Hitachi VC34A Probe User manual

VC34A Probe
INSTRUCTION MANUAL
Tokyo, Japan
Q1E-EP1398-4
© Hitachi, Ltd. 2013,2017. All rights reserved.
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.
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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:

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About this manual
This instruction manual shall provide the procedure for inspection,
operation and reprocessing of VC34A Probe.
The manual also contains the general information and the specification
of the probe. The probe is usable with the HITACHI ultrasound diagnostic
scanner. The operation of the HITACHI ultrasound diagnostic scanner
shall be referred to its instruction manual.
To ensure safe operation, it is essential that you fully understand
the function, operating and maintenance instructions by thoroughly
reading and understanding this manual. Please contact a service support,
if you have any questions concerning the operation of the probe.
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.

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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, dustproof, dark
and dry place and keep away from high
temperature, high humidity and 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 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. General ........................................................ 1
1.1 General..................................................... 1
1.2 Principles of operation..................................... 1
1.3 Intended Use................................................ 2
1.4 Components.................................................. 2
1.5 External View............................................... 3
2. Inspection before Use .......................................... 4
2.1 Inspection for Appropriate Connection....................... 4
2.2 Inspection for Material Surface............................. 4
3. Operation Procedure ............................................ 5
4. Reprocessing Procedure ......................................... 6
4.1 Point of use (Pre-cleaning)................................. 9
4.2 Containment and transportation.............................. 9
4.3 Manual Cleaning and disinfection............................ 9
4.4 Drying..................................................... 12
4.5 Inspection................................................. 12
4.6 Storage.................................................... 12
5. Maintenance and Safety Inspection ............................. 13
6. Safety Precautions ............................................ 14
7. Specifications ................................................ 15
7.1 Probe...................................................... 15
7.2 Suppliers List............................................. 16
8. Disposal of the probe ......................................... 17

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1. General
1.1 General
The model VC34A Probe is a convex array electronic scanning type.
The probe is capable of acquiring Real-time 3D image by mechanical
drive of the acoustic elements.
The acoustic output was measured with operating the Hitachi
Ultrasound diagnostic scanner according to IEC60601-2-37. The
measured acoustic output is listed in the instruction manual of the
Hitachi ultrasound scanner.
The probe is categorized in class IIa according to Directive
93/42/EEC and classified as type BF according to IEC60601-1.
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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1.3 Intended Use
VC34A Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the Hitachi ultrasound
diagnostic scanner.
Fetal
Pediatric
Abdominal
Small organ
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
Direct contact to the eye
1.4 Components
The components of VC34A Probe are given below:
1) Probe ................................... 1 piece
2) Instruction manual ...................... 1 copy
3) Correct Backlash CD-ROM ................. 1 piece
The CD-ROM contains the probe’s specific parameters to be loaded
to the Hitachi ultrasound diagnostic scanner. Hitachi service
engineer installs the CD-ROM to the scanner. Store the CD-ROM in
a safe place.
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Disinfection has not been made to the probe, shipped from the
factory. Prior to use of the probe, be sure to clean and disinfect
the probe.
1.5 External View
The external view of VC34A Probe is shown in Fig. 1.
Immersible part (IPX7)
Scan head
Connector
Cable
Un-immersible part
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 can not be cleaned by water.
Fig. 1 External view
Handle housing
Applied part
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2. Inspection before Use
Prior to use, the probe must be carefully inspected that it is
appropriate for use.
2.1 Inspection for appropriate connection
2.1.1 Confirm that the system is correctly operating. Refer to the
instruction manual for the ultrasound diagnostic scanner.
2.2 Inspection of material surface
2.2.1 Visually inspect the surface of the probe head, housing, the
cable and the connector for any crack, scratch or
denaturalization. If you find any damage, do not use the probe,
and immediately contact a service support.

