SonoSite TEExp Manual de usuario

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

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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

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

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

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

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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