User Guide .1 Laparoscopic Transducer Types 8666 and 8666-RF Laparoscopic Transducer Types 8666 and

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Text of User Guide .1 Laparoscopic Transducer Types 8666 and 8666-RF Laparoscopic Transducer Types 8666 and

  • English BB0532-INovember 2010

    Types 8666 and 8666-RF

    Laparoscopic TransducerUser Guide

  • MANUFACTURERBK Medical ApS

    Mileparken 34

    DK-2730 Herlev

    Tel.:+45 44528100

    Fax:+45 44528199

    www.bkmed.com

    Email: info@bkmed.dk

    BK Medical Customer Satisfaction

    Input from our customers helps us improve our products and services. As part of ourcustomer satisfaction program, we contact a sample of our customers a few months afterthey receive their orders. If you receive an email message from us asking for your feedback,we hope you will be willing to answer some questions about your experience buying andusing our products. Your opinions are important to us. You are of course always welcometo contact us via your BK Medical representative or by contacting us directly.

    2010 BK Medical

    Information in this document may be subject to change without notice.

  • Laparoscopic Transducer Types 8666 and 8666-RF

    Introduction 1

    Scanning Plane 1

    General Information 1

    Service and Repair 2Caring for the Transducer 2

    Cleaning and Disinfection 2

    Starting Scanning 3

    Connecting the Transducer 3Changing Frequency 3Using a Transducer Cover 3Changing Orientation 3

    Operation of Types 8666 and 8666-RF 4

    Operation of the Flexible Tip 4Intraoperative Scanning with Types 8666 and 8666-RF 6Avoiding Damage from the Trocar Edge 6

    Biopsy Facilities 7

    Biopsy System Components for 8666 7Biopsy System Components for 8666-RF 7External Assembly of the Biopsy System 8Intraoperative Biopsy with UA0033 (8666 only) 9Intraoperative Biopsy with UA0034 (8666 only) 14Cleaning After Use 20

    Using Needles Other Than Those Sold by BK Medical 20

    Special Considerations for RF Ablation 20

    3D Ultrasound 20

    Acquiring a 3D Data Set 20

    English BB0532-INovember 2010

  • Maintenance of Types 8666 and 8666-RF 21

    Disposal 21

  • Laparoscopic Transducer Types 8666 and 8666-RF

    Laparoscopic Transducer Types 8666 and 8666-RF

    Introduction

    This is the user guide for Laparoscopic Transducer Types 8666 and 8666-RF and must be used together with Care, Cleaning & Safety which contains important safety information.

    8666 and 8666-RF are intraoperative transducers for laparoscopic ultrasound.

    Note: It is important that users read the user guide in its entirety and familiarize them-selves with the operations of Laparoscopic Transducer Types 8666 and 8666-RF and their biopsy system before use.

    FDA WARNING for the United States of AmericaTypes 8666 and 8666-RF should not be used for fetal examinations.

    Fig. 1. Laparoscopic Transducer Types 8666 and 8666-RF

    Scanning Plane

    Fig. 2. Scanning plane of the transducer Types 8666 and 8666-RF

    General Information

    Product specifications for this transducer can be found in the Product Data sheet that accompanies this user guide.

    WARNINGDo not use the transducer for applications where it may come in direct conductive contact with the patients heart.

    1

  • 8666 and 8666-RF Cleaning and Disinfection

    .

    Service and Repair

    Caring for the TransducerThe transducer may be damaged during use or processing, so it must be checked before use for cracks or irregularities in the surface. It is important to check the black rubber cover over the 2 rocker switches on the transducer handle and the articulation joint on the flexible tip of the transducer to make sure that there are no defects in these areas. It should also be checked thoroughly once a month following the procedure in Care, Cleaning & Safety.

    Cleaning and Disinfection

    To ensure the best results when using BK Medical equipment, it is important to maintain a strict regular cleaning routine.

    Full details of cleaning and disinfection procedures can be found in the Care, Cleaning & Safety booklet that accompanies this user guide. A list of disinfectants and disinfection methods that the transducer can withstand are listed in the Product Data sheet.

    Sterile covers are available. See the Product Data sheet for more details.

    Caution Keep all plugs and sockets absolutely dry at all times.

    WARNINGIf at any time the scanner malfunctions, or the image is severely distorted or degraded, or you suspect in any way that the scanner is not functioning correctly:

    Remove all transducers from contact with the patient.

