AI - User Manual - 453562035461a - en-US PDF

User Manual
English
EPIQ Series and

Affiniti 70 Diagnostic
Ultrasound Systems
Anatomical Intelligence for

Breast (AI Breast)
Contents
Contents
1 Read This First.......................................................................................................................................... 5
Customer Comments........................................................................................................................................ 5
Supplies and Accessories.................................................................................................................................. 5
2 Safety....................................................................................................................................................... 7
3 AI Breast Overview................................................................................................................................. 11
Capabilities...................................................................................................................................................... 11
Components.................................................................................................................................................... 12
Contraindications............................................................................................................................................ 15
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4 Preparing the System.............................................................................................................................. 17

Assembling the Mattress and Field Generator............................................................................................... 17
Positioning the System................................................................................................................................... 24
Connecting the Field Generator and Ultrasound Instruments to the Ultrasound System............................. 28
Assembling the L12-5 50 Transducer and Ultrasound Tracker....................................................................... 30
Attaching and Removing the Ultrasound Tracker............................................................................. 32
5 Using AI Breast....................................................................................................................................... 37
Positioning the Patient.................................................................................................................................... 37
Placing and Removing a Patient Tracker......................................................................................................... 38
Starting the Study........................................................................................................................................... 42
Registration..................................................................................................................................................... 43
AI Breast Registration Display............................................................................................................ 43
Performing Registration.................................................................................................................... 45
Scanning the Breast........................................................................................................................................ 49
AI Breast Sweep Display.................................................................................................................... 49
Verifying Registration........................................................................................................................ 50
Philips
Anatomical Intelligence for Breast (AI Breast) 3

Contents
Performing the Breast Exam with the AI Breast Controls.................................................................. 51

AI Breast Controls.............................................................................................................................. 55
Review............................................................................................................................................................. 57
Reviewing Breast Markers................................................................................................................. 57
Finding Orthogonal Frames............................................................................................................... 59
Using Reverse Lookup........................................................................................................................ 61
Reconstructing 3D Volumes.............................................................................................................. 62
AI Breast Controls in Review.............................................................................................................. 64
6 Maintenance.......................................................................................................................................... 67
Cleaning and Disinfecting the Mattress Cover................................................................................................ 67
Cleaning and Disinfecting the TCU.................................................................................................................. 69
Cleaning and Disinfecting the Field Generator and Cable.............................................................................. 70
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Cleaning the Model 20004 Ultrasound Tracker.............................................................................................. 71
Disinfecting the Model 20004 Ultrasound Tracker......................................................................................... 75
Cleaning the Patient Tracker........................................................................................................................... 78
Disinfecting the Patient Tracker...................................................................................................................... 82
7 Specifications......................................................................................................................................... 85
Safety and Regulatory Requirements............................................................................................................. 87
Service Life...................................................................................................................................................... 88
Index...................................................................................................................................................... 89
Philips
4 Anatomical Intelligence for Breast (AI Breast)

Customer Comments Read This First
1 Read This First

The Anatomical Intelligence for Breast (AI Breast) User Manual is intended to assist you with
the safe and effective operation of the Philips Anatomical Intelligence for Breast (AI Breast)
ultrasound feature. This manual contains information specific only to AI Breast, which is a
licensed option, available on EPIQ and Affiniti 70 ultrasound systems.
Before using this feature, read this manual and the User Manual, the Help, and any User
Information Update documents for your ultrasound system. See the safety information and a
description of all symbols that may be used on the product and its accessories and packaging.
Strictly observe all warnings and cautions.
Customer Comments
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If you have questions about the user information, or you discover an error in the user
information, in the USA, please call Philips at 800-722-9377; outside the USA, please call your
local customer service representative. You can also send e‑mail to the following address:
techcomm.ultrasound@philips.com
Supplies and Accessories

Philips Approved Accessories
Accessory Model Number
Philips Patient Tracker 10001
Philips Ultrasound Tracker for the L12-5 50 transducer 20004
To order a tracking bracket for use in attaching a Philips ultrasound tracker to the L12‑5 50
transducer, contact CIVCO Medical Solutions:
CIVCO Medical Solutions
102 First Street South, Kalona, IA 52247-9589
Philips

Read This First Supplies and Accessories
Telephone: 800-445-6741 (USA and Canada), +1 319-248-6757 (International)

Fax: 877-329-2482 (USA and Canada), +1 319-248-6660 (International)
E-mail: info@civco.com
Internet: www.civco.com
For a list of supplies and accessories for the ultrasound system and transducers, see the
ultrasound system's User Manual.
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Philips

Safety
2 Safety
Please read this information before using AI Breast.
WARNING
Do not use AI Breast until you have read, understood, and know all the safety information
contained in this "Safety" section and in all other sections of this manual and in the User
Manual, the Help, and any User Information Update documents for your ultrasound system.
WARNING
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Do not operate the field generator within 200 mm (8 in) of an installed pacemaker. The
magnetic field produced by the field generator may interfere with the operation of the
pacemaker, which may cause personal injury.
WARNING
The system has not been designed or tested for use during or following cardiac
defibrillation. Cardiac defibrillation may contribute to inaccurate information and possible
personal injury.
WARNING
Do not track instruments in an untested application environment, because an untested
environment may contain elements that affect field generator functions. For example,
electromagnetic field disturbances from other objects in the room and the proximity of
metal and other field generators can adversely affect the system. Failure to test for such
disturbances increases the possibility of inaccurate information and possible personal injury.
Philips

Safety
WARNING
Do not drop the field generator or subject it to impact. Physical damage to the field
generator may alter its calibration and contribute to inaccurate information and possible
personal injury. If the field generator is dropped or damaged, discontinue use and contact
your Philips representative.
WARNING
The field generator is heavy. Failure to take care when moving or lifting it may result in
possible personal injury.
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WARNING
Do not expose tools to a high magnetic field, such as an MRI system, because they may
become magnetized. Tracking with a magnetized sensor may result in incorrect information
and result in possible personal injury. None of the equipment or tools provided by Philips
for use with AI Breast are MRI-safe and may cause serious damage to MRI systems and
personal injury.
WARNING
Do not immerse the tool connection unit or field generator in liquids or allow fluid to enter
them in any way. Immersion in liquids may result in equipment damage, produce a fire or
shock hazard, and result in possible personal injury.
CAUTION
Do not use solvents, such as thinner or acetone, or abrasive cleaners on the system,
transducers, field generator, or tool connection unit.
Philips

Safety
CAUTION
Do not use Sani-Cloth AF3 or Super Sani-Cloth to disinfect the ultrasound system.
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Philips

Safety
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Philips

Capabilities AI Breast Overview
3 AI Breast Overview
Use this section to acquaint yourself with the Anatomical Intelligence for Breast (AI Breast)
feature, its capabilities, and its components.
Capabilities
AI Breast helps you perform a breast ultrasound exam by providing information about the
location of the transducer in relationship to patient anatomy landmarks that you assign.
During the scan of the patient, a graphic representing the breast shows the paths that have
been swept by the transducer.
You can use AI Breast with several imaging modes including 2D, Freehand 3D, and Color
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imaging.
Tools
AI Breast feature supports the following application-specific tools:
• 3D volume reconstruction
• Auto annotation
• Bookmarking
• Orthogonal frames
• Reverse lookup
For more information, see “Performing the Breast Exam with the AI Breast Controls” on
page 51.
Transducers
AI Breast is supported on the following transducers:
Philips

AI Breast Overview Components
System Supported Transducers
EPIQ systems eL18‑4 with EM tracker

L12‑5 50 plus external ultrasound tracker
Affiniti 70 systems eL18‑4 with EM tracker

L12‑5 50 plus external ultrasound tracker
To order a tracking bracket for use in attaching a Philips ultrasound tracker to the L12‑5 50
transducer, see “Supplies and Accessories” on page 5.
Components
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You need the following components from Philips to perform a breast exam with AI Breast.
Tabletop Field Generator and Cable

