SonoSite TEExp Manuel utilisateur
TEExp and TEExi Transducer
Bite Hole Indicator
User Guide
SonoSite, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions.
All other trademarks are the property of their respective owners.
Patents: US 6,371,918, CA 2,373,065, DE 60021552.0, FR 1175173 and GB 1175173.
Distributor
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021
USA
T: 1-888-482-9449 or 1-425-951-1200
F: 1-425-951-1201
EC Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW 2100
Australia
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
Part Number: P20995-01
Publication Date: April 2015
Copyright © 2015 FUJIFILM SonoSite, Inc. All Rights reserved.
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TEExp and TEExi 1
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TEExp and TEExi
Bite Hole Indicator User Guide
Introduction ....................................................................................................................................................... 1
Document conventions .................................................................................................................................................................... 1
Getting help .......................................................................................................................................................................................... 1
Overview ............................................................................................................................................................ 2
Transducer components .................................................................................................................................................................. 2
Testing for bite holes ........................................................................................................................................ 3
Preparing for bite-hole testing ...................................................................................................................................................... 3
Step 1 — Testing the transducer array ....................................................................................................................................... 3
Step 2 — Testing the endoscopic shaft ...................................................................................................................................... 6
If no bite holes are detected ........................................................................................................................................................... 8
If the transducer fails the test ......................................................................................................................................................... 9
Introduction
It is important that you test the TEExp or TEExi transducer for punctures and tears in the waterproof coating
before every procedure. If any damage, irregularity, substandard functioning, or unsafe condition is observed
or suspected, do not use the transducer. Call FUJIFILM SonoSite or your local representative.
Document conventions
The document follows these conventions:
A WARNING describes precautions necessary to prevent injury or loss of life.
A Caution describes precautions necessary to protect the products.
A Note provides supplemental information.
Numbered and lettered steps must be performed in a specific order.
Bulleted lists present information in list format but do not imply a sequence.
Getting help
In addition to this document, you can get help with this product by contacting FUJIFILM SonoSite Technical
Support:
Phone (U.S. or Canada) 877-657-8118
Phone (Outside U.S. or
Canada)
425-951-1330, or call your local representative
Fax 425-951-6700
E-mail service@sonosite.com
2
Overview
Transducer components
A basic understanding of the TEE transducer components is important to successfully performing a bite hole
detection test. In this guide, you will find references to the following components:
The endoscope shaft has no electrically conducting surfaces and is covered with a layer of material that
permits neither fluids nor electricity to pass through it. Electrical safety is maintained for the transducer by
keeping this material intact. Punctures in this material, such as those resulting from bites or improper
handling, can result in fluids entering the endoscopic shaft and the patient being exposed to electrical current.
Each TEExp transducer is tested for electrical isolation and leakage current before it is shipped to a customer.
Web www.sonosite.com
Europe Service Center Main: +31 20 751 2020
English support: +44 14 6234 1151
French support: +33 1 8288 0702
German support: +49 69 8088 4030
Italian support: +39 02 9475 3655
Spanish support: +34 91 123 8451
Asia Service Center +65 6380-5581
WARNING: To avoid injury to the patient, do not use the transducer if the insulating
material has been punctured or otherwise compromised.
Scan head
Controller
Cable
Endoscopic
shaft
Connector
Can be immersed in liquid
Cannot be immersed in liquid
90 cm
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Testing for bite holes
FUJIFILM SonoSite recommends testing the endoscopic shaft and the transducer array for bite holes after
every procedure. You should perform bite hole detection after cleaning the transducer, but before disinfecting
it, so you can identify punctures before exposing them to disinfectants which might leak inside and damage
the transducer.
Preparing for bite-hole testing
Test both the scan head and the endoscopic shaft separately for bite holes. You can use the same equipment
for both tests; however, the tester connection points are different for each test.
