B-K Medical 20R3 User manual

16-01278-EN-07
May 2019 For Professional Users Only
20R3 Transducer
User Guide

20R3 = Ref. Type 9052
LEGAL MANUFACTURER
BK Medical
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 Medical 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
Crystals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Imaging Plane. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Imaging Frequencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Control Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Selecting the Crystal and Imaging Frequency . . . . . . . . . . . . . . . . . . . . . . . 10
Anatomical Position (Insertion Depth) and Crystal Position . . . . . . . . . . . . 10
Image Orientation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Endorectal Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Water Standoff Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Preparing the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Preparing the Reusable Water Standoff System. . . . . . . . . . . . . . . . . . . . . . 12
Preparing the UA0048 Single-Use Water Standoff System. . . . . . . . . . . . . 15
Performing a Rectoscopy Using a Reusable Water Standoff System . . . . . 18
3D Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
English source version
16-01278-EN-07

4

20R3 User Guide (16-01278-EN-07) Introduction 5
Introduction
This is the user guide for the 20R3 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
20R3 is suitable for transrectal and transvaginal imaging.
Patient Population
The patient population is adults.
Figure 1. 20R3 transducer
Physicians
only
Caution Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.

6 May 2019 20R3 User Guide (16-01278-EN-07)
Crystals
The transducer is a mechanical (single-element) multifrequency transducer with a
built-in 3D mover. Inside the transducer head is a two-crystal assembly where the
crystals sit back to back. The assembly can rotate inside the transducer to give a 360º
field of view. No moving parts contact human tissue.
H or L The selected crystal is indicated after the transducer number at the top of the screen:
H (high-frequency) or L (low-frequency).
The crystal assembly can be positioned manually or – if you have a 3D option
installed (see “3D Imaging” on page 23) – by the system.
Figure 2. Movement of the crystal assembly inside the transducer head
Imaging Plane
Figure 3. Imaging plane for the anorectal transducer. The extreme positions of the crystal
assembly are shown.
Imaging Frequencies
Each crystal has 3 imaging frequencies. On the system, the imaging frequency is
displayed on the screen.
-60mm
(fully out)
0mm
(fully in)
Default position
60mm
360°

20R3 User Guide (16-01278-EN-07) General Information 7
Control Buttons
The transducer has 3 control buttons on the handle.
Figure 4. Transducer control buttons.
The Start/Stop/Capture button on the underside of the handle is used to start or stop
imaging. You can specify a user-defined function for a long press (at least one
second) on the button: by default, a long press captures the current image.
The Crystal Position buttons (Forward and Backward) on the upper side move the
crystal assembly.
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.
Forward (In) button Backward (Out) button
Start/Stop/Capture button
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.

8 May 2019 20R3 User Guide (16-01278-EN-07)
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 information.
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
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.
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.

20R3 User Guide (16-01278-EN-07) Starting Imaging 9
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 B requirements of EN60601-1
(IEC 60601-1).
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
Endorectal or Transvaginal Imaging
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.
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.
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 systems.
• Do not use BK transducers with other manufacturers’ systems.
• Do not use unauthorized combinations of transducers and needle guides.
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.

10 May 2019 20R3 User Guide (16-01278-EN-07)
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.
Endorectal Imaging
You must use a water-standoff system (with a water standoff cover) to image the
rectum from the anorectal junction and further into the rectum. See page 11.
Selecting the Crystal and Imaging Frequency
To select the other crystal or change the imaging frequency, please refer to your
system user guide.
Anatomical Position (Insertion Depth) and Crystal Position
When imaging with 20R3, you can calculate where the imaging plane is in the patient
by setting anatomical position (insertion depth) and crystal position.
To set the insertion depth:
1 Find the actual insertion depth by reading the scale on the transducer. Point at
Anat. Pos on the right side of the screen and press [+/- ] until you get to the
insertion depth.
2 The system tracks the crystal position and displays it on the right side of the
screen under Crystal Pos. The crystal position is 0 when the crystal is at the tip
of the transducer. This is the default position. To change the position of the
crystal, either
• Move the image plane down from the default position at the top with the
Backward transducer button until you reach the desired position
or
• Point at Crystal Pos. on the right side of the screen and press [+/- ].
The system calculates the anatomic position based on the insertion depth and the
crystal position (note that crystal position is a negative number):
Anatomic Position=Insertion Depth+Crystal Position.
Insertion Depth Not Set
If you do not set an insertion depth, the system cannot calculate the anatomic
position.
To reset the insertion depth setting, press Home.
If the insertion depth is not set, or is zero, the displayed value next to Anat. Pos. is
NA.