The tabletop field generator (TTFG) emits a weak magnetic field, creating the tracking volume.
The system can track the location of the transducer's tracking sensor when it is inside the
tracking field.
Philips

Components AI Breast Overview
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Tabletop Field Generator
Tabletop Mattress
The mattress comprises a foam pad, foam inserts, and a waterproof cover. The field generator
is inserted into a cutout in the mattress pad. The mattress protects the patient from having
direct contact with the field generator and protects the field generator from having contact
with fluids. The mattress cover includes a centerline strap as well as a graphic over the general
location of the field generator, which may assist in positioning the patient.
Transducer with Tracking Sensor

The transducer is used to scan the patient. The ultrasound tracking sensor provides the location
of the transducer within the tracking field to the ultrasound system software. The ultrasound
tracking sensor is integrated on the eL18‑4 transducer with EM tracker. The Philips
Model 20004 ultrasound tracker is the tracking sensor used with the L12‑5 50 transducer and is
attached with a CIVCO tracking bracket. For information on contacting CIVCO Medical
Solutions, see “Supplies and Accessories” on page 5.
Philips

AI Breast Overview Components
Ultrasound System Software and Hardware

The software takes the position data provided by the hardware and displays patient imaging
data as well as the location and orientation of the tracked transducer connected to the system.
Tool Connection Unit (TCU) and Cable

The TCU is stored on the ultrasound system cart and connects directly to the ultrasound system
with the TCU cable. Sufficient cable length lets you position the TCU close to the working area,
but away from the field generator, for easy access during the procedure. If you are using the
L12‑5 50 transducer, the ultrasound tracker attached to the transducer connects to any port on
the TCU. If you are using patient trackers, they connect to any port on the TCU.
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Tool Connection Unit
Patient Tracker
Optional Philips Model 10001 patient trackers may be applied to the patient around the region
of interest to maintain registration if the patient moves during the study. Patient trackers
consist of a patch that contains two markers, a cable, and a connector.
Philips

Contraindications AI Breast Overview
Contraindications
None known.
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Philips

AI Breast Overview Contraindications
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Philips

Assembling the Mattress and Field Generator Preparing the System
4 Preparing the System

The information and procedures in this section will help you prepare the system for use with
AI Breast. Preparations include:
• “Assembling the Mattress and Field Generator” on page 17
• “Positioning the System” on page 24
• “Connecting the Field Generator and Ultrasound Instruments to the Ultrasound System” on
page 28
• “Assembling the L12-5 50 Transducer and Ultrasound Tracker” on page 30
Assembling the Mattress and Field Generator

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The mattress includes a waterproof, zippered cover with an exit hole for the field generator
cable and includes two cutouts in the foam interior. Two foam inserts are installed in the
cutouts when the field generator is not installed. When used for an AI Breast study, the field
generator is installed in the cutout under the graphic on the mattress cover.
The field generator and mattress assembly can be placed for use only on the following beds:
Examination Bed Description
Biodex Econo Ultrasound Table Model 058‑726: 115 Vac

Model 058‑727: 230 Vac
Hill‑Rom Transport Stretcher Mattress: 76.2 cm (30 in)
Stryker Transport Stretcher Model 748 litter: 76.2 cm (30 in)
If the field generator and mattress have already been assembled, see “Positioning the System”
on page 24.
Philips

Preparing the System Assembling the Mattress and Field Generator
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Tabletop Field Generator
1 Carrying points
2 Cable connector
Philips

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Tabletop Mattress Interior
1 Location of field generator during use
2 Cable channel
3 Location of foam insert or field generator when the mattress needs to be tilted and the field generator
is not in use
Philips

WARNING
Do not drop the field generator or subject it to impact. Physical damage to the field
generator may alter its calibration and contribute to inaccurate information and possible
personal injury. If the field generator is dropped or damaged, discontinue use and contact
your Philips representative.
WARNING
The field generator is heavy. Failure to take care when moving or lifting it may result in
possible personal injury.
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WARNING
Use the field generator only when it is properly placed inside the mattress pad and it is in a
horizontal position. Placing the field generator in a tilted position may damage the field
generator, contributing to inaccurate information and possible personal injury.
WARNING
Before using a mechanism to tilt the examination bed, you must either remove the field
generator from the mattress and replace it with the original foam insert, or move the field
generator to the cutout in the lower portion of the mattress and move the foam insert into
the cutout that is typically used for the field generator.
1. Place the mattress in a flat, horizontal position on a compatible examination bed, with the
field generator graphic on the top side of the mattress.
2. Unzip the mattress cover.
3. Remove the foam insert that is under the tracking field graphic.
Philips
4. Place the field generator on top of the mattress so that the connector is accessible.

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Positioning the Field Generator with the Cable Connected
5. Connect the field generator cable to the connector on the field generator.
Philips

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Field Generator Installed in Mattress
6. Place the field generator in the cutout so that the cable is on the side next to the top cover
of the mattress.
Philips

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Route of the Field Generator Cable
7. Route the cable in the channel provided and through the opening at the top end of the
mattress cover.
Philips

Preparing the System Positioning the System
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Field Generator Cable Exit
8. Zip the mattress cover.
Positioning the System

Before using AI Breast, you must ensure that the system and the environment are prepared for
use. It is important that you evaluate the room setup for correct positioning of the field
generator.
Philips

Positioning the System Preparing the System
WARNING
WARNING
The system has not been designed or tested for use during or following cardiac
defibrillation. Cardiac defibrillation may contribute to inaccurate information and possible
personal injury.
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WARNING
Do not place the field generator within 10 m (33 ft) of another operating field generator;
doing so may contribute to inaccurate information and possible personal injury.
WARNING
Position the field generator cable to prevent tripping hazards and cable damage.
WARNING
Always place the tool connection unit more than 1 m (3.3 ft) from the field generator. If
placed closer, the measurement volume may be affected, contributing to inaccurate
measurements and possible personal injury.
Philips

Preparing the System Positioning the System
WARNING
Place the examination bed so that other equipment and large metal objects in the room do
not interfere with the magnetic tracking components. Maintain these conditions throughout
the procedure.
WARNING
Use the field generator only when it is properly assembled inside the mattress and in a
horizontal position. Placing the field generator in a non-horizontal position may damage the
field generator, contributing to inaccurate information and possible personal injury.
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WARNING
During use, do not place the field generator cable inside the magnetic field volume or wrap
it around the field generator mattress, because it may create magnetic interference that
may contribute to inaccurate information and possible personal injury.
WARNING
Do not place other cables within 30 mm (1.2 in) of the field generator cable during use. If
placed this close, particularly if the cables are parallel to each other, the cables may become
subject to electromagnetic interference. This interference may contribute to inaccurate
information and possible personal injury.
WARNING
Do not coil the field generator cable during use, because it produces enough electric current
that a magnetic field is created when the cable is placed in a circular formation. This
magnetic field may disturb the field generator's magnetic field, contributing to inaccurate
information and possible personal injury.
Philips

Positioning the System Preparing the System
WARNING
Do not disconnect the field generator from the system while the system is powered on.
Disconnecting the field generator while in use may result in generation of electrical sparks,
irreparable field generator damage, and possible personal injury.
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Field Generator Location Indicators
1 Graphic of approximate location of the field generator
2 Blue strap aligned with centerline of the field generator
1. Ensure that the field generator is installed in the correct position in the mattress pad on
the examination bed. It must be installed in the cutout under the field generator graphic on
the mattress cover. See “Assembling the Mattress and Field Generator” on page 17.
2. If you place an additional cover over the mattress cover, ensure that the blue strap that
identifies the location of the centerline of the field generator is visible. This will assist in
positioning the patient.
3. Place the ultrasound system, examination bed, and TCU in the examination room in
accordance with the warnings in this section.
Philips

Connecting the Field Generator and Ultrasound Instruments to
Preparing the System the Ultrasound System
Connecting the Field Generator and Ultrasound

Instruments to the Ultrasound System
WARNING
Always place the tool connection unit more than 1 m (3.3 ft) from the field generator. If
placed closer, the measurement volume may be affected, contributing to inaccurate
measurements and possible personal injury.
NOTE
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The tool connection unit might be warm to the touch during or after use. This is normal and is
expected as part of normal operation.
Philips

