B-K Medical Type 8553 User manual

English
BB0101-H
August 2006
Type 8553
Convex Array Transducer
User Guide

WORLD HEADQUARTERS
Mileparken 34
DK-2730 Herlev
Denmark
Tel.:[phone] / Fax:[phone]
www.bkmed.com
Email: [email protected]
If you have comments about the user documentation, please write to us at the email address above.
We would like to hear from you.
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.
© 2006 BK Medical
Information in this document may be subject to change without notice.

Convex Array Transducer Type 8553
Introduction 1
Scanning Plane 1
General Information 1
Caring for the Transducer 2
Cleaning and Disinfection 2
Starting Scanning 2
Connecting a Transducer 3
Changing Frequency 3
Using a Transducer Cover 3
Using the Transducer Control Button 3
Changing Orientation 3
Puncture Facilities 4
UA0940 4
UA1217 5
Performing Puncture and Biopsy 6
Cleaning after Puncture and Biopsy 7
Disposal 7
BB0101-H
August 2006

1
8553 • Introduction
Convex Array Transducer Type 8553
Introduction
This is the user guide for Convex Array Transducer Type 8553 and must be used together
with Transducer Care, Cleaning & Safety which contains important safety information.
8553 is an abdominal transducer suitable for transcutaneous scanning of the bladder and
kidney, and for intercostal examinations.
Fig. 1. Convex Array Transducer Type 8553
Scanning Plane
Fig. 2. Scanning plane of Type 8553
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.

2
8553 • Cleaning and Disinfection
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 the Transducer Care,
Cleaning & Safety booklet that accompanies this user guide. A list of disinfectants and dis-
infection 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.
Caution
Keep all plugs and sockets absolutely dry at all times.
Starting Scanning
All equipment must be cleaned and disinfected before use.
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.
• 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.

3
8553 • Starting Scanning
Connecting a Transducer
Unscrew the connector plug cover on the transducer (if attached). On the connector plug,
make sure that the red arrow is aligned with the red dot on the transducer socket. Pull back
the outer locking mechanism and insert the plug in the socket. Release the locking mecha-
nism 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.
Apply scanning gel to the tip of the transducer. This improves the screen images by prevent-
ing image artifacts caused by air bubbles.
Pull the transducer cover over the transducer.
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 scanning. Re-apply the gel fre-
quently to ensure good screen images.
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 scanner user guide for
detailed instructions.
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.

4
8553 • Puncture Facilities
Puncture Facilities
Puncture and biopsy is possible with Type 8553. The puncture attachments are illustrated
in the following pages with a brief description of their uses and operating instructions.
UA0940
Fig. 3. Puncture Attachment UA0940
The stainless steel puncture attachment is shown in Fig. 3.; it comprises an attachment lock
screw, a needle guide, a needle-guide lock screw and a variable diameter holder for needles
with diameters from (0.6mm or 24 Gauge) and up to a maximum of (2.1mm or 14 Gauge).
The guide channel is angled at 18°to the transducer’s image axis.
Before mounting the puncture attachment, loosen the needle-guide lock screw, extend the
needle-guide to the 15mm setting and lock in position. Attach the puncture attachment to
the transducer. Tighten the lock screw and check the UA0940 is secure. See Fig. 4..
When the puncture attachment is at the 0mm setting, the distance from the guide channel
entrance of the puncture attachment to the first dot on the scan image puncture line is
65mm for the 8553. See Fig. 6. The distance between the dots is 10mm.
To fit the required needle, turn the variable-diameter holder counterclockwise and insert the
needle. Turn the holder clockwise until tight enough to hold the needle firmly.
WARNING:
It is essential for the patient’s safety that only the correct puncture attachment is used with
Type 8553. Never use unauthorized combinations of transducers and puncture attachments or
other manufacturers’ puncture attachments.
WARNING:
Use only metal needles with this puncture attachment.

5
8553 • Puncture Facilities
All parts of the puncture attachment can be autoclaved or disinfected by total immersion in
a suitable solution.
Fig. 4. Puncture attachment UA0940 mounted on the 8553
UA1217
Fig. 5. Puncture attachment UA1217
The puncture attachment (see Fig. 5.) is recommended for use with catheters and large
diameter needles from 1.2 mm and up to 3.6 mm. It comprises an attachment lock screw, a
needle guide, a needle-guide lock screw and a variable diameter holder for needles (1.2mm
or 18 Gauge) and large bore needles (3.6mm or 9 Gauge). The guide channel is angled at 18°
to the transducer’s image axis.
The distance from the guide channel entrance of the puncture attachment to the first dot on
the scan image puncture line is 65 mm for the 8553. The distance between the dots is 10mm.
These distances are the same as the UA0940, see Fig. 6. for details.
All parts of the puncture attachment can be disinfected by immersion, or can be autoclaved.

6
8553 • Performing Puncture and Biopsy
Performing Puncture and Biopsy
Cover the transducer with a sterile transducer cover.
If the transducer cover is damaged when attaching the puncture attachment, replace it with
a new cover.
See the Product Data sheet for a list of available transducer covers.
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.
Move the transducer until the puncture line transects the target. Insert the needle and mon-
itor 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.
Fig. 6. The distance from the top of UA0940 to the first dot in the puncture line is indicated.
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.
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!
If the needle guide is detached from the transducer during interventional procedures, cover
the transducer with a new transducer cover.
WARNING
When performing a biopsy, always make sure that the needle is fully drawn back inside the
needle guide before moving the probe.

7
8553 • Disposal
Cleaning after Puncture and Biopsy
If biological materials are allowed to dry on the transducer or puncture attachments, disin-
fection and sterilization processes may not be effective. Therefore, you must clean puncture
attachments and transducers immediately after use.
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.
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.