B-K Medical E14C4t User manual

For Professional Users Only
16-01265-EN-07
June 2019
E14C4t Transducer
User Guide

E14C4t = Ref. Type 9018
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:[phone]/Fax:[phone]
www.bkmedical.com
Email: [email protected]
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 representative or by contacting us directly.
© 2019 BK Medical
Information in this document may be subject to change without notice.

3
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using the Transducer Control Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Imaging with E14C4t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Simultaneous Biplane Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Transverse or Sagittal Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Endfire Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Imaging Without Puncture or Biopsy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Adjusting Image Area and Using Expanded Sector (Trapezoidal View). . . 10
Puncture and Biopsy Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
For Transrectal Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
For Transperineal Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Performing Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Cleaning after Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3D Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
English source version
16-01265-EN-07

4

E14C4t User Guide (16-01265-EN-07) Introduction 5
Introduction
This is the user guide for the E14C4t transducer, and it must be used together with
the Care and Cleaning user guide which contains important safety information.
Intended use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis
of the human body.
Indications for Use
E14C4t combines simultaneous biplane imaging and endfire imaging in a single
transducer. E14C4t is designed for transrectal and transvaginal procedures. It is also
suitable for elastography and contrast imaging.
Patient Population
The patient population is adults.
Figure 1. E14C4t transducer
Physicians
only
Caution Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.
Caution T-c2
The tip of the transducer is very delicate. Handle the transducer gently, especially when
you put it down on a hard surface, for example. Also, be careful not to bump the tip.
Transverse button
Sagittal/Endfire button
Tip

6 June 2019 E14C4t User Guide (16-01265-EN-07)
Imaging Plane
E14C4t contains two curved arrays — one for transverse imaging, and one for sagittal
and endfire imaging. The sagittal array of the E14C4t 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.
Figure 2. Imaging plane for E14C4t.
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.
Endfire portion of sagittal arraySimultaneous biplane portion of sagittal array
Transverse array
Transverse array
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.

E14C4t User Guide (16-01265-EN-07) Reprocessing 7
Service and Repair
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 details.
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
WARNING GS-w5
Do not run over transducer cables with system wheels or other heavy equipment. This can
damage the cable, and lead 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 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 electrician or hospital technician should verify the safety of
all equipment.
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.

8 June 2019 E14C4t User Guide (16-01265-EN-07)
Connecting the Transducer
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).
Changing Frequency
The Multi-Frequency Imaging (MFI) facility 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 cross-
contamination. 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 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.
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 needle guides.
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.
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.

E14C4t User Guide (16-01265-EN-07) Imaging with E14C4t 9
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 re-
apply 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.
Using the Transducer Control Buttons
To change the imaging plane, press the button corresponding to that plane (see Figure
1). Pressing the button activates (starts) or freezes (stops) imaging in that plane. One
button enables the sagittal or endfire array. A long press on this button also activates
endfire imaging.
A second button enables the transverse array.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Imaging with E14C4t
Simultaneous Biplane Imaging
E14C4t can transmit transverse (T) and sagittal (S) images simultaneously. When
you press bk3000/bk5000’s Split key or tap LIVE DUAL on bkSpecto, simultaneous
live transmission is automatically activated. On the bk3000/bk5000 screen, this is
indicated by a green dot in front of Simultan.
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.
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.

10 June 2019 E14C4t User Guide (16-01265-EN-07)
Transverse or Sagittal Imaging
Click Simultan/tap LIVE DUAL to toggle simultaneous live transmission on or off.
When simultaneous transmission is off, you can change which plane is active and
which is frozen on bk3000/bk5000 by pressing the Split key or by placing the cursor
on the image you want to be active and pressing the Select key. On the bkSpecto, you
tap the dual view button to toggle between the views.
Endfire Imaging
E14C4t 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 on bk3000/bk5000, click E and select transverse (T) or sagittal (S). On the
bkSpecto, tap T or S on the touchscreen.
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/tap DUAL , 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/tap
LIVE DUAL to toggle simultaneous live transmission on or off.
Imaging Without Puncture or Biopsy
When E14C4t is used for transrectal imaging without the puncture facilities, the
dummy bracket UA1325-w must be in place to give the transducer a smooth surface
and minimize discomfort for the patient. The dummy bracket clicks into position on
the transducer to cover the open channel (see Figure 3).
Figure 3. E14C4t and the dummy channel bracket UA1325-w.
Note: The dummy bracket must be removed before E14C4t is prepared for
disinfection. The bracket can be disinfected using the same methods as explained
later under UA1326.
Adjusting Image Area and Using Expanded Sector (Trapezoidal View)
The width of the image area can be adjusted using the Width key on the system’s
control panel. See the applicable system user guide for instructions.

