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SONOS 7500/5500 Transducer Reference

C:\Documents and Settings\pkeville\My Documents\pkeville\D.0\transduc-

User’s Guide

Transducer Reference

Philips Ultrasound3000 Minuteman RoadAndover, Massachusetts 01810-1099(978) 687-1501www.philips.medical.com

© Copyright 2002Philips Electronics NorthAmerica Corporation

All rights are reserved.Reproduction in whole or inpart is prohibited without theprior written consent of thecopyright holder.

Publication numberM2424-99300-07Edition 7Published December, 2002Printed in U.S.A.

Warranty

The information contained inthis document is subject tochange without notice.

Philips Ultrasound makes nowarranty of any kind withregard to this material,including, but not limited to,the implied warranties ofmerchantability and fitness fora particular purpose.

Philips Ultrasound shall not beliable for errors containedherein or for incidental orconsequential damages inconnection with the furnishing,performance, or use of thismaterial.

This product may contain re-manufactured parts equivalentto new in performance or havehad incidental use.

Trademarks

Philips and third-party productnames may be trademarks orregistered trademarks of theirrespective owners.

WARNING

Electrical Shock Hazard

Do not remove system covers.To avoid electrical shock, useonly supplied power cords andconnect only to properlygrounded wall (wall/mains)outlets.

Explosion Hazard

Do not operate the system inthe presence of flammableanesthetics.

Safety Information

Before you use the Philips ul-trasound system, be sure toread the Safety and Standardsguide.

Pay special attention to the"Warnings" and "Cautions."

The warnings explain the dan-gers of electrical shock and ex-plosion hazard, the safety ofultrasound, applications,guidelines for fetal use, andguidelines for setting controlsthat affect acoustic output andaccuracy of clinical measure-ments.

The cautions explain potentialdangers to equipment.

Warning Symbol Used in theText:

Caution Symbol Used in theText:

WARNING

CAUTION

Warning Symbols used onthe System:

User’s guide symbol: Theproduct will be marked withthis symbol when it is neces-sary for the user to refer to theuser’s guide.

Dangerous voltages symbol:Indicates potential for electri-cal shock.

Monitor Radiation

The monitor used in thissystem complies with the FDAregulations that wereapplicable at the date ofmanufacture (21 CFRSubchapter J).

Prescription Device

The United States Food andDrug Administration requiresthe following labelingstatement:

Caution - Federal Law restrictsthis device to use by or on theorder of a physician.

Important

0123 marking is forCouncil Directive93/42/EEC.

This system complies with theMedical Device Directive.

Authorized EURepresentative:Philips Medizin SystemeBoeblingen, GmbHHewlett-Packard Str. 271034 Boeblingen, Germany

!

Printing History

Edition Publication Date Software Revision

Edition 1 June 1997 SONOS 4500/5500 A.0

Edition 2 January 1998 ImagePoint A.1SONOS 4500/5500 A.1

Edition 3 April 1999 ImagePoint Hx B.0SONOS 4500/5500 B.0

Edition 4 June 2000 ImagePoint Hx B.0SONOS 4500/5500 B.1

Edition 5 September 2000 ImagePoint Hx B.1SONOS 4500/5500 B.1

Edition 6 June 2002 ImagePoint Hx B.1SONOS 4500/5500 C.0

Edition 7 December 2002 SONOS 7500/5500 D.0

Contents-1

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Preface

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

What’s New In This Book For Revision D.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2

Non-supported features at Revision D.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2

Safety Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-3

Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-4

1 Transducer Setup

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

Connection Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Activating Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Changing the Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SONOS 7500 and SONOS 5500 Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Supported Transducers Not Sold With SONOS 7500/5500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Specialty Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

2 Caring for Transducers

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

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

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

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

Contents

Contents

Contents-2

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

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

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

Cleaning and Disinfecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

General Cleaning for Transducers Used in Non-Invasive Procedures . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Cleaning and Disinfection of Transducers Used in Endocavity Procedures . . . . . . . . . . . . . . . . . . . 2-14

Cleaning and Disinfection of TEE Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Cleaning and High-Level Disinfection of Transducers Used in Biopsy Procedures . . . . . . . . . . . . . 2-18

Cleaning and High-Level Disinfection for Transducers Used in Intraoperative Procedures . . . . . . . 2-19

3 Endocavity Transducer

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

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

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

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

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

The Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Contents

Contents-3

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4 TEE Transducers

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

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



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

Checking the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Special Considerations for TEE Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Ensuring Accurate Temperature Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Checking the Patient After the TEE Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

5 Biopsy-Capable Transducers

Transducers Supporting Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Ordering Biopsy Kits and Sheaths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Biopsy Needle Guide Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Biopsy Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Cleaning and DisinfectingTransducers Supporting Biopsies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

6 Intraoperative Transducers

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

Contents

Contents-4

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Intraoperative Probes Used for Animal Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3



Description and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

7 Advanced Imaging

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Description And Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Intended Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Transmit and Receive Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

General Use and Safety Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Auto-Cool Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

8 Transthoracic OmniPlane Transducer

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1


Preface-1

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Preface

About this Book

Chapter 1 shows you how to connect and activate your Philips SONOStransducers. Tables in this chapter list all the transducers available with theSONOS 7500/5500 ultrasound system, including those supporting biopsy.

Chapter 2 describes the care required for your Philips SONOS transducers. Youwill find information in this chapter on handling, storing, general cleaning, anddisinfecting of all supported transducers.

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 the features and use of endocavity,transesophageal (TEE), biopsy-capable, intraoperative, the x4, and transthoracicOmniPlane (TTO) transducers. These chapters also describe the dangerous,potentially lethal effects of improper or careless use of these transducers.

This guide does not:

• Provide instruction in esophagogastroscopic, intraoperative, transthoracic, orendocavity techniques.

• Present medical protocols for conducting a TEE, intraoperative, transtho-racic, or endocavity exam.

• Discuss interpretation of transesophageal, intraoperative, transthoracic, orendocavity imaging patterns.

What’s New In This Book For Revision D.0

Preface-2

What’s New In This Book For Revision D.0

• The SONOS 7500 system.• Description of the features and capabilities of the x4 transducer (Model

21315A), a new UltraBand matrix phased array used in transthoracic and

epicardial imaging.1 See Chapter 7, “Advanced Imaging”.• Description of the features and capabilities of the OmniPlane III (Model

21378A), a new UltraBand sensor for harmonic and contrast imaging. See“OmniPlane III (Model 21378A)” on page 4-15.

• Addition of T-spray to the low-level external cleaning solutions recom-mended for some common transducers. See “General Cleaning for Trans-ducers Used in Non-Invasive Procedures” on page 2-11.

• A new chapter, “Biopsy-Capable Transducers”, that 1) lists each transducerthat supports the use of biopsy needle guides, 2) provides ordering informa-tion for the biopsy kit used by each transducer, and 3) describes the basicneedle guide instructions and the cleaning and disinfecting guidelines forthese biopsy-capable transducers.

1 Not approved in the European Union or Canada for epicardial applications.

Non-supported features at Revision D.0

Previous features not supported at software revision D.0 are the:

• SONOS 4500 system• AMP adapter• Following transducers, as noted in Table 1

Table 1. Transducers not supported on SONOS 7500/5500

TransducerName

Model #TransducerType

Comments

C3540 21253B Curved array Not supported on D.0

C3540 21353B Curved array Not supported on D.0

C5040 21273A Curved array Not supported on D.0

Safety Questions

Preface-3

NOTE For more information on transducers supported by D.0 from previous softwarerevisions of the SONOS system, see “Supported Transducers Not Sold WithSONOS 7500/5500” on page 1-7. You can use these probes with revision D.0, butthey are not sold with the product.

Safety Questions

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

Quality ManagerPhilips Ultrasound3000 Minuteman RoadAndover, MA 01810(978) 687-1501

L5040 21255B Linear array Not supported on D.0




T5012 21364A OmniPlaneTEE

Not supported on D.0

T7506 21366A PediatricBiPlane TEE

Not supported on D.0

T6210 21367A OmniPlane IITEE

Not supported on D.0.

E6514 21370A Endocavity Not supported on D.0

E7511 21371A Endocavity Not supported on D.0

Table 1. Transducers not supported on SONOS 7500/5500

TransducerName

Model #TransducerType

Comments

Additional Information

Preface-4

Additional Information

You must be thoroughly familiar with the operation of the Philips SONOS 7500/5500 ultrasound system to use the Philips specialty transducers described in thismanual.

Use this guide in conjunction with the following books:

• System Basics—Describes the basic operation of the Philips SONOS 7500and Philips SONOS 5500 systems.

• Controls Reference—Provides a detailed description of all system controls.• Safety and Standards Guide—Provides information on safety issues.• Measurements and Calculations Reference—Provides information on mea-

surements and calculations that you can perform on your ultrasound system.

Additionally, several specialty guides and multimedia products describe SONOSimaging applications and optional packages:

• Using Integrated Digital Interface (IDI)

• Using Stress Echocardiography

• Using 3-Dimensional and BiPlane Imaging

• Using Contrast Imaging

• Using Acoustic Quantification

• Using Acoustic Densitometry

• LVO and Contrast CK: A Practical Approach (a video guide to SONOScontrast echocardiography detection techniques)

• Stress Audio CD (a spoken guide to performing SONOS stress echocardio-graphy studies)

• SONOS Live 3D Cardiac Echo: Features and Fundamentals CD (a videoguide to using SONOS live 3D echocardiography detection techniques).

Revision D.0 1-1

1 Transducer Setup

Connecting Transducers

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

Philips SONOS 7500 and 5500

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

2 Lock the connector by turning the transducer latch to the horizontalposition.

Never force atransducer into place.If you feel anyresistance, check thepin positions and tryreinserting.

6apc0148

Vertical

6apc0149

Horizontal

Transducer SetupConnection Tips

1-2 Revision D.0

Connection Tips

• If you feel any resistance when inserting the connector, don’t try to force it inplace. Check the latch and pin positions 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 youhave selected the correct slot (Left, Center, Right, or Non-image underProbe) on the SONOS 7500 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 byturning the latch to the vertical position.

• When using a TEE transducer, always make sure the TEE tip and shaft arestraight before connecting the transducer.

Transducer SetupActivating Transducers

Revision D.0 1-3


Calibration:

• If “Omni Transducer Calibration failed” displays, try unlocking and lockingthe transducer connector.

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

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

Activating Transducers

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

SONOS 7500 or SONOS 5500

Touch Probe. Then touch the softkey indicating where the transducer isconnected.

Probe

Left Center Right Nonimage

Transducer SetupChanging the Frequency

1-4 Revision D.0

Changing the Frequency

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

See the System Basics User’s Guide for more information on the FrequencyFusion icon.

SONOS 7500 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

FrequencyFusion

Transducer SetupSONOS 7500 and SONOS 5500 Transducers

Revision D.0 1-5


SONOS 7500 and SONOS 5500 Transducers

The following table lists transducers supported by the SONOS 7500/ 5500system.

Table 1-1 SONOS 7500 and 5500 Transducers

TransducerName

ModelNumber Transducer Type Applications Comments

x4 21315A Matrix UltraBand Abdominal, Adult andPediatric Cardiac,Epicardial*, Contrast,Harmonics, OB/Gyn.

Supports BiPlaneand live 3D onSONOS 7500.

s3 21311A UltraBand SectorTransducer

Abdominal, Adult Cardiac,Contrast, Harmonic,OB/Gyn, TCD


Abdominal, Adult Cardiac,Contrast, Harmonic,OB/Gyn, TCD


Adult and Pediatric Cardiac,Neonatal Cephalic,Abdominal, Harmonic


Pediatric and NeonatalCardiac, Neonatal Cephalic,Intraoperative

c3540 21321A Curved LinearTransducer -UltraBand

Abdominal, Harmonics, OB/Gyn, Abdominal Vascular.Biopsy capable

C5040 21373A Curved LinearTransducer

Abdominal, OB/Gyn,Vascular. Biopsy capable

E6509 21336A Endocavity CurvedLinear Transducer

Endovaginal OB/Gyn,Endorectal, Urological.Biopsy capable

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

Transducer SetupSONOS 7500 and SONOS 5500 Transducers

1-6 Revision D.0

*Not approved in the European Union or Canada for epicardial applications.** The 21228B, 21223B, and 21221B transducers are supported only on SONOS5500 Revision B.2 and higher.

