B-K Medical 8805 User manual

Linear Array Transducer
Type 8805
English BB0337-F
August 2006
User Guide

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Tel.:[phone]
Fax:[phone]
www.bkmed.com
Email: [email protected]
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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.
© 2006 B-K Medical
Information in this document may be subject to change without notice.

Linear Array Transducer Type 8805
Introduction 1
Scanning Plane 1
General Information 1
Caring for the Transducer 2
Cleaning and Disinfection 2
Starting Scanning 2
Connecting the Transducer 3
Changing Frequency 3
Using a Transducer Cover 3
Using the Transducer Control Button 3
Changing Orientation 4
Puncture Facilities 4
UA1251 4
Performing Puncture and Biopsy 6
Cleaning after Puncture and Biopsy 7
Disposal 7
English BB0337-F
August 2006

1
Linear Array Transducer Type 8805
Linear Array Transducer Type 8805
Introduction
This is the user guide for Linear Array Transducer Type 8805 and must be used together
with Transducer Care, Cleaning & Safety which contains important safety information.
8805 is suitable for musculoskeletal examinations.
Fig. 1. Linear Array Transducer Type 8805
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 and ready. A green
light indicates that the transducer is scanning.
FDA WARNING for the United States of America
Type 8805 is not for fetal use.
Scanning Plane
Fig. 2. Scanning plane of Type 8805
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.

2
8805 • 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 Transducer Care,
Cleaning & Safety 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.
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.
• 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
8805 • Starting Scanning
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 the transducer is attached to the scanner, the diode light is orange.
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.
Each time the button is pressed, a “beep” is emitted.
When the transducer is scanning, the diode light is green. When scanning stops, the light is
orange.
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
8805 • 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 is possible with Type 8805. The puncture attachment is illustrated in
the following pages with a brief description of its use and operating instructions.
UA1251
The puncture attachment (Fig. 3.) comprises a mounting bracket, which secures the
puncture attachment to the transducer handle, and a needle guide. There are three screws
marked A, B, and C in Fig. 3. A is for securing the puncture attachment to the transducer,
B is to allow the needle guide to be adjusted to three different angles of insertion, C is for
holding the needle in place.
To mount UA1251:
1. Mount the puncture attachment by fitting the metal mounting bracket on to the
transducer.
2. The metal raised knobs on either side of the transducer fit into the indentations on the
bracket. The ridge on the thin side of the transducer fits into the groove on the bracket.
3. Tighten the screw (A) to secure the bracket to the transducer.
Adjusting the angle of UA1251:
There are three different angles of insertion available; 30°, 45° and 60° with respect to the
transducer’s image axis.
1. Loosen screw B until the needle guide can move forward and backward.
2. Move the needle guide until it clicks into place in one of the three indentations on the
mounting bracket.
3. Tighten screw B until the needle guide is securely fixed.
Adjusting the needle guide.
The needle guide can accommodate needles from diameter 0.6mm to 3.4mm.
1. Loosen screw C.
2. Insert needle.
3. Tighten screw C until the needle is held firmly.
All parts of the puncture attachment can be autoclaved or disinfected by immersion in a
suitable solution.
WARNING!
It is essential for the patient’s safety that only the correct puncture attachment is used with
Type 8805. Never use unauthorized combinations of transducers and puncture attachments
or other manufacturers’ puncture attachments.

5
8805 • Puncture Facilities
Fig. 3. Puncture attachment UA1251
Fig. 4. Type 8805 with puncture attachment UA1251 mounted
A
B
C

6
8805 • 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
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.
The distance from the entrance of the needle guide to the first dot on the puncture line is 60
mm. The distance between the puncture line dots is 10mm, see Fig. 5. for details.
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.
WARNING
When performing a biopsy, always make sure that the needle is fully drawn back inside the
needle guide before moving the probe.

7
8805 • Disposal
Fig. 5. Puncture line for UA1251 with Type 8805
The transducer and puncture attachment can be removed without disturbing the position of
the needle during puncture.
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
For contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department or hospital.