Dedicated Breast PET System

AC19-0021

The system was commercialized based on a prototype developed under the

project "Development of Molecular Imaging Equipment for Supporting

Medical Treatment of Malignant Tumors and Other Conditions" (from 2006

to 2009) funded by the New Energy and Industrial Technology Development

Organization (NEDO).

Printed in Japan XXXX-XXXXX-XXXXX

Headquarters1, Nishinokyo-Kuwabara-cho, Nakagyo-ku, Kyoto 604-8511, Japanhttps://www.shimadzu.com/med/

Founded in 1875, Shimadzu Corporation, a leader in the development of advanced technologies, has a distinguished history of innovation built on the foundation of contributing to society through science and technology. We maintain a global network of sales, service, technical support and applications centers on six continents, and have established long-term relationships with a host of highly trained distributors located in over 100 countries. For information about Shimadzu, and to contact your local office, please visit our website at www.shimadzu.com

Shimadzu Corporation Medical Systems Division has been certified by TÜV Rheinland as a manufacturer of medical systems in compliance with ISO9001:2015 Quality Management Systems and ISO13485:2016 Medical Devices Quality Management Systems.

Remarks:

• This product is available only in Japan as of Nov.2019. For the sales to outside of Japan, please contact your nearest Shimadzu sales Representative for its details.

• Every value in this catalogue is a standard value, and it may vary a little from the actual at each site.

• The appearances and specifications are subject to change for reasons of improvement without notice.

• Certain configurations may not be available pending regulatory clearance. Contact your Shimadzu representative for information on specific configurations.

• Before operating this system, you should first thoroughly review the Instruction Manual.

The morbidity rate of breast cancer keeps increasing each year and peaks at the

prime of life. Therefore, we developed a completely new type of breast examination

system based on our desire to save as many women from breast cancer and help

them remain vibrant at home or their workplaces as long as possible. That system is

the Elmammo Avant Class dedicated breast PET system.

Ever since the birth of PET systems, Shimadzu Corporation has been diligently

developing new systems and offering state-of-the-art technologies. Now we have

taken all the PET technology we developed thus far and incorporated it in the

Elmammo Avant Class to offer new clinical value for diagnosing breast cancer patients.

Note: The name Elmammo was formed by combining "Elm," a tree that symbolizes trust in the language

of flowers, with "Mamma,"

Born to Be Gentle, a PET Scanner for Women

Dedicated Breast PET System

I m a g e B r e a s t G e n t l y

Patient Comfort

Created Out of Compassion for Women

Breast examinations are sensitive examinations. To minimize the burden on

patients during examinations, the system was designed from a woman's

perspective by incorporating feedback from women throughout the design.

The gentle shape of the design softens the first impression the patient

receives when entering the examination room and helps reduce anxiety

before the examination.

Offers a Gentle Examination Space

Comfortable Examinations

An indentation provided in the bed surface near

the head makes it easier to lay comfortably in the

prone position. The bed is made of a dual structure,

with a soft material used for the mat in direct

contact with the skin and a harder material

required to maintain proper posture used internally.

That means the bed is both comfortable and easy

to set up during examinations. For optimal hygiene,

the materials are also easy to clean.

Preparation for Examination Is

Also Patient-Friendly

The bed height was optimized to make it easier

for patients to get on and off the bed and easier

for medical personnel to provide assistance. The

bed is also surrounded by gentle curves to prevent

patients from bumping any sharp corners when

getting on or off the bed.

Detectors are arranged in a circle surrounding the

breast. The patient is examined in a relaxed

position, with the breast simply placed

comfortably in the detector hole. Because it does

not compress the breast, there is no compression

pain involved.

Examination Without Pain

Soft materialDual structure with soft and

somewhat hard materials

4 5

Injectionroom

HallwayControl room

PET/CT room

Elmammo room

Uptake/recoveryroom

Toilet

Smooth Examination

Achieves a Smooth Examination Process

Examination Process Flow

(Example)

Recovery room

Injection Room

Inject 18F-FDG.

