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NeuViz 16 Pre-installation Instructions Neusoft Medical Systems Co ., Ltd 4541 102 60551 Revision A

NeuViz 16

Pre-installation Instructions

NeuViz 16 Pre-installation Instructions Neusoft Medical Systems Co ., Ltd 4541 102 60551 Revision A

Neusoft Medical Systems Co., Ltd

4541 102 60551 Revision A

Pre-installation Instruction

NeuViz 16

1

INTRODUCTION

4

2

SYSTEM CONFIGURATION

4

2.1

Room Layout

5

2.2

CT suite Required Area

9

2.3

Door and Corridor

Requirement

9

2.4

Compatibility

10

2.5

Software Licensing

10

3

ENVIRONMENTAL DATA

11

3.1

Equipment Heat Loads

11

3.1.1

Examination Room

11

3.1.2

Technical Room (optional)

11

3.1.3

Control Room

11

3.2

Heating, Ventilation & Air Conditioning

11

3.2.1

Examination Room

11

3.2.2

Technical Room (optional)

12

3.2.3

Control Room

12

3.2.4

CT Suite De-Humidification

13

3.3

Acoustical

13

3.3.1

Examination Room

13

3.3.2

Technical Room

13

3.3.3

Control Room

13

3.4

Fringe Field & Magnetic Field

14

3.5

Shielding X-ray

14

3.5.1

System Dose

15

3.5.2

Walls shield

15

NeuViz 16

Pre-installation Instruction

3.5.3

Windows Shield

16

3.5.4

Doors Shield

17

3.6

Requirement on earth conductor

17

3.6.1

Determination of the spot where grounding pole will be laid underground

18

3.6.2

Selection and processing of grounding device

18

3.6.3

Laying grounding pole underground

18

3.7

Air Quality

19

3.8

RF Immunity

20

3.9

Regulatory Compliance

20

3.10

Recycling materials list

20

4

SITE SURVEY

21

4.1

Planning Survey

21

5

SHIPPING & HANDLING

21

5.1

Transport

& Delivery

21

5.2

Rigging &

Lifting

22

5.3

Environmental Data (General)

22

6

MECHANICAL / STRUCTURAL

23

6.1

Equipment weight, Sizes and Center of Gravity

23

6.1.1

Dimensions & Weights

23

6.1.2

Boundary / Space Considerations

25

6.2

Floor

25

6.2.1

Loading

25

6.2.2

Vibration\

26

6.2.3

Leveling

26

6.2.4

Anchoring

27

6.3

Ceiling

28

Pre-installation Instruction

NeuViz 16

6.4

Wall

28

7

ELECTRICAL DATA

29

7.1

Mains Supply & Quality

29

7.1.1

Power Conditioning & UPS (Uninterruptible Power Supply)

32

7.2

Facility Wiring

33

7.2.1

380 VAC

33

7.3

System Cables

35

7.4

Cable Ducts & Raceways

36

7.5

Conduit

pipes

37

7.6

Lighting

37

7.6.1

Examination Room

37

7.6.2

Technical Room

37

7.6.3

Control Room

37

7.7

Power Outlets / Sockets

38

7.7.1

Examination Room

38

7.7.2

Technical Room

38

7.7.3

Control Room

38

8

NETWORK DATA

38

8.1

System requirements

38

NeuViz 16

Pre-installation Instruction

1 INTRODUCTION

The NeuViz 16 CT System is an advanced 16-slice detector continuous-rotation tomographic scanner systems. NeuViz 16 configuration has similar pre-installation and site planning requirements as NeuViz Dual systems. These systems are intended for an installation in smaller room areas as compared to other scanners for simplified site planning.

2 SYSTEM CONFIGURATION

The NeuViz 16 System consists of the following system components:

16 System consists of the following system components: (1) Gantry and Patient Table Couch. (2) Monitor,

(1) Gantry and Patient Table Couch.

(2) Monitor, CTBOX, Keyboard, Microphone, Mouse, Console Table desk

(3) Computer Rack/Host, Network Switch, UPS (optional).

(4) Power Protection Unit 80 kVA Hua Run Voltage Regulator for China only (non-IEC compliant) option.

(5) Teal Isolation Transformer 100 kVA (IEC compliant) option.

Automatic Injectors, CCT are available options; refer to other section in this manual for the UPS and/or Voltage Regulator options that are available with the NeuViz 16 CT Scanner System.

Pre-installation Instruction

NeuViz 16

2.1 Room Layout

The Preferred Room Layouts are examples of a most common CT suite.

It is required to verify before installation:

a) Space requirements meeting delivery, installation, servicing and operation are met.

b) Licensed electrical, mechanical and structural engineers hired by the customer to meet facility

requirements compatible with Neusoft equipment.

c) Certified physicist to determine room radiation protection.

d) All national and local building codes have been met concerning safety.

It is not allowed to place high voltage, UPS, VR or power conditioning equipment closer than 1.5 M (60 inches) from patient couch unless it is certified as a medical grade device. Neusoft strongly recommends that these ancillary components be located in a Technical room (equipment closet) adjacent to the CT Exam room or Control room. This provision may also protect the Neusoft Technician from radiation during equipment installation and servicing.

NeuViz 16

Pre-installation Instruction

Drawing 1, Preferred Room Layout

NeuViz 16 Pre-installation Instruction Drawing 1, Preferred Room Layout 6 Revision A 4541 102 60551

Pre-installation Instruction

NeuViz 16

Drawing 2, Medium Room Layout

Pre-installation Instruction NeuViz 16 Drawing 2, Medium Room Layout 4541 102 60551 Revision A 7

NeuViz 16

Pre-installation Instruction

Drawing 3, Minimum Room Layout

NeuViz 16 Pre-installation Instruction Drawing 3, Minimum Room Layout 8 Revision A 4541 102 60551

Pre-installation Instruction

NeuViz 16

2.2 CT suite Required Area

The following drawing shows the CT required area:

Area The following drawing shows the CT required area: 2.3 Door and Corridor Requirement The following

2.3 Door and Corridor Requirement

The following pictures show the requirement of Door and Corridor

REAR FRONT
REAR
FRONT

NeuViz 16

Pre-installation Instruction

MIN.DOOR OPENING REAR FRONT
MIN.DOOR OPENING
REAR
FRONT

The height of the Scanner Room Door is at least 2M.

