Emc Compliance - Welch Allyn Spot VS100 Directions For Use Manual

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 EN 60601-1-2:2014.
• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
This product 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 this product in the presence of high-frequency surgical
equipment.
• However, it is good practice to avoid using this product in extremely close proximity to
other equipment.
WARNING Avoid using the vision screener adjacent to or stacked with other
equipment or medical electrical systems because it could result in improper
operation. If such use is necessary, observe the vision screener and other
equipment to verify that they are operating normally.
WARNING Use only accessories recommended by Welch Allyn for use with the
vision screener. Accessories not recommend by Welch Allyn might affect the
EMC emissions or immunity.
WARNING Maintain minimum separation distance between the vision screener
and portable RF communication equipment. Vision screener performance might
degrade if you do not maintain a proper distance between equipment.
WARNING This device has not been tested for use in clinical environments near
high-frequency surgical equipment and magnetic resonance imaging. Do not
use this device in environments like these where electromagnetic disturbance is
high.
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