TEEx Transducer
User Guide
c
0086
TEEx Transducer
User Guide
SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021
USA
T: 1-888-482-9449 or 1-425-951-1200
F: 1-425-951-1201
SonoSite Ltd
Alexander House
40A Wilbury Way
Hitchin
Herts SG4 OAP
UK
T: +44-1462-444800
F: +44-1462-444801
Caution:
Federal (United States) law restricts this device to sale by or on the order of a physician.
M-Turbo, MicroMaxx, S Series, SonoSite, and the SonoSite logo are trademarks or registered trademarks of SonoSite, Inc.
Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.
The SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents: 5722412,
5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630,
6817982, 6835177, 6962566, 7169108, 7449640, 7534211, 7549961, 7588541, 7591786, 7604596, 7643040, D456509, D461895, D509900,
D538432, D544962, D558351, D559390, D591423, D592750, D592760, and by the following counterpart foreign patents: AU727381,
AU730822, CA2372158, CA2373065, CN ZL 97113678.5, CN ZL 98106133.8, CN ZL 98108973.9, CN ZL 200830007734.8, DE60021552.0,
DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, DE60 2004 23 816.3-08, FR0815793, FR0875203, FR0881492,
FR1175713, FR1180970, FR1589878, GB0875203, GB0881492, GB1175713, GB1180970, GB1180971, GB1589878, IT0815793, IT0881492,
IT1175713, IT1589878, KR528102, KR532359, NO326202, NO326814, NZ542968, RCD000897368-0001, SP0815793, SP0881492,
SP1589878. Patents pending.
P05341-03 03/2010
Copyright 2010 by SonoSite, Inc.
All rights reserved.
ii
Contents
Chapter 1: Overview
About the user guide ................................................................................................... 1
Conventions ........................................................................................................... 1
About the TEEx transducer ........................................................................................ 1
Intended uses ................................................................................................................. 2
Contraindications .......................................................................................................... 3
Warranty statement ...................................................................................................... 3
Technical Support ......................................................................................................... 3
Chapter 2: Getting Started
Unpacking ........................................................................................................................ 5
Inspecting contents ...................................................................................................... 6
Transducer and system interface ............................................................................. 7
TEEx transducer controls ............................................................................................ 8
Tip deflection ......................................................................................................... 8
Tip deflection brake ...........................................................................................10
Scanplane rotation ............................................................................................11
Chapter 3: Examination
Pre-exam inspection ..................................................................................................13
Precautions ....................................................................................................................14
Bite guard ..............................................................................................................14
Sterile sheath .......................................................................................................15
Emergency retraction ................................................................................................15
Chapter 4: Cleaning, Disinfecting, and Storing
Cleaning and disinfecting ........................................................................................17
Storing .............................................................................................................................18
Transducer ............................................................................................................18
Tip cover ................................................................................................................18
Shipping .........................................................................................................................19
Disposal ...........................................................................................................................19
Chapter 5: Safety
Standards compliance ...............................................................................................21
Annual inspection .......................................................................................................21
Safe operational use ...................................................................................................22
Thermal safety ..............................................................................................................23
Thermal limits ......................................................................................................23
Reducing temperature .....................................................................................23
Temperature calibration test ..........................................................................23
iii
Electrical safety ............................................................................................................ 24
Electrical leakage current test ....................................................................... 24
Bite-hole detection ..................................................................................................... 25
Acoustic output ........................................................................................................... 26
Chapter 6: Transducer Specifications
TEEx/8-3 MHz transducer ......................................................................................... 27
iv
Chapter 1: Overview
Overview
Please read this user guide before using the transesophageal echocardiogram (TEEx/8-3 MHz or
TEEx) transducer for the SonoSite® M-Turbo®, S Series™, or MicroMaxx® ultrasound system.
About the user guide
This user guide provides information on the TEEx transducer. It is designed for a reader familiar with
ultrasound and proper endoscopic techniques; it does not provide training in sonography,
cardiology, or clinical practices. For information about the ultrasound system, see its user guide and
other appropriate literature.
To aid in safeguarding the patient and ensuring reliable transducer operation, SonoSite recommends
having this user guide available for reference during all stages of TEEx transducer handling.
Conventions
The user guide follows these conventions:
• A WARNING describes precautions necessary to prevent injury or loss of life.
• A Caution describes precautions necessary to protect the products.
• Numbered steps in procedures must be performed in order.
• Single-step procedures begin with .
• Items in bulleted lists do not require performance in sequence.
For labeling symbols used, see the ultrasound system user guide.
About the TEEx transducer
WARNING:
To avoid injury to a patient, the TEEx transducer is intended for use by a licensed
physician who has received appropriate training in endoscopic techniques as
dictated by current relevant medical practices, as well as in proper operation of the
ultrasound system and transducer.
Caution:
To avoid inadvertent damage to the transducer, read this user guide before handling
and cleaning the TEEx transducer.
The TEEx transducer is an electronically steered phased array ultrasound transducer assembly,
mounted in a sealed tip at the end of a conventional endoscope.
The TEEx transducer is used to generate a set of ultrasound images or slices within a cone from the
same position in the esophagus. The rotation of the scanplane is driven by a motor in the control
handle.
