8818ug ENG
8818ug ENG
8818ug ENG
Type 8818
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).
© 2012 BK Medical
Information in this document may be subject to change without notice.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using the Transducer Control Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Imaging with Type 8818 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Imaging Without Puncture or Biopsy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Contrast Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Adjusting Image Area and Using Expanded Sector (Trapezoidal View). . . 10
Puncture and Biopsy Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
For Transrectal Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
For Transperineal Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Performing Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning after Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3D Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Magnetic Wheel Mover UA0513. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Variable Friction Support Arm UA0553 . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3
4
Introduction
This is the user guide for Type 8818 and must be used together with Care, Cleaning
& Safety which contains important safety information.
WARNING
The tip of the 8818 transducer (the part containing the arrays) is very delicate. Handle the
transducer gently, especially when you put it down on a hard surface, for example. Also be
very careful not to bump the tip.
Transverse button
Sagittal/Endfire
button
Tip
Imaging Plane
8818 contains two convex arrays — one for transverse imaging, and one for sagittal and
endfire imaging. The sagittal array of the 8818 has a total arc of 210°. In both
simultaneous biplane imaging and endfire imaging, the imaging plane uses a 140°
section of the arc. It is important to note that simultaneous biplane imaging and
endfire imaging use different sections of the sagittal array. Figure 2 illustrates which
section of the array simultaneous biplane and endfire use.
Transverse array
Transverse array
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. A full
explanation of acoustic output data is given in your system user guide.
WARNING
If at any time the system malfunctions, or the image is severely distorted or degraded, or you
suspect in any way that the system is not functioning correctly:
• Remove all transducers from contact with the patient.
• Turn off the system. Unplug the system from the wall and make sure it cannot be used
until it has been checked.
• Do not remove the system cover.
• Contact your BK Medical representative or hospital technician.
WARNING
Always keep the exposure level (the acoustic output level and the exposure time) as low as
possible.
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. After service or repairs
have been carried out, a qualified electrical engineer or hospital technician should verify the
safety of all equipment.
WARNING
Users of this equipment have an obligation and responsibility to provide the highest possible
degree of infection control to patients, co-workers and themselves. To avoid cross
contamination, follow all infection control policies for personnel and equipment that have
been established for your office, department, or hospital.
Starting Imaging
All equipment must be cleaned and disinfected before use.
WARNING
Keep all plugs and sockets absolutely dry at all times.
The transducer is connected to the system using the array Transducer Socket on the
system. To connect, the transducer plug’s locking lever should first be in a horizontal
position. Align the plug to the system 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).
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 sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile
water. 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 imaging. 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 materials.
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.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Endfire Imaging
Type 8818 can perform endfire imaging. A long press on the transducer’s
Sagittal/Endfire button activates endfire imaging. On the screen, this is indicated
by the letter E, which appears to the right of the transducer number. To switch
imaging plane, click E and select transverse (T) or sagittal (S).
When you activate endfire imaging, one image appears (and by default, simultaneous
imaging is off). You must enable split screen imaging as there is no defined isocenter
in this context. When you press the system’s Split key, two images appear on the
screen. The endfire image appears and either a transverse or sagittal image appears,
depending on what was last used during imaging.
Click Simultan to toggle simultaneous live transmission on or off.
Note: The dummy bracket must be removed before 8818 is prepared for disinfection.
The bracket can be disinfected using the same methods as explained later under
UA1326.
Figure 4. Dotted lines indicate expanded transverse sector on the 8818 transducer.
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.
All the biopsy guides for transrectal puncture have a bore diameter of 1.6 mm,
suitable for 17- and 18-gauge needles.
For transrectal puncture, biopsy guides are available in both non-sterile reusable
versions and sterile-packed single-use versions.
WARNING
Disposable components are packaged sterile and are intended for single-use only.
Do not use if:
The sterile-packed biopsy guides must be stored at a temperature range from +15°C
(+57°F) to +25°C (+77°F) and at a storage humidity of 30% to 80%.
Please refer to Care, Cleaning and Safety for an example of how to open a sterile-
packed product.
WARNING
For contaminated disposables such transducer covers or needle guides, follow disposal
control policies established for your office, department or hospital.
Simultaneous Biplane
The sterile single-use biopsy guide UA1322-S, UA1322-S14 and reusable biopsy
guide UA1326 are used for simultaneous biplane imaging.
The puncture line for UA1322-S, UA1322-S14 and UA1326 on 8818 is shown in
Figure 6. UA1322-S and UA1326 have a bore diameter of 1.6mm, suitable for 18-
gauge needles. UA1322-S14 has a bore diameter of 2.1mm, suitable for 14-gauge
needles.The puncture line is angled at 19° to the transducer’s axis.
Figure 6. Illustration of the puncture line for biopsy guide UA1322-S, UA1322-S14 and UA1326.
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. Needle guide UC0100 is marked with a blue band (see
Figure 9). On screen, you will see this corresponds to the color of the puncture line
displayed on the image.
WARNING
Before beginning a puncture or biopsy procedure using dual imaging, ensure that the color
of the puncture line on the system monitor matches that of the needle guide you will insert
your needle into.
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.
WARNING
Do not use excessive force when inserting the needle guide.
4 Insert the assembled needle guide and biopsy channel bracket into the open
channel on the transducer. A small nodule on the end of the channel bracket fits
into an indentation in the channel on the transducer to help you place the bracket
correctly. Click the channel bracket into position on the transducer and lock it
into place (see Figure 11).
Figure 11. Biopsy channel bracket and needle guide mounted on 8818.
After you attach the channel bracket, pull a sterile transducer cover containing a
small amount of sterile imaging gel over the entire assembly (transducer plus biopsy
channel bracket)
WARNING
Ensure that the channel bracket and needle guide are correctly positioned. Never insert the
needle guide while the transducer is inside the patient.
To remove the bracket, remove the outer condom, open the lock and lift the bracket
off the transducer.
Figure 14. Illustration of the puncture line for puncture attachment UA1324.
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 system monitor.
WARNING
The puncture line on the 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.
To remove the puncture line from the image, refer to the applicable system 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.
3D Imaging
3D imaging with the 8818 may be carried out in either of two ways:
• Freehand – where the transducer is combined with the appropriate 3D system
software.
• Using mover support – where the transducer is combined with the appropriate
3D system software, the Magnetic Wheel Mover UA0513 and the Variable
Friction Arm UA0553.
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 system user guide for further details.