Hologic ATEC SAPPHIRE Operator's Manual

Hologic ATEC SAPPHIRE Operator's Manual

Breast biopsy system
Hide thumbs Also See for ATEC SAPPHIRE:

Advertisement

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the ATEC SAPPHIRE and is the answer not in the manual?

Questions and answers

Summary of Contents for Hologic ATEC SAPPHIRE

  • Page 2: Table Of Contents

    Thank you for purchasing the ATEC Sapphire Breast Biopsy and Excision System. ® Table of Contents Warnings and Precautions ..............................2 Introduction ..................................3 Components ..................................5 Product Nomenclature and Disposable Product Selection ....................5 Controls and Functions ..............................8 Console User Interface ..............................
  • Page 3: Warnings And Precautions

    Sapphire Breast Biopsy and Excision System ® Please read all contents of the Operator’s Manual for your ATEC Sapphire Breast Biopsy and Excision System prior to installation and operation. Follow all warnings and instructions as stated in this manual. Keep this manual available during procedures.
  • Page 4: Introduction

    MEDICAL PERSONNEL TRAINED IN THEIR USE AND APPLICATION. Qualified medical personnel should perform a test of the ATEC Sapphire Breast Biopsy and Excision System prior to each procedure or prior to each time a new single patient use disposable is attached to the console.
  • Page 5 1. The console may be used to perform biopsies under ultrasound (U/S), stereotactic (STX) or MRI guidance. 2. The console is NOT intended for use inside the MRI suite. The ATEC Sapphire console must reside outside of the MRI suite. Turn the console power off during MRI imaging to avoid the possibility of image distortion.
  • Page 6: Components

    The specific handpiece to be selected depends on user preference and the type of imaging equipment being used as indicated in Table 4 and Table 5. Please refer to the Hologic website at www.hologic.com for an updated list of disposable product offerings.
  • Page 7 • • • • • • • Innovality Giotto • • • • • • • • • • • Note: Product Availability may vary by Country. Note: For other Imaging Modalities and Equipment, contact your Hologic Representative or Distributor.
  • Page 8 • • • Included in ILS Kit Other MRI Systems • • • • • • Note: Product Availability may vary by Country. Note: For other Imaging Modalities and Equipment, contact your Hologic Representative or Distributor. * Preferred ancillary equipment...
  • Page 9: Controls And Functions

    Controls and Functions The console user interface panels include controls that enable the user to operate the 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.
  • Page 10: System Set Up

    WARNING: a different power cord with the ATEC Sapphire unit. Using a different power cord may create an electrical and fire hazard. DO NOT, under any circumstances, remove the ground wire or ground plug from any power plug. DO NOT use an extension cord with this equipment.
  • Page 11 AC inlet on the left side of the console. 6. ATEC Power Cord Management Plate - Cord should be wound clockwise (cw) around the Cord Management Plate. 7. ATEC Footswitch - Provided by Hologic. Attaches to the right side of the console. Activates handpiece or biopsy device.
  • Page 12 ATEC Footswitch Connection The ATEC footswitch is provided by Hologic and should be attached to the right side of the console upon delivery. Verify footswitch connections prior to use per the Field Replaceable Items Section of this manual. ATEC Vacuum Line Assembly The system will generate vacuum when the proper modes are selected.
  • Page 13 Handpiece Setup and Connections (refer to figure 4) 1. Peel open the saline bag, remove the cap and place the bag on the saline bag hook on the right side of the console. 2. Peel open the sterile pack of the disposable handpiece and place the tray on the top of the console. CAUTION: Leave the protective sheath on handpiece tip.
  • Page 14: System Test

    When performing a biopsy under stereotactic guidance, a stereotactic adapter is required to hold the handpiece in place on a stereotactic system. Hologic offers multiple stereotactic adapter models for the ATEC handpiece. For additional instructions, please refer to the ATEC stereotactic adapter instructions (IFU) and Appendix A.
  • Page 15: Atec Handpiece Operating Instructions

    7. Disconnect the filter chamber to remove the tissue cores from the tissue filter. 8. To deploy a biopsy site marker, refer to the Hologic marker of choice Instructions for Use (IFU). 9. Remove the marker from the needle after deployment.
  • Page 16: Troubleshooting

    Hologic or your distributor to make sure the problem is not a result of misinterpreting the operation of the system. If you are a Hologic customer in the United States, please consult your Hologic Sales Representative or contact Customer Support if you cannot correct a problem using this Operator’s Manual. International customers, please contact your distributor or local Hologic Sales Representative directly with questions, comments and/or technical service issues.
  • Page 17 Problem Possible Cause Possible Remedy Poor quality biopsy cores or no cores 1. Reduced or no vacuum at tip of 1. Restore vacuum at tip of the handpiece handpiece cannula. cannula through the following steps: a. Suction Canister lid is not fully a.
  • Page 18: Warranty

