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.
BK Ultrasound T-Shaped Intraoperative Transducer User Manual – Optimized PDF
BK Ultrasound T-Shaped Intraoperative Transducer User Manual – Original PDF
References
]]>
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 44528100 / Fax:+45 44528199
www.bkmedical.com
Email: [email protected]
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.
Introduction
This is the user guide for the E14CL4b transducer, and it must be used together with the Care and Cleaning user guide which contains important safety information.
Indications for use
E14CL4b is suitable for transrectal imaging, transvaginal imaging, guidance of all transperineal interventional procedures including brachytherapy and
cryotherapy treatments. It is also suitable for elastography and contrast imaging.
E14CL4b contains two arrays — a curved array for transverse (T) imaging, and a linear array for sagittal (S) imaging. Both arrays can be used separately or they
can be used simultaneously. When using the simultaneous biplane feature, you are able to view two planes at once with a single transducer, and this helps determine the true position of the needle and its tip during puncture and biopsy.
Patient Population
The patient population is adults.
Imaging Plane
Figure 1. E14CL4b.
Figure 2. Imaging planes for E14CL4b.
General Information
Product specifications, acoustic output data and data about EMC (electromagnetic compatibility) for this transducer can be found in the Product Data Sheet and the Technical Data (BZ2100) that accompany this user guide.
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 service representative or hospital technician.
WARNING GS-w5
Do not run over transducer cables with system wheels or other heavy equipment. This can damage the cable, leading to degradation and/or corruption of the ultrasound image.
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 electromedical equipment must be carried out only by the manufacturer or BK authorized service 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.
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, following the procedure in Care and Cleaning. It should also be checked thoroughly once a month following the
same procedure.
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.
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.
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
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.
Connecting the Transducer
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 ultrasound systems.
- Do not use BK transducers with other manufacturers’ systems.
- Do not use unauthorized combinations of transducers and puncture attachments.
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 T-w12
To avoid patient injury or damage to a transducer, extra caution may be required when you use a mechanical stepper cradle or robotic accessory with the transducer. This is particularly important when adjusting the cradle/bed position after the transducer has been inserted into the patient. The stepper cradle or robotic accessory may exert excessive force when the transducer position is adjusted, which could harm the patient or damage the transducer.
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
BK recommends the use of a sterile transducer cover to reduce the risk of crosscontamination. See the Product Data Sheet for a list of available transducer covers.
Follow local guidelines for the use of transducer covers in your area.
NOTE: In the United States of America, it is recommended to use transducer covers that have been market cleared. In Canada, use only licensed transducer covers. In Europe, transducer covers must be CE-marked.
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 their latex-sensitive patients and be prepared to treat allergic reactions promptly.
Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile water. This improves screen imaging by preventing image artifacts caused by air bubbles.
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 imaging and reapply frequently.
Follow these precautions when putting sterile covers on a transducer:
- Wear sterile gloves.
- When using a puncture attachment, place it gently over the cover and secure it,
following the instructions for the puncture attachment. - Verify that the cover has not been damaged in the process. If it has, repeat the
procedure with a new transducer cover.
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.
Using the Transducer Control Button
The transducer has two control buttons, one for the sagittal array and one for the transverse array (Fig. 1). Pressing the button activates (starts) or freezes (stops)
imaging in that plane. Press the button for more than one second to make a copy of the image.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system user guide for instructions.
Endorectal Imaging with E14CL4b
E14CL4b is designed for simultaneous biplane imaging of the prostate.
WARNING Colo-w1
Do not use excessive force during insertion. Do not make excessive lateral movements during or after insertion. Risk of injury or tissue damage to the patient could occur under certain circumstances. A digital palpation of the rectum may need to be carried out by a clinician prior to insertion or use of the probe as a precautionary measure.
Adjusting Image Area and Using Expanded Sector (Trapezoidal View)
The width of the image area can be adjusted using the Width key on the scanner’s control panel. See the applicable system user guide for instructions.
With the Expanded Sector feature and E14CL4b, you can increase the transverse sector angle from a default width of 140° to 180°. And, you can increase the default sagittal view of 65mm to a trapezoidal view, which provides an additional 15°on each side.
Figure 3. Dotted lines indicating expanded sectors on E14CL4b.
Puncture and Biopsy Facilities
Puncture and biopsy are possible with the E14CL4b transducer. The puncture attachment is illustrated in the following pages with a brief description of its use and
operating instructions.
