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GE HEALTHCARE
eXplore CT 120 Site Preparation Guide
http://www.gehealthcare.com
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Revision History
Revision History Effective Date
June 20 2008 October 10, 2008 October 16, 2008 November 19, 2008 August 19, 2010
Revision
0 0 1 2 3 Draft Release
Nature of Change
Removed references to "Vision". Other minor corrections throughout. Updated machine weights and dimensions. Added input power option of 110 VAC. Changed dimensional drawing and machine dimensions. Added to chapter 2.1.6, 2.1.7 that customer to supply the generator power input cable. Deleted GE part 5256952 from the GE supplied cable, chapter 3. Updated room dimension specifications with drawings in Chapter 3.
This Guide documents provides instruction on the site preparation for GEs eXplore CT 120. It is only intended for use by qualified personnel. No part of the eXplore CT 120 may be used in a manner not specified by the manufacturer. This Guide is periodically updated. Please ensure you are using the most current version by checking the Common Documentation Library (CDL) at: http://apps.gehealthcare.com/servlet/ ClientServlet?REQ=Enter%2bDocumentation%2bLibrary
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Contents
1
1.1
Introduction ........................................7
Introducing This Guide .......................................................................... 7
1.1.1 1.1.2 1.1.3 1.1.4 Important Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Purpose of This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Who Should Use This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2
2.1
2.2
3
3.1
3.2
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Conduits/Raceways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.3
3.4
3.5
Interconnections/Wiring .......................................................................34
3.5.1 Interconnection Runs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4
4.1
4.2
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Chapter 1 Introduction
Section 1.1 Introducing This Guide
1.1.1 Important Precautions
DAMAGE IN TRANSPORTATION
All packages should be closely examined at time of delivery. If damage is apparent write Damage In Shipment on ALL copies of the freight or express bill BEFORE delivery is accepted or signed for by a GE representative or customer receiving agent. Whether noted or concealed, damage MUST be reported to the carrier immediately upon discovery, or in any event, within 14 days after receipt, and the contents and containers held for inspection by the carrier. A transportation company will not pay a claim for damage if an inspection is not requested within this 14 day period. Call the transportation company immediately after damage is found. At this time be ready to supply name of carrier, delivery date, consignee name, freight or express bill number, item damaged and extent of damage.
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It is important that anyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation Protection, and take adequate steps to protect against injury. The equipment is sold with the understanding that the General Electric Company, Medical Systems Group, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment. Various protective materials and devices are available. It is urged that such materials or devices be used. Note: See topic 2.1.5 for more information on Radiation Safety.
CONTACTING GE HEALTHCARE
Toll Free :1-800-526-3593 Email: PCIServiceEngineering@ge.com Website: http://gehealthcare.com/preclinical_imaging Mail: GE Healthcare 1-1510 Woodcock Street London, ON, Canada N6H 5S1
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1.1.2
Compliance
GE Healthcare eXplore Series CT scanners are compliant with the United States Radiation Control for Health and Safety Act (Title 21, Code of Federal Regulations, Subchapter J) as they pertain to Cabinet X-Ray Systems (21 CFR 1020.40), FDA Report accession number 0212737-0, and Canadian RED Regulations C.R.C., c. 1370. This product is also TUV certified for both the U.S. and Canadian markets, to the applicable American and Canadian standards for safety and performance (UL 61010-1:2004 and CAN/CSA C22.2 No. 61010-1:2004). Certificate #: Report #: Date Issued: U8 08 11 68543 001 090-809417-000 2008/11/26
1.1.3
1.1.4
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ACQUISITION MODES
The system supports the following acquisition modes: static planar imaging with or without table motion (acquires a 2 dimensional image from one projection angle) dynamic planar imaging (observe the motion of a radioactive tracer through the body through the acquisition of a series of planar images of the specimen over time)
CT PARAMETER CONTROLS
Gated acquisition is used when the imaging of interest involves a periodic process such as cardiac and/or respiratory motion. The start of each period is defined by an incoming trigger. The CT system supports the gating triggering from: ECG triggers Respiratory triggers
2.1.2
X-RAY GENERATOR
The 120kV maximum tube voltage system comes with an X-Ray Generator that is positioned beside the CT 120 table. The X-Ray Generator supplies electric power to the X-ray tube; a key function of which is the stepping up and rectification of line voltage to produce a smooth direct current voltage to the X-ray tube.
