GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H
Page 90 of 96
A
PPENDIX
H:
E
LECTROMAGNETIC
C
OMPATIBILITY
(EMC)
Portable and mobile RF communications equipment can affect the Novus. Install and
operate the Novus according to the EMC information presented in this chapter.
The Novus has been tested for EMC emissions and immunity as a stand-alone device.
Do not use the Novus adjacent to or stacked with other electronic equipment. If
adjacent or stacked use is necessary, the user should verify normal operation in the
configuration.
The use of accessories, transducers and cables other than those specified, except for
servicing parts sold by GSI as replacement parts for internal components, may result in
increased EMISSIONS or decreased IMMUNITY of the device.
Anyone connecting additional equipment is responsible for making sure the system
complies with the IEC 60601-1-2 standard.
C
AUTIONS REGARDING
EMC
This instrument is suitable in hospital environments except for near active
HF surgical equipment and RF shielded rooms of systems for magnetic
resonance imaging, where the intensity of electromagnetic disturbance is
high.
Essential performance for this instrument is defined by the manufacturer as:
To generate and present stimulus signals in the audio range as specified in the
applicable IEC 60645 series or ANSI standards in normal condition.
Absence of these performance features can lead to failure in diagnosis.
Use of this instrument adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this instrument
and the other equipment should be observed to verify that they are operating normally.
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
this instrument, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
The GSI Novus is intended for use in the electromagnetic environment specified
below. The customer or the user of the Instrument should assure that it is used in
such an environment.