11-3L 21356A Linear Transducer Peripheral Vascular, SmallParts, Harmonics

D1914V 21228A/B** Non-ImagingDoppler PencilTransducer

Transcranial 1.9 MHz PW

D5009V 21223A/B** Non-ImagingDoppler PencilTransducer

Vascular 5 MHz PW/CW

D1009V 21224A Non-ImagingDoppler PencilTransducer

Vascular 10 MHz CW

D1914C 21221A/B** Non-ImagingDoppler PencilTransducer

Cardiology 1.9 MHz CW

T6207 21381A miniMulti TEETransducer

Pediatric and Adult Cardiac

T6H 21378A TEE OmniPlane III Cardiology, Harmonics,Contrast

Table 1-1 SONOS 7500 and 5500 Transducers (Continued)

TransducerName

ModelNumber

Transducer Type Applications Comments

Transducer SetupSupported Transducers Not Sold With SONOS

7500/5500

Revision D.0 1-7


Supported Transducers Not Sold With SONOS 7500/5500

The following table lists transducers supported on SONOS 7500/5500 fromprevious versions of the SONOS system. You can use these probes on a SONOS7500/5500 system, but they are not sold with the product

Refer to ImagePoint Hx documentation for more information about thesetransducers.

Table 1-2. Supported Transducers Not Sold with SONOS 7500/5500

TransducerName

ModelNumber

Transducer Type Application Comments

D1914C 21222A Non-ImagingDoppler PencilTransducer

Cardiology 1.9 MHz CW


Transcranial 1.9 MHz PW


Vascular 5 MHz PW/CW

C6514 21372A Curved LinearTransducer

Pediatric Abdominal,Neonatal Cephalic,OB/Gyn, Pediatric, SmallParts, Vascular

R5012 21349A TransthoracicOmniPlane SectorTransducer

Pediatric and Adult Cardiac,3-D Acquisition

Not sold with Rev. D.0

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

T6210 21369A OmniPlane II TEESector Transducer

Multiplane, TEE, 3-DAcquisition

Transducer SetupSpecialty Transducers

1-8 Revision D.0

Specialty Transducers

Endocavity Transducer

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

TEE Transducers

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

Table 1-3. Endocavity Connection Information

Philips UltrasoundSystem

Endovaginal/Endorectal 21336A(E6509)

SONOS 7500 Supported at Rev.D.0.

SONOS 5500 B.0 and higher(Endovaginal only)

Table 1-4. TEE Connection Information

PhilipsUltrasoundSystem

OmniPlane II21369A (T6210)

OmniPlane III21378A (T6H)

miniMulti21381A (T6207)

SONOS 7500 Supported at Rev.D.0

Supported at Rev.D.0

Supported at Rev.D.0

SONOS 5500 Rev. A.0 andhigher

Rev D.0 andhigher

Rev B.2.2. andhigher


Revision D.0 1-9


Intraoperative Transducers

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

Transthoracic OmniPlane Transducer

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

NOTE For a list of transducers that support the use of biopsy needle guides and thebiopsy kit used by each, see "Transducers Supporting Biopsy", page 5-1.

Table 1-5. Intraoperative Connection Information


UltraBand, 2-DimensionalPhased Array21315A (x4)

High-FrequencyUltraBand21380A (S12)

High FrequencyIntraoperative21390A (15-6L)

SONOS 7500 Supported at Rev. D.0 Supported at Rev. D.0 Supported at Rev.D.0

SONOS 5500 Not supported at Rev.D.0

Rev. A.0 and higher Rev. B.0 and higher

Table 1-6. Transthoracic OmniPlane Connection Information


Transthoracic OmniPlane21349A (R5012)

SONOS 7500 Supported at Rev. D.0

SONOS 5500 Rev. A.0 and higher


1-10 Revision D.0

Revision D.0 2-1

2 Caring for Transducers

Introduction

This chapter contains information on the general care, handling, and storing ofPhilips transducers for SONOS 7500/5500 systems. The general cleaning ofexternal transducers is discussed, as well as the cleaning and disinfecting ofspecialty transducers, such as endocavity, transesophageal, biopsy-capable, andintraoperative transducers.

As of the date of this publication, you will find the latest cleaning anddisinfection information for all supported transducers in this chapter. It isimportant, however, that you periodically check the following Philips web sitefor the very latest cleaning and disinfection guidelines for all supportedtransducers:

www.medical.philips.com/transducercare

Handling Transducers

Although a transducer is designed for durability, use care when handling it.Dropping or banging the transducer could damage the acoustic cap andpiezoelectric crystals. Cuts in the transducer cable or cracks in the housing coulddestroy the electrical safety features of the transducers. This damage is notcovered by the warranty or your service contract.

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

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

NOTE

CAUTION

Caring for TransducersChecking the Transducer

2-2 Revision D.0


Checking the Transducer

All transducers are exposed to many potentially damaging situations during useand cleaning. Periodically check the transducer for the following signs ofdamage:

• 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 TunnelSyndrome (CTS) and repetitive strain injury. See the Safety and Standards guidefor reference articles.

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

Installing the Ergonomic Grip:

1 Insert the cable through the slot in the grip.

2 Align the slot with the orientation indicator.

3 Slip the transducer head into the grip.

Caring for TransducersStoring Transducers

Revision D.0 2-3

Cleaning the Ergonomic Grip:

1 Wipe with a dry or water-moistened soft cloth. You can also use as 70% iso-propyl alcohol solution (rubbing alcohol), a 10% bleach solution or a 2.4% to3.4% glutaraldehyde-based disinfectant. For a list of the glutaraldehyde-baseddisinfectants that Philips recommends for specific transducers, see page 2-8.

2 Remove any cleaning solution residue with a soft cloth moistened in water.Do not allow cleaning solutions to air-dry on the grip.

Storing Transducers

Storage for Transport

Make sure that the transducer is clean and disinfected before placing it in thecase. 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 caseto transport the transducer from one site to another. To prevent kinking, carefullyplace the transducer in the case. Before closing the lid, make sure no part of thetransducer is protruding from the case. Wrap the case in plastic materialcontaining air pockets (bubble wrap), and pack the wrapped case in a cardboardcarton.

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.

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

Caring for TransducersStoring Transducers

2-4 Revision D.0


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 inadvertenttransducer damage.

• If storing the transducer in the original case or in a drawer, make sure thetransducer is thoroughly dry.

• Avoid storing the transducer in areas of temperature extremes or in directsunlight.

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 theflexible 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 properlyspaced to prevent the transducer from falling.

• Store the transducer separately from other instruments to avoid accidentaltransducer damage.

• Avoid storing the transducer in areas of temperature extremes or in directsunlight.

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.

Caring for TransducersAcoustic Coupling Medium

Revision D.0 2-5

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

• If storing the transducer in the original case, make sure the transducer isthoroughly dry.

• Avoid storing the transducer in areas of extreme temperatures or in directsunlight.

Acoustic Coupling Medium

For proper transmission of the acoustic beam, use the ultrasound transmission gelsupplied by Philips, or another glycol, glycerol, or water-based couplant. Do notuse mineral oil, oil-based couplants, or other non-approved material because itmight 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 intransesophageal, endocavity, and intraoperative imaging applications ortransducer covers used during biopsy. Examine the packaging to confirm latexcontent. Studies have shown that allergic reactions with natural rubber latex canbe experienced. The US Food and Drug Administration has published a medicalalert on latex products dated March 29, 1991.

NOTE

Caring for TransducersCleaning and Disinfecting Transducers

2-6 Revision D.0


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

Cleaning and Disinfecting Transducers

Infection control is an increasingly important issue in health care. You shouldalways clean and disinfect transducers immediately after each use to protectpatients and personnel from a variety of pathogens. The level of disinfectionrequired for an ultrasound transducer will be determined by the type of tissue itcontacts during use.

The most current information on cleaning and disinfecting transducers can befound on the following Philips web site:


The following categories identify uses and required cleaning and disinfectionstandards:

Transducers Used in Non-Invasive Procedures (non-criticaldevice applications)

Applications for transducers used in non-invasive procedures have a very lowprobability for spreading infection since they are used with intact skin. This typeof device requires general cleaning and low-level disinfection. See “GeneralCleaning for Transducers Used in Non-Invasive Procedures” on page 2-11.

NOTE

NOTE

Caring for TransducersCleaning and Disinfecting Transducers

Revision D.0 2-7

Transducers Used in Endocavity and TEE Procedures (semi-critical device applications)

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

For cleaning and disinfection instructions for transducers in the semi-criticaldevice category, see the following:

• “Cleaning and Disinfection of Transducers Used in Endocavity Procedures”on page 2-14

• “Cleaning and Disinfection of TEE Transducers” on page 2-16

Philips recommends that you use a protective sheath with transducers used inendocavity procedures and with all 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 Biopsies and Intraoperative Procedures(critical device applications)

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

• See “Cleaning and High-Level Disinfection of Transducers Used in BiopsyProcedures” on page 2-16

• See “Cleaning and High-Level Disinfection for Transducers Used in Intraop-erative Procedures” on page 2-19.

Caring for TransducersDisinfectants

2-8 Revision D.0


General Information About Cleaning and Disinfection

Your clinic or hospital may have guidelines covering the cleaning anddisinfecting of ultrasound imaging transducers. The following articles alsoprovide a good reference:

“Design, Testing and Labeling of Reusable Medical Devices for Reprocessing inHealth Care Facilities - A Guide for Manufacturers,” AAMI (ed), AAMIPublishing Co. 1995.

Block, Seymour S. “Disinfection, Sterilization, and Preservation,” Lea andFebinger, Philadelphia, 1991.

Establish and clearly post a disinfecting procedure that includes all requireddisinfection steps.

Disinfectants

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

Glutaraldehyde-based Disinfectants

Philips recommends the following 2.4% glutaraldehyde-based disinfectants forsoaking or wiping all transducers. See individual transducer sections in thischapter for specific instructions.

• Cidex™ Activated Dialdehyde Solution

• Omnicide™ Long Life Activated Dialdehyde Solution

• Procide® 14 N.S.

NOTE


Revision D.0 2-9

Additionally, Philips recommends the following 2.4 to 3.4% glutaraldehyde-based disinfectants for the 21315A x4 matrix transducer, the 21311A, 21330A,21350A, 21380A sector transducers, the 21356A linear transducer, and the21369A, 21378A, 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% Glutareldahyde

• Metricide® 28 Day Long-Life Activated Dialdehyde Solution

• Metricide Plus 30® Long-Life Activated Dialdehyde Solution

• Omnicide™ 14NS *

• Omnicide™ 28 *

• 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 theUnited States. The FDA maintains a list of 510k-cleared high-level disinfectantsat www.fda.gov/cdrh/ode/germlab.html

CAUTION You must follow the disinfectant manufacturer's instructions carefully.


2-10 Revision D.0


Non-Glutaraldehyde-Based Disinfectant

CIDEX® OPA Solution (An ortho-phthalaldehyde solution manufactured byAdvanced Sterilization Products) is a non-glutaraldehyde-based product that canbe used to high-level disinfect the transesophageal (TEE) and intraoperativetransducers listed below:

• Model 21369A OmniPlane II

• Model 21378A OmniPlane III

• Model 21381A Pediatric miniMultiplane

• Model 21390A (15-6L) Intraoperative

• Model 21336A Endovaginal/Endorectal

WARNING If you use CIDEX® OPA, a residual solution may remain on your transducersif you do not carefully follow the manufacturer's instructions. ResidualCIDEX® 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 otherdisinfectant, Philips recommends:

• Following the disinfectant manufacturer's instructions carefully (forexample, the manufacturer of CIDEX® OPA recommends rinsing bysoaking probes THREE times in fresh water)

• Using a protective sheath during TEE examinations and a sterile protec-tive sheath during intraoperative examinations

• Limiting the time that probes are soaked in disinfectant solution to theminimum time recommended by the disinfectant manufacturer (e.g., themanufacturer of CIDEX® OPA recommends a minimum of 12 minutes)

Use of CIDEX® OPA on the 21336A Endovaginal/Endorectal transducer willstain the probe. This staining is not toxic and presents no hazard to anyone incontact with the probe. It will not change the function of the probe.