20R3 User Guide (16-01278-EN-07) Endorectal Imaging 11
Image Orientation
The 12 o’clock position on the displayed image is identified by the two control
buttons on the transducer handle pointing to the anterior 12 o’clock position.
To verify crystal orientation:
1 Hold the transducer in the 12 o’clock position, that is, with the 2 control buttons
on the handle pointing to the anterior 12 o’clock position.
2 Touch the tip of the transducer with your finger.
Verify that the image of your finger is displayed at the top of the image displayed on
the screen.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Endorectal Imaging
Water Standoff Systems
You must use a water standoff system to image the rectum from the anorectal
junction and beyond.
BK Medical offers reusable water standoff systems and single-use water standoff
systems. When using a water standoff system, you should always follow policies
established by your office, hospital or institution when you are performing endorectal
imaging.
Reusable Water Standoff
You can use a reusable water standoff system with the following components:
Reusable
water
standoff
system
• Water standoff collar UA0671 with O-ring UA0674
• Plastic extension tube
• 2-way stopcock
• Plastic syringe
• Light cable adaptor UA0682, reusable (for UA0683)
• Non-sterile water standoff covers UA0037
WARNING Colo-w2
To avoid misinterpreting structures in the ultrasound image, verify the orientation of both
crystals in the transducer before you start imaging.

12 May 2019 20R3 User Guide (16-01278-EN-07)
and one of the following rectosigmoidoscopes:
• Rectosigmoidoscope kit UA0672 (DO0164 compatible with Welch Allyn ® light
source, with obturator DO0163)
• Rectosigmoidoscope kit UA0673 (DO0165 compatible with Storz
® light source,
with obturator DO0163)
• Single-use, sterile Rectosigmoidoscope kit UA0683
Single-Use Water Standoff
You can also use a single-use water standoff system UA0048 with the following
components:
Single-use
water
standoff
system
• Inner cover [A]
• Outer cover [B]
• Tape [C]
• Plastic syringe
Figure 5. UA0048 water standoff system components.
NOTE: See the Product Data sheet for ordering information.
Preparing the Patient
1 Always perform a digital palpation before you insert a rectosigmoidoscope or
endo transducer into the rectum.
2 Give the patient an enema – liquid should be held retained as long as possible
before being expelled.
Preparing the Reusable Water Standoff System
Disinfect
before using
The transducer, water standoff collar, O-ring, rectosigmoidoscope and obturator
must be cleaned and disinfected before use. The water standoff collar, O-ring,
rectosigmoidoscope and obturator can be autoclaved.
NOTE: For best results, separate the O-ring from the water standoff collar before
autoclaving. O-rings that are no longer watertight should be replaced.
A
B
Inner cover
Tape
Outer cover
Water tube
Stopcock
C

20R3 User Guide (16-01278-EN-07) Endorectal Imaging 13
To prepare the reusable water standoff system:
1 Place the two O-rings in the outer grooves as shown in this picture.
2 Use a little water to moisten the silicone O-rings inside the water standoff collar.
3 Gently slide the water standoff collar over the transducer.
Make sure that the marker on the water standoff collar is aligned with the marker
on the transducer.
4 Pull a water standoff cover over the transducer, attaching it to the groove on the
water standoff collar. Check the water standoff cover for tears.
5 Secure the water standoff cover in place with 2 or more silicone rubber bands in
each groove (silicone rubber bands are supplied with water standoff cover s
UA0037).
The water outlet is just above the
inner groove. Do NOT block this
Place the O-rings in
these two grooves
Luer Lock valve
(water inlet)
align the two markers
water standoff
collar
two markers aligned
2-3 silicone rubber bands in
each of the two grooves
wire clip

14 May 2019 20R3 User Guide (16-01278-EN-07)
6 Fill the syringe with degassed water. Use the 2-way stopcock and plastic
extension tube to attach the syringe to the Luer lock valve on the water standoff
collar.
7 Fill the water standoff cover with approximately 50ml of degassed water.
Air bubbles may appear in the water standoff cover . You must remove the air bubbles
to avoid artifacts on the ultrasound image.
8 Hold the transducer with the water standoff cover pointing downwards and use
the syringe to aspirate as much air as possible.
9 Refill the water standoff cover with degassed water. Repeat this procedure until
there is no air left in the water standoff cover .
10 Remove enough water from the water standoff cover to allow the system to pass
through the BK Medical rectosigmoidoscope.
11 Lubricate the entire outer surface of the water standoff cover with a glycerine-
based lubricant.
The transducer is designed to pass through Rectosigmoidoscope UA0672,
Rectosigmoidoscope UA0673 or single-use Rectosigmoidoscope UA0683.
The transducer is now prepared for an endorectal examination.
Luer lock valve
Caution: Colo-c1
If you use a rectosigmoidoscope that you do not purchase from BK, it must be fully
cylindrical and have an inner diameter of at least 21 mm.

20R3 User Guide (16-01278-EN-07) Endorectal Imaging 15
Preparing the UA0048 Single-Use Water Standoff System
Before you start, see Fig. 5 to familiarize yourself with the parts of the single-use
water standoff system.
To prepare the single-use water standoff system:
1 Place the transducer in an upright and stable position, for example, in the
system’s transducer holder.
Figure 6. Transducer held in a stable position.
2 Apply water to moisten the transducer.
Figure 7. Moistening the transducer with water.
3 Pull the inner cover (A in Fig. 5) over the transducer. (See Fig. 8.) Check the
inner cover for damage (tears).
Caution: Colo-c2
To avoid damaging the transducer, you MUST lubricate the outer surface of the water
standoff cover before you introduce the transducer with a water standoff system into a
rectosigmoidoscope. Without lubrication you may not be able to withdraw the transducer
from the rectosigmoidoscope. If the transducer cannot be withdrawn from the
rectosigmoidoscope, contact your BK representative immediately.

