2B701-252E*R WARNING: CAUTION: Applications and Specifications

OPERATION MANUAL FOR 1. Do not allow the patient to come in contact with any part of 3) After sterilization, degas the transducer. Gas residues
This transducer is designed for imaging organs, localizing lesions, flow
CONVEX ARRAY TRANSDUCER the ultrasound system other than the transducer or with on the transducer may be harmful to the human body.
measurements, and mapping in diagnostic ultrasound. (Applications
other devices for which safety has not been verified. If the 4) The efficacy of the cleaning solutions, disinfectants, and
MODEL: PVF-381MT diagnostic ultrasound system or other devices are defective, sterilizing gases is not guaranteed by TOSHIBA. Contact
vary depending on the specifications of the diagnostic ultrasound
system.) Applying the transducer to the surface of the patient's body is
This operation manual describes the operating procedures for the there is a risk of electrical shock. the manufacturers for information on the activity of the
the intended method of use. For this reason, do not use this transducer
ultrasound transducer. For the operating precautions and procedures for 2. Before and after examination, confirm that the transducer products.
for invasive procedures such as surgical use. Applicable organs,
the diagnostic ultrasound system and other devices, refer to the relevant and cables are normal. Use of a defective transducer may 7. Do not use the carrying case for storing the transducer. If
method of application, and specifications are listed in the table below.
operation manual. result in electric shock to the patient. the carrying case is used for storage, it may become a
3. Do not subject the transducer to mechanical shock. Use of source of infection. Name Indications Target Method of Frequency Viewing
a defective transducer may result in electric shock to the for use organs application angle*1
Safety Precautions patient. CAUTION: PVF-381MT Abdominal, Abdominal Apply 3.75 MHz 75°
cardiac organs, transducer to
1. Meaning of Signal Words 4. To prevent the possibility of electric shock, do not 1. Observe the following precautions to prevent transducer heart surface of
In this operation manual, the signal words DANGER, disassemble the transducer. malfunction. body
WARNING, CAUTION are used regarding safety and other 5. Never immerse the transducer connector into liquid such as 1) Before connecting or disconnecting a transducer, turn OFF
water or disinfectant. Immersion may cause electrical shock. *1: Viewing angle may vary according to the specifications of the
important instructions. The signal words and their meanings are the power of the diagnostic ultrasound system, or deselect
6. During biopsy, the biopsy needle may fail to reach the target diagnostic ultrasound system.
defined as follows. Please understand their meanings clearly before the transducer to be connected/disconnected.
reading this manual. site or the patient may be injured due to an incorrectly 2) The transducer must not be immersed in a chemical solution Information on the Biopsy Adaptors
performed biopsy, possibly causing side effects, in the for more than three hours.
following situations: 3) Do not permit the transducer to become overheated (more Biopsy adaptors: UAGV013A and UAGV-026A manufactured by
Signal word Meaning
1) A biopsy adaptor other than the applicable models than 60°C) during cleaning, disinfection, and sterilization. Toshiba Medical Systems Corporation
DANGER Indicates an imminently hazardous situation described in this document is used. 4) Repeated cleaning, disinfection, and sterilization will * For the use procedures, sterilization procedures, and other detailed
which, if not avoided, will result in death or 2) The biopsy adaptor is mounted incorrectly. (Be sure to eventually damage the transducer. Minimize cleaning, information, refer to the operation manual for the biopsy adaptor.
serious injury. mount the biopsy adaptor securely and in the correct disinfection, and sterilization. * It is possible to display the biopsy-guiding needle mark on the
Indicates a potentially hazardous situation position and direction.) 2. Ambient conditions monitor.
WARNING
which, if not avoided, could result in death or 7. This transducer is contraindicated for ophthalmic use or any 1) Do not use it in locations where it will be exposed to: For the display procedures and the precautions regarding the needle
serious injury. application that causes the acoustic beam to pass through ● direct sunlight or X-rays mark, refer to the operation manual for the diagnostic ultrasound
the eye. ● sudden changes in temperature system.
