – Immunity requirements for Fire, Intruder and Social Alarm Systems (mandatory for equipment manufactured after December 2000)
• Radio EMC – EN300 220 ‘Electromagnetic Compatibility and Radio Spectrum Matters for Short-Range Devices’ SRD’s, This standard defines the EMC requirements for the low-power radio systems used in social alarms
• ETS 301 489-3 – EMC standard for short range devices (SRD) operating on frequencies between 9 kHz and 40 GHz
We confirm that Tynetec Telecare products fully conform to these mandatory standards.
Users should also request confirmation from their medical device suppliers that the product is manufactured to the appropriate Electromagnetic Compatibility standards relevant to that product.
To download a copy of this statement click here
All of our products are designed and manufactured in accordance with the legal requirements for the environments in which they are to be used.