B-K Medical Type 2052 User manual

English
BB1804-C
January 2014 For Professional Users Only
User Guide
Type 2052
Anorectal 3D Transducer

LEGAL MANUFACTURER
BK MEDICAL
Mileparken 34
2730 Herlev
Denmark
Tel.:[phone]/Fax:[phone]
www.bkmed.com
Email: [e-mail]
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).
BK Medical Customer Satisfaction
Input from our customers helps us improve our products and services. As part of our customer
satisfaction program, we contact a sample of our customers a few months after they receive their orders.
If you receive an email message from us asking for your feedback, we hope you will be willing to
answer some questions about your experience buying and using our products. Your opinions are
important to us. You are of course always welcome to contact us via your BK Medical representative or
by contacting us directly.
If you have comments about the user documentation, please write to us at the email address above.
We would like to hear from you.
© 2014 BK Medical

Contents
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
About the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Crystals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Imaging Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Imaging Frequencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Control Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Preparing the Transducer for Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Checking Before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Selecting the Crystal and Imaging Frequency . . . . . . . . . . . . . . . . . . . . . . . 10
The 2052 Crystal Position Imaging With Pro Focus UltraView 2202 . . . . . 10
Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Image Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Imaging, Freezing and Capturing an Image . . . . . . . . . . . . . . . . . . . . . . . . . 12
Endoanal or Transvaginal Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Endorectal Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Water Standoff Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Preparing the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Preparing the Reusable Water Standoff System. . . . . . . . . . . . . . . . . . . . . . 14
Preparing the UA0048 Single-Use Water Standoff System. . . . . . . . . . . . . 17
Performing a Rectoscopy Using a Reusable Water Standoff System . . . . . 20
3D Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
English source ersion
BB1804-C

4

2052 User Guide (BB1804-C) January 2014 5
General Information
Figure 1. Anorectal 3D transducers type 2052.
This is the user guide for Anorectal 3D Transducer Type 2052. It contains a
description of the transducer, a list of the intended applications, and information
about operating this particular transducer. You must use this guide together with
other documents that contain important information, including vital safety
information.
Table 1-1. Where to find additional information essential to the operation of this transducer.
When connected, the transducer complies with Type B requirements of EN60601-1
(IEC 60601-1).
About the Transducer
Applications
The transducer is suitable for the following types of examinations.
Information not in this user guide Where to find it
How to use the transducer with your system,
including setting up user-defined functions
System User Guide
Safety information and caring for the
transducer
Care, Cleaning & Safety
Cleaning and disinfection Care, Cleaning & Safety
Disinfectants and disinfection methods Product Data Sheet and Care, Cleaning
& Safety
Disposal Care, Cleaning & Safety
Product specifications Product Data Sheet (BP0133)
A ailable accessories, including sterile co ers Product Data Sheet (BP0133)
Acoustic output data Technical Data, User Documentation
CD
Explanation of acoustic output System User Guide
EMC (electromagnetic compatibility) data Technical Data, User Documentation
CD

6 January 2014 2052 User Guide (BB1804-C)
Colorectal Imaging
• endoanal imaging
• endorectal imaging
Pelvic Floor Imaging
• endoanal imaging
• endovaginal imaging of the pelvic floor
Crystals
The transducer is a mechanical (single-element) multifrequency transducer with a
built-in 3D mover. Inside the transducer head is a double crystal assembly where 2
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 25) – 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°

2052 User Guide (BB1804-C) 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.
Beeps
The system emits “beeps” when:
• The Start/Stop/Capture button on the transducer is pressed.
• The crystal arrives at its default position (0mm – see Fig. 2).
Safety Information
Contact your BK Medical representative if you believe the correct functioning of any
BK Medical equipment is impaired in any way.
Forward (In) button Backward (Out) button
Start/Stop/Capture but-
WARNING To a oid tissue damage, always keep the exposure le el (the acoustic output le el
and the exposure time) as low as possible.
WARNING If at any time the system malfunctions, or the image is se erely distorted or
degraded, or you suspect in any way that the system is not functioning correctly:
• Remo e 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 remo e the system co er.
• Contact your BK Medical representati e or hospital technician.

8 January 2014 2052 User Guide (BB1804-C)
Service and Repair
Cleaning and Disinfection
A transducer used for endocavity procedures with no puncture must be cleaned
immediately after use and disinfected before it is used. You must use a transducer
cover. See Care, Cleaning & Safety .
A list of disinfectants and disinfection methods that the transducer can withstand are
listed in the Product Data sheet and Care, Cleaning & Safety .
Preparing the Transducer for Imaging
All equipment must be cleaned and disinfected before use.
Checking Before Use
The transducer may be damaged during use or processing, so it must be checked
before use. Check the transducer more thoroughly once a month. See Care, Cleaning
& Safety . Contact your BK Medical service representative if you detect any signs of
damage or of oil leaking from the transducer.
Using a Transducer Cover
Endoanal or Transvaginal Imaging
You must use a transducer cover. See the Product Data sheet for a list of available
transducer covers, including sterile covers.
Apply imaging gel or other water-soluble agent inside and outside the cover to create
good acoustic contact.
WARNING Ser ice and repair of BK Medical electromedical equipment must be carried out
only by the manufacturer or its authorized representati es. BK Medical reser es the right to
disclaim all responsibility, including but not limited to responsibility for the operating safety,
reliability and performance of equipment ser iced or repaired by other parties. After ser ice
or repairs ha e been carried out, a qualified electrical engineer or hospital technician should
erify the safety of all equipment.
WARNING Users of this equipment ha e an obligation and responsibility to pro ide the
highest degree of infection control possible to patients, co-workers and themsel es. To a oid
cross contamination, follow all infection control policies for personnel and equipment
established for your office, department or hospital.
Caution: Keep all plugs and sockets absolutely dry at all times.
WARNING To a oid harming the patient, do not use the transducer if you detect any signs of
damage.

