ATEC
Pearl, ATEC Sapphire and ATEC Emerald
Breast Biopsy and Excision System
LIT309:RevB
This document contains information that is confidential and proprietary to Suros Surgical Systems, Inc., a Hologic company. The document
and/or information contained herein may NOT be disclosed to any party without the express written consent of Suros. Covered by one or
more of the following patents and other patents pending: 6,758,824 and 6,638,235. © 2007 Suros Surgical Systems, Inc. ATEC, Suros and
Suros Compassionate Technologies are trademarks or registered trademarks of Suros in the United States and other countries. All rights
reserved.
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Do not use the console’s polarized plug with an extension cord.
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Use only disposables that are manufactured by Suros. Use of any other disposables
may result in damage to the console and unintended injury to the patient or
unacceptable clinical results and shall void any warranty provided by Suros herein.
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Only Suros approved accessory equipment and components shall be used with the
ATEC Pearl, ATEC Sapphire and ATEC Emerald. Use of the ATEC Pearl, ATEC
Sapphire and ATEC Emerald with unauthorized accessory equipment and
components shall void any warranty provided by Suros herein.
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All disposables associated with the ATEC Pearl, ATEC Sapphire and ATEC Emerald
are intended for single patient use and are not intended for resterilization and
subsequent reuse. Dispose of all single patient use instruments after opening.
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Do Not Resterilize any ATEC
breast biopsy system single patient use instrument or
accessory. Resterilization may compromise the integrity and mechanical function of
the instrument or accessory, which may result in unintended injury to the patient or
unacceptable clinical results.
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DANGER – There is a risk of explosion if the ATEC Pearl, ATEC Sapphire or ATEC
Emerald is used in the presence of flammable anesthetics or other explosive gases.
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The ATEC Pearl, ATEC Sapphire and ATEC Emerald consoles should only be
opened or serviced by Suros or qualified personnel who have been trained and
certified by Suros.
Cautions
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The ATEC Pearl is not intended for use in MRI suites or with MRI-guided procedures.
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The ATEC Sapphire and ATEC Emerald are not intended for use in MRI suites;
however are intended for use in MRI-guided procedures.
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Instruments or devices which come into contact with bodily fluids may require special
disposal handling to prevent biological contamination.
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Grounding reliability can only be achieved when the console is connected to an
equivalent receptacle marked “Hospital Grade.”
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The console should not touch other electrical equipment during use.
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The console 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 the console does cause harmful interference to other
devices, which can be determined by turning the console off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
o
Re-orient or relocate the receiving device.
o
Increase the separation between the equipment.
