2B701-263E*K WARNING: CAUTION: Name and Function of Each Section

OPERATION MANUAL FOR 1. Do not allow the patient to come in contact with any part of 1. Observe the following precautions to prevent probe malfunction.
Following are the name and functions of each section and immersible
DOPPLER PENCIL PROBE the ultrasound system other than the probe or with other 1) Before connecting or disconnecting a probe, turn OFF the
range of the probe.
devices for which safety has not been verified. If the power of the diagnostic ultrasound system, or deselect the
MODEL: PC-19M diagnostic ultrasound system or other devices are defective, probe to be connected/disconnected.
This probe is classified as "IPX7" with regard to the degree of protection
against harmful ingress of water or particulate matter.
there is a risk of electrical shock. 2) The probe must not be immersed in a chemical solution for
Do not immerse the sections of the probe other than the immersible
2. Before and after examination, confirm that the probe and more than three hours.
range shown in the following figure.
cables are normal. Use of a defective probe may result in 3) Do not perform sterilization of the probe. It may malfunction.
This operation manual describes the operating procedures for the The head section of this probe is a type BF applied part.
electric shock to the patient. 4) Do not permit the probe to become overheated (more than
ultrasound probe. For the operating precautions and procedures for the 3. Do not subject the probe to mechanical shock. Use of a 60°C) during cleaning or disinfection.
diagnostic ultrasound system and other devices, refer to the relevant defective probe may result in electric shock to the patient. 5) Repeated cleaning and disinfection will eventually damage
operation manual. 4. To prevent the possibility of electric shock, do not the probe. Minimize cleaning and disinfection.
disassemble the probe. 2. Ambient conditions
Safety Precautions 5. Never immerse the non-waterproof section of the probe into 1) Do not use the probe in locations where it will be exposed to:
liquid such as water or disinfectant. Immersion may cause ● direct sunlight or X-rays
1. Meaning of Signal Words electrical shock. ● sudden changes in temperature
In this operation manual, the signal words DANGER, 6. Do not use this probe to examine the eyeball. Also, do not ● dust
WARNING, CAUTION are used regarding safety and other use this probe in examinations that may cause ultrasound ● excessive vibration <1> Probe head
important instructions. The signal words and their meanings are beams to pass through the eyeball. ● heat generators This utilizes the piezoelectric effect to convert electrical signals into
defined as follows. Please understand their meanings clearly before 2) Use the probe under the following ambient conditions ultrasound waves, which are transmitted to the body, and to
reading this manual. ● Ambient temperature : 5°C to 35°C generate electrical signals when receiving the reflected ultrasound
● Relative humidity : 30% to 85% (no condensation) waves (echoes).
Signal word Meaning ● Atmospheric pressure : 700 hPa to 1060 hPa <2> Handle
DANGER Indicates an imminently hazardous situation Hold this section to operate the probe.
which, if not avoided, will result in death or The handle can be moved to an easy-to-
serious injury. operate position by loosening the handle
locking screw.
WARNING Indicates a potentially hazardous situation
which, if not avoided, could result in death or
serious injury. <3> Cable
This transmits electric signals between probe body and connector.
CAUTION Indicates a potentially hazardous situation <4> Connector
which, if not avoided, may result in minor or This connects the probe to the diagnostic ultrasound system.
moderate injury.

