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

(1) Q1E-EP0304
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:

(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
[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.

(4) Q1E-EP0304
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.

(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
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
)

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

-5- Q1E-EP0304
5. Pre-use Inspection
The Laparoscopic Ultrasound probe must be inspected prior to every
exam.
-By running your fingers about the exterior surfaces of the
transducer, articulating section, and rigid shaft, carefully
inspect for any signs of mechanical damage such as cracks, cuts,
tears, perforations, or protrusions. Any such damage could
compromise the electrical safety of the probe or cause lacerations
to the patient.
-Inspect the probe cable for damage, i.e. nicks, cuts, or tears in
the cable jacket.
-Check the control levers for proper operation. The levers should
move freely, without binding, and easily move the transducer
through its full range of movement.
If any damage is detected, do not use the probe. There are no
user serviceable parts associated with this instrument. Return
the probe to us or our authorized agent for service.
WARNING

-6- Q1E-EP0304
6. Cleaning, Disinfection and Sterilization
The probe must be reprocessed after each use. Refer to the
reprocessing instruction in this chapter.
WARNINGS
‐The probe is delivered un
s
terile. Prior to the first
use, reprocess the probe.
‐Temperature should not exceed 60°C during
reprocessing
‐Probe connector is not water resistant.
Limitations on
reprocessing
T
he probe is not completely submersible. The immersible
part is shown in Fig.1. The un-
i
mmersible part should
be disinfected by wipe disinfection.
Transportation
before using
T
he probe should be packed in a sterile pouch or
c
ontainer to transport from Central Sterile Supply
D
epartment (CSSD) to an operating room. Be careful not
to damage the sterile pouch or container during
transportation.

-7- Q1E-EP0304
Levels of reprocessing requirements:
Depending on the application of the product and with regard to risk
evaluation, the user has to classify the medical device according to the
current Medical Device Directive for processing of medical devices as
uncritical, semi-critical or critical. Supporting information concerning
this topic is listed in the table below. The user is responsible for correct
classification of the medical device.
Classification Definition Processing
uncritical
Application part only
contacts intact and
uninjured skin
Cleaning
Disinfection
semicritical
Application part contacts
mucosa (intracavitary
application)
Cleaning
D
isinfection (Disinfectant
with virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly
(operative application)
Cleaning
D
isinfection (Disinfectant
with virucidal effect -
minimum)
Sterilization
According to the intended use, EUP-OL334 is classified as critical.

-8- Q1E-EP0304
The flowchart of the reprocessing process of this probe is as follows.
Point of use
(Pre-cleaning)
Manual Cleaning
Rinsing after
m
anual
cleaning
Manual Disinfection
Drying
Manual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
Sterilization
Containment and
transportation

-9- Q1E-EP0304
6.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after each
use. The procedure is as follows:
1) Remove the protective cover.
2) Clean the probe of all patient’s blood or fluid with running tap water
until the surface of the probe looks visually clean.
3) Wipe the whole surface of the probe with gauze pad and remove superficial
visible impurities.
6.2 Containment and transportation
Putting the contaminated equipment into exclusive
shock and damage proof container for transportation is recommended. It
is recommended that instruments are reprocessed as soon as possible and
not later than 4 hours after usage.
6.3 Manual Cleaning and disinfection
Prepare following items before manual
cleaning and disinfection:
a) Detergent: Cidezyme (Johnson & Johnson,
#2258)or another cleaning agent with
approved material compatibility for this
medical device.
b) Disinfectant: Cidex OPA (Johnson & Johnson,
# 20391)or another disinfectant with
approved material compatibility for this
medical device.
c) Two tanks, one for cleaning and one for
disinfection - optional:
1 additional tank for rinsing with deionized/tap water (sufficient size
for immersion of the immersible part of the probe at full length)
d) Soft, fluff free cloth or single use towel
e) Personal protective equipment (gloves, water repellent protective
Point of use
(Pre-cleaning)
Containment and
transportation
Manual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning and
disinfection

