Hardware User Manual
Envisu C-Series SDOIS / 9054-10011 / Revision N 12
Electromagnetic Compatibility (EMC)
• The Spectral Domain Ophthalmic Imaging System is in compliance with the
electromagnetic compatibility requirements in accordance with EN 60601-1-2:2007
Medical Electrical Equipment-collateral standard.
• The device is subject to special precautionary measures for electromagnetic
compatibility: It must be installed and commissioned in accordance with the guidelines
and manufacturer's declarations and recommended safety distances (according to
EMC tables based on IEC 60601-1-2).
• Portable and mobile as well as stationary radio communications equipment can have a
negative effect on the reliability of the system's functionality.
• The Emissions characteristics of this equipment make it suitable for use in hospitals
only (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orientating the equipment.
Warning!
Do not attach any accessory, cable, or other device to the system. To do so
may result in increased EMISSIONS or decreased IMMUNITY of the
system.
Caution!
The device should not be operated near active
HF SURGICAL EQUIPMENT or near magnetic resonance
imaging, where the intensity of EM DISTURBANCES is
high.
Warning!
Risk of Unspecified Accessories/Cables.
Use of accessories, transducers 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.
Warning!
Use of this equipment adjacent to or stacked with 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.
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