Hitachi EUP-C514 Manual de usuario

ConvexArrayProbe

EUP‐C514

INSTRUCTIONMANUAL

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.

Tokyo,Japan

Q1E‐EP0428‐10



©Hitachi,Ltd.2013,2017.Allrightsreserved.

0123

(1) Q1E-EP0428

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-EP0428

About this manual

This instruction manual shall provide instructions for using, cleaning,

disinfecting and/or sterilizing the HITACHI ultrasound probe. 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-EP0428

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

tore the probe in a cool, dustproof and

dark, dry place to avoid high

temperature, humidity and direct

sunlight.

(4) Q1E-EP0428

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 1.7.

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-EP0428

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 ...........................................................3

1.6. Option of Hitachi ultrasound diagnostic scanner ..................3

1.7. External View ....................................................4

2. Inspection before Use ..................................... 5

2.1. Inspection for Appropriate Connection ............................5

2.2. Inspection for Material Surface ..................................5

3. Operation Procedure ....................................... 6

4. Option of Hitachi ultrasound diagnostic sensor ............ 7

4.1. Magnetic Sensor (EZU-RV2S) .......................................7

4.2. Magnetic Sensor (EZU-RV3S) ......................................10

5. Reprocessing Procedure ................................... 13

5.1. Point of use (Pre-cleaning) .....................................15

5.2. Containment and transportation ..................................15

5.3. Manual Cleaning and disinfection ................................15

5.4. Drying ..........................................................18

5.5. Inspection ......................................................18

5.6. Packaging .......................................................18

5.7. Sterilization ...................................................18

5.8. Storage .........................................................20

6. Maintenance and Safety Inspection ........................ 21

7. Safety Precautions ....................................... 22

8. Specification ............................................ 23

8.1. Probe ...........................................................23

8.2. Suppliers List ..................................................24

9. Disposal of the probe .................................... 24

-1- Q1E-EP0428

1. General

1.1. General

The EUP-C514 is a convex array probe.

The acoustic output of the EUP-C514 was measured according to the

IEC60601-2-37 standard and the measurement was conducted by operating

with the Hitachi ultrasound diagnostic scanner.

The measured acoustic output is listed in the instruction manual of

the Hitachi ultrasound diagnostic scanner.

The EUP-C514 is categorized in class IIa according to Directive

93/42/EEC and classified as type BF according to IEC60601-1.

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.

-2- Q1E-EP0428

WARNING

CAUTION

1.3. Intended Use

The EUP-C514 is designed for observation and diagnosis mainly of the

following regions by connecting with the Hitachi ultrasound diagnostic

scanner.

General abdominal organs

General OB/GYN organs

Biopsy (with Biopsy Attachment)

Never use the probe for following applications.

Direct contact to the heart.

Biopsy to the heart.

1.4. Composition

The components of the EUP-C514 are given follows:

1) Probe EUP-C514 ··············· 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 and sterilize the probe.

-3- Q1E-EP0428

CAUTION

1.5. Option

1.5.1. Biopsy Attachment EZU-PA34T

The biopsy attachment EZU-PA34T is a dedicated tool for use as mounted

on a EUP-C514. The optional biopsy attachment EZU-PA34T components are

as follows:

1) Biopsy guide assembly ········ 1 piece

2) Needle guide

(14G, 18G and 21G) ··········· 1 each

3) Brush ························ 1 piece

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 biopsy attachment EZU-PA34T.

1.5.2. Needle Guide Bracket EZU-PA5C1

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-PA5C1.

1.6. Option of Hitachi ultrasound diagnostic scanner

1.6.1. Magnetic Sensor Attachment

1) Magnetic sensor attachment

2) Spacer for EZU-RV2S

Please refer to this instruction manual about the method of handling,

cleaning and sterilizing the Magnetic sensor attachment.

The probe has not been sterilized when it was shipped from a factory.

So before using the probe, clean, disinfect and if necessary sterilize

the probe certainly.

-4- Q1E-EP0428

1.7. External View

Immersible part (IP47)

Un-Immersible part

(IP40)

Applied part

Head

able

Connector

Spacer for EZU-RV2S

(Option of Hitachi

ultrasound diagnostic

scanner)

Magnetic sensor attachment

(

Option of Hitachi ultrasound

diagnostic scanner)

Fig. 1 External View

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 cannot be

cleaned by water.

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