Aspect BIS VISTA Spécifications Page 13

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SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-5
Do not open the BISx for any reason. The seal to prevent liquids from entering the
BISx may be damaged if opened. Service or repairs must be performed only by
qualified biomedical technicians.
The BIS VISTA system has been designed to operate with a BIS Sensor. The sensor
is a silver/silver chloride electrode array that utilizes Aspect's patented Zipprep
technology and uses a proprietary connector. Use of other electrodes is not
recommended.
Do not disconnect the BISx during the software upgrade.
The BIS VISTA system complies with the electromagnetic compatibility
requirements of EN60601-1-2. Operation of this device may affect or be affected by
other equipment in the vicinity due to electromagnetic interference (EMI). If this
occurs:
Increase separation between devices
Re-orient device cabling
Plug devices into separate outlet circuit branches
Refer to Section 9.2 “Electromagnetic Compatibility Specifications.”
When connecting or disconnecting BISx, take care not to touch the exposed contacts
of either connector. Damage due to electrostatic discharge may result.
All work involving opening the instrument case must be performed in a static-safe
environment to prevent damage to electronic components and assemblies. This
environment includes the operator, work area and tools, and any other test or storage
items that might touch the monitor or BISx assemblies.
Important:
The BIS VISTA systems comply with the European Medical Device Directive
(MDD) and applicable regulatory requirements of the country distributed to and
carry the CEXXXX Marking. Declarations of Conformity provided upon request
where appropriate.
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