Connecting the Field Generator and Ultrasound Instruments to
the Ultrasound System Preparing the System
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Tool Connection Unit (TCU) in the EPIQ System Tray
1 System tray
2 Connection port cover
3 TCU connection port
4 TCU instrument ports
5 Field generator connection port
The transducer, any patient trackers, and the ultrasound tracker for the L12‑5 50 (if used) must
be connected to the ultrasound system.
For instructions on connecting the transducer to the system, see the ultrasound system User
Manual.
Philips

Preparing the System Assembling the L12-5 50 Transducer and Ultrasound Tracker
The field generator cable must be connected to the field generator connection port and any
patient trackers or ultrasound trackers must be connected to the tool connection unit, which is
stored in the system tray located on the rear top of the ultrasound cart.
You can connect the instruments to any of the six labeled ports. Sufficient cable length is
provided to allow you to position the TCU close to the working area for easy access during the
procedure. You can also remove the TCU from the tray for convenient placement.
1. Place the TCU in the location you want. For location requirements, see “Positioning the
System” on page 24.
2. Connect the TCU cable from the connection port on the TCU to the connection port on the
system.
3. Connect the field generator cable to the field generator connection port on the system.
4. If used, connect the L12‑5 50 ultrasound tracker and any patient trackers to instrument
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ports on the TCU.
Assembling the L12-5 50 Transducer and Ultrasound

Tracker
If you are using the L12‑5 50 transducer, use a compatible CIVCO tracking bracket to attach a
Philips Model 20004 ultrasound tracker to the transducer. The ultrasound tracker consists of a
connector, a cable, and a tracked-sensor housing with a release tab.
Philips

Assembling the L12-5 50 Transducer and Ultrasound Tracker Preparing the System
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Model 20004 Ultrasound Tracker Components
1 Connector (opening to electrical connections)
2 Pinholes on the connector strain relief
3 Cable
4 Sensor housing
5 Release tab
Philips

WARNING
Before use, the tracker must be cleaned and disinfected according to the instructions
provided in this manual. Failure to follow the cleaning and disinfection instructions creates a
risk of contamination and patient infection. See “Cleaning the Model 20004 Ultrasound
Tracker” on page 71 and “Disinfecting the Model 20004 Ultrasound Tracker” on page 75.
WARNING
Before use, inspect the tracker for any signs of damage or degradation. Do not use if it
shows any sign of damage or degradation.
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CAUTION
Do not attempt to service the tracker. Doing so voids the warranty.
Attaching and Removing the Ultrasound Tracker
CAUTION
Position the ultrasound system and tool connection unit so that the tracker cable is not
strained during the procedure.
NOTE
Make sure that the CIVCO tracking bracket is compatible with the L12-5 50 transducer.
Philips

Attaching the Ultrasound Tracker

For assistance during placement, see the image in “Assembling the L12-5 50 Transducer and
Ultrasound Tracker” on page 30.
1. Select the appropriate ultrasound tracker for the L12-5 50 transducer.
2. Select the appropriate CIVCO tracking bracket for the L12-5 50 transducer.
3. Attach the CIVCO tracking bracket to the transducer. For details, see the instructions
provided with the tracking bracket.
4. Securely attach the tracker to the mounting feature of the tracking bracket.
a. Align the bottom of the tracker with the bracket-mounting feature.
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b. Push the tracker onto the bracket-mounting feature, until it snaps into place.
Philips

CAUTION
Do not attach the top of the tracker first. This can damage the tracker.
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NOTE
Step 5 is optional. Your procedure may not require a cover for the transducer and tracking
bracket.
5. Insert the transducer and the tracking bracket into the cover provided with the tracking
bracket. For details, see the instructions provided by the manufacturer.
6. Connect the tracker to the TCU. Verify that the device functions within the field generator
volume.
Philips

CAUTION
Do not strain the tracker cable near the attachment site of the tracking bracket.
Removing the Ultrasound Tracker

1. When the procedure is complete, remove the cover from the transducer and tracking
bracket (if applicable).
2. Unclip the tracker from the tracking bracket by gently pulling the top release tab away
from the transducer.
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3. Disconnect the tracker from the TCU.
CAUTION
To disconnect the instrument from the TCU, grasp the connector plug and pull gently. Do not
pull on the cable.
Philips

4. Immediately after each use, clean and disinfect the tracker. For more information, see
“Cleaning the Model 20004 Ultrasound Tracker” on page 71 and “Disinfecting the Model
20004 Ultrasound Tracker” on page 75.
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Philips

Positioning the Patient Using AI Breast
5 Using AI Breast
Positioning the Patient
WARNING
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1. After setting up the system for use, position the patient on the examination bed, with the
breasts over the field generator so that the entire scanning region for the breast exam is
within the actual tracking field.
2. Use the blue strap to identify the location of the centerline of the field generator. For each
breast, position the nipple so that it is aligned with the blue strap and in the center of the
field generator.
Philips

Using AI Breast Placing and Removing a Patient Tracker
Field Generator Location Indicators
1 Graphic of the approximate location of the field generator
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2 Blue strap aligned with the centerline of the field generator
Placing and Removing a Patient Tracker

Optional patient trackers consist of a patch that contains two markers, a cable, and a
connector.
Philips

Placing and Removing a Patient Tracker Using AI Breast
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Patient Tracker Components
1 Connector
2 Cable
3 Patch (circular features point away from the patient's skin)
Before using this instrument, read these warnings and “Safety” on page 7.
WARNING
Before the first use, disinfect the patient tracker. See “Disinfecting the Patient Tracker” on
page 82.
Philips

Using AI Breast Placing and Removing a Patient Tracker
WARNING
Ask the patient if they are allergic to adhesives, to determine what type of adhesive to use.
WARNING
Apply the patient tracker only to intact skin. This instrument is for external use only.
WARNING
Avoid placing the patient tracker near any sources of metal interference, such as patient
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table.
WARNING
To reinforce patch placement, it may be necessary to shave or clean the patient's skin with
alcohol. Allow the alcohol to dry before applying the patient tracker.
WARNING
The patient trackers must remain in place during scanning and until registration is complete.
WARNING
This instrument may perform suboptimally on obese patients, due to a lack of palpable bony
structures to guide the placement of the patient tracker. As a result, the accuracy of the
image registration may also be suboptimal.
Philips

Placing and Removing a Patient Tracker Using AI Breast
CAUTION
If the patient tracker is damaged, or after the final use, dispose of the instrument in
accordance with hospital, administrative, or local-government policy.
CAUTION
Do not bend the patient tracker patch more than necessary.
If a patient tracker will be used in the procedure, apply it to the patient now. Secure the tracker
with an appropriate adhesive.
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1. Place the patient tracker, with the circular features pointing away from the skin. Select
locations that are within the field generator volume, and that will not interfere with
scanning or move during scanning. This may be under the clavicular notch, lower sternum,
and so on, with the cable directed away from the work area.
2. Secure the patient trackers to the patient’s skin around the region of interest on bony
structures using an adhesive (for example, Tegaderm dressing). It is imperative that the
trackers remain fixed in position on the patient's skin.
3. Connect the patient tracker to the TCU. Verify that the device functions within the field
generator volume.
4. Perform the procedure.
5. When the procedure is complete, disconnect the patient tracker from the TCU, and remove
the patch from the patient by first removing the adhesives.
CAUTION
To disconnect the instrument from the tool connection unit, grasp the connector plug and
pull gently. Do not pull on the cable.
Philips

Using AI Breast Starting the Study
6. Immediately after each use, follow the cleaning and disinfection guidelines to
decontaminate the instrument. See “Cleaning the Patient Tracker” on page 78 and
“Disinfecting the Patient Tracker” on page 82.
Starting the Study

