No.

2A201-528EN*A

SITE PLANNING MANUAL

FOR
TOSHIBA SCANNER

MODEL TSX-031A
(2A201-528EN*A)

© TOSHIBA MEDICAL SYSTEMS CORPORATION 2007

ALL RIGHTS RESERVED
 No. 2A201-528EN*A

IMPORTANT!

1. No part of this manual may be copied or reprinted, in whole or in part,

without prior written permission.

2. The contents of this manual are subject to change without prior notice
and without legal obligation.

3. The contents of this manual are correct to the best of our knowledge.
Please inform us of any ambiguous or erroneous descriptions, missing
information, etc.
 No. 2A201-528EN*A

REVISION RECORD

REV. DATE REASON PAGE SER. DOC.

(MM/YY) /AUTHOR CHANGED No. PRODUCT.

INI. 01/'07 Mr. Ohgane ------- TM-WP2

*A 05/'07 Review of descriptions in the manual Mr. Ohgane P. 15, 19, 22

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 No. 2A201-528EN*A

Safety Precautions

1. Meaning of Signal Words

In this manual, the signal words DANGER, WARNING, and CAUTION are used to indicate
safety and other important instructions. The signal words and their meanings are defined as follows.
Please understand their meanings clearly before reading this manual.

Signal word Meaning

DANGER Indicates an imminently hazardous situation which, if not avoided, will

result in death or serious injury.

WARNING Indicates a potentially hazardous situation which, if not avoided, could

result in death or serious injury.

CAUTION Indicates a potentially hazardous situation which, if not avoided, may

result in minor or moderate injury.

CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in
property damage.

In addition to the above, the signal word NOTE is used to indicate other important information.

NOTE Indicates reference information that enables more efficient use of the
equipment.

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 No. 2A201-528EN*A

CAUTION: 1. If the system transformer is installed beside the console, adequate distance
must be kept between them. Otherwise, the displayed images may be
adversely affected.

2. The field engineers should examine and check the general works and share
of responsibilities.

3. Power supply system:

Install the special transformer (cubical output transformer) for this system in
the hospital power supply.

4. Air conditioning:

The scanning room must be provided with an independent air conditioning

system.
Even if the room is maintained within the permissible temperature range,
gradual temperature shifts (for example, a slow increase in room temperature
from morning to evening) may adversely affect system performance.
Therefore, the room temperature must be under constant control.

5. Floor leveling work:

Although two different hardeners are available for the epoxy resin (winter-
use hardener and summer-use hardener), the winter-use hardener (B-065)
must be used.
The summer-use hardener is not suitable for work in hospitals or clinics
because it requires a long hardening time and, in some cases, the application
of heat may be necessary to achieve hardening.

6. Floor leveling work:

The anchor must be well caulked to prevent the epoxy resin from being
intruded into the anchor hole.
The paper wound on the anchor must be higher than the epoxy resin depth.

7. Applying resin:

• This job must be performed with a plastic floor-covering sheet laid on the
floor.
• Before mixing the liquid agents, they must be accurately weighed using an
oil replenishment container.
• The oil replenishment container that has been used for weighing must not
be used to apply the resin.
• Gloves, eye protection, etc. must be worn when handling the resin.
• During handling of the resin, good ventilation must be provided since it is
a volatile chemical.

5
 No. 2A201-528EN*A

CONTENTS

Page

Safety Precautions --------------------------------------------------------------------------------------------------------------- 4

1. SCOPE----------------------------------------------------------------------------------------------------------------------- 9

2. APPLICATION-------------------------------------------------------------------------------------------------------------- 9

3. SYSTEM COMPOSITION ----------------------------------------------------------------------------------------------- 9

3.1 Standard Composition ------------------------------------------------------------------------------------------- 9

3.2 Optional Units-----------------------------------------------------------------------------------------------------10

3.3 Miscellaneous-----------------------------------------------------------------------------------------------------10

4. MAIN SPECIFICATIONS FOR SITE PLANNING-----------------------------------------------------------------11

4.1 Classification ------------------------------------------------------------------------------------------------------11

4.2 X-ray Specifications ---------------------------------------------------------------------------------------------11

4.3 X-ray Tube Leakage Dose-------------------------------------------------------------------------------------11

4.4 Power Supply Requirements (For the standard system)-----------------------------------------------11

4.5 Grounding ---------------------------------------------------------------------------------------------------------12

4.6 Wiring Work -------------------------------------------------------------------------------------------------------12

4.7 Site Environment-------------------------------------------------------------------------------------------------12

4.8 External Dimensions and Mass ------------------------------------------------------------------------------12

4.9 Classification ------------------------------------------------------------------------------------------------------12

4.10 Maximum Cable Length ----------------------------------------------------------------------------------------13

4.11 Installation Altitude ----------------------------------------------------------------------------------------------13

4.12 Transport and Storage Conditions---------------------------------------------------------------------------13

4.13 Installation Location Requirements--------------------------------------------------------------------------13

5. SPACE REQUIREMENT -----------------------------------------------------------------------------------------------14

5.1 Scanning Room --------------------------------------------------------------------------------------------------15

5.2 Scan Control Room ---------------------------------------------------------------------------------------------16

5.3 System Operating Environment and EMC-----------------------------------------------------------------17

6. CLASSIFICATION OF INSTALLATION-RELATED WORK ----------------------------------------------------18

6.1 Scope of Work to Be Executed by the Customer --------------------------------------------------------18

6.2 Scope of Work to Be Executed by Toshiba Subsidiaries ----------------------------------------------18

6
 No. 2A201-528EN*A

CONTENTS - continued

Page

7. BUILDING CONSTRUCTION WORK -------------------------------------------------------------------------------19

7.1 Entrance Used to Bring-in the Unit --------------------------------------------------------------------------19

7.2 X-ray Shielding in the Scanning Room ---------------------------------------------------------------------19

7.3 Support -------------------------------------------------------------------------------------------------------------19

7.4 Floor Structure of the Scanning Room ---------------------------------------------------------------------20

7.5 Wiring Pits and Wall Ducts ------------------------------------------------------------------------------------20

7.5.1 Pit and duct sizes -----------------------------------------------------------------------------------20

7.5.2 Partitions in the pit and duct ----------------------------------------------------------------------20

7.5.3 Precautions -------------------------------------------------------------------------------------------21

8. ELECTRICAL WORK----------------------------------------------------------------------------------------------------22

8.1 Electrical Equipment --------------------------------------------------------------------------------------------22

8.1.1 Electrical specification------------------------------------------------------------------------------22

8.1.2 Power transformer and power distribution cabling ------------------------------------------22

8.1.3 Ground fault interrupter ----------------------------------------------------------------------------23

8.1.4 Voltage regulation-----------------------------------------------------------------------------------26

8.1.5 Countermeasures against high-frequency electromagnetic radiation ------------------26

8.2 Power Distribution Board --------------------------------------------------------------------------------------27

8.3 Grounding ---------------------------------------------------------------------------------------------------------27

8.4 Electrical Equipment --------------------------------------------------------------------------------------------28

8.5 Illumination --------------------------------------------------------------------------------------------------------28

8.6 Cable Connections Between the Units ---------------------------------------------------------------------28

8.7 Installing a Communication Line for InnerVision ---------------------------------------------------------29

9. AIR CONDITIONING/WATER SUPPLY AND DRAINAGE WORKS-----------------------------------------30

9.1 Air Conditioning --------------------------------------------------------------------------------------------------30

9.2 Water Supply and Drainage -----------------------------------------------------------------------------------31

10. APPENDED TABLES AND FIGURES ------------------------------------------------------------------------------31

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 No. 2A201-528EN*A

CONTENTS - continued

Page

APPENDIX 1 APPENDED TABLES, FIGURES AND OUTLINE DRAWINGS-----------------------------------32

APPENDIX 2 HANDLING EMC ---------------------------------------------------------------------------------------------59

APPENDIX 3 FLOOR LEVELING WORK MANUAL -------------------------------------------------------------------68

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 No. 2A201-528EN*A

1. SCOPE

This document applies to the Toshiba X-ray CT scanner Activion16 (model TSX-031A).

2. APPLICATION

This document describes the site planning requirements for optimal performance. It also describes
the necessary site facilities and outlines the range of responsibilities during installation work.
This document applies to the following system and model.

System name Model name X-ray output Type of system

Activion16 TSX-031A series 36 kW Multislice system

3. SYSTEM COMPOSITION

3.1 Standard Composition

(1) Scanner

This refers to the CT main unit incorporating the X-ray tube, the high-voltage generator, the
detector unit, etc. Note that the scanner is also referred to as the gantry in this document.
This unit must be fixed with anchor bolts.

(2) Patient couch

The unit on which the patient to be scanned is placed is referred to as the patient couch. It is
provided with a vertical movement mechanism which allows patients to get on and off the
couch easily and facilitates scan center positioning. The patient couch is also provided with a
couch-top slide mechanism for scan slice positioning. This unit must also be fixed with
anchor bolts.

(3) Console

This unit is used to perform CT control, image reconstruction, image processing, etc. It
consists of the following sub-units.

