Hologic ATEC Sapphire Operator's Manual
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Hologic ATEC Sapphire Operator's Manual

Hologic ATEC Sapphire Operator's Manual

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Hologic Ltd.
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Hologic UK Ltd.
Heron House Oaks Business Park, Crewe Road
Unit 2, Link 10, Napier Way
Wythenshawe, Manchester. M23 9HZ, UK
Crawley, West Sussex, RH10 9 RA, UK
Hologic, Inc. | 250 Campus Drive | Marlborough, MA 01752 USA
www.hologic.com | 877.887.8767

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  • Page 1 Hologic UK Ltd. Heron House Oaks Business Park, Crewe Road Unit 2, Link 10, Napier Way Wythenshawe, Manchester. M23 9HZ, UK Crawley, West Sussex, RH10 9 RA, UK Hologic, Inc. | 250 Campus Drive | Marlborough, MA 01752 USA www.hologic.com | 877.887.8767...
  • Page 2 © 2013-2015 Hologic inc. All rights reserved. Hologic, ATEC Eviva, Multicare, 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.

  • Page 3: Table Of Contents

    Congratulations! Thank you for purchasing the ATEC Sapphire Breast Biopsy and Excision System: Sapphire unit. Table of Contents ATEC Breast Biopsy and Excision System: Sapphire ..................... 4 ® Warnings and Precautions ..............................4 Introduction ..................................5 Indications ..................................5 Contraindications ................................5 Components ..................................

  • Page 4: Atec ® Breast Biopsy And Excision System: Sapphire

    Warnings and Precautions Safety and Electrical 1. 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. 2. Unplug the console from the electrical outlet if it is not to be used for several days or an extended period of time.

  • Page 5: Introduction

    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.

  • Page 6: Components

    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.

  • Page 7: Product Nomenclature And Disposable Product Selection

    MRI guidance. The specific handpiece or biopsy device 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 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: 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.

  • Page 10: Atec Breast Biopsy And Excision System: Sapphire Unit Set Up

    WARNING: provided with the console. DO NOT use 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.
  • Page 11 LEFT SIDE RIGHT SIDE 1. Label - Consult this label if you need any information on the electrical ratings of the ATEC Sapphire unit. This label also contains the serial number of your ATEC Sapphire unit. 2. Circuit Breaker - Part of the AC Inlet. If the circuit breaker has been tripped, the black button will not be flush and a white dot will be visible.
  • 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 ATEC Handpiece and Eviva Biopsy Device Connections 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: Atec Breast Biopsy And Excision System: Sapphire Unit Check Out

    When performing a biopsy under stereotactic guidance, a stereotactic adapter is required to hold the ATEC handpiece or Eviva biopsy device 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: Performing A Biopsy Using Ultrasound Guidance

    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). (If using an ATEC Stereotactic Adapter) 9.

  • 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 U.S. or Canada, please consult your Hologic Sales Representative or contact Hologic Customer Support if you cannot correct a problem using this Operator’s Manual. All other international customers, please contact your distributor directly with questions and/or comments.
  • 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

    Hologic’s judgment, affect its stability or reliability, (3) subjected to improper use, negligence or accident, or as to which the purchaser or user has failed to implement all updates or other instructions provided by Hologic, or (4) used other than in accordance with the instructions for such Product established by Hologic in the operating manuals or instructions for use provided by Hologic or with standards generally accepted in the industry for similar products.

  • Page 19: Service And Maintenance

    ATEC Users in the United States All users of the ATEC Sapphire unit in the United States and Canada should contact their Hologic Sales Representative or the Customer Service Department for questions, comments, and/or technical service issues. If you believe the ATEC Sapphire Unit requires service or repair please contact Hologic ATEC Technical Service Support at 888-355-7876, option 2.
  • Page 20 1. Completely unwrap and remove footswitch cord from cord management plate Back of Console 2. Disconnect upper and lower footswitch connectors by pulling out the top lock Cord Management collar and pushing in the bottom lock collar. Once disconnected, call Hologic Plate Technical Service for product retrun instructions. FootSwtich Cord...
  • 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 Philips screwdriver, loosen fastener located on bottom of retaining Power Cord bracket.

  • 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 120V/60 Hz Model 240V/50 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)
  • Page 24 Specifications ATEC Breast Biopsy and Excision System: Sapphire Unit ATEC Footswitch - MRI Compatible Size 6 in. (16cm) Long 4 in. (9cm) Wide 2 in. (5cm) High Weight 1 lb. (0.5kg) Tubing Length 20 ft. (6m) ATEC Handpiece Handpiece Size 1.66 in.

  • Page 25: Electromagnetic Emissions

    ATEC Sapphire Console. 5. The ATEC Sapphire Console should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the ATEC Sapphire Console should be observed to verify normal operation in the configuration in which it will be used.
  • Page 26 Mains power quality should be that of a typical commercial or hospital environment. EN/IEC 61000-4-11 for 0.5 cycle for 0.5 cycle If the user of the ATEC Sapphire Console requires continued operation during power mains interruptions, it is recommended that 60 % dip 60 % dip...
  • 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: 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 num ber Sterilized using irradiation Do not resterilize...
  • Page 29 Symbol Definition Authorised Representative in the European Community Humidity Limitation Temperature Limitation Non - Sterile To identify a type BF applied part complying with IEC 60601-1. Note 1 - B = Body. Note 2 - F = Floating applied part. ATEC and Eviva biopsy devices Alternating Current Manually Reset Breaker...

  • Page 30: Important Contact Information: U.s. Customers And Canadian Customers

    U.S. Customers and Canadian Customers ATEC Breast Biopsy and Excision System: Sapphire Unit Sales Representative Name: ________________________________________________________________________ Phone: ________________________________________________________________________ Email: _________________________________________________________________________ Clinical Education Specialist Name: ________________________________________________________________________ Phone: ________________________________________________________________________ Email: _________________________________________________________________________ Hologic Customer Support: csupport@hologic.com +1 877-887-8767 Hologic Quality: quality.reporting@hologic.com +1 888-355-7876...

  • Page 31: Important Contact Information: For All Other International Customers

    Important Contact Information: For all other International Customers ATEC Breast Biopsy and Excision System: Sapphire Unit Distributor or Local Hologic Sales Representative Information Name: ________________________________________________________________________ Phone: ________________________________________________________________________ Email: _________________________________________________________________________ Country: ______________________________________________________________________________...

  • Page 32: 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 6 thru 9. 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 33: Cleaning Instructions

    Please contact Hologic Customer Support at 1-877-887-8767 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 34 © 2014-2015 Hologic Inc. All rights reserved. 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.
  • Page 36 Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA www.hologic.com 877.887.8767...

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