2052 User Guide (BB1804-C) 9
To put on the cover:
1 Apply gel to the tip of the transducer so that it covers the entire imaging surface
(most of the black part of the transducer). You can also put imaging gel inside
the tip of the cover before you put the cover over the transducer.
Make sure that there is enough imaging gel to cover the entire front end of the
transducer (the black part of the transducer). This prevents image artifacts
caused by air bubbles.
2 Pull the transducer cover over the transducer.
Before imaging, apply a small amount of gel to the outside of the transducer
cover to create good acoustic contact between the patient and the transducer.
4 Re-apply the gel frequently to ensure good screen images.
Endorectal Imaging
You must use a water-standoff system (with a water standoff condom) to image the
rectum from the anorectal junction and further into the rectum. See page 13.
Connecting the Transducer
To connect the transducer:
1 If the connector plug cover (used to protect the plug during cleaning and
disinfection) is screwed on, unscrew it to remove it.
2 Align the red arrow on the connector plug with the red dot on the transducer
socket.
Insert the plug in the socket.
NOTE: To disconnect the transducer, you must pull back the outer locking mechanism
on the plug before you remove the plug from the socket.
Water-
soluble gels
only
WARNING Use only water-based gel (sterile if you are using a sterile transducer co er).
Products containing parabens, petroleum or mineral oils may harm the transducer or
transducer co er.
Latex
WARNING Because of reports of se ere allergic reactions to medical de ices containing latex
(natural rubber), FDA is ad ising health-care professionals to identify their latex-sensiti e
patients and be prepared to treat allergic reactions promptly.
WARNING To pre ent electrical shock, keep all plugs and sockets absolutely dry at all times.

10 January 2014 2052 User Guide (BB1804-C)
Selecting the Crystal and Imaging Frequency
To select the other crystal or change the imaging frequency, please refer to your
system user guide.
The 2052 Crystal Position Imaging With Pro Focus UltraView 2202
This section only applies to Anorectal Transducer Type 2052 when used with the Pro
Focus UltraView 2202 system.
The 2052 Crystal Position Displayed on the Pro Focus UltraView 2202
Screen
The system tracks the crystal position and displays it in cm on the left side of the
screen next to Crystal Pos .
Figure 5. Position of the 2052 transducer crystal.
Default
position
The crystal position is 0 when the crystal is at the tip of the transducer (farthest into
the patient). This is the default position.
The following actions cause the crystal to move to the default position:
• Connecting the transducer to the system.
• Selecting a new preset.
• Pressing the Forward button until the system beeps.
• Entering a new patient ID on the screen.
Other
positions
All other crystal positions are expressed as negative numbers (see Fig. 5 for an
example). -6.0 (cm) is the crystal position closest to the transducer handle.
Changing the 2052 Crystal Position on the Pro Focus UltraView 2202
You can use the Forward and Backward buttons on the transducer handle to move
the crystal.
You can also use the on-screen control to change the crystal position.
To move the crystal in the 2052 transducer:
Transducer
control
button
• Press one of the control buttons on the upper side of the transducer handle (see
Fig. 4) until the crystal is where you want it.
anatomic (body)
position (in cm)
crystal position (in cm)
crystal position slider
insertion depth (in cm)
destination position

2052 User Guide (BB1804-C) 11
A short press moves the crystal. As you hold the button down, the crystal moves
faster.
or
On-screen
control
• Click Crystal Pos under General on the left side of the screen and drag the
slider (or point at Crystal Pos and press [ +/- ] ).
The value you set is displayed in italic font to indicate that it is the desired
(destination) position rather than the actual position (see Fig. 5)
When the crystal reaches the position you have set, the font changes to normal.
Insertion Depth of the 2052 Transducer and Anatomic Position of the
Crystal
When imaging with the 2052, you can specify the transducer insertion depth (how
far the transducer is inserted into the rectum). The system then calculates the
anatomic position (depth in the body) of the crystal and displays that, too, in cm on
the left side of the screen next to Anat. Pos . (See Fig. 5 to see the format of the
display.)
NOTE: If the combination of insertion depth and crystal position results in an
impossible anatomic position, the displayed value next to Anat. Pos. is NA/y , where
y is the insertion depth.
To set the insertion depth:
1 Find the actual insertion depth by reading the scale on the transducer.
2 Click Anat. Pos under General on the left side of the screen and drag the slider
to the actual insertion depth (or point at Anat. Pos 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. There may be cases, however, where you set an
insertion depth and then do not want to use it.
To remove the insertion depth setting:
• Drag the Anat. Pos. (insertion depth) slider to 0.
or
• Make sure the image is frozen, and press the Start/Stop/Capture to move the
insertion depth to zero.
If the insertion depth is not set, or is zero, the displayed value next to Anat. Pos. is
NA .

