2B701-462E*L WARNING: CAUTION: Applications and Specifications

OPERATION MANUAL FOR and cables are normal. Use of a defective transducer may 1. Observe the following precautions to prevent transducer
This transducer is designed for imaging organs, localizing lesions, flow
CONVEX ARRAY TRANSDUCER result in electric shock to the patient. malfunction.
measurements, and mapping in diagnostic ultrasound. Applying the
3. Do not subject the transducer to mechanical shock. Use of 1) Before connecting or disconnecting a transducer, turn OFF
MODEL: PVM-375AT a defective transducer may result in electric shock to the the power of the diagnostic ultrasound system, or deselect
transducer to the surface of the patient's body is the intended method of
use. For this reason, do not use this transducer for invasive procedures
This operation manual describes the operating procedures for the patient. the transducer to be connected/disconnected.
such as surgical use. Applicable organs, method of application, and
ultrasound transducer. For the operating precautions and procedures for 4. To prevent the possibility of electric shock, do not 2) The transducer must not be immersed in a chemical solution
specifications are listed in the table below.
the diagnostic ultrasound system and other devices, refer to the relevant disassemble the transducer. for more than three hours.
operation manual. 5. Never immerse the transducer connector into liquid such as 3) Do not permit the transducer to become overheated (more Indications Target organs Method of Frequency Viewing
water or disinfectant. Immersion may cause electrical shock. than 60°C) during cleaning, disinfection, and sterilization. for use application angle
6. During biopsy, the biopsy needle may fail to reach the target 4) Repeated cleaning, disinfection, and sterilization will Abdominal, Abdominal, Apply 3.75 MHz Approx.
Safety Precautions site or the patient may be injured due to an incorrectly eventually damage the transducer. Minimize cleaning, fetal pelvic organs, transducer 70°
performed biopsy, possibly causing side effects, in the disinfection, and sterilization. fetus, etc. to surface
1. Meaning of Signal Words of body
In this operation manual, the signal words DANGER, following situations: 2. Ambient conditions
WARNING, CAUTION are used regarding safety and other 1) A biopsy adaptor other than the applicable models 1) Do not use it in locations where it will be exposed to:
described in this document is used. ● direct sunlight or X-rays Information on the Biopsy Adaptors
important instructions. The signal words and their meanings are
defined as follows. Please understand their meanings clearly before 2) The biopsy adaptor is mounted incorrectly. (Be sure to ● sudden changes in temperature Biopsy adaptors: UAGV013A manufactured by Toshiba Medical
reading this manual. mount the biopsy adaptor securely and in the correct ● dust Systems Corporation
position and direction.) ● excessive vibration * For the use procedures, sterilization procedures, and other detailed
7. This transducer is contraindicated for ophthalmic use or any ● heat generators information, refer to the operation manual for the biopsy adaptor.
Signal word Meaning
application that causes the acoustic beam to pass through 2) Use the transducer under the following ambient conditions: * It is possible to display the biopsy-guiding needle mark on the
DANGER Indicates an imminently hazardous situation the eye. ● Ambient temperature : 5°C to 35°C
which, if not avoided, will result in death or monitor.
● Relative humidity : 30% to 85% (no condensation) For the display procedures and the precautions regarding the needle
serious injury. CAUTION: ● Atmospheric pressure : 700 hPa to 1060 hPa mark, refer to the operation manual for the diagnostic ultrasound
WARNING Indicates a potentially hazardous situation 1. Precautions concerning transducer operation system.
which, if not avoided, could result in death or 1) To prevent infection, wear sterile protective gloves when
serious injury. using the transducer. Acoustic Energy
2) Wear new protective gloves for every examination.
CAUTION Indicates a potentially hazardous situation 2. In normal diagnostic ultrasound mode, there is no danger of The effects of acoustic energy on human tissue are currently under
which, if not avoided, may result in minor or a low-temperature burn; however keeping the transducer on investigation.
moderate injury. the same region of the patient may cause such a burn. Therefore, it is recommended that diagnostic ultrasound output power be
3. Be sure to use ultrasound gel. Do not use an ultrasound gel set to the lowest possible levels in accordance with the principle of
CAUTION Indicates a potentially hazardous situation which,
that does not list water as the principal ingredient. If castor ALARA (As Low As Reasonably Achievable).
if not avoided, may result in property damage.
oil is used, the transducer may deteriorate, possibly causing Please refer to the operation manual of the diagnostic ultrasound
electric shock. system.
4. When performing biopsy procedures, use only sterile

