Hitachi L44LA User manual

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MN1-6013 Rev.4
L44LA Probe
Instruction Manual
Specication
MN1- 6013 Rev.4
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-5984)” and “Cleaning, Disinfection and Sterilization
(MN1-6000)“ 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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MN1-6013 Rev.4

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MN1-6013 Rev.4
Introduction
This is the instruction manual for L44LA probe. The probe is available by connecting to Hitachi’s ultrasound
diagnostic instrument and can be mainly used for observation of human internal organs through the trocar .
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 the safety information provided to prevent hazards and injuries to the operator or patients.
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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MN1-6013 Rev.4
This instruction manual contains 4 pages of front matter and 12 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. Name of each parts........................................................................................................................................................4
2-3. Specications of the protect tube .................................................................................................................................5
3. Preparations for Use ...................................................................................................................................7
3-1. Visual check ..................................................................................................................................................................7
3-2. Deection portion operation check .............................................................................................................................7
3-3.Conrmation of cleaning and sterilization ....................................................................................................................7
3-4.Verication of operation ................................................................................................................................................7
3-5.Torocar connection check...............................................................................................................................................8
3-6. Probe insertion check....................................................................................................................................................8
4. Operation....................................................................................................................................................9
4-1. Preparations of the protect tube ...................................................................................................................................9
4-2. Insertion of the probe....................................................................................................................................................9
4-3. Operation.....................................................................................................................................................................10
4-4. Pulling out the probe................................................................................................................................................... 11

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MN1-6013 Rev.4
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 placed into direct contact with human internal organs through the
trocar during surgery making ultrasonic observations.
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 patient or operator.
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 range of applied part, the part treated as 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 L44LA probe are as follows.
L44LA Probe ························································· 1 set
Protect tube(MP-2485B)············································ 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-6013) ······································· 1 copy
• Safety (MN1-5984) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6000) ······ 1 copy
1-4. Options
There is no option available for L44LA probe.

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MN1-6013 Rev.4

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MN1-6013 Rev.4
2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
Application: Intraoperative diagnosis
Type of patient contact: Intraoperative
Connectable instruments: ARIETTA 70, ARIETTA 60, Noblus, ARIETTA Precision
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: 36mm
Frequency: 7.0 MHz
Cable length: 3.0 m
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
Cable length
IPX7 range
1000
Range of applied part
Parts treated as applied parts
360
10
Remarks
The dimensions and weight are within ±10% of the indicated values.
Figure 1 External View

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MN1-6013 Rev.4
2-2. Name of each parts
The name of each part is shown in Figure 2 and the explanation for each part is listed in Table 1.
Cap
Ultrasonic irradiation
area
Deection portion
Right-lever
Operating head
Cable
Connector
Protect tube
front mark
(direction mark)
Insertion tube
Left-lever
Figure 2 Name of each parts
Table 1 Name of each part and its explanation
Name Explanation
Ultrasonic irradiation area This incorporates an electronic linear transducer.
front mark
(direction mark)
Near the deection portion corresponds the front mark (direction mark) on
the image display.
Deection portion When operate the left-lever , you can bend the tip up-down direction.
When operate the right-lever , you can bend the tip left -right direction..
Left-lever,Right-lever This part is used to operate the deection portion.
Operating head
When using the probe, hold this part by hand.
Insertion tube The part is inserted into the patient's body with the ultrasonic irradiation area
and deection portion.
Cable This cable propagates the ultrasonic signals that are sent and received.
Connector This cable propagates the ultrasonic signals that are sent and received.
Cap The cap eliminates the gap with the probe and keeps airtightness.
Protect tube Protects the probe from the external tube of torocar.
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 elastic
material.

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MN1-6013 Rev.4
2-3. Specications of the protect tube
Material: Polyetherimide ( Protect tube ), Silicon rubber ( Cap )
Compatible trocar size: 12mm
Service life: Three years
External dimensions: As shown in the gure below.

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MN1-6013 Rev.4

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MN1-6013 Rev.4
3. Preparations for Use
following the instructions below.
3-1. Visual check
Visually check the ultrasonic irradiation area, deflection portion, insertion tube, operating head, cable and the
connector.
•If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are
found, do not use the equipment.
• Try to bend the deection portion in all directions by operating the left-lever and the right-lever and make sure there
are no protrusions or cracks.
•Gently grab the insertion tube to the ultrasonic irradiation area by hand, slide it and make sure there are no catching
or loose parts.
•Make sure the protect tube has no abnomalities such as scars, cracks or separation.
•Make sure the surface of the connector and the cable has no abnomalities such as scars, cracks or separation.
3-2. Deection portion operation check
•Gently operate left and right lever till it stops and check the following:
*The lever can be smoothly operate without any excessive force
* Make sure there are no irregularities in force to turn the angle knob such as catching.
* Make sure the deection portion is bent smoothly in all directions.
3-3.Conrmation of cleaning and sterilization
Conrm that the probe is certainly cleaned and sterilized. The degree of reprocessing depends on the intended use.
Please refer to the separate instruction manual “Cleaning, Disinfection and Sterilization“ for cleaning and sterilization
procedure.
3-4.Verication of operation
Connect the probe to the ultrasound diagnostic instrument and check that the displayed scan type and frequency
correspond to those of the probe. Check also that there is no abnormality in the image.

