BK Ultrasound T-Shaped Intraoperative Transducer User Manual
- June 2, 2024
- BK Medical
Table of Contents
T-Shaped Intraoperative
Transducer
BK MEDICAL
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 4452 8100 / Fax:+45 4452 8199
www.bkultrasound.com
Email: info@bkultrasound.com
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 B-K Medical representative or by
contacting us directly.
Introduction
This is the user guide for T-Shaped Intraoperative Transducer Type 8816 and
must be used together with Transducer Care, Cleaning & Safety which contains
important safety information.
The 8816 is an intraoperative transducer suitable for ultrasound-guided
interventional procedures.
WARNING
Do not use the transducer for applications where it may come in direct
conductive contact with the patient’s heart.
Figure 1. T-Shaped Intraoperative Transducer Type 8816.
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 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.
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.
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 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
Keep all plugs and sockets absolutely dry at all times.
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 intra operative
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
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.
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 mage
artifacts caused by air bubbles.
Pull the transducer cover over the transducer.
WARNING
Use only water-soluble agents or gels. Petroleum or mineral oil-based
materials may harm the cover materials.
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 8816 for scanning
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.
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