5
6. Some ATEC Sapphire
unit consoles may include settings specific to higher altitudes. Please contact Customer Support
or your Distributor if you move your console to a significantly different physical address. Do not operate the ATEC
Sapphire
unit console at altitudes higher than 3,000 meters (9,842 feet).
7. If you are a Hologic customer in the U.S. or in Canada, please consult your Hologic Sales Representative or contact
Customer Support if you cannot correct a problem using this Operator’s Manual. All other international customers,
please contact your distributor directly with questions, comments and/or technical service issues.
Operation
1. THE COMPONENTS OF THE ATEC SAPPHIRE
UNIT ARE FOR USE ONLY BY QUALIFIED MEDICAL PERSONNEL
TRAINED IN THEIR USE AND APPLICATION. Qualified medical personnel should perform a test of the ATEC Breast
Biopsy and Excision System: Sapphire unit prior to each procedure or prior to each time a new single patient use
disposable is attached to the console.
Compatibility
1. The ATEC Sapphire
unit console is NOT intended for use inside the MRI suite. The ATEC Sapphire
unit console must
reside outside of the MRI suite.
2. Use only disposables that are manufactured by Hologic. 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
Hologic.
3. Only Hologic-approved accessory equipment and components shall be used with the ATEC Sapphire
unit. Use of the
ATEC Sapphire
unit with unauthorized accessory equipment and components shall void any warranty provided by
Hologic.
4. All disposables associated with the ATEC Sapphire
unit are intended for single patient use and are not intended for
resterilization and subsequent reuse. Dispose of all single patient use instruments after opening.
Introduction
This manual is written for medical personnel who will be responsible for operating the ATEC Sapphire unit. It is extremely
important that the operator read and thoroughly understand the contents of this manual, be trained by a qualified
applications specialist, and follow the instructions contained herein for reliable, safe and efficient operation of the product.
ONLY
(U.S.) Federal law restricts this device to sale by or on the order of a physician pursuant to
21 CFR 801.109(b)(1).
ATEC Users in the United States and Canada
All users of the ATEC Sapphire unit in the United Sates and Canada should contact their Hologic Sales Representative or
the Hologic Customer Service Department for questions, comments, and/or technical service issues.
Other International ATEC Users
All other international users of the ATEC Sapphire unit should contact their distributor directly with questions, comments,
and/or technical service issues.
Indications
The ATEC Breast Biopsy and Excision System is indicated to provide breast tissue samples for diagnostic sampling of
breast abnormalities. The ATEC Breast Biopsy and Excision System is intended to provide breast tissue for histologic
examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot
be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence
of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled
abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal
using standard surgical procedure.
Contraindications
1. The ATEC Breast Biopsy and Excision System is for diagnostic purposes only and is not intended for therapeutic
applications.
2. The ATEC Breast Biopsy and Excision System is contraindicated for those patients who, based on the physician’s
judgement, may be at increased risk or develop complications associated with core removal or biopsy. Patients