Hitachi S31 Bedienungsanleitung

S31 Probe

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP1376-5

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-EP1376

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-EP1376

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 for 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.

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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-EP1376

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 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.

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CONTENTS

Page

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

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

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

1.3Intended Use............................................. 2

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

1.5External View............................................ 3

2.Inspection before Use ............................... 4

2.1Inspection for Appropriate Connection.................... 4

2.2Inspection for Material Surface.......................... 4

3.Operation Procedure .................................5

4.Cleaning, Disinfection and Sterilization ............ 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Packaging............................................... 12

4.7Sterilization........................................... 13

4.8Storage................................................. 15

5.Maintenance and Safety Inspection .................. 15

6.Safety Precautions .................................16

7.Specifications .....................................17

7.1Probe................................................... 17

7.2Suppliers List.......................................... 18

8.Disposal of the probe .............................. 19

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1. Introduction

1.1 Features

S31 probe is a phased array sector scanning 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 IEC60601-1 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.

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1.3 Intended Use

S31 Probe is designed for observation and diagnosis mainly of the

following regions by connecting with the HITACHI ultrasound scanner.

Pediatric

Never use the probe for following applications.

1) Direct contact to the heart.

2) Biopsy to the heart.

3) Direct contact to the eye

1.4 Composition

The probe components of S31 Probe are as follows:

1) Probe ········································ 1 piece

2) Instruction Manual ··························· 1 copy

Sterilization has not been made to the probe shipped from the

factory.

Prior to use of it, be sure to clean, disinfect and sterilize

it.

WARNING

CAUTION

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1.5 External View

The external view of S31 Probe is shown in Fig. 1.

Ｈｅａｄ

Un-immersible 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.

xternal View

Immersible part (IPX7)

Applied part

Cable Connector

- 4 - Q1E-EP1376

2. Inspection before Use

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

appropriate for use. If not, do not use the probe and immediately

contact a service support.

2.1 Inspection for appropriate connection

1) Confirm that the system is correctly operating. Refer to the

instruction manual for the ultrasound diagnostic scanner.

2) Do not attach or connect unauthorized devices nor instruments

on the probe, such as unauthorized biopsy attachments.

2.2 Inspection of material surface

Visually check the surface of the probe head, housing and cable for

any crack, scratch or denaturalization.

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