Puncture Attachment UA1232
Puncture attachment UA1232 (Fig. 4) is designed for transperineal puncture and biopsy.
It consists of:
- A needle guide and a mounting ring with a lock screw. The needle guide comprises
9 parallel guide channels, spaced 5mm apart, each with an internal diameter of
2.1mm, suitable for an 14 Gauge needle.
The guide channels are angled at 0° to the transducer’s longitudinal axis and 90° to the transverse imaging plane.
Note: The needle guide can be adjusted 90mm lengthwise with respect to the
mounting ring using the adjustment screw.
Figure 4. Puncture attachment UA1232.
To mount UA1232:
- Loosen the lock screw and slide the attachment over the tip of the transducer
until the lock screw pressure-pad meets the steel stud on the side of the
transducer. - The puncture attachment should be correctly positioned (Fig. 5) before the lock
screw is tightened. - No force should be used when attaching the puncture attachment to the
transducer.
Figure 5. E14CL4b with puncture attachment UA1232.
All parts of the puncture attachment can be autoclaved or disinfected by immersion in a suitable solution.
Performing Puncture and Biopsy
WARNING P-w1
Before you start imaging, verify that the type number or name of the transducer and the type number or description of the needle guide you are using match the number displayed on the monitor. Also make sure that the needle guide is positioned correctly. If the numbers
do not match, or if the needle guide position is not correct, the puncture line on the monitor may not correspond to the true puncture path in the tissue. In case of any inconsistency, stop imaging, turn off the system, and contact your BK service representative.
WARNING P-w4
The puncture line on the image is an indication of the expected needle path. To avoid harming the patient, the needle tip echo should be monitored at all times so any deviation from the desired path can be corrected.
If the transducer is not sterilized, cover it 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 Puncture or Biopsy control on the system to superimpose a puncture line on the scan image.
If more than one puncture line is available, refer to the applicable system 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 as it moves along the puncture line to the target. The needle tip echo will be seen as a bright dot on the screen.
The puncture line will differ depending on the imaging plane orientation. In the sagittal plane, the puncture path is indicated by a line of dots. The distance between
each puncture dot is 5mm.
In the transverse plane, a single dot indicates the point at which the needle will transect the imaging plane.
WARNING TC-w4
If you detach the needle guide during interventional procedures, the transducer cover could be damaged. To avoid cross-contamination, cover the transducer with a new transducer cover before reattaching the needle guide.
To remove the puncture line from the scan image, refer to the applicable system user guide for instructions.
WARNING P-w5
Avoid unnecessary tissue damage. When performing a biopsy, always make sure that the needle is fully drawn back inside the needle guide before moving the transducer.
Figure 6. Illustration of the puncture lines for puncture attachment UA1232.
Prostate Volume Determination
Refer to the system user guide for instructions on how to carry out a prostate volume determination, and the best procedure to use.
Radioactive Source Implantation
E14CL4b can be used with the CMS AccuseedTM Brachystepper System and with CIVCO AccuCare stepper units for radioactive seed implantation.
Please consult the appropriate stepper documentation for instructions on Source Implantation, including Preplanning, Needle Loading and Implantation.
E14CL4b should be prepared for transrectal imaging and biopsy as described earlier in this guide, and mounted and ’’locked’’ in the stepping unit.
The volume study of the prostate is performed, the radiation dose planned and the needles loaded.
WARNING B-w5
Always place the cradle in the ’’locked’’ position before seed implantation. When the cradle is in this position, the matrix on the stepping unit corresponds with the matrix puncture pattern in the transverse plane on the scanner’s monitor.
To superimpose the source matrix on to the monitor, refer to the system user guide for further details.
Before starting source implantation, anchor the prostate to the matrix using thread or needles to prevent it moving during needle placement.
Always place the needles individually, starting at the top of the matrix according to the predetermined sequence.
Using a transverse view of the prostate, advance the needle. Change to the sagittal plane to find the position of the needle on the screen and monitor it during insertion.
When the needle is in place, the radioactive sources can be expelled into the gland. The needle is then removed. The sagittal plane can be used to check the
position of the radioactive sources. Repeat this sequence until implantation is complete. The anchors can then be removed.
Cleaning after Puncture and Biopsy
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.
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.
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.
