System Safety And Maintenance - GE Voluson S6 Basic User Manual

2.5 System Safety and Maintenance

2.5.1 Instructions for Use
Voluson® S6/S8 Basic User Manual
5433669-100 Revision 4
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For safety reason, avoid handling fluids in the vicinity of the system. Fluids leaking into
the disk drive can damage the drive.
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The user manual must always be with the scanner system. It is the user's duty to ensure
this!
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Only ultrasound probes conforming to type BF requirements may be used with the
Voluson® S6/S8.
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Do not install software on the system, that has not been released by GE Healthcare, as
this may lead to erroneous data transfer and thereby decrease system performance.
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The Voluson® S6/S8 system has been tested for EMC and is compliant with CISPR11
group 1 class B and IEC60601-1-2. The Voluson® S6/S8 system is approved for use in a
residential district. It is expected that the user has medical experience and is well
informed with the user manual.
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Main power quality should be that of a typical commercial and/or hospital environment. If
the user requires continued operation during power main interruption, it is recommended
that the system be powered from an uninterruptable power source (UPS).
There have been reports of severe allergic reactions to medical devices containing latex
(natural rubber). Operators are advised to identify latex-sensitive patients and be
prepared to treat allergic reactions promptly. Refer to FDA Medical Alert MDA91-1.
This machine must be used in compliance with the law. Some jurisdictions restrict certain uses
such as gender determination.
Federal law restricts this device to sale by or on the order of a physician.
This equipment has been tested and found to comply with the limits for medical devices in IEC
60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the 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 to 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:
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Reorient or relocate the device.
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Increase the distance between equipment.
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Connect the equipment to an outlet on a circuit different from that to which the other
device(s) are connected.
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Consult the manufacturer or field service technician for help.
The Voluson S6/S8 does not contain any operator serviceable internal components. Ensure
that unauthorized personnel do not tamper with the unit.
Safety
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