Analogic bk ultrasound 8811 User manual

English
BB1003-G
May 2016 For Professional Users Only
Linear Array Transducer
User Guide
Type 8811

WORLD HEADQUARTERS
Mileparken 34
DK-2730 Herlev
Denmark
Tel.:[phone] / Fax:[phone]
www.bkultrasound.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.
© 2016 BK Medical
Information in this document may be subject to change without notice.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Scanning Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Starting Scanning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using the Transducer Control Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Puncture and Biopsy Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Puncture Guide Attachment UA1239 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Performing Puncture and Biopsy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cleaning after Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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8811 User Guide (BB1003-G) Introduction 5
Introduction
This is the user guide for Linear Array Transducer Type 8811 and must be used
together with Care, Cleaning & Safety which contains important safety information.
8811 is suitable for breast, small part, peripheral vascular and musculoskeletal
scanning.
Figure 1. Linear Array Transducer 8811
FDA WARNING for the United States of America
8811 is not for fetal use.
Scanning Plane
Figure 2. Scanning plane of 8811
General Information
Product specifications for this transducer can be found in the Product Data sheet that
accompanies this user guide.
WARNING
Do not use the transducer for applications where it may come in direct conductive
contact with the patient’s heart.

6 May 2016 8811 User Guide (BB1003-G)
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.
Service and Repair
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 Care, Cleaning & Safety .
Cleaning and Disinfection
To ensure the best results when using BK Medical equipment, it is important to
maintain a strict regular cleaning routine.
Full details of cleaning and disinfection procedures can be found in 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.
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 BK Medical representative or hospital technician.
WARNING
Always keep the exposure level (the acoustic output level and the exposure time) as low
as possible.
WARNING
Service and repair of BK Medical electromedical equipment must be carried out only by
the manufacturer or its authorized representatives. BK Medical reserves the right to
disclaim all responsibility for the operating safety, reliability and performance of
equipment serviced or repaired by other parties. After repairs have been carried out, a
qualified electrical engineer or hospital technician should verify the safety of all
equipment.

8811 User Guide (BB1003-G) StartingScanning 7
Caution:
Keep all plugs and sockets absolutely dry at all times.
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 BF 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.
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.
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.

8 May 2016 8811 User Guide (BB1003-G)
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.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable scanner
user guide for instructions.
Puncture and Biopsy Facilities
Puncture and biopsy are possible with 8811. The puncture attachments are illustrated
in the following pages with a brief description of their use and operating instructions.
Puncture Guide Attachment UA1239
The UA1239 puncture guide attachment (see Fig. 3) is designed for percutaneous
puncture and biopsy of superficial lesions when used with 8811 (see Fig. 4). It
consists of a bracket for attaching the needle holder to the transducer, and the needle
holder itself which features a three winged shaft that can be rotated in the barrel of
WARNING
Use only water-soluble agents or gels. Petroleum or mineral oil-based materials may harm
the cover material.
WARNING
It is essential for the patient’s safety that only the correct puncture attachment is used with
8811. Never use unauthorized combinations of transducers and puncture attachments or
other manufacturers’ puncture attachments.

8811 User Guide (BB1003-G) Puncture and Biopsy Facilities 9
the needle holder to accommodate different sized needles. There is also a screw for
adjusting the angle of penetration. The needle guide will accept 0.9 mm (20 Gauge),
1.3 mm (18 Gauge) and 2.1 mm (14 Gauge) needles.
Figure 3. Puncture attachment UA1239
The bracket has a 30  45  or 60  angle of insertion to the image axis and these are
shown on the image as lines of dots.
To mount the UA1239:
1 Hold the transducer in your left hand with the black operating button facing
away from you.
2 Hold the UA1239 in your right hand with the adjusting screw facing towards
you, the two ‘legs’ pointing to the left and the moveable swing arm pointing
down.
3 Slide the two legs down over the transducer into the recessed grooves.
4 Lock the swing arm into position at the neck end of the transducer. An audible
"click" indicates when the needle guide is securely attached.
Figure 4. Mounting the puncture attachment UA1239 (shown without cover)
WARNING
Ensure the bracket is positioned correctly.

10 May 2016 8811 User Guide (BB1003-G)
To alter the angle of the needle-guide holder:
1 Loosen the adjustable screw by turning it one quarter revolution counter-
clockwise.
2 Select the desired angle (60  ; 45  ; 30  ).
3 Retighten the adjustable screw.
To select the correct needle barrel:
1 Raise the three winged handle up out of its socket and rotate it until the desired
barrel is next to the small black triangular marking on the top of the needle guide
holder.
2 Push the three winged handle fully back down into its socket.
3 Slide in the desired needle (or catheter).
To detach the needle during interventional procedures:
1 Raise the three winged handle approx. 3mm and rotate counter-clockwise
through 60
 until halted by the small metal nub.
2 The needle (or catheter) can now be released from the needle guide attachment.
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.
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.

8811 User Guide (BB1003-G) Performing Puncture and Biopsy 11
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.
Figure 5. Puncture lines for UA 1239 on 8811
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 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.

12 May 2016 8811 User Guide (BB1003-G)
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.