.

MPTEE, MPTEE mini

Transesophagel Transducer

User Manual

SonoScape Co., Ltd.

Yizhe Building, Yuquan Road, Shenzhen, 518051, China

Tel: 86-755-26722890
Fax: 86-755-26722850
SonoScape Co., Ltd.
Email: sonoscape@sonoscape.net
http://www.sonoscape.com
P/N: 4710.00281A01
 WARNING / CAUTION

 Before using the equipment, carefully study this manual. Keep

this manual at hand for quick reference.

 Reread it periodically for warnings, safety precautions and

maintenance requirements.

 A damaged transducer may cause an electrically hazardous

condition when coupled to the human body.

 Do not use a damaged transducer.

 The transducer is a precision instrument, which must be handled

with care.

 It may be damaged when dropped or abused.

 In particular, do not allow the ultrasonic window in the tip to come

into contact with a sharp object.

 Do not touch this window unnecessarily. Never exert force onto

the window.

 Only a qualified physician who has received appropriate training

should perform examinations with the transducer.

 The connector is not watertight, and should always be kept dry.

 The control unit, although spray-watertight, should not be im-

mersed.

 This equipment contains no operator serviceable components.

 To prevent electric shock, do not remove any covers or panels.

 Inspect the transducer for damage, cracks or bite-marks prior to
each use.

 Before introducing the transducer: do not rub or spray the tip of

the transducer with an anaesthetic agent.

 Please, do use the bite-guard, supplied with the transducer.

 Only use water-based coupling gel.

 As with all diagnostic ultrasound procedures keep exposure

levels and duration to the minimum necessary for the
examination, especially in the Doppler modes.

 Avoid forceful manipulations and excessive force in using the

transducer, which could result in patient injury.

 Withdraw the transducer only with the deflection control in the

unlock mode and with the distal end of the transducer straight.

 Under normal conditions at full acoustic power the temperature of

the tip does not exceed 41°C. Follow the instruction in this user
manual to check this regularly.

 Clean and disinfect as described in this user manual.

 Do not use methods not described in this user manual like

Ethanol, Iodine, Steam, Heat or Ethylene Oxide.

 The up/down deflection may after prolonged use develop an

unwanted amount of free play. In that case, contact the service
organization to re-adjust the steering of the transducer. In this
way, the risk of "buckling" or "U-turning" of the transducer in the
esophagus is minimized.
 Contents

1 General Information ..............................................................1

1.1 Transducer Overview .......................................................1

1.2 Intended Use ....................................................................2
1.3 Manual Object ..................................................................3

2 Preparation Before Use ........................................................4

2.1 Visual Examination ...........................................................4

2.2 Safety Precautions ...........................................................5
2.3 Preparation Instructions ...................................................7

3 Transducer Use.....................................................................9

3.1 Patient Selection ..............................................................9

3.2 Deflection and Scanplane Rotation Controls ....................9
3.2.1 Tip Deflection Control ..............................................10
3.2.2 Lock Operation ........................................................11
3.2.3 Transducer Scanplane Rotation Control ..................12
3.3 Examination ...................................................................13

4 Transducer Cleaning and Disinfection .............................14

5 Transducer Storage ............................................................17

6 Specifications .....................................................................18
 User Manual

1 General Information

1.1 Transducer Overview

SonoScape manufactures two types of transesophageal

transducers with 64 or 48 elements, 5 MHz. All are phased
array transducers, mounted in a sealed tip at the end of a
gastroscope. The transducers are intended for imaging of
the heart through the esophagus and the stomach. The
array can be rotated 180°. A manual rotation wheel on the
handle of the transducer controls the rotation of the scan
plane. The deflection control wheel on the handle of the
transducer controls the deflection of the tip.

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1.2 Intended Use

WARNING
The transducer should be used only by a qualified
physician who has received appropriate training in
proper operation of the transducer and in endoscopic
techniques as dictated by current relevant medical
practices.

The physician conducting the examination must exercise

sound medical judgment in the selection of patients for this
transducer and be skilled in interpreting the data obtained
from the examination with the transducer.