Assemble the following items for this 2-step test:
Water bath with a 5% saline solution (50g NaCl/1 liter water)
A conductor plate made of copper or aluminum with an area of at least 25 cm2 (one is included with bite
hole indicator kit)
Bite hole indicator with leads
Puncture test tool (included with TEE transducer)
Step 1 — Testing the transducer array
To test the transducer array for bite holes or current leakage
Figure 1 Transducer array test setup
WARNING: Take all necessary precautions to avoid contact with non-insulated parts that
have applied voltage.
Black lead
Bite hole indicator
Water bath with 5% saline
solution
Conductor plate
Red leads
Controller
4
1After securing the controller so it does not fall into the water bath, immerse the scan head and endoscopic
shaft in liquid to above the 40 cm mark, but below the 90 cm mark.
2Connect the Bite hole indicator to the transducer connector and the conductor plate:
aConnect the black lead to the conductor plate in the salt-water bath as shown in Figure 2.
Figure 2 Conductor plate attachment
bIdentify the model of TEE transducer you are testing by checking the part number label on the
connector. The top line of the label will include one of these two model names:
TEExp Transducer
TEExi Transducer
WARNING: Do not immerse the controller, cable, or connector in any fluid.
Caution: Do not allow the endoscopic shaft to contact the conductor plate. Doing so
could result in an inaccurate test result.
Note: Use the lead attached to the conductor plate. Do not submerge the indicator
clip.
Conductor plate
Salt-water bath
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This information will be important in the next step.
cConnect the red leads to the knurled socket cap screws on the transducer connector as shown in
Figure 3. The configuration of the leads depends on the model of transducer you have. See step 2b to
determine your transducer model.
Figure 3 Transducer connector attachment
3On the Bite hole indicator, press
4Read the test result:
Leads - The leads are not connected correctly. Check the connections, and test again.
Fail - There was a bite hole detected in the transducer array. Stop the bite hole test procedure. Do not
use the transducer. For remediation steps, see “If the transducer fails the test” on page 9.
Part number label
TEExi
TEExp
6
Pass - No bite holes were found.
All - If all of the lights are illuminated, the battery is low. Replace the battery.
Step 2 — Testing the endoscopic shaft
To test the endoscopic shaft for bite holes or current leakage
Figure 4 Endoscopic shaft test setup
1Insert the puncture test tool under the scanplane controller as shown in Figure 5. The puncture test tool is
included with the TEE transducer.
Figure 5 Insertion of the puncture test tool.
Black lead
Bite hole indicator
Water bath with 5% saline
solution
Conductor plate
Red leads
Controller
Puncture
test tool
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2Immerse the scan head and endoscopic shaft in liquid to above the 40 cm mark, but below the 90 cm mark.
3Connect the Bite hole indicator to the puncture test tool and the conductor plate:
aConnect the black lead to the conductor plate in the salt-water bath as shown in Figure 6.
Figure 6 Conductor plate attachment
WARNING: Do not immerse the controller, the cord, or the connector in any fluid.
Caution: Do not allow the endoscopic shaft to contact the conductor plate. Doing so
could result in an inaccurate test result.
Note: Use the lead attached to the conductor plate. Do not submerge the indicator
clip.
Conductor plate
Salt-water bath
8
bConnect the red leads to the puncture test tool as shown in Figure 7.
Figure 7 Puncture test tool attachment
4Press
5Read the test result:
Leads - The leads are not connected correctly. Check the connections, and test again.
Fail - There was a bite hole detected in the endoscopic shaft. Stop the bite hole test procedure. Do not
use the transducer. For remediation steps, see “If the transducer fails the test” on page 9.
Pass - No bite holes were found.
All - If all of the lights are illuminated, the battery is low. Replace the battery.
6After the test, rinse the endoscopic shaft for one minute with a large volume of clean, lukewarm water to
remove residual saline solution (for example, eight liters).
7Dry the endoscopic shaft with a clean, non-linting towel.
If no bite holes are detected
To identify the transducer as safe, you should include a sticker or certificate that travels with the transducer
that includes the date of the test, the name or other identification of the tester, and the outcome of the test. If
the bite hole test was performed as part of the cleaning process, continue to clean and disinfect the
transducer.
Note: Each clip should be attached separately to the puncture test tool.
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