Chapter 1: Overview
1
For orientation purposes, you may choose to start scanning in one of the transverse planes--for
example, the standard monoplane indicated as 0° on the system screen. After rotating the scanplane
90°, scanning occurs in the longitudinal plane, sweeping through two opposite quadrants of the
cone. When the scanplane rotates 90° farther in the same direction, scanning occurs in the mirror
image of the first transverse plane. The only two planes that are equivalent are the two transverse
planes, one being the mirror image of the other. As shown in Figure 1, a 180° rotation of the scanplane
fills all four quadrants of the conic imaging volume.
The direction of the tip of the endoscope is easily steered using the deflection control wheels on the
handle of the transducer to allow exact positioning of the transducer in the esophagus.
1
4
2
5
3
Figure 1 Multiplane Imaging
1
90° rotation sagittal to mirror image of transverse plane
2
90° rotation transverse to longitudinal plane
3
Conic imaging volume
4
Quadrants filled by first 90° rotation
5
Quadrants filled by second 90° rotation
Intended uses
The TEEx transducer is designed for 2D, M Mode, color Doppler (Color), pulsed wave (PW) Doppler,
and continuous wave (CW) Doppler imaging by applying ultrasound energy through the esophagus
or stomach of the patient into the heart. The TEEx transducer is intended to be used on adults only.
Backscattered ultrasound energy from the patient’s heart forms images of the heart to detect
abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and
to obtain a color depiction of the velocities of blood flowing in the heart.
2
Chapter 1: Overview
Contraindications
Overview
WARNING:
The physician must consider all possible factors before starting the examination.
Contraindications for using the TEEx transducer:
• Fetal imaging
• Pediatric imaging
• Imaging when the patient exhibits the following or similar conditions:
• Esophageal stricture, spasms, lacerations, and trouble swallowing (dysphagia)
• Esophageal diverticula, esophageal varices (swollen veins)
• Gastrointestinal bleeding
• Peptic ulcers, hiatal hernia, esophageal webs and rings
• Recent radiation treatment to the esophagus
• Inability to swallow or accommodate the transducer
• History of gastroesophageal diseases
Warranty statement
The TEEx transducer is warranted for material and workmanship only, for a period of 12 months from
date of shipment from SonoSite.
The warranty does not cover damage caused by patient bite, misuse by the end user, disinfecting or
sterilizing incorrectly or with chemicals not recommended by SonoSite, or circumstances beyond
what is considered normal for the product’s intended application.
Technical Support
To order sheaths, biteguards, tip covers, and other supplies, see www.civco.com.
For technical support, contact SonoSite as follows.
SonoSite Technical Support
Phone
(US or Canada):
877-657-8118
(Outside US and
Canada):
425-951-1330
Or call your representative.
Fax:
425-951-6700
E-mail:
service@sonosite.com
Web site:
www.sonosite.com
Click Support
Chapter 1: Overview
3
Europe Service Center
Phone:
+44-(0)1462-444-800
E-mail:
uk.service@sonosite.com
Japan Service Center
4
Phone:
+81-3-5304-5337
E-mail:
sonositejapan@sonosite.com
Chapter 1: Overview
Chapter 2: Getting Started
It is important to establish and use a check-out procedure to ensure that the transducer is safe to use
and functions properly prior to each use. If you observe or suspect any irregularity, substandard
functioning or unsafe condition, do not use the TEEx transducer. Call SonoSite or your local
representative immediately.
Getting Started
Unpacking
Proper care and maintenance are essential. Follow the unpacking procedures. Contact SonoSite or
your local representative immediately to report any damage or discrepancies.
WARNING:
Unpack
To avoid injury to patient/operator, carefully inspect all equipment after receipt and
prior to each use.
1
2
3
Visually examine the shipping box, shipping case, and the TEEx transducer for
any damage.
Note any breakage or other apparent damage, retain the evidence, and notify
the carrier or shipping agency.
Verify that the shipping case contains the components listed on the packing list:
• TEEx transducer
• TEEx Transducer User Guide
• TEEx Transducer Care
• Bite guards (3)
• Non-sterile tip covers (3)
Chapter 2: Getting Started
5
Tip covers (3)
Bite guards (3)
TEEx transducer
Figure 1 Shipping case with TEEx transducer
WARNING:
To avoid injury to patient:
• Proper care and maintenance are essential for safe operation of the TEEx
transducer.
• The examining physician must exercise sound medical judgment in selecting
patients for this transducer.
Caution:
To avoid permanently damaging the transducer’s internal control wires, do not
deflect the transducer tip using finger pressure directly on the tip.
To avoid inadvertent damage to the transducer, read this user guide before handling
and cleaning the TEEx transducer.
Inspecting contents
After unpacking the contents, perform the following on the TEEx transducer:
• Visual and tactile inspection. See “inspect visually and tactilely” on page 8.
• Tip deflection inspection. See “Inspect Tip Deflection” on page 10.
• Brake inspection. See “Inspect Tip Deflection Brake” on page 10.
• Scanplane rotation inspection. See “Inspect Scanplane Rotation” on page 12.
• Leakage test. See “Electrical safety” on page 24.
