Hitachi EUP-OL334 User manual

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
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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Manufacturer: Hitachi,Ltd.
2-16-1, Higashi-Ueno,Taito-ku,
Tokyo,110-0015,Japan
[phone]
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:

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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.

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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
[phone]
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.

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Definition of symbol
The following symbol is also used for HITACHI Ultrasound Probes.
Location Symbol Definition
Probe connector
T
his instrument complies with Directive
9
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.

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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

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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.

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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
2
)
Articulatin
g
section
1) Transducer
8
) System end connector
7
) Cable
4
) Grip section
5
) Left lever
6
) Right lever
9) Watertight section
(
IP
X
7
)

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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

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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
Up
Down
(
Forward) Left Right
(Backward)
(Forward) Down Up (Backward)
L
eft
Fig.2 Articulating Controls
WARNING