English; Guidance And Manufacturer's Declaration; Emc Compliance - Welch Allyn Spot 4400 Vital Signs Manual De Instrucciones

English

Guidance and manufacturer's declaration

EMC compliance

Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC 60601-1-2:2014/EN
60601-2-1:2015.
• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in these tables and in the Instructions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The device complies with all applicable and required standards for electromagnetic
interference.
• It does not normally affect nearby equipment and devices.
• It is not normally affected by nearby equipment and devices.
• It is not safe to operate the device in the presence of high-frequency surgical
equipment.
• However, it is good practice to avoid using the device in extremely close proximity to
other equipment.
Note The Spot Vital Signs 4400 device has essential performance requirements
associated with blood pressure measurement, oxygen saturation, and
temperature measurement. In the presence of EM disturbances, the
device displays an error code. Once the EM disturbances stop, the Spot
Vital Signs 4400 device self-recovers and performs as intended.
WARNING Use only accessories and cables Welch Allyn recommends for
use with the Spot Vital Signs 4400 device. Accessories and cables not
recommended by Welch Allyn may affect the EMC emissions or immunity.
WARNING Maintain minimum separation distance of 12 inches (30 cm)
between any part of the Spot Vital Signs 4400 device and portable RF
communication equipment (including peripherals such as antenna cables
and external antennas). Performance of the Spot Vital Signs 4400 device
might degrade if proper distance is not maintained.
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