• Navibox............... This is the console main unit incorporating the computer system. It is
placed on the floor.
• Keyboard
• Monitor................ Images and operation screens are displayed on the monitor. The
console of the TSX-031A includes a 19-inch LCD monitor.
• Mouse

A desk on which the monitor, the keyboard, and the mouse are placed and a chair are
required. They are not provided for the system.

(4) Accessories

Calibration phantom, couch accessories, speakers, operation manual, etc.

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 No. 2A201-528EN*A

3.2 Optional Units

(1) System transformer

This is used to convert the voltage of 400-V power-supply facilities to 200 V.

(2) Patient monitoring system

A camera and video display monitor set is used to observe the patient being scanned from
the scan control room.

3.3 Miscellaneous

The desk on which the console is to be placed and the chair for use with the console are not
included with the system.

Note: The desk and the chair selected should meet the requirements below.

• Desk

(1) Height : 800 mm (When the Navibox is installed under the desk, a height of
more than 700 mm is required under the desk.)

(2) Width : 1400 mm

(3) Depth : 700 mm

• Chair

(1) Seat height : The range from 500 to 550 mm should be covered.

(2) High stability (5 legs)

(3) With footrest or foot bar

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 No. 2A201-528EN*A

4. MAIN SPECIFICATIONS FOR SITE PLANNING

4.1 Classification

(1) According to the type of protection against electric shock:

CLASS I EQUIPMENT.

(2) According to the degree of protection against electric shock:

TYPE B APPLIED PART.

(3) According to the degree of protection against ingress of water:

Ordinary EQUIPMENT(IPX0).

(4) According to the degree of safety of application in the presence of a FLAMMABLE

ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:

EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC

MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE.

(5) According to the mode of operation:

CONTINUOUS OPERATION WITH INTERMITTENT LOADING.

4.2 X-ray Specifications

(1) X-ray type : Continuous fan-shaped beam

(2) Maximum X-ray tube voltage : 135 kV

(3) Maximum X-ray tube current : 300 mA

(4) Scan time : Half scan : 0.48 s

Full scan : 0.75, 1.0, 1.5, 2.0, or 3.0 s

4.3 X-ray Tube Leakage Dose

(1) X-ray tube leakage dose : 1.0 mGy or less in 1 hour

(2) Effective beam shielding : At least 2.4 mmPb

(3) X-ray tube inherent filtration : At least 1.1 mmAl eq.

4.4 Power Supply Requirements (For the standard system)

See subsection 8.1.

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 No. 2A201-528EN*A

4.5 Grounding

Grounding must be provided in accordance with all applicable legal requirements for medically
used electrical equipment.

4.6 Wiring Work

Wiring work for the power supply must be provided as detailed in subsections 8.1 and 8.2.

4.7 Site Environment

(1) Ambient temperature, humidity, and calorific value

See appended table 1 "Heat generation by units and environmental conditions".

(2) Vibration

0.98 m/s2 (0.1 G) or less

(3) Explosion-proof structure

The unit has no explosion-proof structure. Never use in the presence of explosive gas.

(4) Other

Check for evidence of excessive dust or dirt.

4.8 External Dimensions and Mass

See appended tables 2-1 and 2-2 "External dimensions and mass".

4.9 Classification

(1) According to the type of protection against electric shock:

CLASS I EQUIPMENT.

(2) According to the degree of protection against electric shock:

TYPE B APPLIED PART.

(3) According to the degree of protection against ingress of water:

Ordinary EQUIPMENT(IPX0).

(4) According to the degree of safety of application in the presence of a FLAMMABLE

ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:

EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC

MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE.

(5) According to the mode of operation:

CONTINUOUS OPERATION WITH INTERMITTENT LOADING.

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 No. 2A201-528EN*A

4.10 Maximum Cable Length

See appended tables 3-1 to 3-3 "List of inter-unit cables".

4.11 Installation Altitude

The installation altitude should be no more than 1000 m above sea level. Prior consultation is
required for installations higher than 1000 m.

4.12 Transport and Storage Conditions

Observe the following conditions during transport and storage after shipment.

(1) Ambinet temperature : -10°C to 50°C

(2) Relative humidity : 40% to 80% (No condensation)

(3) Atmospheric pressure : 700 hPa to 1060 hPa

(4) Vibration : 9.8 m/s2 (1G) or less <during storage>

19.6 m/s2 (2G) or less <during transportation>

4.13 Installation Location Requirements

Group 1 (according to 64/1043/CD/(IEC60364-7-710 (draft))

Note 1: The title of IEC60364-7-710 is "Electrical installations of buildings/Particular

requirements for special installations or locations/Medical locations and associated
areas."

2: Group 1 is "Location where medical electrical equipment is intended to be used, but not
for intracardiac procedure."

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 No. 2A201-528EN*A

5. SPACE REQUIREMENT

The floor space for unit installation should be 21 m2 or more, divided into two rooms.

For patient couch CBTB-018A

Required space : 22 m2 or more

For patient couch CBTB-018B

Required space : 21 m2 or more

Patient couch model Scanner room Operation room Minimum required space
CBTB-018A 5.53 m × 3.02 m 1.50 m × 3.02 m 22 m2
CBTB-018B 4.93 m × 3.02 m 21 m2

See appended figures 2-1 and 2-2 for the sample layouts.

Installation conditions

Installation location : Group 1 according to IEC60364-7-710

NOTE: 1. Group 1 requirement is described in IEC60364-7-710.

2. The title of IEC60364-7-710 is "Electrical installations of buildings - Part 7-710:

Requirements for special installations or locations - Medecal locations".

3. The definition of Group 1 is "Medical location where applied parts are intended to be
used as folows:

- externally;
- invasively to any part of the body, except where Group 2 applies".

The definition of Group 2 is "Medical location where applied parts are intended to be
used in applications such as intracardiac procedures, operating theatres and vital
treatment where discontinuity (failure) of the supply can cause danger to life".

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 No. 2A201-528EN*A

5.1 Scanning Room

The gantry and patient couch are installed in the scanning room.

(1) Installation of the gantry

The space shown in appended figures 2-1 and 2-2 is required for installation and
maintenance of the gantry and inward/outward movements of the couch top.

(2) X-ray shielding

Since the gantry releases X-rays, X-ray shielding of 1.5 mm or more in lead equivalence
should be provided around the scanner room and the entrance.

(3) Ceiling height

As equipment such as contrast medium injection tools are installed on the ceiling, the ceiling
height should be at least 2500 mm from the floor.

(4) Miscellaneous

The following should be provided where required:

• Washstand : For water phantom or contrast medium injector

• Storage rack : For first-aid kit or accessories
• Gases required for medical treatment : Oxygen and nitrogen dioxide
• Vacuum
• Ceiling traveling irrigator : For instillator

(5) Layout

See appended figures 2-1 to 3-2.

(6) Air conditioning

Since the gantry includes components such as detectors or electronic circuits which permit
high-precision measurement, air conditioning is required to maintain high precision. A
detailed description is given later.

(7) Illumination

Illumination should be adjustable, because it is easier to specify the desired scan slice
position using the positioning projectors when illumination is decreased.

(8) Wiring pits and ducts

The wiring pits and ducts should be installed in accordance with the specifications described
later.

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 No. 2A201-528EN*A

5.2 Scan Control Room

CAUTION: If the system transformer is installed beside the console, adequate

distance must be kept between them. Otherwise, the displayed images
may be adversely affected.

The operating console is installed in the scan control room.

(1) Window

The window for monitoring the scanning room should be in front of or on the side of the
console. The lowest window frame should be 90 cm from the floor for easy patient
monitoring. A curtain should be provided for the window facing the outside.

(2) Entry

Doors should be provided at both the corridor and scanning room.

Take extreme care for X-ray leakage from the scanning room door.

(3) Illumination

For easy image reading, install freely adjustable or two-step-adjustable illumination.

(4) Receptacles

At least two standard outlets should be provided near the console for installation of the 3D
workstation and InnerVision PC.

Installation of the outlet for connecting a communication line for InnerVision should also be
taken into consideration.

In addition to the above, the wiring and power distribution ducting or pit should be installed in
accordance with subsection 7.5 "Wiring Pits and Wall Ducts".

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 No. 2A201-528EN*A

5.3 System Operating Environment and EMC

Recently, the EMC (electromagnetic compatibility) problem in hospitals has drawn attention. To
prevent the problem from occurring and to ensure that the system operates in a stable manner,
this system conforms to IEC60601-1-2, the international standards regarding EMC.
The standards specify the requirements taking into account the following points:

<1> Adverse effect on other systems due to noise generated by this system

<2> Adverse effect on this system due to noise generated by other systems

<3> Adverse effect on this system due to static electricity

In actual hospitals, not all systems meet the standards.

Systems such as laser surgical unit, microwave accelerator, microwave thermal therapy system,
etc. emit high-level electromagnetic waves due to their characteristics. This system may adversely
affect ultrasound systems which use faint signals.
With regard to static electricity, the level may easily exceed the level specified in the standards
depending on the operating environment.

Therefore, take extreme care when determining the installation location.

For example, the system should be installed at a location as far from equipment emitting strong
electromagnetic waves as possible.
There are methods for reducing mutual influence to prevent the EMC problem. Refer to
APPENDIX 2 "HANDLING EMC".