BK Medical E14CL4b Transducer User Manual – Optimized PDF
BK Medical E14CL4b Transducer User Manual – Original PDF
References
]]>
Introduction
This is the user guide for the N13C5 transducer and it must be used together with the Care and Cleaning user guide which contains important safety information.
Caution Rx-c1
United States law restricts this device to sale by or on the order of a physician.
Intended use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Indications for Use
System Indications for Use
bk3000, bk3500
- Neonatal cephalic imaging
- Pediatric imaging
bk5000
- Intraoperative (neuro) imaging (neurosurgery)
- Neonatal cephalic imaging
- Intraoperative imaging
- Pediatric imaging
N13C5 is also suitable for elastography1. Needle guide UA1345 provides needle guidance for biopsy and drainage (following craniotomy).
Patient Population
The patient population is neonates2 , infants, children, adolescents and adults.
- Use of N13C5 for elastography has not been CE-marked.
- Neonatal cephalic and pediatric imaging only.
Figure 1. N13C5 transducer
Contraindications
WARNING T-w6: To avoid causing injury to the eye, do not use this transducer for ophthalmic use, or any application that causes the acoustic beam to pass through the eye.
General Information:
Product specifications, acoustic output data and data about EMC (electromagnetic compatibility) for this transducer can be found in the Product Data Sheet and the Technical Data (BZ2100) that accompany this user guide.
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 service 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 AO-w3: To reduce the risk of thermal damage to tissues, be sure to keep the acoustic output as low as possible when you expose the head, brain, or spine of any neonate or fetus to diagnostic ultrasound.
Service and Repair
WARNING SR-w1: Service and repair of BK 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.
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, following the procedure in Care and Cleaning. It should also be checked thoroughly once a month following the same procedure.
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.
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.
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
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.
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).
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
BK recommends the use of a sterile transducer cover to reduce the risk of crosscontamination. See the Product Data Sheet for a list of available transducer covers. Follow local guidelines for the use of transducer covers in your area.
NOTE: In the United States of America, it is recommended to use transducer covers that have been market cleared. In Canada, use only licensed transducer covers. In Europe, transducer covers must be CE-marked.
Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile water. This improves screen imaging by preventing image artifacts caused by air bubbles.
Pull the transducer cover over the transducer. Check for air bubbles between the cover and the transducer and even out if necessary before proceeding.
For Intraoperative Applications:
- Irrigate the organ to be imaged with 0.9% sterile physiological saline solution while imaging.
For Surface Use:
- Gel also creates a good acoustic contact between the skin and the transducer: Therefor, apply a small amount to the outside of the cover prior to imaging and reapply frequently.
Follow these precautions when putting sterile covers on a transducer:
- Wear sterile gloves.
- When using a puncture attachment, place it gently over the cover and secure it, following the instructions for the puncture attachment.
- Verify that the cover has not been damaged in the process. If it has, repeat the procedure with a new transducer cover.
Using the Transducer Control Button
The control button on the transducer controls the imaging.
Press the button to Start or Stop imaging (freeze frame). Press the button for more than one second to make a copy of the image.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system user guide for instructions.
Neurosurgical Imaging with N13C5
WARNING C-J-w1: Do not use a transducer for neurosurgical applications if the patient is suspected of having Creutzfeldt-Jakob disease. If a neurosurgical transducer has been used on a patient suspected of or diagnosed as being Creutzfeldt-Jakob positive, the transducer must be destroyed, following approved procedures for your hospital.
WARNING TC-w5: If the transducer cover is damaged during interventional procedures, follow the policies of the hospital or clinic for treatment of the patient under such circumstances.
Puncture and Biopsy Facilities
The N13C5 transducer can be used for puncture and biopsy. The appropriate puncture attachments are illustrated on the following pages with a brief description of their use and operating instructions.
Single-Use Needle Guide UA1345 for N13C5
Needle guide UA1345 is supplied sterile in peel packs and is for single-use only.
Contents are sterile only if the package is intact. The needle guide, inserts, and palettes must be discarded after use.
WARNING Sterile-w1: Single-use 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-w2: 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.
The sterile-packed needle guide must be stored at a temperature range from +5 ºC (+41 ºF) to +25 ºC (+77 ºF) and a storage humidity of 0% to 80%.
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.
Figure 2. Two needle-guide insert palettes together with needle guide UA1345.
Figure 3. Needle Guide UA1345 for N13C5; the numbered steps refer to the procedure on the following pages describing how to mount the needle guide.
