Hitachi EUP-F531 User manual

Finger‐topProbe
EUP‐F531
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‐EP0415‐7
© 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:

(2) Q1E-EP0415
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 main unit, 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 i
n
jury or property damage if
the caution is ignored.
NOTICE: “Notice”
i
s 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
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 1.5.
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. Introduction ················································· 1
1.1. Features ··················································· 1
1.2. Principles of operation ···································· 1
1.3. Intended Use ··············································· 1
1.4. Components ················································· 2
1.5. External View ·············································· 2
2. Inspection before Use ········································ 3
2.1. Inspection for Appropriate Connection ······················ 3
2.2. Inspection for Material Surface ···························· 3
3. Operation Procedure ·········································· 4
4. Cleaning, Disinfection and Sterilization ····················· 5
4.1. Point of use (Pre-cleaning) ································ 6
4.2. Containment and transportation ····························· 6
4.3. Manual Cleaning and disinfection ··························· 7
4.4. Drying ····················································· 8
4.5. Inspection ················································· 8
4.6. Packaging ·················································· 9
4.7. Sterilization ·············································· 9
4.8. Storage ··················································· 11
5. Maintenance and Safety Inspection ··························· 11
6. Safety Precautions ·········································· 11
7. Specifications ·············································· 12
7.1. Probe ····················································· 12
7.2. Suppliers List ············································ 13
8. Disposal of the probe ······································· 13

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1. Introduction
1.1. Features
The probe of Model EUP-F531 is Convex Array electronic scanning type.
The acoustic output of this probe when connected to ultrasound scanner
was measured according to the IEC60601-2-37 standard. The table of
measured acoustic output data is contained in the operation manual of
each ultrasound scanner. This probe is categorized in class IIa
according to Directive 93/42/EEC. According to IEC 60601-1 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.
1.3. Intended Use
The Finger-top Probe EUP-F531 is designed for observation and diagnosis
mainly of the following regions by connecting with the HITACHI
ultrasound scanner.
Intra-operative
Fetal
Pediatric
Small organ
Peripheral Vessel
Transrectal
Transvaginal
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
WARNING

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1.4. Components
The components of EUP-F531 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.
1.5. External View
The external view of EUP-F531 is shown in Fig.1.
Immersible part: This part can be immersed
i
n 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
Immersible part (IPX7)/
Applied Part
U
n
-
i
mmersible part
Cable
Connector
Head
CAUTION

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that they are
appropriate for use. If not, do not use the probe and immediately contact
a service support.
2.1. Inspection for Appropriate Connection
1) Do not attach or connect unauthorized devices nor instruments on the
probe, such as unauthorized biopsy attachments.
2) Check that the system is correctly operating. Refer to the
instruction manual for the main unit.
2.2. Inspection for Material Surface
Visually inspect the surface of the probe and head, housing, the cable
and the connector for any crack, scratch or denaturalization. If you
find any damage, do not use the probe and contact a service support
immediately.

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3. Operation Procedure
1) Confirm that the probe is disinfected and sterilized.
2) When connecting probe to or removing it from the scanner, the power
of scanner should be put “OFF” without fail.
3) Connect the probe, operate the main unit, and adjust the image
according to the instructions given in the operation manual for the
main unit.
4) Relationship between direction of the probe and the image is shown
in Fig.2. The right-left orientation mark on the image indicates the
direction of the cable side of the probe.
5) Under sterile condition, protecting the probe by using covers is
strongly recommend. Some Latex material may create allergic reaction.
Please use allergy free material covers.
6) After use of the probe, it should be cleaned and disinfected and
sterilized, then store it in an adequate place.
1) Acoustic jelly attached to the scanner as one of accessories is not
sterilized. So, in case the probe is to be used during the surgical
operation or in body cavities, never apply that jelly to the probe.
2) In case the probe is to be used during the surgical operation, we
recommend you to use a sterilized probe cover in order to minimize
sticking of body fluid to the probe. Apply sterilized jelly to the
probe, and then put the probe cover on the probe head. Tightly contact
the probe head with the probe cover.
Fig. 2 Relationship between the directions of the
probe and the Right-left orientation mark
Right-left
orientation mark
C
able side
CAUTION

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4. Cleaning, Disinfection and Sterilization
The probe and accessory must be reprocessed after each use. Refer
to the reprocessing instruction in this chapter.
WARNINGS
‐The probe is delivered unsterile. 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
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
part should be disinfected by wipe disinfection.
Transportation
before using
The 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 dama
g
e the sterile pouch or container during
transportation.
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
Disinfection
(Disinfectant with
virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly
(operative application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
According to the intended use, EUP-F531 probe is classified as critical.

