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DUO
EN 7
SIBELSOUND
· User's manual
Essential operation includes generating acoustic or vibratory signals (complying with the specified accuracy and/or ensuring that it is
not possible to make an incorrect diagnosis of the patient), presenting hearing levels, and storing the complete data into the memory.
Communication with a computer is not considered essential operation, provided that the storage of the complete data is guaranteed.
RISK OF ELECTRICAL SHOCK
No parts are allowed for temporary immersion. MAY CAUSE ELECTRIC DISCHARGE
Contact of liquids with the internal parts of the device and the connectors must always be avoided.
DUO
is designed to be used in conjunction with a software application such as the
W50
Audiometry Software, which runs
SIBELSOUND
on an external device. This device must comply with the current standards of electrical safety and electromagnetic compatibility.
RISK OF EXPLOSION
The system is not designed to work in an explosive environment or in the presence of flammable anesthetics or gases of any kind.
MAY CAUSE EXPLOSION.
RISK OF CONTAMINATION
Perform cleaning and maintenance of device and accessories with the specified frequency and following the instructions in this
manual in order to keep product's safety.
RISK OF INTERFERENCE
This is an electronic medical device; therefore requires special precautions regarding electromagnetic compatibility (EMC): it must
be installed and put in service according to the information attached in
Annex 4. ELECTROMAGNETIC
COMPATIBILITY.
DO NOT use the system in the presence of radio equipment, such as mobile phones, transmitters and similar equipment generating
radio frequency emissions. Follow the recommendations regarding the separation distance specified in the manufacturer's declaration
on electromagnetic compatibility in this manual.
DUO
DO NOT use the
SIBELSOUND
adjacent or stacked with other equipment. It could result in improper operation.
DO NOT use the system in and MRI environment.
520-800-MUM · Rev 1.01
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