Hitachi EUP-F531 Bedienungsanleitung
Finger‐topProbe
EUP‐F531
INSTRUCTIONMANUAL
Notesforoperatorsandresponsiblemaintenancepersonnel
★PleasereadthroughthisInstructionManualcarefullypriortouse.
★KeepthisInstructionManualtogetherwiththesystemwithcaretomakeit
availableanytime.
Tokyo, Japan
Q1E‐EP0415‐7
© Hitachi, Ltd. 2013, 2017. All rights reserved.
0123
(1) Q1E-EP0415
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:
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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
+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.
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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
Inhaltsverzeichnis
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