If planned to install the VR or Power Conditioning device in Control Room, the door width of the control room is at least 800mm or as required of the power conditioning device.

2.4 Compatibility

Note: Neusoft design and manufacturing practices comply with IEC and other regulatory standards as approved medical imaging devices. Refer to Section 2.10 for regulatory compliance listings and agency approvals.

The NeuViz 16 Workspace supports DICOM connectivity 3.0 compliant, PACS, scanners, workstations and printers.

2.5 Software Licensing

Each system is delivered with the options license according to the sales records.

Pre-installation Instruction

NeuViz 16

3 ENVIRONMENTAL DATA

3.1 Equipment Heat Loads

3.1.1 Examination Room

Heat emission

     
 

Scanner Gantry

:

 

5.0

KW (17,075 BTU/hr)

 

1.5

kW (5,123 BTU/hr) – Standby

3.1.2

Technical Room (optional)

 

Heat emission

     
 

Teal Unit (option)

 

:

0.65

KW (2,210 BTU/hr)

 

Hua Run V.R. (China option)

 

:

1.20

KW (4,098 BTU/hr)

3.1.3

Control Room

Heat emission

     
 

Operator Workstation & Computer Rack

 

:

0.75

KW (2,561 BTU/hr)

   
 

Console UPS (option)

 

:

0.11

KW (375.00 BTU/hr)

 

Workstation (option)

 

:

0.29

KW (1,000 BTU/hr)

3.2 Heating, Ventilation & Air Conditioning

3.2.1 Examination Room

Atmospheric pressure 70kPa~106kPa

The gantry requires air-conditioning and good air flow. Additional capacity and circulation must be

considered when other equipment is located in this area including, but not limited to, other system

cabinets or power conditioning equipment.

The ideal stable room temperature for the gantry during operation and including patient comfort is 22

degrees (72 ). Under no instances shall the temperature be allowed to drop below 18 (64 )

or rise above 24 (75 ). Relative humidity 30% to 60% (non-condensing).

The above conditions must be maintained at all times including overnight, weekends and holidays.

Temperature change per hour must not exceed 4.1 (7.5 ) during operation.

Location of room air-conditioning supply vents must not discharge directly over patient table and

treatment area causing discomfort to patient.

See following figure for gantry air flow circulation directions, when it becomes available. Delta heat

rise temperature difference through the gantry is approximately 12 (21.6 )

NeuViz 16

Pre-installation Instruction

NeuViz 16 Pre-installation Instruction 3.2.2 Technical Room (optional) • Atmospheric pressure 70kPa~106kPa

3.2.2

Technical Room (optional)

Atmospheric pressure 70kPa~106kPa

The facility isolation transformer, Teal unit or Voltage Regulator cabinets require good air flow. Additional capacity and circulation must be considered when other equipment is located in this area.

Under no instances shall the temperature be allowed to drop below 18 C (64) or rise above 28 o C (82). Relative humidity 20% to 80% (non-condensing). (Optional) A UPS Battery cabinet should not be exposed to prolonged periods of temperature above 25

The above conditions must be maintained at all times including overnight, weekends and holidays.

Temperature change per hour must not exceed 5 (9 ).

3.2.3

Control Room

Atmospheric pressure 70kPa~106kPa

The Operator Workstation/ Computer Rack require air-conditioning and good air flow. Additional capacity and circulation must be considered when other equipment is located in this area including, but not limited to, UPS, Workstation and Monitoring equipment.

The ideal stable room temperature for the equipment during operation and including technician comfort is 22 (72 ). Relative humidity 35% to 70% (non-condensing). Under no instances shall

Pre-installation Instruction

NeuViz 16

the temperature be allowed to drop below 18 (64 ) or rise above 28 (82 ). Relative humidity

20% to 80% (non-condensing)

The above conditions must be maintained at all times including overnight, weekends and holidays.

Temperature change per hour must not exceed 5 (9 ).

Power conditioning equipment may be located outside of the control room, in order to help eliminate

heat concerns, and may be located in an equipment room within allowable cable length limitations

and temperature ranges specified above.

3.2.4

CT Suite De-Humidification

Exam Room Size (M 2 )

Air-Conditioning Capacity (P)

De-humidify (Watts)

Less than 20

2

5,000 *

More than 20

3

2 x 5,000 *

Operator Room

Not more than 2.5

 

Ceiling Height: 2.8M

   

* Suggested that all south China customers prepare provide one dehumidifier unit for small room and two

units for larger room. For North China, according to local conditions, it is suggested to prepare one unit.

3.3

Acoustical

3.3.1 Examination Room

Audible noise

unit. 3.3 Acoustical 3.3.1 Examination Room Audible noise Scanner Gantry : 68 dB @ 1 meter

Scanner Gantry

:

68 dB @ 1 meter typical

Note: If facility transformers or power conditioning equipment is placed in the exam room it should be

positioned as far away from the gantry (within limitations of the room and cable lengths) or located within a

dedicated closet enclosure, in order to prevent interference of its noise with the patient intercom.

