B-K Medical Type 8661 User manual

Endovaginal Endfire Transducer
Type 8661
English BB0613-G
August 2006
User Guide

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we hope you will be willing to answer some questions about your experience buying and
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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.

Endovaginal Endfire Transducer Type 8661
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 3
Endovaginal Scanning 4
Puncture Facilities 4
Puncture Attachment UA1242 4
Performing Puncture and Biopsy 5
Cleaning after Puncture and Biopsy 6
Disposal 7
English BB0613-G
August 2006

1
Endovaginal Endfire Transducer Type 8661
Introduction
This is the user guide for Endovaginal Endfire Transducer Type 8661 and must be used
together with Transducer Care, Cleaning & Safety which contains important safety informa-
tion.
8661 is an endovaginal endfire transducer suitable for gynecological examinations.
Fig. 1. Endovaginal Endfire Transducer Type 8661
Scanning Plane
The scanning plane of Type 8661 is shown in Fig. 2..
Fig. 2. Scanning plane of Type 8661
The transducers have a groove on the top of their handles, opposite the control button. This
groove shows the direction of the scanning plane.
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.
Endovaginal Endfire Transducer Type 8661

2
8661 • 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.
• 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.

3
8661 • Starting Scanning
Connecting the Transducer
The transducer is connected to the scanner using the array Transducer Socket on the scan-
ner. 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 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 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
8661 • Endovaginal Scanning
Endovaginal Scanning
Before endovaginal scanning, ensure the patient’s bladder is empty.
Smear a small amount of scanning gel over the tip of the transducer cover. This will ease
insertion and improve the screen images.
Puncture Facilities
Puncture and biopsy is possible with Type 8661. 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 UA1242
This metal puncture attachment (see Fig. 3.) is intended for endovaginal puncture and
biopsy with Endovaginal Endfire Transducer Type 8661.
Fig. 3. Puncture attachment UA1242
The puncture attachment consists of a swinging lock-arm and a needle guide with an inner
diameter of 2.2mm, suitable for 20 to 14 gauge needles.
The needle guide is angled 0.5°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 215mm. The dots are 5 mm apart.
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 8661. Never use unauthorized combinations of transducers and puncture attachments or
other manufacturers’ puncture attachments.

5
8661 • Performing Puncture and Biopsy
To mount UA1242 (as shown in Fig. 4.):
Fig. 4. Type 8661 with puncture attachment UA1242
1. Hold the transducer with the groove uppermost and the control button underneath.
2. Position UA1242 on the probe ensuring that the two holes on the underside of the
guide fit on to the raised nubs on the groove of the transducer handle.
3. Lock the swinging arm into position over the bottom of the transducer. An audible click
indicates when the needle guide is securely attached.
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 UA1242 is positioned correctly.
To remove the needle guide, unlock the swinging arm and lift the needle guide off the trans-
ducer.
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.
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.

6
8661 • Performing Puncture and Biopsy
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. 5. Illustration of puncture line for puncture attachment UA1242
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.
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
8661 • Disposal
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.