Imaging Systems

T R A N SD U C E R R E F E R E N C E

SONOS 5500/4500
ImagePoint Hx
PH I L I PS ME D I C AL SY ST E MS

English
M2424-99300-06
 User’s Guide

Transducer Reference

G:\users\C.0 backup\transducers\Transducer C0\To print

© Copyright 2002 Warranty WARNING Warning Symbols used on
Philips Electronics North The information contained in the System:
America Corporation this document is subject to Electrical Shock Hazard

All rights are reserved.

change without notice. Do not remove system covers. !
Philips Medical Systems To avoid electrical shock, use
Reproduction in whole or in User’s guide symbol: The
makes no warranty of any kind only supplied power cords and
part is prohibited without the product will be marked with
with regard to this material, connect only to properly
prior written consent of the this symbol when it is neces-
including, but not limited to, grounded wall (wall/mains)
copyright holder. sary for the user to refer to the
the implied warranties of outlets.
user’s guide.
Publication number merchantability and fitness for Explosion Hazard
M2424-99300-06 a particular purpose.
Do not operate the system in
Edition 6 Philips Medical Systems shall the presence of flammable
Published June, 2002 not be liable for errors anesthetics.
contained herein or for Dangerous voltages symbol:
Printed in U.S.A. Safety Information Indicates potential for electri-
incidental or consequential
damages in connection with Before you use the Philips ul- cal shock.
the furnishing, performance, or trasound system, be sure to
use of this material. read the Safety and Standards Monitor Radiation
guide. The monitor used in this
This product may contain re-
manufactured parts equivalent Pay special attention to the system complies with the FDA
to new in performance or have "Warnings" and "Cautions." regulations that were
had incidental use. applicable at the date of
The warnings explain the dan- manufacture (21 CFR
gers of electrical shock and ex- Subchapter J).
Trademarks plosion hazard, the safety of
Philips and third-party product ultrasound, applications, Prescription Device
names may be trademarks or guidelines for fetal use, and
registered trademarks of their guidelines for setting controls The United States Food and
respective owners. that affect acoustic output and Drug Administration requires
accuracy of clinical measure- the following labeling
ments. statement:

The cautions explain potential Caution - Federal Law restricts

dangers to equipment. this device to use by or on the
order of a physician.
Warning Symbol Used in the
Text: Important

0123 marking is for

WARNING Council Directive
93/42/EEC.
Caution Symbol Used in the This system complies with the
Text: Medical Device Directive.
Authorized EU
CAUTION Representative:
Philips Medizinsysteme
Boeblingen, GmbH
Hewlett-Packard Str. 2
71034 Boeblingen, Germany

Philips Medical Systems

3000 Minuteman Road
Andover, Massachusetts 01810-1099
(978) 687-1501
Printing History

Edition Publication Date Software Revision

Edition 1 June 1997 SONOS 4500/5500 A.0

Edition 2 January 1998 ImagePoint A.1

SONOS 4500/5500 A.1

Edition 3 April 1999 ImagePoint Hx B.0

SONOS 4500/5500 B.0

Edition 4 June 2000 ImagePoint Hx B.0

SONOS 4500/5500 B.1

Edition 5 September 2000 ImagePoint Hx B.1

SONOS 4500/5500 B.1

Edition 6 June 2002 ImagePoint Hx B.1

SONOS 4500/5500 C.0
 Contents

Preface

About this Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-1

Safety Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2

Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2

1 Transducer Setup

Connecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Connection Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Activating Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Changing the Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

SONOS 4500 and SONOS 5500 Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

ImagePoint Hx Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Specialty Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

Endocavity Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
TEE Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Intraoperative Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Transthoracic OmniPlane Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

2 Caring for Transducers

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Handling Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Checking the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

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Ergonomic Grip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Storing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Storage for Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Daily and Long-term Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Acoustic Coupling Medium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Latex Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Transducers Supporting Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Ordering Biopsy Kits and Sheaths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Biopsy Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Biopsy Guide Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Using the Biopsy Needle Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Cleaning Transducers Supporting Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Cleaning and Disinfecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Transducers Used in Non-Invasive Procedures (non-critical device applications) . . . . . . . . . . . 2-9
Transducers Used in Endocavity, Biopsy, and TEE Procedures (semi-critical device applications) .
2-9
Transducers Used in Intraoperative Procedures (critical device applications) . . . . . . . . . . . . . . 2-10
General Information About Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Glutaraldehyde-based Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Non-Glutaraldehyde-Based Disinfectant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Chemicals that Damage Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

General Cleaning for Transducers Used in Non-Invasive Procedures . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Cleaning and Disinfection of Transducers Used in Endocavity Procedures . . . . . . . . . . . . . . . . . . . 2-15

Cleaning and High-Level Disinfection of Transducers Used in Endocavity Procedures . . . . . . 2-16

Cleaning and Disinfecting of Transducers Used in Biopsy Procedures . . . . . . . . . . . . . . . . . . . . . . . 2-17

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Cleaning and High-Level Disinfection of Transducers Used in Biopsy Procedures . . . . . . . . . 2-17

Cleaning and Disinfection of TEE Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Cleaning and High-Level Disinfection of TEE Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Cleaning and Disinfection for Transducers Used in Intraoperative Procedures . . . . . . . . . . . . . . . . 2-20

Cleaning and High-Level Disinfection of Transducers Used in Intraoperative Procedures . . . 2-21

3 Endocavity Transducers

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Equipment Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Accident Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Description and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

The Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Endocavity Transducer Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Endocavity Transducer Preparation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Preparing Patients for an Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Endocavity Exam Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Ordering Biopsy Kits and Sheaths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Disposable Drape for Endocavity Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Endocavity Biopsy Needle Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Endocavity Biopsy Needle Guide Safety and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Precautions for the Endocavity Biopsy Needle Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Contents-3

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Installing the Endocavity Biopsy Needle Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

4 TEE Transducers

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Equipment Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Electrosurgical Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Accident Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Electrical Check-Out Procedure for TEE Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Description and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Basic Transducer Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Manipulating the OmniPlane Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Rotating the OmniPlane Array . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Selecting Patients on Whom to Use the miniMulti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Deflection and Scanplane Rotation Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Tip deflection control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Lock operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Transducer scanplane rotation control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Manipulating the Pediatric Biplane Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Biplane Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Displaying Two Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Checking the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Special Considerations for TEE Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Preparing Patients for a TEE Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Contents-4
 Contents

Exam Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Tip Fold-Over Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Ensuring Accurate Temperature Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38

TEE Auto Cool Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Entering the Patient Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
Entering the Patient Temperature on the SONOS 4500 and 5500 . . . . . . . . . . . . . . . . . . . . . . . 4-40
Monitoring the Distal Tip Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

Checking the Patient After the TEE Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-47

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-48

Bite Guard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-48
Tip Protector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-48
Ordering Bite Guards and Tip Protectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49
Ordering Disinfection Basins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49
Disposable Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49

5 Intraoperative Transducers

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Intraoperative Probes Used for Animal Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Animal Use Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Patient Contact Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Equipment Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Leakage Current Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Contents-5

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add.1
Contents

Defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Accident Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Description and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Trapezoidal Linear Array
(Model 21358B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Preparing the Transducer for Intraoperative Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Disposable Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

6 Transthoracic OmniPlane Transducer

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Accident Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Description and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Rotating the Transthoracic OmniPlane Array . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Contents-6
 Preface

About this Book

Chapter 1 contains information on how to connect and activate your Philips

SONOS and ImagePoint transducers. Tables in this chapter list all the transducers
that you can use with the SONOS 5500/4500 and ImagePoint HX ultrasound
systems, including those supporting biopsy, and describe specialty transducer and
system compatibility.

Chapter 2 describes the care required for your Philips SONOS and ImagePoint
HX transducers. The handling, storing, general cleaning, and disinfecting of all
supported transducers is discussed, as well as the ordering of biopsy starter kits.

NOTE The most current information on cleaning transducers can be found on the fol-
lowing Philips web site:
www.medical.philips.com/transducercare

The remaining chapters describe endocavity, transesophageal (TEE),

intraoperative, and transthoracic OmniPlane (TTO)transducers. They acquaint
you with the capabilities and use of these transducers, as well as the dangerous,
potentially lethal effects of improper or careless use.

This guide does not:

• Provide instruction in esophagogastroscopic, intraoperative, transthoracic, or

endocavity techniques.
• Present medical protocols for conducting a TEE, intraoperative, transtho-
racic, or endocavity exam.
• Discuss interpretation of transesophageal, intraoperative, transthoracic, or
endocavity imaging patterns.

Preface-1

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Safety Questions

Safety Questions

If you have any comments or questions about safety, please contact:

Imaging Systems Quality Manager

Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810
(978) 687-1501

Additional Information

You must be thoroughly familiar with the operation of the Philips SONOS 5500/
4500 or ImagePoint ultrasound system to use the Philips specialty transducers
described in this manual.

Use this guide in conjunction with the following books contained in the
Reference Manual binder:

• System Basics—Describes the basic operation of the Philips SONOS 5500

and Philips SONOS 4500 systems.
• Multifunction Control Reference—Provides a detailed description of all sys-
tem controls.
• Safety and Standards Guide—Provides information on safety issues.
• Measurement and Calculations Reference—Provides information on mea-
surements and calculations that you can perform on your ultrasound system.

Additionally, there are several specialty guides that describe applications and
optional packages, such as Stress Echocardiography, Contrast, 3-D, Acoustic,
and Integrated Digital Interface.

Preface-2
 1 Transducer Setup

Connecting Transducers

The following section describes how to connect transducers to your system.

Philips SONOS 4500, SONOS 5500, and ImagePoint Hx

Never force a 1 With the latch in the vertical position, plug the transducer connector
transducer into place. into the slot.
If you feel any
resistance, check the
pin positions and try
reinserting.

Vertical

6apc0148

2 Lock the connector by turning the transducer latch to the horizontal

position.

Horizontal

6apc0149

Revision C.0 1-1

Transducer Setup
Connecting Transducers

Installing the Transducer Adapter

The AMP adapter is required for following transducers:
SONOS 4500 and 5500:
• 21253B
• 21255B
• 21258B
• 21364A OmniPlane
• 21366A Pediatric Biplane (requires two adapters)
• 21367A OmniPlane II
• 21273A
ImagePoint Hx:
• 21367A OmniPlane II

1 With the latch in the vertical position, plug the transducer adapter into
the slot.

6apc0160

Transducer adapter

2 Push the connector in firmly so the pins are seated correctly. Turn the
latch to the horizontal position.

1-2 Revision C.0

 Transducer Setup
Connecting Transducers

Installing the Transducer Adapter (Continued)

6apc0161

3 Connect an AMP-style transducer to the adapter and lock into place.

LEFT RIGHT

AMP-style transducer

6apc0162

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Transducer Setup
Connection Tips

Connecting the Pediatric Biplane Transducer

When connecting biplane transducers, you need two transducer adapters. No

other transducer may be connected when using the Pediatric Biplane transducer.
Connect the biplane following these steps to ensure that the system will
recognize the transducer.

1 Plug one adapter into the right slot and one into the left slot.

2 Connect the two transducer connectors to the adapters.

3 Lock both connectors into place.

Connection Tips

• If you feel any resistance when inserting the connector, don’t try to force it in
place. Check the latch and carefully reinsert.
• If “NO Probe” displays on the screen, either the system is running an identi-
fication check or the transducer is not properly connected. Check that you
have selected the correct slot (Left, Center, Right, or Non-image under
Probe) on the SONOS 4500 or 5500.
• If “?? Probe” displays, the transducer is not latched into position. This mes-
sage could indicate that the transducer connector is not locked into place.
• Before disconnecting the transducer, unlock the transducer connector by
turning the latch to the vertical position.
• When using a TEE transducer, always make sure the TEE tip and shaft are
straight before connecting the transducer.
• Remove any other transducer connected to the system prior to connecting
the Pediatric Biplane.

1-4 Revision C.0

 Transducer Setup
Activating Transducers

Calibration:

• If “Omni Transducer Calibration failed” displays, try unlocking and locking

the transducer connector.
• With TEE transducers, if “Calibration failed” displays, try unlocking the
transducer connector, straightening the tip and shaft, and then locking the
connector.

NOTE When the transducer is properly connected, and depending on which transducer
you are using, either the frequency or label information displays in the upper left
corner or below the grayscale bar.

Activating Transducers

This section shows you how to activate transducers on your ultrasound system.

SONOS 4500 or SONOS 5500

Touch Probe. Then touch the softkey indicating where the transducer is
connected.

Probe

Left Center Right Nonimage

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Transducer Setup
Activating Transducers

ImagePoint Hx
Up to three imaging To activate a different transducer, press Probe. Each time you press this
transducers and one control another transducer is activated. A label for the active transducer
dedicated Doppler
transducer may be
appears below the grayscale bar.
connected to your
system at one time. A S D F G H J K L ’
System
Z X C V B N M <, . ?
Shift Mic

Volume Patient Preset Home Clear Text

Filter Power
Size Position
Body Marker Zoom
Frequency
Probe
Angle Calcs Dual
Baseline Hx M Mode
Dynamic
Left Right Range
Angio Caliper
2D
Scale Tape
CW Trace GAIN
Focus
Print 2
PW Spectral Erase
Gain Freeze
Color Print 1
Depth
Enter

6APC0045
Probe Control

1-6 Revision C.0

 Transducer Setup
Changing the Frequency

Changing the Frequency

This section tells you how to change the transducer frequency on your ultrasound
system.

SONOS 4500 or SONOS 5500

Turn Frequency Fusion to optimize for penetration, texture, or resolution.
The system optimizes the frequency range based on what setting you choose.

2D

Frequency
Fusion

See the Philips SONOS 4500 and SONOS 5500 System Basics User’s Guide for
more information on the Frequency Fusion icon.

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Transducer Setup
Changing the Frequency

ImagePoint Hx
If the transducer is Press Frequency to change the transducer’s operating frequency.
already operating at the
highest frequency,
’
pressing Frequency A S D F G H J K L
System
selects the lowest Z X C V B N M <, . ?
Shift Mic
frequency. If the
transducer has only one Volume Patient Preset Home Clear Text

frequency, pressing this

control has no effect.

Filter Power
Size Position
Body Marker Zoom
Frequency
Probe
Angle Calcs Dual
Baseline Hx M Mode
Dynamic
Left Right Range
Angio Caliper
2D
Scale Tape
CW Trace GAIN
Focus
Print 2
PW Spectral Erase
Gain Freeze
Color Print 1
Depth
Enter

6APC0045
Frequency control

1-8 Revision C.0

 Transducer Setup
SONOS 4500 and SONOS 5500 Transducers

SONOS 4500 and SONOS 5500 Transducers

The following table lists transducers that can be used with the SONOS 4500 and
SONOS 5500.

Table 1-1 SONOS 4500 and SONOS 5500 Transducers

Type Probe Part Number Application Comments

Curved Linear c3540 21321A Abdominal, Harmonics, OB/
Transducer - Gyn, Abdominal Vascular.
UltraBand Biopsy capable

Curved Linear C3540 21353B Abdominal, OB/Gyn,

Transducer Abdominal Vascular

Curved Linear C3540 21253B * Abdominal, OB/Gyn, Requires an adapter

Transducer Abdominal Vascular

Curved Linear C5040 21373A Abdominal, OB/Gyn,

Transducer Vascular. Biopsy capable

Curved Linear C5040 21273A * Abdominal, OB/Gyn, Requires an adapter

Transducer Vascular

Curved Linear E6509 21336A Endovaginal OB/Gyn,

Transducer Endorectal, Urological.
Biopsy capable

Linear Transducer 15-6L 21390A Intraoperative, Vascular,

Cardiovascular, Small Parts

Linear Transducer 11-3L 21356A Peripheral Vascular, Small

Parts, Harmonics

Linear Transducer L7540 21358B Vascular, Intraoperative,

Small Parts

Linear Transducer L7540 21258B * Vascular, Intraoperative, Requires an adapter

Small Parts

Linear Transducer L5040 21355B Vascular

Linear Transducer L5040 21255B * Vascular Requires an adapter

Non-Imaging D1914V 21228A/B** Transcranial 1.9 MHz PW

Doppler Pencil
Transducer

* Transducers supported from previous software revisions. Not

available for sale with new system orders.
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Transducer Setup
SONOS 4500 and SONOS 5500 Transducers

Table 1-1 SONOS 4500 and SONOS 5500 Transducers (Continued)

Type Probe Part Number Application Comments

Non-Imaging D5009V 21223A/B** Vascular 5 MHz PW/CW
Doppler Pencil
Transducer

Non-Imaging D1009V 21224A Vascular 10 MHz CW

Doppler Pencil
Transducer

Non-Imaging D1914C 21221A/B** Cardiology 1.9 MHz CW

Doppler Pencil
Transducer

OmniPlane TEE T5012 21364A Adult Cardiac, 3-D Requires an adapter

Acquisition

OmniPlane II TEE T6210 21367A * Adult and Pediatric Cardiac Requires an adapter
Sector Transducer

OmniPlane II TEE T6210 21369A Adult and Pediatric Cardiac

Sector Transducer

miniMulti TEE T6207 21381A Pediatric and Adult Cardiac,

Transducer 3-D Acquisition

Pediatric Biplane T7506B 21366A Pediatric Cardiac Requires 2 adapters

Transthoracic R5012 21349A Adult and Pediatric Cardiac,

OmniPlane Sector 3-D Acquisition
Transducer

UltraBand Sector s3 21311A Abdominal, Adult Cardiac, May not be available

Transducer Contrast, Harmonic, with your SONOS
OB/Gyn, TCD 4500

UltraBand Sector s4 21330A Abdominal, Adult Cardiac,

Transducer Contrast, Harmonic,
OB/Gyn, TCD

UltraBand Sector s8 21350A Adult and Pediatric Cardiac,

Transducer Neonatal Cephalic,
Abdominal, Harmonic

UltraBand Sector s12 21380A Pediatric and Neonatal

Transducer Cardiac, Neonatal Cephalic,
Intraoperative

* Transducers supported from previous software revisions. Not available for sale
with new system orders.