3.3.2 Technical Room

Audible noise

the patient intercom. 3.3.2 Technical Room Audible noise Teal Unit (option) Hua Run V.R. (China option)

Teal Unit (option)

Hua Run V.R. (China option)

Audible noise Teal Unit (option) Hua Run V.R. (China option) 3.3.3 Control Room Audible noise Operator

3.3.3 Control Room

Audible noise

Hua Run V.R. (China option) 3.3.3 Control Room Audible noise Operator Workstation & Computer Rack Console

Operator Workstation & Computer Rack

Console UPS (Option)

Workstation & Computer Rack Console UPS (Option) dB @ 1 meter typical : 50 dB @

dB @ 1 meter typical

: 50

dB @ 1 meter typical

: 50

(Option) dB @ 1 meter typical : 50 dB @ 1 meter typical : 50 dB
(Option) dB @ 1 meter typical : 50 dB @ 1 meter typical : 50 dB

dB @ 1 meter typical

: 55

55

dB @ 1 meter typical

NeuViz 16

Pre-installation Instruction

Workstation (Option) 55 dB @ 1 meter typical

Workstation (Option)

Workstation (Option) 55 dB @ 1 meter typical
Workstation (Option) 55 dB @ 1 meter typical

55 dB @ 1 meter typical

3.4 Fringe Field & Magnetic Field

The external field strength at scanner and all other system components must be less than 1 gauss

( 0.1mT).

3.5 Shielding X-ray

Room shielding requirements for CT scanners can be unique for any particular scanner installation. Scanner placement within the scan room as well as specifics about the scan room and the spaces surrounding the scan room should be considered in order to develop a proper scan room shielding design.

Scanner room shielding should therefore be designed and/or at least reviewed and approved by a qualified radiological health physicist or the facility’s radiation safety officer. The completed shielding design should also be inspected and verified to meet industry standards before clinical scanning begins. Other guidelines must be followed as determined by local or country codes and regulations.

The primary and required input from manufacturers for determining the required shielding design is found in the IEC Stray Radiation Dose Map(s) for a particular system. This map presents near worst-case room scatter values in a horizontal plane containing the system’s axis of rotation. The map may also be rotated about its symmetry axis (i.e. the scanner’s axis of rotation) to obtain room scatter values in the vertical direction. From this scatter data and other detailed information about the scanner operation and the site, an adequate and proper shielding design can be developed.

Additional information that could be useful in producing a successful radiation shielding design:

Materials used in the construction of the existing walls, floors, doors and ceilings of the room and surrounding spaces.

Occupancy information (contents and usage) of the surrounding rooms and spaces.

Anticipated operating workload for the scanner to be sited. Some busy modern scanners can experience workloads approaching 1,000,000 mAs/week or more.

Room scatter varies approximately linearly with collimated beam width if other factors remain unchanged. For example, a 20 mm collimated beam width will produce approximately 50% of the room scatter values as that of a 40 mm collimated beam width for a 140 kVp x-ray beam. Like wise an 80 mm collimated beam will produce roughly twice the room scatter as a 40 mm beam width.

Pre-installation Instruction

NeuViz 16

 

The scattered radiation falls off approximately as the square of the distance from the scattering

 

source. For example, the scattered dose at 2 meters is approximately 6.35 mm (¼ inch) the value

at 1 meter.

 

Second and third order scatter from the air in the scanner room can result in a measurable and

 

significant dose behind adequate primary scatter barriers.

 

Typical shielding requirements for modern multi-slice scanner rooms can vary from 1.58 mm (1/16

 

inch) to 3.17 mm (1/8 inch) lead equivalency, depending on the site specifics mentioned above.

3.5.1

System Dose

The image below describes the radiation level in the process of scanning a 320 mm (Body Part) polyethylene

phantom in the scanning room.

mm (Body Part) polyethylene phantom in the scanning room. 3.5.2 Walls shield Scan Condition: 140 kV,

3.5.2 Walls shield

Scan Condition: 140 kV, 16*1.5 mm = 24 mm, 250 * 4mAs

Proportional Scale: 0.5m each lattice

Dosage Unit: uGy/1 mAs

Note: The suggestion is made based on protection equivalent: 2.5 mmPb

If the walls of the scanning room are constructed with common solid bricks (density: 1600 kg / m 3 ), their

thickness should not be less than 425mm. The wall 500mm thick is recommended.

In case the wall is constructed with cement (density: 2400kg / m 3 ), the wall thickness should not be less than

240mm.

NeuViz 16

Pre-installation Instruction

In case the wall is constructed with bricks mixed with cement (density: 2050 kg / m 3 ), the wall thickness should not be less than 275 mm.

The following suggestions are used for reinforcing the existing walls to increase their thickness (as an example, take a wall that is constructed with solid bricks and whose thickness is 240 mm):

Fasten inorganic composite protective boards to the wall with nails. A gap of 5-10mm between the protective board and the wall should be reserved, and the gap will be filled and compacted with the special protective painting two times;

Remove the old wall coat, and spread the treated wall with the special protective painting. The painting should be applied two times at an interval of 8-20 hours (when the wall surface dries to the extent of 70 percent), and the thickness of the coat built up each time should not be more than 6mm. The total thickness of the resulted protective coat should be about 10mm.

Note: On-the-spot guidance given by professionals is preferable while adopting this method to guarantee a proper mixed painting and a right technology, and to avoid cracking of the wall coat.

Fasten wooden board to the wall with nails, then fasten lead sheet 1mm thick to the wooden board with nails, and then adhere a layer of decorating board to the lead sheet.

Note: Persons who work in the lead room for long time may be vulnerable to the adverse effect.

Note: The above-mentioned methods are applied to the walls facing the front and the back of gantry. These two walls are the main protected objectives. As to the lateral walls, ceiling and floor, their protective thickness may be decreased to a lead equivalent of 1.5-2mm.

3.5.3 Windows Shield

Lead glass is used for the watching windows, and their lead equivalent should not be less than 2mmPb.

The protection of the ventilator may be taken into consideration depending on the local reality.

The following points should be paid attention to in case there are windows:

Window blind should be used to avoid the influence of the sunlight on watching screen of display.

The measurement for preventing dust from entering the room should be taken if there are profuse dusts outdoors.

Keep proper room temperature and humidity. The influence of the outdoor environment on the indoor temperature and humidity should be diminished to the minimum in rainy season or in the seasons when temperature fluctuation is great.