For more information on starting a study, see the instructions in your ultrasound system user
documentation.
1. To begin an exam, touch Patient.
2. For a new patient, enter patient data. The last name is required. To move between fields,
use the Tab key, or use the trackball to move the cursor.
3. Select a Procedure and verify the Study Type, and then enter any study-related patient
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history.
4. Click Done.
5. Connect a transducer.
NOTE
Use a compatible CIVCO tracking bracket to attach a Philips Model 20004 ultrasound tracker
to the L12-5 50 transducer.
6. Touch the name of the transducer:

• eL18-4
• L12-5
7. Touch a preset:
• For eL18-4, touch Adv Breast or Dense Breast.
• For L12-5 50, touch Adv Breast or Breast.
Philips

Registration Using AI Breast
8. On the 2D tab, touch AI Breast.
Registration
During registration, you align the transducer on the patient to locate marked positions on the
display.
NOTE
Before starting registration, put the system in 2D or 2D+Color mode.
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AI Breast Registration Display

The AI Breast registration display contains four distinct regions:
Philips

Using AI Breast Registration
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Registration Display
1 AI Breast tab: Shows the steps that have been completed and provides suggestions for the current step.
2 Registration graphic: Shows where to position the transducer.
3 Tracking Field graphic: Shows the position of the transducer within the tracking field. It can be used as a
positioning aid.
4 Tool Status Indicator graphic: A green square indicates that the transducer is properly tracked. A red
square indicates that the transducer is not being properly tracked, either because it is outside the
tracking volume or there is external interference causing improper tracking.
For information on the touch screen controls, see “AI Breast Controls” on page 55.
Philips

Performing Registration
The system guides you in registering the location of the breast within the tracking field.
NOTE
Advise the patient to remain still during registration.
1. Under Sweep Controls, touch either Right Side or Left Side (default) for the breast that will
be examined.
2. Ensure that the entire breast is within the tracking field by positioning the transducer at
the outer borders of the breast and verifying that the square in the Tool Status Indicator
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graphic is green. A red square indicates that the transducer is not detected within the
tracking field.
Philips

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Registration Positions
3. For each position shown on the display, position the transducer on the breast in the same
location and orientation. The center of the face of the transducer must align with the
center of each of the marked positions.
Philips

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Transducer Alignment
4. At each position, verify that the Tool Status Indicator graphic is green. Then press a
trackball button labeled Mark to register the position. When you mark the medial, lateral,
and inferior borders of the breast, consider the extension of breast tissue, and the
complete area that you intend to scan.
NOTE
If the transducer appears to be positioned correctly but the Tool Status Indicator graphic is
red, you may need to reposition the transducer so that it is perpendicular to the bed.
Philips

NOTE
Avoid marking the transducer too close to the boundaries of the breast when performing
registration. This will help ensure that the registration mark drawn on the breast graphic
properly represents the size and position of the actual transducer on the patient.
5. To redo the previously set registration mark, press Erase.

6. To replace the current registration, touch Clear Registration and begin registration again.
7. To slightly change the completed registration:
a. Touch Adjust Position.
b. Position the transducer on an identifiable location on the breast, such as the nipple, and
use the trackball to adjust the transducer position shown on the sweep graphic to align
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with the actual transducer position over the patient's nipple.
c. Touch Adjust Position to save the adjustment.
You can also adjust the registration during an acquisition.
Philips

Scanning the Breast Using AI Breast
Scanning the Breast
AI Breast Sweep Display

The sweep display contains seven distinct regions:
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Sweep Display
1 AI Breast tab: Shows the steps that have been completed and provides suggestions for the current step.
2
Breast Markers: Lists any frames with a (marker) from the current and prior sweeps.
3 Sweep graphic: Shows the transducer position. During a sweep, shows the movement of the transducer
and the area being swept. After a sweep, shows the area that has been swept. The Side-to-Side sweeps
are shown in green. The Up/Down sweeps are shown in blue.
Philips

Using AI Breast Scanning the Breast
4 Tool Status Indicator graphic: A green square indicates that the transducer is properly tracked. A red
square indicates that the transducer is not being properly tracked, either because it is outside the
tracking volume or there is external interference causing improper tracking.
5 Image area: Shows the standard 2D image plus the sweep graphic.
6
Thumbnail area: Shows thumbnails of all acquisitions. Loops with a breast marker are shown with a
(marker).
7 Trackball arbitration icon: Shows trackball state.
Verifying Registration
Before acquiring sweeps of the breast, verify the accuracy of the registration.
4535 620 35461_A/795 * FEB 2020

be examined.
2. Position the transducer at the nipple and confirm that the live transducer mark, which
indicates the position of the transducer, is in the same position.
NOTE
The live transducer mark on the breast graphic will move in real time as the transducer moves
on the breast.
3. If the registration is acceptable, go to “Performing the Breast Exam with the AI Breast
Controls” on page 51.
4. If registration is not acceptable:
a. Position the transducer over the nipple.
b. Touch Adjust Position.
c. Use the trackball to move the body marker graphic over the nipple.
Philips

d. Touch Adjust Position.

e. Go to “Performing the Breast Exam with the AI Breast Controls” on page 51.
Performing the Breast Exam with the AI Breast Controls

Scan the breast area using your preferred screening protocol. Or, use the AI Breast Sweep
Graphic and the Direction controls to show the areas of the breast that are scanned during
acquisitions.
Direction has two settings, Side-to-Side and Up/Down, which can be used for scans in side-to-
side and up/down directions or for scans in radial and anti-radial directions. Use these settings
to perform acquisitions when you scan in opposite directions. After the entire breast is scanned
in one direction, change the Direction setting and sweep the entire breast in the opposite
direction.
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When Direction is set to Side-to-Side, the areas covered by the sweep are green in the sweep
graphic. When Direction is set to Up/Down, the areas covered by the sweep are blue in the
sweep graphic.
Philips

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Side-to-Side Sweep Area
WARNING
Movement of the breast during the sweep may affect the accuracy of the sweep graphic
showing the areas of the breast that were scanned.
NOTE
If you are not using a patient tracker, the patient needs to remain still during the procedure.
NOTE
Use a sufficient amount of gel to ensure smooth scanning.
Philips

NOTE
To use the Find Orthogonal feature, you must acquire scans in orthogonal directions.
1. On the 2D tab, increase the length of the loop acquisition to give you sufficient time to end
each loop acquisition and to perform the scan at your own pace.
NOTE
For information on how to set the cineloop acquisition time and to configure the Acquire
control, see the ultrasound system documentation.
4535 620 35461_A/795 * FEB 2020
be examined.
NOTE
If you want to hide the sweep graphic below the Breast Markers area, touch Sweep Graphic.
3. Touch Direction Side-to-Side (default) or Up/Down.

4. To begin the sweep, press the Acquire control that is configured to capture cineloop
sequences.
NOTE
To begin and end a sweep, press the Acquire control.
Philips

NOTE
Selecting Color during a sweep will stop the loop capture. To continue the loop capture, start
the acquisition again.
5. Sweep the entire breast area. For best results, scan slowly and steadily to optimize the
acquisition. Perform multiple sweeps as necessary.
6. During a sweep, if you notice anything that you may want to return to later, press a
trackball button to add a breast marker. A (marker) appears in the Breast Markers
display area.
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WARNING
If you use auto-annotation, the distance and position of the transducer is approximate. The
values also depend on how accurately the position of the nipple was defined during
registration. For best results, center the region of interest.
7. During a sweep, if you want to add an annotation label indicating the position of the
transducer, touch Freeze. Then touch Auto Annotate. During a live scanning, you can also
touch Auto Annotate to add an annotation label.
8. When the entire breast is scanned in one direction, change the setting of Direction, and
repeat steps 4 through 7, sweeping the entire breast in the opposite direction.
9. To see if all areas were covered in the captures, touch Show All to show the area covered
by the sweeps.
Philips

AI Breast Controls
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AI Breast Touch Screen
The following AI Breast controls are provided. Unless otherwise noted, the controls are on the
touch screen.
Name Description
Adjust Position A control used to enable the trackball to make small adjustments to the position of
the live transducer mark on the breast graphic to better correlate the position of the
transducer on the patient with the position of the transducer on the graphic. For best
results, adjust the position at the nipple.
Auto Annotate A control used to add an annotation based on the position of the center of the
Philips
transducer. For best results, center the region of interest.

