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- 1 - Developing X-ray care units for the initial diagnosis of Covid-19 positive patients outside medical facilities — Setting up infection-protection spaces and online treatment facilities — June 17, 2021 National Institute of Advanced Industrial Science and Technology Tsukuba Medical Center Foundation Ibaraki Prefectural University of Health Sciences Kitasato University Tokyo Metropolitan Public University Corporation Komazawa University Focus Systems Corporation Pureron Japan Co., Ltd. Main Points Enabling doctors to conduct interviews and interpret radiograms online from a remote clinic Use for screening on premises where a cluster has occurred and for follow-ups checks of patients in medical facilities for patients with mild symptoms Reduction of healthcare professional secondary infection Outline Infection-Controlled X-ray Care Units (ICXCU) for use as remote medical care devices for infection prevention have been developed by the following partners: National Institute of Advanced Industrial Science and Technology ("AIST"—Kazuhiko Ishimura, President), Health and Medical Research Institute (Yoshiro Tatsu, Director) Artificial Organ Research Group, Masaki Misawa, Senior Researcher; Medical Devices Research Group, Toshikatsu Washio, Senior Researcher; Naotaka Nitta, Senior Researcher; Institute for Energy Conservation (Teruhisa Horita, Director) Thermofluid System Group, Naoki Takada, Chief Senior Researcher; Industrial Cyber-Physical Systems Research Center (Tamio Tanikawa, Director) Field Robotics Research Team, Eimei Oyama, Senior Researcher; Akiya Kamimura, Research Team Leader; Tsukuba Medical Center Foundation ("Tsukuba Medical Center"—Yasuo Shima, President), Masahiko Hiroki, Department of Neurology, Director; Ibaraki Prefectural University of Health Sciences; Kitasato University; Tokyo Metropolitan Public University Corporation; Komazawa University; Focus Systems Corporation; and Pureron Japan Co., Ltd. X-ray care units are equipped with all the tools necessary for initial diagnosis. These vehicles, which are equipped for conducting chest X-rays, have a ventilation function to prevent infection and a medical information transmission system that enables online examinations. This makes it possible to perform medical checks of patients who have tested positive for Covid-19 outside medical facilities, thereby avoiding their coming into contact with other patients and the use of the same examination rooms as patients who have tested negative, thus speeding up the examination process. The details of this technology will be presented at The 40th JAMIT Annual Meeting (JAMIT 2021), which will take place in Yokohama between October 13th and 15th, 2021. Refer to [Terminology] for the underlined part.

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Developing X-ray care units for the initial diagnosis of Covid-19 positive patients outside

medical facilities

— Setting up infection-protection spaces and online treatment facilities —

June 17, 2021

National Institute of Advanced Industrial Science and Technology

Tsukuba Medical Center Foundation

Ibaraki Prefectural University of Health Sciences

Kitasato University

Tokyo Metropolitan Public University Corporation

Komazawa University

Focus Systems Corporation

Pureron Japan Co., Ltd.

■ Main Points ■

・ Enabling doctors to conduct interviews and interpret radiograms online from a remote clinic

・ Use for screening on premises where a cluster has occurred and for follow-ups checks of patients in

medical facilities for patients with mild symptoms

・ Reduction of healthcare professional secondary infection

■ Outline ■ Infection-Controlled X-ray Care Units (ICXCU) for use as remote medical care devices for infection

prevention have been developed by the following partners: National Institute of Advanced Industrial Science and

Technology ("AIST"—Kazuhiko Ishimura, President), Health and Medical Research Institute (Yoshiro Tatsu,

Director) Artificial Organ Research Group, Masaki Misawa, Senior Researcher; Medical Devices Research

Group, Toshikatsu Washio, Senior Researcher; Naotaka Nitta, Senior Researcher; Institute for Energy

Conservation (Teruhisa Horita, Director) Thermofluid System Group, Naoki Takada, Chief Senior Researcher;

Industrial Cyber-Physical Systems Research Center (Tamio Tanikawa, Director) Field Robotics Research Team,

Eimei Oyama, Senior Researcher; Akiya Kamimura, Research Team Leader; Tsukuba Medical Center

Foundation ("Tsukuba Medical Center"—Yasuo Shima, President), Masahiko Hiroki, Department of Neurology,

Director; Ibaraki Prefectural University of Health Sciences; Kitasato University; Tokyo Metropolitan Public

University Corporation; Komazawa University; Focus Systems Corporation; and Pureron Japan Co., Ltd.

X-ray care units are equipped with all the tools necessary for initial diagnosis. These vehicles, which are

equipped for conducting chest X-rays, have a ventilation function to prevent infection and a medical information

transmission system that enables online examinations. This makes it possible to perform medical checks of

patients who have tested positive for Covid-19 outside medical facilities, thereby avoiding their coming into

contact with other patients and the use of the same examination rooms as patients who have tested negative, thus

speeding up the examination process. The details of this technology will be presented at The 40th JAMIT Annual

Meeting (JAMIT 2021), which will take place in Yokohama between October 13th and 15th, 2021.

