Hitachi C22I User manual

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MN1-6119 Rev. 3
C22I Probe
Instruction Manual
Specication
MN1-6119 Rev. 3
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-5984)” and “Cleaning,Disinfection and Sterilization
(MN1-6000)“ carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2015, 2017. All rights reserved.

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MN1-6119 Rev. 3

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MN1-6119 Rev. 3
Introduction
This is the instruction manual for C22I probe. The probe is available by connecting to Hitachi's ultrasound diagnostic
instrument and can be mainly used for observation of human internal organs during surgery.
Prior to use, read this manual as well as the separate instruction manual “Safety” in which information for safe use is
provided.
The probe bears the CE mark but the mark is valid only when the probe is connected to the ultrasound diagnostic
instrument bearing the CE mark.
Symbols used in this document
Safety information is classied into Danger ,Warning Caution, and Note according to the level of hazard. Those terms
are used in the safety information provided to prevent hazards and injuries to the operator or patients.
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to the
operator or patient.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to the
operator or patient.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to
the operator or patient, or property damage only.
Note
Indicates a strong request concerning an item that must be observed in order to prevent damage or
deterioration of the equipment and also to ensure that it is used efciently.
The type of safety information is indicated by the symbols below.
This symbol means that attention is required.
This symbol means that the described action is prohibited.
This symbol means that the described action is mandatory.

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MN1-6119 Rev. 3
This instruction manual contains 4 pages of front matter and 8 pages of the main content.
CONTENTS
1. General Information...................................................................................................................................1
1-1. Intended use...................................................................................................................................................................1
1-2. Classication of ME equipment....................................................................................................................................1
1-3. Standard components ....................................................................................................................................................1
1-4. Option............................................................................................................................................................................1
2. Specications and Parts name....................................................................................................................3
2-1. Specications.................................................................................................................................................................3
2-2. Name of each parts........................................................................................................................................................4
3. Preparations before use .............................................................................................................................5
3-1. Visual check ..................................................................................................................................................................5
3-2. Conrmation of cleaning, disinfection, and sterilization.............................................................................................5
3-3. Operation check.............................................................................................................................................................5
4. Operation....................................................................................................................................................7
4-1. Operation.......................................................................................................................................................................7

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MN1-6119 Rev. 3
1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended to be used by doctors. The probe is placed in direct contact with human internal organs during
surgery for ultrasonic observation.
Please refer to the ultrasound diagnostic instrument instruction manual used with this probe for the probe intended use
information.
Regarding with the connectable instrument, please refer to section 2-1. Specications of this manual.
Warning
Do not use this equipment for other than its intended use.
Otherwise it could cause burns or other injuries to the patient or operator.
1-2. Classication of ME equipment
This probe is classied as follows according to IEC60601-1.
Please refer to the section 2-1 for the range of applied part, the part treated as applied part, and the range of IPX7.
• Classication based on the degree of protection against electric shock ........ Type BF applied part
• Classication for protection against ingress of liquids .................................. IPX7 (Watertight equipment)
• Operation mode............................................................................................... Continuous operation
• Method of sterilization.................................................................................... Refer to the separate instruction manual
“Cleaning,Disinfection and Sterilization”
1-3. Standard components
The standard components of C22I probe are as follows.
C22I Probe ···························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-6119)········································ 1 copy
• Safety (MN1-5984) ··············································· 1 copy
• Cleaning,Disinfection and Sterilization (MN1-6000) ······ 1 copy
1-4. Option
The following options are available for this probe.
• Reprocessing by liquid detergent, disinfectant or sterilant
Whole the probe is able to immerge into the liquids by putting the connector of the ultrasound probe to the
waterproof case WP-001 as below table.
Precautions about the waterproof case, please refer to the instruction manual.
Accessory for reprocessing by liquid detergent, disinfectant or sterilant
Product Name Product No.
Waterproof case WP-001

