Ziehm Imaging, Inc. QUANTUM, Руководство пользователя, Страница: 34 / 220

Section 3.0
MAN 06–0017H
ZIEHM QUANTUM
User’s Manual Page 34 of 220
WARNING
Do not touch the USB or DICOM ports and Patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
Accessory equipment connected to the analog and digital interfaces must be
certified to the respective IEC standards (i.e. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment.) Furthermore, all
configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the
system complies with the requirements of IEC 60601-1-1. If in doubt, consult the
technical services department of your local representative.
3.5.1 ELECTROMAGNETIC COMPATIBILITY
This equipment has been tested to comply with the limits for medical devices IEC 601-2:1994 for
CE devices.
These limits are designed to provide reasonable protection against harmful interference in 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 causes harmful interference to other devices, which can
be determined by turning 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 the separation between the equipment.
•
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
•
Consult the manufacturer or field service technician for help.
3.5.2 PROTECTIVE EARTHING (PE)
The system must be connected only to power systems having a separate PE conductor.
3.5.3 EQUIPOTENTIAL EARTHING HEART AND BRAIN EXAMINATIONS
If you use the system for examinations of the heart or brain or the surrounding anatomical regions
in combination with other equipment, equal potential Earthing is required for patient and
operating staff safety (IEC 60601-1-1:1992/A1:1995).
3.6 LASER RADIATION
3.6.1 LASER TARGETING DEVICE
As an option, the system may be equipped with a laser targeting device at the Image Intensifer
and/or generator.
The laser targeting device uses diode laser modules which emit laser radiation. Do Not under
and circumstanstances look dirctly at the laser beam or any scattered laser radiation – either
with the naked eye or with optical instruments.