Hitachi S21 Manual de usuario
S21 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1377-5
© Hitachi, Ltd. 2013,2017. All rights reserved.
Notes for operators and responsible maintenance personnel
䖩Please read through this Instruction Manual carefully prior to use.
䖩Keep this Instruction Manual together with the system with care to
make it available anytime.
0123
(䢢1䢢) Q1E-EP1377
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:
(䢢2䢢) Q1E-EP1377
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 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.
(䢢3䢢) Q1E-EP1377
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, dustproof, dark
and dry place and keep away from high
temperature, high humidity and direct
sunlight.
(䢢4䢢) Q1E-EP1377
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 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.
(䢢5䢢) Q1E-EP1377
CONTENTS
Page
1. Introduction ................................................. 1
1.1 Features ................................................. 1
1.2 Principles of operation .................................. 1
1.3 Intended Use ............................................. 2
1.4 Composition .............................................. 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. Cleaning, Disinfection and Sterilization ..................... 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 Packaging ............................................... 12
4.7 Sterilization ........................................... 13
4.8 Storage ................................................. 15
5. Maintenance and Safety Inspection ........................... 15
6. Safety Precautions .......................................... 16
7. Specifications .............................................. 17
7.1 Probe ................................................... 17
7.2 Suppliers List .......................................... 18
8. Disposal of the probe ....................................... 18
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1. Introduction
1.1 Features
S21 probe is a phased array sector scanning type probe.
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 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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1.3 Intended Use
S21 Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound
scanner.
xCardiac
xGeneral abdominal organs
xTranscranial
Never use the probe for following applications.
1) Direct contact to the heart.
2) Biopsy to the heart.
3) Direct contact to the eye
1.4 Composition
The probe components of S21 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 it, be sure to clean, disinfect and sterilize
it.
WARNING
CAUTION
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1.5 External View
The external view of S21 Probe is shown in Fig. 1.
Un-immersible part
I
mmersible part (IP
X
7
)
Fig. 1 External View
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.
Head
Connector
C
able
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. If not, do not use the probe and immediately
contact a service support.
2.1 Inspection of 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 nor instruments
on the probe, such as unauthorized biopsy attachments.
2.2 Inspection of material surface
Visually check the surface of the probe head, housing and cable
for any crack, scratch or denaturalization.
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