BK Medical 6C2 Transducer User Guide

User Guide
6C2 Transducer
16-01268-EN-03
July 2015
For Professional Users Only
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 44528100 / Fax:+45 44528199
www.bkultrasound.com
Email: [email protected]
The serial number label on a BK Medical product contains information about the year of
manufacture.
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.
If you have comments about the user documentation, please write to us at the email address above.
We would like to hear from you.
6C2 = Ref. Type 9040
© 2015 BK Medical
Information in this document may be subject to change without notice.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Attachment UA1250 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Puncture Attachment UA1341 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Performing Puncture and Biopsy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
RF Ablation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Cleaning after Puncture and Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
English source version
16-01268-EN-03
3
4
Introduction
This is the user guide for the 6C2 transducer1, and it must be used together with the
Care and Cleaning user guide which contains important safety information.
Caution Rx-c1
Physicians
only
Federal law in North America restricts this device to sale to, 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
6C2 is suitable for abdominal imaging, fetal imaging, musculoskeletal
(conventional) imaging, obstetric examinations, and bladder and kidney studies. It is
also suitable for contrast imaging2.
Patient Population
The patient population is adults, adolescents, children and infants.
Fig. 1. 6C2 transducer
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.
1. 6C2 has not been licensed by Health Canada.
2. In the USA, contrast-enhanced ultrasound has not been market cleared by the FDA, with the
exception of only select cardiac imaging applications.
6C2 User Guide (16-01268-EN-03)
Introduction
5
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.
Service and Repair
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 electrical engineer 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.
6
July 2015
6C2 User Guide (16-01268-EN-03)
WARNING Reproc-w2
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.
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-w4
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.
• Do not use other manufacturers’ puncture attachments with BK Medical transducers.
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.
6C2 User Guide (16-01268-EN-03)
Starting Imaging
7
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 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.
The transducer makes a “beep” sound each time you press the button.
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Puncture and Biopsy Facilities
Puncture and biopsy are possible with the 6C2 transducer. The puncture attachment
is illustrated on the following pages with a brief description of its use and operating
instructions.
8
July 2015
6C2 User Guide (16-01268-EN-03)
Puncture Attachment UA1250
The puncture attachment (see Fig. 2) comprises an attachment bracket, an attachment
lock screw (item A in Fig. 2), a needle guide, a needle-guide lock screw (item B in
Fig. 2) and a variable diameter holder for fine needles (0.6mm or 24 gauge) and large
bore needles (2.4mm or 13 gauge). The guide channel is angled at 18 to the
transducer’s image axis.
B
A
Figure 2. Puncture attachment UA1250
To mount UA1250:
Note: When mounted the attachment lock screw (item A in Fig. 2) should be on the
side of the transducer handle opposite to the transducer’s control button.
1 Mount the attachment bracket on the transducer. Fit the indentations in the sides
of the bracket over the raised metal knobs on either side of the transducer handle.
2 Fix the attachment bracket in position by tightening the attachment lock screw
(item A in Fig. 2). Tighten the screw up to its “locking point”, after which it will
not be possible to tighten the screw anymore.
3 The biopsy attachment should now be fixed solidly to the transducer’s handle.
4 Using the needle guide locking screw (item B in Fig. 2), adjust the needle guide
according to the size of needle to be used.
The distance from the guide channel entrance of the puncture attachment to the first
dot on the scan image puncture line is 56mm. The distance between the dots is 10
mm (see Fig. 7).
Fig. 3. Puncture attachment UA1250 mounted on 6C2
6C2 User Guide (16-01268-EN-03)
Puncture and Biopsy Facilities
9
All parts of the puncture attachment can be autoclaved or disinfected by immersion
in a suitable solution.
Puncture Attachment UA1341
Sterile Ultra-Pro 3™ is supplied sterile in peel packs and is for single-use only.
Contents are sterile only if the package is intact. The needle guides 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
• Packaged 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 +15 ºC
(+57 ºF) to +25 ºC (+77 ºF) and a storage humidity of 30% 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.
UA1341 is a puncture attachment kit which comprises a reusable plastic
bracket (UA1341) and sterile, single-use needle guides (UA0013). Be careful
not to discard the reusable bracket together with the single-use needle guides.
The bracket can be disinfected by immersion in a suitable solution. See Care
and Cleaning that accompanies this user guide.
To mount puncture attachment UA1341 ready for use:
1 Attach the bracket (UA1341) to the transducer.
2 Pull a transducer cover over the transducer and bracket.
3 Attach insert onto needle guide (UA0013).
4 Attach and lock the needle guide to the bracket.
5 Activate the needle guide quick-release.
10
July 2015
6C2 User Guide (16-01268-EN-03)
UA1341
UA0013
Figure 4. UA1341 and needle guide UA0013
Please consult the Reference Guide that accompanies the single-use needle guides
for more detailed instructions on how to assemble the puncture attachment and
needle guides.
Figure 5. Puncture is possible at an insertion angle of 18º (left) or a wider insertion angle 36.5º
(right). Shown here without transducer cover
Bracket
Needle Guide
Figure 6. 6C2 with single-use needle guide (UA0013) attached
6C2 User Guide (16-01268-EN-03)
Puncture and Biopsy Facilities
11
Performing Puncture and Biopsy
WARNING P-w1
Before you start imaging, verify that the type number of the transducer and the type
number or description of the puncture attachment you are using match the number
displayed on the monitor. If they do not match, 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 local BK Medical 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.
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.
WARNING TC-w5
If the 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 transducer.
12
July 2015
6C2 User Guide (16-01268-EN-03)
UA1250
UA1341
Figure 7. Puncture lines for UA1250 and UA1341
RF Ablation
When performing RF ablation, you must always follow the instructions provided by
the manufacturer of the RF 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 RF needle into the patient and before you energize the needle.
If you use metal needle guides to guide RF 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.
WARNING RF-w1
Carefully examine the RF 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 RF needle.
6C2 User Guide (16-01268-EN-03)
Performing Puncture and Biopsy
13
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.
If pre- and thorough cleaning cannot be done immediately, keep the device moist until
cleaning.
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 contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department, or hospital.
14
July 2015
6C2 User Guide (16-01268-EN-03)