NOTE

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

Revision D.0 2-11

CAUTION The use of any non-glutaraldehyde-based disinfectant other than CIDEX® OPAon the 21369A, 21378A, 21381A, 21390A, and 21336A transducers may causedamage to your transducer. Damage caused by such use is not covered by thewarranty or your service contract.

Use of non-glutaraldehyde-based disinfectants on transducers other than the oneslisted above may cause damage to your transducer. Damage caused by such use isnot covered by the warranty or your service contract.

Chemicals that Damage Transducers

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

• phenol (10% or 100%)

• benzothonium chloride (0.14% in menthol, butylene glycol waterbasesolution)

• 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 chemicalswill cause damage to your transducer. This damage is not covered by thewarranty or your service contract.

General Cleaning for Transducers Used in Non-Invasive Procedures

These general cleaning instructions are indicated for non-critical categorytransducers. All transducers which do not contact mucus membranes, blood,compromised tissue, and are not used in sterile fields can be cleaned by usingthese instructions. It is important that you clean the transducer and cableaccording to the following procedures:


2-12 Revision D.0


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

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

3 Wipe the transducer with either:

• A glutaraldehyde-based disinfectant

• A 10% bleach solution

• Isopropyl alcohol (70%)

See “Glutaraldehyde-based Disinfectants” on page 2-8 for a list of recommendeddisinfectants.

CAUTION The use of 70% isopropyl alcohol (rubbing alcohol) on transducers is restricted.You may wipe only the distal tip of the transducer up to one inch (2.5 cm) from thestrain relief/housing joint with an isopropyl alcohol solution. See Figure 2-1“Restricted Use of Isopropyl Alcohol to Clean Transducers” on page 2-13.

4 You can also wipe the cable with T-spray, a low-level disinfectant for the clean-ing of external transducers only, or a 10% bleach solution. Do NOT use isopro-pyl alcohol on the cable.

CAUTION Isopropyl alcohol may damage parts of your transducer. This damage is not coveredby the warranty or your service contract.


Revision D.0 2-13

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

5 Additionally, you can also wipe the following transducers, including thecables, with T-spray, a low-level disinfectant for the cleaning of externaltransducers only:

• Model 21315A (x4)

• Model 21311A (s3)

• Model 21330 A (s4)

• Model 21350A (s8)

• Model 21380 (s12)

• Model 21356A (11-3L)

6 Remove any residue with a soft cloth moistened in water. Do not allowcleaning solutions or isopropyl alcohol to air-dry on the transducer.

1 inch

A

DB

2.5 cm

C

EF

A - cableB - strain reliefC - strain relief/housing jointD - housingE - Do not use alcohol in this areaF - You may use alcohol in this area

Caring for TransducersCleaning and Disinfection of Transducers Used in Endocavity Procedures

2-14 Revision D.0


Cleaning and Disinfection of Transducers Used in Endocavity Procedures

High-level disinfection is the accepted method of infection control fortransducers used in endocavity procedures. Use of a protective sheath during theexam is also recommended.

Cleaning and High-Level Disinfection of Transducers Used inEndocavity Procedures

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

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 orthe 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 2-8 or “Non-Glutaraldehyde-Based Disinfectant” on page 2-10.

• 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 nearthe connector.

CAUTION Follow the recommendations of the disinfectant manufacturer.

Caring for TransducersCleaning and Disinfection of Transducers Used in Endocavity Procedures

Revision D.0 2-15

4 Remove the transducer from the disinfectant and thoroughly rinse with sterilewater.

5 Check the transducer for any residual organic material. If any is present, dis-infect 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 damages are not covered by the warranty or servicecontract.

Caring for TransducersCleaning and Disinfection of TEE Transducers

2-16 Revision D.0


Cleaning and Disinfection of TEE Transducers

High-level disinfection is the accepted method of infection control for TEEtransducers. It is recommended that a protective sheath be used duringexaminations.

Cleaning and High-Level Disinfection of TEE Transducers

Use this disinfection method for the following transducers:

• Model 21369A, OmniPlane II

• Model 21378A, OmniPlane III

• Model 21381A, miniMultiplane

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

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 removingprotein residuals. A common enzymatic cleaner is one with a pH of 6.0to 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 Model21381A, miniMultiplane, do not immerse past the 65cm marker.CAUTION

Caring for TransducersCleaning and Disinfection of TEE Transducers

Revision D.0 2-17

4 Disinfect the distal tip and flexible shaft by placing them in one of the disin-fectants listed in “Glutaraldehyde-based Disinfectants” on page 2-8 or “Non-Glutaraldehyde-Based Disinfectant” on page 2-10. Be sure to use a disinfec-tant recommended for the transducer you are using.

• Do not use bleach or other disinfectants. Also, avoid transducer contactwith strong solvents such as acetone, freon, and other industrial cleans-ers.

• Do not bend the shaft into less than a one-foot diameter curve. Leavethe tip and shaft in the solution for the amount of time recommended bythe disinfectant manufacturer.

• Do not immerse or rinse the steering mechanism.



5 Remove the distal tip and flexible shaft from the disinfectant and thoroughlyrinse them with sterile water. Follow the instructions for use from the disin-fectant manufacturer.

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

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

8 Lightly wipe the steering mechanism with a pad moistened with 70%isopropyl alcohol.

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

CAUTION The transducer steering mechanism is not sealed. If disinfectant or other fluidenters the steering mechanism, it will corrode the gears and electricalconnections.

Never sterilize the transducer with sterilization techniques such as autoclave,ultraviolet, gamma radiation, gas, steam or heat sterilization techniques. Severedamage will result.

Avoidable transducer damage, such as those conditions listed above, are notcovered by the warranty or service contract.

Caring for TransducersCleaning and High-Level Disinfection of Transducers Used in Biopsy Procedures

2-18 Revision D.0


Cleaning and High-Level Disinfection of Transducers Used in Biopsy Proce-dures

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

Follow the steps below for proper disinfection of transducers used in biopsyprocedures.

Use the disinfection method described in this section for models:

• c3540 (Model 21321A), when used for biopsies

• C5040 (Model 21373A), when used for biopsies

• E6509 (Model 21336A), when used for biopsies

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

• Non-invasive procedure, see “General Cleaning for Transducers Used inNon-Invasive Procedures” on page 2-11.

• Endocavity procedure, see "“Cleaning and Disinfection of Transducers Usedin Endocavity Procedures” on page 2-14


2 Wash the transducer head and cable with soap and water to remove anyprotein buildup; however do not rinse or immerse the cable near theconnector.

To assist in removing protein residuals Philips recommends using anenzymatic cleaner. A common enzymatic cleaner is one with a pH of 6.0 to8.0 (for example, Metrizyme) and contains diluted concentrations ofsurfacants, alcohols, salts, and acids. These cleaners are further diluted duringuse.

3 Disinfect the transducer and cable with one of the glutaraldehyde-baseddisinfectants listed on page 2-8 or the “Non-Glutaraldehyde-BasedDisinfectant” on page 2-10 (Model 21336A only).


NOTE

Caring for TransducersCleaning and High-Level Disinfection for Transducers Used in Intraoperative Procedures

Revision D.0 2-19


• Do not soak the transducer for extended periods of time, such asovernight.


4 Remove the transducer from the disinfectant and thoroughly rinse with sterilewater. Follow the instructions for use from the disinfectant manufacturer.


CAUTION Never sterilize the transducer with sterilization techniques such as autoclave,ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severedamage will result.

Avoidable transducer damage is not covered by the warranty or service contract.

Cleaning and High-Level Disinfection for Transducers Used in IntraoperativeProcedures

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

Use the disinfection method described in this section for the following modelswhen used in interoperative procedures:

• 15-6L (Model 21390A)

• x4 (Model 21315A)

• s12 (Model 21380A)

To clean an intraoperative transducer when it is used in a non-invasive procedure,see “General Cleaning for Transducers Used in Non-Invasive Procedures” onpage 2-11.

NOTE


2-20 Revision D.0


WARNING Intraoperative probes used in animal studies should not be used onhumans. Transducer disinfection procedures described in this chapter arefor usage between humans only.

When the 21390A probe is used for animal studies, the animal use labelmust be attached. See “Animal Use Label” on page 6-3.

Cleaning and High-Level Disinfection of Transducers Used inIntraoperative Procedures

Follow these steps for proper disinfection:


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 thelength of cable near the connector.

To assist in removing protein residuals Philips recommends using an enzymaticcleaner. A common enzymatic cleaner is one with a pH of 6.0 to 8.0 (forexample, 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 2-8.

For the model 21390A (15-6L) transducer, you may use either a glutaralde-hyde-based disinfectant or Cidex® OPA. See “Non-Glutaraldehyde-BasedDisinfectant” on page 2-10 for this information.





NOTE


2-21 Revision D.0


4 Remove the transducer from the disinfectant and thoroughly rinse with sterilewater.


CAUTION Never sterilize the transducer with sterilization techniques such as autoclave,ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severedamage will result.

Avoidable transducer damage is not covered by the warranty or service contract.


2-22 Revision D.0


Revision D.0 3-1

3 Endocavity Transducer

Overview

Endocavity transducers deliver the critical images needed for obstetrical,gynecological, fertility, urological, and prostate studies. The endovaginal andendorectal transducers feature end-firing imaging arrays that deliver a wide fieldof view. This feature lets you consider the whole picture when making yourdiagnosis. Biopsy needle guides work in conjunction with system-generatedguidelines to determine target directions and depth. This chapter providesinformation on the following endocavity transducer:

• 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 thatcan be switched during the imaging session.

Patient Safety

To operate an endocavity transducer, you must be a physician or sonographerwho is properly trained in endocavity techniques, according to currentlyapproved relevant medical standards. You also must be thoroughly familiar withthe safe operation, care, and maintenance of the Philips ultrasound imagingsystem used with the transducer, as well as proficient at interpreting the imagesgenerated. As always, use informed judgment when selecting patients forendocavity exams.

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 eachuse.

• Using mandatory protective equipment, such as a market-approved sheath orcondom, during an exam. See “Ordering Biopsy Kits and Sheaths” on page3-8.

Endocavity TransducerPatient Safety

3-2 Revision D.0

• Inserting and operating the transducer properly.

• Not allowing water or other liquids to drip into the transducer connector orthe interior of the system or onto the keyboard.

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

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

Table 3-1. Patient Safety Summary

Problem Effect on Patient Prevention Details

Mechanicaldamage

Severe trauma, cuts,bleeding, perforations

Inspect transducer using both sight andtouch before exam.

“Checking theTransducer” on page2-2

Insufficientcleaning protocol

Spread of illness ordisease

Thoroughly clean and disinfect transducerafter each use. Cover transducer withprotective sheath. Cover imaging systemwith disposable drape if highly pathogenicorganisms known or suspected.

“Cleaning andDisinfection ofTransducers Used inEndocavityProcedures” onpage 2-14

Improperinsertion orwithdrawal

Cuts, bleeding, ligamentdamage, perforations

Never use force when inserting orremoving transducer.

“Endocavity ExamGuidelines” on page3-7

Any otherirregularity

Potentially seriousconsequences

Do not use transducer. Contact your Philipsservicerepresentative

DefibrillationIssues

Electrical burns Disconnect transducer and removetransducer connector prior to defibrillation.

“Defibrillators” onpage 3-3

Endocavity TransducerEquipment Operation

Revision D.0 3-3

Equipment Operation

Meticulous inspection and correct and careful operation of an endocavitytransducer are important to patient safety. The situations listed in this sectionaffect safe operation as well as the ability to service mechanical problems underPhilips’ one-year warranty or service contract. Repairs necessitated by misuseare not covered and can be very costly, often requiring complete disassembly andrebuilding of the transducer.

The primary areas of misuse are:

• Cuts and abrasions on transducer insulation from sharp instruments such asscalpels, 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

A small hole in the outer layer of the transducer opens a conductive path togrounded metal parts in the transducer. The secondary arcing that could occurduring defibrillation could cause patient burns. The risk of burns is reduced butnot eliminated by using an ungrounded defibrillator. Therefore, remove thetransducer from the patient before defibrillation. A disposable sheathprovides no protective electrical insulation against defibrillation.

Accident Prevention

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

Before defibrillation, always remove the transducer from the patient.

