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.
0123

(1) Q1E-EP1398
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-EP1398
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.

(3) Q1E-EP1398
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.

(4) Q1E-EP1398
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.

(5) Q1E-EP1398
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

-1- Q1E-EP1398
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.

-2- Q1E-EP1398
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.
C
A
U
TI
O
N
WARNIN
G

-3- Q1E-EP1398
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
C
A
U
TI
O
N

-4- Q1E-EP1398
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.