Refer to [Terminology] for the underlined part.

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Example of ICXCU use by local authorities

■ Effects on Society ■

As the spread of Covid-19 infections continues, it is imperative to protect medical workers from secondary

infections and ease the burden carried by public health centers. Along with the growth in the number of new

infections, persons working in public health centers and the medical field labor under increasingly stressful

conditions and the emergency medical system is disrupted. As of June 15th, 2021, the number of infections in

the country had surpassed 770,000 with the number of severe cases growing too. Currently, local authorities

conduct examinations in premises where a cluster occurred, as well as dealing with the management of people

with mild symptoms. They also cooperate with hospitals designated for infectious diseases. However, the

infection of doctors and nurses has had a substantial influence on the medical system. Therefore, it is desirable

to formulate a plan to alleviate the burden carried by public health centers and regional medical services, which

have been bearing a heavy load.

Chest X-rays are a highly efficient way of screening multiple patients with suspected pneumonia, as well as

monitoring patient progress. However, X-ray CT imaging, which is even more accurate, exposes the person to

high levels of radiation and is time-consuming, and each doctor needs to determine whether a chest X-ray is

necessary. In Ibaraki Prefecture, chest X-rays have been strongly recommended for patients who have Covid-19.

Nevertheless, because it is troublesome to disinfect medical equipment touched by a positive patient, this leads

to an increase of secondary infection during imaging procedures at medical facilities. At present, chest X-ray

equipment is taken outside the medical facility and X-rays are performed in negative-pressure tents outdoors.

However, the tents—which are not readily portable—are affected by outside temperatures and weather, making

it impossible to perform examinations during bad weather and at night, when the lighting is insufficient. Also,

once a negative-pressure tent and medical equipment have been set up, they are not easy to move or take down.

This means they cannot be placed directly on premises where a cluster occurred. Therefore, during this

development, we sought to make it possible to diagnose Covid-19 positive patients early on and outside medical

facilities by furnishing mobile vehicles with diagnostic equipment and online medical equipment.

■ Research Details ■

AIST and Ibaraki Medical Center have considered a plan to use specially equipped ambulances with head X-

ray CT imaging capability as a measure for cerebral apoplexy, which is considered the leading cause of aging-

related bedriddenness. This type of ambulance has also been proposed to local authorities and The Japan Stroke

Society. Once again, along with the spread of Covid-19, it has been proposed to switch over from head X-ray CT

equipment to the chest X-ray equipment necessary for pneumonia screening. In light of this, we developed

PCR test

Symptoms suddenly change to medium or

other status Mild

symptoms

Choice of place for

recuperation

Infection-Controlled X-ray Care Units (ICXCU)

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ambulances with X-ray imagining equipment in continued cooperation with public health centers and the Ibaraki

Prefecture government.

During the development of this system, we received support based on a project commissioned as part of the

2020 Virus Infection Measure Technology Development Project (Empirical and Improvement Research Support)

by the Japan Agency for Medical Research and Development (AMED). (Subject: development of Infection-

Controlled X-ray Care Units (ICXCU) as remote medical devices for infection prevention)

■ Research Content ■

[X-ray Care Unit Properties]

To perform a medical check of Covid-19 positive patients outside medical facilities, we have developed online

medical facilities and infection-controlled X-ray care units (ICXCU) (see Image 1). These specially equipped

vehicles are divided into compartments, with air being taken in from the front. This creates a one-way flow of air

to the consultation area from the clean area. A ventilation system is in place, with used air being emitted from the

roof at the back of the consultation room. The air is purified by a low-concentration ozone generator and UV

irradiation, and secondary infection is prevented by means of antimicrobial foil coating in the consultation room

(see Image 2). A numerical simulation of the air flow within the unit is performed to visualize the air flow and

air flow measurements, verifying whether the air is flowing as planned and ventilation is implemented as

prescribed (Image 3).

[How to Use the X-Ray Care Unit]

An operator supervising the online examination and a radiographer, who performs the X-ray, are on standby

inside the unit. The patient enters from the rear door and, after their blood pressure is measured, a chest X-ray is

performed in the X-ray room in the center of the unit. The patient is informed of the diagnosis in the consultation

area at the back of the unit. The online examination system, which is connected to the internet and used to transmit

medical information, is located in the clean area at the front of the unit. The chest X-ray image is transmitted

from here to a medical specialist at a medical facility via a communication app for medical staff. By implementing

a system that allows the online submission of medical and X-ray images without delay, the medical team can

share all information from the preliminary examination to the interview and medical report. While reducing

infection risk, it is also anticipated that it will create quicker examinations with fewer mistakes.

In addition to chest X-ray equipment, the X-ray care unit will contain an automated blood pressure monitor,

an echo imaging device, a vital signs monitor, an electrocardiograph, an electronic stethoscope, and other devices.

This will make it possible, if necessary, to perform initial intervention on patients with underlying conditions (see

Image 4).

