Electromagnetic compatibility
Instructions for use • AIDA C WD310 • AAB272_EN_V2.0_12-2021_IFU_CE-MDR 95
10 Electromagnetic compatibility
10.1 General information on the operating environment
The product is suitable for use in professional healthcare settings. Professional healthcare
facilities include physician offices, dental offices, limited care facilities, freestanding surgical
centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms,
patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system
for MRT).
The product may be used in the vicinity of high frequency surgical units. If the product is used
at the same time as high frequency surgical units, it may experience temporary image
interference.
The emission characteristics of this product make it suitable for use in industrial areas as
well as in hospitals (CISPR 11 Class A) and other professional healthcare environments.
If it is used in a residential environment (for which CISPR 11 Class B is normally
required), the product may not offer sufficient protection for radio transmission operation.
The user might need to take mitigation measures, such as relocating or re-orienting the
product.
WARNING
Electromagnetic interference! Malfunction!
Electromagnetic interference may cause the product to malfunction. As a result of this
malfunction, it may be necessary to replace the defective product or to continue the surgery as
an open procedure.
Do not use the product next to or together with other devices. If such use is required,
monitor the product and the other devices, and follow the relevant instructions in the
event of malfunctions.
Portable HF communications equipment including peripheral devices (e.g., antenna
cables and external antennas) should be used no closer than 30cm from the product,
including cables specified by the manufacturer.
10.2 Cables
WARNING
Reduced immunity! Risk of injury!
The use of accessories or cables other than those specified in the KARLSTORZ instructions
for use may result in increased emissions or decreased immunity of the product. The cables
listed have been shown to comply with the requirements of IEC60601-1-2.
When using other cables, the operator is responsible for checking that they comply with
IEC60601-1-2:2014.