GE BK MEDICAL 8815 Series User manual

English
BB1312-N
April 2023 For Professional Users Only
Intraoperative Transducer
User Guide
Type 8815

BK MEDICAL
Mileparken 34
2730 Herlev
Denmark
Tel.:[phone] / Fax:[phone]
www.bkmedical.com
Email: [e-mail]
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 rep resentative or
by contacting us directly.
© 2023BK Medical
Information in this document may be subject to change without notice.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Scanning Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Starting Scanning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Holding the Transducer for Intraoperative Scanning . . . . . . . . . . . . . . . . . . . . . . 8
Puncture Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Single-Use Needle Guide UA1336. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Sterile Needle Guide UA1336 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Assembling the Needle Guide and Mounting it on the Transducer . . . . . . . 11
Releasing the Needle During Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Performing Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
RF and Microwave Ablation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Cleaning after Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
En glish source version
BB1312-N

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8815 User Guide (BB1312-N)
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Introduction
This is the user guide for Intraoperative Transducer Type 8815 and must be used
together with Care, Cleaning & Safety which contains important safety information.
Figure 1. Intraoperative Transducer Type 8815.
Indications for Use
8815 is an intraoperative transducer (for Breast, Liver, Pancreas, Biliary
system and Kidney, including Pediatric application) suitable for ultrasound-
guided interventional procedures.
Needle guide UA1336 provides guidance for needles or other interventional
devices during an ultrasound-guided procedure. UA1336 positions the needle
relative to the transducer, so that the needle image is in a specified position in the
ultrasound image during procedures that require precise needle placement or
biopsy.
Scanning Plane
Figure 2. Scanning plane for 8815.
WARNING
Do not use the transducer for applications where it may come in direct
conductive contact with the patient’s heart.

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April-2023 8815 User Guide (BB1312-N)
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 data 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 Care, Cleaning & Safety .
Service and Repair
Cleaning and Disinfection
To ensure the best results when using BK Medical equipment, it is important to
maintain a strict 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 cover is 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, 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 electrical engineer or hospital
technician should verify the safety of all equipment.

8815 User Guide (BB1312-N)
7
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.
Note: Sterile, disposable sheaths are recommended for intraoperative use. In the
United States of America, it is recommended that probe sheaths have been market-
cleared. In Canada, use only licensed probe sheaths.
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 that have
been 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.

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April-2023 8815 User Guide (BB1312-N)
Note: For Intraoperative Applications
Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2ml of sterile
water. This improves the screen images by preventing image artifacts caused by air
bubbles.
Pull the transducer cover over the transducer.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable scanner
user guide for instructions.
Holding the Transducer for Intraoperative Scanning
Hold the transducer between two fingers and the thumb (see Figure 3) or any
position which is comfortable for your hand and move the transducer smoothly
over the surface of the organ to produce the best screen image.
Figure 3. Holding 8815 for scanning.
Puncture Facilities
Intraoperative transducer 8815 is designed to support biopsy and other
interventional procedures using single-use needle guide UA1336. The needle
guide is illustrated in the following pages with a brief description of its use and
operating instructions.
WARNING
Use only water-soluble agents or gels. Petroleum or mineral oil-based materials may harm
the cover materials.
WARNING
It is essential for the patient’s safety that only the correct needle guide is used with 8815.
Never use unauthorized combinations of transducers and needle guides or other
manufacturers’ needle guides.

8815 User Guide (BB1312-N)
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Single-Use Needle Guide UA1336
Figure 4. Needle guide UA1336 assembled with 3-angle insert.
Needle guide UA1336 is supplied together with two needle guide insert palettes.
Each palette contains a set of 9 needle guide inserts, one 3-angle and one free-angle.
Figure 5. Two needle guide insert palettes supplied together with needle guide UA1336.
The 3-angle inserts each contain three channels. These channels allow the needle to
be positioned at 25  , 45  or 65  to the image axis of the 8815.
The free-angle inserts are slotted to allow the positioning of the needle at any angle
between 25
 and 65  to the image axis of the 8815 while making sure that the needle
follows the plane of the image.
Wire clip
Needle guide
insert
Needle guide

