Hitachi S3ESEL User manual

i
MN1-6103 Rev.3
S3ESEL Probe
Instruction Manual
Specication
M N1- 6103 Rev.3
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-6105)” and “Cleaning, Disinfection and Sterilization
(MN1-6015)“ carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2014, 2017. All rights reserved.

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MN1-6103 Rev.3

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MN1-6103 Rev.3
Introduction
This is the instruction manual for S3ESEL probe. The probe is available by connecting to Hitachi’s ultrasound
diagnostic instrument and can be mainly used for observations of the heart.
Prior to use, read this manual as well as the separate instruction manual “Safety” in which information for safe use is
provided.
The probe bears the CE mark but the mark is valid only when the probe is connected to the ultrasound diagnostic
instrument bearing the CE mark.
Symbols used in this document
Safety information is classied into Danger, Warning, Caution, and Note according to the level of hazard. Those terms
are used in safety information provided to prevent hazards and injuries to the operator or patient.
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to the
operator or patient.
War ning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to the
operator or patient.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to
the operator or patient, or property damage only.
Note
Indicates a strong request concerning an item that must be observed in order to prevent damage or
deterioration of the equipment and also to ensure that it is used efciently.
The type of safety information is indicated by the symbols below.
This symbol means that attention is required.
This symbol means that the described action is prohibited.
This symbol means that the described action is mandatory.

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MN1-6103 Rev.3
This instruction manual contains 4 pages of front matter and 20 pages of the main content.
CONTENTS
1. General Information...................................................................................................................................1
1-1. Intended use...................................................................................................................................................................1
1-2. Classication of ME equipment....................................................................................................................................1
1-3. Standard components ....................................................................................................................................................1
1-4. Options ..........................................................................................................................................................................1
2. Specications and Parts name....................................................................................................................3
2-1. Specications.................................................................................................................................................................3
2-2.Specications of the bite block ......................................................................................................................................4
2-3. Transducer cover ..........................................................................................................................................................4
2-4. Name of each parts .......................................................................................................................................................5
3. Preparations before use .............................................................................................................................7
3-1. Visual check ..................................................................................................................................................................7
3-2. Deection portion operation check ............................................................................................................................7
3-3. Transducer rotation part operation check .....................................................................................................................7
3-4. Verication of cleaning, disinfection and sterilization ................................................................................................7
3-5.Verication of operation.................................................................................................................................................7
4. Operation....................................................................................................................................................9
4-1. Operation of the bite block............................................................................................................................................9
4-2. Transducer cover usage precautions .............................................................................................................................9
4-3. Insertion of Probe ......................................................................................................................................................10
4-4. Manipulation of Probe ...............................................................................................................................................11
4-5. Manipulation of the deection portion .......................................................................................................................13
4-6. Manipulation of the transducer rotation switch .........................................................................................................14
4-7. Manipulation of the Lock knob and Lock lever......................................................................................................15
4-8. Removing the insertion portion..................................................................................................................................16
4-9. Removal of transducer cover ......................................................................................................................................16

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MN1-6103 Rev.3
1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended for use by a doctor when inserted into the patient’ s esophagus and its tip contacts the
esophageal wall making ultrasonic observations of the heart.
Please refer to the ultrasound diagnostic instrument instruction manual used with this probe for the probe intended use
information.
Regarding with the connectable instrument, please refer to section 2-1. Specications of this manual.
War ning
Do not use this equipment for other than its intended use.
Otherwise it could cause burns or other injuries to the operator or the patient.
1-2. Classication of ME equipment
This probe is classied as follows according to IEC60601-1.
Please refer to the section 2-1 for the applied part, the part treated as the applied part, and the range of IPX7.
• Classication based on the degree of protection against electric shock ........ Type BF applied part
• Classication for protection against ingress of liquids .................................. IPX7 (Watertight equipment)
• Operation mode............................................................................................... Continuous operation
• Method of sterilization.................................................................................... Refer to the separate instruction manual
“Cleaning, Disinfection and Sterilization”
1-3. Standard components
The standard components of S3ESEL probe are as follows.
S3ESEL Probe ························································ 1 set
Bite block SP-7901 ··················································· 2 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-6103)········································ 1 copy
• Safety (MN1-6105) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6015) ······ 1 copy
1-4. Options
There is no option available for S3ESEL probe.

