B-K Medical 8809 User manual

English
BB0911-N
May 2019 For Professional Users Only
8809 Linear Array Transducer
User Guide

LEGAL MANUFACTURER
BK MEDICAL
Mileparken 34
2730 Herlev
Denmark
Tel.:[phone]/Fax:[phone]
www.bkmedical.com
Email: info@bkmedicalcom
The connector label on a BK Medical transducer contains information about the date of manufacture.
BK Medical Customer Satisfaction
Input from our customers helps us improve our products and services. Your opinions are important to
us. You are always welcome to contact us via your BK Medical representative or by contacting us
directly.
© 2019 BK Medical
Information in this document may be subject to change without notice.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Imaging Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using the Transducer Control Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operation of Type 8809. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Cleaning after Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
English source version
BB0911-N

4

8809 User Guide (BB0911-N) Introduction 5
Introduction
This is the user guide for Linear Array Transducer Type 8809 1, and it must be used
together with the Care and Cleaning user guide, which contains important safety
information.
Intended use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis
of the human body.
Indications for Use
The 8809 transducer is designed for peripheral vessel, musculoskeletal,
intraoperative and small parts imaging.
Patient Population
Patient population is adults, adolescents and children.
Figure 1. Linear Array Transducer 8809
1. Use of 8809 in the central vascular or central nervous system is not licensed by Health Canada.
Caution Rx-c1
United States Federal law restricts this equipment to sale by or on the order of a
physician.
WARNING Cardio-w1
To avoid patient injury, do not use the transducer for applications where it may come
in direct conductive contact with the patient's heart.

6 May 2019 8809 User Guide (BB0911-N)
Imaging Plane
Figure 2. Imaging plane of 8809
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 in Technical Data (BZ2100) that accompanies this user guide. A full
explanation of acoustic output is given in your scanner user guide.
Service and Repair
WARNING GS-w2
If at any time the system malfunctions, or the image is severely distorted or degraded, or
you suspect in any way that the system is not functioning correctly:
• Remove all transducers from contact with the patient.
• Turn off the system. Unplug the system from the wall and make sure it cannot be used
until it has been checked.
• Do not try to repair the system yourself.
• Contact your BK Medical representative or hospital technician.
WARNING AO-w1
To avoid tissue damage, always keep the exposure level (the acoustic output level and the
exposure time) as low as possible.
WARNING SR-w1
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, including but not limited to responsibility for the operating safety, reliability
and performance of equipment serviced or repaired by other parties. After service or repairs
have been carried out, a qualified electrician or hospital technician should verify the safety
of all equipment.

8809 User Guide (BB0911-N) Reprocessing 7
Caring for the Transducer
The transducer may be damaged during use or reprocessing, 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 and Cleaning.
Reprocessing
To ensure the best results when using BK Medical equipment, it is important to
maintain a strict cleaning routine.
Complete details and procedures can be found in Care and Cleaning that
accompanies this user guide. A list of reprocessing methods that the transducer
can withstand are listed in the Product Data Sheet.
Sterile covers are available. See the Product Data Sheet for more information.
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
Connecting the Transducer
The transducer is connected to the system using the array transducer socket on the
system. To connect, flip the system’s locking lever to the right. Align the transducer
plug to the system socket and insert securely. Flip the system’s locking lever to the
left to lock it.
When connected the transducer complies with Type BF requirements of EN60601-1
(IEC 60601-1).
WARNING Reproc-w2
Users of this equipment have an obligation and responsibility to provide the highest
possible degree of infection control to patients, co-workers and themselves. The
instructions in this book are meant as a guide. To avoid cross-contamination, follow all
infection control policies (including for reprocessing, packing and storage) for personnel
and equipment that have been established for your office, department or hospital.
WARNING T-w5
To prevent electrical shock and damage to the transducer, the connector pins in the
transducer plug must always be completely dry before you connect to a system.
WARNING GS-w4a
It is essential for the patient’s safety that only the correct equipment is used.
• Do not use other manufacturers’ transducers with BK Medical ultrasound systems.
• Do not use BK Medical transducers with other manufacturers’ systems.
• Do not use unauthorized combinations of transducers and puncture attachments.

8 May 2019 8809 User Guide (BB0911-N)
Changing Frequency
The multifrequency imaging (MFI) control enables you to select the imaging
frequency. See the applicable system user guide for instructions.
Using a Transducer Cover
The transducer should be enclosed in a sterile transducer cover. See the Product Data
Sheet for a list of available transducer covers.
The gel should cover the entire front end of the transducer (black part of the
transducer).
For Intraoperative Applications
Apply sterile gel to the tip of the transducer or fill the transducer cover with 1 to 2 ml
of sterile water.
Pull the transducer cover over the transducer. Check for air bubbles between the
cover and the transducer and even out if necessary before proceeding.
This improves the screen images by preventing image artifacts caused by air bubbles.
Using the Transducer Control Button
The transducer has a control button that you can press to Start or Stop imaging
(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.
WARNING TC-w7
Use only approved non-pyrogenic, sterile probe sheaths (transducer covers). This means that
in the USA they must be market cleared by the FDA and in Europe they must be CE-marked.
In Canada, they must be licensed by Health Canada.
WARNING TC-w1
Some transducer covers can contain latex. Because of reports of severe allergic reactions
to medical devices containing latex (natural rubber), the FDA advises health-care
professionals to identify latex-sensitive patients and be prepared to treat allergic reactions
promptly
Caution T-c3
Use only water-based gel (sterile if you are using a sterile transducer cover). Products
containing parabens, petroleum, or mineral oils may harm the transducer or transducer
cover.

8809 User Guide (BB0911-N) Operation of Type 8809 9
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Operation of Type 8809
Adjustment of Flexible Tip
The transducer has a flexible tip. The tip can be adjusted through an angle of up to
90in four steps: 0, 30, 60 and 90. SeeFig. 3
Figure 3. Transducer 8809’s flexible tip
The transducer should be checked before use for cracks or irregularities in the
surface. It is important to check the black rubber cover on the transducer handle and
the articulation joint on the flexible tip of the transducer to ensure that there are no
defects in these areas. It should also be checked thoroughly once a month following
the procedure in Care and Cleaning.
Intraoperative Imaging with Type 8809
Before intraoperative scanning, refer to Care and Cleaning for disinfection and
sterilization instructions.
Cleaning after Use
Use a suitable brush to make sure that biological material and gel are removed from
all channels and grooves. See Care and Cleaning for cleaning instructions.
30° 90°
0° 60°
WARNING Reproc-w3
Immediately after use, you must pre-clean the device until visually clean (including
device lumens if existing). Conduct the thorough cleaning process as soon as
possible after use in order to prevent bioburden drying on the surface. Dried
bioburden can lead to inefficient cleaning, disinfection and sterilization, causing a
risk of cross-contamination.

10 May 2019 8809 User Guide (BB0911-N)
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.
WARNING D-w1
For disposal of contaminated items such as transducer covers or needle guides or other
disposable items, follow disposal control policies established for your office, department, or
hospital.