Hitachi L34 Manuale utente

L34 Probe

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP1361-7

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-EP1361

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-EP1361

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 ultrasound diagnostic scanner,

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-EP1361

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-EP1361

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 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-EP1361

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 Option ..............................................................3

1.6 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. Reprocessing Procedure ......................................... 8

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

4.2 Containment and transportation .....................................11

4.3 Manual Cleaning and disinfection ...................................11

4.4 Drying .............................................................14

4.5 Inspection .........................................................14

4.6 Packaging ..........................................................14

4.7 Sterilization ......................................................14

4.8 Storage ............................................................16

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

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

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

7.1 Probe ..............................................................19

7.2 Suppliers List .....................................................20

8. Disposal of the probe ......................................... 20

-1- Q1E-EP1361

1. Introduction

1.1 Features

L34 Probe is a linear array electronic scanning type probe.

The acoustic output of these probes when connected to the 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 IEC 60601-1, L34 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-EP1361

1.3 Intended Use

L34 Probe is designed for observation and diagnosis mainly of the

following regions by connecting with the HITACHI ultrasound

diagnostic scanner.

Small organ

Peripheral Vessel

Pediatric

Abdominal

Biopsy (with coupler attachment)

Never use the probe for following applications.

Direct contact to the heart.

Biopsy to the heart.

Direct contact to the eye

1.4 Components

The components of L34 Probe are given below:

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 the probe.

WARNIN

CAUTION

-3- Q1E-EP1361

1.5 Option

1.5.1 Coupler attachment EZU-PA3C1 (Option)

By attaching the coupler attachment EZU-PA3C1, detecting of the

blood flow in the shallow blood vessel is possible, by keeping

a suitable angle. The optional coupler attachment EZU-PA3C1

components are as follows:

Component Model Note

1 Coupler attachment EZU-PA3C1 2 pieces

2 Instruction manual - 1 copy

1.5.2 Coupler attachment EZU-PA3C1H (Option)

By attaching the coupler attachment EZU-PA3C1H, additionally to

the blood flow detection a biopsy through the needle guide is

possible.

The optional coupler attachment EZU-PA3C1H components are as

follows:

Component Part number Model Note

1 Coupler attachment - EZU-PA3C1H 2 pieces

2 Needle Guide * 7424250A - 2 pieces

3 Instruction manual - - 1 copy

* A 20-22 gauge biopsy needle is available inside the needle guide.

1.5.3 Coupler attachment EZU-PA3C2 (Option)

By attaching the coupler attachment EZU-PA3C2, the images for

shallow parts by shifting of a focal zone to the parts are

improved.

The optional coupler attachment EZU-PA3C2 components are as

follows:

Component Model Note

1 Coupler attachment EZU-PA3C2 2 pieces

2 Immobilizing band - 2 pieces

3 Instruction manual - 1 copy

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

of handling, cleaning, disinfection and sterilizing them.

A biopsy should be performed only by a well-trained physician.

Use only the authorized coupler attachment for performing a biopsy.

Before performing a biopsy, display the needle echo in sterile water,

and confirm that the needle echo at each angle overlaps with the

correspondent needle guideline. For the confirmation procedure in

detail, refer to the instruction manual of EZU-PA3C1H.

CAUTION

-4- Q1E-EP1361

1.6 External View

The external view of L34 Probe is shown in Fig. 1.

mmersible part (IP

)

Head

Connector

Cable

Un-

mmersible 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.

Fig. 1 External view

Applied part

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