Hitachi EUP-LV74 Bedienungsanleitung

Linear Array Probe

EUP-LV74

INSTRUCTION MANUAL

Notes for operators and responsible maintenance personnel

Please read through the Instruction Manual carefully prior

to use.

Keep this Instruction Manual for future reference whenever

necessary.

Tokyo , Japan

Q1E-EP1191-6

0123

(1) Q1E-EP1191

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-EP1191

About this manual

This instruction manual shall provide the procedure for inspection,

operation and reprocessing of the EUP-LV74. The manual also

contains the general information and the specification of the

probe. The probe is usable with the HITACHI ultrasound diagnostic

scanner. About the operation of the HITACHI ultrasound diagnostic

scanner please refer to its instruction manual.

To ensure safe operation, it is essential that you fully understand

the function, operating and maintenance instructions by

thoroughly reading and understanding this manual. Please contact

a service support, if you have any questions concerning the

operation of the probe.

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-EP1191

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,

dark and dry place and keep away from

high temperature, high humidity and

direct sunlight.

(4) Q1E-EP1191

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 1.6.

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 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-EP1191

CONTENTS

Page

1. Introduction ······························································································ 1

1.1 General··························································· 1

1.2 Principles of operation··········································· 1

1.3 Intended Use······················································ 1

1.4 Components List··················································· 1

1.5 Accessories······················································· 2

1.6 External View····················································· 3

2. Inspection procedure ·················································································· 4

3. Operation Procedure ·················································································· 5

4. Reprocessing Procedure ············································································· 6

4.1 Point of use (Pre-cleaning)······································· 9

4.2 Containment and transportation···································· 9

4.3 Manual Cleaning and disinfection·································· 9

4.4 Drying···························································· 12

4.5 Inspection························································ 12

4.6 Storage··························································· 12

5. Daily Inspection (Maintenance) ···································································· 13

6. Safety Precautions ···················································································· 13

7. Specifications··························································································· 14

7.1 Probe····························································· 14

7.2 Suppliers List···················································· 15

8. Disposal of the probe················································································· 16

-1- Q1E-EP1191

1. Introduction

1.1 General

The model EUP-LV74 is a linear array electronic scanning type

probe. The probe is capable of acquiring Real-time 3D image by

mechanical drive of the acoustic elements.

The acoustic output was measured with operating the Hitachi

Ultrasound diagnostic scanner according to the IEC 60601-2-37

standard. The measured acoustic output is listed in the

instruction manual of the Hitachi ultrasound scanner.

The probe is categorized in class IIa according to Directive

93/42/EEC and classified as type BF according to IEC 60601-1.

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 EUP-LV74 is designed for observation and diagnosis, mainly

of the following regions.

The EUP-LV74 is operational with only the HITACHI ultrasound

scanner.

Mammary gland

Thyroid

Superficial organs

1.4 Components List

The components of the EUP-LV74 are given below.

1) EUP-LV74..................... 1 piece

2) Instruction Manual........... 1 copy

3) Correct Backlash CD-ROM...... 1 piece

-2- Q1E-EP1191

The CD-ROM contains the probe’s specific parameters to be loaded

to the Hitachi ultrasound diagnostic scanner. Hitachi service

engineer installs the CD-ROM to the scanner. Store the CD-ROM

in a safe place.

1.5 Accessories

1.5.1 Needle Guide Bracket EZU-PA7LV1 (Option)

(1) Needle guide bracket ····· 1 piece

(2) Brush ···················· 1 piece

(3) Spring (Spare) ··········· 2 pieces

(4) Instruction manual ······· 1 copy

(5) Case ····················· 1 piece

Please refer to the instruction manual of EZU-PA7LV1 about the

method of handling, cleaning and disinfecting the needle guide

bracket EZU-PA7LV1.

CAUTION

-3- Q1E-EP1191

1.6 External View

The external view of the EUP-LV74 is given in Fig. 1.

Immersible part (IP

)

Un-

mmersible

part

Scan head

andle housing

Cable

Connector

Immersible part: This part can be immersed in disinfectant

solutio

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.

. 1

xternal View

Applied part

-4- Q1E-EP1191

2. Inspection procedure

Prior to each use, the probe must be carefully inspected that

it is appropriate for use.

(1) Visually inspect the surface of the probe head, the housing,

the cable and the connector for any crack, scratch or

denaturalization.

(2) Confirm that neither unauthorized devices nor instruments

such as unauthorized biopsy attachments are attached to the

probe.

(3) Inspect that the ultrasound diagnostic scanner with which the

probe is connected is correctly operating.

If you find any abnormality, do not use the probe, and immediately

contact a service support.

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