bk ultrasound E13C2 User manual

16-01484-EN-01
June 2018 For Professional Users Only
E13C2 Transducer
UserGuide

E13C2 = Ref. Type 9029
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:[phone] / Fax:[phone]
www.bkultrasound.com
Email: [email protected]
The serial number on a BK Medical product contains information about the year 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.
© 2018 BK Medical
Information in this document may be subject to change without notice.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using the Transducer Control Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Puncture and Biopsy Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Single-Use Sterile Needle Guide UA1339 . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Performing Puncture and Biopsy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cleaning after Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
English source version
16-01484-01 EN

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E13C2 User Guide (16-01484-EN-01) 5
Introduction
This is the user guide for E13C2 and 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
E13C2
1
is suitable for transrectal prostate and transvaginal uterus imaging. It is
also suitable for contrast imaging and elastography.
Needle guide UA1339 provides needle guidance for biopsy.
Patient Population
The patient population is adults.
Figure 1. E13C2 transducer.
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.
Physicians
only
Caution Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.
1. E13C2 has been licensed by Health Canada for use on the bk3000 and bk3500 only.

6 June 2018 E13C2 User Guide (16-01484-EN-01)
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 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 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 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.

E13C2 User Guide (16-01484-EN-01) 7
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
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) 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 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 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.
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.

8 June 2018 E13C2 User Guide (16-01484-EN-01)
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 Button
The control button on the transducer controls the imaging.
Press the button to Start or Stop imaging (freeze frame). Press the button for more
than one second to make a copy of the image.
The transducer makes a “beep” sound each time you press the button.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
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.
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.

E13C2 User Guide (16-01484-EN-01) 9
Puncture and Biopsy Facilities
Puncture and biopsy are possible with the E13C2 transducer. The needle guides are
illustrated in the following pages with a brief description of their use and operating
instructions.
The needle guide is intended for transrectal puncture and biopsy.
You will need:
• reusable needle guide UA1349 or single-use needle guide UA1339
• 17-gauge biopsy needles for use with both needle guides.
Needle guide UA1339 has an inner diameter of 1.7 mm and reusable needle
guide UA1349 has an inner diameter of 1.5 mm, both of them suitable for up
to 17-gauge needles. Needle guide UA1339 is supplied sterile and is for single
use only.
The needle guide is angled 0° towards the long axis of the transducer (i.e. towards
the mid-axis of the scan image with E13C2). The distance from the entrance to the
needle guide and the first puncture line dot on the scan image is 166 mm, as shown
in Fig. 4. The dots are 5 mm apart.
All parts of the UA1349 needle guide can be autoclaved or disinfected by immersion
in a suitable solution.
Figure 2. Reusable needle guide UA1349.
Single-Use Sterile Needle Guide UA1339
Needle guide UA1339 is supplied sterile in peel packs and is for single-use only.
Contents are sterile only if the package is intact. The needle guide must be discarded
after use.
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

10 June 2018 E13C2 User Guide (16-01484-EN-01)
The sterile-packed needle guide must be stored at a temperature range from +5ºC
(+41ºF) to +25ºC (+77ºF) and a storage humidity of 0% to 80%.
.
Figure 3. Single-use needle guide UA1339.
To take a biopsy:
1. Enclose the transducer in a transducer cover.
2. Click the needle guide into place.
3. Insert a needle into the needle guide.
Ensure the needle guide is securely in place and the tip of the needle guide lies
close to the front of the transducer.
The minimum needle length is 25 cm for a biopsy gun with needle guides
UA1339 and UA1349.
Performing Puncture and Biopsy
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.
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.

E13C2 User Guide (16-01484-EN-01) 11
If not sterilized, cover the transducer with a sterile transducer cover.
If the transducer cover is damaged when attaching the needle guide, replace it with a
new cover.
See the Product Data Sheet for a list of available transducer covers.
Press the Puncture Guide button 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.
To remove the puncture line from the scan image, refer to the applicable system user
guide for instructions.
Figure 4. Illustration of the puncture line for needle guides UA1339 and UA1349.
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.

12 June 2018 E13C2 User Guide (16-01484-EN-01)
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.
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.
If pre- and thorough cleaning cannot be done immediately, keep the device moist until
cleaning.
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.