Endocavity TransducerDescription and Use

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Description and Use

This section lists important features of the following endocavity transducer:

Endovaginal/Endorectal(Model 21336A)

Features: Enables high-resolution imaging for obstetrical, gyne-cological, prostate, and urological studies. Capable of2-D, MMode, Color, PW Doppler, Angio, and biopsy.Designed to be easy to hold and manipulate and to pro-vide maximum clinician and patient comfort.

Connection See “Transducer Setup” on page 1-1.

Frequency: 4.0 to 7.0 MHz, plus Fusion settings on SONOS.

Max Sector image: 126 degrees

Specs: Length (transducer & cable) – approximately 263 cmLength of handle & tip – 290 mmRadius of curvature – 8.7 mm

6APCkim1

Endocavity TransducerThe Endocavity Exam

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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 applyto all endocavity transducers.

CAUTION 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 contentsof the gel.


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Endocavity Transducer Preparation Procedure

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

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

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

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

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404e008


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

5 Place enough commercially-available water-based lubricant or sterile jelly onthe end of the covered transducer to facilitate insertion.

Preparing Patients for an Endocavity Exam

Before performing an endocavity exam, it is important that you thoroughlyexplain the exam procedures to the patient. Follow your department guidelinesfor 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 potentialpressure.

• Before each exam, carefully inspect the transducer, as described earlier inthis chapter.

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Endocavity TransducerAccessory Equipment

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

• Forceful insertion, manipulation, or withdrawal of a transducer can result inlacerations, 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.

Accessory Equipment

This section describes accessories and provides ordering information. It alsomentions circumstances that warrant the use of a disposable drape.

Ordering Biopsy Kits and Sheaths

To order biopsy kits and sterile sheaths for the Model 21336A transducer,contact:

CIVCO Medical Instruments Co.102 First StreetKalona, IA 52247-9589 USAE-mail: info @civcomedical.comhttp://www.civco.com

Call 1-800-445-6741 within the United States or 1-319-656-4447 outside of theUnited States. To fax orders call: 1-319-656-4451.

NOTE Biopsy needle guides are available for this transducer. See “Biopsy-CapableTransducers” on page 5-1 for ordering information and instructions for use of thebiopsy kit.


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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 imagingsystem with a drape. Consult your hospital’s rules regarding equipment use in thepresence of infectious disease.


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4 TEE Transducers

Overview

A transesophageal echocardiography (TEE) exam is performed with a transducermounted in a gastroscope, which is positioned in the esophagus or stomach. TEEtransducers offer images that are unobstructed by lungs and ribs, making themimportant diagnostic tools for conditions that transthoracic echocardiographycannot adequately image.

This chapter provides information on the following TEE transducers:

• 21369A, the OmniPlane II transducer, enabling 360o views of the heart,steerable CW Doppler, dual frequency, and frequency agility. Additionalfeatures on the SONOS 7500 and 5500 include frequency fusion andadaptive color flow.

• 21378A, the OmniPlane III transducer, with a new UltraBand sensor for

harmonic and contrast imaging. Enables high resolution imaging and 360o

views of the heart, unobstructed by lungs and ribs. Capable of harmonicimaging, contrast research, tissue doppler, color flow imaging, steerable CWand PW Doppler, frequency agility, and electrocautery suppression. Tipsurface constantly monitored for patient safety. Convenient hanging ring.

• 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.

NOTE To TEE transducer customers: You will find English or translated versions ofthis chapter included separately with all OmniPlane III and miniMulti transducershipments for SONOS 7500/5500.

TEE TransducersOverview

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Audience

Philips TEE transducers are designed for use by physicians who are properlytrained in esophagogastroscopic techniques according to currently approvedrelevant medical practices. It is recommended that physicians operating anyPhilips TEE transducer are:

• Proficient in recognizing and interpreting transesophageal imaging patterns.

• Thoroughly familiar with the safe operation, care, and maintenance of thePhilips phased array ultrasound imaging system used with the transducer.

• Fully informed about the latest TEE methods through literature andseminars.

This chapter discusses the following transducers:

• Model 21369A, OmniPlane II (Cannon-style connector)

• Model 21378A, OmniPlane III (Cannon-style connector)

• Model 21381A, miniMultiplane (Cannon-style connector)

NOTE As of the date of this publication, you can find the latest cleaning anddisinfection information for TEE and other transducers in Chapter 2, "Caring forTransducers", in this manual.It is important, however, that you periodically check the following Philips website for the very latest updates on cleaning and disinfection guidelines for TEEtransducers: www.medical.philips.com/transducercare

TEE TransducersPatient Safety

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Patient Safety

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

Philips recommends thatyou practice using thecontrols beforeperforming everyprocedure mentionedhere.

To operate a TEE transducer, you must be a physician who is properly trained inesophagogastroscopic techniques, according to currently approved relevantmedical practices.

You also must be thoroughly familiar with the safe operation, care, andmaintenance of the Philips ultrasound imaging system used with the transducer,as well as proficient at interpreting the images generated. As always, useinformed 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 eachuse.

• Inserting, removing, and operating the transducer properly.

• Ensuring that the transducer handle does not rest on or touch the patient.

Bite guards aremandatory; protectivesheaths arerecommended for TEEtransducers.

• Using protective equipment, such as a bite guard and a market-approvedsheath, during a TEE exam. See “Accessory Equipment” on page 4-41.

• Not allowing water or other liquids to come in contact with the transducerconnector, 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.

TEE TransducersPatient Safety

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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


Mechanicaldamage

Severe trauma, cuts,bleeding, perforations

Inspect transducer, using both sight andtouch before exam.

page 4-25

Electrical damage Esophageal burns Check transducer for frayed insulation, kinks,or other abnormalities. Follow electricalsafety checking procedures.

page 4-7

Biting, scrapingtransducer

Tooth damage, esophagealburns

Always use a bite guard. page 4-41

Insufficientcleaning protocol

Spread of illness or disease Thoroughly clean and disinfect transducerafter each use. Cover tip and shaft withsheath. Cover imaging system withdisposable drape if highly pathogenicorganisms are known or suspected.

page 2-16

Improper insertionor withdrawal

Esophageal cuts, bleeding,ligament damage,perforations

Never use force when inserting, removing, ormanipulating transducer. During insertion,lock the medial/lateral controls. Duringwithdrawal, place the medial/lateral controlsin freewheeling mode.

page 4-27

Pressure necrosis Death of esophageal liningtissue

Keep deflection controls in freewheelingmode and unplug transducer from systemwhen not imaging. Minimize the pressureapplied to deflection area and distal tip. Donot let distal tip displace a tissue area formore than five minutes.

page 4-27

Increasedtransducertemperature

Esophageal burns Use the TEE preset which has beenestablished to minimize the effects oftemperature. For febrile patients, use theAuto-Cool feature.

page 4-31

Improper patientposition

Transient unilateral vocalcord paralysis

Never use the transducer during anyprocedure requiring extreme neck flexion,such as sitting craniotomies.

page 4-27

TEE TransducersEquipment Operation

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NOTE The Philips diagnostic ultrasound systems and transducers in this manual do notcontain natural rubber latex that contacts humans. Natural rubber latex is notused on any ultrasound transducer, including transthoracic, intraoperative, andtransesophageal transducers. It also is not used on Philips ECG cables for theproducts in this manual.

Equipment Operation

Meticulous inspection and correct and careful operation of a specialty transducerare imperative to patient safety. The situations listed in this section affect safeoperation as well as the ability to service mechanical problems under Philips one-year warranty or service contract. Transducer repairs necessitated by misuse arenot covered and can be very costly, often requiring complete disassembly andrebuilding of the transducer.

The primary areas of customer misuse are:

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

Non-isolatedESUs

Electrical burns Only use isolated-output electrosurgical units(ESUs); the ESU label or service guide, oryour biomedical department, should identifywhether or not the ESU is isolated. Unplugtransducer from the system when you are notimaging.

page 4-7

Defibrillationissues

Electrical burns Disconnect transducer and removetransducer connector prior to defibrillation.

page 4-8


Potentially seriousconsequences

Do not use transducer. Contact yourPhilips servicerepresentative.

Table 4-1 Patient Safety Summary (Continued)


TEE TransducersEquipment Operation

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• Improper disinfection techniques, causing fluid to enter the control headassembly, control housing, and the rest of the transducer.

• Consistently applying too much force to the control wheels of a TEEtransducer, which can break the steering mechanism.

Review the following table to identify specific problems and how to avoid them,and review the pages in this guide where details are provided. Philips alsostrongly recommends that you clearly post stringent protocols for TEE transducercare 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, frayedinsulation, kinks, or other abnormalities.Follow electrical safety checkingprocedures.

page 4-7

Biting transducer Mechanical and electricalhazards

Cover patient’s teeth with a bite guard.Cover the distal tip and flexible shaft witha protective sheath (recommended).

page 4-41

Forcingdeflectioncontrols

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

Incorrect storage Possible damage to highlysensitive elements, cuts inflexible shaft

Suspend transducer from a wall-mounted rack and cover distal tip with tipprotector when not in use.

page 2-3

Internalexposure toliquids

Severe transducer damage thataffects image quality, steeringmechanism, and electricalsafety

Never sterilize transducer using bleach,steam, heat, or ethylene oxide. Neverimmerse steering mechanism in anydisinfectant or liquid.

page 2-16


Potential severe damage Do not use transducer. Contact yourPhilips servicerepresentative

TEE TransducersElectrical Safety

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Electrical Safety

The Philips ultrasound systems and the transducers discussed in this manualcomply 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-outprocedure.

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 surfacesdistal to the control housing. Within the flexible shaft, all active circuits andconductors are surrounded by a chassis-grounded shield that runs the length ofthe transducer.

If the outer layer of the shaft is punctured or cracked, a patient’s esophagus couldbe exposed to chassis leakage current. This leakage current is not hazardousprovided that the ground connector (third wire) in the ultrasound system powercable is intact and connected to a properly grounded wall outlet. Even if theground connector breaks, leakage current will not exceed 100 microampereswhen connected to a 120-volt outlet, or 200 microamperes when connected to a240-volt outlet.

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

Electrosurgical Units

Electrosurgical units (ESUs) and other devices intentionally introduce radiofrequency electromagnetic fields or currents into patients. Because imagingultrasound 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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Combinations of failures in an ESU or other device and in the outer layer of thetransducer shaft can cause electrosurgical currents to return along the transducerconductors. This could burn the patient, and the ultrasound system and transducercould also be damaged. Be aware that a disposable sheath provides no protectiveelectrical insulation at ESU frequencies.

NOTE The OmniPlane III (Model 21378A) has ESU suppression.

Pacemakers

Ultrasound equipment in normal operation, as with other medical electronicdiagnostic equipment, uses high-frequency electrical signals that can interferewith pacemaker operation. Though the possibility of interference is slight, bealert to this potential hazard and halt system operation immediately should younote interference with a pacemaker.

Defibrillators

Observe these precautions when using a TEE transducer when a defibrillation isrequired:

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

• Keep in mind that a disposable sheath provides no protective electrical insu-lation against defibrillation.

• A small hole in the outer layer of the transducer opens a conductive path togrounded metal parts in the transducer. The secondary arcing that couldoccur during defibrillation could cause patient burns. The risk of burns isreduced but not eliminated by using an ungrounded defibrillator.

Accident Prevention

Visually and tactually inspect a TEE transducer for bumps, cracks, and cuts priorto each TEE exam. A small bump on the shaft surface could indicate that a strandfrom the ground shield has broken and is beginning to puncture the outer layer. Ifyou suspect a problem with the flexible shaft, perform the electrical safetychecking procedure provided in Safety and Standards.


Revision D.0 4-9


Use ESUs that have isolated outputs. Return fault/ground fault detection circuitsprovide 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 biomedicalengineer.)


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

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

If the transducer is left in a patient during periods when imaging is not takingplace, unplug the transducer from the system to reduce the possibility of leakagecurrent or ESU interaction. Also make sure that the deflection control brakes areoff and that the transducer is in freewheeling mode.