CAUTION Indicates a potentially hazardous situation ● dust
which, if not avoided, may result in minor or ● excessive vibration
moderate injury. ● heat generators
Indicates a potentially hazardous situation which, 2) Use the transducer under the following ambient conditions:
CAUTION
if not avoided, may result in property damage. ● Ambient temperature : 5°C to 35°C
● Relative humidity : 30% to 85% (no condensation)
● Atmospheric pressure : 700 hPa to 1060 hPa

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2. Meaning of Safety Symbols Important Information Name and Function of Each Section
CAUTION:
Symbol Description 1. Precautions concerning transducer operation For important information, refer to the operation manual provided with Following are the name and functions of each section and immersible
1) To prevent infection, wear sterile protective gloves when the diagnostic ultrasound system. range of the transducer.
"ATTENTION" (Refer to the operation manual.) using the transducer. This transducer is classified as "IPX7" with regard to the degree of
2) Wear new protective gloves for every examination. Composition protection against harmful ingress of water or particulate matter.
3. Meaning of Symbols on Labels 2. In normal diagnostic ultrasound mode, there is no danger of The connector section and ferrite core are not waterproof and must not
a low-temperature burn; however keeping the transducer on When the transducer is received, unpack it and check that all the
Symbol Indication be immersed in liquids such as disinfectant.
the same region of the patient may cause such a burn. following components are present.
The head section of this transducer is a type BF applied part.
Type-BF applied part 3. Be sure to use ultrasound gel. Do not use an ultrasound gel ● Convex array transducer 1
that does not list water as the principal ingredient. If castor ● Carrying case 1
Degree of protection against harmful ingress of oil is used, the transducer may deteriorate, possibly causing ● Cable clamp 1
water or particulate matter: IPX7 electric shock. ● Operation manual 1
(The connector is not waterproof.) 4. When performing biopsy procedures, use only sterile ● Guidelines for cleaning, disinfection, and sterilization 1
Manufacturer ultrasound gel that is certified to be safe*. Also, manage the
ultrasound gel properly to ensure that it does not become a Acoustic Energy
Date of manufacture source of infection.
The effects of acoustic energy on human tissue are currently under
* Consult the manufacturer for details.
investigation. <1> Transducer head
Serial number 5. Sterilize the transducer and biopsy adaptor before and after
Therefore, it is recommended that diagnostic ultrasound output power be This utilizes the piezoelectric effect to convert electrical signals into
an ultrasound-guided biopsy procedure is performed.
Authorized representative in the EC set to the lowest possible levels in accordance with the principle of ultrasound waves, which are transmitted to the body, and to
Failure to do so may result in the transducer and biopsy
ALARA (As Low As Reasonably Achievable). generate electrical signals when receiving the reflected ultrasound
adaptor becoming sources of infection.
4. Safety Precautions Please refer to the operation manual of the diagnostic ultrasound waves (echoes). The lens on the surface is the acoustic lens.
6. Precautions concerning cleaning, disinfection, and
Please observe the following precautions to ensure the safety of system. <2> Biopsy adaptor fixing slot
sterilization
patients as well as operators when using this transducer. Mount the specified biopsy adaptor using this slot.
1) Observe the following precautions to prevent infection.
<3> Grip
DANGER: ● Wear protective gloves when cleaning the transducer.
Hold this section to operate the transducer.
Do not use this transducer in an atmosphere containing ● Wear sterile protective gloves when disinfecting or
<4> Cable
flammable or explosive gases such as anesthetic gases, oxygen, sterilizing the transducer.
This transmits electric signals between transducer body and
and hydrogen because an explosion may occur. ● Wear new protective gloves each time cleaning,
connector.
disinfection, and sterilization are performed.
* The ferrite core may have to be removed when the transducer is
● Clean the transducer before and after examination.
used with certain system models.
Disinfect or sterilize the transducer as required.
<5> Lock handle
2) After cleaning, rinse the transducer thoroughly with
This locks the connector to the diagnostic ultrasound system.
purified water to remove all chemical residues. After
<6> Connector
disinfection, rinse the transducer thoroughly with sterile
This connects the transducer to the diagnostic ultrasound system.
water or deionized water to remove all chemical
residues. Chemical residues on the transducer may be
harmful to the human body.