** The 21228B, 21223B, and 21221B transducers are supported only on SONOS
4500 and 5500 Revision B.2 and higher.

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 Transducer Setup
ImagePoint Hx Transducers

ImagePoint Hx Transducers

The following table lists transducers that can be used with the ImagePoint Hx.

Table 1-2. ImagePoint Hx Transducers

Type Probe Part Number Application Comments

Curved Linear c3540 21321A Abdominal, OB/Gyn,

Transducer Pediatric, Abdominal
Vascular, Harmonics. Biopsy
capable

Curved Linear C3540 21353B * Abdominal, OB/Gyn,

Transducer Pediatric, Abdominal
Vascular. Biopsy capable

Curved Linear C5040 21373A Abdominal, OB/Gyn,

Transducer Pediatric, Vascular. Biopsy
capable

Curved Linear C6514 21372A Pediatric Abdominal,

Transducer Neonatal Cephalic,
OB/Gyn, Pediatric, Small
Parts, Vascular

Endocavity E6509 21336A Endorectal, Endovaginal,

Transducer OB/Gyn, Urological. Biopsy
capable

Endocavity E6514 21370A* Endovaginal, OB/Gyn.

Transducer Biopsy capable.

Endocavity E7511 21371A* Endorectal, Urological.

Transducer Biopsy capable

Linear Transducer L1038 21376A Musculoskeletal, Peripheral

Vascular, Small Parts, Biopsy
capable.

Linear Transducer L7535 21359A Abdominal, Musculoskeletal,

Small Parts, Pediatric,
Vascular. Biopsy capable

Linear Transducer L5035 21360A Musculoskeletal, Pediatric,

Vascular. Biopsy capable

* Transducers supported from previous software revisions. Not

available for sale with new system orders.
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Transducer Setup
ImagePoint Hx Transducers

Table 1-2. ImagePoint Hx Transducers (Continued)

Type Probe Part Number Application Comments

Non-Imaging D1914V 21229A Transcranial 1.9 MHz PW

Doppler Pencil
Transducer

Non-Imaging D5009V 21231A Vascular 5 MHz PW/CW

Doppler Pencil
Transducer

Non-Imaging D1914C 21222A Cardiology 1.9 MHz CW

Doppler Pencil
Transducer

Sector Transducer S2520 21302A Long-range: Abdominal,

Cardiac, TCD

Sector Transducer S4 21330A Long range: Abdominal,

Cardiac, TCD

Sector Transducer S5010 21347A Medium range: abdominal,

Cardiac, Pediatric, Vascular,
Neonatal Cephalic

Sector Transducer S7510 21375B/C Short range: Cardiac,

Pediatric, Vascular, Neonatal
Cephalic

OmniPlane II TEE T6210 21367A * Multiplane, TEE Requires an adapter

Sector Transducer

OmniPlane II TEE T6210 21369A Multiplane, TEE

Sector Transducer

Linear Transducer 15-6L 21390A Intraoperative, Small Parts

Musculosketal,
Cardiovascular, Vascular,

* Transducers supported from previous software revisions. Not available for sale
with new system orders.

1-12 Revision C.0

 Transducer Setup
Specialty Transducers

Specialty Transducers

Endocavity Transducers
The following table defines the necessary revision levels for using endocavity
transducers on the indicated Philips imaging systems.

Table 1-3. Endocavity Connection Information

Endovaginal/
Philips Ultrasound Endovaginal Endorectal
Endorectal 21336A
System 21370A (E6514) 21371A (E7511)
(E6509)

SONOS 5500 B.0 and higher N/A N/A

(Endovaginal only)

SONOS 4500 B.0 and higher N/A N/A

(Endovaginal only)

ImagePoint and Rev. A.1 and higher Rev. A.0 and higher Rev. A.0 and higher
ImagePoint Hx

TEE Transducers
The following table defines the necessary revision levels for using TEE
transducers on the indicated Philips imaging systems.

Table 1-4. TEE Connection Information

Pediatric
Philips OmniPlane OmniPlane II OmniPlane II miniMulti
Biplane
Ultrasound 21364A 21367A 21369A 21381A
21366A
System (T5012) (T6210) (T6210) (T6207)
(T7506B)

SONOS 5500 Rev. A.0 and Rev. A.0 and Rev. A.0 and Rev. A.0 and Rev B.2.2. and
higher (with higher (with higher higher (with higher
transducer transducer transducer
adapter) adapter) adapters)

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Transducer Setup
Specialty Transducers

Table 1-4. TEE Connection Information

Pediatric
Philips OmniPlane OmniPlane II OmniPlane II miniMulti
Biplane
Ultrasound 21364A 21367A 21369A 21381A
21366A
System (T5012) (T6210) (T6210) (T6207)
(T7506B)

SONOS 4500 Rev. B.0 and Rev. B.0 and Rev. B.0 and Rev. B.0 and Rev B.2.2. and
higher (with higher (with higher higher (with higher
transducer transducer transducer
adapter) adapter) adapters)

ImagePoint and N/A Rev A.1 and Rev. A.0 and N/A N/A
ImagePoint Hx higher higher
(with transducer
adapter)

Intraoperative Transducers
The following table defines the necessary revision levels for using intraoperative
transducers on the indicated Philips imaging systems.

Table 1-5. Intraoperative Connection Information

High-Frequency High Frequency Trapezoidal

Philips Ultrasound
UltraBand Intraoperative Linear Array
System
21380A (S12) 21390A (15-6L) 21358B (L7540)

SONOS 5500 Rev. A.0 and higher Rev. B.0 and higher Rev. A.0 and higher

SONOS 4500 Rev. B.0 and higher Rev. B.0 and higher Rev. B.0 and higher

ImagePoint Rev. B.1 and higher

1-14 Revision C.0

 Transducer Setup
Specialty Transducers

Transthoracic OmniPlane Transducer

The following table defines the necessary revision levels for using the
Transthoracic OmniPlane transducer on the indicated Philips imaging systems.

Table 1-6. Transthoracic OmniPlane Connection Information

Philips Ultrasound Transthoracic OmniPlane

System 21349A (R5012)

SONOS 5500 Rev. A.0 and higher

SONOS 4500 Rev. B.0 and higher

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Transducer Setup
Specialty Transducers

1-16 Revision C.0

 2 Caring for Transducers

Introduction

This chapter contains information on the general care, handling, and storing of
Philips transducers for SONOS 5500/4500 and ImagePoint Hx systems. The
general cleaning of external transducers is discussed, as well as the cleaning and
disinfecting of specialty transducers, such as the endocavity, biopsy-capable,
transesophageal, and intraoperative transducers.

Handling Transducers

Although a transducer is designed for durability, use care when handling it.
Dropping or banging the transducer could damage the acoustic cap and
piezoelectric crystals. Cuts in the transducer cable or cracks in the housing could
destroy the electrical safety features of the transducers. This damage is not
covered by the warranty or your service contract.

When you are not using the transducer, place it in the transducer holder located
on the top right side of the system to assure safe, convenient storage. For more
infomation on storing transducers, see "Storing Transducers" on page 2-3.

When you are shaking an ultrasound gel bottle, be careful not to hit the
CAUTION
transducer face with the tip of the bottle. Striking the transducer face with a hard
object can damage the transducer. This damage is not covered by the warranty or
your service contract.

Revision C.0 2-1

Caring for Transducers
Checking the Transducer

Checking the Transducer

All transducers are exposed to many potentially damaging situations during use
and cleaning. Periodically check the transducer for the following signs of
damage:

• Cracks on the handle

• Cracks on the nose piece
• Cuts or gouges on the lens material
• Swelling of the lens material
• Cracks or other signs of damage to the connector
• Bent or damaged pins
• Signs of damage to or inflexibility of the cable

Ergonomic Grip

Repetitive ultrasound scanning has been associated with Carpal Tunnel

Syndrome (CTS) and repetitive strain injury. See the Safety and Standards guide
for reference articles.

Philips has developed a slip-on reusable grip to provide alternative grip options
for the s3, s4, and s8 transducers. To order grips, contact your local Philips
representative.

Installing the Ergonomic Grip:

1 Insert the cable through the slot in the grip.

2 Slip the transducer head into the grip.

3 Align the slot with the orientation indicator.

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 Caring for Transducers
Storing Transducers

Cleaning the Ergonomic Grip:

1 Wipe with a dry or water-moistened soft cloth. You can also use isopropyl
alcohol solution (rubbing alcohol), a 10% bleach solution or a 2.4% glutaral-
dehyde-based disinfectant. For a list of the glutaraldehyde-based disinfectants
that Philips recommends for specific transducers, see page 2-11.

2 Remove any cleaning solution residue with a soft cloth moistened in water.
Do not allow cleaning solutions to air-dry on the grip. For further instructions
on how to minimize the effects on transducers from disenfectants, see page 2-
12.

Storing Transducers

Storage for Transport

Make sure that the transducer is clean and disinfected before placing it in the
case. This will help to avoid contaminating the foam lining of the carrying case.

If a carrying case is provided with your transducer, always use the carrying case
to transport the transducer from one site to another. To prevent kinking, carefully
place the transducer in the case. Before closing the lid, make sure no part of the
transducer is protruding from the case. Wrap the case in plastic material
containing air pockets (bubble wrap), and pack the wrapped case in a cardboard
carton.

Daily and Long-term Storage

External-use Transducers

Be sure to clean and disinfect the external transducers before storing them.

• Store transducers in the transducer holders on the side of the ultrasound sys-
tem.

Revision C.0 2-3

Caring for Transducers
Storing Transducers

• Avoid storing transducers in areas of extreme temperature or in direct sun-

light.

Endocavity Transducers

Be sure to clean and disinfect the endocavity transducers before storing them.

• Store in one of the transducer holders on the side of the ultrasound system.
• Store the transducer separately from other instruments to avoid inadvertent
transducer damage.
• If storing the transducer in the original case or in a drawer, make sure the
transducer is thoroughly dry.
• Avoid storing the transducer in areas of temperature extremes or in direct
sunlight.

TEE Transducers

Be sure to clean and disinfect the TEE transducers before storing them.

• Never store a TEE transducer in the carrying case, except to transport it.
• Be sure the distal tip is straight and protected before storing the transducer.
• To avoid damaging the shaft or steering mechanism, do not bend or coil the
flexible shaft of the transducer in less than a one-foot diameter (30 cm)
circle.
• Store the transducer on a securely mounted wall rack, with slots properly
spaced to prevent the transducer from falling.
• Store the transducer separately from other instruments to avoid accidental
transducer damage.
• Avoid storing the transducer in areas of temperature extremes or in direct
sunlight.

Intraoperative Transducers

Be sure to clean and disinfect the interoperative transducers before storing them.

• Store in the transducer holders on the side of the ultrasound system.

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 Caring for Transducers
Acoustic Coupling Medium

When storing the Model 21390A intraoperative transducer on the system, use the
NOTE
cable management clips with the transducer cable.

• If storing the transducer in the original case, make sure the transducer is
thoroughly dry.
• Avoid storing the transducer in areas of extreme temperatures or in direct
sunlight.

Acoustic Coupling Medium

For proper transmission of the acoustic beam, use the ultrasound transmission gel
supplied by Philips, or another glycol, glycerol, or water-based couplant. Do not
use mineral oil, oil-based couplants, or other non-approved material because it
might damage the transducer.

WARNING Do not use gels that contain any of the following agents:
-- acetone
-- methanol
-- denatured ethyl alcohol
-- mineral oil
-- iodine
-- any lotions or gels containing perfume

Latex Materials

Latex is commonly used in sheaths marketed to help with infection control in

transesophageal, endocavity, and intraoperative imaging applications or
transducer covers used during biopsy. Examine the packaging to confirm latex
content. Studies have shown that allergic reactions with natural rubber latex can
be experienced. The US Food and Drug Administration has published a medical
alert on latex products dated March 29, 1991.

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Caring for Transducers
Transducers Supporting Biopsy

The Philips’ diagnostic ultrasound systems and transducers in this manual do not
NOTE
contain natural rubber latex that contacts humans. Natural rubber latex is not
used on any ultrasound transducer, including transthoracic, intraoperative, and
transesophageal transducers. It also is not used on Philips ECG cables for the
products in this manual.

Transducers Supporting Biopsy

Biopsies can be performed with a variety of probes. The following table lists
transducers that support the use of biopsy needle guides and the biopsy kit used
by each.

Table 2-1. Odering Biopsy Starter Kits

CIVCO Biopsy Starter

Probe Probe Model # Comment
Kit #

c3540 21321A 645-057 Supported for SONOS and ImagePoint Hx

C3540 21353B 645-033 Supported only for ImagePoint Hx

C5040 21373A 645-032 Supported for SONOS and ImagePoint Hx

E6509 21336A 610-588 An endovaginal/endorectal probe. See

"Endovaginal/Endorectal (Model 21336A)",
page 3-5. Supported for SONOS and
ImagePoint Hx

E6514 21370A 610-139 An endovaginal probe. See "Endovaginal

(needle guide only) (Model 21370A)", page 3-6. Supported only for
ImagePoint Hx

E7511 21371A 610-139 An endorectal probe. See "Endorectal (Model

(needle guide only) 21371A)", page 3-7. Supported only for
ImagePoint Hx

L1038 21376A 645-059 Supported only for ImagePoint Hx

L5035 21360A 645-039 Supported only for ImagePoint Hx

L7535 21359A 645-039 Supported only for ImagePoint Hx

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 Caring for Transducers
Transducers Supporting Biopsy

• For specific information on biopsies using endocavity probes, see “Endocav-

ity Biopsy Needle Guide” on page 3-13.

Ordering Biopsy Kits and Sheaths

To order biopsy kits and sheaths, contact:

CIVCO Medical Instruments Co.

102 First Street
Kalona, IA 52247-9589 USA
E-mail: info @civcomedical.com
http://www.civco.com

Call 1-800-445-6741 within the United States or 1-319-656-4447 outside of the

United States. To fax orders call: 1-319-656-4451.

For a list of the CIVCO kit numbers to order the appropriate replacement biopsy
kits for your endocavity transducer, see “Accessory Equipment” on page 3-12

Biopsy Precautions
Always follow these basic precautions when using a biopsy needle guide and
bracket:

• All biopsy procedures must be performed using highly controlled sterile pro-
cedures. Be sure that the biopsy needle package is not opened or damaged
and that the date has not expired.
• Before using the biopsy setup for the first time, it is strongly recommended
that you familiarize yourself with each possible needle position, procedure,
probe, and screen display. See Chapter 2 of the ImagePoint Hx User’s Guide
and Chapter 5 of the SONOS System Basics guide for information on using
biopsy transducers.
• Most needle guides are shipped sterile. Verify on the package that the guide
is sterile.
• Use a sheath with the biopsy needle.
• Most needle guides are disposable. Do not re-use disposable needle guides.
• After use, remove the needle guide from the bracket and discard the needle
guide.

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Caring for Transducers
Transducers Supporting Biopsy

• Most needle guide brackets are not shipped sterile. Follow the manufac-
turer’s instructions to disinfect the needle bracket.

Biopsy Guide Instructions

CIVCO supplies biopsy kits for all transducers in this document that support
biopsy. Follow the manufacturer’s instructions for needle guide use. The
following instructions are covered in CIVCO User’s Guides for each needle
guide:

• Preparation for use

• Attaching the bracket
• Applying a sterile cover
• Attaching a needle guide
• Cleaning and sterilization

Using the Biopsy Needle Guide

The ImagePoint Hx and SONOS 5500/4500 systems display biopsy guidelines
that direct the operation of the biopsy needle. Activate the on-screen guidelines
and carefully watch the image during insertion of the needle to verify the needle
path.

• For a description of system controls for biopsy use, refer to Chapter 2 of the
ImagePoint Hx User’s Guide and Chapter 5 of the SONOS System Basics
guide.
• For biopsy needle guide instructions in this book see “Biopsy Precautions”
on page 2-7 and “Biopsy Guide Instructions” on page 2-8.

Cleaning Transducers Supporting Biopsy

Cleaning and disinfecting instructions for transducers used in biopsy procedures
are included in the next section.

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 Caring for Transducers
Cleaning and Disinfecting Transducers

Cleaning and Disinfecting Transducers

Infection control is an increasingly important issue in health care. You should

always clean and disinfect transducers immediately after each use to protect
patients and personnel from a variety of pathogens. The level of disinfection
required for an ultrasound transducer will be determined by the type of tissue it
contacts during use.

The most current information on cleaning transducers can be found on the

following Philips web site:
www.medical.philips.com/transducercare

The following categories identify uses and required cleaning and disinfection
standards:

Transducers Used in Non-Invasive Procedures (non-critical

device applications)
Applications for transducers used in non-invasive procedures have a very low
probability for spreading infection since they are used with intact skin. This type
of device requires general cleaning. See “General Cleaning for Transducers
Used in Non-Invasive Procedures” on page 2-14.

Transducers Used in Endocavity, Biopsy, and TEE Procedures

(semi-critical device applications)
Transducers used in endocavity, biopsy, and TEE (transesophageal) procedures
belong in the semi-critical device category. As materials in transducers prevent
them from being considered a heat stable device, cleaning and high-level
disinfection is the accepted method of infection control for these devices.

For cleaning and disinfection instructions for transducers in the semi-critical

device category, see the following:

• “Cleaning and Disinfection of Transducers Used in Endocavity Procedures”

on page 2-15

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Caring for Transducers
Cleaning and Disinfecting Transducers

• “Cleaning and High-Level Disinfection of Transducers Used in Biopsy Pro-

cedures” on page 2-17
• “Cleaning and Disinfection of TEE Transducers” on page 2-18

Philips recommends that you use a protective sheath with transducers used in
endocavity and biopsy procedures and a sterile protective sheath with TEE
transducers.

WARNING Never sterilize the transducer with sterilization techniques such as auto-
clave, ultraviolet, gamma radiation, gas, steam, or heat sterilization tech-
niques. Severe damage will result.

Transducers Used in Intraoperative Procedures (critical device

applications)
Transducers used in intraoperative procedures are in the critical device category.
Devices contacting blood, compromised tissue, or when used in a sterile field are
classified in the critical device category. Transducers used in critical applications
require cleaning, high-level disinfection and use of a sterile sheath.