Other features include the fact that, compared with current medical checks performed in negative-pressure

tents, privacy is secured as conversations are not audible outside, it is air-conditioned, and operations are not

limited by bad weather or lack of lighting.

[Use in Premises Where a Cluster Occurred and Temporary Lodging Facilities]

One more way to use this unit is by making use of its function as a mobile unit. If requested by a public health

center, it can be moved to premises where a cluster occurred or temporary lodging facilities, enabling on-site

medical checks and the choice of an optimal recuperation site. Because they are used in premises operated by

local authorities, this type of use has been considered for throughout the region in the future after exchanges of

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ideas with bodies responsible for the Covid-19 response in Ibaraki Prefecture, local public health centers,

municipal medical associations, and health services. In addition to the Covid-19 response, we anticipate the use

of the units in support of first-aid operations during natural disasters.

Image 1: X-ray care unit exterior

The exterior design was selected by medical staff of the Ibaraki Medical Center.

Image 2: Air flow inside the unit as seen from above

Outside air is taken in from the intake fan in the clean area as well as the air conditioner and is then blown

around the consultation area at the back of the unit by an air blower.

The air is then disinfected with a High-Efficiency Particulate Air (HEPA) filter located in the exhaust fan in

the X-ray room and blown out of the unit.

Air conditioner Indoor unit

UV air purifier Sitting bed

Driver's seat

Intake fan Operator Door with aperture

X-ray

Exhaust fan 3 Exhaust fan 2 Exhaust fan 1

Entrance/exit

Radiographer Transparent curtain

Air blower Ozone generator Camera

used for interview

Patient

*Arrows indicate air flow

Clean area Narrow passage Consultation area

Air

cir

cula

tor

- 5 -

Image 3: Example of a numerical simulation of air flow inside the unit

The radiographer stands upstream in the one-way flow of air and is not, therefore, exposed to droplets from the patient.

Image 4: Examination types and equipment on board the X-ray care unit

In addition to the medical equipment needed for medical checks, the unit is also furnished with medical

equipment necessary for initial diagnosis of patients with underlying conditions.

■ Future Plans ■

Demonstration experiments with X-ray care units included in this development have been selected for Ibaraki

Prefecture's 2021 DX Innovation Promotion Project, gaining support from the prefecture. Within this year, it is

planned to set up a unit in the Tsukuba Medical Center Hospital to perform medical checks jointly with negative-

pressure tents. Patients with relatively mild symptoms will be treated in the X-ray care unit, while patients unable

to board the unit will receive medical checks in the negative-pressure tents as they have previously. In the second

half of the year, we plan to demonstrate operation in premises where a cluster occurred and in temporary lodging

X-ray room

Air blower

Unit front

Air flow Radiographer

standby location

Patient location during examination Unit

back

Internet connection with medical specialist Unit space

division

Air circulates more than 12 times per hour

Other on-board equipment

The doctor can examine a patient remotely

A nurse and radiographer are on board

Medical check equipment

- Small echo imaging device - Electronic stethoscope - Heart rate monitor

- Chest X-ray equipment - Completely automated blood pressure monitor

- Pulse oximeter

- Contactless thermometer

*Blue lines indicate air flow

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facilities to give an idea of screening and follow-ups as requested by local authorities and public health centers.

We also plan to demonstrate remote examinations in areas with sparse medical facilities and verify the unit's

functionality as temporary support in relief operations for medical treatment after natural disasters such as

earthquakes and floods.

[Contact details for inquiries] Publication Office, Public Relations Department, National Institute of Advanced Industrial Science and Technology Tsukuba Headquarters and Information Technology Collaborative Research Center Tsukuba Central 1, 1-1-1 Umezono, Tsukuba, Ibaraki 305-8568 TEL: 029-862-6216 FAX: 029-862-6212 E-mail: [email protected]

IR, PR Group, Focus Systems Corporation E-mail: [email protected] Tel: +81 03 5421 7790

[Terminology] ◆ X-ray care unit

A mobile care unit equipped with data transmission tools and furnished with X-ray equipment, blood pressure

monitor, pulse oximeter, and contactless thermometer. It enables medical checks of Covid-19 positive patients

and initial diagnosis with infection-prevention measures in place.

◆ Remote medical care

The doctor and patient, who are in separate locations, use information-communication equipment such as the

internet to provide aid with health improvement, medical treatment, and care.

◆ Medical information transmission system

A system consisting of tools for the transmission of chest X-ray images and echo images and real-time video

communication between the patient and the doctor during online examinations. The doctor can consult the images

in their consultation room and communicate the results via video chat to the patient. One more advantage is that

the medical crew can share the diagnosed condition via tablet.

◆ Medical checks of patients who have tested positive for Covid-19

Initial diagnoses that decide the treatment location of patients after they have tested positive in a PCR test.

This is handled differently depending on local authorities. In Ibaraki Prefecture, the following four procedures

are recommended: chest X-ray, blood pressure, oxygen saturation, and body temperature measurement.