Convex Array Transducer Tyes 8567-S and 8667 User Guide Rev D Aug 2006

WORLD HEADQUARTERS Mileparken 34 DK-2730 Herlev Denmark Tel.:+45 44528100 / Fax:+45 44528199 www.bkmed.com Email: [email protected] If you have comments about the user documentation, please write to us at the email address above. We would like to hear from you. BK Medical Customer Satisfaction Input from our customers helps us improve our products and services. As part of our customer satisfaction program, we contact a sample of our customers a few months after they 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 and using our products. Your opinions are important to us. You are of course always welcome to contact us via your BK Medical representative or by contacting us directly.

© 2006 BK Medical Information in this document may be subject to change without notice.

Convex Array Transducer Types 8567-S and 8667 Introduction

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Scanning Plane

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General Information

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Caring for the Transducer

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Cleaning and Disinfection

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Starting Scanning

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Connecting the Transducer Changing Frequency Using a Transducer Cover Using the Transducer Control Button Changing Orientation

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Transrectal Scanning

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Transvaginal Scanning with Ultrasound Scanner 1402

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Puncture Facilities

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Biopsy System

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Performing Puncture and Biopsy

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Cleaning after Puncture and Biopsy

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Disposal

English BB0889-D August 2006

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Convex Array Transducer Types 8567-S and 8667

Convex Array Transducer Types 8567-S and 8667

Introduction This is the user guide for Convex Array Transducer Types 8567-S and 8667 and must be used together with Transducer Care, Cleaning & Safety which contains important safety information. 8567-S and 8667 are suitable for prostate scanning and transvaginal examinations.

Fig. 1.

Convex Array Transducer Types 8567-S and 8667

Scanning Plane

Fig. 2.

Scanning plane of Types 8567-S and 8667

General Information Product specifications for this transducer can be found in the Product Data sheet that accompanies this user guide. Acoustic output data and data about EMC (electromagnetic compatibility) for this transducer are on the Technical Data CD (BZ2100) that accompanies this user guide. A full explanation of acoustic output is given in your scanner user guide. WARNING If 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 B-K Medical representative or hospital technician.

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8567-S and 8667 • Cleaning and Disinfection WARNING Always keep the exposure level (the acoustic output level and the exposure time) as low as possible.

Caring for the Transducer The transducer may be damaged during use or processing, so it must be checked before use for cracks or irregularities in the surface. It should also be checked thoroughly once a month following the procedure in Transducer Care, Cleaning & Safety.

Cleaning and Disinfection To ensure the best results when using B-K Medical equipment, it is important to maintain a strict regular cleaning routine. Full details of cleaning and disinfection procedures can be found in the Transducer 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. WARNING Users 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 contamination, follow all infection control policies for personnel and equipment established for your office, department or hospital. Caution Keep all plugs and sockets absolutely dry at all times.

Starting Scanning All equipment must be cleaned and disinfected before use.

Connecting the Transducer WARNING Keep all plugs and sockets absolutely dry at all times. The transducer is connected to the scanner using the array Transducer Socket on the scanner. To connect, the transducer plug’s 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 B requirements of EN60601-1 (IEC 60601-1).

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8567-S and 8667 • Starting Scanning

Changing Frequency The 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 Cover The transducer should be enclosed in a transducer cover or a standard condom. See the Product Data sheet for a list of available transducer covers. WARNING Because 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. Apply gel to the tip of the transducer. This improves the screen images by preventing image artifacts caused by air bubbles. Pull the transducer cover over the transducer. Gel also creates a good acoustic contact between the skin and the transducer; therefore, apply a small amount to the outside of the cover prior to scanning. Re-apply the gel frequently to ensure good screen images. WARNING Use only water-soluble agents or gels. Petroleum or mineral oil-based materials may harm the cover material.

Using the Transducer Control Button The transducer has a control button that you can press to Start or Stop scanning (freeze frame). Press the button for more than one second to make a copy of the image. Note: Transducer buttons cannot be used to copy images using the Mini Focus 1402 Ultrasound Scanner. Each time the button is pressed, a “beep” is emitted.

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

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8567-S and 8667 • Transrectal Scanning

Transrectal Scanning Smear a small amount of scanning gel over the tip of the transducer cover. This will ease insertion and improve the screen images. WARNING Do not use excessive force during insertion. Do not make excessive lateral movements during or after insertion. Risk of injury or tissue damage to the patient could occur under certain circumstances. A digital palpation of the rectum may need to be carried out by a clinician prior to insertion or use of the probe as a precautionary measure.

Transvaginal Scanning with Ultrasound Scanner 1402 It is possible to scan transvaginally with Type 8667. Note: Type 8667 is intended for transvaginal scanning only with the Ultrasound Scanner 1402. Before transvaginal scanning, ensure the patient’s bladder is empty. Smear a small amount of scanning gel over the tip of the transducer cover. This will ease insertion and improve the screen images.

