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•
This equipment has been tested and found to comply with the Class B limits for medical
devices according to the IEC 60601-1-2:2014. These limits are designed to provide
reasonable protection against harmful interference in all establishments, including
domestic establishments.
Risks and Benefits
Before using any medical device, it is important to consult your physician and weigh the risks
and benefits.
The following section describes the Benefits and Risks associated with using the Polso
TM
Watch.
Potential Risks Associated with the Polso
TM
Watch
•
As with all medical electrical devices, there is always a risk of electrical, mechanical, and
fire hazards. However, these risks have been mitigated through the design and testing
of the Polso
TM
Watch.
•
As with all devices with small parts, there is always
a risk of a child’s swallowing a
component or choking. Keep small parts away from small children to prevent such
hazards.
•
As with all items applied directly to the skin, there is always a risk of skin irritation,
pressure injury, and general discomfort while a sensor or cuff is applied to a patient.
Periodically check the areas where the patient’s skin
contacts the sensor to prevent
potential issues.