Pre-installation Instruction

NeuViz 16

The window installation in the scanning room should comply with the local

regulation. Regular ventilation of the scanning room should be guaranteed

because X-ray in the room makes the air not healthy. If windows are

necessary, their size should be as small as possible, and single direction

ventilator should be installed as is shown in the right figure. Fixed shade is

made of wood and covered with 2mm Pb.

Fix Active shade shade
Fix
Active
shade
shade

Note: in the precondition of avoiding exposure scan, users can open

the fixed shade and perform ventilation with the fan. After ventilation, users should close the

fixed shade in time before scanning.

Note: the windows should use proper radiation shielding measurements.

3.5.4 Doors Shield

The form of the protective door may be sliding door, double doors, and single door.

In case of the sliding door, its lower side should be placed in the groove 10-15 mm deep beneath the ground,

its upper side should be 100mm higher than that of the entrance, and its width should be 200mm wider than

that of the entrance, so that the door would cover the entrance entirely with an excess of 100mm on either of

two lateral sides when it is closed;

In case of the door fixed on hinge, it should cover the entrance entirely with an excess of over 10mm on each

of the four sides of the door when it is closes.

For the door protection, lead equivalent should not be less than 2mm.

3.6 Requirement on earth conductor

CT scanner system must work under high voltage, so good grounding is critical for the normal and safe functioning of it. The spiral CT scanner demands that grounding resistance should be less than 4.

When connect to a public ground conductor, the grounding resistance should be less than 1.

The fixation of grounding pole should be carried out under the guidance given by the local qualified professionals, and must comply with the local or national regulation

Please take the followings factors into account while fixing the ground wire:

1

Determination of the spot where grounding pole will be laid underground.

2

Selection and processing of grounding pole

3

Laying underground grounding pole

4

Measurement of grounding resistance

NeuViz 16

Pre-installation Instruction

3.6.1 Determination of the spot where grounding pole will be laid underground

The spot where grounding pole will be laid underground should be over 3 meters distant from the nearest building, and be near by control room where exists a cabinet containing three phase Stabilized Power supply Unit (RPU).

Grounding pole of CT scanner system should be over 10 meters distant form the grounding pole of lightning conductor, and no water resource, drainage system, stones and architectural wastes exist in its vicinity.

3.6.2 Selection and processing of grounding device

As a grounding pole, an electrolyzed copper plate 3 mm thick with 1000mm*1000 mm area is preferable.

The connection between copper plate and copper wire could not be made by tin-soldering, and it could be made only by electrical welding and gas welding, and the welded area should not be less than 10 cm 2 .

and the welded area should not be less than 10 cm 2 . Figure 1 Selection

Figure 1 Selection and processing of grounding device

3.6.3 Laying grounding pole underground

Copper plate should be buried in the moist soil under the layer of frozen soil of the land (in Frigid Zone). In general, the laying depth should be more than 2 meters. The procedures for laying are described as follow:

a) Dig a pit whose area should be about 1.5 m 2 and whose depth should be 2 meters;

b) Spread a layer of charcoal 10 mm thick on the bottom of the pit;

c) Spread a layer of common salt (powder) 5mm thick on the layer of charcoal;

d) Lay down the electrolyzed copper plate on the layer of salt;

e) Spread a layer of common salt 5mm thick and a layer of charcoal 10mm thick above the plate;

f) Fill the pit with the soil excavated while watering till the pit is filled completely.

Pre-installation Instruction

NeuViz 16

Pre-installation Instruction NeuViz 16 Figure 2 laying grounding pole underground The upper end of the red

Figure 2 laying grounding pole underground

The upper end of the red copper wire from the underground copper plate should emerge above the ground for 10cm~20cm, and should be connected tightly with the ground wire from the control room by electrical welding, gas welding, or by bolting and clamping, but should not by tin-soldering. The naked part should be wrapped with rubberized tape, and then be led to the control room.

The ground wire leading to the control room should be a copper cable whose cross section should not be less than 6mm

Note: in the region with special geologic conditions, users should invite local power department or qualified professionals for guidance of laying grounding pole underground

2

.

Note: for ground with sand structure, the quality of backfill soil should be taken care of. It is not

allowed to use excavated soil to backfill; it is advised to use soil from other places (only wet

soil).

Note: instruction for the grounding is for reference only.

3.7 Air Quality

Airborne contaminants must be minimized once the Neusoft medical equipment is placed in the clinic/ hospital

facility staging area or CT suite. All major room constructions must be completed eliminating concrete and

drywall dust. Refer to appropriate Room Ready Checklists for more details and level of acceptance.

Once the CT system has been fully installed and turned-over to the customer, air quality must be maintained

throughout the life of the system. Design of the facility HV/AC system must consider common dust and dirt

problems affecting internal equipment sub-components, air flow and system reliability. Air vents (supply,

return, positive, negative, pressurized, or otherwise) should be fully ducted and must never be distributed

through open interstitial ceiling spaces exposed to dust, asbestos and other contaminants.

Chemical contamination must also be considered, in order to avoid corrosion to internal and external

equipment parts and connections.

NeuViz 16

Pre-installation Instruction

3.8 RF Immunity

RF conducted immunity testing and approval: IEC 61000-4-6

RF radiated immunity testing and approval: IEC 61000-4-3

3.9 Regulatory Compliance

The NeuViz 16 system complies with the following regulatory standards and agencies:

UL 60601-1

CAN/CSA C22.2 No.601.1

EN/IEC 60601-1

CISPR 11: Class A+12

FDA 21 CFR, Subchapter J

FDA 21 CFR 1040.10 and 1040.11 (certified to EM/IEC 60825-1)

3.10 Recycling materials list

The following list itemizes the total NeuViz 16 CT system by material and weight content. Contact the Neusoft for additional information and documentation on this topic when required.