    Warranty Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by Hologic is warranted to the original Customer to perform substantially in accordance with published product specifications for one (1) year starting from the date of shipment, or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital imaging mammography x-ray tubes are warranted for twenty-four (24) months, during which the x-ray tubes are fully warranted for the first twelve (12) months and are warranted on a straight-line prorated basis during months 13-24;...
  • Page 19 Services or a Hologic certified technician; contact Technical Support for details about Preventative Maintenance and/or Biomedical training. The ATEC Sapphire unit includes several external components which can be replaced in the field. These external components include: 1. ATEC Footswitch Assembly 2. ATEC Vacuum Line Assembly 3.
  • Page 20 2. Rotate the metal strain-relief bar counter clockwise at least 3 turns. Disconnect connector by grasping connector housing and pulling straight out. 3. Disconnect the footswitch connector. Once disconnected, call Hologic Technical Back of Console Service for product return instructions.
  • Page 21 Item Instructions Power Cord Removal (with the console powered off) 1. Unplug console power cord from wall outlet. 2. Completely unwrap and remove power cord from cord management plate. Cord Management Plate 3. With #1 Phillips screwdriver, loosen fastener located on bottom of retaining bracket. Power Cord 4.
  • Page 22: Cleaning Instructions

    The serial number of your ATEC Breast Biopsy and Excision System: Sapphire unit is located 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 Hologic Customer Support or your distributor regarding your ATEC Sapphire unit.
  • Page 23: Specifications

    Specifications ATEC Breast Biopsy and Excision System: Sapphire Unit ATEC Sapphire Console ATEC Sapphire 100 ATEC sapphire 200 25 in. Wide (63 cm) 25 in. Wide (63 cm) Size 37 in. High (93 cm) 37 in. High (93 cm) 21 in. Deep (53 cm) 21 in.
  • Page 24 Specifications ATEC Breast Biopsy and Excision System: Sapphire Unit ATEC Footswitch - MRI Conditional Size 6 in. (16cm) Long x 4 in. (9cm) Wide x 2 in. (5cm) High Weight 1 lb. (0.5kg) IPX Rating IPX8 Cable Length 20 ft. (6m) ATEC Handpiece Handpiece Size 1.66 in.
  • Page 25 Storage and Transport Environmental Conditions +60 ºC An ambient temperature of -29ºC to +60ºC (-20ºF to +140ºF) -29 ºC A relative humidity range of 30% to 85% excluding condensation Equipment Operating Environmental Conditions +40 ºC An ambient temperature of +15ºC to +40ºC. (+59ºF to +104ºF) +15 ºC A relative humidity range of 30% to 75% 1014 hPa...
  • Page 26: Electromagnetic Emissions

    GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The ATEC Sapphire Console is intended for use in the electromagnetic environment specified below. The customer or the user of the ATEC Sapphire Console should assure that it is used in such an environment.
  • Page 27 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ATEC Sapphire Console is used exceeds the applicable RF compliance level above, the ATEC Sapphire Console should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ATEC Sapphire Console.
  • Page 28 The ATEC Sapphire Console is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ATEC Sapphire Console can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ATEC Sapphire Console as recommended in the following table, according to the maximum output power of the communications device.
  • Page 29: Symbols

    Symbols The following symbols may be found on the product labeling for the ATEC Breast Biopsy and Excision System: Symbol Definition Do not re-use Caution, consult accompanying documents Consult Instructions for use Upper limit of temperature Use by date Batch code Catalogue number Sterilized using irradiation Do not resterilize...
  • Page 30 Symbol Definition This device contains di-(2ethylhexyl) phthalate, DEHP; Benzyl butyl phthalate, BBP; Di-n-butyl phthalate, DBP Authorised Representative in the European Community Humidity Limitation Temperature Limitation Non - Sterile To identify a type BF applied part complying with IEC 60601-1 ATEC and Eviva biopsy devices. Note 1 - B = Body.
  • Page 31: Important Contact Information: U.s. Customers

    Important Contact Information: U.S. Customers ATEC Breast Biopsy and Excision System: Sapphire 100/200 Unit Sales Representative Name: ________________________________________________________________________ Phone: ________________________________________________________________________ Email: _________________________________________________________________________ Clinical Education Specialist Name: ________________________________________________________________________ Phone: ________________________________________________________________________ Email: _________________________________________________________________________...
  • Page 32: Important Contact Information: International Customers

    Important Contact Information: International Customers ATEC Breast Biopsy and Excision System: Sapphire 100/200 Unit Distributor or Local Hologic Sales Representative Information Name: ________________________________________________________________________ Phone: ________________________________________________________________________ Email: _________________________________________________________________________ Country: ______________________________________________________________________________...
  • Page 33: Appendix A: Stereotactic Adapter

    Eviva biopsy device in place on the stereotactic system. Hologic offers four stereotactic adapter models for the ATEC handpiece (refer to Table 5), which are depicted in figures 8 through 11. Various stereotactic adapter models are offered for the Eviva biopsy device (refer to Table 4). For additional instructions on the Eviva adapters and devices, please refer to the Eviva Instructions for Use (IFU).
  • Page 34 Please contact Hologic Customer Support at 800-442-9892 if you believe this accessory, along with the appropriate instructions, was omitted. If you are an international customer, please contact your distributor directly with questions, comments, and/or...
  • Page 35 © 2015 Hologic, Inc. Hologic, ATEC, Eviva, Multicare,Affirm, and Stereoloc are trademarks and/or registered trademarks of Hologic, Inc. and/ or its subsidiaries, in the United States and/or other countries. All other trademarks, registered trademarks, and product names used within this document are the property of their respective owners.

Table of Contents

Save PDF