Emc Guidance - Gima 32916 / LS808-BS Manual Del Usuario

55
Bio-compatibility

EMC GUIDANCE

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning: Don't 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 equip-
ment LS808-BS , including cables specified by the manufacturer. Otherwise, degradation of
the performance 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 excepted 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
ISO 10993-1:2009 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part
5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization
ENGLISH
Compliance
Group 1
Class [ B ]
Class A
Comply