TABLESIDE CONTROLLER
User controlled table motion (versus automated motion driven by the system) is available via the Tableside Controller. The Tableside Controller is the touch screen panel mounted above the Table. This interface is used to set and position the specimen cradle.
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OPERATOR CONSOLE
All scan acquisition and analysis functions are controlled from the Operator Console. The Operator Console consists of 2 LCD display monitors and a host computer.
2.1.3
Optional Components
PCI ANALYSIS WORKSTATION
A PCI analysis workstation is available for user's applications (separate from the Console) The functionality on the PCI analysis workstation includes the following: Registration/fusion display Region of interest (ROI)/volume of interest (VOI) analysis Segmentation analysis Oblique image reformatting Volume rendering Input/Output (I/O) of DICOM Image post-reconstruction filtering such as Gauss.
2.1.4
Regulatory Requirements
Regulatory requirements for imaging facilities vary widely from country to country, and within a countrys various legal districts. As well as conforming to local building and electrical codes, the customer is responsible for ensuring compliance with local regulatory requirements concerning radiation.
2.1.5
Radiation Safety
GE Healthcares eXplore scanner is compliant with the United States Radiation Control for Health and Safety Act (Title 21, Code of Federal Regulations, Subchapter J) as they pertain to Cabinet XRay Systems (21 CFR 1020.40), FDA Report accession number 0212775, and Canadian RED Regulations, C.R.C., c. 1370.
CAUTION
X-RAY PROTECTION
X-Ray equipment, if not properly used, may cause injury. It is important that everyone having anything to do with x-radiation be fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Ave., Bethesda, MD 20814, and of the International Commission on Radiation Protection, and take adequate steps to ensure protection against injury.
RADIATION SAFEGUARDS
The GE eXplore CT 120 utilizes a radiation emitting x-ray source and complies with US and Canadian cabinet x-ray standards (as detailed above) which allow the system to be safely operated
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without additional x-ray shielding. The eXplore CT 120s x-ray tube, using a rotating anode, has a maximum tube potential of 120kVP and a tube current of 125mA. The source and scanning area is completely shielded during X-ray operation. The system is manufactured with redundant mechanical and electronic safety systems that prevent X-ray output any time the scanning door is opened. X-rays cannot be generated at anytime during access to the specimen bed or scanning area. The X-ray tube power may only be switched on from the acquisition computer console. X-rays may only be generated if the scanner door is closed and the X-ray Reset button has been reset. Radiation measurements are taken from the scanner at the time of manufacture to confirm that the maximum exposure level 2 cm from any accessible surface is less than or equal to 0.5 mR/h.
RECOMMENDATIONS
The eXplore CT 120 may only be operated by users who have received training from qualified individuals. Prior to or upon installation of the scanning unit, the facility health and safety or radiation officer must be notified of the presence of the scanning equipment. The user must follow all rules and regulations which govern the use of this class of radiation emitting equipment at the facility in which the unit operates. This may include: use of radiation monitoring devices the display of additional radiation markings or labels on the equipment or the area of use additional x-ray safety training for users as required by the facility registration of the system with local/state/provincial et al authorities that govern radiation protection for non human use
Users must not remove or modify any labels or markings which identify the unit as a radiation emitting device. Users must not tamper with or modify any electronic or mechanical systems within the scanner as this may change the functionality of the system and will void the system warranty. If the system has been modified or damaged in any way, the use of the scanner must be discontinued and GE Healthcare contacted immediately.
2.1.6
Customer Responsibilities
Pre-installation is work necessary to plan and prepare a site for the installation of the eXplore CT 120. This involves procuring required materials and constructing or retrofitting the scan, control and equipment rooms.
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All electrical work should be performed by a certified electrician and must conform to local electrical regulations. Install an outside telephone line next to the Operator Console (and PCI Analysis Workstation if purchased). Install an Ethernet network connection next to the Operator Console (also install a connection next to the PCI Analysis Workstation if part of the system). Ensure environmental room conditions meet temperature and humidity requirements. Provide a desk for the Operator Console (and PCI Analysis Workstation, if part of the system). Arrange for waste disposal of all packaging materials (unless disposal is pre-arranged with GE Healthcare). Complete the Pre-installation Check List in Chapter 4.
