Manual BI160-GE - NORAS MRI products GmbH

1. General Information
General Information
To ensure safe and troublefree operation of this high quality medical device,
please carefully read and follow the instructions in this Operator’s Manual and
pay particular attention to the following information:
• The Immobilization and Biopsy System BI160-GE can only be used with
the GE High Density Mamma Coil.
FDA caution
Federal law restricts this device to sale, distribute and use
by or on the order of a physician.
• Prior to using this device for patient examinations, you should complete a
training program with the device using a phantom! You can order a phantom from
NORAS MRI products GmbH. If a mammographic phantom is not available, you
may use a grapefruit or similar object to become familiar with the system.
• If you would like to receive up-to-date information about any further development
of or new accessories for your Immobilization and Biopsy System, please
send an e-mail with the serial number of your BI160-GE to mri@noras.de.
• Assuming the total system is properly operated and handled, it can be used
for at least 5 years. After 5 years, a narrow inspection must be conducted by the
manufacturer. Due to the rapid technical developments being made in magnetic
resonance imaging, the practical usability of the total system must be assessed
from a mechanical point of view.
• You should inspect the needle block guides and adapters at the latest after 2
years to be sure they are in good condition and replace, if necessary.
BI160-GE
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