• For operators in Europe: any serious accident occurred in relation to the device must be reported to CEFLA s.c. and to the
competent authority of the Member State where the user and/or patient lives.
1.4. ELECTROMAGNETIC SAFETY
Electromagnetic immunity.
The device is intended for use in environments recognised as professional health facilities, as described in IEC 60601-1-2:2014. The device belongs to
CISPR 11 Class A Group 1 and complies with immunity test levels specified by IEC 60601-1-2:2014 for professional health facilities.
Before using any electronic device in health facilities, always check that it is compatible with the other equipment present.
If it is used in a residential environment (as specified in CISPR 11 class B) 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-orienting the equipment.
For further information on immunity levels and characteristics of the electromagnetic environment, see the specific tables in paragraph TECHNICAL
SPECIFICATIONS.
• 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.
• 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.
• 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 the device, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
• Do not subject the device to strong electromagnetic disturbances.
Electrical medical equipment are subject to special precautionary measures in relation to electromagnetic compatibility (EMC). The
equipment must be installed and used according to the Manufacturer’s instructions. Failure to observe the installation
requirements and the Manufacturer’s instructions could affect the equipment position and the correspondence of its operating
parameters.
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