Material Content (global)

Weight(KG)

Material Content (global)

Weight(KG)

Lead (Pb)

25.151

Printed Circuit Boards

6.874

Iron (Fe)

1259.57

Tungsten (W)

2.183

Aluminum (Al)

563.69

All other material types

336.704

Copper (Cu)

15.828

   

Pre-installation Instruction

NeuViz 16

4 SITE SURVEY

4.1 Planning Survey

See Pre-installation Check List for the Site Inspection/ Pre-installation Checklist.

5 SHIPPING & HANDLING

5.1 Transport & Delivery

Floor loading and clearances must be determined as acceptable along the entire delivery path with, but not limited to, doorways, corridors, ramps, elevators and the CT exam room. Neusoft Supervision or by a trained and approved Neusoft representativeis required during the entire delivery and handling process for all CT system equipment or heavy power conditioning equipment. Use of elevator lifts to move CT equipment to another floor level within building must be first approved by the customer’s facility engineer or elevator service provider prior to equipment delivery. Allowable load limits will vary depending on elevator classification for passenger and freight use

All shipments are in wooden crate without transportation kit.

All delivery trucks used to transport the CT system must have shock absorbers as the minimum requirements. Air-ride suspension is preferred. The CT system components must remain in its original packaging from the factory to the warehouse or (in some instances) the customers’ delivery door.

Forklift Specifications:

4500 kg minimum capacity capable of balancing load that is 2.4 M long with center of gravity at midpoint when lowering gantry and wooden crate from delivery truck.

Fork thickness: 184 mm wide by 57 mm high (max).

Fork length: 1524 mm long (min).

Fork spread: 610 mm apart (center to center).

Note: Wooden pallet must remain attached to bottom of gantry for forklift operations. Refer to the following gantry delivery weight combinations to determine a specific configuration:

2035 kg = Configuration for crated delivery: Gantry inside full wooden shipping crate with pallet.

1930 kg = Configuration for moving through hospital building: Gantry (no side covers) with dolly wheels attached.

Refer to the following list for a breakdown on individual components to itemize from:

1850 kg = Gantry without covers

NeuViz 16

Pre-installation Instruction

2035 kg = Full wooden shipping crate including pallet

185 kg = Wooden shipping pallet only

80 kg = Dolly wheels (set of four)

Note: For elevator lifts, it may be possible to reduce gantry weight by temporarily removing the dolly wheels. Contact the HelpDesk for more information and direction as needed.

Once the wooden shipping crate is dismantled, the pallet (or steel shipping tubes) under the gantry can be removed by using the dolly wheels as jacks to raise the gantry. Never attempt to move or push the gantry without the dolly wheels, wooden shipping pallet or steel shipping tubes attached. Dolly wheels P/N 4541 100 50251 must be ordered from Neusoft.

5.2 Rigging & Lifting

Neusoft supervision is required during the entire delivery and handling process of the CT system. For overhead lifting with a crane, the wooden shipping crate must remain attached to the gantry. Nylon straps will wrap around the bottom of the crate’s lower pallet. Minimum roof hatch opening shall be xxx cm L by xxx cm W for the entire crate to fit through. Never tip the gantry or attempt to lay it flat to compensate for low overhead clearances.

5.3 Environmental Data (General)

 

Stock / Transport

Temperature in (°F)

-20/ + 55(-4°F / + 131°F)

Temperature in (°F) /hour

10

(18)

Humidity in % (non-condensing)

10

/ 90

Gradient (°F) /hour

5 (9°F)

Vibrations Frequency range in Hz

10 – 150

Vibrations / Shock Amplitude in mm

0 – 0.75

Vibrations / Shock acceleration in g

0

– 10

Shock acceleration in g

0

– 10

Shock pulse duration in msec

6

– 10

Air pressure in Hecto-pascal

500 / 1060

Note: These temperatures do not apply to phantoms which contain water, which will freeze at temperatures from 0 C (32 F) or lower.

Pre-installation Instruction

NeuViz 16

6 MECHANICAL / STRUCTURAL

6.1 Equipment weight, Sizes and Center of Gravity

See following figures for overall dimensions, center of gravity displacement and weights for NeuViz 16 system

equipment components and accessory or options.

` 6.1.1 Dimensions & Weights
`
6.1.1
Dimensions & Weights

Notice: Refer to Installation and Service Manuals for this product on equipment handling and safety

considerations.

Crate / Box

 

Dimension mm (inches)

Weight kg (pounds)

Length

Width

Height

Packed Gantry (in wooden crate)

2370(93.3)

1030(40.5)

2250(88.6)

2035(4487)

Transport Gantry with wheels (bottom of gantry spaced 30 mm above floor)

3063(120.6)

984(38.7)

1920(75.6)

1930(4255)

Installed Gantry

2210(87)

890(35)

1890(74.5)

1850(4078)

Packed Patient Table Couch (in wooden crate)

2570(101.2)

970(38.2)

1230(48.5)

475(1047)

NeuViz 16

Pre-installation Instruction

Transport Patient Table Couch (with caster wheels)

2300

     

90.6

88534.9

87034.3

383845

Installed Patient

       

Table Couch

(extended)

2440

96.1

57522.7

1100(43.3) (Max)

343(756)

Packed

       

Console Table

1500(59.1)

800(31.5)

100(3.9)

60(132)

Transport

       

Console Table

N/A

3577

Installed

       

1400

46.3(102)

Console Table w/ Monitor & Acc.

55.2

70027.6

74029.3

Packed LCD

   

19” Monitors (ea.)

 

Located on accessories pallet

Transport LCD in own box

       

19” Monitors (ea.)

483(19)

280(11)

584(23)

10(22)

Installed LCD

       

19” Monitors (ea.)

