Hitachi C41V User manual

C41VProbe
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‐EP1363‐6
©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
+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 contains safety precautions, the inspection,
the operation procedure and the reprocessing procedure of C41V Probe.
Please read this manual thoroughly to ensure the safety operation.
If you have any questions concerning the operation of the probe, please
contact a service support.
The following conventions are used throughout the manual to denote
information of special emphasis.
WARNING: “Warning” indicates the presence of a hazard which may result
in severe personal injury, substantial
p
roperty damage, or
death if the warning is ignored.
CAUTION: “Caution” indicates
t
he presence of a hazard which will or
can cause minor personal injury or property damage if the
caution is ignored.
NOTICE: “Notice” indicates information of installation, operation,
or maintenance, 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/heal
thcare/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, dustproof and
dark, dry place to avoid high temperature,
humidity and direct sunlight.
Contains or
presence of
natural rubber
latex
Contains or presence of natural rubber
latex
Do not
re-sterilize
Do not re-sterilize
Do not reuse Do not reuse

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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 1.6.
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 instrumen
t
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 ·············································· 2
1.4 Components ················································ 2
1.5 Accessories (Option) ······································ 3
1.6 Construction ·············································· 4
2. Inspection before Use ········································ 5
2.1 Inspection for Appropriate Connection ····················· 5
2.2 Inspection for Material Surface ··························· 5
3. Operation Procedure ·········································· 6
3.1 Connection and Settings ··································· 6
3.2 Use of Sterile Puncture Adapter (EZU-PA5V) ················ 8
3.3 Display of Needle Guide Line ······························ 9
4. Cleaning, Disinfection and Sterilization ···················· 10
4.1 Point of use (Pre-cleaning) ······························ 11
4.2 Containment and transportation ··························· 11
4.3 Manual Cleaning and disinfection ························· 12
4.4 Drying ··················································· 13
4.5 Inspection ··············································· 13
4.6 Packaging ················································ 14
4.7 Sterilization ············································ 15
4.8 Storage ·················································· 16
5. Maintenance and Safety Inspection ··························· 17
5.1 Daily Inspection ········································· 17
5.2 Storage ·················································· 17
6. Safety Precautions ·········································· 18
7. Specifications ·············································· 19
7.1 Probe ···················································· 19
7.2 Sterile Puncture Adapter EZU-PA5V ························ 20
7.3 Suppliers List ··········································· 21
8. Disposal of the probe ······································· 21

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1. Introduction
1.1 Features
C41V Probe is a Convex Array Probe.
The acoustic output of this probe when connected to ultrasound
diagnostic scanner was measured according to the IEC60601-2-37 standard.
The table of measured acoustic output data is contained in the
operational manual of each ultrasound diagnostic scanner. This probe
is categorized in class IIa according to Directive 93/42/EEC.
According to IEC60601-1 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.

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WARNING
CAUTION
1.3 Intended Use
C41V Probe is designed for observation and diagnosis of the following
regions mainly by connecting with the HITACHI ultrasound diagnostic
scanner.
General OB/GYN organs
Biopsy (with a Sterile Puncture Adapter)
Transvaginal/Transrectal
Never use the probe for following regions.
1) The heart (Do not contact directly.)
2) The eyeball
1.4 Components
Components of C41V Probe are as follows:
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
it.

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CAUTION
1.5 Accessories (Option)
1.5.1 Sterile Puncture Adapter EZU-PA5V (Disposable)
Attachment for ultrasound guided transvaginal or transrectal
biopsy and aspiration of organs, cyst and tumor. The size of
available needle is 16 to 19G. Application requires special care.
Sterile Puncture Adapter EZU-PA5V is as follows:
Component Model Note
Sterile Puncture Adapter EZU-PA5V 24 pcs
NOTE: If you need Sterile Puncture Adapters, please contact a service
support.
A well-trained physician only should perform a biopsy.
1.5.2 Mechanical Compression Unit for Elastography EZU-TEMC1 and
balloon set for Elastography EZU-TEBL2
This mechanical compression unit is used for tissue elasticity imaging,
by using the balloon attached to the probe that is connected to a
Hitachi's digital ultrasound scanner system and electronic scanning
ultrasound tomography system.
Please refer to the instruction manual of option about the method of
handling, cleaning and disinfection of EZU-TEMC1 and EZU-TEBL2.
1.5.3 Condom or Protection Sleeve for Single Use (Disposable)
To protect the probe against contamination, using only lubrication
free condom or protective tube sleeve which is dry type
i
s
recommended.
Lubrication may cause a deterioration of the probe surface. And
latex rubber may create allergic reactions, use of non-allergic
condom or sleeve is strongly recommended.
Take care for the handling of used condom or protection sleeve.

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1.6 Construction
The external view of C41V Probe is shown in Fig. 1.
Immersible part: This part can be immersed in 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
Cable
Connector
Immersible part (IPX7)
Applied part
Un-immersible part