The transducer can be used to form images of the heart to

detect abnormalities, to evaluate the velocity of the blood
flowing in the heart and to obtain a color depiction of the
velocities of the blood flowing in the heart.

WARNING
The transducer is not intended for fetal imaging.

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1.3 Manual Object

This manual gives the user all information necessary to
guarantee a safe and satisfactory use of the transducer. It
also describes how to handle the transducer during all
stages: before, during and after the examination.

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2 Preparation Before Use

2.1 Visual Examination

Visually examine and feel all portions of the transducer
before use, especially the gastroscope shaft and the
flexible section at the distal end of the gastroscope.
Perform the inspection of the flexible section both with the
transducer deflection straight and deflected. There should
be no discontinuities, bumps, dents, holes, abrasions, bite-
marks or any other evidence of wear or damage found.

The hard plastic section at the distal end of the transducer

should be smooth and firmly attached to the gastroscope
shaft.

The cable and the connector that attach the transducer to

the ultrasound console should be free from evidence of
damage.

Check the proper mechanical operation of the transducer.

Rotate the scanplane with the scanplane rotation wheel on
the handle (see Section 0). Make sure that the rotation is
smooth for all scanplanes. Deflect the tip in both up and
down direction using the deflection control wheel on the
handle (see Section 0). Make sure the deflection operates
smoothly.

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Electrical Hazard

Any evidence of damage indicates the transducer cannot

be used and should be returned to SonoScape for
evaluation and repair.

2.2 Safety Precautions

a. The transducer is a precision instrument, which must
be handled with care.
b. It may be damaged when dropped or abused.
c. In particular, do not allow the ultrasonic window in the
tip to come into contact with a sharp object.
d. Do not touch this window unnecessarily. Never exert
force onto the window.
e. Only a qualified physician who has received
appropriate training should perform examinations with
the transducer.
f. The connector is not watertight, and should always be
kept dry. The control unit, although spray-watertight,
should not be immersed.
g. This equipment contains no operator serviceable
components. To prevent electric shock, do not remove
any covers or panels.
h. Before introducing the transducer: do not rub or spray
the tip of the transducer with an anaesthetic agent.

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 User Manual

i. Avoid forceful manipulations and excessive force in

using the transducer, which could result in patient
injury.
j. Withdraw the transducer only with the deflection
control in the unlock mode and with the distal end of
the transducer straight.
k. Never manually deflect the distal tip of the transducer ;
use only the deflection control wheel.
l. Do not kink, tightly coil, or apply excessive force on
the transducer cable or shaft. Insulation failure may
result.
m. Under normal conditions at full acoustic power the
temperature of the tip does not exceed 41°C. To check
that the temperature increase of the tip is within limits:
 Connect the transducer to the
 Daily
Ultrasound system.
 Weekly
 Adjust the Acoustic Power to the
 Monthly
highest value possible.
 Other
 Select Color Doppler mode.
 Wait for 2 minutes.
 Feel at the distal end of the transducer if there is a
relevant temperature Increase, which could be harmful
for the patient.

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2.3 Preparation Instructions

Inspect the transducer as described in section 0.

Clean and disinfect the transducer as described in

Chapter 4.

Make sure the system connector is plugged into the

Ultrasound system and is locked by means of the locking
handle on the connector.

For patient protection a sterile, single-use, latex sheath

can be used.

CAUTION
 Ensure that the sheath’s sterile surface is maintained.

 Devices containing latex may cause severe allergic

reaction in latex sensitive individuals. Refer to FDA’s
March 29, 1991, “Medical Alert on Latex Products”.

 Place the bite guard on the transducer so that after

insertion of the transducer the bite guard can easily be
placed in the patient’s mouth. The bite guard can also
be placed in the patient’s mouth before inserting the
transducer.