488(19.2)

221(8.7)

495(19.5)

8(18)

Packed Host

   

Computer

 

Located on accessories pallet #1

Transport Host

 

Located on accessories pallet #1

 

Computer Rack

Installed Host

       

Computer Rack

660(26)

620(24.4)

720(28.3)

150(331)

Accessories

       

Pallet

1540(60.7)

1220(48.1)

1030(40.1)

235(518)

 

Teal Isolation Transformer Option (50/60 Hz)

 
 

Input: 200 to 480 VAC

Output: 380/220VAC

 

this option is required for all non-380 and 400 VAC sites

Packed 37 kVA Teal Isolation Transformer (IEC compliant)

1320(52)

770(30.4)

830(32.7)

300(662)

Installed 37 kVA Teal Isolation Transformer (IEC compliant)

516(20.3)

552(21.7)

712 (28)

274

Pre-installation Instruction

NeuViz 16

6.1.2 Boundary / Space Considerations

Apply the following space distances mm (inches) around CT equipment as described. Local codes may exceed these requirements:

Host Computer Rack:

914 (36”) front for service

102 (4”) sides for air flow

102 (4”) rear for cables

Gantry Couch:

914 (36”) sides for safe service access

Front and rear distances are usually dictated by table travel and patient access

Ceiling height: Recommended 2.43M (8’-0”); Minimum for air flow 2.3M (7’-6”)

6.2

Floor

6.2.1

Loading

Gantry

Concrete load area: 0.65 Sq. M (6.9Sq. Ft.)

Floor area: 1.7 Sq. M (18.3 Sq. Ft.)

Patient Couch

Concrete load area: 0.09 Sq. M (0.75 Sq. Ft.)

Floor area: 0.75 Sq. M (8 Sq. Ft.)

See following drawing for equipment floor loading displacement and dimensions in relationship to floor contact locations.

NeuViz 16

Pre-installation Instruction

NeuViz 16 Pre-installation Instruction 6.2.2 Vibration\   Operation Gantry & Couch Operation Rest of System

6.2.2 Vibration\

 

Operation Gantry & Couch

Operation Rest of System

Vibrations / Shock range in Hz

10 – 150

10 – 150

Vibrations / Shock amplitude in mm

0 – 0.15

0 – 0.15

Vibrations / Shock acceleration in grms

0

– 2

0

– 2

Shock acceleration in g

0

– 2

0

– 2

Shock pulse duration in msec

6 – 10

6 – 10

Air pressure in Hecto-pascal

500 / 1060

500 / 1060

Note 1: Max. Grms allowable = 0.00001 x (Hz) ^ 1.7 over the range of 1 to 150 Hz. Maximum allowable

vibration of the x-ray focal spot with respect to the patient couch support top. Higher vibrations at

certain frequencies could lead to image degradation. Vibration velocity = 5500 x (Hz) ^ 0.7 uin/sec.

Note 2: Max. Allowable steady state vibration transmitted through floor not to exceed 10 -3 m/s 2 rms

maximum single frequency above baseline from 1 to 80 Hz under gantry and patient couch.

6.2.3 Leveling

See following drawing for equipment floor levelness and waviness tolerances within given equipment

perimeters.

Pre-installation Instruction

NeuViz 16

Pre-installation Instruction NeuViz 16 When shim stock is applied exceeding 4mm in thickness to compensate for

When shim stock is applied exceeding 4mm in thickness to compensate for un-level floor surfaces, improper anchor engagement may occur using the standard mounting hardware supplied with the CT system. Local Neusoft Service representative to determine alternative solutions with customer, such as: deeper anchors, longer studs, through bolting, grout pad, etc.

6.2.4

Anchoring

Gantry

Sleeve anchor with 4000 psi (27.6 MPa) normal weight concrete:

150 mm (5.9”) long by 1/2” (12 mm) diameter with 95 mm (3.7”) embedment

Tension = 3300 lbs (14.7 kN)

Shear = 4580 lbs (20.4 kN)

Torque = 22 ft-lbs (30 Nm)

Patient Couch

NeuViz 16

Pre-installation Instruction

Sleeve anchor with 4000 psi (27.6 MPa) normal weight concrete:

150 mm (5.9”) long by 1/2” (12 mm) diameter with 108 mm (4.3”) embedment

Tension = 3300 lbs (14.7 kN)

Shear = 4580 lbs (20.4 kN)

Torque = 22 ft-lbs (30 Nm)

6.2.4.1

Seismic

Seismic calculations are to be provided through a third-party licensed engineering firm in compliance with state or country regulations. See following drawing for equipment center of gravity weight and locations where available.

center of gravity weight and locations where available. 6.3 Ceiling Finished ceiling height must not restrict

6.3 Ceiling

Finished ceiling height must not restrict service access, air flow and user’s appliances with the CT equipment.

6.4 Wall

N/A

Pre-installation Instruction

NeuViz 16

7 ELECTRICAL DATA

7.1 Mains Supply & Quality

Mains supply

   
 

Configuration

:

3

phase delta, 4 wires (L1, L2, L3, PE) with Teal unit

:

3

phase wye, 5 wire (L1, L2, L3, N, PE) without Teal unit

 

Voltages

:

200

to 480 VAC input with Teal unit

:

380

VAC/ 400 VAC input without Teal unit

 

System Sub-components

:

220

VAC ancillary power is fed directly from the CT gantry to the

control console computer rack

Nominal frequency

:

50Hz / 60Hz

Mains branch power capacity

:

80

kVA Nominal size recommended for dedicated supply circuit

Maximum/ momentary power required

:

65

kVA @ 5 sec. Maximum 50 kW X-ray exposure

 

Steady state/ long time/ processing

:

12

kVA

Standby/ idle

:

 

2 kVA

Line voltage variation

:

+ 10% - 10% total (absolute) limits

Line frequency range

:

50/60 + /- 1 Hz

Phase to phase imbalance

:

5%

Load voltage regulation

:

+/- 5% not to exceed absolute limits

Voltage drop allowed in feeders (copper)

:

2% when supply source and other line impedance contributors do not exceed an additional 3%, which equates to 5% total regulation limit.

