Hitachi C41V Manuel utilisateur

C41VProbe

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‐EP1363‐6

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

0123

(1) Q1E-EP1363

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-EP1363

About this manual

This instruction manual contains safety precautions, the inspection,

the operation procedure and the reprocessing procedure of C41V Probe.

Please read this manual thoroughly to ensure the safety operation.

If you have any questions concerning the operation of the probe, please

contact a service support.

The following conventions are used throughout the manual to denote

information of special emphasis.

WARNING: “Warning” indicates the presence of a hazard which may result

in severe personal injury, substantial

roperty damage, or

death if the warning is ignored.

CAUTION: “Caution” indicates

he presence of a hazard which will or

can cause minor personal injury or property damage if the

caution is ignored.

NOTICE: “Notice” indicates information of installation, operation,

or maintenance, 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/heal

thcare/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

dark, dry place to avoid high temperature,

humidity and direct sunlight.

Contains or

presence of

natural rubber

latex

Contains or presence of natural rubber

latex

Do not

re-sterilize

Do not re-sterilize

Do not reuse

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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

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 instrumen

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-EP1363

CONTENTS Page

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

1.1 Features ·················································· 1

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

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

1.4 Components ················································ 2

1.5 Accessories (Option) ······································ 3

1.6 Construction ·············································· 4

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

2.1 Inspection for Appropriate Connection ····················· 5

2.2 Inspection for Material Surface ··························· 5

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

3.1 Connection and Settings ··································· 6

3.2 Use of Sterile Puncture Adapter (EZU-PA5V) ················ 8

3.3 Display of Needle Guide Line ······························ 9

4. Cleaning, Disinfection and Sterilization ···················· 10

4.1 Point of use (Pre-cleaning) ······························ 11

4.2 Containment and transportation ··························· 11

4.3 Manual Cleaning and disinfection ························· 12

4.4 Drying ··················································· 13

4.5 Inspection ··············································· 13

4.6 Packaging ················································ 14

4.7 Sterilization ············································ 15

4.8 Storage ·················································· 16

5. Maintenance and Safety Inspection ··························· 17

5.1 Daily Inspection ········································· 17

5.2 Storage ·················································· 17

6. Safety Precautions ·········································· 18

7. Specifications ·············································· 19

7.1 Probe ···················································· 19

7.2 Sterile Puncture Adapter EZU-PA5V ························ 20

7.3 Suppliers List ··········································· 21

8. Disposal of the probe ······································· 21

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1. Introduction

1.1 Features

C41V Probe is a Convex Array Probe.

The acoustic output of this probe when connected to ultrasound

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

The table of measured acoustic output data is contained in the

operational manual of each ultrasound diagnostic 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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WARNING

CAUTION

1.3 Intended Use

C41V Probe is designed for observation and diagnosis of the following

regions mainly by connecting with the HITACHI ultrasound diagnostic

scanner.

General OB/GYN organs

Biopsy (with a Sterile Puncture Adapter)

Transvaginal/Transrectal

Never use the probe for following regions.

1) The heart (Do not contact directly.)

2) The eyeball

1.4 Components

Components of C41V 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 the probe, be sure to clean, disinfect and sterilize

it.

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CAUTION

1.5 Accessories (Option)

1.5.1 Sterile Puncture Adapter EZU-PA5V (Disposable)

Attachment for ultrasound guided transvaginal or transrectal

biopsy and aspiration of organs, cyst and tumor. The size of

available needle is 16 to 19G. Application requires special care.

Sterile Puncture Adapter EZU-PA5V is as follows:

Component Model Note

Sterile Puncture Adapter EZU-PA5V 24 pcs

NOTE: If you need Sterile Puncture Adapters, please contact a service

support.

A well-trained physician only should perform a biopsy.

1.5.2 Mechanical Compression Unit for Elastography EZU-TEMC1 and

balloon set for Elastography EZU-TEBL2

This mechanical compression unit is used for tissue elasticity imaging,

by using the balloon attached to the probe that is connected to a

Hitachi's digital ultrasound scanner system and electronic scanning

ultrasound tomography system.

Please refer to the instruction manual of option about the method of

handling, cleaning and disinfection of EZU-TEMC1 and EZU-TEBL2.

1.5.3 Condom or Protection Sleeve for Single Use (Disposable)

To protect the probe against contamination, using only lubrication

free condom or protective tube sleeve which is dry type

recommended.

Lubrication may cause a deterioration of the probe surface. And

latex rubber may create allergic reactions, use of non-allergic

condom or sleeve is strongly recommended.

Take care for the handling of used condom or protection sleeve.

-4- Q1E-EP1363

1.6 Construction

The external view of C41V Probe is shown in Fig. 1.

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.

Fig. 1 External view

Cable

Connector

Immersible part (IPX7)

Applied part

Un-immersible part

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