Related Manuals for Suros ATEC Sapphire Unit
Summary of Contents for Suros ATEC Sapphire Unit
- Page 1 Operator’s Manual Suros Surgical Systems, Inc. | 6100 Technology Center Drive | Indianapolis, IN 46278 USA www.SurosSurgical.com | CustomerSupport@SurosSurgical.com | 877.887.8767...
- Page 2 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.
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Page 3: Table Of Contents
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: ®... -
Page 4: Precautions
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 ®... - Page 5 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.
- Page 6 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.
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Page 7: Introduction
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 ®... - Page 8 Introducer Localization System ® ® ® are safe to use in the MRI suite. 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 ®...
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Page 9: Components
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 ®... - Page 10 Capital Equipment (multiple patient use) Ultrasound Stereotactic Guided Biopsy Guided Biopsy Guided Biopsy Procedures Procedures Procedures ATEC Breast Biopsy and ® Excision System: Sapphire unit ™ ATEC Footswitch ® ATEC Power Cord ® ATEC Vacuum Line Assembly ® ATEC Stereotactic Adapter ®...
- Page 11 (9GA vs 12GA cutting cannula) and the type of imaging equipment being used. Please note that Suros offers two specialized handpieces with a “petite” aperture for stereotactic and MRI-guided biopsy procedures. The standard petite handpiece (ATEC0912-12) for stereotactic-guided breast biopsy allows for breast compression to as little as 20mm.
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Page 12: Console Controls And Functions
Console Controls and Functions The console user interface panels include controls that enable the user to operate the ATEC system ® and indicator lights that provide additional information about system status. A detailed description of each component on the user interface can be found below. Left User Interface Console User Interface 1. -
Page 13: Atec Breast Biopsy And Excision System: Sapphire Unit Set Up
������ �� ��� �� “ Vacuum Ready” Indicator – Illuminates solid green when the console has achieved ������� full vacuum. Flashes green when full vacuum is not achieved within the specified time frame. If this indicator flashes, refer to the Troubleshooting section for suggested steps to diagnose and correct a potential problem. - Page 14 The power cord will connect the ATEC Breast Biopsy and Excision System: Sapphire unit to the ® ™ facility power supply (electrical outlet). Note: This is the location of disconnect from the mains (electrical supply). Note: Ensure that the power cord is in good condition. A damaged power cord can be an electrical shock hazard.
- Page 15 Footswitch Connection v The footswitch is provided by Suros and should be attached to the right side of the console upon delivery. ATEC Suction Canister Assembly ® Once the console has been turned on, the system will generate its own vacuum.
- Page 16 Handpiece Connections Using Aseptic Technique (refer to Figure 3): v Peel open the saline bag, remove the cap and place the bag on the hook on the right side of the console. v Peel open the sterile pack of the disposable handpiece and place tray on the top of the console.
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Page 17: Atec Breast Biopsy And Excision System: Sapphire Unit Check Out
ATEC Breast Biopsy and Excision System: ® Sapphire Unit Check Out ™ Figure 4: ATEC Breast Biopsy and ® v Power up the system by Excision System: Sapphire Unit ™ switching the green “Power” Check Out switch on the console to the “|”... -
Page 18: Using The Atec Breast Biopsy And Excision System: Sapphire Unit
Using the ATEC Breast Biopsy and ® Excision System: Sapphire Unit ™ Using the System (MRI) v When the console is in “Biopsy” mode, depressing the footswitch will activate the vacuum and operation of the handpiece. v When the console is in “Lavage” mode, the user can automatically aspirate and irrigate the biopsy cavity. -
Page 19: Performing A Biopsy Using Stx Or U/S Guidance
Additional operating instructions are required for a stereotactic biopsy and a stereotactic adapter must be utilized. Suros offers four stereotactic adapter models, which are depicted in Figures 6, 7, 8, and 9. -
Page 20: Performing A Biopsy Using A Stereotactic Adapter
Cleaning section of this manual. v For additional training or questions on specific stereotactic applications, please contact your regional Clinical Education Specialist or Suros Customer Support at 1-877-887-8767. If you are an international customer, please contact your distributor with questions. -
Page 21: Atec
To deploy a biopsy site marker, refer to the ATEC TriMark Instructions For Use (IFU). ™ v Suros Customers in the U.S. or Canada should contact their regional Clinical Education Specialist for compatibility and deployment of alternative biopsy site markers. International customers should contact their distributor. -
Page 22: Troubleshooting
If you are a Suros Customer in the U.S. or Canada, please consult your Suros Sales Representative or contact Suros Customer Support if you cannot correct a problem using this Operator’s Manual. - Page 23 Possible Problems Encountered During a Procedure Problem Possible Cause Possible Remedy No power: Power cord is not plugged in at the Check power cord for proper Power switch not console and/ or wall outlet. engagement to console and illuminated wall outlet. Console circuit breaker tripped.
