B-K Medical Type 8506-S User manual

English
BB1154-E
August 2006
Types 8506-S and 8806
Endovaginal Endfire Transducer
User Guide

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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.
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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 BK Medical
representative or by contacting us directly.
© 2006 BK Medical
Information in this document may be subject to change without notice.

Endovaginal Endfire Transducer Types 8506-S and
8806
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
Changing Orientation 3
Puncture Facilities 4
Puncture Attachment UA1263 4
Performing Puncture and Biopsy 5
Endovaginal Biopsy 5
Cleaning after Puncture and Biopsy 6
Disposal 6
English BB1154-E
August 2006

1
Endovaginal Endfire Transducer Types 8506-S and 8806
Introduction
This is the user guide for the Endovaginal Endfire Transducers Types 8506-S and 8806, and
must be used together with Transducer Care, Cleaning & Safety which contains important
safety information.
8506-S and 8806 are suitable for gynecological examinations.
Fig. 1. Endovaginal Endfire Transducer Types 8506-S and 8806
Scanning Plane
Fig. 2. Scanning plane of Types 8506-S and 8806
Endovaginal Endfire Transducer Types 8506-S and
8806

2
8506-S and 8806 • 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
8506-S and 8806 • 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.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable scanner user
guide for 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
8506-S and 8806 • Puncture Facilities
Puncture Facilities
Puncture and biopsy are possible with Types 8506-S and 8806. The puncture attachment is
illustrated in the following pages with a brief description of its use and operating
instructions.
The use of probe sheaths during invasive applications is recommended.
For hygiene reasons, the transducer should be enclosed in a transducer cover or a standard
condom. When sterile conditions are required, cover the transducer with a sterile transducer
cover.
Puncture Attachment UA1263
This metal puncture attachment (see Fig. 3.) is intended for endovaginal puncture and
biopsy with Endovaginal Endfire Transducer Types 8506-S and 8806.
Fig. 3. Puncture attachment UA1263
The puncture attachment consists of a swinging lock-arm and a needle guide with an inner
diameter of 2.1mm, suitable for up to 14 gauge needles.
The needle guide is angled 2°towards the long axis of the transducer (i.e. towards the mid-
axis of the scan image). The distance from the entrance to the needle guide and the first
puncture line dot on the scan image is 170mm. The dots are 5 mm apart, see Fig. 5. for
details.
All parts of the puncture attachment can be autoclaved or disinfected by immersion in a
suitable solution.
To mount UA1263 (as shown in Fig. 4.):
Fig. 4. Types 8506-S and 8806 with puncture attachment UA1263
1. Hold the transducer with the groove on the handle uppermost.
2. Align the two raised nodules on the underside of the attachment with the two holes on
the upperside of the probe’s rod.
3. Lock the swinging arm into position over the bottom of the transducer. An audible click
indicates when the needle guide is securely attached.
WARNING
It is essential for the patient’s safety that only the correct puncture attachment is used with
Types 8506-S and 8806. Never use unauthorized combinations of transducers and puncture
attachments or other manufacturers’ puncture attachments.

5
8506-S and 8806 • Performing Puncture and Biopsy
Caution
Ensure that the tip of the needle guide lies close to the front end of the probe, if not the needle
guide may be damaged and require realignment by B-K Medical technicians.
Caution
Ensure UA1263 is positioned correctly.
To remove the needle guide, unlock the swinging arm and lift the needle guide off the
transducer.
Performing Puncture and Biopsy
Endovaginal 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.

6
8506-S and 8806 • Disposal
Fig. 5. Illustration of puncture line for puncture attachment UA1263
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.
WARNING
For contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department or hospital.
UA1263