Single-use Needle Guide UA1345 (see Figure 3) is for use with N13C5 and is supplied together with two needle guide insert palettes (see Figure 2). Each palette contains a set of 9 needle guide inserts; one palette with 3-angle inserts and one palette with free-angle inserts.
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 N13C5.
The free-angle inserts are slotted to allow positioning of the needle at any angle between 25° and 65° to the image axis of N13C5 while making sure that the needle follows the plane of the image.
Puncture lines indicate expected needle path
The puncture line on the scan image is an indication of the expected needle path (see Figure 7). The distance from the guide channel entrance of the puncture attachment to the first dot on the scan image puncture line is approximately 7.5 mm (0.3 in) for 25°, 12 mm (0.5 in) for 45°, and 19 mm (0.7 in) for 65°. The distance between the dots is 5 mm (0.2 in).
Assembling and Mounting the Needle Guide
To assemble and mount a needle guide on N13C5:
- Apply a small amount of imaging gel to the tip of the transducer and carefully cover the transducer with a sterile cover.
- Select the required needle guide insert by breaking it off the palette (see Figure 2).
- Find the wedge-shaped channel in the needle guide, and slide the insert into the channel in the needle guide until it clicks into place and aligns with the needle guide.
- Hold the assembled needle guide with the bracket pointing down.
- Align the two grooves on the transducer with the two ridges on the needle guide.
- Carefully smooth and stretch the transducer cover along the face of the array and apply pressure until the needle guide clicks into place over the end of the transducer. Figure 4 below shows the needle guide mounted on the transducer.
Figure 4. UA1345 mounted on N13C5(
shown here without transducer cover). - Carefully insert the needle into the needle channel.
Attaching N13C5 and UA1345 to a LEYLA Arm
Needle guide UA1345 (for use with N13C5) has a tab that can be used to secure it to a LEYLA arm (see Figure 5).
Figure 5. N13C5 transducer with needle guide can be attached to a LEYLA arm.
NOTE: Ensure that the transducer cable is secured so that it cannot move and pull the transducer out of position.
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.
How to release the needle guide on N13C5 :
- Hold the transducer with your left hand. With your right hand, carefully push the needle guide insert sideways until it opens up (see Figure 6).
Figure 6. Push to release the needle guide on the N13C5.
- Carefully move the transducer and needle guide away from the needle.
Performing Puncture and Biopsy
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 Puncture or Biopsy control on the system to superimpose a puncture line on the scan image.
If more than one puncture line is available, refer to the applicable system 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 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 TC-w5: If the transducer cover is damaged during interventional procedures, follow the policies of the hospital or clinic for treatment of the patient under such circumstances.
To remove the puncture line from the scan image, refer to the applicable system user guide for instructions.
WARNING P-w5: Avoid unnecessary tissue damage. When performing a biopsy, always make sure that the needle is fully drawn back inside the needle guide before moving the probe.
Figure 7. Illustration of the puncture lines for single-use needle guide UA1345 when mounted on N13C5 transducer. You must take extra care whentaking a free-angle biopsy because the expected needle path is not shown on the screen image.
Cleaning after Puncture and Biopsy
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.
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.
BK Medical N13CP Transducer User Manual – Optimized PDF
BK Medical N13CP Transducer User Manual – Original PDF
References
]]>
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 44528100 / Fax:+45 44528199
www.bkmedical.com
Email: [email protected]
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
Introduction
This is the user guide for the T7P2m1 transducer and it must be used together with the Care and Cleaning user guide which contains important safety information.
Caution Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.
Intended Use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications for Use
T7P2m is suitable for transesophageal imaging of the heart.
Patient Population
The patient population is adults.
Caution T-c2
The tip of the transducer is very delicate. Handle the transducer gently, especially when you put it down on a hard surface, for example. Also, be careful not to bump the tip.
Figure 1. T7P2m transducer
1. T7P2m has not been licensed by Health Canada for use on the bk5000.
Considerations and Contraindications
Transesophageal or transgastric echocardiograms produce clinical data that are unavailable from any other view, but there are some considerations as to which patients you should use the T7P2m for. First of all, the ability of a patient to swallow or accommodate the transducer, but all gastroesophageal diseases or abnormalities must be considered as well.
