Hitachi EUP-L54MA Bedienungsanleitung

Linear Array Probe

EUP-L54MA

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP0995-6

Notes for operators and responsible maintenance personnel

★Please read through this Instruction Manual carefully prior to use.

★Keep this Instruction Manual together with the system with care to make it

available anytime.

0123

(1) Q1E-EP0995

Manufacturer: Hitachi,Ltd.

2-16-1, Higashi-Ueno, Taito-ku, Tokyo,

110-0015, Japan

+81-3-6284-3668

http://www.hitachi.com/businesses/healthcare/index.html

European

Representative: 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

Local Distributor:

(2) Q1E-EP0995

About this manual

This instruction manual shall provide instructions for using, cleaning,

disinfecting and/or sterilizing the HITACHI ultrasound probes. It also

describes safety considerations, maintenance.

For instructions about operating the main unit, refer to the operation

manual for it.

Before using the probe, thoroughly read this manual and keep this book

for future reference.

If you have any questions concerning the manual, please contact a service

support.

The following conventions are used throughout the manual to denote

information of special emphasis.

WARNING: “Warning” is used to indicate the presence of a hazard which

can cause severe personal injury, death, or substantial

property damage if the warning is ignored.

CAUTION: “Caution” is used to indicate the presence of a hazard which

will or can cause minor personal injury or property damage

if the caution is ignored.

NOTICE: “Notice” is used to notify people of installation, operation,

or maintenance information which is important, but not hazard

related.

(3) Q1E-EP0995

Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes

Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are

compliant with EN980:2008 standard. Refer to the following table about the meanings of

them.

Explanation of

Symbol Symbol Descriptive Content

Manufacturer

Company Name and

Address

Hitachi,Ltd.

2-16-1, Higashi-Ueno, Taito-ku, Tokyo,

110-0015, Japan

+81-3-6284-3668

http://www.hitachi.com/businesses/healthcare/

index.html

Authorized

Representative

in The European

Community

Hitachi Medical Systems GmbH

Otto-von-Guericke-Ring 3 D-65205 Wiesbaden,

Germany

Keep away

from Sunlight

Store the probe in a cool, dustproof and dry

environment to avoid high temperature,

humidity and direct sunlight.

(4) Q1E-EP0995

Definition of symbol

The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol Definition

Probe connector

This instrument complies with Directive

93/42/EEC relating to Medical Device

and Directive 2011/65/EU relating to

RoHS

Probe connector IPX7 IPX7 mark

See section 1.5.

Probe connector Type BF APPLIED PART

Probe connector General warning sign

Probe connector Warning; dangerous voltage

Probe connector Caution; Biohazard

Probe connector

Follow the instruction manual to

operate this instrument. If not

avoided, may result in injury, property

damage, or the equipment trouble.

Probe connector

STERRAD sterilization compatibility

mark

Probe connector

Upper Limit of Temperature;

The probes that are applicable to

Ethylene Oxide Gas Sterilization use

symbol of “Upper Limit of Temperature:

55 degrees”.

Probe connector Do not waste the instrument as general

waste. Comply with a local regulation.

Probe connector Rx Only

By prescription only. U.S. Federal Law

restricts this device to sale on order

of a physician only.

(5) Q1E-EP0995

CONTENTS

Page

1.Introduction ................................................... 1

1.1Features ............................................................1

1.2Principles of operation .............................................1

1.3Intended Use ........................................................1

1.4Composition .........................................................2

1.5External View .......................................................2

2.Inspection before Use .......................................... 3

2.1Inspection for Appropriate Connection ...............................3

2.2Inspection for Material Surface .....................................3

3.Operation Procedure ............................................ 4

4.Reprocessing Procedure ......................................... 5

4.1Point of use (Pre-cleaning) .........................................8

4.2Containment and transportation ......................................8

4.3Manual Cleaning and disinfection ....................................8

4.4Drying .............................................................11

4.5Inspection .........................................................11

4.6Packaging ..........................................................11

4.7Sterilization ......................................................11

4.8Storage ............................................................13

5.Maintenance and Safety Inspection ............................. 14

6.Safety Precautions ............................................ 15

7.Specifications ................................................ 16

7.1Probe ..............................................................16

7.2Suppliers List .....................................................17

8.Disposal of the probe ......................................... 18

-1- Q1E-EP0995

1. Introduction

1.1 Features

The probe model EUP-L54MA is a linear array type probe.

