Hitachi L43K User manual

i
MN1-6025 Rev. 6
L43K Probe
Instruction Manual
Specication
MN1-6025 Rev. 6
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
(MN1-6369)“ 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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MN1-6025 Rev. 6

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MN1-6025 Rev. 6
Introduction
This is the instruction manual for L43K probe. The probe is available by connecting to Hitachi’s ultrasound diagnostic
instrument. It is operated by grasping with a forceps and can be mainly used for observation of human internal organs
during surgery.
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.
Warning
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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MN1-6025 Rev. 6
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 ..........................................................................................................................................................................2
2. Specications and Parts name....................................................................................................................3
2-1. Specications.................................................................................................................................................................3
2-2. Name of each parts........................................................................................................................................................4
2.3. Forcep ............................................................................................................................................................................5
3. Preparations before use .............................................................................................................................6
3-1. Visual check ..................................................................................................................................................................6
3-2. Conrmation of cleaning and sterilization...................................................................................................................6
3-3. Operation check.............................................................................................................................................................6
3-4. Probe insertion check ....................................................................................................................................................6
4. Operation....................................................................................................................................................8
4-1. Insertion of the probe ....................................................................................................................................................8
4-2. Operation.......................................................................................................................................................................8
4-3. Pulling out the probe .....................................................................................................................................................9

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MN1-6025 Rev. 6
1. General Information
General information for the probe is provided below.
1-1. Intended use
The L43K transducer is intended for use by trained personnel (doctor, sonographer,etc.) for the diagnostic ultrasound
evaluation during robotic/non-robotic intra-operative and laparoscopic procedures.
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.
Please refer the section 2-3 Forcep for detailed of robotic/non-robotic.
Warning
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 L43K probe are as follows.
L43K Probe ··························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-6025) ······································· 1 copy
• Safety (MN1-5984) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6369) ······ 1 copy

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MN1-6025 Rev. 6
1-4. Options
The following options are available for this probe.
• Reprocessing by liquid detergent, disinfectant or sterilant
Whole the probe is able to immerge into the liquids by putting the connector of the ultrasound probe to the
waterproof case WP-001 as below table 1.
Precautions about the waterproof case, please refer to the instruction manual.
Table 1 Accessory for reprocessing by liquid detergent, disinfectant or sterilant
Product Name Product No.
Waterproof case WP-001

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MN1-6025 Rev. 6
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: 25.6mm
Frequency: 7.0 MHz
Cable length: 3.0 m
Service life: 3 years
Applied part: Probe tip including ultrasonic radiation part, see the section 2-2
Part treated as applied part: Cable up to 0.2 m length from the probe tip
IPX7 range: See Figure 1 (In case that not putting the waterproof case to the ultrasound probe
connector)
In case that putting the waterproof case to the ultrasound probe connector, whole the
probe from the tip of the ultrasound probe to the connector with Waterproof Case WP-001
is IPX7. range
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1



IPX7 range
Applied part

Remark: The tolerance for the dimensions is ±10%.
Figure 1 External View
Unit: mm

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MN1-6025 Rev. 6
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 2.
Cable
Probe tip
Ultrasonic radiation part
Connector
Front mark
)LQ
Figure 2 Name of each parts
Table 2 Name of each part and its explanation
Name Explanation
Ultrasonic radiation part Ultrasound is radiated from this part. The electronic
linear transducer is integrated underneath this part.
Front mark The cable side corresponds to the side of the orientation
mark on the image.
Fin This part is gripped with a forceps during operation.
Cable Cable transfers electric input/output signals.
Connector The connector is connected to the ultrasound diagnostic
instrument.
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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MN1-6025 Rev. 6
2.3. Forcep
Forcepses listed in the table 3 are recommended for using with the probe.
If you are unable to purchase the forceps, please contact our sales ofce.
Table 3 Forcep
Product No. Product Name
AdTec® mini PO305R B.Braun Aesculap®
ProGrasp™ Forceps 420093 Intuitive Surgical, Inc.
*ProGrasp is a Trademark of Intuitive Surgical, Inc.
Caution
Regarding the precautions of the forceps, please refer to its instruction manual.

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MN1-6025 Rev. 6
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 check the probe tip, ultrasonic radiation part, cable, and connector.
If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do
not use the probe.
3-2. 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.
3-3. Operation check
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.
3-4. Probe insertion check
Insert the probe into the trocar and make sure the probe can be smoothly inserted/removed.
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.
Warning
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.