B-K Medical 8551 User manual

English
BB0100-M
November 2007
Type 8551
Endosonic Multiplane Transducer
User Guide

WORLD HEADQUARTERS
Mileparken 34
DK-2730 Herlev
Denmark
Tel.:[phone] / Fax:[phone]
www.bkmed.com
Email: [email protected]
B-K 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 B-K Medical
representative or by contacting us directly.
Trademark:
Luer Lock is a trademark of Abbott Laboratories.
© 2007 B-K Medical
Information in this document may be subject to change without notice.

Endosonic Multiplane Transducer Type 8551
Introduction 1
Scanning Plane 1
General Information 3
Caring for the Transducer 3
Cleaning and Disinfection 3
Starting Scanning 4
Connecting the Transducer 4
Changing Frequency 4
Using a Transducer Cover 4
Using the Transducer Control Button 5
Changing Orientation 5
Assembling the 8551 for Transrectal Use 5
Puncture Facilities 6
Built-in Transrectal Puncture Canal 6
Performing Puncture and Biopsy 7
Transrectal Biopsy 8
Cleaning after Puncture and Biopsy 8
Disposal 9
BB 0100-M
November 2007

Endosonic Multiplane Transducer 8551 User Guide (BB0100) Nov. 2007 1
Endosonic Multiplane Transducer Type 8551
Introduction
This is the user guide for Endosonic Multiplane Transducer Type 8551 and must be used
together with Transducer Care, Cleaning & Safety which contains important safety informa-
tion.
8551 is a mechanical (single-element) multiplane transducer for transrectal scanning.
Fig. 1. Endosonic Multiplane Transducer Type 8551
Scanning Plane
The scanning plane rotation axis is perpendicular to the transducer’s longitudinal axis. The
scanning plane rotation axis is angled 16°to the sector mid-line to ensure the optimal view
of the prostate gland and the biopsy needle (see Fig. 2).
Fig. 2. A single crystal is rotated to produce both longitudinal and transverse images.
The scanning plane can be rotated 90°using the lever on the transducer housing. Longitu-
dinal images are produced when the lever points to 0° (Fig. 3); transverse images are pro-
duced when the lever points to 90° (Fig. 4). Scanning in intermediate (oblique) planes is also
possible.
Control button
start/stop scanning
Lever changes
scanning plane
Needle canal
entrance
Attach catheter with Luer LockTM
for water standoff inlet here
Water stand-
off outlet
Needle canal
exit
Endosonic Multiplane Transducer Type 8551

2 Nov. 2007 Endosonic Multiplane Transducer 8551 User Guide (BB0100)
8551 • Introduction
Fig. 3. Longitudinal scanning. The lever on the transducer’s housing should be pointing at
0°
Fig. 4. Transverse scanning. The lever on the transducer’s housing should be pointing at
90°
Scanning plane orientation is shown on the monitor. The scanning plane rotation axis may
also be displayed.
If the patient is placed in the left lateral position, as is often recommended, image orienta-
tion requirements can still be met. See Fig. 3 and Fig. 4
To change the orientation of the image on the monitor, refer to the applicable scanner user
guide for instructions.
921467e
921468e

Endosonic Multiplane Transducer 8551 User Guide (BB0100) Nov. 2007 3
8551 • General Information
General Information
Product specifications for this transducer can be found in the Product Data sheet that
accompanies this user guide.
Acoustic output data and data about EMC (electromagnetic compatibility) for this trans-
ducer are on the Technical Data CD that accompanies this user guide. A full explanation of
acoustic output is given in your scanner user guide.
Caring for the Transducer
The transducer may be damaged during use or processing, so it must be checked before use
for cracks or irregularities in the surface. It should also be checked thoroughly once a month
following the procedure in Transducer Care, Cleaning & Safety.
Cleaning and Disinfection
To ensure the best results when using B-K Medical equipment, it is important to maintain
a strict regular cleaning routine.
Full details of cleaning and disinfection procedures can be found in Transducer Care, Clean-
ing & Safety that accompanies this user guide. A list of disinfectants and disinfection meth-
ods that the transducer can withstand are listed in the Product Data sheet.
Sterile covers are available. See the Product Data sheet for more details.
WARNING
If at any time the scanner malfunctions, or the image is severely distorted or degraded, or
you suspect in any way that the scanner is not functioning correctly:
• Remove all transducers from contact with the patient.
• Turn off the scanner. Unplug the scanner from the wall and make sure it cannot be
used until it has been checked.
• Do not remove the scanner cover.
• Contact your B-K Medical representative or hospital technician.
WARNING
Always keep the exposure level (the acoustic output level and the exposure time) as low as
possible.
WARNING
Users of this equipment have an obligation and responsibility to provide the highest degree
of infection control possible to patients, co-workers and themselves. To avoid cross contami-
nation, follow all infection control policies for personnel and equipment established for your
office, department or hospital.

4 Nov. 2007 Endosonic Multiplane Transducer 8551 User Guide (BB0100)
8551 • Starting Scanning
Caution
Do not stick anything into the water inlet to clean it. Poking something into this hole can
damage the water channel inside the transducer. You can clean the water channel by flushing
it with water soon after use, before any foreign matter such as scanning gel has a chance to
harden.
Starting Scanning
All equipment must be cleaned and disinfected before use.
Connecting the Transducer
1. Unscrew the connector plug cover on the transducer (if attached).
2. On the connector plug, make sure that the red arrow is aligned with the red dot on the
transducer socket.
3. Pull back the outer locking mechanism and insert the plug in the socket.
4. Release the locking mechanism to secure in place.
When connected the transducer complies with Type B requirements of EN60601-1 (IEC
60601-1).
Changing Frequency
The Multi-Frequency Imaging (MFI) facility enables you to select the scanning frequency.
See the applicable scanner user guide for instructions. The selected frequency is displayed
at the top of the screen.
Using a Transducer Cover
The transducer should be enclosed in a transducer cover or a standard condom. See the
Product Data sheet for a list of available transducer covers.
1. Apply gel to the tip of the transducer. This improves the screen images by preventing
image artifacts caused by air bubbles.
2. Pull the transducer cover over the transducer.
3. Gel also creates a good acoustic contact between the skin and the transducer; there-
fore, apply a small amount to the outside of the cover prior to scanning. Re-apply the
gel frequently to ensure good screen images.
WARNING
Keep all plugs and sockets absolutely dry at all times.
WARNING
Because of reports of severe allergic reactions to medical devices containing latex (natural
rubber), FDA is advising health-care professionals to identify their latex-sensitive patients
and be prepared to treat allergic reactions promptly.
WARNING
Use only water-soluble agents or gels. Petroleum or mineral oil-based materials may harm
the cover material.

Endosonic Multiplane Transducer 8551 User Guide (BB0100) Nov. 2007 5
8551 • Assembling the 8551 for Transrectal Use
Using the Transducer Control Button
The transducer has a control button that you can press to Start or Stop scanning (freeze
frame). Press the button for more than one second to make a copy of the image.
Each time the button is pressed, a “beep” is emitted.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable scanner user
guide for instructions.
Assembling the 8551 for Transrectal Use
The 8551 may be equipped with a water standoff facility to improve focusing during trans-
rectal scanning of the prostate. A rubber sheath is mounted on the end of the transducer and
filled with water to ensure good acoustic contact with the rectal wall. By varying the amount
of water in the sheath it is possible to alter the position of the transducer’s focal zone in the
tissue.
If the water standoff facility is required, follow the steps below to assemble it. Fig. 5 illus-
trates each step.
Fig. 5. Assembly of the water standoff facility (pictures 1 through 6)
1. Mount the rubber sheath UA0799 on the transducer and roll it down until it covers the
groove furthest away from the tip of the transducer (see Picture 2 above).
2. Pull “O” ring QA0185 over the rubber sheath and position it in the groove nearest the
tip of the transducer (Picture 3). The “O” ring holds the rubber sheath securely in
place.
3. Attach a catheter with a Luer Lock to the water standoff inlet (Picture 4) and fill the
rubber sheath with water using a standard disposable syringe (Picture 5).
Caution
Use a catheter with soft tubing. Tubing with hard plastic ends can damage the transducer’s
metal water port.

6 Nov. 2007 Endosonic Multiplane Transducer 8551 User Guide (BB0100)
8551 • Puncture Facilities
Air bubbles may appear in the rubber sheath, which will disrupt the path of the ultra-
sound beam and cause image artifacts. They must be removed.
4. To remove all air from the rubber sheath, hold the transducer with the rubber sheath
pointing downwards. Then, using the syringe, draw off as much air as possible (Picture
6).
5. Refill the sheath with water. Continue to draw off as much air as possible and refill the
sheath with water until you are sure that there is no air left in either the sheath or the
water outlet.
6. Now that you have removed air bubbles that could interfere with the scanning image,
draw all the water out of the rubber sheath. (The transducer will be inserted into the
patient without water in the sheath. After the transducer is inserted, water can be
introduced again into the sheath.)
7. Cover the probe with a standard condom containing a small amount of scanning gel.
Note: Before you start scanning, the patient may require a small enema to clean the rectum
as fecal material may disturb the ultrasound image.
Puncture Facilities
Transrectal puncture and biopsy are possible with the 8551 using the built-in canal. The
puncture equipment is illustrated in the following pages with a brief description of its use
and operating instructions.
Built-in Transrectal Puncture Canal
The 8551 has a built-in needle canal for transrectal puncture and biopsy. The needle canal
has an inner diameter of 2.1mm. The guide canal is angled at 21°to the transducer’s longi-
tudinal axis.
An additional needle guide fits into the built-in guide canal for transrectal puncture. This
guide, UC 5299, has an internal diameter of 1.7mm and is also available in an extended ver-
sion (UC5299-E). Fig. 6 shows the transducer assembled for transrectal puncture.
WARNING
Do not use excessive force during insertion. Do not over-inflate the balloon. 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 mea-
sure.
WARNING!
It is essential for the patient’s safety that only the correct needle guide is used with the 8551.
Never use unauthorized combinations of transducers and needle guides or other manufactur-
ers’ puncture attachments.