16 May 2019 20R3 User Guide (16-01278-EN-07)
Figure 8. Putting on the inner cover.
4 Create a tape handle: Partly remove the protective strip from the tape so only the
first cm of the tape is exposed. Then bend the first (sticky) cm in half and tape
the sides together to create a 0.5 cm “handle”. (See Fig. 9.)
Figure 9. Creating a tape “handle”.
NOTE: Make sure you do not tape more than the first cm together. The tape will be
too short to fit around the transducer.
5 Push the non-handle end of the tape through the opening in the inner cover and
wind the tape tightly around the cover and then around the water tube that forms
the opening.
Make sure that when you wind the tape around, it covers the top of the water
tube on the inner cover by 1-2 mm.
Follow the steps shown in Fig. 10. The tape must be tight so that when you put
water in the standoff, it doesn’t run out under the tape.
Inner cover on correctly
Expose 1 cm of the tape.
Bend tape to
make little
handle.
0.5 cm
handle

20R3 User Guide (16-01278-EN-07) Endorectal Imaging 17
Figure 10. How to place the tape around the water standoff cover. The tape should cover the
bottom of the grey part of the transducer.
Figure 11. Inner cover correctly taped.
6 Pull the outer cover (B in Fig. 5) over the transducer and inner cover. Make sure
that it completely covers the tape, as shown in Fig. 12.
Figure 12. Pulling the outer cover on to cover the tape completely.
7 Using a standard syringe, fill the water standoff system slowly with degassed
water (max 200 ml).
NOTE: Make sure that the stopcock on the water tube is positioned correctly to allow
water to pass through the tube. (See Fig. 13.)
Handle
1
34
2
Top of outer
cover

18 May 2019 20R3 User Guide (16-01278-EN-07)
Figure 13. Open and closed positions of stopcock.
Remove air
bubbles
Air bubbles may appear in the inner cover. You must remove the air bubbles to
avoid artifacts on the ultrasound image
8 Hold the transducer with the tip pointing downwards and use the syringe to
aspirate as much air as possible.
9 Close the stopcock to seal the system and unscrew the syringe so you can push
the air out of it.
10 Screw the syringe back on, open the stopcock and repeat this procedure until
there is no air left in the inner cover.
11 Lubricate the entire outer surface of the standoff that will enter the patient.
Aspirate enough water from the standoff to allow for easy insertion.
The transducer is now prepared for an endorectal examination.
Performing a Rectoscopy Using a Reusable Water Standoff System
The patient is examined in the left lateral decubitus or the dorsal lithotomy position.
Follow policies established for your office, department or hospital for the use of a
rectosigmoidoscope.
To perform an endorectal examination:
Prepare the water standoff system before you start. (See “Preparing the Patient” on
page 12.)
Always perform a digital palpation before you insert a rectosigmoidoscope or endo
transducer into the rectum.
Open Closed
WARNING Colo-w4
To avoid tissue damage, always perform a thorough rectoscopy before doing an endorectal
imaging.

20R3 User Guide (16-01278-EN-07) Endorectal Imaging 19
Using a Rectosigmoidoscope
Insert the obturator fully into the rectosigmoidoscope and apply gel to the outside tip.
Introduce the rectosigmoidoscope as far as the beginning of the rectal ampulla (4–5
cm).
Slowly remove the obturator.
Use the light source and visually inspect the rectum. If necessary, empty the rectum.
Using visual guidance, advance the rectosigmoidoscope to the level of interest – so
that it just covers the area you want to image.
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.
WARNING Colo-w3
To avoid patient injury, if you advance the rectosigmoidoscope or the
transducer/rectosigmoidoscope combination any further into the rectum, you must do it
under visual guidance using the conventional techniques that are approved at your hospital.

20 May 2019 20R3 User Guide (16-01278-EN-07)
Inserting the transducer and reusable water standoff system
Reusable
water
standoff
system
Make sure that the entire outer surface of the water standoff cover is thoroughly
lubricated with a glycerine-based lubricant.
Insert the transducer just until the tip of the transducer is at the far end of the
rectosigmoidoscope.
The end of the rectosigmoidoscope nearest you will be at the 200 mm mark on the
transducer if you are using either the UA0672 or UA0673 rectosigmoidoscope. If
you are using the single-use rectosigmoidoscope UA0683 then it will be at the
190 mm mark.
Hold the transducer in position and pull the rectosigmoidoscope slowly back toward
yourself until the rim touches the water standoff collar UA0671.
NOTE: It is important to hold collar and rectoscope tight together.
Click the wire clip over the rectosigmoidoscope to hold it in place with the water
standoff collar. Do not reposition the transducer relative to the patient while you are
doing this.
rectosigmoidoscope
wire clip
click the wire clip
over the
rectosigmoidoscope