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MN1-6103 Rev.3
2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
Application: Heart and thoracic aorta
Type of patient contact: Transesophageal
Connectable instruments: ARIETTA 70, Noblus, ALOKA ARIETTA 850, ALOKA LISENDO 880
NOTE:
At the time of publication of this manual, the connectable diagnostic
ultrasound instrument or instrument software version available with this
probe is different for each country, please refer to the instrument instruction
manual or contact your local Hitachi representative.
Field of view: 90°
Scan direction Any direction in ±90° relative to insertion direction of insertion portion
Frequency: 5.0 MHz±20%
Cable length: 1560 mm
Service life: 3 years
Applied part: See Figure 1
Part treated as Applied part: See Figure 1
IPX7 range: See Figure 1
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
Unit: mm
(mm)
14
30
10
Range of applied part
Parts treated as applied parts
IPX7 range
1000
Enlarged view of probe tip
Remarks: The tolerance for the dimensions is ±10%.
Figure 1 External View

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MN1-6103 Rev.3
2-2.Specications of the bite block
Material Polyetherimide
Service life Three years
External dimensions As shown in the gure below.
40 33
50
Unit: mm
Remarks: The tolerance for the dimensions is ±10%.
Figure 2 External view of the bite block
2-3. Transducer cover
Use by covering the transducer cover over the insertion portion.
Transducer cover CIVCO Transducer cover 610-933
Remarks
The transducer cover is not included this probe-kit.

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MN1-6103 Rev.3
2-4. Name of each parts
The name of each part is shown in Figure 3 and the explanation for each part is listed in Table 1.
Insertion portion
Proximal head
Bite block
Deection portion
Lock knob
Switch
Angle knob for U/D defrection
Lock lever
Probe tip
Ultrasonic
Radiation part
Angle knob for L/R defrection
Figure 3 Name of each parts
Ring

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MN1-6103 Rev.3
Table 1 Name of each part and its explanation
Name Explanation
Ultrasonic radiation part Ultrasound is radiated from this part. The electronic
Sector transducer is integrated underneath this part.
Deection portion Operating the angle knob allows this part to be bent in
any desired direction.
Insertion portion The probe is inserted into the patient's body up to this
section.
Angle knob for U/D defrection This part is used to UP/DOWN operate the deection
portion.
Angle knob for L/R defrection This part is used to LEFT/RIGHT operate the deection
portion.
Lock lever
This part make the angle knob for U/D defrection xed
any direction.
Lock knob This part make the angle knob for L/R defrection xed
any direction.
Proximal head
When using the probe, hold this part by hand.
Switch pushing this switches makes rotation of the transducer 0
to 180.
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the
ultrasound diagnostic instrument.
Ring This part is used for hanging the proximal head
Bite block This is put in patient's mouth so that keep the path of the
probe inserted into the body
Caution
Do not pull, bend, twist, or apply excessive force to the cable.
The probe may malfunction due to cable disconnection.
Do not subject the ultrasonic radiation part to hard impact.
The impact may cause damage to the transducer, and that results in noise or no echo in the image.
In most cases, the ultrasonic radiation part itself is not damaged because the part is made of plastic
material.
Do not bend or twist the deection portion unnecessarily or manually .
This could make the probe unusable.
Keep the angle knob in the free position during an operation of curving.
Operating the probe while locked, it may become unusable.
There is no mark to indicate front direction of probe.
It becomes right axis angle operation, in Continuing pushing Transducer rotasion switch and completly
turning Tranceducer. See section 4-7.
Remarks
According to the property of a acoustic medium which lled a tip ,the change of color may be seen in menblane
But there is no inuence on the performance and safety of the probe.