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 No. 2A201-528EN*A

6. CLASSIFICATION OF INSTALLATION-RELATED WORK

6.1 Scope of Work to Be Executed by the Customer

The work listed below should be executed by the customer as a general rule.

(1) Construction work A. New construction, extension, and reconstruction works of the
building
B. X-ray shielding in the scanning room
Wall shielding
Door and frame shielding
Window and frame shielding
C. Reinforcement for floor load
D. Wiring pit and ducting
E. Interior finish work of the building
(2) Electrical work A. Power supply system
B. Power distribution board
C. Grounding
D. "X-ray on" indication lamp during X-ray exposure, piping, and wiring
E. Interior illumination and dimmers
F. Installation of a communication line for InnerVision
(3) Air conditioning and A. Air conditioning work (heater, cooler, and ventilation)
plumbing system
B. Water supply and drainage work (e.g., for a washstand)

See section 7 or subsequent for details concerning the execution of the work.

6.2 Scope of Work to Be Executed by Toshiba Subsidiaries

(1) Bringing-in, installation and adjustment of the entire system

(2) Intersystem wiring and cable connections to the customer's facilities

(3) Installation of the InnerVision service processor and connection to the public telephone line

CAUTION: The field engineers should examine and check the general works and
share of responsibilities.

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 No. 2A201-528EN*A

7. BUILDING CONSTRUCTION WORK

7.1 Entrance Used to Bring-in the Unit

To carry the units into the room without any difficulty, conditions such as sufficient door size,
corridor width and ceiling height must be satisfied in advance.

(1) Bringing-in method

The system is normally shipped with the covers mounted.

If it is necessary to disassemble the system to reduce the external dimensions or mass for
any reason, consult Toshiba in advance.

(2) External dimensions and mass

Appended figures 1-1 and 1-2 show the external dimensions and the mass of the gantry and
the required size of the bringing-in entrance.

(3) Bringing-in jig

It is recommended that the bringing-in jig be used to facilitate installation of the main body of
the scanner.

(4) Bringing-in with the patient couch tilted

The external dimensions and mass of the patient couch at the time of tilted bringing-in are
shown in appended figures 1-3 and 1-4.

7.2 X-ray Shielding in the Scanning Room

The X-ray shielding of 1.5 mm or more in lead equivalent (approximately 13 cm in concrete

thickness and ρ=2.35 g/cm3) must be provided for the scanning room wall, ceiling, floor, window
glass for patient monitor from the scan control room, and the door in strict conformance with the
Medical Treatment Regulations.

7.3 Support

The rooms in which the units are to be installed must be able to withstand the load of the units.
For the mass of each unit, see appended tables 2-1 and 2-2 "External dimensions and mass".

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 No. 2A201-528EN*A

7.4 Floor Structure of the Scanning Room

The structure of the floor must permit the driving of anchor bolts for securing the gantry and the
patient couch. It is recommended that the thickness of the floor should be more than 150 mm. To
ensure levelness of the installation floor for the base, perform floor leveling work using epoxy resin
for the gantry and patient couch.

(Refer to appended figure 7 "Floor leveling work using epoxy resin" and APPENDIX 3 "FLOOR
LEVELING WORK MANUAL".)

7.5 Wiring Pits and Wall Ducts

Wiring pits, wall ducts, and conduit pipes should be provided to facilitate wiring and
interconnections between the units of the system.

7.5.1 Pit and duct sizes

The pit and duct sizes depend on the layout of the units, the number of cables, the sectional
area of bundled cables, and required clearances. These factors must be checked by the field
engineer.
The clearance required for a pit or a duct are as follows:

• For the system power ..................................................400 percent of the total sectional area of
the cables
• For the console
(for power and signal generation)................................ 250 percent of the total sectional area
of the cables

For cable interconnections between the units, the number of cables, and their sectional areas,
see appended figure 5 "Cable connections" and tables 3-1 to 3-3 "List of inter-unit cables".

7.5.2 Partitions in the pit and duct

The wiring pit and duct should preferably be divided into three sections as a countermeasure
against noise: one for the system power, one for signal lines between the gantry and the
console, and one for the console power. At a minimum there must be at least two sections: one
for power lines and one for signal lines.

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 No. 2A201-528EN*A

7.5.3 Precautions

(1) The pit and duct must be electrically shielded.

(2) The pit and duct must be protected against flooding.

(3) The cover should be divided into sections approximately 1 meter in length.

Divided into
Iron cover approximately1 meter
sections
Floor surface

Iron sheet Iron sheet

(Fixed to the (Fixed to the
floor using floor using

100
bolts) bolts)

100 100 100

Figure 7-1 Sectional view of a sample wiring pit

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 No. 2A201-528EN*A

8. ELECTRICAL WORK

8.1 Electrical Equipment

8.1.1 Electrical specification

Number of phases Three phases

Line voltage 200 V
Frequency 50 Hz or 60 Hz
Power capacity (Notes 1, 3) 75 kVA
Rated capacity (Actual load capacity) 52 kVA
Power supply load 0.061 Ω or less
Voltage variation due to changing load 5% or less
Line voltage variation 10% or less (Note 2)

NOTE: 1. The cables between the power receiving transformer and the system power
distribution board must exceed the minimum nominal sectional area, obtained from
the cable length and the transformer capacity, as shown in appended figures 4-1
and 4-2.

2. This specification must be met even when a load is applied.

3. If the actual load capacity of the system is greater than the power supply unit
capacity, confirm that there are no problems with the power supply unit when the
system is operated.

8.1.2 Power transformer and power distribution cabling

(1) Works for the power transformer and power distribution cabling must be performed to meet
the electrical specification shown above.

(2) Design and installation should be made considering the maximum input currents listed
below if a power distribution cable is very long.

See appended figures 4-1 and 4-2 "Power supply system".

Output systems Maximum input current

System current (3-phase at 200 V) Approximately 160 A (36 kW)
(with a three-phase full-wave rectified
circuit and reactor)

* Power is calculated assuming a power factor of 1.0.

CAUTION: Install the special transformer (cubical output transformer) for this
system in the hospital power supply.

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 No. 2A201-528EN*A

8.1.3 Ground fault interrupter

If a ground fault interrupter is to be installed, note the following points:

• The sensitivity current should be 100 mA.

• The ground fault interrupter should be noise proof.

(For example, Toshiba NJV series or equivalent)

When the ground fault interrupter or the alarm functions, perform the countermeasures
described below.

(1) Leakage current based on the IEC standards

(The leakage current test was conducted according to the IEC standards and it was
confirmed that the results completely satisfy the standards.)

International standards IEC60601-1 Medical electrical equipment

and test methods 19 Continuous leakage current and patient auxiliary currents
Allowable value Earth leakage current (note 3) 5 mA
Conditions After the humidity preconditioning treatment, the leakage current
during scanning was measured at an input voltage of 200 V ±10%.

When the leakage current measurement test is performed, the circuit shown in the figure
below is added to the grounding cable of the system.

This test is designed to simulate the worst conditions, i.e., the case where all the leakage
currents flow through the body of a person touching the system with the ground cable
disconnected. The circuit simulates the resistance of the human body and its insensitivity
to high-frequency electromagnetic radiation. As the result, the high frequency of 10 kHz is
reduced by approximately a factor of ten.

Therefore, the current may differ from that running through the ground cable in normal use.

R1 Measuring device
CT system (10 k)

R2
(1 k)

C1
Ground cable (0.015μF)

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 No. 2A201-528EN*A

(2) Leakage current in normal use

In addition to the standard test, the current of the ground cable was measured during
normal use. It was seen that the current waveform included a noise waveform. However,
frequency analysis showed that the level near the frequency of 50 Hz, which is of most
relevance to safety considerations, was less than 10 mA; and the main frequency element
was a high frequency element of more than 10 kHz.

CT systems include a large-capacity inverter and the operation frequency of the inverter is
of the order of tens of kHz. Therefore, noise with a frequency of the same order occurs
within the inverter. To prevent this noise element from coming out, a noise filter is installed.
As this noise filter transfers the noise element to the ground cable, the high-frequency
leakage current increases.

(3) Countermeasures

Replace the breaker with the Toshiba-recommended breaker.

Countermeasures against incorrect operation due to high-frequency elements have been

taken in the leakage detector of the recommended breaker, therefore the effects of the
high-frequency elements are eliminated.

The actual characteristics are shown in figure 8-1.

For the leakage alarm as well as for the breaker, investigate countermeasures to reduce
high-frequency electromagnetic radiation.

Since the 50-Hz element is small, if the high-frequency element is reduced, it becomes
possible to eliminate the problem without changing the sensitivity setting.

If the above actions cannot be performed, the following emergency measures can be
performed.

• Change the sensitivity current.

• Set the time before operation of the alarm so that it is longer than the scan time.
(Example: 120 seconds)

If the constants of the noise filter, etc. of the CT system are changed, adverse effects such
as EMI noise may result.
Therefore, countermeasures cannot be performed at the CT system.

In addition, use only noise filters, etc. manufactured by Toshiba. The noise filter of this
system is designed taking into account extreme phenomena such as lightning. If a noise
filter made by a manufacturer other than Toshiba is used, the system may not be protected
adequately.

