Electromagnetic Compatibility; Specifications And Technical Information: Emc (Electromagnetic Compatibility) - D-Heart 4021 Manual De Instrucciones

User Manual Smartphone ECG Device

9. ELECTROMAGNETIC COMPATIBILITY

This device is classified in class B according to IEC60601-1-2.
This instrument has been tested and found to comply with the limits for medical devices to the
IEC60601-1-2 and Medical Device Directive 93/42/EEC. These limits are intended to provide
reasonable protection against harmful interference in a typical medical environment. This instrument
generates, uses and can radiate radio frequency energies and, if not put in service and used in
accordance with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular location.
If the system does cause harmful interference to other devices, which can be determined by turning
the system off and on, try to eliminate the interference by adopting one or more of the following
measures:
•
reorient and/or relocate the receiving device;
•
increase the distance between the devices;
•
connect the system to an outlet on a different circuit than that to which the other devices is
connected;
•
consult the manufacturer or field service technician for help.
Essential performance: continuous operation (measurement status).
a. SPECIFICATIONS AND TECHNICAL INFORMATION: EMC (ELECTROMAGNETIC COMPATIBILITY)
Guidance and manufacturer's declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Emissions test
RF emissions CISPR 11
D-Heart
Compliance Electromagnetic environment - guidance
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very
Group 1
low and are not likely to cause any interference
in nearby electronic equipment.
11