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MN1-6103 Rev.3
3. Preparations before use
This chapter describes preparations needed to use the probe safely. Please prepare the probe prior to each use by
following the instructions below.
3-1. Visual check
Visually and tactually make certain that any of the following abnormalities has not taken place:
Insertion portion is free from holes, dents, scratches, cracks, deformations, color changes and the like on the surface.
Also there is no leakage of the oil inside the transducer.
Manipulate the deection portion using the angle knob and check for any protrusions or cracks in this area.
Lightly grip insertion portionand deection portion by hand and let it slide. Then, it shall neither catch your hand on
the way nor shall it be slack.
Make sure that all surfaces of the probe connector, cable and proximal head are free of scratches, cracks or exfoliation.
Bite block is free from holes, dents, scratches, cracks, deformations, color changes and the like on the surface.
Transducer cover is free from holes, dents, scratches, cracks, deformations, color changes and the like on the surface.
3-2. Deection portion operation check
Gently turn the angle knob in each direction until it stops and check the following:
* Make sure there are no catching or irregularities in force to turn the angle knob.
* Make sure the deection portion is bent smoothly in all directions.
Operate the lock lever to make sure there are no abnormalities in the curvature holding or releasing functions.
3-3. Transducer rotation part operation check
Push the switches in each direction of the transducer as far as it will go on the displayed screens,and confirm the
following.
* Make sure the transducer rotates smoothly in all directions.
3-4. Verication of cleaning, disinfection and sterilization
Verify that cleaning, disinfection and sterilization are conducted according to the intended use.
3-5.Verication of operation
“Connecting to the ultrasound diagnostic instrument” and check that the selected probe match the sector display and
the displayed frequency and check the image for errors.
Remarks:
Please refer to the documentation supplied with the ultrasound diagnostic instrument for how to connect the probe
and information displayed on the monitor.
If the probe is operated in still air, brightness on the top of the image may be non uniform, but this does not affect the
performance of the probe.
War ning
Make preparations prior to each use.
The operator and the patient may be injured if the equipment has any abnormality.
If any abnormality is found in the equipment, stop using it and contact our ofce written on the back
cover.
Caution
Do not use the probe if the displayed scan type and frequency do not correspond to those of the probe.
Incorrect acoustic output can result in burns or other injuries to the patient. Contact our ofce written
on the back cover.

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MN1-6103 Rev.3

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MN1-6103 Rev.3
4. Operation
This chapter describes the operation of the probe.
4-1. Operation of the bite block
Put this in patient's mouth so that keep the path of the probe inserted into the body
Probe
Bite block SP-7901
Figure 4
War ning
Use the bite block supplied with the probe.
If the probe is bitten, the probe may be damaged and a hazard to the patient will occur.
4-2. Transducer cover usage precautions
Inside of transducer cover, use the sterilized echo jelly(gel) which is attached transducer cover
Transducer cover
Sterilized echo jelly(gel) which is attached transducer cover
Figure 5
War ning
Use the transducer cover over the insertion portion.
If the transducer cover is not used and will contact Lignocaine Hydrochloride such as xylocaine
jelly or gel , this may cause exterior deterioration.
Use Hitachi-approved transducer cover only.
If use transducer cover which not reccomended can cause an adverse reaction by the body of the patient..
Check that the transducer cover is sterilized.
Use of an infected item could spread infection to the patient.
Inside of transducer cover, use the sterilized echo jelly(gel) which is attached
transducer cover If use echo jerry which not reccomended by instruction manual, it is cause to
deterioration.probe surface.
Do not reuse the transducer cover .
Use of an infected item could spread infection to the patient.
Do not apply unsterilized acoustic medium to the outer surface of the transducer cover .
Use of an acoustic medium that is contaminated by a pathogen can cause an infection on the patient.