Contraindications
- Esophageal spasm
- Esophageal stricture
- Esophageal laceration
- Esophageal perforation
- Esophageal diverticula (e.g. Zenker’s diverticulum)
- Esophageal stent
- Carcinoma of the esophagus or pharynx
- Previous esophageal surgery
- Esophageal varices
- Pharyngeal pouch
- Intra-aortic balloon pump
- Coarctation of the aorta
- Severe coagulopathy
- Large diaphragmatic hernia may significantly hinder TEE imaging because of lack of transducer mucosal approximation.
- Atlantoaxial disease and severe generalized cervical arthritis: TEE should never be performed if there is any question about stability of cervical spine.
- Patients who received extensive radiation to the mediastinum: this can cause significant difficulty in probe manipulation within the esophagus and is a relative contraindication if the anatomy of the esophagus is not known.
- Upper gastrointestinal bleeding significant dysphagia and odynphagia are also relative contraindications.
NOTE: These contraindications are typical examples of what the examining
physician must consider before the examination. The list is not all-inclusive.
WARNING Cardio-w2
To avoid patient injury, always remove the transducer from the patient before applying a defibrillator.
General Information
Product specifications, acoustic output data and data about EMC (electromagnetic compatibility) for this transducer can be found in the Product Data Sheet and the Technical Data (BZ2100) that accompany this user guide.
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 service 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.
Service and Repair
WARNING SR-w1
Service and repair of BK 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.
Caring for the Transducer
The transducer may be damaged during use or reprocessing, so it must be checked before use for cracks, irregularities, or bite-marks in the surface, following the procedure in Care and Cleaning. It should also be checked thoroughly once a month following the same procedure.
Note that the hard plastic section at the distal end of the transducer should be smooth and firmly attached to the gastroscope shaft.
Caution T-c9
Never manually deflect the tip of the transducer, use only the control wheels. Do not kink, tightly coil or apply excessive force to the transducer cable or shaft. This might lead to insulation failure.
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.
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.
Before You Start Imaging
Check the proper mechanical operation of the transducer. Rotate the scan plane with the push-buttons on the handle (see “Transducer Scan Plane” on page 13). Make sure that the rotation is smooth for all scan planes.
Move the tip both left/right and up/down using the control wheels on the handle (see “Using the Transducer Control Wheels” on page 9). Make sure that movement operates smoothly and that you are familiar with the operation of the flexible tip before you use it on a patient.
Before use, all equipment must be reprocessed according to expected use.
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.
Caution T-c10
Never spray or rub the tip of the transducer with an anesthetic agent. This could damage the transducer
Starting Imaging
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 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 ultrasound systems.
- Do not use BK transducers with other manufacturers’ systems.
- Do not use unauthorized combinations of transducers and needle guides.
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
WARNING TC-w9
To avoid patient injury, always use a transducer cover
BK recommends the use of a sterile transducer cover to reduce the risk of crosscontamination. See the Product Data Sheet for a list of available transducer covers. Follow local guidelines for the use of transducer covers in your area.
NOTE: In the United States of America, it is recommended to use transducer covers that have been market cleared. In Canada, use only licensed transducer covers. In Europe, transducer covers must be CE-marked.
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 their latex-sensitive patients and be prepared to treat allergic reactions promptly.
Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile water. This improves screen imaging by preventing image artifacts caused by air bubbles.
Follow these precautions when putting sterile covers on a transducer:
- Wear sterile gloves.
- Verify that the cover has not been damaged in the process. If it has, repeat the procedure with a new transducer cover.
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.
Using a Bite Guard
Place the bite guard in the patient’s mouth before inserting the transducer. The bite guard can also be placed on the transducer so that after the insertion, the bite guard can easily be placed in the patient’s mouth.
WARNING T-w10
Always use a bite guard. Failure to use the bite guard may result in damage to the transducer and thereby a risk of patient injury.
Patient Temperature
The patient temperature is set at 37°C (98.6°F) as a default. If the patient has a temperature greater than this, manually enter that temperature on the system. Otherwise, the temperature of the transducer tip may be inaccurately calculated.
WARNING Exam-w6
To avoid patient injury, make sure to enter the correct patient core temperature into the system. An incorrectly entered patient temperature may result in esophageal discomfort.
Adjusting Patient Temperature
bk3000 and bk5000 Ultrasound Systems:
- Start the Exam.
- Click Patient Temp on the image tab.
- Adjust the patient temperature using the scale button.
- Click to set the temperature.
Figure 2. Patient Temp scale button
The patient temperature will be displayed in the image data at the top of the monitor to the left of the ultrasound image just above transducer temperature.