Contact SonoSite or your local representative immediately to report any damage or discrepancies.
See “Technical Support” on page 3.
WARNING:
6
To avoid injury to the patient, do not use the TEEx transducer if any irregularity,
substandard function or unsafe condition is observed or suspected.
Chapter 2: Getting Started
Transducer and system interface
The TEEx transducer consists of an electronically steered phased array ultrasound transducer
assembly mounted in a sealed tip at the end of a conventional endoscope. It connects to the
ultrasound system with a cable and connector. See Figure 2.
1
Getting Started
11
4
9
5
6
10
2
7
3
8
Figure 2 TEEx transducer:
1
Flexible endoscopic shaft
7
Transducer cable
2
Articulation section
8
Transducer connector
3
Transducer tip with scanhead
9
Scanplane control buttons
4
Deflection brake
10
Attachment ring
5
Deflection control wheels
11
Handle
6
Neutral marker
Chapter 2: Getting Started
7
TEEx transducer controls
The endoscope is designed for one-hand operation of the deflection and scanplane controls. Figure 3
shows the user holding the endoscope handle in the left hand. Thumb and first and second fingers
operate the deflection and scanplane controls.
Check the mechanical operation and physical integrity of the transducer after taking it out of the box
and before each exam.
Figure 3 Transducer in left hand
WARNING:
inspect
visually and
tactilely
To avoid injury to the patient:
• Do not use the TEEx transducer if any irregularity, substandard function or unsafe
condition is observed or suspected.
• Do not use the TEEx transducer if any metallic protrusions, holes, rough spots,
cracks, or dents are found.
You should inspect the TEEx transducer visually and tactilely after taking it out of the
box and before each exam.
1 Visually examine and feel the entire surface of the flexible shaft and deflection
section with the transducer in both straight and deflected position.
2 Examine the transducer tip for any holes or dents.
Tip deflection
The TEEx transducer endoscope has two wheels for controlling the transducer tip deflection.
The wheels control anterior/posterior and left/right tip deflection. Figure 4 shows the deflection
wheels in the neutral (undeflected) position. (There is no brake for left/right deflection.)
The lower wheel has brake and freely-moving modes. In the brake mode, the movement of the
deflection wheel is restrained. This is for holding the tip in a certain position.
Special care should be taken when inserting and removing the transducer.
Caution:
8
To avoid damaging the transducer, do not deflect the distal tip of the transducer by
direct application of force. Use the deflection wheels for this task.
Chapter 2: Getting Started
1
2
3
4
Getting Started
5
6
Figure 4 Deflection controls. For orientation purposes, hold the transducer pointing away with
control wheels up and the flexible shaft in a straight position.
1
Turn upper wheel counterclockwise to move the tip to the left. Movement is 50° (within10°).
2
Turn upper wheel clockwise to move the tip to the right. Movement is 50° (within10°).
3
Turn lower wheel counterclockwise to move the tip posterior. Movement is 50° (within10°).
4
Turn lower wheel clockwise to move the tip anterior. Movement is 125° (within 5°).
5
Lower deflection control wheel
6
Upper deflection control wheel
WARNING:
To avoid injury to the patient, if you observe a sharp “U-turn” of the transducer tip
during the tip deflection inspection (that is, the transducer tip angle exceeds the
maximum deflection angles given above), do not use the transducer.
Chapter 2: Getting Started
9
Inspect Tip
Deflection
Inspect the tip deflection on the TEEx transducer after taking it out of the box and
before each exam.
1 Deflect the tip in all four directions and confirm that the angle is within the
ranges specified in Figure 2 on page 7 (with reference to the endoscope shaft).
2 Confirm that the deflection controls operate smoothly.
3 Check that when the deflection controls are in the neutral position that the
transducer tip is also in a neutral position (undeflected).
Tip deflection brake
To retain the tip in a deflected position, friction can be applied to the anterior/posterior deflection
control.
The brake for the anterior/posterior deflection is a handle under the deflection wheel (see Figure 5).
There is no brake for the right/left deflection.
1
2
3
4
5
Figure 5 Tip deflection brake operation
1
Transducer tip
4
Neutral position marker
2
Tip control in unlocked position (brake off )
5
Wheel position markers
3
Tip control in locked position (brake on)
Inspect Tip
Deflection
Brake
10
Inspect the tip deflection brake on the transducer after taking it out of the box and
before each exam.
1 Confirm that the brake is in the unlocked position.
2 Deflect the tip to the anterior direction.
3 Move the brake to the locked position.
4 Confirm that the tip is locked in the deflected position.
5 Unlock the brake and confirm that the tip straightens easily.
6 Repeat steps 1-5 for the posterior direction.
Chapter 2: Getting Started
Scanplane rotation
The scanplane rotation is driven by a motor in the transducer handle and is controlled by buttons on
the handle (see Figure 6).
1
Getting Started
2 3 4
Figure 6 Scanplane rotation controls
1
Transducer tip
2
Counterclockwise button (increases angle)
3
Biplane button (rotates angle to orthogonal biplane)
4
Clockwise button (decreases angle)
A scanplane indicator on the system screen shows the orientation. The scanplane angle is indicated
by a marker and a value. See Figure 7. The screen shows the angle relative to the standard monoplane,
displayed as 0°. The scanplane angle ranges from 0° to 180°.