Name Description
Cancel A control used to exit the AI Breast protocol and clear all registrations.
Clear Registration A control used to clear the current registration.
Direction Up/Down A control used to set the direction of the sweep to be parallel to the length of the
patient's body or orthogonal to the direction of the sweep when Direction is set to
Side-to-Side.
Direction Side-to-Side A control used to set the direction of the sweep to be perpendicular to the length of
the patient's body or orthogonal to the direction of the sweep when Direction is set
to Up/Down.
Erase A control on the control panel used to erase the last registration mark and let you
register the location again.
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Left Side A control used to select the breast on the patient's left side.
Pause A control used to pause the AI Breast protocol and let you to access imaging modes
that are not supported in AI Breast.
Resume A control used to resume the AI Breast protocol.
Right Side A control used to select the breast on the patient's right side.
Show All A control used to display both the Side-to-Side and Up/Down sweep coverage.
Sweep Graphic A control used to display or hide the sweep graphic outside the 2D acquisition region.
Philips

Review Using AI Breast
Review
In addition to the standard system features in Review, you can:
• Review marked sweeps.
• Find frames orthogonal to the current frame.
• Find previously acquired loops that were in the same location as the current frame.
• Reconstruct 3D volumes from acquired loops.
NOTE
For information on other tasks you can perform in Review, see the ultrasound system Help.
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Reviewing Breast Markers

The acquisition number in the Breast Markers display area corresponds to the number of the
sweep. All breast markers made during a sweep are listed under the acquisition in which they
occurred.
1. To view an image frame associated with a specific breast marker, click that (marker) in
the Breast Markers display area.
2. View the sweep in Review.
Philips

Using AI Breast Review
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Review Display
3. To view any sweep with a breast marker, click a (marker) under Breast Markers or click
any thumbnail with a marker in the lower left corner.
4. While viewing a sweep, if you want to add an annotation label indicating the position of
the transducer, do one of the following:
• Touch Auto Annotate. The annotation will be added to the current frame.
• Touch Freeze and then touch Auto Annotate. The annotation will be added to the
current frame.
5. To delete a marker, click Remove Tag.
6. To return to the AI Breast protocol, click Close Review.
Philips

Finding Orthogonal Frames

In Review you can view frames with a transducer orientation orthogonal (90 degrees plus or
minus 20 degrees) to the transducer orientation in the current frame in a side-by-side display.
1. To enter Review mode and view a frame of interest, do one of the following:
• Touch Review and select an acquisition.
• Click a (marker) in the Breast Markers display area.

2. Stop the cineloop playback and view the frame of interest in a 1-up layout.
3. To display loops that include frames that are orthogonal to the selected frame, touch Find
Orthogonal on the Review touch screen.
Loops that have frames that are orthogonal to the frame of interest are highlighted with
4535 620 35461_A/795 * FEB 2020
in the thumbnail area.

4. Click a loop in the thumbnail area to display on the right side of the side-by-side display.
Philips

4535 620 35461_A/795 * FEB 2020

Loops with Orthogonal Frames
5. To quickly view all the frames from different loop acquisitions that are identified as being
orthogonal to the frame of interest, turn the Frame soft key. To scroll through all frames of
a given loop, regardless of whether or not a specific frame is identified as orthogonal, use
the trackball.
6. To capture the image, press the Acquire control that is configured to capture an image. You
can make measurements and annotations, and use other system controls as needed.
Philips

Using Reverse Lookup

In Review, you can view frames from current and previous studies where the transducer
position was within 5 mm of the transducer position in the current frame.
1. To enter Review mode and view a frame of interest, do one of the following:
• Touch Review and select an acquisition.
• Click a (marker) in the Breast Markers display area.

2. Stop the cineloop playback and view the frame of interest in a 1-up layout.
3. Touch Reverse Lookup on the Review touch screen.
4. To display loops that were acquired in the same location, use the trackball to select a
location on the breast graphic.
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Loops that have images acquired in the vicinity of the selected location are highlighted with
in the thumbnail area.
Reverse Lookup
5. Click a loop in the thumbnail view to display it.

Philips

4535 620 35461_A/795 * FEB 2020

Loops in a Selected Location
6. To quickly view all the frames from different loop acquisitions that are identified as being
acquired in the same location, turn the Frame soft key. To scroll through all frames of a
given loop, use the trackball.
Reconstructing 3D Volumes
In Review, you can create reconstructions of calibrated 3D volumes from 2D images and loops.
Those reconstructions allow you to isolate and scroll through the images in any of the MPR
views to identify suspicious lesions quickly.
1. To enter Review mode and view a frame of interest, touch Review and select a 2D image
or loop.
2. View the frame of interest in a 1-up layout.
Philips

3. Touch Reconstruct 3D to display a 3D reconstruction.
NOTE
To save the 3D reconstruction to the system database and display it in the thumbnail area, you
must touch Save 3D. The 3D reconstructions are marked with .
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Manipulating the 3D Volume
4. To view or change the layout of the different MPR planes generated from the 3D
reconstruction, use the AutoVue touch screen controls.
5. To reposition the 3D reconstruction in all of the MPR views simultaneously, click and move
the crosshair in any of the views. For example, if the crosshair is positioned within the axial
MPR view (or A-plane), the sagittal (or B-plane) and the coronal (or C-plane) views update
Philips
to reflect the position of the crosshair within the axial view.

6. To scroll through the slices of the 3D reconstruction, click anywhere in an MPR view,
avoiding the crosshair, and move the trackball. For example, scrolling through the different
slices in the coronal plane can allow you to review the breast volume from the skin line all
the way down to the chest wall.
7. To accept the adjustments to the 3D reconstruction, touch Save MPRs.
8. To save the 3D reconstruction to the system database, touch Save 3D.
AI Breast Controls in Review

The following AI Breast controls are provided in Review. Unless otherwise noted, the controls
are on the touch screen.
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NOTE
For information on other tasks you can perform in Review, see the ultrasound system Help.
NOTE
When you use Find Orthogonal or Reverse Lookup, to display a marked loop, click the
thumbnail. If you double-click the thumbnail, the system will exit the current mode.
Name Description
Auto Annotate A control used to add an annotation based on the position of the center of the
transducer. For best results, center the region of interest.
Find Orthogonal A control used to find any loops that include transducer position information where
the transducer was orthogonal (90 degrees plus or minus 20 degrees) to the
transducer orientation in the current frame. Loops are marked with .
Philips

Name Description
Frame A soft key control located along the top of the control panel. Used to scroll through
the frames in a loop.
Reconstruct 3D A control used to start the reconstruction of a calibrated 3D volume acquired from a
loop. 3D reconstructions are marked with .
Remove Tag
A control used to delete the selected (marker).
Reverse Lookup A control used to display the Click Breast Image for Lookup graphic. Click a location
on the graphic to search all the patient's studies for any loops that include transducer
position information and whose position was within 5 mm of the transducer position
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in the selected location. Loops are marked with .

Philips

4535 620 35461_A/795 * FEB 2020

Philips

Cleaning and Disinfecting the Mattress Cover Maintenance
6 Maintenance
Maintenance should be performed regularly and as needed.
For information about transducer and system maintenance, see Care and Cleaning of
Ultrasound Systems and Transducers and Disinfectants and Cleaning Solutions for Ultrasound
Systems and Transducers (available with your system documentation) or the "Transducer and
System Care" website:
www.philips.com/transducercare
For compatible disinfectants and cleaning solutions for the eL18-4 transducer, see the eL18-4
Transducer User Information Update.
4535 620 35461_A/795 * FEB 2020
Cleaning and Disinfecting the Mattress Cover

The products in the following table are compatible with the mattress cover:
Cleaning Solutions Disinfectants
Mild soap solution1 • 70% isopropyl alcohol (IPA)

• Opti-Cide3 (QUAT/IPA based)
• Oxivir Tb (accelerated hydrogen peroxide based)
• PI-Spray II (QUAT based)
• Protex
• Sani-Cloth HB (QUAT based)
• Sani-Cloth Plus (QUAT/IPA based)
1. Mild soap solutions do not contain any harsh ingredients and are not irritating to the skin.
They must not contain fragrance, oils, or alcohols. Hand sanitizers are not approved for
use.
Philips

Maintenance Cleaning and Disinfecting the Mattress Cover
WARNING
Always use protective eyewear and gloves when cleaning, disinfecting, or sterilizing any
equipment.
WARNING
WARNING
4535 620 35461_A/795 * FEB 2020

Before performing any system maintenance or cleaning, always turn off the system and
disconnect it from the power source.
1. Turn off power to the system.