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2.1.7
Source
Customer supplied. For example: GEs R4502AD, Main Disconnect Control, 480VAC, surface mount with flush mount kit included, two remote push button switches GE supplied GE supplied GE supplied GE supplied GE supplied GE supplied
Table CT Gantry Operator Console System emergency OFF system X-RAY ON warning light(s), controller, and wiring SYSTEM READY and POWER ON lights, controller and wiring (as required) Telephone line(s) with outside access (at the Operator Console, PCI Analysis Workstation) Ethernet connection, 100 BaseT minimum, Gigabit preferred, with Internet access (at the PCI Analysis Workstation) Standard System Interconnect Cables GE phantoms: 1" wire phantom (5248747) CT value calibration phantom (2382720) Operator Console & PCI Analysis Workstation desks Generator power input cable Min. 100A capacity, max. diameter 1.3", min. 3 conductor System power input cable Ethernet input cable
Customer supplied
Customer supplied
GE supplied GE supplied
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1771 800
660
440
1388
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1771 800
1820
1321
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1388
1892
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Component CT Gantry (including shielding) Table Console (including optional desk) Generator Optional PCI Analysis Workstation (including optional desk) flares to 660 mm at CT end
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3.1.1
WARNING
If temperature guidelines are not met, calibration, performance, and reliability of the equipment may be compromised. No components of the imaging equipment should be located near heating or air conditioning ducts, windows, or other devices which might significantly affect the ambient air temperature. Any equipment that is to be installed in these rooms must be operable within these parameters.
TEMPERATURE MONITORING
First, assess your environments heat. If necessary, temporarily install a temperature recorder close to where the system will be installed. Note readings before installation and again after installation to verify true temperature conditions for your environment. Consider your HVAC needs and redundancy. You may wish to consider an air conditioner with two compressor units rather than one. A backup (redundant) air conditioner permits system operation during an extended repair of the primary air conditioner.
ATMOSPHERIC PRESSURE
from 700hPa to 1100hPa.
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3.1.2
Humidity
The minimum/maximum relative humidity level should not exceed 30%-60% (non-condensing) in the scan room at all times. The recommended relative humidity level is <50% (non-condensing). The maximum humidity change in the scan and control room shall not exceed 5% RH/hr. Any equipment that is to be installed in these rooms must operate within these parameters.
HUMIDITY MONITORING
First, assess your environments humidity. If necessary, temporarily install a humidity recorder close to where the CT 120 will be installed. Note readings before installation and again after installation to verify true humidity conditions for your environment. Consider your HVAC needs and redundancy. You may wish to consider an air conditioner with two compressor units rather than one. A backup (redundant) air conditioner permits CT 120 system operation during an extended repair of the primary air conditioner.
3.1.3
Cooling Requirements
The following cooling requirements do not include cooling for the room lighting, personnel or nonCT 120 equipment present.
Cooling Requirements
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3.1.4
EMI REDUCTION
If fields of excessive EMI are known or suspected to be present, consult GE service personnel for recommendations. Consider the following if you attempt to reduce EMI: External field strength decreases rapidly with distance from source of magnetic field. External leakage magnetic field of a three-phase transformer is much less than that of a bank of three single phase transformers of equivalent power rating. Large electric motors are a source of substantial EMI. High-powered radio signals are a source of EMI. Maintain good screening of cables and cabinets.
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3.2.2
Ceiling Heights
A ceiling height of 108" (2743mm) is recommended. A ceiling height of 79" (2000mm) is the absolute minimum acceptable height for installation purposes.
3.2.3
FLOOR LEVELNESS
The floor levelness requirement is important for accurate patient positioning. Floor levelness in the scan room must not be greater than 0.3125" (8mm) between depression and high spots over any 120" (3048mm) distance within the area of the CT 120 Gantries and the area around the Table.
FLOOR VIBRATION
The equipment may be sensitive to vibration in the frequency range of 0.5 to 20 Hz depending on the amplitude of the vibration. It is the customers responsibility to contract a vibration consultant or qualified engineer to implement design modifications to meet the specific limits, However, it is ultimately the customer/architect/engineer responsibility to design the site solution.
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The maximum steady state vibration transmitted through the floor should not exceed 10-3 m/s2 rms maximum single frequency above ambient baseline from 0.5 to 80 Hz (measured during a normal operating period). Transient Vibration The behavioral characteristics must be such that any measurable transient disturbance must also be minimized to less than 0.01 m/s2 peak-to-peak. Equipment Location To minimize the interference, the equipment should be placed on a solid floor, located as far as possible from the following vibration sources: Parking lots Roadways Subways Trains Hallways Elevators Heliports Power plants containing pumps, motors, air handling equipment, and air conditioning units.