Conductor impedance

:

Ohms/ 1000 ft. (305M), .85 PF, copper wires in steel conduit

Power factor

:

0.85 min. PF

Mains resistance (for all source impedance measured at the CT Gantry)

:

100 mOhm line to line, max at 380 VAC

:

Measured current 480 VAC

:

Standby 2.4 Amps, 3 phase average

(standby, steady state, maximum, inrush)

Steady state 15 Amps

Maximum 78 Amps (50 kW scan @ 480 VAC, 0.85 PF) 5 sec.

Measured current 380 VAC

:

Standby 3 Amps, 3 phase average

(standby, steady state, maximum, inrush)

Steady state 18 Amps

Maximum 98 Amps (50 kW scan @ 380 VAC, 0.85 PF) 5 sec.

NeuViz 16

Pre-installation Instruction

   

Inrush 188 Amps

Voltage variation

:

+10 %, -10 % total within absolute limits @ 380 VAC

:

+10 %, -10 % total within absolute limits @ 400 VAC

Voltage impulse

:

+/- 2kV per IEC 61000-4-4

Voltage surge

:

Line to ground 2KV volts (peak) max. less than 100ns

Voltage sag

:

95%, 1 cycle, 5 seconds

Static frequency variation

:

+/-1 Hz

Harmonic voltage distortion (single, total)

:

5 % max. THDv

Room safety disconnect circuit breaker or fuse

   
 

To Teal unit

:

100

Amp @ 480 VAC, Circuit Breaker Time Trip Curve/

Characteristic Class “D” or an equivalent rating for line fuses.

:

125

Amp @ 380 to 400 VAC, Circuit Breaker Time Trip Curve/

Characteristic Class “D” or an equivalent rating for line fuses.

:

200

Amp @ 200 to 240 VAC, Circuit Breaker Time Trip Curve/

 

Characteristic Class “D” or an equivalent rating for line fuses.

 

To Gantry (without Teal unit)

:

125

Amp @ 380 VAC, Circuit Breaker Time Trip Curve/

 

Characteristic Class “D” or an equivalent rating for line fuses.

125

Amp @ 400 VAC, Circuit Breaker Time Trip Curve/

Characteristic Class “D” or an equivalent rating for line fuses.

Equipment Isolation The CT system equipment components shall be insulated from building steel, such as;
Equipment Isolation The CT system equipment components shall be insulated from building steel, such as;

Equipment Isolation

The CT system equipment components shall be insulated from building steel, such as; raceways, trough ducts, junction boxes, floor rebar, etc. Apply NeuViz Isolation Template P/N 4541 101 35021 under Gantry and Couch (see following drawing). Only isolated ground wires from the facility power source or power conditioner shall provide proper grounding to the CT system, assuring safety and ground quality in compliance with country and local codes. See Protective Earth Ground paragraph below.

Pre-installation Instruction

NeuViz 16

Pre-installation Instruction NeuViz 16 Supply Device Facility power supply needed to feed the following approved CT
Supply Device Facility power supply needed to feed the following approved CT system power protection

Supply Device

Facility power supply needed to feed the following approved CT system power protection units:

a) Teal 37 kVA Isolation Transformer: delta input from source with newly derived wye output supply to gantry. This unit is IEC compliant.

b) Hua Run 80 kVA Voltage Regulator (China option): wye input from source with newly derived wye output supply to gantry. Non-IEC compliant.

c) Controlled Power Company 75kVA Voltage Regulator : delta input from source with newly derived wye output supply to gantry. This unit is IEC compliant.

Apply a dedicated 75 kVA branch isolation transformer (3% regulation rating or better, 2% is

Apply a dedicated 75 kVA branch isolation transformer (3% regulation rating or better, 2% is preferred),

or purchase a approved power conditioning device, to create a separately derived source whenever:

2% is preferred), or purchase a approved power conditioning device, to create a separately derived source

a.

The isolated earth (PE) and neutral (N) conductors are not available from the main

 

power supply source at the Neutral / Ground reference point.

 

b. The run length of feeders exceeds 61 meters (200 ft).

c. It is necessary to improve power factors and reduce fault current.

NeuViz 16

Pre-installation Instruction

 

d.

It is necessary to adjust voltages to meet CT system input ranges.

 

e.

It is necessary to reduce harmonic currents induced in the supply.

Protective Earth Ground

 

A

dedicated protective earth conductor shall be supplied by the facility. Preferably, the earth conductor

will have its origin at the electric utility’s power entrance to the facility or a newly derived supply source. This conductor shall be sized equal to and routed with the output conductors between the supply device and Teal unit. Water piping, electrical conduits and raceways may not be suitable grounding electrodes.

Over-current Protection

 

Over-current protection shall be provided from the facility power supply to the Teal unit, or as specified by local and national codes. Where external protective devices are applied, such as circuit breaker or line fuses, the recommended branch circuit protection level shall be 100 Amp rated at 480 VAC, 125 Amp rated at 380 to 400 VAC and 200 Amp rated at 200 to 240 VAC. Apply Type - D class mini circuit breakers.

Remote Emergency Off (EPO)

 

As a minimum, there shall be a means for remotely turning OFF the power at the supply device or power protection unit on the supply side of the Teal unit. These switches are to be installed in the control room near the operator’s console or as determined by local or national codes. Other remote means of disconnecting power at the supply device or power conditioner may be required by local code. The Teal unit has built-in provisions to accommodate a remote EPO switch.

Room Safety Disconnect

 

A

means shall be provided to lockout power to the Teal unit as may be required by local or national

codes. This passive 3 phase room disconnect switch is to be located with a run distance not greater than 25 ft. (7.6m) from the input power terminals of the Teal with minimum Amp ratings as specified above (see Over-current Protection). Neusoft requires that this disconnect be located within visual inspection of the Hua Run or Teal unit and CT scanner gantry such that service personnel can lockout the power source, and easily view its state of operation.

Filters, Surge Suppressor & Phase Protection

 

Line filters and surge protection devices may be provided within Neusoft approved Power Conditioning equipment.

Ground Fault Detectors

 

Provide ground fault detection equipment according to local or national codes.