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 Procedures for Operating the Transducer Connection to the Diagnostic Ultrasound System Disinfection ● Atmospheric pressure : 700 hPa to 1060 hPa
3. Do not use the carrying case for storing the transducer.
This transducer should be used as described in the following procedure. 1. Connecting the transducer Before disinfection, the transducer must be cleaned. If the carrying case is used for storage, it may become a source of
The proper clinical technique to be used for operating the transducer After turning OFF the diagnostic ultrasound system or deselecting <<Items to be used : Sterile protective gloves, disinfectant, sterile water infection.
should be selected on the basis of specialized training and clinical the transducer, insert the connector into the transducer connector or deionized water, sterile cloth or gauze>> 4. Between examinations, keep the transducer in a sterile
experience. When a biopsy procedure is to be performed, sterilize the slot of the diagnostic ultrasound system, then turn the lock handle (1) Wear sterile protective gloves to prevent infection. environment.
transducer before and after the procedure (or confirm that the transducer 90° clockwise to lock it securely. (The diagnostic ultrasound system Wear new sterile protective gloves each time disinfection is performed. 5. When the transducer is transported to a different hospital or is sent
has been sterilized). may require that the transducer be oriented correctly for (2) Disinfect the transducer using the disinfectants shown in the table below. to your TOSHIBA representative for repair, be sure to disinfect or
connection.) (3) Rinse off all residual disinfectant from the transducer with sterile water or sterilize it and keep it in the carrying case to prevent infection.
deionized water. Confirm that the disinfectant has been completely
removed. Do not reuse the sterile water or deionized water. Disposal
(4) Dry the surface of the transducer using sterile cloth or gauze. Do not use
heat to dry the transducer. Contact your TOSHIBA representative when you wish to dispose of this
(5) Confirm that the transducer shows no signs of damage, deformation, or transducer.
peeling. Do not dispose of this transducer without consulting your TOSHIBA
representative.
Chemical name Trade name Procedures
NOTE:
Glutaraldehyde CIDEX PLUS® Time : 20 min.
28 day solution Temperature : Room temperature Concerning the WEEE label
(3.4%) The following information is only for EU member
Ortho- CIDEX® OPA Time : 12 min. states:
phthalaldehyde (0.55%) Temperature : Room temperature The use of this symbol indicates that this product
2. Disconnecting the transducer Peroxygen VirKon® (1%) Time : 10 min. should not be treated as household waste.
After turning OFF the diagnostic ultrasound system or deselecting Temperature : Room temperature By ensuring that this product is disposed of
the transducer, turn the lock handle 90° counterclockwise to release Hydrogen peroxide, PeraSafeTM*1 Time : 10 min. correctly, you will help prevent potential negative
it, and pull it out straight. Peracetic acid (1.62%) Temperature : Room temperature consequences for the environment and human
Peracetic acid NU-CIDEX
®
Time : 5 min. health, which could otherwise be caused by
(0.35%) Temperature : Room temperature inappropriate waste-handling of this product.
For more detailed information concerning the
● For chemicals other than those specified that can be used to disinfect this
return and recycling of this product, please consult
transducer, refer to the guidelines for cleaning, disinfection, and sterilization
the supplier from whom you purchased the
(2B701-813EN).
product.
*1: PeraSafe™ may be classified as a sterilizing agent or as a high-level
disinfectant depending on the regulations of the particular country.
* For system products, this label may be attached to the main unit
* For the detailed handling procedures for a chemical, refer to the documentation only.
provided by the manufacturer.
* In order to maintain the effectiveness of the chemical, confirm the
concentration, replacement interval, working temperature, etc. specified in the
documentation provided by the manufacturer.

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Inspections Before and After Use Cleaning Sterilization

The following checks should be performed for the transducer. Checks <<Items to be used : Protective gloves, cleaning solution, purified water, sterile Before sterilization, the transducer must be cleaned.
before and after use are the responsibility of the user. cloth or gauze, single-use sponge*>> <<Items to be used: Sterile protective gloves, sterilant>>
*: The single-use sponge must not include any abrasive parts or contain any abrasive cleanser.
<< Checks before use >> (1) Wear sterile protective gloves to prevent infection.
(1) Wear protective gloves to prevent infection.
1. Checks before system power ON Wear new sterile protective gloves each time sterilization is
Wear new protective gloves each time cleaning is performed.
Check the transducer surface, cable sheath, connector, etc. for performed.
(2) Wash off all organic materials (such as blood or other bodily fluids) Trademarks
external abnormalities such as protruding parts, cracks, or peeling. (2) Sterilize the transducer using the gases listed in the table below.
from the transducer under purified water. A single-use sponge can PeraSafe™ is a trademark of Antec International Ltd.