3.2.4
Conduits/Raceways
Carefully consider advantages and disadvantages of conduits, floor ducts and surface raceways for running cables. Make cable passageways large enough to install any cable with all other cables already installed. When routing power cables, all three phase wires and ground must be run in the same conduit or raceway duct-work. Power cables should be routed separately from system control cables (for example, use a separate trough in the duct). If conduit is used, the minimum conduit size is 4 in. and a maximum of one elbow may be used between pull locations. Note: See the Sections System Input Power Requirements and Interconnections/Wiring for more detail.
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Component
Load Pattern mm
Normal Mounting Method * Anchor bolts Anchor bolts Seismic Kit Seismic Kit
106
458 x 410
564
N/A
Seismic Kit
Mounting Requirements *Use the GE supplied mounting hardware only if approved by qualified personnel.
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3.3.2
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The main disconnect(s) shall be located within 5 feet (1.5 m) of power panel. Power wiring between the facility main distribution panel and the power panel should be kept as short as possible. See the Lockout/Tagout requirement below. Note: The Operator Console is typically wired to the speCZT power panel. If housed in a separate room, however, the Console may be powered by a separate facility input (100 - 230 VAC). The optional PCI Analysis Workstation is not connected to the speCZT power panel but powered by a separate facility input..
3.4.2
POWER AUDIT
A site power audit is required for the CT 120. This site power audit can be arranged with the GE Power Quality team, or through your sales person.
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previous power problems with other X-ray systems or computer installations should be reviewed with your GE representative. Verify any brown-out (low voltage) conditions, which may occur during summer months, do not exceed the allowable range. Some analyzer models that are suitable for power line monitoring are: Dranetz Model 658 Dranetz Model 656A BMI 3630 RPM
3.4.3
Facility Source
Power to the system should be supplied by a dedicated feeder from the nearest Main Distribution Panel. A protective disconnect device must be provided in the power line supplying the CT 120 in accordance with National Electric Code and applicable local codes.
WARNING
The disconnect device must be located within forty feet of the system, visible to service personnel, and must have provision for tagout / lockout. The rating of the disconnect device depends on the nominal line voltage. It must provide overcurrent protection and have a low voltage release, with multi-point remote control capability.
3.4.4
Rating
Voltage 105 to 115 or 208 to 230 VAC Capacity 4.2 kVA @ 85% P.F. Frequency 50 or 60 Hz +/- 1.0 Hz Installation Category II Pollution Degree 2
3.4.5
Regulation
The size of the facility transformer and feeder wires determine load regulation presented to the system. Total load regulation as measured at the power input terminals must not exceed 6%.
3.4.6
Grounding
The resistance between the power input terminals ground and the facility earth ground must not exceed 0.5 ohm. In addition, the total resistance between the power input terminals ground and earth must not exceed 2 ohms. Resistance between any two grounded devices must not exceed 0.1 ohm to ensure equal potential ground system within the scan room.
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3.5.1
Interconnection Runs
6 7
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GE Part Number
5325025
Description
Facility to Main PDU
2411913-5
50ft 15.24m
Between Modules:
3 5255208-3 (Generator Communication Cable (DSUB 15)), 5214670-2 (Generator-Tube Tube Ground Cable), 5272068-2 (X-ray Tube Stator Cable), 5265721-2(High Voltage Cathode Cable), 52657213 (High Voltage Anode Cable), 5255209 (Generator DIO Cable (DSUB 25)) X-Ray Generator to CT system 20ft 6.096m
Main PDU to optional PCI Analysis Workstation 5245036 Main PDU to Operator Console Ethernet switch to Console
2411913-4
50ft 15.24m
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Doorways
height, width and depth of all elevators (note the number of doors and the location of the panel) Elevator Door
Elevator Interior
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Hall Hall
Scan room dimensions, including: width and depth of room layout size and location of all doors and windows location of all electrical receptacles, with circuit numbers location of all telephone/network receptacles location and size of all conduits, floor ducts and raceways
Equipment room dimensions (if required), including: width and depth of room layout size and location of all doors and windows location of all electrical receptacles, with circuit numbers location of all telephone/network receptacles (note the bandwidth of the network) location and size of all conduit, floor ducts and raceways material of flooring and flooring thickness
4.1.2
A drop from a height greater than one half inch () may induce structural damage to the frame or other major components. Damage resulting from a drop (e.g., bent frame, misalignment) may not be obvious until after system installation is complete.