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MN1-6103 Rev.3
Caution
Check the transducer cover for abnormalities before use.
Regarding the storage of the transducer cover, follow the instructions of the back side of the outside bag of
the transducer cover.
Check that the acoustic medium has no air bubbles inside the transducer cover that is covering the probe.
Air bubbles inside the transducer cover can result in misdiagnosis caused by overlooking or
misinterpreting lesions due to poor image quality or improper rendering.
4-3. Insertion of Probe
Insert the probe from bite block.
War ning
Do not try to forcibly perform operations.
Excessive force cause injury to the patient. If an abnormal resistance force is felt, stop use of the
equipment.
Operation must be performed by a skilled doctor.
Improper operation can injure the patient. Operations must be performed by a doctor who fully understands
the characteristics of ultrasound diagnostics and who is skilled and has a thorough knowledge of
transesophageal echocardiography.
Do not use the patient who has esophageal barices.
This mau cause serious injury to the patient.
Follow the information in this manual and the documentation supplied with any equipment used
together with this probe.
Use that is not in accordance with the supplied documentation can result in a serious or moderate
injury, equipment breakdown, or physical damage that impairs operation.
Do not use on the eyes.
This probe is not intended for use on the eyes. The acoustic output can have an adverse effect on the eyes.
Do not attempt to disassemble, modify, or repair the equipment.
Electric shock or other unforeseen accidents could result. Contact one of our ofces and/or
distributor's ofces listed on the back cover to request repair.
Don't submerge or immerse of Proximal head and Connector into water or chemical solution .
This probe is not waterproof. As a result of immersion in water or chemical solu tion, it can cause a
breakdown of probe. Regarding waterproof part ,please see chapter 2-1
Wear medical gloves during examination.
Conducting examinations with the bare hands can expose the operator to a risk of infection.
This probe must not be used in direct with the heart.
This may cause patient to receive an electric shock.
Select the size of the probe with the patient’s physical constitution in mind.
Using a portion that is too large and unt for the patient’s physical constitution is very dangerous
and can harm the patient.

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MN1-6103 Rev.3
Do not try to forcibly perform operations.
Excessive force cause injury to the patient. If an abnormal resistance force is felt, stop use of the
equipment.
Use the transducer cover over the insertion portion.
If the transducer cover is not used and will contact Lignocaine Hydrochloride such as xylocaine
jelly or gel , this may cause exterior deterioration.
If the transducer cover is not used, residual pathogens on the probe could infect the patient.
4-4. Manipulation of Probe
Place the ultrasonic radiation part of the probe onto the inner organ surface by grasping the n with forceps during
surgery. An image of the region of interest is displayed on the monitor of the ultrasound diagnostic instrument. For
details on displaying and adjusting the image, refer to the documentation supplied with the ultrasound diagnostic
instrument.
War ning
If the probe gets bent in the esophageal (J turn), do not try to move the probe by force.
If the image reverses suddenly or the image disappears suddenly at the time of the insertion, J-turn
should occur. If a J-turn should occur, do not try to pull back the probe by force, but rather, preferably
under x-ray monitoring to check the state of the probe, carefully push the probe until its tip comes into the
stomach and straighten the bend by operating the angle knob before pulling back the probe. Forcing it to
move can injure the patient.
Occuring J-turn
The probe gets bent
in the esophageal
Push the probe until stomach
and straighten
Keep the angle knob in the free position during an operation of pulling out.
Removing the deection portion while locked may injure the patient.
Dispose of the probe used for patients with Creutzfeldt-Jakob disease.
Otherwise, there is a risk of infection to the operator or patient. Our ultrasound probe is not compatible
with any disinfection/sterilization method for Creutzfeldt-Jakob disease.

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MN1-6103 Rev.3
Caution
Constantly check for anything abnormal about the patient’s condition and the equipment.
Continued use without noticing that an abnormal condition has occurred can result in an electric
shock and injury to the operator or patient. If an abnormal condition occurs, immediately move the
equipment away from the patient and stop use of the probe.
The equipment is vulnerable to damage by impact. Therefore, handle it with care.
There is a risk of damage to the equipment when the equipment is fallen or hit somewhere.
Do not use this probe with other equipment except for those specically approved in the manual.
Use with unapproved equipment can result in an electric shock, burn, or other injury to the patient
or operator and damage to the probe and the other equipment.
Scan for minimum time necessary at the lowest possible acoustic output.
Acoustic output may affect the patient’s internal tissues.
For details about the acoustic output, please refer to the documentation supplied with the ultrasound
diagnostic instrument.
Regularly perform maintenance inspection and safety tests of the equipment.
If you use equipment for a long period of time, it can reduce the performance, or cause smoke or fire. If
anything unusual occurs, immediately stop using it and contact one of our ofces and/or distributor's ofces
listed on the back cover.
Use, move and transport the equipment under the environmental conditions specified in this manual.
Otherwise, it may be damaged.
Do not use with a debrillator.
This should result in the probe damaged. If you have to use a debrillator with the probe in place, make sure
to conduct a safety tests according to instruction manual MN1-6105.
Keep the angle knob in the free position during an operation of curving.
Operating the probe while locked, it may become unusable.
Do not bend or pull the insertion portion unnecessarily.
This could make the probe unusable.
Do not touch the connector terminal pin of the probe.
Electrostatic discharge may result in malfunction of the probe.
Do not touch the probe connector of the ultrasound diagnostic instrument and the patient at the same time. It
can cause electric shock to the patient.

