D-0134090-A – 2022/11
VisualEyes™ - Instructions for Use - EN
Page
114
Electromagnetic compatibility (EMC)
This section is valid for the VisualEyes™ system including all variant of goggles.
This equipment is suitable in hospital and clinical environments except for near-active HF surgical
equipment and RF-shielded rooms of systems for magnetic resonance imaging, where the intensity of
electromagnetic disturbance is high.
NOTICE: ESSENTIAL PERFORMANCE for this equipment is defined by the manufacturer as:
This equipment does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL
PERFORMANCE cannot lead to any unacceptable immediate risk.
Final diagnosis shall always be based on clinical knowledge.
Use of this equipment adjacent to other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
Use of accessories and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation. The list of accessories and cables can be found in this
section.
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this equipment, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result in improper operation.
This equipment complies with IEC60601-1-2:2014+AMD1:2020, emission class B group 1.
NOTICE: There are no deviations from the collateral standard and allowances uses.
NOTICE: All necessary instructions for maintenance comply with EMC and can be found in the general
maintenance section in this instruction. No further steps required.
NOTICE: If Non-Medical Electronic Equipment (Typical information technology equipment) is attached, it
is the responsibility of the operator to ensure that this equipment comply to applicable standards and the
system as whole complies to the EMC requirements. Commonly used standards for EMC testing
information technology equipment and similar equipment
are:
Emissions testing
EN 55032 (CISPR 32)
Electromagnetic Compatibility Of Multimedia Equipment – Emission
Requirements
EN 61000.3.2
Electromagnetic compatibility (EMC) – Limits for harmonic current emissions
(AC mains only, Equipment input current less than or equal to 16 A per phase)
EN 61000.3.3
Electromagnetic compatibility (EMC) – Limits – Limitation of voltage changes,
voltage fluctuations and flicker in public low-voltage supply systems (AC mains
only, Equipment input current less than or equal to 16 A per phase)
Immunity testing
EN 55024 (CISPR 24)
Information technology equipment – Immunity characteristics – Limits and
methods of measurement
1
Products include personal computer, PC, tablet, laptop, notebook, mobile device, PDA, Ethernet hub, router, WiFi, computer
peripheral, keyboard, mouse, printer, plotter, USB storage, Hard drive storage, solid-state storage and many more
.