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The CT 120 system including Gantry, Operator Console, and Specimen Table is not designed to tolerate the excessive shock or vibration that may occur during unloading. For example, rolling the Operator Console across a washboard style ramp may vibrate components to the extent of loosened or broken connections, etc. Damage resulting from shock or vibration (e.g., monitor, CDROM, or hard-drive failure) may not be evident until after system installation is complete. All system components must remain upright at all times, and must not be tipped. Nor should the Gantry be hoisted. The Gantry should be moved by rolling on dollies only. Movement through hallways, doorways, elevators, etc., must be done without tipping or lifting the Gantry.
STORAGE
If the CT 120 system is to be stored before installation, store in a warehouse. Protect the system from weather, dirt and dust. Storage temperature should not exceed 0 to +100 F (-18 to +40 C). Maintain relative humidity (non-condensing) between 30 and 60%. Do not store the system for more than 90 days.
4.1.3
CHEMICAL CONTAMINATION
Wet film processors must never be installed in the same room as the scanner due to the possibility of chemically contaminating the components. Such chemicals can contribute to increased equipment failures, increased system downtime, and decreased reliability. Film processor equipment installation must meet the manufacturers requirements (e.g. ventilation specifications) and all applicable national and local codes. Also, consideration should be given to the location of this equipment and chemical fumes relative to human contact as it relates to the location of this equipment and chemicals in the scan room.
4.1.4
Individual Components
CT 120 GANTRY CONSIDERATIONS
To avoid dropping the Gantry, dock-to-dock shipment is recommended. Other methods are acceptable provided that the system is not dropped or otherwise mishandled. For example, the system may be moved via a flat-bed wrecker or by rolling it across smooth sidewalks or other paved surfaces. The Gantrys covers are shipped pre-mounted to the system (although the covers may be removed once unpacked, if needed, to transport the Gantry to its final location). The Gantry is mounted on elevating casters. Once unpacked, the casters are elevated and the Gantry is rolled to the scan room.
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Clear door openings for moving equipment into building must be 42 X 82 in. (1067 X 2083 mm) minimum, if there is an 8 ft. (2438 mm) corridor width. Elevator requirements To move the CT 120 from the receiving location to the scan room, consider elevator capacity and size. By removing covers from the Gantry, the width/length and elevator depth requirements are reduced. Contact a representative of elevator manufacturer if weight exceeds elevator capacity. For alternative lifting arrangements and instructions, contact GE Installation Support Services.
TABLE CONSIDERATIONS
Table covers are shipped mounted to the specimen table and the table is attached to the CT gantry. The table is mounted on caster wheels.
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GE Y N
CUST Y N DATES
Project schedule verified with contractor, facilities department, and GE? Construction completion date matches delivery date? Power & Ground survey complete, date____________________ contact____________________ Delivery date is scheduled for:____________________ First Use date is scheduled for:____________________ Applications training dates: On Site scheduled for:____________________
GE Y N
CUST Y N
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GE Y N
CUST Y N
EQUIPMENT
Must be completed 5 weeks prior to the delivery
Order reviewed for completeness and compatibility with existing equipment? Has the location of any peripherals been determined and planned accordingly with GE representatives?
List peripherals_____________________________________________________________
Have any additional services to be provided by GE been discussed and agreed upon?
GE Y N
CUST Y N
NETWORKING
Must be completed 5 weeks prior to the delivery
Have IP addresses and Host Names been obtained?________ CT 120 service telephone line(s) identified and installed? Network installed? Network jacks installed and tested? Network options ordered______ DICOM print______PCI Analysis Workstation______ Test network connections and Internet connectivity?
GE Y N
CUST Y N
OTHER
Must be completed prior to the delivery
Arrangements made in the schedule to allow for remodeling, if required? (i.e. wall, floor, or ceiling repair work, painting, other cosmetic finishes) Have arrangements been made to clean the floor after any previous equipment removal and prior to install? Delivery route identified and verified with proper personnel? Appropriate arrangements made with traffic for delivery? Will acceptance testing or Biomedical testing be required? Trash bins available for the removal of paper, boxes, etc. during installation? Waste disposal of packaging materials arranged? Contact person identified at customer site?
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