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2. Meaning of Safety Symbols CAUTION: Important Information Name and Function of Each Section
Symbol Description ultrasound gel that is certified to be safe*. Also, manage the
For important information, refer to the operation manual provided with Following are the name and functions of each section and immersible
ultrasound gel properly to ensure that it does not become a
the diagnostic ultrasound system. range of the transducer.
"ATTENTION" (Refer to the operation manual.) source of infection.
This transducer is classified as "IPX7" with regard to the degree of
* Consult the manufacturer for details. Composition protection against harmful ingress of water or particulate matter.
3. Meaning of Symbols on Labels 5. Sterilize the transducer and biopsy adaptor before and after
The connector section and ferrite core are not waterproof and must not
an ultrasound-guided biopsy procedure is performed. When the transducer is received, unpack it and check that all the
Symbol Indication be immersed in liquids such as disinfectant.
Failure to do so may result in the transducer and biopsy following components are present.
The head section of this transducer is a type BF applied part.
Type-BF applied part adaptor becoming sources of infection. ● Convex array transducer 1
6. Precautions concerning cleaning, disinfection, and ● Carrying case 1
Degree of protection against harmful ingress of sterilization ● Cable clamp 1
water or particulate matter: IPX7 1) Observe the following precautions to prevent infection. ● Operation manual 1
(The connector is not waterproof.) ● Wear protective gloves when cleaning the transducer. ● Guidelines for cleaning, disinfection, and sterilization 1
● Wear sterile protective gloves when disinfecting or
Manufacturer
sterilizing the transducer.
● Wear new protective gloves each time cleaning,
Date of manufacture
disinfection, and sterilization are performed.
Serial number ● Clean the transducer before and after examination.
Disinfect or sterilize the transducer as required.
Authorized representative in the EC 2) After cleaning, rinse the transducer thoroughly with <1> Transducer head
purified water to remove all chemical residues. After This utilizes the piezoelectric effect to convert electrical signals into
4. Safety Precautions disinfection, rinse the transducer thoroughly with sterile ultrasound waves, which are transmitted to the body, and to
Please observe the following precautions to ensure the safety of water or deionized water to remove all chemical generate electrical signals when receiving the reflected ultrasound
patients as well as operators when using this transducer. residues. Chemical residues on the transducer may be waves (echoes). The lens on the surface is the acoustic lens.
DANGER: harmful to the human body. <2> Biopsy adaptor fixing slot
3) After sterilization, degas the transducer. Gas residues Mount the specified biopsy adaptor using this slot.
Do not use this transducer in an atmosphere containing on the transducer may be harmful to the human body. <3> Grip
flammable or explosive gases such as anesthetic gases, oxygen, 4) The efficacy of the cleaning solutions, disinfectants, and Hold this section to operate the transducer.
and hydrogen because an explosion may occur. sterilizing gases is not guaranteed by TOSHIBA. Contact <4> Cable
the manufacturers for information on the activity of the This transmits electric signals between transducer body and
WARNING: products. connector.
1. Do not allow the patient to come in contact with any part of 7. Do not use the carrying case for storing the transducer. If * The ferrite core may have to be removed when the transducer is
the ultrasound system other than the transducer or with the carrying case is used for storage, it may become a used with certain system models.
other devices for which safety has not been verified. If the source of infection. <5> Lock handle
diagnostic ultrasound system or other devices are defective, This locks the connector to the diagnostic ultrasound system.
there is a risk of electrical shock. <6> Connector
2. Before and after examination, confirm that the transducer This connects the transducer to the diagnostic ultrasound system.

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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. 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). (2) Disinfect the transducer using the disinfectants shown in the table below. to your TOSHIBA representative for repair, be sure to disinfect or
(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:
2. Disconnecting the transducer phthalaldehyde (0.55%) Temperature : Room temperature The use of this symbol indicates that this product
After turning OFF the diagnostic ultrasound system or deselecting Peroxygen VirKon® (1%) Time : 10 min. should not be treated as household waste.
the transducer, turn the lock handle 90° counterclockwise to release Temperature : Room temperature By ensuring that this product is disposed of
it, and pull it out straight. Hydrogen peroxide, PeraSafeTM*1 Time : 10 min. correctly, you will help prevent potential negative
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 2B701-462E*L
* 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 1997-2014
● Relative humidity : 30% to 95% (no condensation) ALL RIGHTS RESERVED
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