See “Cleaning and Disinfection for Transducers Used in Intraoperative

Procedures” on page 2-20.

General Information About Cleaning and Disinfection

Your clinic or hospital may have guidelines covering cleaning and disinfecting
ultrasound imaging transducers. The following articles also provide a good
reference:

“Design, Testing and Labeling of Reusable Medical Devices for Reprocessing in

Health Care Facilities - A Guide for Manufacturers,” AAMI (ed), AAMI
Publishing Co. 1995.

Block, Seymour S. “Disinfection, Sterilization, and Preservation,” Lea and

Febinger, Philadelphia, 1991.

Establish and clearly post a disinfecting procedure that includes all required
NOTE
disinfection steps.

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 Caring for Transducers
Disinfectants

Disinfectants

The following high-level disinfectants have been tested with your Philips
transducers, as specified below, and are compatible with the material used in the
transducers. Use of any other disinfectants can void your system warranty and
service contract.

Glutaraldehyde-based Disinfectants
Philips recommends the following 2.4% glutaraldehyde-based disinfectants for
all transducers:

• Cidex™ Activated Dialdehyde Solution

• Omnicide™ Long Life Activated Dialdehyde Solution
• Procide® 14 N.S.

Philips recommends the following 2.4% to 3.4% glutaraldehyde-based

disinfectants for the 21364A, 21367A, 21369A, and 21381A TEE transducers:

• aidal plus *
• abcoCIDE 14 *
• abcoCIDE 28 *
• Cidex™ Activated Dialdehyde Solution
• Cidex Formula 7™ Long-Life Activated Dialdehyde Solution
• Cidex Plus™ 28 Day Solution
• Cetylcide-G® Concentrate and Diluent Concentrate
• MaxiCide Plus *
• MedSci 3% Glutaneldehyde
• Metricide® 28 Day Long-Life Activated Dialdehyde Solution
• Metricide Plus 30® Long-Life Activated Dialdehyde Solution
• Omnicide™ 14NS *
• Omnicide™ 28 *

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Caring for Transducers
Disinfectants

• Omnicide™ Long Life Activated Dialdehyde Solution

• Omnicide™ Plus
• Procide® 14 N.S.
• PSS Select *
• PSS Select NS *
• PSS Select Plus *
• Wavicide® - 01

* Those disinfectants noted with asterisks are not FDA cleared for use in the
United States. The FDA maintains a list of 510k-cleared high-level disinfectants
at www.fda.gov/cdrh/ode/germlab.html

You must follow the disinfectant manufacturer's instructions carefully.

NOTE

Non-Glutaraldehyde-Based Disinfectant
CIDEX® OPA Solution (An ortho-phthalaldehyde solution manufactured by
Advanced Sterilization Products) is a non-glutaraldehyde-based product that can
be used to high-level disinfect the transesophageal (TEE) and intraoperative
transducers listed below:

• Model 21364A OmniPlane

• Models 21367A and 21369A OmniPlane II
• Model 21390A (15-6L) Intraoperative
• Model 21336A Endovaginal/Endorectal

WARNING If you use CIDEX® OPA, a residual solution may remain on your transducers
if you do not carefully follow the manufacturer's instructions. Residual
CIDEX® OPA on TEE transducers may cause the following:
• Temporary staining of the mouth and lip area
• Irritation or chemical burns of the mouth, throat, esophagus and stom-
ach

To minimize any effects from residual CIDEX® OPA, or any other

disinfectant, Philips recommends:

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 Caring for Transducers
Disinfectants

• Following the disinfectant manufacturer's instructions carefully (for

example, the manufacturer of CIDEX® OPA recommends rinsing by
soaking probes THREE times in fresh water)
• Using a sterile sheath during TEE and intraoperative examinations
• Limiting the time that probes are soaked in disinfectant solution to the
minimum time recommended by the disinfectant manufacturer (e.g., the
manufacturer of CIDEX® OPA recommends a minimum of 12 minutes)

Use of CIDEX® OPA on the 21336A Endovaginal/Endorectal transducer will

NOTE
stain the probe. This staining is not toxic and presents no hazard to anyone in
contact with the probe. It will not change the function of the probe.

CAUTION The use of any non-glutaraldehyde-based disinfectant other than CIDEX® OPA
on the 21364A, 21367A, 21369A, 21390A, and 21336A transducers may cause
damage to your transducer. Damage caused by such use is not covered by the
warranty or your service contract.

Use of non-glutaraldehyde-based disinfectants on transducers other than the ones

listed above may cause damage to your transducer. Damage caused by such use is
not covered by the warranty or your service contract.

Chemicals that Damage Transducers

The following chemicals have been tested with Philips transducers and found to
degrade or discolor the grip.

• phenol (10% or 100%)

• benzothonium chloride (0.14% in menthol, butylene glycol waterbase
solution)
• pHisohex (3% hexachlorophene in petrolatum, lanolin cholesterol, polypro-
pylene glycol, water)
• benzoyl peroxide (10% in propylene glycol, water)
• hydrogen peroxide

Some of these chemicals are commonly found in clinic or hospital settings;

others are found in antibacterial skin cleaners or lotions. Use of these chemicals
will cause damage to your transducer. This damage is not covered by the
warranty or your service contract.

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Caring for Transducers
General Cleaning for Transducers Used in Non-Invasive Procedures

General Cleaning for Transducers Used in Non-Invasive Procedures

These general cleaning instructions are indicated for non-critical category

transducers. All transducers which do not contact mucus membranes, blood,
compromised tissue, and are not used in sterile fields can be cleaned by using
these instructions. It is important that you clean the transducer and cable
according to the following procedures:

1 After every patient exam, wipe the ultrasound transmission gel off the
transducer.

2 Wipe the transducer and cable with a dry or water-moistened soft cloth.

3 Wipe the transducer with a glutaraldehyde-based disinfectant, isopropyl alco-

hol, or a 10% bleach solution. See “Glutaraldehyde-based Disinfectants” on
page 2-11 for a list of recommended disinfectants.

The use of isopropyl alcohol (rubbing alcohol) on transducers is restricted. You

NOTE
may wipe only the distal tip of the transducer up to one inch (2.5 cm) from the
strain relief/housing joint with an isopropyl alcohol solution. SeeFigure 2-1
“Restricted Use of Isopropyl Alcohol to Clean Transducers” on page 2-15.

4 You can also wipe the cable with a glutaraldehyde-based disinfectant or a

10% bleach solution. Do not use isopropyl alcohol on the cable.

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 Caring for Transducers
Cleaning and Disinfection of Transducers Used in Endocavity Procedures

WARNING Isopropyl alcohol may damage parts of your transducer. This damage is not
covered by the warranty or your service contract.

Figure 2-1. Restricted Use of Isopropyl Alcohol to Clean

Transducers

C D
B A - cable
A
B - strain relief
C - strain relief/housing joint
D - housing
E - Do not use alcohol in this area
F - You may use alcohol in this area
1 inch
2.5 cm

F
E

Remove any residue with a soft cloth moistened in water. Do

not allow cleaning solutions or isopropyl alcohol to air-dry on
the transducer.

Cleaning and Disinfection of Transducers Used in Endocavity Procedures

High-level disinfection is the accepted method of infection control for

transducers used in endocavity procedures. Use of a protective sheath during the
exam is also recommended.

To clean an endocavity transducer when it is used in a non-invasive procedure,

NOTE
see “General Cleaning for Transducers Used in Non-Invasive Procedures” on
page 2-14.

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Caring for Transducers
Cleaning and Disinfection of Transducers Used in Endocavity Procedures

Cleaning and High-Level Disinfection of Transducers Used in

Endocavity Procedures
Disinfect the transducer prior to the first exam, and after every exam thereafter.
Establish and clearly post a disinfectant procedure that includes the following
steps:

1 Unplug the transducer from the system.

2 Wash the transducer head and cable with soap and water to remove any pro-
tein buildup; however do not rinse or immerse the cable near the connector or
the connector itself.

To assist in removing protein residuals, Philips recommends using an enzy-

matic cleaner. A common enzymatic cleaner is one with a pH of 6.0 to 8.0
(e.g. Metrizyme) and contains diluted concentrations of surfacants, alcohols,
salts, and acids. These cleaners are further diluted during use.

3 Disinfect the transducer and the cable with one of the disinfectants listed in
“Glutaraldehyde-based Disinfectants” on page 2-11 or “Non-Glutaraldehyde-
Based Disinfectant” on page 2-12.

• Avoid transducer contact with strong solvents such as acetone, freon,

and other industrial cleansers.
• Do not soak the transducer for extended periods of time, such as over-
night.
• Do not rinse or immerse the connector or the portion of the cable near
the connector.

NOTE Follow the recommendations of the disinfectant manufacturer.

4 Remove the transducer from the disinfectant and thoroughly rinse with sterile
water.

5 Check the transducer for any residual infectious material. If any is present,
disinfect the transducer again.

WARNING Never sterilize the transducer with sterilization techniques such as auto-
clave, ultraviolet, gamma radiation, gas, steam, or heat sterilization tech-
niques. Severe damage will result.

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 Caring for Transducers
Cleaning and Disinfecting of Transducers Used in Biopsy Procedures

Avoidable transducer damages are not covered by the warranty or service

contract.

Cleaning and Disinfecting of Transducers Used in Biopsy Procedures

Cleaning and High-Level Disinfection of Transducers Used in

Biopsy Procedures
Follow the steps below for proper disinfection of transducers used in biopsy
procedures.

To clean a biopsy-capable transducer when it is used in a:

NOTE
• Non-invasive procedure, see “General Cleaning for Transducers Used in
Non-Invasive Procedures” on page 2-14.
• Endocavity procedure, see "“Cleaning and High-Level Disinfection of
Transducers Used in Endocavity Procedures” on page 2-16

1 Unplug the transducer from the system.

2 Wash the transducer head and cable with soap and water to remove any pro-
tein buildup; however do not rinse or immerse the cable near the connector or
connector.

To assist in removing protein residuals Philips recommends using an enzy-

matic cleaner. A common enzymatic cleaner is one with a pH of 6.0 to 8.0
(for example, Metrizyme) and contains diluted concentrations of surfacants,
alcohols, salts, and acids. These cleaners are further diluted during use.

3 Disinfect the transducer and cable with one of the glutaraldehyde-based disin-
fectants listed on page 2-11.

• Do not rinse or immerse the connector or the portion of the cable near
the connector.
• Avoid transducer contact with strong solvents such as acetone, freon,
and other industrial cleansers.

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Caring for Transducers
Cleaning and Disinfection of TEE Transducers

• Do not soak the transducer for extended periods of time, such as over-
night.

NOTE Follow the recommendations of the disinfectant manufacturer.

4 Remove the transducer from the disinfectant and thoroughly rinse with sterile
water.

5 Check the transducer for any residual infectious material. If any is present,
remove it and disinfect the transducer again.

WARNING Never sterilize the transducer with sterilization techniques such as auto-
clave, ultraviolet, gamma radiation, gas, steam, or heat sterilization tech-
niques. Severe damage will result.

Avoidable transducer damage is not covered by the warranty or service

contract.

Cleaning and Disinfection of TEE Transducers

High-level disinfection is the accepted method of infection control for TEE

transducers. It is recommended that a sheath be used during examinations.

Cleaning and High-Level Disinfection of TEE Transducers

Use this disinfection method for the following transducers:

• Model 21364A, OmniPlane

• Models 21367A and 21369A, OmniPlane II
• Model 21381A, miniMultiplane
• Model 21366A, Pediatric Biplane

Clean and disinfect the transducer immediately after each use to protect patients
and personnel from a variety of pathogens. Establish and clearly post a cleaning
procedure that includes the following steps:

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 Caring for Transducers
Cleaning and Disinfection of TEE Transducers

1 Disconnect the transducer from the system.

2 Remove all organic matter and other residue, using the following procedure.

a. Soak gauze pads in mild, soapy water. Do not use iodine-based soaps.
Philips recommends using an enzymatic cleaner to assist in removing
protein residuals. A common enzymatic cleaner is one with a pH of 6.0
to 8.0 (e.g., Metrizyme) and contains diluted concentrations of surfa-
cants, alcohols, salts, and acids. These cleaners are further diluted dur-
ing use.

b. Wipe the distal tip and flexible shaft up to the control housing
(steering mechanism) with the gauze pads.

3 Rinse the distal tip and flexible shaft well, using water.

Do not rinse or immerse the control housing, cable, or connector. For the Model
CAUTION 21381A, miniMultiplane, do not immerse past the 65cm marker.

4 For the Model 21366A Pediatric Biplane Transducer, if debris is present

between the two sensors on the tip, clean with a cotton or foam-tipped swab
dipped in one of the high-level disinfectants. (Use glutaraldehyde-based dis-
infectant only.)

5 Disinfect the distal tip and flexible shaft by placing them in one of the disin-
fectants listed in “Glutaraldehyde-based Disinfectants” on page 2-11 or
“Non-Glutaraldehyde-Based Disinfectant” on page 2-12. This disinfectant
procedure is only allowed with certain models (see the list). Be sure to use a
disinfectant recommended for the transducer you are using.

• Do not use bleach or other disinfectants. Also, avoid transducer contact

with strong solvents such as acetone, freon, and other industrial cleans-
ers.
• Do not bend the shaft into less than a one-foot diameter curve. Leave the
tip and shaft in the solution for the amount of time recommended by the
disinfectant manufacturer.
• Do not immerse or rinse the steering mechanism.
• Do not soak the transducer for extended periods of time, such as over-
night.

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Caring for Transducers
Cleaning and Disinfection for Transducers Used in Intraoperative Procedures

Follow the recommendations of the disinfectant manufacturer.

NOTE
6 Remove the distal tip and flexible shaft from the disinfectant and thoroughly
rinse them with sterile water.

7 Check the transducer for any residual organic material. If any is present,
remove it and disinfect the transducer again.

8 Dry the distal tip and flexible shaft with a soft cloth or pad.

9 Lightly wipe the steering mechanism with a pad moistened with 70% isopro-
pyl alcohol.

10 Hang the transducer on a wall-mounted rack and let it air dry.

WARNING The transducer steering mechanism is not sealed. If disinfectant or other

fluid enters the steering mechanism, it will corrode the gears and electrical
connections.

Never sterilize the transducer with sterilization techniques such as auto-

clave, ultraviolet, gamma radiation, gas, steam or heat sterilization tech-
niques. Severe damage will result.

Avoidable transducer damage, such as those conditions listed above, are

not covered by the warranty or service contract.

Cleaning and Disinfection for Transducers Used in Intraoperative Procedures

High-level disinfection and the use of a sterile sheath is the accepted method of
infection control for this critical category of device.

Use the disinfection method described in this section for models:

• 15-6L (Model 21390A)

• s12 (Model 21380A)
• L7540 (Model 21358B)

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Caring for Transducers
Cleaning and Disinfection for Transducers Used in Intraoperative Procedures

To clean an intraoperative transducer when it is used in a non-invasive procedure,

NOTE see “General Cleaning for Transducers Used in Non-Invasive Procedures” on
page 2-14.

WARNING Intraoperative probes used in animal studies should not be used on

humans. Transducer disinfection procedures described in this chapter are
for usage between humans only.

When the 21390A probe is used for animal studies, the animal use label
must be attached. See “Animal Use Label” on page 5-3.

Cleaning and High-Level Disinfection of Transducers Used in

Intraoperative Procedures
Follow these steps for proper disinfection:

1 Unplug the transducer from the system.

2 Wash the transducer head and cable with soap and water to remove any pro-
tein buildup; however, do not rinse or immerse the connector itself or the
length of cable near the connector.

• To assist in removing protein residuals Philips recommends using an

enzymatic cleaner. A common enzymatic cleaner is one with a pH of 6.0
to 8.0 (e.g. Metrizyme) and contains diluted concentrations of surfa-
cants, alcohols, salts, and acids. These cleaners are further diluted dur-
ing use.

3 Disinfect the transducer and cable with one of the glutaraldehyde-based disin-
fectants listed on page 2-11. For the model 21390A (15-6L) transducer, you
may use either a glutaraldehyde-based disinfectant or Cidex® OPA. See
“Non-Glutaraldehyde-Based Disinfectant” on page 2-12 for this information.

• Do not rinse or immerse the connector or the portion of the cable near
the connector.
• Avoid transducer contact with strong solvents such as acetone, freon,
and other industrial cleansers.
• Do not soak the transducer for extended periods of time, such as over-
night.

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Caring for Transducers
Cleaning and Disinfection for Transducers Used in Intraoperative Procedures

Follow the recommendations of the disinfectant manufacturer.

NOTE
4 Remove the transducer from the disinfectant and thoroughly rinse with sterile
water.

5 Check the transducer for any residual infectious material. If any is present,
remove it and disinfect the transducer again.

WARNING Never sterilize the transducer with sterilization techniques such as auto-
clave, ultraviolet, gamma radiation, gas, steam, or heat sterilization tech-
niques. Severe damage will result.

Avoidable transducer damage is not covered by the warranty or service

contract.

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 3 Endocavity Transducers

Overview

Endocavity transducers deliver the critical images needed for obstetrical,

gynecological, fertility, urological, and prostate studies. The endovaginal and
endorectal transducers feature end-firing imaging arrays that deliver a wide field
of view. This feature lets you consider the whole picture when making your
diagnosis. Biopsy needle guides work in conjunction with system-generated
guidelines to determine target directions and depth. This chapter provides
information on the following endocavity transducers:

• 21336A, curved linear endovaginal/endorectal transducer, enabling high-res-

olution imaging frequency. Capable of 2-D, Color, PW Doppler imaging,
and Angio. Offers a choice of two 2-D and Color and Angio frequencies that
can be switched during the imaging session.
• 21370A, curved linear endovaginal transducer, enabling high-resolution
imaging at 5 or 7.5 MHz frequency. An off-set end-fire transducer, it is capa-
ble of high-resolution imaging of the pelvic area for obstetrical and gyneco-
logical studies. Offers a choice of two 2-D and Color and Angio frequencies
that can be switched during the imaging session.
• 21371A, curved linear endorectal transducer, enabling high-resolution imag-
ing at 5 or 7.5 MHz frequency for urological studies. Offers a choice of two
2-D and Color and Angio frequencies that can be switched during the imag-
ing session.