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MN1-6103 Rev.3
4-5. Manipulation of the deection portion
After inserting the insertion portion into the patient’ s esophagus, ex the tube as indicated below in order to observe
the target region.
UP
Turn the angle knob(for U/D operation) to crockwise direction
to bend the defrectin portion in the in the ultrasound radiation
part side.
DOWN
Turn the angle knob(for U/D operation) to countercrockwise
direction to bend the defrectin portion in the in the ultrasound
radiation part side.
120°
90°
UP
DOWN
U/D operation
L/R operation
UP
DOWN
RIGHT
LEFT
RIGHT
Turn the angle knob(for L/R operation) to
crockwise direction to bend the defrectin
portion to the right side (from Radiation
part side view).
Turn the angle knob(for L/R operation) to
countercrockwise direction to bend the
defrectin portion to the left side(from Radiation
part side view).
45°
45°
RIGHT
LEFT
Ultrasonic
Radiation part
Figure 6

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MN1-6103 Rev.3
4-6. Manipulation of the transducer rotation switch
After inserting the insertion portion of the probe into the esophagus of the patient, rotate the transducer
using the method shown in the gure below, in order to observe the region of interest.
The angle indication is a reference level.
(1) CCW rotation switch (2) CW rotation switch
Figure 7
(1) CCW rotation switch
This switch rotates the transducer in the counterclockwise (CCW) direction.
In Continuing pushing this switch, Tranceducer angle becomes 180 degrees.
Tranceducer front side
The front mark (direction mark) side on the image display
180°
Figure 8
(2) CW rotation switch
This switch rotates the transducer in the clockwise (CW) direction.
In Continuing pushing this switche, Tranceducer angle becomes 0 degrees.
0°
Tranceducer front side
The front mark (direction mark) side on the image display
Figure 9

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MN1-6103 Rev.3
4-7. Manipulation of the Lock knob and Lock lever.
After inserting the insertion portion into the patient’ s esophagus, ex the portion as indicated below in order
to observe the target region.
(1) Lock of angle knob(for L/R operation)
Turn the lock knob to x an angle of the diection portion and opposite direction to free.
White : Free
Red : Lock
Figure 10
(2) Lock of angle knob(for U/D operation)
Push the lock knob to x an angle of the diection portion and opposite direction to free.
White : Free
Red : Lock
Figure 11

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MN1-6103 Rev.3
4-8. Removing the insertion portion
Turn free the lock lever and lock knob and straighten the deection portion in order to remove the insertion portion
from the patient’ s esophagus.
Be sure to immediately wash and properly disinfection after use.
War ning
Keep the angle knob in the free position during an operation of pulling out.
Removing the deection portion while locked may injure the patient.
When blood attaches to Probe or accessories, please do cleaning and sterilization.
If reuse without sterilizing , there might be the infection to the patient .
4-9. Removal of transducer cover
Transducer cover wrapped in tissue paper and removed from the probe.
Dispose of used tissue paper and transducer cover using infection prevention procedures based on the rules of your
facility
Caution
Before disposing of the equipment, disinfect or take other infection-prevention measures.
Disposal of the equipment without taking the proper preventative measures can lead to infection.
After remove the equipment from the patient, check for anything abnormal about the transducer cover.
If the transducer cover stay inside of the patient's body, the transducer cover can cause injury to the
patient. Remove the transducer cover including probe with carefully.When the transducer cover stay inside
of the patient's body, perform the required medical treatment.