USER MANUAL 16-2045
Rev. 09/2017
Page 8 of 25
Connect the potential equalisation cable to the equipotential socket C7 at the back of the
device.
Devices connecting to the input/output ports must comply with the IEC 60950-1
standard.
4 Regulatory advice
4.1 Compliance
This device is designed and manufactured by a Ackermann proven to have a certified quality
system.
It meets the requirements of European directive 93/42/CEE, on medical devices.
Consequently, it particularly meets the standards of electrical safety (IEC) and
electromagnetic compatibility (EMC) ad hoc.
4.2 Electromagnetic interferences and electrostatic discharge
Although this product complies with EMC standards, it may in very special circumstances
interfere with other devices, or itself be the object of interference from other devices or an
unfavorable electromagnetic environment.
In order to avoid these situations, it is advisable to:
• Ensure of the quality of the electric power system (especially the grounding of all devices
and medical carts.
• Keep the device away from electromagnetic sources (e.g. compressors, motors,
transformers, HF generators, etc.).
4.3 Medical device vigilance
Like any medical device, this device is subject to the stipulations governing medical device
vigilance, and therefore any serious malfunction must be reported to the manufacturer as
quickly and as accurately as possible. For manufacturer contact details, refer to the first
page of the manual.
4.4 End of lifecycle
This device carries the recycling symbol in compliance with European directive 2002/96
CEE on Waste Electrical and Electronic Equipment (DEEE or WEEE). By correctly
disposing of this device you are helping to prevent harmful effects on the environment and
on human health.