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MN1-6119 Rev. 3
Unit: mm
2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
Application: Intraoperative diagnosis
Type of patient contact: Intraoperative
Connectable instruments: ARIETTA 70, ARIETTA 60, Noblus, ARIETTA Precision
NOTE:
At the time of publication of this manual, the connectable diagnostic ultrasound
instrument or instrument software version available with this probe is different
for each country, please refer to the instrument instruction manual or contact
your local Hitachi representative.
Field of view: 82°
Frequency: 3.5 MHz
Cable length: 2.9 m
Service life: 3 years
Applied part: Probe tip including ultrasonic radiation part, see the section 2-2
Part treated as applied part: Cable up to 0.2 m length from the probe tip
IPX7 range: See Figure 1 (In case that not putting the waterproof case to the ultrasound
probe connector)
In case that putting the waterproof case to the ultrasound probe connector,
whole the probe from the tip of the ultrasound probe to the connector with
Waterproof Case WP-001 is IPX7. range
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
Remark: The tolerance for the dimensions is ±10%.
Figure 1 External View
1000
41
2322
Cable length
IPX7 range
Applied part

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MN1-6119 Rev. 3
2-2. Name of each parts
The name of each part is shown in Figure 2 and the explanation for each part is listed in Table 1.
Front side
Ultrasonic radiation part
Connector
Probe tip
Cable
Figure 2 Name of each parts
Table 1 Name of each part and its explanation
Name Explanation
Ultrasonic radiation part Ultrasound is radiated from this part. The electronic
convex transducer is integrated underneath this part.
Front side The side corresponds to the side of the orientation mark
on the image.
Probe tip This part is gripped during operation.
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the
ultrasound diagnostic instrument.
Caution
Do not pull, bend, twist, or apply excessive force to the cable.
The probe may malfunction due to cable disconnection.
Do not subject the ultrasonic radiation part to hard impact.
The impact may cause damage to the transducer, and that results in noise or no echo in the image.
In most cases, the ultrasonic radiation part itself is not damaged because the part is made of elastic
material.

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MN1-6119 Rev. 3
3. Preparations before use
This chapter describes preparations needed to use the probe safely. Please prepare the probe prior to each use by
following the instructions below.
3-1. Visual check
Visually check the probe tip, ultrasonic radiation part, cable, and connector.
If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do
not use the probe.
Check also the options as necessary.
3-2. Conrmation of cleaning, disinfection, and sterilization
Conrm that the probe is certainly cleaned, disinfected, and sterilized. The degree of reprocessing depends on the
intended use. Please refer to the separate instruction manual “Cleaning, Disinfection and Sterilization“ for cleaning,
disinfection, and sterilization procedure.
3-3. Operation check
Connect the probe to the ultrasound diagnostic instrument and check that the displayed scan type and frequency
correspond to those of the probe. Check also that there is no abnormality in the image.
Remark: Please refer to the documentation supplied with the ultrasound diagnostic instrument for how to connect the
probe and information displayed on the monitor.
If the probe is operated in still air, brightness on the top of the image may be non uniform, but this does not
affect the performance of the probe.
Warning
Make preparations prior to each use.
The operator and the patient may be injured if the equipment has any abnormality.
If any abnormality is found in the equipment, stop using it and contact our ofce written on the back
cover.
Caution
Do not use the probe if the displayed scan type and frequency do not correspond to those of the probe.
Incorrect acoustic output can result in burns or other injuries to the patient. Contact our ofce written
on the back cover.

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4. Operation
This chapter describes the operation of the probe.
4-1. Operation
Place the ultrasonic radiation part of the probe onto the inner organ surface during surgery. An image of the region of
interest is displayed on the monitor of the ultrasound diagnostic instrument. For details on displaying and adjusting the
image, refer to the documentation supplied with the ultrasound diagnostic instrument.
Caution
Do not operate the probe with excessive force.
Use with excessive force could result in injury to the patient.
Scan for minimum time necessary at the lowest possible acoustic output.
Acoustic output may affect the patient’s internal tissues.
For details about the acoustic output, please refer to the documentation supplied with the ultrasound
diagnostic instrument.
Do not touch the connector terminal pin of the probe.
Electrostatic discharge may result in malfunction of the probe.
Do not touch the probe connector of the ultrasound diagnostic instrument and the patient at the same
time. It can cause electric shock to the patient.

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MN1-6119 Rev. 3
US Importer: Hitachi Healthcare Americas Corporation
Address: 1959 Summit Commerce Park, Twinsburg, Ohio 44087
Distributor
MN1-6119 Rev. 3 ’17.08.31
■Manufacturer
Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan
■Contact
[phone]
http://www.hitachi.com/businesses/healthcare/index.html
Overseas Offices:
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