 

Cable Containment

 

All system cables shall be contained in raceways or metallic conduit pipes as approved by local codes. The CT system cables are not plenum rated.

Minimal Allowed Cable Bending

 

The fiber optics in this system must be handled carefully. The minimum bend radius is 5 cm (2 inches). All other cables have a minimum bending radius of 10x the cable diameter.

7.1.1 Power Conditioning & UPS (Uninterruptible Power Supply)

Nominal input voltage to the Hua Run voltage regulator (China option only) requires 380 VAC, 50 Hz.

Nominal input voltage to the Controlled Power Company voltage regulator (ROW) requires 380 Vac/ 400Vac,

50/ 60 Hz. Use of Teal isolation transformer has input range of 200-480 VAC, 50/60 Hz.

Pre-installation Instruction

NeuViz 16

Other commercial brands may not be compatible. Neusoft must approve substituting or adding other power protection equipment, contact Helpdesk if additional information is required.

7.2 Facility Wiring

7.2.1 380 VAC

Run distances and cable/ conductor sizes from Facility Supply to Room Safety Disconnect or input of Teal Unit based on 380 VAC input:

0

– 50 Ft. (15.2 M)

: 4

#2 (35 MM 2 ) power and earth [See Note 1]

51 – 100 Ft. (30.5M)

: 4

#1 (42 MM 2 ) power and earth [See note 1]

101 – 200 Ft. (61M)

: 4

#00 (70 MM 2 ) power and earth [See Note 1]

Run distances and cable/ conductor sizes from Room Safety Disconnect or Teal Unit output to CT Gantry based on 380 VAC input:

0

– 52 Ft. (16 M)

: 16

MM 2 power and earth power, neutral and earth

0

– 69 Ft. (25 M)

: 21

MM 2 power and earth power, neutral and earth

Note 1: A neutral wire is required to input of CT Gantry, from facility supply or from output of Teal unit. Size (MM 2 ) of neutral wire to be determined by national or local building codes. Neusoft recommends same size as power feeders and isolated ground wires.

Note 2: Nominal protection ratings of circuit breakers suggested by Neusoft must not exceed amp ratings of the feeder wires, as specified by local or national codes.

Note 3: Neusoft supplied power cable is available up to 30 M. Contact Neusoft for availability. Provide input voltage information for obtaining correct cable set.

Note 4: Licensed electrical contractor shall supply and install all copper cable/ conductor wiring described above and is responsible for connecting to supplied voltage regulator, isolation transformer or power filter equipment. FSE will make final connections to scanner gantry and consoles, as required.

NeuViz 16

Pre-installation Instruction

See following figure for Mains Connection Wiring required of the customer’s facility.

See following figure for Mains Connection Wiring required of the customer’s facility. 34 Revision A 4541

Pre-installation Instruction

NeuViz 16

Pre-installation Instruction NeuViz 16 7.3 System Cables Cable Containment All system cables shall be contained in

7.3 System Cables

Cable Containment

All system cables shall be contained in metallic raceways, troughs or conduit pipes as approved by local codes. The CT system cables are not plenum rated.

Minimal Allowed Cable Bending

The fiber optics in this system must be handled carefully. The minimum bend radius is 5 cm (2 inches). All other cables have a minimum bending radius of 10x the cable diameter.

See following figure for cable chart defining specific lengths, routings, diameters and connector sizes.

NeuViz 16

Pre-installation Instruction

NeuViz 16 Pre-installation Instruction 7.4 Cable Ducts & Raceways See following figure for cable duct/trough and

7.4 Cable Ducts & Raceways

See following figure for cable duct/trough and raceway sizes, routings and details.

Pre-installation Instruction

NeuViz 16

Pre-installation Instruction NeuViz 16 7.5 Conduit pipes N/A 7.6 Lighting 7.6.1 Examination Room

7.5

Conduit pipes

N/A

7.6

Lighting

7.6.1

Examination Room

Light levels for operation of imaging equipment to be specified by customer.

Light levels for servicing equipment to be a minimum of 500 lux

7.6.2

Technical Room

Light levels for servicing equipment to be a minimum of 500 lux

7.6.3

Control Room

Light levels for operation of imaging equipment to be specified by customer.

NeuViz 16

Pre-installation Instruction

Light levels for servicing equipment to be a minimum of 500 lux

Lights with adjustable dimmers are recommended to control illumination levels.

7.7 Power Outlets / Sockets

7.7.1

Examination Room

Quantity of wall sockets is customer and code dependent.

A minimum of one socket within close proximity to gantry is required for servicing.

7.7.2

Technical Room

A minimum of one socket within close proximity to equipment is required for servicing.

7.7.3

Control Room

Quantity of wall sockets is customer and code dependent. Specific requirements will depend on Hard Copy units, other options and customer’s own equipment.

A minimum of one socket within close proximity to CT Console is required for servicing.

8 NETWORK DATA

8.1 System requirements

The following specifies the minimum network requirements for NeuViz 16 System installation:

10/100/1000 Mbit connections

The following applies when connecting to the hospital’s network:

The local system administrator must assign IP address, subnet masks and gateways.

It is strongly advised to connect the CT system to the hospital network through a router of an intelligent switch.

Pre-installation

 

Delivered

: N/A

To be ordered

: N/A

Pre-installation Instruction

NeuViz 16

To be arranged locally

:

Network connections (RJ 45) at:

Host Computer Rack

:

Ethernet Connection must be 10/100/1000 Mbit

Installation

   

Delivered

:

N/A

To be ordered

:

N/A

To be arranged locally

:

CAT 6 cable (not longer than 6 meter)

Neusoft Medical Systems Co., Ltd

Address: No. 16, Shiji Road, Hunnan Industrial Area, Shenyang, Liaoning, China, 110179 Manufactured by: Philips and Neusoft Medical Systems Co., Ltd. Address: Neusoft Park, Hun Nan Industrial Area, Shenyang 110179, China Telephone: 8008908528 Fax: 0086-24-83780480