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The flowchart of the reprocessing process of this probe is as follows.
4.1. 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.
4.2. 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.
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
Point of use
(Pre-cleaning)
Containment and
transportation

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4.3. 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
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 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.
M
anual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning
and disinfection

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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 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.
4.4. Drying
1) Wipe the equipment with a single-use, fluff-free wipe
or towel to remove moisture from the surface of the equipment.
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 55 °C.
4.5. Inspection
Inspect the equipment for any damage such as crack, scratch or
deformation. Do not use it if any damage is found.
Drying
Fig. 3 Immersion of
the probe
Water, Detergent
or Disinfectant

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4.6. 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.
Additionally the equipment can be placed on plastic mesh wires supplied
for plasma sterilization and then packed as mentioned above.
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.
4.7. 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® 50, 100S or 200 (*) Short Cycle
Plasma Sterilization:
Sterrad® NX or 100NX (*) Standard 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"
1) Before performing sterilization, check that the operation data of
sterilizer are in conjunction with min. and max. data applicable for
the probe and the Magnetic sensor attachment.
2) Do not sterilize the probe and the Magnetic sensor attachment by Steam
Autoclaving. If you autoclave them, they suffers serious damage and
will be not functional.
Packaging
Sterilization
WARNING

-10- Q1E-EP0415
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
F
ig.
4
P
ackaging in the pouch
T
YVEK Pouch
Sealed
Probe
F
ig.
5
S
ealing
Fig. 6 Packaging in a tray
Probe in
the Pouch
Tray for
sterilization

-11- Q1E-EP0415
4.8. Storage
Store the equipment in a cool, dustproof, dry, and dark
s
pace
to avoid high temperature, humidity and direct sunlight.
Limitations for the time for sterilized equipment belong to
package.
5. Maintenance and Safety Inspection
1) After using the probe, it
s
hould be cleaned and disinfected
or sterilized according to “4.
C
leaning, Disinfection and
Sterilization”, store the probe in a cool and dark space to
avoid high temperature, humidity and direct sunlight.
2) Visually inspect the surface of the probe head, the housing, the cable
and the connector for any crack, scratch or denaturalization. If you
find any damage, do not use the probe, and contact a service support
immediately.
6. Safety Precautions
Never use the probe if the probe head, housing or cables are cracked
or damaged.
Warning is case of using probe covers which latex is contained to.
The latex may cause such allergic reactions as itching, rubor,
urticaria, swelling, fever, anhelation, wheezing, and depression of
blood pressure, shock and so on. For the patients suspected of latex
allergy, do not use the latex-containing medical devices. If you
observe any of above mentioned symptoms in your patient during the
operation, stop the use of the latex-containing medical devices
immediately and take an appropriate treatment to the patient.
By examination of an early pregnancy the exposure time shall be as
short as possible. Start examination with acoustic output power set
to L (Low).
The probe connector is not water proof. Do not allow liquid to contact
the connector.
Do not drop, hit or bent the probe.
Use only water, detergents and disinfectants in the suppliers list.
Between uses store the probe holder of scanner.
The probe is not delivered disinfected or sterilized.
WARNING
CAUTION

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7. Specifications
7.1. Probe
Type: EUP-F531
Center frequency: 6.5MHz
Technology: High density Convex Array Probe
Dimensions: See Fig. 7
Weight: Approx. 0.6kg (incl. cable and connector)
Scanning angle: 100°
Probe materials: Bio-compatible allergy free components
Acoustic output: According to IEC60601-2-37 (See Main Unit
manual.)
Applicable system: Depending on production and upgrade
status.
F
or detailed information contact
a service support.
Classification: MDD classification IIa.
Cleaning:
A
pplicable detergents are listed in the
suppliers list
Disinfection:
A
pplicable disinfectants are listed in
the suppliers list
Sterilization: ETO gas sterilization
Operating conditions:
Ambient temperature; 25 – 35°C
Contact surface temperature
(temperature of examinee);
Max. 42°C
Relative humidity; 30 – 85%
Storage conditions:
Temperature; –10 – +55°C
Relative humidity; 10 – 95% (subject to no condensation)

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7.2. Suppliers List
The products listed below are seriously tested and approved for use
with the Convex Array Probe EUP-F531.
Product name manufacturer purpose
Cidezyme Johnson & Johnson Enzymatic detergent
Meliseptol HBV-Tücher Braun Disinfectant
Incidin Liquid Henkel Hygiene GmbH Disinfectant
Incidur Spray Henkel Hygiene GmbH Disinfectant
STERANIOS 2% ANIOS Disinfectant
Bacillol 25 BODE CHEMIE Disinfectant
CIDEX Johnson & Johnson Disinfectant
CIDEX plus Johnson & Johnson Disinfectant
CIDEX OPA Johnson & Johnson Disinfectant
Gigasept FF Schülke & Mayr Disinfectant
ALKACIDE ALKAPHARM Disinfectant
ANIOXYDE 1000 Laboratoires ANOIS Disinfection
Virkon S Antec Disinfectant
ALKAZYME ALKAPHARM Cleaner
Please contact your local distributor for a current version of the
"Disinfectant/Sterilization Method Compatibility for Ultrasound Probe
and Accessory List
8. Disposal of the probe
Recycle or dispose of equipment properly in compliance with your
organizational rules and your local laws.
Before disposing of equipment, disinfect or take other
infection-prevention measures.
Disposal of equipment without taking the proper preventative
measures can lead to infection.
Waste Electrical and Electronic Equipment (WEEE) Directive
The illustration on the right is required by the EU
WEEE Directive to appear on all electrical and
electronic equipment.
For proper disposal of this product in an EU nation,
contact an EU office or agency and observe
appropriate local and national regulations and laws.
CAUTION

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E
Q1E-EP0415
Unit:mm
Fig. 7 Dimensions
21
29.5
2200
1
6
15060
65