2. Disconnect the field generator from the system.
3. Wipe the mattress cover with a clean, soft cloth dampened an approved product.
4. Allow the mattress cover to air dry.
Philips

Cleaning and Disinfecting the TCU Maintenance
Cleaning and Disinfecting the TCU

The products in the following table are compatible with the TCU:

• Super Sani-Cloth wipes
use.
4535 620 35461_A/795 * FEB 2020
WARNING
equipment.
WARNING
WARNING
Philips

Maintenance Cleaning and Disinfecting the Field Generator and Cable
CAUTION
Do not use Sani-Cloth AF3 or Super Sani-Cloth to disinfect the ultrasound system.
1. Wipe the TCU with an approved product.

2. Allow the TCU to air dry.
Cleaning and Disinfecting the Field Generator and Cable

The products in the following table are compatible with the field generator and cable:
4535 620 35461_A/795 * FEB 2020


• Incidin Plus 2%
• Opti-Cide3 (QUAT/IPA based)
• Meliseptol
use.
WARNING
equipment.
Philips

Cleaning the Model 20004 Ultrasound Tracker Maintenance
WARNING
WARNING
1. Turn off power to the system.

4535 620 35461_A/795 * FEB 2020
2. Disconnect the field generator from the system.

3. Wipe the field generator and cable with a clean, soft cloth dampened with an approved
product.
4. Allow the field generator and cable to air dry.
Cleaning the Model 20004 Ultrasound Tracker

Establish and clearly post the following cleaning and disinfecting procedures.
Cleaning the tracker is an essential step before effective disinfection. Immediately after each
use, remove the tracker from the transducer and disconnect it from the TCU. Then clean and
disinfect the tracker using these procedures, to protect patients and personnel from
transmission of potential pathogens.
WARNING
equipment.
Philips

Maintenance Cleaning the Model 20004 Ultrasound Tracker
WARNING
Throughout the cleaning procedure, discard and replace soiled wipes or cotton swabs as
needed. Continue cleaning until you have removed all visible soil from the tracker.
CAUTION
Do not use alcohol or any alcohol-based chemicals to clean the tracker.
CAUTION
Do not allow sharp objects, such as scalpels or cauterizing knives, to come in contact with
4535 620 35461_A/795 * FEB 2020

the tracker, including the cable.
CAUTION
Throughout the cleaning process, protect the connector to keep liquid out of the connector’s
electrical contacts.
CAUTION
Do not use a wire brush to clean the tracker.
CAUTION
Do not autoclave the tracker.
Philips

Cleaning the Model 20004 Ultrasound Tracker Maintenance
For assistance during disinfection, see the figure in “Assembling the L12-5 50 Transducer and
1. Prepare one of the following solutions for use in this cleaning process:
• A mild detergent solution or surfactant: 5 ml (1 tsp) of concentrated liquid detergent
into 3.8 l (1 gal) of lukewarm tap water (22°C to 43°C [72°F to 110°F])
• An enzymatic cleaning solution prepared according to the manufacturer’s instructions,
such as Enzol Enzymatic Detergent or Steris Prolystica 2x Concentrate Enzymatic
Presoak and Cleaner.
2. With the prepared solution, wet a clean, soft, lint-free wipe (or cloth), and squeeze out the
excess liquid.
4535 620 35461_A/795 * FEB 2020
NOTE
The wipe or cloth should be damp but not dripping.
3. Use the damp wipe to thoroughly wipe the entire surface of the sensor housing and release
tab. Pay careful attention to the finger grips on the release tab. Wipe the sensor housing
and release tab for a minimum of 1 minute and until you remove all visible soil.
4. Use a new solution-dampened wipe to thoroughly wipe the entire cable for a minimum of
30 seconds and until you remove all visible soil.
5. With the prepared solution, wet a lintless, sharp-tip, cotton swab and squeeze out the
excess liquid.
NOTE
The swab should be damp but not dripping.
Philips

Maintenance Cleaning the Model 20004 Ultrasound Tracker
6. Use the swab to thoroughly clean the pinholes on the connector strain relief, until you
remove all visible soil.
7. Use a new solution-dampened wipe to thoroughly wipe the connector portion of the
ultrasound tracker for a minimum of 30 seconds and until you remove all visible soil.
CAUTION
8. Wet a new clean, soft, lint-free wipe (or cloth) with lukewarm tap water (22°C to 43°C [72°F
to 110°F]). Squeeze out excess liquid.
4535 620 35461_A/795 * FEB 2020

NOTE
9. Use the damp wipe to thoroughly wipe the release tab and sensor housing for a minimum
of 30 seconds to remove cleaning residue.
10. Rewet the wipe with lukewarm tap water and thoroughly wipe the entire cable for a
minimum of 30 seconds.
11. Rewet the wipe with lukewarm tap water and carefully wipe the connector portion for a
12. After wiping, thoroughly dry the release tab, sensor housing, and cable with a clean, dry,
lint-free wipe or cloth.
13. Visually inspect the tracker in a well-lit area to confirm the absence of any soil or adhesive.
14. If you see any soil or adhesive, repeat step 2 through step 13 (using fresh wipes and cotton
swabs) until you see no soil or adhesive.
Philips

Disinfecting the Model 20004 Ultrasound Tracker Maintenance
15. If you see no soil or adhesive, and the tracker is completely dry, it is ready for disinfection.
For more information, see “Disinfecting the Model 20004 Ultrasound Tracker” on
page 75.
Disinfecting the Model 20004 Ultrasound Tracker

After the tracker has been cleaned, it is ready for disinfection.
WARNING
equipment.
4535 620 35461_A/795 * FEB 2020
CAUTION
CAUTION
CAUTION
Philips

Maintenance Disinfecting the Model 20004 Ultrasound Tracker
For assistance during disinfection, see the figure in “Assembling the L12-5 50 Transducer and
1. Put the cleaned tracker alone in a clean, dry, disinfected or sterilized basin, placing the
connector in an upward position, away from the cable, to prevent liquid or moisture from
entering the connector.
2. Using one of the following disinfectant wipes, thoroughly wipe the entire surface of the
sensor housing and release tab for a minimum of 30 seconds.
• Pre-saturated cleaning wipes with a 1:10 bleach solution as the active ingredient (for
example, Sani-Cloth Bleach Wipes or Dispatch Wipes)
• Clean, lint-free, sterile wipes saturated with a spray containing a quaternary ammonium
disinfection solution
• Clean, lint-free, sterile wipes saturated with a 1:10 bleach solution of 100 ml (3.4 oz)
4535 620 35461_A/795 * FEB 2020

household bleach (4% to 6% sodium hypochlorite) in 900 ml (1 qt) lukewarm distilled
water (22°C to 43°C [72°F to 110°F])
3. Use a new disinfectant wipe to thoroughly wipe the cable portion of the ultrasound tracker
in both directions for a minimum of 30 seconds.
4. Use a new disinfectant wipe to thoroughly wipe the connector portion of the ultrasound
tracker for a minimum of 30 seconds.
CAUTION
5. Use a disinfectant-saturated swab to wipe each pinhole on the connector strain relief for
3 seconds.
Philips

Disinfecting the Model 20004 Ultrasound Tracker Maintenance
NOTE
6. Use a new disinfectant wipe to thoroughly wipe all sections of the tracker for a minimum of
30 seconds to ensure that all surfaces are damp.
7. Allow the tracker to stand after wiping for the minimum time required by the wipe
manufacturer. If you are using the 1:10 bleach solution, allow the tracker to stand for a
minimum of 4 minutes.
8. After the minimum standing time, saturate a clean, lint-free, sterile wipe with sterile water
and squeeze out excess liquid.
4535 620 35461_A/795 * FEB 2020
NOTE
9. Use the wipe saturated with sterile water to thoroughly wipe the sensor housing, release
tab, cable, and connector portion of the tracker for a minimum of 1 minute. Pay careful
attention to the pinholes on the connector strain relief.
CAUTION
10. Allow the tracker to air dry.

