Suros ATEC Sapphire Unit User manual

Suros Surgical Systems, Inc. | 6100 Technology Center Drive | Indianapolis, IN 46278 USA
www.SurosSurgical.com | [email protected] | 877.887.8767
Operator’s Manual

Copyright © 2006 Suros Surgical Systems, Inc. ATEC and Suros Compassionate Technologies are trademarks or registered
trademarks of Suros Surgical Systems, Inc. in the United States and other countries. All rights reserved.
Covered by one or more of the following patents and other patents pending: 6,758,824 and 6,638,235.
LIT417:RevA

Congratulations!
Thank you for purchasing the ATEC®
Breast Biopsy and Excision System:
Sapphire™ unit.
Contents
Precautions .......................................................................................1
Warnings and Cautions ....................................................................1
Introduction ......................................................................................4
Indications ........................................................................................4
Contraindications .............................................................................4
Components .....................................................................................6
Console Controls and Functions ......................................................9
ATEC® Breast Biopsy and Excision System:
Sapphire™ Unit Set Up ...................................................................10
ATEC® Breast Biopsy and Excision System:
Sapphire™ Unit Check Out .............................................................14
Using the ATEC® Breast Biopsy and Excision System:
Sapphire™ Unit ...............................................................................15
Performing a Biopsy Using MRI Guidance ...................................15
Performing a Biopsy Using STX or U/S Guidance .......................16
Performing a Biopsy Using a Stereotactic Adapter .......................17
ATEC® Handpiece Operating Instructions .....................................18
Troubleshooting .............................................................................19
Warranty .........................................................................................21
Service and Maintenance ...............................................................22
Cleaning Instructions .....................................................................26
Owner’s Record .............................................................................27
Specifications .................................................................................28
Important Contact Information .....................................................30

ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
Precautions
Please read all contents of the Operator’s Manual for your ATEC® Breast Biopsy and Excision System:
Sapphire™ unit prior to installation and operation. Follow all warnings and instructions as stated in
this manual and retain for future reference. Physicians should inform patients about all potential risks
and adverse events discussed in this manual with respect to the use of the ATEC® Breast Biopsy and
Excision System: Sapphire™ unit.
As used below, the term “Suros™” means Suros Surgical Systems, Inc., a Delaware corporation. As
used below, the term “ATEC® Breast Biopsy and Excision System: Sapphire™ unit” means the ATEC
Sapphire™ console unit and all available ATEC® Breast Biopsy and Excision System components, as
more fully described in the Components section below (unless the context dictates otherwise).
v Should any object or liquid fall into the ATEC Sapphire™ console, unplug the console
and have it checked by qualified personnel before operating it any further.
v Unplug the console from the electrical outlet if it is not to be used for several days
or an extended period of time.
v Allow adequate air circulation around the console to prevent internal heat build-up. Do
not place the console on surfaces or near materials that may block the ventilation openings.
v Do not install the console in a location near heat sources such as radiators or air ducts,
or in a place subject to direct sunlight, excessive dust, mechanical vibration or shock.
v To keep the console looking new, periodically clean it with a soft cloth. Stubborn stains
may be removed with a cloth lightly dampened with a mild detergent solution. Never
use strong solvents or abrasive cleansers since these will damage the console casing.
The console should only be cleaned after the power cord is disconnected from the power
outlet and the console.
v Do not place the console on an unstable surface. The console may fall, causing serious
injury and damage to the appliance. Quick stops, excessive force and uneven surfaces
may cause the console to overturn.
Warnings and Cautions
Warnings
v THE COMPONENTS OF THE ATEC® BREAST BIOPSY AND EXCISION
SYSTEM: 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.
v To prevent fire or shock hazard, do not expose the console to rain or moisture.
v To prevent shock hazard, do not use the console’s polarized plug with a receptacle
or other outlet unless the blades can be fully inserted to prevent blade exposure.
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ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
v Do not use the console’s polarized plug with an extension cord.
v 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.
v Only Suros-approved accessory equipment and components shall be used with the ATEC®
Breast Biopsy and Excision System: Sapphire™ unit. Use of the ATEC® Breast Biopsy and
Excision System: Sapphire™ unit with unauthorized accessory equipment and components
shall void any warranty provided by Suros herein.
v All disposables associated with the ATEC® Breast Biopsy and Excision System: 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 and use.
v Do not resterilize any ATEC® Breast Biopsy and Excision System: Sapphire™ unit 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.
v DANGER: There is a small risk of explosion if the ATEC® Breast Biopsy and Excision
System: Sapphire™ unit is used in the presence of flammable anesthetics or other explosive gases.
v The ATEC® Breast Biopsy and Excision System: Sapphire™ unit console should only be
opened or serviced by Suros or qualified personnel who have been trained and certified by
Suros Surgical Systems, Inc.
Cautions
v Console not intended for use in the MRI suite.
v Instruments or devices which come into contact with bodily fluids may require special
disposal handling to prevent biological contamination.
v Grounding reliability can only be achieved when the console is connected to an equivalent
receptacle marked “Hospital Grade.”
v The console should not touch other electrical equipment during use.
v 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 Reorient or relocate the receiving device.
o Increase the separation between the equipment.
o Connect the console to an outlet on a circuit different from that to which the other
device(s) are connected.
o Consult Suros for technical help.
v Damage to the power cord may cause a fire or shock hazard. When unplugging the
power cord, please hold by the plug and remove it carefully. Do not damage or modify
the console power cord.
v When the console is not being used, turn off all power switches and place the console
in a location where it will not be damaged.
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ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
3
v Do not place the console on an unstable surface. The console may fall, causing serious
injury and damage to the unit. Quick stops, excessive force and uneven surfaces may
cause the console to overturn.
v Some ATEC® Breast Biopsy and Excision System: Sapphire™ unit consoles may include
settings specific to higher altitudes. Please contact Suros Customer Support or your
distributor if you move your console to a significantly different physical address.
v If you are a Suros customer in the U.S. or in Canada, consult your Suros Sales
Representative or Suros Customer Support if you cannot correct a problem using
this Operator’s Manual. If you are an international customer, please contact your
distributor directly with questions, comments and/or technical service issues.
Symbols
The MR within a triangle is intended to alert the user that a component
or components of the system are “MRI Conditional” and may be brought
into an MRI suite.

ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
Introduction
This manual is written for medical personnel who will be responsible for operating the ATEC® Breast
Biopsy and Excision System: 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.
CAUTION: Federal law restricts this device to sale by or on the order of a physician pursuant
to C.F.R. 801.109(b)(1).
ATEC® Users in the United States and Canada
All users of the ATEC® Breast Biopsy and Excision System: Sapphire™ unit in the United States
and Canada should contact their Suros Sales Representative or the Suros Customer Service
Department for questions, comments, and/or technical service issues.
International ATEC® Users
All international users of the ATEC® Breast Biopsy and Excision System: Sapphire™ unit should
contact their distributor directly with questions, comments, and/or technical service issues.
Indications
v 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
v The ATEC® Breast Biopsy and Excision System: Sapphire™ unit is for diagnostic use only
and is NOT indicated for therapeutic use. The ATEC® Breast Biopsy and Excision System:
Sapphire™ unit is NOT intended to be used outside of the standards, specifications and
limitations for the ATEC® Breast Biopsy and Excision System: Sapphire™ unit as outlined
in this manual and other related materials.
v The ATEC® Breast Biopsy and Excision System: Sapphire™ unit is contraindicated for those
patients where increased risk or complications may be associated with biopsy based on the
physician’s judgment. Patients receiving anticoagulant therapy or who may have bleeding
disorders may be at increased risk of procedural complications.
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ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
Notes on the MRI Environment
v The ATEC® Breast Biopsy and Excision System: Sapphire™ unit may be used to perform
biopsies under ultrasound, stereotactic or MRI guidance.
v The ATEC® Breast Biopsy and Excision System: Sapphire™ unit console is not intended
for use in the MRI suite. The ATEC® Breast Biopsy and Excision System: Sapphire™ unit
console must reside outside of the MRI suite.
v The ATEC® footswitch, ATEC® MRI handpiece and ATEC® Introducer Localization System
are safe to use in the MRI suite.
v Suros offers a variety of disposable handpiece configurations. However, when performing
MRI-guided breast biopsy procedures, an ATEC® MRI handpiece must be used. The
ATEC® Introducer Localization System is available for localizing the area targeted
for biopsy. The ATEC® MRI handpiece and ATEC® Introducer Localization System is
specifically designed for use in the MRI environment. ATEC® handpieces designed for use
with MRI guidance are compatible with the red receptacle marked “MRI” on the console.
v ATEC® handpieces designed for use with stereotactic (STX) and ultrasound (US)
guidance are compatible with the red receptacle marked “US/STX” on the console.
v The particular handpiece selected for use with ultrasound or stereotactic guidance
depends on user preference and the type of stereotactic system being used. Please refer
to the Disposable Component Selection section of this manual for additional guidance.
v A complete list of ATEC® handpieces and other disposables suited for MRI, stereotactic
or ultrasound-guided biopsy procedures is included in the Components section.
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ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
Components
Below is a list of available components for the ATEC® Breast Biopsy and Excision System:
Sapphire™ unit.
Capital Equipment (multiple patient use)
ATEC® Breast Biopsy and Excision System: Sapphire™ unit
ATEC® Footswitch
ATEC® Power Cord
ATEC® Vacuum Line Assembly
ATEC® Stereotactic Adapter for use on stereotactic systems
Single Patient Use Disposable Components for
Procedures Using Stereotactic or Ultrasound Guidance
ATEC® Handpiece
ATEC® Suction Canister
ATEC® Tissue Filters
ATEC® Remote Tissue Filter Adapter (RTFA)
The RTFA is for use with Lorad® upright stereotactic systems and Siemens stereotactic systems.
ATEC® Needle Guides
For use with stereotactic systems.
Single Patient Use Disposable Components
for MRI-Guided Procedures
ATEC® MRI Handpiece
ATEC® Introducer Localization System
ATEC® Suction Canister
ATEC® Tissue Filters
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ATEC® Breast Biopsy and Excision System: Sapphire™ Unit Operator’s Manual
Capital Equipment (multiple patient use)
MRI
Guided Biopsy
Procedures
Ultrasound
Guided Biopsy
Procedures
Stereotactic
Guided Biopsy
Procedures
ATEC® Breast Biopsy and
Excision System: Sapphire™ unit v v v
ATEC® Footswitch v v v
ATEC® Power Cord v v v
ATEC® Vacuum Line Assembly v v v
ATEC® Stereotactic Adapter v
Single Patient Use Disposable Components
MRI
Guided Biopsy
Procedures
Ultrasound
Guided Biopsy
Procedures
Stereotactic
Guided Biopsy
Procedures
ATEC® MRI Handpiece v
ATEC® Introducer Localization System v
ATEC® Handpiece v v
ATEC® Suction Canister with Lid v v v
ATEC® Tissue Filters optional optional optional
ATEC® Remote Tissue Filter Adapter
(RTFA) optional
ATEC® Needle Guides v
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