6
receiving anticoagulant therapy or who may have bleeding disorders may be considered at increased risk of procedural
complications.
Notes on the MRI Environment
1. The ATEC Sapphire
unit may be used to perform biopsies under ultrasound (U/S), stereotactic (STX) or MRI guidance.
2. 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.
3. The ATEC MRI footswitch, ATEC MRI handpiece and ATEC MRI Introducer Localization System (ILS) are specifically
designed for use in the MRI suite. Items which may be brought into the MRI suite wil be marked with the “MRI
Conditional” symbol.
4. Hologic offers a variety of disposable handpiece configurations. However, when performing MRI-guided breast biopsy
procedures, an ATEC MRI handpiece MUST be used. ATEC handpieces designed for use with MRI guidance are
compatible with the
red
receptacle marked “MRI” on the console. The ATEC MRI Introducer Localization System (ILS) is
available for localizing the area targeted for biopsy.
5. An overview of the products suited for MRI, Stereotactic (STX) and Ultrasound (U/S) guided biopsy procedures is
included in the Components section.
Notes on the Stereotactic and Ultrasound Environment
1. ATEC handpieces designed for use with stereotactic (STX) and ultrasound (U/S) guidance are compatible with the
red
receptacle marked “US/STX” on the console.
2. The particular handpiece selected for use with ultrasound (U/S) and stereotactic (STX) guidance depends on user
preference and the type of stereotactic (STX) system being used. Please refer to the Disposable Product Selection
section of this manual for additional guidance.
Components
TABLE 1: CAPITAL EQUIPMENT (MULTIPLE PATIENT USE)
Stereotactic Guided Biopsy
Procedures
Ultrasound Guided Biopsy
Procedures
MRI Guided Biopsy
Procedures
ATEC Breast Biopsy and Excision
System: Sapphire
unit
•
•
•
ATEC Footswitch
•
•
•
ATEC Power Cord
•
•
•
ATEC Vacuum Line Assembly
•
•
•
ATEC Stereotactic Adapter
•
N/A
N/A
Eviva Stereotactic Adapter
•
N/A
N/A
TABLE 2: DISPOSABLE COMPONENTS (SINGLE PATIENT USE)
Stereotactic Guided Biopsy
Procedures
Ultrasound Guided Biopsy
Procedures
MRI Guided Biopsy
Procedures
ATEC Handpiece
•
•
N/A
ATEC MRI Handpiece
N/A
N/A
•
ATEC Introducer Localization
System (ILS)
N/A
N/A
•
Eviva Biopsy Device
•
N/A
N/A
Needle Guide (ATEC and Eviva
®
)
•
N/A
N/A
ATEC Canister with Lid
•
•
•
ATEC Tissue Filter
optional
optional
optional
ATEC Remote Tissue Filter
Adapter (RTFA)
See Note 1
N/A
N/A
Note 1: To be used with Hologic Stereoloc
®
II upright sterotactic system and Siemens stereotactic systems. Optional for all other stereotactic systems.