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

Electrical Check-Out Procedure for TEE Transducers

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

TEE TransducersDescription and Use

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Description and Use

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

• OmniPlane II (Model 21369A), using the Cannon-style connector

• OmniPlane III (Model 21378A), using the Cannon-style connector

• miniMultiplane (Model 21381A), using the Cannon-style connector

Basic Transducer Parts

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

• Brakes for OmniPlane transducers

• Array rotation buttons for the OmniPlane transducers


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Deflection Control Basics

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

Figure 4-1. Basic TEE Transducer Parts

008E11C

Deflection controls

Control housing

Distal tip

Deflection area

Flexible shaft

System connector cable

Transducer connector


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

Never apply excessive force when operating the deflection controls duringimaging. 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 transducerbe straightened and both friction brakes released before withdrawing thetransducer from the patient. In the neutral position the tip is straight whenboth white circles on the control wheels are aligned and point toward thecenter of the array rotation button.

Figure 4-2. Deflection Control Movement

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

2. Radwin, Martin, et al., “Transesophageal Echocardiography: Intubation Techniques,” PhilipsApplication Note 5091-2804E, 1992.


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Temperature Controls

The TEE transducers discussed in this manual have temperature sensors in thedistal tip. An automatic warning appears on the ultrasound screen if the distal tiptemperature 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 temperaturemore accurately, and can prevent unnecessary interruptions while scanning. Seepage 4-31 for more details of the TEE Auto-Cool feature.


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

OmniPlane II(Model 21369A)

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 andanterior/posterior tip movement, with an adjustable frictionbrake. Capable of color flow imaging, steerable CW and PWDoppler, and frequency agility. Tip surface constantly moni-tored for patient safety. Convenient hanging ring.

Connection: See “Transducer Setup” on page 1-1.

Specs: Tip – 14.4 mm x 11.5 mm, 34 mm longShaft – 10.5 mm diameter, 100 cm long

5apc040


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.

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

OmniPlane III(Model 21378A)

Features: New UltraBand sensor for harmonic and contrast imaging.

Enables high resolution imaging and 360o views of the heart,unobstructed by lungs and ribs. Capable of harmonic imag-ing, contrast research, tissue doppler, color flow imaging,steerable CW and PW Doppler, frequency agility, and elec-trocautery suppression. Tip surface constantly monitored forpatient safety. Convenient hanging ring.


Specs: Tip – 14.9 mm diameter, 34.7 mm longShaft – 10.4 mm diameter, 100 cc long


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Manipulating the OmniPlane II Tip

This section contains details of OmniPlane II deflection controls and brakes. Besure to read “Deflection Control Basics” on page 4-11 for backgroundinformation pertaining to SONOS TEE transducers.

The larger inner wheel controls anterior/posterior movement, while the smallerouter wheel controls medial/lateral movement. Aligning the white circles on eachwheel with the center of the array rotation buttons places the tip of the TEE probeinto the neutral position.

Each wheel has a friction brake that holds the tip position without locking it inplace. Use the minimal setting needed to maintain tip position. This allows the tipto straighten if it meets additional resistance.

• The brake for the larger wheel (anterior/posterior movement) is the leverwith the arrow on it. Push the lever in the direction of the arrow to increasethe resistance, or holding power, of the brake.

• The brake for the smaller wheel (medial/lateral movement) is the knob thatsits on top of the wheel. Turn this knob clockwise to increase resistance.

Figure 4-3. OmniPlane II Deflection Controls and Brakes

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Array rotation buttons

Neutral position indicators (no deflection)

Medial/lateral control

Friction brake for anterior/posteriorcontrol

Anterior/posterior control knob

Friction brake for medial/lateral control


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Manipulating the OmniPlane III Tip

This section contains details of OmniPlane III deflection controls and brakes. Besure to read “Deflection Control Basics” on page 4-11 for backgroundinformation pertaining to SONOS TEE transducers.

Figure 4-4. OmniPlane III Deflection Controls and Brake

The larger inner knob controls anterior/posterior movement, while the smallerouter knob controls medial/lateral movement. Aligning the ribs on each knobwith the center of the array rotation buttons places the tip of the TEE probe intothe neutral position.

The knobs can be controlled by a detent brake that holds the tip position withoutlocking it in place. This allows the tip to straighten if it meets additionalresistance. When the detent break actuator is rotated to the right (as shown) bothknobs are in the freewheeling mode. When the detent break actuator is centeredthe small knob (medial/lateral movement) is in the detent mode,and when theactuator is rotated to the left, both knobs are in the detent mode.

Array rotation buttons

Neutral position indicators(no deflection)

Detent break actuator

Medial/lateral control

Anterior/posterior control knob


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During insertion, engage medial/lateral detente to limit movement 1 or use

freewheeling mode (no deflection and no brake resistance)2 to prevent patientinjury.

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 currentor ESU interaction. Also, make sure the transducer is in freewheeling mode.

Rotating the OmniPlane Array

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

• On the SONOS 7500 and 5500 use the array rotation buttons on the trans-ducer handle.

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

b. To decrease rotation, press the button that is proximal to the system.Rotation stops when you release either button.

• You can use the method described above, or you can use the array rotationcontrols on the system’s touch panel.

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

b. To decrease the degree of rotation continuously, press Down (touchingDown again stops the rotation).

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

1. Radwin, Martin, et al., “Transesophageal Echocardiography: Intubation Techniques,” AgilentApplication Note 5091-2804E, 1992.

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


Revision D.0 4-19


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. Becausethe center of the array is the pivot point, you can achieve a 360o view, as shownin the following figure.

Figure 4-5. OmniPlane Array

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

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

Transducer Calibration Failed Message

If you see a “Calibration failed” message on the screen, you can continue toimage. However, the transducer may lack the full 180o rotation capacity, and therotation 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.

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


Revision D.0 4-21


Selecting Patients on Whom to Use the miniMulti

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

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 rotationwheel on the handle of the transducer controls the rotation ofthe 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.


Specs: Tip – 10.7 mm x 8.0 mm, 27 mm longShaft – 7.4 mm diameter, 70 cm long


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Philips recommends that you use the miniMulti TEE transducer only on patientsweighing 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 thepossible effects of other therapies the patient is undergoing. You must alsoconsider all gastro-esophageal abnormalities or difficulty swallowing.

Deflection and Scanplane Rotation Control

The control handle is designed for one-hand operation. Normally, you shouldoperate the control handle with your left hand. Thumb, first and second fingerscontrol 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 themovement of the deflection wheel is restrained. This is used to hold the tip in acertain 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 controlsdeflection of the miniMultiplane 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 orexceeds the maximal deflection angles given above, do not use the trans-ducer. Contact the service organization to re-adjust the steering of thetransducer. In this way, the risk of "buckling" or "U-turning" of the trans-ducer in the esophagus is minimized.


Revision D.0 4-23


Lock operation

To protect the patient and the transducer, unlock the deflection control wheninserting or withdrawing the transducer.

White

Unlock

Lock

Red


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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 inbetween can also be chosen. This makes it possible to scan a conical imagingvolume.

CAUTION Do not use excessive force on the scanplane rotation control wheel at its outer

positions as this may damage the endoscope mechanism.1, 2

Short AxisAngle = 180°

Long AxisAngle = 90°

Short AxisAngle = 0°

1. Radwin, Martin, et al., “Transesophageal Echocardiography: Intubation Techniques,” AgilentApplication Note 5091-2804E, 1992.

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


Revision D.0 4-25


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.

Checking the Transducer

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

Inspect the Transducer

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

Also check for excessive flexibility in the tip, particularly in themedial/lateral direction. Do not use the transducer if the tip is extremely flexible.Contact your Philips service representative if you have any questions on tipflexibility.

Verify Operation of the Controls

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

Also test the position-holding and free-wheeling modes of operation. Rememberthat the controls must be in free-wheeling mode (no deflection and no brakeresistance) when repositioning or withdrawing the transducer, as well aswhenever you are not imaging.

TEE TransducersSpecial Considerations for TEE Exams

4-26 Revision D.0

Special Considerations for TEE Exams

Special consideration regarding a TEE exam is advisable for patients withexisting gastroesophageal abnormalities such as esophageal varices, hiatalhernia, tumor, diverticula, esophageal webs and rings, fistulae, or peptic ulcers,as well as for patients who have had anti-reflux procedures. In addition, youshould:

• Consider the patient’s size and ability to accommodate the transducer tip andshaft.

• 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 pathologyduring an exam. Particularly with pediatric patients, be alert for congenitalproblems with the esophagus or stomach.

• Use the Auto-Cool feature when examining a patient with an above-normaltemperature. The Auto-Cool feature is described on page 4-31.

This list is not comprehensive. Rather, it suggests areas to investigate whenconsidering TEE for a particular patient.

Preparing Patients for a TEE Exam

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

• In addition to gathering routine background information such as currentmedication and allergies, investigate any history of chronic obstructive lungdisease, esophageal strictures, varices, or bleeding.

• Inform the patient to go without food or water for at least six hours prior tothe exam. Also advise the patient that he or she should not plan to drive afterthe exam, as sedatives are often used.


Revision D.0 4-27


• 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 ofthe patient, and can monitor the patient’s blood pressure and general responses.For unexpected occurrences, an emergency cart with basic life supportequipment should be ready. Throughout the exam it is important to carefullymonitor the patient’s reactions and assure that ventilation and vital signs arestable.

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 4-29 for details.

Maintain a patent airway.

For surgical patients, endotracheal intubation establishes a stable, patent airwayprior to insertion of the transducer. For awake patients, carefully monitor thepatient’s breathing at all times.

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


4-28 Revision D.0

Minimize the possibility of pressure necrosis (tissue death).

Do not let the distal tip displace any one segment of tissue for more than fiveconsecutive minutes. Also make sure the deflection area and the distal tip are in aposition 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 fromthe system during periods of poor perfusion, circulatory arrest, or thehypothermic phase of open heart surgery. To discontinue scanning, unlock thetransducer connector according to the instructions in “Transducer Setup” on page1-1.

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

A thorough inspection procedure is required for the safety of the patient andyourself, 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 andwithdrawal.

Forceful insertion, manipulation, or withdrawal of a transducer can result inlacerations, bleeding, perforation, tearing of adhesions, and ligament damage.Also, be aware that the tip can fold over, causing similar damage; the next sectionprovides 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 orbottom. Support the transducer’s proximal head, either by having an assistant

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


Revision D.0 4-29


hold the steering mechanism or by clamping the transducer at the steeringmechanism. However, if you use a clamp, be sure that it neither interferes withsteering nor is on any portion of the flexible shaft. Clamping the flexible shaftalways damages the transducer.

Tip Fold-Over Problem

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

Problem Prevention

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

Insertion techniqueYou might find transducer insertion easier if you guide the transducer into thepatient’s mouth with your fingers. You also might want to block medial/lateral tipmovement.

NOTE All patients must wear a bite guard during a TEE exam. A bite guard protectsagainst dangerous transducer mechanical and electrical malfunction caused byinvoluntary biting. Even anesthetized patients require bite guards to prevent dam-age to both their teeth and the transducer. See “Bite Guard” on page 4-41 forinformation on the bite guards available from Philips.

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

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

• Catching the tip in pharyngeal recesses.

• Insertion when a patient is being uncooperative, or having a convulsion orspasm.


4-30 Revision D.0

Patient esophageal pathologyCarefully review a patient’s medical history for obstructing pathologies oranatomical irregularities before performing a TEE exam.

Improper transducer maintenanceThoroughly examine the transducer and test the controls before each exam. Besure to check for excessive flexibility in the tip. Details are provided in “Whenrepositioning or withdrawing a TEE transducer, put the controls in free-wheelingmode. Also whenever the transducer is not being used during a procedure, makesure it is in free-wheeling mode and unplugged from the system” on page 4-25.

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 consultantsrecommend that you gently try to manipulate the transducer. If the tip is notlocked 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 thetransducer.

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

TEE TransducersEnsuring Accurate Temperature Sensing

Revision D.0 4-31


Ensuring Accurate Temperature Sensing

The Philips TEE transducers discussed in this manual contain a built-intemperature sensor near the distal tip of the transducer. The sensor monitors thetransducer’s temperature to prevent potential burning of esophageal tissue. Thesensor is also affected by patient core temperatures. The system assumes that thepatient temperature is normal, and calculates the distal tip temperatureaccordingly. If the patient’s temperature is above 37oC (98.6oF), the Auto-Coolfeature calculates a distal tip temperature that may be inaccurate. This couldexpose 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 temperatureaccuracy.