Angle
Marker
Figure 7 Scanplane indicator
Caution:
To avoid damaging the transducer connector, do not allow foreign material in the
connector.
Chapter 2: Getting Started
11
Scanplane
Calibration
1
2
Rotate
scanplane
Press the outer buttons on the transducer handle:
• The button closest to the transducer tip rotates the scanplane
counterclockwise (scanplane angle increases).
• The button farthest from the transducer tip rotates the scanplane clockwise
(scanplane angle decreases).
The scanplane rotates 180° from a standard transverse plane (short axis) to the
longitudinal plane (long axis), ending at the mirror image of the first transverse
plane (short axis). The angular position appears on the system screen. The 0°
short axis reference position is defined as follows: When you view the
transducer through the acoustic window of the transducer tip, the transducer is
in the extreme clockwise position.
Change
Biplane
Press the biplane button (the center button) on the endoscope handle. See
Figure 6.
The scanplane rotates at full speed from the current position to the orthogonal
position. (For example, if the present position is 22°, the scanplane rotates to
112°. If the present position is 162°, the scanplane rotates to 72°.)
Pressing the button again rotates the scanplane back to the original position.
Inspect
Scanplane
Rotation
12
Connect the transducer, and turn on the ultrasound system. (For instructions,
see the ultrasound system user guide.)
A scanplane positioning calibration test automatically begins. This calibration
cycle lasts 5 to 10 seconds. Afterward, the transducer temperature sensor is
activated, and the transducer temperature is displayed, indicating that the
transducer is ready for use.
Press the scanplane rotation buttons.
If the calibration test fails (no response from the scanplane buttons after
calibration), reconnect the transducer to repeat the calibration test.
Inspect the scanplane rotation on the transducer after taking it out of the box and
before each exam.
1 Connect the TEEx transducer to the ultrasound system.
2 Without inserting the transducer, obtain an image. For example, rest the
transducer on a surface and adjust the gain to visualize the image on-screen.
3 Press the scanplane control buttons on the handle to rotate the scanplane
counterclockwise (0° to 180°) and clockwise (180° to 0°). See Figure 6.
4 Confirm that the image on-screen changes in relation to the numbers on the
scanplane indicator. See Figure 7.
While you press the scanplane rotation buttons, the transducer motor should
be running as the image is changing.
Note: Do not rely only on the scanplane indicator on-screen to verify that the
scanplane is rotating.
Chapter 2: Getting Started
Chapter 3: Examination
While echocardiographs from the transesophageal or transgastric position provide important clinical
data not available from any other view, the examining physician must consider a number of
conditions when selecting a patient for safe use of the transducer. The list of contraindications and
considerations do not constitute a complete list of all possible factors the examining physician must
consider before starting the examination. They are presented only as examples. See
“Contraindications” on page 3.
WARNING:
To avoid trauma to the patient’s stomach or esophagus, do not use excessive force
during insertion, positioning, or withdrawal.
To prevent damage to the patient’s esophagus when inserting or withdrawing the
transducer, the control wheel must be in the freely moving, neutral, and un-braked
state. See Figure 5 on page 10.
Exam
Pre-exam inspection
Perform the following before each exam:
• Visual tactile inspection. See “inspect visually and tactilely” on page 8.
• Tip deflection inspection. See “Inspect Tip Deflection” on page 10.
• Brake inspection. See “Inspect Tip Deflection Brake” on page 10.
• Scanplane rotation inspection. See “Inspect Scanplane Rotation” on page 12.
• Leakage test or bite-hole inspection test. See “Electrical leakage current test” on page 24 or
“Bite-hole detection” on page 25.
• Clean and disinfect transducer. See “Cleaning, Disinfecting, and Storing” on page 17.
Contact SonoSite or your local representative to report any damage or discrepancies.See “Technical
Support” on page 3.
WARNING:
To avoid injury to the patient:
• SonoSite recommends performing the above procedures prior to each exam.
• Do not use the transducer if any metallic protrusions, holes, rough spots, cracks, or
dents are found.
• If during the deflection test a sharp “U-turn” of the transducer tip is observed (the
transducer tip angle exceeds the maximum deflection angles), do not use the
transducer. Call SonoSite or your local representative.
Some gels and sterilants can cause an allergic reaction in some individuals.
Chapter 3: Examination
13
Precautions
Techniques for introducing the TEEx transducer into the patient are beyond the scope of the user
guide. There are numerous medical texts and articles that thoroughly address this topic. Observe the
following precautionary measures when conducting an exam.
• Maintaining an unobstructed airway is a prime consideration for all patients.
• Prolonged pressure on the esophagus by the tip of the transducer may lead to a pressure necrosis
condition. Thus, in operating room monitoring applications, the tip should be removed from the
esophagus wall when not scanning, by releasing it in the neutral position. If continuous
monitoring is required, the transducer tip should be repositioned often.