Figure 3. Patient Temperature in image data
bk3500 Ultrasound System:
- Start the Exam.
- Tap Patient Temperature on the touch screen.
- Adjust the patient temperature using the related dial.
The patient temperature will be displayed in the image data on the system monitor, just above the transducer temperature.
Transducer Temperature
The temperature of the tip is monitored by the system, and is displayed in the image data on the system monitor. If the temperature passes 41°C (105.8°F), the position indicator turns yellow, and a message is displayed telling you that the temperature in the transducer is elevated, you should freeze the image and wait for the temperature to come down. But also to check the patient temperature to make sure that the right temperature is entered in the system.
Figure 4. Position indicator turns yellow at temperature above 41°C on bk5000
Should the temperature reach 43°C (109.4°F), an alarm will sound and the freeze function is activated. A message is displayed to tell you that scanning is frozen. The position indicator will turn red.
Figure 5. Position indicator turns red at temperature above 43°C on bk5000
When the transducer temperature falls to 42°C, scanning will resume.
Operation of the Flexible Tip
WARNING T-w11
Avoid violent manipulations and excessive force when using the transducer, as this can result in patient injury.
Transducer Controls
The flexible tip is controlled by:
- 2 wheels for the orientation of the flexible tip, placed on top of the transducer handle.
- 2 lock switches to manage the action of the control wheels. These 2 switches are located beneath the control wheels on the side of the transducer handle.
- 2 push buttons to control the scan plane rotation, clockwise and counterclockwise respectively.
Using the Transducer Control Wheels
The control handle is designed for one-handed operation. Thumb, index finger and middle fingers control the 4-way control wheels, locking switches and scan plane rotation push buttons.
The top wheel controls the left/right motion of the flexible tip. The bottom wheel controls the up/down motion of the flexible tip. The action of the wheels can be switched between a smooth continuous action and a more restrained action where the tip is locked between movements of the wheel.
Each wheel has a separate lock switch that controls its action, and these switches are used independently.
Neutral Position is when the tip is in zero position (see Fig. 10) and the movement of the tip is not locked.
Figure 6. Control handle of the T7P2m (array to the left, cable to the right).
Adjustment of the Flexible Tip
The flexible tip of the transducer can be adjusted through an angle of 120° upwards, 90° downwards and 45° to the left and right. See Fig. 7 and Fig. 8.
The position of the tip is adjusted by the control wheels on top of the transducer handle.
Figure 7. Movement of the T7P2m flexible tip. Up and down.
Figure 8. Movement of the T7P2m flexible tip. Right and left.
WARNING T-w8
To avoid patient injury and risk of ‘buckling’ or ‘U-turning’ in the esophagus, ensure that the maximum movement of the tip is 90° to 120° upwards, 60° to 90° downwards and 30° to 45° left and right before inserting the transducer. If movement exceeds the maximum angles given above, do not use the transducer. Contact your BK service representative to have the steering of the transducer readjusted.
Lock Switches
The lock switches are located beneath the control wheels on the side of the transducer handle. See Fig. 9. Push the button on the right side (back) of the transducer handle to activate the lock switch, and on the left side (front) to deactivate it.
Figure 9. Lock switches front (press to deactivate) and back (press to activate).
WARNING T-w9
To avoid patient injury, unlock the control wheels and set them in zero position when inserting or withdrawing the transducer.
Zero Position
Figure 10. Control wheels zero position
Both control wheels have a zero position. This position is indicated by a line on the control wheel and transducer handle, and a slight click when these lines are aligned. When both wheels are adjusted to the zero position, the tip of the transducer will be in the straight, non-adjusted, zero position.
Transducer Scan Plane
The transducer scan plane can be rotated from 0° (transversal plane) via 90°
(longitudinal plane) to 180° (transversal plane, left/right inverted). You can also chose any plane in between. This makes it possible to scan a conical imaging volume.
Figure 11. Transducer scan plane.
The current rotation angle is displayed in the top left corner of the image on the monitor:
Figure 12. Scan plane rotation angle on the system monitor.
WARNING PN-w1
To avoid pressure necrosis, remove the tip from the esophagus wall when you are not imaging. Do this by releasing the tip to the neutral position.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system user guide for instructions.
Cleaning after Use
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.
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.
BK Medical T7P2m Transducer User Manual – Optimized PDF
BK Medical T7P2m Transducer User Manual – Original PDF