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WARNING

 The use of a bite-guard is mandatory. Failure to use

the bite-guard may result in damage to the
transducer, which could result in a safety hazard.
Damage to the transducer due to biting is not
covered by the transducer’s warranty.
 Apply a sufficient amount of water-soluble acoustic
coupling gel on the transducer acoustic window.

CAUTION
 Only use water-soluble acoustic coupling gel. Other
coupling gels containing ingredients like ethanol,
mineral oil, Iodine, lotions, lanolin, aloe vera, methyl
alcohol or ethyl parabenzoic acid can cause
transducer damage.

 If used, place the latex sheath over the transducer and

gastroscope shaft up to but not covering the handle.
Rub the tip carefully to ensure that all air bubbles have
been removed from the transducer’s acoustic window
area. In addition to the gel on the acoustic window,
apply a sufficient amount of acoustic coupling gel on
the outside of the sheath at the tip of the transducer.

 Do not exert force on the window area.

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3 Transducer Use

3.1 Patient Selection

Although the transducer can provide clinical data not
available from other instruments, there are some
considerations to be made in patient selection for safe use
of the transducer.

CAUTION

 The ability of a patient to swallow or accommodate the

transducer should be considered.

 Any history of gastro-esophageal diseases must be

determined and considered as well as the possible
effects of other therapies the patient is undergoing.

 All gastro-esophageal abnormalities must be

considered as well.

3.2Deflection and Scanplane Rotation Controls

The control handle is designed for one-hand operation.
Normally the operator takes the control handle in his left
hand. Thumb, first and second fingers control the
deflection and scanplane rotation control wheels.

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The larger wheel on the handle is for controlling the

transducer tip deflection. This wheel has a locked and
freely moving mode. In the locked mode the movement of
the deflection wheel is restrained. This is used to hold the
tip in a certain position. A metallic ring around the body of
the handle, which clicks on/off, controls the lock.

The wheel on top is the scanplane rotation control wheel.

3.2.1 Tip Deflection Control

The deflection control wheel located on the handle of the

transducer can control the deflection of transducer tip.

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WARNING
Check if the maximum deflection of the tip is 90°to 120°
upward and 60° to 90° downwards. If the up/down
deflection shows an unwanted amount of free play or
exceeds the maximal deflection angles given above, do
not use the transducer. Contact the service organization
to re-adjust the steering of the transducer. In this way, the
risk of "buckling" or "U-turning" of the transducer in the
esophagus is minimized.

3.2.2 Lock Operation

To protect the patient and the transducer, unlock the

deflection control when inserting or withdrawing the
transducer.
White

Unlock

Red

Lock

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3.2.3 Transducer Scanplane Rotation Control

The transducer scanplane can be rotated from 0°

(transversal plane) via 90° (longitudinal plane) to 180°
(transversal plane, left/right inverted). All planes in
between can also be chosen. This makes it possible to
scan a conical imaging volume.

CAUTION

Do not use excessive force on the scanplane rotation control

wheel at its outer positions as this may damage the
gastroscope mechanism.

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3.3 Examination
The actual examination with the transducer is beyond the
scope of this manual. There are many medical articles and
books, which very thoroughly address this topic. There are
however specific cautions that should be considered.

CAUTION
 Long-term exposure to ultrasound should be minimized.
Although there have been no confirmed adverse effects
produced by diagnostic levels of ultrasound, unnecessary
patient exposure to ultrasound energy should be avoided,
especially in the Doppler mode.
 Prolonged pressure on the esophagus by the tip of the
transducer may lead to a Pressure Necrosis phenomenon.
Thus in monitoring applications the tip should be removed
from the esophagus wall when you are not scanning by
releasing it in the neutral position. If continuous monitoring
is required the transducer tip should often be re-positioned.
 Whenever active scanning is not desired ‘freeze’ the image
and release the deflection control.
 Position the array such, that good acoustical contact is
made. Before rotating the array, actuate the ratchet ('brake')
on the up/down movement. If this is not done, rotating the
array can mean loss of acoustical contact!