CAUTION Indicates a potentially hazardous situation which,

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2. Meaning of Safety Symbols Important Information Procedures for Operating the Probe
CAUTION:
Symbol Description 1. Precautions concerning probe operation For important information, refer to the operation manual provided with This probe should be used as described in the following procedure. The
1) To prevent infection, wear sterile protective gloves when the diagnostic ultrasound system. proper clinical technique to be used for operating the probe should be
"ATTENTION" (Refer to the operation manual.) using the probe. selected on the basis of specialized training and clinical experience.
2) Wear new protective gloves for every examination. Composition
3. Meaning of Symbols on Labels 2. In normal diagnostic ultrasound mode, there is no danger of
a low-temperature burn; however, keeping the probe on the When the probe is received, unpack it and check that all the following
Symbol Indication components are present.
same region of the patient may cause such a burn.
Type-BF applied part 3. Be sure to use ultrasound gel. Do not use an ultrasound gel ● Doppler pencil probe 1
that does not list water as the principal ingredient. If castor ● Operation manual 1
Degree of protection against harmful ingress of oil is used, the probe may deteriorate, possibly causing ● Cable clamp 1
water or particulate matter: IPX7 electric shock. ● Clamps 2
(The cable and connector are not waterproof.) 4. Air bubbles entering ultrasound gel may prevent high-quality ● Carrying case 1
Manufacturer blood flow signals from being obtained. ● Guidelines for cleaning, disinfection, and sterilization 1
5. Precautions concerning cleaning and disinfection
1) Observe the following precautions to prevent infection. Applications and Specifications
Date of manufacture
● Wear protective gloves when cleaning the probe.
This probe is designed for flow measurements in diagnostic ultrasound.
Serial number ● Wear sterile protective gloves when disinfecting the
Applying the probe to the surface of the patient's body is the intended
probe.
CE mark method of use. For this reason, do not use this probe for invasive
● Wear new protective gloves each time cleaning and
procedures such as surgical use. Applicable organs, method of
disinfection are performed.
Authorized representative in the EC application, and specifications are listed in the table below.
● Clean the probe before and after examination.
4. Safety Precautions Disinfect the probe as required. Indications Target
Method of application Frequency
Please observe the following precautions to ensure the safety of 2) After cleaning, rinse the probe thoroughly with purified for use organs
patients as well as operators when using this probe. water to remove all chemical residues. After Cardiac Heart Apply probe to surface of body 1.9 MHz
disinfection, rinse the probe thoroughly with sterile
DANGER: water or deionized water to remove all chemical Acoustic Energy
Do not use this probe in an atmosphere containing flammable or residues. Chemical residues on the probe may be
explosive gases such as anesthetic gases, oxygen, and harmful to the human body. The effects of acoustic energy on human tissue are currently under
hydrogen because an explosion may occur. 3) The efficacy of the cleaning solutions and disinfectants investigation.
is not guaranteed by TOSHIBA. Contact the Therefore, it is recommended that diagnostic ultrasound output power be
manufacturers for information on the activity of the set to the lowest possible levels in accordance with the principle of
products. ALARA (As Low As Reasonably Achievable).
6. Do not use the carrying case for storing the probe. If the Please refer to the operation manual of the diagnostic ultrasound
carrying case is used for storage, it may become a source of system.
infection.

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The following checks should be performed for the probe. Checks before Before disinfection, the probe must be cleaned. Contact your TOSHIBA representative when you wish to dispose of this
and after use are the responsibility of the user. <<Items to be used : Sterile protective gloves, disinfectant, sterile water probe.
<< Checks before use >> or deionized water, sterile cloth or gauze>> Do not dispose of this probe without consulting your TOSHIBA
1. Checks before system power ON (1) Wear sterile protective gloves to prevent infection. representative.
Wear new sterile protective gloves each time disinfection is performed.
Check the probe surface, cable sheath, connector, etc. for external NOTE:
abnormalities such as protruding parts, cracks, or peeling. (2) Disinfect the probe using the disinfectants shown in the table below.
(3) Rinse off all residual disinfectant from the probe with sterile water or Concerning the WEEE label
2. Checks after system power ON deionized water. Confirm that the disinfectant has been completely The following information is only for EU member
(1) Confirm that the probe head is not abnormally hot (check by removed. Do not reuse the sterile water or deionized water. states:
touching the surface of the head). (4) Dry the surface of the probe using sterile cloth or gauze. Do not use heat to The use of this symbol indicates that this product
(2) Check the CW-mode image for noise or discontinuous display. dry the probe. should not be treated as household waste.
<< Checks after use >> (5) Confirm that the probe shows no signs of damage, deformation, or peeling. By ensuring that this product is disposed of
Check the probe surface, cable sheath, connector, etc. for external correctly, you will help prevent potential negative
Chemical name Trade name Procedures
abnormalities such as protruding parts, cracks, or peeling. consequences for the environment and human
Glutaraldehyde CIDEX PLUS® Time : 20 min.
● If an abnormality is found on the probe, immediately stop using it and 28 day solution Temperature : Room temperature
health, which could otherwise be caused by
contact your TOSHIBA representative. (3.4%) inappropriate waste-handling of this product.
Peroxygen VirKon® (1%) Time : 10 min. For more detailed information concerning the
Examples of dangerous misuse Possible result
Temperature : Room temperature return and recycling of this product, please consult
Using a probe which has a malfunction or Misdiagnosis, electrical shock, injury, TM*1
abnormality burns, pain
Hydrogen peroxide, PeraSafe Time : 10 min. the supplier from whom you purchased the
Peracetic acid (1.62%) Temperature : Room temperature product.
Using a probe without performing cleaning or Infection
Peracetic acid NU-CIDEX® (0.35%) Time : 5 min. * For system products, this label may be attached to the main unit
disinfection
Temperature : Room temperature
Using a probe with a flabby probe head Misdiagnosis, electrical shock only.
Immersion of the connector into a disinfectant Fire, electrical shock, malfunction ● For chemicals other than those specified that can be used to disinfect this
Using a cracked probe Electrical shock, injury, pain probe, refer to the guidelines for cleaning, disinfection, and sterilization (2B701-
Performing disinfection not as specified in this Infection, malfunction, deterioration of 813EN).
manual performance 3. Disconnecting the probe *1: PeraSafe™ may be classified as a sterilizing agent or as a high-level
Dropping the probe Electrical shock, misdiagnosis, burns, (1) Turn OFF the power of the diagnostic ultrasound system or disinfectant depending on the regulations of the particular country.
pain, deterioration of performance deselect the probe. Then, release the cable from the clamp. * For the detailed handling procedures for a chemical, refer to the documentation
Disassembling the probe Fire, electrical shock, deterioration of (2) Hold the cable connector and pull it straight out of the provided by the manufacturer.
performance connector slot. * 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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Connection to the Diagnostic Ultrasound System Cleaning Storage and Transportation