• Decrease acoustic output, using the Power control, before introducing a TEEtransducer, and keep it at the lowest possible setting during an exam, todecrease the transducer temperature.

• Use the TEE Manual Auto-Cool Safety feature to enter the patient tempera-ture if it is above 37oC (98.6oF), as described in the next section.

• Use the Adaptive Auto-Cool Safety Feature with the OmniPlane III trans-ducer, as described in “Adaptive Auto-Cool Safety Feature” on page 4-38.

TEE Manual Auto-Cool Safety Feature

Use the TEE Manual Auto-Cool Safety feature to enter above-normal patienttemperatures. By default, the system shows both the patient and distal tiptemperature while scanning.

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


4-32 Revision D.0

If the distal tip temperature reaches 41oC (105.8oF), a warning message appearsand the transducer temperature displays in inverse video. If the temperature

reaches 44oC (111.2oF), a warning appears with the patient and transducertemperatures, and the system stops imaging until the distal tip cools to 43.5oC orlower.

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 isabove normal, whether from fever or therapeutic heating from a cardiac bypassheart-lung machine, perform the steps below before insertion. Also follow thesesteps 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 actualtemperature in the esophagus. For patients undergoing surgery, you candetermine this temperature by direct measurement or by monitoring thetemperature of blood returning from the bypass pump heat exchanger. For closedchest situations, rectal temperature is the best estimate of core temperature. Youalso 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 or2oC to the measured axillary temperature.


Revision D.0 4-33


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

Entering the Patient Temperature on the SONOS 7500 and5500

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

1 Touch Probe.

2 Adjust Pat Temp to the current patient temperature.

Probe

Probe

Pat Temp37.0oC


4-34 Revision D.0

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

4 Rotate the PATIENT TEMP control to adjust the PAT T to thepatient’s current temperature. The default, when the system is turnedon, is 37oC. The current patient temperature displays beside the PAT T:label on the imaging screen.

6apc0158

PAT T:37.0oC


Revision D.0 4-35


Monitoring the Distal Tip Temperature

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

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

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

Figure 4-6. TEE Temperature Display

300e004

PAT T:37.0oCTEE T:37.0oC


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If the distal tip reaches 41oC (105.8oF) during imaging, a message appears on thescreen (Figure 4-7.).

Figure 4-7. TEE Auto-Cool Imminent Display

300e004

TEE auto cool imminent. Reduce

PAT T:37.0oC

TEE T:41.0oC

power and/or adjust Pat Temp.


Revision D.0 4-37


If the distal tip reaches 44oC (111.2oF) during imaging, a message displays on thescreen (Figure 4-8.).

Resuming Imaging

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

Figure 4-8. TEE Auto-Cool In Progress Display

300e004

TEE auto cool in progress.Wait for transducer to cool oractivate Xducer and adjust Pat Tempto set the current patient temp.

PAT T:37.0oC

TEE T:44.0oC


4-38 Revision D.0

WARNING The “Reconnect the transducer.” error message is often caused by a poorlyseated 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 .

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

Adaptive Auto-Cool Safety Feature

NOTE In the D.0 release this feature is exclusive to the Omni III transducer.

The Adaptive Auto-Cool Safety Feature is enabled when Adaptive Auto Cool ison. The Adaptive Auto Cool On/Off control is found under Probe Setup.

1. Ding-Jiu, et al., “Thermodamage, Thermosensitivity and Thermotolerance of Normal SwineEsophagus,” 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 ofTime and Surface Temperature in the Causation of Cutaneous Burns,” Am J of Path 23, 1947,pp. 695-720.

ResetReset

AdaptiveAutoCool

Probe


Revision D.0 4-39


If the distal tip reaches a computed temperature of 41 oC (105.8 oF) duringimaging: (1) the TEE T temperature is displayed in inverse video, (2) imagingcontinues, and (3) the message below appears.

If the distal tip reaches a computed temperature of 42 oC (107.6 oF) duringimaging in any Harmonic/Contrast or Doppler modes: (1) the system willautomatically transition to Fundamental/2D, (2) the TEE T temperature isdisplayed in inverse video, (3) imaging continues, and (4) the message below isdisplayed for 15 seconds.

If the distal tip reaches a computed temperature of 43 oC (109.4 oF) duringimaging: (1) the TEE T temperature is displayed in inverse video, (2) imagingstops, and (3) the message below appears.

When the distal tip temperature drops below 42.5 oC (108.5 oF), the systemresumes imaging.

TEE auto cool imminent. Reducepower and/or adjust Pat Temp.

Alert auto coolactivated.

TEE auto cool in progress.Wait for transducer to cool oractivate Probe and adjust Pat Tempto set the current patient temp.


4-40 Revision D.0

Patient and Distal Tip Temperature Display Setup on theSONOS 7500 and 5500

1 Press and touch Probe.

2 Touch TEE Temp Display to turn the temperature display on or off.

3 Adjust TEE Temp to display either C (Centigrade) or F (Fahrenheit).

Setup

Probe

Even when this controlis off, the systemdisplays thetransducertemperature if itapproaches thetemperature limit.

Probe

TEE TempDisplay

To make a changepermanent, save it aspart of a preset. SeeSystem Basics formore information.Press Setup to returnto imaging.

TEE TempoC

TEE TransducersChecking the Patient After the TEE Exam

Revision D.0 4-41


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 stepsyou 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 anyfever, chills, chest pain, or bleeding.

• Tell the patient not to eat or drink for at least two hours, or until swallowingreturns to normal after anesthesia has worn off. It is especially important thatthe patient not ingest hot foods or fluids during this period.

• Call the patient the day after the exam to make sure there are nocomplications.

Accessory Equipment

Each TEE transducer comes with a disposable bite guard and tip protector. Thissection describes these accessories and provides ordering information for theseand for protective sheaths, which are recommended for examinations with TEEtransducers. It also mentions circumstances that warrant the use of a disposabledrape.

Damage caused whenpatients bite or scrape aTEE transducer is notcovered in thetransducer’s warranty orservice contract. Youmust use bite guards tohelp prevent suchaccidents.

Bite Guard

All patients must wear a bite guard during a TEE exam. A bite guard protectsagainst dangerous transducer mechanical and electrical malfunction caused byinvoluntary biting. Even anesthetized patients require bite guards to prevent

TEE TransducersAccessory Equipment

4-42 Revision D.0

damage to both their teeth and the transducer. Philips supplies two disposablebite guards suitable for both awake and anesthetized patients.

Tip Protector

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

Ordering Bite Guards and Tip Protectors

To order additional bite guards and tip protectors in the United States, contact thePhilips Medical Supplies Center at 1-800-225-0230. In Canada, call 1-800-387-3154. In other countries, contact your local Philips sales representative.You canalso go to the following Philips web site for the latest ordering information:


Ordering Disinfection Basins

To order TEE disinfection basins, contact your local Philips customerrepresentative.

Figure 4-9. Bite Guards

0008e2a


Revision D.0 4-43


Ordering Protective Sheaths

It is recommended that you use protective sheaths with TEE transducers duringexaminations. To order protective sheaths for TEE transducers, contact:



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 imagingsystem with a disposable drape. Consult your hospital’s rules regardingequipment use in the presence of infectious disease.


4-44 Revision D.0

Revision D.0 5-1

5 Biopsy-Capable Transducers

Transducers Supporting Biopsy

Biopsies can be performed with a variety of probes. The following table liststransducers that support the use of biopsy needle guides and the biopsy kit usedby each.

Ordering Biopsy Kits and Sheaths

To order biopsy kits and sheaths, contact:



Table 5-1. Ordering Biopsy Starter Kits

TransducerName

Model # CIVCO Biopsy StarterKit #

Comment

c3540 21321A 645-057 Supported for SONOS

C5040 21373A 645-032 Supported for SONOS

E6509 21336A 610-588 An endovaginal/endorectal probe. See“Endovaginal/Endorectal (Model 21336A)” onpage 3-4. Supported for SONOS.

Biopsy-Capable TransducersBiopsy Needle Guide Instructions

5-2 Revision D.0


Biopsy Needle Guide Instructions

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

• Preparation for use

• Attaching the bracket

• Applying a sterile cover

• Attaching a needle guide

• Cleaning and sterilization

Using the Biopsy Needle Guide

The SONOS 7500/5500 system displays biopsy guidelines that direct theoperation of the biopsy needle. Activate the on-screen guidelines and carefullywatch the image during insertion of the needle to verify the needle path.

For a description of system controls for biopsy use, refer to Chapter 5 of theSONOS System Basics guide.

Biopsy Precautions

Always follow these basic precautions when using a biopsy needle guide andbracket:

• All biopsy procedures must be performed using highly controlled sterile pro-cedures. Be sure that the biopsy needle package is not opened or damagedand that the date has not expired.

• Before using the biopsy setup for the first time, it is strongly recommendedthat you familiarize yourself with each possible needle position, procedure,

Biopsy-Capable TransducersCleaning and Disinfecting Transducers Supporting Biopsies

Revision D.0 5-3

probe, and screen display. See 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 sterile protective 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.

� Most biopsy brackets are not shipped sterile. Follow the manufacturer�s instructions to disinfect the biopsy bracket.

Cleaning and Disinfecting Transducers Supporting Biopsies

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.

Cleaning and disinfecting instructions for transducers used in biopsy procedures are included in �Cleaning and High-Level Disinfection of Transducers Used in Biopsy Procedures� on page 2-18.

The most current information on cleaning and disinfecting transducers can be found on the following Philips web site


Biopsy-Capable TransducersCleaning and DisinfectingTransducers Supporting Biopsies

5-4 Revision D.0


Revision D.0 6-1

6 Intraoperative Transducers

Overview

An intraoperative transducer is used during surgery to help a surgeon locate andvisualize anatomical structures, to visualize blood flow patterns and quantifyvelocities, and to image and measure anatomic and physiologic parameters ofinterest to the surgeon.

This chapter shows you how to prepare the following transducers for use inintraoperative applications:

• 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 of minute defects. It allows trapezoidalimaging. The 21390A provides a small profile, making it easy to maneuver,and enabling interrogation of a site with restricted access or within a verysmall incision.

• 21380A, the high-frequency UltraBand Sector transducer, enables excellent2-D resolution by providing imaging in a range of frequencies, up to 12.0MHz. Small, lightweight design with a thin, flexible cable permits easymanipulation for neonatal and pediatric patients and on the organ surface.

• 21315A, a fully-functional UltraBand, 2-dimensional phased array. Capableof steering in both elevation and lateral dimensions, and can focus at anydepth. Enables Live 3D and BiPlane imaging by exhibiting all the behaviorsof a sector probe, and having the additional capability of scanning volumes(lateral x elevation x depth). Capable of 2D, Live 3D, and Harmonics, and

can be used for intraoperative imaging.1

NOTE See “Advanced Imaging” on page 7-1 for a complete description list of the fea-tures of the 21315A (x4 ) transducer.

___________________________________________________________________

1. Not approved in the European Union or Canada for epicardial imaging.

Intraoperative TransducersIntended Use

6-2 Revision D.0


Audience

Philips intraoperative transducers are designed for use under the guidance ofphysicians who are properly trained in intraoperative ultrasound imagingtechniques, according to currently approved relevant medical practices. It isrecommended 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 thePhilips phased array ultrasound imaging system and transducer.

• Fully informed about the latest intraoperative methods through literature andseminars.

Intended Use

Intraoperative studies are performed by surgeons, anesthesiologists, orsonographers to obtain images that can be used to:

• Help a surgeon locate and visualize anatomical structures, before, during, orafter 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 thesurgeon before, during, or after a surgical procedure.

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

NOTE For intraoperative use on the heart and central circulatory system, only the21390A 15-6L intraoperative transducer is approved in EU countries.

Intraoperative TransducersIntraoperative Probes Used for Animal Studies

Revision D.0 6-3

Intraoperative Probes Used for Animal Studies

WARNING Intraoperative probes used in animal studies should not be used onhumans. Transducer disinfection procedures for cross usage betweenanimals and humans have not been validated.

When the 21390A probe is used for animal studies, the animal use labelmust 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 humansubjects” 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 anintraoperative transducer.

