Nds Surgical Imaging Dome Ex User Manual - Regulatory Compliance
Regulatory Compliance
Canada, European Union, United States
This display has been tested and found to comply with IEC/EN 60601-1 and
IEC/EN 60601-1-2 standards, and is certified to meet medical standard C22.2
No. 601.1-M90 (C US Mark).
The medical display, in
addition to meeting
medical requirements,
has been tested and
found to comply with the
limits for Federal
Communications
Commission (FCC) Class B
computing devices in a
typically configured system since many medical offices are located in
residential areas. (This applies to all Dome Ex displays except the
Dome E3cHB, Dome E3cHB DisplayPort, and Dome E5 displays, which are
Class A.) It is the system integrator’s responsibility to test and ensure that
the entire system complies with applicable electromagnetic compatibility
(EMC) laws.
Warning on Dome E3cHB, Dome E3cHB DisplayPort, and Dome E5
The Dome E3cHB, Dome E3cHB DisplayPort, and Dome E5 displays are
Class A products. In a domestic environment, either of these products may
cause radio interference, in which case the user may be required to take
adequate measures.
Radio transmitting equipment, cellular phones, etc. shall not be used in
close proximity of the devices, since this could influence the performance
of the device.
Particular precaution must be considered during use of strong emission
sources, such as High Frequency surgical equipment and similar, so that,
for example, the HF-cables are not routed on or near the devices. If in
doubt, contact a qualified technician or your local representative.
Dome E2, Dome E2cHB, Dome E3, Dome E3cHB,
Dome E3cHB DisplayPort, and Dome E5