16-01463-EN-07
February 2020
For Professional Users Only
T7P2m Transducer
T7P2m = Ref. Type 9027
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.
© 2020 BK Medical
Information in this document may be subject to change without notice.
1
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Patient Population. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Considerations and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Before You Start Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using a Bite Guard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Patient Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Transducer Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operation of the Flexible Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Transducer Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Cleaning after Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
English source version
16-01463-EN-07
2
T7P2m User Guide
(16-01463-EN-07)
3
Introduction
This is the user guide for the T7P2m
1
transducer and it must be used together with
the
Care and Cleaning
user guide which contains important safety information.
Intended Use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis
of the human body.
Indications for Use
T7P2m is suitable for transesophageal imaging of the heart.
Patient Population
The patient population is adults.
Figure 1. T7P2m transducer
1. T7P2m has not been licensed by Health Canada for use on the bk5000.
Physicians
only
Caution
Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.
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.
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February 2020
T7P2m User Guide
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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.
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
Cardio-w2
To avoid patient injury, always remove the transducer from the patient before applying a
defibrillator.
T7P2m User Guide
(16-01463-EN-07)
5
Service and Repair
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.
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
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
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.
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
.
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February 2020
T7P2m User Guide
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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.
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
Reproc-w2
Users of this equipment have an obligation and responsibility to provide the highest
possible degree of infection control to patients, co-workers and themselves. The
instructions in this book are meant as a guide. To avoid cross-contamination, follow all
infection control policies (including for reprocessing, packing and storage) for personnel
and equipment that have been established for your office, department or hospital.
WARNING
T-w5
To prevent electrical shock and damage to the transducer, the connector pins in the
transducer plug must always be completely dry before you connect to a system.
Caution
T-c10
Never spray or rub the tip of the transducer with an anesthetic agent. This could damage
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 needle guides.
T7P2m User Guide
(16-01463-EN-07)
7
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 cross-
contamination. 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.
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.
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
TC-w9
To avoid patient injury, always use a transducer cover.
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.
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.
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.
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February 2020
T7P2m User Guide
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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.
Adjusting Patient Temperature
bk3000 and bk5000 Ultrasound Systems:
1
Start the Exam.
2
Click
Patient Temp
on the image tab.
3
Adjust the patient temperature using the scale button.
4
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:
1
Start the Exam.
2
Tap
Patient Temperature
on the touch screen.
3
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.
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.
T7P2m User Guide
(16-01463-EN-07)
9
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
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 counter-
clockwise 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.
WARNING
T-w11
Avoid violent manipulations and excessive force when using the transducer, as this can
result in patient injury.
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February 2020
T7P2m User Guide
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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.
Left/Right
Up/Down
Scanning plane rotates
clockwise
Scanning plane rotates
counter-clockwise
Lock switch for Left/Right
Lock switch for
Up/Down
T7P2m User Guide
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11
Figure 7. Movement of the T7P2m flexible tip. Up and down.
Figure 8. Movement of the T7P2m flexible tip. Right and left.
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.
Up
Down
Zero
position
Right
Left
Zero
position
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.
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February 2020
T7P2m User Guide
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Figure 9. Lock switches front (press to deactivate) and back (press to activate).
Zero Position
Figure 10. Control wheels zero position
Lock switch Left/Right
Lock switch Up/Down
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
T7P2m User Guide
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13
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
.
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February 2020
T7P2m User Guide
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Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Cleaning after Use
Use a suitable brush to make sure that biological material and gel are removed from
all channels and grooves. See
Care and Cleaning
for cleaning instructions.
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
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.
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.
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