USER MANUAL 16-2090
Rev. 09/2017
Page 6 of 27
4 Regulatory advice
4.1 Compliance
This product is designed and manufactured by 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 devicees or an unfavorable
electromagnetic environment.
This medical electrical equipment needs special precautions regarding EMC and needs to be installed
according to EMC information.
Mobile RF communications equipment can affect this medical electrical equipment.
Image transfers from the camera to a monitor may be susceptible to electromagnetic disturbances
and electric system disturbances.
In order to avoid these situations, it is advisable to:
•
Ensure of the quality of the electric power system (especially the grounding of all devicees 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.
