Hitachi L44LA User manual

i
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
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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