(3) Confirm that the transducer shows no signs of damage,
2. Checks after system power ON be used for washing. Do not use a brush, because it may damage ® ® ® ®
CIDEZYME , NU-CIDEX , STERRAD , CIDEX OPA, and CIDEX
deformation, or peeling.
(1) Confirm that the acoustic lens of the transducer is not the transducer. ®
PLUS are registered trademarks of Advanced Sterilization Products.
abnormally hot (check by touching the lens). (3) Immerse the transducer in a cleaning solution shown in the table Procedure
Chemical and trade name
VirKon® is a registered trademark of Antec International Ltd.
(2) Check the 2D-mode image for noise, discontinuous display, or (Sterilization method) Temperature Humidity Pressure Time
below to dissolve or remove all remaining organic materials. Use a This manual may also include trademarks of companies other than those
black areas. single-use sponge if necessary. If dried organic materials are Ethylene Gas 50°C 50% Operating Exposure time:
listed above.
oxide gas*1 concentration pressure 7 hours
<< Checks after use >> present on the transducer, immerse it in the cleaning solution for a
10% [gauge] Aeration time:
Check the transducer surface, cable sheath, connector, etc. for external prolonged period. 980 hPa 12 hours
abnormalities such as protruding parts, cracks, or peeling. (4) Remove all residual organic materials and cleaning solution from (1.0 kgf/cm2) IMPORTANT!
the transducer by rinsing it under purified water. Confirm that all ®
● If an abnormality is found on the transducer, immediately stop using it Hydrogen STERRAD Use the sterile cartridge specifically designed for each sterilizer.
1. No part of this manual may be copied or reprinted, in whole
and contact your TOSHIBA representative. organic materials and cleaning solution have been completely peroxide 50, 100, 100S There are no sterilization-related parameters (temperature,
plasma*2 humidity, pressure, or time) to be set by the operator. or in part, without written permission.
removed.
Examples of dangerous misuse Possible result 2. The contents of this manual are subject to change without
(5) Dry the surface of the transducer using sterile cloth or gauze. Do ● For chemicals other than those specified that can be used to sterilize
Using a transducer which has a malfunction or Misdiagnosis, electrical shock, injury, prior notice and without our legal obligation.
not use heat to dry the transducer. this transducer, refer to the guidelines for cleaning, disinfection, and
abnormality burns, pain
(6) Confirm that the transducer shows no signs of damage, sterilization (2B701-813EN).
Using a transducer without performing cleaning, Infection
disinfection, or sterilization deformation, or peeling. *1: After sterilization, thoroughly degas the transducer to remove all gas For Europe:
Using a transducer with a flabby acoustic lens Misdiagnosis, electrical shock Chemical type Trade name Method and time residues on the transducer.
*2: Note that the label on the transducer may fade and the connector Zilverstraat 1, 2718 RP
Immersion of the connector into a disinfectant Fire, electrical shock, malfunction Enzyme CIDEZYME
®
Time : 1 min. EC REP
Using a cracked transducer Electrical shock, injury, pain (0.8%) Temperature : Room temperature handle may become difficult to turn. These are not abnormalities. Zoetermeer, The Netherlands
Performing disinfection or sterilization not as Infection, malfunction, deterioration of TOSHIBA MEDICAL SYSTEMS EUROPE B.V.
Ethyl alcohol Ethanol 80% Wiping only Storage and Transportation
specified in this manual performance
Temperature : Room temperature
http://www.toshiba-medical.eu
Dropping the transducer Electrical shock, misdiagnosis, burns,
pain, deterioration of performance ● For chemicals other than those specified that can be used to clean 1. To prevent the transducer from being damaged, do not store it in For other countries, please contact your local distributor.
Disassembling the transducer Fire, electrical shock, deterioration of this transducer, refer to the guidelines for cleaning, disinfection, and locations where it may be exposed to:
performance sterilization (2B701-813EN). ● direct sunlight or X-rays
* For the detailed handling procedures for a chemical, refer to the ● dust
documentation provided by the manufacturer. ● excessive vibration
2. Store or transport the transducer under the following ambient 2B701-252E*R
* In order to maintain the effectiveness of the chemical, confirm the
concentration, replacement interval, working temperature, etc. conditions:
specified in the documentation provided by the manufacturer. ● Ambient temperature : -10°C to 50°C © TOSHIBA MEDICAL SYSTEMS CORPORATION 1995-2014
● Relative humidity : 30% to 95% (no condensation) ALL RIGHTS RESERVED
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