1. Attaching the cable clamp <<Items to be used : Protective gloves, cleaning solution, purified 1. To prevent the probe from being damaged, do not store it in
Trademarks
Attach the cable clamp to the connector panel by means of double- water, sterile cloth or gauze, single-use sponge>> locations where it may be exposed to:
sided tape, as shown below. (1) Wear protective gloves to prevent infection. ● direct sunlight or X-rays PeraSafe™ is a trademark of Antec International Ltd.
® ® ®
Wear new protective gloves each time cleaning is performed. ● dust CIDEZYME , NU-CIDEX , and CIDEX PLUS are registered trademarks
(2) Wash off all organic materials (such as blood or other bodily fluids) ● excessive vibration of Advanced Sterilization Products.
from the probe under purified water. A single-use sponge can be 2. Store or transport the probe under the following ambient conditions: VirKon® is a registered trademark of Antec International Ltd.
used for washing. Do not use a brush, because it may damage the ● Ambient temperature : 5°C to 40°C This manual may also include trademarks of companies other than those
probe. ● Relative humidity : 30% to 85% (no condensation) listed above.
(3) Immerse the probe in a cleaning solution shown in the table below ● Atmospheric pressure : 700 hPa to 1060 hPa
to dissolve or remove all remaining organic materials. Use a 3. Do not use the carrying case for storing the probe.
IMPORTANT!
single-use sponge if necessary. If dried organic materials are If the carrying case is used for storage, it may become a source of
present on the probe, immerse it in the cleaning solution for a infection. 1. No part of this manual may be copied or reprinted, in whole
prolonged period. 4. Between examinations, keep the probe in a sterile environment. or in part, without written permission.
(4) Remove all residual organic materials and cleaning solution from 5. When the probe is transported to a different hospital or is sent to 2. The contents of this manual are subject to change without
the probe by rinsing it under purified water. Confirm that all your TOSHIBA representative for repair, be sure to disinfect it and prior notice and without our legal obligation.
organic materials and cleaning solution have been completely keep it in the carrying case to prevent infection.
removed.
(5) Dry the surface of the probe using sterile cloth or gauze. Do not For Europe:
use heat to dry the probe. The equipment described in this manual is in accordance with the
(6) Confirm that the probe shows no signs of damage, deformation, or requirements of the Medical Device Directive 93/42/EEC.
peeling. Zilverstraat 1, 2718 RP
EC REP
Chemical type Trade name Method and time Zoetermeer, The Netherlands
®
Enzyme CIDEZYME Time : 1 min. TOSHIBA MEDICAL SYSTEMS EUROPE B.V.
(0.8%) Temperature : Room temperature http://www.toshiba-europe.com

● For chemicals other than those specified that can be used to clean Unauthorized modification of the product or configuration invalidates the
this probe, refer to the guidelines for cleaning, disinfection, and CE Marking.
2. Connecting the probe sterilization (2B701-813EN).
For other countries, please contact your local distributor.
(1) Turn OFF the power of the diagnostic ultrasound system or * For the detailed handling procedures for a chemical, refer to the
deselect the probe. Then, insert the connector of the probe documentation provided by the manufacturer.
cable into the connector slot of the diagnostic ultrasound * In order to maintain the effectiveness of the chemical, confirm the
system and lock it securely. concentration, replacement interval, working temperature, etc.
(2) Secure the cable using the clamp. specified in the documentation provided by the manufacturer. 2B701-263E*K
If the cable is not secured, noise may enter the image or the
cable may become damaged. © TOSHIBA MEDICAL SYSTEMS CORPORATION 1995-2012
ALL RIGHTS RESERVED
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