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Page 24: Warranty
Product, or part thereof, that has been: (1) adversely affected due to use with devices manufactured or distributed by persons not authorized by Suros, (2) repaired or altered by persons not authorized by Suros in a way so as to, in Suros’... -
Page 25: Service And Maintenance
Service and Maintenance Suros offers a variety of Extended Service Protection and Preventive Maintenance options. For additional information, please visit the Suros website at www.SurosSurgical.com or contact your Suros Sales Representative, Suros Customer Support, or your distributor. If you believe your ATEC... - Page 26 2) Disconnect upper and lower footswitch connectors by pulling out the top lock collar and pushing in the bottom lock collar. Once disconnected, place foot- switch in Suros box and return to Suros for evaluation. Installing new footswitch assembly (with the console powered off)
- Page 27 Field Replaceable Items (cont.) Item Instructions Vacuum Line Assembly White Lock Collar Vacuum Line Connector ATEC Breast Biopsy and Excision System: Sapphire Unit Operator’s Manual ® ™...
- Page 28 Field Replaceable Items (cont.) Item Instructions Power Cord Removal (with the console powered off) Unplug console power cord from wall outlet. Completely unwrap and remove power cord Cord from cord management plate. Management With a #0 Philips screwdriver loosen fastener Plate located on bottom of retaining bracket.
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Page 29: Cleaning Instructions
Cleaning Instructions This section provides instructions on how to clean components of the ATEC Breast Biopsy and ® Excision System: Sapphire unit. WARNING: Single patient use disposable items are not intended ™ for reuse and should not be cleaned or resterilized. ATEC Breast Biopsy and Excision System: ®... -
Page 30: Owner's Record
™ on the panel on the left side of the console. Record this number in the space provided below. Refer to this serial number whenever you contact Suros Customer Support or your distributor regarding your ATEC Breast Biopsy and Excision System: Sapphire unit. -
Page 31: Specifications
Specifications ATEC Breast Biopsy ® and Excision System: Sapphire Unit ™ 240V/50 Hz Model 120V/60 Hz Model Size 25 in. Wide (63cm) 25 in. Wide (63cm) 37 in. High (93cm) 37 in. High (93cm) 21 in. Deep (53cm) 21 in. Deep (53cm) Footprint 525 in (3400 cm... - Page 32 More Information For product availability, labeling limitations and more information, contact your Suros Sales Representative or call Suros Customer Support toll free at 877-887-8767. If you are an international customer, please contact your distributor for more information. Product information can also be found on the Suros website at www.SurosSurgical.com.
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Page 33: Important Contact Information
Important Contact Information ATEC Breast Biopsy and Excision System: ® Sapphire Unit ™ Suros Sales Representative Name: Phone: Email: Suros Clinical Education Specialist Name: Phone: Email: Suros Customer Support CustomerSupport@SurosSurgical.com 1-877-887-8767 Distributor Information Name: Phone: Email: Country: ATEC Breast Biopsy and Excision System: Sapphire Unit Operator’s Manual... - Page 34 Suros Surgical Systems, Inc. | 6100 Technology Center Drive | Indianapolis, IN 46278 USA www.SurosSurgical.com | 877.887.8767...
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