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 No. 2A201-528EN*A

5000

1000
Operation current (mA)

500

100

50

50 100 500 1K 10K 100K

Frequency (Hz)

Figure 8-1 Frequency characteristics of the sensitivity of the recommended breaker

(Example for NJV225F) to electrical short circuits

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 No. 2A201-528EN*A

8.1.4 Voltage regulation

(1) All the units are designed to withstand power variation of ±10%.

(2) If variation exceeds ±10%, the automatic voltage adjusting unit should be used (must be
ordered separately).

8.1.5 Countermeasures against high-frequency electromagnetic radiation

(1) High-frequency electromagnetic radiation

The original alternating current is in the form of a sine wave, but the input current of an
inverter, etc. is in the form of a wave with step-like distortions. General electric appliances
such as TV sets, personal computers, air-conditioners, etc. generate high-frequency
electromagnetic radiation. Elevators or other motor-driven device can also generate high-
frequency radiation. Since CT systems include an inverter, they can be sources of high
frequency radiation.

If the total level of the high frequency radiation becomes excessively high, some units may
become abnormal because resonance occurs in a capacitor or a reactor due to the
adverse effects of wave distortion.

(2) Measures for controlling high-frequency electromagnetic radiation

If excessive high-frequency electromagnetic radiation is generated, take the following

countermeasures.

• Mount an alternating-current filter for the prevention of high-frequency electromagnetic

radiation to the main power source to reduce high-frequency electromagnetic radiation.

• Insert alternating-current filters in the distribution panels of the major devices generating
high-frequency electromagnetic radiation to partially reduce the radiation.

Since Toshiba does not handle these filters now, a specialist must be consulted to
determine appropriate countermeasures based on the line capacity and the level of
radiation.

26
 No. 2A201-528EN*A

8.2 Power Distribution Board

(1) When 400 V is supplied

Ground resistance:
As per applicable legal
requirements.

NFB
100A Ground bar

For 3-phase 400 V

NOTE: The mounting orientation must be in accordance with IEC60447.

Figure 8-2 Cable connections to the power distribution board

8.3 Grounding

(1) Grounding must be provided as described in subsection 4.5 of this document.

(2) Route the grounding wires used exclusively for this system into the power distribution board
and connect to the grounded busbar.

(3) The grounded busbar must have grounding terminals for this system.

15 mm or more

E3
M6 tap hole
15 mm pitch
Tin coating to the copper board
(thickness of 5 mm or more)

Figure 8-3 Grounded busbar

(4) The grounding lines for wall ducts, the power distribution board case, and wiring pits must not
be connected to the grounded busbar shown above. These lines must be grounded via
another route.

27
 No. 2A201-528EN*A

8.4 Electrical Equipment

Electrical work should be executed according to the procedures below:

(1) Mount an "X-ray ON" lamp (100 VAC or 200 VAC) indicating "X-ray exposure in progress"
above the entrance to the scanning room and connect the power cable of the lamp to the
corresponding power supply facility (100 VAC or 200 VAC) of the site. At this time, connect a
250-V/0.5-A fuse in series to the power input line. In addition, route the cable as described
below to turn ON the lamp in synchronization with the desired CT system operation.
Connection must be performed during system installation.

<1> To turn ON the lamp in synchronization

with the power ON operation : Route the cable near the console.

<2> To turn ON the lamp in synchronization

with the X-ray exposure start operation : Route the cable near the gantry
(use the X-ray system duct for cabling).

8.5 Illumination

Freely adjustable or two-step-adjustable illumination should be installed in the scanning room.

Place illuminating fixtures so that light does not reflect on the display monitor of the console.
Illumination should be adjustable in the range from 10 to 300 lux.

8.6 Cable Connections Between the Units

Cable connections should be made with reference to appended figure 5 "Cable connections",
appended tables 3-1 to 3-4 "List of inter-unit cables", and appended figures 3-1 and 3-2 "Pit layout
example".

28
 No. 2A201-528EN*A

8.7 Installing a Communication Line for InnerVision

The Toshiba medical equipment remote maintenance system InnerVision is intended to provide
the following service functions:

• Diagnosis, inspection, etc. of the medical equipment

• Image check

By installing a service processor between the medical equipment and a communication line,
externally transferred information is restricted (masking of personal ID information included in the
image information such as patient name) to prevent transmission of personal information over a
communication line, thus ensuring privacy and improving security.

Installation of the medical equipment, a service processor, and a single communication line for
connection to the TAC (Technical Assistance Center) computer should be completed within the
warranty period (including the period of installation of the equipment).

(1) Operating conditions

1. InnerVision remote support service expires when the warranty period of the equipment
ends.

If a maintenance contract is signed after the warranty period ends, InnerVision remains
available. Otherwise, the InnerVision service processor can no longer be used.

2. Since some facilities at the institution may be required for InnerVision, obtain prior
permission from the user.

29
 No. 2A201-528EN*A

9. AIR CONDITIONING/WATER SUPPLY AND DRAINAGE WORKS

9.1 Air Conditioning

(1) Air conditioning system

Refer to calorific values and environmental requirements of each room given in appended
table 1 and install an air conditioning system which satisfies the given environmental
requirements. Insure appropriate air flow in the rooms so that temperature distribution is
uniform.

Take extreme care with air conditioning in the scanning room. Temperature fluctuation in this
room must be within the range given in the specification. The temperature setting need not
be constant throughout year. It is important to have the same temperature when calibration
data is acquired as when examinations are performed.
It is recommended, however, that the temperature be maintained at approximately 26°C for
patient comfort.

The temperature in the scanning room should be within the tolerance 1.5 hours before the
first examination every morning. When the door is opened, for example, to bring the patient
in or out, the temperature can be outside the tolerance for a short time (approximately 3
minutes). The appropriate temperature, however, should be restored until scanning of the
next patient is started.

In addition, take care that the temperature near the floor does not get too low or high, because
air near the floor is taken into the gantry. (Check for the presence of a boiler room downstairs
or if air is cold near the floor because the scanning room is located in the basement.)

Tolerance: ± 2°C

1.5H
Timer Air Starting time
ON conditioning
ON

Temperature conditions in the scanning room

CAUTION: The scanning room must be provided with an independent air

conditioning system.
Even if the room is maintained within the permissible temperature
range, gradual temperature shifts (for example, a slow increase in
room temperature from morning to evening) may adversely affect
system performance. Therefore, the room temperature must be
under constant control as shown in the above figure.

(2) Dust

Since the inside of the console is easily affected by dust, take extreme care to keep dust from
the console.

30
 No. 2A201-528EN*A

9.2 Water Supply and Drainage

A water supply and drainage facility is not required for this system, however, it is recommended
that a washstand be provided.

10. APPENDED TABLES AND FIGURES

(1) Appended table 1 : Heat generation by units and environmental conditions

(2) Appended tables 2-1 and 2-2 : External dimensions and mass

(3) Appended tables 3-1 to 3-4 : List of inter-unit cables

(4) Appended figures 1-1 to 1-4 : External dimensions and mass of the gantry and patient
couch

(5) Appended figures 2-1 and 2-2 : Room layout example

(6) Appended figures 3-1 and 3-2 : Pit layout example

(7) Appended figures 4-1 and 4-2 : Power supply system

(8) Appended figure 5 : Cable connections

(9) Appended figure 6 : Inter-unit distances

(10) Appended figure 7 : Floor leveling work using epoxy resin

(11) Appended figures 8-1 and 8-2 : Gantry and patient couch

(12) Appended figures 9-1 and 9-2 : Grounding and anchoring positions of the gantry and the
patient couch

(13) Appended figures 10-1 and 10-2 : Layout of the gantry and patient couch

(14) Appended figure 11 : Console

(15) Appended figure 12 : Speaker

(16) Appended figure 13 : System transformer (CETF004B)

31
 No. 2A201-528EN*A

APPENDIX 1 APPENDED TABLES, FIGURES AND OUTLINE DRAWINGS

Appended table 1 Heat generation by units and environmental conditions

Maximum heat Normal heat

Names of rooms Environmental conditions
generation*1 generation*1
and units
[kW] [kJ/h]*2 [kW] [kJ/h] Temperature*3 (°C) Relative humidity (%)
1. Scanning room (9.4) (33870) (3.0) (10800) 20°C to 26°C 40% to 80%
Tolerance: ±2°C (No condensation)
• Gantry 8.9 32070 2.7 9720
• Patient couch 0.5 1800 0.3 1080
2. Scan control room (2.7) (9720) (2.7) (9720) 16°C to 28°C 40% to 80%
(No condensation)
• Console 2.7 9720 2.7 9720

*1: Maximum heat generation is the heat that is generated when continuous scanning is performed at
the maximum output rating of the unit.

Normal heat generation is the heat that is generated when scanning is not performed.

*2: 1 kW = 860 kcal/h, 1 cal = 4.19 J

*3: A temperature from 0°C to 40°C is permissible if the units are not operated.