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MN1-6013 Rev.4
3-5.Torocar connection check
• Make sure the protect tube can be smoothly and correctly attached/detached to/from the torocar outer sheath and its
tip is protruded from the trocar outer sheath when the protect tube is locked.
Move the protect tube up and down after it is locked and make sure the tip
is protruded in all conditions.
Torocar outer sheath
Remark: 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.
3-6. Probe insertion check
With the protect tube locked to the trocar outer sheath, insert the probe into the protect tube and make sure the probe
can be smoothly inserted/removed.

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MN1-6013 Rev.4
4. Operation
This chapter describes the operation of the probe.
4-1. Preparations of the protect tube
Attach the cap to protect tube.
Attach the cap
4-2. Insertion of the probe
① Insert the protect tube into the torocar outer sheath and x the lever
to the trocar outer sheath.
[Remarks]
After xing the lever, cover the insertion opening for the probe by
nger to prevent gas leakage. Lever
②Operatig left and right lever , please straight the deection portion
of the probe.
Left-lever
Right-Lever
③Gently insert the tip of the probe into the insertion opening of the
protect tube.
Probe

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MN1-6013 Rev.4
4-3. Operation
Place the ultrasonic radiation part of the probe onto the inner organ surface 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
Be sure to wear sterilized medical gloves during handling the equipment to prepare.
Handling of the equipment with your bare hands expose the patient to a risk of infection.
Always use a protective tube.
If the probe is damaged during operation, the patient can be injured.
Use a trocar outer sheath that is the right size for the protective tube.
When the trocar outer sheath is not the right size, the tube can be loose or difcult to insert and could
result in a hazardous situation. Use a trocar outer sheath with a diameter of 12 mm and prepare it
before operation.
Attach the protective tube correctly to the trocar outer sheath.
The patient can be injured if the protective tube moves unexpectedly or comes off during the
operation. Also, if the cap is not attached correctly, the lled gas inside the patient's body will be
released, making it difcult to perform the procedure.
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.
Caution
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.
Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output.
There is the possibility that the patient’s internal tissues could be affected.
For details about the acoustic output, please refer to the documentation supplied with the ultrasound
diagnostic instrument.
Do not touch the waterproof connector terminal pin of the probe.
The probe may deteriorate or be damaged due to electrostatic discharge.
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.
Please do not move the right and left lever at the same time.
It may caused the wire of Probe loosens and does not come straight back. In addition, the blurring
within 10 degrees is normal from a central axis.
Note
Before inserting the probe into the body, conrm the deection portion is straight. When the probe is used for
an extended period of time, the deection portion may not be straightened.

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MN1-6013 Rev.4
4-4. Pulling out the probe
① Operatig left and right lever , please straight the deection portion of
the probe.
Left-lever
Right-lever
Deection portion of probe
②Gently pull out the probe from the protect tube. Probe
Torocar outer sheath
Protect tube
③Take care that the torocar outer sheath does not move and pull out
the protect tube by release the lever from the torocar outer sheath.
Lever of
protect tube
Torocar outer sheath
④Immediately wash and sterilize the probe, protect tube and cap.
War ning
When removing the probe, straighten the deection portion and pull out slowly and carefully.
If pulling out the probe with excessive force ,it may cause the harm to a patient.
If you feel resistance during operation such as it catching on something, do not operate excessive force
and please check patient abdominal cavity with an endoscope.
Be sure to sterilize the probe and accessories which blood adhered.
Otherwise, there is a risk of infection. Be sure to remove the cap from protect tube before washing.

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MN1-6013 Rev.4
US Importer: Hitachi Healthcare Americas Corporation
Address: 1959 Summit Commerce Park, Twinsburg, Ohio 44087
Distributor
MN1-6013 Rev.4 ’17.08.31
■Manufacturer
Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan
■Contact
[phone]
http://www.hitachi.com/businesses/healthcare/index.html
Overseas Offices:
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany
EU Importer: Hitachi Medical Systems Europe Holding AG
Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland