2B701-233E*Q
This manual contains warnings regarding foreseeable potential
OPERATION MANUAL FOR
BIOPSY ADAPTOR
MODEL: UAGL006A
This operation manual describes the operating procedures for the biopsy
adaptor. For the operating precautions and procedures for the
transducer and other devices, refer to the relevant operation manual.
Safety Precautions
1. Meaning of Signal Words
In this operation manual, the signal words DANGER,
WARNING, CAUTION are used regarding safety and other
important instructions. The signal words and their meanings are
defined as follows. Please understand their meanings clearly before
reading this manual.
Signal word Meaning
! DANGER Indicates an imminently hazardous situation
which, if not avoided, will result in death or
serious injury.
! WARNING Indicates a potentially hazardous situation
which, if not avoided, could result in death or
serious injury.
! CAUTION Indicates a potentially hazardous situation
which, if not avoided, may result in minor or
moderate injury.
CAUTION Indicates a potentially hazardous situation which, if
not avoided, may result in property damage.
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2. Meaning of Safety Symbols
Symbol Description
"ATTENTION" (Refer to the operation manual.)
3. Meaning of Symbols on Labels
Symbol Indication
Manufacturer
Serial number
Authorized representative in the EC
4. Safety Precautions
Please observe the following precautions to ensure the safety of
patients as well as operators when using this adaptor.
! WARNING:
1. Biopsy procedures require a thorough understanding of
diagnostic ultrasound and adequate training. If biopsy
procedures are performed without sufficient understanding
and training, the patient may be injured.
2. The biopsy needle may fail to reach the target site or the
patient may be injured due to an incorrectly performed
biopsy, possibly causing side effects, in the following
situations:
1) A transducer other than the applicable transducer models
described in this document is used.
2) The biopsy adaptor is mounted incorrectly. (Be sure to
mount the biopsy adaptor securely and in the correct
position and direction.)
3) A component of the biopsy adaptor is not attached
properly or is detached.
(Confirm that the components are attached securely by
touching them with your hand before use.)
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7.
! WARNING: ! CAUTION: dangers. Be alert at all times to dangers other than those indicated.
3. Use a biopsy needle suitable for the purpose of the biopsy 3. Precaution concerning storage 8. TOSHIBA shall not be liable for damage or loss that result from
and for this biopsy adaptor. Do not use the carrying case for storing the biopsy adaptor. negligence or from ignoring the precautions and operating
4. During biopsy procedures, the needle may deviate from the If the carrying case is used for storage, it may become a instructions contained in this operation manual.
desired course due to tissue characteristics or the type of
needle. In particular, needles with a small diameter may
source of infection. 9. Please keep this operation manual with the equipment. Whenever
4. For details of the transducer to be used, refer to the relevant the administrator or person responsible for this equipment is
deviate to a greater degree. When performing biopsy transducer operation manual. Also observe the following
procedures, take care always to monitor the target region and changed, be sure to hand over this operation manual.
instructions.
the image of the needle. 1) Sterilize the transducer before and after biopsy
5. Sterilize the biopsy adaptor before and after an ultrasound- Composition
procedures.
guided biopsy procedure is performed. Failure to do so may 2) When using ultrasound gel during biopsy procedures, use When the biopsy adaptor is received, unpack it and check that all the
result in the biopsy adaptor becoming a source of infection. only sterile ultrasound gel. following components are present.
6. During inspections before use, confirm that the biopsy 5. Even when the target for biopsy and the biopsy needle are (1) Biopsy adaptor ........................................................................ 1
needle appears at almost the same position as the selected visible on the image, the needle may not actually reach the
needle mark displayed on the image. (2) Needle guides ......................................................................... 6
target due to dispersion of the ultrasound beam. Be (3) Carrying case .......................................................................... 1
7. The needle mark displayed on the ultrasound image particularly careful when the target for biopsy is small.
depending on the diagnostic ultrasound system should be (4) Operation manual .................................................................... 1
* Diagnostic ultrasound systems produce tomographic plane (5) Guidelines for cleaning, disinfection, and sterilization ............. 1
used as a reference. The needle mark does not indicate the images with a certain thickness along the width direction of
actual position of the biopsy needle. For the operating Applications and Specifications
procedures for the needle mark, refer to the operation
the transducer.
If the target object and the biopsy needle are positioned in
manuals for the diagnostic ultrasound system. the beam as shown in figure 1, they may appear in the image This biopsy adaptor is intended for use as a biopsy guide using a
8. The needle guide can be used for this biopsy adaptor only. transducer for TOSHIBA diagnostic ultrasound systems. Using the
as shown in figure 2.
Do not use other similar needle guides. The patient may be biopsy adaptor in combination with commercially available biopsy
injured. <<Conceptual view>>
needles makes it possible to perform biopsy procedures under real-time
9. Always use a needle guide that corresponds to the gauge No. observation. The specifications of the biopsy adaptor are shown in the
of the biopsy needle. Use of an incorrect needle guide may table below:
result in injury to the patient.
Table 1 Specifications of the biopsy adaptor
10. When the radiofrequency wave needle cannula is used Biopsy
together with this biopsy adaptor, confirm in advance that the Transducer Applicable
Biopsy needle Biopsy Biopsy
insulating sheaths on the surface of the needle cannula are needle adaptor
Applicable transducer biopsy
angle
not damaged and observe the following precautions. needle
1) Carefully operate the needle cannula. Target object UAGL006A PLF-503AT, 703AT 11G to 22G 42° to 75°
2) Before use, confirm that the needle number of the needle PLK- 503AT, 703AT/01 needles can
guide matches the gauge number of the needle cannula. PLM-503AT, 703AT, 1204AT be used by
3) Before use, confirm that the needle cannula operates Figure 1 Dispersion of the Figure 2 The biopsy needle PLN-503AT, 703AT, 1204AT replacing the
smoothly.
ultrasound beam appears to enter the target PLQ-703A, 1203A needle guide.
If any abnormalities are found in the biopsy adaptor or needle PVM-656AT
cannula, stop using them immediately. The insulating object on the image.
sheaths may become damaged, resulting in thermal injury to
the tissues around the damaged sections.
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! CAUTION: ! CAUTION: Name of Each Section
1. Precautions concerning biopsy adaptor operation The biopsy needle may not actually reach the target object,
1) To prevent infection, wear sterile protective gloves when even if it appears to do so on the image.
using the biopsy adaptor. To minimize this problem, note the points below:
2) Wear new protective gloves for every examination. 1) Do not rely only on the echo of the needle tip on the image.
2. Precautions concerning cleaning, disinfection, and Pay careful attention to the target object, which should
sterilization Scanning
shift slightly when the biopsy needle comes into contact
1) Observe the following precautions to prevent infection. with it. direction
 Wear protective gloves when cleaning the biopsy 2) Perform biopsy only after confirming the size of the object display mark
Biopsy
adaptor. to be biopsied and the probable success of biopsy.
adaptor
 Wear sterile protective gloves when disinfecting and
sterilizing the biopsy adaptor.
Important Information
 Wear new protective gloves each time cleaning,
disinfection, and sterilization are performed. 1. The responsibility for the maintenance and management of the product UAGL006A
 Clean and sterilize the biopsy adaptor before and after after delivery resides with the customer who has purchased the product.
each examination. 2. The warranty does not cover the following items, even during the
Note that local regulations may require that the biopsy warranty period:
adaptor be disinfected before sterilization. 1) Damage or loss due to misuse or abuse.
2) After cleaning, rinse the biopsy adaptor thoroughly with 2) Damage or loss caused by Acts of God such as fires,
purified water to remove all chemical residues. After earthquakes, floods, lightning, etc.
disinfection, rinse the biopsy adaptor thoroughly with 3) Damage or loss caused by failure to meet the specified Transducer
sterile water or deionized water to remove all chemical conditions for this equipment, such as inadequate power supply,
residues. Chemical residues on the biopsy adaptor may improper installation, or unacceptable ambient conditions. Needle guide holder
be harmful to the human body.
4) Damage or loss due to mobile use in a vehicle which is not
3) After sterilization, degas the biopsy adaptor. Gas authorized by TOSHIBA.
residues on the biopsy adaptor may be harmful to the Biopsy angle
5) Damage or loss involving equipment purchased from a source
human body. setting screw
other than TOSHIBA or its authorized distributors or agents.
4) The efficacy of the cleaning solutions, disinfectants, and
DEG 75 70 60 50 42
3. This equipment shall not be used by persons other than fully qualified Biopsy angle scale
sterilizing gases is not guaranteed by TOSHIBA. Contact
and certified medical personnel. Biopsy angle mark
the manufacturers for information on the activity of the 17
4. Do not make changes or modifications to the hardware of this
products.
product.
5) Do not sterilize the biopsy adaptor using a method other Needle attachment/
than that described in this manual. If another method is 5. In no event shall TOSHIBA be liable for problems, damage, or loss
detachment lever
used, the biopsy adaptor may not be sterilized properly or caused by relocation, modification, or repair performed by personnel
other than those designated by TOSHIBA. Needle insertion
may become defective. Needle guide
6. The purpose of this equipment is to provide physicians with data for hole
6) The biopsy adaptor has been confirmed to be tolerant for
200 sterilizations using the method described in this clinical diagnosis. The responsibility for diagnostic procedures lies
manual. with the physicians involved. TOSHIBA shall not be liable for the
results of diagnostic procedures.
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Center Deviation Depending on the Needle Diameter Adjusting the Biopsy Needle 3. Immerse the biopsy adaptor in a cleaning solution shown in the table Procedure
below to dissolve or remove all remaining organic materials. Use a Sterilization Gas
Needle size can be changed from 11G to 22G by changing the needle single-use sponge if necessary. If dried organic materials are method concentration Temperature Humidity Pressure Time
For this biopsy adaptor, there may be center deviation of up to a
maximum of 1.25 mm relative to the needle mark, depending on the guide. Confirm that the needle number on the needle guide is identical to present on the biopsy adaptor, immerse it in the cleaning solution for Ethylene 10% 50°C 50% Operating Exposure
diameter of the biopsy needle. (The needle mark is aligned almost the gauge number on the biopsy needle. a prolonged period. oxide gas pressure time:7 hours
exactly with the center of the 22G biopsy needle.) Take this deviation Insert the needle guide into the needle guide holder and close the needle 4. Remove all residual organic materials and cleaning solution from the [gauge] Aeration time:
into consideration when biopsy procedures are performed. attachment/detachment lever. biopsy adaptor by rinsing it under purified water. Confirm that all 980 hPa
2
12 hours
organic materials and cleaning solution have been completely (1.0 kgf/cm )
Center of the needle mark Adjusting the Needle Guide Holder
removed. Hydrogen
*1
STERRAD  Use the sterile cartridge specifically designed for
22G The gap between the body surface and the needle guide can always be 5. Dry the surface of the biopsy adaptor using sterile cloth, gauze, or an peroxide each sterilizer. There are no sterilization-related
set to the minimum by sliding the needle guide holder. 50/100/100S/
11G air blower. Do not use heat to dry the biopsy adaptor. plasma 200 parameters (temperature, humidity, pressure, or
The needle guide holder can be slid manually by loosening the biopsy 6. Confirm that the biopsy adaptor is free of damage, deformation, time) to be set by the operator.
angle setting screw. After adjustment, tighten the screw securely. stripping, or malfunction.  For chemicals other than those specified that can be used to
Biopsy Procedures Chemical type Trade name Method and time sterilize this biopsy adaptor, refer to the guidelines for cleaning,
Enzyme CIDEZYME  Time : 1 min. disinfection, and sterilization (2B701-815EN).
1.25 mm

Needle guide
1.25 mm
Inspections Before and After Use
Be sure to check the biopsy adaptor before and after examination.
<<Checks before use>>
1. Clean and sterilize the biopsy adaptor, or confirm that the biopsy
adaptor has been cleaned and sterilized. Note that local regulations
may require that the biopsy adaptor be disinfected before sterilization.
(Refer to "Cleaning", "Disinfection", and "Sterilization" in this manual.)
2. Confirm that the biopsy adaptor is free of damage, deformation,
stripping, malfunction, or loose or missing parts.
3. Confirm that the biopsy adaptor is securely mounted in the correct
position.
4. During inspections before use, confirm that the biopsy needle
appears at almost the same position as the selected needle mark
displayed on the image as described below:
1) Prepare a container of sterile water.
2) Place the head of the transducer (with the biopsy adaptor
mounted) in the water.
3) When the biopsy needle appears on the image, confirm that the
biopsy needle is displayed at almost the same position as the
selected needle mark.
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1. Set MARK DISP on the TCS menu of the diagnostic ultrasound (0.8%) Temperature : Room temperature
system to ON to display the needle mark. The current angle of the *1: Note that it may be hard to turn knobs after sterilization. This is
needle mark is displayed on the right of the screen. The model of the  For chemicals other than those specified that can be used to not an abnormality.
biopsy adaptor is displayed at the bottom of the screen. (The model clean this biopsy adaptor, refer to the guidelines for cleaning, 3. After gas sterilization, thoroughly degas the biopsy adaptor to remove
may not be displayed, depending on the presets.) disinfection, and sterilization (2B701-815EN). all gas residues.
Needle mark * For the detailed handling procedures for a chemical, refer to the 4. Confirm that the biopsy adaptor is free of damage, deformation,
documentation provided by the manufacturer. stripping, or malfunction.
Angle of the * In order to maintain the effectiveness of the chemical, confirm the Operation, Storage, and Transportation
concentration, replacement interval, working temperature, etc.
NA needle mark 1. Do not use the carrying case for storing the biopsy adaptor.
specified in the documentation provided by the manufacturer.
If the carrying case is used for storage, it may become a source of
Disinfection infection.
2. Observe the following environmental conditions to operate, store, and
Before disinfection, the biopsy adaptor must be cleaned.
transport the biopsy adaptor.
UAGL006A Model of the Note that local regulations may require that the biopsy adaptor be
 Ambient temperature : 5°C to 35°C (-10°C to 50°C for storage
biopsy adaptor disinfected before sterilization.
and transportation)
Biopsy range mark <<Items to be used: Sterile protective gloves, disinfectant, sterile water
 Relative humidity : 30% to 85% (no condensation)
2. Operate the knob on the panel of the diagnostic ultrasound system to or deionized water, sterile cloth or gauze>>
(30% to 95% (no condensation) for
change the angle of the needle mark so that the mark is positioned 1. Wear sterile protective gloves to prevent infection. storage and transportation)
on the biopsy region. Wear new sterile protective gloves each time disinfection is performed.
 Atmospheric pressure : 700 hPa to 1060 hPa
3. Loosen the biopsy angle setting screw. 2. Disinfect the biopsy adaptor using the disinfectants shown in the table 3. Between examinations, keep the biopsy adaptor in a sterile
4. Set the biopsy angle mark of the needle guide to the desired biopsy below.
environment.
angle. 3. Rinse off all residual disinfectant from the biopsy adaptor with sterile
4. When the biopsy adaptor is transported to a different hospital or is
5. Tighten the biopsy angle setting screw. water or deionized water. Confirm that the disinfectant has been sent to your TOSHIBA representative for repair, be sure to sterilize it
6. Perform biopsy. completely removed. Do not reuse the sterile water or deionized water. and keep it in the carrying case to prevent infection.
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<<Checks after use>> Detaching the Biopsy Needle 4. Dry the surface of the biopsy adaptor using sterile cloth, gauze, or an Disposal
1. Confirm that the biopsy adaptor is free of damage, deformation, air blower. Do not use heat to dry the biopsy adaptor.
stripping, malfunction, or loose or missing parts. 1. Push the needle attachment/detachment lever to disengage the lever 5. Confirm that the biopsy adaptor is free of damage, deformation, Be sure to dispose of the biopsy adaptor only after sterilizing it. The
2. Clean and sterilize the biopsy adaptor. Note that local regulations from the hook. stripping, or malfunction. adaptor is made of polyetherimide resin. When disposing of the adaptor,
may require that the biopsy adaptor be disinfected before sterilization. 2. Open the lever to detach the biopsy needle from the biopsy adaptor. be sure to comply with all applicable laws or regulations.
Chemical name Trade name Procedures
(Refer to "Cleaning", "Disinfection", and "Sterilization" in this manual.) Glutaraldehyde CIDEX PLUS Time : 20 min.
 If an abnormality is found on the biopsy adaptor, immediately stop 28 day solution Temperature : Room temperature
using it and contact your TOSHIBA representative. (3.4%)
DEG 75 70 60 50 42
Ortho- CIDEX  OPA Time : 12 min.
Examples of dangerous misuse Possible result phthalaldehyde Temperature : Room temperature
(0.55%)
Using a biopsy adaptor without Bleeding, pain, incorrect biopsy Trademarks
Needle guide Hydrogen peroxide,
*1
PeraSafe™ (1.62%) Time : 10 min.
sufficient knowledge and training PeraSafe™ is a trademark of Antec International Ltd.
Hook Peracetic acid Temperature : Room temperature
Using a biopsy adaptor without Infection (1) Push CIDEZYME, CIDEX OPA, CIDEX PLUS, and STERRAD are
Needle  For chemicals other than those specified that can be used to disinfect registered trademarks of Advanced Sterilization Products.
performing sterilization insertion hole this biopsy adaptor, refer to the guidelines for cleaning, disinfection, This manual may also include trademarks of companies other than those
Using an inappropriate transducer Bleeding, pain, incorrect biopsy and sterilization (2B701-815EN).
(2) Open listed above.
Using the biopsy adaptor when it is Bleeding, pain, incorrect biopsy *1: PeraSafe™ may be classified as a sterilizing agent or as a high-level
positioned incorrectly disinfectant depending on the regulations of the particular country.
Needle attachment/detachment lever IMPORTANT!
Using a biopsy needle not suitable for Bleeding, pain, incorrect biopsy * For the detailed handling procedures for a chemical, refer to the
this biopsy adaptor Removing the Biopsy Adaptor documentation provided by the manufacturer. 1. No part of this manual may be copied or reprinted, in whole
* In order to maintain the effectiveness of the chemical, confirm the or in part, without written permission.
Hold the transducer and the biopsy adaptor and pull out the adaptor.
concentration, replacement interval, working temperature, etc. 2. The contents of this manual are subject to change without
Mounting the Biopsy Adaptor
specified in the documentation provided by the manufacturer. prior notice and without our legal obligation.
Slide the biopsy adaptor into the biopsy adaptor mounting notch on the
Sterilization
transducer, and fix the biopsy adaptor. Confirm that the biopsy adaptor is
For Europe:
fixed at the correct mounting position. Before sterilization, the biopsy adaptor must be cleaned.
Note that local regulations may require that the biopsy adaptor be EC REP Zilverstraat 1, 2718 RP
disinfected before sterilization. Zoetermeer, The Netherlands
<<Items to be used: Sterile protective gloves, sterilizing agent>> TOSHIBA MEDICAL SYSTEMS EUROPE B.V.
Cleaning http://www.toshiba-medical.eu
1. Wear sterile protective gloves to prevent infection.
<<Items to be used: Protective gloves, cleaning solution, purified water, Wear new sterile protective gloves each time sterilization is performed.
For other countries, please contact your local distributor.
sterile cloth or gauze, single-use sponge*>> 2. Perform high-pressure steam sterilization, EOG sterilization, or
*: The single-use sponge must not include any abrasive parts or contain hydrogen peroxide plasma sterilization.
any abrasive cleanser. For high-pressure steam sterilization, place the biopsy adaptor in the
1. Wear protective gloves to prevent infection. packing case and put it in the sterilizer. Perform steam heating using
Wear new protective gloves each time cleaning is performed. prevacuum 3 times and then perform sterilization (sterilization
2. Wash off all organic materials (such as blood or other bodily fluids) temperature: 134°C, holding time: 18 minutes). 2B701-233E*Q
from the biopsy adaptor under purified water. A single-use sponge Other temperatures and holding times can be used if microbiological
can be used for washing. Do not use a brush, because it may testing confirms that they achieve sterilization.  TOSHIBA MEDICAL SYSTEMS CORPORATION 1997-2014
damage the biopsy adaptor. ALL RIGHTS RESERVED
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