    Turn off the scanner. Unplug the scanner from the wall and make sure it cannot be used until it has been checked.

    Do not remove the scanner cover.

    Contact your BK Medical representative or hospital technician.

    WARNINGAlways keep the exposure level (the acoustic output level and the exposure time) as low as possible.

    WARNINGService and repair of BK Medical electromedical equipment must be carried out only by the manufacturer or its authorized representatives. BK Medical reserves the right to disclaim all responsibility, including but not limited to responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. After service or repairs have been carried out, a qualified electrical engineer or hospital technician should verify the safety of all equipment.

    WARNINGUsers of this equipment have an obligation and responsibility to provide the highest degree of infection control possible to patients, co-workers and themselves. To avoid cross contami-nation, follow all infection control policies for personnel and equipment established for your office, department or hospital.

    2

  • 8666 and 8666-RF Starting Scanning

    Starting Scanning

    All equipment must be cleaned and disinfected before use.

    Connecting the Transducer

    The transducer is connected to the scanner using the array Transducer Socket on the scan-ner. To connect, the transducer plugs locking lever should first be in a horizontal position. Align the plug to the scanner socket and insert securely. Turn the locking lever clockwise to lock in place.

    When connected the transducer complies with Type BF requirements of EN60601-1 (IEC 60601-1).

    Changing FrequencyThe Multi-Frequency Imaging (MFI) facility enables you to select the scanning frequency. See the applicable scanner user guide for instructions. The selected frequency is displayed at the top of the screen.

    Using a Transducer CoverIf the transducer is not sterile, it must be enclosed in a sterile disposable transducer cover for intraoperative use. See the Product Data sheet for a list of available transducer covers.

    Note: These sterile disposable sheaths are only for use with the transducer without its biopsy system. They cannot be used when the biopsy system is attached to the transducer.

    Note: In the United States of America, it is recommended that probe sheaths have been market-cleared. In Canada, use only licensed probe sheaths.

    Apply sterile gel to the tip of the transducer (to cover the black scanning array) or fill the transducer cover with 1 to 2ml of sterile water. This improves the screen images by prevent-ing image artifacts caused by air bubbles.

    Pull the transducer cover over the transducer. Use a sterile lubricant to make sure the transducer does not stick in the trocar.

    .

    Changing OrientationTo change the orientation of the image on the monitor, refer to the applicable scanner user guide for instructions.

    WARNINGKeep all plugs and sockets absolutely dry at all times.

    WARNINGBecause of reports of severe allergic reactions to medical devices containing latex (natural rubber), FDA is advising health-care professionals to identify their latex-sensitive patients and be prepared to treat allergic reactions promptly.

    WARNINGUse only water-soluble agents or gels. Petroleum or mineral oil-based materials may harm the cover material.

    3

  • 8666 and 8666-RF Operation of Types 8666 and 8666-RF

    Operation of Types 8666 and 8666-RF

    Operation of the Flexible TipTransducer Controls

    The flexible tip is controlled by:

    2 levers for the orientation of the flexible tip, one on either side of the transducer han-dle.

    2 rocker switches to control the action of the adjustment levers. These 2 switches are located under a black rubber cover on the underside of the transducer handle.

    The Upright PositionAll of the following instructions for the use of this transducer are based on it being in the upright position. This is where the 2 levers are uppermost and the 2 rocker switches are underneath, see Fig. 3.

    Fig. 3. Transducer Types 8666 and 8666-RF when held in the upright position

    Adjustment of the Flexible TipThe transducer is equipped with a flexible tip. This tip can be adjusted through an angle of up to 90 in 4 planes, with reference to the handle in its upright position; up, down, left and right, see Fig. 4. and Fig. 5.

    The position of the tip is adjusted by 2 levers, one on either side of the transducer handle. As an extra guide, there are direction arrows on the handle, beside each lever. These give an indication of the direction of movement of the flexible tip when the corresponding lever is adjusted.

    Adjustment levers

    4

  • 8666 and 8666-RF Operation of Types 8666 and 8666-RF

    Up and Down MovementThe up and down movement of the tranducers tip is controlled by the lever on the right-hand side of the transducer handle. Moving the lever forwards moves the tip downwards. Moving the lever backwards moves the tip upwards. See Fig. 4.

    Fig. 4. Movement of the Types 8666 and 8666-RFs flexible tip. Up and down

    Left and Right MovementThe left and right movement of the transducers tip is controlled by the lever on