BK Medical E14CL4b Transducer User Manual
- June 2, 2024
- BK Medical
Table of Contents
E14CL4b Transducer
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 44528100 / Fax:+45 44528199
www.bkmedical.com
Email: info@bkmedical.com
The connector label on a BK Medical transducer contains information about the date of manufacture.
BK Medical Customer Satisfaction
Input from our customers helps us improve our products and services. Your
opinions are important to
us. You are always welcome to contact us via your BK Medical representative or
by contacting us directly.
Introduction
This is the user guide for the E14CL4b transducer, and it must be used
together with the Care and Cleaning user guide which contains important safety
information.
Indications for use
E14CL4b is suitable for transrectal imaging, transvaginal imaging, guidance of
all transperineal interventional procedures including brachytherapy and
cryotherapy treatments. It is also suitable for elastography and contrast
imaging.
E14CL4b contains two arrays — a curved array for transverse (T) imaging, and a
linear array for sagittal (S) imaging. Both arrays can be used separately or
they
can be used simultaneously. When using the simultaneous biplane feature, you
are able to view two planes at once with a single transducer, and this helps
determine the true position of the needle and its tip during puncture and
biopsy.
Patient Population
The patient population is adults.
Imaging Plane
Figure 1. E14CL4b.
Figure 2. Imaging planes for E14CL4b.
General Information
Product specifications, acoustic output data and data about EMC (electromagnetic compatibility) for this transducer can be found in the Product Data Sheet and the Technical Data (BZ2100) that accompany this user guide.
WARNING GS-w2
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 try to repair the system yourself.
-
Contact your BK service representative or hospital technician.
WARNING GS-w5
Do not run over transducer cables with system wheels or other heavy equipment.
This can damage the cable, leading to degradation and/or corruption of the
ultrasound image.
WARNING AO-w1
To avoid tissue damage, always keep the exposure level (the acoustic output
level and the exposure time) as low as possible.
WARNING SR-w1
Service and repair of BK electromedical equipment must be carried out only by
the manufacturer or BK authorized service 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 electrician or hospital technician should verify
the safety of all equipment.
Caring for the Transducer
The transducer may be damaged during use or reprocessing, so it must be
checked before use for cracks or irregularities in the surface, following the
procedure in Care and Cleaning. It should also be checked thoroughly once a
month following the
same procedure.
Reprocessing
To ensure the best results when using BK Medical equipment, it is important to
maintain a strict cleaning routine.
Complete details and procedures can be found in Care and Cleaning that
accompanies this user guide.
A list of reprocessing methods that the transducer can withstand are listed in
the
Product Data Sheet.
Sterile covers are available. See the Product Data Sheet for more information.
WARNING Reproc-w2
Users of this equipment have an obligation and responsibility to provide the
highest possible degree of infection control to patients, co-workers and
themselves. The instructions in this book are meant as a guide. To avoid
cross-contamination, follow all infection control policies (including for
reprocessing, packing and storage) for personnel and equipment that have been
established for your office, department or hospital.
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
WARNING T-w5
To prevent electrical shock and damage to the transducer, the connector pins
in the transducer plug must always be completely dry before you connect to a
system.
Connecting the Transducer
WARNING GS-w4a
It is essential for the patient’s safety that only the correct equipment is
used.
- Do not use other manufacturers’ transducers with BK ultrasound systems.
- Do not use BK transducers with other manufacturers’ systems.
- Do not use unauthorized combinations of transducers and puncture attachments.
The transducer is connected to the system using the array transducer socket on the system. To connect, flip the system’s locking lever to the right. Align the transducer plug to the system socket and insert securely. Flip the system’s locking lever to the left to lock it.
When connected, the transducer complies with Type BF requirements of EN60601-1 (IEC 60601-1).
WARNING T-w12
To avoid patient injury or damage to a transducer, extra caution may be
required when you use a mechanical stepper cradle or robotic accessory with
the transducer. This is particularly important when adjusting the cradle/bed
position after the transducer has been inserted into the patient. The stepper
cradle or robotic accessory may exert excessive force when the transducer
position is adjusted, which could harm the patient or damage the transducer.
Changing Frequency
The multifrequency imaging (MFI) control enables you to select the imaging
frequency. See the applicable system user guide for instructions.
Using a Transducer Cover
BK recommends the use of a sterile transducer cover to reduce the risk of
crosscontamination. See the Product Data Sheet for a list of available
transducer covers.
Follow local guidelines for the use of transducer covers in your area.
NOTE : In the United States of America, it is recommended to use
transducer covers that have been market cleared. In Canada, use only licensed
transducer covers. In Europe, transducer covers must be CE-marked.
WARNING TC-w1
Some transducer covers can contain latex. Because of reports of severe
allergic reactions to medical devices containing latex (natural rubber), the
FDA advises 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 screen imaging by preventing image
artifacts caused by air bubbles.
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
and reapply frequently.
Follow these precautions when putting sterile covers on a transducer:
-
Wear sterile gloves.
-
When using a puncture attachment, place it gently over the cover and secure it,
following the instructions for the puncture attachment. -
Verify that the cover has not been damaged in the process. If it has, repeat the
procedure with a new transducer cover.
Caution T-c3
Use only water-based gel (sterile if you are using a sterile transducer
cover). Products containing parabens, petroleum, or mineral oils may harm the
transducer or transducer cover.
Using the Transducer Control Button
The transducer has two control buttons, one for the sagittal array and one for
the transverse array (Fig. 1). Pressing the button activates (starts) or
freezes (stops)
imaging in that plane. Press the button for more than one second to make a
copy of the image.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable
system user guide for instructions.
Endorectal Imaging with E14CL4b
E14CL4b is designed for simultaneous biplane imaging of the prostate.
