FujiFilm SonoSite TEEx User manual

TEEx, 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.Value
from Innovation is a trademark of FUJIFILM Holdings America Corporation.
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.
Part Number: P20995-03
Publication date: November 2017
Copyright © 2017 FUJIFILM SonoSite, Inc. All rights reserved.
Manufacturer
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
FUJIFILM SonoSite B.V.
Joop Geesinkweg 140
1114 AB Amsterdam,
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.

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Introduction 1
Nederlands
TEEx, 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 (TEEx, TEExi, and TEExp) .................................................................................. 4
Step 2 — Testing the endoscopic shaft (TEExi and TEExp only) ..................................................................................... 7
Step 3 — Cleaning the transducer (TEEx, TEExi, and TEExp) ........................................................................................... 9
If no bite holes are detected ............................................................................................................................................................. 10
If the transducer fails the test ........................................................................................................................................................... 10
Introduction
It is important that you test the TEEx, TEExi,or TEExp 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

2 Overview
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:
Phone
(outside U.S. or
Canada)
425-951-1330, or call your local representative
Fax [phone]
Email [e-mail]
Web www.sonosite.com
Europe Service Center
Main: [phone]
English support: [phone]
French support: [phone]
German support: [phone]
Italian support: [phone]
Spanish support: [phone]
Asia Service Center [phone]

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Testing for bite holes 3
Nederlands
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 transducer is tested for electrical isolation and leakage current before it is shipped to a
customer.
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.
WARNING To avoid injury to the patient, do not use the transducer if the insulating
material has been punctured or otherwise compromised.
WARNING Take all necessary precautions to avoid contact with non-insulated parts that
have applied voltage.
Scan head
Controller
Cable
Endoscopic
shaft
Connector
Can be immersed in liquid
Cannot be immersed in liquid
90

4 Testing for bite holes
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 only with the TEExi and TEExp transducers)
Step 1 — Testing the transducer array (TEEx, TEExi, and TEExp)
To test the transducer array for bite holes or current leakage
Figure 1 Transducer array test setup
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:
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.
Black lead
Bite hole indicator
Water bath with 5% saline
solution
Conductor plate
Red leads
Controller

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Testing for bite holes 5
Nederlands
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 the model name.
This information will be important in the next step.
Note Use the lead attached to the conductor plate. Do not submerge the indicator
clip.
Conductor plate
Salt-water bath
Part number label

6 Testing for bite holes
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 10.
Pass - No bite holes were found.
All - If all of the lights are illuminated, the battery is low. Replace the battery.
If you are testing the TEEx transducer, proceed directly to “Step 3 — Cleaning the transducer (TEEx,
TEExi, and TEExp)” on page 9.
If you are testing the TEExi or TEExp transducer, continue with “Step 2 — Testing the endoscopic shaft
(TEExi and TEExp only)” on page 7.
TEEx/TEExi
TEExp

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Testing for bite holes 7
Nederlands
Step 2 — Testing the endoscopic shaft (TEExi and TEExp only)
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 TEExi and TEExp transducer.
Figure 5 Insertion of the puncture test tool.
2Immerse the scan head and endoscopic shaft in liquid to above the 40 cm mark, but below the 90 cm
mark.
WARNING Do not immerse the controller, the cord, or the connector in any fluid.
Black lead
Bite hole indicator
Water bath with 5% saline
solution
Conductor plate
Red leads
Controller
Puncture
test tool

8 Testing for bite holes
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
bConnect the red leads to the puncture test tool as shown in Figure 7.
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.
Note Each clip should be attached separately to the puncture test tool.
Conductor plate
Salt-water bath