Hitachi L44LA1 User manual

MN1-6101 Rev. 3

L44LA1 Probe

Instruction Manual

Specication

MN1-6101 Rev. 3

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.

MN1-6101 Rev. 3

iii

MN1-6101 Rev. 3

Introduction

This is the instruction manual for L44LA1 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.

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.

MN1-6101 Rev. 3

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

3.Preparations before use ..............................................................................................................................5

3-1. Visual check ..................................................................................................................................................................5

3-2. Conrmation of cleaning, disinfection, and sterilization.............................................................................................5

3-3. Operation check.............................................................................................................................................................5

3-4. Probe insertion check....................................................................................................................................................6

4. Operation....................................................................................................................................................7

4-1. Insertion of the probe ....................................................................................................................................................7

4-2. Operation.......................................................................................................................................................................7

4-3. Pulling out the probe .....................................................................................................................................................8

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MN1-6101 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 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.

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 cleaning, disinfection, and sterilization........................................ Refer to the separate instruction manual

“Cleaning, Disinfection and Sterilization”

1-3. Standard components

The standard components of L44LA1 probe are as follows.

L44LA1 Probe ······················································· 1 set

Storage case ··························································· 1 set

Instruction Manual

• Specication (MN1-6101)········································ 1 copy

• Safety (MN1-5984) ··············································· 1 copy

• Cleaning, Disinfection and Sterilization (MN1-6000) ······ 1 copy

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MN1-6101 Rev. 3

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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MN1-6101 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: 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: 38mm

Frequency: 7.5 MHz

Cable length: 2.9 m

Service life: 3 years

Applied part: See Figure 1

Part treated as applied part: See Figure 1

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

Remarks

The dimensions and weight are within ±10% of the indicated values.

Figure 1 External View

Unit: mm

Cable length

IPX7 range

Applied part

Parts treated as applied parts

450

12 505

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MN1-6101 Rev. 3

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.

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 side The Insertion tube side corresponds to the side of the orientation mark on the

image.

Insertion tube The part is inserted into the patient's body with the ultrasonic irradiation area.

Transducer portion marker This indicates the position of the surface for ultrasound emission. The surface

is slightly depressed as can be conrmed by touching it.

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.

Ultrasonic radiation part

Transducer portion marker

Cable

Connector

Front side

Insertion tube

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MN1-6101 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 check the ultrasonic radiation part, insertion tube, cable and the connector.

•If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do

not use the equipment.

•Gently grab the insertion tube to the ultrasonic radiation part by hand, slide it and make sure there are no catching or

loose parts.

3-2. Conrmation of cleaning, disinfection, and sterilization

Confirm that the probe is certainly cleaned, disinfected, and sterilized. The degree of reprocessing depends on the

intended use. Please refer to the separate instruction manual “Cleaning, Disinfection and Sterilization“ for cleaning,

disinfection, 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.

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.

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MN1-6101 Rev. 3

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.

3-4. Probe insertion check

Insert the probe into the trocar and make sure the probe can be smoothly inserted/removed.

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