Patient Safety

To operate an endocavity transducer, you must be a physician or sonographer

who is properly trained in endocavity techniques, according to currently
approved relevant medical standards. You also must be thoroughly familiar with
the safe operation, care, and maintenance of the Philips ultrasound imaging
system used with the transducer, as well as proficient at interpreting the images
generated. As always, use informed judgment when selecting patients for
endocavity exams.

Revision C.0 3-1

Endocavity Transducers
Patient Safety

You can help ensure patient safety when using an endocavity transducer by:

• Verbally preparing each patient for the procedure prior to the exam.
• Scrutinizing the entire transducer and testing all of the controls before each
use.
• Using mandatory protective equipment, such as a market-approved sheath or
condom, during an exam. See “Ordering Biopsy Kits and Sheaths” on page
3-12.
• Inserting and operating the transducer properly.
• Not allowing water or other liquids to drip into the transducer connector or
the interior of the system or onto the keyboard.

The following table summarizes patient safety problems, how to prevent them,
and the pages in this guide where details are provided.

Table 3-1. Patient Safety Summary

Problem Effect on Patient Prevention Details

Mechanical Severe trauma, cuts, Inspect transducer using both sight and “Checking the
damage bleeding, perforations touch before exam. Transducer” on page
2-2

Insufficient Spread of illness or Thoroughly clean and disinfect transducer “Cleaning and
cleaning protocol disease after each use. Cover transducer with Disinfection of
protective sheath. Cover imaging system Transducers Used in
with disposable drape if highly pathogenic Endocavity
organisms known or suspected. Procedures” on
page 2-15

Improper Cuts, bleeding, ligament Never use force when inserting or “Endocavity Exam
insertion or damage, perforations removing transducer. Guidelines” on page
withdrawal 3-10

Any other Potentially serious Do not use transducer. Contact your Philips
irregularity consequences service
representative

Defibrillation Electrical burns Disconnect transducer and remove “Defibrillators” on

Issues transducer connector prior to defibrillation. page 3-3

NOTE The diagnostic ultrasound systems and transducers discussed in this manual do
not contain natural rubber latex that contacts humans. Natural rubber latex is not

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 Endocavity Transducers
Equipment Operation

used on any ultrasound transducer, including transthoracic, intraoperative, and

transesophageal transducers. It also is not used on Philips SONOS and Image-
Point ECG cables.

Equipment Operation

Meticulous inspection and correct and careful operation of an endocavity

transducer are important to patient safety. The situations listed in this section
affect safe operation as well as the ability to service mechanical problems under
Philips’ one-year warranty or service contract. Repairs necessitated by misuse
are not covered and can be very costly, often requiring complete disassembly and
rebuilding of the transducer.

The primary areas of misuse are:

• Cuts and abrasions on transducer insulation from sharp instruments such as

scalpels, scissors, and clamps.
• Improper disinfection of the transducer, causing fluid to enter the transducer.
• Damage caused by dropping transducer onto a hard surface.

Electrical Safety

Defibrillators
The outer insulating layer of the transducer, if intact, is designed to withstand
electrical stress created by defibrillation. A small hole in the outer layer of the
transducer, however, opens a conductive path to grounded metal parts in the
transducer. The secondary arcing that could occur during defibrillation could
cause patient burns. The risk of burns is reduced but not eliminated by using an
ungrounded defibrillator. Therefore, remove the transducer from the patient
before defibrillation. A disposable sheath provides no protective electrical
insulation against defibrillation.

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Endocavity Transducers
Description and Use

Accident Prevention
Use defibrillators that do not have grounded patient circuits. Refer to the
defibrillator service guide, or consult with a biomedical engineer to determine
whether or not a defibrillator patient circuit is grounded.

Before defibrillation, always remove the transducer from the patient.

Description and Use

This section lists important features of the following endocavity transducers:

Endovaginal/Endorectal
(Model 21336A)

6APCkim1

Features: Enables high-resolution imaging for obstetrical, gyne-

cological, prostate, and urological studies. Capable of
2-D, MMode, Color, PW Doppler, and Angio.
Designed to be easy to hold and manipulate and to pro-
vide maximum clinician and patient comfort.

Connection See “Connecting Transducers” on page 1-1.

Frequency: 5.0 and 7.5 MHz on ImagePoint.

4.0 to 7.0 MHz, plus Fusion settings on SONOS.

Max Sector image: 126 degrees

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 Endocavity Transducers
Description and Use

Endovaginal/Endorectal
(Model 21336A)
Specs: Length (transducer & cable) – approximately 263 cm
Length of handle & tip – 290 mm
Radius of curvature – 8.7 mm

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Endocavity Transducers
Description and Use

Endovaginal
(Model 21370A)

404e001

Features: Enables high-resolution imaging at 5.0 or 7.5 MHz fre-

quency for obstetrical and gynecological studies. An
off-set and end-fire transducer capable of 2-D, Color,
PW Doppler, and Angio.

Connection: See “Connecting Transducers” on page 1-1.

Frequency: 5.0 and 7.5 MHz

Max Sector image: 110 degrees

Specs: Length (transducer & cable) – approximately 234 cm

Length of handle & tip – 254 mm
Radius of curvature – 14 mm

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 Endocavity Transducers
Description and Use

Endorectal
(Model 21371A)

404e002

Features: Enables high-resolution imaging at 5.0 or 7.5 MHz fre-

quency for prostate and urological studies. Capable of
2-D, Color, PW Doppler, and Angio

Connection: See “Connecting Transducers” on page 1-1.

Frequency: 5.0 and 7.5 MHz

Max Sector image: 114 degrees

Specs: Length (transducer & cable) – approximately 234 cm

Length of handle & tip – 254 mm
Radius of curvature – 11 mm

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Endocavity Transducers
The Endocavity Exam

The Endocavity Exam

This section discusses how to:

• Prepare the endocavity transducer for use

• Prepare the patient for the exam
• Endocavity exam guidelines

Endocavity Transducer Preparation

Follow the steps below to prepare the transducer for use. These instructions apply
to all endocavity transducers.

WARNING Do not use gels that contain any of the following agents:
-- acetone
-- methanol
-- denatured ethyl alcohol
-- mineral oil
-- iodine
-- any lotions or gels containing perfume

Check with the gel manufacturer if you have any questions regarding the contents
of the gel.

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 Endocavity Transducers
The Endocavity Exam

Endocavity Transducer Preparation Procedure

1 Place an adequate amount of ultrasound coupling gel at the tip of the inside
surface of the sheath. Gloves should be worn during this procedure.

404e007

CAUTION Use acoustic coupling gel only inside the sheath; do not use coupling gel outside
of the sheath. For proper transmission of the acoustic beam, use the ultrasound
transmission gel supplied by Philips, or another glycol, glycerol, or water-based
couplant inside the sheath. Do not use mineral oil, oil-based couplants, or other
non-approved material because they might damage the transducer.

2 Place the sheath over the transducer or unroll the sheath until it covers the
insertable portion of the transducer.

404e008

3 Use an elastic band to hold the sheath in place at the transducer handle.

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Endocavity Transducers
The Endocavity Exam

4 Gently pat the sheath to remove any air pockets. Check for tears or damage
before proceeding.

5 Place enough commercially-available water-based lubricant or sterile jelly on

the end of the covered transducer to facilitate insertion.

404e015

Preparing Patients for an Endocavity Exam

Before performing an endocavity exam, it is important that you thoroughly
explain the exam procedures to the patient. Follow your department guidelines
for patient preparation.

Endocavity Exam Guidelines

This section lists considerations when performing an endocavity exam.

• Never use excessive force when inserting, operating, or withdrawing a trans-

ducer.
• Minimize the possibility of pressure necrosis (tissue death).
• Do not let the tip displace any one segment of tissue for more than five con-
secutive minutes. Also, make sure the tip is in a position of least potential
pressure.
• Before each exam, carefully inspect the transducer, as described earlier in
this chapter.

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 Endocavity Transducers
The Endocavity Exam

• A thorough inspection procedure is required for the safety of both you and
the patient, and to ensure the continued correct functioning of the transducer.
• Forceful insertion, manipulation, or withdrawal of a transducer can result in
lacerations, bleeding, perforation, tearing of adhesions, and ligament dam-
age.
• Refrain from handling the tip of the transducer.
• Use the handle of the transducer as much as possible.

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Endocavity Transducers
Accessory Equipment

Accessory Equipment

This section describes accessories and provides ordering information. It also

mentions circumstances that warrant the use of a disposable drape.

Ordering Biopsy Kits and Sheaths

To order biopsy kits and sheaths for the Models 21336A, 21370A, and 21371A
transducers, contact:

CIVCO Medical Instruments Co.

102 First Street
Kalona, IA 52247-9589 USA
E-mail: info @civcomedical.com
http://www.civco.com

Call 1-800-445-6741 within the United States or 1-319-656-4447 outside of the

United States. To fax orders call: 1-319-656-4451.

Use the following CIVCO numbers to order the appropriate replacement biopsy
kit for your transducer:

Kit Number Kit Contents Transducer

610-139 24 sterile omni guides 21370A, 21371A

610-006 24 sterile civ-flex covers (11.9cm tapered to

4.6cmx61cm)

610-213 24 sterile latex covers (2.6x30cm)

610-590 24 sterile EC guides 21336A

610-588 24 sterile EC guides with 24 sterile civ-flex covers

(11.9cm tapered to 4.6cmx61cm)

610-693 24 sterile EC guides with 24 latex covers

(3.5x20cm and 2x20cm)

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 Endocavity Transducers
Endocavity Biopsy Needle Guide

Disposable Drape for Endocavity Exams

During exams when you believe contamination of the imaging system can occur,
it is recommended that you take universal precautions and cover the imaging
system with a disposable drape. Consult your hospital’s rules regarding
equipment use in the presence of infectious disease.

Endocavity Biopsy Needle Guide

This section describes how to use the biopsy needle guide with the endocavity
transducers. The needle guide mounts onto the transducer to guide a biopsy
needle during a biopsy or aspiration procedure.

Endocavity Biopsy Needle Guide Safety and Maintenance

The endocavity transducers are intended for use in endocavity scanning
applications. Proper transducer preparation is required to ensure patient and user
safety.

Precautions for the Endocavity Biopsy Needle Guide

Always follow these basic precautions when using the biopsy needle guide:

• Most needle guides are shipped sterile and are disposable. DO NOT reuse
disposable needle guides. Please verify on the packaging that the needle
guide is sterile.
• After use, remove the needle guide from the transducer and discard the dis-
posable guide.

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Endocavity Transducers
Endocavity Biopsy Needle Guide

Installing the Endocavity Biopsy Needle Guide

The following sections describe how to install the endocavity biopsy needle
guide:

• Preparation of the endocavity transducer for biopsy.

• Mounting the endocavity biopsy needle guide to the transducer.

Preparation of the Endocavity Transducer for Biopsy Use

1 Make sure you use a sheath on the transducer.

2 Check the sheath for tears or damage before proceeding.

WARNING The biopsy needle guide and endocavity transducer must be cov-
ered with a sheath during biopsy procedures.

Mounting the Endocavity Biopsy Needle Guide to the Transducer

1 Remove the biopsy needle guide from its package.

2 Locate the attachment guides (tabs) found on the underside of the needle
guide. Note: these guides fit into the notches on the transducer shaft. The
illustrations below show the location of the notches on an uncovered trans-
ducer.

Endorectal (21371A) and Endovaginal (21370A) Transducers Tab Locations

404e006

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 Endocavity Transducers
Endocavity Biopsy Needle Guide

Endovaginal/Endorectal Transducer (21336A) Tab Locations

6APCkimt

3 Put the sheath on the transducer. (See “Endocavity Transducer Preparation

Procedure” on page 3-9.) Align the guides with the notches on the transducer
shaft, and snap the needle guide into place.
Endorectal (21371A) and Endovaginal (21370A) Transducers with Sheath
and Guide Alignment

404e006

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Endocavity Transducers
Endocavity Biopsy Needle Guide

Endovaginal/Endorectal Transducer (21336A) with Sheath and Guide

Alignment

6APCkimta

4 Check the sheath on the transducer to make sure it did not tear or get damaged
in the process of installing the needle guide.

5 Place an adequate amount of ultrasound coupling gel at the tip of the inside
surface of a second sheath.

6 Add the second sheath over the transducer and needle guide, making sure that
there are no air bubbles between the two sheaths.

404e009

7 The following picture illustrates how the needle pierces the outer sheath.

WARNING Do not insert the needle into the guide until the transducer is
inserted into the patient.

404e010

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 4 TEE Transducers

Overview

A transesophageal echocardiography (TEE) exam is performed with a transducer

mounted in a gastroscope, which is positioned in the esophagus or stomach. TEE
transducers offer images that are unobstructed by lungs and ribs, making them
important diagnostic tools for conditions that transthoracic echocardiography
cannot adequately image.

This chapter provides information on the following TEE transducers:

• 21364A, the OmniPlane transducer, enabling 360o views of the heart, steer-
able CW Doppler, dual frequency, and frequency agility. Additional features
on the SONOS 4500 and 5500 include frequency fusion and adaptive color
flow.
• 21367A and 21369A, the OmniPlane II transducers, enabling 360o views of
the heart, steerable CW Doppler, dual frequency, and frequency agility.
Additional features on the SONOS 4500 and 5500 include frequency fusion
and adaptive color flow.
The difference between the two transducers is their connector to the ultra
sound system. The 21367A uses an AMP-style connector with a transducer
adapter and the 21369A connects directly to the ultrasound system using a
Cannon®style connector.

• 21381A, the miniMultiplane transducer, with a small tip array, enabling 180o
rotation for 360o views of the heart. Additional features of this small, light-
weight transducer include steerable CW Doppler and PW Doppler studies.
• 21366A, the Pediatric Biplane transducer, enabling both transverse and lon-
gitudinal views, and steerable CW Doppler for examinations of pediatric and
small adult patients.

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TEE Transducers
Overview

Audience

Philips TEE transducers are designed for use by physicians who are properly
trained in esophagogastroscopic techniques according to currently approved
relevant medical practices. It is recommended that physicians operating any
Philips TEE transducer are:

• Proficient in recognizing and interpreting transesophageal imaging patterns.

• Thoroughly familiar with the safe operation, care, and maintenance of the
Philips phased array ultrasound imaging system used with the transducer.
• Fully informed about the latest TEE methods through literature and semi-
nars.

This chapter discusses the following transducers:

• Model 21364A, OmniPlane

• Model 21367A, OmniPlane II (AMP-style connector) with trans-
ducer adapter
• Model 21369A, OmniPlane II (Cannon-style connector)
• Model 21381A, miniMultiplane (Cannon-style connector)
• Model 21366A, Pediatric Biplane

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 TEE Transducers
Patient Safety

Patient Safety

Philips transducers are built to be safe, sturdy, and reliable. However, on a few
occasions patients have experienced complications due to improper use of a TEE
transducer. This section provides information on patient safety when using a TEE
transducer.

Philips recommends that To operate a TEE transducer, you must be a physician who is properly trained in
you practice using the esophagogastroscopic techniques, according to currently approved relevant
controls before medical practices.
performing every
procedure mentioned
here. You also must be thoroughly familiar with the safe operation, care, and
maintenance of the Philips ultrasound imaging system used with the transducer,
as well as proficient at interpreting the images generated. As always, use
informed judgement when selecting patients for TEE exams.

You can help ensure patient safety when using a TEE transducer by:

• Verbally preparing each patient for the procedure prior to the exam.
• Scrutinizing the entire transducer and testing all of the controls before each
use.
• Inserting, removing, and operating the transducer properly.
• Ensuring that the transducer handle does not rest on or touch the patient.
• Using protective equipment, such as a bite guard and a market-approved
sheath, during a TEE exam. See “Accessory Equipment” on page 4-48.
• Not allowing water or other liquids to come in contact with the transducer
connector, the interior of the system, or onto the keyboard.

NOTE To avoid damaging gastroscope cables, be sure that the distal tip is in the neutral
(straight) position when inserting a transducer into or removing it from a sheath.

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TEE Transducers
Patient Safety

The following table summarizes patient safety problems, how to prevent them,
and the pages in this guide where details are provided.

Table 4-1 Patient Safety Summary

Problem Effect on Patient Prevention Details

Mechanical Severe trauma, cuts, Inspect transducer using both sight and page 4-32
damage bleeding, perforations touch before exam.

Electrical damage Esophageal burns Check transducer for frayed insulation, kinks, page 4-7
or other abnormalities. Follow electrical
safety checking procedures.

Biting, scraping Tooth damage, esophageal Use a bite guard. page 4-48
transducer burns

Insufficient Spread of illness or disease Thoroughly clean and disinfect transducer page 2-18
cleaning protocol after each use. Cover tip and shaft with
sheath. Cover imaging system with
disposable drape if highly pathogenic
organisms are known or suspected.

Improper insertion Esophageal cuts, bleeding, Never use force when inserting, removing, or page 4-34
or withdrawal ligament damage, manipulating transducer. During insertion,
perforations lock the medial/lateral controls. During
withdrawal, place the medial/lateral controls
in free-wheeling mode.

Pressure necrosis Death of esophageal lining Keep deflection controls in free-wheeling page 4-34
tissue mode and unplug transducer from system
when not imaging. Minimize the pressure
applied to deflection area and distal tip. Do
not let distal tip displace a tissue area for
more than five minutes.

Increased Esophageal burns Use the TEE preset which has been page 4-38
transducer established to minimize the effects of
temperature temperature. For febrile patients, use the
auto cool feature.

Improper patient Transient unilateral vocal Never use the transducer during any page 4-34
position cord paralysis procedure requiring extreme neck flexion,
such as sitting craniotomies.