12 January 2014 2052 User Guide (BB1804-C)
Imaging
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 the Image Orientation
See the system user guide.
Imaging, Freezing and Capturing an Image
To start or stop imaging (freeze the image):
• Press the Start/Stop/Capture button (see Fig. 4) briefly.
To copy the image:
• Press the Start/Stop/Capture button for more than one second.
NOTE: Your system may be set up so that a long press on the button has a different
function.
Endoanal or Transvaginal Imaging
Preparing the Transducer
You must use a transducer cover. (See “Using a Transducer Cover” on page 8.)
WARNING To a oid misinterpreting structures in the ultrasound image, erify the
orientation of both crystals in the transducer before you start imaging.

2052 User Guide (BB1804-C) 1
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 UA0676
• 2-way stopcock UA0677
• Plastic syringe UA0678
• Light cable adaptor UA0682, reusable (for UA0683)
• Non-sterile water standoff condoms UA0037
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 e.g. UA0678.

14 January 2014 2052 User Guide (BB1804-C)
Figure 6. 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.
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.
Gently slide the water standoff collar over the transducer.
A
B
Inner co er
Tape
Outer co er
Water tube
Stopcock
C
The water outlet is just abo e the
inner groo e. Do NOT block this
Place the O-rings in
these two groo es
Luer Lock al e
(water inlet)

2052 User Guide (BB1804-C) 15
Make sure that the marker on the water standoff collar is aligned with the marker
on the transducer.
4 Pull a water standoff condom over the transducer, attaching it to the groove on
the water standoff collar. Check the water standoff condom for tears.
5 Secure the water standoff condom in place with 2 or more silicone rubber bands
in each groove (silicone rubber bands are supplied with water standoff condoms
UA0037).
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 condom with approximately 50ml of degassed water.
align the two markers
water standoff
collar
two markers aligned
2-3 silicone rubber bands in
each of the two groo es
wire clip
Luer lock al e

16 January 2014 2052 User Guide (BB1804-C)
Air bubbles may appear in the water standoff condom. You must remove the air
bubbles to avoid artifacts on the ultrasound image.
8 Hold the transducer with the water standoff condom pointing downwards and
use the syringe to aspirate as much air as possible.
9 Refill the water standoff condom with degassed water. Repeat this procedure
until there is no air left in the water standoff condom.
10 Remove enough water from the water standoff condom to allow the system to
pass through the BK Medical rectosigmoidoscope.
11 Lubricate the entire outer surface of the water standoff condom 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.
Caution: You must lubricate the condom before you insert the system into the
rectosigmoidoscope. The lubricant must be glycerine-based.
Caution: If you use a rectosigmoidoscope that you do not purchase from BK Medical, it
must be fully cylindrical and ha e an inner diameter of at least 21 mm.
Caution: You MUST lubricate the outer surface of the water standoff condom before you
introduce the transducer with a water standoff system into a rectosigmoidoscope.
Without lubrication you may not be able to retract the transducer from the
rectosigmoidoscope. This can damage the transducer.
Caution: If the transducer cannot be withdrawn from the rectosigmoidoscope, contact
your BK Medical representati e immediately.

2052 User Guide (BB1804-C) 17
Preparing the UA0048 Single-Use Water Standoff System
Before you start, see Fig. 6 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 7. Transducer held in a stable position.
2 Apply water to moisten the transducer.
Figure 8. Moistening the transducer with water.
Pull the inner cover (A in Fig. 6) over the transducer. (See Fig. 9.) Check the
inner cover for damage (tears).
Figure 9. Putting on the inner cover.
Inner co er on correctly

18 January 2014 2052 User Guide (BB1804-C)
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. 10.)
Figure 10. 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. 11. The tape must be tight so that when you put
water in the standoff, it doesn’t run out under the tape.
Figure 11. How to place the tape around the water standoff condom. The tape should cover the
bottom of the black part of the transducer.
Expose 1 cm of the tape.
Bend tape to
make little
handle.
0.5 cm
handle
Handle
1
34
2

2052 User Guide (BB1804-C) 19
Figure 12. Inner cover correctly taped.
6 Pull the outer cover (B in Fig. 6) over the transducer and inner cover. Make sure
that it completely covers the tape, as shown in Fig. 13.
Figure 13. 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. 14.)
Figure 14. Open and closed positions of stopcock.
Remo e 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.
Top of outer
co er
Open Closed

20 January 2014 2052 User Guide (BB1804-C)
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 14.)
Always perform a digital palpation before you insert a rectosigmoidoscope or endo
transducer into the rectum.
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).
WARNING To a oid tissue damage, always perform a thorough rectoscopy before doing an
endorectal imaging.