11. Place the disinfected device in an appropriate dry storage area.
Philips

Maintenance Cleaning the Patient Tracker
Cleaning the Patient Tracker

Establish and clearly post the following cleaning and disinfection procedures. Cleaning the
tracker is an essential step before effective disinfection.
Immediately after each patient use, decontaminate the tracker according to these cleaning and
disinfection procedures, to protect patients and personnel from transmission of potential
pathogens.
WARNING
equipment.
4535 620 35461_A/795 * FEB 2020

WARNING
Throughout the cleaning procedure, discard and replace soiled wipes or cotton swabs as
needed. Continue cleaning until you have removed all visible soil from the tracker.
CAUTION
CAUTION
Do not allow sharp objects, such as scalpels or cauterizing knives, to come in contact with
the tracker, including the cable.
Philips

Cleaning the Patient Tracker Maintenance
CAUTION
Do not use a wire brush to clean the tracker.
For assistance during cleaning, see the following figure.

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Patient Tracker Components
1 Opening to electrical connections
2 Pinholes on the connector strain relief
3 Cable
Philips

Maintenance Cleaning the Patient Tracker
4 Patch
5 Pinholes on the patch strain relief
6 Connector
1. Prepare one of the following solutions for use in this cleaning process:
• A mild detergent solution or surfactant: 5 ml (1 tsp) of concentrated liquid detergent
into 3.8 l (1 gal) of lukewarm tap water (22°C to 43°C [72°F to 110°F])
• An enzymatic cleaning solution prepared according to the manufacturer’s instructions,
such as Enzol Enzymatic Detergent or Steris Prolystica 2x Concentrate Enzymatic
Presoak and Cleaner.
2. With the prepared solution, wet a lintless, sharp-tip, cotton swab and a clean, soft, lint-free
wipe (or cloth), and squeeze out the excess liquid.
4535 620 35461_A/795 * FEB 2020

NOTE
The swab and the wipe or cloth should be damp but not dripping.
3. Use the damp swab to thoroughly clean the pinholes on the patch strain relief, until you
remove all visible soil.
4. Use the damp wipe to thoroughly wipe the entire surface of the patient tracker patch. Pay
careful attention to the area where the adhesive was applied, to remove any adhesive
residue. Wipe the patch for a minimum of 1 minute and until you remove all visible soil.
5. Use a new solution-dampened wipe to thoroughly wipe the entire cable for a minimum of
30 seconds and until you remove all visible soil.
6. Use a new solution-dampened swab to thoroughly clean the pinholes on the connector
strain relief, until you remove all visible soil.
7. Use a new solution-dampened wipe to thoroughly wipe the connector portion of the
patient tracker. Wipe the connector for a minimum of 30 seconds and until you remove all
Philips
visible soil.

Cleaning the Patient Tracker Maintenance
CAUTION
8. Wet a new clean, soft, lint-free wipe (or cloth) with lukewarm tap water (22°C to 43°C [72°F
to 110°F]). Squeeze out excess liquid.
NOTE
4535 620 35461_A/795 * FEB 2020
9. Use the damp wipe to thoroughly wipe the patient tracker patch for a minimum of
30 seconds to remove cleaning residue.
10. Rewet the wipe with lukewarm tap water and thoroughly wipe the entire cable for a
11. Rewet the wipe with lukewarm tap water and carefully wipe the connector portion for a
12. After wiping, thoroughly dry the patient tracker patch, cable, and connector with a clean,
dry, lint-free wipe or cloth.
13. Visually inspect the patient tracker in a well-lit area to confirm the absence of any soil or
adhesive.
14. If you see any soil or adhesive, repeat step 2 through step 13 (using fresh wipes and cotton
swabs) until you see no soil or adhesive.
15. If you see no soil or adhesive, and the device is completely dry, the patient tracker is ready
for disinfection (see “Disinfecting the Patient Tracker” on page 82).
Philips

Maintenance Disinfecting the Patient Tracker
Disinfecting the Patient Tracker

After the tracker has been cleaned, it is ready for disinfection.
WARNING
equipment.
CAUTION
4535 620 35461_A/795 * FEB 2020

CAUTION
CAUTION
For assistance during disinfection, see the image in “Cleaning the Patient Tracker” on page 78.
1. Put the cleaned tracker alone in a clean, dry, disinfected or sterilized basin, placing the
connector in an upward position, away from the cable and patch portions of the device, to
prevent liquid or moisture from entering the connector.
2. Using one of the following disinfectant wipes, thoroughly wipe the entire surface of the
Philips
patient tracker patch for a minimum of 30 seconds.

Disinfecting the Patient Tracker Maintenance
• Pre-saturated cleaning wipes with a 1:10 bleach solution as the active ingredient (for
example, Sani-Cloth Bleach Wipes or Dispatch Wipes)
• Clean, lint-free, sterile wipes saturated with a spray containing a quaternary ammonium
disinfection solution
• Clean, lint-free, sterile wipes saturated with a 1:10 bleach solution of 100 ml (3.4 oz)
household bleach (4% to 6% sodium hypochlorite) in 900 ml (1 qt) lukewarm distilled
water (22°C to 43°C [72°F to 110°F])
3. Use a new disinfectant wipe to thoroughly wipe the cable portion of the patient tracker in
both directions for a minimum of 30 seconds.
4. Use a new disinfectant wipe to thoroughly wipe the connector portion of the patient
tracker for a minimum of 30 seconds.
4535 620 35461_A/795 * FEB 2020
CAUTION
5. Use a disinfectant-saturated swab to wipe each pinhole on the patch and connector strain
reliefs for 3 seconds.
NOTE
6. Use a new disinfectant wipe to thoroughly wipe all sections of the patient tracker for a
minimum of 30 seconds to ensure that all surfaces are damp.
Philips

Maintenance Disinfecting the Patient Tracker
7. Allow the patient tracker to stand after wiping for the minimum time required by the wipe
manufacturer. If you are using the 1:10 bleach solution, allow the tracker to stand for a
minimum of 4 minutes.
8. After the minimum standing time, saturate a clean, lint-free, sterile wipe with sterile water
and squeeze out excess liquid.
NOTE
9. Use the wipe saturated with sterile water to thoroughly wipe the patch, cable, and
connector portion of the patient tracker for a minimum of 1 minute. Pay careful attention
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to the pinholes on the strain reliefs.
CAUTION
10. Allow the patient tracker to air dry and place the disinfected device in an appropriate dry
storage area.
Philips

Disinfecting the Patient Tracker Specifications
7 Specifications
Philips reserves the right to change specifications contained herein or discontinue manufacture
at any time without prior notice. Current specifications are supplied with each system
purchased or are available from your Philips representative.
Field Generator Dimensions

Width: 50.7 cm (20 in)
Length: 76.2 cm (30 in)
Depth: 3.4 cm (1.3 in)
Weight without cable: 13.3 kg (29.3 lb)
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Field Measurement Volume

The field generator is characterized with a dome measurement volume. For the dimensions of
the characterized volume, see the figure. This figure provides context only and should not be
used for inspection.
Philips

Specifications Disinfecting the Patient Tracker
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Field Generator Measurement Volume (Dimensions Shown in mm)
1 Measurement volume
2 Tabletop field generator
Pressure Limits
See the ultrasound system's User Manual.
Philips