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 TEE Transducers
Equipment Operation

Table 4-1 Patient Safety Summary (Continued)

Problem Effect on Patient Prevention Details

Non-isolated Electrical burns Only use isolated-output electrosurgical units page 4-7
ESUs (ESUs); the ESU label or service guide, or
your biomedical department, should identify
whether or not the ESU is isolated. Unplug
transducer from the system when you are not
imaging.

Defibrillation Electrical burns Disconnect transducer and remove page 4-8

issues transducer connector prior to defibrillation.

Any other Potentially serious Do not use transducer. Contact your

irregularity consequences Philips service
representative.

NOTE The Philips’ diagnostic ultrasound systems and transducers in this manual do not
contain natural rubber latex that contacts humans. Natural rubber latex is not
used on any ultrasound transducer, including transthoracic, intraoperative, and
transesophageal transducers. It also is not used on Philips ECG cables for the
products in this manual.

Equipment Operation

Meticulous inspection and correct and careful operation of a specialty transducer

are imperative to patient safety. The situations listed in this section affect safe
operation as well as the ability to service mechanical problems under Philips’
one-year warranty or service contract. Transducer repairs necessitated by misuse
are not covered and can be very costly, often requiring complete disassembly and
rebuilding of the transducer.

The primary areas of customer misuse are:

• Cuts and abrasions on the transducer and insulation from teeth or sharp
instruments, such as scalpels, scissors, and clamps.

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TEE Transducers
Equipment Operation

• Improper disinfection techniques, causing fluid to enter the control head

assembly, control housing, and the rest of the transducer.
• Consistently applying too much force to the control wheels of a TEE
transducer, which can break the steering mechanism.

Review the following table to familiarize yourself with specific problems, how to
avoid them, and the pages in this guide where details are provided. Philips also
strongly recommends that you clearly post stringent protocols for TEE transducer
care, based on the information in this guide, to minimize the chance of damage.

Table 4-2. Problem Prevention Summary

Problem Effect on Equipment Prevention Details

Current leakage Serious electrical hazards Check transducer for cuts, frayed page 4-7
insulation, kinks, or other abnormalities.
Follow electrical safety checking
procedures.

Biting transducer Mechanical and electrical Cover patient’s teeth with a bite guard. page 4-48
hazards Cover the distal tip and flexible shaft with
a sheath (optional).

Forcing Breaks steering mechanism Operate deflection controls gently. page 4-11
deflection
controls

Incorrect storage Possible damage to highly Suspend transducer from a wall- page 2-3
sensitive elements, cuts in mounted rack and cover distal tip with tip
flexible shaft protector when not in use.

Internal Severe transducer damage that Never sterilize transducer using bleach, page 2-18
exposure to affects image quality, steering steam, heat, or ethylene oxide. Never
liquids mechanism, and electrical immerse steering mechanism in any
safety disinfectant or liquid.

Any other Potential severe damage Do not use transducer. Contact your
irregularity Philips service
representative

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 TEE Transducers
Electrical Safety

Electrical Safety

The Philips ultrasound systems and transducers discussed in this manual comply
with common medical device electrical safety standards.

This section includes information about TEE transducer leakage current,

interaction with other devices, accident prevention, and electrical check-out
procedure.

Leakage Current

Each Philips TEE transducer discussed in this manual is classified as BF as

described in IEC 60601-1:1995. There are no exposed conductive surfaces distal
to the control housing. Within the flexible shaft, all active circuits and conductors
are surrounded by a chassis-grounded shield that runs the length of the
transducer.

If the outer layer of the shaft is punctured or cracked, a patient’s esophagus could
be exposed to chassis leakage current. This leakage current is not hazardous
provided that the ground connector (third wire) in the ultrasound system power
cable is intact and connected to a properly grounded wall outlet. Even if the
ground connector breaks, leakage current will not exceed 100 microamperes
when connected to a 120 volt outlet, or 200 microamperes when connected to a
240 volt outlet.

Leakage hazards are further reduced when the ultrasound system is plugged into
an isolated power outlet, which is standard in most operating rooms.

Electrosurgical Units
Electrosurgical units (ESUs) and other devices intentionally introduce radio
frequency electromagnetic fields or currents into patients. Because imaging
ultrasound frequencies are coincidentally in the radio frequency range,
ultrasound transducer circuits are susceptible to radio frequency interference.
While an ESU is in use, severe noise interferes with the black and white image,
and completely obliterates the color image.

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TEE Transducers
Electrical Safety

Combinations of failures in an ESU or other device and in the outer layer of the
transducer shaft can cause electrosurgical currents to return along the transducer
conductors. This could burn the patient, and the ultrasound system and transducer
could also be damaged. Be aware that a disposable sheath provides no protective
electrical insulation at ESU frequencies.

Pacemakers
Ultrasound equipment in normal operation, as with other medical electronic
diagnostic equipment, uses high-frequency electrical signals that can interfere
with pacemaker operation. Though the possibility of interference is slight, be
alert to this potential hazard and halt system operation immediately should you
note interference with a pacemaker.

Defibrillators
The outer insulating layer of the transducer, if intact, is designed to withstand
electrical stress created by defibrillation. A small hole in the outer layer of the
transducer, however, opens a conductive path to grounded metal parts in the
transducer. The secondary arcing that could occur during defibrillation could
cause patient burns. The risk of burns is reduced but not eliminated by using an
ungrounded defibrillator. Therefore, disconnect the transducer and remove the
transducer connector from the system before defibrillation. A disposable sheath
provides no protective electrical insulation against defibrillation.

Accident Prevention
Visually and tactually inspect a TEE transducer for bumps, cracks, and cuts prior
to each TEE exam. A small bump on the shaft surface could indicate that a strand
from the ground shield has broken and is beginning to puncture the outer layer. If
you suspect a problem with the flexible shaft, perform the electrical safety
checking procedure provided in the next section.

Use ESUs that have isolated outputs. Return fault/ground fault detection circuits
provide additional protection. (To determine if an ESU has an isolated output,
read the label on the ESU, refer to the ESU service guide, or ask a biomedical
engineer.)

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 TEE Transducers
Electrical Safety

Use defibrillators that do not have grounded patient circuits. Refer to the
defibrillator service guide, or consult with a biomedical engineer to determine
whether or not a defibrillator patient circuit is grounded.

Before defibrillation, always disconnect and remove the transducer from the
system.

Require periodic electrical safety checks to ensure that the grounding system in
your area remains intact.

If the transducer is left in a patient during periods when imaging is not taking
place, unplug the transducer from the system to reduce the possibility of leakage
current or ESU interaction. Also make sure that the deflection control brakes are
off and that the transducer is in free-wheeling mode.

NOTE A leakage current detector (the Dale 800) is listed on the Philips Transducer web
site at www.medical.philips.com/transducercare. For an example how to test cur-
rent leakage, using a Dynatech Nevada 232 Safety/ECG Analyzer, see “Leakage
Current Testing” on page 5-6.

Electrical Check-Out Procedure for TEE Transducers

Regularly perform an electrical safety check to determine if there is a hole in the
transducer’s outer insulating layer. The electrical check-out procedure is
described in Safety and Standards.

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TEE Transducers
Description and Use

Description and Use

This section discusses the basic parts of a TEE transducer and lists important
features of the following TEE transducers:

• OmniPlane (Model 21364A)

• OmniPlane II (Model 21367A) using the AMP-style connector with trans-
ducer adapter
• OmniPlane II (Model 21369A) using the Cannon-style connector
• miniMultiplane (Model 21381A) using the Cannon-style connector
• Pediatric Biplane (Model 21366A)

Basic Transducer Parts

This section labels and describes individual parts that are common to TEE
transducers. Many of the parts and their operation are similar among Philips TEE
transducers. Differences not shown in the following figure are:

• Brakes for OmniPlane transducers

• Array rotation buttons for the OmniPlane transducers
• Bifurcated connector cable and two connectors for the Pediatric Biplane
transducer

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 TEE Transducers
Description and Use

Figure 4-1. Basic Transducer Parts

Deflection controls

Control housing

Distal tip
Deflection area

Flexible shaft

System connector cable

Transducer connector

008E11C

Deflection Control Basics

The deflection controls on the TEE transducers discussed in this manual move
the deflection area, located between the distal tip and flexible shaft. The
deflection area bends when you operate the controls, permitting anterior,
posterior, and lateral positioning for most transducers.

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TEE Transducers
Description and Use

Figure 4-2. Deflection Control Movement

WARNING To prevent tissue damage such as pressure necrosis, gastroesophageal lac-

erations, bleeding, tearing of adhesions, ligament damage, and perforation:

Never apply excessive force when inserting or withdrawing the transducer,

or when operating the deflection controls.1, 2

Lock medial/lateral movement during insertion. Use free-wheeling mode

when withdrawing the transducer and any time you are not imaging.

Never apply excessive force when operating the deflection controls during
imaging. Don’t allow the transducer to remain at a maximum deflection for
long periods of time.1.

WARNING To prevent tissue damage Philips recommends that the tip of the transducer
be straightened and both friction brakes released before withdrawing the
transducer from the patient. In the neutral position the tip is straight when
both white circles on the control wheels are aligned and point toward the
center of the array rotation button.

1. Urbanowitz, John, H., et al., “Transesophageal Echocardiography and its Potential for Esophageal
Damage,” Anesthesiology 72:1, 1990.
2. Radwin, Martin, et al., “Transesophageal Echocardiography: Intubation Techniques,” Philips
Application Note 5091-2804E, 1992.

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 TEE Transducers
Description and Use

Temperature Controls

The TEE transducers discussed in this manual have temperature sensors in the
distal tip. An automatic warning appears on the ultrasound screen if the distal tip
temperature exceeds a specified limit, and the system discontinues scanning.

Use the TEE auto cool feature to enter above-normal patient temperatures.
Entering a patient’s temperature enables the system to calculate tip temperature
more accurately, and can prevent unnecessary interruptions while scanning. See
page 4-38 for details of the auto cool feature.

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TEE Transducers
Description and Use

OmniPlane
(Model 21364A)

210e003a

Features: Enables high resolution imaging and 360o views of the heart,
unobstructed by lungs and ribs. Incrementally rotates from the
horizontal plane at 0o, to the vertical plane at 90o, to a left/
right reversed horizontal plane at 180o. Enables lateral and
anterior/posterior tip movement, with an adjustable friction
brake. Capable of color flow imaging, steerable CW and PW
Doppler, and frequency agility. Tip surface constantly moni-
tored for patient safety. Convenient hanging ring.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Tip – 16.9 mm x 11.6 mm, 44 mm long

Shaft – 10.5 mm diameter, 100 cm long

NOTE Philips recommends that you only use the OmniPlane transducer on patients
weighing at least 40 kg (88 lbs), to ensure the esophagus can comfortably accom-
modate the transducer.

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 TEE Transducers
Description and Use

OmniPlane II
(Model 21367A and 21369A)

5apc040

Features: Enables high resolution imaging and 360o views of the heart,
unobstructed by lungs and ribs. Incrementally rotates from the
horizontal plane at 0o, to the vertical plane at 90o, to a left/
right reversed horizontal plane at 180o. Enables lateral and
anterior/posterior tip movement, with an adjustable friction
brake. Capable of color flow imaging, steerable CW and PW
Doppler, and frequency agility. Tip surface constantly moni-
tored for patient safety. Convenient hanging ring.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Tip – 14.4 mm x 11.5 mm, 34 mm long

Shaft – 10.5 mm diameter, 100 cm long

NOTE Philips recommends that you only use the OmniPlane II transducer on patients
weighing at least 25 kg (55 lbs), to ensure the esophagus can comfortably accom-
modate the transducer.

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TEE Transducers
Description and Use

Manipulating the OmniPlane Tip

This section contains details of OmniPlane deflection controls and brakes. Be
sure to read “Deflection Control Basics” on page 4-11 for background
information pertaining to SONOS and ImagePoint TEE transducers.

Figure 4-3. OmniPlane Deflection Controls and Brakes

Array rotation buttons

Neutral position indicators (no deflection)

Medial/lateral control

Friction brake for anterior/posterior

control

Anterior/posterior control

Friction brake for medial/lateral control

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The larger inner wheel controls anterior/posterior movement, while the smaller
outer wheel controls medial/lateral movement. Aligning the white circles on each
wheel with the center of the array rotation buttons places the tip of the TEE probe
into the neutral position.

Each wheel has a friction brake that holds the tip position without locking it in
place. Use the minimal setting needed to maintain tip position. This allows the tip
to straighten if it meets additional resistance. The brake for the larger wheel
(anterior/posterior movement) is the lever with the arrow on it. Push the lever in
the direction of the arrow to increase the resistance, or holding power, of the
brake. The brake for the smaller wheel (medial/lateral movement) is the knob
that sits on top of the wheel. Turn this knob clockwise to increase resistance.

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 TEE Transducers
Description and Use

During insertion, lock medial/lateral movement1 or use free-wheeling mode (no

deflection and no brake resistance)2 to prevent patient injury.

CAUTION When repositioning or withdrawing a TEE transducer, put the controls in free-
wheeling mode. If the transducer is left in the patient for an extended period,
unplug the transducer from the system to reduce the possibility of leakage current
or ESU interaction. Also, make sure the transducer is in free-wheeling mode.

Rotating the OmniPlane Array

You can rotate the OmniPlane array to achieve a 360o view of the heart in the
following ways:

• On the ImagePoint, use the array rotation buttons on the transducer

handle.

a. To increase rotation, press the array rotation button that is distal to the
system.

b. To decrease rotation, press the button that is proximal to the system.

Rotation stops when you release either button.
• On the SONOS 4500 and 5500, you can use the method described above, or
you can use the array rotation controls on the system’s touch panel.

a. To increase the degree of rotation continuously, touch Up (touching Up

again stops the rotation).

b. To decrease the degree of rotation continuously, press Down (touching

Down again stops the rotation).

c. Turn Seek Angle to locate a specific angle. When you touch Seek, the
array rotates to the specified angle.

1. Radwin, Martin, et al., “Transesophageal Echocardiography: Intubation Techniques,” Agilent

Application Note 5091-2804E, 1992.
2. Urbanowitz, John H., et al., “Transesophageal Echocardiography and its Potential for Esophageal
Damage,” Anesthesiology 72:1, 1990.

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TEE Transducers
Description and Use

An icon shows the current degree of rotation. Depending on image orientation,

the icon appears in the upper or lower right side of the imaging screen. Because
the center of the array is the pivot point, you can achieve a 360o view, as shown
in the following figure.

Figure 4-4. OmniPlane Array

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 TEE Transducers
Description and Use

Before connecting the transducer, be sure the tip and shaft are straight. When you
lock the connector into the transducer slot, the OmniPlane transducer recalibrates
itself to the 0o (horizontal plane) position. As with any array movement, the
motor makes a humming sound while recalibrating.

Transducer Calibration Failed Message

If you see a “Calibration failed” message on the screen, you can continue to
image. However, the transducer may lack the full 180o rotation capacity, and the
rotation displayed on the screen could be inaccurate.

If you see this message, try the following procedure:

For Cannon-style connectors:

1 Make sure that the transducer’s shaft and tip are straight.

2 Unlock the transducer connector from the system.

3 Reseat the transducer connector in the system slot.

4 Lock the connector.

For AMP-style connectors with the transducer adapter:

1 Make sure that the transducer’s shaft and tip are straight.

2 Unlock the transducer connector from the system.

3 Unplug the transducer connector from the transducer adapter.

4 Reseat the transducer adapter in the system slot.

5 Plug the transducer connector into the transducer adapter.

6 Lock the connector.

If you still see the message, contact your Philips service representative.

NOTE Do not rotate the control knobs while calibration is in progress.

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TEE Transducers
Description and Use

miniMultiplane
(Model 21381A)

Features: A small transducer that enables high resolution imaging and

360o views of the heart, unobstructed by lungs and ribs. The
array inside the tip can be rotated 180o. A manual rotation
wheel on the handle of the transducer controls the rotation of
the scan plane. A deflection control wheel on the handle con-
trols the deflection of the tip. Capable of color flow imaging,
steerable CW and PW Doppler, and frequency agility. Tip sur-
face temperature is constantly monitored for patient safety.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Tip – 10.7 mm x 8.0 mm, 27 mm long

Shaft – 7.4 mm diameter, 70 cm long

Selecting Patients on Whom to Use the miniMulti

Although the miniMulti TEE transducer can provide clinical data not available
from other instruments, you should consider what patients can safely use the
transducer.

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 TEE Transducers
Description and Use

WARNING The miniMulti TEE transducer is not intended for fetal imaging.

Philips recommends that you only use the miniMulti TEE transducer on patients
weighing at least 3.5 Kg (7.7lbs.)

CAUTION The ability of a patient to swallow or accommodate the transducer should be con-
sidered.

You must consider any history of gastro-esophageal diseases as well as the

possible effects of other therapies the patient is undergoing. You must also
consider all gastro-esophageal abnormalities or difficulty swallowing.

Deflection and Scanplane Rotation Control

The control handle is designed for one-hand operation. Normally, you should
operate the control handle with your left hand. Thumb, first and second fingers
control the deflection and scanplane rotation control wheels.

The smaller wheel on the handle is for controlling the transducer tip deflection.
This wheel has a locked and freely moving mode. In the locked mode the
movement of the deflection wheel is restrained. This is used to hold the tip in a
certain position. A metallic ring around the body of the handle, which clicks on/
off, controls the lock.

The larger wheel on top is the scanplane rotation control wheel.

Tip deflection control

The deflection control wheel found on the handle of the transducer controls
deflection of the miniMulti TEE Transducer tip.

WARNING Check if the maximum deflection of the tip is 120° upward and 90° down-
wards. If the up/down deflection shows an unwanted amount of free play or
exceeds the maximal deflection angles given above, do not use the trans-
ducer. Contact the service organization to re-adjust the steering of the

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TEE Transducers
Description and Use

transducer. In this way, the risk of "buckling" or "U-turning" of the trans-

ducer in the esophagus is minimized.

Lock operation
To protect the patient and the transducer, unlock the deflection control when
inserting or withdrawing the transducer.