• Long term exposure to ultrasound should be minimized. Although there have never been any
bioeffects demonstrated at the acoustic output levels of the TEEx transducer, it is prudent to
minimize patient exposure to ultrasound according to the principle of ALARA (As Low As
Reasonably Achievable). Please see the ultrasound system user guide.
• In consideration of the above two points, you should freeze the image, which turns off the power
to the transducer, and allow the endoscope deflection controls to be disengaged whenever active
scanning is not desired.
• Proper patient preparation is essential for successful examinations. This includes restrictions on
food and liquid intake as well as a thorough explanation of the examination procedure and other
instructions as the particular situation warrants.
• The use of a bite guard during all TEEx examinations is mandatory to protect the transducer from
possible damage.
• The use of protective gloves during the examination is encouraged. Please see the U.S. Food and
Drug Administration’s Medical Alert on Latex Products (FDA 1991).
• In addition to the high level disinfection, a protective sheath may provide even greater protection
against contamination of the probe. Contact CIVCO for protective sheaths and applicators for
protective sheaths.
Bite guard
Caution:
To avoid damaging the transducer, use a bite guard during all TEEx examinations.
Biting the endoscope may cause severe, permanent damage to the transducer,
making it unsafe for future patient use.
Damage to the transducer from failure to use a bite guard voids the transducer
warranty.
Each TEEx transducer from SonoSite is delivered with three bite guards. Use of a bite guard is
mandatory. Contact a local SonoSite representative if you need help ordering more bite guards.
Re-use, cleaning, and sterilization of the bite guards should be done according to instructions
provided by the manufacturer of the bite guard.
14
Chapter 3: Examination
Figure 1 Bite guard: Side view (left) and front view (right)
Sterile sheath
There are various sterile sheaths available to eliminate direct contact between the patient and the
endoscope. Follow the user instructions for a particular sheath when applying and removing the
sheath from the TEEx transducer. Contact CIVCO to order sterile sheaths and applicators for sterile
sheaths.
Caution:
To provide suitable acoustic coupling within the sheath, SonoSite recommends using a sterile gel.
Install
Transducer
Sheath
Note: SonoSite recommends the use of market-cleared, transducer sheaths for
intracavitary applications. To lessen the risk of contamination, install the sheath only
when you are ready to perform the procedure.
1 Place gel inside the sheath.
2 Insert the transducer into the sheath.
3 Pull the sheath over the transducer and cable until the sheath is fully extended.
4 Secure the sheath using the bands supplied with the sheath.
5 Check for and eliminate bubbles between the footprint of the transducer and
the sheath.
Any bubbles between the footprint of the transducer and the sheath can affect
the ultrasound image.
6 Inspect the sheath to ensure that there are no holes or tears.
Emergency retraction
If the transducer tip should get jammed in a deflected position inside the patient and if all attempts
to release the deflected tip should fail, follow the procedure “Retract Transducer” to assure a safe
retraction of the transducer.
Chapter 3: Examination
15
Exam
To avoid damaging the TEEx transducer, ensure that its tip is straight during
application and removal of the sheath. During removal of the sheath, be careful not
to use excessive force on the transducer tip; otherwise permanent damage to the
TEEx transducer may occur.
Retract
Transducer
16
1
2
Disconnect the transducer from the ultrasound system.
At an accessible location between the transducer handle and the patient, cut
the entire endoscope shaft, including all internal wiring, using heavy duty
cutting pliers or another suitable tool.
The deflection mechanism is now released and the transducer may be safely
retracted.
Chapter 3: Examination
Chapter 4: Cleaning, Disinfecting, and Storing
Cleaning and disinfecting
The TEEx transducer must be cleaned and disinfected before each exam.
In addition to protecting patients and employees from disease transmission, the disinfectant you
choose must be safe for the transducer. SonoSite routinely reviews new medical disinfectants for
compatibility with the transducer housing, cable and lens. For the latest list of compatible
disinfectants, see the TEEx Transducer Care enclosed with the transducer.
Carefully follow the manufacturer’s instructions and recommendations for preparing and using the
solution.
Caution:
To avoid damaging the transducer, do not immerse the system connector or the
transducer handle in any fluid.
DO NOT soak or saturate transducers with solutions containing alcohol, bleach,
ammonium chloride compounds, or hydrogen peroxide.
Clean
Transducer
To avoid injury to the patient, follow the disinfectant manufacturer’s
recommendation for rinsing.
Use only disinfectants that are listed in the TEEx Transducer Care enclosed with the
transducer. In addition, see local and national regulations.
Chapter 4: Cleaning, Disinfecting, and Storing
17
Clean, Disinfect,
and Store
WARNING:
Clean the TEEx transducer immediately after extraction from the patient. Do not
allow bodily fluids to dry on it.
1 Unless using a sheath, do the following:
a Immediately rinse the endoscopic shaft for one minute using a large volume
of fresh, lukewarm water (for example, 8 liters).
If immediate rinsing is impossible, dry the endoscopic shaft with a wipe or
cloth moistened with water.
b Clean the transducer in enzymatic cleaner according to the soak time
indicated. Follow the manufacturer’s instructions, and observe dilution rates.
Use a plastic container or the wall rack tube for enzymatic solution.
2 Rinse the endoscopic shaft for one minute with a large volume of fresh,
lukewarm water to remove residual detergent or gel (for example, 8 liters).