32
 No. 2A201-528EN*A

Appended table 2-1 External dimensions and mass

External dimensions
Unit name Mass (kg)
Width (mm) Depth (mm) Height (mm)
Gantry (with cover) 2070 900 1910 1280
Patient couch [CBTB-018A] 630 2690 450 450
Patient couch [CBTB-018B] 630 2390 450 420
Navibox CPU BOX 450 815 700 100
REC BOX 450 815 700 85
Keyboard 574 247 90 3
19-inch LCD monitor 414 203 500 8
Speaker 140 135 200 2

Appended table 2-2 External dimensions and mass (optional)

External dimensions
Unit name Mass (kg)
Width (mm) Depth (mm) Height (mm)
Patient monitor 225 260 240 6
Camera (including lens and stand) 105 380 315 4
System transformer 800 770 980 550

33
 No. 2A201-528EN*A

Appended table 3-1 List of inter-unit cables (1/2)

Power cables

*: Values in parentheses are for multislice systems.

Number of Outer cable

Cable Wiring Connected Connected Standard Effective Retract length Maximum
cores × section diameter Connector diameter (mm) Remarks
No. pit to: (1) to: (2) length (m)* length (m)* (m) length (m)
area (mm2) (mm)
P01 P Gantry Console 14 12 1.5 while 19 3 cores × 5.5 17.5 Solderless contact while
connecting to (1) connecting to (1)
0.5 while Solderless contact while
connecting to (2) connecting to (2)
P03 P System Gantry 11 8 1.5 while 15 3 cores × 35 35.2 Solderless contact while
transformer (15) (12) connecting to (1) connecting to (1)
1.5 while Open wire while
connecting to (2) connecting to (2)
P04 P Gantry Console 14 12 1.5 while 19 6 cores × 0.75 11.5 Solderless contact while
(19) (17) connecting to (1) connecting to (1)
0.5 while Connector (28 × 21 × 28)
connecting to (2) plus solderless contact
P00 P Power box System 5 3 1.5 while 5 3 cores × 35 35.3 Solderless contact while
transformer connecting to (1) connecting to (2)
0.5 while
connecting to (2)

34
 No. 2A201-528EN*A

Appended table 3-1 List of inter-unit cables (2/2)

Power cables

*: Values in parentheses are for multislice systems.

Number of Outer cable

Cable Wiring Connected Connected Standard Effective Retract length Maximum
cores × section diameter Connector diameter (mm) Remarks
No. pit to: (1) to: (2) length (m)* length (m)* (m) length (m)
area (mm2) (mm)
E01 P Power box Gantry 11 8 1.5 while 15 1 core × 35 12.2 Solderless contact while
(15) (12) connecting to (1) connecting to (1)
1.5 while Solderless contact while
connecting to (2) connecting to (2)
E00 P Power box System 5 3 1.5 while 5 1 core × 35 11.94 Solderless contact while
transformer connecting to (1) connecting to (2)
0.5 while
connecting to (2)

35
 No. 2A201-528EN*A

Appended table 3-2 List of inter-unit cables (TSX-031A multislice system)

Signal cables

Number of Outer cable

Cable Wiring Connected Connected Standard Effective Retract length Maximum
cores × section diameter Connector diameter (mm) Remarks
No. pit to: (1) to: (2) length (m)* length (m)* (m) length (m)
area (mm2) (mm)
S01 S Console Gantry 14 12 0.5 while 19 1 pair 11 Connector (22 × 8 × 25)
(19) (17) connecting to (1) Optical fiber
1.5 while
connecting to (2)
S02 S Console Gantry 14 12 0.5 while 19 36 cores × 0.08 11.3 Connector (62 × 20 × 52)
(19) (17) connecting to (1) shielding while connecting to (1)
1.5 while Connector (62 × 20 × 52)
connecting to (2) while connecting to (2)
S03 S Console (a) Gantry 14 12 0.5 while 19 3 cores × 0.18 4.2 Connector (φ29 × 52)
(19) (17) connecting to (1) shielding while connecting to (1)
(b) Speaker 14 12 1.5 while 19 2 cores × 0.5 5.1 Connector (φ25 × 49)
(Gantry) (19) (17) connecting to shielding while connecting to (2)-(a)
(2)-(a)
(c) Speaker 11 9 1.5 while 11 2 cores × 0.5 5.1
(C-room) connecting to shielding
(2)-(b)
1.5 while
connecting to
(2)-(c)

36
 No. 2A201-528EN*A

Appended table 3-3 List of inter-unit cables

Cables attached to the gantry

Number of Outer cable

Cable Wiring Connected Connected Standard Effective Retract length Maximum
cores × section diameter Connector diameter (mm) Remarks
No. pit to: (1) to: (2) length (m)* length (m)* (m) length (m)
area (mm2) (mm)
FCS12 S Gantry Patient – – – – 25TP × 0.08 8.3 Connector (77 × 20 × 52) (1) connected
couch shielding while connecting to (2) inside gantry
FCP40 P Gantry Patient – – – – 8 cores × 0.75 9.1 Connector (28 × 33 × 28) (1) connected
couch 3 cores × 0.5 6.4 Compound cable inside gantry
FCP39 P Gantry – – – – 4 cores × 0.5 6.5 Compound
cable
FCE01 E Gantry Patient – – – – 1 core × 8.9 7.8 Solderless contact while (1) connected
couch connecting to (2) inside gantry

Appended table 3-4 List of cables between the consoles (CPU BOX - REC BOX)

Cables for connection between the consoles are required.

Number of Outer cable

Cable Wiring Connected Connected Standard Effective Retract length
cores × section diameter Connector diameter (mm) Remarks
No. pit to: (1) to: (2) length (m)* length (m)* (m)
area (mm2) (mm)
CS01 CONSOLE CONSOLE 6 6 0.4 2 cores 11 Connector (22 × 8 × 25) Minimum permissible
CPU BOX REC BOX Optical fiber bending radius: 110 mm

CS02 CONSOLE CONSOLE 6 6 0.4 25 pairs × 0.38 12.3 Connector

CPU BOX REC BOX shielding (52.4 × 39 × 12.7)
CS03 CONSOLE CONSOLE 6 6 0.4 25 pairs × 0.38 12.3 Connector
CPU BOX REC BOX shielding (72.9 × 49 × 19)
CP01 CONSOLE CONSOLE 6 6 0.4 3 cores × 1.93 14.2 Crimp terminal
CPU BOX REC BOX

37
 No. 2A201-528EN*A

Recommended values for bringing-in route

Door height 2070 mm or more
Door width 980 mm or more

Mass: 1280 kg

Appended figure 1-1 External dimensions and mass of the gantry and required size
of the bringing-in entrance

Mass: 1420 kg (including the bringing-in jig)

Appended figure 1-2 External dimensions and mass of the gantry with the
gantry bringing-in jig mounted

38
 Center of gravity

39
Mass: 540 kg

Appended figure 1-3 External dimensions and mass of the patient couch (CBTB-018A) when the tilted bringing-in method is used
No. 2A201-528EN*A
40
Appended figure 1-4 External dimensions and mass of the patient couch (CBTB-018B) when the tilted bringing-in method is used
No. 2A201-528EN*A
 No. 2A201-528EN*A

Patient couch: CBTB-018A

<1> Gantry
3072

350 2070 652

<2> Patient couch
(CBTB-018A)

<4>

148
250
<3> Console
(CPU BOX

ARM UP HOLDER
REC BOX

HEADREST
Liquid-crystal monitor

1494
2190 (STROKE)
Keyboard

GANTRY
Mouse)

1800
<4> Patient observation
system
(This is not included in

900

46
the system configuration.

344
390
5530

In this example layout, <1>

the patient observation
monitor is provided by

COUCH

7130
the hospital.)

2690
<5> PC for InnerVision
<2>

374
630
(100)

<5>
<3>
1500

Unit: mm

Appended figure 2-1 Room layout example

41
 No. 2A201-528EN*A

Patient couch: CBTB-018B

<1> Gantry 3072

<2> Patient couch 350 2070 652

(CBTB-018B)

<3> Console

148
<4>

250
(CPU BOX
REC BOX
Liquid-crystal monitor

1194
Keyboard

1890 (STROKE)

GANTRY
Mouse)

1500
<4> Patient observation
system
(This is not included in
the system configuration.

900

46
In this example layout,

344
390
4930

<1>
the patient observation
monitor is provided by
the hospital.)