White

Unlock

Red

Lock

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 TEE Transducers
Description and Use

Transducer scanplane rotation control

The transducer scanplane can be rotated from 0° (transversal plane) via 90°
(longitudinal plane) to 180° (transversal plane, left/right inverted). All planes in
between can also be chosen. This makes it possible to scan a conical imaging
volume.

Short Axis
Angle = 0°

Long Axis
Angle = 90°

Short Axis
Angle = 180°

CAUTION Do not use excessive force on the scanplane rotation control wheel at its outer
positions as this may damage the endoscope mechanism.

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TEE Transducers
Description and Use

Pediatric Biplane
(Model 21366A)

0008e9a

Be sure to read Features: Enables high resolution imaging unobstructed by lungs, ribs,
“Biplane Images” on or scar tissue. Capable of showing both transverse and longi-
page 4-27 for more tudinal images as well as color flow imaging, PW Doppler,
information.
and steerable CW Doppler.

Longitudinal images provide better anatomical assessment of

congenital heart disease. Specifically, the longitudinal plane
offers optimal views of the right ventricular outflow tract, the
interventricular septum, the interatrial septum, and the pul-
monary valve and proximal main pulmonary artery. This
enables full anatomic assessment as well as physiologic eval-
uation with color and Doppler. Potential applications include
interventional procedures such as balloon valvuloplasty of the
aortic valve and clamshell closure of an atrial septal defect, as
well as the follow-up of patients with retrosternal conduits
and monitoring interventions, including laser valvuloplasty of
the pulmonary valve.a

a. Lam, Jan, et al., “Usefulness of Biplane Transesophageal Echocar-

diography in Neonates, Infants and Children with Congenital Heart
Disease,” American Journal of Cardiology 72, 1993, pp. 699-706.

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 TEE Transducers
Description and Use

Pediatric Biplane (Continued)

Note that it is possible to observe the right coronary artery at
full length in the longitudinal plane, but not in the transverse
plane. However, the longitudinal plane cannot show the four-
chamber section through the heart, both distal right and left
pulmonary arteries in continuity with the bifurcation, and
bifurcation of the left coronary artery.b

Tip surface temperature constantly monitored for patient

safety.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Tip – 9.1 mm x 8.6 mm, 22 mm long

Shaft – 8 mm diameter, 70 cm long

b. Lam, Jan, et al., “Usefulness of Biplane Transesophageal Echocar-

diography in Neonates, Infants and Children with Congenital Heart
Disease,” American Journal of Cardiology 72, 1993, pp. 699-706.

NOTE Philips recommends that you only use the Pediatric Biplane transducer on
patients weighing at least 3 kilograms (6.6 lbs).

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TEE Transducers
Description and Use

Manipulating the Pediatric Biplane Tip

This section contains details of Pediatric Biplane deflection controls and detents.
Be sure to read “Deflection Control Basics” on page 4-11 for background
information pertaining to Philips TEE transducers.

Figure 4-5. Pediatric Biplane Deflection Controls and Detents

Neutral position indicators (no deflection)

Medial/lateral control

Anterior/posterior control

Position 1: Both knobs detent

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Position 2: Medial/lateral knob detent Anterior/posterior

knob freewheeling

Position 3: Both knobs freewheeling

The larger inner wheel controls anterior/posterior movement, while the smaller
outer wheel controls medial/lateral movement. Align the white circles on each
control wheel perpendicular to the control handle for a neutral position of the
TEE tip.

Each wheel has a detent that holds the tip position without locking it in place.
Use the minimal setting needed to maintain tip position. This allows the tip to
straighten if it meets additional resistance. The knob detents operate as illustrated
in Figure 4-5.

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 TEE Transducers
Description and Use

During insertion, lock medial/lateral movement1 or use free-wheeling mode (no

deflection and no detent)2 to prevent patient injury. Locking medial/lateral
movement (detent lever position 2) may enable easier acquisition of optimal
views in either transesophageal or transgastric locations.

CAUTION When repositioning or withdrawing a TEE transducer, put the controls in free-
wheeling mode. Also whenever the transducer is not being used during a proce-
dure, make sure it is in free-wheeling mode and unplugged from the system.

Biplane Images
The default orientation for both transverse and longitudinal images is a sector
with the apex at the top. A default longitudinal image is shown below.

Figure 4-6. Default Longitudinal Biplane Orientation

5.0 MHZ-V

300e004

1. Radwin, Martin, et al., “Transesophageal Echocardiography: Intubation Techniques,” Agilent

Application Note 5091-2804E, 1992.
2. Urbanowitz, John H., et al., “Transesophageal Echocardiography and its Potential for Esoph-
ageal Damage,” Anesthesiology 72:1, 1990.

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TEE Transducers
Description and Use

There are at least two ways to determine which plane is shown:

• Look for a V for vertical (longitudinal plane) or H for horizontal (transverse

plane) beside the transducer frequency in the upper left corner, as shown in
Figure 4-6.
• Touch Probe. The Left and Right controls indicate which connector is
active. Look for a V for vertical (longitudinal plane) or H for horizontal
(transverse plane) beside the transducer frequency in the control label.

You can configure the longitudinal image so that it is always initially inverted,
which makes the distinction between transverse and longitudinal images more
obvious. If you configure inverted longitudinal images, transverse images retain
apex-at-the-top orientations. You also can reverse the longitudinal image and
orientation icon.

Inverting Longitudinal Images on the SONOS 4500 and 5500

1 Touch the imaging mode.

2D COLOR PW CW ANGIO

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 TEE Transducers
Description and Use

Inverting Longitudinal Images on the SONOS 4500 and 5500

The longitudinal 2 Touch U/D Invert.
image will now
be inverted, as
2D COLOR PW CW ANGIO
shown in Figure
4-7.
U/D
Invert

Figure 4-7. Inverted Longitudinal Image

By default, the
orientation icon for
longitudinal
images is left of
the image,
regardless of
whether or not the
images are up/
down inverted.

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TEE Transducers
Description and Use

Reversing Longitudinal Images on the SONOS 4500 and 5500

1 Touch the imaging mode and then Secondary Controls.

2D COLOR PW CW ANGIO

Secondary
Controls

Longitudinal images 2 Touch L/R Invert.

will now be reversed
from the default
position, with the 2D COLOR PW CW ANGIO

orientation icon on the Secondary

right, as shown in Controls L/R
Figure 4-8. Invert

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 TEE Transducers
Description and Use

Figure 4-8. Reversed Longitudinal and Inverted Image

300e005

Displaying Two Images

You can see a longitudinal image beside a transverse image if you store one of
the views while you are reviewing a study. It is not possible to see two live
images of the different views simultaneously. See the System Basics guide for
details.

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TEE Transducers
Checking the Transducer

Checking the Transducer

Before each TEE exam, carefully inspect the transducer and try the controls, as
described in the following sections.

Inspect the Transducer

Carefully inspect the entire surface of the distal tip and flexible shaft for
protrusions, holes, dents, abrasions, cuts, burrs, or cracks that could be extremely
hazardous to both you and your patient. Carefully feel the tip and shaft for
problems, and visually scrutinize the entire transducer. If you suspect an
electrical problem, follow the electrical safety checking procedure on page 4-7.

Also check for excessive flexibility in the tip, particularly in the

medial/lateral direction. Do not use the transducer if the tip is extremely flexible.
Contact your Philips service representative if you have any questions on tip
flexibility.

Verify Operation of the Controls

Use the deflection controls to position the tip every way possible, both to ensure
that the controls work properly and to get used to the feel of the particular TEE
transducer. Make sure that the controls operate smoothly without binding, and
that you can achieve all possible positions easily before introduction of the TEE
transducer into a patient.

Also test the position-holding and free-wheeling modes of operation. Remember

that the controls must be in free-wheeling mode (no deflection and no brake
resistance) when repositioning or withdrawing the transducer, as well as
whenever you are not imaging.

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Special Considerations for TEE Exams

Special Considerations for TEE Exams

Special consideration regarding a TEE exam is advisable for patients with

existing gastroesophageal abnormalities such as esophageal varices, hiatal
hernia, tumor, diverticula, esophageal webs and rings, fistulae, or peptic ulcers,
as well as for patients who have had anti-reflux procedures. In addition, you
should:

• Consider the patient’s size and ability to accommodate the transducer tip and
shaft.
• Check for any history of gastroesophageal disease or difficulty swallowing.
• Evaluate the potential overall effects of mediastinal radiation, chemotherapy,
anticoagulation, or steroid therapy.
• Remain aware that you may discover unsuspected esophageal pathology
during an exam. Particularly with pediatric patients, be alert for congenital
problems with the esophagus or stomach.
• Use the auto cool feature when examining a patient with an above-normal
temperature. The auto cool feature is described on page 4-38.

This list is not comprehensive. Rather, it suggests areas to investigate when

considering TEE for a particular patient.

Preparing Patients for a TEE Exam

These suggestions for pre-exam patient preparation do not constitute an
exhaustive list of all possible factors to explore before performing
transesophageal echocardiography, nor do they imply medical protocols. Instead,
they reflect basic guidelines resulting from extensive consultation with
physicians throughout the design, development, and clinical investigation periods
of Philips TEE transducers.

• In addition to gathering routine background information such as current

medication and allergies, investigate any history of chronic obstructive lung
disease, esophageal strictures, varices, or bleeding.
• Inform the patient to go without food or water for at least six hours prior to
the exam. Also advise the patient that he or she should not plan to drive after
the exam, as sedatives are often used.

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TEE Transducers
Special Considerations for TEE Exams

• Thoroughly explain the procedure to the patient before the exam.

• Follow institutional guidelines for obtaining patient consent for a transe-
sophageal echocardiography examination.
• Be sure that a recent ECG, CBC, and SMA6 are available as a baseline.

Exam Guidelines
During a TEE exam, an assistant can provide oral and pharyngeal suctioning of
the patient, and can monitor the patient’s blood pressure and general responses.
For unexpected occurrences, an emergency cart with basic life support
equipment should be ready. Throughout the exam it is important to carefully
monitor the patient’s reactions and assure that ventilation and vital signs are
stable.

In the operating room, do not use TEE transducers during surgical procedures
requiring extreme neck flexion, such as sitting craniotomies.1, 2

The rest of this section lists other important considerations.

Minimize the possibility of transducer tip fold over.

This problem has occurred rarely, but its consequences can be serious. Please see
“Tip Fold-Over Problem” on page 4-36 for details.

Maintain a patent airway.

For surgical patients, endotracheal intubation establishes a stable, patent airway

prior to insertion of the transducer. For awake patients, carefully monitor the
patient’s breathing at all times.

1. Gussenhoven, Elma, et al., “Transesophageal Two-dimensional Echocardiography: Its Role in

Solving Clinical Problems,” Journal of the American College of Cardiology, 1986, pp. 975-979.
2. Cucchiara, R.F., et al., “Air Embolism in Upright Neurosurgical Patients: Detection and Localiza-
tion by Two-dimensional Transesophageal Echocardiography,” Anesthesiology, 1984, pp. 353-355.

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Special Considerations for TEE Exams

Minimize the possibility of pressure necrosis (tissue death).

Do not let the distal tip displace any one segment of tissue for more than five
consecutive minutes. Also make sure the deflection area and the distal tip are in a
position of least potential pressure, and that the transducer is in a free-wheeling
mode and unplugged whenever you are not imaging.1

Prevent potential esophageal damage.

Philips recommends that you stop TEE scanning and unplug the transducer from
the system during periods of poor perfusion, circulatory arrest, or the
hypothermic phase of open heart surgery. To discontinue scanning, unlock the
transducer connector according to the instructions in “Connecting Transducers”
on page 1-1.

Before each TEE exam, carefully inspect the transducer, as described earlier
in this chapter.

A thorough inspection procedure is required for the safety of the patient and
yourself, and to ensure the continued correct functioning of the transducer.

Never use excessive force when inserting, operating, or withdrawing a trans-

ducer, and make sure the deflection area is straight during insertion and
withdrawal.

Forceful insertion, manipulation, or withdrawal of a transducer can result in

lacerations, bleeding, perforation, tearing of adhesions, and ligament damage.
Also, be aware that the tip can fold over, causing similar damage; the next section
provides details.

Refrain from handling the distal tip, and do not clamp any part of the flexi-
ble shaft.

If you must handle the distal tip, grasp it on the sides. Do not touch the top or
bottom. Support the transducer’s proximal head, either by having an assistant

1. Urbanowitz, John H., et al., “Transesophageal Echocardiography and its Potential for Esophageal
Damage,” Anesthesiology 72:1, 1990.

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TEE Transducers
Special Considerations for TEE Exams

hold the steering mechanism or by clamping the transducer at the steering

mechanism. However, if you use a clamp, be sure that it neither interferes with
steering nor is on any portion of the flexible shaft. Clamping the flexible shaft
always damages the transducer.

Tip Fold-Over Problem

On rare occasions, TEE transducer tips can fold over during insertion. The effects
can be serious if the situation is handled incorrectly—the esophagus could be
scraped, perforated, or otherwise damaged. Please read this information to better
understand the problem and its avoidance.

Problem Prevention

The following factors could cause the tip to fold over. Other factors could also be
involved; the list below is not exhaustive.

Insertion technique
You might find transducer insertion easier if you guide the transducer into the
patient’s mouth with your fingers. You also might want to block medial/lateral tip
movement.

NOTE All patients should wear a bite guard during a TEE exam. A bite guard protects
against dangerous transducer mechanical and electrical malfunction caused by
involuntary biting. Even anesthetized patients require bite guards to prevent dam-
age to both their teeth and the transducer. See “Bite Guard” on page 4-48 for
information on the bite guards available from Philips.

Definitely avoid the following situations when inserting any TEE transducer into
a patient:

• Any excessive flexion of the transducer tip, particularly in the medial/lateral

direction.
• Catching the tip in pharyngeal recesses.
• Insertion when a patient is being uncooperative, or having a convulsion or
spasm.

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 TEE Transducers
Special Considerations for TEE Exams

Patient esophageal pathology

Carefully review a patient’s medical history for obstructing pathologies or
anatomical irregularities before performing a TEE exam.

Improper transducer maintenance

Thoroughly examine the transducer and test the controls before each exam. Be
sure to check for excessive flexibility in the tip. Details are provided in
“Checking the Transducer” on page 4-32.

Problem Recognition

The TEE transducer tip could be folded over in the patient if you encounter:

• Resistance to advancing or removing the transducer.

• An inability to rotate control knobs.
• Fixation of control knobs in the maximum flexion position.
• Extreme difficulty in obtaining an image.

Problem Correction

If you suspect the transducer tip is folded over, our physician consultants
recommend that you gently try to manipulate the transducer. If the tip is not
locked or jammed in a doubled-over position and you can move it forward,
advance the transducer into the stomach. Then straighten the tip and remove the
transducer.

If you cannot move the tip in any direction, our consultants recommend that you
x-ray the patient to evaluate the situation. You might also want to involve a
gastroenterologist or anesthesiologist.

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TEE Transducers
Ensuring Accurate Temperature Sensing

Ensuring Accurate Temperature Sensing

The Philips TEE transducers discussed in this manual contain a built-in

temperature sensor near the distal tip of the transducer. The sensor monitors the
transducer’s temperature to prevent potential burning of esophageal tissue. The
sensor is also affected by patient core temperatures. The system assumes that the
patient temperature is normal, and calculates the distal tip temperature
accordingly. If the patient’s temperature is above 37oC (98.6oF), the auto cool
feature calculates a distal tip temperature that may be inaccurate. This could
expose patients to excessive temperatures, or could cause an unwarranted “auto
cool” condition during which the system stops scanning.

To ensure patient safety and avoid an unnecessary interruption while scanning:

• Enter an accurate patient core temperature to ensure distal tip temperature

accuracy.
• Decrease acoustic output, using the Power control, before introducing a TEE
transducer, and keep it at the lowest possible setting during an exam, to
decrease the transducer temperature.
• Use the TEE auto cool feature to enter the patient temperature if it is above
37oC (98.6oF), as described in the next section.

TEE Auto Cool Feature

Use the TEE auto cool feature to enter above-normal patient temperatures. By
default, the system shows both the patient and distal tip temperature while
scanning.

NOTE The patient temperature displayed on the ultrasound screen is always either 37oC
or the temperature that you manually enter. The system does not report actual
patient temperature.

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 TEE Transducers
Ensuring Accurate Temperature Sensing

If the distal tip temperature reaches 41oC (105.8oF), a warning message appears
and the transducer temperature displays in inverse video. If the temperature
reaches 44oC (111.2oF), a warning appears with the patient and transducer
temperatures, and the system stops imaging until the distal tip cools to 43.5oC or
lower.

WARNING To avoid risk of esophageal burn for adult patients, minimize the time spent
imaging at distal tip temperatures in excess of 43oC. Exposure should be
limited to 10 minutes or less at 43oC or above.

Sufficient data on thermal tolerance of the esophagus in neonate and pedi-

atric patients does not exist, but it is likely these patients are more vulnera-
ble than adults. Minimize the time spent imaging at distal tip temperatures in
excess of 41oC.

Entering the Patient Temperature

Always check a patient’s temperature before inserting a TEE transducer. If it is
above normal, whether from fever or therapeutic heating from a cardiac bypass
heart-lung machine, perform the steps below before insertion. Also follow these
steps if the patient’s temperature rises during an exam.

WARNING To protect the patient and ensure the effectiveness of the auto cool feature,
always enter the correct patient temperature.

Choose the patient’s core temperature, or more specifically, the actual

temperature in the esophagus. For patients undergoing surgery, you can
determine this temperature by direct measurement or by monitoring the
temperature of blood returning from the bypass pump heat exchanger. For closed
chest situations, rectal temperature is the best estimate of core temperature. You
also can use oral temperatures, even though they can be 1oC lower than core.
However, for axillary temperatures, which can be 2oC lower than core, add 1 or
2oC to the measured axillary temperature.

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TEE Transducers
Ensuring Accurate Temperature Sensing

Each time you turn off or reset the system, the system assumes a patient temperature
of 37oC. To ensure patient safety, always enter a patient’s temperature if it is above
normal.

