B-K Medical Type 8565 User manual

English
BB0616-H
August 2006
Types 8565 and 8665
Convex Array Transducer
User Guide

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Email: [email protected]
If you have comments about the user documentation, please write to us at the email address above.
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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 Types 8565 and 8665
Introduction 1
Scanning Plane 1
General Information 2
Caring for the Transducer 2
Cleaning and Disinfection 2
Starting Scanning 3
Connecting the Transducer 3
Changing Frequency 3
Using a Transducer Cover 3
Using the Transducer Control Button 3
Changing Orientation 4
Puncture Facilities 4
UA0940 4
UA1217 5
Performing Puncture and Biopsy 6
Cleaning after Puncture and Biopsy 7
Disposal 7
English BB 0616-H
August 2006

1
Convex Array Transducer Types 8565 and 8665
Convex Array Transducer Types 8565 and 8665
Introduction
This is the user guide for Convex Array Transducer Types 8565 and 8665 and must be used
together with Transducer Care, Cleaning & Safety which contains important safety
information.
8565 and 8665 are suitable for abdominal scanning.
Fig. 1. Convex Array Transducer Types 8565 and 8665
A small diode on the transducer’s handle indicates whether the transducer is active. An
orange light indicates that the transducer is connected to the scanner. A green light
indicates that the transducer is scanning.
Scanning Plane
Fig. 2. Scanning plane of Types 8565 and 8665

2
8565 and 8665 • 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
transducer 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 the Transducer Care,
Cleaning & Safety booklet that accompanies this user guide. A list of disinfectants and
disinfection 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.
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
contamination, follow all infection control policies for personnel and equipment established
for your office, department or hospital.

3
8565 and 8665 • Starting Scanning
Starting Scanning
All equipment must be cleaned and disinfected before use.
Connecting the Transducer
The transducer is connected to the scanner using the array Transducer Socket on the
scanner. To connect, the transducer plug’s locking lever should first be in a horizontal
position. Align the plug to the scanner socket and insert securely. Turn the locking lever
clockwise to lock 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 gel to the tip of the transducer. This improves the screen images by preventing 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
frequently 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.
Note: Transducer buttons cannot be used to copy images using the Mini Focus 1402
Ultrasound Scanner.
Each time the button is pressed, a “beep” is emitted.
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
8565 and 8665 • Puncture Facilities
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable scanner user
guide for instructions.
Puncture Facilities
Puncture and biopsy are possible with Types 8565 and 8665. 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
Stainless steel puncture attachment UA0940 (Fig. 3.) comprises: an attachment lock screw;
a needle guide; a needle-guide lock screw; and a variable diameter holder for fine needles
(0.6mm/24 gauge) and large bore needles (2.1mm/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 (see Fig. 4.). Tighten the lock screw and check that UA0940 is secure.
WARNING
It is essential for the patient’s safety that only the correct puncture attachment is used with
Types 8565 and 8665. Never use unauthorized combinations of transducers and puncture
attachments or other manufacturers’ puncture attachments.
WARNING
Use only metal needles with this puncture attachment.

5
8565 and 8665 • Puncture Facilities
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 Types 8565 and 8665 (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.
All parts of the puncture attachment can be autoclaved or disinfected by immersion in a
suitable solution.
Fig. 4. Puncture attachment UA0940 mounted on Type 8565/8665
UA1217
Fig. 5. Puncture attachment UA1217
Puncture attachment UA1217 (see Fig. 5.) is for use with catheters and comprises: an
attachment lock screw; a needle guide; a needle-guide lock screw; and a variable diameter
holder for fine needles (1.2mm/18 gauge) and large bore needles (3.6mm/9 gauge). The guide
channel is angled at 18°to the transducer’s image axis.

6
8565 and 8665 • Performing Puncture and Biopsy
The distance from the guide channel entrance of the puncture attachment to the first dot on
the scan image puncture line is 65 mm. The distance between the dots is 10mm (see Fig. 6.).
All parts of the puncture attachment can be autoclaved or disinfected by immersion in a
suitable solution.
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
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.
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
corrected.
WARNING!
If the needle guide is detached from the transducer during interventional procedures, cover
the transducer with a new transducer cover.

7
8565 and 8665 • Disposal
Fig. 6. Puncture lines for UA0940 and UA1217
Cleaning after Puncture and Biopsy
If biological materials are allowed to dry on the transducer or puncture attachments,
disinfection 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
needle 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
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. See the
applicable scanner user guide for further details.
WARNING
When performing a biopsy, always make sure that the needle is fully drawn back inside the
needle guide before moving the probe.

8
8565 and 8665 • Disposal
WARNING
For contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department or hospital.