COUCH

6530
<5> PC for InnerVision

2390
<2>

374
630
(100)

<5>
<3>
1500

Unit: mm

Appended figure 2-2 Room layout example

42
 No. 2A201-528EN*A

Patient couch: CBTB-018A

<1> Gantry

<2> Patient couch

(CBTB-018A)

<3> Console
(CPU BOX, REC BOX,
Liquid-crystal monitor,
Keyboard, Mouse)

<4> PC for InnerVision

<1>

Pit for power cable

Pit for signal cable

<2>

<4>
<3>

Appended figure 3-1 Pit layout example

43
 No. 2A201-528EN*A

Patient couch: CBTB-018B

<1> Gantry

<2> Patient couch

(CBTB-018B)

<3> Console
(CPU BOX, REC BOX,
Liquid-crystal monitor,
Keyboard, Mouse)

<4> PC for InnerVision

<1>

Pit for power cable

Pit for signal cable

<2>

<4>
<3>

Appended figure 3-2 Pit layout example

44
 No. 2A201-528EN*A

Voltage 200 V 75 kVA (Actual load 57 kVA) Nominal sectional area for the wiring cables (mm2)
600 V, IV wire used
Conduit wiring
50

Coefficient of variation (%)

60
6

5
80

Transformer capacity
100
150 kVA
4 100 kVA 125
75 kVA 150

0 10 20 30 40 50 60 70 80 90 100
Distance between the power receiving transformer and the
power distribution board (unit: m)

Appended figure 4-1 Power supply system

45
 No. 2A201-528EN*A

Voltage 200 V 75 kVA (Actual load 62 kVA) Nominal sectional area for the wiring cables (mm2)
600 V, 3-core CV wire used
Conduit wiring
60

Coefficient of variation (%)

80

5
Transformer capacity
150 kVA 100

4 100 kVA
75 kVA

150
3

0 10 20 30 40 50 60 70 80 90 100
Distance between the power receiving transformer and the
power distribution board (unit: m)
Appended figure 4-2 Power supply system

46
 No. 2A201-528EN*A

[COLOR : BLUE]

[SPEAKER] S03 : (CX70-03724-1) [COLOR : BLACK]

GANTRY
[SPEAKER]
C-ROOM
S03 : (CX70-03724-1)
[CNN4]
S01 : (BSX70-0489-01)
[CNN1] [DAS]
S02 : (CX70-02731-1)
[CNN2] [VOICE]
[GTS.XC]
[CNN5] P04 : (CX70-03728-1)
[TB 2]
[TB5] P01 : (CX70-03723-1)

P01
[TB 1]
E01 : (PX70-02585-1)
[EP1] CS01
[CONT FC-AL] [CONT FC-AL]
P03 : (PX70-02583-1) E00 CS02
[TB2] [200V] [S-CONT 1] [S-CONT 1]
System P00 Power CS03
transformer box [S-CONT 2] [S-CONT 2]
CP01
[TB 3] [R-TB1]
*SIGNAL (FCS12)
[CN456] [CNN2]
*POWER (FCP40)
[TB380] [CNN1]
*POWER (FCP40) CKCN CKCN
[CN505]
*POWER (FCP39) (CPU BOX) (REC BOX)
[CN517] [COLOR : WHITE] [COLOR : WHITE]
*EARTH (FCE01)
[EP1]
*SIGNAL (FCS46) CBTB
[CN408] [CNN8]
CGGT
FOOT-SW
[COLOR : BLUE]

Note: The FCP40 and FCP39 cables are connected to CNN1 of CBTB.
The CNN1 connector is mounted to FCP40 and the FCP39 cable is connected later.

Appended figure 5 Cable connections

47
 No. 2A201-528EN*A

Navibox
(REC BOX)

17
Gantry Navibox
(CPU BOX)
12

Patient 11
couch System
transformer
Speaker control
room side

12 5

Power box

Unit: m

Distance between the units = Cable length - Retract length

(Refer to appended tables 3-1 and 3-2.)

(Distance between the units when cables of standard lengths are used)

Appended figure 6 Inter-unit distances

48
 No. 2A201-528EN*A

190 265 4-φ24 DRILL 135 DEEP FOR M16

255 815 1255 195

205

5-φ18 DRILL 120 DEEP FOR M12

1840

1520

1960

2032

2122
316
510

450

310

300
220
720 800
100 190
1700 310 330 645

Appended figure 7 Floor leveling work using epoxy resin

Note: During floor work, pour epoxy resin into the range shown in the figure above to make the installation
surface.

(1) Epoxy resin

• Epoxy resin (Epichlon 857) specific gravity 1.2

• Hardener (Epichlon B-065) specific gravity 1.2

Mixture ratio : 857: B-065 = 3:1 (w/w)

The proper mixture ratio should be confirmed with the
manufacturer because the ratio differs depending on the particular
formulation.

Time required for hardening : 48 hours at ordinary room temperature

(ambient temperature 25°C)

(2) Complete this work before carrying in the system because a period of 2 to 5 days is required for
the epoxy resin to harden (differs depending on the temperature).

(3) For procedures for pouring epoxy resin, refer to APPENDIX 3 "FLOOR LEVELING WORK
MANUAL" attached to this site planning manual.

(4) The tolerance for the dimensions given in the figure above is within ±1 mm, which can be
measured using a tape measure.

49
 No. 2A201-528EN*A

1903
344 (556) 1494

30° 30°
WALL
(TILT ANGLE)

1992 (MAX. HEIGHT FROM FLOOR)

588 (STROKE)
2046
1910
960

451
390
2070
FLOOR 2690 2190 (STROKE) 250

X-RAY PLANE TO COUCH DISTANCE

HORIZONTAL SCAN AREA

(A) BODY SCAN

1472 COUCH TOP

(B) HEAD SCAN

328 COUCH TOP Unit: mm

Appended figure 8-1 Gantry and patient couch (for patient couch CBTB-018A)

50
 No. 2A201-528EN*A

1903
344 (556) 1194

30° 30°
WALL
(TILT ANGLE)

1992 (MAX. HEIGHT FROM FLOOR)

588 (STROKE)
2046
1910
960

451
390
2070
FLOOR 2390 1890 (STROKE) 250

X-RAY PLANE TO COUCH DISTANCE

HORIZONTAL SCAN AREA

(A) BODY SCAN

1172 COUCH TOP

(B) HEAD SCAN

328 COUCH TOP Unit: mm

Appended figure 8-2 Gantry and patient couch (for patient couch CBTB-018B)

51
 No. 2A201-528EN*A

390

X-RAY-PLANE

5-φ18 DRILL 120 DEEP FOR M12 4-φ24 DRILL 135 DEEP FOR M16

255 815 1255 2050

A 205 195

WALL
DETAIL A
110 110

1840

1950
2032
2092
160 494
450
366

360

304
316

234
345 (315)

FROM X-RAY PLANE

φ18 φ24
120

130

1610 315 160

1680 345 845 1520

ANCHOR

Unit: mm

Appended figure 9-1 Grounding and anchoring positions of the gantry and the patient couch (for patient couch CBTB-018A)

52
 No. 2A201-528EN*A

390

X-RAY-PLANE

5-φ18 DRILL 120 DEEP FOR M12 4-φ24 DRILL 135 DEEP FOR M16

255 815 1255 1750

A 205 195

WALL
DETAIL A
110 110

1950
2032
2092
1840
160

366
494
450

360

304
316

234
345 315

FROM X-RAY PLANE

φ18 φ24
120

130

1610 315 160

1680 345 845 1220

ANCHOR
Unit: mm

Appended figure 9-2 Grounding and anchoring positions of the gantry and the patient couch (for patient couch CBTB-018B)

53
 No. 2A201-528EN*A

POINT (OUTLET)
CABLE REFERENCE
4552 578

390 1800 WALL

GANTRY

HEADREST
(STANDARD)
COUCH

2070
630

328 344

2187 2190 (STROKE) 328 250

2690 900 1494

46
Unit: mm

Appended figure 10-1 Layout drawing (top view) of the gantry and patient couch (patient couch: CBTB-018A)

54
 No. 2A201-528EN*A

POINT (OUTLET)
CABLE REFERENCE
3952 578

390 1500 WALL

GANTRY

HEADREST
(STANDARD)
COUCH

2070
630

328 344

1887 1890 (STROKE) 328 250

2390 900 1194

46
Unit: mm

Appended figure 10-2 Layout drawing (top view) of the gantry and patient couch (patient couch: CBTB-018B)

55
 No. 2A201-528EN*A

<1> Liquid-crystal monitor

<2> Mouse
<3> Keyboard
<4> Navibox (CPU BOX)
<5> Navibox (REX BOX)
<1>

815
Cable length
700

Between the Navibox (CPU BOX) and the keyboard : 6 m

<3> Between the Navibox (CPU BOX) and the monitor : 6 m
Between the keyboard and the mouse : 1.8 m
1400

<2>

1260*1
800
700

700
<4> <5>

450 450
815
45

45 Unit: mm

Appended figure 11 Console

(Note: The desk used is a recommended one. The desk must be provided at the site.)
*1 The height of the monitor is adjustable (±50 mm).

56
 32
INPUT

200

200
145
140 135 86

57
R900

135
R400
Approx. 2 kg

Appended figure 12 Speaker

No. 2A201-528EN*A
 No. 2A201-528EN*A

700

600
PL NFB
800

Front side

Approx. 400 kg

Appended figure 13 System transformer (CETF004B)

58
 No. 2A201-528EN*A

APPENDIX 2 HANDLING EMC

1. Introduction

With regard to EMC, information regarding EMI noise and static electricity are described below.

2. Effects of EMI Noise and Countermeasures

(1) Symptoms

Some of the symptoms of EMI noise are listed below:

1. Noise occurs on the screen of an ultrasound system being used near the CT system.

2. Waveforms obtained by ECG equipment used near the CT system are irregular.

3. Noise which causes flickering on CRTs used near the CT system.

4. An abnormal image or a communication error may occur if an electric scalpel or a

microwave unit is used.

(2) Causes

The X-ray unit of the CT system includes a large capacity inverter unit. When this inverter unit
operates, EMI noise in the MHz range level conforms to the IEC 60601-102 standards, some
system combinations may generate noise problems.

