Anorectal Transducer User Guide Type 2050 and Type 2052 English BB1804-B December 2009
WORLD HEADQUARTERS Mileparken 34 DK-2730 Herlev Denmark Tel.:+45 44528100 / Fax:+45 44528199 www.bkmed.com Email: info@bkmed.dk 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.
Contents General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 About the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Crystals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scanning Plane . . . . . . . . . . . . . . . . . . . .
General Information Figure 1. Anorectal transducers types 2050 and 2052. This is the user guide for Anorectal Transducers Types 2050 and 2052. It contains a description of the transducers, a list of the intended applications, and information about operating these particular transducers. You must use this guide together with other documents that contain important information, including vital safety information.
About the Transducer Applications The transducer is suitable for the following types of examinations. Colorectal Scanning • endoanal scanning • endorectal scanning Pelvic Floor Scanning • endoanal scanning • endovaginal scanning of the pelvic floor FDA WARNING for the United States of America The transducer should not be used for fetal examinations. Crystals The transducer is a mechanical (single-element) multifrequency transducer with a built-in 3D mover.
Scanning Plane 360° Figure 3. Scanning plane for the anorectal transducer. The extreme positions of the crystal assembly are shown. Scanning Frequencies Each crystal has 3 scanning frequencies. On the scanner, the scanning frequency is displayed on the screen. Control Buttons The transducer has 3 control buttons on the handle. Forward (In) button Backward (Out) button Start/Stop/Capture button Figure 4. Transducer control buttons.
Safety Information WARNING Always keep the exposure level (the acoustic output level and the exposure time) as low as possible. 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.
Using a Transducer Cover Endoanal or Transvaginal Scanning You must use a transducer cover. See the Product Data sheet for a list of available transducer covers, including sterile covers. Apply scanning gel or other water-soluble agent inside and outside the cover to create good acoustic contact. Water-soluble gels only Latex WARNING Use only water-based gel (sterile if you are using a sterile transducer cover).
3 Insert the plug in the socket. NOTE: To disconnect the transducer, you must pull back the outer locking mechanism on the plug before you remove the plug from the socket. Selecting the Crystal and Scanning Frequency To select the other crystal or change the scanning frequency, please refer to your scanner user guide. The 2052 Crystal Position Scanning With Pro Focus 2202 This section only applies to Anorectal Transducer Type 2052 when used with the Pro Focus 2202 scanner.
Changing the 2052 Crystal Position on the Pro Focus You can use the Forward and Backward buttons on the transducer handle to move the crystal. You can also use the on-screen control to change the crystal position. To move the crystal in the 2052 transducer: Transducer control button • Press one of the control buttons on the upper side of the transducer handle (see Fig 4) until the crystal is where you want it. A short press moves the crystal. As you hold the button down, the crystal moves faster.
or • Make sure the image is frozen, and press the transducer control button to move the insertion depth to zero. If the insertion depth is not set, or is zero, the displayed value next to Anat. Pos. is NA. Scanning Image Orientation The 12 o’clock position on the displayed image is identified by the two control buttons on the transducer handle pointing to the anterior 12 o’clock position. WARNING Before you start scanning, verify the orientation of both crystals in the transducer.
Endorectal Scanning Water Standoff System You must use a water standoff system to scan the rectum from the anorectal junction and beyond. BK Medical recommends using a rectosigmoidoscope when attempting to scan proximally in the rectum (approximately 10cm or more from the anal verge).
To prepare the water standoff system: 1 Place the two O-rings in the outer grooves as shown in this picture. The water outlet is just above the inner groove. Do NOT block this Place the O-rings in these two grooves Luer Lock valve (water inlet) 2 3 Use a little water to moisten the silicone O-rings inside the water standoff collar. Gently slide the water standoff collar over the transducer. Make sure that the marker on the water standoff collar is aligned with the marker on the transducer.
wire clip 2-3 silicone rubber bands in each of the two grooves 5 6 Secure the water standoff condom in place with 2 or more silicone rubber bands in each groove (silicone rubber bands are supplied with water standoff condoms UA0037). Fill the syringe with degassed water. Use the 2-way stopcock and plastic extension tube to attach the syringe to the Luer lock valve on the water standoff collar. Luer lock valve Fill the water standoff condom with approximately 50ml of degassed water.
Refill the water standoff condom with degassed water. Repeat this procedure until there is no air left in the water standoff condom. 10 Remove enough water from the water standoff condom to allow the setup to pass through the BK Medical rectosigmoidoscope. 11 Lubricate the entire outer surface of the water standoff condom with a glycerinebased lubricant, such as UA0675. 9 Caution: You must lubricate the condom before you insert the setup into the rectosigmoidoscope. The lubricant must be glycerine-based.
Using a rectosigmoidoscope 3 Insert the obturator fully into the rectosigmoidoscope and apply gel to the outside tip. 4 Introduce the rectosigmoidoscope as far as the beginning of the rectal ampulla (4–5 cm). 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. 5 6 7 Slowly remove the obturator. Use the light source and visually inspect the rectum.
Inserting the transducer and water standoff system 8 Make sure that the entire outer surface of the water standoff condom is thoroughly lubricated with a glycerine-based lubricant. 9 Insert the transducer just until the tip of the transducer is at the far end of the rectosigmoidoscope. The end of the rectosigmoidoscope nearest you will be at the 200 mm mark on the transducer if you are using either the UA0672 or UA0673 rectosigmoidoscope.
Scanning 12 To start scanning, press the Start/Stop/Capture button on the underside of the transducer handle. Scan the exposed area. (For a 3D scan, see “3D Scanning” on page 19.) 13 If you have not scanned the entire object of interest in the first pass, pull the transducer together with the rectosigmoidoscope back another 4–6 cm, and scan again. Removing the transducer from the patient 14 When you have completed the examination, empty the water from the water standoff condom, using a syringe.
Transducer Support Collar UA0679 Figure 6. The support collar on the transducer without and with a fixation clamp. Caution: It is strongly recommended that you use the transducer support collar to reinforce the transducer handle when you use a fixation device (such as the variable friction support arm UA0553) to hold the transducer in place. Slide the collar over the handle of the transducer and clamp it in place.