E14C4t User Guide (16-01265-EN-07) Puncture and Biopsy Facilities 11
With the Expanded Sector feature you can increase the transverse sector angle from
a default width of 140 to 180.
Figure 4. Dotted lines indicate expanded transverse sector on E14C4t.
Puncture and Biopsy Facilities
Puncture and biopsy are possible with E14C4t. The appropriate puncture attachments
are illustrated in the following pages with a brief description of their uses and
operating instructions. The transducer has an open channel into which the
appropriate puncture accessories fit when the dummy channel bracket (UA1325-
w) has been removed (see Figure 3).
For Transrectal Puncture
With E14C4t, 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.
For transrectal puncture, biopsy guides are available in both non-sterile reusable
versions and sterile-packed single-use versions.
Non-Sterile Biopsy Guides (Light Green)
The dummy channel bracket UA1325-w and the reusable biopsy guides (UA1326,
UA1327 and UA1328) are non-sterile when supplied. This is also the case with
Puncture attachment UA1324. They must all be reprocessed following the procedure
in Care and Cleaning.
The dummy channel bracket and reusable biopsy guides may be damaged during use
or processing, so they must be checked before use for cracks or irregularities in the
surface. They should also be checked thoroughly once a month following the
procedure in Care and Cleaning.

12 June 2019 E14C4t User Guide (16-01265-EN-07)
Sterile Biopsy Guides (Dark Green)
The sterile single-use biopsy guides (UA1322-S, UA1322-S14, UA1323-S and
UA1329-S) come assembled in peel packs. Contents are only sterile if the package
is intact.
Recommended needle length is 20 cm (7.8 inches) for anesthetic procedures and 25
cm (9.8 inches) for biopsy procedures.
The sterile-packed biopsy guides must be stored at a temperature range from +5°C
(+41°F) to +25°C (+77°F) and at a storage humidity of 0% to 80%.
Simultaneous Biplane
The sterile single-use biopsy guide UA1322-S, UA1322-S14 and reusable biopsy
guide UA1326 are used for simultaneous biplane imaging.
Figure 5. Reusable biopsy guide UA1326.
The puncture line for UA1322-S, UA1322-S14 and UA1326 on E14C4t is shown in
Figure 6.
WARNING Sterile-w1
Single-use components are packaged sterile and are intended for single-use only.
Do not use if:
• integrity of packaging is violated
• expiration date has passed
• package label is missing
WARNING Sterile-w2
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.
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.

E14C4t User Guide (16-01265-EN-07) Puncture and Biopsy Facilities 13
UA1322-S and UA1326 have a bore diameter of 1.6 mm, suitable for 18-gauge
needles.
UA1322-S14 has a bore diameter of 2.1 mm, 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.
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 E14C4t 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 angle of insertion at 0is marked with a blue band. On
screen, you will see this corresponds to the color of the puncture line displayed on
the image.
WARNING P-w8
Before beginning a puncture or biopsy procedure using dual scanning, ensure that the color
of the puncture line on the scanner monitor matches that of the needle guide you will insert
your needle into.

14 June 2019 E14C4t User Guide (16-01265-EN-07)
Figure 9. Reusable biopsy guide UA1328.
The puncture lines for UA1328 and UA1329-S on E14C4t 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 E14C4t:
1 If a dummy channel bracket is mounted on the transducer, remove it.
2 Pull a sterile transducer cover containing a suitable amount of sterile imaging
gel over the transducer.
3 Slide the needle guide into the biopsy channel bracket.
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).
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.

E14C4t User Guide (16-01265-EN-07) Puncture and Biopsy Facilities 15
Figure 11. Biopsy channel bracket and needle guide mounted on E14C4t.
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-w (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 5 mm apart, each with an internal
diameter of 2.1 mm, suitable for a 14-gauge needle. The guideis parallel to the
centerline of the transducer.
Note: The needle guide can be adjusted 70 mm lengthwise with respect to the
mounting ring, using the adjustment screw.
Figure 12. Puncture attachment UA1324.
Mounting the Transperineal Puncture Guide
To mount the transperineal puncture attachment, ensure that the dummy channel
bracket UA1325-w is in place. Pull a sterile transducer cover over the transducer.
Loosen the clamp on UA1324, and slide the attachment over the tip of the transducer
until it meets the steel stud on the side of the transducer. The puncture attachment
should be correctly positioned so that the groove slides easily over the stud. No force
should be used when attaching the puncture attachment to the transducer.
WARNING P-w9
Ensure that the channel bracket and needle guide are correctly positioned. Never insert the
needle guide while the transducer is inside the patient.

16 June 2019 E14C4t User Guide (16-01265-EN-07)
Figure 13. Puncture attachment UA1324 mounted on E14C4t.
The puncture lines for UA1324 on E14C4t are shown in Figure 14.
Figure 14. Illustration of the puncture line for puncture attachment UA1324.

E14C4t User Guide (16-01265-EN-07) Puncture and Biopsy Facilities 17
Performing Puncture and Biopsy
Superimpose
puncture line
Press the system Puncture or Biopsy control button to superimpose a puncture line
on the 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 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.
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.
To remove the puncture line from the image, refer to the applicable system user guide
for instructions.
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.
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.
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.

18 June 2019 E14C4t User Guide (16-01265-EN-07)
Cleaning after Puncture and Biopsy
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.
3D Imaging
3D imaging with the E14C4t is possible:
• Freehand – where the transducer is combined with the appropriate 3D system
software.
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 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.
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.