Hitachi VC41V User manual

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MN1-5863 Rev.5
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-5994)” and “Cleaning, Disinfection and Sterilization
(MN1-6002)“ carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2014, 2017. All rights reserved.
VC41V Probe
Instruction Manual
Specication
MN1-5863 Rev.5

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MN1-5863 Rev.5

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MN1-5863 Rev.5
Introduction
This is the instruction manual for VC41V probe. The probe is available by connecting to Hitachi's ultrasound
diagnostic instrument and can be mainly used for observation of the uterus and surrounding organs
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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MN1-5863 Rev.5
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
4-2. How to mount the rubber boot......................................................................................................................................8
4-3. How to remove the rubber boot.....................................................................................................................................9
This instruction manual contains 4 pages of front matter and 12 pages of the main content.

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MN1-5863 Rev.5
1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended for use by a doctor or other qualied operator for inserting into a human vagina and making
ultrasonic observations of the uterus and surrounding organs.
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 VC41V probe are as follows.
VC41V Probe ························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-5863)········································ 1 copy
• Safety (MN1-5994) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6002) ······ 1 copy
1-4. Option
The following options are available for VC41V probe.
• Rubber boot RB-945BP-NS (non-sterile)

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2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
Application: Obstetric and gynecological areas
Type of patient contact: Transvaginal
Connectable instruments: ARIETTA 70, ARIETTA 60
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.
Electronic scan eld of view: 140°
Mechanical scan eld of view: 90°
Frequency: 6.0 MHz
Cable length: 2.0 m
Service life: 3 years
Applied part: See Figure 1
Part treated as applied part: See Figure 1
IPX7 range: See Figure 1
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
337
140
Range of applied part
Parts treated as applied parts
IPX7 range
1000
φ41
φ25
Cable length
Remark: The tolerance for the dimensions is ±10%.
Figure 1 External View
Unit: mm

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MN1-5863 Rev.5
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.
Connector
Insertion portion
Handle
Rubber boot
Cable
Ultrasonic radiation part
Front mark
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.
Insertion portion The component that is inserted into the patient.
Front mark The dimple corresponds to the side of the orientation
mark on the image.
Handle This section is held when performing insertion..
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the
ultrasound diagnostic instrument.
Rubber boot This covers the insertion portion for preventing infection.
Follow the instructions in section 4-2
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 plastic
material.

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MN1-5863 Rev.5
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 ultrasonic radiation part, insertion portion, handle, cable, connector and rubber boot.
If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do
not use the probe.
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 and how to mount/remove the rubber boot.
4-1. Operation
Mount a probe cover on the probe and insert the probe into the body cavity. 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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4-2. How to mount the rubber boot
Apply a suitable amount of ultrasound gel on the ultrasonic radiation part and then cover it with the rubber boot.
Remove air bubbles or wrinkles on the ultrasonic radiation part.
Apply a suitable amount
of ultrasound gel
Rubber boot
Figure 3 How to mount the rubber boot
Warning
Use by covering the rubber boot over the insertion portion.
If the rubber boot is not used, residual pathogens on the scanner could infect the patient.
Use Hitachi-approved rubber boots only.
Use of an item lacking biocompatibility can cause an adverse reaction by the body of the patient.
Check that the rubber boot is sterilized.
Use of an infected item could spread infection to the patient.
Do not reuse the rubber boot.
Use of an infected item could spread infection to the patient.
Do not apply unsterilized acoustic medium to the outer surface of the rubber boot.
Use of an acoustic medium that is contaminated by a pathogen can cause an infection on the patient.
Do not use on patients who may have an allergic reaction to latex products.
Use of the rubber boot for these types of patients could result in anaphylactic shock. Ask the patient
about allergy history beforehand.
Caution
Check the rubber boot for abnormalities before use.
Store the rubber boots in a cool, dry location not exposed to direct sunlight and do not use rubber
boots that have exceeded their expiration date (for items where the expiration date is not displayed,
2 years from the displayed sterilization date) or severe discoloration, cracks, or other visible defects
nds.
Check that the acoustic medium has no air bubbles inside the rubber boot that is covering the scanner.
Air bubbles inside the rubber boot can result in misdiagnosis caused by overlooking or
misinterpreting lesions due to poor image quality or improper rendering.

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4-3. How to remove the rubber boot
(1) Wrap the rubber boots in tissue paper and remove the rubber boots from the probe.
(2) Dispose tissue paper and the rubber boots according to the infection prevention procedures of your facility.
Caution
Before disposing of the equipment, disinfect or take other infection-prevention measures.
Disposal of the equipment without taking the proper preventative measures can lead to infection.

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US Importer: Hitachi Healthcare Americas Corporation
Address: 1959 Summit Commerce Park, Twinsburg, Ohio 44087
Distributor
■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
MN1-5863 Rev.5 ‘17.08.31