Emc Guidance; Technical Description - DarioHealth LS802-GP User Manual

EMC Guidance

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning: Do not use near active HF surgical equipment and the RF shielded room of an ME system
for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: 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.
Warning: 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.
Warning: 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 equipment
LS802-GP, including cables specified by the manufacturer. Otherwise, degradation of the perfor-
mance of this equipment could result.

Technical description

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with
regard to electromagnetic disturbances for the expected service life.
2. Guidance and manufacturer's declaration - electromagnetic emissions and Immunity
Table 1
Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Not applicable
Not applicable
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