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April-2023 8815 User Guide (BB1312-N)
The puncture line pattern is shown in Figure 6 The distance between the guide
channel of the needle guide to the first dot on the scan image puncture line is 12-
15mm depending on which angle is chosen. The distance between the dots is 5 mm.
Figure 6. Illustration showing the puncture line and blind spot (See 4th “WARNING”on
page 12).
Sterile Needle Guide UA1336
Needle guide UA1336 and the needle guide insert palettes are supplied sterile in peel
packs and are for single-use only. Contents are only sterile if the package is intact.
The needle guide, the inserts and both palettes must be discarded after use.
The sterile-packed needle guides must be stored at a temperature range from +15°C
(+57°F) to +25°C (+77°F) and at a storage humidity of 30% to 80% .
Please refer to Care, Cleaning and Safety for an example of how to open a sterile-
packed product.
blind spot
WARNING
Disposable components are packaged sterile and are intended for single-use only.
Do not use if:
• Integrity of packaging is violated.
• Expiration date has passed.
• Package label is missing.
WARNING
Sterile-packed components must be stored in a safe environment and kept out of direct
sunlight. Large temperature changes during storage may cause condensation and violate
the integrity of the packaging.
WARNING
For contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department or hospital.

8815 User Guide (BB1312-N)
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Assembling the Needle Guide and Mounting it on the Transducer
Apply a small amount of scanning gel to the tip of the transducer and carefully cover
the transducer with a sterile cover (for readability, the transducer here is shown
without transducer cover).
Releasing the Needle During Biopsy
You can release the needle during biopsy so that the needle guide and transducer can
be removed from the patient, leaving only the needle in place.
Select the required needle guide insert by breaking it off the
palette.
Find the wedge shaped channel in the needle guide and
slide the insert into the channel in the needle guide from
above until it clicks into place and aligns with the needle
guide.
Taking care not to damage the transducer cover or the
surface of the transducer array, gently place the wire clip
over the small nodule on the tip of the transducer. Gently
place and clip the needle guide into place as shown.
Caution: Ensure the needle guide is positioned correctly.
Carefully insert the needle into the needle channel.
Caution: Do not let it scrape the inside of the needle channel.
Hold the transducer with your left hand. With your right
hand, carefully push the needle guide insert sideways until
it opens up. Carefully move the transducer and needle guide
away from the needle.

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April-2023 8815 User Guide (BB1312-N)
Performing Puncture and Biopsy
Cover the transducer with a sterile transducer cover.
If the transducer cover is damaged when attaching the needle guide, replace it with a
new cover.
Note: Sterile, disposable sheaths are recommended for intraoperative use; and in the
U.S.A. it is recommended that probe sheaths have been market-cleared. In Canada,
use only licensed probe sheaths.
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 .
WARNING
If the needle guide is detached from the transducer during interventional procedures,
cover the transducer with a new transducer cover before reattaching the needle guide..
WARNING
It is essential for the patient’s safety that only the correct needle guide, as described in this
guide, are used. Never use unauthorized combinations of transducers and needle guide or
other manufacturers needle guide.
Before beginning a puncture or biopsy procedure, always check that the type number of
the transducer and the type number or description of the needle guide 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. You must take extra care when taking a free-angle biopsy because the
expected needle path is not shown.
WARNING
The 8815 transducer cannot monitor the first 1.2-1.5 cm of the puncture line (the blind
spot, see Figure 6). Extra care should be taken during insertion until the needle tip echo
can be seen on the image.

8815 User Guide (BB1312-N)
13
To remove the puncture line from the scan image, refer to the applicable scanner user
guide for instructions.
RF and Microwave Ablation
When performing RF or Microwave ablation, you must always follow the
instructions provided by the manufacturer of the ablation equipment. Be sure to pay
attention to all warnings.
Do not use excessive force when you insert the needle into the needle guide.
Do not tighten adjustable needle guides so much that they can damage the needle.
If possible, carefully release and remove the needle guide from the transducer after
you insert the ablation needle into the patient and before you energize the needle.
If you use metal needle guides to guide RF or Microwave ablation, you must make
sure that the insulation on the needle is not damaged when the needle is moved back
and forth in the needle guide.
Cleaning after Puncture and Biopsy
If biological materials are allowed to dry on the transducer, disinfection and
sterilization processes may not be effective. Therefore, you must clean transducers
immediately after use.
Use a suitable brush to make sure that biological material and gel are removed from
all channels and grooves. See
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
If the needle guide is detached from the transducer during interventional procedures,
cover the transducer with a new transducer cover.
WARNING
Carefully examine the ablation needle before each insertion, to make sure that the
insulation is intact. Make sure that the needle is not damaged during insertion. If the
insulation is scratched, replace the needle with a new ablation needle.
WARNING
For contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department or hospital.

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April-2023 8815 User Guide (BB1312-N)