Hitachi EUP-OL334 Bedienungsanleitung

Laparoscopic Probe

EUP-OL334

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-EP0304-8

0123

(1) Q1E-EP0304

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-EP0304

About this manual

Before handling the Laparoscopic Ultrasound probe, read this instruction

manual carefully.

This instruction manual is intended to provide the ultrasound system user

with important information relating to the features, specifications, and

proper care of the Laparoscopic Ultrasound probe.

This instruction manual presents warnings about possible probe damage

that can occur as a result of improper handling and the potential hazards

such probe damage presents to patients undergoing a laparoscopic

ultrasound imaging procedure.

This instruction manual in no way presumes to provide instructions or

recommendations in laparoscopic imaging techniques or protocol.

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-EP0304

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 place and keep

away from high temperature, high humidity,

or direct sunlight.

(4) Q1E-EP0304

Definition of symbol

The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol Definition

Probe connector

his instrument complies with Directive

3/42/EEC relating to Medical Device and

Directive 2011/65/EU relating to RoHS

Probe connector IPX7

IPX7 mark

See section 3.

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-EP0304

CONTENTS

Page

1. Purpose, Features and Operating Conditions .....................1

1.1 Purpose ...................................................1

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

1.3 Features ..................................................1

1.4 Operating Conditions ......................................2

2. Equipment Composition ..........................................2

3. Component Description ..........................................2

4. Articulating Controls ..........................................4

5. Pre-use Inspection .............................................5

6. Cleaning, Disinfection and Sterilization .......................6

6.1 Point of use (Pre-cleaning) ...............................9

6.2 Containment and transportation ............................9

6.3 Manual Cleaning and disinfection ..........................9

6.4 Drying ...................................................11

6.5 Inspection ...............................................12

6.6 Packaging ................................................12

6.7 Sterilization ............................................13

6.8 Storage ..................................................15

7. Operation .....................................................15

8. Maintenance and Safety Inspection .............................18

9. Storage .......................................................18

10. When Fault is Suspected .......................................18

11. Specifications ................................................19

12. Disposal of the probe .........................................20

-1- Q1E-EP0304

1. Purpose, Features and Operating Conditions

1.1 Purpose

This probe has been designed to observe the gallbladder, liver

and so on under the laparoscopic operation with it connected

to the Hitachi Electronic Ultrasound Scanner.

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.

1.3 Features

1) Frequency of 7.5MHz allows you to obtain a sharp image of

shallow area.

2) Scanning system of 40R convex allows you to observe a wide

field of view.

3) It is provided with the articulating mechanism with which

the transducer tip may be articulated 90° in the up/down and

right/left planes respectively. This mechanism allows you

to make a diagnosis of suitable region.

-2- Q1E-EP0304

1.4 Operating Conditions

Be sure to observe the following conditions when using this

probe:

a) Ambient temperature : +5°C ~ +35°C

b) Relative humidity : 30 ~ 85%

c) Atmospheric pressure : 70 ~ 106hPa

2. Equipment Composition

1) Laparoscopic probe......... 1

2) Carrying case.............. 1

3) Instruction Manual......... 1

3. Component Description

3) Inserting section(Applied part)

Fig.1 Component Description

10) Non watertight section

)

Articulatin

section

1) Transducer

) System end connector

) Cable

) Grip section

) Left lever

) Right lever

9) Watertight section

(

)

-3- Q1E-EP0304

1) Transducer : Transmits and receives ultrasound.

2) Articulating section : Section to articulate the transducer tip in

the up/down plane or right/left plane with

the right or left lever.

3) Inserting section : Section that can be inserted into the trocar.

4) Grip section : Section to grip the probe.

5) Left lever : Lever to control articulation in the up/down

plane.

6) Right lever : Lever to control articulation in the

right/left plane.

7) Cable : Cable to connect the grip and the system end

connector.

8) System end connector : Section to connect this instrument with the

ultrasound scanner unit.

9) Watertight action : Section that can be immersed in the sterilant

solution and section cleaning solution.

10) Non watertight action : Section that should not be poured on section

with water or the section sterilant solution,

or should not be immersed in it. Otherwise

it may be damaged. Never immerse it in water

or the sterilant solution.

Never use the probe which transducer and inserting section show

any damage such as cracks or cuts, or which cable jacket is broken.

If using as it is damaged, electric shock may result.

Connector section of the probe is not watertight. Never pour any

liquid on it or immerse it in any liquid. If neglected, it may

be damaged.

WARNING

CAUTION

-4- Q1E-EP0304

4. Articulating Controls

The control handle section of the probe features two control levers

that are used to control the movement and position of the articulating

section/transducer.

Never bend or manipulate the articulating section of the probe

with your hands or fingers. This can result in severe damage

to the articulating mechanism.

The Laparoscopic Ultrasound probe is a precision equipment and care

must be exercised to avoid damaging it. The Laparoscopic Ultrasound

probe should only be handled by trained personnel.

The left lever controls articulating in the up/down plane.

Forward=down; backward=up. The right lever controls articulation in

the left/right plane. Forward=left; backward=right. Refer to

Fig.2.

Right lever

Left

Right

Down

(

Forward) Left Right

(Backward)

(Forward) Down Up (Backward)

eft

Fig.2 Articulating Controls

WARNING

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