Uptake Room

Wait in a quiet state.

Scan Room B

Examine with a dedicated breast PET system.

Return to a quiet state and then leave.

Examine with a whole body PET/CT system.

Scan Room A

6 7

Simple Setup Process

Setting up the examination is easy, because the Elmammo Avant

Class doesn't require breast compression. Simply have the patient

lie face down on the bed, with the breast positioned in the

detector hole. That is all the preparation required for examinations.

Lying in the prone position inhibits breast movement during

examinations, so that examinations can be performed with

confidence. It also means patient setup can be accomplished very

quickly, with minimal exposure to medical personnel to provide

assistance.

Units: mm

Advanced Technology

Comparison of Whole Body PET and Elmammo Images

The higher spatial resolution achieved

results in rendering even more detailed

drug accumulations in tissue more

clearly than conventional whole body

PET systems (in a comparison by

Shimadzu).

In a comparison of mini-DERENZO

phantom images, the whole body PET

system did not properly render 2.4 mm

and smaller rod sizes, whereas the

Elmammo rendered them clearly.

State-of-the-Art DOI Technology Optimized

for Breasts

Using smaller detecting elements reduces the probability

(sensitivity) of detecting radiation. To ensure high sensitivity for

detecting even tiny amounts of radiation after a whole body PET

examination, the system positions the detectors as close to the

breast as possible and is the first clinical PET system in the world to

include DOI technology*1. Due to a unique detector configuration

and algorithm, the system provides far more information and

higher precision than a whole body PET system.

Ensures High Quantitative Analysis Capability

The higher resolution reduces partial volume effects*2 and helps

ensure quantitative analysis capability. High quantitative ability

was ensured by applying the absorption and scattering correction

technology we have accumulated from developing whole body

PET systems. The system also supports SUV diagnostics*3, which

involves numerically evaluating the malignancy level of lesions.

Configured with 1.44 mm square detecting elements, the world's

smallest detecting element used for a clinical PET system (as of

September 2014), the system offers higher resolution for viewing

detailed drug distributions. Furthermore, uniform voxel size

spacing in the three orthogonal cross-section images provides

uniform high resolution images within the field of view. The ability

to acquire images in the prone position, which is less affected by

body movement due to breathing, is another reason sharp images

can be obtained.

Provides High Resolution Images

mini-DERENZO Phantom Whole Body PET System Elmammo

Whole Body PET System Elmammo

State-of-the-Art Technology Provides Highly Precise Breast Examinations 75Ø

4.8 4.0

1.6 2.4

1.2 3.2

Edge of FOV Edge of FOV

Edge of FOVCenter of FOV Center of FOV Edge of FOV

DOI DetectorConventional Detector

DOI detectors are able to determine the depth in the scintillator where gamma rays are detected.

With conventional detectors, resolution is the highest at the center of the field of view and decreases the closer it is to the edge, where quantitative values are underestimated.With DOI detectors, resolution is maintained throughout the detector, so that quantitative ability is ensured all the way to the edges.

*1 DOI (depth of interaction) technology: Technology that can determine the depth inside the detecting element where radiation was detected, used to provide both high sensitivity and high resolution.

*2 Partial volume effect: Phenomenon where the smaller the object being imaged, the more the true size and PET image values are underestimated.

*3 SUV (standardized uptake value): A simple index for expressing the intensity of FDG accumulations in a tumor. In general, a high SUV value indicates high malignancy. The SUV is calculated by the following formula: PET image (radioactivity concentration of tumor)/(radioactivity dose/body weight).

Conventional Detector DOI Detector

Gammarays

Gammarays

8 9

Scanner

weight: 293 kg

Layout Dimensions

10 11

2271 mm

10

30

mm

67

0 m

m

Console

weight: 107 kg

Example for Minimum installation layout (Scale Size: 1/100)

Elmammo room

Console

2.5m

　More than 1.2 m

4m

Control room