Entering the Patient Temperature on the SONOS 4500 and

5500
Reminder: The TEE probe must be connected and activated for the patient
temperature control to appear on the panel.

1 Touch Probe.

Probe

2 Adjust Pat Temp to the current patient temperature.

Probe

Pat Temp
37.0oC

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 TEE Transducers
Ensuring Accurate Temperature Sensing

3 The current patient temperature displays beside the PAT T: label on the
imaging screen.

o
T:3 7.0 C
PAT

6apc0158

Entering the Patient Temperature on ImagePoint

1 Press the Probe control until you activate the transducer.

Filter Power
Size Position
Body Marker Zoom
Frequency
Probe
Angle Calcs Dual
Baseline Hx M Mode
Dynamic
Left Right Range
Angio Caliper
2D
Scale Tape
CW Trace GAIN
Focus
Print 2
PW Spectral Erase
Gain Freeze
Color Print 1
Enter Depth

6APC0045
Probe Control

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TEE Transducers
Ensuring Accurate Temperature Sensing

2 Rotate the PATIENT TEMP control to adjust the PAT T to the

patient’s current temperature. The default, when the system is turned
on, is 37oC. The current patient temperature displays beside the PAT T:
label on the imaging screen.

[MORE] L/R PATIENT COLORIZE PERSIST VIDEO SWEEP

2-D INVERT TEMP OFF 0 INVERT 25 MM/S

Monitoring the Distal Tip Temperature

The transducer temperature appears in the upper part of the screen, in inverse
video, if the distal tip exceeds 41oC (105.8oF). The temperature always displays
here if your system is set up to show the temperature throughout a TEE exam.

Figure 4-9. TEE Temperature Display

PAT T:37.0oC
TEE T:37.0oC

300e004

A less-than sign (<) after TEE T indicates that the transducer’s distal tip
temperature is below the patient temperature (PAT T) assumed by the system
(either 37oC or the temperature you entered).

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 TEE Transducers
Ensuring Accurate Temperature Sensing

A colon (:) after TEE T indicates that the tip temperature is greater than or equal
to the patient temperature.

If the distal tip reaches 41oC (105.8oF) during imaging, a message appears on the
screen (Figure 4-10.).

Figure 4-10. TEE Auto Cool Imminent Display

PAT T:37.0oC
TEE T:41.0oC

TEE auto cool imminent. Reduce

power and/or adjust Pat Temp.

300e004

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TEE Transducers
Ensuring Accurate Temperature Sensing

If the distal tip reaches 44oC (111.2oF) during imaging, a message displays on the
screen (Figure 4-11.).

Figure 4-11. TEE Auto Cool In Progress Display

PAT T:37.0oC
TEE T:44.0oC

TEE auto cool in progress.

Wait for transducer to cool or
activate Xducer and adjust Pat Temp
to set the current patient temp.

300e004

If you are using a Biplane transducer, the system displays both the horizontal
(TEE H) and vertical (TEE V) temperatures. If either one of these temperatures
reaches 44oC, imaging stops and does not resume until the temperatures for both
arrays are below 43.5oC.

Resuming Imaging

If the distal tip temperature drops to 43.5oC, the system resumes imaging. If the
auto cool message persists longer than one minute, or if an error message
appears, contact your Philips ultrasound service representative.

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 TEE Transducers
Ensuring Accurate Temperature Sensing

WARNING The “Reconnect the transducer.” error message is often caused by a poorly
seated transducer connector, but could be caused by a failure in the auto
cool safety logic. In the case of a logic failure, distal tip temperatures could
reach 46.5oC in hyperthermic patients (40 – 41oC) before the error causes
scanning to stop. At this temperature, esophageal burns may occur.1 , 2

If you encounter the “Reconnect the transducer” error message:

1 Be sure the transducer connector is properly seated.

2 Press Reset
Reset .

If the system does not resume imaging immediately, contact your Philips service
representative.

1. Ding-Jiu, et al., “Thermodamage, Thermosensitivity and Thermotolerance of Normal Swine

Esophagus,” Int J Hyperthermia 3:2, 1987, pp. 143-151.
2. Moritz, A. R. and Henriques, F. C., “Studies of Thermal Injury, II. The Relative Importance of
Time and Surface Temperature in the Causation of Cutaneous Burns,” Am J of Path 23, 1947,
pp. 695-720.

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TEE Transducers
Ensuring Accurate Temperature Sensing

Patient and Distal Tip Temperature Display Setup on the

SONOS 4500 and 5500
1 Press Setup and touch Probe.

Probe

Even when this control 2 Touch TEE Temp Display to turn the temperature display on or off.
is off, the system
displays the
transducer Probe
temperature if it
approaches the
temperature limit.
TEE Temp
Display

To make a change 3 Adjust TEE Temp to display either C (Centigrade) or F (Fahrenheit).

permanent, save it as
part of a preset. See
System Basics for
more information.
Press Setup to return
to imaging.

TEE Temp
oC

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 TEE Transducers
Checking the Patient After the TEE Exam

Patient and Distal Tip Temperature Display Setup on ImagePoint

1 Press Setup .
2 Highlight Preset Parameters from the menu and then press Enter .
3 Using the trackball, highlight the parameters you want to change:

• TEE Temp Units - C or F

• TEE Temp Display - On or Off.

If you choose not to have the temperatures always displayed, the patient
temperature only shows if you enter a patient temperature above 37oC. During an
auto cool warning or activation, both the patient and distal tip temperature
appear, regardless of the setting.

Checking the Patient After the TEE Exam

You should follow your institutional guidelines for post TEE exams. In addition,
you might want to include the following recommendations in your guidelines.
These recommendations are neither exhaustive nor restrictive, but suggest steps
you might want to incorporate into your post TEE exam routine.

• Inspect the patient’s throat for any bleeding.

• Examine the patient for postural hypotension or difficulty walking.
• Instruct the patient to contact you immediately if he or she experiences any
fever, chills, chest pain, or bleeding.
• Tell the patient not to eat or drink for at least two hours, or until swallowing
returns to normal after anesthesia has worn off. It is especially important that
the patient not ingest hot foods or fluids during this period.
• Call the patient the day after the exam to make sure there are no
complications.

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TEE Transducers
Accessory Equipment

Accessory Equipment

Each TEE transducer comes with a disposable bite guard and tip protector. This
section describes these accessories, and provides ordering information. It also
mentions circumstances that warrant the use of a disposable drape.

Damage caused when Bite Guard

patients bite or scrape a
TEE transducer is not All patients should wear a bite guard during a TEE exam. A bite guard protects
covered in the
against dangerous transducer mechanical and electrical malfunction caused by
transducer’s warranty or
service contract. Be sure involuntary biting. Even anesthetized patients require bite guards to prevent
to use bite guards to help damage to both their teeth and the transducer. Philips supplies two disposable
prevent such accidents. bite guards suitable for both awake and anesthetized patients.

Figure 4-12. Bite Guards

0008e2a

CAUTION The M2203A bite guard strap contains natural rubber latex, which may cause
allergic reactions.

Tip Protector
When not using a carrying case to transport a TEE transducer, you should use a
tip protector on its distal tip. The tip protector helps prevent serious damage to
the transducer’s lens. Philips supplies tip protectors designed for each of its TEE
transducers.

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 TEE Transducers
Accessory Equipment

Ordering Bite Guards and Tip Protectors

To order additional bite guards and tip protectors in the United States, contact the
Philips Medical Supplies Center at 1-800-225-0230. In Canada, call 1-800-387-
3154. In other countries, contact your local Philips sales representative.

M2203A Bite guard kit (pediatric)

M1828A Bite guard kit (adult)

M2243A Tip protector for 21364A

M2273A Tip protector for 21367A and 21369A

To order the following tip protector in the United States, contact the Philips
Support Materials Center at 1-800-722-0659. In other countries, contact your
local Philips sales representative.

21366-80150 Tip protector for 21366A and 21381 (miniMulti)

Ordering Disinfection Basins

To order the following disinfection basin, contact your local Philips customer
representative.

21110A TEE disinfection basin

Disposable Drape
During exams where you believe contamination of the imaging system can occur,
it is recommended that you take universal precautions and cover the imaging
system with a disposable drape. Consult your hospital’s rules regarding
equipment use in the presence of infectious disease.

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 5 Intraoperative Transducers

Overview

An intraoperative transducer is used during surgery to help a surgeon locate and

visualize anatomical structures, to visualize blood flow patterns and quantify
velocities, and to image and measure anatomic and physiologic parameters of
interest to the surgeon. This chapter provides information on the following
intraoperative transducers:

• 21390A, the 15.0 - 6.0 MHz UltraBand linear transducer, provides high-res-
olution near field imaging to assist surgeons in assessing arterial reconstruc-
tions, vein bypass grafts, or revision for minute defects. It allows trapezoidal
imaging. The 21390A provides a small profile, making it easy to maneuver,
and enabling interrogation of a site with restricted access or within a very
small incision.
• 21380A, the high-frequency UltraBand Sector transducer, enabling excellent
2-D resolution by providing imaging in a range of frequencies, up to 12.0
MHz. Provides capability for intraoperative imaging. Small, lightweight
design with a thin, flexible cable permits easy manipulation for neonatal and
pediatric patients and on the organ surface.
• 21358B, the trapezoidal linear array transducer, used for trapezoidal imaging
in the operating room for greater opportunities to access wide-field imaging
during detailed surgical procedures.

Audience

Philips intraoperative transducers are designed for use under the guidance of
physicians who are properly trained in intraoperative ultrasound imaging
techniques, according to currently approved relevant medical practices. It is
recommended that physicians operating any Philips intraoperative transducer are:

• Proficient in recognizing and interpreting imaging patterns.Thoroughly

familiar with the safe operation, care, and maintenance of the Philips phased
array ultrasound imaging system and transducer.
• Fully informed about the latest intraoperative methods through literature and
seminars.

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Intraoperative Transducers
Intended Use

This chapter discusses the following transducers:

• Model 21390A, 15.0 - 6.0 MHz UltraBand

• Model 21380A, high-frequency UltraBand
• Model 21358B, trapezoidal linear array

Intended Use

Intraoperative studies are performed by surgeons and/or anesthesiologists to

obtain images that can be used to:

• Help a surgeon locate and visualize anatomical structures, before, during, or

after a surgical procedure.
• Help a surgeon visualize blood flow patterns and quantify velocities before,
during, or after a surgical procedure.
• Image and measure anatomic and physiologic parameters of interest to the
surgeon before, during, or after a surgical procedure.

You can also use the transducers discussed in this chapter for adult, pediatric, and
neonatal heart and vessel imaging.

NOTE For intraoperative use on the heart and central circulatory system, only the
21390A 15-6L intraoperative transducer is approved in EU countries.

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 Intraoperative Transducers
Intraoperative Probes Used for Animal Studies

Intraoperative Probes Used for Animal Studies

WARNING Intraoperative probes used in animal studies should not be used on

humans. Transducer disinfection procedures for cross usage between
animals and humans have not been validated.

When the 21390A probe is used for animal studies, the animal use label
must be attached.

Animal Use Label

If the 21390A intraoperative probe is to be used on animals, attach the label
“This transducer is for use in animal or other studies that do not involve human
subjects” that accompanies the probe. To attach the label:

1 Wipe the side of the connector, opposite the serial number label, with an iso-
propyl alcohol moistened cloth and dry with a soft cloth.

2 Place the label on the transducer connector housing at the indented area
(opposite the serial number label).

Patient Safety

This section lists conditions that can adversely affect patients when you use an
intraoperative transducer.

To operate an intraoperative transducer, you must be under the guidance of a

physician who is properly trained in intraoperative ultrasound imaging
techniques, according to currently approved relevant medical practices. Also,
you must be thoroughly familiar with the safe operation, care, and maintenance
of the Philips ultrasound imaging system used with the transducer, as well as be
proficient at interpreting the images generated.

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Intraoperative Transducers
Patient Safety

You can help ensure patient safety when using an intraoperative transducer by:

• Scrutinizing the entire transducer before each use.

• Using mandatory protective equipment, such as an approved sheath, during
an intraoperative exam. See “To order any of the supplies listed, please con-
tact the Medical Supplies Center at 1-800-225-0230 from anywhere in the
USA. For other countries, contact your local representative or sales office.
Ordering Sheaths” on page 5-16.
• Operating the transducer properly.
• Not allowing water or other liquids to drip into the transducer connector or
the interior of the system or onto the keyboard.

WARNING All intraoperative studies must be performed with a type CF classified

transducer. If your transducer is not labeled type CF on the transducer
connector, contact your Philips service representative.

Be sure to use a transducer sheath when performing all intraoperative

studies.

Always remove the transducer from the patient before defibrillation.

Patient Contact Parts

Latex is commonly used in sheaths marketed to help with infection control in
transesophageal, endocavity, and intraoperative imaging applications or
transducer covers used during biopsy. Examine the packaging to confirm latex
content. Studies have shown that allergic reactions with natural rubber latex can
be experienced. The US Food and Drug Administration has published a medical
alert on latex products dated March 29, 1991.

NOTE The diagnostic ultrasound systems and transducers discussed in this manual do
not contain natural rubber latex that contacts humans. Natural rubber latex is not
used on any ultrasound transducer, including transthoracic, intraoperative, and
transesophageal transducers. It also is not used on SONOS or ImagePoint ECG
cables.

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 Intraoperative Transducers
Equipment Operation

Equipment Operation

Meticulous inspection and correct and careful operation of an intraoperative

transducer are imperative to patient safety. The situations listed in this section
affect safe operation as well as the ability to service mechanical problems under
Philips’ one-year warranty or service contract. Transducer repairs necessitated by
misuse are not covered and can be very costly, often requiring complete
disassembly and rebuilding of the transducer.

The primary areas of customer misuse are:

• Cuts and abrasions on transducer insulation and lens from sharp instruments
such as scalpels, scissors, and clamps.
• Improper disinfection techniques, causing fluid to enter the transducer.
• Damage caused by dropping the transducer on a hard surface.

NOTE If you find any signs of damage to the transducer, patient safety may be in
question. Do not use the transducer and contact your Philips service representa-
tive.

Philips strongly recommends that you clearly post stringent protocols for
intraoperative transducer care, based on the information in this guide, to
minimize the chance of damage.

Electrical Safety

All Philips ultrasound systems and transducers comply with common medical
device electrical safety standards.

This section includes information about testing leakage currents on intraoperative

transducers.

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Intraoperative Transducers
Electrical Safety

Leakage Current
SONOS and ImagePoint transducers that are approved for intraoperative use are
labeled on the transducer connector as type CF in accordance with IEC
60601-1. Type CF classification indicates that the degree of protection from
electrical shock afforded by the transducer is suitable for all patient applications
including direct cardiac and intraoperative applications.

Leakage Current Testing

Leakage current tests should be performed by a technically qualified person any
time that the transducer is dropped or if cracks or cuts are found on the
transducer.

Normal leakage current testing frequency should be based on the procedures

established by the hospital for operating room-based equipment.

NOTE Attach the transducer to the ultrasound system and test with an appropriate safety
analyzer to ensure that IEC 60601-1 type CF leakage limits are not exceeded.

The following procedure tests the current leakage, using a Dynatech Nevada 232
Safety/ECG Analyzer. This procedure shows one example. The procedure for
your safety analyzer may be very different.

NOTE Another leakage current detector (the Dale 800) is listed on the Philips Trans-
ducer web site at www.medical.philips.com/transducercare.

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 Intraoperative Transducers
Electrical Safety

Test # 1 - Transducer Leakage Current Test (Source)

Hot System
Transducer
Under
Neutral immersed in
Test
saline solution
AC Micro
Ground green or Main power switch “ON” ammeter
green/yellow

1 Plug the safety analyzer into power.

2 Plug the ultrasound system into the safety analyzer.

3 Connect the transducer being tested to the ultrasound system.

4 Immerse 5 cm of the transducer into saline solution.

5 Set the safety analyzer Mode switch to the ECG position.

6 Set the safety analyzer Leads switch to the ALL (all ECG Leads) position.

7 Connect a lead to any ECG terminal on the safety analyzer and immerse the
other end into the saline solution.

8 Set the safety analyzer Polarity switch to Normal.

9 Note the Normal condition leakage reading.

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Intraoperative Transducers
Electrical Safety

10 Hold the safety analyzer Ground Open switch in the Open position (Single
Fault condition) and note the leakage reading on the output display.

11 Repeat Steps 9 and 10 with the Polarity switch in the Reverse position. The
applicable limits are:
10 microamps rms (Normal condition)
50 microamps rms (Single fault condition)

Test # 2 - Transducer Leakage Current Test with Mains Voltage Applied (Sink)

Hot - System Transducer

Under immersed in
Neutral - Test saline
solution
Ground green AC Micro
or green/yellow ammeter
Main power switch “ON”
Mains
LIMITS 50 microamps rms voltage
300e045

WARNING There is considerable hazard in performing this test. Use precautionary

measures to avoid accidental contact with line voltage. In addition, any time
that the ground connection has been opened, do not touch the chassis or
patient cable during the test.

1 Plug the safety analyzer into power.

2 Plug the ultrasound system into the safety analyzer.

3 Connect the transducer being tested to the ultrasound system.

4 Immerse 5 cm of the transducer into saline solution.

5 Set the safety analyzer Mode switch to the ECG position.

6 Set the safety analyzer Leads switch to the Isolation Test position.

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 Intraoperative Transducers
Electrical Safety

7 Connect a lead to any ECG terminal on the safety analyzer. Leave the other
end of the lead disconnected for now.

8 Hold the Isolation Test button down and note the leakage reading on the out-
put display. This is the correction factor which will be subtracted from the
final reading.