In particular, when an ultrasound system is used in the vincinity of a CT system, the former is
easily affected by noise produced by the latter.

Possible routes of transmission of EMI noise are listed below.

1. EMI noise is radiated from the CT system, CT cables, etc. to the air in the form of the
electric wave and enters the ultrasound system via the ultrasound system cable or some
other unit connected with the ultrasound system which plays the role of an antenna. (This
is called radiation noise.)

2. EMI noise transmits through a CT system cable, transfers to an ultrasound system cable,
and enters the ultrasound system through this cable. (This is called conduction noise.)

The routes of noise entry described above may often exist simultaneously.

(3) Countermeasures

There are two main approaches to counter this problem; the prevention of noise generation in
the system generating the noise, and the prevention of noise entry into the system affected by
the noise. Both approaches must be investigated as countermeasures.

Actual countermeasures are described below for the example of an ultrasound system, electric
scalpel, and a microwave unit used in combination with a CT system.

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(1) Countermeasures for the CT system

Cause/route
Cause/route Countermeasures
identification procedure
• System receives • Turn OFF the power of the • Change the orientation or position of the
radiation noise. CT system and check system receiving noise.
whether there is any change • If the problem still occurs after the above
in the noise characteristics of measures have been taken, the scanning
the ultrasound system. room must be shielded using sintered-
ferrite or a rubber material that absorbs
the noise-causing signals.
• System receives • Remove the electric scalpel • Orient the CT X-ray unit so that the noise
radiation noise. or microwave unit from the is minimum.
(When the CT system is CT system. Alternatively, • If the problem still occurs after the above
affected) turn OFF the power of the measures have been taken, the scanning
electric scalpel or microwave room must be shielded using sintered-
unit. ferrite or a rubber material that absorbs
the noise-causing signals.
• Conduction noise via • Turn OFF the power of the • Insert an EMI filter in the power-supply
the power-supply line CT system and check line. (For this system, the filter is already
whether there is any change installed.)
in the noise characteristics of
the ultrasound system.
• Conduction noise via • Turn OFF the power of the • Make the connections independent.
the ground cable. CT system and check
whether there is any change For example, place a new ground cable
in the noise characteristics of for the CT system.
the ultrasound system.
(Difficulty: High)
• Radiation noise from • Perform simple shielding of • Shield the cables using mesh-type
CT cables the cables of the CT system shielding material.
using aluminum foil, ground
If the noise is reduced, the cables, and check the (Difficulty: High)
the cause is radiation results.
noise from CT cables. (Since CT systems have several units
(Difficulty: High) and many cables, this procedure may be
difficult.)

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(2) Countermeasures for the ultrasound system

Cause/route
Cause/route Countermeasures
identification procedure
Radiation noise Move the ultrasound system to Ask the customer to use the ultrasound
a location far from the CT system at a location away from the CT
system. Check whether or not system if possible.
the noise is reduced.
Conduction noise via Disconnect all the cables of If the noise vanishes as a result of these
cables optional units (printer, VCR, actions, the route of entry of the noise lies
imager, etc.) connected to the in one of the cables.
ultrasound system. Insert a Connect the cables of the optional units one
power-supply filter in the power- by one to identify which cables are the
supply line of the ultrasound noise routes, and perform the following
system. countermeasure. (Since several cables
may be noise routes, check all the cables.)
• Use power-supply filters with the power
supplies of the optional units from which
the cables serving as the noise entry
routes come.
• Insert a core and filter between the
ultrasound system and each of the cables
serving as a noise entry route. (For the
BNC cable of the imager, a filter for BNC
connectors is provided.)
Radiation noise due to the If the noise does not vanish, the Replace the transducer.
transducer acting as an transducer could also be the
antenna cause. Change the transducer
of the ultrasound system to a
transducer with reinforced
shielding (for example, a
double-shielded transducer).
Conduction noise from the Remove the power-supply filter Insert the power-supply filter.
power-supply line or the in the above status (status in
ground which conduction noise via
cables is checked) and check
the result.
Entry from cables
exposed to radiation noise
• Radiation noise from Check whether the cables of the Change the cable routing to increase the
the cables of the CT ultrasound system and the distance between the cables.
system transfers to the optional units are close to the
cables of the ultrasound cables of the CT system.
system and enters the If they are close, change the
system via the cables. cable routing to increase the
distance between the sets of
cables and check whether the
noise is reduced.
• Radiation noise from Perform simple shielding of the Shield the cables using a mesh type of
the cables of the cables of the ultrasound system shielding material.
ultrasound system using aluminum foil and ground
transfers to the cables the cables and then check
of the CT system and whether the noise is reduced.
enters the system via
the cables.

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3. Influence of Static Electricity and Required Countermeasures

3.1 What is static electricity?

The Static Electricity Handbook of the Static Electricity Institute (published by Ohm Inc.) defines
static electricity as "electricity where the spatial movement of electric charges is small and the
effects of the magnetic field due to the slight spatial movement of electric charges are negligible in
comparison to the effects of the electric field." That is, static electricity is electricity which resides
in the material and moves little.

To study actual phenomena related to static electricity, however, dynamic electricity phenomena
(for example, static discharge) caused by static electricity phenomena must be included in the
scope of study.

Thus, the study of static electricity phenomena includes the study of some dynamic electricity
phenomena. It should be noted that the voltages involved in static electricity phenomena are
generally higher in comparison to those involved dynamic electricity phenomena, but the total
amount of electricity (electric charge) involved is generally much less for static electricity
phenomena than for dynamic electricity phenomena.

3.2 Necessity of countermeasures against static electricity

CT systems contain various semiconductor devices which are very sensitive to static electricity.

The following table shows the static electricity levels at which each device is damaged.

Table A-3

Voltage range resulting in

Type of component
component damage (V)
VMOS 30 to 1,800
MOS FET 100 to 200
GaAs FET 100 to 300
EPROM 100
JFET 140 to 7,000
SAW 150 to 500
OP-AMP 190 to 2,500
CMOS 250 to 3,000
Schottky diodes 300 to 2,500
Film resistors 300 to 3,000
Bipolar transistors 380 to 7,000
ECL 500 to 1,500
SCR 680 to 1,000
Schottky TTL 1,000 to 2,500

The level of static electricity that can cause damage differs depending on the type of device.
Damage may be result from static electricity levels of less than 100 V as shown in the above table.
This system conforms to EMC standards IEC60601-1-2 and therefore is not damaged due to
supplied voltage of 3 kV (contact) or 8 kV (in the air).
If this system is to be used in an atmosphere where static electricity of more than 3 kV is present,
countermeasures against static electricity must include the CT system as well as the environment
in which the CT system is installed as targets.

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3.3 Suppression and prevention of static electricity

Antistatic measures for nonconductors

(1) Increasing relative humidity

As shown in tables A-4 and A-5, the generation of static electricity can be prevented by
increasing the relative humidity.

Table A-4 Dependence of generated static electricity voltage on relative humidity

Static electricity voltage (V)

Static electricity generated by
10% to 20% RH 65% to 90% RH
Walking on a carpet 35,000 1,500
Walking on a vinyl floor 12,000 250
Working at a work table 6,000 100
Storing/removing work instructions 7,000 600
in/from a vinyl cover
Picking up an ordinary polyethylene bag 20,000 1,200
from a work table
Sitting on a work chair with a 18,000 1,500
polyurethane foam cushion

*: The voltage can be reduced to less than 1/10 by increasing the humidity.

Table A-5 Relationship between the humidity and the

static electricity voltage for various fibers

Static electricity voltage (kV)

Fiber
50% RH 65% RH 80% RH
Wool 4.9 2.0 0.8
Cotton 0.1 0.0 0.0
Viscose rayon 4.7 1.6 0.5
Acetate rayon 6.0 3.5 3.3

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 No. 2A201-528EN*A

However, increasing humidity too much causes humidity hazard.

(Refer to figure A-1.)
Relative hazard ratio

10
Overall hazard ratio
8
Leakage hazrd
6 Humidity Corrosion hazard
hazard Annoyance hazard
4
Clean room
2 Static hazard ratio
55%
0
10 20 30 40 50 60 70 80 90 100
Relative humidity (%)

Figure A-1 The relation between relative humidity andrelative hazard ratio

The above relationship indicates that the relative humidity for systems should be controlled in
the 50% to 55% range as far as possible.

(2) Countermeasures using conductive materials

The above method (increasing relative humidity) is not always optimal because humidity
hazard may be caused. Therefore, preventive measures using conductive materials are
outlined below. (An example comparing conductive shoes with normal shoes is presented.)

Figure A-2 Nonconductive flooring material Figure A-3 Conductive flooring material

Figure A-2 illustrates an example of walking in place followed by standing on a nonconductive

floor with normal shoes and conductive shoes. (The static electricity voltage may be higher
depending on the material of the clothes, etc.) Wearing conductive shoes makes it possible
to decrease the static electricity voltage level. However, the static electricity voltage even at
this level could damage devices, as shown in table A-3.

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 No. 2A201-528EN*A

Figure A-3 illustrates an example of walking in place followed by standing on a conductive

floor with normal shoes and conductive shoes. Preventive measures against static electricity
using a conductive floor and conductive shoes are extremely effective.