Puncture Facilities Transrectal puncture and biopsy are possible with Types 8567-S and 8667. The puncture attachment is illustrated in the following pages with a brief description of its use and operating instructions. WARNING It is essential for the patient’s safety that only the correct puncture attachment is used with Types 8567-S and 8667. Never use unauthorized combinations of transducers and puncture attachments or other manufacturers’ puncture attachments.

Biopsy System The biopsy system consists of: – a metal puncture attachment UA1256 (item A in Fig. 3.) ture attachment UA1256-U;

or single use plastic punc-

– a re-usable biopsy gun, for example a Bard® Magnum® biopsy gun (item B in Fig. 3.); – 17 gauge biopsy needles for use with UA1256 or 18 gauge needles for use with UA1256-U. The biopsy system shown in Fig. 3. is intended for transrectal puncture and biopsy only.

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8567-S and 8667 • Puncture Facilities

A

A B

Fig. 3.

B

The puncture attachment UA1256 and Bard® Magnum® biopsy gun

The puncture attachment UA1256 comprises a needle guide with an inner diameter of 1.5mm, suitable for up to 17 gauge needles. The single use puncture attachment UA1256-U comprises a needle guide with an inner diameter of 1.3mm, suitable for up to 18 gauge needles. The needle guide is angled 0° towards the long axis of the transducer (i.e. towards the midaxis of the scan image with Types 8567-S and 8667). The distance from the entrance to the needle guide and the first puncture line dot on the scan image is 126mm as shown in Fig. 6. The dots are 5mm apart. All parts of the puncture attachment can be autoclaved or disinfected by immersion in a suitable solution. Puncture attachment UA1256-U is supplied sterile and is for single use only. WARNING Cover the transducer with a sterile transducer cover before mounting the puncture attachment. To mount the puncture attachment, position it over the transducer and click into place (see Fig. 4.).

Fig. 4.

Type 8567-S/8667 with puncture attachment UA1256

Caution: Ensure the puncture attachment is securely in place and the tip of the needle guide lies close to the front end of the probe. If not, the needle guide may be damaged and require realignment by B-K Medical technicians. To attach the biopsy gun: 1. Hold the transducer with the puncture attachment uppermost.

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8567-S and 8667 • Performing Puncture and Biopsy 2. Position the biopsy gun on the puncture attachment as shown in Fig. 5..

Fig. 5.

Type 8567-S/8667 with puncture attachment UA1256 and Bard® Magnum® biopsy gun in place

The biopsy gun featured is a Bard® Magnum® reusable biopsy gun, which is an optional accessory with Transducer Types 8567-S and 8667. Other biopsy guns can also be used with UA1256 and UA1256-U. If using another biopsy gun, ensure that it can use needles with a minimum length of 16cm. Consult your local B-K Medical representative for further information. WARNING Before performing a biopsy, please refer to the user manual supplied with the biopsy gun.

Performing Puncture and Biopsy Transrectal Biopsy WARNING It is essential for the patient’s safety that only the correct puncture attachments, as described in this guide, are used. Never use unauthorized combinations of transducers and puncture attachments or other manufacturers puncture attachments. Before beginning a puncture or biopsy procedure, always check that the type number of the transducer and the type number or description of the puncture attachment match exactly those displayed on the scanner monitor. WARNING The puncture line on the scan image is an indication of the expected needle path. The needle tip echo should be monitored at all times so any deviation from the desired path can be corrected. Cover the transducer with a sterile transducer cover. If the transducer cover is damaged when attaching the puncture attachment, replace it with a new cover. See the Product Data sheet for a list of available transducer covers. Press the scanner Puncture or Biopsy control button to superimpose a puncture line on the scan image. If more than one puncture line is available, refer to the applicable scanner user guide for instructions on how to change which one appears. 6

8567-S and 8667 • Disposal Move the transducer until the puncture line transects the target. Insert the needle and monitor it as it moves along the puncture line to the target. The needle tip echo will be seen as a bright dot on the screen. WARNING If the needle guide is detached from the transducer during interventional procedures, cover the transducer with a new transducer cover. To remove the puncture line from the scan image, refer to the applicable scanner user guide for instructions. WARNING When performing a biopsy, always make sure that the needle is fully drawn back inside the needle guide before moving the probe.

Fig. 6.

Illustration of the puncture line for puncture attachment UA1256

Cleaning after Puncture and Biopsy If biological materials are allowed to dry on the transducer or puncture attachments, disinfection and sterilization processes may not be effective. Therefore, you must clean puncture attachments and transducers immediately after use. Use a suitable brush to make sure that biological material and gel are removed from all needle guides and other channels and grooves. See Transducer Care, Cleaning & Safety for cleaning instructions.

Disposal When the transducer is scrapped at the end of its life, national rules for the relevant material in each individual land must be followed. Within the EU, when you discard the transducer, you must send it to appropriate facilities for recovery and recycling. See the applicable scanner user guide for further details. WARNING For contaminated disposals such as transducer covers or needle guides, follow disposal control policies established for your office, department or hospital.

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