9 Immerse the other end of the lead into the saline solution.

10 Hold the Isolation Test button down and take the leakage reading again. Sub-
tract the correction factor found in step 8 to get the accurate leakage measure-
ment. The leakage must be less than the following limit:

50 microamps rms

Defibrillators
The outer insulating layer of the transducer, if intact, is designed to withstand
electrical stress created by defibrillation. A small hole in the outer layer of the
transducer, however, opens a conductive path to grounded metal parts in the
transducer. The secondary arcing that could occur during defibrillation could
cause patient burns. The risk of burns is reduced but not eliminated by using an
ungrounded defibrillator. Therefore, remove the transducer from the patient
before defibrillation. A disposable sheath provides no protective electrical
insulation against defibrillation.

Accident Prevention
Use defibrillators that do not have grounded patient circuits. Refer to the
defibrillator service guide, or consult with a biomedical engineer to determine
whether or not a defibrillator patient circuit is grounded.

Before defibrillation, always remove the transducer from the patient.

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Intraoperative Transducers
Description and Use

Description and Use

This section lists important features of the 21390A, 21380A, and 21358B models
of intraoperative transducers.

Also discussed in this section is how to prepare the transducers for use in
intraoperative applications.

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 Intraoperative Transducers
Description and Use

High-Frequency Intraoperative Linear Array

(Model 21390A)

Features: UltraBand 15.0 - 6.0 MHz, 128 element transducer which pro-
vides high-resolution near field imaging to assist vascular sur-
geons in assessing arterial reconstructions, vein bypass grafts,
or revision for minute defects. The 21930A allows trapezoidal
imaging. It provides a small profile, which is easy to maneu-
ver, enabling interrogation of a site with restricted access or
within a very small incision. Capable of color flow imaging,
Angio, PW Doppler, and Intelligent Doppler.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Nose Footprint – 39 x12 mm

Handle length – 9.9 cm
Weight – 35 gm (transducer head)
Cable - 244 cm

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Intraoperative Transducers
Description and Use

High-Frequency UltraBand
(Model 21380A)

s12

Features: Improved performance by providing imaging in a range of fre-

quencies, up to 12.0 MHz, which enables high resolution for
the finest anatomical structures. Small, lightweight design
with a thin, flexible cable that permits easier manipulation for
neonatal and pediatric patients. Intraoperative imaging capa-
bility assists surgeons in performing a more confident, quality
surgical procedure. Capable of color flow imaging, CW and
PW Doppler, and frequency agility.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Nose Footprint – 19 x 12 mm

Handle length – 6cm
Weight – 50 g (transducer head)

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 Intraoperative Transducers
Description and Use

Trapezoidal Linear Array

(Model 21358B)

6apc0165

Features: Excellent image quality is provided by imaging frequencies up

to 10 MHz, enabling a wide-field of view through Philips’
trapezoidal imaging. This standard Philips imaging transducer
provides surgeons with a cost-effective solution to meet their
specific imaging needs. Capable of B-mode, color flow imag-
ing, ultrasound angiography, and intelligent Doppler.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Nose Footprint – 5 x 1.5 cm

Handle length – 11.07 cm
Weight – 290 g (transducer head)

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Intraoperative Transducers
Description and Use

Preparing the Transducer for Intraoperative Imaging

Follow the steps below to prepare the transducer for use in intraoperative
imaging applications.

If you are using the Models 21380A, 21390A, or 21358B transducers, use a
sheath filled with sterile gel or saline according to the directions in Steps 1 and 2.

1 Place 20 cc of sterile gel or saline into the sheath. Visually inspect the sheath
for leaks before proceeding.

2 Insert the transducer into the sheath and unfurl the sheath until it covers the
transducer and its cable. The sheath must be unfurled far enough to maintain
the sterile field.

416e015 6apc0144

21358A, 21380A 21390A

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 Intraoperative Transducers
Description and Use

3 The use of a sterile elastic band or clip to hold the proximal end of the sheath
in place is recommended.

4 Ensure that wrinkles over the face of the transducer are minimized. Check the
sheath for tears or damage before proceeding.

5 When operating the transducer, make sure that proper orientation is main-
tained to avoid interpretation confusion.

6 Imaging improves with adequate coupling between the patient surface and
sheath surface. Sterile water works as a good acoustic coupling agent during
surgery.

NOTE Make sure that the imaging surface is moist so that good acoustic contact is
achieved. A dry surface results in excessive artifact.

Disposable Drape
During exams where you believe contamination of the imaging system can occur,
it is recommended that you take universal precautions and cover the imaging
system with a disposable drape. Consult your hospital’s rules regarding
equipment use in the presence of infectious disease.

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Intraoperative Transducers
Accessory Equipment

Accessory Equipment

This section describes accessories and provides ordering information. It also

mentions circumstances that warrant use of a disposable drape.

To order any of the supplies listed, please contact the Medical

Supplies Center at 1-800-225-0230 from anywhere in the USA.
For other countries, contact your local representative or sales
office.

Table 6-1 Supplies and Accessories For Use With SONOS and ImagePoint Transducers

Description Part Number Comments

ULTRASOUND GEL

Aquasonic Gel - USA 40483A 12, 8.5 Oz. bottles

Aquasonic Gel - USA 40483B 1, 5 liter bottle refill

Ultrasound Gel - EUR 40404A 12 bottles

Ultrasound Gel - EUR 40404B 1, 5 liter bottle refill

Basin 21110A

Ordering Sheaths

To order transducer sheaths for the Models 21380A, 21390A, and 21358B
transducers, contact:

CIVCO Medical Instruments Co.

102 First Street
Kalona, IA 52247-9589 USA
E-mail: [email protected]
http://www.civco.com

Call 1-800-445-6741 within the United States or 1-319-656-4447 outside of the

United States. To fax orders call: 1-319-656-4451

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 Intraoperative Transducers
Accessory Equipment

• For the Models 21380A, order CIVCO part number 610-657.

• For the Model 21390A, order CIVCO part number 610-657.
• For the Model 21358B, order CIVCO part number 610-023.

If you use a transducer sheath other than the one listed above, you must use a
market cleared sterile sheath and ensure that the following minimum dimensions
are met.

• For the Model 21380A transducers, 5.8 cm (W) x 150 cm (L).

• For Model 21390A transducer, 4.5 cm (W) x 240 cm (L).
• For Model 21358B transducer, 6.5 cm (W) x 150 cm (L).

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Intraoperative Transducers
Accessory Equipment

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 6 Transthoracic OmniPlane Transducer

Overview

A transthoracic OmniPlane transducer contains a motor in its housing that is used

to rotate the transducer’s array through 180o. This design enables 3-D acquisition
of data sets transthoracically.

The following transthoracic transducer is discussed in this chapter:

• 21349A, the transthoracic OmniPlane transducer, enabling 3-D acquisition

of data sets, steerable CW and PW Doppler, and adaptive color flow.

This chapter discusses the Model 21349A Transthoracic OmniPlane transducer.

Electrical Safety

Defibrillators
The outer insulating layer of the transducer, if intact, is designed to withstand
electrical stress created by defibrillation. A small hole in the outer layer of the
transducer, however, opens a conductive path to grounded metal parts in the
transducer. The secondary arcing that could occur during defibrillation could
cause patient burns. The risk of burns is reduced but not eliminated by using an
ungrounded defibrillator. Therefore, remove the transducer from the patient
before defibrillation. A disposable sheath provides no protective electrical
insulation against defibrillation.

Accident Prevention
Use defibrillators that do not have grounded patient circuits. Refer to the
defibrillator service guide, or consult with a biomedical engineer to determine
whether or not a defibrillator patient circuit is grounded.

Before defibrillation, always remove the transducer from the patient.

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Transthoracic OmniPlane Transducer
Electrical Safety

Description and Use

This section lists important features of the Model 21349A Transthoracic
OmniPlane transducer.

NOTE The Philips’ diagnostic ultrasound systems and transducers in this manual do not
contain natural rubber latex that contacts humans. Natural rubber latex is not
used on any ultrasound transducer, including transthoracic, intraoperative, and
transesophageal transducers. It also is not used on Philips ECG cables for the
products in this manual.

6-2 Revision C.0

 Transthoracic OmniPlane Transducer
Electrical Safety

.
Transthoracic OmniPlane
(Model 21349A)

6APC0154

Features: Rotatable phased array transducer housed in a small, light-

weight transthoracic transducer handle. Used for 3-D acquisi-
tion of data sets and improved views for 2-D imaging enabling
superior diagnostic decisions. Lightweight, ergonomic design
facilitates examination efficiency. Incrementally rotates from
the horizontal plane at 0o, to the vertical plane at 90o, to a left/
right reversed horizontal plane at 180o. Modes of operation
include color flow imaging, steerable CW and PW Doppler,
and adaptive color flow.

Connection: See “Connecting Transducers” on page 1-1.

Specs: Nose Footprint – 18.7 mm diameter

Handle length – 12.7 cm
Weight – 130 g (transducer head)

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Transthoracic OmniPlane Transducer
Electrical Safety

Rotating the Transthoracic OmniPlane Array

You can rotate the Transthoracic OmniPlane array to achieve a 360o view of the
heart by using the array rotation controls on the ultrasound system’s touch panel.

1 To increase the degree of rotation continuously, touch Up (touching Up again

stops the rotation).

2 To decrease the degree of rotation continuously, press Down (touching Down

again stops the rotation).

3 Turn Seek Angle to locate a specific angle. When you touch Seek, the array
rotates to the specified angle.

4 Touch Slow Speed to slow down the speed of the up and down rotation.

You can move the array up to 180o. An icon shows the current degree of rotation.
Depending on image orientation, the icon appears in the upper or lower right side
of the imaging screen. Because the center of the array is the pivot point, you can
achieve a 360o view, as shown in the following figure.

6-4 Revision C.0

 Transthoracic OmniPlane Transducer
Electrical Safety

Figure 6-1. Transthoracic OmniPlane Array Rotation

0° 0° 180°
0° 0°

0° 45° 180°
45 °
45 °

0° 180° 90 °
90°
90 °

0° 135 ° 180°
135 ° 135 °

0° 180° 180°

180 ° 180 °
6apc0151

When you lock the connector into the transducer slot, the Transthoracic
OmniPlane transducer calibrates itself to the 0o (horizontal plane) position. As
with any array movement, the motor makes a humming sound while calibrating.

Revision C.0 6-5

Transthoracic OmniPlane Transducer
Electrical Safety

Transducer Calibration Failed Message

If you see a “Omni Transducer Calibration failed” message on the screen, you
can continue to image. However, the transducer may lack the full 180o rotation
capacity, and the rotation displayed on the screen could be inaccurate.

If you see this message, try the following procedure:

1 Unlock the transducer connector from the system.

2 Reseat the transducer connector in the system slot.

3 Lock the connector.

If you still see the message, contact your Philips service representative.

6-6 Revision C.0

 Index

A biplane cleaning and disinfection

images 4-27 endocavity transducers
accessories pediatric biplane 4-24 2-16
endocavity 3-12 transducer 4-24 intraoperative
intraoperative 5-16 bite guard 4-48 transducers 2-21
TEE 4-48 bleeding 4-12 TEE 2-18
acoustic coupling medium brakes connection information
2-5 OmniPlane 4-16 endocavity transducers
what gels not to use 2-5 OmniPlane II 4-16 1-13
AMP connector 1-3 intraoperative 1-14
for model 21367A 4-1 TEE 1-13
array rotation controls,TEE
C Transthoracic
4-17 calibration failed message OmniPlane transducer
array rotation 1-15
4-19, 6-6
controls,Transthoracic Cannon connector connection tips 1-4
OmniPlane 6-4 for model 21369A 4-1 cracks 2-2
auto cool feature,TEE 4-38, carpal tunnel syndrome
critical device category
4-47 and ultrasound scanning for transducers 2-10
2-2
B checking transducers D
intraoperative 2-2
biopsy TEE 4-8, 4-32 damage
CIVCO starter kit 2-6 chemicals warranty issues 2-13,
cleaning and disinfecting damaging transducers 2-15, 2-17, 2-18, 2-20,
transducers 2-8 2-13 2-22
guide instructions 2-8 CIVCO damaged pins 2-2
transducers supporting contact information 2-7 defibrillators 4-8
2-6 cleaning deflection controls
biopsy needle guide transesophageal and checking 4-32
on-screen guidelines 2-8 endocavity transducers general 4-11
precautions using 2-7, 2-9 OmniPlane 4-16
2-8 web site for Preface-1, OmniPlane II 4-16
system controls 2-8 2-9 Pediatric Biplane 4-26
biopsy starter kits detents
ordering 2-6 Pediatric Biplane 4-26
biopsy transducers
cleaning and disinfecting
2-17

Index-1
 Index

disinfectants endocavity transducers guidelines

FDA clearance for 2-12 cleaning and disinfection endocavity exam 3-10
glutaraldehyde-based 2-16 TEE exam 4-33
2-11 connection information
non-glutaraldehyde-base 1-13
d 2-12 revision levels for using I
to use 2-11 1-13 installing needle guide,
disinfection storage 2-4
endocavity biopsy 3-14
endocavity transducers enzymatic cleaner 2-17, 2-19 intraoperative probe
2-16 ergonomic grip 2-2 animal use label 5-3
high-level 2-9 cleaning 2-3
using for animals 5-3
low-level 2-9 installing 2-2 intraoperative studies
distal tip 4-3, 4-35 ordering 2-2 require type CF
drape 5-15 error message
transducer 5-4
calibration failed 1-5 intraoperative transducer
error messages
E calibration failed 4-19,
approved by EU 5-2

electrical safety 6-6

intraoperative 5-5 ESU,electrosurgical units 4-7
exam guidelines
TEE 4-7
endocavity biopsy endocavity 3-8
installing needle guide TEE 4-33
external-use transducers
3-14
mounting needle guide storage 2-3
3-14
needle guide 3-13 F
needle guide maintenance
3-13 flexible shaft 4-35
needle guide precautions frequency
3-13 changing on system 1-7
needle guide safety 3-13 optimizing on system 1-7
preparing transducers frequency agility 4-14, 4-20,
3-14 5-12
endocavity exam
guidelines 3-10
G
gels
which to use 2-5

Index-2
 Index

intraoperative transducers leakage current P

accessory equipment detectors listed 5-6
5-16 intraoperative pacemakers 4-8
accident prevention 5-9 transducers 5-6 part numbers
all require type CF TEE transducers 4-7 of ImagePoint HX
classified 5-4 testing 5-6 transducers 1-11
and defibrillators 5-9 longitudinal images 4-27 of SONOS 4500/5500
cleaning and disinfection transducers 1-9
2-21 PAT T display 4-42
connection information M patient safety
1-14 non-use of latex 5-4
message
defined 5-1 “?? Probe” 1-4 patient safety, intraoperative
electrical leakage testing “NO Probe” 1-4 electrical 5-5
5-6 patient safety,TEE
messages
illustrations of 5-10 calibration failed 1-5, auto cool 4-38
models described 4-19, 6-6 bite guard 4-48
in-depth 5-10 electrical 4-7
thermistors in TEE
no cross-use between transducer open 4-45 post-exam guidelines
animals and humans 5-3 4-47
ordering supplies for pre-exam considerations
5-16 N 4-33
patient safety 5-3 pressure necrosis 4-12,
prepare for imaging 5-14 needle guide 4-35
requirements for using endocavity biopsy 3-13 tissue damage 4-12
5-1 mounting for endocavity patient temperature
revision levels for using biopsy 3-14 entering on the HP
1-14 needle guide maintenance, SONOS 1800 and HP
storage 2-3, 2-4 endocavity biopsy 3-13 ImagePoint 4-41
supported models needle guide precautions entering on the HP
described 5-1 endocavity biopsy 3-13 SONOS 5500 4-40
uses of 5-2 needle guide safety setting display on the HP
endocavity biopsy 3-13 SONOS 1800 and HP
ImagePoint 4-47
L pediatric biplane transducer
O 4-24
lacerations 4-12
latex 2-5, 5-4 ordering preparing endocavity
biopsy kits and sheaths transducers 3-8
2-7 pressure necrosis 4-12, 4-35

Index-3
Index

R TEE transducers transducers

array rotation controls activating 1-5
rubber latex 4-17 applications for, listed
never used 2-6 auto cool feature 4-38 1-9
cleaning and disinfection changing frequency of
2-18 1-7
S connection information checking for damage 2-2
1-13 chemical damage 2-13
semicritical devices 2-9
disinfectants cleaning 2-9
shaft 2-4, 4-35
recommended 2-11 connecting 1-1
sheath, intraoperative
distal tip 2-4 cracks 2-2
transducers 5-14, 5-16
exam guidelines 4-33, daily storage 2-3
storage
4-36 damage not under
external-use 2-3
flexible shaft 2-4 warranty 2-13, 2-15,
intraoperative 2-4
parts 4-10 2-17, 2-18, 2-20, 2-22
TEE 2-4
revision levels for using damaged pins 2-2
swelling 2-2
1-13 disinfectants to use 2-11
storage 2-4 general cleaning 2-9
T T display 4-42 handling 2-1
temperature controls installing AMP adapter
TEE 4-13, 4-38 1-2
auto cool feature 4-38 tip fold-over 4-36 part numbers of 1-9
TEE disinfection basins 4-49 tip protector 4-48 specialty
TEE tip manipulation tissue damage 4-12, 4-35 transducers,listed by
general 4-11 transducer revision level 1-13
OmniPlane 4-16 adapter for model supporting biopsy 2-6
OmniPlane II 4-16 21367A 4-1 swelling of lens material
Pediatric Biplane 4-26 2-2
tables of all supported
1-9
transporting 2-3
used with ImagePoint Hx
1-11
used with SONOS 4500/
5500 1-9
web site address 2-9
transducers,biopsy
cleaning and disinfecting
2-17

Index-4
 Index

Transthoracic OmniPlane
transducer
array rotation controls
6-4
calibration failed
message 6-6
connection information
1-15
defibrillator safety issues
6-1
model 21349A described
6-1
revision levels for using
1-15
specifications for 6-3

W
warranty
coverage limits indicated
2-13, 2-15, 2-17, 2-18,
2-20, 2-22
web site
for cleaning transducers
Preface-1, 2-9
for FDA-cleared
disinfectants 2-12
leakage current testing
product 5-6
what gels to use 2-5

Index-5
Index

Index-6