This method should therefore be used during site planning to prevent damage due to static
electricity caused by users or service personnel.

Materials and manufacturers are listed below.

Reference manufacturer: Achilles Inc.

• Conductive floor --------- Conductive floor tiles SKY-11

• Conductive slippers ---- ICS-0100

• Conductive shoes------- ICM0100 (for men)

ICM0230 (for women)

The installation area of the conductive floor is shown in the attachment. (Refer to figures
A-4-1 and A-4-2 "Room layout example".)
It is recommended that special consultation with the flooring material manufacturer be held
before building the floor.

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 No. 2A201-528EN*A

Conductive floor space

350 2070 652
<1> GTS service space

Connect the ground cable of the

conductive floor to the gantry.

<2> Servo amplifier service space

Connect the ground cable of the

conductive floor to the gantry.

600
<5>
<3>, <4>
Gantry front service space

900 <1> <2>

Connect the ground cable of the
conductive floor to the patient
couch.

<5> Gantry rear side and GCIF2

service space

Connect the ground cable of the

conductive floor to the gantry. <3> <4>
2600

<6> Console service space

Connect the ground cable of the

conductive floor to the console
ground.

720 630 720

1500

<6>

3000

Unit: mm

Figure A-4-1 Room layout example

(for patient couch CBTB-018A)

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 No. 2A201-528EN*A

Conductive floor space

350 2070 652
<1> GTS service space

Connect the ground cable of the

conductive floor to the gantry.

<2> Servo amplifier service space

Connect the ground cable of the

conductive floor to the gantry.

600
<5>
<3>, <4>
Gantry front service space

Connect the ground cable of the 900

<2>
<1>
conductive floor to the patient
couch.

<5> Gantry rear side and GCIF2

service space

Connect the ground cable of the

conductive floor to the gantry.
2300

<3> <4>
<6> Console service space

Connect the ground cable of the

conductive floor to the console
ground.

720 630 720

1500

<6>

3000

Unit: mm

Figure A-4-2 Room layout example

(for patient couch CBTB-018B)

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 No. 2A201-528EN*A

APPENDIX 3

FLOOR LEVELING WORK MANUAL

(TECHNIQUES FOR USING EPOXY RESIN)

FOR

Activion16

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 No. 2A201-528EN*A

1. OUTLINE

This manual describes the procedures for performing floor work using epoxy resin to ensure
levelness of the installation floor for the gantry and patient couch of the Activion16.

This manual, although written specifically for the Activion16, is also applicable to other models.

2. TOOLS AND MATERIALS REQUIRED

Tools or materials required Quantity Remarks

(1) Plastic L-angle plates 12 Used for the frames for applying epoxy resin
(20 × 20 × 1830 mm) (reusable).
(2) Adhesive tape (product number 252, 4 rolls Used to fix the plastic L-angle plates.
18 mm × 35 m)
(3) Cutter 2 Used to remove the floor covering
(4) Saw 1 Used to cut the plastic L-angle plates.
(5) Basin (60 cm in diameter) or bucket 1 Used for mixing epoxy resin.
(6) Ladle 1 Used for mixing epoxy resin.
(7) Caulking compound (joint sealant) 1 Used to prevent leakage of the epoxy resin.
Silicone sealant Cemedine 8060 clear
(8) Caulking gun 1 Used to apply caulking compound.
(9) Tape measure 2 Used to measure dimensions and to draw lines.
(10) Spatula 1 For caulking
(11) Epoxy resin (Epichlon 830) 1 can 18 liters/can
(12) Diluted solution (Epichlon 520) 1 can 18 liters/can
(13) Winter-use hardener 1 can 18 liters/can
(Epichlon B-065)
(14) Rags 1 bundle
(15) Grinder 1
(16) Technodisk 1
(external diameter 100 mm)
(17) Plastic sheet (2 m x 2 m) 1
(18) Spray lubricant (CRC-556) 1 Used for epoxy resin finishing.
(19) Electric mixer (BMV-150A) 1 It is recommended that an electric mixer be
manufactured by Toshiba used to mix the resin.

<Supplier of the epoxy resin>

Epoxy resin and hardener: Dai-Nippon Ink & Chemicals, Inc.

CAUTION: Although two different hardeners are available for the epoxy resin (winter-
use hardener and summer-use hardener), the winter-use hardener (B-065)
must be used.
The summer-use hardener is not suitable for work in hospitals or clinics
because it requires a long hardening time and, in some cases, the
application of heat may be necessary to achieve hardening.

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 No. 2A201-528EN*A

3. WORK PROCEDURES

The main work procedures are as follows:

Marking off the floor

Drilling the anchor holes

Removing the floor covering

Making the frames for resin application

Applying resin

Finishing (forming)

End

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 No. 2A201-528EN*A

The following shows the application area. (It is recommended that the full-scale gauge be used for
marking and anchor hole drilling work.)

190 265 4-φ24 DRILL 135 DEEP FOR M16

255 815 1255 195

205

5-φ18 DRILL 120 DEEP FOR M12

1840

1520

1960

2032

2122
316
510

450

310

300
220
720 800
100 190
1700 310 330 645

Unit: mm

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 No. 2A201-528EN*A

3.1 Marking

(1) Determine the installation locations for the gantry and the patient couch (refer to appended
figures 2-1 and 2-2).

(2) Mark off the resin application areas on the floor sections of the determined installation
locations.

3.2 Drilling the Anchor Holes and Removing the Floor Covering

(1) Drill the anchor holes at the marked positions using an electric drill with 24-mm and 18-mm
bits.

(2) Cut a slit 10 to 15 mm inside the marking line on the floor using a cutter.

Marking line

10 to 15 mm Cut the dotted-line

(over the section with a cutter
entire edge)

(3) Remove the floor covering inside the marking line. (Entire area inside the marking line)

(4) Clean the area from which the floor covering has been removed.

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 No. 2A201-528EN*A

3.3 Making the Frames for Resin Application

(1) Cut off the plastic L-angle plates along the marking line using a saw. Treat the corners as
shown below.

(2) Tape along the marking line of the plastic L-angle plates that have been cut off.

(a) Tape the outside of the plastic L-angle plate to secure it.

Secure with adhesive tape

(b) Use the spatula to spread the caulking compound all over the corner inside the L-angle
plate.

Caulking compound Adhesive tape

(c) Tape outside sections of the corners between the plastic L-angle plates.

(d) Cut out part of the plastic L-angle plates for the gantry and the patient couch to make an
epoxy resin passageway.

(This job must be performed to ensure that the bottoms of the gantry and the patient
couch are flush.)

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 No. 2A201-528EN*A

(e) Using a spatula, apply caulking compound (joint sealant) to all sections where the resin
may leak, such as the connections at the corners of, and the joints between, the plastic
L-angle plates, the clearances between the installation surface and the base, etc.

Apply the tape.

Epoxy resin passageway

Combine two plastic L-angle

plates to form the passageway.

(f) Wind paper on the anchor a couple of times and fix it using the tape. Insert this anchor
into the anchor hole and perform caulking.

Anchor

Caulking

Paper

CAUTION: The anchor must be well caulked to prevent the epoxy resin from
being intruded into the anchor hole.
The paper wound on the anchor must be higher than the epoxy resin
depth.

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 No. 2A201-528EN*A

3.4 Applying Resin

(1) Place epoxy resin (major agent), hardener, and pigment into a basin, and mix them
thoroughly using a ladle.

Mixture ratio : Epoxy resin: hardener = 3:1 (w/w)

Specific gravity : Epoxy resin 1.20

Hardener 1.20

CAUTION: 1. This job must be performed with a plastic floor-covering sheet

laid on the floor.

2. Before mixing the liquid agents, they must be accurately

weighed using an oil replenishment container.

3. The oil replenishment container that has been used for weighing
must not be used to apply the resin.

4. Gloves, eye protection, etc. must be worn when handling the

resin.

5. During handling of the resin, good ventilation must be provided

since it is a volatile chemical.

(2) Pour the liquid mixture into the frames.

Since the resin has a certain degree of viscosity, the mixture must be poured evenly. The
amount of mixture poured should be such that the minimum thickness of the resin is about
5 mm.

(3) Allow about one hour after the start of pouring to observe closely for leakage of the resin
from the frames. If leakage is seen, immediately seal the leak using adhesive tape or
caulking compound (joint sealant).

(4) After pouring has been completed, apply a spray lubricant CRC-556 to the epoxy resin
surface. This eliminates any bubbles from the resin surface to ensure a smooth finish.

3.5 Finishing the Resin Surface

(1) After allowing the resin to stand for 48 hours or more, check that the surface has become
hard (press the surface with a push-pull gauge and confirm that the surface is not dented).

(2) Remove the frames. Remove the gantry-to-couch epoxy resin passageway using a saw.

(3) Remove any rough edges or bulges from the corners and the surface using a grinder. Finish
the entire surface so that it is flat and smooth.

75 E
 LEGAL MANUFACTURER

1385, SHIMOISHIGAMI, OTAWARA-SHI, TOCHIGI-KEN 324-8550, JAPAN

"Made for Life" is a trademark of Toshiba Medical Systems Corporation.