-10- Q1E-EP0304
skirt, face protection mask or protective glasses, see also
instructions of the manufacturer for the detergent and the
disinfectant)
Manual Cleaning:
Prepare the detergent solution in a tank with cold water (please follow
the instructions of the detergent manufacturer regarding application,
dilution and contact time).
1) The temperature of the detergent solution should be between 15-30 °C,
concentration is 1.6%. Please note the minimum contact time of the
detergent in the manufacturer’s instruction. If a differing detergent
is used, please also note the approved material compatibility for the
medical device.
2) Immerse the immersible part of the probe without connector into the
diluted detergent solution (see Figure 3). Wipe the immersible part
of the probe under the surface of the detergent solution with a soft
cloth to remove all visible soil. Be sure that all grooves of the probe
are implemented during the cleaning process.
3) The immersible part of the probe should be left in the detergent
solution according to the specified contact time of the detergent
manufacturer.
4) Wipe the un-immersible parts of the probe with a soft cloth dipped
with the detergent solution.
5) Rinse the immersible part of the probe with running tap water for 1
minute. (alternatively: immerse the immersible part of the probe in
a tray filled with deionized water/tap water (see Fig.3) for 5 min.)
6) Visually check the outer surface of the probe for cleanness. If
necessary, use magnifying glass for visually check. If there is still
soil visible, repeat all above steps.
Manual disinfection:
1) Prepare the disinfectant solution in a tank with cold water (please
follow the instructions of the disinfectant manufacturer regarding
application, concentration, microbiological efficiency, service life

-11- Q1E-EP0304
and contact time).
2) Confirm the concentration of the disinfectant before immersing the
probe. Although Cidex® OPA does not need to be diluted, it is recommended
to use test strips to verify the concentration. The test strips can
indicate whether or not the concentration is above the Minimum
Effective Concentration (MEC). Please also note the expiration date
of the test stripes. Temperature of disinfectant solution should be
minimum 20 °C. The minimum contact time is 5 minutes. If a different
disinfectant is used, follow the manufacturer’s instructions. Please
also consider the material compatibility for the medical device.
3) Immerse the immersible part of the probe into the disinfectant (see
Fig. 3). Set a clock to insure the recommended contact time which is
5 minutes.
4) Rinse the immersible part of the probe with deionized water for 1 minute.
(alternatively: immerse the immersible part of the probe in a tray
filled with deionized water (see Fig.3) for 5 min.)
5) Visually check the outer surface of the probe for leavings of the
disinfectant. If necessary, repeat the rinsing.
6.4 Drying
1) Wipe the equipment with a single-use, fluff-free wipe or towel to remove
moisture from the surface of the equipment.
Fig.3 Immersion of
t
he probe
.
Drying
Water,
Detergent or
Disinfectant

-12- Q1E-EP0304
2) Dry the equipment naturally in an ambient temperature between 15-30°C
for a minimum of 4 hours. Alternatively the equipment can be dried using
a drying heater at a temperature of less than 60°C.
6.5 Inspection
Inspect the equipment for any damage such as crack, scratch or deformation.
Do not use it if any damage is found.
6.6 Packaging
Pack the equipment in a sterile barrier such as Polypropylene fleece or
transparent package made from Polyethylene film and Tyvek®, and then place
it into a tray. The tray should be also covered with a sterile barrier.
The equipment can be packed in a simple or double packing.
Please note that the size of a sterile barrier should be large enough
to be able to pack the equipment leaving sufficient space to seal it
completely.
A sterile barrier should be sealed by an appropriate sealing machine and
it is important to confirm that the package is sealed completely. If the
sealing is not complete, pack and reseal again.
Packaging

-13- Q1E-EP0304
6.7 Sterilization
The probe and accessory can be sterilized using either ethylen oxide gas
(EtO) sterilization or plasma sterilization (see table below).
Follow the manufacturer's instructions of the sterilizer regarding usage,
temperature and sterilization-time.
The sterilization method and operating conditions are as follows.
Sterilization Method Condition
Plasma Sterilization:
STERRAD® 100S or 200 (*) Short Cycle
ETO Sterilization
Gas Type: 10% EO/ 90% HCFC
Temperature: 50-55°C
Exposure Time: More than 120 minutes
Pressurization: 162-200kPa
Depressurization: 13-8kPa
Relative humidity: 40-90%
Aeration is minimum 12 hours
* STERRAD® systems are manufactured by "Johnson & Johnson"
* This probe cannot put into STERRAD® 50 system because the chamber is
small for putting this probe.
1) Before performing sterilization, check that the operation data
of sterilizer are in conjunction with min. and max. data
applicable for the probe.
2) Do not sterilize the probe by Steam Autoclaving. If you autoclave
it, it suffers serious damage and will be not functional.
1) Plasma Sterilizer, STERRAD® NX™ is not applicable to this probe. Please
use the systems other than STERRAD® NX™ series.
2) Never perform sterilization other than specified. The probe may be
damaged.
Sterilization
WARNING
CAUTION

-14- Q1E-EP0304
The packaging before sterilization is as follows.
1) Put the probe into TYVEK pouch.
2) Seal the TYVEK Pouch using a heat sealer. Ensure that the seal is
complete.
3) Put the sealed pouch into a tray or plastic mesh wire for sterilization.
Probe
T
YVEK
Pouch
Probe
T
YVEK
Pouch
Sealed
Fig.4 Packaging in the pouch
Fig.5 Sealing