Hitachi EUP-C524 Bedienungsanleitung

Convex Array Probe

EUP-C524

INSTRUCTION MANUAL

Tokyo,Japan

Q1E-EP0385-6

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-EP0385

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 Ultrasound Logistics,

Zweigniederlassung der Hitachi Medical Systems Europe

Holding AG

Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany

EU Importer: Hitachi Medical Systems Europe Holding AG

Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland

Local Distributor:

(2) Q1E-EP0385

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.

(3) Q1E-EP0385

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 Ultrasound Logistics,

Zweigniederlassung der Hitachi Medical Systems

Europe Holding AG

Carl-Zeiss-Strasse 5,

D-72555 Metzingen, Germany

Keep away from

Sunlight

Store the probe in a cool, dustproof and dark, dry

place to avoid high temperature, humidity and direct

sunlight.

(4) Q1E-EP0385

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

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-EP0385

CONTENTS

Page

1. General ························································ 1

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

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

1.3 Intended Use ························································2

1.4 Composition ·························································2

1.5 Option ······························································2

1.6 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) ·········································7

4.2 Containment and transportation ······································7

4.3 Cleaning and disinfection ···········································8

4.4 Drying ·····························································10

4.5 Inspection ·························································10

4.6 Packaging ··························································11

4.7 Sterilization ······················································12

4.8 Storage ····························································14

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 ········································· 18

-1- Q1E-EP0385

1. General

1.1 General

The probe of Model EUP-C524 is Convex Array electronic scanning

type.

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.

-2- Q1E-EP0385

1.3 Intended Use

The Convex Array Probe EUP-C524 is designed for observation and

diagnostic mainly of the following regions by connecting with

the HITACHI ultrasound scanner.

Abdominal

Pediatrics

Fetal

Small organ

1.4 Composition

The probe components of the EUP-C524 are as follows:

1) Probe EUP-C524...........1 piece

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

1.5 Option

Needle Guide Bracket EZU-PA5C2

1) Needle guide bracket.....1 piece

2) Brush....................1 piece

3) Spring (Spare)...........2 pieces

4) Instruction Manual.......1 copy

5) Biopsy case..............1 piece

Please refer to the instruction manual of option about the method

of handling, cleaning and sterilizing the needle guide bracket

EZU-PA5C2.

-3- Q1E-EP0385

1.6 External View

The external view of the EUP-C532 is shown in Fig.1.

Immersible part (IP47)

Head

Connector

Cable

Un-immersible part

(IP40)

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 the EUP-C524

Applied part

-4- Q1E-EP0385

2. Inspection before Use

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

appropriate for use.

2.1 Inspection for 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 for 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.

Inhaltsverzeichnis

Andere Hitachi Medizinische Geräte Handbücher

Hitachi

Hitachi C252 Bedienungsanleitung

Hitachi

Hitachi OPTIGEN AP 720STM Bedienungsanleitung

Hitachi

Hitachi EUP-L73S Bedienungsanleitung

Hitachi

Hitachi C22P Bedienungsanleitung

Hitachi

Hitachi EUP-C715 Bedienungsanleitung

Hitachi

Hitachi C42T Bedienungsanleitung

Hitachi

Hitachi EUP-L74M Bedienungsanleitung

Hitachi

Hitachi S211 Bedienungsanleitung

Hitachi

Hitachi VC34A Probe Bedienungsanleitung

Hitachi

Hitachi EUP-CC531S Bedienungsanleitung

Hitachi

Hitachi L441 Bedienungsanleitung

Hitachi

Hitachi EUP B715 Bedienungsanleitung

Hitachi

Hitachi L43K Bedienungsanleitung

Hitachi

Hitachi UST-5710-7.5 Bedienungsanleitung

Hitachi

Hitachi S31KP Bedienungsanleitung

Hitachi

Hitachi CC41R1 Bedienungsanleitung

Hitachi

Hitachi UST-9135P Bedienungsanleitung

Hitachi

Hitachi EUP-OL334 Bedienungsanleitung

Hitachi

Hitachi UST-678 Bedienungsanleitung

Hitachi

Hitachi UST-9124 Bedienungsanleitung

Hitachi

Hitachi EUP-VV531 Bedienungsanleitung

Hitachi

Hitachi SCENARIA Bedienungsanleitung

Hitachi

Hitachi EUP-L65 Bedienungsanleitung

Hitachi

Hitachi EUP-C516 Bedienungsanleitung

Beliebte Medizinische Geräte Handbücher anderer Marken

TekTone

TekTone Tek-CARE160 Bedienungsanleitung

NeuroMetrix

NeuroMetrix Quell 2.0 Bedienungsanleitung

AMT

AMT XLR8 Bedienungsanleitung

EDAN

EDAN SONOTRAX Pro Bedienungsanleitung

Restorative Therapies

Restorative Therapies RT300 Bedienungsanleitung

Gendex

Gendex Expert DC Bedienungsanleitung

Dexcowin

Dexcowin ADX4000W Bedienungsanleitung

Libelium

Libelium MySignals Bedienungsanleitung

Acelity

Acelity V.A.C.ULTA 4 Bedienungsanleitung

Caputron

Caputron ActivaDose II tDCS Bedienungsanleitung

Plinth 2000

Plinth 2000 93CDT Bedienungsanleitung

GE SENOGRAPHE 800T Bedienungsanleitung

GE Definium 5000 Bedienungsanleitung

Kanmed

Kanmed GE-1380 Bedienungsanleitung

Huntleigh

Huntleigh FD1 Bedienungsanleitung

Stryker

Stryker SPR Plus Bedienungsanleitung

Tobii Dynavox

Tobii Dynavox I-Series Bedienungsanleitung

S-Capepod

S-Capepod Evac Cocoon Bedienungsanleitung