The acoustic output of this probe when connected to ultrasound

scanner was measured according to the IEC60601-2-37 standard.

The table of measured acoustic output data is contained in the

operation manual of each ultrasound scanner.

This probe is categorized in class IIa according to Directive

93/42/EEC.

According to IEC 60601-1 the probe is classified as type BF.

1.2 Principles of operation

This probe and the ultrasound diagnostic scanner enable image

diagnosis using ultrasonic waves.

This system operates under the principles described below.

1) When an electric pulse signal is applied from the transmitter

to the transducer of the probe, the transducer converts

electric signals into mechanical vibration energy for

emitting pulse-shaped ultrasonic waves into the body part,

liquid or other medium contacting the transducer.

2) The emitted ultrasonic waves are reflected by boundaries with

different acoustic characteristics (acoustic impedance)

within the body.

3) The transducer is also used to receive reflected ultrasonic

waves. The transducer vibrates mechanically due to the

received ultrasonic waves and converts mechanical vibrations

into electric energy. Electric signals are converted to shades

of brightness by brightness modulation to obtain an image.

1.3 Intended Use

The Linear Array Probe EUP-L54MA is designed for observation and

diagnosis mainly of the following regions by connecting with the

HITACHI ultrasound scanner.

Mammary gland

Thyroid

Superficial organs

-2- Q1E-EP0995

Never use the probe for following applications.

Direct contact to the heart.

1.4 Composition

The probe components of the EUP-L54MA are as follows:

1) Probe EUP-L54MA ...................... 1 piece

2) Instruction manual ................... 1 copy

Sterilization has not been made to the probe, shipped from the

factory. Prior to use of the probe, be sure to clean, disinfect

and sterilize the probe.

1.5 External View

The external view of EUP-L54MA is shown in Fig. 1.

Immersible part (IPX7)

Head

mmersible part

Immersible part:

This part can be immersed in disinfectant

solution and also can be cleaned by water.

Un-immersible part:

This part should not be immersed in

disinfectant solution and also can not be

cleaned by water.

Fig. 1 External view of EUP-L54MA

Applied part

able

Connector

CAUTION

WARNING

-3- Q1E-EP0995

2. Inspection before Use

Prior to use, the probe must be carefully inspected that it is

appropriate for use.

2.1 Inspection of appropriate connection

2.1.1 Confirm that the system is correctly operating. Refer to the

instruction manual for the ultrasound diagnostic scanner.

2.1.2 Do not attach or connect unauthorized devices or instruments

on the probe, such as unauthorized biopsy attachments.

2.2 Inspection of material surface

2.2.1 Visually inspect the surface of the probe and head, housing,

the cable and the connector for any crack, scratch or

denaturalization. If you find any damage, do not use the probe

and contact a service support immediately.

-4- Q1E-EP0995

3. Operation Procedure

1) Confirm that the probe is cleaned, disinfected or sterilized.

2) Connect the probe, operate the main unit, and adjust the image

according to the instructions given in the operation manual for

the main unit.

3) Relationship between direction of the probe and the image is shown

in Fig. 2. The right-left orientation mark on the image indicates

the direction of the index mark on the probe.

4) Under sterile condition, protect the probe by using covers. Some

Latex material may create allergic reaction. Please use allergy

free material covers.

5) After the use of the probe, it should be cleaned and disinfected

or sterilized, then store it in an adequate place.

Fig. 2 Relationship between Index Mark and the Right-left

orientation mark

Right-left orientation mark

Index mark

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