User Guide Type 8818 Biplane and Endfire Transducer English BB1505-F June 2012 For Professional Users Only
BK MEDICAL Mileparken 34 2730 Herlev Denmark Tel.:+45 4452 8100 / Fax:+45 4452 8199 www.bkmed.com Email: info@bkmed.dk The serial number of a BK Medical product contains information about the year of manufacture. To obtain the date of manufacture of a product, please contact your BK Medical representative or write to us at the email address above, including the product’s serial number (SN number). BK Medical Customer Satisfaction Input from our customers helps us improve our products and services.
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Caring for the Transducer. . . . . . . .
Introduction This is the user guide for Type 8818 and must be used together with Care, Cleaning & Safety which contains important safety information. Indications for Use Biplane and Endfire Transducer Type 8818 combines simultaneous biplane imaging and endfire imaging in a single transducer. Type 8818 is designed for transrectal procedures. WARNING The tip of the 8818 transducer (the part containing the arrays) is very delicate.
Simultaneous biplane portion of sagittal array Endfire portion of sagittal array Transverse array Transverse array Figure 2. Imaging plane for Type 8818. 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 in Technical Data (BZ2100) that accompanies this user guide.
Service and Repair WARNING Service 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.
Changing Frequency The Multi-Frequency Imaging (MFI) facility enables you to select the imaging frequency. See the applicable system 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.
Imaging with Type 8818 Simultaneous Biplane Imaging 8818 can transmit transverse (T) and sagittal (S) images simultaneously. When you press the system’s Split key, simultaneous live transmission is automatically activated. On the screen, this is indicated by a green dot in front of Simultan. Transverse or Sagittal Imaging Click Simultan to toggle simultaneous live transmission on or off.
Contrast Imaging See the system user guide for instructions on how to perform contrast imaging. Viewing B-Mode and Contrast Images Simultaneously When performing contrast imaging, use the system's split screen functionality to see the B-mode image and the contrast image simultaneously. By default, the system will present one image on top and one on the bottom.
For Transrectal Puncture With Type 8818, you can perform transrectal puncture and biopsy by imaging in one of three ways: • Simultaneous biplane (imaging in both the transverse and sagittal planes). • • Endfire (imaging in the sagittal plane). Dual (combines both the simultaneous biplane and endfire imaging in one biopsy guide). All the biopsy guides for transrectal puncture have a bore diameter of 1.6 mm, suitable for 17- and 18-gauge needles.
WARNING Sterile-packed components must be stored in a safe environment and kept out of direct sunlight. Large temperature changes during storage may cause condensation and violate the integrity of the packaging. Please refer to Care, Cleaning and Safety for an example of how to open a sterilepacked product. WARNING For contaminated disposables such transducer covers or needle guides, follow disposal control policies established for your office, department or hospital.
Endfire The sterile single-use biopsy guide UA1323-S and reusable biopsy guide UA1327 are used in endfire imaging. Figure 7. Reusable biopsy guide UA1327. The puncture line for UA1323-S and UA1327 on 8818 is shown in Figure 8. The needle guide is parallel to the centerline of the transducer. Figure 8. Illustration of the puncture line for biopsy guides UA1323-S and UA1327. Dual The sterile single-use biopsy guide UA1329-S and reusable biopsy guide UA1328 are used in dual imaging.
The puncture lines for UA1328 and UA1329-S on Type 8818 are shown in Fig. 10. The needle guides are angled at 0° and 19° to the transducer’s axis. Figure 10. Illustration of the puncture line for biopsy guides UA1328 and UA1329-S. During endfire imaging, only the endfire biopsy line can be displayed on screen. Mounting a Transrectal Biopsy Guide To mount a biopsy guide on 8818: 1 If a dummy channel bracket is mounted on the transducer, remove it.
For Transperineal Puncture The metal puncture attachment UA1324, shown in Figure 12, is designed for transperineal puncture and biopsy. When UA1324 is being used, the dummy channel bracket UA1325 (shown in Figure 3) must be in place. UA1324 consists of a needle guide and a mounting ring with clamp. The needle guide comprises 9 parallel guide channels, spaced 5mm apart, each with an internal diameter of 2.1mm, suitable for a 14-gauge needle. The guide is parallel to the centerline of the transducer.
The puncture lines for UA1324 on 8818 are shown in Figure 14. Figure 14. Illustration of the puncture line for puncture attachment UA1324. Performing Puncture and 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.
WARNING If the needle guide is detached from the transducer during interventional procedures, cover the transducer with a new transducer cover. If the cover is damaged during interventional procedures, follow the policies of the hospital or clinic for treatment of the patient under such circumstances. To remove the puncture line from the image, refer to the applicable system user guide for instructions.
WARNING For contaminated disposals such as transducer covers or needle guides, follow disposal control policies established for your office, department or hospital.
LEGAL MANUFACTURER : BK Medic al ApS , Milepa rken 34, 2730 Herlev, Denma rk. Tel.: +45 44528100 Fax : +45 44528199 E mail: info@bkmed.
