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

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2. Inspection before Use
Prior to use, the probe and accessories must be carefully inspected
that they are appropriate for use. If you find any damage, do not use
them and contact a service support immediately.
2.1 Inspection for Appropriate Connection
1) Confirm that the system is correctly operating. Refer to the
instruction manual for the ultrasound diagnostic scanner.
2) Do not attach or connect unauthorized devices or instruments on the
probe, such as unauthorized biopsy attachments.
3) Confirm that the Sterile Puncture Adapter and software version and
then settings of the scanner are appropriate for the probe. Attach
the Sterile Puncture Adapter on the probe. Set the ultrasound
diagnostic scanner to display the “Needle guide line”. (Refer to
the operation manual for the ultrasound diagnostic scanner.) Keep
the probe head in the water and insert a puncture needle in the Sterile
Puncture Adapter. Then, confirm that the needle is inserted smoothly
and the echo of the needle is displayed on the dot line “Needle guide
line” on the monitor.
2.2 Inspection for Material Surface
1) Visually inspect the surface of the probe head, housing and cable
for any crack, scratch or denaturalization.
2) Visually inspect the envelope of the Sterile Puncture Adapter for
any break, deformation, crack or denaturalization. If you find any
damage, do not use the Sterile Puncture Adapter.

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WARNING
3. Operation Procedure
3.1 Connection and Settings
1) Confirm that the probe is cleaned, disinfected and sterilized.
2) It is recommended to use a disposable probe cover for preventing
a patient from infection and the probe cover should be made of allergy
free material to avoid allergic reaction.
3) Connect the probe to the ultrasound diagnostic scanner and operate
the scanner and adjust the image according to the instructions given
in the operation manual for the ultrasound diagnostic scanner.
4) Put proper quantity of sterilized acoustic jelly on the probe head
as a couplant. (See Fig. 2.)
5) Put a probe cover on the probe and draw the probe cover until the
end of the probe shaft. To avoid air bubbles, be careful to press
the probe cover gently against probe head and to keep jelly on the
probe head. If air bubbles appear on the probe head, remove air
bubbles by pushing jelly with finger. (See Fig. 3 and Fig. 4.)
Be careful with a probe cover made out of
l
atex. The latex may
cause such allergic reactions as itching, rubor, urticaria
,
swelling, fever, anhelation, wheezing, and depression of blood
pressure, shock and so on.
If your patient shows any of the above mentioned symptoms
d
uring
the operation, stop the use of protective sleeve immediately and
take an appropriate treatment to the patient.
Sterilized acoustic jelly
F
ig.
2
Probe cover
Air bubble
Sterilized acoustic jelly
Fig. 3
Fig. 4

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6) Fix jelly on the top of the probe with sterile adhesive tape. (See
Fig. 5.)
7) Insert the probe gentry and adjust the probe’s position for a clear
view of the desired image. By turning or tilting the probe, a “turn
around” imaging is possible. If the image is insufficient, use
sterile saline solution. This solution improves the contact between
probe and organ.
8) After using the probe, clean, disinfect and sterilize the probe
immediately.
9) Store the probe in the environment indicated in “5 Maintenance and
Safety Inspection”.
S
terilized tape
Fig. 5

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3.2 Use of Sterile Puncture Adapter (EZU-PA5V)
The process of attaching the Sterile Puncture Adapter (EZU-PA5V) to
the probe is as follows. If the Sterile Puncture Adapter is used, careful
handling is necessary to avoid damage of the probe cover. During open
or minimal invasive surgery, use the protection sleeve to cover probe
and cable.
1) Attach a sterile probe cover to the probe. (See “3.1 Connection and
Settings”)
2) Put the picks of the Sterile Puncture Adapter to the grooves on the
tip of the probe. (See Fig. 6.)
3) Push the other end of the Sterile Puncture Adapter until fix the
dents of the Sterile Puncture Adapter to the projection on the probe.
(See Fig. 7.)
Sterile Puncture Adapter (EZU
-
P
A5V)
P
robe cover
F
ig.
6
F
ig.
7

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CAUTION
3.3 Display of Needle Guide Line
When puncture is to be conducted, the needle guideline can be displayed
by dot marks. Operation procedure for displaying the needle guideline
on the ultrasound diagnostic scanner must be referred to the part of
“Needle guide line” in the manual of the connected the ultrasound
diagnostic scanner.
NOTE: The needle guide line will be displayed to provide a visual guide
to the direction of the puncture needle pathway. Be sure to check
the actual location of the needle on the ultrasound image when
performing the puncture operation.
The needle guide line can be displayed with this probe; however, some
image display may not be appropriate for puncture procedure according
to the location of observation field-of-view.
Use observation field-of-view that is appropriately according to the
location of puncture.

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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
container to transport from
C
entral Sterile Supply
D
epartment (CSSD) to an operating room. Be careful
n
ot to damage 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, C41V probe is classified as semicritical.

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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 and leavings of ultrasound jelly
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
C
leaning
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 Fig.8). 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.8) 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.8). 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.8) 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 probe with a single-use, fluff-free wipe or
towel to remove moisture from the surface of the
probe.
2) Dry the probe 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.
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.8 Immersion of
the probe
Water, Detergent
or Disinfectant

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4.6 Packaging
Pack the probe 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 probe can be placed on plastic mesh wires supplied
for plasma sterilization and then packed as mentioned above.
The probe 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