To operate an intraoperative transducer, you must be under the guidance of aphysician who is properly trained in intraoperative ultrasound imagingtechniques, according to currently approved relevant medical practices. Also,you must be thoroughly familiar with the safe operation, care, and maintenanceof the Philips ultrasound imaging system used with the transducer, as well as beproficient at interpreting the images generated.

Intraoperative TransducersPatient Safety

6-4 Revision D.0


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 a sterile protective sheath,during an intraoperative exam. See “Ordering Sheaths” on page 6-15.

• Operating the transducer properly.

• Not allowing water or other liquids to drip into the transducer connector orthe 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 transducerconnector, contact your Philips service representative.

Be sure to use a transducer sheath when performing all intraoperativestudies.

Always remove the transducer from the patient before defibrillation.

Patient Contact Parts

Latex is commonly used in sheaths marketed to help with infection control intransesophageal, endocavity, and intraoperative imaging applications ortransducer covers used during biopsy. Examine the packaging to confirm latexcontent. Studies have shown that allergic reactions with natural rubber latex canbe experienced. The US Food and Drug Administration has published a medicalalert on latex products dated March 29, 1991.

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

Intraoperative TransducersEquipment Operation

Revision D.0 6-5

Equipment Operation

Meticulous inspection and correct and careful operation of an intraoperativetransducer are imperative to patient safety. The situations listed in this sectionaffect safe operation as well as the ability to service mechanical problems underPhilips’ one-year warranty or service contract. Transducer repairs necessitated bymisuse are not covered and can be very costly, often requiring completedisassembly and rebuilding of the transducer.

The primary areas of customer misuse are:

• Cuts and abrasions on transducer insulation and lens from sharp instrumentssuch 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 inquestion. Do not use the transducer and contact your Philips service representa-tive.

Philips strongly recommends that you clearly post stringent protocols forintraoperative transducer care, based on the information in this guide, tominimize the chance of damage.

Electrical Safety

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

This section includes information about testing leakage currents on intraoperativetransducers.

Intraoperative TransducersElectrical Safety

6-6 Revision D.0


Leakage Current

SONOS transducers approved for intraoperative use are labeled on the transducerconnector as type CF in accordance with IEC 60601-1. Type CFclassification indicates that the degree of protection from electrical shockafforded by the transducer is suitable for all patient applications including directcardiac and intraoperative applications.

Leakage Current Testing

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

Normal leakage current testing frequency should be based on the proceduresestablished by the hospital for operating room-based equipment.

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

The following procedure tests the current leakage, using a Dynatech Nevada 232Safety/ECG Analyzer. This procedure shows one example. The procedure foryour 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.


Revision D.0 6-7

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 theother end into the saline solution.

8 Set the safety analyzer Polarity switch to Normal.

9 Note the Normal condition leakage reading.

Test # 1 - Transducer Leakage Current Test (Source)

Hot

Neutral

SystemUnderTest

Transducerimmersed insaline solution

Main power switch “ON”AC MicroammeterGround green or

green/yellow


6-8 Revision D.0


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

11 Repeat Steps 9 and 10 with the Polarity switch in the Reverse position. Theapplicable limits are:

10 microamps rms (Normal condition)

50 microamps rms (Single fault condition)

WARNING There is considerable hazard in performing this test. Use precautionarymeasures to avoid accidental contact with line voltage. In addition, any timethat the ground connection has been opened, do not touch the chassis orpatient 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.

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

-

-

300e045

Transducerimmersed insalinesolution

AC Microammeter

Mainsvoltage

SystemUnderTest

LIMITS 50 microamps rms

Main power switch “ON”

Ground greenor green/yellow

Hot

Neutral

Intraoperative TransducersDescription and Use

Revision D.0 6-9

7 Connect a lead to any ECG terminal on the safety analyzer. Leave the otherend 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 thefinal 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


Accident Prevention



Description and Use

This section lists important features of the 21390A and 21380A models ofintraoperative transducers.


6-10 Revision D.0


This section also shows you how to prepare the 21390A, 21380A, and 21315Atransducers for use in intraoperative applications.

NOTE See “Advanced Imaging” on page 7-1 for a list of the important features of the213154A transducer.


Revision D.0 6-11

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 trapezoidalimaging. It provides a small profile, which is easy to maneu-ver, enabling interrogation of a site with restricted access orwithin a very small incision. Capable of color flow imaging,Angio, PW Doppler, and Intelligent Doppler.


Specs: Nose Footprint – 39 x12 mmHandle length – 9.9 cmWeight – 35 gm (transducer head)Cable - 244 cm


6-12 Revision D.0


High-Frequency UltraBand(Model 21380A)

Features: Improved performance by providing imaging in a range of fre-quencies, up to 12.0 MHz, which enables high resolution forthe finest anatomical structures. Small, lightweight designwith a thin, flexible cable that permits easier manipulation forneonatal and pediatric patients. Intraoperative imaging capa-bility assists surgeons in performing a more confident, qualitysurgical procedure. Capable of color flow imaging, CW andPW Doppler, and frequency agility.


Specs: Nose Footprint – 19 x 12 mmHandle length – 6cmWeight – 50 g (transducer head)

s12


Revision D.0 6-13

Preparing the Transducer for Intraoperative Imaging

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

If you are using the Models 21380A, 21390A, or 21315A transducers, use asheath 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 sheathfor leaks before proceeding.

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

416e015 6apc0144

21315A, 21380A 21390A


6-14 Revision D.0


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

4 Ensure that wrinkles over the face of the transducer are minimized. Ensurethat there are no bubbles over the lens face. Check the sheath for tears ordamage 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 andsheath surface. Sterile water works as a good acoustic coupling agent duringsurgery.

NOTE Make sure that the imaging surface is moist so that good acoustic contact isachieved. 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 imagingsystem with a disposable drape. Consult your hospital’s rules regardingequipment use in the presence of infectious disease.

Intraoperative TransducersAccessory Equipment

Revision D.0 6-15

Accessory Equipment

This section provides ordering information for accessory equipment.

Ordering Supplies and Accessories

To order supplies and accessories in the United States, contact the PhilipsMedical Supplies Center at 1-800-225-0230. In Canada, call 1-800-387-3154. Inother countries, contact your local Philips sales representative.You can also go tothe following Philips web site for the latest ordering information:


Ordering Sheaths

To order sterile protective sheaths for transducers, contact:

CIVCO Medical Instruments Co.102 First StreetKalona, IA 52247-9589 USAE-mail: [email protected]://www.civco.com


Intraoperative TransducersAccessory Equipment

6-16 Revision D.0


Revision D.0 7-1

7 Advanced Imaging

Overview

The x4 Transducer

The x4 transducer (Model 21315A) is a fully-functional, UltraBand, matrix phasedarray. It is used in transthoracic and epicardial imaging 1. The x4 is fully capable ofsteering in both elevation and lateral dimensions, and can focus at any depth.

The x4 matrix array technology enables Live 3D and BiPlane imaging by exhibitingall the behaviors of a sector probe and by having the capability of scanning volumes(lateral x elevation x depth). The x4 transducer is optimized for high frame ratestypically used in cardiology.

The x4 is also capable of 2D and Harmonics and can be used for intraoperativeimaging.

Live 3D Echo

Live 3D Echo refers to the real-time acquisition and rendering of three-dimensionalultrasound data. Live 3D is an integrated feature that acquires and renders three-dimensional acoustic data in real time. Acoustic data is obtained using the x4transducer. The acoustic data is sent to a PC for post processing, scan conversion,and rendering.

Legacy controls are used as they are normally used during 2D imaging, and allowthe user to manipulate the system in the way they are accustomed.

BiPlane Imaging

BiPlane imaging allows for simultaneous side by side viewing of two separate live2D images by taking advantage of the 2-dimensional set of elements in the Matrixtransducer. This allows the user to see cardiac function from two simultaneous liveslices.

For information on additional Live 3D cardiac and BiPlane scanning capabilities ofthe x4 transducer, refer to the 3-Dimensional and BiPlane Imaging User’s Guide.

___________________________________________________________________


Advanced ImagingDescription And Uses

7-2 Revision D.0


Description And Uses

This section lists important features of the x4 transducer (Model 21315A).

x4 Transducer (Model 21315A)

Features: Fully-functional UltraBand matrix phased array. Capable ofsteering in both elevation and lateral dimensions, and can focus atany depth. Enables Live 3D and BiPlane imaging by having theadditional capability of scanning volumes (lateral x elevation xdepth). Capable of 2D, Live 3D, and Harmonics, and can be usedfor intraoperative imaging.


Advanced ImagingIntended Uses

Revision D.0 7-3

Intended Uses

Cardiologists, surgeons, anesthesiologists, and sonographers can use the x4 transducer for:

� Adult, pediatric, and neonatal heart and vessel imaging

� Live 3D fetal cardiac and abdominal imaging

� Intraoperative imaging 1

The design of the x4 transducer enables you to perform:

Transthoracic imaging in 2D, Live 3D, and BiPlane modes. You can:

-- Perform live 3D cardiac and biplane imaging directly without resorting to offline rendering of captured images in 2D (where two orthogonal views of the heart allow a biplane view of the heart.)

-- Evaluate wall motion and perform biplane calculations on the same cardiac cycle.

_____________________________________________________


Advanced ImagingTransmit and Receive Parameters

7-4 Revision D.0


Controls for the x4 Transducer

Select the x4 transducer by touching the Control key under the Probe key.

Application-specific controls enabled by the x4 transducer are documented in theirapplication guides.

Refer to the 3-Dimensional and BiPlane Imaging User’s Guide for a description ofthe specific Live 3D and BiPlane controls enabled by the x4 transducer.

Transmit and Receive Parameters

The x4 transducer has several coefficient tables for transmit and receive parameters.These coefficient tables consume large amounts of memory and must be calculatedon power up, when the probe type changes, and each time the line spacing changes.

The following dialog box is displayed automatically whenever the calculations arenecessary, such as when the x4 transducer is first selected. By default, a complete setof coefficient tables for the currently selected Volume Size is performed, and the

Centerx4

Advanced ImagingGeneral Use and Safety Guidelines

Revision D.0 7-5

progress bar in the dialog box shows the amount completed. The user does notinitiate the calculations.

During calculations, the user can select the Postpone button to interrupt them and godirectly to scanning. However, when an imaging mode is later selected that requirescalculations that were postponed, a similar dialog box will appear without aPostpone button, and the calculations will run to completion.

General Use and Safety Guidelines

Procedures for installing, connecting, activating, handling, inspecting, and storingthe x4 transducer are regulated by the general use and safety guidelines fortransducers as documented in Chapter 1, “Transducer Setup” and Chapter 2, “Caringfor Transducers “ in this manual and in the Safety and Standards Guide.

For specific guidelines on preventing accidents, preparing the x4 transducer forintraoperative imaging, repetitive strain injury, and using the x4 transducer auto-cool safety features, see the following sections in this chapter:

• Accident Prevention

• Preparing Transducers for Intraoperative Imaging

• Repetitive Strain Injury

• Auto-Cool Safety

Preparing Scanner

Postpone

Advanced ImagingGeneral Use and Safety Guidelines

7-6 Revision D.0


Accident Prevention

Safe, hygenic use of the x4 transducer is regulated by the conditions and guidelinesthat apply to the following:

• Cleaning and disinfection of transducers used in non-invasive and intraoperativeprocedures, as documented in “Cleaning and Disinfecting Transducers” on page 2-6.

• Patient safety, equipment operation, electrical safety, and defibrillators forinteroperative transducers, as documented in the sections “Patient Safety”,“Equipment Operation”,and “Electrical Safety” in Chapter 6 in this manual.

Preparing the x4 Transducer for Intraoperative Imaging

For information on preparing the x4 transducer for intraoperative imaging, see:

• “Preparing the Transducer for Intraoperative Imaging” on page 6-13.

• “Cleaning and Disinfecting Transducers” on page 2-6.

Repetitive Strain Injury

Repetitive ultrasound scanning has been associated with Carpal Tunnel Syndrome(CTS) and repetitive strain injury. See the Safety and Standards guide for referencearticles.

Accessory Equipment

For ordering information for accessories and sheaths, see “Accessory Equipment”on page 6-15.