Endosonic Multiplane Transducer 8551 User Guide (BB0100) Nov. 2007 7
8551 • Performing Puncture and Biopsy
Fig. 6. 8551 assembled for transrectal puncture (here shown without cover)
Both needle guides (UC5299 and UC5299-E) can be autoclaved or disinfected by immersion
in a suitable solution.
Performing Puncture and Biopsy
1. Draw all water out of the rubber sheath.
2. Remove transducer from patient.
3. Remove any standard condom.
4. Carefully insert needle guide (UC5299 or UC5299-E) into the built-in needle canal.
5. Cover the probe with a sterile condom containing a small amount of sterile scanning
gel. The condom should not cover the entrance of the needle canal, see Fig. 6.
See the Product Data sheet for a list of available transducer covers.
WARNING
It is essential for the patient’s safety that only the correct puncture attachments, as described
in this guide, are used. Never use unauthorized combinations of transducers and puncture
attachments or other manufacturers puncture attachments.
Before beginning a puncture or biopsy procedure, always check that the type number of the
transducer and the type number or description of the puncture attachment match exactly
those displayed on the scanner monitor.
WARNING
The puncture line on the scan image is an indication of the expected needle path. The needle
tip echo should be monitored at all times so any deviation from the desired path can be cor-
rected.
WARNING
Do not use excessive force during insertion. Ensure that the needle guide is correctly posi-
tioned.
Never insert the needle guide while the transducer is inside the patient.
Water standoff
rubber sheath
Needle guide
Pull cover up to here

8 Nov. 2007 Endosonic Multiplane Transducer 8551 User Guide (BB0100)
8551 • Performing Puncture and Biopsy
6. Press the scanner Puncture or Biopsy control button to superimpose a puncture line on
the scan image.
If more than one puncture line is available, refer to the applicable scanner user guide for
instructions on how to change which one appears.
7. Insert the transducer in the patient.
8. 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.
To remove the puncture line from the scan image, refer to the applicable scanner user guide
for instructions.
Transrectal Biopsy
Transrectal puncture and biopsy are possible in all planes. B-K Medical recommends that
transrectal biopsies are taken while scanning in the longitudinal plane.
The puncture line will differ depending on the scanning plane orientation.
In the longitudinal plane the puncture path is indicated by a line of dots. The distance
between each puncture dot is 5mm.
In oblique and transverse planes, a single dot indicates the point at which the needle will
transect the scanning plane image rotation axis.
The distance from the entrance of the built-in needle guide to the puncture dot on the scan-
ning plane rotation axis is 107.5mm in all planes, see Fig. 7.
Fig. 7. Transrectal puncture with 8551
Cleaning after Puncture and Biopsy
If biological materials are allowed to dry on the transducer or needle guide, disinfection and
sterilization processes may not be effective. Therefore, you must clean needle guides and
transducers immediately after use.
WARNING
When performing a biopsy, always make sure that the needle is fully drawn back inside the
needle guide before moving the probe.

Endosonic Multiplane Transducer 8551 User Guide (BB0100) Nov. 2007 9
8551 • Disposal
Use a suitable brush to make sure that biological material and gel are removed from all nee-
dle guides and other channels and grooves. See Transducer Care, Cleaning & Safety for
cleaning instructions.
Caution
Do not stick anything into the water inlet to clean it. Poking something into this hole can
damage the water channel inside the transducer. You can clean the water channel by flushing
it with water soon after use, before any foreign matter such as scanning gel has a chance to
harden.
Disposal
When the transducer is scrapped at the end of its life, national rules for the relevant mate-
rial in each individual land must be followed. Within the EU, when you discard the trans-
ducer, you must send it to appropriate facilities for recovery and recycling. See the
applicable scanner user guide for further details.
WARNING
For contaminated disposals such as transducer covers or needle guides, follow disposal con-
trol policies established for your office, department or hospital.

10 Nov. 2007 Endosonic Multiplane Transducer 8551 User Guide (BB0100)
8551 • Disposal