User Guide Type 8824 I and T Shaped Intraoperative Transducer English BB 1823-C August 2012 For Professional Users Only
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 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Scanning Planes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Service and Repair . . . . . . . . . . .
Introduction This is the user guide for I and T Shaped Intraoperative Transducer Type 8824 and must be used together with Care, Cleaning & Safety which contains important safety information. T array I array Figure 1. I and T Shaped Intraoperative Transducer Type 8824 seen from different angles Indications for Use The 8824 is a simultaneous biplane transducer for ultrasound-guided interventional procedures.
Simultaneous Biplane Scanning The transducer can transmit transverse (T) and sagittal (S) images simultaneously. When you press the scanner’s Split button, simultaneous live transmission is automatically activated. On the screen, this is indicated by a green dot in front of the Simultan button. Click on Simultan to toggle simultaneous live transmission on or off. Alternatively, a long press on the scanner’s Split button turns simultaneous live transmission off.
WARNING Always keep the exposure level (the acoustic output level and the exposure time) as low as possible. 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.
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 BF requirements of EN60601-1 (IEC 60601-1).
Changing Orientation To change the orientation of the image on the monitor, refer to the applicable scanner user guide for instructions. When using vertical split screen, you can change the Left / Right image orientation of each scanning plane independently: 1 Select the image plane by clicking in it. 2 Click L/R on the right side of the screen. Holding the Transducer for Intraoperative Scanning Hold the transducer between two fingers and the thumb (see Fig.
Needle guide UA1337 Figure 5. Needle guide UA1337 with free-angle insert mounted on the 8824 (here shown without cover) Needle guide UA1337 is supplied together with two needle guide insert palettes. Each palette contains a set of 9 needle guide inserts, one 3-angle and one free-angle. Figure 6. Two needle guide palettes supplied together with needle guide UA1337 The 3-angle inserts each contain three channels.
The puncture line pattern is shown in Fig. 7 The distance between the guide channel of the puncture attachment to the first dot on the scan image puncture line is 1215mm depending on which angle is chosen. The distance between the dots is 5mm. Figure 7. Puncture lines using the 3-angle inserts Sterile needle guide UA1337 Needle guide UA1337 and the needle guide insert palettes are supplied sterile in peel packs and are for single-use only. Contents are only sterile if the package is intact.
WARNING For contaminated disposals such as transducer covers or needle guides, follow disposal control policies established for your office, department or hospital. Assembling the Needle Guide and Mounting it on the Transducer Apply a small amount of scanning gel to the tip of the transducer and carefully cover the transducer with a sterile cover (for readability, the transducer here is shown without transducer cover). Select the required needle guide insert by breaking it off the palette.
Releasing the Needle During Biopsy You can release the needle during biopsy so that the needle guide and transducer can be removed from the patient, leaving only the needle in place. Hold the transducer with your left hand. With your right hand, carefully push the needle guide insert sideways until it opens up. Carefully move the transducer and needle guide away from the needle.
If more than one puncture line is available, refer to the applicable scanner user guide for instructions on how to change which one appears. 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.
