Hitachi SML44 Manual de usuario

MN1-6363 Rev. 1

CMUT Linear SML44 Probe

Instruction Manual

Specication

MN1-6363 Rev. 1

Notes for operators and responsible maintenance personnel

★

Please read through this Instruction Manual as well as the separate Instruction

Manual “Safety (MN1-5980)” and “Cleaning, Disinfection and Sterilization

(MN1-5998)“ carefully prior to use.

★

Keep this Instruction Manual together with the ultrasound diagnostic instru-

ment for any future reference.

MN1-6363 Rev. 1

iii

MN1-6363 Rev. 1

Introduction

This is the instruction manual for SML44 probe. The probe is available by connecting to Hitachi's ultrasound

diagnostic instrument and can be mainly used for observation of supercial organs.

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.

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.

MN1-6363 Rev. 1

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

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

4-1. Operation.......................................................................................................................................................................7

4-2. How to attach/release the magnetic position sensor and the magnetic position sensor attachment............................8

4-2-1. How to attach the magnetic position sensor...................................................................................................8

4-2-2. How to release the magnetic position sensor ................................................................................................9

4-3. Marking Assist ...........................................................................................................................................................10

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MN1-6363 Rev. 1

1. General Information

General information for the probe is provided below.

1-1. Intended use

This probe is intended to be used by doctors or other qualified operators. The probe is placed on the body for

observation of surrounding organs.

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 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 SML44 probe are as follows.

SML44 Probe ························································ 1 set

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

Instruction Manual

• Specication (MN1-6363) ······································· 1 copy

• Safety (MN1-5980)················································ 1 copy

• Cleaning, Disinfection and Sterilization (MN1-5998) ······ 1 copy

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MN1-6363 Rev. 1

1-4. Options

The following options are available for SML44 probe.

• Real Time Virtual Sonography (RVS)

Please use the option listed in Table 1 for performing RVS. Regarding how to attach/release the attachment, please

refer to the section 4-2..

Table 1 Option for RVS

Product Name Product No.

Magnetic Sensor Attachment RV-014

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MN1-6363 Rev. 1

2. Specications and Parts name

The specications and the name of each part are provided below.

2-1. Specications

Application: Mammary gland, Supercial organs, Vascular

Type of patient contact: Surface

Connectable instruments: ALOKA ARIETTA 850

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: 2.2 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 1 m length from the probe tip

IPX7 range: See Figure 1

Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument

External dimensions: See Figure 1

Remark: The tolerance for the dimensions is ±10%.

Figure 1 External View

Cable length

129

IPX7 range

26.5 Unit : mm

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MN1-6363 Rev. 1

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 mark The side of the front mark corresponds to the side of the

front mark on the image.

Probe tip This part is gripped during operation.

Cable Cable transfers electric input/output signals.

Connector The connector is the part which 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.

Cable

Probe tip

Front mark Ultrasonic radiation part Connector

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MN1-6363 Rev. 1

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.

Check also the options as necessary.

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. Conrm also that options are properly cleaned, disinfected and sterilized.

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.

Caution

Do not use the probe if the displayed scan type and frequency displayed 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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MN1-6363 Rev. 1

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