WARNING Colo-w1
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.
Adjusting Image Area and Using Expanded Sector (Trapezoidal View)
The width of the image area can be adjusted using the Width key on the
scanner’s control panel. See the applicable system user guide for
instructions.
With the Expanded Sector feature and E14CL4b, you can increase the transverse
sector angle from a default width of 140° to 180°. And, you can increase the
default sagittal view of 65mm to a trapezoidal view, which provides an
additional 15°on each side.
Figure 3. Dotted lines indicating expanded sectors on E14CL4b.
Puncture and Biopsy Facilities
Puncture and biopsy are possible with the E14CL4b transducer. The puncture
attachment is illustrated in the following pages with a brief description of
its use and
operating instructions.
Puncture Attachment UA1232
Puncture attachment UA1232 (Fig. 4) is designed for transperineal puncture and
biopsy.
It consists of:
- A needle guide and a mounting ring with a lock screw. The needle guide comprises
9 parallel guide channels, spaced 5mm apart, each with an internal diameter of
2.1mm, suitable for an 14 Gauge needle.
The guide channels are angled at 0° to the transducer’s longitudinal axis and
90° to the transverse imaging plane.
Note : The needle guide can be adjusted 90mm lengthwise with respect to
the
mounting ring using the adjustment screw.
Figure 4. Puncture attachment UA1232.
To mount UA1232:
-
Loosen the lock screw and slide the attachment over the tip of the transducer
until the lock screw pressure-pad meets the steel stud on the side of the
transducer. -
The puncture attachment should be correctly positioned (Fig. 5) before the lock
screw is tightened. -
No force should be used when attaching the puncture attachment to the
transducer.
Figure 5. E14CL4b with puncture attachment UA1232.
All parts of the puncture attachment can be autoclaved or disinfected by immersion in a suitable solution.
Performing Puncture and Biopsy
WARNING P-w1
Before you start imaging, verify that the type number or name of the
transducer and the type number or description of the needle guide you are
using match the number displayed on the monitor. Also make sure that the
needle guide is positioned correctly. If the numbers
do not match, or if the needle guide position is not correct, the puncture
line on the monitor may not correspond to the true puncture path in the
tissue. In case of any inconsistency, stop imaging, turn off the system, and
contact your BK service representative.
WARNING P-w4
The puncture line on the image is an indication of the expected needle path.
To avoid harming the patient, the needle tip echo should be monitored at all
times so any deviation from the desired path can be corrected.
If the transducer is not sterilized, cover it 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 Puncture or Biopsy control on the system to superimpose a puncture
line on the scan image.
If more than one puncture line is available, refer to the applicable system
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 as it moves along the puncture line to the target. The needle tip echo will be seen as a bright dot on the screen.
The puncture line will differ depending on the imaging plane orientation. In
the sagittal plane, the puncture path is indicated by a line of dots. The
distance between
each puncture dot is 5mm.
In the transverse plane, a single dot indicates the point at which the needle
will transect the imaging plane.
WARNING TC-w4
If you detach the needle guide during interventional procedures, the
transducer cover could be damaged. To avoid cross-contamination, cover the
transducer with a new transducer cover before reattaching the needle guide.
To remove the puncture line from the scan image, refer to the applicable system user guide for instructions.
WARNING P-w5
Avoid unnecessary tissue damage. When performing a biopsy, always make sure
that the needle is fully drawn back inside the needle guide before moving the
transducer.
Figure 6. Illustration of the puncture lines for puncture attachment UA1232.
Prostate Volume Determination
Refer to the system user guide for instructions on how to carry out a prostate
volume determination, and the best procedure to use.
Radioactive Source Implantatio n
E14CL4b can be used with the CMS AccuseedTM Brachystepper System and with
CIVCO AccuCare stepper units for radioactive seed implantation.
Please consult the appropriate stepper documentation for instructions on
Source Implantation, including Preplanning, Needle Loading and Implantation.
E14CL4b should be prepared for transrectal imaging and biopsy as described
earlier in this guide, and mounted and ’’locked’’ in the stepping unit.
The volume study of the prostate is performed, the radiation dose planned and
the needles loaded.
WARNING B-w5
Always place the cradle in the ’’locked’’ position before seed implantation.
When the cradle is in this position, the matrix on the stepping unit
corresponds with the matrix puncture pattern in the transverse plane on the
scanner’s monitor.
To superimpose the source matrix on to the monitor, refer to the system user
guide for further details.
Before starting source implantation, anchor the prostate to the matrix using
thread or needles to prevent it moving during needle placement.
Always place the needles individually, starting at the top of the matrix
according to the predetermined sequence.
Using a transverse view of the prostate, advance the needle. Change to the
sagittal plane to find the position of the needle on the screen and monitor it
during insertion.
When the needle is in place, the radioactive sources can be expelled into the
gland. The needle is then removed. The sagittal plane can be used to check the
position of the radioactive sources. Repeat this sequence until implantation
is complete. The anchors can then be removed.
Cleaning after Puncture and Biopsy
WARNING Reproc-w3
Immediately after use, you must pre-clean the device until visually clean
(including device lumens if existing). Conduct the thorough cleaning process
as soon as possible after use in order to prevent bioburden drying on the
surface. Dried bioburden can lead to inefficient cleaning, disinfection and
sterilization, causing a risk of cross-contamination.
Use a suitable brush to make sure that biological material and gel are removed from all channels and grooves. See Care and Cleaning 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.
WARNING D-w1
For disposal of contaminated items such as transducer covers or needle guides
or other disposable items, follow disposal control policies established for
your office, department or hospital.
BK Medical E14CL4b Transducer User Manual – Optimized
PDF
BK Medical E14CL4b Transducer User Manual – Original
PDF