Hitachi C22K User manual

C22K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‐EP1389‐5

©Hitachi,Ltd.2013,2017.Allrightsreserved.

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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 instructions for using, cleaning,
and 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.

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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 place and keep
away from high temperature, high humidity,
or 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 1.6.
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 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 ··············································· 1
1.4 Components ················································· 2
1.5 Option ····················································· 2
1.5.1 Puncture adapter (MP-2781) ······························ 2
1.5.2 Puncture adapter (MP-2781-5) ···························· 2
1.5.3 Puncture adapter (MP-2781-25) ··························· 2
1.5.4 CIVCO Bracket (CIV-614-108) ····························· 2
1.6 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) ································ 7
4.2 Containment and transportation ····························· 7
4.3 Manual Cleaning and disinfection ··························· 8
4.4 Drying ····················································· 9
4.5 Inspection ················································· 9
4.6 Packaging ················································· 10
4.7 Sterilization ············································· 11
4.8 Storage ··················································· 13
5. Maintenance and Safety Inspection ··························· 13
6. Safety Precautions ·········································· 14
7. Specifications ·············································· 15
7.1 Probe ····················································· 15
8. Suppliers List ·············································· 15
9. Disposal of the probe ······································· 16

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WARNING
1. General
1.1 General
C22K Probe is a Convex Array Probe.
The acoustic output of this probe when connected to ultrasound scanner
was measured according to IEC 60601-2-37 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 IEC 60601-1 the probe is classified as type BF.
1) Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
Direct contact to the eye
2) Never use the probe with (HF) surgical equipment.
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.
1.3 Intended Use
C22K Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound scanner.
Intraoperative

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CAUTION
CAUTION
1.4 Components
The components of C22K Probe are given below:
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
the probe.
1.5 Option
1.5.1 Puncture adapter (MP-2781)
1) Puncture adapter (MP-2781-MB) ··········· 1 set
2) Needle guide G18 (MP-2781-G18) ·········· 1 piece
3) Needle guide knob (MP-2781-KNO-B) ······· 1 piece
4) Adjustment hexagon screwdriver ·········· 1 piece
5) Instruction manual ······················ 1 copy
1.5.2 Puncture adapter (MP-2781-5)
1) Puncture adapter unit (MP-2781-5-MB) ···· 1 set
2) Adjustment hexagon screwdriver ·········· 1 piece
3) Instruction manual ······················ 1 copy
1.5.3 Puncture adapter (MP-2781-25)
1) Puncture adapter unit (MP-2781-25-MB) ··· 1 set
2) Adjustment hexagon screwdriver ·········· 1 piece
3) Instruction manual ······················ 1 copy
1.5.4 CIVCO Bracket (CIV-614-108)
Please refer to the instruction manual of option about the method of
handling, cleaning, disinfection and sterilization.
1) Sterilization has not been made to the MP-2781, MP-2781-5 and
MP-2781-25 shipped from the factory. Prior to use of them, be sure
to clean and sterilize them.
2) A biopsy should be performed only by a well-trained physician. Use
only the authorized puncture adapter for performing a biopsy.

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1.6 External View
The external view of C22K Probe is shown in Fig. 1.
Fig.
1
E
xternal View
Immersible part (IPX7)
Cable
Connector
Un-immersible part
H
e
ad
/
A
pplied part
Immersible
part:
This part can be immersed in disinfectant
solution and also can be cleaned by water.
Un-immersible
part:
This
p
art should not be immersed in
disinfectant solution and also cannot be
cleaned by water.

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2. Inspection before Use
Prior to use, the probe must be carefully inspected that they are
appropriate for use.
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.
2.2 Inspection for Material Surface
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.