Appendix: Safety And Regulatory Notices - Optelec Braille ALVA USB 640 Comfort User Manual

Optelec

Appendix: Safety and regulatory notices

This equipment has been developed and tested in order to comply with the following
regulations:
and
Medical electrical equipment requires special precaution regarding EMC (Electro
Magnetic Compatibility), and must be installed and put into service according to EMC
guidelines.
WARNING: The use of accessories, transducers and cables other than those
specified and sold by the manufacturer of the ALVA USB 640 Comfort as
replacement component parts may result in increased emissions or decreased
immunity of the ALVA USB 640 Comfort.
By design, the ALVA will shut down in case of an ESD 8kV test pulse. The ALVA
USB 640 Comfort will have to be switched back on to resume operation.
CE Caution
 The input and output parts need to be connected correctly;
 The unit is designed for exclusive interconnection with IEC/EN 60XXX certified
equipment outside of the user environment, and with IEC/EN 60601-1 certified
equipment within the user environment.
 This device complies with EN 60601-1-2. To minimize interference from other
equipment, a minimum distance of 0.5 m shall be kept from other potential
electromagnetic sources, such as a mobile phone.
 Equipment connected to analog or digital interfaces must comply with the
respective IEC/EN standards (e.g. IEC/EN 60950-1 for data-processing
equipment, and with IEC/EN 60601-1 for medical equipment).
 Do not open the housing.
 Only qualified service personnel should service the unit.
 All possible forms of configuration must comply with the current version of the
IEC/EN 60601-1-1 system standard directive.
 Please be aware that connecting additional equipment to the signal input part
or signal output part of the device entails that a medical system is being
configured. Therefore, the individual, who is configuring and interconnecting
the system, is responsible for the entire system, and must make sure it is
compliant with the current version of the requirements of the IEC/EN 60601-1-
1 system standard. In case of any doubt about system compliance under the
current version of the requirements of the IEC/EN 60601-1-1 system standard,
please consult the technical service department or your local representative.
FCC
FCC Notice
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
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for a Class B digital device, pursuant to part 15 rules.
ALVA USB 640 Comfort
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