Safety and Regulatory Requirements Specifications
Humidity Limits
Temperature Limits
Electrical Parameters
Safety and Regulatory Requirements

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Classification
• Tabletop field generator: Type B applied part
• Ultrasound transducers: Type BF and Type CF applied parts, as labeled on the transducer
Electromechanical Safety Standards Met

The system complies with the requirements of IEC 60601-1 Medical Electrical Equipment,
General Requirements for Safety, including all applicable collateral and particular standards, as
well as all applicable national deviations.
Compliance
Philips products comply with relevant international and national standards and laws.
Information on compliance will be supplied by your local Philips representative, or the
manufacturer, on request.
Philips

Specifications Service Life
Service Life
Service life is defined by IEC 60601-1 as the amount of time that a medical device is expected to
remain safe for use. The service life for medical device components may be defined by hours of
use or number of times used.
NOTE
Regular maintenance is necessary for a medical device or component to perform for its
expected service life.
The service life for the tabletop field generator (TTFG), in combination with the PercuNav
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system tray, tool connection unit (TCU), and TCU cable assemblies, is 80,000 hours.
Philips

Index
Index
A Comments
Accessories 5 customer 5
Acquisition number 57 Compliance 87
Adjust Position control 55 Components 11, 12
Annotation 54 Contraindications 15
Assembling Customer
L12-5 50 transducer and ultrasound comments 5
tracker 30
mattress and field generator 17 D
Auto Annotate control 55, 64 Defibrillation 24
Auto Annotation 51 Direction 51
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Direction control 55
B Disinfecting
Breast markers 57 field generator 70
removing 57 mattress 67
reviewing 57 patient tracker 82
setting 51 TCU 69
viewing 57 ultrasound tracker 76
Breast Markers display 57 Displays 43, 49
Breast Markers 57
C protocol 43, 49
Capabilities 11 registration 43
Capture number 57 Sweep 49
CIVCO tracking bracket 32
Cleaning E
field generator 70 Erase control 55
mattress 67 Examination bed 11, 12, 17
patient tracker 79
TCU 69
ultrasound tracker 71
Clear Registration control 55
Philips

Index
F Markers 51, 57
Field generator 11, 12, 17 Mattress 11, 12, 17
cable connector 17 cleaning 67
cleaning 70 cover 17
connecting 30 disinfecting 67
disinfecting 70 graphic 17
positioning 24 inserts 17
tracking field graphic 24 Measurement volume 85
warnings 24
Find Orthogonal control 59, 64 O
Finding related loops 61 Orthogonal frames 59
finding 59
I
IEC 60601-1 87
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P
Imaging 11 Pacemakers 24
Instruments Patient
maintenance 67 positioning 37
patient tracker 38 Patient tracker 11, 12
ultrasound tracker 30 cleaning 79
Interference disconnecting the cables 38
magnetic 24 disinfecting 82
placing 38
L removing 38
Left Side control 55 Protocol 43, 49
M R
Magnetic interference 24 Reconstruct 3D controls 62, 64
Maintenance 67 Reconstructing 3D volumes 62, 64
field generator 70
mattress 67
patient tracker 82
TCU 69
ultrasound tracker 71, 76
Philips

Index
Registration 43, 45 Specifications 85

adjusting 45 electrical parameters 85
clearing 45 humidity limits 85
erasing 45 measurement volume 85
performing 45 pressure limits 85
steps 45 temperature limits 85
tool status 45 Standards
tracking field 45 safety 87
verifying 50 Study
Registration display 45 starting 42
Remove Tag control 64 Supplies 5
Reverse Lookup control 61, 64 Sweep controls 45
Reviewing breast markers 57 Sweep Graphic 51
Right Side control 55 Sweep Graphic control 55
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Room setup 24 Sweeping the breast 51

Systems
S supported 5
Safety 7
defibrillation 7, 24 T
field generator 24 Tabletop field generator 11, 12, 17
magnetic fields 7, 24 Type B classification 87
MRI 7, 24 Tabletop mattress 11, 12
pacemakers 7, 24 TCU 11, 12
setup 7, 24 cleaning 69
standards 87 connecting instruments 30
warnings 7, 24 disinfecting 69
Scanning, breast 51 Tool connection unit (TCU) 11, 12
Service life 88 Touch screen 55, 64
Setup 24 controls 55
Show All control 55 Review controls 64
Philips

Index
Tracking field W
graphic 37 Warnings 7, 24
indicators 24, 37 defibrillation 7, 24
location 24 field generator 24
volume 85 magnetic fields 7, 24
Tracking field graphic 24 MRI 7, 24
Transducers 11, 12 pacemakers 7, 24
supported 5 safety 7
tracker 11, 12 setup 7, 24
Type BF and Type CF 87
Type B Classification
tabletop field generator 87
Type BF transducers 87
Type CF transducers 87
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U
Ultrasound systems
preparing for use with AI Breast 17
supported 5
Ultrasound tracker 11, 12
attaching 32
cleaning 71
disinfecting 76
placing 32
removing 32
Philips

www.philips.com/healthcare
Philips Ultrasound, Inc.

22100 Bothell Everett Hwy
Bothell, WA 98021-8431
USA
EC REP
Philips Medical Systems Nederland B.V.

Veenpluis 6
5684 PC Best
The Netherlands
2797
© 2020 Koninklijke Philips N.V.

All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is
prohibited without the prior written consent of the copyright owner.
Published in USA
4535 620 35461_A/795 * FEB 2020 - en-US

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User Manual

EPIQ Series and

Anatomical Intelligence for

4 Preparing the System.............................................................................................................................. 17

Anatomical Intelligence for Breast (AI Breast) 3

Performing the Breast Exam with the AI Breast Controls.................................................................. 51

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4 Anatomical Intelligence for Breast (AI Breast)

1 Read This First

Supplies and Accessories

Philips Patient Tracker 10001

Philips Ultrasound Tracker for the L12-5 50 transducer 20004

Anatomical Intelligence for Breast (AI Breast) 5

Telephone: 800-445-6741 (USA and Canada), +1 319-248-6757 (International)

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6 Anatomical Intelligence for Breast (AI Breast)

Anatomical Intelligence for Breast (AI Breast) 7

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8 Anatomical Intelligence for Breast (AI Breast)

Anatomical Intelligence for Breast (AI Breast) 9

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10 Anatomical Intelligence for Breast (AI Breast)

Anatomical Intelligence for Breast (AI Breast) 11

System Supported Transducers

EPIQ systems eL18‑4 with EM tracker

Affiniti 70 systems eL18‑4 with EM tracker

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Tabletop Field Generator and Cable

12 Anatomical Intelligence for Breast (AI Breast)

Tabletop Field Generator

Transducer with Tracking Sensor

Anatomical Intelligence for Breast (AI Breast) 13

Ultrasound System Software and Hardware

Tool Connection Unit (TCU) and Cable

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14 Anatomical Intelligence for Breast (AI Breast)

Anatomical Intelligence for Breast (AI Breast) 15

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16 Anatomical Intelligence for Breast (AI Breast)

4 Preparing the System

Assembling the Mattress and Field Generator

Biodex Econo Ultrasound Table Model 058‑726: 115 Vac

Hill‑Rom Transport Stretcher Mattress: 76.2 cm (30 in)

Stryker Transport Stretcher Model 748 litter: 76.2 cm (30 in)

Anatomical Intelligence for Breast (AI Breast) 17

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18 Anatomical Intelligence for Breast (AI Breast)

Tabletop Mattress Interior

1 Location of field generator during use

Anatomical Intelligence for Breast (AI Breast) 19

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20 Anatomical Intelligence for Breast (AI Breast)

Positioning the Field Generator with the Cable Connected

Anatomical Intelligence for Breast (AI Breast) 21

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22 Anatomical Intelligence for Breast (AI Breast)

Route of the Field Generator Cable

Anatomical Intelligence for Breast (AI Breast) 23

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8. Zip the mattress cover.

Positioning the System

24 Anatomical Intelligence for Breast (AI Breast)

Anatomical Intelligence for Breast (AI Breast) 25