Advanced ImagingAuto-Cool Safety

Revision D.0 7-7

Auto-Cool Safety

Some probes (such as the x4 and TEE transducers) use Auto-Cool thermal controlsoftware to prevent overheating. This software issues onscreen warning messagesand, if necessary, terminates the imaging session to prevent transducer overheating.

This section documents the Auto-Cool safety features and requirements specific tothe x4 transducer.

If the x4 transducer reaches a computed temperature of 42.0oC (107.4oF) duringimaging: (1) imaging continues, and (2) the message below appears:

If the x4 transducer reaches a computed temperature of 42.5oC (108.5 oF) duringimaging: (1) imaging stops, and (2) the message below appears:

When the x4 transducer temperature drops below 40.5 oC (104.9 oF), the systemresumes imaging.

The following warning message will display (1) at temperatures above 47.7 oC, (2)if a failure exists in the Auto-Cool safety logic, or (3) if the x4 transducer connectoris not properly seated:

Autocool Warning

Autocool Active

Reconnect the transducer, then pressReset. If problem persists, contactyour Philips service representative.

Advanced ImagingAuto-Cool Safety

7-8 Revision D.0


Revision D.0 8-1

8 Transthoracic OmniPlane Transducer

Overview

A transthoracic OmniPlane transducer contains a motor in its housing that is usedto rotate the transducer’s array through 180o. This design enables 3-D acquisitionof data sets transthoracically.

The following transthoracic transducer is discussed in this chapter:

• 21349A, the transthoracic OmniPlane transducer, enabling 3-D acquisitionof data sets, steerable CW and PW Doppler, and adaptive color flow.

Electrical Safety

Defibrillators


Accident Prevention



Transthoracic OmniPlane TransducerElectrical Safety

8-2 Revision D.0

Description and Use

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

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

Repetitive Strain Injury

Repetitive ultrasound scanning has been associated with Carpal TunnelSyndrome (CTS) and repetitive strain injury. See the Safety and Standards guidefor reference articles.


Revision D.0 8-3

.

Transthoracic OmniPlane(Model 21349A)

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 enablingsuperior diagnostic decisions. Lightweight, ergonomic designfacilitates 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 operationinclude color flow imaging, steerable CW and PW Doppler,and adaptive color flow.


Specs: Nose Footprint – 18.7 mm diameterHandle length – 12.7 cmWeight – 130 g (transducer head)

6APC0154


8-4 Revision D.0

Rotating the Transthoracic OmniPlane Array

You can rotate the Transthoracic OmniPlane array to achieve a 360o view of theheart 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 againstops the rotation).

2 To decrease the degree of rotation continuously, press Down (touching Downagain stops the rotation).

3 Turn Seek Angle to locate a specific angle. When you touch Seek, the arrayrotates 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 sideof the imaging screen. Because the center of the array is the pivot point, you canachieve a 360o view, as shown in the following figure.


Revision D.0 8-5

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

Figure 8-1. Transthoracic OmniPlane Array Rotation

6apc0151

0

45

90

135

180

0

45

90

135

180

0

90

45

135

180

°0 180°°

°0 180°

°0 180°

°0 180°

°0 180°

°

°

°

°°

°

°

°

° °

°

°

°

°


8-6 Revision D.0

Transducer Calibration Failed Message

If you see a “Omni Transducer Calibration failed” message on the screen, youcan continue to image. However, the transducer may lack the full 180o rotationcapacity, 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.

Index-1

Numerics3D

using the x4 transducer7-1

Aaccessories

endocavity 3-8intraoperative 6-15TEE 4-41

acoustic coupling medium2-5

what gels not to use 2-5array rotation controls,TEE4-18array rotationcontrols,TransthoracicOmniPlane 8-4auto cool feature,TEE 4-31auto-cool feature

adaptive, for Omni III4-38

Bbiopsy

CIVCO starter kit 5-1cleaning and disinfectingtransducers 5-3guide instructions 5-2transducers supporting5-1

biopsy needle guideon-screen guidelines 5-2precautions using 5-2system controls 5-2

biopsy starter kitsordering 5-1

biopsy transducerscleaning and disinfecting2-18

biplane imagingdescribed 7-1

bite guard 4-41bleeding 4-12brakes

OmniPlane II 4-16

Ccalibration failed message4-20, 8-6carpal tunnel syndrome

and ultrasound scanning2-2, 7-6, 8-2

checking transducersintraoperative 2-2TEE 4-8, 4-25

chemicalsdamaging transducers2-11

CIVCOcontact information forbiopsy kits 5-1ordering accessories 3-8,4-43, 6-15web site 3-8, 4-43, 6-15

cleaningtransesophageal andendocavity transducers2-7web site for Preface-1,2-6

cleaning and disinfectionendocavity transducers2-14intraoperativetransducers 2-20TEE 2-16

connection informationendocavity transducers1-8intraoperative 1-9TEE 1-8TransthoracicOmniPlane transducer1-9

connection tips 1-2cracks 2-2critical device category

for transducers 2-7

Ddamage

warranty issues 2-11,2-12, 2-15, 2-17, 2-21

damaged pins 2-2defibrillators

precautions using othertransducers with 3-3, 8-1precautions using TEEtransducers with 4-8

deflection controlschecking 4-25general 4-11OmniPlane II 4-16

Index

Index

Index-2

disinfectantsFDA clearance for 2-9glutaraldehyde-based 2-8non-glutaraldehyde-based 2-10to use 2-8

disinfectionendocavity transducers2-14high-level 2-7low-level 2-6

distal tip 4-3, 4-28drape

using during exams 3-9,6-14

Eelectrical safety

intraoperative 6-5TEE 4-7

endocavity examguidelines 3-7

endocavity transducersaccident prevention 3-3cleaning and disinfection2-14connection information1-8disposable drape 3-9exam guidelines 3-7misuse of equipment 3-3model 21336A 3-4ordering accessories 3-8overview 3-1patient safety 3-1preparing for use 3-5

revision levels for using1-8sheaths for 3-6storage 2-4using defibrillators with3-3using gels with 3-5

enzymatic cleaner 2-16, 2-18ergonomic grip 2-2

cleaning 2-3installing 2-2ordering 2-2

error messagescalibration failed 1-3,4-20, 8-6

ESU,electrosurgical units 4-7exam guidelines

endocavity 3-5TEE 4-26

external-use transducersstorage 2-3

Ffeatures

new at D.0 Preface-2non-supported at D.0Preface-2

flexible shaft 4-28frequency

changing on system 1-4optimizing on system 1-4

frequency agility 6-12

Ggels

for endocavity 3-5which to use 2-5

glutaraldehyde-baseddisinfectants

listed for use 2-8guidelines

endocavity exam 3-7TEE exam 4-26

HHigh-FrequencyIntraoperative Linear Array(Model 21390A)

described 6-11High-Frequency UltraBandtransducer (Model 21380A)

described 6-12

IImagePoint Hx

table of supportedtransducers on SONOS1-7

intraoperative studiesrequire type CFtransducer 6-4

intraoperative transducerapproved by EU 6-2

Index

Index-3

intraoperative transducersaccessory equipment6-15, 7-6accident prevention 6-9all require type CFclassified 6-4and defibrillators 6-9animal use label 6-3cleaning and disinfection2-20connection information1-9defined 6-1electrical leakage testing6-6illustrations of 6-9models describedin-depth 6-9no cross-use betweenanimals and humans 6-3ordering supplies for6-15, 7-6patient safety 6-3prepare for imaging 6-13requirements for using6-2revision levels for using1-9storage 2-3, 2-4supported modelsdescribed 6-1uses of 6-2using for animals 6-3

Llacerations 4-12latex 2-5, 6-4

leakage currentdetectors listed 6-6intraoperativetransducers 6-6TEE transducers 4-7testing 6-6

linear transducersdisinfectantsrecommended 2-9

live 3D echodescribed 7-1new controls 7-1

Mmatrix transducer(x4)

auto-cool safety 7-7controls for 7-4description and uses of7-1disinfectantsrecommended 2-9ordering supplies for 7-6preparing forinteroperative imaging7-6safety guidelines 7-5

messages“?? Probe” 1-2“NO Probe” 1-2calibration failed 1-3,4-20, 8-6thermistors in TEEtransducer open 4-38

miniMultiplane transducercontrols for 4-22described 4-21

model numbersof ImagePoint HXtransducers 1-7of SONOS 7500/5500transducers 1-5

OOmniPlane array

rotating 4-18OmniPlane II transducer

deflection controls andbrakes 4-16described 4-14manipulating tip 4-16

OmniPlane III transducerdeflection controls andbrakes 4-17described 4-15has ESU suppression 4-8manipulating tip 4-17

orderingbiopsy kits and sheaths3-8, 5-1interoperativeaccessories 6-15TEE accessories 4-41

Index

Index-4

Ppacemakers 4-8PAT T display 4-35patient safety

defibrillators 3-3, 4-8,8-1endocavity 3-2how to prevent problems3-2non-use of latex 6-4

patient safety, intraoperativeelectrical 6-5

patient safety,TEEauto cool 4-31bite guard 4-41electrical 4-7post-exam guidelines4-41pre-exam considerations4-26pressure necrosis 4-12,4-28tissue damage 4-12

patient temperatureentering on the HPSONOS 5500 4-33

pressure necrosis 4-12, 4-28

Rrepetitive strain injury 2-2,7-6, 8-2rubber latex

never used 2-6

Ssafety features

auto cool for TEE 4-31auto-cool for Omni III4-38

sector transducersdisinfectantsrecommended 2-9

semicritical devices 2-7shaft 2-4, 4-28sheath

endocavity transducers3-6

sheath, intraoperativetransducers 6-13, 6-15SONOS D.0 release

non-supported featuresPreface-2tables of supportedtransducers 1-5what’s new in Preface-2

storageexternal-use 2-3intraoperative 2-4TEE 2-4

supported featuresnew at D.0 Preface-2non-supported at D.0Preface-2

swelling 2-2

TTEE

auto cool feature 4-31TEE disinfection basins 4-42TEE tip manipulation

general 4-11TEE transducers

accessories 4-41and defibrillators 4-8array rotation controls4-18auto cool feature 4-31bite guard 4-41cleaning and disinfection2-16connection information1-8controls for 4-22disinfectantsrecommended 2-9distal tip 2-4exam guidelines 4-25,4-26, 4-29flexible shaft 2-4inspecting 4-25models supported 4-1parts 4-10preparing patients forexams 4-26protective sheaths 2-16,4-43revision levels for using1-8storage 2-4T display 4-35temperature controls4-13, 4-31tip fold-over 4-29tip protector 4-41

tissue damage 4-12, 4-28

Index

Index-5

transducersactivating 1-3applications for, listed1-5biopsy, how to clean2-18cautions withdefibrillators 3-3, 4-8,8-1changing frequency of1-4checking for damage 2-2chemical damage 2-11cleaning 2-6, 5-3connecting 1-1cracks 2-2daily storage 2-3damage not underwarranty 2-11, 2-12,2-15, 2-17, 2-21damaged pins 2-2disinfectants to use 2-8general cleaning 2-6handling 2-1model numbers of 1-5non-supported at D.0Preface-2not sold with SONOS1-7OmniPlane III 4-15specialty,listed byrevision level 1-8supporting biopsy 5-1swelling of lens material2-2tables of all supported1-5transporting 2-3

used with SONOS 7500/5500 1-5web site address 2-6, 5-3x4 7-1

Transthoracic OmniPlanetransducer

array rotation controls8-4calibration failedmessage 8-6connection information1-9defibrillator safety issues8-1model 21349A described8-1revision levels for using1-9specifications for 8-3

Transthoracic OmniPlanetransducer (Model 21349A)

described 8-3T-spray 2-12, 2-13

Wwarranty

coverage limits indicated2-11, 2-12, 2-15, 2-17,2-21

web sitefor cleaning transducersPreface-1, 2-6, 5-3for FDA-cleareddisinfectants 2-9for ordering information4-42, 6-15leakage current testingproduct 6-6

what gels to use 2-5what’s new in this releasePreface-2

Xx4 transducer

auto-cool safety for 7-5controls for 7-4description of 7-1disinfectantsrecommended 2-9intended uses 7-3ordering supplies for 7-6preparing forintraoperative imaging7-5safety guidelines 7-5

Index

Index-6

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