3 Dry the endoscopic shaft with a soft towel.
Caution:
Disinfect
Transducer
To avoid damaging the transducer:
• Do not expose the transducer to the disinfectant longer than specified to achieve
the desired effect and never longer than one hour.
• Do not steam autoclave or Ethylene-Oxide (ETO) sterilize the transducer.
• Do not immerse the transducer in a solution containing ethanol.
1
2
3
Following the manufacturer’s instructions, perform high-level disinfection.
• Observe dilution rate and soak time.
• Immerse the endoscopic shaft into the disinfection fluid with the transducer
handle placed in the wall rack holder.
• Use a wall rack tube for the disinfectant.
Do the following three times: Rinse the endoscope shaft with potable and/or
sterile water for at least one minute (five minutes maximum) with a large
volume of fresh water (for example, 8 liters)
Dry the transducer with a soft towel.
Storing
Transducer
Caution:
Store
Transducer
To avoid damaging the transducer, do not use the shipping case for other than short
term storage or to ship the transducer. When shipping the transducer in the
shipping case, do not allow any part of the transducer to protrude beyond the case.
Never store a moist TEEx transducer in the shipping case.
1
2
3
Clean and disinfect the transducer. See “Cleaning and disinfecting” on page 17.
Thoroughly dry the transducer with a clean cloth.
Store the TEEx transducer in a vertical orientation on a wall rack.
• Avoid direct sunlight and exposure to x-rays. Recommended storage
temperature range: between 0° C and +45° C.
• If using a wall mounted rack for storage, ensure that it is securely mounted
and that the storage slots do not mar the scope and are sized to prevent the
transducer from inadvertently falling.
Tip cover
The tip cover encloses and protects the distal end/scanhead of the endoscope from mechanical strain
and impact during transportation and storage.
Caution:
18
To avoid damaging the transducer, discard the tip cover after use. The tip cover is a
single-use device.
Chapter 4: Cleaning, Disinfecting, and Storing
Shipping
To reduce the risk of spreading diseases, the following safety precautions must be followed carefully.
WARNING:
Shipping temperature range: -40° C to +70° C.
The shipping case in which the TEEx transducer was delivered must never come in
contact with a non-disinfected transducer.
To disinfect a transducer, use the procedure “Disinfect Transducer” on page 18.
Before returning a transducer to SonoSite or your local representative, always
disinfect the transducer. This disinfection must be documented on the “Certificate of
Cleanliness” and attached to the packing list.
Disposal
WARNING: The transducer shall not be destroyed by incinerating or burning. The transducer
connector contains a battery that may explode if exposed to very high temperatures.
Return the transducer to SonoSite or your local SonoSite representative for disposal.
Clean, Disinfect,
and Store
Chapter 4: Cleaning, Disinfecting, and Storing
19
20
Chapter 4: Cleaning, Disinfecting, and Storing
Chapter 5: Safety
Patient safety is ensured only when a well-designed product is used in a safe and responsible manner.
It is important that the user establishes and uses a check-out procedure to ensure that the transducer
is safe to use and functions properly prior to each use. If any irregularity, substandard functioning, or
unsafe condition is observed or suspected, do not use the TEEx transducer. Contact SonoSite or your
local representative immediately.
Standards compliance
The TEEx transducer conforms to the Medical Device Directive 93/42/EEC. It is a class IIA medical
device. Symbols and terms used on the transducer are explained in the ultrasound system user guide.
In addition, the TEEx transducer conforms to the requirements in the following standards.
• CAN/CSA C22.2, No. 601.1-M90:1990, Canadian Standards Association, Medical Electrical
Equipment–Part 1. General Requirements for Safety.
• Medical Device Directive, 93/42/EEC.
• IEC 60601-1:1988 Medical Electrical Equipment-Part1. General Requirements for Safety.
• EN 60601-1: 1990, European Norm, Medical Electrical Equipment-Part1. General Requirements for
Safety.
• IEC 1157/EN61157: 1994, Requirements for declaration of the acoustic output of medical
diagnostic ultrasonic equipment.
• EN 60601-1-2: 2001, Medical Electrical Equipment-Part 2. Collateral standard; Electromagnetic
Compatibility, Requirements and tests.
• EN 60601-2-37: 2001, European Norm, Particular requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment
• UL 60601-1:2003, Underwriters Laboratories Medical Electrical Equipment-Part1. General
Requirements for Safety.
In addition to the regular inspections described elsewhere in this document, perform the following
tests at least annually on the TEEx transducer:
• Temperature calibration test. See “Temperature calibration test” on page 23.
• Leakage current test. See “Electrical leakage current test” on page 24.
Chapter 5: Safety
21
Safety
Annual inspection
Safe operational use
WARNING:
To avoid injury to the patient:
• Consult the medical literature regarding techniques, complications, and hazards
prior to transesophageal procedures. Study this user guide thoroughly prior to
performing a transesophageal procedure.
• The TEEx transducer is intended for use by a licensed physician who has received
appropriate training in endoscopic techniques as dictated by current relevant
medical practices, as well as in proper operation of the ultrasound system and
transducer.