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3. Operation Procedure
1) Confirm that the probe is cleaned and disinfected.
2) Covering the probe with a disposal probe cover to protect the probe
is recommended. The probe cover should be allergy free material
to avoid allergic reaction. Apply acoustic coupling gel inside and
outside of the probe cover. Acoustic coupling gel is required as
a couplant.
3) Connect the probe to the ultrasound diagnostic scanner, operate
the scanner, and adjust the image, all according to the instructions
given in the operation manual for the ultrasound diagnostic scanner
with which the probe is used as connected.
4) Confirm the direction of the probe. The relationship between the
direction of the probe and the B-mode image is shown in Fig. . The
right-left orientation mark on the image indicates the direction
of the index mark on the probe.
5) Perform the reprocessing procedure in accordance with the procedure
stated in “4. Reprocessing procedure” every time immediately after
completing the ultrasound examination.
6) Store the probe in accordance with the storage condition indicated
in “8. Specification”.
Fig. 2 Relationship between Index Mark
and Right-left
o
rientation mark
Right-left
orientation mark
Index mark
H

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4. Reprocessing Procedure
The probe must be reprocessed after each use. Refer to the reprocessing
instruction in this chapter
WARNINGS
‐The probe
i
s delivered unsterile. Prior to the first
use, reprocess the probe.
‐Temperature should not exceed 40°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
The probe should be packed in a sterile pouch or
container to transport from Central Sterile Supply
Department (CSSD) to an operating room. Be careful not
to damage the sterile pouch or container during
transportation.

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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, VC34A probe is classified as uncritical.

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

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4.1 Point of use (Pre-cleaning)
Pre-cleaning should be done immediately after each use.
The procedure is as follows:
1) Remove the probe 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.
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 submergible 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)
Containment and
transportation
Manual Cleaning
R
insing after manual
cleaning
Manual Disinfection
R
insing after manual
disinfection
M
anual cleaning and
disinfection
Point of use
(Pre-cleaning)

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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. 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-immergible 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.

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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.
Fig. 3 Immersion of the probe
Water
Detergent
Disinfectant

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4.4 Drying
1) Wipe the probe with a single-use, fluff-free wipe or towel to remove
moisture from the surface of the equipment.
2) Dry the probe naturally in an ambient temperature between 15-30°C
for a minimum of 4 hours. Alternatively the probe can be dried using
a drying heater at a temperature of less than 40°C.
4.5 Inspection
Inspect the probe for any damage such as crack, scratch or deformation.
Do not use it if any damage is found.
4.6 Storage
Store the equipment in a cool, dustproof and dark space to avoid
high temperature, humidity and direct sunlight. Limitations for
the time for sterilized equipment belong to package.
1) Do not sterilize this probe by pressurizing/ depressurizing
sterilization system such as ETO and Plasma system. If you sterilize
the probe by these systems, the membrane that seals the oil bursts and
the probe will not be functional.
2) Do not sterilize this probe by autoclave. If you autoclave the probe,
the probe suffers serious damage and will be not functional.
Drying
WARNING

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5. Maintenance and Safety Inspection
1) 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 immediately contact a service support.
2) Inspect the functionality of Real-time 3D mode. If you find
abnormalities such as abnormal noise, do not use the probe,
and contact immediately a service support.
3) After using the probe, the probe should be cleaned and
disinfected according to “4. Reprocessing Procedure”, store the
probe in a cool and dark space to avoid high temperature,
humidity and direct sunlight.

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6. Safety Precautions
1) If you find that the probe head, the housing or cable are cracked
or damaged, do not use the probe, and immediately contact a
service support.
2) For the patients suspected of having latex allergy, do not use
latex-containing medical devices. Latex may cause allergic
reactions such as itching, rubor, urticaria, swelling, fever,
anhelation, wheezing, depression of blood pressure, and shock.
If your patients display the above-mentioned symptoms, stop
using latex-containing medical devices immediately and provide
prompt treatment to your patients.
1) Start examination with acoustic power low and set the acoustic
power as low as possible for ultrasound examination of an early
pregnancy. And minimize the ultrasound exposure time.
2) Disinfect the probe prior to the initial use since the probe
is not delivered disinfected.
3) Use only detergents and disinfectants listed in “7.2 Suppliers
list”.
4) Use sterile acoustic coupling gel depending on the diagnostic
part. The acoustic coupling gel which is an accessory of Hitachi
Ultrasound diagnostic scanner is non-sterile acoustic coupling
gel.
5) Do not hit or drop the probe because the inside of the probe
head is easily broken by mechanical shocks.
6) Do not allow liquid to contact/enter the probe connector, as
the probe connector is not waterproof.
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