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4 Transducer Cleaning and Disinfection

 Biological Hazard
Adequate cleaning and, if necessary disinfection are
carried out to Prevent disease transmission. It is the
responsibility of the user to verify and maintain the
effectiveness of the procedure used. A single-use,
sterile disposable sheath can be used.

CAUTION
Keep the control handle and system connector out of any
cleaning or disinfection solutions. The control handle and cable
may be cleaned with a damp cloth, but only the distal end of the
transducer up to the 100cm marker on the shaft (70cm for
SonoScape’s mini TEE transducers) may be placed into a
disinfection solution.

 Daily
 Weekly
 Monthly
 Other
After each use

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 Transducer Cleaning

a) Clean the tip and flexible shaft with gauze pads

soaked in mild soapy lukewarm water (below 26°C
is recommended). For other authorized cleaning
agents, please contact our Customer Support
Representative.

b) Remove any materials that could interfere with the

disinfection procedure.

c) Rinse the distal tip and shaft with lukewarm water,

in which one can hold one's hand without pain.
Proceed until all visible soap residue has been
removed.

CAUTION
Do not clean any portion of the transducer with methanol or
ethanol. Such substance can cause irreparable damage to the
transducer.
d) Air-dry or dry with a soft cloth.

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 Transducer Disinfection

When necessary ultrasound transducers can be

disinfected using liquid chemical germicides. For other
authorized disinfection liquids which have been tested for
compatibility with the materials used to construct the
transducer, please contact our Customer Support
Representative. Follow the disinfectant manufacturer's
recommendations for solution preparation, immersion time
and rinsing.
a) Place the cleaned and dried transducer surface in
contact with the disinfection solution. Take care
that only the distal end up to the 100cm marker is
immersed.
b) Rinse the transducer tip and shaft with water and
dry prior to storage.

CAUTION
 The transducer should never be left in the disinfection
solution for more than 1hour.
 Do not forget to rinse the transducer directly after
disinfection.

WARNING

Do not use other disinfection methods like Iodine,

Steam, Heat or Ethylene Oxide.

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5 Transducer Storage
The transducer is a sensitive and expensive instrument.
Use great care when storing the transducer. Make sure
the transducer is adequately cleaned and disinfected prior
to storage.

The transducer can be stored in its original case.

WARNING

Avoid damage to the transducer by allowing nothing to

protrude beyond the case when closing the lid.

A wall mounted transducer hanger can also be used for

storage. Make sure the transducer control handle, cable
and connector are adequately supported. The shaft should
hang down freely.

The storage environmental conditions must fall within the

following range:

Storage Temperature: -20 - 55°C

Relative Humidity: 20 - 90%, non-condensing

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6 Specifications
The transducer is in conformity with the relevant
provisions of the European Medical Device Directive
93/42/EEC. The transducer is categorized in Class IIa.
The transducer is classified according to IEC 601-1 as
class I, type BF, defibrillator-proof.
 Transducer Type
MPTEE, MPTEE mini
 Mechanical Dimensions

Items MPTEE MPTEE mini

Shaft external diameter 8mm 6.8mm
Shaft length 100cm 70cm
Transducer tip width 14mm 11mm
Transducer tip height 10.4mm 7.9mm

Length of the inflexible distal

41mm 36mm
part of the transducer tip

 Transducer

Items MPTEE MPTEE mini

Center frequency 5.0 MHz 5.0 MHz
Type phased array array
Number of elements 64 48
Aperture 9 mm 7.25 mm
Focus 50 mm 30 mm

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 Scanplane Rotation Minimum

180°
 Tip Deflection
Rotation MPTEE MPTEE mini
Up 120°± 10° 20°± 10°
Down 90°± 10° 90°± 10°

 Leakage Current /Dielectric Strength

Meet the requirements of IEC 601.
 Biocompatibility
All external materials of the transducer have passed
relevant biocompatibility tests according ISO 10993.
 Environmental requirements

Operating Temperature: 0 - 40°C

Storage Temperature: -20 - 55°C
Relative Humidity: 20 - 90%, non-condensing
Atmospheric Pressure: 700 - 1060hPa

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