• Check the transducer prior to each use to assure that it is safe to use and functions
properly. If any irregularity, substandard functioning, or unsafe condition is
observed or suspected, do not use the TEEx transducer. Call SonoSite or your local
representative. See “Pre-exam inspection” on page 13.
• If the transducer tip should get jammed in a deflected position inside the patient,
and all attempts to release the deflected tip should fail, follow procedure “Retract
Transducer” on page 16 to assure a safe retraction of the transducer. The deflection
mechanism is designed to provide safe operation during normal use.
• Perform a bite hole inspection test on the transducer at the end of each
disinfecting period or before each exam. See “Bite-hole detection” on page 25.
• Do not use conventional coupling gel intended for external use.
• Avoid forceful intubation pressure which can cause lacerations or perforation of
the gastrointestinal tract.
• Remove the transducer from the patient when using a defibrillator.
• SonoSite recommends cleaning and disinfecting transducers after each use. See
Chapter 4, “Cleaning, Disinfecting, and Storing.”
To avoid injury to the patient and damage to the transducer, use a bite guard during
all transesophageal exams.
To maintain proper level of sterility, the use of a protective sheath in addition to the
high level disinfection, may provide the proper level of protection against
contamination of the transducer.
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. See 21 CFR 801.437, User labeling for devices
that contain natural rubber.
Caution:
To avoid damaging the equipment, clean and disinfect the transducer using the
recommended procedures only.
To avoid damaging the transducer, the TEEx transducer shall be handled only by
trained personnel. The TEEx transducer is a precision instrument and can be
inadvertently damaged.
22
Chapter 5: Safety
Thermal safety
Experts generally agree that to avoid damage to body tissues during long-term exposures, the
temperature of the transducer tip where contacting tissue should be less than 43° C.
A thermal-safety system in the ultrasound system displays the transducer’s operating temperature
on-screen and prevents it from exceeding given limits.
If the temperature sensor is not working properly when you connect the transducer to the system,
the image freezes and a warning appears.
Thermal limits
The system has two levels of upper thermal limit: 41.0° C and 42.5° C. If the transducer-tip
temperature reaches 41.0° C, the temperature is highlighted on-screen, the image freezes, and a
warning appears. This warning appears only once per exam. To continue, press OK. If the temperature
reaches 42.5° C, the image freezes and cannot be unfrozen until the temperature falls below 42.0° C.
To resume imaging, press the FREEZE or UNFREEZE key.
The system has a lower thermal limit of 17.5° C. If the transducer-tip temperature reaches 17.5° C, the
temperature is highlighted on-screen, and the image freezes and cannot be unfrozen until the
temperature rises above 18.0° C. To resume imaging, press the FREEZE or UNFREEZE key.
Temperature
Figure 1 Transducer-tip temperature on-screen: Within limit (left) and outside limit (right)
Reducing temperature
Temperature calibration test
At least once a year, verify the temperature measurement function to the specifications. See “Thermal
safety” on page 23.
Chapter 5: Safety
23
Safety
The following are general guidelines for reducing temperature in 2D or Doppler imaging modes:
• Using 2D imaging (2D imaging typically results in the lowest transducer surface temperature.)
• In 2D imaging, selecting the Res or Gen optimization setting and increasing the image depth
• In PW Doppler imaging, decreasing the PRF and/or positioning the Doppler sample gate to a
shallower depth
• In CW Doppler imaging, increasing the depth of the CW Doppler sample line (2D image depth prior
to turning on Doppler trace mode)
• In any imaging mode, freezing the image temporarily reduces the transducer surface temperature.
In color imaging, no imaging changes reduce the transducer surface temperature.
Test Setup
Assemble the following items for the test:
• Temperature stabilized water bath
• Temperature gauge with accuracy of +/- 0.1° C
Temperature
Calibration
Test
1
Adjust the water bath temperature to 41.8° +/- 0.1° C and monitor the
temperature with the gauge.
If an accurate and stable water bath is not available, account for the added
inaccuracy when reading the temperature from the ultrasound system.
Deviation of more than +/- 0.5° C is not acceptable. Maintaining this accuracy
without temperature regulation may be difficult.
2 Connect the TEEx transducer to the ultrasound system or select it if you are
using the Triple Transducer Connect.
3 Press FREEZE.
4 Put the transducer tip in the water bath.
At least 10 cm of the distal end must be submerged.
5 Observe the temperature indicated on the system screen.
6 Wait until the temperature display is stabilized at 41.8° +/-0.5° C plus/minus any
water bath temperature deviation.
7 Observe that the Warning pop-up window appears.
If the temperature shutdown works as described in “Thermal safety” on page 23, the
transducer passes the test. If not, contact SonoSite or your local SonoSite
representative.
Electrical safety
You should perform the electrical leakage current test on the TEEx transducer after taking it out of the
box. You should also perform it either before each exam or—if you perform the bite-hole inspection
test before each exam—yearly (at a minimum).
Electrical leakage current test
SonoSite ultrasound systems with accessories are designed to meet the requirements for patient
safety described in IEC 60601-1:1988 Medical Electrical Equipment-Part1. General Requirements for
Safety. To maintain patient safety it is important to have a low electrical leakage current in the
product.
