To avoid damaging the system, use ESD minimizing devices where needed. These ESD
minimizing devices include: anti-static mats, humidifiers, and spray. Proper discharge is
required before handling any electronic device such as an ESD strap.
3.1.4
Electromagnetic and Radio Frequency Interference
This equipment has been tested and found to comply with the EMC limits for the Medical
Device Directive 93/42/EEC (EN 55011 Class 1 and EN 60601-1-2). These limits are
designed to provide reasonable protection against harmful interference in a typical medical
installation. The equipment generates, uses and can radiate radio frequency (RF) energy
and if not installed and used in accordance with these instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference with other devices, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of the following
measures:
•
Reorient or relocate the receiving device
•
Increase separation distance between equipment
•
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) is connected
•
Consult the manufacturer or field service technician for help.
Warning: The SONIX should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the SONIX should be observed in order to
verify normal operation in the configuration in which it will be used.
Table 3-5: EN 60601-1-2:2001 (Table 201)
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
SONIX Ultrasound Systems are intended for use in the electromagnetic environment specified below.
The customer or the user of the SONIX Ultrasound System should ensure that it is used in such an
environment.
Emissions test
Compliance level
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The SONIX Ultrasound System uses RF energy only for its
internal functions. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
The SONIX Ultrasound Systems is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
SONIX Service Manual
SSM – 001, Revision F
Chapter 3: System Installation
15
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