The endoscope shaft has no electrically conducting surfaces and is covered with a layer of material
that permits neither fluids nor electricity to pass through it. Electrical safety is maintained for the
transducer by keeping this material intact. Each TEEx transducer is tested for electrical isolation and
leakage current before it is shipped to a customer.
WARNING:
24
To avoid injury to the patient, do not use the transducer if the insulating material has
been punctured or otherwise compromised.
Chapter 5: Safety
The integrity of the insulating material cannot always be confirmed by visual inspection. A program
for measuring the electrical leakage current on a regular basis should be established. As a minimum,
leakage tests according to EN 60601-1/IEC 60601.1 §19 must be performed once a year, or as required
by local regulation. The leakage limits associated with Type BF Applied Part must be met. The test
requires access to the ultrasound system and to standardized test equipment. The transducer has to
be immersed in a Normal Saline solution (9g NaCl per liter water) to above the 40 cm mark (but below
the handle).
SonoSite recommends keeping a written log of the results.
WARNING:
Only qualified personnel should measure electrical leakage current. Take all
necessary precautions to avoid contact with non-insulated parts that have applied
voltage.
Bite-hole detection
Bite-holes or other damage of the endoscope surface can be detected by isolation or leakage current
tests as described in EN 60601-1. Alternatively, bite holes can be detected without access to the
ultrasound system, by the following simplified procedure, which is safe and easy to perform. The test
equipment is shown in Figure 2.
>10M Ω
5
OK
Ω
3
4
V/Ω Com
6
50g NaCl/1 liter H2O
Safety
1
>25 cm2
Cu
2
Figure 2 Equipment for detecting bite-holes in the endoscope shaft:
1
Water bath
4
TEEx transducer
2
Copper or aluminum sheet
5
Positive lead
3
Multimeter
6
Negative lead
Chapter 5: Safety
25
Test Setup
Assemble the following items for the test:
• Water bath with a 1 Normal saline solution (9g NaCl/1 liter water)
• Copper or aluminum sheet with an area of at least 25 cm2
• Digital multimeter with 40 MOhm scale (calibrated to NIST).
Bite-Hole Test 1
2
3
4
WARNING:
Submerse the TEEx transducer with the endoscope shaft in liquid to above the
40 cm mark (but below the handle).
Connect the leads of the multimeter. See Figure 2.
Note: The multimeter can be connected to transducer and copper or aluminum
sheet using alligator clips.
• Connect the positive lead to the bare metal where the cable enters the
transducer connector.
• Connect the negative lead to the copper or aluminum sheet in the
salt-water bath.
Set the multimeter to measure resistance (range > 40 MOhms).
Wait at least 2 seconds and verify that the resistance is acceptable (greater than
10 MOhms).
Note: If there is a bite hole, the resistance may vary considerably during the
measurement and between different multimeters.
To avoid injury to the patient, do not use the transducer if the resistance value is less
than 10 MOhms. Endoscope insulation may be damaged and should be verified by a
SonoSite representative.
Acoustic output
For acoustic output information, see the ultrasound system user guide.
26
Chapter 5: Safety
Chapter 6: Transducer Specifications
TEEx/8-3 MHz transducer
Endoscopic shaft
External Diameter: 10.5 mm
Length: 110 cm
Clockwise rotation of the lower deflection control wheel will deflect the
tip anterior. Counterclockwise rotation of the lower deflection wheel
will deflect the tip posterior.
Clockwise rotation of the upper deflection control wheel will deflect
the tip to the right.
Counterclockwise rotation of the upper deflection wheel will deflect
the tip to the left.
Maximum deflection
Anterior: 120° minimum, 130° maximum
Posterior: 40° minimum, 60° maximum
Right and Left: 40° minimum, 60° maximum
Scanplane rotation
The transducer scans images in any plane within a 180° (nominal) cone
from a transverse plane, through the longitudinal plane and ending at
the mirror of the first transverse plane.
The scanplane rotation is motor-driven, with speed and direction
selected with buttons on the endoscope handle. Maximum speed: 180°
in approximately 5 seconds.
Scan Angle
90° maximum
Transducer tip
dimensions
Length: 35 mm*
Cross-section maximum: 14 mm x 12.5 mm
Electrical Safety
Conforms to applicable UL, CSA, IEC requirements for class BF.
Temperature
accuracy
±0.5° C within the range of 35° to 45° C
Transducer tip
temperature limits
Upper: 42.5° C
Lower: 17.5° C
Transducer
Center Frequency 5.0 MHz
Cable length
2m
Biocompatibility
All patient contact materials of the TEEx transducer/endoscope system
comply with ISO 10993-1. The transducer is latex free.
Chapter 6: Transducer Specifications
27
Specifications
Steering orientation
Environmental limits
(shipping and
storage)
Temperature:
Shipping: -35° to+65° C
Storage: 0° to +45° C
Humidity: 15 to 95% R.H.
Pressure: 700 to1060 hPA (0.7 - 1.05 ATM)
* Defined as the length of the inflexible distal part of the transducer.
28
Chapter 6: Transducer Specifications
P05341-03
*P05341-03*